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 .
The examiner acknowledges receipt of amendment and remarks filed 01/02/2026.
Claim 22 is canceled.
Claims 16, 23 and 34 are amended.
Claims 16-21 and 23-35 are pending.
Priority
This application is a 371 of PCT/EP2021/087200 filed 12/22/2021 and which claims benefit of Germany application 10 2020 134 827.4 filed 12/23/2020.
Response to Arguments
The limitation of canceled claim 22 has been moved into claim 16 and claim 23 by specifying that the hydrogel is based on polyurethane.
On pages 5 and 6 of the remarks filed 01/02/2026, citing paragraph [0256] of Aslam, applicant argues the rejection under 35 USC 102 should be dropped because Aslam refers to the use of polyurethane film instead of hydrogel.
Response: The examiner disagrees with applicant that Aslam does not teach hydrogel that is polyurethane based because, Aslam is directed to treating wound with composition comprising hydrogel (see the whole document, paragraph [0121]). Aslam also teaches that hydrogel covered with polyurethane film is used to treat wound (paragraph [0088]) and this meets the limitation of hydrogel is polyurethane-based. Further, Aslam teaches that the pharmaceutical composition for treating wound dressing comprises hydrogel (see the abstract, paragraphs [0121], [0122], [0124], [0125], [0234], [0235]) and the dressing comprised of polyurethane or silicone is contemplated (paragraph [0252]). The examiner agrees with applicant that film dressings comprise polyurethane (paragraph [0256]). Applicant appears to imply wound dressing film cannot be hydrogel. This is not persuasive because hydrogel dressings for wound is known to be in the form of film. For example, an evidentiary reference, Moreau et al. “Hydrogel films and coatings by swelling-induced gelation” in PNAS, vol. 113, no. 47, Nov 2016, pp 13295-13300, teaches that hydrogel films are used wound healing at the second full paragraph of page 13295, left column. This evidentiary reference is cited in response to applicant’s argument.
On pages 7 and 8 of the remarks filed 01/02/2026, applicant argues that the arguments presented with respect to the rejection under 35 USC 102 are applicable in the rejection under 35 USC 103. Applicant further argues that JP 2018509455 and JP 2018531652 do not cure the deficiencies of Aslam because these references do not teach polyurethane based hydrogels and Aslam cannot be modified to use polyurethane-based hydrogel.
Response: JP 2018509455 was relied upon for teaching that wound dressing film article layers are known to have MVTR of 300 g/m2/day to 1000 g/m2/day (see paragraphs [0074]-[0076] of the English Trans) such that before the effective date of the invention, the ordinary skilled artisan would reasonably expect the hydrogel wound dressing film of Aslam to have associated MVTR that may include 300 g/m2/day to 1000 g/m2/day. JP 2018531652 A, using the Eng Trans, PE2E, was relied upon for teaching that bruises and subcutaneous wound are best viewed using colored protective goggles; pressure ulcers are conspicuously named (See the whole translation) such that it would be reasonable to house or store the hydrogel and the goggles in a container as required by claim 35.
Regarding the obviousness type double patenting rejection, applicant argues that the claims of 10,130,521 B2 and 9,579,413 B2 teach multilayered wound dressings having first and second layers and a transition layer or water impermeable and moisture vapor permeable polymer film/foam. Applicant argues that the amendment to claim 16 overcomes the rejection.
Response: The examiner disagrees because the claims do not exclude layers. The dressings are hydrogels containing 10-80% water (US 10,130,521 B2) and 25-65% water (9,579,413 B2) and the hydrogel is polyurethane based.
Therefore, the rejections are maintained below.
Maintained Rejections
Minor Modification Necessitated by Amendment
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-20, 23-24, 27, 28, 30, 31 and 33 remain rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Aslam (US 2019/0046547 A1).
Claim 22 is canceled and the limitation is moved into claims 16 and 23.
Claims 16-20 are directed to hydrogel that has water content of from 40% to 90%. “For use in the treatment of pressure ulcers and/or prophylaxis …ulcers” is the intended use of the hydrogel. The body of the claim fully and intrinsically sets forth all the limitations of the claimed invention, in this case a hydrogel. A prior art hydrogel that has water content of from 40% to 90% would be capable of the intended use of the hydrogel. The hydrogel of Aslam is based on polyurethane (paragraph [0256].
For claims 16 and 18, Aslam teaches a hydrogel that has 70% water (see at least paragraphs [0124], [0246], [0321], [0341], claims 7 and 8). The 70% water is a specific point within the claimed ranges 40% to 90% (claim 16), 60%-85% (claim 18).
Treating pressure ulcer in claims 16 and 17 is the intended use of the hydrogel.
For claim 19, release of moisture per square centimeter within 24 hours flows inherently from a hydrogel that has 70% water content.
For claim 20, the claimed absorption capacity per gran hydrogel within 24 hours flows inherently from a hydrogel that has water content of 70%.
For claims 23 and 24, Aslam teaches treating pressure ulcers by administering/applying the hydrogel wound dressing directly to the target area, the hydrogel has water content of 70% (paragraphs [0024], [0029], [0030], [0129], [0149], [0199], [0223] [0264], [0277], [0280] and claims 1-2, 6-8).
