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 .
Claims 31-50 are pending as amended 6/15/23 and are considered herein.
Formalities
Applicant’s priority is recognized to be a CON to 16/734,156 (US PAT 11,7157,5140, filed 1/3/2020, which is a CON to 16/381,557 (US PAT 10,525,090), filed 4/11/2019, which claims benefit of 62/656,768, filed 4/12/2018.
The IDS filings of 9/27/23; 2/15/24; 9/24/24; 11/26/24; and 1/8/25, and the references therein have been considered. Signed copies of the IDSs are supplied herewith.
The drawings of 6/15/23 are accepted, as it is noted the office has granted the petition for color drawings on 8/14/23.
The specification of 6/15/23 is accepted.
Claim Objections
Applicant is advised that should claim 31 be found allowable, claims 36, 38, and 39 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 36 teaches the replication defective virus has reduced cytotoxicity versus wild-type. However, such necessarily occurs, as it is replication defective. Claim 38 requires the formulation to be suitable for various forms of administration, however, the composition itself is so-suitable, and thus, the structure is the same scope. Claim 39 requires the composition to be suitable for topical administration. However, this does not change the composition claimed. Thus, for each of these claims, despite the slight difference in wording, these claims have substantially the same scope.
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 31-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,717,547. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 31: Claim 1 is drawn to the same replication defective herpes virus, with a TGM transgene, and a pharmaceutically acceptable excipient.
Claims 32-33: HSV-1 is claimed in Claim 1.
Claim 34: TGM 1-7 are claimed in Claim 2.
Claim 35: human TGM is claimed in Claim 3.
Claim 36: as stated in the objection warning, above, the replication defective virus is necessarily reduced in cytotoxicity.
Claim 37: HSV-1 is claimed in Claim 1.
Claim 38: several intended forms of administration are claimed (Claim 4).
Claim 39: topical administration formulation is claimed in Claims 4-5.
Claim 40: Similar to patent claim 1, the same composition is delivered, and the essential written description is to express the TGM (e.g., brief summary). Thus, this is what is intended to occur.
Claim 41: the subject may be human, as in Claim 12.
Claim 42: the same forms of administration of taught in Claim 13.
Claim 43: topical administration is taught in Claim 14.
Claims 44-45: HSV-1 is taught in Claim 11.
Claim 46: the same TGM 1-7 is claimed in Claim 15.
Claim 48: as it is replication defective, it necessarily has reduced cytotoxicity.
Claim 49: HSV-1 is taught in Claim 11.
Claim 50: Claim 16 teaches cells of the skin.
Thus, in light of the patent, the invention is obvious. The artisan would do so to express the TGM transgene. The Artisan would expect success, as it is claimed subject matter.
Claims 31-50 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 10,525,090. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 31: Claim 1 teaches an HSV comprising a TGM1 transgene and an excipient. Claim 3 indicates it may be replication defective.
Claim 32: Claim 4 teaches the same Markush of virus genomes.
Claim 33: Claims 4-5 each indicate HSV-1.
Claim 34: Claim 1 teaches TGM1.
Claim 35: Claim 7 teaches human TGM1.
Claim 36: Claim 3 indicates replication defective, which is necessarily reduced in cytotoxicity.
Claim 37: HSV1 is taught as well as replication defective (Claims 1 and 3).
Claim 38-39: Claims 12-13 teach the same, although it is argued the broad claim structure has not changed, as it merely an intended use, and not an actual administration.
Claim 40: Claim 14 parallels Claim 1, but is to the treatment of ARCI. Claim 29 teaches replication defective.
Claim 41: Claim 15 indicates human treatment.
Claims 42-43: the routes of administration include at least topical (Claim 14).
Claim 44: the same genomes are taught (Claim 20).
Claim 45: Claims 21-22 teach HSV-1.
Claim 46: TGM1 is taught in Claim 14.
Claim 47: Claim 32 teaches human TGM1.
Claim 48: Claim 25 teaches reduced cytotoxicity.
Claim 49: Claim 20 teaches the same genomes.
Claim 50: topical administration necessarily yields targeting of skin cells, and Claim 14 provides topical administration.
