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 38-67 are pending, as amended 12/13/23, and are considered herein.
Formalities:
The specification of 5/30/23 is accepted.
The drawings of 5/30/23 are accepted.
The IDS of 5/30/23 and its references have been considered, and is signed by the Examiner herewith.
Applicant’s priority is the present Application, filed 5/30/23, through a continuation to 16/612,648 (now US PAT 11,701,437) filed 11/11/19, through a 371 to PCT/US18/32600 filed 5/14/18, and to 62/505,308, filed 5/12/17.
Claim Objections
Applicant is advised that should claim 38 be found allowable, claim 46 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 46 requires the time over which the transgene is expressed, is “over a sustained period of time”. A period of time may be any period of time. Thus, despite the slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 1 and/or 46 be found allowable, claim 47 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 46 requires the time over which the transgene is expressed, is “over a sustained period of time”. A period of time may be any period of time. Additionally, Claim 47 recites “to provide immunity against a target disease”. However, this is in the mind of the practitioner, and does not appear to alter the scope of polypeptides encompassed. Thus, despite the slight difference in wording, these claims have substantially the same scope.
Applicant is advised that should claim 38 be found allowable, claim 48 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 48 requires the target polypeptides to be introduced systemically within the subject by introduction into a circulatory system of the subject. However, Claim 38 requires the target polypeptide to be secreted from the cells, and introduced systemically within the subject. Thus, despite the slight difference in wording, these claims have the same substantial scope.
Claim Rejections - 35 USC § 112
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.
Claims 42, 46-48, 53, and 55-63 are 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.
Claim 42 depends from Claim 411, which is not yet of record. Thus, its scope is not clear. However, for purposes of substantial consideration, it will be considered to depend from Claim 41.
Claim 46 recites the polypeptide encoded by the transgene is produced by the cells over a sustained period of time. Such is not clear. A period of time is open-ended, and can be as long or short as desired. The specification provides no definition for a “sustained period of time”. Thus, it is not clear what is meant. (Note also: claim objection warning, above.)
Claim 47 recites the polypeptide encoded by the transgene is produced by the cells over a sustained period of time. Such is not clear. A period of time is open-ended, and can be as long or short as desired. The specification provides no definition for a “sustained period of time”. Thus, it is not clear what is meant. (Note also: claim objection warning, above.)
Claim 48 recites “a circulatory system of the subject”. Such lacks proper antecedent basis. The subject inherently contains a circulatory system, and there is only one known blood system in subjects, and thus, the proper wording is “the circulatory system of the subject”.
Claim 53 recites that the target polypeptide includes “a fibroblast-facilitated neutralizing antibody against HIV-1”. It is not clear what is meant. How does the fibroblast facilitate the neutralizing antibody? Is it possible that what is meant is that the antibody is produced by fibroblasts? The claim either lacks essential structure or fails to provide sufficiently to the fibroblast of the parent claim, Claim 38.
Claims 55-63 depend from Claim 411, which is not yet of record. Thus, the scope is not clear. For purposes of the compact prosecution, the claims will be considered to depend from Claim 41.
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 38-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 11,701,437. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 38: Patent Claim 1 teaches a method of systemic delivery of a polypeptide to a subject by genetic modification of skin cells. Claim 22 teaches the skin cells may be fibroblasts. Claim 1 teaches transfection of the cells with an AAV, which may be AAV5 AAV, or AAV6.2 in Claim 30. Claim 1 teaches the virus encodes the foreign polypeptide(s). Claim 1 teaches the cells express the polypeptide(s) and the same excreted and introduced systemically within the subject.
Claim 39: Patent Claim 22 teaches fibroblasts.
Claim 40: As the composition of the adenovirus is administered to the skin, (e.g., patent Claim 2), absent reason to believe otherwise, keratinocytes are transfected.
Claim 41: the fibroblasts are skin cells (e.g., Claim 1 and 22).
Claim 42: topical administration is taught (e.g., Claim 2).
Claim 43: Claim 3 teaches non-replicating cells.
Claim 44: Claim 4 teaches the polypeptide is a therapeutic agent.
Claim 45: Claims 8-10 teach sustained production.
Claim 47: Claim 9 teaches sustained production and immunity against a target disease.
Claim 48: Claim 11 teaches introduction into the circulatory system.
Claim 50: Claim 13 teaches humans.
Claim 51: Claim 15 teaches antibody against HIV-1.
Claim 52: Claim 16 teaches broadly neutralizing antibody against HIV-1.
Claim 53: Claim 17 teaches fibroblast facilitated neutralizing antibody against HIV-1.
Claim 54: Claim 18 teaches camelid nanobody.
Claim 55: Claim 19 teaches the skin is treated to be permeabilized to the virus.
Claim 56: Claim 20 teaches the stratum corneum of the skin is processed to be permeabilized to the virus.
Claim 57: Claim 21 teaches cavitational US or microdermabrasion to disrupt the stratum corneum and the virus is transported to the epidermis, papillary and reticulous dermis.
Claim 58: Claim 23 teaches treatment with US prior to virus administration.
Claim 59: Claim 24 teaches US application prior to, and stopping prior to, administration of the virus.
Claim 60: Claim 25 teaches about 20-100 kHz.
Claim 61: Claim 26 teaches about 1 to 10 watts/cm2.
Claim 62: Claim 27 teaches about 1-10 minutes.
Claim 63: Claim 28 teaches US duty cycles between 25-100%.
Claim 64: Claim 31 teaches cytokines.
Claim 65: Claim 32 teaches the same Markush of target polypeptides.
Claim 66: Claim 33 contains the same Markush of target polypeptide antibodies.
Claim 67: Claim 34 teaches IFN-gamma.
Thus, in light of the patent, the invention is obvious. The Artisan would do so, and expect success, as it is claimed.
Claims 38-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 11,701,437 in view of Hengge, et al. (2000) “Adeno-Associated Virus Expresses Transgenes in Hair Follicles and Epidermis”, Molecular Therapy, 2(3): 188-194.
As shown above, the base claims are obvious over the patent alone, however the aspect of transfecting keratinocytes is not claimed in the patent. (Just in case it is somehow argued you can target only one type of cell.)
On the other hand, Hengge, which the Artisan would be aware of for transfecting the skin, teaches the AAV can transfect keratinocytes of the skin (e.g., ABSTRACT).
Thus, at the time of invention, it would have been obvious to transfect keratinocytes of the skin with AAV to effect the patent’s methods. The Artisan would do so because they understood that AAV can affect those skin cells, and the patent teaches the skin. The Artisan would expect success, as the components are utilized for art-recognized purposes.
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