DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
The claim listing filed 24 April 2024 is pending. Claims 1-336 are canceled. Claims 337-358 are pending. Claims 337-358 are being examined on the merits in this office action.
Priority
This application, which discloses and claims only subject matter disclosed in prior Application No. 17/244,839, filed 04 October 2019, appears to claim only subject matter directed to an invention that is independent and distinct from that claimed in the prior application, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application may constitute a divisional application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on 27 December 2024, 12 February 2025, 27 June 2025, and 04 November 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the examiner.
The information disclosure statement filed 26 April 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but foreign patent JP-2015-523999-A, referred to therein has not been considered. All other cited foreign patent document or non-patent literature publication have been considered by the examiner, unless lined through.
The IDSs filed 11 June 2025 and 18 September 2025 are not considered due to references discloses in the IDSs being disclosed in later filed disclosure statements.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 337-358 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment (excluding preventing or reducing the likelihood) of C3 glomerulopathy, does not reasonable provide enablement for preventing or reducing the likelihood of C3 glomerulopathy. The claims contain subject matter (a method for treating C3 glomerulopathy) which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
This is a scope of enablement rejection.
The test for enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d (Fed. Cir. 1988). Whether undue experimentation is required is not based upon a single factor, but rather is a conclusion reached by weighing many factors (see Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
These factors include, but are not limited to:
The breadth of the claims;
The nature of the invention;
The state of the prior art;
The level of one of ordinary skill;
The level of predictability in the art;
The amount of direction provided by the inventor;
The existence of working examples; and
The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The relevant factors are addressed below on the basis of comparison of the disclosure, the claims, and the state of the prior art in the assessment of undue experimentation.
Regarding claims 337-343, the nature of the invention is directed to treatment (including preventing or reducing the likelihood) of C3 glomerulopathy comprising administering a long-acting compstatin analog (LACA). The direction and guidance stated in the specification does not define preventing using any way other than what is known in the art, causing a disease or symptom or manifestation of a disease not to occur for at least a period of time. That is, in order to be fully enabled to practice the full scope of the claimed invention, the skilled artisan would have to accept that a treatment method comprising administering a LACA will prevent C3 glomerulopathy in a subject in need. The claim is broad and inclusive of all individuals due to most patient populations wanting to prevent C3 glomerulopathy. The breadth of the claim exacerbates the nature of the subject matter to which the present claims are directed.
The state of the prior art and the level of predictability is low but predictable. While the state of the art is high in regard to the treatment of C3 glomerulopathy, the state of the art when it comes to preventing C3 glomerulopathy using a LACA is underdeveloped. Particularly, there is no known method for the prevention of C3 glomerulopathy. There is plenty of art on using medicaments to help treat C3 glomerulopathy (i.e. bortezomib or rituximab (with or without plasma exchange)), but there is a lack of significant guidance from the present specification or prior art with regard to the actual prevention of disorder occurrence. Art on preventing the occurrence of C3 glomerulopathy has a very high level of unpredictability. Lioufas et al., hereafter “Lioufas”, (“Durable remission of C3 glomerulonephritis with mycophenolate mofetil.” Nephrology, (2017) 22: 36–39. doi: 10.1111/nep.12939.) teaches that no method has been prevent to have been beneficial regarding the prevention of C3 glomerulopathy, but complement inhibition is among a promising option (pg. 39, “The natural history of C3G is highly variable. Moreover, no treatment has been proven to be beneficial, although complement inhibition is a tantalizing option.”). The prior art does not show evidence of any medical treatment, including a LACA as described in the instant invention, as being able to prevent C3 glomerulopathy.
The amount of direction provided by the inventors and existence of working examples is minimal. It has been established that "the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art." In re Fisher, 427 F.2d 833, 839 166 USPQ 18, 24 (CCPA 1970). Applicant fails to present specific guidance on how prevention of C3 glomerulopathy can be achieved by administering the LACA (CA28-2TS-BF) as described in the instant claims. Furthermore, Applicants do not show that the claimed invention can prevent C3 glomerulopathy. Applicant shows Long-Acting Compstatin Analogs having complement activation inhibiting activity ([0555-0608] “Example 16: Complement Activation Inhibiting Activity of a Long-Acting Compstatin Analog - … CA28-2TS-BF was synthesized using a reactive bifunctional PEG of the TS type in terms of the NHS carboxylate attachment chemistry, which was linked to two molecules of CA28-AEEAc-Lys via the primary amine of the lysine side chain. … Results - Based on the inhibition curves shown in the figures and underlying data, the complement inhibiting activity of CA28-2TS-BF is at least as great as that of CA28 on a molar basis within the experimental error of the assay. These results further confirm the suitability of long-acting compstatin analogs described herein, e.g., for therapeutic purposes.”). Applicant also shows Long-Acting Compstatin Analogs having pharmacokinetic properties ([0609] “Example 17: Pharmacokinetic Properties of Long-Acting Compstatin Analog Administered by the Intravenous or Subcutaneous Route - This Example describes determination of pharmacokinetic parameters of long-acting compstatin analog CA28-2TS-BF…”).
The level of one of ordinary skill needed to use the LACA of the instant invention to prevent the occurrence of C3 glomerulopathy is high. The artisan would need to know exactly what portion of LACA would result in the prevention of C3 glomerulopathy without necessary support from the specification or the assistance of prior art.
Claims 334-350 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment (excluding preventing or reducing the likelihood) of C3 glomerulopathy, does not reasonable provide enablement for preventing or reducing the likelihood of C3 glomerulopathy. The claims contain subject matter (a method for treating C3 glomerulopathy) which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
This is a scope of enablement rejection.
The test for enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the application coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d (Fed. Cir. 1988). Whether undue experimentation is required is not based upon a single factor, but rather is a conclusion reached by weighing many factors (see Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
These factors include, but are not limited to:
The breadth of the claims;
The nature of the invention;
The state of the prior art;
The level of one of ordinary skill;
The level of predictability in the art;
The amount of direction provided by the inventor;
The existence of working examples; and
The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The relevant factors are addressed below on the basis of comparison of the disclosure, the claims, and the state of the prior art in the assessment of undue experimentation.
Regarding claims 344-350, the nature of the invention is directed to treatment (including preventing or reducing the likelihood) of membranoproliferative glomerulonephritis comprising administering a long-acting compstatin analog (LACA). The direction and guidance stated in the specification does not define preventing using any way other than what is known in the art, causing a disease or symptom or manifestation of a disease not to occur for at least a period of time. That is, in order to be fully enabled to practice the full scope of the claimed invention, the skilled artisan would have to accept that a treatment method comprising administering a LACA will membranoproliferative glomerulonephritis in a subject in need. The claim is broad and inclusive of all individuals due to most patient populations wanting to prevent membranoproliferative glomerulonephritis. The breadth of the claim exacerbates the nature of the subject matter to which the present claims are directed.
The state of the prior art and the level of predictability is low but predictable. While the state of the art is high in regard to the treatment of membranoproliferative glomerulonephritis, the state of the art when it comes to preventing membranoproliferative glomerulonephritis using a LACA is underdeveloped. Particularly, there is no known method for the prevention of membranoproliferative glomerulonephritis. There is plenty of art on using medicaments to help treat membranoproliferative glomerulonephritis, but there is a lack of significant guidance from the present specification or prior art with regard to the actual prevention of disorder occurrence. Art on preventing the occurrence of membranoproliferative glomerulonephritis has a very high level of unpredictability. Levin ("Management of membranoproliferative glomerulonephritis: Evidence-based recommendations", Kidney International, https://doi.org/10.1046/j.1523-1755.1999.07006.x) teaches that membranoproliferative glomerulonephritis (MPGN) can be treated using a trail of aspirin, dipyridamole, or a combination of the two for 12 months (pg. S-41, “In adults with MPGN, impaired renal function, and/or nephrotic-range proteinuria, a trial of aspirin (325 mg daily), dipyridamole (75 to 100 mg tid), or a combination of the two for 12 months is reasonable (grade B)”). The lack of significant guidance from the present specification or prior art with regard to the actual prevention of membranoproliferative glomerulonephritis. The prior art does not show evidence of any medical treatment, including a LACA as described in the instant invention, as being able to prevent membranoproliferative glomerulonephritis.
The amount of direction provided by the inventors and existence of working examples is minimal. It has been established that "the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art." In re Fisher, 427 F.2d 833, 839 166 USPQ 18, 24 (CCPA 1970). Applicant fails to present specific guidance on how prevention of membranoproliferative glomerulonephritis can be achieved by administering the LACA (CA28-2TS-BF) as described in the instant claims. Furthermore, Applicants do not show that the claimed invention can prevent membranoproliferative glomerulonephritis. Applicant shows Long-Acting Compstatin Analogs having complement activation inhibiting activity ([0555-0608] “Example 16: Complement Activation Inhibiting Activity of a Long-Acting Compstatin Analog - … CA28-2TS-BF was synthesized using a reactive bifunctional PEG of the TS type in terms of the NHS carboxylate attachment chemistry, which was linked to two molecules of CA28-AEEAc-Lys via the primary amine of the lysine side chain. … Results - Based on the inhibition curves shown in the figures and underlying data, the complement inhibiting activity of CA28-2TS-BF is at least as great as that of CA28 on a molar basis within the experimental error of the assay. These results further confirm the suitability of long-acting compstatin analogs described herein, e.g., for therapeutic purposes.”). Applicant also shows Long-Acting Compstatin Analogs having pharmacokinetic properties ([0609] “Example 17: Pharmacokinetic Properties of Long-Acting Compstatin Analog Administered by the Intravenous or Subcutaneous Route - This Example describes determination of pharmacokinetic parameters of long-acting compstatin analog CA28-2TS-BF…”).
The level of one of ordinary skill needed to use the LACA of the instant invention to prevent the occurrence of membranoproliferative glomerulonephritis is high. The artisan would need to know exactly what portion of LACA would result in the prevention of membranoproliferative glomerulonephritis without necessary support from the specification or the assistance of prior art.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 351-358 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 351 recites “A method of treating a subject who has received an organ transplant...”. The claim is indefinite because it is unclear what “the method” is meant to treat. The specification shows that in some embodiments, the invention is used to inhibit transplant rejection; however, the claim does not recite that the LACA is used to treat transplant rejection and it is improper to read limitations from the specification into the claims. The metes and bounds of the claim are unclear. Appropriate correction is required.
For the sake of compact prosecution, the Examiner is interpreting claim 351 to mean “A method of treating organ rejection occurrence in a subject who has received an organ transplant comprising...”.
Claims 352-358 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, due to their dependency on claim 351, a rejected claim, without correcting the indefiniteness of claim 351.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 337-341 and 343 are rejected under 35 U.S.C. 103 as being unpatentable over Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, in view of Vernon et al., hereafter “Vernon”, (“Partial Complement Factor H Deficiency Associates with C3 Glomerulopathy and Thrombotic Microangiopathy.” Journal of the American Society of Nephrology 27(5):p 1334-1342, May 2016. DOI: 10.1681/ASN.2015030295).
Francois teaches cell-reactive compstatin analogs and compositions comprising cell-reactive compstatin analogs. In some aspect, the cell-reactive compstatin analogs treat complement mediated disorders, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ (for example, C3 glomerulopathy). (See the compstatin analog of Figure 10C of Francois, which according to its caption assumes a PEG moiety of 40 kD and corresponds to CA28-2TS-BF (LACA-40 in the instant specification and also Figure 10C) reading upon the structural composition limitations of claims 337 and 343)):
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Additional compstatin analogs are taught, e.g., pg. 178, Table 5.
