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 .
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/21/2025 has been entered.
DETAILED ACTION
Claims 1-4, 13, 14 and 17-30 are pending in the Claim Set filed 08/21/2025.
Claims 1, 19 and 20 have been amended.
Claims 5-12, 15 and 16 are cancelled.
Herein, claims 1-4, 13, 14 and 17-30 are for examination.
Withdrawn Rejections
The rejection of claims 1-4, 13, 14 and 20-30 under 35 U.S.C. 103(a) as being unpatentable over Chono et al (US 20040142024) in view of Ishibashi et al (US20100234471, cited IDS filed 1/27/2021) is withdrawn in view of the New Grounds of rejection a set forth below.
New Objection
Claims 1 is objected to because of the following informalities:
The term ‘terpin’ in claims 1, 19 and 20 appears to be misspelled.
It should recite ‘terpene resin’ and not ‘terpin resin’
Specification at page 22 lists terpene resin (tackifier) [0042]; Terpene resin at page 28 [0059]; and, in Tables 1-2, 29-30; Table 5 at page 32.
Appropriate correction is required.
New Grounds of Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL - The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 13, 14 and 17-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a New Matter rejection.
There is lack of written description for claims 1, 19 and 20.
Claims 1 and 20 ((currently amended) recite, in part:
preparing a first mixture of lactic acid and the hydroxy acid in the above amounts and subsequently preparing a second mixture by adding lidocaine or a salt thereof in the above amount to the first mixture;
preparing an elastomer mixture by generating a third mixture by dissolving SIS and terpin resin in toluene, generating a fourth mixture by adding to the first mixture glycerin monostearate, polyoxyethylene hydrogenated castor oil 40, propylene carbonate, and gelled
hydrocarbon and mixing with heat. and dissolving the fourth mixture; and
mixing (adding) the second mixture to the elastomer mixture.
Claim 19 (currently amended) recite, in part:
(a) mixing lactic acid in an amount of 0.6 to 1.2 moles per mole of lidocaine or a salt thereof with the hydroxy acid in an amount of 0.3 to 0.8% by weight of the adhesive layer to form a first mixture;
(b) adding lidocaine or a salt thereof in an amount of 10 to 20% by weight of the adhesive layer to the first mixture to form a second mixture; and
(c) preparing an elastomer mixture by generating a third mixture by dissolving SIS and terpin resin in toluene, generating a fourth mixture by adding to the first mixture glycerin monostearate, polyoxyethylene hydrogenated castor oil 40, propylene carbonate, and gelled hydrocarbon and mixing with heat. and dissolving the fourth mixture; and
(d) adding the elastomer mixture to the second mixture to prepare a uniform composition.
There is lack of support for the claim amendments (underlined) to claims 1, 19 and 20.
For example,
Specification at page 6 states:
Para. [0010] (in part): The present inventors have extensively studied to reach the object, and have succeeded that a mixture of lactic acid and tartaric acid is preliminarily prepared in a specific amount and then lidocaine is added thereto in a specific molar ratio to prepare a uniform composition.
Para. [0049], page 25: In addition, the composition for adhesive layer in the patch preparation of the present invention can be prepared by mixing each ingredient in the adhesive layer and then stirring them. For example, a composition for adhesive layer can be prepared by dissolving an elastomer and a tackifier in toluene, adding other additive such as a surfactant and a solvent such as an ester thereto and mixing with heating, dissolving the mixture, and then adding lidocaine, lactic acid and a hydroxy acid having 4 to 6 carbon atoms thereto and stirring them. Lidocaine may be added into the mixture solution produced by mixing lactic acid and a hydroxy acid having 4 to 6 carbon atoms.
Para. [0059], page 28: Specifically, according to the solvent method, styrene-isoprene-styrene block copolymer (SIS) and terpene resin were dissolved in toluene, and then glycerin monostearate, polyoxylethylene hydrogenated castor oil 40, propylene carbonate and gelled hydrocarbon were added thereto and mixed with heating, and the mixture was dissolved to prepare an adhesive layer. Separately, lactic acid and tartaric acid were mixed, and to the mixture solution was added lidocaine to prepare a uniform composition. The composition was mixed with the above adhesive layer to prepare a uniform composition for adhesive layer.
