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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/27/2026 has been entered.
Status of Claims
Amendment filed on 02/27/2026 is acknowledged.
Claim 1 is amended. Claims 6 and 17 remain cancelled. Claims 19-22 are new.
Claims 1-5, 7-16, and 18-22 are pending and being examined on the merits herein.
Priority
The instant application, filed on 02/03/2023, is a 371 of PCT/EP2021/070578, filed on 07/22/2021, which claims foreign priority to European Patent Office 20189832.7, filed on 08/06/2020.
Previous Withdrawn Rejections
The nonstatutory double patenting rejections are withdrawn on 08/29/2025 over Patent No. 11752114 and Application No. 17603885 because applicant’s terminal disclaimer submitted and approved on 08/01/2025 has overcome the rejections, and the application 17603885 has been abandoned.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “… one pressure sensitive adhesive and ketamine” in line 4. It is suggested to add a comma behind ketamine, as such: “… one pressure sensitive adhesive, and ketamine or a pharmaceutically …” .
Recitation in claim 1 “… a silicone pressure sensitive adhesive and wherein the matrix …” in lines 6-7 is recommended to add semicolon “;” in front of “and wherein”, meanwhile move the second “wherein …” down to next line and align with other “wherein …” phrases in the claim. The correct format would appear as:
“wherein the at least one pressure sensitive adhesive comprises a silicone pressure sensitive adhesive; and
wherein the matrix layer comprises at least one penetration enhancer which comprises methyl laurate; and
wherein the transdermal therapeutic system …”.
In claim 1, please also add word “and” behind the semicolon of line 3, to keep the consistent format within the claim.
Appropriate correction is required.
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, 7-11, 13-16, and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (WO 2017/003935, 01/05/2017, IDS of 02/03/2023), in view of Kohane et al. (WO2018053140, 03/22/2018, PTO-892) and Patron et al. (US20170087199, 03/30/2017).
Tang throughout the reference teaches a transdermal drug delivery device comprising ketamine for the treatment of major depressive disorder and /or pain (e.g., Abstract).
For Claims 1 and 11, Figure 1 of Tang, as shown below, discloses a delivery device comprising a backing film (1) affixed atop the adhesive drug matrix (2) which is supported by a release liner (3). The adhesive drug matrix layer contains the drug (e.g., ketamine, Abstract) and the adhesive, as well as penetration enhancers, plasticizers, antioxidants (corresponding to instant claim 11), pH modifiers, and other ingredients that aid in drug release and permeation through skin, and in maintaining drug stability (Pg. 15). Tang specifies that the adhesive-drug layer may be a pressure sensitive adhesive, and useful ingredients include silicone polymers, and acrylate copolymers such as Duro-Tak 87-2516, 87-2852 and 87-2194 (Pg. 12, bottom paragraph).
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Tang teaches the backing layer to be made of polymeric films such as polyester (PET), as elected, selected from a finite number of options. That supports the adhesive drug matrix and protect the transdermal delivery device from the environment (Pg. 12, 3rd paragraph). While Tang does not directly teach the backing layer to not be permeable to the active ingredients, this is an inherent property in the species of backing layer elected and demonstrated by the instant specification.
Tang teaches that skin permeation enhancers include but not limited to, sulphoxides (e.g. dimethylsulphoxide, DMSO), Azones (e.g. laurocapram), pyrrolidones (e.g. 2-pyrrolidone, 2P), alcohols and alkanols (ethanol, or decanol), glycols (e.g. propylene glycol (PG)), surfactants and terpenes (e.g., Pg. 13, bottom). Tang emphasizes that persons skilled in the art understands that other known skin permeation enhancers can be readily employed with the transdermal delivery devices of the invention (e.g., Pg. 21, last 2nd paragraph).
Tang exemplifies in Examples 1-5 with variations of ingredients including Examples 1-2 without adding crystallization inhibitors (Pg. 21, Table 6), and states that all examples provide good skin permeability (Pg. 22, bottom), especially, 24 h cumulative permeation (mg/cm2) of ketamine in transdermal delivery device of Example 2, which does not contain crystallization inhibitor, exhibits the best level at 3.72 (Pg. 23 top, Table 7) among all examples with transdermal bioavailability of example 2 within 24 hours reaching at about 78% (Pg. 17 top, Table 5), suggesting that effective ketamine permeation and accumulation of the ketamine transdermal delivery device does not have to comprise crystallization inhibitor.