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Regarding claim 337, Francois teaches a Long-acting compstatin analog (LACA) comprising a clearance-reducing moiety attached to two compstatin analog moieties comprising a polymer, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc) ([0061] “In some aspects, the invention provides long-acting compstatin analogs, wherein the long-acting compstatin analogs comprise a moiety such as polyethylene glycol (PEG) …”; [00235] “In some embodiments, the present invention provides click-functionalized compstatin analogs for, e.g., conjugation to a complementary moiety on a partner molecule or biomolecule. In some embodiments, a complementary partner molecule or biomolecule is a polymer, peptide, protein, or a molecule that functions as a clearance-reducing moiety.”; [00472] “Bifunctional, linear monomethoxy-NHS-activated ester/carbonate PEGs with molecular weights of 40 kD and differing in terms of the NHS carboxylate attachment chemistry were obtained from NOF America Corp. (White Plains, NY). The activated PEGs were coupled to the lysine side chain of CA28-AEEAc-Lys via an amide bond such that two CA28-AEEAc-Lys moieties were coupled to each PEG chain. All compounds were acetylated on the N-terminus and amidated on the C-terminus of the CA28-AEEAc-Lys moieties, and cyclized via a disulfide bond between Cys2 and Cysl2.”). See screenshot of Figure 10C and Table 5, above. Francois teaches that the long-acting compstatin can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments. ...”), while teaching an example in which the test subjects were administered, subcutaneously, 7mg/kg on appropriate days ([00503] “Animals were dosed at 7 mg/kg via intravenous or subcutaneous administration at time 0 on the appropriate day(s).”).
The only difference between Francois and the instant application is Francois does not explicitly teach administering 1080 mg of CA28-2TS-BF to treat C3 glomerulopathy.
At the time of before the effective filing date of the claimed invention, an artisan of ordinary skill would have been motivated to select CA28-2TS-BF from the list of compstatin analogs taught by Francois because CA28-2TS-BF is long acting and stable. There would be a reasonable expectation of success because CA28-2TS-BF performs as similar to/better than CA28 (native).
It would be obvious to artisan to arrive at 1080 mg because it is routine optimization.
Regarding the limitation of being a method of treating a subject in need of treatment of C3 glomerulopathy, Francois teaches that the instant invention treat complement-mediated disorder, one of which being atypical hemolytic uremic syndrome (aHUS) ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder. … In some embodiments, the complement-mediated disorder is paroxysmal nocturnal hemoglobinuria (PNH), atypical [hemolytic] uremic syndrome (aHUS) …”). Francois also teaches that CA28-2TS-BF is capable of alternative pathway (AP) inhibition ([00495] “The complement activation inhibitory activity of CA28 and CA28-2TS-BF was assessed by measuring the effect of the compounds on complement activation … via the alternative pathways using standard complement inhibition assays.”; [00498] “Based on the inhibition curves shown in the figures and underlying data, the complement inhibiting activity of CA28-2TS-BF is at least as great as that of CA28 on a molar basis within the experimental error of the assay. These results further confirm the suitability of long-acting compstatin analogs described herein, e.g., for therapeutic purposes.”).
Francois does not teach the complement mediated disorder is C3 glomerulopathy.
Vernon teaches that C3 glomerulopathy, a complement-mediated disease, and aHUS being associated with complement alternative pathway abnormalities (pg. 1334, “The complement–mediated renal diseases C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome (aHUS) strongly associate with inherited and acquired abnormalities in the regulation of the complement alternative pathway (AP). ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin of Francois to treat C3 glomerulopathy due to Francois teaching that the LACA described can be used to treat complement mediated disorders, like aHUS, specifically by complement activation inhibition, by inhibiting AP abnormalities and Vernon teaching that C3 glomerulopathy and aHUS are both complement-mediated diseases that occur when there is an abnormality in the complement alternative pathway.
Therefore, the invention as a whole is prima facie obvious over the references.
Regarding claim 338, Francois teaches the LACA being administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, ...”).
Regarding claim 339, Francois teaches the LACA being administered twice weekly (every 3-4 days) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, …”).
Regarding claim 340, Francois teaches the LACA being administered thrice weekly (every other day; M-W-F) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, …”).
Regarding claim 341, Francois teaches the LACA being administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, ...”).
Regarding claim 343, Francois teaches the structure in Figure 10c (See above) and the pacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc) in Table 5 (See above).
Claim 342 is rejected under 35 U.S.C. 103 as being unpatentable over Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, in view of Vernon et al., hereafter “Vernon”, (“Partial Complement Factor H Deficiency Associates with C3 Glomerulopathy and Thrombotic Microangiopathy.” Journal of the American Society of Nephrology 27(5):p 1334-1342, May 2016. DOI: 10.1681/ASN.2015030295), as applied to claim 337 above, and further in view of Andrien et al., hereafter “Andrien” (US 9,107,861), as cited in the IDS filed 26 April 2024.
Regarding claim 342, Francois teaches a Long-acting compstatin analog and a method of treating a complement-mediated disease using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder. … In some embodiments the method comprises administering a long-acting compstatin analog to the subject.”; [00259] “In some embodiments a surface forms part of a medical device, tubing, membrane, reservoir, implant, or other material that may come in contact with blood (e.g., extracorporeally) or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois does not teach that the complement mediated disorder is C3 glomerulopathy.
Vernon teaches that C3 glomerulopathy, a complement-mediated disease, and aHUS being associated with complement alternative pathway abnormalities (pg. 1334, “The complement–mediated renal diseases C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome (aHUS) strongly associate with inherited and acquired abnormalities in the regulation of the complement alternative pathway (AP). ”).
Francois and Vernon do not teach the method of claim 337, wherein the LACA is administered using an on-body delivery device, as required by claim 342.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2,“ In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that’s the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound subcutaneously as taught by Francois in order to administer the long-acting compstatin analogs to treat a patient suffering from a complement-mediated disease or disorder, specifically C3 glomerulopathy, and taught by Vernon. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of complement associated conditions or diseases. Therefore, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Claims 344-348, 350-355, and 357-358 are rejected under 35 U.S.C. 103 as being anticipated by Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024.
Francois teaches cell-reactive compstatin analogs and compositions comprising cell-reactive compstatin analogs. In some aspect, the cell-reactive compstatin analogs treat complement mediated disorders, e.g., to inhibit complement-mediated damage to a cell, tissue, or organ. (See the compstatin analog of Figure 10C of Francois, which according to its caption assumes a PEG moiety of 40 kD and corresponds to CA28-2TS-BF (LACA-40 in the instant specification and also Figure 10C) reading upon the structural composition limitations of claims 344, 350-351 and 358)):
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Regarding claim 344, Francois teaches a Long-acting compstatin analog (LACA) comprising a clearance-reducing moiety attached to two compstatin analog moieties comprising a polymer, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc) ([0061] “In some aspects, the invention provides long-acting compstatin analogs, wherein the long-acting compstatin analogs comprise a moiety such as polyethylene glycol (PEG) …”).”; [00235] “In some embodiments, the present invention provides click-functionalized compstatin analogs for, e.g., conjugation to a complementary moiety on a partner molecule or biomolecule. In some embodiments, a complementary partner molecule or biomolecule is a polymer, peptide, protein, or a molecule that functions as a clearance-reducing moiety.”; [00472] “Bifunctional, linear monomethoxy-NHS-activated ester/carbonate PEGs with molecular weights of 40 kD and differing in terms of the NHS carboxylate attachment chemistry were obtained from NOF America Corp. (White Plains, NY). The activated PEGs were coupled to the lysine side chain of CA28-AEEAc-Lys via an amide bond such that two CA28-AEEAc-Lys moieties were coupled to each PEG chain. All compounds were acetylated on the N-terminus and amidated on the C-terminus of the CA28-AEEAc-Lys moieties, and cyclized via a disulfide bond between Cys2 and Cysl2.”). See screenshot of Figure 10C and Table 5, above. Francois teaches that the long-acting compstatin can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., …”), while teaching an example in which the test subjects were administered, subcutaneously, 7mg/kg on appropriate days ([00503] “Animals were dosed at 7 mg/kg via subcutaneous administration at time 0 on the appropriate day(s).”).
Regarding the limitation of “treating a subject in need of treatment of membranoproliferative glomerulonephritis”, Francois teaches the LACA being used to treat membranoproliferative glomerulonephritis ([00384] “In some embodiments a cell-reactive, long-acting, or targeted compstatin analog is used to treat a subject suffering from or at risk of membranoproliferative [glomerulonephritis] (MPGN)”).
The only difference between Francois and the instant application is Francois does not explicitly teach administering 1080 mg of CA28-2TS-BF to treat MPGN.
At the time of before the effective filing date of the claimed invention, an artisan of ordinary skill would have been motivated to select CA28-2TS-BF from the list of compstatin analogs taught by Francois because CA28-2TS-BF is long acting and stable. There would be a reasonable expectation of success because CA28-2TS-BF performs as similar to/better than CA28 (native).
It would be obvious to artisan to arrive at 1080 mg because it is routine optimization.
Regarding claim 345, Francois teaches the LACA being administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, ...”).
Regarding claim 346, Francois teaches the LACA being administered twice weekly (every 3-4 days) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, …”).
Regarding claim 347, Francois teaches the LACA being administered thrice weekly (every other day; M-W-F) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, …”).
Regarding claim 348, Francois teaches the LACA being administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, ...”).
Regarding claim 350, Francois teaches the structure in Figure 10c (See above) and the spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc) in Table 5 (See above).
Regarding claim 351, Francois teaches a Long-acting compstatin analog (LACA) comprising a clearance-reducing moiety attached to two compstatin analog moieties comprising a polymer, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc) ([0061] “In some aspects, the invention provides long-acting compstatin analogs, wherein the long-acting compstatin analogs comprise a moiety such as polyethylene glycol (PEG) …”).”; [00235] “In some embodiments, a complementary partner molecule or biomolecule is a polymer, peptide, protein, or a molecule that functions as a clearance-reducing moiety.”; [00472] “Bifunctional, linear monomethoxy-NHS-activated ester/carbonate PEGs with molecular weights of 40 kD and differing in terms of the NHS carboxylate attachment chemistry were obtained from NOF America Corp. (White Plains, NY). The activated PEGs were coupled to the lysine side chain of CA28-AEEAc-Lys via an amide bond such that two CA28-AEEAc-Lys moieties were coupled to each PEG chain. All compounds were acetylated on the N-terminus and amidated on the C-terminus of the CA28-AEEAc-Lys moieties, and cyclized via a disulfide bond between Cys2 and Cysl2.”). See screenshot of Figure 10C and Table 5, above. Francois teaches that the long-acting compstatin can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”), while teaching an example in which the test subjects were administered, subcutaneously, 7mg/kg on appropriate days ([00503] “Animals were dosed at 7 mg/kg via intravenous or subcutaneous administration at time 0 on the appropriate day(s).”).
Regarding the limitation “treating a subject who has received an organ transplant”, Francois teaches the LACA being administered to an organ transplant recipient to inhibit organ rejection and/or failure ([00358] “For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370]“In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”).
The only difference between Francois and the instant application is Francois does not explicitly teach administering 1080 mg of CA28-2TS-BF to treat a subject who has received an organ transplant.
At the time of before the effective filing date of the claimed invention, an artisan of ordinary skill would have been motivated to select CA28-2TS-BF from the list of compstatin analogs taught by Francois because CA28-2TS-BF is long acting and stable. There would be a reasonable expectation of success because CA28-2TS-BF performs as similar to/better than CA28 (native).
