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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/25/2026 has been entered.
Election/Restrictions
Applicant’s amendment filed on 3/25/2026 is acknowledged. New claims 26 and 27 are added.
Claims 1, 5-8, 12, 16-18 & 26-27 are under examination on the merits.
Response to Arguments
Applicant’s arguments filed 3/25/2026 have been fully considered but they are not persuasive. The previous rejections under 35 U.S.C. §103 are hereby withdrawn in favor of new rejections, see below. The previous Double Patenting rejection is maintained.
Withdrawn Objections
Claim Objections
The previous objection to Claim 1 is withdrawn due to Applicant’s amendment submitted on 3/25/2026.
Withdrawn Rejections
The previous rejections are hereby withdrawn in favor of new rejections, see below:
35 U.S.C. §103: Claims 1, 8, 26 & 27 as being unpatentable over Van der Burg (PGPub US 20150056234 A1, published 2/26/2015, filed 8/6/2014) in view of Bouwes Bavinck (J Investig Dermatol Symp Proc. 2001 Dec;6(3):207-11. doi: 10.1046/j.0022-202x.2001.00048.x); Claims 12 and 16-17 as being unpatentable over Baker, et al. (PGPub US 20070014810 A1, published 1/18/2007, filed 1/3/2005) in view of Bouwes Bavinck (J Investig Dermatol Symp Proc. 2001 Dec;6(3):207-11. doi: 10.1046/j.0022-202x.2001.00048.x); Claims 5-7 as being unpatentable over Van der Burg and Bouwes Bavinck, as applied to claims 1, 8, 26, and 27, and further in view of Baker, et al. (PGPub US 20070014810 A1, published 1/18/2007, filed 1/3/2005); and Claim 18 as being unpatentable over Van der Burg and Bouwes Bavinck, as applied to claims 1, 8, 26, and 27 above, and further in view of Flynn, et al. (Proc Natl Acad Sci U S A. 2011 Apr 26;108(17):7131-6. doi: 10.1073/pnas.1103869108. Epub 2011 Apr 5. PMID: 21467219).
Maintained Rejections
Double Patenting
(Previous Rejection Maintained) Claims 1, 5-8, 18, 26 & 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12, 15, and 17-21 of copending Application No. 18/273,466 (reference application) in view of Bavinck.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant’s arguments are unpersuasive because:
Although the patent term filing date of the ‘466 application is after the earlier patent term filing date of the instant application, the instant claims are rejected under 35 U.S.C. §§103 and 112. Consequently, withdrawal of the provisional nonstatutory double patenting rejection under MPEP § 804(I)(B)(1)(b)(i) is not appropriate.
New Rejections
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 18 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a New Matter rejection.
Claim 1 recites “a composition comprising: a plurality of antigenic peptides, each comprising a sequence of 9-30 amino acids from one or more E1, E2, E4, E5, E6, or E7 proteins from commensal human papilloma viruses, wherein the papilloma viruses are low risk [..] HPV4 [..] and a T cell adjuvant”, and claim 18 recites “wherein the T cell adjuvant is selected from poly-ICLC”.
Applicant’s amendment filed 3/25/2026 directs support to “throughout the specification and claims as originally filed.” Applicant further argues that Table A of the specification provides support for HPV4. While Table A discloses that HPV4 may be used as one of the strains from which antigenic peptides are utilized, it does not specifically mention use of HPV4 in concert with an adjuvant, so Applicant’s argument (3/25/2026 remarks p. 5) is unconvincing.
The specification indicates that in some embodiments, the compositions can also include an adjuvant to increase T cell response, alternatively or in addition, an adjuvant comprising poly-ICLC (pp. 3 & 28, spec. filed 7/17/2025).
Notably, the claims and specification as filed, or originally, do not provide for a composition comprising: a plurality of antigenic peptides, each comprising a sequence of 9-30 amino acids from one or more E1, E2, E4, E5, E6, or E7 proteins from commensal human papilloma viruses, wherein the papilloma viruses are low risk HPV4 and a T cell adjuvant that is poly-ICLC.
Such limitation recited in the present claims, which did not appear in the specification, as filed, introduces new concepts and violates the description requirement of the first paragraph of 35 U.S.C. §112. Applicant is required to cancel the new matter in response to this Office Action. Alternatively, Applicant is invited to provide sufficient written support for the “limitation” indicated above. See MPEP §714.02, §2163.05-06, and §2173.05(i).
