DETAILED ACTION
In view of the appeal brief filed on Nov. 11, 2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejections are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/Alicia Chevalier/ Supervisory Patent Examiner, Art Unit 1788
Examiner’s Note
NOTE: In section V. SUMMARY OF CLAIMED SUBJECT MATTER of the Appeal Brief filed 10/01/2025, independent claim 1 does not include the “…by weight of the adhesive, and (c) a catalyst.” limitation, while independent claim 17 does include this limitation. In section X. CLAIMS APPENDEX of the Appeal Brief filed 10/01/2025, independent claim 1 does include the “…by weight of the adhesive, and (c) a catalyst.” limitation; independent claim 17 is identical in both of sections V and X.
In section V. SUMMARY OF CLAIMED SUBJECT MATTER of the Appeal Brief filed 11/11/2025 (Corrections to the Brief filed 10/1/2025), independent claim 1 does not include the “…by weight of the adhesive, and (c) a catalyst.” limitation, while independent claim 17 does include this limitation. In section X. CLAIMS APPENDEX of the Appeal Brief filed 11/11/2025 (Corrections to the Brief filed 10/1/2025), independent claim 1 does include the “…by weight of the adhesive, and (c) a catalyst.” limitation; independent claim 17 is identical in both of sections V and X.
For the purposed of examination of the instant application as outlined in the current action set forth below, the claim listings filed 7/15/2025 will be examined.
All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through, except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only claims having the status of “currently amended” or “withdrawn” if also being amended, shall include markings. If a withdrawn claim is currently amended, its status in the claim listing may be identified as “withdrawn— currently amended.” (see MPEP 714)
Claim 1 of the claim listings filed 5/12/2025 recited “…by weight of the adhesive, and (c) a catalyst.” However, these limitations has not been properly deleted from the current claims via a strikethrough.
Claim 17 was amended as set forth the claim listings filed 5/12/2025 to recite that the isocyanate was present at 5% to 7% via underlying, but was again annotated with underlying in the current claims.
Strike-throughs are annotations demonstrating that limitations from the previous claim listings have been omitted from the current claim listings. Current claims 2-8, 10-16 and 18-20 filed 7/15/2025 were canceled in the claim listings filed 5/12/2025 and 9/4/2024 via both a “canceled” status and the strike-through indications, and thus the latter annotation should not be present in the current claim listings.
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 .
Claim Objections
Claim 9 is objected to because of the following informalities: the claim is dependent on canceled claim 7. Appropriate correction is required.
Rejections
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 112
Claims 1 and 9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, the Examiner respectfully submits that the recitation that the “(b) an isocyanate of 5% to 7 %” is not supported by the specification as originally filed. Attention is respectfully directed to said specification at paragraphs 0010, 0013, 0020 (an associated Fig. 4), 0037 and 0048 (an associated Fig. 4), which are the instances presently disclosed that discuss the presently claimed isocyanate compound(s). It is noted that nowhere within the specification as originally filed is there any indication that the claimed/disclosed isocyanate component of the polyurethane is present as a percentage (i.e., 5% to 7%), as recited in current claim 1 nor as “% by weight” as recited in current claim 17.
The Examiner notes that Fig. 4 provides an x-axis that ranges from “5 to 7,” but does not provide any units, including percentages, weight %, mol%, etc. Paragraphs 0047-0048 seem to indicate that the y-axis of the graph provides adhesion values, albeit also unitless (e.g., N/mm2, grams/force, etc.). Also, the examples presently disclosed mention exemplary PU mixture adhesives generally comprising the claimed compounds (a), (b) and (c) (para 0037-0038) without disclosing their numerical proportions while paragraph 0042 mentions “four different PU adhesives” that only appear to differ in thickness.
Continuing, paragraph 0046 presently disclosed mentions the “PU adhesive coating of the present disclosure,” but again does not stipulate any compositional proportions comprising the adhesive coating. Example 5 (para 0049-0057) discloses exemplary PU adhesive as STRATEX Gel Sheet 800-13, but does provide the compositional elements of this trademarked item nor has the Examiner been able to locate any literature to this end.
