DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 3/23/2026.
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 .
Status of the Claims
Claims 1 and 3 have been amended. Claim 7 has been cancelled. No claims are newly added. Accordingly, claims 1-6 and 8-21 remain pending in the application. Claims 13-21 stand withdrawn from further consideration, with traverse. Claims 1-6 and 8-12 are currently under examination.
Withdrawn Rejections
Applicant’s amendment renders the rejection of claim 3 under 35 USC 112(b) moot. Specifically, the claim has been amended to provide clarity to the claim. Thus, said rejection has been withdrawn.
Maintained Rejections
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 1-6 and 8-12 stand rejected under 35 U.S.C. 103 as being unpatentable over Menon et al. (US 2020/0030499 A1, Jan. 30, 2020, hereafter as “Menon”) in view of Hobbs et al. (US 2005/0249791 A1, Nov. 10, 2005, hereafter as “Hobbs”).
The instant claims are drawn to an antimicrobial-impregnated adhesive sheet, comprising: an antimicrobial; a pressure-sensitive adhesive having a hydrophilic-lipophilic balance (HLB) value of less than 5; wherein the sheet comprises a first major surface and a second major surface; wherein the sheet comprises multiple surface depressions extending inwardly from the first major surface, 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.
Regarding instant claim 1, Menon teaches compositions containing chlorhexidine gluconate (an antimicrobial) in a hydrophobic vehicle or resin system (abstract). Menon teaches that the resin system comprises at least one polymer and can be an adhesive, e.g., a pressure sensitive adhesive (PSA) ([0022]). Figure 1 illustrates an article 100 comprising a substrate 110 and a chlorhexidine gluconate-containing composition 120 (first and second major surfaces). Menon teaches that said articles include surgical drapes and wound dressings (first and second major surfaces) ([0055]). Menon teaches that the chlorhexidine gluconate composition can be applied directly to a substrates, e.g., sprayed or otherwise coated onto a porous or non-porous substrate ([0020]). Menon teaches a particular embodiment wherein chlorhexidine gluconate is first coated at 4.6 mg/cm2 over the first major surface of the drape; next, using surface extraction (based on a surface availability analysis), it was determined that 4.2 mg/cm2 of chlorhexidine gluconate-related surface availability remained after a period of 30 minutes, which indicates that at least 30% of the CHG is initially available on the first major surface (Table 10; [0048] and [0058]). Menon also teaches that after aggressing accelerated aging (aged at 66°C for 6 weeks, equivalent to 2 years) a 0.2 log reduction occurred after 5 minutes of incubation and a 3.1 log reduction after 30 minutes ([0064]). Menon further teaches that even after said aggressive accelerated aging, there was considerable antimicrobial activity ([0064]).
Regarding the HLB limitation of being less than 5, Menon also teaches that, in some embodiments, the HLB value of the hydrophobic vehicle is no greater than 7 ([0015]. Menon further teaches optimizing the HLB value by modifying the ratio of hydrophilic vehicle ([0003] and [0013]). Menon teaches optimizing the HLB value of the carrier is important in effectively solubilizing chlorhexidine gluconate while maintaining good antibacterial activity ([0052]). It is noted that the teaching of an HLB of no greater than 7 overlaps with the claimed HLB value of less than 5. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (MPEP 2144.05(I)).
Further, while Menon does not explicitly teach an HLB value of less than 5, 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 optimize the HLB value of the pressure-sensitive adhesive in Menon by way of routine experimentation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Menon teaches HLB values of no greater than 7 as well as optimizing the HLB value by modifying the ratio of hydrophilic vehicle such that chlorohexidine is effectively solubilized and maintains good antibacterial activity.
Menon is also silent to a plurality of surface depressions extending inwardly from the first major surface.
Hobbs teaches an antimicrobial article (e.g., surgical drapes) comprising a layer of a thermoplastic polymer, and an adhesive layer having an antimicrobial agent dispersed therein (abstract). Hobbs teaches that the thermoplastic polymer layer may comprise a pattern of elevated areas or relatively thick portions, separated by valleys, or relatively thin portions, wherein the elevated areas take the form of ridges, mounds, peaks, cylinders, grooves or other embossments which may be uniform or varies in shape and dimensions and are generally disposed in a regular arrangement or pattern ([0037]). Hobbs taches that patterns that are suitable include four-sided square pyramids, truncated four-sided square pyramids, cones, straight lines, wavy lines, square or rectangular blocks, hemispheres, grooves and the like and are imparted to at least a portion of the thermoplastic polymer layer ([0037]).
Menon and Hobbs are both drawn to antimicrobial impregnated articles such as surgical drapes, thus, 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 include a plurality of surface depressions extending inwardly from the first major surface into the invention of Menon as suggested by Hobbs with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Hobbs teaches that embossing antimicrobial articles such as surgical drapes is a suitable and conventional method of imparting pattern to the antimicrobial article ([0037]-[0040]).
Regarding instant claim 2, Menon and Hobbs teach the elements discussed above including that the embossments are uniform (Hobbs at [0037]).
Regarding instant claim 3, Menon and Hobbs teach the elements discussed above. Menon demonstrates the effect of vehicle loading on surface availability and antimicrobial activity ([0058] and Table 10). Menon also teaches that as the plasticizer fraction in the adhesive is increased, a concomitant increase in the amount of chlorhexidine gluconate is released per unit time and that the effect of the difference in release can also be seen in the direct time kill data ([0058]). Example D2 in Table 10 reports a log reduction of 5.7 at 10 min, 15 min and 20 min which implies that no further release of chlorhexidine occurred after 10 minutes. Furthermore, 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 optimize the release of the antimicrobial in Menon by way of routine experimentation with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to do so because Menon teaches that as the plasticizer fraction in the adhesive is increased, a concomitant increase in the amount of chlorhexidine gluconate is released per unit time.
