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 with traverse of Group II, claims 14-21, in the reply filed on 11/12/2025 is acknowledged. The traversal is on the ground(s) that the inventions as claimed can be readily evaluated in one search without placing undue burden on the Examiner. This is not found persuasive because Groups I, II, and II are drawn to inventions classified in three different categories, requiring a thorough search of each classification category for each invention. Applicant argues that a search of one group of claims will reveal art to the others. The Examiner respectfully asserts that while each group does relate to an orally dissolving film, a search for the invention of Group I would include a search of all bits and a search of Group III would include a search of all methods of delivering active agents to an animal, thus the search burden his high. The Applicant also argues that restriction would place an undue burden by requiring payment of two separate filing fees for examination of the nonelected claims, as well as the added costs associated with prosecuting three applications and maintaining three patents. Please refer to MPEP 821.04(a) regarding rejoinder following a restriction requirement between product claims:
“Where restriction was required between independent or distinct products, or between independent or distinct processes, and all claims directed to an elected invention are allowable, the examiner should withdraw any restriction requirement between the elected invention and any nonelected invention that depends from or otherwise requires all the limitations of an allowable claim. For example, a requirement for restriction should be withdrawn when a generic claim, linking claim, or subcombination claim is allowable and any previously withdrawn claim depends from or otherwise requires all the limitations thereof. Claims that require all the limitations of an allowable claim will be rejoined and fully examined for patentability in accordance with 37 CFR 1.104. Claims that do not require all the limitations of an allowable claim remain withdrawn from consideration. However, in view of the withdrawal of the restriction requirement, if any claim presented in a divisional application includes all the limitations of a claim that is allowable in the parent application, such claim may be subject to a double patenting rejection over the claims of the parent application. Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). “
Additionally, please refer to MPEP 821.01(b) regarding rejoinder following a restriction requirement between product and process claims:
“Where claims directed to a product and to a process of making and/or using the product are presented in the same application, applicant may be called upon under 35 U.S.C. 121 to elect claims to either the product or a process. See MPEP § 806.05(f) and § 806.05(h). The claims to the nonelected invention will be withdrawn from further consideration under 37 CFR 1.142. See MPEP § 821 through § 821.03. However, if applicant elects a claim(s) directed to a product which is subsequently found allowable, withdrawn process claims which depend from or otherwise require all the limitations of an allowable product claim will be considered for rejoinder. All claims directed to a nonelected process invention must depend from or otherwise require all the limitations of an allowable product claim for that process invention to be rejoined. Upon rejoinder of claims directed to a previously nonelected process invention, the restriction requirement between the elected product and rejoined process(es) will be withdrawn.”
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 4, 5, 12, 13, and 35-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/12/2025.
Priority
The instant application claims priority to provisional application 63/474,447 with a filing date of 8/14/2022, provisional application 63/474,445 with a filing date of 8/14/2022, and provisional application 63/462,599 with a filing date of 11/18/2022. Support for claims 14-21, 26-33, 34, and 38 can be found in provisional application 63/462,599 and are therefore being examined with a priority date of 11/18/2022.
Status of the Claims
Claims 14-21, 26-34, and 38 are pending and under current examination. Claims 1, 4, 5, 12, 13, and 35-37 are pending and withdrawn from consideration. Claims 2, 3, 6-11, and 22-25 are cancelled.
Claim Objections
Claim 29 is objected to because of the following informalities:
Claim 29, line 4, recites “…glycine, glutamine arginine, …”. This is clear typographical error and should be amended to read “…glycine, glutamine, arginine…”.
Claim 29, line 4, recites the “arginine” limitation twice. This is redundant. The claim should be amended to recite “arginine” only once.
Appropriate correction is required.
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 14, 15, 18-20, 26, 32, 33, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bauer (CA3125807 A1, publication date: 7/16/2020).