Claims 17 and 21-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 17, see the rejection of claims 1 and 9 under the identical statute set forth above.
Claims 1 and 9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, it is unclear from the claim limitations, and in light of the specification as originally filed, what is being claimed given that it is unclear to what units the “5% to 7%” limitations are referring; that is, % by weight, mole %, etc.
Regarding claim 1, it is unclear from the claim limitations if the recited adhesive layer (i.e., the PSA) comprising the flexible substrate film is further limited via the recited polyurethane adhesive also comprising the flexible substrate film, or if the recited polyurethane adhesive comprising the flexible substrate film is in addition to the previously recited adhesive layer (i.e., the PSA layer).
Regarding claim 1, it is unclear from the claim limitations, and in light of the specification as originally filed, what is being claimed given that it is unclear if the proportions of the (b) isocyanate are relative to the adhesive layer (i.e., the PSA layer) as a whole;
or if the polyurethane adhesive is a component of the adhesive layer (i.e., the PSA layer) such as a polyurethane polymer comprising the overall adhesive layer (i.e., the PSA layer);
or some other interpretation.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 9 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Regarding claim 9, attention is respectfully directed to paragraphs 0012 and 0014, wherein the specification as originally filed discloses that the claimed substrate film comprises the materials recited in current claim 1 or the materials recited in current claim 9. However, the materials recited in said current claim 9 do not further limit those recited in said current claim 1.
Claim Rejections - 35 USC § 103
Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tinius (US 2017/0051189 A1) in view of Adachi (WO 2014/148582 A1). The Examiner notes that citations from the ‘582 reference were taken from a machine translation, which is included with the current action, as is the original document.
Regarding claims 1 and 9, Tunius teaches an adhesive medical dressing (100) (wound dressing) attached to skin (20) comprising absorbent layer (130) (absorbent pad) disposed beneath (lower surface) protective backing layer (140) (film base), which is in-turn attached to the underside of occlusive cover layer (180) via weak adhesive (190), wherein the edges of layer (140) comprise switchable adhesive composition (170) (adhesive layer extending across a surface area) (para 0151-0152; Fig. 1) having a thickness of 60 m (para 0075-0076)
Tinius also teaches that the adhesive composition (170) comprises:
a pressure sensitive adhesive (PSA) component in an amount of 10 to 95 % by weight;
an oligomeric curable component in an amount of 10 to 85% by weight;
a photoinitiator (catalyst mix) in an amount of 0.1 to 10% by weight;
and a stabiliser in an amount of 0.01 to 2% by weight (para 0067);
wherein the oligomeric curable component is polyurethane of formula (I) CA(BA)nC with, n = 0 to 100;
“A” is a diisocyanate;
“B” is a diol; and,
“C” is a hydroxyl containing double bond carrying molecule (para 0008-0012, 0044),
with said diols comprising polypropylene glycol and polyethylene glycol ((a) polyol mixture) (para 0058).
Tinius further teaches that the adhesive (170) is applied to a carrier film (substrate film) (para 0074-0078) such as a film of, inter alia, thermoplastic polyester elastomer and non-wovens (flexible, current claim 9) (para 0079).
Tinius is silent to the proportions of the recited isocyanate of 5-7% (e.g., by weight) of the adhesive (170) and to the presently claimed adhesive having a mean thickness of 73 to 384 mm.
However, Tinius does instruct the skilled artisan that higher molecular weight oligomers provide a desired avoidance of migration (para 0053); to diminish toxicity by avoiding oligomers with too much hydrophilicity (para 0056); and employs polymeric glycols (i.e., diols) such as the above noted polypropylene glycol and polyethylene glycol towards improved moisture breathability (para 0058). Tinus also teaches that the isocyanates are diisocyanate compounds (para 0057).
Furthermore, while Tunius teaches that the thickness is typically 60 m (para 0076), Tunius does not dissuade one skilled in the art from the thickness(es) identical to that presently claimed.
