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 request for continued examination under 37 CFR 1.114, amendment and remarks filed 04/24/2026.
Claims 16, 21, 23 and 34 are amended.
New claims 36-37 are added.
Claims 16-21 and 23-37 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/24/2026 has been entered.
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
Under 35 USC 102: i) On pages 5-7 of the remarks filed 04/24/2026, applicant argues Aslam does not anticipate the claims identified in the rejection because Aslam fails to disclose hydrogel containing polyurethane because Aslam lists film dressings as a separate category from hydrogel dressings (citing paragraph [0255] of Aslam) and that paragraphs [0256] and [0257] of Aslam describes film dressings and hydrogel dressings as different and distinct, and that paragraph [0321] of Aslam describes that hydrogel and film are two separate components of a dressing. Also that Aslam and Moreau do not disclose hydrogels containing polyurethane. Applicant also argues that the disclosure and claim 7 of US 10130521 B2, cited in the obviousness type double patenting rejection, teach that the dressing comprises a hydrogel matrix as a first layer and a backing layer comprising a film as separate components; that column 8, lines 55-58 of US 10130521 B2 teaches the backing foil may be made of different polymers including polyurethane and foams are particularly fabricated from polyurethane, polyether urethane, polyester urethane, polyether-polyamide copolymers, polyacrylate or polymethacrylate.
Response: i) Regarding paragraphs [0255]-[0257] and film dressing and hydrogel dressing, the examiner notes that paragraphs [0255]-[0257] is one embodiment. The claims have not excluded film dressing or gauze dressing or occlusive dressing as the form for the hydrogel composition that has the intended use of treating pressure ulcers. Aslam teaches polyurethane foam and foam is a form of dressing that can be used to treat wounds/ulcers. Gleaning from applicant’s specification to understand the claims, the as filed specification in at least the last full paragraph of page 10, teaches films and foams as form for the hydrogel dressing. In another embodiment, Aslam teaches that hydrogel covered with a thin film of polyurethane is a debridement dressing. The polyurethane film covered hydrogel is a hydrogel dressing that meets the limitation of polyurethane based dressing for wound treatment as disclosed in paragraph [0088]. Aslam also teaches polyurethane dressing including LYOFOAM (paragraph [0252]). Therefore, the examiner disagrees. Moreau was an evidentiary reference to address applicant’s argument to show that hydrogel films are used as wound healing hydrogels. Moreau was not used as art in the rejections. Regarding US 10130521 B2, the claimed hydrogel composition does not exclude multilayered hydrogel dressing. The fact that US 10130521 B2 teaches in the body of the disclosure teaches that backing foil may be made of different polymers including polyurethane and foams are particularly fabricated from polyurethane, polyether urethane, polyester urethane, polyether-polyamide copolymers, polyacrylate or polymethacrylate, this teaching in the body of the disclosure of US 10130521 B2 does not invalidate the claimed dressing comprising polyurethane foam.
ii) in the paragraph bridging pages 7 and 8, applicant argus that Aslam with or without Moreau does not disclose hydrogel having a 3-dimensional, polyurethane based matrix as required by the presently amended claims.
Response: Aslam was not combined with Moreau to reject the claims. The examiner disagrees with applicant because Aslam teaches polyurethane film covered hydrogel (paragraph [0088]), and a polyurethane file covered hydrogel dressing is a polyurethane based dressing for wound treatment as disclosed in paragraph.
iii) For claims 19, 20, 30 and 33, applicant argues that a water content of a material does not necessarily determine how much water is released.
Response: Claim 16 is a product claim comprising 40-90% water. Releasing water is a characteristic of the hydrogel of claim 16. Thus, releasing water from the hydrogel of claim 16 is an inherent characteristic. The same is applicable to claims 30 and 33 that depend from claim 23.
For rejections under 35 USC 103: iv) Claims 21 and 34, applicant argues that Aslam does not teach pH of between 7.2 to 8.2 now claimed by the amendment and that one skilled in the art would not have been motivated to alter the pH to be higher than 6.5, pH that is seen in healthy people; v) claims 25 and 26, applicant argues that the skilled artisan would not have been motivated to combine the industrial films of Miinea with the medical hydrogels of Aslam tom determine a suitable thickness of a hydrogel for skin or wound conditions, vi) claim 29, applicant argues that the rejection should be withdrawn because JP 2018509455 does not disclose hydrogel for treating wound where the hydrogel comprises a cover layer having the moisture vapor transmission rate, vii) claims 32 and 35, applicant argues that the rejection of claims 32 and 35 should be withdrawn because the resulting combination of Aslam and JP 2018531652 would not result in each and every limitation of the present claims.