For Claims 2-3 and 16, Tang indicates that the transdermal delivery system directs to the racemic mixture of ketamine, while it is generally believed that the anesthetic and/or antidepressant effect of ketamine is mainly through the action of S-ketamine because in vitro S-ketamine has about a 4-fold greater affinity than the R-ketamine on NMDA receptor binding. Tang points out that embodiments containing the R-ketamine or the S-ketamine enantiomers are also with the scope of the invention. Therefore, it would have been obvious to formulate the transdermal system to comprise S-ketamine and in the form of ketamine free base (Pg. 2, 3rd paragraph).
For Claim 4, Tang teaches the adhesive can be a pressure sensitive adhesive, including but not limited to, PIB, silicone polymers such as polydimethylsiloxane with high molecular weight containing residual silanol functionality on the ends of the polymer chains and BIO-PSA (Dow Corning Corporation), and acrylate copolymers (e.g., Pg. 12 bottom – Pg. 13 top). Tang emphasizes that persons skilled in the art understands that other known pressure sensitive adhesives can be readily employed with the transdermal delivery devices (e.g., Pg. 21, middle).
For claims 5, 8 and 10, Tang teaches the transdermal delivery device comprising about 1-35 wt. % of ketamine, about 30-90 wt. % of pressure sensitive adhesive, about 1-10 wt. % of skin permeation enhancer (Pg. 28, Claim 3), overlapping with the pressure sensitive adhesive amount of 70-95 wt. % in instant claim 5, the at least one penetration enhancer amount of 1-15 wt. % in instant claim 8, the ketamine amount of 1-25 wt.% in instant claim 10.
For claims 7 and 9, Tang exemplifies the formulation in Examples 1-5 showing ingredients and relative weight amounts in the formulation, e.g., skin permeation enhancers oleyl oleate, oleyl alcohol, levulinic acid, diethylene glycol, can be 5 wt.% (Pg. 21, Table 6) (corresponding to instant claim 7). In examples 1-4 formulations, the matrix layer with DuroTak 387-2052 or DuroTak 87-2677 (Henkel Adhesives, known as polyisobutylene and styrenic rubber adhesives) is free of (meth)acrylate (Pg. 21, Table 6) (Corresponding to instant claim 9).
For Claims 11 and 18, Tang teaches antioxidants are employed to prevent drug degradation by oxidation (corresponding to antioxidant in instant claim 11), including but not limited to, butylated hydroxyanisole (BHA), butylhydroxy toluene (BHT), tert-Butylhydroquinone, ascorbic acid, and tocopherols (Pg. 14, 3rd paragraph) (corresponding to instant claim 18).
For Claim 13, Tang teaches the transdermal delivery system contains a release liner that protects the transdermal delivery device during storage and is removed before its use (Pg. 13, paragraph 2), in other words, a detachable protective layer on that side of the matrix layer on which the backing layer is not arranged (corresponding to instant claim 13) as shown in Fig. 1 above.
For Claims 14-15, Tang teaches a method of treating major depressive disorders and for treating pain comprising administration of the transdermal delivery device comprising ketamine (e.g., Claims 6-7, 21, and 23).
For Claim 20, Tang teaches skin permeation enhancers are employed to enhance the skin
permeability of the drug through the skin, including but not limited to, sulphoxides (e.g. dimethyl-sulphoxide, DMSO), Azones (e.g. laurocapram), pyrrolidones (e.g. 2-pyrrolidone, 2P), alcohols and alkanols (ethanol, or decanol), glycols (e.g. propylene glycol (PG)), surfactants and terpenes (e.g., Pg. 13, bottom), therefore, the transdermal therapeutic system does not have to comprise levulinic acid as skin permeation enhancer.
For Claim 21, Tang teaches that gel forming agents (corresponding to gelling agents) such as hydroxypropyl methylcellulose (corresponding to hydroxypropyl cellulose), PVP, and/or other cellulose polymers (e.g., Pg. 18, top), and many others (e.g., Pg. 19, top) can be included in the transdermal therapeutic system.