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 1, 5-8, 12, 16-18 & 26-27 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 1, 8, 12, and 26 recite the limitation “the papilloma viruses are low risk”. However, the specification does not define “low risk”, and the metes and bounds of the claims are unclear because it is not clear what “low risk” refers to. Low is subjective and different practitioners could have different definitions. For example, “low risk” could refer to risk of transmission, causing malignancies in particular or all subject populations, the proportion of infected subjects who suffer severe disease, etc. Even if one of these parameters were required to be used, there is still no way to know what “low” means and how low a value must be to be considered “low”.
The term “low” in claims 1, 8, 12, and 26 is a relative term which renders the claims indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claimed commensal human papilloma viruses of the claims are rendered indefinite by the use of the term “low risk”.
The presence of multiple interpretation renders the claims indefinite. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite."). Because claims 5-7, 16-18, and 26-27 depend from claims 1, 8, or 12, they are also indefinite for the same reason.
New Rejections
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 8, 26 & 27 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Burg (PGPub US 20150056234 A1, published 2/26/2015, filed 8/6/2014; hereinafter referred to as “Van der Burg”) in view of Hashe, et al. (Front Microbiol. 2018 May 2;9:874. PMID: 29770129).
The claimed invention encompasses a composition comprising a plurality of antigenic peptides, each comprising a sequence of 9-30 amino acids from one or more E1, E2, E4, E5, E6 or E7 proteins from commensal human papilloma viruses, wherein the papilloma viruses are low risk HPV2, HPV3, HPV4, HPV7, HPV10, HPV27, HPV28, HPV57, HPV77, HPV5, HPV8, HPV9, HPV12, HPV14, HPV15, HPV17, HPV19, HPV20, HPV21, HPV22, HPV23, HPV24, HPV25, HPV36, HPV37, HPV38, HPV47, HPV49, HPV75, HPV76, HPV80, HPV92, HPV93, HPV96, HPV107, HPV110, HPV111, HPV129, HPV151, HPV164, HPV1, or HPV63, HPV65, HPV50, or HPV95, and a T cell adjuvant that increases T cell response to the antigenic peptides (representative claim 1).
The Prior Art
Van der Burg teaches vaccines that comprise T cell epitopes specific for HPV E6 and E7 oncoproteins (Abstract; paras. [0012]-[0015]) derived from particular HPV serotypes, including serotype 33 (paras. [0016], [0034]) which is indicated as having a low risk, cutaneotropic γ-HPV characteristic according to the specification and Table A (Spec. Page 19, para. 2). The vaccines are used for methods of prevention and/or treatment of HPV related diseases (Abstract). Van der Burg further teaches that the peptides are preferably at least 19 amino acids in length, but may specifically be at least 19-30 residues in length (paras. [0016], [0018]). Further, the compositions may comprise at least 2, and up to 20, different peptides for treatment and/or vaccination of human subjects, along with pharmaceutically acceptable excipients, adjuvants, and immune modulators (para. [0043]). The peptides may comprise a contiguous amino acid sequence selected from the full length amino acid sequences of at least one of the HPV E6 and E7 proteins (para. [0016]), and that the HPV-specific immune response is directed toward all parts of the E6 and E7 oncoproteins (para. [0012]). Van der Burg also teaches that the epitopes included in the composition from the contiguous amino acid sequence may have overlapping residues (para. [0020]).
However, it does not teach low risk commensal human papillomaviruses, such as HPV2, HPV3, HPV4, HPV7, HPV10, HPV27, HPV28, HPV57, HPV77, HPV5, HPV8, HPV9, HPV12, HPV14, HPV15, HPV17, HPV19, HPV20, HPV21, HPV22, HPV23, HPV24, HPV25, HPV36, HPV37, HPV38, HPV47, HPV49, HPV75, HPV76, HPV80, HPV92, HPV93, HPV96, HPV107, HPV110, HPV111, HPV129, HPV151, HPV164, HPV1, or HPV63, HPV65, HPV50, or HPV95.
