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 .
Claim Status
Claims 1-8 are pending.
Priority
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The foreign priority document is not in English. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/29/23 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 2, 3, 6 and 7 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.
Parenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125). These claims contain parentheses which raises the question as to which term is required by the claim because the subject matter in the parentheses is not identical in scope. In one interpretation, the claims use both narrow and broad limitations. For example, claims 2 and 6 recite “(100% by mass)” but an initial content of dimethyl sulfoxide could be different. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In an alternative interpretation, the limitation is redundant when the initial content of dimethyl sulfoxide is 100%. Similarly, the limitation of “(mass of diclofenac sodium : mass of dimethyl sulfoxide)” is either of a different scope or redundant. Accordingly, the parenthetical expressions do not contribute to clearness or exactness in stating Applicant’s invention. Correction is required. The Examiner suggests deleting the parenthetical expressions.
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 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.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hatanaka et al. (US9308187) and Yamamoto et al. (US6991095) and Tohara et al. (WO2016103999; English translation provided).
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.
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical formulation research scientist, as is the case here, then one can assume comfortably that such an educated artisan will have knowledge of not only transdermal drug delivery systems, including the function of each component like the drug reservoir, release membrane, adhesive, backing, and liner, as well as how to select appropriate polymers, adhesives, and permeation enhancers to optimize drug release, adhesion, and stability, but also knowledge about the packaging requirements to maintain product integrity, shelf life, and ease of use for the patient.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 3, 5 and 7, Hatanaka et al. teach a patch comprising a support layer and an adhesive layer, wherein the adhesive layer comprises diclofenac sodium and dimethyl sulfoxide solvent wherein a mass ratio between the diclofenac sodium and the dimethyl sulfoxide (mass of diclofenac sodium:mass of dimethyl sulfoxide) is 1:0.75 to 1:3 (Abstract; claims 1 and 5), which overlaps the claimed range of 1:1 to 1:2. The “support layer” is reasonably interpreted to read upon a backing layer. Hatanaka et al. teach 2-10% by mass sodium diclofenac relative to the total mass of the adhesive layer (Claim 5), which overlaps the claimed range of 1-10% by mass. See MPEP 2144.05(I): 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).
Regarding claims 4 and 8, Hatanaka et al. teach a content of 3-10% by mass of dimethyl sulfoxide relative to the total mass of the adhesive layer (Claim 5), which overlaps the claimed range of 4-8% by mass.
Regarding claims 1-8, Yamamoto et al. teach the concept of a packaged patch with a patch package composed of a laminated packaging material (Abstract; Figure 1) comprising sodium diclofenac and a pressure sensitive adhesive (Claims 7-9). Aluminum foil is the outer packaging layer (Figure 1; column 5, lines 29-43; Example 3) but can be made of other materials that block moisture including polyester (Column 9, lines 21-35; Column 10, lines 42-44). Yamamoto et al. teach that the packaged patch is held in a stable state for prolonged periods (Abstract).
