DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 7/14/2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/28/2026 has been entered.
Status of the Claims
Claims 1-4 and 8 have been amended. Claims 7, 20 and 21 are cancelled. Claims 22 and 23 are newly added. Accordingly, claims 1-6, 8-19 and 22-23 remain pending in the application. Claims 13-19 stand withdrawn from further consideration, with traverse. Claims 1-6, 8-12 and 22-23 are currently under examination.
Election/Restrictions
Applicant is kindly reminded of the potential for rejoinder of withdrawn claims.
Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder.
Withdrawn Objections/Rejections
Applicant’s amendment renders the rejection of claims 1-6 and 8-12 under 35 USC 103 over Menon in view of Hobbs moot. Specifically, the references do not teach the newly added limitation regarding multiple surface depressions extending inwardly from the first major surface and comprising aqueous phase regions. Thus, said rejection has been withdrawn.
Claim Rejections - 35 USC § 112
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.
Claim 8 is 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.
37 CFR §1.118 (a) states that "No amendment shall introduce new matter into the disclosure of an application after the filing date of the application".
There is no explicit or implicit teaching in the specification for a pressure-sensitive adhesive comprising an acrylic polymer or copolymer and further comprising a natural rubber or synthetic rubber polymer or copolymer, or a silicone polymer; the subject matter was not properly described as filed. The specification states at page 3, lines 30-38,
In some embodiments, the pressure-sensitive adhesive may be selected from an acrylic polymer or copolymer. In some embodiments, the acrylic polymer or copolymer may be the reaction product one of monomers selected from an alkyl (meth)acrylate, N-vinyl pyrrolidone, N-vinyl caprolactam, (alkyl- substituted)acrylamide, (alkyl-substituted)methacrylamide, 2-hydroxyethyl (meth)acrylate or and a combination thereof In some embodiments, the pressure-sensitive adhesive may be selected from a rubber polymer or copolymer. Suitable rubber polymers include natural rubber, polybutadiene, and polyisobutylene. Suitable rubber copolymers include styrenic block copolymers such as styrene-butadiene- styrene, styrene-isoprene-styrene, and styrene-ethylene-butadiene-styrene. In some embodiments, the pressure-sensitive adhesive may be selected from a tackified silicone polymer.
The specification, thus, provides support only for an acrylic polymer or copolymer, a rubber polymer or copolymer, or a tackified silicone polymer, in the alternative. Applicant is invited to identify the portion of the specification that teaches said limitation, as the examiner has not been able to locate the applicable disclosure. The claims within this rejection are examined as written by the applicant; at this time new matter must be considered as part of the claimed subject matter.
MPEP 2163.06 notes: "If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981)." MPEP 2163.02 teaches that "Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed...If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application. MPEP 2163.06 further notes "When an amendment is filed in reply to an objection or rejection based on 35 U.S.C. 112, first paragraph, a study of the entire application is often necessary to determine whether or not "new matter" is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure".
This is a new matter rejection. Correction is respectfully requested.
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 1-6, 8-12, 22 and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-12, 16-19 and 23-25 of copending Application No. 19/119,944 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and subject matter of the copending claims are significantly overlapping.
The instant claims are drawn to an antimicrobial-impregnated adhesive sheet, comprising: an antimicrobial; and a pressure-sensitive adhesive comprising an acrylic polymer or copolymer having a hydrophilic-lipophilic balance (HLB) value of less than 5, wherein the acrylic polymer or copolymer comprises isooctyl acrylate, acrylamide, N-vinyl pyrrolidone, or a combination of two or more thereof; wherein the antimicrobial-impregnated adhesive sheet comprises a first major surface and a second major surface; wherein the antimicrobial-impregnated adhesive sheet comprises multiple surface depressions extending inwardly from the first major surface and comprising aqueous phase regions; and wherein an available fraction of the antimicrobial at the first major surface is at least 30% of a total amount of the antimicrobial in the antimicrobial-impregnated adhesive sheet.
