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 application was filed 19 March 2021 and is the national stage entry of PCT/US2019/052504 filed 23 September 2019. The Applicant claims priority to provisional application 62/734,810 filed 21 September 2018. The effective filing date of the application is 21 September 2018.
Examiner’s Note
The Applicant's amendments and arguments filed 22 September 2025 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 22 September 2025, it is noted that claim 124 has been amended and claim 125 has been newly added. Support for the amendment(s) and/or new claim(s) can be found from para. 150 of the specification. No new matter has been added.
Declaration
The declaration under 37 CFR 1.132 filed 22 September 2025 is insufficient to overcome the rejection of claims 105-125 based upon Borges and drugs.com, as evidenced by knowde.com and bayviewrx.com as set forth in the last Office action because: the Applicant claims better tolerability of bitter taste when grapefruit extract is added, leading to higher sales of their product. Since incorporating taste masking agents is well-known in the art to provide a more palatable taste for bitter pharmaceutical products, the addition of grapefruit extract in order to improve the taste and patient satisfaction is not surprising or new. The Applicant bears the burden of proof, providing hard evidence of sales and attributing that success directly to the novel aspects of the invention, rather than factors like advertising or brand recognition, to establish its patentability, which is not entirely clear from the declaration alone.
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.
Claim(s) 105-123 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borges et al. (WO 2015/016727 A2), as evidenced by knowde.com and bayviewrx.com.
Borges teaches an orodispersible film (entire teaching; abs) that may disintegrate within 4-8 minutes (para. 6). The film may comprise active ingredients such as apomorphine, sildenafil, and tadalafil (para. 33). Nutraceutical/active agents (para. 6) include grapefruit extract (para. 34), flavoring agents include spearmint oil (para. 24), and plasticizers include polyethylene glycol (para. 18). The amount of active agent or nutraceutical agent may be 0.001-60% (para. 32). The composition thus far addresses claims 105-107, 110, 111, 113-116, 119, 120, 122. The composition’s disintegration studies are interpreted as performed through a disintegration test, addressing claim 123. Troches and oral films are interpreted as a solid dosage form capable of dissolving in the mouth (bayviewrx.com, pg. 1).
The UV and NF01 limitations of claims 108, 109, 112, 117, 118, and 121 are interpreted as inherent properties of spearmint oil and grapefruit extract. NF01 is naturally present in grapefruit (evidenced by knowde.com, pg. 1). “Products of identical chemical composition cannot have mutually exclusive properties.” 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. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
Borges does not teach an exact combination of apomorphine, grapefruit extract, and sildenafil in claim 105.
In regards to selecting a combination of sildenafil, apomorphine, grapefruit extract, PEG, tadalafil, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Greenspoon teaches an oral formulation that may comprise sildenafil citrate, flavorings such as grapefruit or spearmint oil, and cannabidiol, whereas the claimed invention is directed towards a composition comprising a bitter active ingredient and a bitterness reducing agent. Since Greenspoon teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Borges teaches an oral film that comprises apomorphine, sildenafil, tadalafil, PEG, grapefruit extract, and spearmint oil, whereas the claimed invention is directed towards a composition comprising apomorphine, sildenafil, and a bitterness reducing agent comprising grapefruit extract. Since Borges teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
In regards to the amounts of components in claims 105-107 and 114-116, Borges teaches that the amount of active agent or nutraceutical agent may be 0.001-60% (para. 32). That being said and in lieu of objective evidence of unexpected results, the amounts can be viewed as a variable that achieves the recognized result of successfully making the oral pharmaceutical composition. The optimum or workable range of amounts 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). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of active agents as nonobvious.
Claim(s) 105-125 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borges et al. (WO 2015/016727 A2) and drugs.com, as evidenced by knowde.com and bayviewrx.com.
In regards to claim(s) 105-123, Borges, as applied supra, is herein applied in its entirety for its teachings of an oral film that comprises apomorphine, sildenafil, tadalafil, PEG, grapefruit extract, and spearmint oil.
Borges does not specifically teach PEG 1450 in their composition in claims 124 and 125.
Drugs.com teaches that PEG 1450 is a common inactive ingredient used in the pharmaceutical industry with a wide range of uses. For example, PEG 1450 may be used as a solvent, plasticizer, surfactant, or lubricant (pg. 1).
Borges teaches using PEG in their composition but does not specifically teach using PEG 1450 in claims 124 and 125. One of ordinary skill in the art would have been motivated to use the teaching from drugs.com of using PEG 1450 as a common inactive pharmaceutical ingredient to address this deficiency. A person of ordinary skill in the art would have led to use PEG 1450 in Borges’ teaching since Borges PEG as a plasticizer or surfactant (para. 18 and 27) and drugs.com teaches that PEG 1450 is a pharmacologically inactive substance and common excipient.
