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 .
Applicant’s election without traverse of Group I, claim 1, in the reply filed on 06/05/2026 is acknowledged.
Claims 2 and 3 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/05/2026.
Claim Status
Claims 1-3 are pending.
Claims 2 and 3 are withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: it appears that the first comma of line 2 should be removed for proper sentence punctuation. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Hatanaka et al (US 20150202171 A1, cited on IDS dated 02/13/2024, hereinafter “Hatanaka”).
Hatanaka discloses an adhesive patch comprising a support layer and an adhesive layer and a method for producing the patch (abs, ¶¶ 51). The adhesive layer is formed onto the surface of the support layer (¶ 47). In embodiments, diclofenac is included at 2.79 wt% of the adhesive layer (table 3).
Where Hatanaka discloses a pressure sensitive adhesive matrix patch comprising diclofenac, which appears to be in its free acid form, with an adhesive to obtain an adhesive composition, and forming the adhesive layer on the surface of the support layer (i.e., laminating), the active steps of the instantly claimed method are met. The examiner notes that wt% and mass% are the same under normal Earth gravity.
While Hatanaka does not appear to disclose diclofenac indolinone suppression specifically, it appears that were the adhesive patch of Hatanaka comprises the same components and is formulated by the same active steps of the instantly claimed method, it appears that the active steps would inherently also suppress the generation of diclofenac indolinone, whether recognized or not, thereby meeting the instantly claimed method. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. See MPEP 2112.02(I). Further, when a claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. See MPEP 2112.02(II). While Hatanaka do not appear to show a specific recognition of the suppression of diclofenac indolinone, it appears that the preamble of the claim is merely direct to the result of mixing diclofenac free acid in the amounts as instantly claimed with an adhesive.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Venkateshwaran et al (WO 0024386 A1, cited on IDS dated 02/13/2024, hereinafter “Venkateshwaran”).
Venkateshwaran discloses a pressure sensitive adhesive matrix patch comprising a backing layer and a hydrophobic pressure sensitive adhesive matrix (abs, pp 6 ln 4-14, 14 ln 13-20). The drug is mixed with the adhesive, and a backing layer is laminated to the surface of the adhesive matrix (pg 6 ln 4-14, tables 9, 10, claim 21). In particular embodiments, the patch comprises 0.9 wt% or 1.8 wt% diclofenac free acid (example 7, tables 9, 10).
Where Venkateshwaran discloses a method of formulating an adhesive patch comprising mixing diclofenac free acid at 0.9 wt% or 1.8 wt% with an adhesive to obtain an adhesive composition, wherein the adhesive layer is laminated to a backing layer, the active steps of the instantly claimed method are met. The examiner notes that wt% and mass% are the same under normal Earth gravity.
While Venkateshwaran does not appear to disclose diclofenac indolinone suppression specifically, it appears that were the adhesive patch of Venkateshwaran comprises the same components and is formulated by the same active steps of the instantly claimed method, it appears that the active steps would inherently also suppress the generation of diclofenac indolinone, whether recognized or not, thereby meeting the instantly claimed method. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. See MPEP 2112.02(I). Further, when a claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. See MPEP 2112.02(II). While Venkateshwaran do not appear to show a specific recognition of the suppression of diclofenac indolinone, it appears that the preamble of the claim is merely direct to the result of mixing diclofenac free acid in the amounts as instantly claimed with an adhesive.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel et al (Int J Pharm Pharm Sci, 2012, Vol 4, Issue 1, 296-299, cited on IDS dated 04/01/2024, hereinafter “Patel”).
Patel discloses adhesive patches of diclofenac acid (i.e., diclofenac free acid), wherein diclofenac acid was mixed with a pressure sensitive adhesive until homogenous, wherein the mixture was casted on a release liner and laminated (abs, pg 297 1st col 1st ¶). In particular embodiments, diclofenac free acid was included at 5 wt% and 7.5 wt% of the adhesive (table 1). In patches containing 5% of drug, crystallization was not observed (pg 297 2nd col last ¶).
Where Patel discloses a method of formulating an adhesive patch comprising mixing diclofenac free acid at 5 wt% and 7.5 wt% with an adhesive to obtain an adhesive composition, wherein the adhesive is laminated to a backing layer, the active steps of the instantly claimed method are met. The examiner notes that wt% and mass% are the same under normal Earth gravity.