Response: iv) The pH is claimed as a range which indicates that the pH can be varied and there is no factual showing that the pH in the range claimed provides unexpected results; v) Miinea was relied upon for teaching that wound dressing films have thickness of 0.5 to 100 mil (0,0127 mm to 2,54 mm), vi) 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, vii) JP 2018531652 was relied upon for teaching that bruises and subcutaneous wound are best viewed using colored protective gears of claims 32 and 35.
Obviousness-type Double Patenting: Applicant argues that claim 1 of US 9579413 B2 describes hydrophilic polyurethane foam having water content of 35% to 65% and does not describe hydrogel having a polyurethane based matrix. Also, claim 1 of US 10130521 B2 teaches hydrophilic polyurethane foam having water content of at least 10% to at most 80%. However, the instant claims did not exclude hydrophilic polyurethane and the claims are not limited to polyurethane that are not hydrophilic. The rejections are maintained below.
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 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Aslam (US 20190046547 A1).
Claims 16-20 are directed to transparent hydrogel comprising at least one solid phase and at least one liquid phase, where the solid phase has a three-dimensional matrix and the hydrogel has a water content of from 40% to 90%, and where the three-dimensional matrix is a polyurethane-based matrix.
Aslam discloses hydrogel that is covered polyurethane film (paragraph [0088]), the hydrogel is about 70% water (paragraphs [0174], [0246]), pharmaceutical composition comprising hydrogel biomaterial (paragraph [0233]-[0236], claims 6-8), LYOFOAM polyurethane dressings (paragraphs [0248], [0252], [0255]). In one embodiment, the dressing is in the form of a gauze or scaffold and the scaffold is a 3-dimensional scaffold (paragraph [0248]). The water is the liquid phase of claims 16 and 23 and the 70% is a specific point within the claimed range of 40% to 90%. The solid phase is the polymeric hydrogel biomaterial. The polyurethane dressing and the hydrogel covered by polyurethane film read on polyurethane based hydrogel matrix of the claims.
Aslam teaches that film dressings that the dressings may be transparent allowing the progress of healing to be checked (paragraph [0256]). The dressings in Aslam comprises hydrogel (paragraph [0088].
While “for use in the treatment of pressure ulcer” is the intended use of the hydrogel, Aslam teaches that its pharmaceutical composition is effective to treat chronic non-healing wounds, namely, diabetic wounds, venous wounds, surgical wounds, cancer wounds, pressure ulcers, arterial ulcers and diabetic wounds are not limited to diabetic foot ulcers (paragraph [0264]).
Thus, for claims 16 and 23, when Aslam’s composition is polyurethane based transparent hydrogel scaffold, which is in a three-dimensional structure, comprising 70% water, Aslam teaches all the elements of claims 16 and 23. The comprising language of the claims is open.
For claims 16 and 17, while treating pressure ulcer is an intended use, 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 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).
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 gram 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) 16-20, 23-24, 27, 28, 30-31 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cartmell et al., (EP 0 630 629 A1) in view of Shima Tavakoli et al., “Advanced Hydrogels as Wound Dressings” in Biomolecules, 2020, pp 1-20.
Cartmell discloses transparent hydrogel wound dressing comprising nonporous transparent polyurethane backing layer to permit viewing the healing process without removal of the wound dressing (see the whole document with emphasis on the abstract, column 3, lines 32-34, 59-60; column 5, line 68 to column 6, line 1; column 8, lines 36-38, 48; column 1, line 3-4; column 2, lines 45-56; column 4, lines 10-12; column 5, lines 13-17). The hydrogel product comprises 61% water (column 10, lines 23-38; claim 1, 7). The water meets the limitation of the liquid phase and the polymer and the salts meet the limitation, The wound to be healed is decubitus ulcer or open surgical wounds (column 1, lines5, 6; column 5, line 53) and decubitus ulcer is same as pressure ulcer.
For claims 16 and 23, Cartmell does not teach the hydrogel to be in 3-D structure. However, hydrogels are known to be three-dimensional (3D) networks (see section 5 of page 5 of 20 of Shima Tavakoli).
Therefore, before the effective date of the invention, the artisan having the information taught in Shima Tavakoli would have reasonably expected the hydrogel of Cartmell to be in a three-dimensional network.
For claims 16 and 17, while treating pressure ulcer is an intended use, Cartmell teaches treating decubitus ulcer, a pressure ulcer, by providing wound dressing product containing hydrogel (column 5, lines 49-54).