Thus, in light of the patent, the invention is obvious. The Artisan would make it, and expect success, as it is claimed subject matter.
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 31-50 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 topical administration of TCM1 transgene-carrying herpes virus, to treat TGM1-caused ARCI, does not reasonably provide enablement for the breadth of reasons for doing it, the breadth of virus types, and the breadth of transglutaminase gene. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
The claims are broad for enhancing/increasing/augmenting/supplementing the expression of any TGM polypeptide in any cells of the subject, comprising administering by any route of administration, any herpesvirus encoding the TGM polypeptide. Claim 42 indicates the administration may be topical, transdermal, subcutaneous, intradermal, or tranmucosal, indicating the broad claims encompass more. Claim 44 includes several herpesvirus types. Claim 46 indicates the TGM polypeptide may be one of TGM1 through TGM7, indicating the broad claims encompass more. The virus types may also be chosen from a Markush in Claim 49, indicating the broad claims encompass more. The compositions are included, as they are to “pharmaceutical compositions” and thus, are intended for the use as in the claimed subject matter. As it is a claimed intended use, they are required to be enabled for their claimed breadth also.
The specification focuses on the purpose for doing so, as being to treat ARCI, which is a group of disorders and is “genetically and phenotypically a heterogenous group of disorders” (e.g., paragraph bridging pages 1-2). In other words, it is not caused by a single gene in every case, and also, the phenotype can differ, presumably due to the particular mutations involved. Applicant’s examples show HSV encoding TGM1 (Example 1), analysis of the vectors in vitro for infection and expression of TGM1 (Example 2). In vivo analysis of the vectors encoding hTGM1 demonstrating ability to infect skin and express hTGM1 (Example 3). In vitro characterization of the best performing vector in immortalized and primary patient cells, which were normal or homozygous for an inactivating TGM1 mutation, demonstrating the expression of functional TGM1 upon infection (Example 4), demonstration of infection and expression of TGM1 in tissue culture models (Example 5), and treatment of BALB/c mice with topical delivery demonstrating safe delivery and expression of TGM1, demonstrating safety (Example 6). However, the claims are simply to expression in any cells, and there is no descriptive reason for doing so, other than to find out what happens, which lacks utility, much less enablement.
A recent review, Vahlquist, et al. (2018) “Inherited Nonsyndromic Ichthyoses: An Update on Pathophysiology, Diagnosis and Treatment”, American Journal of Clinical Dermatology, 19(1): 51-66, citing art redating the priority, teaches that ichthyoses have many common symptoms, including hyperkeratinosis, skin scaling, and inflammation (ABSTRACT).
Given the common symptoms between all o the ichthyses yet distinct causes with distinct genes, and the fact that expression of exogenous TGM1 can only correct instances of TGM1 which are not working correctly, as well as the lack of demonstrating other ichthyosis-caused symptoms or non-TGM1 mutation caused ARCI could be treated by compensating with TGM1 expression, The Artisan would have to experiment to determine if any other symptom could be treated, except TGM1 inactivating mutations of ARCI, and further determine if the TGM1 through TGM7 and other unnamed transglutaminases would provide any enabled utility.
With regard to administration routes, the specification provides antecedent basis (e.g., paragraph 133), but the examples only demonstrate HSV1 and topical adminsitraiton (e.g., Example 6).
The Art demonstrates that HSV viruses have a broad host range and can infect virtually all cell types (e.g., Karanesh, et al. (2011) “Herpes simplex virus infects most cell types in vitro: clues to its success”, Virology Journal, 8: 481 (11 pages). Therefore, if one were to deliver the virus by any route other than topical, the TGM would not be expressed where needed, in the skin. Thus, again the Artisan would have to look for enabled uses of the method, beyond topical administration in the skin.
Because of the wide variety of embodiments that lack utility, and lack of predictability with regard to the reasons for performing the method, the scope of disease treated, and the scope of viruses and transgenes, the Artisan would have to experiment to find a reason to perform the vast majority of embodiments, which demonstrates a lack of enablement for the presently claimed scope.
Conclusion
No claim is allowed.
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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