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 .
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.
Claim 36 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 36 states, “comprising or consisting of the amino acid sequence of SEQ ID NO:1…”. Recitation of open and closed claim language renders the metes and bounds of the claim indefinite. (MPEP 2111.03)
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 8-9, 15, 53 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2021188892 A1.
WO 2021188892 A1 discloses, “In an exemplary embodiment, the rAAV is formulated in a solution comprising NaCl (e.g., 200 mM NaCl), MgCl2 (e.g., 1 mM MgCl2 ), Tris (e.g., 20 mM Tris), pH 8.0, and poloxamer 188 (e.g., 0.005% or 0.01% poloxamer 188).” (paragraph 00166). Therefore, they have disclosed a composition containing a rAAV with a buffer (Tris), a salt (MgCl), a cryoprotectant (poloxamer 188), and a surfactant (poloxamer 188) with a final pH of 8.0. This anticipates claim 1. The buffer is specified to be Tris, and at a concentration of 20mM, which anticipates claim 2 and 3. They go on to specify that the salt concertation is about 200nM NaCl and 1mM MgCl. This anticipates claim 4 as 201 mM is “about” 200nM. About means within one standard deviation, and the assumed standard deviation is 0.005%. Claim 5 is also anticipated as MgCl is listed as a salt. Claim 8 and claim 9 are anticipated as the surfactant is listed as poloxamer 188 (claim 9) and its concentration is specified to be 0.005%, which falls within the range specified by claim 8 (0.002%-0.2%). They go on to disclose, “In an exemplary embodiment, the AAV capsid is an AAV serotype 8 (AAV8) capsid…” (paragraph 0014). Therefore, they have disclosed that the AAV vector of the composition be the AAV 8 serotype (claim 15). Claim 53 is merely the addition of instructions to the composition defined and anticipated by WO 2021188892 A1. The inclusion of instructions for use does not impart patentable weight to the claimed kit. The instructions constitute non-functional descriptive material that merely recites intended use of the components without structurally modifying them. Importantly, the instructions do not create a functional relationship between the components. (MPEP 2111.05 and MPEP 2112.01)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6-7, 10, 12, 14, 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021188892 A1 as applied to claim 1 above, and further in view of WO 2018128689 A1, JP 2023545424, and WO 2022159679 A2 and supported by Bhattacharya, S 2018, Nass, S et al. 2018 and Srivastava, A. et al. 2021.
WO 2021188892 A1 anticipates the composition of claim 1. WO 2021188892 A1 does not disclose any suggestion for the concentration of AAV in solution. It also does not disclose the use of sucrose as a cryoprotectant, specifically in a concertation from 1%-10% (w/v) and it does not disclose a composition where the transgene is APT7B. It does not disclose any suggestions on the viscosity, conductivity, or density of the composition either. It also does not disclose a lyophilized form of the composition, or a vial with the composition.
WO 2018128689 A1 discloses, “When administered to a subject, the liquid or reconstituted dosage unit may include a therapeutically effective amount of the AAV such that the reconstituted dosage unit delivers from 1E+10 vp/ml to 5E+15 vp/ml or 1E+10 cp/ml to 5E+15 cp/ml.” (paragraph 120). Furthermore, WO 2018128689 A1 discloses, “In exemplary aspects, the pharmaceutical composition of the present disclosure comprises: … about 1% to about 10% (w/v) sucrose…” (paragraph 0006). Furthermore, WO 2018128689 A1 discloses “In some embodiments, the invention provides a liquid formulation. In certain embodiments, the formulation is lyophilized from a liquid formulation.” (paragraph 007). Importantly, “At each testing time point (1, 2, 3, 6 and 10) one vial was reconstituted with 5.5 ml purified water” (paragraph 00163).
JP 2023545424 discloses a “pharmaceutical composition comprising a recombinant adeno-associated expression cassette encoding a transgene.” (paragraph 0006). Furthermore, “In some embodiments, the pharmaceutical compositions provided herein have a viscosity of ≦183 mPas” (Section 4.1 “Formulation of Pharmaceutical Compositions” paragraph 007).
