DETAILED ACTION
The receipt is acknowledged of applicant’s amendment, request for RCE and IDS, all filed 10/31/2025.
Claims 1, 5-6, 8-11, 13, 15-70 are currently pending.
Claims 13, 15-69 are withdrawn from further consideration without traverse in the reply filed on 05/16/2023.
Claims 1, 5, 6, 8-11 and 70 are subject of this office 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/31/2025 has been entered.
Co-pending Applications
Applicants must bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 6, 8-11 and 70 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Stinchcomb (2002/0111377), Klokkers et al. (US 2004/0086552), as evidenced by Goodman et al. (US 2001/0006671), Smith (US 2016/0022627), Doroudian et al. (US 2018/0360757), and optionally Vardi et al. (WO 2020/079686), all references are of record.
Applicant Claims
Claim 1 is directed to a transdermal pharmaceutical composition comprising
- about 1% to about 15% w/w of nabilone;
further wherein the pharmaceutical composition comprises:
- about 5% to about 15% w/w of at a solvent comprising propylene glycol,
- about 2% to about 15% w/w of a permeation enhancer comprising oleic acid;
- about 50% to about 80% of a silicone pressure sensitive adhesive;
- about 5% to about 15% w/wat least one suspending agent comprising silicone dioxide;
and
- about 0.5% to about 0.7% w/w of an antioxidant comprising butylated hydroxytoluene,
wherein the pharmaceutical composition provides a continuous flux of active agent over seven days.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Stinchcomb teaches transdermal drug delivery of cannabinoids including nabilone from a transdermal matrix patch to increase the drug concentration in a subject suffering from chronic pain to relief such pain. The polymer matrix delivers nabilone in uniform sustained manner over a period of at least 4 days. The matrix comprises nabilone, or synthetic forms thereof, and acrylate or silicone adhesive (abstract; ¶¶ 0003, 0006, 0008, 0019, 0020, 0032, 0041, 0042, 0044).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While Stinchcomb teaches transdermal adhesive matrix to deliver nabilone for at least 4 days, the reference does not teach penetration enhancer, propylene glycol solvent, antioxidant, and silicone dioxide suspending agent as claimed by claim 1.
Klokkers teaches self-adhesive matrix for transdermal drug delivery including nabilone. The matrix comprising adhesive polymer, active agent, 0.1-10% silicone dioxide, propylene glycol, 3% oleic acid. The adhesive is polysiloxane. Silicon dioxide increases the penetration of active agents through the skin. (See the entire document, and in particular: abstract; ¶¶ 0043, 0057, 0060-0061, 0069, 0082, 0098, 00141). Silicon dioxide is a suspending agent as evidenced by Goodman ¶¶ [0006, 0022, 0066-0070].
Smith teaches transdermal patch comprising adhesive polymer matrix for systemic delivery of cannabinoids to treat chronic pain. The patch comprises 5-13% of cannabinoids (abstract; ¶¶ 0020-0024, 0029-0055, 0103, 0105). The polymer matrix comprises 2-20% of carrier agent comprising permeation enhancers, e.g. oleic acid, solvents, e.g. propylene glycol and 20-99% surfactant (¶¶ 0057-0059, 0095, 0112, 0123). The polymer matrix comprises polysiloxane adhesive (¶¶ 0029 0027).
Doroudian teaches transdermal composition for delivery of cannabinoid comprising antioxidants including 0.1-0.5% BHT as antioxidant to stabilize cannabinoid (¶¶ 0035-0044, 0101, 0141, Table 1).
Vardi teaches that there is a need to deliver cannabinoids and synthetic forms thereof, e.g. CBD and THC, transdermally over extended period of time, e.g. weeks or months, to achieve consistent therapeutically effective levels of cannabinoid in the blood stream. The reference teaches transdermal pharmaceutical formulation comprising the cannabinoids, up to 5% silica gel or fumed silica, and BHT as an antioxidant to enhance the antioxidant properties and stability of cannabinoids (abstract; ¶¶ 0005, 0017, 0029-0030, 0044, table 1).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide transdermal adhesive matrix comprising nabilone to relief pain as taught by Stinchcomb, and use the transdermal adhesive matrix taught by Klokkers comprising polysiloxane adhesive polymer, silicone dioxide, propylene glycol, and oleic acid. One would have been motivated to do so because Klokkers, evidenced by Goodman, teaches such polymer matrix increases the penetration of nabilone through the skin. One would reasonably expect formulating transdermal polymer matrix to deliver nabilone comprising polysiloxane adhesive, oleic acid, propylene glycol and silicone dioxide that has increased permeation through the skin.
