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 .
DETAILED ACTION
Claim Status
Claims 25-44 are newly added.
Claims 25-44 are pending and under consideration.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 29 Nov 2023, 18 Jan 2024, 15 Feb 2024, 18 Apr 2024, 02 May 2024, 30 Jul 2024, 21 Oct 2024, 31 Oct 2024, 01 Apr 2025, and 30 Sep 2025 are in compliance with the provisions of 37 CFR 1.97, except where noted. Accordingly, the information disclosure statement is being considered by the examiner.
WO 2013/191128, WO 2018/124089, WO 2018 141662, WO 2009/0961315, and JP 8026985 listed on IDS filed 18 Jan 2024 were not considered as copies were not provided.
Claim Objections
Claims 25 and 29 are objected to because of the following informalities:
Claim 25 recites “wherein the patch is used to be applied to an affected part once a day and so that a dose…” The wording here is difficult to read and could be improved, perhaps with wording such as “wherein the patch is applied to an affected part once a day so that a dose...”
Claim 29 recites “the patch is used to be alternately applied.” This wording could be improved for better readability, such as “the patch is alternately applied.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 27, 31, 34, 36, 38, and 43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 is indefinite in the recitation of an “adhesive mass” for improper antecedent basis. It is not clear if “adhesive mass” is intended to refer to the adhesive layer, the adhesive base, or to a section of the patch including the adhesive layer and the backing layer.
Claim 31 is unclear in the recitation of concentration-time curve values over the time of administration to a final time point upon a single administration of the patch. The time period of “a single administration of the patch” is arbitrary and not clearly defined. For example, a single administration may be 1 hour, 1 day, or any time before the patient decides to remove the patch. When the comparison is simply to “a single administration” period the same patch can have different concentration-time curve values and may or may not meet the limitation depending on how long the administration time is. Thus, it is unclear how the concentration-time curve value with a single administration limits the claim.
Claim 34 is unclear in the recitation of “a release rat of diclofenac Is 8.6% to 10.7% upon a single administration of the patch” as it is not clear how this is intended to limit the claim. The time period of “a single administration of the patch” is arbitrary and not clearly defined. For example, a single administration may be 1 hour, 1 day, or any time before the patient decides to remove the patch. When the comparison is simply to “a single administration” period the same patch can have different release rates. Thus, it is unclear how this phrase is intended to limit the claim.
Claim 36 is unclear in the recitation of concentration-time curve values at an administration interval when administration of the patch once a day is repeated to reach a steady state. The time period of “an administration interval” is arbitrary and not clearly defined. For example, a single administration interval may be 1 hour or 2 hours, or any time before the patient decides to remove the patch for the day. When the comparison of the concentration-time curve is simply to “an administration interval” the same patch can have different concentration-time curve values and may or may not meet the limitation depending on how long the administration interval is. Thus, it is unclear how the concentration-time curve values at an undefined administration interval limits the claim.
Claim 38 recites a “release rate of diclofenac is 9.3% to 14%.” It is unclear what “release rate” means in this context as the percentages are not associated with any time. It is unclear how the 9.3% to 14% is intended to limit the claim. For example, it is not clear if the percentages represent how much of the total diclofenac is released after a specific time such as 1 hour or if this is intended to represent the total amount of diclofenac that is released upon administration in comparison to starting amount in the patch.
Claim 43 lacks proper antecedent basis for “the organic acids” as claim 25 recites “an organic acid” and it is unclear if the plural acids in claim 43 refers to the same acid of claim 25 or to a different set of acids.
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.
Claims 25-44 are rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (US 2015/0202171, published 23 Jul 2015, listed in IDS filed 18 Jan 2024) as evidenced by DRT (Foral 85®-Hydrogenated Resin by DRT).
