DETAILED ACTION
The receipt is acknowledged of applicant’s IDS filed 11/20/2023; and election and IDS both filed 03/19/2026.
Claims 1-10 are pending.
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 .
Election/Restrictions
Applicant’s election without traverse of invention of group I, claims 1-7 in the reply filed on 03/09/2026 is acknowledged.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/09/2026.
Claim Rejections - 35 USC § 112 (a)
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 1-7 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The expression “preset deviation range” in claim 1 is not described in the present specification. Applicants did not describe any thickness of the base sheet or any preset thickness, and how much is the deviation range? The expression is recited without description of the expression does not convey to one of ordinary skill in the art that applicants were in possession of the claimed subject matter because one of ordinary skill in the art could not recognize or understand the expression from its the mere recitation. Claims employing limitation at the point of novelty, such as applicants' , neither provide those elements required to practice the inventions, nor “inform the public” during the life of the patent of the limits of the monopoly asserted. The expression could encompass any thickness of the base sheet and any deviation range and the claimed expression represents only an invitation to experiment regarding possible thicknesses.
The test for determining compliance with the written description requirement is whether the disclosure of the application as originally filed reasonably conveys to one skilled in the art that the inventor had the possession at the time of the later claimed subject matter, rather than the presence or absence of literal support in the specification for the claimed language. See In re Kaslow, 707 F 2d 1366, 1375 (Fed. Cir. 1983). See MPEP 2163.06.
The written description requirement prevents applications from using the amendment process to update the disclosure in their disclosures (claims or specification) during the pendency before the patent office. Otherwise applicants could add new matter to their disclosures and date them back to their original filing date, thus defeating an accurate accounting of the priority of the invention. See 35 USC 132. The function of description requirement is to ensure that the inventor had possession, as of filing date of the application relied on, the specific subject matter claimed by him.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it").
To satisfy the written description requirement, the applicant does not have to utilize any particular form of disclosure to describe the subject matter claimed, but the description must clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. Carnegie Mellon Univ. v. Hoffmann-La Roche Inc., 541 F.3d 1115, 1122 (Fed.Cir.2008) (quoting In re Alton, 76 F.3d 1168, 1172 (Fed.Cir.1996)). In other words, the applicant must `convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and demonstrate that by disclosure in the specification of the patent.
Written description requirement, serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed. Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed.Cir. 2005). The requirement serves a teaching function, as a quid pro quo in which the public is given meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time. (Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 922 (Fed.Cir.2004) (quoting Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 970 (Fed.Cir.2002)). A patentee can lawfully claim only what he has invented and described, and if he claims more his patent is void; Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed.Cir.2000). The purpose of the written description requirement] is to ensure that the scope of the right to exclude and does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.
Claim Rejections - 35 USC § 112 (b)
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 1-7 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.
The expression “preset thickness deviation range” recited by claim 1 is not defined in the specification in terms of what is it thickness and how much is the thickness deviation range. The expression is interpreted as any thickness of the base sheet that has been determined and preset for the base sheet.
The term “partially” in claim 4 is a relative term which renders the claim indefinite. The term “partially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The indefiniteness of the term is exacerbated by the term “at least”. How much the first and second recess need to overlap to meet the expression “at least partially overlap”? 5%, 10% 99%.
Claim 6 is generally narrative and confusing. The recitation of “at least one of the first recesses or the second recesses has a mesh shape on the plane of the base sheet” renders the claim indefinite, failing to conform with current U.S. practice. It is not clear how the recess would have a mesh shape, and how this mesh shape on the plane of the base sheet? They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
The boundaries of coverage for the above 112/b rejections are not imposed by the disclosure. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Watanabe et al. (US 2021/0137799, IDS filed 03/19/2026).
Claim 1 is directed to a patch for attachment on the skin, comprising: a base sheet; and a film disposed on the base sheet and having a preset thickness deviation range.
Watanabe disclosed a patch comprising a support substrate and one or two adhesive layers comprising plurality of recesses, and comprise active agents. Figure 35 shows skin-adhesive film 310K includes an end component 318 and a center component 319 having compositions different from each other. Both the end component 318 and the center component 319 are in contact with the support substrate 331. When viewed in a direction perpendicular to the second surface 311R, the end component 318 is located at least in the annular region OR, and the center component 319 is located at least in the center region CR. The end component 318 and the center component 319 are connected to each other at their ends. The end component 318 and the center component 319 are in contact with each other in a plane parallel to the extending direction of the skin-adhesive film 310K, that is, in a plane parallel with the surface of the support substrate 331. Specifically, the end component 318 and the center component 319 are in contact with each other in the first surface 311F. That is, the first surface 311F is composed of the end component 318 and the center component 319. Thus, a portion of the skin-adhesive film 310K near the first surface 311F, extending along the surface of the support substrate 331, is made of materials different in part. Figure 35 shows that the component 318 has smaller thickness than 319, and further shows that component 318 has a recess and 319 has a recess overlapping each other and neighboring each other. Components 318 and 319 have different air permeability. Recesses may have a mesh shape. (See the entire document, and in particular: ¶¶ 0009, 0061, 0053, 0056, 0066-0069, 0332-0334, 0429-0431, 0494-0498; claims 2 and 15; Figures 17, 22 and 35).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe et al. (US 2021/0137799, IDS filed 03/19/2026).