It would be obvious to artisan to arrive at 1080 mg because it is routine optimization.
Regarding claim 352, Francois teaches the LACA being administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, ...”).
Regarding claim 353, Francois teaches the LACA being administered twice weekly (every 3-4 days) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, …”).
Regarding claim 354, Francois teaches the LACA being administered thrice weekly (every other day; M-W-F) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, …”).
Regarding claim 355, Francois teaches the LACA being administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, ...”).
Regarding claim 357, Francois teaches the LACA being administered to a subject that received a transplant and that in some embodiments, the transplant can be a kidney transplant ([00358] “Kidneys, liver, lungs, pancreas, and heart are among the organs that can be successfully transplanted. … For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370] “In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”).
Regarding claim 358, Francois teaches the structure in Figure 10c (See above) and the spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc) in Table 5 (See above).
Claims 349 and 356 are rejected under 35 U.S.C. 103 as being unpatentable over Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, as applied to claims 344 and 351 above, and further in view of Andrien et al., hereafter “Andrien” (US 9,107,861), as cited in the IDS filed 26 April 2024.
Regarding claim 349, Francois teaches a Long-acting compstatin analog and a method of treating membranoproliferative glomerulonephritis using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([00384] “In some embodiments a cell-reactive, long-acting, or targeted compstatin analog is used to treat a subject suffering from or at risk of membranoproliferative [glomerulonephritis] (MPGN)”; [00259] “In some embodiments a surface forms part of a medical device, tubing, membrane, reservoir, implant, or other material that may come in contact with blood (e.g., extracorporeally) or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois does not teach the method of 344, wherein the LACA is administered using an on-body delivery device, as required by claim 349.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2, “In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that’s the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound subcutaneously as taught by Francois in order to administer the long-acting compstatin analogs to treat a patient suffering from a complement-mediated disease or disorder. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of complement associated conditions or diseases. Therefore, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Regarding claim 356, Francois teaches a Long-acting compstatin analog and a method of treating a subject that received an organ transplant using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([00358] “For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370]“In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”; [00259] “In some embodiments a surface forms part of a medical device, tubing, membrane, reservoir, implant, or other material that may come in contact with blood (e.g., extracorporeally) or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois does not teach the method of 351, wherein the LACA is administered using an on-body delivery device, as required by claim 356.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2,“In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound subcutaneously as taught by Francois in order to administer the long-acting compstatin analogs to treat a patient suffering from a complement-mediated disease or disorder.
One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of complement associated conditions or diseases. Therefore, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 337-341 and 343 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, and 12 of U.S. Patent No. 10,035,822, in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, in view of Vernon et al., hereafter “Vernon”, (“Partial Complement Factor H Deficiency Associates with C3 Glomerulopathy and Thrombotic Microangiopathy.” Journal of the American Society of Nephrology 27(5):p 1334-1342, May 2016. DOI: 10.1681/ASN.2015030295). Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘822 and/or in view of Francois and Vernon as described below.
Regarding claim 337, US ‘822 claims a long-acting compstatin analog comprising a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising an 8-amino-3,6-dioxaoctanoic acid (AEEAc), where the clearance reducing moiety comprises polymer, wherein each end of the linear polymer is linked to one of the compstatin analog moieties by way of a carbamate, wherein the linear polymer is PEG having an average molecular weight of about 40 kD. (See claims 1, 2, 8 and 12).
The difference between the claims of ‘822 and the instant claim 337 is that the instant invention claims the use of the composition (A method of treating a subject in need of treatment of C3 glomerulopathy) the administration schedule, and a specific dosage.
Francois teaches a Long-acting compstatin analog can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly…”).
At the time of before the effective filing date of the claimed invention, an artisan of ordinary skill would have been motivated to select CA28-2TS-BF from the list of compstatin analogs taught by Francois because CA28-2TS-BF is long acting and stable. There would be a reasonable expectation of success because CA28-2TS-BF performs as similar to/better than CA28 (native).
It would be obvious to artisan to arrive at 1080 mg because it is routine optimization.
Francois also teaches that the instant invention treat complement-mediated disorders ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder.”).
Regarding the limitation of being a method of treating a subject in need of treatment of C3 glomerulopathy, Francois teaches that the instant invention treat complement-mediated disorder, one of which being atypical hemolytic uremic syndrome (aHUS) ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder. … In some embodiments, the complement-mediated disorder is paroxysmal nocturnal hemoglobinuria (PNH), atypical [hemolytic] uremic syndrome (aHUS) …”). Francois also teaches that CA28-2TS-BF is capable of alternative pathway (AP) inhibition ([00495] “The complement activation inhibitory activity of CA28 and CA28-2TS-BF was assessed by measuring the effect of the compounds on complement activation … via the alternative pathways using standard complement inhibition assays.”; [00498] “Based on the inhibition curves shown in the figures and underlying data, the complement inhibiting activity of CA28-2TS-BF is at least as great as that of CA28 on a molar basis within the experimental error of the assay. These results further confirm the suitability of long-acting compstatin analogs described herein, e.g., for therapeutic purposes.”).
Francois does not teach that the complement mediated disorder is C3 glomerulopathy.
Vernon teaches that C3 glomerulopathy, a complement-mediated disease, and aHUS being associated with complement alternative pathway abnormalities (pg. 1334, “The complement–mediated renal diseases C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome (aHUS) strongly associate with inherited and acquired abnormalities in the regulation of the complement alternative pathway (AP). ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin of Francois to treat C3 glomerulopathy due to Francois teaching that the LACA described can be used to treat complement mediated disorders, like aHUS, specifically by complement activation inhibition, by inhibiting AP abnormalities and Vernon teaching that C3 glomerulopathy and aHUS are both complement-mediated diseases that occur when there is an abnormality in the complement alternative pathway.
The claimed invention is drawn to the use of a patented compound. In specific situations, it is permissible for the examiner to review the Specification of a copending application to determine the scope of use of the product. (“To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”). The specification of ‘822 states that the compound could be used to treat aHUS (col. 2, lines. 33-34, “The invention provides methods of treating a subject in need of treatment for a complement - mediated disorder.” ; col. 96, lines 39-41, “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered to a subject suffering from atypical hemolytic syndrome (aHUS).”). One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘822 with the dosage and treatment schedule of Francois due to both ‘822 and Francois teaching a LACA being used to treat complement-mediated disorders, specifically aHUS.
Regarding claim 338, ‘822 claims the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, ….”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered weekly due to both ‘822 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 339, ‘822 claims the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient twice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered twice weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days...”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered weekly due to both ‘822 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 340, ‘822 claims the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient thrice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered thrice weekly (every other day, M-W-F schedule) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, ….”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered weekly due to both ‘822 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 341, ‘822 claims the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient every three days.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, ….”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered weekly due to both ‘822 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 343, ‘822 claims a LACA. ‘822 does not claim the LACA having the structure described ion the instant claim 358.
Francois teaches the structure in Figure 10c (See below) and the spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc) in Table 5 (See below).
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One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a structure as disclosed by Francois due to Francois teaching a Long-acting compstatin analog (see [0061], [00235], and [00472]) having the same clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising an 8-amino-3,6-dioxaoctanoic acid (AEEAc), where the clearance reducing moiety comprises polymer, wherein each end of the linear polymer is linked to one of the compstatin analog moieties by way of a carbamate, wherein the linear polymer is PEG having an average molecular weight of about 40 kD. (See claims 1, 2, 8 and 12)
Claim 342 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, and 12 of U.S. Patent No. 10,035,822, in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, in view of Vernon et al., hereafter “Vernon”, (“Partial Complement Factor H Deficiency Associates with C3 Glomerulopathy and Thrombotic Microangiopathy.” Journal of the American Society of Nephrology 27(5):p 1334-1342, May 2016. DOI: 10.1681/ASN.2015030295), as applied to claim 337 above and further in view of Andrien et al., hereafter “Andrien” (US 9,107,861), as cited in the IDS filed 26 April 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘822 and/or in view of Francois, Vernon, and Andrien as described below.
Regarding claim 342, ‘822 claims the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claims 1, 2, 8 and 12) ‘822 does not teach that the LACA is administered using an on-body delivery device.
Francois teaches a Long-acting compstatin analog and a method of treating a complement-mediated disease using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder. … In some embodiments the method comprises administering a long-acting compstatin analog to the subject.”; [00259] “In some embodiments a surface forms part of a medical device… or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois does not teach that the complement mediated disorder is C3 glomerulopathy.
Vernon teaches that C3 glomerulopathy, a complement-mediated disease, and aHUS being associated with complement alternative pathway abnormalities (pg. 1334, “The complement–mediated renal diseases C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome (aHUS) strongly associate with inherited and acquired abnormalities in the regulation of the complement alternative pathway (AP). ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin of Francois to treat C3 glomerulopathy due to Francois teaching that the LACA described can be used to treat complement mediated disorders, like aHUS, specifically by complement activation inhibition, by inhibiting AP abnormalities and Vernon teaching that C3 glomerulopathy and aHUS are both complement-mediated diseases that occur when there is an abnormality in the complement alternative pathway.
Francois and Vernon do not teach the method of claim 337, wherein the LACA is administered using an on-body delivery device, as required by claim 342.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2,“ In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the LACA of ‘822 with the method of treatment as disclosed by Francois and use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound, as taught by ‘822 and Francois, subcutaneously in order due to both ‘822 and Francois teaching that the LACA is able to treat a subject suffering from a complement-mediated disease or disorder, specifically C3 glomerulopathy, and taught by Vernon. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of complement associated conditions or diseases. Therefore, the invention as a whole is prima facie obvious over the ‘822 reference, when combined with the knowledge of the prior art.
Claims 344-348, 350-355, and 358 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8 and 12 of U.S. Patent No. 10,035,822, in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘822 and/or in view of Francois and Vernon as described below.
Regarding claim 344, US ‘822 teaches a long-acting compstatin analog comprising a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising an 8-amino-3,6-dioxaoctanoic acid (AEEAc), where the clearance reducing moiety comprises polymer, wherein each end of the linear polymer is linked to one of the compstatin analog moieties by way of a carbamate, wherein the linear polymer is PEG having an average molecular weight of about 40 kD. (See claims 1, 2, 8 and 12)
The difference between the claims of ‘822 and the instant claim 344 is that the instant invention claims the use of the composition (A method of treating a subject in need of treatment of membranoproliferative glomerulonephritis) the administration schedule, and a specific dosage.
Francois teaches a Long-acting compstatin analog can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments. In some embodiments, covalently attached, long-acting, or targeted compstatin analogs protect cells, tissues, organs, for a period of weeks or months without need for retreatment…”), while teaching an example in which the test subjects were administered, subcutaneously, 7mg/kg on appropriate days ([00503] “Animals were dosed at 7 mg/kg via intravenous or subcutaneous administration at time 0 on the appropriate day(s).”). Regarding the limitation of “treating a subject in need of treatment of membranoproliferative glomerulonephritis”, Francois teaches the LACA being used to treat membranoproliferative glomerulonephritis ([00384] “In some embodiments a cell-reactive, long-acting, or targeted compstatin analog is used to treat a subject suffering from or at risk of membranoproliferative [glomerulonephritis] (MPGN)”).
The only difference between Francois and the instant application is Francois does not explicitly teach administering 1080 mg of CA28-2TS-BF to treat MPGN.
