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 .
DETAILED ACTION
This Office Action is a reply to Applicant’s Election (Response to Restriction Requirement) filed June 9, 2026.
Claims 1, 2, 5-7, 18, 19, 22-24, 28, 29, 31, 32, 36, 43, 48, 52-55, and 61 are pending in the instant application.
Election/Restrictions
Applicant’s election (without traverse) of Group I in the reply filed on June 9, 2026 is acknowledged. Applicant’s further species election of the human H-ferritin gene as recited in claim 6 is also acknowledged.
Claims 18, 19, 22, 29, 54 and 55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 1, 2, 5-7, 23, 24, 28, 31, 32, 36, 43, 48, 52, 53, and 61 have been examined on the merits as detailed below:
Information Disclosure Statement
Applicant’s information disclosure statement (IDS) filed February 20, 2026 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Applicant’s IDS filed September 17, 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Applicant’s IDS filed September 16, 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Applicant’s IDS filed September 15, 2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Applicant’s IDS filed August 19, 2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR §1.97. Accordingly, the Examiner has considered the information disclosure statement, and a signed copy is enclosed herewith.
Drawings
The Drawings filed on November 16, 2023 are acknowledged and have been accepted by the Examiner.
Claim Interpretation
The claims are drawn to a recombinant host comprising: at least a first set of chromosomes and a second set of chromosomes, wherein at least one of the first set of chromosomes and the second set of chromosomes comprise a recombinant gene encoding ferritin or a homologue thereof, and wherein the recombinant host is a fungus, an alga, a protozoan, a microscopic helminth, and/or a microorganism. The present Specification discloses: “As used herein, “homologue” means one chromosome of a homologous pair.”
Where claims recite the phrase, “ferritin or a homologue thereof”, the Examiner will therefore interpret the term, “homologue” as Applicants have defined in their Disclosure.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 5-7, 23, 24, 28, 31, 32, 36, 43, 48, 52, 53, and 61 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The following quotation from section 2163 of the Manual of Patent Examination Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the disclosure must provide written support for the entire scope of the genus. Support for a genus is generally found where the Applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed and that applicant was in possession of the claimed genus.
The instant claims are drawn to a recombinant host comprising: at least a first set of chromosomes and a second set of chromosomes, wherein at least one of the first set of chromosomes and the second set of chromosomes comprise a recombinant gene encoding ferritin or a homologue thereof, and wherein the recombinant host is a fungus, an alga, a protozoan, a microscopic helminth, and/or a microorganism. The present Specification provides examples wherein the overexpression of ferritin from one transgene in diploid yeast results in higher iron levels than when expressed in a haploid yeast. More specifically, haploid yeasts or diploid yeasts were genetically modified to express human ferritin, and hemoglobin recovery and hematocrit recovery were observed in iron-deficient model rats by feeding a diet containing the above-mentioned haploid yeasts or diploid yeasts and iron. Figs. 5-8. From this, it is recognized that when yeast is used as a host, individuals who have consumed it can efficiently and stably ingest iron.
Regarding those claims that recite a ferritin homologue or claim 28 which recites that the homologue has 80% sequence identity with human H-ferritin, there is insufficient written description of the recombinant gene encoding ferritin encompassed by the claims. The present Specification discloses human H-ferritin (SEQ ID NO:1) (amino acid sequence/(SEQ ID NO:2) (nucleic acid sequence), but does not describe any ferritin homologue sequences or a homologue having 80% sequence identity with human H-ferritin that functions as expressed in a recombinant host claimed.
Second, there is insufficient written description of the recombinant host encompassed by the claims because the disclosure doesn’t demonstrate possession of the full genus. The claims are drawn to a recombinant host, wherein the recombinant host is a fungus, an alga, a protozoan, a microscopic helminth, and/or a microorganism, however, the present Specification only provides examples wherein the overexpression of ferritin from one transgene in diploid yeast results in higher iron levels than when expressed in a haploid yeast. There is no example or disclosure for fungi or microorganisms as generic terms, let alone algae protozoa or microscopic helminths.
