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 .
Response to Election/Restriction filed on June 1, 2026 is acknowledged.
Claims 1-20 are pending in this application.
Applicant has not filed a Power of Attorney (POA) on the record. Applicant is required to file a POA in response to this office action.
Restriction
5. Applicant’s election of Group 1 (claims 1-19) and elected the following species:
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in the reply filed on June 1, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The restriction is deemed to be proper and is made FINAL in this office action. Applicant indicates that claims 1-2, 5-6, 9, 12-15, 17 and 19 read on the elected species. Claim 20 is withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. Claims 3-4, 7-8, 10-11, 16 and 18 are withdrawn from further consideration as being drawn to nonelected species. Claim 19 depends from nonelected species claim 11, therefore, claim 19 is withdrawn from further consideration. Claims 1-2, 5-6, 9, 12-15 and 17 are examined on the merits in this office action.
Objections
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
6. Claim 1 is objected for the following: Claim 1 recites, “A method of treating glaucoma, comprising administering to an eye in need thereof...”. Dependent claims recite, “…wherein the administering step…” Applicant is recommended to amend claim 1 to recite, “A method of treating glaucoma, comprising a step of administering…”
7. Claim 9 is objected to for the following: Claim 9 recites, “The method of claim 1, wherein the administration step comprises delivering recombinant serpinA3 administered by intravitreal injection.” The should be corrected to recite, “The method of claim 1, wherein the administering step comprises intravitreal injection of the serpinA3 polypeptide.” Furthermore, the term “administration” is different from “administering”. Applicant is required to correct these errors.
8. Claim 12 is objected for the following: Claim 12 recites, “The method of claim 1, further comprising treating the eye, or a person comprising the eye, a second, different glaucoma treatment…” The recitation “or a person comprising the eye” needs to be rephrased or deleted.
Rejections
35 U.S.C. 101
9. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
10. Claims 13-15 and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim(s) 13-15 and 17 recite(s) an abstract idea, determining, observing, detecting and diagnosing. This judicial exception is not integrated into a practical application because the claims recite mental processes. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the following reasons. This judicial exception is not integrated into a practical application because the claim recites abstract idea, which falls into the mental process grouping. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because for the following reasons.
The rationale for this determination is explained below and is based on the analysis presented in the USPTO’s “2014 Interim Eligibility Guidance” as set forth on December 16, 2014, Revised Guidance set forth on May 2016, and 2019 Revised patent Subject Matter Eligibility Guidance set forth on January 7, 2019. See MPEP 2106.04(c).
Step 1: The instant claims are directed to a series of steps, therefore, is a process.
Step 2a Prong 1: The claims recites “detecting a resultant amelioration” which falls within mental processes (concepts performed in the human mind, including an observation, evaluation, judgment, and opinion) grouping of Abstract Ideas.
Step 2a Prong 2: This judicial exception is not integrated into a practical application because the recited determination of knee joint pain does not require any particular application of the recited detecting a resultant amelioration, and is at best the equivalent of merely adding the words “apply it” to the judicial exception.
Step 2b: The claims, as a whole, do not recite any additional elements that amount to significantly more than the judicial exception. Specifically, the claims do not include any elements in addition to a mere instructions to apply an exception. The recitation of detecting a resultant amelioration of the glaucoma, which does not require any particular application of the recited detection and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Therefore, mere instructions to apply an exception cannot provide an inventive concept .
In sum, when the relevant steps are analyzed, they weigh against a significant difference. Accordingly, claims 13-15 and 17 do not qualify as eligible subject matter.
Please see MPEP 2106.04(c).
U.S.C. 112(b)
11. 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.
12. Claim 9 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.
13. Claim 9 recites the limitations “the administration step” and "recombinant serpinA3" in the claim (lines 1-2). There is insufficient antecedent basis for these limitation in the claim. Claim 9 depends from claim 1. Claim 1 recites, “administering…a serpinA3 polypeptide…” Claim 1 does not recite “administration” and “a recombinant serpinA3 polypeptide”. Therefore, there is lack of antecedent basis.
U.S.C. 103
14. 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.
15. 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.
16. 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.
17. 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.