Response to Arguments
Applicant's arguments filed 22 September 2025 have been fully considered but they are not persuasive.
The Applicant argues that the claims are not obvious over the cited prior art (Remarks, pgs. 19-20).
Applicant’s argument is not found persuasive. Borges teaches an oral film that comprises apomorphine, sildenafil, tadalafil, PEG, grapefruit extract, and spearmint oil, whereas the claimed invention is directed towards a composition comprising apomorphine, sildenafil, and a bitterness reducing agent comprising grapefruit extract. Since Borges teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
The Applicant argues that the “random picking-and-choosing rationale” and Borges provides no reasoning to combine the ingredients to arrive at the claimed invention (Remarks, pg. 21).
Applicant’s argument is not found persuasive. The Applicant is reminded that the teachings of KSR are actually an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385, 1395-96 (U.S.2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious”; “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions” exemplified by the holdings of cases such as Merck v. Biocraft.
The Applicant argues that there are thousands of possible combinations of agents and no motivation to combine the ingredients (Remarks, pg. 21).
Applicant’s argument is not found persuasive. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
The Applicant argues that Borge’s disclosure focuses on pramipexole-containing oral formulations and provides no working examples comprising apomorphine and sildenafil (Remarks, pgs. 21-22).
Applicant’s argument is not found persuasive. The Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123).
The Applicant argues that Borges only mentions grapefruit extract once as one of hundreds of agents or supplements and a skilled artisan would not have been led to select and combine with apomorphine and sildenafil (Remarks, pg. 22).
Applicant’s argument is not found persuasive and has been addressed above.
The Applicant argues that there is no motivation to combine sildenafil, apomorphine, and grapefruit extract in the amounts recited (Remarks, pgs. 22-23).
Applicant’s argument is not found persuasive. In regards to the amounts of components in claims 105-107 and 114-116, Borges teaches that the amount of active agent or nutraceutical agent may be 0.001-60% (para. 32). That being said and in lieu of objective evidence of unexpected results, the amounts can be viewed as a variable that achieves the recognized result of successfully making the oral pharmaceutical composition. The optimum or workable range of amounts 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). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of active agents as nonobvious.
The Applicant argues that there is no reason why a skilled artisan would optimize the weight percent of the active agent and nutraceutical agent (Remarks, pg. 23).
Applicant’s argument is not found persuasive. The amounts of agents can be viewed as variables that achieves the recognized result of successfully making the dosage form composition. Since Borges teaches that the active agent or nutraceutical agent may be 0.001-60% (para. 32), the determination of concentrations for ingredients in a product is well-known in the art and a person of ordinary skill in the art would have been compelled, with a reasonable expectation of success, to optimize in order to achieve the desired dosage which would, for example, provide the most desirable pharmacokinetic profile, and, as such, would have arrived at the claimed invention.
The Applicant argues an alleged unexpected result of superior bitterness reducing ability when grapefruit extract is used and cites Examples 4i to 4p (Remarks, pg. 24).
Applicant’s argument is not found persuasive. The results in Examples 4i to 4p use different ingredients as well as different amounts of ingredients. The examples also use different combinations of taste masking agents, which makes it difficult to determine that the grapefruit extract alone provided a superior benefit over the other taste masking agents. Since the ingredients, the amounts, and the combination of ingredients are not inconsistent, it is unclear that the results are surprising or unexpected.
The Applicant argues commercial success of their product, Ready (Remarks, pgs. 25-26).
Applicant’s argument is not found persuasive. Since incorporating taste masking agents is well-known in the art to provide a more palatable taste for bitter pharmaceutical products, the addition of grapefruit extract in order to improve the taste and patient satisfaction is not surprising or new. The Applicant bears the burden of proof, providing hard evidence of sales and attributing that success directly to the novel aspects of the invention, rather than factors like advertising or brand recognition, to establish its patentability.
The Applicant argues that claims 124 and 125 are not obvious since the cited references allegedly do not teach all the elements of the claims (Remarks, pgs. 26-27).
Applicant’s argument is not found persuasive. Borges teaches using PEG in their composition but does not specifically teach using PEG 1450 in claims 124 and 125. One of ordinary skill in the art would have been motivated to use the teaching from drugs.com of using PEG 1450 as a common inactive pharmaceutical ingredient to address this deficiency. A person of ordinary skill in the art would have led to use PEG 1450 in Borges’ teaching since Borges PEG as a plasticizer or surfactant (para. 18 and 27) and drugs.com teaches that PEG 1450 is a pharmacologically inactive substance and common excipient.
Conclusion
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.
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/D.A.K./Examiner, Art Unit 1613
/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613