For claims 16 and 18, Cartmell teaches a hydrogel that has 61% water (column 10, lines 23-38; claim 1, 7). The 61% water is a specific point within the claimed ranges 40% to 90% (claim 16), 60%-85% (claim 18).
For claim 19, release of moisture per square centimeter within 24 hours flows inherently from a hydrogel that has 61% 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 61%.
For claims 23 and 24, Cartmell teaches treating decubitus ulcer/pressure ulcers by applying the hydrogel wound dressing directly to the target area, the hydrogel has water content of 61% (abstract, column 3, lines 32-34, 59-60; column 5, line 68 to column 6, line 1; column 8, lines 36-38, 48; column 1, line 3-4; column 2, lines 45-56; column 4, lines 10-12, 23-28; column 5, lines 13-17; claims 1 and 7).
For claim 27, the hydrogel of Cartmell is transparent (column 3, line 33; column 5, line 58 to column 6, line 1; column 8, lines 11-19, 58; claim 7).
For claim 28, the backing layer is composed of polyurethane (column 4, line 10-12) that is 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 61% 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 gram hydrogel within 24 hours flows inherently from a hydrogel that has water content of 61%.
Therefore, Cartmell in view of Shima Tavakoli renders claims 16-20, 23-24, 27, 28, 30, 31 and 33 prima facie obvious.
Alternative Rejection
Claim Rejections - 35 USC § 103
over Aslam
Aslam (US 20190046547 A1) has been applied under 35 USC 102 above to teach claims 16 and 23. The rejection here is in the alternative.
Claim(s) 16-20, 23-24, 27, 28, 30-31 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aslam (US 20190046547 A1) in combination with Shima Tavakoli et al., “Advanced Hydrogels as Wound Dressings” in Biomolecules, 2020, pp 1-20, and Abhishek Gupta et al., “The production and application of hydrogels for wound management: A review” in European Polymer Journal, 2019, 134-151.
Claims 16-20 are directed to transparent hydrogel comprising at least one solid phase and at least one liquid phase, where the solid phase has a three-dimensional matrix and the hydrogel has a water content of from 40% to 90%, and where the three-dimensional matrix is a polyurethane-based matrix.
Aslam discloses hydrogel that is covered polyurethane film (paragraph [0088]), the hydrogel is about 70% water (paragraphs [0174], [0246]), pharmaceutical composition comprising hydrogel biomaterial (paragraph [0233]-[0236], claims 6-8), LYOFOAM polyurethane dressings (paragraphs [0248], [0252], [0255]). In one embodiment, the dressing is in the form of a gauze or scaffold and the scaffold is a 3-dimensional scaffold (paragraph [0248]). The water is the liquid phase of claims 16 and 23 and the 70% is a specific point within the claimed range of 40% to 90%. The solid phase is the polymeric hydrogel biomaterial. The polyurethane dressing and the hydrogel covered by polyurethane film read on polyurethane based hydrogel matrix of the claims.
Aslam teaches that film dressings that the dressings may be transparent allowing the progress of healing to be checked (paragraph [0256]). The dressings in Aslam comprises hydrogel (paragraph [0088].
While “for use in the treatment of pressure ulcer” is the intended use of the hydrogel, Aslam teaches that its pharmaceutical composition is effective to treat chronic non-healing wounds, namely, diabetic wounds, venous wounds, surgical wounds, cancer wounds, pressure ulcers, arterial ulcers and diabetic wounds are not limited to diabetic foot ulcers (paragraph [0264]).
For claims 16 and 23, in the case the three dimension scaffold is not representative of the hydrogel composition in Aslam, it is well known in the art that hydrogels have three-dimensional network (see section 5 of page 5 of 20 of Shima Tavakoli). Therefore, before the effective date of the invention the ordinary skilled artisan would reasonably expect that the hydrogel product of Aslam is a 3D-network.
Furthermore, it is known in the art that the transparent nature of hydrogel dressing allows clinical assessment of the healing process without the need to remove the dressing (last three lines of the first full paragraph of the right column of page 138 of Abhishek Gupta). Therefore, before the effective date of the invention, would reasonably expect the hydrogel of Aslam to be transparent with the predictable expectation that the artisan would assess the healing process of the wound without removing the hydrogel dressing.
For claims 16 and 17, while treating pressure ulcer is an intended use, 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 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).
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 gram hydrogel within 24 hours flows inherently from a hydrogel that has water content of 70%.
Therefore, Aslam in combination with Shima Tavakoli and Abhishek Gupta renders claims 16-20, 23-24, 27, 28, 30, 31 and 33 prima facie obvious.