Regarding claim 14, Bauer discloses a flexible oral thin film (pg. 14, second paragraph) for the administration of active substances (pg. 1, first paragraph and pg. 32 Table 5). The oral thin film dissolves in the oral cavity in a period of less than about 10 minutes (pg. 14, fifth paragraph). The claims recite the limitation “for an equus animal” and “of an equus animal”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the oral thin film embraced by Bauer reads on the instant claims. The limitations of claims 15, 18-20, 26, and 38 further limit the intended use, but fail to further limit the structure of the claim. See MPEP 2112.01 (II).
Regarding claim 15, Bauer discloses that the oral thin film dissolves in the oral cavity in a period of less than about 10 minutes (pg. 14, fifth paragraph).
Regarding claim 18, Bauer discloses that the oral thin film can be applied via the oral mucosa, especially sublingually or buccally (pg. 29, second paragraph).
Regarding claim 19, Bauer discloses that the active substance is included in a pocket positioned between the first and second film layers of the oral thin film (pg. 29, third paragraph).
Regarding claim 20, Bauer discloses a flexible oral thin film (pg. 14, second paragraph) for the administration of active substances (pg. 1, first paragraph). With regards to the “conform to the contours of the surface onto which it is placed” limitations of instant claim 20, the prior art teaches the same flexible film as claimed and therefore, the contour conforming properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claim 26, Bauer discloses that the active substance may be selected from the group of cannabinoids and may also contain vitamin E and/or a pharmaceutically acceptable derivative of vitamin E (pg. 3, second paragraph). Bauer discloses an exemplary oral thin film that contains both THC, lactose, and vitamin E (pg. 32, Table 5, Column D).
Regarding claim 32, Bauer discloses an exemplary oral thin film comprising polyvinyl alcohol as the polymer film and another oral thin film that comprises pullulan as the polymer film (pg. 32, Table 5, Column B and D). The instant specification defines mucoadhesive polymer to include pullulan and stabilizing polymer to include polyvinyl alcohol (pg. 8 lines 19-22 of instant specification), therefore the Examiner considers the pullulan and polyvinyl alcohol disclosed by Bauer to read on the limitations of the instant claims.
Regarding claim 33, Bauer discloses exemplary oral films that include a colorant and flavoring (pg. 32, Table 5 Columns A-C).
Regarding claim 38, Bauer discloses a flexible oral thin film (pg. 14, second paragraph) for the administration of active substances (pg. 1, first paragraph). The oral thin film dissolves in the oral cavity in a period of less than about 10 minutes (pg. 14, fifth paragraph). The claims recite the limitation “for an equus animal” and “of an equus animal”; the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in or order to patentably distinguish the claimed invention form the prior art, therefore the oral thin film embraced by Bauer reads on the instant claim. See MPEP 2112.01 (II). With regards to the “conform to the contours of an equus animal’s gums, buccal surface, gingiva, interdental space, and sublingual space” limitations of instant claim 38, the prior art teaches the same flexible film as claimed and therefore, the contour conforming properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
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 14, 15, 18-21, 26, 32, 33, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Bauer (CA3125807 A1, publication date: 7/16/2020).
Applicant’s Invention
Applicant’s claim 14 is drawn to an oral active agent delivery system for equus animals, the system comprising a flexible orally dissolving film (ODF) and one or more active agents for an equus animal, wherein when the delivery system is placed in an aqueous environment of an oral cavity of an equus animal, at least 95% by weight of the ODF dissolves over a time period of 5 to 120 minutes. Applicant’s claim 38 is drawn to An oral active agent delivery system comprising a flexible orally dissolving film (ODF) and one or more active agents disposed on a surface of, or incorporated within, the ODF, wherein: the active agent is a nutrient or a medicament for an equus animal; the ODF is shaped to conform to the contours of an equus animal's gums, buccal surface, gingiva, interdental space, and sublingual space; and the delivery system is designed to dissolve in an equus animal's aqueous environment, such that at least 95% by weight of the ODF dissolves over a time period of 5 to 120 minutes.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 14, 15, 18-20, 26, 32, 33, and 38, Bauer anticipates the relevant limitations as described in the anticipation rejection above.