WO 2022159679 A2 discloses, “In one aspect, provided herein is method for purifying or isolating recombinantly expressed virus particles, e.g., recombinant adeno-associated virus (rAAV), optionally comprising a transgene… contacting a preparation, e.g., harvest media comprising recombinant virus particles with an affinity chromatography media under conditions that allow binding of virus particles to the affinity chromatography media. The bound viral particles are eluted from the affinity chromatography media using an elution buffer and recovering an eluate, comprising the eluted viral particles.” (paragraph 0227). “Generally, the affinity elution buffer has a conductivity in a range from about 5 mS/cm to about 8 mS/cm.” (paragraph 216).
WO 2018128689 A1 (vp/ml) and claim 10 (vg/ml) use different methods (vp/ml = ELISA and vg/ml = ddPCR) to measure the same metric, viral titer. Therefore, it would be obvious to one of skill in the art to use one unit of titer as a general guideline to help formulate an expected range of titer values when using different methods of tittering. Furthermore, WO 2018128689 A1 and claim 10 disclose overlapping titer values. This renders claim 10 obvious.
Cryoprotectants are compounds that are included in solutions to protect them from damage during freeze-thaw cycles and/or lyophilization, and sucrose is known cryoprotectant. (Bhattacharya, S 2018). WO 2018128689 A1 provides a suggestion/teaching to include sucrose as a cryoprotectant in AAV solutions, and in a range that overlaps the range outlined in claim 7. Therefore, claim 6 and 7 are rendered obvious.
Furthermore, WO 2018128689 A1 also provides a motivation for lyophilizing the compositions (aka for long term cryo-storage and transportation), and suggests how to resuspend the lyophilized composition. This renders 39-40 obvious.
Srivastava, A. et al. 2021 details, “Increase in aggregation and viscosity with increase in AAV product concentration makes these products difficult to administer in small volumes of concentrated vector to certain sites, such as the central nervous system” (product degradation section, paragraph 1). JP 20235454 then provides a suggestion/teaching to keep the viscosity of the composition under 183 mPa. This renders claim 12 obvious.
Nass, S et al. 2018 details how conductivity of buffer solutions (as determined by salt gradients) affects binding and elution behaviors for full capsid during the purification process for AAV vectors. WO 2022159679 A2 then provides a suggestion/teaching to alter the conductivity of the AAV containing solution to values that fall within the specified range of claim 14 (eg. 1mS/cm – 40mS/cm). This renders claim 14 obvious.
Claims 11, 13, 22, and 25 are rejected under 35 U.S.C 103 unpatentable over WO 2021188892 A1 in view of Srivastava, A. et al. 2021 and US 2011076744.
WO 2021188892 A1 teaches all limitations of claim 1 as described above. It does not teach the limitations of “pH of the composition is about 7.3 to about 7.9, optionally about 7.6.” (claim 11), or “wherein the density of the composition is about 0.5 g/cm3 to about 5 g/cm3, optionally about 1 g/cm3 to about 1.5 g/cm3, or optionally about 1.03 g/cm3 “ (claim 13), or “comprising a recombinant adeno-associated virus (rAAV) vector; about 20 mM Tris; about 100 mM MgCl2;about 4% (w/v) sucrose; and about 0.02% (w/v) poloxamer 188, wherein the pH of composition is from about 7.1 to about 8.1. “(claim 22) or, “The composition of claim 22, wherein the rAAV vector comprises a vector genome comprising a transgene and one or more elements…,” (claim 25).
Srivastava, A. et al. 2021 teaches that viscosity is an important factor to consider in AAV formulations. Furthermore, US 2011076744 A1 teaches the optimization of various parameters to prevent AAV aggregation. Specifically, US 2011076744 A1 discloses, “The invention relates to methods of preventing aggregation of virions in a preparation of virions by adding excipients to achieve an ionic strength high enough to prevent aggregation. In another aspect the invention relates to compositions of virions having an ionic strength high enough to prevent aggregation. (paragraph 0012). Srivastava, A. et al. 2021 also teaches the optimization of ionic strength by varying the types and concentrations of salts used in each formulation. (figure 8). Additionally, Srivastava, A. et al. 2021 discloses, “Aggregation of capsid proteins can cause immunogenic response in AAV products. Nonionic surfactants such as polysorbate 80, polysorbate 20, and poloxamer 188 can protect proteins against surface-induced damage by competing with proteins for adsorption sites on surfaces” (surfactants section paragraph 1). Furthermore, “AAV degradation pathways can be divided into two major categories-physical and chemical instabilities. The degradation of the viral vectors depends on the solution conditions, in particular pH, ionic strength and raw material/excipient contaminants, and external factors such as temperature, shear stress, freeze/thaw, and light.” (Degradation mechanisms of AAVs section paragraph 1). Additionally, “Given the wide availability, low cost, and ease of use, sucrose can be adopted by AAV manufacturers to improve the manufacturing yield and stability.” (Osmolytes paragraph 1). Finally, “The buffer type and pH can impact vector stability and infectivity.” (buffering agents and Ph paragraph 1). Transgenes are the payload of the AAV gene therapy vectors, without them efficacy would be moot. Importantly, WO 2021188892 A1 discloses, “In some embodiments, an rAAV produced using a composition or method described herein comprises a packaged vector genome comprising a coding sequence for a protein transgene” (paragraph 0013).
