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 .
DETAILED ACTION
Continued Examination under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/01/2026 has been entered.
Status of the Application
3. Claims 10-12, 15-16, 19-31 are pending in this office action.
Claims 13, 14, 17, 18 were cancelled.
Claims 30, 31 are new.
Claims 10-12, 15-16, 19-31 have been rejected.
Claim Rejections - 35 USC § 103
4. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 US.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
5. — The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action.
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
6. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
7. Claims 10-12, 16, 20-23, 25-31 are rejected under 35 U.S.C. 103(a) as being unpatentable over Melgarejo et al. (EP 1825761 A1) in view of NPL Biomin I (Biomin Trials on autolyzed yeast Levabon Rumen E, Field Trial made for weaning calves, 2012) and as evidenced by NPL Biomin II (Biomin trials on identical autolyzed yeast ‘Levabon Rumen E’, used for Biomin Trial used for lactating calves, 2012; This publication is applicants’ submission on 12/08/2020) and as evidenced by NPL Brewer vs Saccharomyces and further as evidenced by NPL Goat ruminant.
8. Regarding claims 10, 16, Melgarejo et al. discloses a ruminant animal feed composition containing wheat straw in combination with yeast e.g., Brewer’s yeast (page 3 under “Detailed Description”, paragraphs 3-6; in para 6, it recites “brewer’s yeast) and straw is chopped (3cm-15 cm) form (page 3 under “Object of the Invention” and under “Detailed Description”, paragraph 3). It is to be noted that Brewer’s yeast and Saccharomyces cerevisiae yeast are same as is evidenced by NPL Brewer vs Saccharomyces (page 1).
Melgarejo et al. is silent about “autolyzed yeast” from Saccharomyces cerevisiae.
NPL Biomin, I disclose that supplementing autolyzed yeast to the animal (calves) diet provides the benefit of having daily weight gain, and feed intake of weaning calves when compared to control group (at least in Conclusion, Figs 2-4).
It is Known that the disclosed autolyzed yeast (Levabon Rumen E) as disclosed by NPL Biomin I (Under Aim of the trial) is the autolyzed yeast from Saccharomyces cerevisiae as is evidenced by publication NPL Biomin Il.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Melgarejo et al. with the teaching of NPL Biomin I to supplement with autolyzed yeast to the animal (calves) diet in order to provide the benefit of having daily weight gain, and feed intake of weaning calves when compared to control group (at least in Conclusion, Figs 2-4).
It is , to be noted that the combined teaching of Melgarejo et al. in view of Biomin I meet the claim limitations of amended claims 10, 16 to show prima facie case of obviousness. 103 obviousness rejection is proper as discussed above.
Therefore, the disclosed wheat straw and autolyzed yeast containing animal feed are identical to the claimed wheat straw and autolyzed yeast containing animal feed composition. Therefore, the disclosed wheat straw and autolyzed yeast containing animal feed therefore, will have identical claimed property including the claimed property of “ wherein the step of administering the prebiotic improves the degradation of the wheat straw” as claimed in amended claims 10, 16.
Therefore, the disclosed wheat straw and autolyzed yeast containing animal feed are identical to the claimed wheat straw and autolyzed yeast containing animal feed composition. Therefore, the disclosed wheat straw and autolyzed yeast containing animal feed therefore, will have identical claimed property including the claimed property of “ wherein the step of administering the prebiotic improves the degradation of the wheat straw” as claimed in claims 10, 16.
9. Regarding claims 11, 20, 25, it is to be noted that NPL Biomin I disclosed feed composition supplemented with and without autolyzed yeast to compare supplemented group vs control group as disclosed by NPL Biomin I (at least under Conclusion and Tables 1, 2 and 3). It is to be noted that the teaching of autolyzed yeast of NPL Biomin I modified wheat straw and yeast feed of Melgarejo et al. (page 3 under “Detailed Description”) to the animal (calves) diet in order to provide the benefit of having daily weight gain, and feed intake of weaning calves when compared to control group (at least in Conclusion, Figs 2-4) as discussed above. Therefore, it meets “administered simultaneously” as claimed in claims 11, 20 and 25.
10. Regarding claims 12, 22, 27, it is known that disclosed ruminant e.g., dairy cow as disclosed by Melgarejo et al. (page 3) in view of NPL Biomin I (at least under Aim of the Trial) belong to Bovidae family, therefore, bovines (also can be evidenced by Google search).