For Claim 22, Tang teaches that gel forming agents (also can be abuse deterrent agents, e.g., Pg. 18 top) are employed to form a gel structure upon mixing with a solvent, e.g., alcohol, absorb the solvent and swell, thereby forming a viscous or semi-viscous substance that significantly reduces and/or minimizes the amount of free solvent which can contain an amount of solubilized drug (e.g., Pg. 18, bottom). Tang exemplifies 70% isopropyl alcohol (same as isopropanol) as effective solvent in a simulation of denatonium benzoate as an abuse deterrent agent in example 6 (Pg. 23 bottom -Pg. 24, top).
Tang does not teach one penetration enhancer comprises or consists of methyl laurate as recited in instant claims 1 and 19 respectively and the silicone pressure sensitive adhesive comprises a dimethiconol/ trimethylsiloxysilicate crosspolymer and /or a trimethylsilyl treated dimethiconol/ trimethylsiloxysilicate crosspolymer as recited in instant claim 4.
Kohane throughout the reference teaches compositions and methods for delivery of therapeutic agents across a barrier, and the compositions include a therapeutic agent (e.g., antimicrobial agent, antibiotic, or anesthetic agent), a permeation enhancer which increases the flux of the therapeutic agent across the barrier, and a matrix forming agent (e.g., Abstract; Pg. 129, Claim 1; [0014-0016].
Kohane indicates that ketamine is a sedation anesthetic agent (e.g., [00263]; [00296]), which belongs to the type of agents proper for the transdermal drug delivery as Kohane teaches (e.g., Abstract; [00177]). Kohane specifies that the therapeutic drug delivery device is designed specifically for crossing the dermal barrier, the thinnest layer of skin tympanic membrane in the ear (e.g. [0005]). Transdermal drug delivery system uses chemical permeation enhancers to safely increase small molecule flux (e.g., [0010]). Kohane indicates that the composition can comprise between about 1% and 30% of the permeation enhancer (consisting of one permeation enhancer) or combination of permeation enhancers (e.g., Pg. 129-130, Claims 1 and 2). Kohane teaches that the permeation enhancer can be methyl laurate, myristic acid, palmitic acid, stearic acid, oleic acid, linoleic acid, linolenic acid, cholic acid, and many others (e.g., Pg, 133, Claims 24 and 27; [0027]; [0029]; [0087]). Therefore, Kohane teaches that permeation enhancer can comprise methyl laurate for transdermal therapeutic delivery (corresponding to instant claim 1), and the permeation enhancer can consist of one compound which can be methyl laurate (corresponding to instant claim 19).
Patron discloses compositions comprising cooling agents with excipients that can be incorporated into a patch or film or an adhesive for transdermal drug delivery and the transdermal patch can be constructed in multiple layers (Abstract; [0121]).
Patron specifies that exemplary transdermal carriers include lauric acid and many others [0121], and lauric acid is used as skin penetration enhancer [0084], while methyl laurate and dimethiconol/ trimethylsiloxysilicate both can be included as suitable excipients for the composition among a huge list of compounds [0024]. Patron also teaches antioxidant compounds alpha-tocopherol and ascorbyl palmitate as suitable excipients [0024]. MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty."). For this instance, methyl laurate as skin permeation enhancer is the property of the compound, since prior art teaches using the compound in transdermal delivery device, the property much necessarily present in prior art. Similar as dimethiconol/ trimethyl-siloxysilicate, since prior art teaches the compound, the property of such polymer as pressure-sensitive silicone adhesive must necessarily present in prior art.
It would have been prima facie obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to implement transdermal ketamine drug delivery system disclosed in Tang and take the opportunity to select proper permeation enhancer and excipients taught by Kohane and Patron to arrive at current invention. Patron points out that it is sometimes advantageous to include an agent causing a cooling sensation in the delivery of a pharmaceutical compound, and the excipients suitable for incorporating with the cooling agents include methyl laurate and dimethiconol/ trimethylsiloxysilicate among a huge list of compounds [0024], implying that these excipients would not disrupt the cooling effects or be better even add tranquillizing influence, meanwhile Kohane teaches that skin permeation enhancer such as methyl laurate can be used safely in the thinnest delicate layer of skin to trans-tympanic membrane for treating middle ear infections, an artisan in the field would have the motivation to take advantage of the benefit and safety from such ingredients and incorporate into the transdermal drug delivery device in Tang.
