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 .
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 with traverse of Group I, claims 11, 16-18, and 27-30 in the reply filed on June 8, 2026 is acknowledged. The traversal is on the ground(s) that the non-elected claims are linked by a common technical feature: an HPV18 L1 mutant containing an HPV59 L2-derived polypeptide directly inserted into the DE loop at the recited positions, between amino acids 134 and 135 or between amino acids 137 and 138. Applicant argues that the nonelected claims each depend from or otherwise require the same chimeric protein of claim 11, and therefore are linked to the elected claims by the same common inventive concept.
This is found persuasive and the restriction requirement between Groups I, II, III and IV is withdrawn.
Claims 11, 16-30 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 27, 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 11, 16-30 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.
Regarding Claims 11 and 30. The claim recites “mutant with a 32-amino acid truncation at C-terminus of the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 478, 484, 496, 499, 504, 506 to glycine (G) and amino acids 485, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 478, 485, 496, 499, 504, 506 to glycine (G) and amino acids 486, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 478, 484, 496, 499, 502, 506 to glycine (G), amino acids 485, 500 to serine (S) and amino acid 504 to aspartate (D) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 478, 485, 496, 502, 506 to glycine (G), amino acids 486, 500 to serine (S) and amino acids 499, 504 to aspartate (D) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 484, 496, 499, 504, 506 to glycine (G) and amino acids 485, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 485, 496, 499, 504, 506 to glycine (G) and amino acids 486, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; and wherein the polypeptide from HPV type 59 L2 protein is selected from any of the polypeptides as shown in SEQ ID No. 3, SEQ ID No. 4, SEQ ID No. 5 and SEQ ID No. 6, the polypeptide from the HPV type 59 L2 protein is inserted into the DE loop of the mutant of the HPV type 18 L1 protein, and the polypeptide from the HPV type 59 L2 protein is inserted between amino acids 137 and 138 or between amino acids 134 and 135 of the mutant of the HPV type 18 L1 protein by direct insertion.
The claim is rejected because it is not clear whether the SEQ ID NOs: 1 contains the claimed mutations of whether the mutations are to be made within SEQ ID NO: 1. Applicant is suggested to delete “as shown in” from the claims and recite “selected from the group consisting of”.
Claim 24. A polymer which is a chimeric pentamer or chimeric virus-like particle comprising the human papillomavirus chimeric protein according to claim 11, or formed by the human papillomavirus chimeric protein according to claim 11.
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 11. Applicant should clarify what are the structural metes and bounds of the chimeric protein formed by the human papillomavirus chimeric protein according to claim 11. Applicant is suggested to recite specific structural limitations instead of product by process limitations.
Claim 18. Applicant is required to delete “as shown in” and recite: “selected from the group consisting of”.
Claim 20. Applicant is required to delete “using” and recite structural limitations regarding the polynucleotide sequence.
Claim 21. Applicant is required to delete “as shown” and recite: “selected from the group consisting of”.
Claim 29. Applicant is required to delete “for use in human”.
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 24, 27 and 28 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 24. A polymer which is a chimeric pentamer or chimeric virus-like particle comprising the human papillomavirus chimeric protein according to claim 11, or formed by the human papillomavirus chimeric protein according to claim 11.
Claim 27. 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 11 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 24. Applicant is suggested to rewrite the claim into independent form, (add a new claim).
Regarding claim 27. 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 11 and the second vaccine contains the polymer or claim 24.
Claim 28. The vaccine for the prevention of papillomavirus infection and/or papillomavirus infection-induced diseases according to claim 27, further comprising at least one virus-like particle or chimeric virus-like particle of mucosa-tropic and/or skin-tropic HPVs. The claims are rejected because it is drawn to two different products simultaneously in one claim.
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.
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 28 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 28. The vaccine for the prevention of papillomavirus infection and/or papillomavirus infection-induced diseases according to claim 27, further comprising at least one virus-like particle or chimeric virus-like particle of mucosa-tropic and/or skin-tropic HPVs.
The claim is rejected because Applicant’s specification fails to provide sufficient written description support for chimeric virus-like particle of mucosa-tropic and/or skin-tropic HPVs.
Pertinent references
Li et al. (US Patent 9,364,529) discloses a sequence identical with present SEQ ID NO: 1 (see SEQ ID NO: 4 in Li.). Le et al. do not teach or suggest mutant with amino acid substitutions of amino acids 477, 478, 484, 496, 499, 504, 506 to glycine (G) and amino acids 485, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 478, 485, 496, 499, 504, 506 to glycine (G) and amino acids 486, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 478, 484, 496, 499, 502, 506 to glycine (G), amino acids 485, 500 to serine (S) and amino acid 504 to aspartate (D) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 478, 485, 496, 502, 506 to glycine (G), amino acids 486, 500 to serine (S) and amino acids 499, 504 to aspartate (D) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 484, 496, 499, 504, 506 to glycine (G) and amino acids 485, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 485, 496, 499, 504, 506 to glycine (G) and amino acids 486, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; and wherein the polypeptide from HPV type 59 L2 protein is selected from any of the polypeptides as shown in SEQ ID No. 3, SEQ ID No. 4, SEQ ID No. 5 and SEQ ID No. 6, the polypeptide from the HPV type 59 L2 protein is inserted into the DE loop of the mutant of the HPV type 18 L1 protein, and the polypeptide from the HPV type 59 L2 protein is inserted between amino acids 137 and 138 or between amino acids 134 and 135 of the mutant of the HPV type 18 L1 protein by direct insertion.
