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 office action is in response to the application filed on February 13, 2025.
Priority
The current application is a Continuation of abandoned US Application 18/826,458.
Status of Application
Claims 263-282 are pending. Claims 263-282 are presented for examination.
Drawings
The drawings are objected to because Figures 1-3, 5, and 8 are illegible – the majority of the text is too blurry to read. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is less than 50 words and contains the implied phrase “the present disclosure provides” in line 1. Correction is required. See MPEP § 608.01(b).
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.
Claims 263-282 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 263 recites a ratio of stabilizing agent to plant-based oil. However, there is no basis given for the ratio (e.g., w/w or w/v).
Claims 270 and 271 similarly recite ratios of haloalkane to MCT without providing a basis for the ratio.
Claims 272 and 273 also recite ratios of MCT to plant-based oil without providing a basis for the ratio.
Claims 264-269 and 274-282 are included in the rejection as they depend from a rejected base claim.
Claim Rejections - 35 USC § 103
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 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.
Claims 263-274 and 276-282 are rejected under 35 U.S.C. 103 as being unpatentable over Hay et al. (WO 2021/205420; listed on IDS dated July 21, 2025), herein after referred to as Hay.
Regarding claims 263, 264, 266-268, 272-274, and 279, Hay discloses a method of generating a bromoform-lipid composition [00356] for reducing methane production in a ruminant [0026], the method comprising:
preparing an aqueous dispersion (i.e., mixture) comprising:
(i) bromoform (i.e., a haloalkane);
(ii) tricaprin (i.e., a stabilizing agent for improving stability of the haloalkane in the consumable composition) [00356]; and
(iii) vegetable oils (i.e., plant-based oil that is different from the stabilizing agent) [00300],
wherein the mixture is freeze-dried to prepare the dry bromoform-lipid mixture which is a concentrate (i.e., the mixture comprises the consumable composition),
wherein the bromoform (i.e., haloalkane) is obtained from Sigma-Aldrich, Inc. ([00356]-[00357]) or is obtained synthetically [00295] (i.e., is not derived from a biomass).
Hay teaches that vegetable oils can be included with the bromoform [00300].
Hay teaches an amount of 33.7 wt.% tricaprin (i.e., stabilizing agent) [00356] but is silent as to the amount of the vegetable/plant-based oil, and is therefore silent as to the ratio of the stabilizing agent to the plant-based oil being 1:100-50:100 (instant claim 263), 3:97-10:90 (instant claim 272), and 5:95 (instant claim 273).
However, where it is known that fat/oil content effects the texture of a final composition, it would have been obvious to one of ordinary skill in the art, to have adjusted, through no more than routine experimentation, the ratio of the MCT/stabilizing agent to the vegetable/plant-based oil to obtained a desired texture of the composition.
Regarding claim 265, Hay teaches that the amount of bromoform in the composition is 0.01-2.5 wt.% or above ([00172]; [00181]), which either lies inside or overlaps with the claimed range of 0.001-8 wt.%. 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). See MPEP 2144.05.I.
Regarding claim 269, Hay teaches that tricaprin (i.e., a medium-chain triglyceride) is included in the composition [00356]. Since tricaprin is composed of three capric acid compounds, the MCT is also considered to comprise capric acid.
Regarding claims 270 and 271, Hay teaches that the amounts of bromoform (i.e., haloalkane) and tricaprin (i.e., MCT) are 11.7 wt.% and 33.7 wt.%, respectively [00356]. Thus, the ratio of the haloalkane to the MCT is 0.35 which lies within both claimed ranges of 1:99-1:1 and 10:90-30:70.
Regarding claim 276, Hay teaches that the mixture further comprises an essential oil [00118].
Regarding claim 277, Hay teaches that the mixture is an aqueous dispersion that includes an aqueous phase and components that are added as water solutions ([00356]-[00357]). Thus, Hay is considered to teach that the mixture further comprises water.
Regarding claim 278, Hay is silent as to the amounts of water and plant-based oil and as such is silent as to that the ratio of water to the plant-based oil is about 5:95.
However, where it is known that water and fat/oil content effects the texture of a final composition, it would have been obvious to one of ordinary skill in the art, to have adjusted, through no more than routine experimentation, the ratio of the water to the vegetable/plant-based oil to obtained a desired texture of the composition.
Regarding claim 280, Hay teaches combining the mixture with a feed prior to providing the composition to a ruminant (claim 20).
Regarding claim 281, Hay teaches that the feed is a pellet [00273].
Regarding claim 282, Hay teaches administering the mixture to a ruminant (Abstract; [0002]; claims 13 and 20).
Hay is silent as to that the mixture is sufficient to effect at least 60% reduction in expulsion of methane as compared to a ruminant lacking the mixture.
However, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Since the composition and method of Hay are substantially identical to that of the claimed composition and method, the prior art composition and method must necessarily possess the same properties and characteristics as the composition and method claimed. Therefore, Hay is considered to teach the methane reduction as claimed since the compositions and methods must necessarily exhibit the same properties.
Claim 275 is rejected under 35 U.S.C. 103 as being unpatentable over Hay et al. (WO 2021/205420; listed on IDS dated July 21, 2025), as applied to claims 263 and 274 above, and further in view of De Nys et al. (US PG Pub. 2022/0031780; listed on IDS dated July 21, 2025), herein after referred to as Hay and De Nys, respectively.
Hay teaches the method of generating a consumable composition for methane reduction as set forth above with regard to claims 263 and 274.
Hay is silent as to that the vegetable oil is canola oil.
De Nys, in the same field of invention, teaches compositions for methane reduction in ruminants (Abstract), the compositions comprising bromoform and a vegetable oil, the vegetable oil being canola oil (claims 1, 14, and 15). De Nys teaches a suitable vegetable oil for methane reduction compositions where Hay is silent, thereby offering a guideline as to suitable types of vegetable oils. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used the canola oil of De Nys as the vegetable oil of Hay, thereby arriving at the claimed invention, with the reasonable expectation that canola oil is a suitable vegetable oil for use in the invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Lay et al., US Patent 11,529,310, teaches a method for methane reduction in a ruminant comprising administering a composition containing bromoform.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 9:00-6:00 EST.
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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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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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