Claim(s) 16, 21, 23, 34 and 36-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aslam (US 20190046547 A1) in combination with Shima Tavakoli et al., “Advanced Hydrogels as Wound Dressings” in Biomolecules, 2020, pp 1-20, and Abhishek Gupta et al., “The production and application of hydrogels for wound management: A review” in European Polymer Journal, 2019, 134-151, as applied to claims 16 and 23, in view of Junginger et al. (US 9579413 B2).
Claim 21 depends on claim 16. Claim 34 depends on claim 23.
Aslam in combination with Shima Tavakoli and Abhishek Gupta have been described above to render renders claims 16 and 23 prima facie obvious.
For claims 21 and 34, Aslam does not teach that the pH of the polyurethane based hydrogel is from 7.2 to 8.2.
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]). Further, Junginger teaches pH of 7.3-7.5 is advantageous pH for wound healing (column 3, lines 65-66).
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 neutral pH's of 7,3 to 7.5 or suitable pH that would not increase susceptibility to bacterial infections using buffer, new claims 36-37, to achieve desired pH.
Therefore, Aslam in combination with Shima Tavakoli and Abhishek Gupta and further in view of Junginger renders claims 21 and 34 and 36-37 prima facie obvious.
Claim(s) 23 and 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aslam (US 20190046547 A1) in combination with Shima Tavakoli et al., “Advanced Hydrogels as Wound Dressings” in Biomolecules, 2020, pp 1-20, and Abhishek Gupta et al., “The production and application of hydrogels for wound management: A review” in European Polymer Journal, 2019, 134-151, as applied to claim 23, in view of Miinea et al., (US 20190321507 A1).
Claims 25-26 depend on claim 23. Aslam in combination with Shima Tavakoli and Abhishek Gupta have been described above to render claim 23 prima facie obvious.
Aslam in combination with Shima Tavakoli and Abhishek Gupta does not teach that 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 combination with Shima Tavakoli and Abhishek Gupta and further 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 20190046547 A1) in combination with Shima Tavakoli et al., “Advanced Hydrogels as Wound Dressings” in Biomolecules, 2020, pp 1-20, and Abhishek Gupta et al., “The production and application of hydrogels for wound management: A review” in European Polymer Journal, 2019, 134-151, as applied to claims 23 and 28, in view in view of JP 2018509455 A, Eng Trans.
Claim 29 depends on claim 28 which depends on claim 23.
Aslam in combination with Shima Tavakoli and Abhishek Gupta have been described above to render claims 23 and 28 prima facie obvious. Aslam in combination with Shima Tavakoli and Abhishek Gupta 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 combination with Shima Tavakoli and Abhishek Gupta in view of JP 2018509455 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 20190046547 A1) in combination with Shima Tavakoli et al., “Advanced Hydrogels as Wound Dressings” in Biomolecules, 2020, pp 1-20, and Abhishek Gupta et al., “The production and application of hydrogels for wound management: A review” in European Polymer Journal, 2019, 134-151, as applied to claims 16 and 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 in combination with Shima Tavakoli and Abhishek Gupta have been described above to render claims 16, 23 and 31 prima facie obvious. Aslam in combination with Shima Tavakoli and Abhishek Gupta 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 combination with Shima Tavakoli and Abhishek Gupta in view of JP 2018531652 A 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 16-21, 23-37 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1 and 7; and 1-14 of U.S. Patent Nos. 10130531 B2 and 9579413 B2, respectfully, in view of Shima Tavakoli et al., “Advanced Hydrogels as Wound Dressings” in Biomolecules, 2020, pp 1-20, and Abhishek Gupta et al., “The production and application of hydrogels for wound management: A review” in European Polymer Journal, 2019, 134-151. The difference between the issued claims and the examined claims is that the issued claims do not teach that the hydrogel is three-dimensional and trans parent. However, it is known in the art that hydrogels are three-dimensional network (see section 5 of page 5 of 20 of Shima Tavakoli). Therefore, before the effective date of the invention, the artisan having the information taught in Shima Tavakoli would have reasonably expected the hydrogel of the claims of issued claims of US 10130531 B2 to be in a three-dimensional network.
The issued claims do not say that the hydrogel is transparent. However, it is known in the art that the transparent nature of hydrogel dressing allows clinical assessment of the healing process without the need to remove the dressing (last three lines of the first full paragraph of the right column of page 138 of Abhishek Gupta). Therefore, before the effective date of the invention, would reasonably expect the hydrogel of Aslam to be transparent with the predictable expectation that the artisan would assess the healing process of the wound without removing the hydrogel dressing.
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.
Conclusion
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/BLESSING M FUBARA/Primary Examiner, Art Unit 1613
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