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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11) in the reply filed on February 12th, 2026 is acknowledged. Applicant’s election of species “water soluble carboxylate glass, as claimed in Claims 9-10” is acknowledged. Claim 11 is drawn to a non-elected species encompassing a polymer bonded phosphate glass.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The requirement is still deemed proper and is therefore made FINAL.
Claims 11-14 are pending and were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim.
Claims 1-10 are pending and were examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in the instant application filed on November 13th, 2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. The priority date is May 14th, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 7th, 2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: under the heading "Example 3", "Sodium" and "Calcium" are capitalized when they should be lowercase.
Appropriate correction is suggested.
Claim Objections
Claim 7 objected to because of the following informalities: 5-15g should be written 5-15 g. Appropriate correction is suggested.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The term “configure” in claim 7 is understood by the examiner to encompass both the choice of chemical compounds used in the claimed composition and their spatial arrangement within the claimed composition. The term “seaweed” is understood by the examiner to encompass organisms of the genus Asparagopsis (instant specification, page 7 of 10, lines 6-8). The term “bolus” is understood to encompass solid objects administered into an animal’s gastrointestinal tract to deliver active agents over a sustained period of time to animals (instant specification, Detailed Description of the Invention, paragraph 5). Instant claim 10 is understood as requiring that at least one of the metal carboxylates must have a melting point less than 300 °C, but it is possible to for metal carboxylates, such as sodium acetate, with a melting point above 300 °C to also comprise the glass (instant specification, Example 1).
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 7 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 omitted steps are: the steps of configuring the claimed bolus to release 10-200 mg bromoform per day in the reticulo rumen of a ruminant animal.
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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over De Nys and Magnusson (WO 2020113279 A1) and further in view of Wardell and Duffy (WO 90/11756).
Claim 1 recites: “A water soluble or water dispersible rumen bolus article suitable for oral administration to a reticulo rumen of a ruminant animal comprising a seaweed extract enriched in bromoform”. Claim 2 recites: “The water soluble or water dispersible rumen bolus article according to Claim 1, in which bromoform constitutes at least 60% of the seaweed extract by weight”. Claim 3 recites: “The water soluble or water dispersible rumen bolus article according to Claim 1, in which bromoform constitutes at least 60% of the seaweed extract by weight”. Claim 4 recites: “The water soluble or water dispersible rumen bolus article according to Claim 1, in which the seaweed extract is lyophilised seaweed extract”. Claim 5 recites: “The water soluble or water dispersible rumen bolus article according to Claim 1, in which the seaweed extract enriched in bromoform constitutes 1 to 20% by weight of the water soluble or water dispersible rumen bolus article”. Claim 6 recites: “The water soluble or water dispersible rumen bolus article according to Claim 1, in which the seaweed extract enriched in bromoform constitutes 5 to 15% by weight of the water soluble or water dispersible rumen bolus article”. Claim 7 recites: “The water soluble or water dispersible rumen bolus article according to Claim 1, comprising 5-15g bromoform and configured to release 10-200 mg bromoform per day in the reticulo rumen of a ruminant animal”. Claim 8 recites: “The water soluble or water dispersible rumen bolus article according to Claim 1 comprising a water soluble matrix and bromoform distributed throughout the matrix, in which the water soluble matrix comprises a water soluble glass”. Claim 9 recites: “The water soluble or water dispersible rumen bolus article according to Claim 1 comprising a water soluble matrix comprising a water soluble carboxylate glass and bromoform distributed throughout the matrix”.
De Nys and Magnusson recite Asparagopsis oil compositions suitable for reducing total methane production in a ruminant animal (Abstract), where the Asparagopsis oil is prepared by contacting the biomass with at least one oil to extract at least one bioactive agent from the biomass into the at least one oil (claim 1; instant claims 1 and 2), where the bioactive agent is bromoform (claim 15; instant claims 1 and 2) and bromoform is an anti-methanogenic agent (claim 20). The Asparagopsis oil composition is administered orally into the gastrointestinal tract of a ruminant animal (De Nys and Magnusson, page 32 lines 4-7 and 30-32, page 33 line 1; instant claim 1). De Nys and Magnusson also recite: “Ruminants produce CH4 as a by-product of the anaerobic microbial fermentation of feeds in the rumen and, to a lesser extent, in the large intestine” (Background of the Invention, paragraph 3); therefore, an Asparagopsis oil composition comprising an anti-methanogenic agent would have its utility within the rumen of the ruminant animal. Wardell and Duffy recite a system for administering an active agent, comprising a water soluble glass:
“The invention provides a slow release vitreous system comprising a water soluble glass having a softening point of less than 320°C and preferably less than 200°C wherein said water soluble glass has dissolved or admixed therein an active agent such as a pharmaceutical which is stable at the melting point of the glass and which releases to an aqueous environment of use over a predetermined time period” (Abstract; instant claims 1 and 8).
