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 .
Claim Status
The amendment of 12/18/2025 has been entered. Claims 19-21 and 25-38 are currently pending in this US patent application and were examined on their merits.
Withdrawn Rejections
All rejections of claims 22-24 set forth in the previous Office action are withdrawn in light of the amendment of 12/18/2025, which canceled these claims.
All rejections of the claims under 35 U.S.C. §§ 102(a)(1) and 103 over Hargrove as set forth in the previous Office action are withdrawn in light of the amendment of 12/18/2025 and in favor of the rejections presented below, which have been made in light of the information provided in the information disclosure statement of 12/18/2025.
Information Disclosure Statement
The information disclosure statement filed in this application on 12/18/2025 has been received and considered.
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.
Claims 19-21 and 25-38 are newly rejected as necessitated by amendment and information disclosure statement under 35 U.S.C. 103 as being unpatentable over Hargrove et al., J. Mol. Biol. 266: 1032-1042 (1997; cited on the IDS filed 08/08/2023), in view of Nguyen et al., Curr. Microbiol. 55: 89-93 (2007; cited on the IDS filed 12/18/2025).
Hargrove teaches the transformation of the gene for soybean leghemoglobin a into bacterial cells (see entire document, including page 1039, right column, paragraph 2). The transformed cells were grown in LB medium and induced with IPTG to express leghemoglobin a (page 1039, right column, paragraph 4; cf. claims 19-21 and 25-38).
However, Hargrove does not teach that the recombinant soybean leghemoglobin is secreted into the culture medium or the concentration in the medium recited in instant claims 19-21.
Nguyen teaches the IPTG-inducible expression and secretion of recombinant proteins in Bacillus subtilis, which are attractive industrial microorganisms because of their high growth rate, capacity to secrete proteins into the culture medium, and GRAS (generally recognized as safe) status with the US FDA (see entire document, including page 89, left column, paragraphs 1-2; cf. claims 19-21).
While Hargrove does not teach the use of a Bacillus subtilis expression system to express soy leghemoglobin, it would have been obvious to one of ordinary skill in the art to do so because Nguyen teaches expression vectors for use in Bacillus subtilis that allow for the recombinant protein to be secreted into the culture medium, thereby simplifying the purification of the protein. One of ordinary skill in the art would have a reasonable expectation that using the Bacillus subtilis expression/secretion system of Nguyen to produce the soybean leghemoglobin of Hargrove would successfully result in the expression and secretion of soybean leghemoglobin into the Bacillus subtilis culture medium.
While Hargrove and Nguyen do not teach a concentration of leghemoglobin in the culture medium that falls within the range recited in instant claims 19-21, the instantly recited range would be within the realm of routine experimentation. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 part II A. It would have been obvious to one of ordinary skill in the art at the time Applicants' invention was made to determine all operable and optimal concentrations of leghemoglobin expressed by the cells because the amounts of ingredients in a culture medium are art-recognized, result-effective variables known to affect the growth of the cells, and because the amount of recombinant protein produced by a cell is an art-recognized, result-effective variable known to affect the yield of the process, which would have been optimized in the art to provide the desired yield from the cells.
Therefore, claims 19-21 and 25-38 are rendered obvious by Hargrove in view of Nguyen and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 12/18/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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 Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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, Sharmila Landau, can be reached at (571)272-0614. 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.
/Erin M. Bowers/Primary Examiner, Art Unit 1653 05/26/2026
Prosecution Insights