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 .
Response to Amendment
The Amendment filed 08/26/2025 in which claims 13-15 were amended, and claim 16 was canceled, has been entered. Claims 1-12 were previously withdrawn.
Claims 13-15 are under examination on the merits.
Priority
(Previous objection, withdrawn) Applicant’s amendments concerning claim for foreign priory to two prior-filed applications: the Chinese application No. CN- 201911161596.2 filed on 11/22/2019 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as indicated above, and PCT application CN 2020/126654 filed 11/05/2020 submitted on 06/26/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed on 08/26/2025.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 08/26/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed on 03/26/2025.
Nucleotide and/or Amino Acid Sequence Disclosures
(Previous objection, withdrawn) Applicant’s amendments to the Specification concerning nucleotide and/or amino acid sequence disclosures submitted on 08/26/2025 have overcome the objection previously set forth in the Non-Final Office Action mailed on 03/26/2025.
Claim Objections
(Previous objections, withdrawn as to claims 13 and 15) Applicant’s amendments to claims 13 and 15 have overcome previous objections to those claims.
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.
(Previous rejection, withdrawn as to claims 13-16) Claims 13-16 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to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.
See claims 13-16 as submitted on 08/26/2025.
The previous rejections of claim 16 is moot in view of Applicant’s cancelation of this claim.
Applicant’s amendments to claims 13-15 have overcome previous rejections to those claims.
(New rejection, necessitated by amendment as to claims 13-15) Claims 13-15 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.
Amended claim 13 recites “the IBV H120 vaccine strain has the nucleotide sequence of SEQ ID NO: 11, and the other IBV strain has the nucleotide sequence of SEQ ID NO: 12.” It is not clear if Applicant intended to recite “comprising”, “consisting essentially of” or “consisting of” to define the scope of a claim in relation to SEQ ID NOs: 11 and 12. See MPEP 2111.03. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claim 13 was interpreted herein as referring to the open-ended language of comprising a nucleotide sequence of the SEQ ID NOs: 11 and 12.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
(Previous rejection, maintained and modified as necessitated by amendment as to claims 13 and 15) Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al., in view of Yuan et al., further in view of GenBank accession number FJ807652 (see PTO-892: Notice of References Cited) and GenBank accession number KJ524616 (prior art of record).
See claims 13-15 as submitted on 08/26/2025.
Regarding amended claim 13, it is noted that the amendment requires two new limitations: 1) “wherein a sequence encoding a signal peptide of the first S1 gene in the backbone vector is retained during the replacement”, and 2) the IBV H120 vaccine strain has the nucleotide sequence of SEQ ID NO: 11, and the other IBV strain has the nucleotide sequence of SEQ ID NO: 12. It is also noted that the previously limitation with respect to simultaneous replacement of an S1 gene and an N gene is no longer required by the claim as it is an optional embodiment of the claimed method.
With respect to the first new limitation of “wherein a sequence encoding a signal peptide of the first S1 gene in the backbone vector is retained during the replacement”. As explained previously, Zhou et al. teach a method for preparation of an epidemic infectious bronchitis virus vaccine, wherein an infectious bronchitis virus (IBV) H120 strain is used as a backbone vector and wherein the spike (S) protein of the backbone vector is replaced with that of a more virulent IBV stain termed ck/CH/IBYZ/2011 to formulate a recombinant rH120-YZ (Abstract, page 3). Zhou et al. further teach that such construct, comprising a backbone of the IBV H120 strain and the S protein of a more virulent strain, produce a recombinant IBV that remains attenuated but induces protective immunity in BHK cells (Abstract, claims 1, 2, page 7).
Zhou et al. does not teach wherein a sequence encoding a signal peptide of the first S1 gene in the backbone vector is retained during the replacement.
However, Yuan et al. teach and suggest optimizing a IBV vaccine vector by including a sequence for a signal peptide recognized by the producer cells in order to increase the expression and yield (page 3). In the instant case, BHK cells are used (Specification, ¶ [44]), not the insect cells used by Yuan et al.
