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 .
Claim Objections
Claim 132 is objected to because of the following informalities: Claim 132 should recite the word “and” before the word “Togaviridae”. 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.
Claim 314 is 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 treating HIV in a subject, does not reasonably provide enablement for preventing HIV in a subject. 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 or use the invention commensurate in scope with these claims.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including the nature of the invention, the state of the prior art, the breadth of the claims, the amount of guidance in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, and the quantity of experimentation necessary. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
Nature of the invention. The claims are drawn to methods of preventing HIV in a subject.
State of the prior art. It is well known in the art and even to the general public that medical science, despite decades of intense searching, has not found any compound that can be credibly said to prevent HIV infection in humans.
The difficulties inherent to developing an HIV preventive are well known. For the sake of clarity, some of those problems are outlined here:
1) the extensive genomic diversity associated with HIV, due in large part to error prone reverse transcription of its RNA genome,
2) the fact that the modes of viral transmission include virus-infected mononuclear cells, which pass the infecting virus to other cells in a covert form (cell to cell transmission), as well as via free virus transmission,
3) the existence of latent forms of the virus,
4) the complexity and variation of the elaboration of the disease (see, for example, Matthews et al., 1987, AIDS Research and Human Retroviruses, 3(1):197-206), and
5) the property of some portions of HIV proteins or peptides to actually cause immunosuppression or other detrimental consequences.
The existence of these obstacles prevents one of ordinary skill in the art from accepting any therapeutic regimen on its face given the intense interest in developing HIV treatments or preventatives and the lack of success in doing so.
Breadth of the claims. The claims are very broad, encompassing treating and preventing HIV in humans.
Guidance in the specification and working examples. There is one example demonstrating reduced viral load compared to the placebo after administration of the claimed fusion protein.
While the specification does contain statements regarding the use of the fusion proteins to prevent or treat HIV in a subject, the specification fails to teach or describe such use. Applicant has not provided any evidence in the instant specification that the disclosed fusion proteins can prevent HIV in a subject. There are no specific teachings in the disclosure that would allow one to have a reasonable expectation of success in transferring the treatment data to preventing HIV in a subject. One is left with speculation and an invitation to experiment.
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 54, 57, 132, and 133 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.
Claims 54 and 57 recite “comprising or consisting of an amino acid sequence of any one of SEQ ID NOs:82-89” and “comprising a nucleic acid sequence of any one of SEQ ID NOs: 150-159”, respectively. It is not clear if applicant is claiming a portion of the sequence or the entire sequence. If applicant intends to claim the entire sequence, then the claims should be amended to recite “comprising or consisting of the amino acid sequence of any one of SEQ ID NOs:82-89” and “comprising the nucleic acid sequence of any one of SEQ ID NOs: 150-159”, respectively.
Claim 132 recites the limitation "the viral vector" in reference to claim 63. There is insufficient antecedent basis for this limitation in the claim.
Claim 133 recites the limitation "the viral vector" in reference to claim 63. There is insufficient antecedent basis for this limitation in the claim.
In claim 133, it is not clear if the phrase “(a.k.a. Pichinde mammarenavirus or Pichinde arenavirus)” is intended to be part of the claim or not.
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 54, 60, 63, 69-80, 128 and 216 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-8 of U.S. Patent No. 12053517.
The instant claims are directed to a polynucleotide comprising a nucleic acid sequence encoding one or more fusion polypeptides comprising or consisting of an amino acid sequence of any one of SEQ ID NOs: 82-89, or an amino acid sequence that is at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% identical to any one of SEQ ID NOs: 82-89, wherein the full-length of the fusion polypeptide comprises at least 350 amino acids and up to 385 amino acids, and wherein the fusion polypeptide is capable of inducing, promoting or stimulating an immune response in a human.
The patented claims are directed to the immunogenic composition of claim 2, comprising first and second viral vectors comprising one or more polynucleotides encoding the following first fusion polypeptide and second fusion polypeptide, optionally joined or connected by one or more linkers: a) a first polynucleotide or first viral vector comprising one or more polynucleotides encoding a first fusion polypeptide and a second fusion polypeptide comprising SEQ ID NOs: 82 and 83, or fusion polypeptides that are at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% identical to any one of SEQ ID NOs: 82 and 83, respectively, and b) a second polynucleotide or second viral vector comprising one or more polynucleotides encoding a first fusion polypeptide and a second fusion polypeptide comprising SEQ ID NOs: 86 and 87, or fusion polypeptides that are at least 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98% or 99% identical to any one of SEQ ID NOs: 86 and 87, respectively.
Instant claims 54, 60, 63, 69, and 71 are taught by patented claim 3.
Instant claims 70 and 72 are taught by patented claim 4.
Instant claims 74 and 76 are taught by patented claim 5.
Instant claims 73 and 78 are taught by patented claim 6.
Instant claims 75 and 77 are taught by patented claim 7.
Instant claims 79 and 80 are taught by patented claim 8.
Instant claim 128 is taught by patented claims 3-8.
For instant claim 216, it would have been obvious to one of ordinary skill in the art to package components into a kit. One would be motivated to do this for commercial exploitation of the invention by providing convenience for the end user.
Allowable Subject Matter
Claims 57, 105-109, 139, 312 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicole Kinsey White whose telephone number is (571)272-9943. The examiner can normally be reached M to Th 6:30 am to 6:00 pm.
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/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