Regarding claim 21, Bauer teaches that the oral thin film has an area of about 0.5 cm2 to about 10 cm2 (pg. 13, sixth paragraph). The delivery form may be rectangular (pg. 23, fourth paragraph).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 14, 15, 18-20, 26, 32, 33, and 38, Bauer anticipates the relevant limitations as described in the anticipation rejection above.
Regarding claim 21, Bauer does not teach an oral thin film with a long axis 5 inches in length and a short axis 3 inches in length.
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 14, 15, 18-20, 26, 32, 33, and 38, as noted in the anticipation in the rejection above Bauer anticipated claims 14, 15, 18-20, 26, 32, 33, and 38; so in anticipating claims 14, 15, 18-20, 26, and 38, said claims are also considered obvious under 35 U.S.C. 103 over Bauer for the reasons set forth below (“lack of novelty is the epitome of obviousness” May, 574 F.2d at 1089, 197 USPQ at 607 (citing in re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Regarding the dimensions of the orally dissolving film as specified in claim 21, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Bauer teaches that the size of the delivery form is expediently dimensioned to accommodate a corresponding amount of active-substance-containing filling (pg. 23, third paragraph) and that oral thin films are limited in terms of their maximum size because the user should be able to place the film in the mouths without any problems (pg. 18, third paragraph). The Applicants' specification provides no evidence that the selected dimensions in claim 21 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the effect that the dimensions of the film have on the amount of active substance that may be contained within and the comfort of the end user, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the dimensions of the oral thin film. One of ordinary skill in the art would have been motivated to change the dimensions as this could be expected to be advantageous for accommodating the desired amount of active substance or sizing the film to fit comfortably within the mouth of the end user.
Claims 14-16, 18-21, 26, 29, 32, 33, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Puri (U.S. Patent Application Publication No. 2007/004023, publication year: 2007) in view of BirdDog Bioventures (YouTube, available 5/23/2018) and Loving (The Horse, publication date: 2/20/2016).
Applicant’s Invention
Applicant’s claim 14 is drawn to an oral active agent delivery system for equus animals, the system comprising a flexible orally dissolving film (ODF) and one or more active agents for an equus animal, wherein when the delivery system is placed in an aqueous environment of an oral cavity of an equus animal, at least 95% by weight of the ODF dissolves over a time period of 5 to 120 minutes. Applicant’s claim 38 is drawn to An oral active agent delivery system comprising a flexible orally dissolving film (ODF) and one or more active agents disposed on a surface of, or incorporated within, the ODF, wherein: the active agent is a nutrient or a medicament for an equus animal; the ODF is shaped to conform to the contours of an equus animal's gums, buccal surface, gingiva, interdental space, and sublingual space; and the delivery system is designed to dissolve in an equus animal's aqueous environment, such that at least 95% by weight of the ODF dissolves over a time period of 5 to 120 minutes.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 14 and 38, Puri teaches film compositions which rapidly dissolve in the presence of moisture to release the active ingredient contained therein into the moist environment in which it is placed [0011]. Typically, the substantially aqueous environment will be within the oral cavity [0015]. The film may completely dissolve within 90 seconds following exposure to the moist environment [0006]. The wettability and dissolution rates of the film may be modified by one skilled in the art to target a specific delivery profile [0016]. The films may be administered to domestic and non-domestic animals. Film for veterinary administration may administer, for example, a breath freshening agent, flavor, dietary supplement, functional food, pharmaceutical, and/or nutraceutical active [0037].
Regarding claim 15, Puri teaches that the wettability and dissolution rates of the film may be modified by one skilled in the art to target a specific delivery profile [0016].
Regarding claim 16, Puri teaches the relevant limitations of claim 14 above. Puri also teaches that the film may contain proteins [0032].