Hashe discloses that there is controversy in the scientific field about whether certain types of cutaneous human papillomaviruses are causally involved in the development of non-melanoma skin cancer (NMSC; Abstract). Hashe further discloses that while several of HPV vaccines are licensed, they are targeted against two, four, or nine mucosal HPV types, and present limitations, making the development of broad protective second-generation HPV vaccines necessary (p. 11, col. 1, para. 2). Hashe also teaches that the response elicited by HPV vaccines are largely type-specific and cross-reactivity against different HPV types is almost absent, and the licensed vaccines target, at best, the high risk types that cause 90% of the cervical cancer and no cutaneous types (p. 11, col. 1, para. 2). Hashe further discloses that more than 40 HPV types are plausible for being targeted by a vaccine to prevent human diseases: mucosal high-risk HPVs implied in the pathogenesis of cervical and other cancers (HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, and 68), additional mucosal types which cause genital warts (HPV6 and 11), several beta HPV types potentially linked to NMSC (HPV5, 8, 9, 12, 14, 15, 17, 19, 20, 21, 22, 23, 24, 25, 36, 37, 38, 47, and 49), and the different alpha (HPV2, 3, 10, 27, 28, and 57), gamma (HPV4, 60, and 65), mu (HPV1, 63), and nu (HPV41) types that induce different lesions, because they are a special burden in children and immunocompromised patients (p. 11, col. 1, para. 2 ). And that given the potential benefits of covering so many different HPV types, a broad-protecting prophylactic HPV vaccine is a rational goal for second-generation vaccine development (p. 11, col. 1, para. 2).
It would have been obvious to one of ordinary skill in the art to modify the vaccines taught by Van der Burg to incorporate use of HPV antigens derived from the HPV types that Hashe states are plausible of being targeted by a vaccine to prevent human diseases, such as several beta HPV types potentially linked to NMSC (HPV5, 8, 9, 12, 14, 15, 17, 19, 20, 21, 22, 23, 24, 25, 36, 37, 38, 47, and 49), and the different alpha (HPV2, 3, 10, 27, 28, and 57), gamma (HPV4, 60, and 65), mu (HPV1, 63), and nu (HPV41) types that induce different lesions, because they are a special burden in children and immunocompromised patients. One of ordinary skill in the art would have been motivated to form immunogenic compositions against such low risk strains because those HPV subtypes are associated with human disease. Therefore, claims 1, 8, 26, and 27 were prima facie obvious to one of ordinary skill in the art before the priority date of the instant invention.
Claims 12 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Baker, et al. (PGPub US 20070014810 A1, published 1/18/2007, filed 1/3/2005) in view of Hashe, et al. (supra).
The Prior Art
Baker teaches methods and pharmaceutical compositions related to HPV epitope vaccines (Abstract). Baker further teaches a multi-epitope “mini-gene” vaccine strategy where various CTL, HTL, and antibody epitopes from various proteins are incorporated into a single vaccine composition used to target multiple dominant and subdominant epitopes (paras. [0014]-[0015] & [0017]). Use of epitope-based vaccines has several advantages, including selection of conserved epitopes that are not subject to immune escape due to variability and/or mutations (para. [0032]). Additionally, epitope-based vaccines provide the ability to direct and focus an immune response to multiple antigens from the same pathogen, for example, epitopes derived from multiple strains of HPV may be included, such as HPV strains 6a, 6b, 11a, 16, 18, 31, 33, 45, 52, 56, and 58 (para. [0035]). Baker also teaches nucleic acid vaccines encoding such peptides, where the multi-epitope nucleic acid constructs encode a plurality of HPV CTL epitopes (paras. [0043]-[0046]). Baker further teaches a multi-epitope polynucleotide construct comprising nucleic acids encoding HPV CTL epitopes of E6 and E7 proteins from HPV 16, 18, 31, 33, and 45 (para. [0061]). The multi-epitope constructs taught by Baker may include 5-75, or 150 or more, epitope-encoding nucleic acid sequences (paras. [0278] and [0337]), and the encoded epitope peptides may be about 8 to 50 residues in length, most preferably about 13 amino acid residues in length (paras. [0278]-[0279]). The vaccine compositions may be in the form of viral vectors, such as adenovirus, adeno-associated virus, or retrovirus viral vectors (paras. [0485], [0789]). However, it does not teach low risk commensal human papillomaviruses, such as HPV2, HPV3, HPV4, HPV7, HPV10, HPV27, HPV28, HPV57, HPV77, HPV5, HPV8, HPV9, HPV12, HPV14, HPV15, HPV17, HPV19, HPV20, HPV21, HPV22, HPV23, HPV24, HPV25, HPV36, HPV37, HPV38, HPV47, HPV49, HPV75, HPV76, HPV80, HPV92, HPV93, HPV96, HPV107, HPV110, HPV111, HPV129, HPV151, HPV164, HPV1, or HPV63, HPV65, HPV50, or HPV95.