Accordingly, there is no support for the limitation: generating a fourth mixture by adding to the first mixture.
Specification clearly discloses that a mixture of lactic acid and tartaric acid is preliminarily prepared and then lidocaine is added thereto, wherein styrene-isoprene-styrene block copolymer (SIS) and terpene resin were dissolved in toluene, and then glycerin monostearate, polyoxylethylene hydrogenated castor oil 40, propylene carbonate and gelled hydrocarbon were added thereto and mixed with heating and then mixed with the mixture of lactic acid, tartaric acid and lidocaine.
The rejections can be overcome by the following proposed amendment:
Amend claims 1 and 20 to recite, in part:
preparing a first mixture of lactic acid and the hydroxy acid in the above amounts and subsequently preparing a second mixture by adding lidocaine or a salt thereof in the above amount to the first mixture;
preparing an elastomer mixture by generating a third mixture by dissolving SIS and terpin resin in toluene, generating a fourth mixture by adding to the elastomer mixture glycerin monostearate, polyoxyethylene hydrogenated castor oil 40, propylene carbonate, and gelled hydrocarbon and mixing with heat, and dissolving the fourth mixture; and mixing the second mixture to the elastomer mixture.
Amend claim 19 to recite, in part:
(a) mixing lactic acid in an amount of 0.6 to 1.2 moles per mole of lidocaine or a salt thereof
with the hydroxy acid in an amount of 0.3 to 0.8% by weight of the adhesive layer to form a first
mixture;
(b) adding lidocaine or a salt thereof in an amount of 10 to 20% by weight of the adhesive layer to the first mixture to form a second mixture; and
(c) preparing an elastomer mixture by generating a third mixture by dissolving SIS and terpin
resin in toluene, generating a fourth mixture by adding to the elastomer mixture glycerin monostearate, polyoxyethylene hydrogenated castor oil 40, propylene carbonate, and gelled hydrocarbon and mixing with heat. and dissolving the fourth mixture; and
(d) adding the elastomer mixture to the second mixture to prepare a uniform composition.
M.P.E.P. §2163 states that new or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement.
Thus, the disclosure does not provide support for the claim amendments by changing the scope of the disclosure; thereby, constituting new matter.
The remaining claims do not resolve the issues with claims 1, 19 and 20 and are rejected as depending from a rejected claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS - Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 13, 14 and 21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 13 and 14 are either directly or indirectly dependent on claim 1.
Claims 13 and 14 recite:
13. (previously presented): The patch preparation of claim 1, wherein the adhesive layer further comprises a surfactant.
14. (original): The patch preparation of claim 13, wherein the surfactant is a non-ionic surfactant with a H LB value of 4 to 14.
However, instant claim 1 (in part) already recites: glycerin monostearate (i.e., surfactant), polyoxyethylene hydrogenated castor oil 40 (i.e., surfactant), propylene carbonate, and gelled Hydrocarbon (i.e., both glycerin monostearate and polyoxyethylene hydrogenated castor oil 40 are non-ionic surfactants)
Specification at para. [0027] (in part) states: non-ionic surfactant(s) is glycerol monostearate (i.e., glycerin monostearate) and polyoxyethylene castor oil (hydrogenated castor oil). Para. [0028]: The surfactant of the present invention is preferably a surfactant with a HLB value of 4 to 14.
Thus, claims 13 and 14 do not further limit the subject matter of the claim upon which it depends. Further, claim 14 is dependent on a rejected claim.
Further, claim 21 is directly dependent on claim 20.
21. (previously presented): The patch preparation according to claim 20, wherein the softener comprises the gelled hydrocarbon.
However, claim 20 (in part) already recites: and gelled hydrocarbon.
Specification at para, [0043] (in part) states: Example of the softener is gelled hydrocarbon.
Thus, claim 21 does not further limit the subject matter of the claim upon which it depends.
Therefore, claims 13, 14 and 21 do not further limit the subject matter of claim(s) upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
New Grounds of Rejection.
Claim Rejections - 35 USC § 103
(Reformulated in view of the claim amendments)
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-4, 13, 14 and 20-30 are rejected under 35 U.S.C. 103(a) as being unpatentable over Chono et al (US 20040142024) in view of Spengler et al (US 2007/0065390) and Ishibashi et al (US20100234471, cited IDS filed 1/27/2021).
