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 1-12 in the reply filed on December 23, 2025 is acknowledged. Claims 13-22 are withdrawn as being drawn to non-elected invention. Claims 1-12 are under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 12, 2023 has been considered by the examiner.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yang et al. (US Patent Application Publication US 2012/0034264).
Yang et al. teach an engineered cell comprising a heterologous polynucleotide encoding an influenza H1N1 hemagglutinin antigen, wherein the cell is a Vero cells, BHK cells, MDCK cells, 293 cells and COS cells, including 293T cells, COS7 cells (see paragraphs [0063], [0112] and [0113]. Thus, by this disclosure Yang et al. anticipate the present 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US Patent Application Publication US 2012/0034264) as applied to claim 1 and further in view of Liu et al, (US Patent Application Publication US 2012/0107911).
Yang et al. teach an engineered cell comprising a heterologous polynucleotide encoding an influenza H1N1 hemagglutinin antigen, wherein the cell is a Vero cells, BHK cells, MDCK cells, 293 cells and COS cells, including 293T cells, COS7 cells (see paragraphs [0063], [0112] and [0113].
Yang et al. do not teach present SEQ ID NO: 1 or a sequence having 90% identity with present SEQ ID NO: 1.
Liu et al. teach recombinant influenza hemagglutinin protein identical with present SEQ ID NO: 1 (see SEQ ID NO: 22 in Liu et al. and the sequence alignment below).
It would have been prima facie obvious to provide Yang’s engineered cell comprising a heterologous polynucleotide encoding an influenza H1N1 hemagglutinin antigen, wherein the antigen is Liu’s polypeptide sequence comprising present SEQ ID NO: 1 because Liu et al. teach inducing cross-protective immune responses against various influenza strains following administering a vaccine comprising a polypeptide identical with present SEQ ID NO: 1 (see paragraphs [0056], [0081] and Example 1).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Present SEQ ID NO: 1 and SEQ ID NO: 22 in Liu et al.
Query Match 100.0%; Score 3016; Length 565;
Best Local Similarity 100.0%;
Matches 565; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MKANLLVLLCALAAADADTICIGYHANNSTDTVDTVLEKNVTVTHSVNLLEDSHNGKLCR 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MKANLLVLLCALAAADADTICIGYHANNSTDTVDTVLEKNVTVTHSVNLLEDSHNGKLCR 60
Qy 61 LKGIAPLQLGKCNIAGWLLGNPECDPLLPVRSWSYIVETPNSENGICYPGDFIDYEELRE 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 LKGIAPLQLGKCNIAGWLLGNPECDPLLPVRSWSYIVETPNSENGICYPGDFIDYEELRE 120
Qy 121 QLSSVSSFERFEIFPKESSWPNHNTNGVTAACSHEGKSSFYRNLLWLTEKEGSYPKLKNS 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 QLSSVSSFERFEIFPKESSWPNHNTNGVTAACSHEGKSSFYRNLLWLTEKEGSYPKLKNS 180
Qy 181 YVNKKGKEVLVLWGIHHPPNSKEQQNLYQNENAYVSVVTSNYNRRFTPEIAERPKVRDQA 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 YVNKKGKEVLVLWGIHHPPNSKEQQNLYQNENAYVSVVTSNYNRRFTPEIAERPKVRDQA 240
Qy 241 GRMNYYWTLLKPGDTIIFEANGNLIAPMYAFALSRGFGSGIITSNASMHECNTKCQTPLG 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 GRMNYYWTLLKPGDTIIFEANGNLIAPMYAFALSRGFGSGIITSNASMHECNTKCQTPLG 300
Qy 301 AINSSLPYQNIHPVTIGECPKYVRSAKLRMVTGLRNIPSIQSRGLFGAIA GFIEGGWTGM 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 AINSSLPYQNIHPVTIGECPKYVRSAKLRMVTGLRNIPSIQSRGLFGAIA GFIEGGWTGM 360
Qy 361 IDGWYGYHHQNEQGSGYAADQKSTQNAINGITNKVNTVIEKMNIQFTAVGKEFNKLEKRM 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 IDGWYGYHHQNEQGSGYAADQKSTQNAINGITNKVNTVIEKMNIQFTAVGKEFNKLEKRM 420
Qy 421 ENLNKKVDDGFLDIWTYNAELLVLLENERTLDFHDSNVKNLYEKVKSQLKNNAKEIGNGC 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 ENLNKKVDDGFLDIWTYNAELLVLLENERTLDFHDSNVKNLYEKVKSQLKNNAKEIGNGC 480
Qy 481 FEFYHKCDNECMESVRNGTYDYPKYSEESKLNREKVDGVKLESMGIYQILAIYSTVASSL 540
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 481 FEFYHKCDNECMESVRNGTYDYPKYSEESKLNREKVDGVKLESMGIYQILAIYSTVASSL 540
Qy 541 VLLVSLGAISFWMCSNGSLQCRICI 565
|||||||||||||||||||||||||
Db 541 VLLVSLGAISFWMCSNGSLQCRICI 565
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US Patent Application Publication US 2012/0034264) as applied to claim 1 and further in view of Zeng et al. (US Patent Application Publication US 2014/0004047) as evidenced by Rebello et al. (US Patent Application Publication US 2021/0348129).