For claim 27, the hydrogel of Aslam is transparent (paragraph [0256], [0321]).
For claim 28, the hydrogel is covered by polyurethane (paragraph [0088]) that is on the side facing away from the skin.
For claim 30, release of moisture per square centimeter within 24 hours flows inherently from a hydrogel that has 70% water content.
For claim 31, the hydrogel product applied to the wound/pressure ulcer affected area is a medical device such that the affected area is between the skin and the medical device.
For claim 33, the claimed absorption capacity per gran hydrogel within 24 hours flows inherently from a hydrogel that has water content of 70%.
Therefore, Aslam teaches all the elements of claims 16-20, 23-24, 27, 28, 30, 31 and 33.
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.
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) 16, 21, 23 and 34 remain rejected under 35 U.S.C. 103 as being unpatentable over Aslam (US 2019/0046547 A1) as applied to claims 16 and 23.
Claim 21 depends on claim 16. Claim 34 depends on claim 23.
Aslam has been described above to teach claims 16 and 23.
For claims 21 and 34, Aslam does not teach that the pH of the polyurethane based hydrogel is from 5 to 9.
However, Aslam teaches that the normal surface of the skin has a pH of between 4 and 6.5 in healthy people; but varies according to the area of skin on the body; and that this low pH forms an acid mantle that enables the skin barrier function; Aslam also teaches that damage to the skin increases the skin pH making the skin susceptible to bacterial infections (paragraph [0008]).
Therefore, before the effective date of the invention, the ordinary skilled artisan would formulate the hydrogel to have pH closer to skin pH that when used would not increase the skin’s/wound’s/pressure sore’s susceptibility to bacterial infections which would include pH’s of 5-7 or suitable pH that would not increase susceptibility to bacterial infections.
Thus, Aslam renders claims 21 and 34 prima facie obvious.
Claim(s) 23, 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aslam (US 2019/0046547 A1), as applied to claim 23, in view of Miinea et al. (US 20190321507 A1).
Claims 25-26 depend on claim 23. Aslam has been described above to teach claim 23.
Aslam does not teach the thickness of the hydrogel wound dressing.
In one embodiment, Aslam teaches the use of film dressing, semi-permeable film dressing, hydrogel dressing and combinations (paragraph [0248], [0256]).
Miinea teaches that wound dressing films can have thickness of from 0.5 to 100 mil (0.0127 mm to 2.54 mm) (paragraphs [0020]-[0022], [0030], [0032], [0103], [0104], Figs. 3 and 5).
Therefore, before the effective filing date of the invention, the ordinary skilled artisan would look to Miinea to ascertain the size of hydrogel film dressing that can be used to effectively cover and treat pressure ulcer or wound which may include film having thickness of 0.5 mm to 2.0 mm (the thickness range of 0.0127 mm to 2.54 mm in Miinea allows for the claimed range of 0.5mm to 2.0mm and 1.0mm to 2.0 mm).
Thus, Aslam in view of Miinea renders claims 25-26 prima facie obvious.
Claim(s) 23, 28 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aslam (US 2019/0046547 A1), as applied to claim 23, in view of JP 2018509455 A, Eng Trans.
Claim 29 depends on claim 28 which depends on claim 23.
Aslam has been described above to teach claims 23 and 28. Aslam does not teach moisture vapor transmission (MVTR) of claim 29. However, JP 2018509455 teaches that wound dressing film article layers are known to have MVTR of 300 g/m2/day to 1000 g/m2/day (see paragraphs [0074]-[0076] of the English Trans). Therefore, before the effective date of the invention, the ordinary skilled artisan would reasonably expect the hydrogel wound dressing film of Aslam to have associated MVTR that may include 300 g/m2/day to 1000 g/m2/day.
Therefore, Aslam in view of JP 2018509455 A renders claim 29 prima facie obvious.
Claim(s) 16, 23, 31, 32 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aslam (US 2019/0046547 A1), as applied to claim 23, in view of JP 2018531652 A, Eng Trans, PE2E.
Claim 35 depends on claim 16. Claim 31 depends on claim 23. Claim 32 depends on claim 31.
Aslam has been described above to teach claims 16, 23 and 31.
Aslam does not teach the protective gears of claims 32 and 35.
However, JP 2018531652 A, using the Eng Trans, PE2E, teaches that bruises and subcutaneous wound are best viewed using colored protective goggles; pressure ulcers are conspicuously named (See the whole translation). It is reasonable to house or store the hydrogel and the goggles in a container as required by claim 35.
Thus, Aslam in view of JP 2018531652 A, Eng Trans, PE2E, renders claims 32 and 35 prima facie obvious.
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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 16-22 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 10130521 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the wound dressing composition of issued claims 1 and 7 comprise hydrogel based on polyurethane that has water content of from 20-80% with this range overlapping the claimed range of 40-80%. The issued range allows for the claimed range of 40-80%.
Claims 16-21 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 9579413 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the issued claims teach polyurethane based hydrogel composition that comprises 35-65% water overlapping the claimed range of 40-80%. The issued range allows for a range of 40-65% which is within the claimed range.
No claim is allowed.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Conclusion
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613