Regarding Instant Claims
The claims are in open format. The transitional term ‘comprising’ is open-ended and does not exclude additional, unrecited elements or method steps. See, e.g. Mars Inc. V. H. J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) (See MPEP 2111.03.
Regarding claim 1-4, 13, 14 and 20-30,
Chono teaches a patch formulation for external use where a basic drug, an organic acid and an organic acid salt are combined as essential components, wherein the basic drug: lidocaine, is preferably in the form of its acid addition salt, wherein the organic acid is at least one acid selected from lactic acid, tartaric acid and citric acid, wherein the patch formulation for external use comprising a basic drug comprises good percutaneous absorption property of the drug and good stability (Abstract; [0010]). Chono teaches that the patch formulation comprises an adhesive layer, a backing layer for supporting the adhesive layer and a release liner established on the adhesive layer, wherein the patch formulation comprises the basic drug, organic acid and an organic acid salt in the adhesive layer, wherein the basic drug used in the adhesive layer is preferably as an acid addition salt of the basic drug, wherein the acid addition salt is lidocaine hydrochloride [0014-0015]. Further, Chono teaches that the basic drug may be in either form of inorganic or organic salts, wherein the basic drug is preferably in the range from 0.1 to 20% by weight of the total weight of the composition of the adhesive layer ([0016]; [0021]). Thus, Chrono teaches that lidocaine is present in the adhesive layer in the range of from 0.1 to 20% wt., of which overlaps with the claimed amount of 10 to 20% by weight of the adhesive layer. In addition, lidocaine being present in the range of from 0.1 to 20% wt. also overlaps with 10% by weight in the adhesive layer as recited in claim 30. Moreover, Chrono teaches that addition of less than 0.1 % by weight of the drug results in an insufficient potency, while addition of more than 20% by weight results in a poor physical property as a patch formulation ([0016]; [0021]). Further, Chono teaches that in the patch formulation the organic acid used in the adhesive layer is the organic acid is at least one acid selected from lactic acid, tartaric acid and citric acid in the range of 0.1 to 1.0% by weight [0017-0018], of which overlaps with the calimed amount ranges. Thus, it would have been well within the purview to optimized the amounts of organic acids in a range of 0.3 to 0.8% by weight of the adhesive layer to best achieve a patch formulation comprising targeted properties in view of Chrono. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art." In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Accordingly, a patch preparation comprising a support, an adhesive layer, and a release liner, wherein the adhesive layer comprises lidocaine or a salt thereof, lactic acid, a hydroxy acid selected from the group consisting of citric acid and tartaric acid, wherein the amount of lidocaine or a salt thereof is 0.1 to 20% by weight of the adhesive layer would have been would have been prima facie for one of ordinary skill in the art to provide before the effective filing date of the claimed invention. Further, a patch formulation comprising lidocaine 10 to 20% by weight of the adhesive layer, as recited in claim 1 (in part), would have been prima facie obvious to provide, since Chrono teaches the patch formulation comprises lidocaine or a salt thereof is 0.1 to 20% by weight of the adhesive layer of which encompasses the claimed amount of lidocaine. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257,191 USPQ 90 (CCPA 1976); In re Woodruff, 91 9 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Chono teaches that ratio of the acid addition salt of the basic drug to the organic acid, when they are compounded ranges from 5:1 to 1:5 (by equivalent ratio) [0019]. Alternatively, when inverted to lactic acid to lidocaine 1:5 to 5:1 ratio (i.e., inverted from 5:1 to 1:5), that would yield a ratio of 0.2 to 5 of lactic acid to lidocaine. Since lactic acid is a monoprotic acid a ratio of 0.2 to 5 of lactic acid to lidocaine overlaps with amount of lactic acid is 0.6 to 1.2 moles per mole of lidocaine. Therefore, the claimed amount of lactic acid is 0.6 to 1.2 moles per mole of lidocaine is encompassed by a ratio of 0.2 to 5 of lactic acid to lidocaine as taught by Chrono. Moreover, Chrono teaches that if the ratio of the acid addition salt of the basic drug to the organic acid is out of the range from 5:1 to 1:5, both stability and skin permeability will be reduced [0019]. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Chono further teaches that by including particular amounts of an organic acid and an organic acid salt into a patch formulation for external use which contains a basic drug in the form of an acid addition salt then more stable ion pairs are formed therein than in a patch including the organic acid salt alone, of which is capable of elevating skin permeability of the drug therein and can be maintained constantly therein [0011].