11. Regarding claims 10, 16, 21, 26, NPL Biomin I disclose that an average initial weight of 94-95 kg calves (Table 1) receives 10 gm /calf/day (Under Trial Design, last two lines of first page and Table 1) which meet claimed ranges between 2 and 20g/head/day for claims 13, 17 and between 5 and 10 g/head/day for claims 21 and 26. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). It is to be noted that and it is known that ‘large animals’ belong to bovines (cows) including those in the growth phase as is evidenced by applicants’ specification also (in PGPUB [0034]- [0036]).
12. Regarding claims 10, 16, 23, 28 Melgarejo et al. discloses ruminant animal (at least in Abstract). It is Known that NPL Biomin I (2012) made the trial using the autolyzed yeast (Levabon Rumen E) product in the diet of weaning calves as ruminants. However, it is applicable for any ruminant animals because autolyzed yeast provides benefits to rumen and therefore, it recites the name ‘Levabon Rumen E’ which is also evidenced by NPL Autolyzed yeast Biomin II that this product is applicable to and made broadly for ruminants (at least on page 1, e.g., ‘autolyzed yeast provides benefits to rumen’ another publication from same company). It is Known and is evidenced by applicant’s own specification that ruminants belong to sheep or goat (small) also (in PGPUB [0034]-[0036]). It is evidenced from NPL Goat ruminant that the weaning goat has about 45 kg body weight (at least on page which is about half than weaning calves. Therefore, small animals will have less body weight. Therefore, it is within the skill of one of ordinary skill in the art to include the teaching of NPL Biomin | as guideline for about 95 kg body weight weaning calves as ruminant can get 10 g/calf/day (Table 1) and can optimize the amount of ‘autolyzed yeast’ prebiotic based on the body weight of the type of ruminant which may be half the amount if the body weight is half. Itis known that e.g., the body weight of goat or sheep small animals have less and may be 45 Ibs. (i.e., about 22.5 kg) which is about 1/4" of the weight of weaning calves. Therefore, it will be about 2.0-2.5 g/small ruminant /day [based on the disclosure by NPL Biomin | (Table 1)]. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). This is also optimizable.
Absent showing of unexpected results, the specific amount of prebiotic is not considered to confer patentability to the claims. As the amount of prebiotic autolyzed yeast are variables that depends on the body weight of the ruminants, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of prebiotic in Melgarejo et al. discloses in view of NPL Biomin I, to amounts, including that presently claimed, in order to obtain the desired effect e.g., desired beneficial prebiotic effect of autolyzed yeast (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
13. Regarding claims 24 and 29, as discussed above that NPL Biomin I disclose that the beneficial effects of ‘autolyzed yeast’ in ruminants and also disclosed the efficacy of autolyzed yeast (Levabon Rumen E) on improving rumen function (at least on page 1). It is also disclosed by NPL Autolyzed yeast that autolyzed yeast (Saccharomyces cerevisiae) promote the functioning of the cellulolytic flora and thus improve the digestibility of forage (page 1, second paragraph). It is therefore, the common forage food habit and common improved functioning of the cellulolytic flora which is applicable to any ruminant including small ruminants also. Therefore, the process used for weaning calves are applicable to sheep or goat because they belong to ruminant family.
14. Regarding claims 30, 31, it is to be noted that claims 30, 31 recite the claim limitation of the method of “measuring a loss of dry matter through incubation in ruminal fluid”.
It is to be noted that claims 30, 31 broadly claims the method of measurement of the loss of dry matter when wheat straw is incubated in ruminal fluid. It is within the skill of one of ordinary skill in the art to perform this simply by using a common weighing machine to measure the weight of the wheat straw in order to determine the difference of weight before and after the incubation of wheat straw in ruminal fluid in order to determine the difference of weight and therefore, the weight loss which determines the degradation of the wheat straw.
15. Claim 15 is rejected under 35 U.S.C. 103(a) as being unpatentable over Melgarejo et al. (EP 1825761 A1) in view of NPL Biomin I (Biomin Trials, Field Trial 2012) and as evidenced by NPL Biomin II as applied to claim 10 and further in view of Vyas D et al. (J. Anim. Sci. 2014,92:724-732).
16. Regarding claim 15, it is to be noted that as because NPL Biomin I does not specifically mention the prebiotic yeast is powder, it would have any form including powder form also.