18. Claim(s) 1-2, 5-6, 9, 12-15 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen reference (US 2020/0157158, filed with IDS) in view of Zhang et al (Diabetes, 2010, 59: 1809-1816, filed with IDS). Chen reference teaches treating glaucoma by locally administering to an eye in need thereof formulations of a Wnt5a inhibitor (see abstract). Chen reference teaches that the method can be used alone to lower intraocular pressure and to prevent or treat glaucoma, and/or in combination with other therapeutic approaches, such as eye drops, medications, laser, implanted devices, and surgery, etc. to prevent or treat glaucoma (see paragraph [0023]), meeting the limitation of instant claim 12, in part. Chen reference teaches the method further comprising detecting a resultant amelioration of glaucoma by decrease in retinal ganglion cell (RGC) death or axonal damage (see claims 11-20, for example), meeting the limitation of instant claims 13-15 and 17. Chen reference teaches administering step comprises delivering the therapeutic polypeptide, the administering step comprises delivery by eye drop or by intracameral, subconjunctival injection or intravitreal injection (see claims 2-4, for example), meeting the limitation of instant claims 1-2, in part, 5-6 and 9.
The difference between the reference and the instant claims is that the reference does not teach serpinA3 polypeptide.
19. However, in regards to instant claims 5-6 and 9, Zhang et al teach SERPINA3K inhibits Wnt pathway activation in diabetic retinas (see Title and Objective). Zhang et al teach that SERPINA3K was injected intravitreally into streptozotocin-induced diabetic rats (see Research Design and Methods). Zhang et al teach that SERPINA3K is a serine protease inhibitor, and its levels were decreased in retinas with diabetic retinopathy. The purpose of this study was to investigate the role of SERPINA3K in the regulation of CTGF (connective tissue growth factor) and fibrogenesis and its mechanism of action…increased SERPINA3K blocked the Wnt pathway activation in diabetic retinas and in cells treated with high glucose. Further, SERPINA3K also attenuated the Wnt3a-induced activation of the canonical Wnt pathway and the overexpression of CTGF…SERPINA3K is an antifibrogenic factor, and its antifibrogenic activity is through blocking the Wnt pathway (see throughout the reference, for example, “Results”). Furthermore, in regards to instant claims 1-2 and 9, Zhang et al teach recombinant proteins of SERPINA3K (see for example, p. 1810, left column, “Recombinant proteins, adenovirus, plasmids, transfection, and reporter Assay”).
20. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Chen reference and Zhang et al because both references teach a method of treating glaucoma by administering a polypeptide that is a Wnt5 inhibitor and by inhibiting Wnt expression pathway. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success because Chen reference teaches administering to an eye in need thereof formulation of a Wnt5a inhibitor, and Zhang et al teach inhibition of connective tissue growth factor overexpression by administering SERPINA3K polypeptide by intravitreal injection. One Since Zhang et al teach that SERPINA3K inhibits Wnt pathway activation in diabetic retinas, it would have been obvious to one of ordinary skill in the art that serpinA3 polypeptide could be used as the Wnt inhibitor for the glaucoma treatment method to provide any increased specificity and/or efficacy. One of ordinary skill in the art would have a reasonable expectation of success, since Chen reference teaches a method of treating glaucoma by inhibiting Wnt pathway, and Zhang et al teach that SERPINA3K inhibits Wnt pathway activation, one would at least expect that serpinA3 polypeptide would have the same effect. Therefore, the combined art is prima facie obvious over instant claims 1-2, 5-6, 9, 12-15 and 17.
Improper Markush
21. Claims 1, 5-6, 9, 12-15 and 17 are rejected on the judicially created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F. 2d 716, 721-22 (CCPA 1980) and Ex parte Hazumi, 3 USPQ 2d 1059, 1060 (BPAI 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons: The compounds claimed do not share a common structural feature. For example, serpinA3 polypeptide and the polypeptide encoding nucleic acids do not share a common core sequence. Polypeptides involve amino acids and amide bonds. Nucleic acids involve sugars, bases, phosphates and glycosidic bonds.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. § 134 and 37 CFR 41.31 (a)(1) (emphasis provided).
Art of Interest
Kontoh-Twumasi et al (Investigative Ophthalmology and Visual Science, iovs.arvoJournals.org, published 2/7/2024, pp. 1-9) teach roles of serine protease inhibitors A1 and A3 in ocular pathologies (see Title). Kontoh-Twumasi et al teach that SerpinA3, also known as a-1-antichymotyrpsin, is expressed both extracellularly and intracellularly in various tissues…It exerts anti-inflammatory, anti-angiogenic, antioxidant, and antifibrotic activities. Both SerpinA1 and SerpinA3 have been implicated in conditions such as keratitis, diabetic retinopathy, age-related macular degeneration, glaucoma, cataracts, dry eye disease, keratoconus, uveitis, and pterygium (see abstract).
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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/JULIE HA/Primary Examiner, Art Unit 1654
7/8/2026
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