Hatanaka teaches a patch comprising a support layer and an adhesive layer where the adhesive layer comprises diclofenac sodium, dimethyl sulfoxide, citric acid (abstract) and oleic acid ([0015]). A support layer is understood to render obvious a “backing layer” as in the instant claims. Hatanaka teaches that the adhesive layer may be laminated ([0046]). Hatanaka teaches that the citric acid may be from 0.15 to 9% by mass relative to the total mass of the adhesive layer ([0032]) and the oleic acid is from 1 to 10% by mass relative to the total mass of the adhesive layer ([0036]). The citric acid and oleic acid and the amounts cited above render obvious the organic acids of claims 25, 43 and 44. 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). Hatanaka teaches the adhesive layer with rubber type adhesives ([0037]) including a combination of adhesives such as polyisobutylene and styrene-isoprene-styrene block copolymers ([0038]), rendering obvious the adhesive base of claim 25 and 39. Hatanaka teaches a combination of tackifiers such as alicyclic saturated hydroocarbon resins and hydrogenated rosin esters ([0041]) such as FORAL 85. As evidenced by DRT, FORAL 85 is a glycerol ester of highly hydrogenated wood rosin (page 1). Thus, Hatanaka renders obvious the components of claim 40. Hatanaka teaches the adhesive layer may have a plasticizer ([0037]) such as liquid paraffin ([0043]), rendering obvious claim 41. Hatanaka teaches that the diclofenac sodium may be from 2 to 10% by mass relative to the total mass of the adhesive layer ([0029]), rendering obvious claim 42. Regarding claim 26, Hatanaka teaches that the patch may have an area of 50 to 200 cm2 ([0049]). Hatanaka teaches that the area of the patch is not particularly limited as long as a skin permeation amount of diclofenac that is therapeutically effective can be attained ([0049]). Hatanaka teaches that the thickness of the adhesive layer is normally 10 to 500 μm ([0046]).
Hatanaka does not expressly teach selecting the components and their percentages for the patch with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed a patch with a support layer and an adhesive layer where the adhesive layer comprises diclofenac sodium dimethyl sulfoxide, oleic acid, citric acid, and stryrene-isoprene-stryrene block copolymer and polyisobutylene (i.e. the adhesive base). One of ordinary skill in the art would have been motivated to do so as patch formulation and each of these components are taught by Hatanaka a suitable for forming a patch. One of ordinary skill in the art would have a reasonable expectation of successfully forming a diclofenac sodium patch as taught by Hatanaka since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions. Regarding the adhesive mass as in claim 27, the examiner notes that the mass per area would be dependent on the components of the layer and the thickness of the adhesive layer. The same components as the required per the patch of the instant claims are obvious and the adhesive layer may vary from 10 to 500 μm, as known from Hatanaka. Although Hatanaka does not explicitly teach the adhesive mass, the varying thickness of the layer would result in varying mass values per unit area and the limitation is met from the product obvious from the prior art. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
The examiner notes that the claims consist of various intended uses for the product. The limitations that patch is for “treating osteoarthritis” and “knee osteoarthritis” (claim 28) are intended uses of the claimed patch. Similarly, the last limitation in claim 25 that the patch is applied once a day so that a dose of diclofenac sodium per administration is 70-150 mg, and the limitation of application to inner and outer sides of a knee every day (claim 29) are intended uses of the patch. These limitations describe how the patch is applied and what dosing is desired for a single administration but this does not further define the patch itself. The intended use of a product claim carries no patentable weight. See MPEP 2111.02. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"). It is obvious to adjust the amount of diclofenac delivered by the patch to meet needs for a particular therapeutic treatment, as taught by Hatanaka, and the application time and location do not further define the patch.
Regarding claim 30 and the maximum plasma concentration, claims 31-32 and 36 and the area under concentration-time curve per administration, claim 33 and 37 and the half-life of the plasma concentration, and claims 34 and 35 and the amount of diclofenac released in an administration of the patch, these limitations describe what happens in the body after administration, how long the patch may be administered for and how the patch functions upon administration, but do not clearly differentiate the claimed patch from the patch that is obvious from the teachings of Hatanaka, as described in the rejection above. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). As the same product of the claims is obvious from the teachings of Hatanaka, claims 30-37 and the properties described therein do not overcome the case of obviousness.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Hatanaka.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 25-44 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-50 of U.S. Patent No. 11,872,320. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the reference claims.