It would have been obvious to combine the Asparagopsis extract recited by De Nys and Magnusson with the slow release system of Wardell and Duffy, with the predictable result of making “a water soluble or water dispersible rumen bolus article suitable for oral administration to a reticulo rumen of a ruminant animal comprising a seaweed extract enriched in bromoform” (instant claim 1) comprising a water soluble glass, with bromoform distributed throughout the matrix (instant claim 8).
Although De Nys and Magnusson do not explicitly recite bromoform constituting at least 60% of a seaweed extract by weight, they do recite a means of predictably increasing the concentration of bromoform in the extract by using more Asparagopsis material per unit of extraction solvent, i.e. oil (Example 3 and Figure 8). One of skill in the art could have quantitated bromoform in different extracts using GC/MS analysis (De Nys and Magnusson, Example 1, paragraph 9). One of skill in the art could have measured the methane reduction in a ruminant animal administered a bolus comprising an extract with a known weight percent of bromoform, and repeated this procedure for boluses comprising extracts with different weight percents of bromoform (De Nys and Magnusson, Example 5). Therefore, it would have been obvious to one of skill in the art over routine optimization to prepare a seaweed extract comprising 60% bromoform by weight (instant claim 3).
Although De Nys and Magnusson do not explicitly recite lyophilizing a seaweed extract, lyophilization is a method broadly known in the art for removing water from a material. It would have been obvious to one of skill in the art to use lyophilization to decrease the weight and volume of an extract to improve its ease of transport and storage (instant claim 4).
Although De Nys and Magnusson do not explicitly recite the weight percentage of seaweed extract in a rumen bolus, one of skill in the art could have controlled the weight percent of the seaweed extract in the rumen bolus by using a laboratory scale to weight the extract, other bolus components, and the final bolus. One of skill in the art could have measured the methane reduction in a ruminant animal administered a bolus comprising a known weight percent of seaweed extract, and repeated this procedure for boluses comprising different weight percents of seaweed extract (De Nys and Magnusson, Example 5). Therefore, one of skill in the art could vary the percentage of seaweed extract comprising the bolus to optimize the bolus for methane reduction. Therefore, the weight percentages of seaweed extract in the bolus of 1-20% and 5-15 % are obvious over routine optimization (instant claims 5 and 6).
Although De Nys and Magnusson (WO 2020113279 A1) and Wardell and Duffy do not recite a rumen bolus comprising 5-15 g bromoform and configured to release 10-200 mg bromoform per day, one of skill in the art could have included a compound that is more hydrophobic than the carboxylate glass throughout the matrix of the bolus composition to delay the erosion of a water soluble rumen bolus inside the rumen of a ruminant animal. Examples of such compounds are waxes. Different waxes comprising an ester group and aliphatic hydrocarbon chain(s) of different lengths would predictably have different water solubilities. Different boluses comprising different waxes and different weights of constituents (such as waxes, carboxylate glass, and bromoform) could be evaluated as follows. The bolus could be placed in an artificial rumen, removed from the artificial rumen daily and weighed to measure the dissolution rate, and the reduction of methane could be measured in the artificial rumen (De Nys and Magnusson, page 22 of 67 lines 19-30). With a known weight percentage of bromoform in the bolus (as discussed of record above), one of skill in the art could calculate the rate of bromoform release from the rate of bolus dissolution. Therefore, it would be obvious to one of skill in the art over routine optimization of the bolus for methane reduction to make a rumen bolus comprising 5-15 g bromoform and configured to release 10-200 mg bromoform per day in the reticulo rumen of a ruminant animal (instant claim 7).
As argued above, it would have been obvious to combine the inventions of De Nys and Magnusson, and Wardell and Duffy to make a rumen bolus comprising a seaweed extract and a water-soluble glass, with bromoform distributed throughout the matrix. Wardell and Duffy recite:
“Low melting point water soluble glasses for example the acetate glasses have been described … It has not however been appreciated that the combination of the low softening point of the acetate and other carboxylates and nitrate type glasses combined with their variable water solubility provides an excellent slow release vehicle for heat-sensitive substances, such as biologically active substances, to an aqueous environment of use” (Description, Slow Release Vitreous Systems, paragraph 5; instant claim 9).
Therefore, it would have been obvious to one of skill in the art to make a water soluble or water dispersible rumen bolus comprising a carboxylate glass (instant claim 9).
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over De Nys and Magnusson (WO 2020113279 A1) in further view of Wardell and Duffy (WO 90/11756) as applied to claims 1-9 above, and further in view of Wardell and Duffy (WO 90/11756) and ILO-WHO ICSC (ICSC: 0547).
