Prosecution Insights
Last updated: August 06, 2026
Application No. 18/233,659

ORAL ACTIVE AGENT DELIVERY SYSTEM FOR ANIMALS AND METHOD

Final Rejection §103§112§Other
Filed
Aug 14, 2023
Priority
Aug 14, 2022 — provisional 63/474,447 +2 more
Examiner
MEYERS, ELIZABETH ANNE
Art Unit
1617
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
BIRD DOG BIOVENTURES, LLC
OA Round
2 (Final)
29%
Grant Probability
At Risk
3-4
OA Rounds
1m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants only 29% of cases
29%
Career Allowance Rate
4 granted / 14 resolved
-31.4% vs TC avg
Strong +91% interview lift
Without
With
+90.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 1m
Avg Prosecution
44 currently pending
Career history
76
Total Applications
across all art units

Statute-Specific Performance

§101
1.2%
-38.8% vs TC avg
§103
40.4%
+0.4% vs TC avg
§102
10.5%
-29.5% vs TC avg
§112
27.1%
-12.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 14 resolved cases

Office Action

§103 §112 §Other
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 . 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 4, 5, 12-16, 18, 21, and 26-43 are pending. Claims 14-16, 18, 21, 26-34, and 38-43 are under current examination. Claims 4, 5, 12-13, and 35-37 stand withdrawn with traverse. Claims 1, 17, and 19-20 are cancelled. Claim 18 has the improper status identifier. The status identifier must be amended to read “Claim 18. (Previously Presented)” or the current amendment must be clearly identified. The preamble of claim 29 has been amended but the amendment has not been underlined in the amendments to the claims. All claims being currently amended must be presented with markings to indicate the changes that have been made relative to the immediate prior version. See MPEP 714 (II)(C)(B). Withdrawn Claim Objections and Rejections All rejections pertaining to claims 17 and 19-20 are moot because the claims are cancelled in the amendments to the claims filed 5/15/2026. All objections to claim 29 are withdrawn in view of the amendments to the claims filed 5/15/2026. All rejections under 35 U.S.C. 102 and 35 U.S.C. 103 over Bauer (CA3125807 A1, publication date: 7/16/2020) have been withdrawn in view of the amendments to the claims filed 5/15/2026. All rejections not reiterated have been withdrawn. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 14-16, 18, 21, 26-34, and 39-41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 14 recites the limitation “the ODF comprises a hydrophilic or water-soluble polymer comprising a mucoadhesive polymer”. This renders the claim indefinite because it is not clear if the hydrophilic or water-soluble polymer must comprise a mucoadhesive polymer, if only the water-soluble polymer must include a mucoadhesive polymer, or if the mucoadhesive polymer must be included in addition to the hydrophilic or water-soluble polymer. Claim 29 recites the limitation “the laminated bit of claim 16”. There is insufficient antecedent basis for this limitation in the claim. Regarding claims 15-16, 18, 21, 26-28, 30-34, and 39-41, claims depending from rejected claims have also been rejected because they incorporate all of the limitations of the claims from which they depend, but fail to resolve the indefiniteness concerns outlined above. Claim Rejections - 35 USC § 103 Applicant’s amendments to the claims filed 5/14/2026 have necessitated the new grounds of rejection. 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 14-16, 18, 26-28, 32, 33, and 38-43 are rejected under 35 U.S.C. 103 as being unpatentable over Baranowitz (U.S. Patent Application No. 2017/0071966, publication year: 2017). Determination of the scope and the content of the prior art (MPEP §2141.01) Regarding claims 14, 18, and 38, Baranowitz teaches an oral mucosal delivery composition in the form of a bioadhesive patch or film [0084]. The composition may be in buccal or sublingual dosage form [0017]. The film is a monolithic material containing one or more dissolved or dispersed active ingredients closely associated with a surrounding, rate-controlling heterogenous material [0090]. The buccal dosage form includes mucoadhesive formulations [0085] and the polymer included in the film may comprise pullulan and hydroxypropylmethyl cellulose [0109]. The dosage form may be administered to horses [0039] and should dissolve at a moderate rate [0115]. Moderate dissolving films are flexible [0107], dissolve in about 1 to 30 minutes [0106], and is not easily removed once it is placed in the oral cavity of the user [0107]. The films may be any desired thickness and shape such that it may be placed into the oral cavity of the user [0105]. With regards to the “conform to…the contours of an equus animal’s gums…” limitations of instant claims 14 and 38, the prior art teaches the same film comprising the same mucoadhesive