In addition, Adachi teaches polyurethane-based PSAs towards the application of patches to skin (para 0001), and that the art recognizes the import of patches having excellent moisture permeability (para 0003). Adachi also teaches that the polyurethane comprises (A) an active hydrogen compound having an average molecular weight of 1.2 × 104 or more (12,000 g/mol or more) and an average functionality of 3 (3 OH/mol); (B) an active hydrogen compound having an average molecular weight of 0.1 × 104 or more (1,000 g/mol or more) and an average functionality of 2 (2 OH/mol); and (C) an organic polyisocyanate having an average functionality of 2 (2 NCO/mol); wherein (A) is present at 40 to 90 parts by weight per 100 parts by weight of the combination of (A) and (B) (10 to 60 parts by weight of (B)) (para 0010). See also the abstract of the original document of Adachi to demonstrate that the -NER4- and -NER5- citations in the machine translation are 104.
Adachi also instructs that the compounds (A), (B) and/or (C) have an average number of functional groups greater than 2 and a sufficient molecular weight towards a polyurethane having sufficient flexibility and tack (para 0012), with the inventive adhesives demonstrating excellent moisture permeability and adhesive properties at adhesive layer thicknesses less than 100 mm (para 0013). Adachi continues to teach that the adhesive strength can be adjusted based on the thickness of the adhesive layer (para 0040) with thickness values ranging from 5 to 100 mm (para 0041), which overlaps the presently claimed mean thickness of 73 to 384 mm.
As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Adachi further teaches that compound (A) comprises a polyether polyol and compound (B) comprises polyether glycols such as, inter alia, polyethylene glycol and polypropylene glycol (para 0022); and wherein compound (C) comprises, inter alia, diphenylmethane diisocyanate (2 NCO/mol; molecular weight ~ 250 g/mol) (para 0029). Lastly, Adachi teaches that the NCO/OH molar ratio of compounds (A) and (B)/compound (C) is 0.7/1 to 1/1 towards increase adhesive strength, stability over time and the reduction of bleeding out (para 0031).
The Examiner respectfully proffers that following numerical analysis of the proportions of the compounds (A)/(B) and (C) as disclosed in Adachi. Adachi discloses an NCO/OH molar ratio of 0.7:1, which is encompassed by the disclosed range of the molar ratio of the reference (i.e., 0.7/1 to 1/1. Adachi also teaches that (A) is present at 40 parts by weight per 100 parts by weight of the combined amounts of (A) and (B), and (B) is present at 60 parts by weight per 100 parts by weight of the combined amounts of (A) and (B), which are encompassed by the disclosed parts by weight range of the reference, and thus Adachi teaches the average -OH functionality of the combination of (A) and (B) is (0.4 × 3 OH/mol) + (0.6 × 2 OH/mol) = 1.2 OH/mol + 1.2 OH/mol = 2.4 OH/mol.
As noted above, the molecular weight of diphenylmethane diisocyanate is 250 g/mol. Adachi also teaches that (A) has an average molecular weight of, for example, 1.2 × 104 (12,000 g/mol) and (B) has an average molecular weight of, for example, 0.1 × 104 (1,000 g/mol), both of which are encompassed by the disclosed ranges of molecular weights of the reference. Thus, Adachi teaches that the average molecular weight of the combined molecular weights of (A) and (B) in the polyurethane is (0.4 × 12,000 g/mol) + (0.6 × 1,000 g/mol) = 4,800 + 600 = 5,400 g/mol. Given an NCO/OH molar ratio of 0.7/1, the combined grammage of (A) and (B) towards the disclosed polyurethane is 5,400 g/mol ÷ 2.4 OH/mol = 2250 grams; and the grammage of (C) is 250 g/mol ÷ (2.4 × 0.7 NCO/mol) = 149 grams.
Therefore, Adachi teaches a polyurethane comprising the isocyanate compound (C) in a proportion given by (grams of (C) ÷ grams of ((A) + (B) + (C)) × 100 = (149 g of (C) ÷ 2399 g of (A)/(B)/(C)) × 100 = 6.2 % by weight, which overlaps that presently claimed (5% to 7%).