The teachings of Hashe are described above.
It would have been obvious to one of ordinary skill in the art to modify the epitope vaccines and compositions taught by Baker to incorporate use of HPV antigens from the HPV types potentially linked to NMSC (HPV5, 8, 9, 12, 14, 15, 17, 19, 20, 21, 22, 23, 24, 25, 36, 37, 38, 47, and 49), and the different alpha (HPV2, 3, 10, 27, 28, and 57), gamma (HPV4, 60, and 65), mu (HPV1, 63), and nu (HPV41) types, as taught by Hashe, to form vaccines against such commensal strains. One of ordinary skill in the art would have been motivated to do so to form immunogenic compositions against such low risk strains because those HPV subtypes are potentially linked to NMSC or induce different lesions, and because they are a special burden in children and immunocompromised patients. Therefore, claims 12 and 16-17 were prima facie obvious to one of ordinary skill in the art before the priority date of the instant invention.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Burg and Hashe (supra), as applied to claims 1, 8, 26, and 27, and further in view of Baker, et al. (supra).
The Prior Art
The teachings of Van der Burg and Hashe are described above. However, they do not teach a plurality of antigenic peptides comprise peptides derived from proteins from a plurality of commensal human papilloma viruses, or at least 200 peptides each having a unique sequence, or a plurality of peptides for each unique sequence.
Baker teaches methods and pharmaceutical compositions related to HPV epitope vaccines (Abstract). Baker further teaches a multi-epitope “mini-gene” vaccine strategy where various CTL, HTL, and antibody epitopes from various proteins are incorporated into a single vaccine composition used to target multiple dominant and subdominant epitopes (paras. [0014]-[0015] & [0017]). Use of epitope-based vaccines has several advantages, including selection of conserved epitopes that are not subject to immune escape due to variability and/or mutations (para. [0032]). Additionally, epitope-based vaccines provide the ability to direct and focus an immune response to multiple antigens from the same pathogen, for example, epitopes derived from multiple strains of HPV may be included, such as HPV strains 6a, 6b, 11a, 16, 18, 31, 33, 45, 52, 56, and 58 (para. [0035]). Baker also teaches nucleic acid vaccines encoding such peptides, where the multi-epitope nucleic acid constructs encode a plurality of HPV CTL epitopes (paras. [0043]-[0046]). Baker further teaches a multi-epitope polynucleotide construct comprising nucleic acids encoding HPV CTL epitopes of E6 and E7 proteins from HPV 16, 18, 31, 33, and 45 (para. [0061]). The multi-epitope constructs taught by Baker may include 5-75, or 150 or more, epitope-encoding nucleic acid sequences (paras. [0278] and [0337]), and the encoded epitope peptides may be about 8 to 50 residues in length, most preferably about 13 amino acid residues in length (paras. [0278]-[0279]). The vaccine compositions may be in the form of viral vectors, such as adenovirus, adeno-associated virus, or retrovirus viral vectors (paras. [0485], [0789]).
It would have been obvious to one of ordinary skill in the art to modify the vaccine compositions taught by Van der Burg to incorporate antigenic peptides derived from proteins from a plurality (as taught by Baker) of commensal human papillomaviruses, as taught by Hashe. Van der Burg teaches compositions comprising a plurality of antigenic peptides comprising a sequence of 9-30 amino acids derived from human papillomaviruses and a T cell adjuvant. Baker teaches immunogenic vaccine compositions against HPV can encode peptides specific for multiple HPV strains and multiple different antigenic proteins thereof. Hashe teaches several beta HPV types are potentially linked to NMSC (HPV5, 8, 9, 12, 14, 15, 17, 19, 20, 21, 22, 23, 24, 25, 36, 37, 38, 47, and 49), and the different alpha (HPV2, 3, 10, 27, 28, and 57), gamma (HPV4, 60, and 65), and mu (HPV1, 63) types that induce different lesions, and are a special burden in children and immunocompromised patients. It would have been obvious to one of ordinary skill in the art for the composition to comprise at least 200 peptides each having unique sequences because Baker teaches the compositions may encode 150 or more unique peptides, and that further epitopes from additional strains may be added to the compositions. Additionally, it would have been obvious that the composition could comprise a plurality of peptides for each unique sequence because Van der Burg teaches that the epitopes included in the composition from the contiguous amino acid sequence may have overlapping residues. One of ordinary skill in the art would have been motivated to combine the teachings in order to generate an effective immunogenic composition that has broad coverage a wide array of HPV epitopes from multiple strains. Therefore, claims 5-7 were prima facie obvious to one of ordinary skill in the art before the priority date of the instant application.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Van der Burg and Hashe (supra) as applied to claims 1, 8, 26 & 27 above, and further in view of Stahl-Hennig, et al. (PLoS Pathog. 2009 Apr;5(4):e1000373).