Written description requirement for claims that recite recombinant gene encoding ferritin or a homologue thereof is not met because the Specification does not provide any description of any variants or what sequences could be modified (added, deleted or mutated) that retain the function as claimed. Furthermore, the Specification fails to show a representative species of recombinant host, wherein the recombinant host is a fungus, an alga, a protozoan, a microscopic helminth, and/or a microorganism. Only yeast has been reduced to practice as claimed. Accordingly, the claims encompass a genus of recombinant host which are not adequately described.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). It is noted that conception is not achieved until reduction to practice has occurred regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
To satisfy the written description requirement an applicant must describe the invention is such a way as to convey to one skilled in the art that applicant had the invention in his possession when the application was filed. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). In cases such as the instant application where a genus is claimed, the specification must contain “either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Id. at 1350. However, written description requirement for claims that recite a recombinant host comprising: at least a first set of chromosomes and a second set of chromosomes, wherein at least one of the first set of chromosomes and the second set of chromosomes comprise a recombinant gene encoding ferritin or a homologue thereof, and wherein the recombinant host is a fungus, an alga, a protozoan, a microscopic helminth, and/or a microorganism is not met.
The entire genus of recombinant host comprising: at least a first set of chromosomes and a second set of chromosomes, wherein at least one of the first set of chromosomes and the second set of chromosomes comprise a recombinant gene encoding ferritin or a homologue thereof, and wherein the recombinant host is a fungus, an alga, a protozoan, a microscopic helminth, and/or a microorganism does not exist in the instant application. That is, adequate written description support does not exist to practice the full scope of the invention claimed. The specification nor the art discloses neither a representative number of species recombinant host that would enable one of skill to immediately envision the genus of recombinant host required to practice the full scope of the invention. Only the yeast recombinant host has been reduced to practice.
The above position is further supported by In re Clarke, 148 USPQ 665, (CCPA 1966), which held that;
“It appears to be well settled that a single species can rarely, if ever, afford support for a generic claim. In re Soll, 25 C.C.P.A. (Patents) 1309, 97 F.2d 623, 38 USPQ 189; In re Wahlforss et al., 28 C.C.P.A. (Patents) 867, 117 F.21 270, 48 USPQ 397. The decisions do not however fix any definite number of species which will establish completion of a generic invention and it seems evident therefrom that such number will vary, depending on the circumstances of particular cases. Thus, in the case of a small genus such as halogens, consisting of four species, a reduction to practice of three, or perhaps even two, might serve to complete the generic invention, while in the case of a genus comprising hundreds of species, a considerably large number of reductions to practice would probably be necessary.”
As stated above, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic claim. Given the breadth of the claims, the Specification lacks sufficient variety of species to reflect the variance in the genus.
In conclusion, the Specification as filed does not provide sufficient descriptive support for the myriad of recombinant hosts embraced by the claims. For the reasons discussed above, the 35 USC § 112 rejection for written description is therefore applicable.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 pre-AIA 35 U.S.C. 103(a) 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 1, 2, 5-7, 23, 24, 28, 31, 32, 36, 43, 48, 52, 53, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over WO2019/236611 A1 to Wolf and Connor (submitted and made of record on the IDS filed August 19, 2024) in view of U.S. Patent Publication 20070087425 to Ohto.
The claims are drawn to a recombinant host comprising: at least a first set of chromosomes and a second set of chromosomes, wherein at least one of the first set of chromosomes and the second set of chromosomes comprise a recombinant gene encoding ferritin or a homologue thereof, and wherein the recombinant host is a fungus, an alga, a protozoan, a microscopic helminth, and/or a microorganism.
