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 .
Applicant’s amendment and argument of 9/4/26 are entered.
Claims 6 and 8-9 are amended.
Claim 10 is canceled.
Claims 1 and 3-9 are pending and considered herein.
Claim Status, Canceled Claim(s)
In light of the cancelation of Claim 10, all objections/rejections against such claim(s) are withdrawn.
Formalities:
The IDS filing of 9/4/26 and references therein are considered. A signed copy is provided herewith.
Claim Objections
In light of the amendments to Claims 9 and 6, the warning and objective, respecitively, against these claims, are withdrawn.
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, 3-5, and 7 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,793,862. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 1 and 9: The patent teaches AAV8 vector (e.g., Claim 8) encoding Ssu72 (Claim 1) operably linked to a TBG (e.g., Claim 11) or CMV promoter (e.g., Claim 13), which is used in the claimed methods.
Claim 3: the Ssu72 peptide may have SEQ ID NO: 1 (e.g., Claim 2).
Claim 4: the polynucleotide may be SEQ ID NO: 2 (e.g., Claim 3).
Claim 5: Claim 1 teaches similar treatment of similar disorders, comprising systemic or intra-hepatic injection of an expression vector encoding Ssu72, the patient having lowered expression/activity of Ssu72 in the liver than normal. Claim 8 teaches it may be an AAV8 vector.
Claim 7: Claim 14 teaches similar prevention of the same Markush of disorders, comprising administering an expression vector, which may be AAV8 (e.g., Claim 20), operably linked to a TBG or CMV promoter (e.g., Claims 23-24), the Ssu72 peptide being SEQ ID NO: 1, and the patient having lowered expression activity of Ssu72 in the liver intra-hepatic administration (e.g., Claim 14). The operably linked promoter may be CMV (e.g., Claim 10) or TBG (e.g., Claim 11).
Claim 9: the patent claims are to systemic/intrahepatic administration, which necessarily requires a carrier, e.g., water, otherwise it could not be so-administered.
Thus, in light of the patent, the compositions and methods are obvious. The Artisan would make the composition and perform the methods, in the process of practicing the claimed methods, and would expect success as it is claimed subject matter.
Claims 1 and 3-9 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11,793,862 in view of Sands (2011) “AAV-Mediated Liver-Directed Gene Therapy”, Methods in Molecular Biology, 807: 141-57 (provided as an NIH Public Access document, 17 pages long).
As shown above, the claims are obvious over the patent alone, aside from Claims 6 and 8, which require the systemic administration to be one of several. One of these several is intravenous injection. The same is not claimed in the patent’s claims. However, the Artisan, interested in targeting the liver with AAV would be aware of Sands for teaching AAV-Mediated Liver-Directed Gene Therapy (i.e., the title). Sands teaches that AAV8, administered by way of intra-portal vein injection (one form of intravenous) targets the liver effectively (e.g., ABSTRACT).
Thus, in light of the patent and Sands, it would be obvious to perform an intra-hepatic portal vein injection of AAV8 to deliver the vector to the liver. The Artisan would do so, because it is an effective method of liver delivery. The Artisan would expect success, as the components are utilized for art-recognized purposes.
Claims 1, 3-4, and 9 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 11,918,632. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1: Claim 1 teaches an AAV vector with a promoter operably linked to a coding sequence of Ssu72. Claim 4 makes clear it may be an AAV8 vector. Claims 5-6 teach the TBG promoter.
Claim 3: Claim 2 teaches Ssu72 may have amino acid sequence of SEQ ID NO: 1.
Claim 4: Claim 3 teaches the nucleotide may be SEQ ID NO: 2.
Claim 9: the patent claims are to systemic/intrahepatic administration, which necessarily requires a carrier, e.g., water, otherwise it could not be so-administered.
Thus, in light of the patent, the invention is obvious. The Artisan would make the vectors, in the process of practicing the claimed invention. The Artisan would expect success, as it is claimed.
Response to Argument – NSDP rejections
Applicant’s argument of 9/4/26 have been considered but are not found persuasive.
Applicant argues that the claims are to distinct statutory classes (p. 5, paragraph 4).
Such is not persuasive. There is no restriction against it, and the compositions are required to be made to affect the methods of the claims of the patents.
Applicant argues that the compositions have distinct uses (Id.).
Such is not persuasive. The compositions are still required. Its not like they do not exist for the patent. There is no restriction against it, and the compositions are required to be made to affect the methods of the claims of the patents.
Applicant argues that Claim 9 requires a carrier, and this is not claimed by the patents (p. 5, last paragraph).
Such is not persuasive. The formulations require carriers, otherwise they could not be so-administered by system/intra-hepatic injection, as claimed.
Applicant argues that Claims 3-4 define the product by particular sequences (Id.).
Such is not persuasive. Clearly the patents claim the same sequences, as provided above.
Applicant argues that Claims 5 and 7 require administration of the vectors claimed (Id.).
Such is not persuasive. The secondary art provides specifically for intra-portal vein injection.
Applicant argues that the AAV8 vector, incombination with TBG or CMV rpomtoer and a polynucleotide encoding Ssu72, is not taught in either patent (p. 6, paragraph 2).
Such is not persuasive. Theres really nothing to argue, except that the argument appears to ignore the substance of the rejections.
Applicant argues the elements of the AAV8, TBG promoter, and Ssu72 are reached through separately-depending claims, rather than in a single claimed construct (p. 6, paragraphs 3-4).
Such is not persuasive. This is not a rejection for anticipation, but a non-statutory double patenting rejection, previously referred to by the office as an “obviousness-type” double patenting rejection. The analysis does not require anticipation of the whole of the claim in the same order, but an obviousness-type analysis.
Applicant argues, without citation of case law, that the claims are provided with no teaching, suggestion or rationale and reasonable expectation of success, to combine the elements, besides hindsight construction (p. 6, penultimate paragraph).
Such is not persuasive. The motivation is they are part of the invention claimed for such treatments. If they are disparate parts, how is it they are all in the claims? Also, the rationale and expectation are provided, as they are claimed limitations.
Applicant argues that Sands is concerned with liver targeting of AAV and does not suggest AAV8, with Ssu72 with the TBG or CMV promoter or the specific diseases Applicant claims (p. 7, paragraphs 2-3).
Such is not persuasive. Sands is not utilized in a rejection for anticipation. It is an obiovusness standard that is required, in conjunction with the claims of the patent. Sands is clearly provided with reasoning why it is utilized. What is wrong with its reasoning? As far as teaching the specific elements in the order Applicant claims, the rejection is not against Sands alone, but with the patent.
Claims Free of the Art
The claims remain free of the Art of record. Hwang, et al. (2021) “Ssu72 Dual-Specific Protein Phosphatase: From Gene to Diseases”, International Journal of Molecular Sciences, 22: 3791, 17 pages long, provides a review of the state of the Art for the Ssu72 in disease. It is noted that Ssu72 shown to be associated with fatty liver diseases, as of 2016 (e.g., page 8 and Figure 3). However, it had not been shown in animal models to reduce the level of disease and slow its progression, by way of replacement, until Applicant’s disclosure. Applicant’s disclosure in several mouse models is extensive showing phenotypic, genotypic expression, fibrosis, and fat depositions, which all demonstrate treatment and slowing the progression of the diseases. The animal models are also well known and accepted models. Thus, the claims are free of the art of record.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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