Regarding claim 18, Puri teaches film compositions which rapidly dissolve in the presence of moisture to release the active ingredient contained therein into the moist environment in which it is placed [0011]. Typically, the substantially aqueous environment will be within the oral cavity [0015], and may be applied to the tongue, mucosal tissue, or the like [0013]. The Examiner considers the phrase “mucosal tissue” to read on the gums and buccal surface limitations of the instant claim.
Regarding claim 19, Puri teaches film compositions which rapidly dissolve in the presence of moisture to release the active ingredient contained therein into the moist environment in which it is placed [0011].
Regarding claims 20 and 38, Puri teaches that the films of the invention can be made in the form of an article such as a strip, tape, a patch, a sheet, a dressing or any other form known to those skilled in the art. The dosage system may be produced in any desirable unit form. In addition to having various shapes, the dosage units produced may come in various sizes depending on the end use application [0050]. Puri also teaches that the device will be in the form of a strip of a size suitable to deliver a pre-selected amount of drug into the oral cavity without bending or folding the film [0051]. The films are strong and flexible [0010]. With regards to the “conform to the contours” limitations of instant claims 20 and 38, the prior art teaches the same flexible film as claimed and therefore, the contour conforming properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claim 21, Puri teaches that generally the device will be in the form of a strip of a size suitable to deliver a pre-selected amount of drug into the oral cavity without bending or folding the film. Generally a strip of about 1 in width and about 1.5 in in length will be used for oral administration [0051]. Puri also teaches that the dosage units produced may come in various sizes depending on the end use application [0050].
Regarding claim 26, Puri teaches film compositions which rapidly dissolve in the presence of moisture to release the active ingredient contained therein into the moist environment in which it is placed [0011]. Typically, the substantially aqueous environment will be within the oral cavity [0015]. The films may be administered to domestic and non-domestic animals. Film for veterinary administration may administer, for example, a breath freshening agent, flavor, dietary supplement, functional food, pharmaceutical, and/or nutraceutical active [0037].
Regarding claim 29, Puri teaches the relevant limitations of claims 14 and 16 above.
Regarding claim 32, Puri teaches that the films may contain high amylose starch, dextrin, pectin, chitin, chitosan, collagen, starch, modified starch, and gelatin [0021]. The films may also contain hydroxypropylmethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, and polyvinyl alcohol [0021]. The specification defines a stabilizing polymer to include a cellulose derivative and polyvinyl alcohol, therefore the Examiner considers the cellulose derivatives and polyvinyl alcohol embraced by Puri to read on the “stabilizing polymer” of the instant claim.
Regarding claim 33, Puri teaches that the films may contain plasticizers, colorants, flavors, and flavor enhancers [0032].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 14, 16, and 38, Puri does not teach an active ingredient for an equus animal or the dissolution rate embraced by the instant claims. However, this deficiency is cured by BirdDog Bioventures and Loving.
BirdDog Bioventures teaches oral mucosal adhesive strips for delivering metabolites and amino acids to horses to support exercise recovery (see video at 0:05-0:23). Loving teaches that it’s best to provide a horse with amino acids within 45 minutes after exercise to ensure fast recovery and optimal effects. (pg. 3)
Regarding claim 15, Puri does not teach a dissolution rate embraced by the instant claims. However, this deficiency is cured by Loving.
Loving teaches that it’s best to provide a horse with amino acids within 45 minutes after exercise to ensure fast recovery and optimal effects. (pg. 3)
Regarding claim 18, Puri does not teach that the film may be applied to an equus animal’s gums, buccal surface, gingiva, interdental space, and the sublingual space. However, this deficiency is cured by BirdDog Ventures.
BirdDog Bioventures teaches oral mucosal adhesive strips for delivering metabolites and amino acids to horses to support exercise recovery (see video at 0:05-0:23).
Regarding claim 21, Puri does not teach a film with the dimensions embraced by the instant claim.
Regarding claim 29, Puri does not teach the inclusion of amino acids for administration to horses. However, this deficiency is cured by BirdDog Bioventures and Loving.
