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 .
Priority
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/US2018/018775 filed 02/20/2018, which claims the benefit of the priority of US Provisional application 62/461,467 filed 02/21/2017 and 62/530,565 filed 07/10/2017.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Claims 12-19, 21, 48-49, 55, 60-61, 63, 67 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I and III or based on the elected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/02/2026. Applicant’s election without traverse of Group II drawn to a method of slowing or preventing, in the reply filed on 02/02/2026 is acknowledged.
Applicant further elects the species compstatin analog of SEQ ID NO: 28 and the steps of claim 44. As a result, claim 45 is withdrawn.
Claim Status
Claims 12-19, 21,39, 44-45, 47-49, 55, 60-61, 63, and 67 are pending. Claims 1-11, 20, 22-38, 40-43, 46, 50-54, 56-59, 62, 64-66, and 68-84 are canceled. Claims 12-19, 21, 45, 48-49, 55, 60-61, 63, and 67 are withdrawn.
Claims 39, 44, and 47 are being examined on the merits in this office action.
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 39, 44, and 47 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 a method of slowing down IRORA and/or cRORA, does not reasonably provide enablement for a method to prevent IRORA and/or cRORA. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1561 (Fed. Cir., 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558,1564 (Fed. Cir. 1996).
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547, the court recited eight factors to consider when assessing whether or not a disclosure would require undue experimentation. These factors are:
1) the quantity of experimentation necessary
2) the amount of direction or guidance provided
3) the presence or absence of working examples
4) the nature of the invention
5) the state of the art
6) the relative skill of those in the art
7) the predictability of the art
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099,1108,427 F.2d 833, 839,166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The breadth of the claims and the nature of the invention
The invention is drawn to a method of slowing or preventing development of iRORA and/or cRORA in a subject, the method comprising: providing, to a subject determined to have one or more drusen in at least one eye, a treatment regimen, wherein the treatment regimen comprises administering to the at least one eye of the subject an effective amount of a C3 inhibitor.
The examiner notes that the instant specification defines “preventing” as causing a disease, disorder, condition or symptom or manifestation of such not to occur for at least a period of time in at least some individuals. Thus, the term has been interpreted expansively.
The term “preventing” is a potent and absolute term indicating that the method of prevention will necessarily prevent the onset of any iRORA and/or cRORA regardless of the cause and in every instance by the administration of the claimed composition. The term “preventing” encompasses a wide range of situations, from preventing a disease from occurring to preventing it from progressing. The applicant is claiming a “method of preventing” in claim 39. Prevention, as defined by Merriam-Webster dictionary, is to keep from happening or existing, which implies taking advance measure against something possible or probable. In addition, preventing embraces complete 100% inhibition. Therefore, the evidence of 100% prevention would be more challenging to obtain than the evidence of treatment since one would have to show that the administration of any C3 inhibitor would never develop any iRORA and/or cRORA. The instant specification is bereft of evidence of prevention of iRORA and/or cRORA. The specification does not demonstrate the efficacy of the elected C3 inhibitor in preventing iRORA and/or cRORA. Since absolute success in preventing iRORA and/or cRORA is not reasonably possible based on the state of the art at the earliest effective filing date of the instant application, the specification, which lacks an objective showing that iRORA and/or cRORA can be actually prevented, is viewed as lacking.
The claims are thus broad insofar as to suggest that following administration of the claimed C3 inhibitor, one will not experience any iRORA and/or cRORA.
The state of the prior art and the level of predictability in the art and the relative skill of those in the art
The state of the art is such that there is evidence that iRORA and/or cRORA, eye diseases such as GA and AMD can be slowed down but not prevented (Corradetti et al.) Given that there is no evidence in the art of a compound that has been found to generally prevent iRORA and/or cRORA, preventing iRORA and/or cRORA is not considered enabled. One of ordinary skill in the art would not be able to use the claimed invention to prevent iRORA and/or cRORA and achieve a reasonable level of success in doing so due to the absence in the art of a compound that is able to prevent iRORA and/or cRORA. It is well established that a utility rejection is therefore proper when the scope of enablement is not reasonably correlated to the scope of the claim.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)”. The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.”
The instant specification is focused on the method of slowing development of iRORA and/or cRORA in a subject as shown in Fig. 5. The specification does not disclose the effect of C3 inhibitor in preventing iRORA and/or cRORA. A method of preventing iRORA and/or cRORA is therefore unpredictable given there is no evidence in the art of a compound that can prevent iRORA and/or cRORA.