Query Match 100.0%; Score 2732; Length 509;
Best Local Similarity 100.0%;
Matches 507; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MALWRPSDNTVYLPPPSVARVVNTDDYVTRTSIFYHAGSSRLLTVGNPYFRVPAGGGNKQ 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 3 MALWRPSDNTVYLPPPSVARVVNTDDYVTRTSIFYHAGSSRLLTVGNPYFRVPAGGGNKQ 62
Qy 61 DIPKVSAYQYRVFRVQLPDPNKFGLPDTSIYNPETQRLVWACAGVEIGRGQPLGVGLSGH 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 63 DIPKVSAYQYRVFRVQLPDPNKFGLPDTSIYNPETQRLVWACAGVEIGRGQPLGVGLSGH 122
Qy 121 PFYNKLDDTESSHAATSNVSEDVRDNVSVDYKQTQLCILGCAPAIGEHWAKGTACKSRPL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 123 PFYNKLDDTESSHAATSNVSEDVRDNVSVDYKQTQLCILGCAPAIGEHWAKGTACKSRPL 182
Qy 181 SQGDCPPLELKNTVLEDGDMVDTGYGAMDFSTLQDTKCEVPLDICQSICKYPDYLQMSAD 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 183 SQGDCPPLELKNTVLEDGDMVDTGYGAMDFSTLQDTKCEVPLDICQSICKYPDYLQMSAD 242
Qy 241 PYGDSMFFCLRREQLFARHFWNRAGTMGDTVPQSLYIKGTGMRASPGSCVYSPSPSGSIV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 243 PYGDSMFFCLRREQLFARHFWNRAGTMGDTVPQSLYIKGTGMRASPGSCVYSPSPSGSIV 302
Qy 301 TSDSQLFNKPYWLHKAQGHNNGVCWHNQLFVTVVDTTRSTNLTICASTQSPVPGQYDATK 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 303 TSDSQLFNKPYWLHKAQGHNNGVCWHNQLFVTVVDTTRSTNLTICASTQSPVPGQYDATK 362
Qy 361 FKQYSRHVEEYDLQFIFQLCTITLTADVMSYIHSMNSSILEDWNFGVPPPPTTSLVDTYR 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 363 FKQYSRHVEEYDLQFIFQLCTITLTADVMSYIHSMNSSILEDWNFGVPPPPTTSLVDTYR 422
Qy 421 FVQSVAITCQKDAAPAENKDPYDKLKFWNVDLKEKFSLDLDQYPLGRKFLVQAGLRRKPT 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 423 FVQSVAITCQKDAAPAENKDPYDKLKFWNVDLKEKFSLDLDQYPLGRKFLVQAGLRRKPT 482
Qy 481 IGPRKRSAPSATTSSKPAKRVRVRARK 507
|||||||||||||||||||||||||||
Db 483 IGPRKRSAPSATTSSKPAKRVRVRARK 509
Kanda et al. (US Patent 9,023,364) discloses a sequence identical with present SEQ ID NO: 3 (see SEQ ID NO: 15 in Kanda.). Le et al. do not teach or suggest mutant with amino acid substitutions of amino acids 477, 478, 484, 496, 499, 504, 506 to glycine (G) and amino acids 485, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 478, 485, 496, 499, 504, 506 to glycine (G) and amino acids 486, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 478, 484, 496, 499, 502, 506 to glycine (G), amino acids 485, 500 to serine (S) and amino acid 504 to aspartate (D) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 478, 485, 496, 502, 506 to glycine (G), amino acids 486, 500 to serine (S) and amino acids 499, 504 to aspartate (D) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 484, 496, 499, 504, 506 to glycine (G) and amino acids 485, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; a mutant with amino acid substitutions of amino acids 477, 485, 496, 499, 504, 506 to glycine (G) and amino acids 486, 500, 502 to serine (S) in the amino acid sequence as shown in SEQ ID No. 1; and wherein the polypeptide from HPV type 59 L2 protein is selected from any of the polypeptides as shown in SEQ ID No. 3, SEQ ID No. 4, SEQ ID No. 5 and SEQ ID No. 6, the polypeptide from the HPV type 59 L2 protein is inserted into the DE loop of the mutant of the HPV type 18 L1 protein, and the polypeptide from the HPV type 59 L2 protein is inserted between amino acids 137 and 138 or between amino acids 134 and 135 of the mutant of the HPV type 18 L1 protein by direct insertion.
Query Match 100.0%; Score 115; Length 21;
Best Local Similarity 100.0%;
Matches 21; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 LYKTCKQAGTCPSDVINKVEG 21
|||||||||||||||||||||
Db 1 LYKTCKQAGTCPSDVINKVEG 21
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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