With respect to the second new limitation of claim 13 of “the IBV H120 vaccine strain has the nucleotide sequence of SEQ ID NO: 11, and the other IBV strain has the nucleotide sequence of SEQ ID NO: 12”, GenBank accession number FJ807652 and GenBank accession number KJ524616 were cited for teaching sequences comprising instant SEQ ID NO: 11 and SEQ ID NO: 12 respectively.
It would have been prima facie obvious to one of skill in the art before the effective filing date to have incorporated the teachings of Yuan et al. about optimizing a IBV vaccine vector by including a signal peptide which allows for increased expression and yield in chicken cells into the vaccine vector of Zhou et al. given that Zhou et al. already teach that the construction of a vector comprising the backbone of an apathogenic strain and a heterologous gene from a pathogenic strain results in a recombinant IBV that remains attenuated but induces protective immunity. One of skill in the art would have been motivated to do so given that sequences for signal peptides are well known in the art and are routinely swapped and optimized for the benefit of increased expression and yields in different cell lines as taught by Yuan et al. See MPEP 2144.05 Optimization Within Prior Art Conditions or Through Routine Experimentation. Further, it would have been prima facie obvious to one of skill in the art before the effective filing date to have retained the signal peptide of the original IBV H120 strain given that Zhou et al. already demonstrate effective expression and yields with the signal peptide of the original H120 strain in BHK cells (page 6). Further, it would have been prima facie obvious to one of skill in the art before the effective filing date to incorporated the IBV sequences from GenBank accession number FJ807652 and GenBank accession number KJ524616 into the claimed method since these sequences were known in the art.
One of ordinary skill in the art would have had reasonable expectation of success in formulating a method of IBV vaccine preparation comprising known sequences of an H120 backbone vector with the S1 protein of a more virulent strain while retaining the optimal signal peptide sequence of the original H120 strain given that the methods of increasing IBV expression and yields based on swapping and optimizing signal peptides are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claims 14-15, as indicated previously, Yuan et al. teach simultaneous co-expression of the S1 and N genes (Abstract, page 1, 2), wherein the second IBV strain is a wilt-type virus isolated from China in 2011 (ck/CH/IBYZ/2011) (Abstract, page 3).
Accordingly, claims 13-15 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date especially in the absence of evidence to the contrary.
The rejection is maintained for reasons of record.
(Previous rejection, withdrawn as to claim 16) Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. in view of Yuan et al., as applied to claims 13-15 above, further in view of Feng et al. (prior art of record).
The previous rejections of claim 16 is moot in view of Applicant’s cancelation of this claim.
Response to Arguments
Applicant's arguments filed 08/26/2025 have been fully considered but they are not persuasive.
Applicant contends on page 9 of the Remarks submitted on 08/26/2025:
“All of the cited prior art documents failed to disclose or suggest that the sequence encoding the signal peptide in S1 gene of the backbone vector is retained during the replacement.”
In response:
As explained above in detail the cited prior art teaches optimization of an IBV vaccine vector by swapping a signal peptide (see Yuan et al.). Further Zhou et al. already demonstrate effective expression and yields with the signal peptide of the original H120 strain in BHK cells (page 6), these are the same cells in instant application. In combination the cited references teach and suggest the method of claim 13 wherein the signal peptide of the H120 strain is retained for expression in BHK cells. Applicant's arguments against the references individually are not persuasive because one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant contends on page 9 of the Remarks submitted on 08/26/2025:
“Surprisingly, the inventors of the instant application have found that retaining an original signal peptide region of the S1 gene in a backbone vector is a key factor for successfully rescuing and obtaining the recombinant virus in a comparative experiment of two groups that retain or do not retain the original signal peptide region of the S1 gene in the backbone vector.”
In response:
As to applicant’s alleging surprising results, applicant has not provided any data nor baseline or basis for comparison of surprising versus unsurprising results in view of the instant claim language, rather merely stating or asserting or concluding that results are surprising. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas J Visone can be reached at (571) 270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672