While Patel does not appear to disclose diclofenac indolinone suppression specifically, it appears that were the adhesive patch of Patel comprises the same components and is formulated by the same active steps of the instantly claimed method, it appears that the active steps would inherently also suppress the generation of diclofenac indolinone, whether recognized or not, thereby meeting the instantly claimed method. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. See MPEP 2112.02(I). Further, when a claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. See MPEP 2112.02(II). While Patel do not appear to show a specific recognition of the suppression of diclofenac indolinone, it appears that the preamble of the claim is merely direct to the result of mixing diclofenac free acid in the amounts as instantly claimed with an adhesive.
Claim Rejections - 35 USC § 103
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al (US 20150202171 A1, cited on IDS dated 02/13/2024, hereinafter “Hatanaka”), in view of Katsuyuki (JP 2019055928 A, cited on IDS dated 04/01/2024), as evidenced by PubChem (Diclofenac, retrieved 2026) and Millipore Sigma (Diclofenac sodium salt, retrieved 2026).
Hatanaka is discussed above, and purely arguendo, if somehow the suppression of diclofenac indolinone is not inherent to the method, the following applies.
Katsuyuki teaches it was known that the suppression of the production of the decomposition product of indolinone can be suppressed by suppressing the solubility of diclofenac in adhesive patches ¶¶ 3, 4). As evidenced by PubChem, diclofenac free acid has a solubility of 2.37 mg/L in water (solubility). As evidenced by Millipore Sigma, diclofenac sodium has a solubility of 25 mg/mL in water.
Where Hatanaka discloses a pressure sensitive adhesive matrix patch comprising diclofenac, which appears to be in its free acid form, with an adhesive to obtain an adhesive composition, and forming the adhesive layer on the surface of the support layer (i.e., laminating), the active steps of the instantly claimed method are met. The examiner notes that wt% and mass% are the same under normal Earth gravity.
Regarding suppressing generation of diclofenac indolinone, it would have been obvious to use the method of Hatanaka discussed above to suppress generation of diclofenac indolinone, by specifically selecting the diclofenac free acid form over the sodium salt, where adhesive patches comprising lower solubility diclofenac were known to suppress the generation of the decomposition product diclofenac indolinone, as taught by Katsuyuki, in order to provide a more stable adhesive patch with limited decomposition product.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Venkateshwaran et al (WO 2000024386 A1, hereinafter “Venkateshwaran”), in view of Katsuyuki (JP 2019055928 A, cited on IDS dated 04/01/2024), as evidenced by PubChem (Diclofenac, retrieved 2026) and Millipore Sigma (Diclofenac sodium salt, retrieved 2026).
Venkateshwaran is discussed above, and purely arguendo, if somehow the suppression of diclofenac indolinone is not inherent to the method, the following applies.
Katsuyuki is discussed above.
Where Venkateshwaran discloses a method of formulating an adhesive patch comprising mixing diclofenac free acid at 0.9 wt% or 1.8 wt% with an adhesive to obtain an adhesive composition, wherein the adhesive layer is laminated to a backing layer, the active steps of the instantly claimed method are met. The examiner notes that wt% and mass% are the same under normal Earth gravity.
Regarding suppressing generation of diclofenac indolinone, it would have been obvious to use the method of Venkateshwaran discussed above to suppress generation of diclofenac indolinone, by specifically selecting the diclofenac free acid form over the sodium salt, where adhesive patches comprising lower solubility diclofenac were known to suppress the generation of the decomposition product diclofenac indolinone, as taught by Katsuyuki, in order to provide a more stable adhesive patch with limited decomposition product.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Patel et al (Int J Pharm Pharm Sci, 2012, Vol 4, Issue 1, 296-299, cited on IDS dated 04/01/2024, hereinafter “Patel”), in view of Katsuyuki (JP 2019055928 A, cited on IDS dated 04/01/2024), as evidenced by PubChem (Diclofenac, retrieved 2026) and Millipore Sigma (Diclofenac sodium salt, retrieved 2026).
Patel is discussed above, and purely arguendo, if somehow the suppression of diclofenac indolinone is not inherent to the method, the following applies.
Katsuyuki is discussed above.
Where Patel discloses a method of formulating an adhesive patch comprising mixing diclofenac free acid at 5 wt% and 7.5 wt% with an adhesive to obtain an adhesive composition, wherein the adhesive is laminated to a backing layer, the active steps of the instantly claimed method are met. The examiner notes that wt% and mass% are the same under normal Earth gravity.
Regarding suppressing generation of diclofenac indolinone, the skilled artisan would have a reasonable expectation of success in using the method discussed above for the method suppression of the generation of diclofenac indolinone, where lower solubility diclofenac, such as the diclofenac free acid, was known to suppress the generation of the degradation product diclofenac indolinone in adhesive patch compositions, as taught by Katsuyuki.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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