See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.).
As a result, the specification needs to have more details on how to make and use the invention in order to be enabling. The relative skill of those in the art is high. However, the art of preventing iRORA and/or cRORA is highly unpredictable.
The examiner cites Corradetti et al. (Clinical and Experimental Ophthalmology (2025) 263:669–677).
Corradetti teaches that the administration of avacincaptad pegol (ACP), to subjects with drusen that the rates of progression from iRORA to cRORA and drusen to iRORA/cRORA were reduced in eyes treated with ACP 2 mg vs. sham, with increasing separation between groups over time, suggesting early intervention may slow disease progression (Abstract). Corradetti does not teach the method prevented iRORA/cRORA.
In light of the state of the prior art, it is apparent that the instantly claimed C3 inhibitor is not capable of use to prevent iRORA/cRORA.
The amount of direction or guidance provided and the presence or absence of working examples
The claims are drawn to a method of slowing or preventing development of iRORA and/or cRORA in a subject, the method comprising: providing, to a subject determined to have one or more drusen in at least one eye, a treatment regimen, wherein the treatment regimen comprises administering to the at least one eye of the subject an effective amount of a C3 inhibitor. The instant specification does not include other examples showing effect of any C3 inhibitor to prevent iRORA and/or cRORA.
The quantity of experimentation necessary
Given the well-known unpredictability of the art as well the incomplete experimental evidence commensurate in scope with the claims, the skilled artisan would not be able to agree that any C3 inhibitor to prevent iRORA and/or cRORA. In order to determine if the claimed C3 inhibitor can prevent iRORA and/or cRORA, the suitable dosage as well as clinical trials or assays that can correlate to clinical efficacy of such treatment would be needed. In addition, prevention embraces complete 100% inhibition. The specification does not include data of prevention of iRORA and/or cRORA. This is undue experimentation given the limited guidance and experimentation provided by the applicant.
In view of the Wands factors discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in unduly burdensome experimentation to assess whether administration of any C3 inhibitor can prevent iRORA and/or cRORA. Thus, the rejection of these claims under 35 USC 112(a) is proper.
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 39, 44 and 47 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.
Regarding claim 39, the phrase "for example" or “e.g.” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 44 has a similar issue.
Regarding claims 39, and 44, the claim contain a parenthesis. It is unclear whether the limitations in the parenthesis are a required part of the claimed invention.
Claim 47 depends on an indefinite claim 39 and is thus rejected.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 39 and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chi et al. (Adv Exp Med Biol. 2010;703:127–135).
Regarding claim 39, Chi teaches a method of administering C3 inhibitor Compstatin on primate model with early-onset macular degeneration and drusen (Abstract; Section 2), that the subjects showed evidence of drusen (Page3, 2nd paragraph). Chi teaches that the C3 inhibitor Compstatin analog is Ac-I[CV(1MeW)QDWGAHRC]T-NH2, and that the compstatin was intravitreally injected into eight affected monkeys at different dose and intervals, that affected monkeys were injected at 1 mg dose at 1 month interval while other four affected monkeys at 50 μg dose at 1 week interval (Page 3, section 4, line 1-6). Chi teaches that the compstatin was injected for 3 months or 6 months (Page 3, section 4, 2nd paragraph, line 1-7). Chi teaches that result showed drusen disappearance after 6 months of intravitreal injection.
Examiner notes that Chi teaches administering the instant C3 inhibitor, at the instant duration, to the instant patient population i.e. subjects that have one or more drusen in the eye. Thus, the expected result of slowing or preventing development of iRORA and/or cRORA would naturally flow as a result of practicing the instant invention. Further, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “ MPEP 2112.01. The teachings of Chi anticipate claim 39.
Regarding claim 47, Chi teaches that the C3 inhibitor Compstatin analog is Ac-I[CV(1MeW)QDWGAHRC]T-NH2, and that the compstatin was intravitreally injected into eight affected monkeys at different dose and intervals (Page 3, section 4, line 1-6).
Claims 39 and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Francois et al. (WO2014028861A1 – hereinafter “Francois”).
