DETAILED ACTION
Claims 1-6 and 9-18 are currently pending. Claims 1-6 and 9-10 are currently under examination.
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 .
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 06/11/2026 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Withdrawn Rejection
The 112(b) rejection over claim 8 is withdrawn as a result of Applicant canceling claim 8.
Examiner’s Note
Applicant's amendments and arguments filed 06/11/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 06/11/2026, it is noted that claims 1 and 9 are amended.
Modified Rejection:
The following rejections are modified based on Applicant’s claim amendments.
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(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 90/11756 (Applicant provided IDS 12/07/2023) in view of GB 2 163 346 (Applicant provided IDS 12/07/2023), WO2015/109362 (IDS 12/07/2023) and WO2020/0113279 (IDS 12/07/2023).
Regarding claim 1, a water-soluble glass bolus article in a form suitable for oral administration to a ruminant animal, the article comprising carboxylate glass and an organic active agent is met by the ‘756 publication teaching a slow release vitreous system comprising a water soluble glass having a softening point of less than 320 degrees C, preferably less than 200 degrees C, wherein said water soluble glass has dissolved or administered therein an active agent such as a pharmaceutical which is stable (abstract). Carboxylate glass is taught (page 4, lines 1-5, Table 1). The active agent is taught for veterinary use (page 15, lines 13-20, claim 10). The active agents may be significant animals for example to ruminants (page 9, lines 1-7).
Regarding claims 2-5, the limitation of wherein the carboxylate glass is formed for a metal carboxylate having a melting point of less than 300 degrees C, metal acetates, metal propanoates and different anions is met by the ‘756 publication teaching K acetate and Ca propanoate (Table 1, page 4, lines 5-15).
The ’756 publication does not specifically teach a bolus article in a form suitable for oral administration (claim 1).
The ‘346 publication teaches a water-soluble glass lumen bolus for treating mineral deficiency in a ruminant animal. The compristion of the bolus is such that when the bolus is lodged in the reticule rumen, it has a release rate of not more than 25 mg per square centimeter of its surface area per day, so making possible bolus which can be administered to animal to release the required element on elements over periods up to one year or more (abstract).
The combination of references does not specifically teach 1-20% organic active agent by weight (claim 6), or seaweed extract enriched in bromoform (claim 1).
The ‘362 publication 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 ingredient such as vitamins, mineral, amino acids are also known to be administered to ruminant animals ([0162]-[0164]). The at least one species of red marine macroalgae is administered in a dose of at least 3% of the organic matter administered to the ruminant animal ([012], [62]).
The ‘279 publication teaches preparing Asparagopsis oil compositions comprising extracting at least one bioactive form a biomass of Asparagopsis into an oil to form the compristion. These compositions are suitable for reducing total gas production and/or methane production in ruminant or pseudo-ruminant animal (abstract). The bioactive agent is taught to be selected from a group consisting of bromochloroacetic acid, bromoform, dibromoacetic acid and dibromochloromethane (page 4, lines 15-25).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the glass composition as taught by the ‘756 to a ruminant animal as the ‘756 publication a drug releasing glass composition to be administered to ruminant animals and the ‘346 publication teaches bolus treatment for ruminant animal formed of water-soluble glass. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to form a bolus article as taught by the ‘346 publication from the carboxylate glass taught by the ‘756 publication because the ‘346 publication and the ‘756 publication re both directed to water-soluble active agent containing glass formulations administered to ruminant animals.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use bromoform seaweed extract in the device taught by the ‘756 publication because the ‘756 publication teaches the use of active agents to be administered to ruminant animals and the ‘279 publication teaches the use of bromoform extract from seaweed to be used to treat methane gas in ruminant animals. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘756 publication teaches active agents to administered to animals for example ruminant for slow release and the ‘279 publication teaches bromoform to be used to reduce total gas production in ruminant animals, thus it would be obvious to include bromoform in the device of the ‘756 publication to treat gas production in a ruminant animal. One ordinary skill in the art before the filing date of the claimed invention would be motivated to use the concentration of seaweed extract taught by the ‘362 publication and optimize as the ‘362 publication teaches known range of amounts of seaweed material to be administered to ruminant animal to reduce gas production.
That being said and in lieu of objective evidence of unexpected results, the dosage can be viewed as a variable which achieves the recognized result of successfully treating a specific patient. The optimum or workable range of dosing can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of dosage nonobvious.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 90/11756, GB 2 163 346, WO2015/109362 and WO2020/0113279 as applied to claims 1-6 above, and further in view of US 4,262,632 (previously applied).