Especially, Tang teaches that silicone polymers and penetration enhancers are proper for the transdermal ketamine delivery system treating depression and/or pain, as Tang states that silicone polymer polydimethylsiloxane is suitable for the device, and emphasizes that persons skilled in the art understands that other known pressure sensitive adhesives or permeation enhancers can be readily employed with the transdermal delivery devices, an artisan swapping polydimethylsiloxane with dimethiconol/ trimethylsiloxysilicate from Patron would not only suit the transdermal delivery system design, but also constitute the advantageous property Patron suggests. Simple substitution of one known element for another to obtain predictable results renders obviousness. See The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Artisans in the field would have reasonable expectations of success because selecting these components would yield predictable favorable results and meet intended use of the transdermal drug delivery composition. Furthermore, 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. 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).
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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the amounts taught in prior art overlap with the pressure sensitive adhesive amount, the penetration enhancer amount, and the ketamine amount. Furthermore, “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition (MPEP §2144.05 (II)). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Tang et al. (WO 2017/003935, 01/05/2017, IDS of 02/03/2023) in view of Kohane et al. (WO2018053140, 03/22/2018, PTO-892) and Patron et al. (US20170087199, 05/30/2017) as applied to claims 1-5, 7-11, 13-16, and 18-22 above, and further in view of Marchant et al. (WO2019079291, 04/25/2019, in record of 05/02/2025).
Tang, Kohane and Patron combined teaching teaches a transdermal therapeutic ketamine (e.g., S-ketamine, R-ketamine, and racemic mixture) delivery system for treating depression and/or pain, comprising backing layer, a detachable protective release layer, at least one matrix layer, wherein the matrix layer contains at least one pressure sensitive adhesive which can be silicone pressure sensitive adhesive, and the matrix layer can comprise at least one penetration enhancer (e.g., levulinic acid, oleyl alcohol, methyl laurate), wherein the matrix layer may contain at least one antioxidant, and the transdermal therapeutic system may or may not comprise crystallization inhibitor, as discussed in detail above.
Tang teaches transdermal delivery device size with corresponding dosage strength (e.g., Pg. 8, Table 1), and teaches the preparation of matrix layer (Step 2) onto the abuse deterrent layer (Step 1) which is 3 mils thick, and the laminated sheet can be die-cut into transdermal delivery devices in various sizes to obtain desired dosages of the drug (e.g., Pg. 24 bottom -Pg. 25 bottom). Tang indicates that the transdermal delivery device, e.g., transdermal and dermal patches, provides flexibility in dose, dosage release rate, patch size, and duration of application to allow for optimization (e.g., Pg. 5, middle).
Tang, Kohane and Patron combined teaching does not teach the matrix layer has an area weight of 30 to 400 g/m2 as recited in instant claim 12.
Marchant describes composition and device for delivery of active agents to skin surfaces (Title). Marchant describes a transdermal delivery device including at least one backing layer, an active layer (corresponding to matrix layer in instant invention), and a removable release liner (Abstract). It indicates in embodiments that the active layer may have weight of at 2 mg/cm2, or at least 5 mg/cm2, or at least 10 mg/cm2, or up to 50 mg/cm2, or up to 30 mg/cm2 (equivalent to at 20 g/m2, or at least 50 g/m2, or at least 100 g/m2, or up to 500 g/m2, or up to 300 g/m2) [0067, Fig. 1-2]. In another embodiment, the active layer may have a coating weight of at least 40 g/m2, or at least 80 g/m2, or at least 150 g/m2, or up to 650 g/m2, or up to 500 g/m2 [0068, Fig. 3]. The ranges overlap with that in instant claim 12.
It would have been prima facie obvious to implement the area weight of the drug-containing layer taught by Marchant into the transdermal ketamine delivery system obtained from Tang, Kohane and Patron to arrive at instant invention. Persons of ordinary skill in the art would modify and optimize the layer area weight through nothing more than “routine experimentation” because Tang points out the transdermal delivery device provides flexibility in dose, dosage release rate, patch size, and duration of application to allow for optimization and the flexible parameters can be adjusted by the formulator and/or the clinician to provide the optimal ketamine plasma concentration-time profile for the individual patient that maximizes efficacy and minimizes adverse side effects to achieve the ketamine transdermal delivery device of the present invention is particularly effective for the treatment of MDD and pain (Pg. 5, 3rd paragraph), and it is obvious that thickness, weight, and size of the patches/ transdermal matrix layer affect dosage and would have to be considered during preparation. Even though values may differ from prior art, a prima facie case of obviousness typically exists where the claimed ranges "overlap or lie inside ranges disclosed by the prior art". In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Response to Arguments
Applicant's remarks/arguments filed on 02/27/2026 have been fully considered. In light of claim amendment, new ground of rejections has been established as presented in this office action. Remarks/arguments relevant to the new ground of rejections are responded below.
