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 Group I, claims 1, 2, 6 and 8-17 in the reply filed on June 12, 2026 is acknowledged. Claims 2 and 11-17 were canceled. Claims 3-5, 7, and 18-20 are withdrawn. Claims 1, 6 and 8-10 are under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 28, 2023 has been considered by the examiner.
Claim Rejections - 35 USC § 112
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, 6 and 8-10 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 pre-AIA the applicant regards as the invention.
Claim 1. A human papillomavirus chimeric protein comprising or consisting of a HPV type 58 L1 protein or a mutant of the HPV type 58 L1 protein, and a polypeptide from a HPV type 16 L2 protein inserted into a surface region of the HPV type 58 L1 protein or the mutant of the HPV type 58 L1 protein, wherein the amino acid sequence of the HPV type 58 L1 protein is as shown in SEQ ID NO: 1, and the amino acid sequence of the HPV type 16 L2 protein is as shown in SEQ ID NO: 2, wherein the amino acid sequence of the human papillomavirus chimeric protein is as shown in any one of SEQ ID NOs: 10, 12, 14, 15, 17 and 19.
The claim is rejected because it is not clear whether the SEQ ID NOs: 10, 12, 14, 15, 17 and 19 are the claimed mutant variants of wild type proteins.
Claim 6. A polymer which is a chimeric pentamer or chimeric virus-like particle comprising the human papillomavirus chimeric protein according to claim 1, or formed by the human papillomavirus chimeric protein according to claim 1.
The claims are rejected because it is not clear what are the metes and bounds of the product by process limitations: “formed by the human papillomavirus chimeric protein according to claim 1.
Correction and/or clarification is required.
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.
Claims 6, 8-10 are 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 6. A polymer which is a chimeric pentamer or chimeric virus-like particle comprising the human papillomavirus chimeric protein according to claim 1, or formed by the human papillomavirus chimeric protein according to claim 1.
Claim 8. A vaccine for the prevention of human papillomavirus infection and/or human papillomavirus infection-induced diseases, comprising the human papillomavirus chimeric protein according to claim 1 or the polymer according to claim 6, an adjuvant, as well as an excipient or carrier for use in vaccines.
The claims are rejected because they are drawn to two different products simultaneously in one claim.
Regarding claim 6. Applicant is suggested to rewrite the claim into independent form, (add a new claim), wherein one vaccine contains the product of claim 1 and the second vaccine contains the variant of the product of claim 1.
Regarding claim 8. Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Applicant is suggested to rewrite the claim into independent form, (add a new claim), wherein one vaccine contains the product of claim 1 and the second vaccine contains the polymer or claim 6.
35 U.S.C. § 112(d) and (e) and 37 C.F.R. § 1.75(c). Section 112(d) requires that every dependent claim must reference a previously set forth claim and specify a further limitation of the subject matter. Section 112(e) adds rules specific to multiple dependent claims: the claim must reference other claims in the alternative only, it cannot serve as a basis for another multiple dependent claim, and it incorporates by reference only the limitations of the particular claim being considered, not all referenced claims simultaneously. Correction is required.
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 1, 6 and 8-10 are 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.
Claim 1. A human papillomavirus chimeric protein comprising or consisting of a HPV type 58 L1 protein or a mutant of the HPV type 58 L1 protein, and a polypeptide from a HPV type 16 L2 protein inserted into a surface region of the HPV type 58 L1 protein or the mutant of the HPV type 58 L1 protein, wherein the amino acid sequence of the HPV type 58 L1 protein is as shown in SEQ ID NO: 1, and the amino acid sequence of the HPV type 16 L2 protein is as shown in SEQ ID NO: 2, wherein the amino acid sequence of the human papillomavirus chimeric protein is as shown in any one of SEQ ID NOs: 10, 12, 14, 15, 17 and 19.
Claim 9. The vaccine for the prevention of human papillomavirus infection and/or human papillomavirus infection-induced diseases according to claim 8, further comprising at least one virus-like particle or chimeric virus-like particle of mucosa-tropic and/or skin-tropic HPVs.