Wolf and Connor teach a composition containing a microorganism expressing ferritin and an iron element (Claim 1). Wolf and Connor describes that human H-ferritin can be used as ferritin (Claim 3), microorganisms are used (Claim 6), and it is used as a dietary supplement containing the above composition (Claim 14). Wolf and Connor also describe that when producing genetically modified yeast, an expression cassette containing a TDH3 promoter, human H-ferritin genes, and URA3 genes is incorporated into the chromosomes of the yeast strain BY4741 ([0166]).
The invention described by Wolf and Connor uses yeast strain BY4741 as a host for expressing ferritin. It should be noted that the yeast strain BY4741 is a heterotrophic haploid yeast microorganism.
The human ferritin of Wolf and Connor comprises the nucleic acid sequence of SEQ ID NO: 2 of the present invention and the amino acid sequence of SEQ ID NO: 1 of the present invention.
Also, the invention described by Wolf and Connor may optionally further comprise a second microbe or host organism. Further, the second microbe may additionally or alternatively comprise a probiotic.
Wolf and Connor do not necessarily teach wherein the recombinant host comprises a second set of chromosomes.
OHTO discloses a recombinant host (a recombinant host cell microorganism; paragraphs [0048)-(0050), [00581) comprising: at least a first set of chromosomes and a second set of chromosomes (the microorganism is a diploid cell; paragraph [0058]}, wherein at least one of the first set of chromosomes and the second set of chromosomes comprise a recombinant gene (genomic integration of a recombinant gene; paragraph [0049)); a recombinant host (a recombinant host cell microorganism; paragraphs [0048)-(0050], [0058)) comprising a prototroph (the microorganism is a prototroph; paragraph [0058)) comprising a recombinant gene {genomic integration of a recombinant gene; paragraph [0049]).
Ohto teach a recombinant host wherein recombinant DNA (for expression or genomic integration) is introduced for constructing and testing pathway genes, and wherein the host is a prototroph, a diploid cell, or a prototroph and simultaneously a diploid cell. Ohto teach that it is preferable to use a microorganism that is a diploid cell and at the same time a prototroph, which grows without supplementation of specific nutrients to the medium. Specific examples of hosts used in the Ohto invention include yeast (e.g., Saccharomyces cerevisiae) haploid strains, A451 strain, YPH499 strain, YPH500 strain, W303-1A strain and W303-1B strain, but the desired production strain is prototroph and diploid cell, both at once.
Before the effective filing date of the claimed invention, a recombinant host comprising: a set of chromosomes comprising a recombinant gene encoding ferritin, and wherein the recombinant host is a yeast microorganism was taught and suggested in the prior art of Wolf and Connor.
It would have been obvious for a person skilled in the art to modify the recombinant host of Wolf and Connor to include a second set of chromosomes as taught by Ohto for the purpose of expanding and stably expressing ferritin that contributes to iron storage in cells. That is, in order to express ferritin more stably without nutrient supplementation, the skilled artisan would have been motivated to make a recombinant host using the diploid yeast described in Ohto with the haploid yeast microorganism of Wolf and Connor.
A person of ordinary skill in the art would have expected reasonable success to devise a recombinant host comprising: at least a first set of chromosomes and a second set of chromosomes, wherein at least one of the first set of chromosomes and the second set of chromosomes comprise a recombinant gene encoding ferritin, and wherein the recombinant host is a microorganism using the successful recombinant yeast host teachings of Wolf and Connor combined with the recombinant yeast host teachings Ohto.
Therefore, the subject matter of claims 1, 2, 5-7, 23, 24, 28, 31, 32, 36, 43, 48, 52, 53, and 61 is obvious over Wolf and Connor in view of Ohto.
Conclusion
No claims are allowable at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Terra C. Gibbs whose telephone number is 571-272-0758. The examiner can normally be reached from 8 am - 5 pm M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Ram Shukla can be reached on 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TERRA C GIBBS/ Primary Examiner, Art Unit 1635
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