Srivastava, A. et al. 2021 and US 2011076744 A1 do not specifically teach the limitations of “pH of the composition is about 7.3 to about 7.9, optionally about 7.6.” (claim 11), or “wherein the density of the composition is about 0.5 g/cm3 to about 5 g/cm3, optionally about 1 g/cm3 to about 1.5 g/cm3, or optionally about 1.03 g/cm3 “ (claim 13), or “comprising a recombinant adeno-associated virus (rAAV) vector; about 20 mM Tris; about 100 mM MgCl2;about 4% (w/v) sucrose; and about 0.02% (w/v) poloxamer 188, wherein the pH of composition is from about 7.1 to about 8.1. “(claim 22), or “The composition of claim 22any one of claims 22-24, wherein the rAAV vector comprises a vector genome comprising a transgene and one or more elements…,” (claim 25). However, Srivastava, A. et al. 2021 and US 2011076744 do teach optimization of pH, ionic strength and salt composition, buffer choice and concentration, and the use of excipients such as sucrose and poloxamer 188, as well altering the viscosity by changing solution parameters. Therefore, it would be obvious to modify the composition of ‘892 according to the teachings of Srivastava, A. et al. 2021 and US 2011076744 during routine optimization resulting in the aforementioned limitations (claim 11, 13, 22). The combination of claim 22 being rendered obvious combined with the fact the WO 2021188892 A1 discloses that the rAAV contains a transgene, claim 25 is rendered obvious.
In the case of a result-effective variable, the discovery of an optimum value of the variable in a known process is ordinarily within the skill of the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Therefore, it would have been obvious to one of ordinary skill in the art to determine through routine experimentation the optimum or workable ranges of parameters such as doubling-time, growth rate, and cell seeding concentration since the variables would have been recognized as result-effective. (MPEP2144.05(II)). See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 17, 29, 30-31, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021188892 A1, Srivastava, A. et al. 2021 and US 2011076744 as applied to claim 22 above, and further in view of EP4257155A2 and US 11147887 B2, supported by Litwin, T et al, 2019 and Biswas, M et al. 2020.
WO 2021188892 A1, Srivastava, A. et al. 2021 and US 2011076744. render claim 22 obvious as stated above. However, WO 2021188892 A1 does not disclose the following specific compositions:
1) Claim 29 of the application states: a capsid polypeptide of the AAV3B serotype, about 14 mM to about 26 mM Tris; about 70 mM to about 130 mM MgCl2; about 2.8% (w/v) to about 5.2% (w/v) sucrose; and about 0.014% (w/v) to about 0.26% (w/v) poloxamer 188, wherein the pH of the composition is from about 7.1 to about 8.1
2) Claim 31 of the application states: a capsid polypeptide of the AAV3B serotype and a vector genome comprising a transgene encoding a copper transporting ATPase 2 protein or fragment thereof about 20 mM Tris; about 100 mM MgCl2;about 4% (w/v) sucrose; and about 0.02% (w/v) poloxamer 188, wherein the pH of composition is from about 7.1 to about 8.1.
3) Claim 36 of the application states: a capsid polypeptide of the AAV3B serotype and a vector genome comprising a transgene encoding a copper transporting ATPase 2 comprising or consisting of the amino acid sequence of SEQ ID NO:1;about 20 mM Tris; about 100 mM MgCl2;about 4% (w/v) sucrose; and about 0.02% (w/v) poloxamer 188, wherein the pH of composition is from about 7.1 to about 8.1.
WO 2021188892 A1 also does not disclose the use of the AAV3B serotype as the vector, or the use of the ATP7B gene as the transgene or SEQ ID NO: 1.