BirdDog Bioventures teaches oral mucosal adhesive strips for delivering metabolites and amino acids to horses to support exercise recovery (see video at 0:05-0:23). Loving teaches that its best to provide a horse with amino acids, such as lysine and branch-chain amino acids such as valine, leucine, and isoleucine(pg. 2), within 45 minutes after exercise to ensure fast recovery and optimal effects (pg. 3).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 14, 16, and 38, it would have been prima facie obvious to one of ordinary skill in the art of filing to utilize the oral film composition of Puri to deliver an active ingredient to an equus animal. One would have understood in view of BirdDog Bioventures that an oral mucoadhesive strip may be used to deliver metabolites and amino acids to horses to support exercise recovery. It would have been obvious to include the metabolites and amino acids taught by BirdDog Bioventures as the active ingredient for veterinary administration taught by Puri. One would have been motivated to include such active compounds for administration to equus animals in order to support exercise recovery in horses. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because BirdDog Bioventures teaches that oral mucoadhesive strips may be used to deliver metabolites and amino acids to horses to support exercise recovery.
Regarding the dissolution time of the orally dissolving film as specified in claims 14 and 15, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Puri teaches that the wettability and dissolution rates of the film may be modified by one skilled in the art to target a specific delivery profile [0016] and Loving teaches that it’s best to provide a horse with amino acids within 45 minutes after exercise to ensure fast recovery and optimal effects (pg. 3). The Applicants' specification provides no evidence that the selected dissolution time in claim 14 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the optimal time period for administration of amino acids to a horse for exercise recovery, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the dissolution rate of the film to target the desired delivery profile. One of ordinary skill in the art would have been motivated to change the dissolution rate as this could be expected to be advantageous for fast recovery and optimal effects rendered by the amino acids in exercise recovery of a horse.
Regarding claim 18, it would have been prima facie obvious to one of ordinary skill in the art of filing to apply the film embraced by Puri to the gums or buccal surface of an equus animal. One would have understood in view of Puri that the film may be applied to the tongue or mucosal tissue of the oral cavity and that the films may be used for veterinary administration. One would have also understood in view of BirdDog Bioventures that an oral mucoadhesive strip may be used to deliver metabolites and amino acids to horses to support exercise recovery. It would have been obvious to apply the film embraced by Puri to the oral mucosal tissue of a horse. One of ordinary skill in the art of filing would have been motivated to apply the film to the oral mucosal tissue of a horse in order to deliver the active ingredients to a horse in need of the active ingredients for exercise recovery. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because BirdDog Bioventures teaches oral mucoadhesive strips for delivery of active ingredients to horses.
Regarding the dimensions of the orally dissolving film as specified in claim 21, MPEP 2144.05 states:
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Furthermore, Puri teaches that the dosage units produced may come in various sizes depending on the end use application [0050]. The Applicants' specification provides no evidence that the selected dimensions in claim 21 was not due to routine optimization and/or that the results should be considered unexpected compared to the prior art. Due to the variability of the size of the film embraced by Puri, it would have been prima facie obvious to a person of ordinary skill in the art at the time of the invention to combine these teachings and alter the dimensions of the film for the end application to an equus animal’s oral mucosal tissue. One of ordinary skill in the art would have been motivated to change the size as this could be expected to be advantageous for application to an equus animal’s oral mucosal tissue.
Regarding claim 29, it would have been prima facie obvious to one of ordinary skill in the art of filing to include a branched chain amino acid or other non-essential amino acid in the film embraced by Puri. One would have understood in view of Loving that horses require amino acids such as lysine and branch-chain amino acids within 45 minutes after exercise to ensure fast recovery and optimal effects. One would have also understood in view of BirdDog Bioventures that amino acids may be provided to a horse via an oral mucosal adhesive strip for exercise recovery. It would have been obvious to include the amino acids taught by Loving in the film embraced by Puri. One of ordinary skill in the art of filing would have been motivated to include lysine or branch-chain amino acids in order to aid in horse recovery after exercise. The artisan of ordinary skill in the art would have had reasonable expectation of success because Puri teaches that the film may be include dietary supplements and nutraceuticals for veterinary applications.