However, NPL Biomin I is silent about “prebiotic is in a powder form”
Vyas et al. discloses that the yeast in active and inactive form can be used in dry form in the feed composition to serve as both probiotic (page 724 Under Introduction, col 2) and prebiotic (Page 725, Under Introduction, col 1 mid-section e.g., prebiotic). Vyas et al. also discloses that dry yeast as both the active dry yeast and killed dry yeast forms function as probiotic and prebiotic (at least in Abstract, Introduction and conclusion), therefore one of ordinary skill in the art may consider dry form as preferred choice to mix the desired amount with respect to dry matter for daily ration. Besides storage for dry yeast is convenient also to use directly dosed daily at the time of feeding (Abstract).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify NPL Biomin I to include the teaching of Vyas et al. to consider dry powdered form of prebiotic yeast because dry form as preferred choice provides advantages of using to mix the desired amount with respect to dry matter for daily ration. Besides, storage for dry yeast is convenient also to use directly dosed daily at the time of feeding (Abstract).
17. Claim 19 is rejected under 35 U.S.C. 103(a) as being unpatentable over Melgarejo et al. (EP 1825761 A1) in view of NPL Biomin I (Biomin Trials, Field Trial 2012) and as evidenced by NPL Biomin II as applied to claim 10 and further in view of Tricarcio et al. (US 2011/0200705 A1).
18. Regarding claim 19, Melgarejo et al. in view of NPL Biomin I are silent about “yeast extract”.
Tricarcio et al. discloses that ruminant feed includes dietary supplement ([0009]) and dietary supplement can be yeast extract derived from Saccharomyces cerevisiae also which provides more protein in the dairy cow feed composition ([0081]). It is to be noted that as because the disclosed Saccharomyces cerevisiae yeast extract is identical to the claimed Saccharomyces yeast extract, therefore, it will have the identical property including prebiotic property of claimed Saccharomyces yeast extract to meet claim 19.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Melgarejo et al. with the teaching of Tricarcio et al. who discloses that the yeast extract form provides more soluble protein in the dairy cow feed composition ([0081]) with a general assumption in the field that extracted soluble protein is completely degraded in the rumen due to a purported high fractional rate of degradation ([0064]).
Response to arguments
19. Applicant’s arguments and amendments have been considered. Applicant’s arguments and amendments are not persuasive. After review, it is noticed that new claims 30, 31 can be addressed using the same combinations of prior arts of record and addressed in this office action above.
It is to be noted that applicant’s argument of secondary prior art by Biomin I is identical to NPL Biomin I used in the last office action and the same ( “NPL Biomin I”) is maintained in this office action.
20. Applicants argued
(a) on third page that Melgarejo consistently attributes any improvement in straw utilization to mechanical processing of the straw itself, emphasizing that straw is subjected to physical, chemical or enzymatic pre -treatment and not biological modulation of ruminal activity by autolyzed yeast or extracted yeast (Bold lines),
(b) On fourth page, “Thus, Melgarejo teaches that degradation depends primarily on modification of the physical structure of the straw, not on any effect arising from administration of yeast. As a result, based on Melgarejo's teaching, the person of ordinary skill in the art would not have been encouraged to use only yeast to improve the degradation of wheat straw. On the contrary, amended claims 10 and 16 clearly requires that "the administering of the prebiotic improves the degradation of the wheat straw", which is entirely silent from Melgarejo.
(c ) On fourth page, “However, Biomin I fails to teach or suggest that administering an autolyzed yeast improves the ruminal degradation of wheat straw. Instead, Biomin I is directed to evaluating the effect of autolyzed yeast on broad animal performance parameters, such as average daily weight gain, feed intake, and feed efficiency in calves (see, e.g., Biomin I, "Aim of the trial" and "Results and discussion"). Biomin, I demonstrate that supplementation with autolyzed yeast leads to improved growth performance and feed utilization, as reflected in increased weight gain and improved feed conversion ratios (see Figures 1-4).
(d) On fifth page, Specifically, Biomin I evaluates growth performance parameters such as weight gain and feed efficiency and does not measure or disclose any improvement in degradation of wheat straw or other lignocellulosic substrates. ……If the claimed effect were inherent to yeast, such processing would NOT be necessary. Thus, the outstanding Office Action provides no evidence demonstrating that administration of autolyzed yeast necessarily results in improved degradation of wheat straw.
