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 .
Applicant’s election without traverse of group, claims 36-38 and 59, as well as the species Ile174Asn, and position 4269 according to SEQ ID NO: 1 in the reply filed on 5/15/25 is acknowledged.
Claims 1-5, 15-17, 66, 85-87, and 104 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/15/25.
Due to lack of prior art, Ile174Asn, Arg231Cys, Arg248Cys, or His266Gln have been rejoined.
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 36-38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to delivery of an inhibitor wherein the “ANGPTL7 inhibitor comprises an inhibitory nucleic acid molecule that hybridizes to a sequence within an ANGPTL7 genomic nucleic acid molecule or mRNA molecule and decreases expression of the ANGPTL7 polypeptide in a cell in the subject”. However, the specification does not adequately describe the structure required for the agent to have the function of decreasing expression of ANGPTL7. Without further description of the structure required for the function, one would not be able to readily recognize which inhibitory nucleic acid molecules that hybridize to any sequence of any length within any ANGPTL7 genomic nucleic acid molecule or mRNA molecule would achieve the required function and would therefore not be able to recognize that applicant was in possession of the entire claimed genus at the time of filing.
Although the specification discloses that inhibitory agents include antisense molecules, siRNA, shRNA, or Cas protein and gRNAs, these species are not representative of the entire claimed genus. Additionally, not any siRNA, for example, that is able to hybridize to any sequence of any length within any ANGPTL7 genomic nucleic acid molecule or mRNA molecule would achieve the required function.
The MPEP states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. See MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618. Additionally, in Carnegie Mellon University v. Hoffman-La Roche Inc., Nos. 07-1266, -1267 (Fed. Cir. Sept. 8, 2008), the Federal Circuit affirmed that a claim to a genus described in functional terms was not supported by the specification’s disclosure of species that were not representative of the entire genus. Furthermore, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The claims are rejected under the written description requirement for failing to disclose adequate species to represent the claimed genus, the genus being inhibitory nucleic acid molecule that hybridizes to a sequence within an ANGPTL7 genomic nucleic acid molecule or mRNA molecule and decreases expression of the ANGPTL7 polypeptide in a cell in the subject.
The Guidelines for Examination of Patent Applications under the 35 USC § 112, first paragraph, “Written Description” Requirement”, published at Federal Register, Vol. 66, No. 4, pp. 1099-1111 outline the method of analysis of claims to determine whether adequate written description is present. The first step is to determine what the claim as a whole covers, i.e., discussion of the full scope of the claim. Second, the application should be fully reviewed to understand how applicant provides support for the claimed invention including each element and/or step, i.e., compare the scope of the claim with the scope of the description. Third, determine whether the applicant was in possession of the claimed invention as a whole at the time of filing.
Thus, having analyzed the claims with regard to the Written Description guidelines, it is clear that the specification does not disclose a representative number of species within the instant enormous genus that function as claimed. Thus, one skilled in the art would be led to conclude that Applicant was not in possession of the claimed invention at the time the application was filed.
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 36-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,845,989 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are obvious variations of each other. Claims 1 and 2 of US ‘989 B2 are as follows:
1. A method of treating a patient having glaucoma or increased intraocular pressure (TOP), the method comprising administering an angiopoietin like 7 (ANGPTL7) inhibitor to the patient, wherein the ANGPTL7 inhibitor comprises an antisense molecule that hybridizes to a sequence within an ANGPTL7 mRNA or an ANGPTL7 genomic nucleic acid molecule and decreases expression of the ANGPTL7 polypeptide in a cell in the patient.
2. The method according to claim 1, wherein the antisense molecule comprises an antisense nucleic acid molecule, a small interfering RNA (siRNA), or a short hairpin RNA (shRNA) that hybridizes to an ANGPTL7 mRNA.
The instant claims are directed to a method of treating a subject with an agent that treats or inhibits glaucoma or increased intraocular pressure (IOP), wherein the species of US ‘989 B2 are glaucoma or increased intraocular pressure (IOP). Determination of Il2174Asn as instantly recited is a species that anticipates the broader genus of claim 1 of US ‘989 B2, as evidenced by claim 3 of US ‘989 B2 that recites the additional step of detecting the presence of variants. The inhibitory agents recited in US ‘989 B2 are species that anticipate the instant genus of any agent that inhibits any ophthalmic condition.
Claims 36-38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 11,767,526 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are obvious variations of each other. Claims 1-3 of US ‘526 B2 are as follows:
1. A method of treating a patient having glaucoma or increased intraocular pressure (IOP), the method comprising administering an angiopoietin like 7 (ANGPTL7) inhibitor to the patient, wherein the patient lacks an ANGPTL7 predicted loss-of-function variant nucleic acid molecule or is heterozygous for an ANGPTL7 predicted loss-of-function variant nucleic acid molecule, wherein the ANGPTL7 predicted loss-of-function variant nucleic acid molecule encodes ANGPTL7 Arg177Stop or Trp188Stop.
2. The method according to claim 1, wherein the ANGPTL7 inhibitor comprises an antisense nucleic acid molecule, a small interfering RNA (siRNA), or a short hairpin RNA (shRNA) that hybridizes to an ANGPTL7 mRNA.
3. The method according to claim 1, further comprising detecting the presence or absence of the ANGPTL7 predicted loss-of-function variant nucleic acid molecule in a biological sample from the patient.
The instant claims are directed to a method of treating a subject with an agent that treats or inhibits glaucoma or increased intraocular pressure (IOP), wherein the species of ‘526 B2 are glaucoma or increased intraocular pressure (IOP). Determination of Il2174Asn as instantly recited is a species that anticipates the broader genus of claim 1 of US ‘526 B2, as evidenced by claim 3 of US ‘989 B2 that recites the additional step of detecting the presence of variants. The inhibitory agents recited in US ‘526 B2 are species that anticipate the instant genus of any agent that inhibits any ophthalmic condition.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy R Hudson whose telephone number is (571)272-0755. The examiner can normally be reached M-F 8:00am-6:00pm.
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/AMY ROSE HUDSON/Primary Examiner, Art Unit 1636