DETAILED ACTION
The receipt is acknowledged of applicant’s amendment filed 11/20/2025.
Claims 1, 8, 10-11, 23-25, and 32-41 are pending.
Claims 8, 10, 23-25, and 32-41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention II and species of the claimed device, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/30/2025.
Claims 1 and 11 are subject of this office 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 .
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 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14 and 16 of U.S. Patent No. 12,109,318. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed and claimed in the issued patent and would be covered by the issued claims since the issued claims and the instant application are claiming common subject matter as follows: device for the topical delivery of a topical formulation, the device comprising: a flexible material and a compartment configured to contain the topical formulation, wherein the compartment comprises a side wall, a top, and an opening that is opposite the top, wherein the flexible material comprises a front side and a back side, wherein the flexible material surrounds the-side wall opening, and the side wall protrudes from the front side of the flexible material, and wherein, when the device is placed onto the skin of a patient, the device is on top of the skin, the back side of the flexible material is in contact with the patient's skin, and the surface of the top that faces the opening is exposed to the patient's skin via the opening. The issued claims anticipate the current claims.
Claims 1 and 11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of copending Application No. 18/896,312 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed in the referenced copending applications and would be covered by any patent granted on the copending applications since the referenced copending applications and the instant application are claiming common subject matter as follows: device for the topical delivery of a topical formulation, the device comprising: a flexible material and a compartment configured to contain the topical formulation, wherein the compartment comprises a side wall, a top, and an opening that is opposite the top, wherein the flexible material comprises a front side and a back side, wherein the flexible material surrounds the-side wall opening, and the side wall protrudes from the front side of the flexible material, and wherein, when the device is placed onto the skin of a patient, the device is on top of the skin, the back side of the flexible material is in contact with the patient's skin, and the surface of the top that faces the opening is exposed to the patient's skin via the opening. The copending claims and the current claims anticipate each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 and 11 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 1 is confusing because claim 1 does not set forth the metes and bounds of the claim. The claim recites “the surface of the top that faces the opening….”, the claim is not clear regarding what is the top? Top of what? It seems that the claims recite different parts from different embodiments. The examiner suggests to claim one embodiment and not different parts from different embodiments. The boundaries of coverage is 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
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.
Claims 1 and 11 are rejected under 35 U.S.C. 103 as being unpatentable overhang et al. (US 2006/0105028, currently cited on PTO 892).
Applicant Claims
Claim 1 is directed to a device for the topical delivery of a topical formulation, the device comprising:
a flexible material and a compartment configured to contain the topical formulation,
wherein the compartment comprises a side wall, a top, and an opening that is opposite the top,
wherein the flexible material comprises a front side and a back,
wherein the flexible material surrounds the opening, and the side wall protrudes from the front side of the flexible material, and
wherein, when the device is placed onto the skin of a patient, the device is on top of the
skin, the back side of the flexible material is in contact with the patient's skin, and the surface of
the top that faces the opening is exposed to the patient's skin via the opening.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Zhang teaches patch comprising an open cavity being configured to become a closed cavity upon application and adherence to a skin surface. The cavity is configured to contain topical formulation to contact skin upon application of the patch. The cavity is a drug reservoir and defined by the patch wall forming a ring. The ring is covered with adhesive on the side facing the skin for adhering the ring surrounding the open cavity patch to the skin. The material of the patch is flexible, and the patch is a single structure. The adhesive layer that attach the side wall to the skin reads on the claimed flexible layer wherein the side wall protrudes from the flexible material (see the entire document, and in particular: abstract; ¶¶ 0006, 0007, 0022, 0023, 0025, 0030, 0032, 0035, 0038, 0041; figures; examples; and claims).
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)
Regarding claim 1, while the reference teaches patch comprising side wall surrounding cavity containing active material, and teaches the side wall is covered at its lower side by an adhesive layer, that reads on the side wall protrudes from the flexible layer, and teaches the material of the patch is flexible including the skin adhesive layer is flexible, the reference does not teach the flexible layer, i.e. adhesive, surrounds the side wall as claimed by claim 1.
However, it would have been obvious to increase the size and thickness of the adhesive layer and extend it to surround part of the side wall for better adherence to the skin, and in this case the side wall that is protruded from the flexible adhesive will be surrounded partially by the flexible adhesive as instantly claimed. in any event, applicant failed t show any unexpected result obtained from extending side wall being protruding from the front side of the flexible material.
Regarding claim 11 that the compartment is a unitary piece, this is taught by the Zhang and as also shown by the figures of the reference.
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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 11 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611 /I.G./