At the time of before the effective filing date of the claimed invention, an artisan of ordinary skill would have been motivated to select CA28-2TS-BF from the list of compstatin analogs taught by Francois because CA28-2TS-BF is long acting and stable. There would be a reasonable expectation of success because CA28-2TS-BF performs as similar to/better than CA28 (native).
It would be obvious to artisan to arrive at 1080 mg because it is routine optimization.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin as described in claims 1, 2, 8, and 12 of ‘822 because the claims teach a LACA identical to the LACA of Francois, which was show to be used to treat membranoproliferative glomerulonephritis and be administered to a subject in the amount of 1080mg due to routine optimization. The claimed invention is drawn to the use of a patented compound. In specific situations, it is permissible for the examiner to review the Specification of a copending application to determine the scope of use of the product. (“To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”). The specification of ‘822 states that the compound could be used to treat membranoproliferative glomerulonephritis (col. 102, lines. 49-52, “In some embodiments a cell-reactive, long-acting, or targeted compstatin analog is used to treat a subject suffering from or at risk of membranoproliferative [glomerulonephritis] (MPGN), e.g., MPGN type I, MPGN type II, or MPGH type III.”). One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘822 with the dosage and treatment schedule of Francois due to both ‘822 and Francois teaching a LACA being used to treat membranoproliferative glomerulonephritis.
Regarding claim 345, ‘822 claims a LACA, which the instant invention is using in the treatment of membranoproliferative glomerulonephritis as described. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered weekly due to both ‘822 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 346, ‘822 claims a LACA, which the instant invention is using in the treatment of membranoproliferative glomerulonephritis as described. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient twice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered twice weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered twice weekly due to both ‘822 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 347, ‘822 claims a LACA, which the instant invention is using in the treatment of membranoproliferative glomerulonephritis as described. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient thrice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered thrice weekly (every other day, M-W-F schedule) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered thrice weekly due to both ‘822 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 348, ‘822 claims a LACA, which the instant invention is using in the treatment of membranoproliferative glomerulonephritis as described. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient every three days.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered every three days due to both ‘822 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 358, ‘822 claims a LACA. ‘822 does not claim the LACA having the structure described ion the instant claim 358.
Francois teaches the structure in Figure 10c (See below) and the spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc) in Table 5 (See below).
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One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a structure as disclosed by Francois due to Francois teaching a Long-acting compstatin analog (see [0061], [00235], and [00472]) having the same clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising an 8-amino-3,6-dioxaoctanoic acid (AEEAc), where the clearance reducing moiety comprises polymer, wherein each end of the linear polymer is linked to one of the compstatin analog moieties by way of a carbamate, wherein the linear polymer is PEG having an average molecular weight of about 40 kD. (See claims 1, 2, 8 and 12)
Regarding claim 351, US ‘822 teaches a long-acting compstatin analog comprising a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising an 8-amino-3,6-dioxaoctanoic acid (AEEAc), where the clearance reducing moiety comprises polymer, wherein each end of the linear polymer is linked to one of the compstatin analog moieties by way of a carbamate, wherein the linear polymer is PEG having an average molecular weight of about 40 kD. (See claims 1, 2, 8 and 12)
The difference between the claims of ‘822 and the instant claim 344 is that the instant invention claims the use of the composition (A method of treating a subject who has received an organ transplant) the administration schedule, and a specific dosage.
Francois teaches a Long-acting compstatin analog can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments. In some embodiments, covalently attached, long-acting, or targeted compstatin analogs protect cells, tissues, organs, for a period of weeks or months without need for retreatment…”), while teaching an example in which the test subjects were administered, subcutaneously, 7mg/kg on appropriate days ([00503] “Animals were dosed at 7 mg/kg via intravenous or subcutaneous administration at time 0 on the appropriate day(s).”). Regarding the limitation “treating a subject who has received an organ transplant”, Francois teaches the LACA being administered to an organ transplant recipient to inhibit organ rejection and/or failure ([00358] “For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370]“In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”).
The only difference between Francois, ‘822 and the instant application is Francois does not explicitly teach administering 1080 mg of CA28-2TS-BF to treat a subject that received an organ transplant.
At the time of before the effective filing date of the claimed invention, an artisan of ordinary skill would have been motivated to select CA28-2TS-BF from the list of compstatin analogs taught by Francois because CA28-2TS-BF is long acting and stable. There would be a reasonable expectation of success because CA28-2TS-BF performs as similar to/better than CA28 (native).
It would be obvious to artisan to arrive at 1080 mg because it is routine optimization.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin as described in claims 1, 2, 8, and 12 of ‘822 because the claims teach a LACA identical to the LACA of Francois, which was show to be used to treat a subject who has received an organ transplant and be administered to a subject in the amount of 1080mg due to routine optimization. The claimed invention is drawn to the use of a patented compound. In specific situations, it is permissible for the examiner to review the Specification of a copending application to determine the scope of use of the product. (“To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”). The specification of ‘822 states that the compound could be used to treat a subject who has received an organ transplant (col. 101, lines. 21-23, “In some embodiments , a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”). One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘822 with the dosage and treatment schedule of Francois due to both ‘822 and Francois teaching a LACA being used to treat a subject who has received an organ transplant.
Regarding claim 352, ‘822 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered weekly due to both ‘822 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 353, ‘822 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient twice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered twice weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered twice weekly due to both ‘822 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 354, ‘822 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient thrice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered thrice weekly (every other day, M-W-F schedule) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered thrice weekly due to both ‘822 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 355, ‘822 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a patient every three days.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered every three days due to both ‘822 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 357, ‘822 claims a LACA, which the instant invention is using in the treatment of a subject who has received a kidney transplant as described. (See claims 1, 2, 8 and 12) ‘822 does not teach administering the LACA to a subject that received a kidney transplant.
Francois teaches the LACA being administered to a subject that received a transplant and that in some embodiments, the transplant can be a kidney transplant ([00358] “Kidneys, liver, lungs, pancreas, and heart are among the organs that can be successfully transplanted. … For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370] “In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a treatment method administered to a subject that has received a kidney transplant due to both ‘822 and Francois teaching the same compound and both ‘822 and Francois teaching the LACA being used to treat subjects that received transplants.
Regarding claim 358, ‘822 claims a LACA. ‘822 does not claim the LACA having the structure described ion the instant claim 358.
Francois teaches the structure in Figure 10c (See below) and the spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc) in Table 5 (See below).
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One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated with a reasonable expectation of success to use the LACA of ‘822 in a structure as disclosed by Francois due to Francois teaching a Long-acting compstatin analog (see [0061], [00235], and [00472]) having the same clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising an 8-amino-3,6-dioxaoctanoic acid (AEEAc), where the clearance reducing moiety comprises polymer, wherein each end of the linear polymer is linked to one of the compstatin analog moieties by way of a carbamate, wherein the linear polymer is PEG having an average molecular weight of about 40 kD.
Claims 349 and 356 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, and 12 of U.S. Patent No. 10,035,822, in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, as applied to claims 344 and 351 above, and in further view of Andrien et al., hereafter “Andrien” (US 9,107,861), as cited in the IDS filed 26 April 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘822 and/or in view of Francois, Vernon, and Andrien as described below.
Regarding claim 349, ‘822 claims the LACA used in the treatment of membranoproliferative glomerulonephritis as described in the instant invention. (See claims 1, 2, 8 and 12) ‘822 does not teach that the LACA is administered using an on-body delivery device.
Francois teaches a Long-acting compstatin analog and a method of treating membranoproliferative glomerulonephritis using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([00384] “In some embodiments a cell-reactive, long-acting, or targeted compstatin analog is used to treat a subject suffering from or at risk of membranoproliferative [glomerulonephritis] (MPGN)”; [00259] “In some embodiments a surface forms part of a medical device, tubing, membrane, reservoir, implant, or other material that may come in contact with blood (e.g., extracorporeally) or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois does not teach the method of claim 344, wherein the LACA is administered using an on-body delivery device, as required by claim 349.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2,“ In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the LACA of ‘822 with the method of treatment as disclosed by Francois and use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound, as taught by ‘822 and Francois, subcutaneously in order due to both ‘822 and Francois teaching that the LACA is able to treat a subject suffering from membranoproliferative glomerulonephritis. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of membranoproliferative glomerulonephritis. Therefore, the invention as a whole is prima facie obvious over the ‘822 reference, when combined with the knowledge of the prior art.
Regarding claim 356, ‘822 claims the LACA used in the treatment of a subject that received an organ transplant as described in the instant invention. (See claims 1, 2, 8 and 12) ‘822 does not teach that the LACA is administered using an on-body delivery device.
Francois teaches a Long-acting compstatin analog and a method of treating a subject that received an organ transplant using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([00358] “For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370]“In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”; [00259] “In some embodiments a surface forms part of a medical device, tubing, membrane, reservoir, implant, or other material that may come in contact with blood (e.g., extracorporeally) or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois and ‘822 do not teach the method of 351, wherein the LACA is administered using an on-body delivery device, as required by claim 356.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2,“In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the LACA of ‘822 with the method of treatment as disclosed by Francois and use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound, as taught by ‘822 and Francois, subcutaneously in order due to both ‘822 and Francois teaching that the LACA is able to treat a subject that received an organ transplant. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of a subject that received an organ transplant. Therefore, the invention as a whole is prima facie obvious over the ‘822 reference, when combined with the knowledge of the prior art.
Claims 337-341 and 343 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, and 7-8, of U.S. Patent No. 10,875,893 (hereafter ‘893), in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, in view of Vernon et al., hereafter “Vernon”, (“Partial Complement Factor H Deficiency Associates with C3 Glomerulopathy and Thrombotic Microangiopathy.” Journal of the American Society of Nephrology 27(5):p 1334-1342, May 2016. DOI: 10.1681/ASN.2015030295). Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘893 and/or in view of Francois and Vernon as described below.
Regarding claim 337, US ‘893 teaches a method of treating a complement-mediated disorder in a subject, the method comprising subcutaneously administering to the subject a long-acting compstatin analog comprising a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide having an amino acid sequence as set form in SEQ ID NO: 28, extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by an 8-amino-3,6-dioxaoctanoic acid (AEEAc) spacer; and the clearance reducing moiety comprises a PEG polymer having an average molecular weight of about 40 kDa, wherein each end of the polymer is linked to one of the compstatin analog moieties by way of a linker moiety that is or comprises a carbamate and an method of treating a complement-mediated disorder in a subject comprising the method of administering a long-acting compstatin analog. (See claims 1, 3-5 and 8)
The difference between the claims of ‘893 and the instant claim 337 is that the instant invention claims the use of the composition (A method of treating a subject in need of treatment of C3 glomerulopathy) the administration schedule, and a specific dosage.
Francois teaches a Long-acting compstatin analog can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly…”).
At the time of before the effective filing date of the claimed invention, an artisan of ordinary skill would have been motivated to select CA28-2TS-BF from the list of compstatin analogs taught by Francois because CA28-2TS-BF is long acting and stable. There would be a reasonable expectation of success because CA28-2TS-BF performs as similar to/better than CA28 (native).
It would be obvious to artisan to arrive at 1080 mg because it is routine optimization.
Francois also teaches that the instant invention treat complement-mediated disorders ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder.”).