Further, Chono teaches the patch formulation for external use where the adhesive layer may contain not only the basic drug, the organic acid and the organic acid salt as essential components (i.e., as described above), but also an absorption enhancer, a plasticizer, e.g., liquid paraffin (softener of instant claim 20), a lipophilic/hydrophobic polymer, e.g., styrene-isoprene-styrene block copolymer (SIS) [0030] (elastomer: instant claims 1, 19 and 20), a tackifier, e.g., preferably terpene resin [0032] (recited in claim 1: See: preparing the elastomer) and other additives comprise polybutene (instant claim 22) and castor oil [0028] (instant claim 23) [0024-0043]. In addition, Chono teaches that adhesive layer may also comprise an absorption enhancer polyethylene-hardened castor oil (HCO type) (i.e., a PEG hydrogenated castor oil) and glycerol fatty acid ester [0025] (i.e., emulsifier: a type of a surfactant) (See entire document). Chrono teaches that the adhesive layer may container an absorption enhancer, wherein any compound that can promote the adsorption of a drug by skill may be suitable as absorption enhancer [0024-0025].
Chrono teaches provided that the patch formulation for external use according to the present invention comprises a basic drug, an organic acid salt and an organic acid, the other composition or the material of any other component may be of any type or any kind ([0041]). Chono teaches a process of producing a patch formulation having a composition described above and for external use, may not be limited but any applicable one [0041]
Thus, the prior art of Chrono makes prima facie obvious a patch preparation comprising a support, an adhesive layer and a release liner, wherein the adhesive layer comprises lidocaine or a salt thereof, lactic acid, a hydroxy acid selected from the group consisting of citric acid and tartaric acid, wherein the amount of lidocaine or a salt thereof is 0.1 to 20% by weight of the adhesive layer, wherein the adhesive layer further comprises styrene-isoprene-styrene block copolymer (SIS) (elastomer) and terpin resin (tackifier) (i.e., terpin resin and terpene resin are used to refer to the same material. Specification at page 22 lists terpene resin (tackifier) [0042] and at page 28 [0059]; Tables 1-2 on pp. 29-30; Table 5 at page 32. Chrono teaches that the adhesive layer may container an absorption enhancer, wherein any compound that can promote the adsorption of a drug by skill may be suitable as absorption enhancer [0024-0025].
However, Chrono does not teach that the adhesive layer specifically contains polyethylene hydrogenated castor oil 40 (instant claims 1, 19, 20: See: preparing the elastomer; and further comprises an ester, e.g., propylene carbonate (instant claims 1, 19, 20: See: preparing the elastomer) or that the adhesive layer contains a non-ionic surfactant (recited in instant claims 13, 14), such as, e.g., glycerin monostearate (i.e., non-ionic surfactant (recited in instant claims 1, 19, 20) or a gelled hydrocarbon (claims 1, 19 and 20).
Furthermore, Chrono does teach the ‘wherein the adhesive layer is prepared by process comprising (recited in claims 1, 19 and 20):
: preparing a first (1st) mixture of lactic acid and the hydroxy acid (i.e., selected from citric acid; tartaric acid) in the above amounts and subsequently preparing a second (2nd) mixture by adding lidocaine or a salt thereof in the above amount to the first mixture,
preparing an elastomer mixture by generating a third (3rd) mixture by dissolving SIS (lipophilic/hydrophobic polymer) and terpin resin (tackifier) in toluene (solvent),
generating a fourth (4th) mixture by adding to the first mixture glycerin monostearate, polyoxyethylene hydrogenated castor oil 40, propylene carbonate, and gelled hydrocarbon and mixing with heat and dissolving the fourth mixture; and mixing the second mixture to the elastomer mixture.
However, Spengler and Ishibashi, as a whole, cure the deficiencies.
Firstly, Chrono teaches that adhesive layer comprises the acid addition salt of lidocaine and also includes an absorption enhancer polyethylene-hardened castor oil (HCO type), See above. However, Chrono does not explicitly teach that the polyethylene-hardened castor oil (HCO-type) is polyethylene hydrogenated castor oil 40 (as claimed).