Claims 27 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Puri (U.S. Patent Application Publication No. 2007/004023, publication year: 2007) in view of BirdDog Bioventures (YouTube, available 5/23/2018) and Loving (The Horse, publication date: 2/20/2016), as applied to claims 14-16, 18-21, 26, 29, 32, 33, and 38 above, and further in view of Pazdzior (Mad Barn, publication date: 7/21/2022).
Applicant’s Invention
Puri, in view of BirdDog Bioventures and Loving, renders obvious the relevant limitations of claims 14 and 16 above. Applicant’s claim 27 further adds the limitation of the delivery system of claim 16, wherein the active agent comprises an electrolyte selected from the group consisting of salts of sodium, potassium, magnesium, calcium, and a combination thereof. Applicant’s claim 28 adds the limitation of the delivery system of claim 16, wherein the active agent comprises a sugar selected from the group consisting of dextrose, glucose, and a combination thereof.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 27 and 28, Puri teaches the relevant limitations of claims 14 and 16 above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 27 and 28, Puri does not teach the inclusion of an electrolyte or a sugar. However, this deficiency is cured by BirdDog Bioventures, Loving, and Pazdzior.
BirdDog Bioventures teaches oral mucosal adhesive strips for delivering metabolites and amino acids to horses to support exercise recovery (see video at 0:05-0:23). Loving teaches that in order to build strong muscle, a horse needs all 10 essential amino acids in his diet (pg. 2). Loving also teaches that electrolytes with a small amount of sugar are another dietary supplement that can help muscle recovery from exercise (pg. 4). Pazdzior teaches that a commercial electrolyte supplement can be beneficial when your horse is sweating heavily, working in hot or humid conditions, or working harder and/or longer than they are accustomed to (pg. 7). Sodium is an acceptable electrolyte supplement in performance horses (pg. 9). Pazdzior also teaches that electrolyte supplements containing carbohydrate sources such as dextrose or fructose improve the speed at which water and electrolytes are absorbed in the digestive tract. Dextrose can also replenish energy stores (glycogen) in the body, helping to support exercise recovery (pg. 10).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 27 and 28, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to include and electrolyte and sugar in the film embraced by Puri. One would have understood in view of BirdDog Bioventures that metabolites and amino acids may be administered to horses to aid in exercise recovery and in view of Loving that electrolytes and small amount of sugar are a dietary supplement that can aid in muscle recovery after exercise in horses. One would have also understood in view of Pazdzior that sodium and dextrose are suitable for supplementation in horses to support exercise recovery. It would have been obvious to include sodium salt and dextrose in the film embraced by Puri for administration to horses for exercise recovery. One of ordinary skill in the art of filing would have been motivated to include sodium salt and dextrose in order to aid in the muscle recovery of a horse after exercise. The artisan of ordinary skill would have had reasonable expectation of success because Puri teaches that the film may contain dietary supplements and nutraceuticals for veterinary administration.
Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Puri (U.S. Patent Application Publication No. 2007/004023, publication year: 2007) in view of BirdDog Bioventures (YouTube, available 5/23/2018) and Loving (The Horse, publication date: 2/20/2016), as applied to claims 14-16, 18-21, 26, 29, 32, 33, and 38 above, and further in view of Laos (WO2019/200440, publication year: 2019).
Applicant’s Invention
Puri, in view of BirdDog Bioventures and Loving, renders obvious the relevant limitations of claims 14 and 16 above. Applicant’s claim 30 further adds the limitation of the delivery system of claim 16, wherein the active agent comprises an agent selected from the group consisting of a decapeptide and a growth hormone.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 30 and 31, Puri teaches the relevant limitations of claims 14 and 16 above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 30 and 31, Puri does not teach the inclusion of a decapeptide or growth hormone. However, this deficiency is cured by Laos.