Applicant Claims
Claim 1 is directed to a patch for attachment on the skin, comprising: a base sheet; and a film disposed on the base sheet and having a preset thickness deviation range.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Watanabe teaches a patch comprising a support substrate and one or two adhesive layers comprising plurality of recesses, and comprise active agents. Figure 35 shows skin-adhesive film 310K includes an end component 318 and a center component 319 having compositions different from each other. Both the end component 318 and the center component 319 are in contact with the support substrate 331. When viewed in a direction perpendicular to the second surface 311R, the end component 318 is located at least in the annular region OR, and the center component 319 is located at least in the center region CR. The end component 318 and the center component 319 are connected to each other at their ends. The end component 318 and the center component 319 are in contact with each other in a plane parallel to the extending direction of the skin-adhesive film 310K, that is, in a plane parallel with the surface of the support substrate 331. Specifically, the end component 318 and the center component 319 are in contact with each other in the first surface 311F. That is, the first surface 311F is composed of the end component 318 and the center component 319. Thus, a portion of the skin-adhesive film 310K near the first surface 311F, extending along the surface of the support substrate 331, is made of materials different in part. Figure 35 shows that the component 318 has smaller thickness than 319, and further shows that component 318 has a recess and 319 has a recess overlapping each other and neighboring each other. Components 318 and 319 have different air permeability. Recesses may have a mesh shape. (See the entire document, and in particular: ¶¶ 0009, 0061, 0053, 0056, 0066-0069, 0332-0334, 0429-0431, 0494-0498; claims 2 and 15; Figures 17, 22 and 35).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012) &
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Watanabe discloses all the limitations of claim 1, and suggests all the limitations of claims 2-7, however does not teach a single embodiment identical to claims 2-7.
As such, the instant prior art does not appear to provide sufficient specificity, i.e., involves some “picking and choosing” to give rise to anticipation. See, Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). That being said, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect.... the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)).
Given the broadest reasonable interpretations of the claims the limitations of claims 2-7 are taught by the reference as follows.
Regarding claim 2, that “ the patch of claim 1, wherein the film has water permeability or gas permeability, and wherein a portion of the film having a smaller thickness has higher water permeability or gas permeability than a portion thereof having a greater thickness”, Watanabe teaches by Figure 35 component 318 has smaller thickness than 319, and components 318 and 319 have different air permeability. Air permeability implies permeability to gas and moisture of the air. Further components having different thicknesses are expected to have different permeability to air. Thicker component expected to have more resistance to the passage of air than thinner component. In any event applicants failed to show any unexpected results obtained from the different thickness and permeabilities.
Regarding claim 3 that “the patch of claim 1, wherein the film includes: a first layer adjacent to the base sheet and having a first base having a first thickness and a first recess of which thickness is smaller than the first thickness; and a second layer disposed on one side of the first layer, and having a second base having a second thickness and a second recess of which thickness is smaller than the second thickness”, components 318 and 319 of Figure 35 suggests the different thickness of the two components and their attachments to different parts of the support sheet that reads on the claimed two bases. Applicants failed to show unexpected results obtained from first and second bases.
Regarding claim 4 that “the patch of claim 3, wherein the first recess and the second recess at least partially overlap each other”; Figure 35 of the reference teaches components 318 and 319 are partially overlapping.
Regarding claim 5 that “the second recess is disposed between neighboring first recesses”, Figure 35 shows that recesses of components 318 and 319 are neighboring each other.
Regarding claim 6 that “at least one of the first recess or the second recess has a mesh shape on the plane of the base sheet”, the reference teaches the recesses may have mesh shape.
Regarding claim 7 that “the second layer contains an effective material to be delivered to the skin”, the reference teaches active agent in any of the adhesive layers to be delivered to the skin.
Therefore, consistent with the above reasoning, it would have obvious to one having ordinary skill in the art to have selected the various combinations of features claimed from within the prior art disclosure, specifically limitations of claims 2-7 to achieve the present invention.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached at 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ISIS A GHALI/Primary Examiner, Art Unit 1611
Prosecution Insights