Spengler teaches compositions comprising lidocaine hydrochloride (addition salt of lidocaine) and a non-ionic surfactant for skin care which provides physiologic action on the skin, wherein the non-ionic surfactant is PEG-40 hydrogenated castor oil (same as HCO-40; and also, called polyethylene hydrogenated castor oil 40, as claimed). Additionally, Spengler teaches that the salt can be any type material suitable for use in a skin care composition ([0015]; [0018]; [0023]; [0026], [0034]; [0043]; [0048]; [0053]; Table 4 [0054-0057]; claim 4).
Thus, it would have been prima facie obvious to provide PEG-40 hydrogenated castor oil (polyethylene hydrogenated castor oil 40) as a non-ionic surfactant in the adhesive layer as taught by Chrono. One skilled in the art before the effective filing date of the claimed invention would haven motivated to add PEG-40 hydrogenated castor oil to the lidocaine salt composition with a reasonable expectation that PEG-40 hydrogenated castor oil, acting as an adsorption enhancer, would enhance the formulation’s topical physiologic action on the skin.
Ishibashi teaches a lidocaine-containing transdermal absorption tape preparation in which lidocaine is present in a state uniformly compatibilized with or dispersed in the base without causing the precipitation of a lidocaine crystal even when lidocaine is present in a high concentration in the preparation. Thus, because of the absence of precipitation of a lidocaine crystal, the transdermal absorption tape preparation of lidocaine shows no deterioration of the adhesive power to the skin can be provided ([0006]. Moreover, Ishibashi teaches that lactic acid salt of lidocaine (an equimolar salt) produces an ionic liquid that causes no precipitation of a lidocaine crystal in the base of a tape preparation even in a high concentration of lidocaine, and that lidocaine in the form of an ionic liquid provides the skin permeability thereof higher than otherwise.
Ishibashi teaches that lidocaine-containing transdermal absorption tape preparation comprises 10 to 40 w/w % of lidocaine (overlaps with amount of Lidocaine in claims 1, 19, 20 and 30), moreover, Ishibashi teaches lactic acid in a molar amount 0.6 to 1.2-fold that of lidocaine (Ishibashi: [0011[; claim 1(2)) (of which is recited in claims 1, 19 and 20).
Additionally, Ishibashi teaches that lidocaine-containing transdermal absorption tape preparation comprises an elastomer, wherein the elastomer is styrene-isoprene-styrene block (SIS) ([0015]; [0016]; [0038]; See entire document) (reads on instant claims 1, 19, 20) wherein an adhesive mass layer (i.e., reads on adhesive layer) called a base of which comprises the elastomer and a tackifier, a softening agent, a filler, an antioxidant, and the like [0037], wherein a liner (i.e., reads on release liner) is used to protect the adhesive mass layer, wherein it has a shape selected from sheet, zonal, circular, elliptical, rhomboidal, and other shapes [0058], and, further, wherein the base composition (adhesive layer) containing the lactic acid salt of lidocaine is coated directly on the backing (i.e., reads on support [0055]). Further, Ishibashi teaches that the use of propylene carbonate (i.e., reads on an ester) as a transdermal absorption promoting agent enhances the transdermal absorbability and tissue permeability of the ionic liquid of the lactic acid salt of lidocaine ([0007]; [0046]; Table 2: [0067]). Further, Ishibashi teaches propylene carbonate ([0084]; Tables 2, 4-5) (ester recited instant claims 1, 19 and 20). Thus, one skilled in the art would have recognized the advantages of including propylene carbonate and would have been motivated to include propylene carbonate in a patch formulation for external use as taught by Chrono. Furthermore, one skilled in the art would have been motivated to do so in order enhance the transdermal absorbability and tissue permeability of lidocaine or salt thereof having a reasonable expectation of success. Ishibashi teaches preferred non-ionic surfactants that is a nonionic surfactant having an HLB value ranging from 6 to 12, e.g., monoglyceride stearate (i.e., glycerin monostearate ([0014]; [0045]; [0050]; [0054; Table 5; claim 8); i.e., non-ionic surfactant: reads on instant claims 1, 13, 14; 19, 20). Additionally, Ishibashi teaches the preparation comprise polyoxyethylene castor oil (a hydrogenated castor oil) ([0014]; [0050]; [0054]; Tables 2-5). Ishibashi teaches softening agent that is gelatinous hydrocarbons [0040] (reads on gelled hydrocarbon recited in claims 1, 19, 20, 21) and liquid paraffin [0040]. Similarly, Chono also teaches the patch formulation comprising an adhesive layer having a liquid paraffin (i.e., softener [0043]). Thus, it would have been obvious to include a gelatinous hydrocarbon and/or substitute a gelatinous hydrocarbon (i.e., gelled hydrocarbon) for a liquid paraffin in the adhesive layer of Chono since they are taught as being softeners and are obvious functionally equivalent additives. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the patch formulation as taught by Chrono to further comprise an ester: propylene carbonate, since enhances the transdermal absorbability of a drug and further optimize the amounts of lactic acid to lidocaine to provide lactic acid in a molar amount 0.6 to 1.2-fold that of lidocaine in view of Ishibashi having a reasonable of success of that this molar amount range would provide no deterioration of the adhesive power to the skin and would be expected to inhibit precipitation of a lidocaine crystal in the adhesive layer. Moreover, Ishibashi teaches that a lidocaine and lactic acid salt thereof provides the advantages that lactic acid has no unpleasant odor and inhibits lidocaine crystal formation ([0006-0026].
Furthermore, Chrono and Ishibashi both teach the formulation comprises polyoxyethylene castor oil (a hydrogenated castor oil), Thus, it would have been prima facie obvious to provide PEG-40 hydrogenated castor oil (polyethylene hydrogenated castor oil 40) as a non-ionic surfactant in the adhesive layer as taught by Chrono and Chrono and Ishibashi, because Spengler explicitly teaches using PEG-40 hydrogenated castor oil combined with a lidocaine salt composition provides physiologic action on the skin. Thus, one skilled in the art would haven motivated to add PEG-40 hydrogenated castor oil to the lidocaine salt composition as taught by Chrono and Ishibashi, as a whole, with a reasonable expectation that PEG-40 hydrogenated castor oil, acting as an adsorption enhancer, would enhance the composition’s topical physiologic action on the skin.
Further, Ishibashi teaches ‘Preparation of Tape Preparation Containing Lactic Acid Salt of Lidocaine; (Example 2, page 4): [0066] Tape preparations containing a lactic acid salt of lidocaine were prepared with the compositions described in Table 2 (page 4). That is, SIS and terpene resin were dissolved in toluene, to which polybutene, BHT, liquid paraffin, plastibase, a surfactant, a solvent, and the like were then added and mixed under heating. After confirming the dissolution thereof, lidocaine and lactic acid were added thereto to provide a uniform base. The resultant base was coated to prepare a tape preparation. In particular, Table 2 lists drug: lidocaine; lactic acid; surfactants: polyoxyethylene castor oil (a hydrogenated castor oil) and monoglyceride stearate (i.e., glycerin monostearate); terpine resine (tackifier); SIS (elastomer); softening agent: liquid paraffin (Ishibashi teaches softening agent that is gelatinous hydrocarbons [0040] (reads on gelled hydrocarbon recited in claims 1, 19, 20, 21) and liquid paraffin [0040]. Thus, it would have been obvious to include a gelatinous hydrocarbon and/or substitute a gelatinous hydrocarbon (i.e., gelled hydrocarbon) for a liquid paraffin in preartion method as taught by Ishibashi.
It would have been well within the purview of one of ordinary skill in art to provide a patch formulation comprising an adhesive layer prepared by a process, wherein a mixture comprising lidocaine, lactic acid and hydroxy acids citric acid and tartaric acid, wherein the amount of lactic acid is 0.6 to 1.2 moles per mole of lidocaine or a salt thereof, was prepared and an elastomer mixture is generated by dissolving SIS (elastomer ) in terpene resin, then add and mix with polyethylene hydrogenated castor oil 40, monoglyceride stearate (surfactant), propylene carbonate (enhances the transdermal absorbability and tissue permeability), and a gelled hydrocarbon under heating, and then further mixing and dissolving the mixture comprising lidocaine, lactic acid and hydroxy acids citric acid and tartaric acid in the elastomer mixture, in view of the teachings of chrono and Ishibashi, as a whole ,having a reasonable expectation of success
Moreover, a change in the order of steps in a process claim is prima facie obvious in the absence of new and unexpected results. "Selection of any order of mixing ingredients is prima facie obvious." In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930).
