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 .
Status of the Application
Receipt is acknowledged of the amendment and response filed 4/8/2026. Claims 1-6,9-15,18, 20,21,23 and 25 are pending in the application. Claims 1,4-6,11-13,15,18,20-21 and 23 were amended.
Claim Rejections - 35 USC § 103
Claim(s) 1, 4, 6, 9,10,12,13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lee and Schimdt-Dannert et al. (US 2005/0089972 Al) and further in view of Maruhashi (US4,436,663).
Regarding claim 1-3 Lee discloses a method for producing heme/metalloporphyrin porphyrin by culturing a heme-producing microorganism having a heme synthesis pathway gene in a medium containing a carbon source (abstract, [0042],[ Fig 1 and 2, [0033],[0034]). As the claim is directed to producing Zinc -protoporphyrin or heme, Lee is relevant prior art.
Lee does not specifically detail generally known methods to extract zinc protoporphyrin or heme from the cells. Maruhashi discloses recovering heme by suspending solids form cell culture in water, dissolving in aqueous lower alcohol at pH 8 precipitating with acid with acid and further separating porphyrins (for example see column 4 line 55 through column 5 line 50).
It would have been obvious to one of ordinary skill in the art to have selected a food grade solvent, ethanol to recover a zinc protoporphyrin for food applications with a reasonable expectation of success.
Regarding claim 2 Lee discloses expression of the heme synthesis pathway gene is induced when an OD600 value of the culture reaches a value in the claimed range, maximized at 62.7 for example (Example 5-2 [0187]).
Regarding claim 3 Lee discloses a concentration of iron ions of an exemplary 20mg/L (0.36mM) [174] falling within the claimed range.
Regarding claims 4, 6,9,10 and 12-14, Lee discloses fed batch processes for culturing microorganisms producing heme in a culture medium as claimed and Schimdt-Dannert discloses methods and conditions to produce porphyrins using microorganisms that contain one or more exogenous nucleic acids are described that produce
porphyrins in high yield. Conditions to produce porphyrins including metalloporphyrins and zinc protoporphyrin are described [0135]. The references discloses adjusting process conditions to optimize the production of heme/porphyrin. One of ordinary skill in the art would therefore adjust conditions for a zinc protophyrin or heme with a reasonable expectation of success.
The claims present optimized conditions for the production of a zinc protoporphyrin or heme, which would have been experimentally accomplished by one of ordinary skill in the art, based on optimization of conditions taught in Lee and Schimdt-Dannert for the production of heme/porphyrins.
Regarding claim 15,17,18,21 and 23, Lee discloses recovering the produced heme (claim 11) which is recoverable by known methods in the art. Maruhashi discloses recovering heme by suspending solids form cell culture in water, dissolving in aqueous lower alcohol at pH 8 , precipitating with acid with acid and further separating porphyrins (for example see column 4 line 55 through column 5 line 50).
It would have been obvious to one of ordinary skill in the art to have selected a food grade solvent, ethanol to recover a porphyrin for food applications with a reasonable expectation of success.
Claim 25 is rejected under 35 USC 103 as being unpatentable over a meat food product or a meat-like food product in Varadan et al. (US 20170188612 A1) .
Claim 25 is a product by process claim. A product by process claim is not limited by manipulations of process steps only the structure implied by the steps.
In the instant case, the product is a food with flavor similar to meat, which could be any meat or meat containing product for example beef containing product, which inherently contains heme, which is a porphyrin, metalloporphyrin as claimed.
Varadan et al. disclose a food product with flavor similar to meat wherein the product contains a heme compound [0005]. Similarly, a Zinc -protoporphyrin or would produce a characteristic profile.
Claims1-6,9-15,18, 20,21,23 and 25 are therefore prima facie obvious in view of the art.
Response to Arguments
Claim amendments render the rejection of claims under 35 USC 112(b) and 35 USC 102 moot. However, applicant’s arguments in view of the amended claims are not completely persuasive. The claims remain obvious over the art for the reasons provided.
Conclusion
THIS ACTION IS MADE FINAL. 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 Subbalakshmi Prakash whose telephone number is (571)270-3685. The examiner can normally be reached Monday-Friday.
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, Emily Le can be reached at (571) 272-0903. 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.
/SUBBALAKSHMI PRAKASH/Primary Examiner, Art Unit 1793
Prosecution Insights