In response to (a)-(d), it is to be noted that the examiner does not agree.
The allegations made in (b) above that the person of ordinary skill in the art would not have been encouraged to use ‘only yeast’ to improve the degradation of wheat straw is not correct evaluation. It is “autolyzed or extracted yeast and not “yeast”. That is why NPL Biomin I is used as secondary prior art.
It is also to be noted that the allegations made in (c ) above, is not proper. The reason is NPL Biomin I is used as secondary prior art to modify Melgarejo et al. to teach or suggest that administering an autolyzed yeast improves the nutritional quality (Motivation) by providing weight gain etc. ( at least under Conclusion, Figs 2-4). Even if ruminal degradation of wheat straw is not disclosed by NPL Biomin I , there is an effective motivation to combine NPL Biomin I to modify yeast of Melgarejo et al. with the autolyzed yeast of NPL Biomin I. Also, as mentioned in the last office action (Final Rejection mailed 1/9/2026, item #27 and included affidavit filed 1/27/2025 ) that even if the starter feed may not mention specifically wheat straw, however, chopped wheat straw is equivalent to barley and hay etc. (grain) which serves the common source of fiber which is “difficult to digest” component. Therefore, NPL Biomin I is proper and combinable to Melgarejo et al.
Regarding the substance of the examiner’s obviousness rejection as argued above , third paragraph of the remarks), the requirements for obviousness are discussed in MPEP § 2142. As explained in the previous Office Action, the only difference between claims 10 and 16 and the teachings of Melgarejo et al. is the prebiotic as extracted or autolyzed yeast which is taught by NPL Biomin I in the prior art. Therefore, as also explained in the previous Office Action, one of ordinary skill in the art would reasonably have expected that implementing the autolyzed yeast /extracted yeast containing animal feed of NPL Biomin I into the Meljarejo’s wheat with yeast containing animal feed system would have been obvious to one of ordinary skill and would have resulted in a more efficient system as suggested by Biomin I . The rejection of claim 1 as obvious over Melgarejo et al. in view of NPL Biomin I is, therefore, maintained.
It is , therefore, to be noted that we should consider the combined teaching of Melgarejo et al. in view of NPL Biomin I because 103 obviousness rejection is proper as discussed above.
Therefore, the disclosed wheat straw and autolyzed yeast containing animal feed are identical to the claimed wheat straw and autolyzed yeast containing animal feed composition. Therefore, the disclosed wheat straw and autolyzed yeast containing animal feed therefore, will have identical claimed property including the claimed property of “ wherein the step of administering the prebiotic improves the degradation of the wheat straw” as claimed in claims 10, 16.
There is no need to consider that one single prior art should teach to demonstrate that administration of autolyzed yeast necessarily results in improved degradation of wheat straw. It is 103 obviousness rejection.
Unexpected Result:
20. Applicants argued on third page that " Effect of the prebiotic on the degradation of wheat straw. The results in Fig. I (in Applicants specification) show that the degradation of the dry matter is increased significantly in the presence of the prebiotic, whether it is the yeast extract or the autolyzed yeast, the yeast extract giving higher performance than the autolyzed. The use of a prebiotic therefore improves the degradation of wheat straw in vitro. The process according to the invention is therefore particularly advantageous in that it makes it possible to improve the degradation of wheat straw."
Applicant’s argued the same argument on page 5, fourth paragraph “ As for the present specification, Applicant explicitly describes the improvement in degradation as a surprising discovery. Accordingly, the rejection based on inherency is not supported by the cited references”.
In response, it is to be noted that applicants’ allegations of in vitro condition are not an issue. The reason is applicants’ specification has examples which demonstrates by creating an in vivo condition using ruminal fluid and fermentation module (i.e. within the biological system) (in PGPUB [0060], [0067]) to perform the experiment. Therefore, the experimental result is applicable under in vivo condition. It is to be noted that the amended method claims 10, 16 are broad. Claims 10 and 16 are broad. Claims 10, 16 claims the method steps used using any amounts of wheat straw and prebiotic which is yeast extract or autolyzed yeast. it is also not unexpected result. The reason is already discussed in the prior office action (Final Rejection mailed 1/9/2026, item #28) and is applicable here also.
The rejection is made as non-final.
Conclusion
30. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792
Prosecution Insights