The copending claims are drawn to an antimicrobial-impregnated adhesive sheet, comprising: an aqueous antimicrobial composition comprising an antimicrobial; a pressure-sensitive adhesive; a first major surface; a second major surface; and a plurality of surface depressions extending inwardly from the first major surface; and wherein an initial available fraction of the antimicrobial at the first major surface is at least 30% of a total amount of the antimicrobial in the antimicrobial-impregnated adhesive sheet; wherein the plurality of surface depressions corresponds to dried down equivalents of discrete aqueous phase regions, and wherein the antimicrobial-impregnated adhesive sheet exhibits a retention of the initial available fraction of the antimicrobial at the first major surface, after accelerated aging, of at least 50%; a medical article thereof; and a method of making thereof. The copending claims further recite wherein the multiple surface depressions are distributed over the first major surface such that a number of the surface depressions per square millimeter differs by no more than 10%; wherein the antimicrobial-impregnated adhesive sheet exhibits a rate of antimicrobial release of no more than 10 minutes; wherein each surface depression of the plurality of multiple surface depressions has an average longest dimension of between 4 micrometers and 100 micrometers; wherein each surface depression of the multiple surface depressions may have has a spherical shape; wherein the pressure-sensitive adhesive has an HLB value of less than 5; wherein the pressure-sensitive adhesive is selected from the group consisting of an acrylic polymer or copolymer, a natural rubber or synthetic rubber polymer or copolymer, and a silicone polymer; wherein the substrate is a polymeric film; further comprising a release liner in contact with the antimicrobial-impregnated adhesive sheet; wherein the medical article is a surgical drape; and wherein the antimicrobial composition comprises water, and wherein the water is present in the aqueous antimicrobial composition in an amount of 20 wt-% to 80 wt-%.
The copending application differ from the instant application in that the copending application recites, “wherein the plurality of surface depressions corresponds to dried down equivalents of discrete aqueous phase regions” whereas the instant application recites, “multiple surface depressions... comprising aqueous phase regions”.
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 substitute the dried down equivalent of discrete aqueous phase regions with aqueous phase regions with a reasonable expectation of success because the copending application states that the dried down aqueous phase regions are equivalent to aqueous phase regions and it is prima facie obvious to substitute equivalents known for the same purpose (MPEP 2144.06).
The copending application also differs from the instant application in that the copending application does not explicitly claim the particular acrylic polymers/copolymers, isooctyl acrylate, acrylamide, N-vinyl pyrrolidone, or a combination thereof. However, the copending application explicitly states that the acrylic polymer or copolymer can be the reaction product of monomers selected from an alkyl (meth)acrylate, N-vinyl pyrrolidone, N-vinyl caprolactam, (alkyl-substituted)acrylamide, (alkyl-substituted)methacrylamide, 2-hydroxyethyl (meth)acrylate or a combination thereof (page 3, lines 35-38). Accordingly, the scope of “an acrylic polymer” and “an acrylic copolymer” encompass the particular acrylic polymers/copolymers claimed in the instant application. The examiner has relied upon the specification to delineate the scope of the invention embraced by the application, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
The copending application also differs from the instant application in that the copending application does not explicitly claim the particular antimicrobials, chlorhexidine gluconate, chlorhexidine acetate, octenidine hydrochloride, polyhexamethylene biguanide salts, a quat ammonium salt, a chlorhexidine salt, a silver salt, a water-soluble iodophor, triclosan, or combinations thereof (instant claim 22). However, the copending application explicitly states that the antimicrobials can be chlorhexidine gluconate (CHG), chlorhexidine acetate, octenidine hydrochloride, polyhexamethylene biguanide salts (PHMB), quat ammonium salts, chlorhexidine salts, silver salts, water- soluble iodophors, triclosan, or combinations thereof (page 5, lines 13-16). Accordingly, the scope of “antimicrobial” encompass the particular antimicrobials claimed in the instant application. The examiner has relied upon the specification to delineate the scope of the invention embraced by the application, consistent with the decision in Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co. U.S. Court of Appeals Federal Circuit, 95 USPQ2d 1797.
Thus, the subject matter of the instant claims is not patentably distinct from the subject matter of the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments, filed 7/14/2026, regarding the double patenting rejection have been fully considered but they are not persuasive.
Applicant argues that the claims have been amended and asserts that the amended claims are distinct from the copending claims. Remarks, page 9.
In response, it is respectfully submitted that the claim amendments have been considered and the rejection has been modified to account for said claim amendments. However, the amended claims are not distinct from the copending claims for the reasons explained in the rejection above.
Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said rejection is maintained.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
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, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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