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 .
Status of the Claims
Claims 1, 3-11, and 13-18 are pending.
Claims 9 & 10 are withdrawn from consideration as directed to non-elected inventions.
Claims 1, 3-8, 11, and 13-18 are presented for examination and rejected as set forth below.
Claim Interpretation
Applicants claims are directed to a plaster, which the examiner interprets as representing a transdermal patch, composition combining defined concentrations of brucine with a “framework material,” a combination of humectant and cosolvent, a combination of a crosslinking agent and a crosslinking regulator, and water, which possesses a backing layer and an anti-adhesive layer. Claims 3 and 13 narrow the identity of the humectant to, among others, sorbitol, propylene glycol, and glycerin, and the cosolvent to, among others, DMSO and polysorbate 80. Claims 4 and 14 narrow the identity of the crosslinking agent and crosslinking regulator to, among others, aluminum glycinate and tartaric or citric acid, respectively. Claim 5 narrows the identity of the backing layer to include non-woven fabrics and the antiadhesive layer to polypropylene or polyethylene films. Claim 6 adds any of a particular antioxidant to the composition, with Claims 7 and 15 adding a preservative such as ethyl or methylparaben. Claims 8, 16, and 17 adds a filler to the composition, including kaolin. Claim 11 narrows the concentration of each of the brucine, “framework material,” combination of humectant and cosolvent, combination of a crosslinking agent and a crosslinking regulator, and water, which possesses a backing layer and an anti-adhesive layer. Claim 18 specifies a patch containing specific components.
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, 3-8, 11, and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Nardi (U.S. PGPub. 2019/0388360), in view of Gao (CN101590028)(machine translation provided), and Wu (Ping Wu, et al, A Novel Brucine Gel Transdermal Delivery System Designed for Anti-Inflammatory and Analgesic Activities, 18 Int. J Mol. Sci. 757 (2017)).
Nardi describes pharmaceutical patches used for the systemic and non-systemic administration of pharmacologically active agents to achieve, for example, pain relief. [0002-04]. Nardi indicates that the skilled artisan in the area of transdermal drug delivery appreciates a variety of elements are commonly incorporated into transdermal drug delivery patches, which ordinarily contain each of a drug containing layer sandwiched between each of a backing layer and a release liner. [0026-31]. Nardi indicates that the active agent, in the case of the particular Nardi composition a combination of lidocaine as analgesic and diclofenac as combination analgesic/antiinflammatory, is provided in the form of a hydrogel adhesive layer. [0032; 0042; 0051; 0063; 0076-78]. Each of the active agents identified in the compositions of Nardi are described as being present in concentrations of at least 0.1% by weight, a range overlapping and therefore rendering obvious the range of active agent recited by the claims. [0056; 0067], See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Nardi indicates that polyacrylic acids and polyacrylates, as well as the sodium polyacrylate and HPMC of newly added Claim 18, are known to serve as hydrogel carriers in these transdermal patches. [0009; 0083-84]. While not identifying the “partially neutralized product of polyacrylic acid” newly added to Claim 1, applicants attention is directed to Gao, which indicates that the partially neutralized products of polyacrylic acid newly added to the claims have long been known to be useful as framework materials for transdermal drug delivery patches, including each of the NP -600 and NP-700 polymers applicants specification exemplifies as suitable embodiments of such polymers. Gao Pg.3, “Preferred Embodiment” paragraph 3. Water, glycerol, propylene glycol, sorbitol, and urea of the present claims are identified as additional constituents of the hydrogel. [0085]. Nardi indicates that permeation enhancers including each of the presently claimed propylene glycol, glycerol, DMSO, polysorbates such as polysorbate 80, and citric acid may be present in concentrations of, for example, between 1-20% of the composition, a range overlapping and therefore rendering obvious that of the instant claims. [0092-0100]. Antioxidants, chelating agents such as the sodium edetate of Claim 6, and preservatives including methyl and ethyl parabens are includable in the compositions, with the chelating agents includable in concentrations of about 0.001-10% by weight, and preservatives advantageously present in concentrations of between 0.001-1% by weight, a range overlapping and therefore rendering obvious that of the instant claims. [0106-11]. Nardi indicates that non-woven materials represent a particular form of the surface layer, and polyethylene or polypropylene a particular release liner, addressing the limitations of Claim 5. [0114-19]. Nardi goes on to exemplify one particular patch composition combining the pharmaceutical active with each of the methyl paraben of Claim 7, propylene glycol, glycerol, sorbitol, and urea of Claims 3 and 13, polyacrylic acid and sodium polyacrylate, kaolin of Claims 8 and 17, aluminum glycinate and tartaric acid of Claims 4 and 14, and water of Claim 1. While concentrations of “framework material,” the combination of humectant and cosolvent, combination of a crosslinking agent and a crosslinking regulator, and water may differ between the disclosure of Nardi and those of the present claims, Nardi describes each of polyacrylates including sodium polyacrylate, polyvinyl alcohols, and povidones, of water, glycerol, propylene glycol, sorbitol, and urea, of propylene glycol, glycerol, DMSO, polysorbate 80, and citric acid as providing various desired properties to the compositions into which they are incorporated. On this basis, a person of ordinary skill in the art would reasonably conclude that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Nardi. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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.).
Despite the breadth of teaching concerning the manner in which a skilled artisan may formulate a transdermal analgesic/antiinflammatory patch, Nardi does not indicate that brucine may serve as an analgesic/antiinflammatory agent for transdermal delivery.
