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
Claims 1-15,17,18,20,21,23 and 25 as amended in a preliminary amendment filed 1/30/2024 are pending in the application.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 3/28/2025 and 8/29/2025 were filed before the first Office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim 1 and dependent claims 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.
Claim 1 recites a method of producing a compound selected from the group consisting of heme, porphyrins, metalloporphyrin and porphyrin analogs. However, heme is a porphyrin, heme is a metalloporphyrin, metalloporphyrin is a porphyrin, and porphyrin analogs is a broad term that includes compounds from all these classes. A broad recitation of a limitation and a narrower recitation of the limitation in a single claim in a Markush group, renders the claim indefinite. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate correction is required.
Claims 4,5, 11 recite “the production of zinc-protoporphyrin among metalloporphyrins is increased by increasing a concentration of zinc ions.” There is no antecedent basis for “the production of zinc- protoporphyrin”. Furthermore, the phrase “among metalloporphyrins” does not clarify what the comparison is with and “increased” is a relative term rendering the claims indefinite. Appropriate correction is required to enable a meaningful comparison with the art.
Claim 6 and 9 recite “the residual carbon” without antecedent basis.
Claim 15,20,21 recite “the produced” without antecedent basis.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3,5,7,8,11, is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (US 2019/0382817 Al).
Regarding claim 1, 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]).
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 claim 5 and 11, Lee discloses a zinc ion concentration from 2.2g/L ZnSO4.7H2O corresponding to 7.65 mM falling within the claimed range.
Regarding claim 7, Lee discloses carbon source glycerol in the culture medium (Examples 3 and 4).
Regarding claim 8, Lee discloses a fed batch process wherein the feeding solution contains iron (0167] [0180]).
Lee therefore anticipates the subject matter in claims 1-3,5,7,8 and 11, rendering the claims unpatentable.
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.
Claim(s) 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) in view of generally known methods in the art.
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. As applicant has not claimed a particular compound being produced, and a culture for its production, a meaningful comparison with prior art is not possible.
The claims appear to present optimized conditions for the production of a specific compound, 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.
Claims 15,17,18, 20,21 and 23 are rejected under 35 USC 103 as being unpatentable over Lee in view of Maruhashi (US4,436,663).
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].
Claims 4, 6, 9,10,12-15, 17,18,20,21,23 and 25 are therefore prima facie obvious in view of the art.
Correspondence
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.
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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.
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/SUBBALAKSHMI PRAKASH/Primary Examiner, Art Unit 1793