Regarding the limitation of being a method of treating a subject in need of treatment of C3 glomerulopathy, Francois teaches that the instant invention treat complement-mediated disorder, one of which being atypical hemolytic uremic syndrome (aHUS) ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder. … In some embodiments, the complement-mediated disorder is paroxysmal nocturnal hemoglobinuria (PNH), atypical [hemolytic] uremic syndrome (aHUS) …”). Francois also teaches that CA28-2TS-BF is capable of alternative pathway (AP) inhibition ([00495] “The complement activation inhibitory activity of CA28 and CA28-2TS-BF was assessed by measuring the effect of the compounds on complement activation … via the alternative pathways using standard complement inhibition assays.”; [00498] “Based on the inhibition curves shown in the figures and underlying data, the complement inhibiting activity of CA28-2TS-BF is at least as great as that of CA28 on a molar basis within the experimental error of the assay. These results further confirm the suitability of long-acting compstatin analogs described herein, e.g., for therapeutic purposes.”).
Francois does not teach that the complement mediated disorder is C3 glomerulopathy.
Vernon teaches that C3 glomerulopathy, a complement-mediated disease, and aHUS being associated with complement alternative pathway abnormalities (pg. 1334, “The complement–mediated renal diseases C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome (aHUS) strongly associate with inherited and acquired abnormalities in the regulation of the complement alternative pathway (AP). ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin of Francois to treat C3 glomerulopathy due to Francois teaching that the LACA described can be used to treat complement mediated disorders, like aHUS, specifically by complement activation inhibition, by inhibiting AP abnormalities and Vernon teaching that C3 glomerulopathy and aHUS are both complement-mediated diseases that occur when there is an abnormality in the complement alternative pathway.
The claimed invention is drawn to the use of a patented compound. In specific situations, it is permissible for the examiner to review the Specification of a copending application to determine the scope of use of the product. (“To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”). The specification of ‘893 states that the compound could be used to treat aHUS (col. 2, lines. 36-37, “The invention provides methods of treating a subject in need of treatment for a complement - mediated disorder.” ; col. 92, lines 49-51, “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered to a subject suffering from atypical hemolytic syndrome (aHUS).”). One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘893 with the dosage and treatment schedule of Francois due to both ‘893 and Francois teaching a LACA being used to treat complement-mediated disorders, specifically aHUS.
Regarding claim 338, ‘893 claims the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered weekly due to both ‘893 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 339, ‘893 claims the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient twice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered twice weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered weekly due to both ‘893 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 340, ‘893 claims the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient thrice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered thrice weekly (every other day, M-W-F schedule) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered weekly due to both ‘893 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 341, ‘893 claims the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient every three days.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered weekly due to both ‘893 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 343, ‘893 claims a LACA having the structure :
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(See claims 2 and 7).
Claim 342 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5 and 8 of U.S. Patent No. 10,875,893 (hereafter ‘893), in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, in view of Vernon et al., hereafter “Vernon”, (“Partial Complement Factor H Deficiency Associates with C3 Glomerulopathy and Thrombotic Microangiopathy.” Journal of the American Society of Nephrology 27(5):p 1334-1342, May 2016. DOI: 10.1681/ASN.2015030295), as applied to claim 337 above and further in view of Andrien et al., hereafter “Andrien” (US 9,107,861), as cited in the IDS filed 26 April 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘893 and/or in view of Francois, Vernon, and Andrien as described below.
Regarding claim 342, ‘893 claims the LACA, being described in the instant invention in the treatment of C3 glomerulopathy, being used to treat complement-mediated disorders. (See claims 1, 3-5 and 8) ‘893 does not teach that the LACA is administered using an on-body delivery device.
Francois teaches a Long-acting compstatin analog and a method of treating a complement-mediated disease using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder. … In some embodiments the method comprises administering a long-acting compstatin analog to the subject.”; [00259] “In some embodiments a surface forms part of a medical device, tubing, membrane, reservoir, implant, or other material that may come in contact with blood (e.g., extracorporeally) or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois also teaches that the instant invention treat complement-mediated disorders ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder.”).
Regarding the limitation of being a method of treating a subject in need of treatment of C3 glomerulopathy, Francois teaches that the instant invention treat complement-mediated disorder, one of which being atypical hemolytic uremic syndrome (aHUS) ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder. … In some embodiments, the complement-mediated disorder is paroxysmal nocturnal hemoglobinuria (PNH), atypical [hemolytic] uremic syndrome (aHUS) …”). Francois also teaches that CA28-2TS-BF is capable of alternative pathway (AP) inhibition ([00495] “The complement activation inhibitory activity of CA28 and CA28-2TS-BF was assessed by measuring the effect of the compounds on complement activation … via the alternative pathways using standard complement inhibition assays.”; [00498] “Based on the inhibition curves shown in the figures and underlying data, the complement inhibiting activity of CA28-2TS-BF is at least as great as that of CA28 on a molar basis within the experimental error of the assay. These results further confirm the suitability of long-acting compstatin analogs described herein, e.g., for therapeutic purposes.”).
Francois does not teach that the complement mediated disorder is C3 glomerulopathy.
Vernon teaches that C3 glomerulopathy, a complement-mediated disease, and aHUS being associated with complement alternative pathway abnormalities (pg. 1334, “The complement–mediated renal diseases C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome (aHUS) strongly associate with inherited and acquired abnormalities in the regulation of the complement alternative pathway (AP). ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin of Francois to treat C3 glomerulopathy due to Francois teaching that the LACA described can be used to treat complement mediated disorders, like aHUS, specifically by complement activation inhibition, by inhibiting AP abnormalities and Vernon teaching that C3 glomerulopathy and aHUS are both complement-mediated diseases that occur when there is an abnormality in the complement alternative pathway.
Francois and Vernon do not teach the method of claim 337, wherein the LACA is administered using an on-body delivery device, as required by claim 342.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2,“ In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the LACA of ‘893 with the method of treatment as disclosed by Francois and use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound, as taught by ‘893 and Francois, subcutaneously in order due to both ‘893 and Francois teaching that the LACA is able to treat a subject suffering from a complement-mediated disease or disorder, specifically C3 glomerulopathy, and taught by Vernon. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of complement associated conditions or diseases. Therefore, the invention as a whole is prima facie obvious over the ‘893 reference, when combined with the knowledge of the prior art.
Claims 344-348, 350-355, and 358 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8 and 12 of U.S. Patent No. 10,875,893 (hereafter ‘893), in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘822 and/or in view of Francois and Vernon as described below.
Regarding claim 344, US ‘893 teaches a method of treating a complement-mediated disorder in a subject, the method comprising subcutaneously administering to the subject a long-acting compstatin analog comprising a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide having an amino acid sequence as set form in SEQ ID NO: 28, extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by an 8-amino-3,6-dioxaoctanoic acid (AEEAc) spacer; and the clearance reducing moiety comprises a PEG polymer having an average molecular weight of about 40 kDa, wherein each end of the polymer is linked to one of the compstatin analog moieties by way of a linker moiety that is or comprises a carbamate and an method of treating a complement-mediated disorder in a subject comprising the method of administering a long-acting compstatin analog. (See claims 1, 3-5 and 8)
The difference between the claims of ‘893 and the instant claim 344 is that the instant invention claims the use of the composition (A method of treating a subject in need of treatment of membranoproliferative glomerulonephritis) the administration schedule, and a specific dosage.
Francois teaches a Long-acting compstatin analog can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments. In some embodiments, covalently attached, long-acting, or targeted compstatin analogs protect cells, tissues, organs, for a period of weeks or months without need for retreatment…”), while teaching an example in which the test subjects were administered, subcutaneously, 7mg/kg on appropriate days ([00503] “Animals were dosed at 7 mg/kg via intravenous or subcutaneous administration at time 0 on the appropriate day(s).”). At a prescribed dosage of 7mg/kg, a patient weighing 154.3kg, would receive a dosage of about 1080 mg of the LACA. Regarding the limitation of “treating a subject in need of treatment of membranoproliferative glomerulonephritis”, Francois teaches the LACA being used to treat membranoproliferative glomerulonephritis ([00384] “In some embodiments a cell-reactive, long-acting, or targeted compstatin analog is used to treat a subject suffering from or at risk of membranoproliferative [glomerulonephritis] (MPGN)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin as described in claims 1, 3-5 and 8 of ‘893 because the claims teach a LACA identical to the LACA of Francois, which was show to be used to treat membranoproliferative glomerulonephritis and be administered to a subject in the amount of 1080mg due to routine optimization. The claimed invention is drawn to the use of a patented compound. In specific situations, it is permissible for the examiner to review the Specification of a copending application to determine the scope of use of the product. (“To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”). The specification of ‘822 states that the compound could be used to treat membranoproliferative glomerulonephritis (col. 98, lines. 59-62, “In some embodiments a cell-reactive, long-acting, or targeted compstatin analog is used to treat a subject suffering from or at risk of membranoproliferative [glomerulonephritis] (MPGN), e.g., MPGN type I, MPGN type II, or MPGH type III.”). One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘893 with the dosage and treatment schedule of Francois due to both ‘893 and Francois teaching a LACA being used to treat membranoproliferative glomerulonephritis.
Regarding claim 345, ‘893 claims a LACA, which the instant invention is using in the treatment of membranoproliferative glomerulonephritis as described. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered weekly due to both ‘893 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 346, ‘893 claims a LACA, which the instant invention is using in the treatment of membranoproliferative glomerulonephritis as described. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient twice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered twice weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered twice weekly due to both ‘893 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 347, ‘893 claims a LACA, which the instant invention is using in the treatment of membranoproliferative glomerulonephritis as described. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient thrice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered thrice weekly (every other day, M-W-F schedule) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered thrice weekly due to both ‘893 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 348, ‘893 claims a LACA, which the instant invention is using in the treatment of membranoproliferative glomerulonephritis as described. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient every three days.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered every three days due to both ‘893 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 358, ‘893 claims a LACA having the structure :
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(See claims 2 and 7).
Regarding claim 351, US ‘893 teaches a long-acting compstatin analog comprising a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising an 8-amino-3,6-dioxaoctanoic acid (AEEAc), where the clearance reducing moiety comprises polymer, wherein each end of the linear polymer is linked to one of the compstatin analog moieties by way of a carbamate, wherein the linear polymer is PEG having an average molecular weight of about 40 kD. (See claims 1, 2, 8 and 12)
The difference between the claims of ‘893 and the instant claim 344 is that the instant invention claims the use of the composition (A method of treating a subject who has received an organ transplant) the administration schedule, and a specific dosage.
Francois teaches a Long-acting compstatin analog can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments. In some embodiments, covalently attached, long-acting, or targeted compstatin analogs protect cells, tissues, organs, for a period of weeks or months without need for retreatment…”), while teaching an example in which the test subjects were administered, subcutaneously, 7mg/kg on appropriate days ([00503] “Animals were dosed at 7 mg/kg via intravenous or subcutaneous administration at time 0 on the appropriate day(s).”). At a prescribed dosage of 7mg/kg, a patient weighing 154.3kg, would receive a dosage of about 1080 mg of the LACA. Regarding the limitation “treating a subject who has received an organ transplant”, Francois teaches the LACA being administered to an organ transplant recipient to inhibit organ rejection and/or failure ([00358] “For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370]“In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin as described in claims 1, 3-5 and 8 of ‘893 because the claims teach a LACA identical to the LACA of Francois, which was show to be used to treat a subject who has received an organ transplant and be administered to a subject in the amount of 1080mg due to routine optimization. The claimed invention is drawn to the use of a patented compound. In specific situations, it is permissible for the examiner to review the Specification of a copending application to determine the scope of use of the product. (“To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”). The specification of ‘822 states that the compound could be used to treat a subject who has received an organ transplant (col. 97, lines. 32-34, “In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”). One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘893 with the dosage and treatment schedule of Francois due to both ‘893 and Francois teaching a LACA being used to treat a subject who has received an organ transplant.