The claims and teachings of the cited references are as of record.
Claim 10 recites: “The water soluble or water dispersible rumen bolus article according to Claim 1 comprising a water soluble matrix comprising a water soluble carboxylate glass and bromoform distributed throughout the matrix, in which the carboxylate glass is formed from one or more metal carboxylates having a melting point of less than 300°C”.
Wardell and Duffy recite a system for administering an active agent, comprising a water soluble glass (Abstract). Wardell and Duffy recite an example carboxylate glass comprised of the metal carboxylates CH3CO2K (potassium acetate) and (CH3CO2)2Ca (calcium acetate) in a ratio of 1:1 with a melting point of 270 °C (Example 1, Table 1; instant claims 9 and 10). Potassium acetate and calcium acetate are recited in the instant specification (Example 1) as example constituents in glass production for the instantly claimed invention, and potassium acetate has a melting point of 292 °C (ILO-WHO ICSC; instant claim 10).
De Nys and Magnusson, Wardell and Duffy, and ILO-WHO ICSC are relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teachings provided by the references with respect to providing the weight percentages of bromoform in the seaweed extract and rumen bolus, the mass of bromoform comprising the bolus, and the mass of bromoform released per day in the rumen; the adjustments of particular conventional working conditions (e.g., the selection from among known components and determining one or more suitable ranges (amounts, proportions, ratios thereof) in which to provide the rumen bolus); is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the
skilled artisan.
From the teachings of De Nys and Magnusson in view of Wardell and Duffy and ILO-WHO ICSC, the invention as a whole, drawn to a rumen bolus as described in Claim 1, would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, and one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show
a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
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, 5, 6 and 8-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/560449 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following overlapping in subject matter. Both applications recite a water-soluble glass bolus article suitable for oral administration to a ruminant animal, the article comprising: carboxylate glass; and an organic active agent (reference independent claim 1; instant independent claim 1, dependent claim 8, and dependent claim 9). Both applications recite an organic active agent consisting of a plant extract where the plant extract is a seaweed extract enriched in bromoform (reference dependent claims 7 and 8; instant independent claim 1). Both applications recite the bolus comprising 1-20% of the active agent by weight (reference dependent claim 6; instant dependent claims 5 and 6). Both applications recite the carboxylate glass formed from at least one metal carboxylate where the metal carboxylate(s) have/has a melting point less than 300 °C (reference dependent claims 2-5; instant dependent claim 10).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, and 3-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 3-10 of copending Application No. 18/560451 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following overlapping subject matter. Both applications recite a water soluble or water dispersible rumen bolus article suitable for oral administration to a reticulo rumen of a ruminant animal comprising a seaweed extract enriched in at least one bioactive agent; wherein the rumen bolus article when administered to the reticulo rumen of the ruminant animal is configured to release the seaweed or seaweed extract over a sustained period of time (reference independent claim 1; instant independent claim 1 and dependent claim 7). Both applications recite a water soluble or water dispersible rumen bolus article, in which the bioactive agent constitutes greater-than or equal to 5% of the seaweed extract by weight (reference dependent claims 3 and 4; instant dependent claim 3). Both applications recite water soluble or water dispersible rumen bolus article in which the seaweed extract is lyophilized seaweed extract (reference dependent claim 5; instant dependent claim 4). water soluble or water dispersible rumen bolus article in which the seaweed extract enriched in bromoform constitutes 1 to 20% by weight of the water soluble or water dispersible rumen bolus article (reference dependent claim 6; instant dependent claims 5 and 6). Both applications recite a water soluble or water dispersible rumen bolus article comprising 5-15 g bioactive agent and configured to release 10-200 mg bioactive per day in the reticulo rumen of a ruminant animal (reference dependent claim 7; instant dependent claim 7). Both applications recite a water soluble or water dispersible rumen bolus article comprising a water soluble matrix and bioactive agent distributed throughout the matrix, in which the water soluble matrix comprises a water soluble glass (reference dependent claim 8; instant dependent claim 8). Both applications recite a water soluble or water dispersible rumen bolus article comprising a water soluble matrix comprising a water soluble carboxylate glass and a bioactive agent distributed throughout the matrix (reference dependent claim 9; instant dependent claim 9). Both applications recite a water soluble or water dispersible rumen bolus article comprising a water soluble matrix comprising a water soluble carboxylate glass and a bioactive agent distributed throughout the matrix, in which the carboxylate glass is formed from one or more metal carboxylates having a melting point of less than 300 °C (reference dependent claim 10; instant dependent claim 10).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert F Spaine whose telephone number is (571)272-9099. The examiner can normally be reached 8:00 AM - 4:00 PM United States Eastern Time, Monday-Friday.
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/R.F.S./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655