Claims are rejected because there is lack of structure and function correlation between the claimed mutants of the HPV type 58 L1 protein and the claimed vaccine functionality.
Additionally, there is lack of written description support and lack of structure and function correlation for the claimed mutants and the human papillomavirus infection-induced diseases.
There is lack of written description support for the genus of mutants of the HPV type 58 L1 protein and human papillomavirus infection-induced diseases.
Pertinent references
Li. US Patent 9,382,296 discloses a sequence identical with present SEQ ID NO: 1. Li does not disclose polypeptide from a HPV type 16 L2 protein inserted into a surface region of the HPV type 58 L1 protein or any of present SEQ ID NOs: 10, 12, 14, 15, 17 and 19.
Xie et al. US Patent 12,139,514 disclose a sequence having 95.7% similarity with present SEQ ID NO: 14 (see SEQ ID NO: 144). Xie et al. do not disclose polypeptide from a HPV type 16 L2 protein inserted into a surface region of the HPV type 58 L1 protein or any of present SEQ ID NOs: 10, 12, 14, 15, 17 and 19.
Query Match 95.7%; Score 2506.5; Length 473;
Best Local Similarity 96.9%;
Matches 467; Conservative 0; Mismatches 2; Indels 13; Gaps 1;
Qy 2 RPSEATVYLPPVPVSKVVSTDEYVSRTSIYYYAGSSRLLAVGNPYFSIKSPNNNKKVLVP 61
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Db 5 RPSEATVYLPPVPVSKVVSTDEYVSRTSIYYYAGSSRLLAVGNPYFSIKSPNNNKKVLVP 64
Qy 62 KVSGLQYRVFRVRLPDPNKFGFPDTSFYNPDTQRLVWACVGLEIGRGQPLGVGVSGHPYL 121
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 65 KVSGLQYRVFRVRLPDPNKFGFPDTSFYNPDTQRLVWACVGLEIGRGQPLGVGVSGHPYL 124
Qy 122 NKFDDTETSNRYPAQPGSDNRECLSMDYKQTQLCLIGCKPPTGEHWGKGVACNNNAAATD 181
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 125 NKFDDTETSNRYPAQPGSDNRECLSMDYKQTQLCLIGCKPPTGEHWGKGVACNNNAAATD 184
Qy 182 CPPLELFNSIIEDGDMVDTGFGCMDFGTLQANKSDVPIDICNSTCKYPDYLKMASEPYGD 241
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 185 CPPLELFNSIIEDGDMVDTGFGCMDFGTLQANKSDVPIDICNSTCKYPDYLKMASEPYGD 244
Qy 242 SLFFFLRREQMFVRHFFNRAGKLGEAVPDDLYIKGSGNTAVIQSSAFFPTPSGSIVTSES 301
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 245 SLFFFLRREQMFVRHFFNRAGKLGEAVPDDLYIKGSGNTAVIQSSAFFPTPSGSIVTSES 304
Qy 302 QLFNKPYWLQRAQGHNNGICWGNQLFVTVVDTTRSTNMTLCTEVTKEGTYKNDNFKEYVR 361
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 305 QLFNKPYWLQRAQGHNNGICWGNQLFVTVVDTTRSTNMTLCTEVTKEGTYKNDNFKEYVR 364
Qy 362 HVEEYDLQFVFQLCKITLTAEIMTYIHTMDSNILEDWQFGLTPPPSASLQDTYRFVTSQA 421
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 365 HVEEYDLQFVFQLCKITLTAEIMTYIHTMDSNILEDWQFGLTPPPSASLQDTYRFVTSQA 424
Qy 422 ITCQKLYKTCKQAGTCPPDIPPKEKEDPLNKYTFWEVNLKEKFSADLDQFPLGRKFLLQS 481
||||| ||||||||||||||||||||||||||||||||||||||||
Db 425 ITCQK-------------TAPPKEKEDPLNKYTFWEVNLKEKFSADLDQFPLGRKFLLQS 471
Qy 482 GL 483
||
Db 472 GL 473
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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