Instant Claims are directed to product-by-process claims which is a product claim. Product-by-Process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695,698,227 USPQ 964, 966 (Fed. Cir. 1985).
Thus, all the claimed elements herein are known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention, wherein, as here, there is no unobvious distinction between the claimed patch preparation of the patch preparation that is made prima facie obvious by Chrono and Ishibashi, as a whole.
Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802,218 USPQ 289,292 (Fed. Cir. 1983). ("a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim.") see Amgen Inc. v. F. Hoffman-La Roche Ltd., 580F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009) at 1370). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In the present case, the claimed patch preparation is found to be prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Chono (US 20040142024), Spengler (US 2007/0065390) and Ishibashi (US20100234471), as a whole.
Claims 17 and 18 under pre-AIA 35 U.S.C. 103(a) are rejected as being unpatentable over Chono et al (US 20040142024) in view of Spengler et al (US 2007/0065390) and Ishibashi et al (US20100234471, cited IDS filed 1/27/2021) as applied to claim 1-4, 13, 14 and 19-23 above and further in view of Hashimoto et al (US20140037710, of record) and Sablotsky et al (USP4814168).
The teachings of Chono, Spengler and Ishibashi, as a whole, are described above.
Chono and Ishibashi differs from the claims in that they do not teach the thickness or the surface area of the adhesive layer.
However, Hashimoto and Sabrosky cure the deficiencies.
Regarding the thickness of the patch, Hashimoto teaches a method of producing a patch, which can easily give the patch excellent skin permeation of a drug, e.g., lidocaine [[0052], and can reduce variation in skin permeation of the drug for each pharmaceutical preparation (Title, Abstract; [0021]). Hashimoto teaches the patch comprises a support layer, adhesive layer and release liner ([0023]; [0026-0028]; [0071]; [0084-0086]; See entire document), wherein the thickness of the support layer 2-3000 µm [0081], the thickness of adhesive layer about 10-300 µm, e.g., 100 µm after drying ([0083]; [0101]) and the thickness of the release liner is about 2-3000 µm, e.g., 75 µm ([0086]; [0101]). Thus, in would be obvious to those skilled in the art that the overall combined thickness of the patch is in the range of about 2-3000 µm that overlaps with the thickness of the patch preparation as recited in claim 17 that is 0.5-2.000 mm (500- 2000 µm). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. 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). See MPEP 2144.05.
Regarding the surface area of the adhesive layer, Sapolsky teaches a transdermal multipolymer drug delivery system (i.e., patch) comprising a drug containing adhesive preparation, wherein the adhesive surface area is in the range of 1 to 200 square centimeters (cm2) (Abstract; col,.10, lns.4-21), of which overlaps with the narrower claimed range of the adhesive layer of 100-200 cm2. A prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness. In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83.
One of ordinary skill in the art would have recognized the advantage of having a patch thickness in a range of about 2-3000 µm in view of Hashimoto and would have been motivated to do so in order to provide a patch preparation that has a thickness that provides excellent skin permeation of the lactic acid salt of lidocaine having a reasonable expectation of success. Further, Sablotsky teaches a surface area of 1 to 200 square centimeters that allows incorporation of the amount of a drug that is sufficient to deliver a required dose. Thus, it would have been well within the purview of one of ordinary skill in art to optimize the surface area of the adhesive layer within the range of 1 to 200 cm2 as taught by Sablotsky to deliver an amount of the lactic acid salt of lidocaine that is sufficient to deliver a therapeutically effective dose that causes no deterioration of the adhesive power to the skin in accordance with the teachings of Chono and Ishibashi, as a whole.
It would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, in the absence of evidence to the contrary, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Chono, Spengler, Ishibash, Hashimoto and Sablotsky, as a whole.
Response to Arguments
Applicant argues that the pending claims are not obvious because, as the examiner agrees on page 12 of the office action, the invention claimed results in unobvious or unexpected advantageous properties. Furthermore, without acquiescing to the merits of the rejections, Applicant has amended claims 1 and 19 to be commensurate in scope with what the examiner views as the corresponding disclosure in the specification.