Further, one having ordinary skill in the art would have used the adhesive matrix taught by Smith comprising oleic acid and propylene glycol because Smith teaches such elements are suitable for transdermal polymeric matrix to deliver cannabinoids to the skin to treat chronic pain.
Furthermore, one having ordinary skill in the art would have included 0.1-0.5% BHT taught by Doroudian in the transdermal formulation taught by the combination of the above references because Doroudian teaches BHT is antioxidant that stabilizes cannabinoid in transdermal formulations.
Further, optionally, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide transdermal composition comprising cannabinoid, propylene glycol, oleic acid, silicone dioxide and BHT to treat pain as taught by the combination of Stinchcomb, Klokkers evidenced by Goodman, Smith and Doroudian, and formulate the transdermal composition to deliver cannabinoid for more than 4 days as taught by Stinchcomb, and further for weeks and months as taught by Vardi. One would have been motivated to do so because Stinchcomb teaches transdermal composition that deliver cannabinoids for more than 4 days increases cannabinoids concentration in a subject suffering from chronic pain to relief such pain in uniform sustained manner, and because Vardi teaches there is a need to deliver cannabinoids transdermally over extended period of time, e.g. weeks or months, to achieve consistent therapeutically effective levels of cannabinoid in the blood stream. One would reasonably expect formulating transdermal composition to deliver cannabinoid to treat pain for extended period of time, more than 4 days, or more e.g. weeks or months, in a uniform sustained manner to achieve consistent therapeutically effective levels of cannabinoid in the blood stream.
Regarding nabilone claimed by claim 1, Stinchcomb and Klokkers teach nabilone.
Regarding the claimed amounts of nabilone of 1-15%, and the amount of propylene glycol of 5-15% and amount of oleic acid of 5-15%, Smith teaches 5-13% of cannabinoids, and 2-20% of both solvent and permeation enhancer that fall within the claimed amount. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding 5-15% silicone dioxide as claimed by claim 1, Klokkers teaches 0.1-10% and Vardi teaches up to 5% that overlaps with the claimed amount. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the concentration of BHT of about 0.5% to about 0.7% as claimed by claim 1, Doroudian teaches 0.1-0.5% that overlaps with the claimed amount. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the continuous flux over 7 days as claimed by claim 1 and continuous rate of delivery as claimed by claim 70, combination of the cited references teaches the instantly claimed transdermal formulation comprising the claimed ingredients in the claimed amount, therefore, the transdermal formulation of the prior art is expected to provide the claimed continuous flux and delivery rate for up to seven days since materials and their properties are inseparable, absent evidence to the contrary.
Regarding transdermal formulations including transdermal patch as claimed by claims 5, 9 and 10, Smith and Stinchcomb teach the claimed formulations and transdermal matrix patch.
Regarding the carriers claimed by claim 6 and their amount as claimed by claim 8, Smith teaches 20-99% surfactant that overlap with the claimed amounts. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding using the transdermal composition for treating chronic pain as claimed by claim 11, this is taught by both Smith and Stinchcomb.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
Rejection under 35 USC§ 103
Applicants argue that the claims as amended are directed to a transdermal pharmaceutical composition with nabilone as the active agent. None of the cited references teaches or suggests the presently claimed transdermal composition formulated specifically for nabilone with the recited excipients in the recited amounts, nor do they demonstrate that a person of ordinary skill would have had a reasonable expectation of success in achieving the claimed continuous seven-day delivery of nabilone.
