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
This application is final. Any rejections from the previous Official Action not repeated below have been withdrawn.
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 1-8 and 12-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a customized feed method for delivering customized enzyme mixtures for broilers or pigs , does not reasonably provide enablement for a customized feed to address all zootechnical objectives for all animals.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
At the outset, it is acknowledged that the level of skill (D) is high as the claims are directed to a method of producing a customized feed. Researchers in these fields often have PhDs. A PhD is the highest degree level a student can achieve and basically it acts as your initiation into the world of research and academia.
However, as to the breadth of the claims (A) in the present invention, the claims are directed to a method for formulating a customized feed to address one or more zootechnical objectives. Thus, the claims are very broad.
As to the nature of the invention (B), state of the prior art (C) and level of predictability (E), people have been working with food for thousands of years. However, the breadth of the claims are such that they cover a multitude of objectives with no evidence provided that such objectives can be addressed or that the solutions for addressing such objectives would be the same for all species with a broad array of feed materials.
As to the amount of direction provided by the inventor (F) and quantity of experimentation (H), there are only two examples. While the first example is directed to providing enzyme compositions to pigs with the second example limited to finding certain enzymes for broilers, the disclosure does not enable the breadth of the zootechnical objectives claimed to be treated with general “customized enzyme” compositions. Moreover, the Examples are limited to very specific feed (see Figure 3).
In view of the above, it is most respectfully submitted that although the level of skill in the art is high, the evidence available to date indicates that the level of experimentation needed to make or use the claimed invention in its current breadth is undue.
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.
Claims 1, 3-5, 12-16, and 22-28 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation animal specific data, and the claim also recites one or more of animal nutritional needs, animal weight, animal activity level, ammonia production level of the animal, animal body temperature, ambient temperature and humidity, animal weight, animal water intake, animal body pH, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
It is also noted that applicant does use the terminology “selected from the group consisting of” in claim 26 to that one of the statistical machine learning model must be chosen from the Markush group. This seems to suggest that the term “including” serves as exemplary language.
Claim 1 also recites updating the statistical or machine learning model using data derived from monitoring animal performance after administration of the customized animal feed, the updated model being used to improve the design of future customized enzyme compositions and customized animal feed. It is not clear what constitutes the improved design of future customized enzyme compositions and animal feeds.
Claims 22-23 recite the phrase “including”. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 25 recites the limitation "the enzyme performance score" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 27 recites the limitation "the diet formulation plan" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Response to Arguments
Applicant's arguments filed 2/2/2026 have been fully considered but they are not persuasive.
The applicant argues that claim 1 does not require that the method address every possible zootechnical objective for every species. Instead, claim 1 recites a data-driven method for formulating and producing a customized animal feed tailored to specific, received physiological and environmental data for a particular animal. The claim scope is thus commensurate with the method described and enabled in the specification, which provides guidance for adapting feed formulations across species using measurable animal-specific inputs and predictive modeling. The applicant also argues that the claimed method is not directed to a fixed feed formula but rather to a computational process that adapts to the needs of different animals through a defined methodology. The specification discloses how animal-specific data is received via an interface, processed by a statistical or machine learning model, and translated into a customized feed formulation through enzyme indexing, performance scoring, and predictive modeling. These elements are implemented in a technological context and result in the physical manufacture and administration of a customized feed. The system includes feedback through sensor-based performance monitoring, which is used to further refine the model. This full cycle is well-supported and repeatable. It is also argued that the specification provides ample guidance regarding model selection (e.g., decision trees, neural networks, support vector machines), relevant data inputs, database structure, raw material characterization, and enzyme evaluation. Additionally, the specification includes two working examples: one involving pigs and another involving broilers. These examples demonstrate that the method is operable and adaptable across species.
However, the breadth of the claims are such that they cover a multitude of objectives with no evidence provided that such objectives can be addressed or that the solutions for addressing such objectives would be the same for all species with a broad array of feed materials.
As to the amount of direction provided by the inventor (F) and quantity of experimentation (H), there are only two examples. While the first example is directed to providing enzyme compositions to pigs with the second example limited to finding certain enzymes for broilers, the disclosure does not enable the breadth of the zootechnical objectives claimed to be treated with general “customized enzyme” compositions. Moreover, the Examples are limited to very specific feed (see Figure 3).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP A DUBOIS whose telephone number is (571)272-6107. The examiner can normally be reached M-F, 9:30-6:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHILIP A DUBOIS/ Examiner, Art Unit 1791 /Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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