DETAILED 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 .
Status
Applicant’s responses dated 05 March 2026 and 25 March 2026 to the previous Office action dated 10 September 2025 are acknowledged. Pursuant to amendments therein, claims 1-30 and 32-35 are pending in the application.
The rejections under 35 U.S.C. 103 made in the previous Office action are maintained herein, and new claim 35 is newly rejected under 35 U.S.C. 103.
The double patenting rejection made in the previous Office action is maintained herein, and new claim 35 is newly rejected under double patenting.
Election/Restrictions
Claims 22-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 28 August 2024.
Claims 1-21, 30, and 32-35 are under current consideration.
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.
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.
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.
Claim(s) 1-21, 30, 32, and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naimer (US 6,573,419 B2; issued 03 June 2003; of record) in view of Ward (U.S. Patent No. 5,000,172; issued 19 March 1991; of record).
Naimer discloses a compression dressing, comprising: (a) an elongated, self-adhering elastic bandage strip; and (b) an absorbent pad being of substantially lesser length than said self-adhering elastic bandage strip, said absorbent pad being affixed to a terminal end of said self-adhering elastic bandage strip; said elastic bandage strip being designed, and of sufficient length, such that said absorbent pad may be applied to a wound on a body part, and the remainder of said strip or portion thereof, may be wrapped around said absorbent pad and said body part to hold the compression dressing in place and to exert a compressive force on the wound for a period of time to permit a therapeutic effect to the wound (claim 1) wherein said self-adhering elastic bandage strip includes an elastomeric substrate layer and an adhesive layer adhered thereto on one surface thereof, said absorbent pad being affixed to a non-adhesive surface of said elastic bandage strip at said terminal end thereof (claim 3) wherein said self-adhering elastic bandage strip is selected having self-adherence properties so as to allow unrolling of a roll of said self-adhering elastic bandage strip without elastic extension of said elastic bandage strip (claim 4) wherein said self-adhering elastic bandage strip is constructed so as to have self-adhesive properties sufficient to cause two adjacent layers of the compression dressing to remain adhered to one another under elastic extension without the use of a fastening mechanism (claim 5) wherein said self-adhering elastic bandage strip is constructed of a material including partially extended, longitudinally, vertically or irregularly extended elastic fibers bound to a fiber base to provide firm elastic extendibility in the longitudinal and vertical directions (claim 6) wherein said self-adhering elastic bandage strip is constructed of a transparent material (claim 7) wherein said elastic bandage strip is constructed of non-woven elastomeric fibers having firm elastic extendibility in longitudinal and vertical directions, and an adhesive, and having self-adhesive properties sufficient to cause two adjacent layers of the bandage to remain adhered to one another without the use of a fastening mechanism (claim 8) wherein said self-adhering elastic bandage strip is constructed of clear polyolefin polymer or copolymer films having firm elastic extendibility in the longitudinal and vertical directions, and having self-adhesive properties sufficient to cause two adjacent layers of said self-adhering elastic bandage strip to remain adhered to one another without the use of a fastening mechanism (claim 9) wherein said films are printed polyolefin polymer or copolymer films (claim 10) wherein said self-adhesive elastic bandage strip is constructed of a clear polyolefin polymer or copolymer film coated on one surface with an extendable, self-adhesive adhesive effective to cause two adjacent layers of said self-adhering elastic bandage strip to remain adhered to one another without the use of a fastening mechanism (claim 11) wherein said absorbent pad is affixed to said self-adhering elastic bandage strip by an affixing method selected from the group consisting of stitching, welding, needletacking and bonding (claim 12) wherein said bonding is effected by an adhesive selected from a group consisting of natural rubber based adhesives and acrylic adhesives (claim 13) wherein said absorbent pad is constructed of foamed, woven or nonwoven material of natural or synthetic fibers selected from the group consisting of rayon, polyester, polyurethane, polyolefin, cellulose, cellulose derivatives, cotton, orlon and hydrogel polymeric materials (claim 14) wherein said absorbent pad includes a coagulant (claim 15) wherein the compression dressing is rolled into a roll and packaged in a sterile packaging (claim 16) wherein a method of application of the compression dressing over a wound in a body part comprises: (a) positioning said absorbent pad over the wound so as to effectively cover the wound; (b) orienting said self-adhering elastic bandage strip substantially in continuation or perpendicularly to a length of said absorbent pad; and (c) wrapping the body part, covering at least said absorbent pad (claim 19) wherein the strip provides compressive pressure sufficient to provide a therapeutic benefit including control of bleeding without restricting arterial blood flow to the point of ischemia distal to the bandaged body part (i.e., sufficient pressure to prevent exsanguination from an arterial wound without exceeding the pressure that would cause arterial blood flow to cease to a distal limb) (column 6 lines 35-57) wherein a preferred embodiment does not adhere to skin (column 6 lines 57-60).