Yang et al. teach an engineered cell comprising a heterologous polynucleotide encoding an influenza H1N1 hemagglutinin antigen, wherein the cell is a Vero cells, BHK cells, MDCK cells, 293 cells and COS cells, including 293T cells, COS7 cells (see paragraphs [0063], [0112] and [0113].
Yang et al. do not teach Pax7+ mammalian muscle cell multinucleated myotube expressing myosin heavy chain (MHC) and actin.
Zeng et al. teach expression of viral proteins in Pax7+ mammalian bovine satellite muscle cells (see Example 1, and paragraphs [0180], [0185]).
Rebello et al. teach culturing muscle cells for food production comprising mammalian cells comprising multinucleated myotube expressing myosin heavy chain (MHC) and actin (Examples 9, 14 and 16, paragraphs [0057], [0061]).
It would have been prima facie obvious to provide Zeng’s et al. Pax7+ mammalian bovine satellite muscle cells expressing Yang et al. teach an engineered cell comprising a heterologous polynucleotide encoding an influenza H1N1 hemagglutinin antigen, because Zhang et al. teach successful expression of viral proteins in Pax7+ mammalian bovine satellite muscle cells (see Example 1).
Regarding present claim 9. Rebello et al. provide evidence that mammalian muscle cells comprise multinucleated myotube expressing myosin heavy chain (MHC) and actin. Thus, the limitation of present claim 9 is an inherent property of the cells in Yang and Zeng.
Thus, the present invention would have been prima facie obvious at the time the invention was made.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (US Patent Application Publication US 2012/0034264) as applied to claim 1 and further in view of Adamson et al. (Genetics, 2011, Vol. 189, p. 495-506) as evidenced by Abmayr et al. (Development 2012, p. 641-656).
Yang et al. teach an engineered cell comprising a heterologous polynucleotide encoding an influenza H1N1 hemagglutinin antigen, wherein the cell is a Vero cells, BHK cells, MDCK cells, 293 cells and COS cells, including 293T cells, COS7 cells (see paragraphs [0063], [0112] and [0113].
Yang et al. do not teach Drosophila adult muscle progenitor (DrAMPC) or the multinucleated myotube expressing myosin heavy chain and ecdysone receptor.
Adamson et al. teach Drosophila adult muscle progenitor (DrAMPC), expressing influenza virus M1 protein (see Materials and Methods).
Regarding present claim 12. Abmyr et al. provides evidence that the multinucleated myotube expressing myosin heavy chain and ecdysone receptor are an inherent property of the Drosophila adult muscle progenitor (DrAMPC).
It would have been prima facie obvious to provide Adamson et al. Drosophila adult muscle progenitor (DrAMPC), expressing Yang’s influenza H1N1 hemagglutinin antigen because Adamson et al. teach successful expression of influenza virus proteins in Drosophila adult muscle progenitor (DrAMPC) (see Materials and Methods).
Thus, the present invention would have been prima facie obvious at the time the invention was made.
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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