DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on September 12, 2025, has been received and entered.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 4, 2026 has been entered.
Claim Disposition
3. Claims 1-13, 15, 17 and 20 have been cancelled. Claims 34-36 have been added. Claims 14, 16, 18-19 and 21-36 are pending and are under examination.
Claim objection
4. Claims 14, 16, 18-19 and 21-36 are objected to for the following informalities:
For clarity it is suggested that claim 14 is amended to read, “…..wherein the codon-modified human gene has a sequence….., wherein the wild-type human…….SEQ ID NO:9, [[and]] wherein the codon-modified equine…, and wherein the wild-type equine…..”.
composition having [[comprising]] a recombinant …..particle with [[comprising]] a recombinant nucleic acid comprising a codon-modified gene….wherein [[ the codon-modified gene encodes]] the IL-1Ra is a human IL-1Ra or equine IL-1Ra, wherein ….”. See also claim 34 with similar language. The dependent claims hereto are also included.
Claims 16 and 19 are identical to claims 35 and 36 directed to human and equine, thus deletion of one set is need.
Appropriate correction is required.
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.
5. Claims 14, 16, 18-19 and 21-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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 claimed invention is directed to a pharmaceutical composition comprising a recombinant rAAV particle comprising a recombinant nucleic acid comprising a codon-modified gene encoding IL-1Ra (human/equine) that increases expression of IL-1Ra compared to a wild type gene encoding the same …..” (see claim 14 in its entirety and claim 34 with similar language). The claimed invention is not adequately described because no activity is recited for the composition and no specific structure because the claimed invention recites 10-30% sequence mismatch compared to the wildtype human set forth in SEQ ID NO:9 or 10-30% sequence mismatch set forth in SEQ ID NO:1 for the equine. There are no indicia as to a specific position deleted or a specific amino acid substituted or inserted or whether said structure once modified retains activity. Additionally, there is increased expression compared to the wildtype, but no assertion of increased or retained activity of the native structure with these modification which are not specifically described. The claims recite percentages of mismatch, however, the mismatch is not defined and also not limited to just 30% with the open language in the claims. Thus, the structure can be 70% identical to the recited SEQ ID NOs: 9 or 1 but not limited to such. No correlation is made between structure and function. The composition can be construed as for administration to a subject and no activity is provided, nor is the structure adequately described. The claimed invention is encompasses a large variable genus genes. It is generally acknowledged in the art that multiple genes can encode the same protein and a single amino acid change can be detrimental to the structure-function relationship. In addition, there are no indicia as to how much increase the gene modification results in. The claim language is broad, no structure function correlation is made and encompasses a large variable genus of products. Thus the claimed invention is not adequately described.
The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
Basis For NonStatutory Double Patenting
6. 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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
7. Claims 14, 16, 18, 22-25 and 34-35 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 14-22 and 28-33 of U.S. Application No. 19/556,106. An obvious-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); and In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). Although the conflicting claims are not identical, they are not patentably distinct from each other.
The instant application claims are directed to a pharmaceutical composition comprising a recombinant rAAV particle having a recombinant nucleic acid with a codon-modified gene encoding IL-1Ra that increases expression of IL-1Ra compared to a wild type human….with 10-30% mismatch to SEQ ID NO:9 (see claim 14 in its entirety). The copending application claims are drawn to a pharmaceutical composition comprising a vector comprising and IL-1Ra encoding nucleic acid sequence with 10-30% mismatch to wildtype human IL-1Ra. The dependent claims align with the instant application in reciting a codon-modified gene encoding IL-1Ra that increases expression of IL-1Ra compared to a wild type human….with SEQ ID NO: 9 being that structure. The two sets of claims differ because the instant claims recite human or equine IL-1Ra, however, it is in the alternative and still encompasses the copending claim to human IL-1Ra.
Although the scope of the two sets of claims differs, the two sets of claims are an obvious variation of each other, thus prima facie obvious. This is a provisional obvious type double patenting rejection.
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.
8. 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.
9. Claim(s) 14, 16, 18-19 and 21-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghivizzani et al. (US2008/0187576 of record in the application) in view of Cho (US 2013/0295614 of record in the application), Wehling (US2012/0237587, of record in the application), Goodrich, et al. (hereinafter 'Goodrich'), (WO2018035441, August 19, 2016 of record in the application) and Fotin-Mleczek (WO2016170176, October 27, 2016).
Ghivizzani et al. (hereinafter 'Ghivizzani') discloses a recombinant adeno-associated virus (rAAV) particle (recombinant AAV vectors and particles; paragraph [0025])
comprising a recombinant nucleic acid (recombinant DNA or RNA; paragraph [0152]) comprising a gene encoding IL-1Ra (viral vector encoding IL-1ra; paragraph [0022]). Ghivizzani does not disclose wherein the particle comprises a codon-modified gene encoding IL-1Ra. However, Cho discloses a recombinant (vector-transfected) IL-1Ra (paragraphs [0058], [0084]) wherein the IL-1Ra is comprises a codon-modified
gene encoding IL-1Ra (codon-optimized IL-1Ra; paragraph [0047]). Wehling, et al. (hereinafter 'Wehling') discloses equine IL-1Ra (eqiL-1Ra) (paragraph [0030]). Goodrich discloses a recombinant nucleic acid (optimized transgene (recombinant nucleic acid); abstract; page 3, first column, second paragraph) comprising a codon-modified gene encoding IL-1Ra (page 8, first column, first paragraph) and teach the structures with substantial sequence similarity (SEQ ID NO: 1, 2 and 11), such as 92.6% sequence identity with SEQ ID NO:2. In addition, Fotin-Mleczek teach a structure that is substantially similar to SEQ ID NO: 9 (see abstract and entire document). Based on the variability encompassed in the claimed invention, meets the limitations.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because, it would have been obvious to have modified the disclosure of Ghivizzani to provide wherein the rAAV particle comprises a codon-modified gene encoding IL-1Ra, because codon-modification of nucleic acid encoding IL-1Ra for use in vector transfection as disclosed by Cho would have motivated the use of codon-optimized IL-1Ra for delivery in the recombinant adeno-associated virus as previously disclosed by Ghivizzani in order to enhance the recombinant yield of IL-1Ra. The combination of the references render the claimed invention as obvious.
Moreover, the Supreme Court pointed out in KSR, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSR, 127 S. Ct. at 1741. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” Id. at 1741. The Court further advised that “[a] person of ordinary skill is…a person of ordinary creativity, not an automation.” Id. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
WO2016170176A1
WIPO (PC61701762016170176A1
Response to Arguments
10. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Applicant made amendments to the claims and indicated that they are now allowable, however, the amendments did not obviate the 112 first paragraph rejection for the reasons stated above and herein. The applicant has claimed a pharmaceutical composition with a pharmaceutically acceptable carrier that comprises a recombinant nucleic acid with a codon modified gene encoding IL-Ra (human or equine) and there is no activity or specific structure provided for the claimed composition. Note that new rejections and objections have been instituted for the reasons set forth above.
Conclusion
11. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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