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 .
This rejection is Final. Any rejections from the previous Official Action from the previous Official Action not repeated below have been withdrawn.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 11-12 and 14-28 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 computer-implemented method of composing an animal feed comprising an A/X soybean meal ration between 1.8 and 2.6 with different levels of dietary xylanase (SEQ ID NO 2), alpha-galactosidase (SEQ ID NO 17) and multi-carbohydrase (RVB) in a corn and soybean meal based diet for broiler chickens, does not reasonably provide enablement for composing an animal feed with at least one carbohydrase in combination with an animal feed with a defined A/X fiber fraction, wherein the selected carbohydrase is selected and in an amount based on the A/X fiber fraction of the feed.
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 computer-implemented method of composing an animal 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 computer-implemented method of composing an animal feed, comprising determining a factor by which enzyme activity is reduced as a function of a determined A/X soybean meal ratio. The method addresses this reduced enzyme activity by determining what carbohydrase and amount can be added. None of the claims recite a specific carbohydrase that can address this reduced activity. 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 claims are directed to a method for formulating a customized animal feed with at least one carbohydrase in combination with a defined A/X fiber fraction, wherein the at least type and amount of the at least one enzyme is based on the A/X fiber fraction. However, there is no indication that all carbohydrases would respond in the same way. The category of carbohydrases is a large category of enzymes and there is no evidence that they would provide the same results. Moreover, it is not clear that the animal would respond to different enzymes in the same manner or that even feeds with different ingredients but the same A/X fiber fraction would respond in the same way.
As to the amount of direction provided by the inventor (F) and quantity of experimentation (H), it is noted that the only example provided is limited to a method of composing an animal feed for broiler chickens comprising an A/X soybean meal ratio of 1.87 with different levels of dietary xylanase (SEQ ID NO 2), alpha-galactosidase (SEQ ID NO 17) and multi-carbohydrase (RVB). Moreover, the broiler chickens were placed on a strict regime as to when and how much they were fed. Table 2 on page 59 of the present specification also shows that the diet were fed was highly specific and included a variety of ingredients not set forth in the claims.
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 11-12 and 14-28 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.
Claim 11 is rejected for reciting “dietary fibers, specifically arabinoxylans and xylose.” Regarding claim 11, the phrase "specifically" 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).
Claim 26 is rejected for reciting “dietary fibers, including arabinoxylans and xylose.” Regarding claim 26, the phrase "including" 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).
Claims 12, 14-25, 27-28 are rejected as they depend on claims 11 and 26, respectively.
Response to Arguments
Applicant's arguments filed 2/17/2026 have been fully considered but they are not persuasive.
The applicant argues that the Official Action has not considered the requirement of A/X soybean meal ratio and its use.
However, the claims are not limited to the use of A/X soybean meal ration. As noted above, the claims are directed to a method for formulating a customized animal feed with at least one carbohydrase in combination with a defined A/X fiber fraction. But the category of carbohydrases is a large category of enzymes and there is no evidence that they would provide the same results. Moreover, it is not clear that the animal would respond to different enzymes in the same manner or that even feeds with different ingredients but the same A/X fiber fraction would respond in the same way. While the specification does provide an example, the example is limited to a method of composing an animal feed for broiler chickens comprising an A/X soybean meal ratio of 1.87 with different levels of dietary xylanase (SEQ ID NO 2), alpha-galactosidase (SEQ ID NO 17) and multi-carbohydrase (RVB). Moreover, the broiler chickens were placed on a strict regime as to when and how much they were fed. Table 2 on page 59 of the present specification also shows that the diet were fed was highly specific and included a variety of ingredients not set forth in the claims.
As to the indefiniteness rejection, the applicant argues that the terms “specifically” and “including” are definite. However, MPEP § 2173.05(c) notes that including a broad limitation alongside a narrow limitation in the same claim causes confusion about what is required.
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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