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 request for continued examination, amendment and response filed 2/24/2026. Claims 14,25 and 31 were amended and new claim 34 was added.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/24/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/2/2026 and 2/24/2026 were filed before close of prosecution in the application. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is 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 14 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.
Regarding claim 14, the limitation “wherein said hybrid foodstuff does not include plasma or serum” renders the claim indefinite because a person of ordinary skill in the art cannot determine with reasonable certainty whether a given prepared food meets this limitation.
Plasma and serum are typically cell culture inputs. They are not structurally identifiable components of a final processed food. Following cell harvesting, washing, and incorporation into a food matrix, any plasma-derived or serum-derived constituents would be biochemically indistinguishable from other proteins, peptides or metabolites present in the food composition.
The limitation is interpreted as trying to define the claimed product by a process condition (use of a serum free culture) rather than by structural characteristics of the final product. However, the claim does not recite any structural features that would distinguish a product thus produced from a product prepared without this condition, rendering the scope indeterminate.
A meaningful comparison with prior art is not possible. Appropriate correction is required.
Response to Arguments
Applicant’s arguments in view of the amended claims have been considered but are not persuasive for the following reasons:
The amended claims rely on distinctions arising from the manner in which cultured animal cells are produced (e.g. absence of plasma or serum during culture). However, such distinctions are not reflected in any structurally identifiable features of the claimed product.
As discussed above, the limitation of absence of plasma or serum, that cannot be verified in a final product, renders the product claim indefinite.
If applicant intends to rely on specific culture conditions or processing steps , such conditions if supported in the disclosure, are more appropriately recited in a method claim that explicitly sets forth the relevant steps. Furthermore, any claim to structurally distinguishing features in a product made by the method should be supported by evidence demonstrating that the conditions in the method yield unexpected properties in a final product.
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