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 .
Response to Arguments
In the response, dated 6/2/2026, the Applicant provided amendments to the claims and arguments drawn to the previous rejections. The Applicant has canceled claims 1-8, amended claim 9, and added new claims 12-18. The cancelation of claims 1-8 renders the 35 USC 112(b), 35 USC 112(d), and 35 USC 101 rejections moot, and as such, these rejections have been withdrawn.
On page 4 of the Applicant’s Arguments, the Applicant asserts that the Examiner has not provided reasonable support for inherent anticipation. To the contrary, Kadota explicitly teaches a method that involves the administration of lipase or cellulase to a subject, wherein these enzymes were produced from a mold that forms on koji. See paragraph [0047]. Kadota’s method appears no different than the claimed method; that is to say, the claimed method provides for no different active steps compared to the method disclosed in Kadota. As such, everything that happens following the administration of these enzymes would be inherent to the enzymes, per se, and is not influenced by the artisan that administered them. This assessment is supported by the MPEP’s section on inherent anticipation. See MPEP 2112(II). There does not need to be any prior art revelation that these enzymes provide for the claimed function, as long as the prior art reference provides for an anticipating method. For example, if an artisan were to provide Kadota’s method, which is the same as the claimed method, the Applicant has provided no evidence to suggest that Kadota’s method would not result in the claimed increase in bacterial species; just because Kadota was not looking for this change, does not mean it did not happen. As was stated in the cited section of the MPEP: “The new realization alone does not render that necessary [sic] prior art patentable.” Kadota does not need to acknowledge the increase in Lactobacilli or Bifidobacterium for their numbers to increase as a result of methods that involve the administration of lipase or cellulase derived from koji mold.
On page 4 of the Applicant’s Arguments, the Applicant states “Clearly, not all enzymes from Aspergillus would necessarily increase the [probiotic bacteria]”. While this is likely true, it does not affect the fact that Kadota explicitly teaches embodiments that can include lipase or cellulase as possible options; as these enzymes are described as products of A. niger, it would be reasonable to assume that Kadota is not providing a list for the artisan to choose from, but rather an incomplete listing of enzymes expected to be present with A. niger. The other disclosed enzymes are immaterial to the claims and rejection.
On page 4 of the Applicant’s Arguments, the Applicant states that the new limitation “… in need of an increase…” distinguishes the claimed method from that of the prior art. First, the claimed subject-pool is not defined, and there is nothing in the specification that would inform the skilled artisan as to what the inventors consider what values would warrant “in need of an increase.” Second, Kadota provides the claimed enzymes in animal feed and states, throughout the body of the specification, why this feed would be useful. By providing this treated feed, Kadota implicitly suggests that any subject that consumes it must necessarily be “in need.” See paragraph [0044].
As discussed above, all rejections drawn towards claims 1-8 are withdrawn. The rejection of claim 9 is maintained for the reasons provided in the previous rejection, and those discussed in the response above. The Applicant has added new claims 12-18, which will be discussed in the rejections below. No claim is allowed.
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 18 is 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 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The claim requires that the artisan must confirm an increase in the number of Lactobacilli and Bifidobacterium; however, as there is no step drawn towards an initial determination, it is unclear how this step can be accomplished. As such, the omitted method step must involve the initial determination of the presence of Lactobacilli and Bifidobacterium.
Claim Rejections - 35 USC § 102
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 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 9 and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kadota, et al (PGPub 2009/0155417). Kadota teaches an additive to animal feed that comprises a member of the Aspergillus genus, including A. niger, and at least one of the enzymes produced from the fungus. See claim 1, paragraph [0001]. Kadota indicates that the enzymes can include lipase and cellulase. See paragraph [0047].
With respect to claim 9, since Kadota teaches a feed additive, wherein the enzymes are necessarily provided in a manner consistent with that claimed. When considering the claimed active steps, if an animal eats the feed, all of the claimed active steps would be fulfilled. See paragraph [0017] [0047]. Kadota also indicates that the method provides for improvement of the intestinal flora, wherein administration of the enzymatic composition can provide for an improvement of “good” flora, and a reduction of “bad” flora; this need for an improvement in intestinal flora would necessarily overlap with the claimed subject-pool. See paragraph [0044]. As such, it would be reasonable to assume that if Kadota describes all of the claimed active steps, and generally suggests an improvement in “good” flora, then any improvement in bacterial strains that provide for probiotic activities, like those in the Lactobacillus and Bifidobacteria genera, would be inherent to the method. See MPEP 2112(II).
With respect to claim 12, Kadota teaches providing the composition in animal feed, and as such, accomplishes the claimed limitation.
With respect to claims 13 and 14, as discussed above, Kadota teaches the koji mold A. niger, and indicates that one of the enzymes produced by A. niger includes cellulase.
With respect to claims 15 and 16, although administered as a food, Kadota explicitly describes pharmaceutical uses for the food as a feed additive, as it is described as reducing pathogenic gut bacteria. See paragraph [0044]. Since the instant specification provides no explicit requirements for a pharmaceutical preparation, Kadota’s feed additive would fulfill the claimed limitation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kadota, et al (PGPub 2009/0155417) and Ianiro, et al (Current Drug Metabolism, 17, 187-193, 2016). Kadota teaches animal feed additives and does not teach human consumption of the enzyme.
Ianiro teaches that humans supplement certain digestive enzymes, like lipase, in order to aid in gastrointestinal diseases; these supplements are commercially available. See page 187, “Introduction” section and “Enzyme Features” section; page 189, Table 1. Ianiro, however, indicates that these enzymes are generally extracted from animal sources. See page 187, “Enzyme Features,” 2nd paragraph. Ianiro does not teach enzymes derived from koji mold.
Based upon the fact that both Kadota and Ianiro teach administration of the claimed enzyme is linked to digestive health, it would be reasonable to state that the lipase disclosed in Kadota would act as an obvious variant to that of Ianiro. That is to say, the ordinary artisan would expect the function of both enzymes to predictably overlap. There would be implicit motivation to utilize the enzyme of Kadota, instead of those provided by animal sources, since many human subjects prefer to consume vegetarian- or vegan-based options.
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 DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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