Regarding claims 1-8, Tohara et al. teach package for a patch to assure high temporal stability of a drug comprising a packaging bag formed of a laminate including a cyclic polyolefin (Tilte; Abstract) where the drug is provided on a support with a pressure sensitive adhesive (Claim 1). Tohara et al. teach that the package has at least 3 layers where the innermost layer contains the cyclic polyolefin and an oxygen barrier layer is proved in the outer layer and an outer layer to the oxygen barrier layer (Claim 11; Description of the Embodiments section: “Packaging bag”). Tohara et al. also teach employing polyethylene terephthalate (Sections: “Outer layer” and “Laminate”). Tohara et al. teach in Examples 1-2 a laminate structure comprising: cyclic olefin; polyethylene terephthalate; and aluminum film. Tohara et al. teach that the drugs include anti-inflammatory agents (Section: “drugs”). Tohara et al. teach sealing the opening after inserting the patch (Section: “Manufacturing method of patch products”).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
1. The difference between the instant application and Hatanaka et al. is that Hatanaka et al. do not expressly teach sealing the diclofenac-containing patch in a packaging bag the packaging bag being formed of a laminate at least comprising: an innermost layer composed of at least one selected from the group consisting of polyethylene terephthalate and cycloolefin polymer; an oxygen barrier layer arranged outside the innermost layer; and an outer layer arranged outside the oxygen barrier layer. This deficiency in Hatanaka et al. is cured by the teachings of Yamamoto et al. and Tohara et al.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to put the patch of Hatanaka et al. in a packaging bag the packaging bag being formed of a laminate at least comprising: an innermost layer composed of at least one selected from the group consisting of polyethylene terephthalate and cycloolefin polymer; an oxygen barrier layer arranged outside the innermost layer; and an outer layer arranged outside the oxygen barrier layer, as suggested by Yamamoto et al. and Tohara et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Yamamoto et al. already teach and suggest placing diclofenac patches in a package and that the packaged patch is held in a stable state for prolonged periods. Tohara et al. provide a laminated packaging bag that assures high stability and reads upon the claimed packaging bag for anti-inflammatory drugs with the same innermost layer, oxygen barrier layer and outer layer arranged outside the oxygen barrier layer. It is then desirable for the ordinary artisan to use the laminated packaging bag of Tohara et al. to seal the diclofenac sodium/DMSO patch of Hatanaka et al. in the packaging bag of Tohara et al. with a reasonable expectation of success. So doing reads upon a method for stabilizing diclofenac sodium patch package product. It would appear to be at the discretion of the ordinary artisan to construct the innermost layer from polyethylene terephthalate and/or cycloolefin polymer in the absence of unexpected results.
2. The difference between the instant application and Hatanaka et al. is that Hatanaka et al. do not expressly teach the functional limitations of: wherein after storing the package product under conditions of 60°C and 75% relative humidity for two weeks, a content of the dimethyl sulfoxide is maintained at 40% by mass or more based on an initial content of the dimethyl sulfoxide (100% by mass); after storing the package product under conditions of 60°C and 75% relative humidity for two weeks, the mass ratio of the initial content of the diclofenac sodium to the content of the dimethyl sulfoxide (mass of diclofenac sodium: mass of dimethyl sulfoxide) is maintained at 1 :0.6 to 1:2; after storing the package product under conditions of 60°C and 75% relative humidity for two weeks, the content of the dimethyl sulfoxide is maintained at 3% by mass or more based on the total mass of the adhesive layer.
This deficiency in Hatanaka et al. is cured by the teachings of Yamamoto et al. and Tohara et al. As explained above, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to package the patch of Hatanaka et al., in the packaging bag of Yamamoto et al., as suggested by Yamamoto et al. and Tohara et al. and produce the instant invention. The functional stability limitations naturally flow from having the same packaging as claimed. Especially when Tohara et al. teach and suggest an assurance of high stability over time. See MPEP 2112.01(I): 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). "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 re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
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 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 9308187 in view of Yamamoto et al. (US6991095) and Tohara et al. (WO2016103999). The instant application and the patent name different inventive entities but are commonly assigned to Hisamitsu Pharmaceutical Co., Inc. As discussed supra, the patent teaches a patch comprising a support layer and an adhesive layer, wherein the adhesive layer comprises diclofenac sodium and dimethyl sulfoxide solvent wherein a mass ratio between the diclofenac sodium and the dimethyl sulfoxide (mass of diclofenac sodium:mass of dimethyl sulfoxide) is 1:0.75 to 1:3 (Claims 1 and 5), which overlaps the claimed range of 1:1 to 1:2. The “support layer” is reasonably interpreted to read upon a backing layer. Hatanaka et al. teach 2-10% by mass sodium diclofenac relative to the total mass of the adhesive layer (Claim 5), which overlaps the claimed range of 1-10% by mass. See MPEP 2144.05(I): 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).
