DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Preliminary Amendment filed on January 30, 2025, has been received and entered.
Claim Disposition
3. Claims 19, 22 and 23 were canceled. Claims 1-18 and 20-21 are pending and are under examination.
Information Disclosure Statement
4. The Information Disclosure Statement filed on January 30, 2025, has 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.
Specification Objection
5. The specification is objected to for the following informalities:
The specification is objected to because the organism names are not consistently italicized throughout the specification see page 21, for example.
Appropriate correction is required.
Claim objection
6. Claims 1-18 and 20-21 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to recite “…. composition [[the steps of]]:
…….at least one enzyme [[capable of polymerizing said]] that polymerizes the at least one substrate [[,]].…….incubating the mixture of [[step]] a) to form…..”. See also claims 2 and 21 with similar language. The dependent claims hereto are also included.
For clarity it is suggested that claims 3-18 and 20 are amended to delete “according to” and instead recite ‘of’.
Claim 17 is objected to because the organism names are not italicized.
Appropriate correction is required.
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.
7. Claims 1-18 and 20-21 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 is directed to “a method for producing a stable hydrogel-cell composition comprising providing a reaction mixture comprising at least one polymerizable substrate and at least one enzyme capable of polymerizing said at least one substrate, and cells, and incubating the mixture of ….(see claim 1 in its entirety). The claimed invention encompasses a large variable genus of cells, substrates and enzymes, that are not adequately described. The enzymes are asserted as being capable of polymerizing which is not a positive recitation of the activity especially with no specific enzyme claimed (see claims 1, 2 and 21). The specification discloses a cellodextrin phosphorylase (enzyme), sugar phosphate (substrate) and Lactococcus lactis (cells) which are specific embodiments that the claims are not necessarily limited to. It is noted that some of the dependent claims recite the missing information but the independent claims have to stand on their own. Thus the claimed invention is overly broad and not commensurate in scope with the disclosure in the specification. Thus the claimed invention is not adequately described. No correlation is made between structure and function for the enzyme of the claimed invention, and does not demonstrate possession of the large genus. 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.
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, 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.
8. Claims 1-18 and 20-21 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and or use the invention. The specification does not contain the required information for a deposit. The specification provides a deposit certificate, and the claimed invention requires the deposited cells. It is disclosed that a deposit was made for Lactococcus lactis 10123 on February 4, 2022, Deposit number DSM2-DSM 34156. Thus use of the claimed invention requires deposited material, but deposit of material does not ensure that it will readily be available during the duration of the patent. Applicant's deposit would satisfy the enablement requirements of 35 U.S.C. 112, provided that the following conditions are met. It is noted that the specification indicates that a deposit was made and provides the depository name and address, the date the deposit was made and the deposit number. However, no information regarding public availability is provided or whether the deposit was made under the Budapest Treaty. Thus, the invention is not adequately described and one skilled in the art would not have access to the necessary materials to be able to practice the claimed invention. Applicant refers to the deposit number (note that the deposit number is missing on page 58 of the specification), however, this is not sufficient to illustrate that the information is publicly available or give the assurance that all of the conditions of 37 CFR 1.801-1.809 have been met. If deposits have not been made under the BudapestTreaty, then in order to certify that the deposits meet the criteria set forth in 37 CFR 1.801-1.809, applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(A) During the pendency of this application, access to the invention will be afforded tothe Commissioner upon request;
(B) All restrictions upon availability to the public will be irrevocably removed upongranting of the patent;
(C) The deposits will be maintained in a public depository for a period of 30 years or 5years after the last request or for the effective life of the patent, whichever is longer;(D) The deposits were viable at the time of deposit;
(E) The deposits will be replaced if they should ever become non-viable.
This requirement is necessary when a deposit is made under the provisions of theBudapest Treaty as the Treaty leaves these specific matters to the discretion of each member State. Amendment of the specification to disclose the date of the deposit and the complete name and address of the depository is required. For further information concerning deposit practice, applicants attention is directed to In re Lundark 773 F 2d 1216 227 USPQ CCAFC and 37 CFR1.801-1.809.
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.
9. Claims 1-18 and 20-21 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.
Claims 1, 2, 21 and the dependent claims hereto lack clear antecedent basis for the recitation ‘said cells and xanthan’.
Claims 15 and 20 are indefinite for the recitation of "preferably” and “more preferably” for parameters pertaining to the mixture, as the phrase preferably renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP 2173.05(d).
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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