It is well settled that where the prior art describes the components of a claimed compound or compositions in concentrations within or overlapping the claimed concentrations a prima facie case of obviousness is established. See In re Harris, 409 F.3d 1339, 1343, 74 USPQ2d 1951, 1953 (Fed. Cir 2005); In re Peterson, 315 F.3d 1325, 1329, 65 USPQ 2d 1379, 1382 (Fed. Cir. 1997); In re Woodruff, 919 F.2d 1575, 1578 16 USPQ2d 1934, 1936-37 (CCPA 1990); In re Malagari, 499 F.2d 1297, 1303, 182 USPQ 549, 553 (CCPA 1974).
Indeed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to provide the adhesive (170) of Tinius with the presently claimed thickness and the proportions of the isocyanate component for the oligomeric curable component towards said adhesive (170) demonstrating a balance of excellent moisture permeability, sufficient flexibility, tack, adhesive properties (e.g., adhesive strength), stability over time and the reduction of bleeding out as in the present invention.
The Examiner notes that the proportions of the isocyanate compounds discussed above over the combination of Tinius and the analogous Adachi reference hold true whether the interpretation to the presently claimed invention reciting that the isocyanate proportions of 5 to 7 % (e.g. by weight) is based on the polyurethane adhesive (i.e., a polyurethane polymers comprising the PSA layer), or is based on the entirety of the adhesive composition as whole, of which the polyurethane polymer would be one component among others. For example, the analysis set forth above is only taking into consideration ONLY the isocyanate’s contribution to the % by weight of the polyurethane polymer (i.e., the oligomeric curable component of Tinius) rather than the entirety of adhesive (170). However, given that the oligomeric curable component of Tinius is present up 85 % by weight of the PSA (170), the combination of Tinius/Adachi would provide the isocyanate compounds at 0.85 × 6.2 % by weight = 5.3 % by weight of the total of PSA (170), which is still within the presently claimed range. See also the rejections under 35 U.S.C. 112(a) and (b) set forth above.
Claim(s) 17 and 21-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tinius (US 2017/0051189 A1) in view of Adachi (WO 2014/148582 A1).
Regarding claims 17 and 21-28, Tinius/Adachi teaches the dressing (100) (i.e. a medical device or bandage, current claims 22-24) set forth above in the prior art rejection of claims 1 and 9, which is equally applicable to the current claims.
Response to Arguments
Appellant's arguments, see the Appeal Brief filed 10/1/2025 and the Appeal Brief filed 11/112025, with respect to the rejections of claims 1 and 9 over Tinius in view of Fukano et al. and in further view of Bandou et al. under 35 U.S.C. 103 and claims 17 and 21-28 over Tinius in view of Fukano et al. and in further view of Bandou et al. under 35 U.S.C. 103 as set forth in paragraphs 4-5 of the action mailed 5/28/2025 have been fully considered but they are not persuasive.
In regards to Section VII. STATEMENT OF ISSUES, Items 1-3, of the Appeal Brief the Examiner respectfully directs the Appellant’s attention to at least the prior art rejections set forth above, where it is noted that the Fukano and Bandou references are no longer employed to remedy the noted deficiencies of Tinius. The analogous Adachi reference has been employed to this end in their stead. Both Tinius and Adachi are conspicuously directed to medical dressings/bandages that employ polyurethane-based adhesives to attach the dressings/bandages to skin tissue (see, for example para 0036 of Adachi).
In regards to Section VIII. STATEMENT OF THE CASE (37 C.F.R § 41.37 (c)(6)) of the Appeal Brief, the Examiner respectfully directs the Appellant’s attention to the rejections of the claimed invention over 35 U.S.C. 112(a) and (b) set forth above, and to the relevant portions of the specification as originally filed discussing the presently claimed proportions of the (b) isocyanate component. Examples 2 and 4 at paragraphs 0045-0048, and the associated Figures 3-4, demonstrate adhesion to a metal plate while varying the alleged proportions of the isocyanate component. No mention is made to the isocyanate effects on adhesion or atraumatic removal of the presently disclosed adhesion to skin. See also Example 5 beginning paragraphs 0049-0057 and the associated Figure(s). Indeed, paragraph 0068 specifically discloses that no human testing was conducted or observed.