Naimer does not disclose spaced apart blood migration markings for indicating the migration of blood across the absorbent pad, the blood migration markings being visible through wrappings of the elastic bandage strip as claimed, or skin adhesive as claimed.
Ward discloses a wound dressing system comprising a transparent dressing with a transparent layer having reference marks which are capable of being used to monitor the wound (abstract) wherein the reference marks can be a grid (column 8 lines 17-19) of columns and rows (Fig. 2) wherein the reference marks may be indexed with suitable letters or numbers to enable the size of the wound to be recorded (column 8 lines 36-39) wherein the dressing may have adhesive coated over one entire surface or over part of it such as around the periphery (column 1 line 67 to column 2 line 6) wherein the adhesive is for contact with the skin (column 3 lines 50-52).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Naimer and Ward by including on the transparent bandage strip of Naimer as discussed above reference marks as in Ward which are capable of being used to monitor the wound wherein the reference marks are a grid of columns and rows (i.e., spaced apart blood migration markings for indicating the migration of blood across the absorbent pad, the blood migration markings being visible through wrappings of the elastic bandage strip given that the elastic bandage strip is transparent) and wherein the reference marks are indexed with suitable letters or numbers to enable the size of the wound to be recorded (i.e., indicia for identifying individual ones of the columns and rows), with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to be able to monitor the wound and enable the size of the wound to be recorded as suggested by Ward.
It also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Naimer and Ward by including on the transparent bandage strip of Naimer as discussed above skin adhesive coated over the entire surface or over part of it such as around the periphery (i.e., skin adhesive on the second inner side of and at the terminal end of the strip for adhering to skin) as in Ward, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to help adhere the strip to the skin as suggested by Ward, given that Naimer indicates such a possibility even though a preferred embodiment thereof does not adhere to skin, given that preferred embodiments do not constitute a teaching away per MPEP 2123(II).
Regarding the claimed term “absorbent hemorrhagic indicator pad”, the absorbent pad of Naimer as discussed above absorbs blood from wounds, and such absorption is visible given that the bandage strip thereof is transparent, and the reference marks of Ward provide a reference for the size of the wound and blood thereof, and thus the absorbent pad of the dressing of Naimer in view of Ward as discussed above is an “absorbent hemorrhagic indicator pad”.
Regarding claim 5, the adhesive of the dressing of Naimer in view of Ward as discussed above is encompassed by the claimed fastening device.
Further regarding claims 30 and 34, although Naimer discloses that a preferred embodiment does not adhere to skin, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments, per MPEP 2123(I), and preferred embodiments do not constitute a teaching away from nonpreferred embodiments, per MPEP 2123(II), and thus it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice a nonpreferred embodiment of Naimer by using adhesive that adheres to skin in the dressing and method of Naimer in view of Ward as discussed above, with a reasonable expectation of success.
Claim(s) 1-21, 30, and 32-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Naimer in view of Ward as applied to claims 1-21, 30, 32, and 34-35 above, and further in view of Ager et al. (WO 98/51247 A1; published 19 November 1998; of record).
Naimer and Ward are relied upon as discussed above.
Naimer and Ward do not disclose compression markings as in claim 33.
Ager et al. discloses an extension indicator for determining a predetermined extension applied to a medical bandage used in compression therapy comprising first and second co-operating members secured to an extensibly deformable article wherein each member bears visual indication means which upon extension are adapted to align with each other to indicate a predetermined extension (abstract) for ensuring that enough pressure is applied to a limb to achieve therapeutic benefit without over-tightening the bandage (page 1 lines 28-32).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Naimer and Ward and Ager et al. by including an extension indicator with visual indication means per Ager et al. as discussed above on the strip of the compression dressing of Naimer in view of Ward as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to ensure that enough pressure is applied to a limb to achieve therapeutic benefit without over-tightening the bandage as suggested by Ager et al.
