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 .
Election/Restrictions
Applicant’s election without traverse of invention I in the reply filed on 7/22/26 is acknowledged.
Claims 29, 35, 39-43 and 45 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/22/26.
Claims 1-5, 12, 14, 25, 27, 28, 32, 38 and 48 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/1/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 12 and 48 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.
Paragraph 79: The term "cleavable variant" is to be understood to mean a variant (also referred to herein as a "functional variant" that has a different amino acid sequence to the peptide to which it is compared (i.e., a comparator or reference sequence), which may include a natural (i.e., native) sequence or a synthetic variant thereof, yet retains the ability to be cleaved by a host cell peptidase.
Claim 12 is recites the limitation "the virus" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 48 is recites the limitation "the compositition" in line 1. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 32 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 32 recites, “A vaccine composition comprising the vaccine construct according to claim 1”. However, claim 32 does not require an additional limitation to further limit the vaccine construct of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 38 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 38 recites, “A kit comprising the vaccine construct according to claim 1”. However, claim 38 does not require an additional limitation to further limit the vaccine construct of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim 48 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 48 recites, “A kit comprising the composition according to claim 32”. However, claim 48 does not require an additional limitation to further limit the composition of claim 32. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 12, 14, 25, 27, 32, 38 and 48 are rejected under 35 U.S.C. 102a1 as being anticipated by Bartosch et al. (US PGPub 20060222661).
The claimed invention is drawn to a vaccine construct comprising a nucleic acid sequence encoding a polyprotein, wherein the polyprotein comprises (i) an immunogen and (ii) two or more viral structural proteins capable of forming a virus-like particle (VLP), wherein at least two of the two or more viral structural proteins are separated by a signal peptidase sequence such that, when the polyprotein is expressed in a host cell, the signal peptidase sequence undergoes host cell peptidase-dependent cleavage to liberate the two or more viral structural proteins, thereby allowing the liberated structural proteins to self-assemble into a VLP.
The signal peptidase sequence is utilized by a hepatitis C virus with the sequence of SEQ ID NO: 1. The virus is a Hepacivirus.
The immunogen can be a heterologous immunogen that is not a viral antigen.
Each of the two or more viral structural proteins are separated by a signal peptidase sequence.
The two viral structural proteins are selected from HCV core protein, HCV E1 and HCV E2 glycoproteins.
The signal peptidase sequence is capable of being cleaved by a peptidase that is heterologous to the host cell.
The invention also requires a vaccine composition comprising the vaccine construct; a kit comprising the vaccine construct; and a kit comprising the vaccine composition. As established above in the 35 USC 112d rejections, the claims with these additional limitations do not further limit the claimed vaccine construct.
Bartosch et al. teach the generation of a polyprotein for containing HCV structural proteins, E1 and E2, separated by a signal peptide (SP) [see Figure 6A below] One specific example of a SP is SEQ ID NO: 1, which is identical to SEQ ID NO:1 of the instant invention. The E1 and E2 proteins can assemble into hepacivirus pseudo particles. [see abstract and paragraphs 25-26 and 42] Bartosch et al. also teach at paragraph 66 a "pharmaceutically acceptable carrier" refers to any vehicle wherein the vaccine composition according to the invention may be formulated, and at paragraphs 103-106 another aspect of the invention is the use of three nucleic acid sequences for the preparation of a medicament useful as a vaccine against hepatitis C, wherein the nucleic acid sequences are: a first nucleic acid sequence comprising a packaging competent retroviral-derived genome; a second nucleic acid sequence comprising a cDNA encoding core proteins from said retrovirus; a third nucleic acid sequence comprising a cDNA encoding a polyprotein comprising successively a signal peptide from a type I membrane protein, preferably a HCV core protein, and a HCV E1 protein and/or a HCV E2 protein. Bartosch et al. also teach the presence of a heterologous type I membrane protein in place of the HCV core protein signal sequence, which can be the signal sequence of immunoglobulins, or to signal sequences of viral type I glycoproteins, in particular retroviral surface glycoproteins [see paragraphs 69 and 49] and Bartosch et al. teach HCV-like particles may further carry a transgene encoding an immune modulator, which allows for enhancement of the raised immune reaction. [see paragraph 255]
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Therefore, Bartosch et al. anticipate the claimed invention.
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.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Bartosch et al. as applied to claims 1-5, 12, 14, 25, 27, 32, 38 and 48 above, and further in view of Hoerr et al. (US PGPub 2008/0171711).
The claimed invention also comprises that the immunogen is a cancer-associated antigen.
The teaches of Bartosch et al. are summarized above, while they teach that heterologous sequences can be encoded and transgenes can also be part their HCV particles and they teach at paragraph 259 “in still another embodiment the particles of the invention may be used as vectors for gene transfer and/or gene therapy. Gene therapy is defined as the introduction of genetic material into a cell in order to either change its phenotype or genotype. Owing to their tropism for hepatic cells, either primary or cancerous, the hepacivirus-like particles, and in particular the HCV-like particles, described herein comprise an efficient gene delivery system specific for hepatocytes.”
Hoerr et al. teach at paragraph [0023] particularly preferred tumor antigens are MAGE, in particular MAGE-A1 and MAGE-A6, melan-A, GP100, tyrosinase, survivin, CEA (carcino-embryonal antigen), Her-2/Neu and mucin-1. It is furthermore preferred if an RNA mixture according to the invention contains at least one viral tumor antigen (for example HPV-E7 or HCV polyprotein or adenovirus protein E3, E1a or E1b), optionally in combination with at least one preferably autologous tumor antigen of human origin from the patient to be treated. The autologous tumor antigen preferably comprises one of the above-stated antigens, in particular MAGE, specifically MAGE-A1 and MAGE-A6, melan-A, GP100, tyrosinase, survivin, CEA (carcino-embryonal antigen), Her-2/Neu, mucin-1, PSA, p53, Bcr-abl, PDGFR, Her3 or cyclin. An RNA mixture according to the invention very particularly preferably comprises one or two different viral tumor antigens in combination with 2 to 6 different autologous tumor antigens from the patient. In the case of an RNA mixture without viral tumor antigens, it is likewise preferred that said mixture contains 2 to 6 different tumor antigens, in particular selected from among the group of the above-stated tumor antigens.
It would have been obvious to one of ordinary skill in the art to modify the compositions taught by Bartosch et al. in order to include a cancer-associated antigen as part of their HCV structural protein vaccine construct. One would have been motivated to do so, given the suggestion by Bartosch et al. that an HCV expression construct encoding signal peptides and structural proteins can include heterologous sequences and that hepacivirus can target primary or cancerous cells. There would have been a reasonable expectation of success, given the knowledge that nucleic acid sequences (RNA) encoding HCV polyprotein can also contain tumor antigen encoding sequences, as taught by Hoerr et al. Thus the invention as a whole was clearly prima facie obvious to one of ordinary skill in the art at the time the invention was made.
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 1-4, 25 and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 14, 26 and 38 of copending Application No. 18294857 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both inventions are drawn to a vaccine construct comprising a nucleic acid sequence encoding a polyprotein, wherein the polyprotein comprises (i) an immunogen and (ii) two or more viral structural proteins capable of forming a virus-like particle (VLP), wherein at least two of the two or more viral structural proteins are separated by a signal peptidase sequence such that, when the polyprotein is expressed in a host cell, the signal peptidase sequence undergoes host cell peptidase-dependent cleavage to liberate the two or more viral structural proteins, thereby allowing the liberated structural proteins to self-assemble into a VLP.
The signal peptidase sequence is utilized by a hepatitis C virus.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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/BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671
