DETAILED ACTION
Notice of Pre-AlA 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 .
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 26, 2026, has been entered.
Claim Disposition
3. Claims 1-176, 179-180, 182-185, 187 and 197 have been cancelled. Claim 202 has been added. Claims 177-178, 181, 186, 188-196 and 198-202 are pending. Claims 177-178,181,186, 188-192 and 198-200 are under examination. Claims 193-196 are withdrawn as directed to a non-elected invention. The claims are only being examined to the extent that pertain to the elected subject matter.
Information Disclosure Statement
4. The Information Disclosure Statements filed on January 26, 2026 and February 3, 2026, have been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
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.
5. Claims 177-178, 181, 186, 188-192 and 198-202 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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.
The claimed invention as amended is directed to a nutritional composition comprising a yeast cell or filamentous fungal cell comprising at least one recombinant animal protein expressed by the yeast cell or the filamentous fungal cell, wherein a) multiple copies of a nucleic acid sequence encoding the recombinant animal protein are integrated into a genome of the yeast cell or filamentous fungal cell…” (see claim 177 in its entirety). The claimed invention is not adequately described because there are no indicia as to what yeast or fungal cell. The claimed invention encompasses a large variable genus of cells. The art generally recognizes that there is over 1500 yeasts and more than 88 filamentous fungus. The invention has not established that every yeast or fungus would work in the claimed invention wherein multiple genes encoding animal protein are integrated into the genome of the cell and expresses the protein in the laundry list of proteins. The instant specification discloses in Figures 12-18 protein expression in S. cerevisiae, K. phaffi, K. lactis and S. pombe, however this is not representative of the large genus encompassed in the claims. In addition, the claimed invention is directed to the phylum ascomycete, which is known in the art to be a massive and diverse group of fungi that includes both single-celled yeasts and multicellular filamentous fungi, however, no specific embodiment is recited in the claims. Applicant has not demonstrated possession of the enormous genus of organisms encompassed in the claims.
Furthermore, no reference gene or structure is provided or the recombinant nature of the gene/protein. The claimed invention also recites that the composition is substantially free of antibiotics, growth hormones and animal meat. However, the art recognizes that meat is a big source of animal protein. Note that claim 181 recites several animals as the source of the proteins, thus the recitation of “substantially free” appears to be contradictory. In addition, the nutritional drink encompasses at least one ingredient selected from: any fat, any carbohydrate, any non-recombinant protein, any fiber, any nutritional supplement and combinations thereof. The claimed invention is also directed to any flavoring agent the comprises any carbohydrate, any sugar, any nucleic acid, any free fatty acid, any amino acid or amino acid derivative, any vitamin, any mineral, any antioxidant or any combination therefore. Thus, the claimed invention is not adequately described.
The invention of claim 177 for example, encompasses a large genus of natural proteins and genes, yeast and fungal cells. The claimed invention encompasses a large variable genus of structures not adequately described, thus no correlation is made between structure and function. The ordinary skilled worker has no glimpse of what these genus encompass. The dependent claims hereto do not rectify the missing information in claim 177. Although the claimed invention recites a laundry list of recombinant animal proteins such as annexin, profilin, cofilin, coronin no structure-function correlation is made. The claimed invention also provides a laundry list of where the proteins come from such as chicken, sheep, crab etc., which further establishes a large variable genus.
The claims also recite multiple different recombinant proteins (see claim 186 for example). There are no definitive recitation in the claims of structures that represent a corresponding wild-type structure for comparison. Not knowing a baseline makes it difficult to compare as applicant intends.
The instant specification fails to provide adequate description for the large genus encompassed in the claims. The claims encompasses any gene, the expression product, any yeast and any fungus. The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus. Therefore, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of the proteins and variants thereof.
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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "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). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus of polypeptides, and therefore, 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).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
6. Claim 192 is 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 192 lacks clear antecedent basis for the recitation of “…the nutrition profile for a farm animal…”.
Correction is required.
Basis For NonStatutory Double Patenting
7. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970);and, In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
8. Claims 177-181,183-184,186,188-192 and 197-200 (withdrawn claims 193-196) are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 21-22 and 24-38 of co-pending application U.S. Application No. 19/030,061. An obvious-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claim(s) because the examined claim is either anticipated by, or would have been obvious over, the reference claim(s). See In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); and In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). Although the conflicting claims are not identical, they are not patentably distinct from each other.
The instant claims are directed to a composition formulated for a pet food (cat or dog in a dry kibble form). The co-pending application claims are directed to a pet food or animal feed composition. Although the scope of the two sets of claims differs, the two sets of claims are an obvious variation of each other, thus prima facie obvious. This is a provisional obvious type double patenting rejection.
Response to Arguments
9. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that the rejection under 112, first/second paragraphs remains for the reasons set forth above and herein but has been amended to reflect changes made to the claims. Applicant traverses the rejections by stating that the claims have been amended. The amendment resolved some issues raised but not all. The claimed invention is not adequately described with respect to the yeast and fungal cell and multiple recombinant DNAs and expression products. Applicant states that 18 genera is provided and 42 species, however, the claims are not limited to those and again the genus encompassed is vast and a representative amount of species is not demonstrated by applicant. It is noted that the claimed invention provides the proteins, however, the recitation of multiple genes that encodes said protein is not adequately described. With regard to the 112, second paragraph rejection, the amendment was made only to one portion of the claim and not all occurrences was addressed. Thus for these reasons the rejection remains. Note that a new rejection under Obvious Type Double Patenting has been instituted.
Conclusion
10. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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