The ‘320 patent recites an method for treating osteoarthritis with a patch the same as the instant patch. The method is shown here.
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Claims 2 and 3 render obvious the patch size and mass of adhesive mass of the instant claims and claims 4 and 5 indicates knee osteoarthritis and application to inner and outer sides of knee.
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Claims 6-14 recite plasma concentrations, concentration-time curves and release rates that overlap with and render obvious the instant claims.
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Claims 15-17 recite amounts of diclofenac and organic acid that renders obvious the components of the instant claim.
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Claim 18 recites alicyclic saturated hydrocarbon resin and hydrogenated rosin glycer ester in the adhesive layer and claim 34 recites liquid paraffin.
Thus, the patch used in the ‘320 patent renders obvious the patch of the instant claims.
Claims 25-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14, 15 and 17-27 of copending Application No. 17/763,921 in view of Hatanaka et al. (US 2015/0202171, published 23 Jul 2015, listed in IDS filed 18 Jan 2024).
The ‘921 application recites a method for relieving cancer pain with a patch that has a backing layer and an laminated adhesive layer comprising an adhesive base, and diclofenac sodium (claim 14), comprising 75 mg diclofenac (claim 15), styrene-isoprene-styrene block copolymer, polyisobutylene (claim 17), DMSO (claim 19), oleic acid (claim 21), alicyclic saturated hydrocarbon resin and hydrogenated rosin glycerin ester (claim 23), liquid paraffin (claim 25) and an area of 50-150 cm2.
The ’921 application does not recite 3-7% diclofenac, citric acid, or the percentage of acid. These deficiencies are made up for in the teachings of Hatanaka.
The teachings of Hatanaka are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included diclofenac from 2-10%, citric acid from 0.15-9%, and oleic acid from 1-10% as Hatanaka teaches similar diclofenac patches and these components and percentages are known to be suitable for such patches and it would be obvious to use these prior art elements for the same purpose of forming a patch. The examiner notes that the ‘921 application does not recite that the patch is for treating osteoarthritis, but this is an intended use of the patch in the instant claims and does not distinguish the patch from what is obvious. Similarly, the limitations regarding how the patch is applied and the resulting effects on the user such as the plasma concentration are intended uses and properties that result from using the same patch that is obvious over the ‘921 claims.
This is a provisional nonstatutory double patenting rejection.
Claims 25-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 19/227,061 in view of Hatanaka et al. (US 2015/0202171, published 23 Jul 2015, listed in IDS filed 18 Jan 2024).
The ‘061 application recites a method for relieving lumbago with a patch that has a backing layer and an laminated adhesive layer comprising an adhesive base, and 0.7-1.5 mg/cm2 diclofenac sodium (claim 1), styrene-isoprene-styrene block copolymer, polyisobutylene (claim 3), DMSO (claim 4), oleic acid (claim 6), alicyclic saturated hydrocarbon resin and hydrogenated rosin glycerin ester (claim 8), liquid paraffin (claim 10), 50-100 mg diclofenac (claim 11) and an area of 50-150 cm2 (claim 14).
The ‘061 application does not recite 3-7% diclofenac, citric acid, or the percentage of acid. These deficiencies are made up for in the teachings of Hatanaka.
The teachings of Hatanaka are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included diclofenac from 2-10%, citric acid from 0.15-9%, and oleic acid from 1-10% as Hatanaka teaches similar diclofenac patches and these components and percentages are known to be suitable for such patches and it would be obvious to use these prior art elements for the same purpose of forming a patch. The examiner notes that the ‘061 application does not recite that the patch is for treating osteoarthritis, but this is an intended use of the patch in the instant claims and does not distinguish the patch from what is obvious. Similarly, the limitations regarding how the patch is applied and the resulting effects on the user such as the plasma concentration are intended uses and properties that result from using the same patch that is obvious over the ‘061 claims and Hatanaka.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner., Art Unit 1600