Regarding instant claim 4, Menon and Hobbs teach the elements discussed above. Hobbs, as discussed above, teaches various patterns/shapes as well as that there are typically about 5 to 20 embossments per lineal centimeter ([0037]-[0038]). Given these teachings, 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 optimize the average longest dimension of the surface depressions by way of routine experimentation with a reasonable expectation of success. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (MPEP 2144.05(II)(A)). A skilled artisan would have been motivated to do so because it is the normal desire of scientists or artisans to improve upon what is already generally known.
Regarding instant claim 5, Menon and Hobbs teach the elements discussed above. Hobbs, as discussed above, teaches various patterns/shapes including mounds and hemispheres (spherical) ([0037]).
Regarding instant claim 6, Menon and Hobbs teach the elements discussed above. Menon also teaches that the adhesive layer thickness ranges from 50-510 microns ([0046]). MPEP 2144.05(I) states, “In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Because the claimed range of 5-100 microns overlaps with the range of 50-510 microns disclosed by the prior art, a prima facie case of obviousness exists.
Regarding instant claim 8, Menon and Hobbs teach the elements discussed above. Menon also teaches the particular polymers, acrylates, rubbers, copolymers, etc. ([0022], [0023] and [0029]).
Regarding instant claim 9, Menon and Hobbs teach the elements discussed above including the antimicrobial-impregnated adhesive sheet of claim 1. Menon, as discussed above, also illustrates an article 100 comprising a substrate 110 having a first surface and second surface opposite the first surface and a chlorhexidine gluconate-containing composition 120 on the first surface (Figure 1).
Regarding instant claim 10, Menon and Hobbs teach the elements discussed above. Hobbs further teaches that substrate is a polymeric film ([0006] and [0057]).
Regarding instant claim 11, Menon and Hobbs teach the elements discussed above. Menon also teaches a release liner in contact with the adhesive layer ([0046]).
Regarding instant claim 12, Menon and Hobbs teach the elements discussed above including medical articles such as surgical drapes ([0055]).
Thus, the combined teachings of Menon and Hobbs render the instant claims prima facie obvious.
Response to Arguments
Applicant's arguments, filed 3/23/2026, regarding the 103 rejection over Menon and Hobbs have been fully considered but they are not persuasive.
Applicant argues that the Office Action does not explain why the disclosure of Hobbs corresponds to a plurality of surface depressions extending inwardly from the first major surface of the antimicrobial-impregnated adhesive sheet as recited in claim 1. Applicant notes that the cited portions of Hobbs describe surface patterning of a thermoplastic polymer layer, whereas claim 1 recites surface depressions extending inwardly from the first major surface of the antimicrobial-impregnated adhesive sheet. Remarks, pages 7-8.
In response, it is respectfully submitted that, as stated in the rejection, Hobbs teaches that the thermoplastic polymer layer may comprise a pattern of elevated areas or relatively thick portions, separated by valleys, or relatively thin portions, wherein the elevated areas take the form of ridges, mounds, peaks, cylinders, grooves or other embossments which may be uniform or varies in shape and dimensions and are generally disposed in a regular arrangement or pattern ([0037]). Hobbs teaching that there are elevated areas as well as valleys implies that the patterned polymer layer will have some portions, i.e., elevations or valleys depending on the polymer layer’s orientation, extending inwardly. Thus, the surface patterning of Hobbs reads on the claimed “surface depressions”. Applicant’s argument is unpersuasive.
Applicant also argues that the claimed press-sensitive adhesive having a HLB value of less than 5 yields unexpected results and points to Example 5 and Table 10 in the instant specification. Remarks, pages 8-9.
In response, it is respectfully submitted that MPEP 716.02(d) states, “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support’”. The instant claims recite, “a pressure-sensitive adhesive having a hydrophilic-lipophilic balance (HLB) value of less than 5”. Said limitation encompasses a broad range of PSAs whereas Example 5/Table 10 of the instant specification demonstrates particular combinations of PSAs in particular ratios. For example, Polymers 1-6 in Table 10 are various combinations of isooctyl acrylate (IOA), acrylamide (ACm), N-vinyl pyrrolidone (NVP) and vinyl acetate (Vac) in particular ratios. Additionally, the data only shows HLB values of between “3.26 and 4.6”. Thus, the data does not show evidence over the full range of an “HLB value of less than 5”. While the data provided appears to demonstrate unexpected results, said results are not commensurate in scope with the claimed invention, i.e., the claims are broader in scope than the evidence provided.
Thus, for these reasons, Applicant’s arguments are found unpersuasive. Said rejection is maintained.
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 and 8-12 stand 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 described above.
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 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; and wherein the medical article is a surgical drape.
The copending application anticipates that subject matter of the instant claims.
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 3/23/2026, with respect to the double patenting rejection have been fully considered but they are not persuasive.
Applicant essentially requests that the rejection is held in abeyance until allowable subject matter is indicated. Remarks, page 9.
In response, it is respectfully submitted that applicant’s request is acknowledged. The rejection remains applicable at this time and is, therefore, maintained for the reasons of record.
Conclusion
All claims have been rejected; no claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Casey S. Hagopian
Examiner, Art Unit 1617
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
Prosecution Insights