Applicant asserts that Tang teaches away from the present claims because crystallization inhibitor in Tang’s solution to ketamine solubility, stability, and long-term performance plays a central role, and artisans would not have such a motivation to generate a transdermal therapeutic system as free of crystallization inhibitor as shown in amended claims.
In response to applicant's argument that the references fail to show certain features of the invention, when crystallization inhibitor is not comprised in the system as claimed, it is noted that the features upon which applicant relies (i.e., ketamine solubility, stability, and long-term performance) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
MPEP 2145.D.I states "[a] prior art reference that "teaches away" from the claimed invention is a significant factor to be considered in determining obviousness. However, "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994)"; Furthermore, "the prior art's mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed .... " In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 692, 2023 USPQ2d 448 (Fed. Cir. 2023)". Because solubility, stability, and long-term performance are not the features being claimed, Tang’s working examples, e.g., Examples 3-5, requiring crystallization inhibitors for long-term stability is not teaching away from instant claims. Especially, Tang also teaches the examples without crystallization inhibition, e.g., Example 2, provides excellent ketamine accumulation result after 24 hr among all the examples. This outstanding ketamine accumulation resulting from crystallization inhibitor-free compositions would have motivated artisans in the field to modify and optimize the composition in order to maintain such benefit.
Moreover, “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983), and "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), and "Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments." In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Tang also teaches ingredients in general in the transdermal therapeutic delivery device, and crystallization inhibitor is just one of the many optional ingredients that can be included in the transdermal device. There is no evidence in Tang to show that without crystallization inhibitor would always fail to have ketamine long-term stability, outside Tang’s exemplified embodiments. Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Moreover, as presented in office action above, prior art, Tang, Kohane and Patron teaches current invention, and stability of the transdermal therapeutic device as property of the taught composition, would necessarily present in prior art.
Applicant asserts that combination of references Tang and Patron involves impermissible hindsight reconstruction because of Patron’s undifferentiated list and lacking of motivation of such combination.
In light of applicant’s remark and claim amendment, Kohane has been added to address the issue. Further, 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).
The reasoning of the combination of reference is presented above in detail in the office action. The most relevant paragraph is copied below for reference:
It would have been prima facie obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to implement transdermal ketamine drug delivery system disclosed in Tang and take the opportunity to select proper permeation enhancer and excipients taught by Kohane and Patron to arrive at current invention. Patron points out that it is sometimes advantageous to include an agent causing a cooling sensation in the delivery of a pharmaceutical compound, and the excipients suitable for incorporating with the cooling agents include methyl laurate and dimethiconol/ trimethylsiloxysilicate among a huge list of compounds [0024], implying that these excipients would not disrupt the cooling effects or be better even add tranquillizing influence, meanwhile Kohane teaches that skin permeation enhancer such as methyl laurate can be used safely in the thinnest delicate layer of skin to trans-tympanic membrane for treating middle ear infections, an artisan in the field would have the motivation to take advantage of the benefit and safety from such ingredients and incorporate into the transdermal drug delivery device in Tang.
Especially, Tang teaches that silicone polymers and penetration enhancers are proper for the transdermal ketamine delivery system treating depression and/or pain, as Tang states that silicone polymer polydimethylsiloxane is suitable for the device, and emphasizes that persons skilled in the art understands that other known pressure sensitive adhesives or permeation enhancers can be readily employed with the transdermal delivery devices, an artisan swapping polydimethylsiloxane with dimethiconol/ trimethylsiloxysilicate from Patron would not only suit the transdermal delivery system design, but also constitute the advantageous property Patron suggests. Simple substitution of one known element for another to obtain predictable results renders obviousness. See The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Please refer to the entire office action as a complete response to the remarks/arguments.
Conclusion
No claim is allowed.
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/DX.Z./ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616
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