Regarding claim 39, Francois teaches a method of administering a C3 inhibitor to a subject [0007-0008, 00377] wherein the subject has drusen [00174, 00228], and wherein the subject also has early or intermediate AMD [0005, 0009, 0015, 00228]. Francois teaches that the compound or composition is administered intravitreally [00430] and the composition is administered over a period of weeks or months e.g. 6-12 months or 1-2 years [00438]. Francois teaches that the time period for the subject to develop the eye condition is between 6 months and 5 years [0006, 0011].
Examiner notes that Francois teaches administering the instant C3 inhibitor, at the instant duration, to the instant patient population i.e. subjects that have one or more drusen in the eye. Thus, the expected result of slowing or preventing development of iRORA and/or cRORA would naturally flow as a result of practicing the instant invention. Additionally, Examiner notes that the limitations of the wherein clause, wherein the subject does not develop iRORA and/or cRORA for at least 6 month etc., Examiner notes that Francois discloses the active step of administering the instant C3 inhibitor to the patient population and thus the result of the subject not developing iRORA and/or cRORA for at least 6 month etc. would have been inherently accomplished. Further, Examiner notes that the limitations of the wherein clause is a discovery of a previously unappreciated property of the method steps. Further, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “ MPEP 2112.01.
Regarding claim 47, Francois teaches that the compound or composition is administered intravitreally [00430] and the composition is administered over a period of weeks or months e.g. 6-12 months or 1-2 years [00438].
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.
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 44 is rejected under 35 U.S.C. 103 as being unpatentable over Francois et al. (WO2014028861A1 – hereinafter “Francois”) as applied to claim 39 above, and further in view of C
Francois teaches a method of administering a C3 inhibitor to a subject [0007-0008, 00377] wherein the subject has drusen [00174, 00228], and wherein the subject also has early or intermediate AMD [0005, 0009, 0015, 00228]. Francois teaches that the compound or composition is administered intravitreally [00430] and the composition is administered over a period of weeks or months e.g. 6-12 months or 1-2 years [00438]. Francois teaches that the time period for the subject to develop the eye condition is between 6 months and 5 years [0006, 0011].
Examiner notes that Francois teaches administering the instant C3 inhibitor, at the instant duration, to the instant patient population i.e. subjects that have one or more drusen in the eye. Thus, the expected result of slowing or preventing development of iRORA and/or cRORA would naturally flow as a result of practicing the instant invention. Additionally, Examiner notes that the limitations of the wherein clause, wherein the subject does not develop iRORA and/or cRORA for at least 6 month etc., Examiner notes that Francois discloses the active step of administering the instant C3 inhibitor to the patient population and thus the result of the subject not developing iRORA and/or cRORA for at least 6 month etc. would have been inherently accomplished. Further, Examiner notes that the limitations of the wherein clause is a discovery of a previously unappreciated property of the method steps. Further, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “ MPEP 2112.01.
Francois does not teach the steps of determining iRORA as recited in claim 44.
Guymer teaches optical coherence tomography (OCT) based anatomical changes often identified prior to the development of “complete RPE and outer retinal atrophy (cRORA)” in age-related macular degeneration (AMD) (Abstract). Guymer teaches that in the context of AMD with conventional drusen, iRORA is defined on OCT by the following criteria: (1) a region of signal hypertransmission into the choroid and (2) a corresponding zone of attenuation or disruption of the RPE, with or without persistence of basal laminar deposits (BLamD), and (3) evidence of overlying photoreceptor degeneration, i.e., subsidence of the inner nuclear layer (INL) and outer plexiform (OPL), presence of a hyporeflective wedge in the Henle fiber layer (HFL), thinning of the outer nuclear layer (ONL), disruption of the external limiting membrane (ELM), or disintegrity of the ellipsoid zone (EZ) (Page 7, 1st paragraph). Guymer teaches area of photoreceptor loss is a zone of attenuation and disruption of the RPE (<250µm) and a region of signal hypertransmission into the choroid is < 250 μm in continuity (page16, last 2 lines). Guymer teaches that iRORA starts developing at 6 months and continues until after 48 month (Page 19, 1st paragraph).
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 teachings of Francois and Guymer and use the method of Guymer to detect iRORA since Guymer teaches that the method was important to provide descriptive OCT and histological examples of disease progression (Abstract). One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in using the method of Guymer to detect iRORA since Guymer teaches that the method was important in showing progression of atrophy (Abstract). The disclosures render obvious claim 44.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MERCY H SABILA/Examiner, Art Unit 1654