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 .
Status of Claims: 1-20 are pending and under examination in this office action.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed December 12, 2023. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
Claim Objections
Claim 1 is objected to because of the following informalities: The abbreviation DMSO should be given as its full name or with the full name in parenthesis therewith when first used. 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.
Claim 1 is 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 claim recites that the adhesive is compatible with DMSO. Since there is no indication what the substrate is , it is unclear how to know it is compatible with DMSO. Clarity is required.
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(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Piferi et al. (WO 2009/042155) in view of Smith et al. (US 2010/0221313) and further in view of Androila et al. (DE 3642931) and Rogers et al. (KR 20200015919).
Piferi teaches a medical system (see 002) comprising a patch (see abstract) and a fiducial marker (see abstract) wherein the patch comprises a substrate comprising silicone (i.e., see 0020), a pocket (see 0015) with an opening (see 001310), wherein the patch bonds to the skin via the adhesive (see 0088 as required also by instant claim 20) and wherein the patch is used for introducing, e.g., stem cells into the body (see 0079), wherein the system is used for imaging (see 0022 as required by instant claim 13). With regards to instant claim 2, the patch comprises a peelable liner (see 00104, as required by instant claim 20 also). Piferi also teaches that the MRI-visible fiducial has a first and second material (see 0015) and the material may comprise a visible liquid (to which the Examiner interpretes as a dye (as required by instant claims 5-6 and 18) and allows imaging (as required by instant claim 13, see 0022) . The reference also teaches the substrate is a stretchable material (as required by instant claim 17, see 0020)
However Piferi fails per-se to teach introduction of the first material and the second material sequentially. Although Piferi did not per se teach an imaging agent and that the material is configured to activate by radiation, the act recognizes that fiducial marker are objects used for imaging and is activated by radiation (absent factual evidence to the contrary, as required by instant claims 7-8). Piferi also fails to teach a flap.
Smith teaches with regards to instant claim 1, a transdermal reservoir patch (see tittle) comprising a substrate (150) and adhesive layer adhered to the substrate (160), wherein the patch is configured to adhere to the skin and form a pocket space between the substrate and the skin to hold a drug (135) and protrudes outwards (see Fig. 1, see also para 0038-0039 and Fig. 1). With regards to instant claim 2, comprises a peelable liner (see 0058-0059), a first and second material (see abstract, as required by instant claim 3) to be applied to the skin surface 9see 0081). Additionally, Smith teaches sequentially introducing the pharmaceutical agent from the first adhesive layer to the second adhesive layer (see 0014, as required by instant claim 4).
Andriola teaches multiple sided transdermal patch for delivery of controlled amount of active (see description) with a removeable protective layer (i.e., peelable, as required by instant claim 2) comprising a flap opening for introducing the active agent (thus an opening with a closure, see Fig. 8, as required by instant claims 1 and 15) and therefore configured to hold the material for about 1 sec to 5mins (as required by instant claim 16).
Rogers teaches a microfluid patch comprising an adhesive that binds to the skin, comprising the use of dye (see example 1) wherein the radiation is an electromagnetic radiation (as required by instant claims 7 and 9, see translation) and the opening can be a tube (see translation as required by instant claims 14-15). Although Rogers did not per-se teach that the dye is fluorescent, since an electromagnectic radiation is applied it is within the purview of the skilled artisan to use a dye that fluoresces with a reasonable expectation of success for easy visability and diagnosis.
It would have been obvious to one of ordinary skill in the art to have expanded the teachings of Piferi to include Smith’s Andriola and Roberts teaching to form a system comprising a substrate that has a pocket to hold the material or drug in the opening with a reasonable expectation of success to combine these references and make the modification because they are drawn to same technical fields (constituted with same ingredients and share common utilities, and pertinent to the problem which applicant concerns about. MPEP 2141.01(a).
Although the recited references fail to teach that the patch further comprises a stretchable material, the flab either has the same or different substrate, it would have been obvious to one of ordinary skill in the art to have the same or different substrates such as material selected from the group consisting of polyvinyl, PET, silicone, polyethylene, polyurethane, and polyamide as taught by Piferi (see 0020). The combination would have resulted in the instant claimed invention at the time the invention was made.
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 - 20 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 - 16 of U.S. Patent No. 11872111. Although the conflicting claims are not identical, they are not patentably distinct from each other. The reasons are as follows:
· The claims of the patent recites a device comprising a patch comprising: (i) a substrate… device further comprises a peelable liner, compatible with DMSO, flexible , comprises a dye, a clamp to open and close, the opening etc and the instant is to a system comprising a patch, has a substrate compatible with DMSO, an opening comprising a flap to react to the skin etc.
It would have been obvious to one of ordinary skill in the art to have used the instant claims in practicing the patented claims with a reasonable expectation as a system in the instant claims can be a device as well see patented claims 12. The current application claims are obvious variation of the patented application claims
· Both applications recite using the same compositions and/or derivatives thereof.
In view of the foregoing, the patented claims and the current application claims are obvious variations.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/ Primary Examiner, Art Unit 1615 11/20/25