Regarding claim 352, ‘893 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered weekly due to both ‘893 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 353, ‘893 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient twice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered twice weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered twice weekly due to both ‘893 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 354, ‘893 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient thrice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered thrice weekly (every other day, M-W-F schedule) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered thrice weekly due to both ‘893 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 355, ‘893 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a patient every three days.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered every three days due to both ‘893 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 357, ‘893 claims a LACA, which the instant invention is using in the treatment of a subject who has received a kidney transplant as described. (See claims 1, 3-5 and 8) ‘893 does not teach administering the LACA to a subject that received a kidney transplant.
Francois teaches the LACA being administered to a subject that received a transplant and that in some embodiments, the transplant can be a kidney transplant ([00358] “Kidneys, liver, lungs, pancreas, and heart are among the organs that can be successfully transplanted. … For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370] “In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘893 in a treatment method administered to a subject that has received a kidney transplant due to both ‘893 and Francois teaching the same compound and both ‘893 and Francois teaching the LACA being used to treat subjects that received transplants.
Regarding claim 358, ‘893 claims a LACA having the structure :
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(See claims 2 and 7).
Claims 349 and 356 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-5 and 8 of U.S. Patent No. 10,875,893 (hereafter ‘893), in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, as applied to claims 344 and 351 above, and in further view of Andrien et al., hereafter “Andrien” (US 9,107,861), as cited in the IDS filed 26 April 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘893 and/or in view of Francois, Vernon, and Andrien as described below.
Regarding claim 349, ‘893 claims a method of treating a complement-mediated disorder by administering LACA subcutaneously, that same as what is used in the treatment of membranoproliferative glomerulonephritis as described in the instant invention. (See claims 1, 3-5 and 8) ‘893 does not teach that the LACA is administered using an on-body delivery device.
Francois teaches a Long-acting compstatin analog and a method of treating membranoproliferative glomerulonephritis using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([00384] “In some embodiments a cell-reactive, long-acting, or targeted compstatin analog is used to treat a subject suffering from or at risk of membranoproliferative [glomerulonephritis] (MPGN)”; [00259] “In some embodiments a surface forms part of a medical device, tubing, membrane, reservoir, implant, or other material that may come in contact with blood (e.g., extracorporeally) or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois does not teach the method of claim 344, wherein the LACA is administered using an on-body delivery device, as required by claim 349.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2,“ In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of treating using LACA as disclosed by ‘893 and Francois and use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound, as taught by ‘893 and Francois, subcutaneously in order due to both ‘893 and Francois teaching that the LACA is able to treat a subject suffering from membranoproliferative glomerulonephritis. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of membranoproliferative glomerulonephritis. Therefore, the invention as a whole is prima facie obvious over the ‘893 reference, when combined with the knowledge of the prior art.
Regarding claim 356, ‘893 claims a method of treating a complement-mediated disorder by administering LACA subcutaneously, that same as what is used in the treatment of a subject that received an organ transplant as described in the instant invention. (See claims 1, 3-5 and 8) ‘893 does not teach that the LACA is administered using an on-body delivery device.
Francois teaches a Long-acting compstatin analog and a method of treating a subject that received an organ transplant using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([00358] “For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370]“In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”; [00259] “In some embodiments a surface forms part of a medical device, tubing, membrane, reservoir, implant, or other material that may come in contact with blood (e.g., extracorporeally) or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois and ‘893 do not teach the method of 351, wherein the LACA is administered using an on-body delivery device, as required by claim 356.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2,“In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the LACA of ‘893 with the method of treatment as disclosed by Francois and use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound, as taught by ‘893 and Francois, subcutaneously in order due to both ‘893 and Francois teaching that the LACA is able to treat a subject that received an organ transplant. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of a subject that received an organ transplant. Therefore, the invention as a whole is prima facie obvious over the ‘893 reference, when combined with the knowledge of the prior art.
Claims 337-341 and 343 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6, of U.S. Patent No. 11,903,994 (hereafter ‘994), in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, in view of Vernon et al., hereafter “Vernon”, (“Partial Complement Factor H Deficiency Associates with C3 Glomerulopathy and Thrombotic Microangiopathy.” Journal of the American Society of Nephrology 27(5):p 1334-1342, May 2016. DOI: 10.1681/ASN.2015030295). Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘994 and/or in view of Francois and Vernon as described below.
Regarding claim 337, ‘994 teaches a method of treating a complement-mediated eye disorder in a subject, the method comprising intravitreally administering 15mg of a long-acting compstatin analog (LACA) comprising a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide having an amino acid sequence as set form in SEQ ID NO: 28, extended by a lysine residue or a sequence comprising a lysine residue at the C-terminus, wherein the lysine residue is separated from the cyclic portion of the peptide by an 8-amino-3,6-dioxaoctanoic acid (AEEAc) spacer; and the clearance reducing moiety comprises a PEG polymer having an average molecular weight of about 40 kDa, wherein each end of the polymer is linked to one of the compstatin analog moieties by way of a linker moiety that is or comprises a carbamate, to a subject in need of treatment. (See claim 1)
The difference between the claims of ‘822 and the instant claim 337 is that the instant invention claims the use of the composition (A method of treating a subject in need of treatment of C3 glomerulopathy) the administration schedule, and a specific dosage.
Francois teaches a Long-acting compstatin analog can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly…”).
At the time of before the effective filing date of the claimed invention, an artisan of ordinary skill would have been motivated to select CA28-2TS-BF from the list of compstatin analogs taught by Francois because CA28-2TS-BF is long acting and stable. There would be a reasonable expectation of success because CA28-2TS-BF performs as similar to/better than CA28 (native).
It would be obvious to artisan to arrive at 1080 mg because it is routine optimization.
Francois also teaches that the instant invention treat complement-mediated disorders ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder.”).
Regarding the limitation of being a method of treating a subject in need of treatment of C3 glomerulopathy, Francois teaches that the instant invention treat complement-mediated disorder, one of which being atypical hemolytic uremic syndrome (aHUS) ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder. … In some embodiments, the complement-mediated disorder is paroxysmal nocturnal hemoglobinuria (PNH), atypical [hemolytic] uremic syndrome (aHUS) …”). Francois also teaches that CA28-2TS-BF is capable of alternative pathway (AP) inhibition ([00495] “The complement activation inhibitory activity of CA28 and CA28-2TS-BF was assessed by measuring the effect of the compounds on complement activation … via the alternative pathways using standard complement inhibition assays.”; [00498] “Based on the inhibition curves shown in the figures and underlying data, the complement inhibiting activity of CA28-2TS-BF is at least as great as that of CA28 on a molar basis within the experimental error of the assay. These results further confirm the suitability of long-acting compstatin analogs described herein, e.g., for therapeutic purposes.”).
Francois does not teach that the complement mediated disorder is C3 glomerulopathy.
Vernon teaches that C3 glomerulopathy, a complement-mediated disease, and aHUS being associated with complement alternative pathway abnormalities (pg. 1334, “The complement–mediated renal diseases C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome (aHUS) strongly associate with inherited and acquired abnormalities in the regulation of the complement alternative pathway (AP). ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin of Francois to treat C3 glomerulopathy due to Francois teaching that the LACA described can be used to treat complement mediated disorders, like aHUS, specifically by complement activation inhibition, by inhibiting AP abnormalities and Vernon teaching that C3 glomerulopathy and aHUS are both complement-mediated diseases that occur when there is an abnormality in the complement alternative pathway.
The claimed invention is drawn to the use of a patented compound. In specific situations, it is permissible for the examiner to review the Specification of a copending application to determine the scope of use of the product. (“To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”). The specification of ‘822 states that the compound could be used to treat aHUS (col. 2, lines. 33-34, “The invention provides methods of treating a subject in need of treatment for a complement - mediated disorder.” ; col. 96, lines 39-41, “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered to a subject suffering from atypical hemolytic syndrome (aHUS).”). One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘822 with the dosage and treatment schedule of Francois due to both ‘822 and Francois teaching a LACA being used to treat complement-mediated disorders, specifically aHUS.
Regarding claim 338, ‘994 claims a LACA identical to the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claim 1) ‘994 does not teach administering the LACA to a patient weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered weekly due to both ‘994 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 339, ‘994 claims a LACA identical to the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claim 1) ‘994 does not teach administering the LACA to a patient twice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered twice weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered weekly due to both ‘994 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 340, ‘994 claims a LACA identical to the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claim 1) ‘994 does not teach administering the LACA to a patient thrice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered thrice weekly (every other day, M-W-F schedule) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered weekly due to both ‘994 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 341, ‘994 claims a LACA identical to the LACA used in the treatment of C3 glomerulopathy as described in the instant invention. (See claim 1) ‘994 does not teach administering the LACA to a patient every three days.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered weekly due to both ‘994 and Francois teaching the same compound and Francois teaching a method of using an already patented compound.
Regarding claim 343, ‘994 claims a LACA having the structure :
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(See claims 6).
Claim 342 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,903,994 (hereafter ‘994), in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, in view of Vernon et al., hereafter “Vernon”, (“Partial Complement Factor H Deficiency Associates with C3 Glomerulopathy and Thrombotic Microangiopathy.” Journal of the American Society of Nephrology 27(5):p 1334-1342, May 2016. DOI: 10.1681/ASN.2015030295), as applied to claim 337 above and further in view of Andrien et al., hereafter “Andrien” (US 9,107,861), as cited in the IDS filed 26 April 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘944 and/or in view of Francois, Vernon, and Andrien as described below.
Regarding claim 342, ‘994 claims the LACA, being described in the instant invention in the treatment of C3 glomerulopathy, being used to treat complement-mediated eye disorders. (See claim 1) ‘994 does not teach that the LACA is administered using an on-body delivery device.
Francois teaches a Long-acting compstatin analog and a method of treating a complement-mediated disease using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder. … In some embodiments the method comprises administering a long-acting compstatin analog to the subject.”; [00259] “In some embodiments a surface forms part of a medical device, tubing, membrane, reservoir, implant, or other material that may come in contact with blood (e.g., extracorporeally) or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois does not teach that the complement mediated disorder is C3 glomerulopathy.
Vernon teaches that C3 glomerulopathy, a complement-mediated disease, and aHUS being associated with complement alternative pathway abnormalities (pg. 1334, “The complement–mediated renal diseases C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome (aHUS) strongly associate with inherited and acquired abnormalities in the regulation of the complement alternative pathway (AP). ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin of Francois to treat C3 glomerulopathy due to Francois teaching that the LACA described can be used to treat complement mediated disorders, like aHUS, specifically by complement activation inhibition, by inhibiting AP abnormalities and Vernon teaching that C3 glomerulopathy and aHUS are both complement-mediated diseases that occur when there is an abnormality in the complement alternative pathway.
Francois and Vernon do not teach the method of claim 337, wherein the LACA is administered using an on-body delivery device, as required by claim 342.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2,“ In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the LACA of ‘994 with the method of treatment as disclosed by Francois and use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound, as taught by ‘994 and Francois, subcutaneously in order due to both ‘994 and Francois teaching that the LACA is able to treat a subject suffering from a complement-mediated disease or disorder, specifically C3 glomerulopathy, and taught by Vernon. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of complement associated conditions or diseases. Therefore, the invention as a whole is prima facie obvious over the ‘994 reference, when combined with the knowledge of the prior art.
Claims 344-348, 350-355, and 358 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,903,994 (hereafter ‘994), in view of Francois et al., hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘994 and/or in view of Francois and Vernon as described below.