The patent does not expressly teach sealing the diclofenac-containing patch in a packaging bag the packaging bag being formed of a laminate at least comprising: an innermost layer composed of at least one selected from the group consisting of polyethylene terephthalate and cycloolefin polymer; an oxygen barrier layer arranged outside the innermost layer; and an outer layer arranged outside the oxygen barrier layer and the resulting stability functional parameters. However as set forth above and incorporated here by reference, it is a known concept to package a diclofenac patch in packaging through the teachings of Yamamoto et al. Tohara et al. provide a laminated packaging bag that assures high stability and reads upon the claimed packaging bag for anti-inflammatory drugs with the same innermost layer, oxygen barrier layer and outer layer arranged outside the oxygen barrier layer. It is then desirable for the ordinary artisan to use the laminated packaging bag of Tohara et al. to seal the diclofenac sodium and DMSO solvent patch of Hatanaka et al. in the packaging bag of Tohara et al. with a reasonable expectation of success. So doing reads upon a method for stabilizing diclofenac sodium patch package product. The claimed stability functional parameters naturally flow from having the same active agent in the same packaging bag. Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter in view of the secondary references.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8 and 10-12 of U.S. Patent No. 12178922 in view of Yamamoto et al. (US6991095) and Tohara et al. (WO2016103999). The instant application and the patent name different inventive entities but are commonly assigned to Hisamitsu Pharmaceutical Co., Inc. The patent teaches a patch with a backing layer and an adhesive layer with 2-12 mass% DMSO or 2-10% mass DMSO or 2-8% mass DMSO (Claims 1, 10-11) or 3-12% (Claim 12) and diclofenac sodium (Claims 6 and 8).
The patent does not expressly claim an initial amount of diclofenac sodium of 1-10% by mass or a ratio of diclofenac sodium to DMSO of 1:1 to 1:2. However, the scope of the diclofenac sodium concentration can range from 1-20% (Column 2, lines 43-43) and can be in a ratio of 1:0.72 to 1:3 with the DMSO (Column 2, lines 52-60). MPEP 804: “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.” Thus, the claimed amounts and ratios are obvious and within the scope of the patent.
The patent does not expressly teach sealing the diclofenac-containing patch in a packaging bag the packaging bag being formed of a laminate at least comprising: an innermost layer composed of at least one selected from the group consisting of polyethylene terephthalate and cycloolefin polymer; an oxygen barrier layer arranged outside the innermost layer; and an outer layer arranged outside the oxygen barrier layer and the resulting stability functional parameters. However as set forth above and incorporated here by reference, it is a known concept to package a diclofenac patch in packaging through the teachings of Yamamoto et al. Tohara et al. provide a laminated packaging bag that assures high stability and reads upon the claimed packaging bag for anti-inflammatory drugs with the same innermost layer, oxygen barrier layer and outer layer arranged outside the oxygen barrier layer. It is then desirable for the ordinary artisan to use the laminated packaging bag of Tohara et al. to seal the diclofenac sodium and DMSO solvent patch of the patent in the packaging bag of Tohara et al. with a reasonable expectation of success. So doing reads upon a method for stabilizing diclofenac sodium patch package product. The claimed stability functional parameters naturally flow from having the same active agent in the same packaging bag. Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the patented subject matter in view of the secondary references.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 17433289 in view of Yamamoto et al. (US6991095) and Tohara et al. (WO2016103999). The copending has the same inventive entity and assignee. The copending is directed to:
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The copending application does not expressly teach sealing the diclofenac-containing patch in a packaging bag the packaging bag being formed of a laminate at least comprising: an innermost layer composed of at least one selected from the group consisting of polyethylene terephthalate and cycloolefin polymer; an oxygen barrier layer arranged outside the innermost layer; and an outer layer arranged outside the oxygen barrier layer and the resulting stability functional parameters. However as set forth above and incorporated here by reference, it is a known concept to package a diclofenac patch in packaging through the teachings of Yamamoto et al. Tohara et al. provide a laminated packaging bag that assures high stability and reads upon the claimed packaging bag for anti-inflammatory drugs with the same innermost layer, oxygen barrier layer and outer layer arranged outside the oxygen barrier layer. It is then desirable for the ordinary artisan to use the laminated packaging bag of Tohara et al. to seal the diclofenac sodium and DMSO solvent patch of the copending application in the packaging bag of Tohara et al. with a reasonable expectation of success. So doing reads upon a method for stabilizing diclofenac sodium patch package product. The claimed stability functional parameters naturally flow from having the same active agent in the same packaging bag. Accordingly, the ordinary artisan would have recognized the obvious variation of the instantly claimed subject matter over the copending application subject matter in view of the secondary references.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613