EP 4257155 A2 discloses, “In exemplary embodiments, the application provides expression vectors that have been designed for delivery by an AAV. The AAV can be any serotype, for examples… AAV3b…”. It is important to note that AAV3B serotype has a high tropism for hepatocytes (Biswas, M et al. 2020). Biswas, M et al. 2020 disclose, “Hepatic gene therapy via systemic AAV administration is an advantageous delivery strategy for long-lived and sustained correction of genetic disorders such as hemophilia, Wilson’s disease…” (Discussion section paragraph 1). Combining this serotype with a transgene designed to treat hepatic disease/ disorders is clearly obvious. Additionally, Litwin, T et al, 2019 discloses, “WD is caused by mutations in the ATP7B gene that encodes the copper-transporting P-type ATPase, ATP7B, which is located mainly in the trans-Golgi network of hepatocytes and is involved in copper transport in the circulation and biliary excretion.“ (introduction paragraph 1). EP 4257155 A2 further discloses, “In certain embodiments, an expression vector designed for delivery by an AAV comprises a 5' ITR, an enhancer, a promoter, an ATP7B transgene…”. (paragraph 0147). Finally, US 11147887 B2 discloses SEQ ID NO: 1 in gene therapy to treat Wilson’s disease.
As stated before, the WO 2021188892 A1, Srivastava, A. et al. 2021 and US 2011076744 disclosures provides the teaching/suggestions to optimize the compositions in claims 29, 31, and 36, which renders their biochemical limitation obvious. Furthermore, EP 4257155 A2 discloses the use of the AAV3B vector carrying the ATPB7B transgene and Litwin, T et al, 2019 and Biswas, M et al. 2020 provide the motivation to combine the serotype and transgene with the aforementioned compositions. Finally, US 11147887 B2 provides SEQ ID NO:1 in the treatment of Wilson’s disease.
Claims 42, 44, 46-48 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021188892 A1 as applied to claim 1 above, and further in view of EP 4257155 A2.
EP 4257155 A2 discloses, “the application provides methods of increasing ATP7B expression in a cell, tissue or subject, treating a disease or disorder associated with a decrease in ATP7B expression or deficiency in ATP7B function in a subject, or treating Wilson's disease by administering a nucleic acid molecule, expression vector, host cell, pharmaceutical composition, or virion comprising a variant ATP7B nucleic acid sequence as described herein. Any known technique can be used to deliver the variant ATP7B nucleic acid sequence to cells of interest to confer or induce in vitro, in vivo, or ex vivo expression of the variant ATP7B transgene in a cell, tissue or subject of interest.” (paragraph 0196). Furthermore, “In one embodiment, the pharmaceutical composition is suitable for use in human subjects and is administered intravenously.” (paragraph 0194). EP 4257155 A2 does not disclose a method specifically listing administering the AAV composition to treat Wilson’s disease and it does not disclose using the composition outlined in claim 1.
WO 2021188892 A1 anticipates claim 1 as states above. EP 4257155 A2 also provides a suggestion to use a “virion comprising a variant ATP7B nucleic acid sequence”, “administered intravenously” for “treating Wilson's disease”. Therefore, the “method of treating a disease comprising administering an effective amount of the pharmaceutical composition of claim l” (claim 42), “administered intravenously” (claim 44), to treat Wilson’s disease (claims 46-48) is merely the addition of the disclosed composition from WO 2021188892 A1 in the methods outlined in EP 4257155 A2. Therefore, claims 42, 44, 46-48 are rendered obvious.
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 1-15, 22, 29 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of copending Application No. 18569368 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a composition containing any AAV serotype, and the additional limitations of the composition in the current application are obvious additions and inherent properties of the composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15, 22, 25, 29-30, 40, 42 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16, 22-25, 28 of copending Application No. 18258027 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-15 and reference claims 1-15, 22, and 29 all claim AAV compositions that differ only in obvious variations of chemicals, inherent properties, and optimized concentrations. Claims 25, 30 and claim 16 claim an AAV composition where the AAV has a transgene. Claim 40 and claim 25 both claim a vial of one of the AAV compositions. Claim 42 and claim 28 both claim a method of treating a disease comprising administering one of the compositions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam M Smith whose telephone number is (571)272-7517. The examiner can normally be reached Monday- Friday 10:30AM-5PM.
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/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638