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 .
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.
Claim 1-8 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Telfer et al (GB 2163346) in view of Machado (WO2015/109362) and Paul (WO2020/124167).
Telfer et al teaches a water-soluble glass rumen bolus for treating a mineral deficiency in a ruminant animal. The composition of the bolus is such that when the bolus is lodged in the reticulo rumen, it has a release rate of not more than 25 mg per square centimeter of its surface area per day, so making possible boluses which can be administered to the animal to release the required element or elements over periods up to one year or more (abstract).
Telfer et al does not teach the addition of seaweed or seaweed extract.
Machado teaches a method for reducing total gas production and/or methane production in a ruminant animal comprising the step of administering to said ruminant animal an effective amount of at least one species of red marine macroalgae (claim 1). More specifically, it discloses that red marine macroalgae (seaweed) is known to be administered to ruminant animals. Other ingredients such as vitamins, minerals, amino acids are also known to be administered to ruminant animals ([0162], [0164]).
Wardell discloses a method for boosting innate immunity in an animal with an alternative complement pathway, comprising the step of administering to said animal an effective amount of a red seaweed of Asparagopsis species, an extract therefrom or residual biomass following an extraction process (claim 1). It also discloses that the red seaweed is present in an animal feed but also other components selected from a group consisting of proteins, fish oil, binders, fillers, vitamins and minerals, amino acid supplements, colorants, chelating agents and preservatives (claims 15 and 20).
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. See MPEP 2144.06. Here, the actives are all taught to be beneficial for bovine and as such, it would be obvious to combine them in the delivery system of the primary reference.
With regards to claims 3, 4, 7, and 13, where the actives are taught for specific purposes in the prior art, it would have been obvious to optimize the content and release based on the desired effect. See MPEP 2144.05(II).
With regards to claim 5, the claim is directed to a product, not the process of making the product. Therefore, any seaweed extract appears to meet the limitation.
Claim 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Telfer et al (GB 2163346) in view of Machado (WO2015/109362) and Paul (WO2020/124167), the combination further in view of Wardell (WO9011756).
Telfer et al, Machado and Paul are discussed above but do not teach carboxylate glass.
Wardell teaches carboxylate glasses were known to be used in delivery systems (abstract and claims).
It would have been obvious to one of ordinary skill in the art to use known glasses in the method of the primary references, given they are all taught to be water soluble and for delivery of actives.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 18/560,449 and 18/560507 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending applications are also directed to water soluble rumen bolus articles with seaweed extract and actives. They vary only in the order of dependent claims and specific amounts or properties of each component, which appear to overlap the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Conclusion
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612