As mentioned in the above 103 rejection, all of the limitations of claims 1-6 are taught by the combination of the ‘756 publication, the ‘346 publication, the ‘362 publication and the ‘279 publication.
The combination of references does not specifically teach the glass bolus article has a specific gravity of 1 to 7 g/cm3 (claim 9) or 2 to 4 g/cm3 (claim 10).
The ‘632 patent teaches adjusting a specific gravity of a device to reside permanently in the animal’s second stomach or reticulum (abstract). The capsule is taught to be plunged into the animal’s stomach to orally administered drugs (column 2, lines 50-65). Capsuled with the specific gravity of 1.7 or greater have been successfully retained and permanent retention is assured with the specific gravities of 2 or greater. Glass housing is taught to give necessary specific gravity (column 5, line 50 to column 6, line 5).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a specific gravity as taught by the ‘632 patent for the device taught by the ‘756 publication because the ‘632 patent teaches a specific gravity for the device to remain in the stomach of a ruminant animal. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘632 patent teaches a glass housing with weight to obtain he desired specific gravity and the ‘756 publication is directed to a glass containing composition. One of ordinary skill in the art would have a reasonable expectation of success as the ‘756 publication and the ‘632 publication are both directed glass containing devices to be administered orally to ruminant animals.
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 1-2 and 5-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/560,451 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘451 application is directed to a bolus article for administration to a rumen of an animal comprising at least one metal carboxylate glass with a melting point of less than 300 degrees C and a seaweed extract enriched with bromoform, reading on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2 and 5-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4-14 of copending Application No. 18/560,507 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘507 application is directed to a bolus article for administration to a rumen of an animal comprising at least one metal carboxylate glass with a melting point of less than 300 degrees C and a seaweed extract enriched with bromoform, reading on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the ‘756 publication has no understanding that such bolus article is effective at reducing methane production in an animal. The ‘346 publication does not cure the deficiencies as it only directed to deliver inorganic active agents that can survive the high temperatures. As a result, one of ordinary skill in the art would not combine the opposite teachings of the ‘756 publication and the ‘346 publication to arrive at the amended claim 1.
In response, the ‘756 publication teaches a slow-release water soluble glass with a low melting point to administer an active agent to ruminants (abstract, page 9, line 1-7). The ‘346 publication teaches water-soluble glass lumen bolus for treating ruminant animal wherein the bolus is lodged in the reticule rumen to release an active agent (abstract). Thus the ‘756 publication teaches the glass device to deliver the active agent to a rumen, however does not specifically recite bolus article. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the glass composition as taught by the ‘756 to a ruminant animal as the ‘756 publication a drug releasing glass composition to be administered to ruminant animals and the ‘346 publication teaches bolus treatment for ruminant animal formed of water-soluble glass. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to form a bolus article as taught by the ‘346 publication from the carboxylate glass taught by the ‘756 publication because the ‘346 publication and the ‘756 publication re both directed to water-soluble active agent containing glass formulations administered to ruminant animals.
Applicant argues the ‘362 publication teaches administration of seaweed to animal however make clear that is a feed supplement and no reference is made to sustained release ([0106], [0132]). The ‘279 publication does not mention or contemplate the sustained release of an extract enriched in bromoform.
In response, the ‘362 publication teaches the composition to be administered to the animal’s gastro-intestinal tract by oral route which may be supplementing the feed but additionally may be carried out using stomach tube or any other means possible for directly introduce in the animal’s gastrointestinal tract [106]. Thus the ‘362 publication multiple modes of administration to ruminant animal may be used, as long as the delivery is to the gastrointestinal tract. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use bromoform seaweed extract in the device taught by the ‘756 publication because the ‘756 publication teaches the use of active agents to be administered to ruminant animals and the ‘279 publication teaches the use of bromoform extract from seaweed to be used to treat methane gas in ruminant animals. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘756 publication teaches active agents to administered to animals for example ruminant for slow release and the ‘279 publication teaches bromoform to be used to reduce total gas production in ruminant animals, thus it would be obvious to include bromoform in the device of the ‘756 publication to treat gas production in a ruminant animal. The ‘756 publication teaches administration to animal of the glass composition for releasing active agent (page 15, lines 13-20) and the ‘346 publication teaches water soluble glass rumen bolus (abstract) to the recticulo rumen of the animal (page 1, lines 1-10), thus teaching administration to the gastrointestinal tract of an animal and the ‘362 publication teaches delivery by any means to the gastrointestinal tract of the animal.
Double Patenting:
Applicant argues the double patenting rejections be held in abeyance until the claims are considered otherwise allowable.
In response, Applicant’ has presented to substantive arguments and thus are maintained for reasons of record.
Conclusion
No claims are allowed.
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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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