The Prior Art
The teachings of Van der Burg and Hashe are described above. However, they do not disclose use of a T cell adjuvant poly-ICLC.
Stahl-Hennig discloses Toll-like receptor ligands as adjuvants for the induction of antigen-specific immune responses in the design of vaccines, and that poly ICLC is a synthetic double-stranded adjuvant (Abstract). Stahl-Hennig further discloses immunization of rhesus macaques with human papillomavirus (HPV)16 capsomeres, and that poly ICLC helped to induce HPV16-specific Th1 immune response and a strong anti-HPV16 antibody response, whereas another adjuvant did not induce HPV16-specific Th1 immune responses (Abstract). Stahl-Hennig teaches dsRNA compounds are effective adjuvants for the induction of adaptive pathogen-specific T cell and humoral immune responses (p. 10, col. 1, paras 1-2).
It would have been obvious to one of ordinary skill in the art to modify the antigenic compositions taught by Van der Burg to utilize poly-ICLC as a T-cell adjuvant. Van der Burg teaches compositions that comprise T cell adjuvants and antigenic peptides derived from human papilloma viruses. Hashe teaches several beta HPV types are potentially linked to NMSC (HPV5, 8, 9, 12, 14, 15, 17, 19, 20, 21, 22, 23, 24, 25, 36, 37, 38, 47, and 49), and the different alpha (HPV2, 3, 10, 27, 28, and 57), gamma (HPV4, 60, and 65), and mu (HPV1, 63) types that induce different lesions, and are a special burden in children and immunocompromised patients. Stahl-Hennig teaches that poly-ICLC is a potent adjuvant for T-cell responses when used in vaccinations against HPV16 capsomers. One of ordinary skill in the art would have been motivated to use poly-ICLC as the adjuvant in compositions comprising a plurality of antigenic peptides from strains disclosed by Hashe as being associated with human disease, which Hashe proposes vaccinating against. Therefore, claim 18 was prima facie obvious to one of ordinary skill in the art before the priority date of the instant application.
Response to Arguments
Applicant’s arguments are not persuasive with regard to the new rejections under 35 U.S.C. §103:
It is true that Van der Burg and Baker each relate to vaccines to treat and/or prevent cancers associated with “high-risk” HPV, however, as disclosed by the new reference Hashe (Front Microbiol. 2018 May 2;9:874. PMID: 29770129), several HPV beta HPV types are potentially linked to non-melanoma skin cancer (HPV5, 8, 9, 12, 14, 15, 17, 19, 20, 21, 22, 23, 24, 25, 36, 37, 38, 47, and 49), and that the different alpha (HPV2, 3, 10, 27, 28, and 57), gamma (HPV4, 60, and 65), and mu (HPV1, 63) types that induce different lesions, and are a special burden in children and immunocompromised patients (p. 11, col. 1, para. 2 ), though several of these subtypes are designated as “low risk” by the instant disclosure. Further, the new reference Hashe (infra) explains that given the potential benefits of covering so many different HPV types, a broad-protecting prophylactic HPV vaccine is a rational goal for second-generation vaccine development (p. 11, col. 1, para. 2). One reason why one of ordinary skill in the art would wish to vaccinate against these “low risk” subtypes is that they induce different lesions, and are a special burden in children and immunocompromised patients.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Regarding Applicant’s unexpected results that immunity to commensal cutaneous papillomaviruses protects against carcinogen-induced skin cancer, the results are not commensurate in scope with the claims. While the unexpected results are that papillomavirus colonization delayed DMBA/TPA tumor onset and reduced multiplicity and burden in C57Bl/6J and FVB mice, and that vaccination-induced or natural anti-MmuPV1 immunity reduced tumors, CD8+ T-cell depletion abrogated protection, and the benefit persisted in Xpc-/- mice, the claimed invention encompasses many other HPV serotypes and additional peptides derived from other proteins, which no unexpected result was demonstrated for.
Conclusion
No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY MARK SIFFORD whose telephone number is (571)272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671
/Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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