Regarding claim 344, ‘994 teaches a method of treating a complement-mediated eye disorder in a subject, the method comprising intravitreally administering 15mg of a long-acting compstatin analog (LACA) comprising a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide having an amino acid sequence as set form in SEQ ID NO: 28, extended by a lysine residue or a sequence comprising a lysine residue at the C-terminus, wherein the lysine residue is separated from the cyclic portion of the peptide by an 8-amino-3,6-dioxaoctanoic acid (AEEAc) spacer; and the clearance reducing moiety comprises a PEG polymer having an average molecular weight of about 40 kDa, wherein each end of the polymer is linked to one of the compstatin analog moieties by way of a linker moiety that is or comprises a carbamate, to a subject in need of treatment. (See claim 1)
The difference between the claims of ‘994 and the instant claim 344 is that the instant invention claims the use of the composition (A method of treating a subject in need of treatment of membranoproliferative glomerulonephritis) the administration schedule, and a specific dosage.
Francois teaches a Long-acting compstatin analog can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments. In some embodiments, covalently attached, long-acting, or targeted compstatin analogs protect cells, tissues, organs, for a period of weeks or months without need for retreatment…”), while teaching an example in which the test subjects were administered, subcutaneously, 7mg/kg on appropriate days ([00503] “Animals were dosed at 7 mg/kg via intravenous or subcutaneous administration at time 0 on the appropriate day(s).”). At a prescribed dosage of 7mg/kg, a patient weighing 154.3kg, would receive a dosage of about 1080 mg of the LACA. Regarding the limitation of “treating a subject in need of treatment of membranoproliferative glomerulonephritis”, Francois teaches the LACA being used to treat membranoproliferative glomerulonephritis ([00384] “In some embodiments a cell-reactive, long-acting, or targeted compstatin analog is used to treat a subject suffering from or at risk of membranoproliferative [glomerulonephritis] (MPGN)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin as described in claim 1 of ‘994 because the claims teach a LACA identical to the LACA of Francois, which was show to be used to treat membranoproliferative glomerulonephritis and be administered to a subject in the amount of 1080mg due to routine optimization. The claimed invention is drawn to the use of a patented compound. One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘994 with the dosage and treatment schedule of Francois due to both ‘994 and Francois teaching a LACA being used to treat complement-mediated disorders.
Regarding claim 345, ‘994 claims a LACA identical to the LACA used in the treatment of membranoproliferative glomerulonephritis as described in the instant invention. (See claim 1) ‘994 does not teach administering the LACA to a patient weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered weekly due to both ‘994 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 346, ‘994 claims a LACA identical to the LACA used in the treatment of membranoproliferative glomerulonephritis as described in the instant invention. (See claim 1) ‘994 does not teach administering the LACA to a patient twice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered twice weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered twice weekly due to both ‘994 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 347, ‘994 claims a LACA identical to the LACA used in the treatment of membranoproliferative glomerulonephritis as described in the instant invention. (See claim 1) ‘994 does not teach administering the LACA to a patient thrice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered thrice weekly (every other day, M-W-F schedule) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered thrice weekly due to both ‘994 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 348, ‘994 claims a LACA identical to the LACA used in the treatment of membranoproliferative glomerulonephritis as described in the instant invention. (See claim 1) ‘994 does not teach administering the LACA to a patient every three days.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered every three days due to both ‘994 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 358, ‘994 claims a LACA having the structure:
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(See claim 6).
Regarding claim 351, ‘994 teaches a method of treating a complement-mediated eye disorder in a subject, the method comprising intravitreally administering 15mg of a long-acting compstatin analog (LACA) comprising a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide having an amino acid sequence as set form in SEQ ID NO: 28, extended by a lysine residue or a sequence comprising a lysine residue at the C-terminus, wherein the lysine residue is separated from the cyclic portion of the peptide by an 8-amino-3,6-dioxaoctanoic acid (AEEAc) spacer; and the clearance reducing moiety comprises a PEG polymer having an average molecular weight of about 40 kDa, wherein each end of the polymer is linked to one of the compstatin analog moieties by way of a linker moiety that is or comprises a carbamate, to a subject in need of treatment. (See claim 1)
The difference between the claims of ‘994 and the instant claim 344 is that the instant invention claims the use of the composition (A method of treating a subject who has received an organ transplant) the administration schedule, and a specific dosage.
Francois teaches a Long-acting compstatin analog can be administered weekly, twice weekly (every 3-4 days), thrice weekly (every other day; M-W-F), and every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments. In some embodiments, covalently attached, long-acting, or targeted compstatin analogs protect cells, tissues, organs, for a period of weeks or months without need for retreatment…”), while teaching an example in which the test subjects were administered, subcutaneously, 7mg/kg on appropriate days ([00503] “Animals were dosed at 7 mg/kg via intravenous or subcutaneous administration at time 0 on the appropriate day(s).”). At a prescribed dosage of 7mg/kg, a patient weighing 154.3kg, would receive a dosage of about 1080 mg of the LACA. Regarding the limitation “treating a subject who has received an organ transplant”, Francois teaches the LACA being administered to an organ transplant recipient to inhibit organ rejection and/or failure ([00358] “For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370]“In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin as described in claim 1 of ‘994 because the claims teach a LACA identical to the LACA of Francois, which was show to be used to treat a subject who has received an organ transplant and be administered to a subject in the amount of 1080mg due to routine optimization. The claimed invention is drawn to the use of a patented compound. One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘994 with the dosage and treatment schedule of Francois due to both ‘994 and Francois teaching a LACA being used to treat a subject who has received an organ transplant.
Regarding claim 352, ‘994 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claim 1) ‘994 does not teach administering the LACA to a patient weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered weekly due to both ‘994 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 353, ‘994 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claim 1) ‘994 does not teach administering the LACA to a patient twice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered twice weekly ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered twice weekly due to both ‘994 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 354, ‘944 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claim 1) ‘994 does not teach administering the LACA to a patient thrice weekly.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered thrice weekly (every other day, M-W-F schedule) ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered thrice weekly due to both ‘994 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 355, ‘994 claims a LACA, which the instant invention is using in the treatment of a subject who has received an organ transplant as described. (See claim 1) ‘994 does not teach administering the LACA to a patient every three days.
Francois teaches a Long-acting compstatin analog (see [0061], [00235], and [00472]) can be administered every three days ([00440] “In some embodiments, a cell-reactive, long-acting, or targeted compstatin analog is administered at time intervals greater than 24 hours. For example, doses could be administered on average every other day, every 3-4 days, weekly, every other week, etc., in various embodiments.”).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered every three days due to both ‘994 and Francois teaching the same compound and Francois teaching a method of treatment schedule for an already patented compound that has been shown to be used in the way the instant application is trying to patent.
Regarding claim 357, ‘994 claims a LACA, which the instant invention is using in the treatment of a subject who has received a kidney transplant as described. (See claim 1) ‘994 does not teach administering the LACA to a subject that received a kidney transplant.
Francois teaches the LACA being administered to a subject that received a transplant and that in some embodiments, the transplant can be a kidney transplant ([00358] “Kidneys, liver, lungs, pancreas, and heart are among the organs that can be successfully transplanted. … For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370] “In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘994 in a treatment method administered to a subject that has received a kidney transplant due to both ‘994 and Francois teaching the same compound and both ‘994 and Francois teaching the LACA being used to treat subjects that received transplants.
Regarding claim 358, ‘994 claims a LACA having the structure :
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(See claim 6).
Claims 349 and 356 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 11,903,994 (hereafter ‘994), in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, as applied to claims 344 and 351 above, and in further view of Andrien et al., hereafter “Andrien” (US 9,107,861), as cited in the IDS filed 26 April 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘994 and/or in view of Francois, Vernon, and Andrien as described below.
Regarding claim 349, ‘994 claims a method of treating a complement-mediated eye disorder by administering LACA, that same LACA as what is used in the treatment of membranoproliferative glomerulonephritis as described in the instant invention. (See claim 1) ‘994 does not teach that the LACA is administered using an on-body delivery device.
Francois teaches a Long-acting compstatin analog and a method of treating membranoproliferative glomerulonephritis using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([00384] “In some embodiments a cell-reactive, long-acting, or targeted compstatin analog is used to treat a subject suffering from or at risk of membranoproliferative [glomerulonephritis] (MPGN)”; [00259] “In some embodiments a surface forms part of a medical device, tubing, membrane, reservoir, implant, or other material that may come in contact with blood (e.g., extracorporeally) or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois does not teach the method of claim 344, wherein the LACA is administered using an on-body delivery device, as required by claim 349.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2,“ In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the method of treating using LACA as disclosed by ‘994 and Francois and use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound, as taught by ‘994 and Francois, subcutaneously in order due to both ‘994 and Francois teaching that the LACA is able to treat a subject suffering from membranoproliferative glomerulonephritis. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of membranoproliferative glomerulonephritis. Therefore, the invention as a whole is prima facie obvious over the ‘994 reference, when combined with the knowledge of the prior art.
Regarding claim 356, ‘994 claims a method of treating a complement-mediated eye disorder by administering LACA, the same LACA as what is used in the treatment of a subject that received an organ transplant as described in the instant invention. (See claim 1) ‘994 does not teach that the LACA is administered using an on-body delivery device.
Francois teaches a Long-acting compstatin analog and a method of treating a subject that received an organ transplant using a delivery device, which can be implanted into the body in the form of a prosthetic or a drug delivery device ([00358] “For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370]“In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”; [00259] “In some embodiments a surface forms part of a medical device, tubing, membrane, reservoir, implant, or other material that may come in contact with blood (e.g., extracorporeally) or be temporarily or indefinitely implanted into the body of a subject (e.g., a prosthetic device or drug delivery device).”).
Francois and ‘893 do not teach the method of 351, wherein the LACA is administered using an on-body delivery device, as required by claim 356.
Andrien teaches antibodies that are useful for treatment of complement-mediated disorders in a subject (col. 28-29, lines. 66-67 and 1-2,“In this manner, non-human antibodies can be modified to make them more suitable for human clinical application (e.g., methods for treating or preventing a complement-mediated disorder in a subject).”).
Andrien teaches that the composition could be administered subcutaneously, using a device, which could be a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection (col. 43, lines. 10-16, “Subcutaneous administration can be accomplished by means of a device. The device means may be a syringe, a prefilled syringe, an auto-injector either disposable or reusable, a pen injector, a patch injector, a wearable injector, an ambulatory syringe infusion pump with subcutaneous infusion sets or other device for combining with the antibody drug for subcutaneous injection.”). Andrien also teaches that the administration could be achieved via an implant (col. 43, lines. 16-33,“ Administration can be achieved by, e.g., local infusion, injection, or by means of an implant. The implant can be of a porous, non-porous, or gelatinous material, including membranes, such as sialastic membranes, or fibers. … A composition described herein can be delivered to the subject by way of an implantable device based on, e.g., diffusive, erodible, or convective systems, e.g., osmotic pumps, biodegradable implants, electrodiffusion systems, electroosmosis systems, vapor pressure pumps, electrolytic pumps, effervescent pumps, piezoelectric pumps, erosion-based systems, or electromechanical systems.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the LACA of ‘994 with the method of treatment as disclosed by Francois and use a syringe pump and/or an on-body delivery device (e.g., implant or wearable injector) as taught by Andrien. One of ordinary skill in the art would have been motivated to do so in order to deliver the compound, as taught by ‘994 and Francois, subcutaneously in order due to both ‘994 and Francois teaching that the LACA is able to treat a subject that received an organ transplant. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success given that both Andrien and Francois teach subcutaneous delivery of long acting (e.g., PEG conjugated) peptides for the treatment of a subject that received an organ transplant. Therefore, the invention as a whole is prima facie obvious over the ‘994 reference, when combined with the knowledge of the prior art.