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 1-21, 30, 32, and 34-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 6,573,419 (the claims of Naimer) in view of Naimer and Ward.
The claims of Naimer do not disclose blood migration markings as instantly claimed.
Ward discloses a wound dressing system comprising a transparent dressing with a transparent layer having reference marks which are capable of being used to monitor the wound (abstract) wherein the reference marks can be a grid (column 8 lines 17-19) of columns and rows (Fig. 2) wherein the reference marks may be indexed with suitable letters or numbers to enable the size of the wound to be recorded (column 8 lines 36-39) wherein the dressing may have adhesive coated over one entire surface or over part of it such as around the periphery (column 1 line 67 to column 2 line 6) wherein the adhesive is for contact with the skin (column 3 lines 50-52).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the claims of Naimer and Naimer and Ward by including on the transparent bandage strip of the claims of Naimer as discussed above reference marks as in Ward which are capable of being used to monitor the wound wherein the reference marks are a grid of columns and rows (i.e., spaced apart blood migration markings for indicating the migration of blood across the absorbent pad, the blood migration markings being visible through wrappings of the elastic bandage strip given that the elastic bandage strip is transparent) and wherein the reference marks are indexed with suitable letters or numbers to enable the size of the wound to be recorded (i.e., indicia for identifying individual ones of the columns and rows), with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to be able to monitor the wound and enable the size of the wound to be recorded as suggested by Ward.
It also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of the claims of Naimer and Naimer and Ward by including on the transparent bandage strip of the claims of Naimer as discussed above skin adhesive coated over the entire surface or over part of it such as around the periphery (i.e., skin adhesive on the second inner side of and at the terminal end of the strip for adhering to skin) as in Ward, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to help adhere the strip to the skin as suggested by Ward, given that Naimer indicates such a possibility even though a preferred embodiment thereof does not adhere to skin, given that preferred embodiments do not constitute a teaching away per MPEP 2123(II).
Regarding the claimed term “absorbent hemorrhagic indicator pad”, the absorbent pad of the claims of Naimer as discussed above absorbs blood from wounds, and such absorption is visible given that the bandage strip thereof is transparent, and the reference marks of Ward provide a reference for the size of the wound and blood thereof, and thus the absorbent pad of the dressing of the claims of Naimer in view of Naimer and Ward as discussed above is an “absorbent hemorrhagic indicator pad”.
Regarding claim 5, the adhesive of the dressing of the claims of Naimer in view of Naimer and Ward as discussed above is encompassed by the claimed fastening device.
Further regarding claims 30 and 34, although Naimer discloses that a preferred embodiment does not adhere to skin, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments, per MPEP 2123(I), and preferred embodiments do not constitute a teaching away from nonpreferred embodiments, per MPEP 2123(II), and thus it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to practice a nonpreferred embodiment of Naimer by using adhesive that adheres to skin in the dressing and method of the claims of Naimer in view of Naimer and Ward as discussed above, with a reasonable expectation of success.
Response to Weinstein Declaration
The Weinstein declaration under 37 CFR 1.132 filed 05 March 2026 is insufficient to overcome the obviousness and double patenting rejections because Naimer specifically suggests the monitoring of continued bleeding when the dressing is applied (column 7 lines 63-66) for a compression dressing (abstract), rendering declarant’s assertion that “motivations underlying monitoring-oriented dressings and those underlying trauma compression systems are fundamentally different” (declaration paragraph 14) unpersuasive.
Response to Arguments
Applicant's arguments filed 05 March 2026 have been fully considered but they are not persuasive.
See above with respect to the declaration.
Applicant argues with respect to the limitations of claims 10 and 35 that rapid unrolling and adjustability features combined with self-adherence properties and blood migration markings provide a non-obvious advantage (remarks pages 21-23). In response, “rapid unrolling and adjustability” is not claimed, and the self-adhering elastic bandage strip of Naimer is selected having self-adherence properties so as to allow unrolling of a roll of said self-adhering elastic bandage strip without elastic extension of said elastic bandage strip (claim 4) wherein said self-adhering elastic bandage strip is constructed so as to have self-adhesive properties sufficient to cause two adjacent layers of the compression dressing to remain adhered to one another under elastic extension without the use of a fastening mechanism (claim 5), as discussed in the rejections.
Conclusion
No claims are allowed.
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 MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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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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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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