In response to this argument, it is argued that both Stinchcomb and Klokkers clearly teach nabilone as active agents. Combination of the cited references teaches the recited excipients in the claimed amounts. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that motivation to combine the references exists, and reasonable expectation to achieve the present invention is presented as set forth in this office action. It is well established that the claims are given the broadest interpretation during examination. A conclusion of obviousness under 35 U.S.C. 103 (a) does not require absolute predictability, only a reasonable expectation of success; and references are evaluated by what they suggest to one versed in the art, rather than by their specific disclosure. In re Bozek, 163 USPQ 545 (CCPA 1969). It has been held by the court that it is obvious to combine prior art elements according to known methods to yield predictable results. A finding that the prior art included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, was held obvious by the court.
Applicants argue that Smith, Vardi, and Doroudian are teaching formulation for CBD and/or THC, not for nabilone. Although Klokkers and Stinchcomb mention nabilone in a general list of possible actives, they do not teach the presently claimed specific excipient set and ranges in a formulation containing only nabilone, nor do they show that the formulations optimized or taught for CBD/THC would operate in the same manner after replacement with nabilone. The rejection assumes that the excipient systems taught for CBD/THC would provide motivation to one of ordinary skill in the art to directly translate the formulation to nabilone to produce the same delivery profile; however, no cited reference demonstrates that substitution, nor that such substitution would predictably produce the claimed seven-day continuous flux.
In response to this argument, applicant’s attention is directed to the scope of the present claims that are directed to composition, and all the elements of the claimed composition are taught by combination of the cited references. As applicants themselves noted that Stinchcomb and Klokkers both teach nabilone. Klokkers teaches self-adhesive matrix for transdermal drug delivery including nabilone. The matrix comprising adhesive polymer, 0.1-10% silicone dioxide, propylene glycol, 3% oleic acid. The adhesive is polysiloxane. Silicon dioxide increases the penetration of active agents through the skin. If any of the cited references was to teach the claimed transdermal composition comprising nabilone and the claimed excipients in the claimed amounts, such a reference would have been an anticipatory references. The current rejection is based on combination of the references and what such references would have suggested to one having ordinary skill in the art. The cited references teaches nabilone as art equivalent to the CBD and THC, and the cited references teach all of nabilone, CBD and THC are suitable for delivery from transdermal polymer matrix comprising the claimed excipients in the claimed amounts. None of the cited references teaches against using nabilone for transdermal formulations used for CBD and THC, and no teaching that formulations optimized or taught for CBD/THC would not operate in the same manner after replacement with nabilone, especially in light of the teachings of both Stinchcomb and Klokkers. There is motivation to one of ordinary skill in the art to directly translate the formulation of the prior art that teaches other cannabinoids to nabilone to produce the same formulation and expected to provide the same profile. The substitution can be find in the cited references or in the knowledge of one skilled in the art. Conclusion of obviousness does not require absolute predictability, only reasonable expectation of success, as presented in this office action. Regarding the claimed seven-day continuous flux, it is an expected property from the combination of the cited references, absent evidence to the contrary.
Applicants disagree with the position taken by the examiner that "the transdermal formulation of the prior art is expected to provide the claimed continuous flux and delivery rate for up to seven days since materials and their properties are inseparable, absent evidence to the contrary", and argue inherency cannot be established merely by asserting that similar excipients are used elsewhere. None of the cited references discloses a nabilone formulation demonstrating delivery for at least seven days, and none teaches that the recited excipient combination and level ranges, when applied specifically to nabilone, necessarily or inevitably produce the claimed delivery duration.
In response to this argument, it is argued that the cited references suggested delivering nabilone from transdermal formulation comprising adhesive matrix of polysiloxane, oleic acid, propylene glycol and silicone dioxide, as claimed, in the claimed amounts. Any claimed agents are drawn from the teachings of the cited references based on their suitability for delivering cannabinoids. Since the references suggest all the components of the instant claims, the properties, delivery rate or period, of the instant composition would be an intrinsic property. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). If the prior art meets the structure recited, the properties must be met or Applicant's claim is incomplete. The discovery of a new action underlying a known process does not make it patentable. MEHL/Biophile, 192 F.3d at 1365, 52 U.S.P.Q.2d at 1303. Also, it is irrelevant that the prior art observers did not recognize the property or function of the disputed claim; if the prior art inherently possessed that characteristic, it anticipates. See Verdeegal Brothers, lnc. v. Union Oil Co. of Cal., 814 F.2d 628, 633, 2 U.S.P.Q.2d 1051, 1054 (Fed. Cir. 1987). This is believed to be applicable here because anticipation is the epitome of obviousness.