Applicant’s arguments have been fully considered but they are not persuasive, because, first of all, the Examiner did not agree that on page 12 of the office action the claimed invention results in unobvious or unexpected advantageous properties. In fact, what was stated was ‘However, the process as recited in instant claims of preparing the adhesive that generated alleged unexpected results is not commensurate in scope with the disclosure in the specification (See Office Action on pages 12-14).
Now, regarding Applicants arguments: Applicant has amended claims 1 and 19 to be commensurate in scope with what the examiner views as the corresponding disclosure in the specification is not persuasive. As a matter of fact, Applicants’ claimed amendments introduce New Matter in the Claim Set filed 8/21/2025., therefore, by that reason alone, instant claims are not commensurate in scope. Moreover, Applicants have amended Instant Claims to recite (in part): generating a fourth mixture by adding to the first mixture glycerin monostearate, polyoxyethylene hydrogenated castor oil 40, propylene carbonate, and gelled hydrocarbon. Thus, there are no boundary conditions directed to the amounts of glycerin monostearate (surfactant), polyoxyethylene hydrogenated castor oil 40 (surfactant), propylene carbonate, and gelled hydrocarbon (softener).
Specification at page 17, para. [0028] states: The amount of the surfactant is, for example, 0.01 to 2% by weight, and preferably 0.01 to 1% by weight. Therefore, the subject matter directed a surfactant of Instant claims is broader than what is sufficient supported by the Disclosure. Further, the Specification at pages 17, para. [0043] states: The amount of the softener is, for example, 0.01 to 50% by weight, preferably 10 to 40% by weight, and furthermore 25 preferably 20 to 40% by weight. Therefore, the subject matter directed a softener of Instant claims is broader than what is sufficient supported by the Disclosure. Furthermore, Instant Claims recite the terms: terpin resin. without setting any physical boundary conditions thereof. However, Specification at page 22, para. [0028] explicitly states: Examples of the tackifier, e.g., terpin resin: the amount of the tackifier is, for example, 0.01 to 50% by weight, preferably 10 to 40% by weight, and furthermore preferably 20 to 40% by weight. Therefore, the subject matter directed a tackifier: terpin resin, of Instant claims is broader than what is sufficient supported by the Disclosure.
Regarding said unexpected results, the claims are limited to the scope of the invention that is commensurate with the showing of unexpected results. MPEP states the following: 716.02(d) Unexpected Results Commensurate in Scope with Claimed Invention: Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289,296 (CCPA 1980). Accordingly, the surfactants: glycerin monostearate, polyoxyethylene hydrogenated castor oil 40; propylene carbonate; and gelled hydrocarbon (softener) and terpin resin (Tackifier) as disclosed in the Specification and examples 1-3 are not commensurate in scope with the instant claims. The scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claims.
Applicants argue that because the cited references fail to render obvious claims 1, 19, and 20, they also fail to render obvious any claims that depend thereupon. Further, Applicants argue that he combination of Chono and Ishibashi fail to render obvious claim 1, on which claims 17 and 18 depend on. Further, Hashimoto and Sablotsky fail to remedy the deficiencies in Chono and Ishibashi because Hashimoto and Sablotsky are relied upon for their alleged disclosure of features found in claims 17 and 18.
Applicant’s arguments have been fully considered but they are not persuasive, because Applicants did not distinctly and specifically point out the supposed errors in the prior art applied in the above rejections. Furthermore, as described above, there is no unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the prior art of Chono and Ishibashi, as whole. Thus, the teachings of Hashimoto and Sablotsky render prima facie obvious the subject matter of claims 17-18. Additionally, Applicants did not distinctly and specifically point out the supposed errors in the prior art of Hashimoto and Sablotsky either individually or in combination.
Conclusions
No claim is allowed.
Claim 19 directed to ‘A Method for manufacturing a patch preparation’ would be in condition for allowance after the New Matter rejection is overcome.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Thurman Wheeler whose telephone number is (571)-270-1307. The examiner can normally be reached Monday-Friday 10am-6pm EST.
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/T.W./ Examiner, Art Unit 1619
/SARAH ALAWADI/ Primary Examiner, Art Unit 1619
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