and hydrophilic polymers as claimed as claimed and therefore, the 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 15, Baranowitz teaches that The dosage form may be administered to horses [0039] and should dissolve at a moderate rate [0115]. Moderate dissolving films are flexible [0107] and dissolve in about 1 to 30 minutes [0106]. Regarding claim 16, Baranowitz teaches that the film may include a sweetener such as glucose, dextrose, invert sugar, fructose, and combinations thereof [0134] and a complexing agent such as amino acids and proteins [0097]. Regarding claim 21, Baranowitz teaches that the films may be any desired thickness and size such that it may be placed into the oral cavity of the user [0105]. Regarding claim 26, Baranowitz teaches that the film comprises beta-carotene and cholic acid [0080]. Beta-carotene is a dietary supplement and provitamin [0041]. Regarding claim 27, Baranowitz teaches that the film may include sodium cholate [0061]. The Examiner considers sodium cholate to read on the “salts of sodium” limitation of the instant claim. Regarding claim 28, Baranowitz teaches that the film may include a sweetener such as glucose, dextrose, invert sugar, fructose, and combinations thereof [0134]. Regarding claim 32, Baranowitz teaches that the film may comprise polymers such as gelatin, pullulan, hydroxypropyl methyl cellulose, polyvinyl pyrrolidone [0109], and polyvinylalcohols [0120]. The instant specification defines a stabilizing polymer to include a cellulose derivative, polyvinylpyrrolidone, and polyvinyl alcohol (pg. 8 lines 19-2 of the instant specification), therefore the Examiner considers the polyvinyl pyrrolidone, polyvinyl alcohols, and hydroxypropyl methyl cellulose of Baranowitz to read on the “stabilizing polymer” limitation of the instant claim. Regarding claim 33, Baranowitz teaches that the film may include plasticizers [0118], a permeation enhancer [0013], coloring agents, flavors [0118], and stabilizers [0119]. Regarding claims 39-43, Baranowitz teaches that the polymer included in the film may comprise pullulan and hydroxypropylmethyl cellulose [0109]. Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.02) Regarding claims 14-16, 18, 26-28, 32, 33, and 38-43, Baranowitz does not teach a single embodiment or example meeting all limitations of the invention of claims 14-16, 18, 26-28, 32, 33, and 38-43. Finding of a Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) Regarding claims 14-16, 18, 26-28, 32, 33, and 38-43, within the broader scope of Baranowitz all of the limitations of the invention of claims 14-16, 18, 26-28, 32, 33, and 38-43 are met. It would have been prima facie obvious for one having ordinary skill in the art to choose the limitations in the instant claims from those disclosed by Baranowitz and arrive at this conclusion because such was contemplated by Baranowitz. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Baranowitz (U.S. Patent Application No. 2017/0071966, publication year: 2017), as applied to claims 14-16, 18, 26-28, 32, 33, and 38-43 above, and further in view of Anttila et. al. (Frontiers in Veterinary Science, article 879048, publication date: 5/12/2022). Determination of the scope and the content of the prior art (MPEP §2141.01) Baranowitz teaches that the films may be any desired thickness and size such that it may be placed into the oral cavity of the user [0105]. Desirably, the individual film dosage has a small size, which is between about 0.5-1 inch by about 0.5-1 inch [0115]. The film may be administered to horses [0039]. Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.02) Baranowitz does not teach that the films may be a size within the range embraced by the instant claim. However, this deficiency is cured by Anttila. Anttila teaches that the mean mouth width of mares and geldings of different horse and pony breeds is 131.3 mm (Table 3). This is equivalent to 5.16 inches (1mm=0.039 inches). Finding of a Prima Facie Obviousness Rationale and Motivation (MPEP §2142-2143) Regarding the dimensions of the oral 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, Baranowitz teaches that the films may be any desired thickness and size such that it may be placed into the oral cavity of the user [0105] and Anttila teaches that the mean mouth width of mares and geldings of different horse and pony breeds is 131.3 mm (Table 3). This is equivalent to 5.16 inches (1mm=0.039 inches). 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 average size of a horse’s mouth, 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 of Baranowitz. One of ordinary skill in the art would have been motivated to change the dimension as this could be expected to be advantageous for adjusting the film to fit the mouth of a horse. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Baranowitz (U.S. Patent Application No. 2017/0071966, publication year: 2017), as applied to claims 14-16, 18, 26-28, 32, 33, and 38-43 above, and further in view of BirdDog Bioventures (YouTube, available 5/23/2018, of record) and Loving (The Horse, publication date: 2/20/2016, of record). Determination of the scope and the content of the prior art (MPEP §2141.01) Baranowitz teaches that the film may comprise a complexing agent such as amino acids and proteins [0097] and that the dosage form may be administered to horses [0039]. Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.02) Baranowitz does not teach the inclusion of the amino acids 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 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 Facie 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 include a branched chain amino acid or other non-essential amino acid in the film embraced by Baranowitz. 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 Baranowitz. 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 Baranowitz teaches that the film may be include amino acids, dietary supplements and nutraceuticals for administration to horses. Claims 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Baranowitz (U.S. Patent Application No. 2017/0071966, publication year: 2017), as applied to claims 14-16, 18, 26-28, 32, 33, and 38-43 above, and further in view of Laos (WO2019/200440, publication year: 2019, of record). Determination of the scope and the content of the prior art (MPEP §2141.01) Regarding claims 30 and 31, Baranowitz 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, Baranowitz 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 Facie 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 Baranowitz. 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 Baranowitz. 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 Baranowitz (U.S. Patent Application No. 2017/0071966, publication year: 2017), as applied to claims 14-16, 18, 26-28, 32, 33, and 38-43 above, and further in view of Quitman (U.S. Patent No. 403,213, issue date: 5/14/1889, of record). Determination of the scope and the content of the prior art (MPEP §2141.01) Baranowitz teaches the relevant limitations of the claim 14 as described above. Ascertainment of the Difference Between Scope of the Prior Art and the Claims (MPEP §2141.02) Baranowitz does not teach an oral film laminated onto a bit for an equus animal. 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 Facie 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 Baranowitz 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 Baranowitz 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 Baranowitz 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 Quitman teaches that medicaments for horses may be administered via a bit for dissolution into the mouth. Response to Arguments Applicant's arguments filed 5/15/2026 have been fully considered but they are not persuasive. Applicant’s arguments with respect to the rejections under 35 U.S.C. 102 and 103 over Bauer and under 35 U.S.C. over Puri have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. On page 7, Applicant argues that major advantages of the instant invention are that the delivery system bypasses the GI tract and first pass metabolism and that the delivery system allows for controlled release of the active agents. This is not found persuasive. In response, the Examiner respectfully asserts that the described benefits had been recognized in the art as of the instant effective filing date. Baranowitz teaches that buccal or sublingual delivery provides for rapid absorption, faster onset of therapeutic action and avoidance of liver or gut wall first pass metabolism [0079] and that the solid dosage form can provide immediate release or controlled release or a combination thereof [0082]. Therefore, the advantages argues by Applicant were already recognized in the art as of the instant effective filing date. On page 11, Applicant argues that the combination of cited material can only occur by the impermissible use of hindsight reasoning. On page 12, Applicant argues that there is no teaching, suggestion, or incentive indicated in any of the cited materials that provides a motivation to combine their teachings to provide the present invention. This is not found persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Please also refer to MPEP 2141.03(I) regarding the factors to consider when determining level of ordinary skill: "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. In the instant case, Baranowitz teaches that the orally dissolving film may be administered to horses and include a sweetener such as glucose, dextrose, invert sugar, fructose, and combinations thereof [0134] and a complexing agent such as amino acids and proteins [0097]. One of ordinary skill in the art would have recognized that the film of Baranowitz may be administered to horses and would therefore have been motivated to apply the teachings of BirdDog Bioventures and Loving to adapt the ingredients included in the film for administration to horses. On page 13, Applicant argues that one of skill in the art would never combine the teachings of Quitman with the references of record. This is not found persuasive. Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”). Please also refer to MPEP 2141.03(I) regarding the factors to consider when determining level of ordinary skill: "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396. In the instant case, one of ordinary skill in the art would have understood that the bit of Quitman is suitable for administration of equine medicaments that may be dissolved in the saliva of the horse and would therefore understand that the film of Baranowitz may also be administered via a bit. Response to Declaration Declarant’s arguments filed 5/22/2026 have been fully considered but they are not persuasive. On page 2, Declarant argues that the horse’s oral structure includes many challenges that preclude simply enlarging ODFs used in humans and that given the lack of structural similarity between human and horse oral environments one skilled in the animal arts would likely dismiss human ODFs as being inadequate for the equine oral environment. This is not found persuasive. As described in the obviousness rejection above, the oral film of Baranowitz may be administered to horses and therefore the artisan of ordinary skill in the art would have a reasonable expectation of success in optimizing the size of the film for administration to a horse. Furthermore, Baranowitz teaches that the film may comprise pullulan and hydroxypropyl methylcellulose, the same mucoadhesive and hydrophilic polymers as claimed. While the Examiner agrees that the instant invention is not a simple expansion of the use of human ODFs, the teachings of Baranowitz include administration to horses, therefore one of ordinary skill in the art could reasonably conclude that the film formulation is suitable for delivery of the active agents to horses and could reasonably optimize the size of the film for administration to a horse. On page 4, Declarant argues that the generation of the subject invention was not a simple expansion of the use of human ODFs and that the establishment of an efficacious equus ODF required significant experimentation that required drawing from many different technologies that are not taught by observation of human ODFs. This is not found persuasive. In response, the Examiner respectfully draws attention to MPEP 2123 (I) which states: “a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989).” In the instant case, Baranowitz teaches an orally dissolving film that may be administered to horses that may comprise pullulan and hydroxypropyl methyl cellulose. Baranowitz also teaches that moderate dissolving films have a good level of mucoadhesion and are also flexible and quickly wettable. Moderate dissolving films have a dissolution rate between about 1 minute and 20 minutes, while providing an acceptable mucoadhesion level such that the film is not easily removable once it is placed in the oral cavity of the user [0107]. One of ordinary skill in the art of filing would have therefore reasonably concluded that the orally dissolving film of Baranowitz that may contain pullulan and hydroxypropyl methyl cellulose and be administered to horses would also have the mucoadhesive and flexibility characteristics of the instant invention. Therefore, the Declarant’s arguments are not persuasive. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET. 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, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. ELIZABETH ANNE MEYERSExaminer, Art Unit 1617 /KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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Prosecution Timeline

Aug 14, 2023
Application Filed
Dec 15, 2025
Non-Final Rejection mailed — §103, §112, §Other
May 08, 2026
Examiner Interview Summary
May 15, 2026
Response Filed
May 22, 2026
Response after Non-Final Action
Jul 23, 2026
Final Rejection mailed — §103, §112, §Other (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12636244
PERSONAL CARE COMPOSITION CONTAINING A BIOSURFACTANT
2y 7m to grant Granted May 26, 2026
Patent 12514749
EYE LUBRICANT
3y 5m to grant Granted Jan 06, 2026
Study what changed to get past this examiner. Based on 2 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
29%
Grant Probability
99%
With Interview (+90.9%)
3y 1m (~1m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 14 resolved cases by this examiner. Grant probability derived from career allowance rate.

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