Laos teaches a proteinaceous composition for delivery to a subject (pg. 3 lines 31). The composition can be administered by mucosal application (pg. 24 line 16) to any mammal, including horses (pg. 20 line 23-26). The composition may include a bioactive peptide molecule that comprises, consists, or consists essentially of at least a portion of a BPC 157 amino acid sequence (pg. 5 lines 16-17). BPC 157 was found to have substantial healing properties in a diverse range of injuries including healing of wounds, burns, gastrointestinal disease, and tendon injuries (pg. 59 lines 29-31).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 30 and 31, it would have been prima facie obvious to one of ordinary skill in the art of filing to include BPC-157 in the film embraced by Puri. One would have understood in view of Laos that BPC-157 is suitable for mucosal delivery to horses and that BPC-157 has healing properties for tendon injuries. It would have been obvious to include a peptide such as BPC-157 in the film embraced by Puri. One of ordinary skill in the art of filing would have been motivated to include BPC-157 in the composition in order to impart the healing properties for tendon injuries to horses in exercise recovery. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because Laos teaches that BPC-157 is suitable for mucosal administration in horses.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Puri (U.S. Patent Application Publication No. 2007/0042023, publication year: 2007) in view of BirdDog Bioventures (YouTube, available 5/23/2018) and Loving (The Horse, publication date: 2/20/2016), as applied to claims 14-16, 18-21, 26, 29, 32, 33, and 38 above, and further in view of Quitman (U.S. Patent No. 403,213, issue date: 5/14/1889).
Applicant’s Invention
Puri, in view of BirdDog Bioventures and Loving, render obvious the relevant limitations of claim 14 above. Applicant’s claim 34 further adds the limitation of a laminated bit for use in an equus animal comprising an equus animal bit and an oral active agent delivery system of claim 14 laminated onto the bit.
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Puri teaches the relevant limitations of claim 14 as described above. Puri also teaches that the film-forming ingredients may be coated onto a substrate material to form a film [0007]. The films exhibit moisture and blocking resistance, yet are quickly wetted when exposed to water, such as when placed on the tongue or other substrate surface, followed by rapid dissolution [0014].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Puri does not teach a laminated bit comprising an oral active agent delivery system laminated onto the bit. However, this deficiency is cured by Quitman.
Quitman teaches a porous receptacle containing veterinary medicine to be administered to a horse. The porous receptable is attached to the bit and when the bit is in the mouth of the animal, the medicine is gradually dissolved or taken up by the saliva and swallowed (lines 50-59). Quitman also teaches that effective condition-powders and medicines generally cannot be made palatable to an animal, and when mixed with food they tend to cause it to reject what it would otherwise eat. Condition-powders and medicines are also not as efficacious when taken alone. Additionally, Quitman teaches that little reliance can be placed upon the average groom or hostler in the matter of administering medicines regularly and judiciously (lines 24-36).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art of filing to utilize the film embraced by Puri to coat a horse bit. One would have understood in view of Quitman that a receptable containing veterinary medicine to be administered to a horse may be attached to a bit so that when the bit is in the mouth of animal, the medicine is gradually dissolved or taken up by the saliva and swallowed. It would have been obvious that the film embraced by Puri may also be attached to a bit so that the film may gradually dissolved and release the active agent into the saliva of the horse. One of ordinary skill in the art of filing at the time the invention was made would have been motivated to coat a bit with the film embraced by Puri in order to make the active ingredient more palatable to the horse, maximize the efficacy of the active agent, and to facilitate ease of administration for the lay person responsible for care of the horse. The artisan of ordinary skill in the art of filing would have had reasonable expectation of success because Puri teaches that the film-forming ingredients may be coated onto a substrate material to form a film [0007].
Conclusion
No claims are allowed.
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/ELIZABETH ANNE MEYERS/Examiner, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614