Claims 337-343 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-12, 15, 17-19, 22-24, of U.S. Patent No. 11,040,107 (hereafter ‘107), in view of Francois et al. hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024, in view of Vernon et al., hereafter “Vernon”, (“Partial Complement Factor H Deficiency Associates with C3 Glomerulopathy and Thrombotic Microangiopathy.” Journal of the American Society of Nephrology 27(5):p 1334-1342, May 2016. DOI: 10.1681/ASN.2015030295). Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘107 and/or in view of Francois and Vernon as described below.
Regarding claim 337, ‘107 teaches a method of treating a complement-mediated disorder comprising administering a long-acting compstatin analog (LACA) to the subject subcutaneously according to a dosing schedule in which about 1080 mg of the LACA is administered thrice weekly, every three days, twice weekly, or weekly, wherein the LACA comprises a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc); wherein the clearance reducing moiety comprises the polymer, wherein each end of the polymer is linked to one of the compstatin analog moieties by wav of a carbamate, and wherein the polymer is PEG having an average molecular weight of about 40 kD. (See claim 1 and 8)
The difference between the claims of ‘107 and the instant claim 337 is that the instant invention claims the use of the composition (A method of treating a subject in need of treatment of C3 glomerulopathy).
Regarding the limitation of being a method of treating a subject in need of treatment of C3 glomerulopathy, Francois teaches a LACA identical to the invention as described in ‘107 treating complement-mediated disorder, one of which being atypical hemolytic uremic syndrome (aHUS) ([0007] “The invention provides methods of treating a subject in need of treatment for a complement-mediated disorder. … In some embodiments, the complement-mediated disorder is paroxysmal nocturnal hemoglobinuria (PNH), atypical [hemolytic] uremic syndrome (aHUS) …”). Francois also teaches that CA28-2TS-BF is capable of alternative pathway (AP) inhibition ([00495] “The complement activation inhibitory activity of CA28 and CA28-2TS-BF was assessed by measuring the effect of the compounds on complement activation … via the alternative pathways using standard complement inhibition assays.”; [00498] “Based on the inhibition curves shown in the figures and underlying data, the complement inhibiting activity of CA28-2TS-BF is at least as great as that of CA28 on a molar basis within the experimental error of the assay. These results further confirm the suitability of long-acting compstatin analogs described herein, e.g., for therapeutic purposes.”).
Francois does not teach that the complement mediated disorder is C3 glomerulopathy.
Vernon teaches that C3 glomerulopathy, a complement-mediated disease, and aHUS being associated with complement alternative pathway abnormalities (pg. 1334, “The complement–mediated renal diseases C3 glomerulopathy (C3G) and atypical hemolytic uremic syndrome (aHUS) strongly associate with inherited and acquired abnormalities in the regulation of the complement alternative pathway (AP). ”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin of Francois to treat C3 glomerulopathy due to Francois teaching that the LACA described can be used to treat complement mediated disorders, like aHUS, specifically by complement activation inhibition, by inhibiting AP abnormalities and Vernon teaching that C3 glomerulopathy and aHUS are both complement-mediated diseases that occur when there is an abnormality in the complement alternative pathway.
The claimed invention is drawn to the use of a patented compound. In specific situations, it is permissible for the examiner to review the Specification of an application to determine the scope of use of the product. (“To avoid improperly treating what is disclosed in a reference patent or copending application as if it were prior art in the context of a nonstatutory double patenting analysis, the examiner must first properly construe the scope of the reference claims. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02.”). The specification of ‘822 states that the compound could be used to treat aHUS (col. 1, lines 61-63, “In some aspects, the invention provides methods of treating a subject in need of treatment for a complement-mediated disorder...” ; col. 94, lines 6-8, “In some embodiments , a cell-reactive , long-acting , or targeted compstatin analog is administered to a subject suffering from atypical hemolytic syndrome (aHUS)”. One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘107 with the dosage and treatment schedule of Francois due to both ‘107 and Francois teaching a LACA being used to treat complement-mediated disorders, specifically aHUS.
Regarding claim 338, ‘107 teaches the method of claim 1, wherein the LACA is administered weekly. (See claims 2 and 10)
Regarding claim 339, ‘107 teaches the method of claim 1, wherein the LACA is administered twice weekly. (See claims 3 and 11)
Regarding claim 340, ‘107 teaches the method of claim 1, wherein the LACA is administered thrice weekly. (See claims 4 and 12)
Regarding claim 341, ‘107 teaches the method of claim 1, wherein the LACA is administered every three days. (See claim 5 and 9)
Regarding claim 342, ‘107 teaches the method of claim 1, wherein the LACA is administered using an on-body delivery device. (See claim 17)
Regarding claim 343, ‘107 claims a LACA having the structure:
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(See claims 22-24).
Claims 344-358 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8-12, 15, 17-19, 22-24, of U.S. Patent No. 11,040,107 (hereafter ‘107), in view of Francois et al., hereafter “Francois”, (WO2014/078734), as cited in the IDS filed 26 April 2024. Although the claims at issue are not identical, they are not patentably distinct from each other because the instantly claimed invention is anticipated and/or made prima facie obvious by the invention of US ‘994 and/or in view of Francois and Vernon as described below.
Regarding claim 344, ‘107 teaches a method of treating a complement-mediated disorder comprising administering a long-acting compstatin analog (LACA) to the subject subcutaneously according to a dosing schedule in which about 1080 mg of the LACA is administered thrice weekly, every three days, twice weekly, or weekly, wherein the LACA comprises a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc); wherein the clearance reducing moiety comprises the polymer, wherein each end of the polymer is linked to one of the compstatin analog moieties by wav of a carbamate, and wherein the polymer is PEG having an average molecular weight of about 40 kD. (See claim 1 and 8)
The difference between the claims of ‘994 and the instant claim 344 is that the instant invention claims the use of the composition (A method of treating a subject in need of treatment of membranoproliferative glomerulonephritis) the administration schedule, and a specific dosage.
Francois, regarding the limitation of “treating a subject in need of treatment of membranoproliferative glomerulonephritis”, teaches the LACA being used to treat membranoproliferative glomerulonephritis ([00384] “In some embodiments a cell-reactive, long-acting, or targeted compstatin analog is used to treat a subject suffering from or at risk of membranoproliferative [glomerulonephritis] (MPGN)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin as described in claims 1 and 8 of ‘107 because the claims teach a LACA identical to the LACA of Francois, which was show to be used to treat membranoproliferative glomerulonephritis The claimed invention is drawn to the use of a patented compound. One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘107 to treat membranoproliferative glomerulonephritis as described in Francois due to both ‘107 and Francois teaching a LACA being used to treat complement-mediated disorders.
Regarding claim 345, ‘107 teaches the method of claim 1, wherein the LACA is administered weekly. (See claims 2 and 10)
Regarding claim 346, ‘107 teaches the method of claim 1, wherein the LACA is administered twice weekly. (See claims 3 and 11)
Regarding claim 347, ‘107 teaches the method of claim 1, wherein the LACA is administered thrice weekly. (See claims 4 and 12)
Regarding claim 348, ‘107 teaches the method of claim 1, wherein the LACA is administered every three days. (See claim 5 and 9)
Regarding claim 349, ‘107 teaches the method of claim 1, wherein the LACA is administered using an on-body delivery device. (See claim 17)
Regarding claim 350, ‘107 claims a LACA having the structure:
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(See claims 22-24).
Regarding claim 351, ‘107 teaches a method of treating a complement-mediated disorder comprising administering a long-acting compstatin analog (LACA) to the subject subcutaneously according to a dosing schedule in which about 1080 mg of the LACA is administered thrice weekly, every three days, twice weekly, or weekly, wherein the LACA comprises a clearance-reducing moiety attached to two compstatin analog moieties, wherein each compstatin analog moiety comprises a cyclic peptide comprising an amino acid sequence as set forth in SEQ ID NO: 28 extended by a lysine residue or a sequence comprising a lysine residue at the N-terminus, C-terminus, or both, wherein the lysine residue is separated from the cyclic portion of the peptide by a spacer comprising 8-amino-3,6-dioxaoctanoic acid (AEEAc); wherein the clearance reducing moiety comprises the polymer, wherein each end of the polymer is linked to one of the compstatin analog moieties by wav of a carbamate, and wherein the polymer is PEG having an average molecular weight of about 40 kD. (See claim 1 and 8)
The difference between the claims of ‘107 and the instant claim 351 is that the instant invention claims the use of the composition (A method of treating a subject who has received an organ transplant).
Francois, regarding the limitation “treating a subject who has received an organ transplant”, teaches the LACA being administered to an organ transplant recipient to inhibit organ rejection and/or failure ([00358] “For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370]“In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the long-acting compstatin as described in claims 1 and 8 of ‘107 because the claims teach a LACA identical to the LACA of Francois, which was show to be used to treat a patient that received an organ transplant. The claimed invention is drawn to the use of a patented compound. One of ordinary skill in the before the effective filing date of the claimed invention would be motivated with reasonable expectation of success to use the LACA of ‘107 to treat a subject that received an organ transplant as described in Francois due to both ‘107 and Francois teaching a LACA being used to treat complement-mediated disorders.
Regarding claim 352, ‘107 teaches the method of claim 1, wherein the LACA is administered weekly. (See claims 2 and 10)
Regarding claim 353, ‘107 teaches the method of claim 1, wherein the LACA is administered twice weekly. (See claims 3 and 11)
Regarding claim 354, ‘107 teaches the method of claim 1, wherein the LACA is administered thrice weekly. (See claims 4 and 12)
Regarding claim 355, ‘107 teaches the method of claim 1, wherein the LACA is administered every three days. (See claim 5 and 9)
Regarding claim 356, ‘107 teaches the method of claim 1, wherein the LACA is administered using an on-body delivery device. (See claim 17)
Regarding claim 357, ‘107 claims a LACA, which the instant invention is using in the treatment of a subject who has received a kidney transplant as described. (See claims 1 and 8) ‘107 does not teach administering the LACA to a subject that received a kidney transplant.
Francois teaches the LACA being administered to a subject that received a transplant and that in some embodiments, the transplant can be a kidney transplant ([00358] “Kidneys, liver, lungs, pancreas, and heart are among the organs that can be successfully transplanted. … For purposes of the invention, an organ, tissue, or cell (or population of cells) that is be transplanted, is being transplanted, or has been transplanted may be referred to as a "graft".”; [00370] “In some embodiments, a long-acting compstatin analog is administered to a graft recipient to inhibit graft rejection and/or graft failure.”).
One of ordinary skill in the art would have been motivated with a reasonable expectation of success to use the LACA of ‘107 in a treatment method administered to a subject that has received a kidney transplant due to both ‘107 and Francois teaching the same compound and both ‘107 and Francois teaching the LACA being used to treat subjects that received transplants.
Regarding claim 358, ‘107 claims a LACA having the structure:
PNG
media_image1.png
940
420
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Greyscale
(See claims 22-24).
Status of Claims
Claims 337-358 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Claims 351-358 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Claims 337-358 are rejected under 35 U.S.C. 103. Claims 337-358 are rejected on the ground of nonstatutory double patenting.
No claims are allowed.
Conclusion
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/Daliyah M. Brown/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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