Applicants argue, while the Office Action cites invokes range overlap for certain components, that doctrine applies only when the same composition and context is disclosed. Here, the art cited for overlapping ranges pertains to different active agents and different formulation objectives. Absent a teaching that those same ranges are suitable for a nabilone formulation to achieve the same functional outcome, prima facie obviousness based solely on numerical overlap is not established.
In response to this argument, it is pointed out to the teachings of Smith regarding the amount of cannabinoids of 5-13% in general that can be applied to any species of cannabinoid. In any event, those of ordinary skill in the art would have been readily optimized effective dosages and concurrent administration regimens as determined by good medical practice and the clinical condition of the individual patient. Determination of the appropriate dosage for treatment involving pain relief using cannabinoids would have been routinely made by those of ordinary skill in the art and is within the ability of tasks routinely performed by them without undue experimentation, especially in light of the dosage information disclosed prior art. One would have been motivated to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities), and pertinent to the problem which applicant concerns about. MPEP 2141.01(a). “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the claimed ranges.
One of skill in the art is free to select components available in the prior art, In re Winslow, 151 USPQ 48 (CCPA, 1966). The examiner recognizes that references cannot be arbitrarily combined that there must be some reason why one skilled in the art would be motivated to make the proposed combination of primary and secondary references, In re Nomiya, 184 USPQ 607 (CCPA 1975). However, there is no requirement that a motivation to make the modification be expressly articulated. It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason.
Combination of the cited references teaches transdermal composition comprising all the claimed ingredients: nabilone, propylene glycol, oleic acid, silicone adhesive, silicone dioxide and BHT, and all the ingredients in amounts either embracing or overlapping with the claimed amounts. Therefore, the resulting flux of the transdermal composition taught by combination of the cited reference would be expected, absent evidence to the contrary. According to MPEP 2112.02, products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches a substantially identical transdermal preparation, and the flux or any property applicant achieve and/or claims are expected. Furthermore, since the examiner does not possess access to laboratory equipment, burden shifts to applicant to show unexpected results by declaration or otherwise as In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). When the prior art discloses all the limitations of a claim except a property or function and the examiner cannot determine whether or not the reference possesses properties which anticipate or render obvious the claimed invention, the examiner can shift the burden of proof to applicant.
Further, In Alza Corp. v. Mylan Laboratories, Inc., 464 F.3d 1286, 80 USPQ2d 1001 (Fed. Cir. 2006), the court found that because the absorption properties of oxybutynin would have been reasonably predictable at the time of the invention, there would have been a reasonable expectation of successful development of a sustained-release formulation of oxybutynin as claimed. The prior art, as evidenced by the specification, had recognized the obstacles to be overcome in development of sustained-release formulations of highly water-soluble drugs, and had suggested a finite number of ways to overcome these obstacles. The claims were obvious because it would have been obvious to try the known methods for formulating sustained-release compositions, with a reasonable expectation of success. The court was not swayed by arguments of a lack of absolute predictability. The examiner believes the present claims are reasonably expected from the cited prior art. Further, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).
The cited references show that it was well known in the art before the filing date of the present invention to use the claimed ingredients in compositions for transdermal delivery of active agents including cannabinoids. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. ln re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA
1972); ln re Susi, 58 CCPA 1074, 1079-80) 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960). Based on the disclosure by these references that these substances are used in transdermal compositions to increase drug delivery through the skin, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating transdermal compositions.
Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See ln re Sussman, 1943 C.D. 518; In re Huellmantel 139 USPQ 496; ln re Crockett 126 USPQ 186.
Further, “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). See MPEP 2144.05. There is no evidence of record as to the criticality of the claimed ranges. It is well settled that “the discovery of an optimum value of a variable in a known process is usually obvious.” Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1368 (Fed. Cir. 2007). The rationale for determining the optimal parameters for prior art result effective variables “flows from the ‘normal desire of scientists or artisans to improve upon what is already generally known.’” (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)). One having ordinary skill in the art would have determined the optimal value of oleic acid from those taught by the cited references to achieve the best permeation of cannabinoid into the skin.
The obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (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.").
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./