This is cured by the teachings of Wu, describing the use of brucine as an antiinflammatory and analgesic active agent formulated for transdermal delivery. (Abs.). Indeed, Wu indicates that in formulating gel transdermal drug delivery systems, brucine demonstrates compatibility with component described as useful in the formulation of topical drug delivery patches by Nardi, including carboxymethylcellulose, ethanol, glycerin, polysorbate 80 (recited as TWEEN-80) and propylene glycol. (Pg.8).
It therefore would have been prima facie obvious to have combined brucine with combinations of partially neutralized polyacrylate as framework material, propylene glycol, glycerin or sorbitol as a humectant, polysorbate 80 or DMSO as cosolvent, aluminum glycinate and tartaric acid, sodium edetate, as well as methylparaben and kaolin and placed such a combination on a non-woven backing layer with a polyethylene or polypropylene film as anti-adhesive layer. A person having ordinary skill in the art would have been motivated to do so because each of the combinations of partially neutralized polyacrylate as framework material, propylene glycol, glycerin or sorbitol as a humectant, polysorbate 80 or DMSO as cosolvent, sodium edetate as a chelating agent/antioxidant, aluminum glycinate and tartaric acid, as well as methylparaben and kaolin and placed such a combination on a non-woven backing layer with a polyethylene or polypropylene film as anti-adhesive layer are identified by Nardi as desirable constituents of a transdermal analgesic/antiinflammatory drug delivery patch. It must be remembered that “[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)). “[W]hen 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.). The use of brucine in such an art-suggested patch amounts to little more than the substitution of one analgesic/antiinflammatory active for another. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). The idea for their exchange them flows logically from their having been individually taught in the prior art as useful for the same purpose. In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Claims 1, 3-8, 11, and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Nardi, Gao, and Wu as applied to Claims 1, 3-8, 11, and 13-17 above, and further in view of Levy (WO2014/138212), and Li (CN1903295)(machine translation provided).
Nardi, Gao, and Wu, discussed in greater detail above, suggest formulations of transdermal analgesic plasters whereby a hydrogel containing brucine may also contain each of water, glycerin, propylene glycol, polysorbates as penetration enhancers, sodium polyacrylate and HPMC as components of the hydrogel gel former ([0083-85; 0096]), parabens as preservatives, aluminum glycinate and sodium edetate ([0238]) which Nardi suggests may be interchanged with the equivalent chelator disodium edetate ([0107]), tartaric acid, a non-woven fiber backing layer, and a polypropylene film. [0114-19; 0238].
Despite this, as required by newly added claim 18, ethylparaben is not described by any of Nardi, Gao, or Wu as a suitable preservative, nor is polysorbate 60 particularly identified as a suitable polysorbate generically described by Nardi as a suitable transdermal drug delivery component.
This is cured in part by the teachings of Levy, which indicates that polysorbate 60 was, at the time the instant application was filed, known to be useful as a carrier for topical and transdermal drug delivery systems. [0076]. In a similar manner, Li establishes that ethylparaben was, at the time the instant application was filed, known as a preservative for transdermal drug delivery plasters.
Therefore the skilled artisan was aware at the time the instant application was filed that brucine was known to be useful as a transdermal analgesic. The skilled artisan was also aware that each of the glycerin, propylene glycol, sodium polyacrylate, aluminum glycinate, ethylparaben, disodium edetate, tartaric acid, HPMC, polysorbate 60, and water were known to form hydrogel analgesic delivery patches which may be mounted on a non-woven fabric backing layer and protected by a polypropylene film anti-adhesive layer were taught by the art at the time the application was filed as desirable constituents of a transdermal analgesic/antiinflammatory drug delivery patch. It must be remembered that “[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)). “[W]hen 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.). While amounts of glycerin, propylene glycol, sodium polyacrylate, aluminum glycinate, ethylparaben, disodium edetate, tartaric acid, HPMC, polysorbate 60, and water may differ between the disclosure of Nardi, Gao, Wu, Levy, and Li and those of the present claims, Each of glycerin, propylene glycol, sodium polyacrylate, aluminum glycinate, ethylparaben, disodium edetate, tartaric acid, HPMC, polysorbate 60, and water are recognized by the art of record as providing various desired properties to the drug delivery compositions into which they are incorporated. On this basis, a person of ordinary skill in the art would reasonably conclude that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by the art to arrive at the composition of Claim 18. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where 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.).
Response to Arguments
Applicant's arguments filed 19 December 2025 have been fully considered but they are not persuasive.
Applicants arguments concerning the amendments to Claim 1 concerning the identity of the polymeric framework material for inclusion in the plasters claimed are unpersuasive in view of the modification to the rejections discussed above, establishing the art recognized partially neutralized polyacrylates as suitable drug delivery plaster framework materials for use as a generic polyacrylate per the teachings of Nardi.
Applicants arguments concerning the advantageous properties associated with the use of partially neutralized polyacrylates versus carboxymethylcellulose or gelatin are unpersuasive, for at least the reason that applicants have not compared the inventive compositions to the closest prior art which exists, which the examiner asserts is the exemplified embodiment of Nardi’s analgesic patch. See Pg.13: “Inventive Example 8 – Pharmaceutical Patch.” Evidence of unexpected results must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicants arguments concerning Claim 18 are unpersuasive, as applicants have simply recited the limitations of the claim and asserted the art previously of record does not address them. In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[T]he Board reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art.”). As set forth above, even the composition of Claim 18 represents an obvious modification of the prior art.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
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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.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614