In regards to Section IX. SUMMARY OF THE ARGUMENT, the Appellant’s attention is respectfully directed to the updated priori art rejections over Tinius in view the analogous Adachi invention, to the cited references as a whole, and to the Examiner’s response to the Appellant’s position as postured in Section VII. STATEMENT OF ISSUES, Items 1-3, of the Appeal Brief. Specifically, Fukano and Bandou were nowhere employed in said prior art rejections. Instead, the clearly analogous Adachi reference is currently employed to remedy the presently argued deficiencies of Tinius.
Thus, the Examiner submits that the current prior art rejections and the Examiner’s current response to the Appellant’s arguments of said Sections VII and VIII constitute a fair and complete response to the Appellant’s position in Section IX of the Appeal Brief pertaining to Bandou (and Fukano) lacking analogy or relevance (i.e., motivation for the prior art combination) to the Tinius invention.
Turning now to Section X. ARGUMENT (37 C.F.R § 41.37 (c)(8)), I. Concise Description of the Invention, the Appellant’s attention is respectfully directed to the above sections of the current action. The Examiner notes that independent claim 1 is the only claim requiring a “wound dressing” with claims 22-24 reciting only intended use. As noted above, current claim 1 does not recite “% by weight” or “catalyst” limitations. The Examiner also respectfully reiterates that, while there is no evidence of record positively excluding the presently claimed/disclosed adhesives from “skin compatibility,” there is no presently disclosed data demonstrating adhesion results such as trauma, discomfort or pain to the skin tissue of patients.
The basis for the Appellant’s position set forth in Section X. ARGUMENT (37 C.F.R § 41.37 (c)(8)), 2. Bandou is Non-Analogous Art;
sub-section A. Not the Same Field of Endeavor;
sub-section B. Not Reasonably Pertinent to the Problem Addressed;
sub-section C. The Examiner’s “Reasonably Pertinent” Argument is Overly Broad;
sub-section D. Distinguishing Atlas Powder;
sub-section E. Case Law Confirms Bandou is Too Remote;
and sub-section F. Examiner’s Viscosity and Cohesion: Rationale is Overly
Generalized,
has been addressed above. Specifically, Bandou has not been employed in the current prior art rejections, whereas newly-cited Adachi is clearly relevant in both analogy and pertinence to the primary Tinius reference as well as the presently claimed/disclosed invention.
The basis for the Appellant’s position set forth in Section X. ARGUMENT (37 C.F.R § 41.37 (c)(8)), 3. No Motivation to Combine without hindsight;
4. Burden of Proof Remains With the Examiner;
5. No Articulated Rationale to Combine Without Hindsight;
has been addressed above. Further, the disclosures of Tinus and Adachi provide one skilled in the art with the rationale and motivation towards the prior art combination. As noted above, Tinius instructs the skilled artisan towards higher molecular weight oligomers (i.e., the disclosed diols) provide diminished migration, and to diminished toxicity by avoiding oligomers with too much hydrophilicity; and employs the polypropylene and polyethylene glycols (i.e., diols) towards improved moisture.
Adachi also recognizes the import of patches having excellent moisture permeability, as well as sufficient flexibility and tack, adhesive properties (e.g., adhesive strength), stability over time and the reduction of bleeding out based on factors such as the proportions of the polyols and the isocyanates as expressed in the disclosed molar ratio of NCO/OH.
Conclusion
The prior art made of record and not relied upon is considered pertinent to Appellant’s disclosure:
US 2004/0151902 A1 to Ansell is directed switchable adhesive polyurethane polymers (abstract; para 0060) comprising diisocyanates and diols (para 0116-0118) with proportions disclosed as molar ratios (para 0136), wherein the adhesives are directed for use in dressings (para 0179).
See also WO 96/26966 A1 to Shah et al. (page 4, lines 28-33 and page 7, lines 1-13).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANK D DUCHENEAUX whose telephone number is (571)270-7053. The examiner can normally be reached 8:30 PM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alicia A Chevalier can be reached at 571-272-1490. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRANK D DUCHENEAUX/Primary Examiner, Art Unit 1788 1/29/2026