DETAILED ACTION
Examiner’s Note
The Examiner acknowledges the cancelation of claims 1, 9 and 17, and the addition of new claims 29-30 in the amendments filed 6/1/2026.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Applicant’s arguments, see the claim amendments and the remarks filed 6/1/2026, with respect to the objection to claim 9 as set forth in paragraph 3 of the action mailed 2/3/2026, have been fully considered and are persuasive. The objection to claim 9 has been withdrawn.
Applicant’s arguments, see the claim amendment and the arguments filed 6/1/2026, with respect to the rejections of claims 1 and 9 and claims 17 and 21-28 under 35 U.S.C. 112(a) as set forth in paragraphs 5-6 of the action mailed 2/3/2026, have been fully considered and are persuasive. The rejections of claim 1, 9, 17 and 21-28 have been withdrawn. These rejections have been withdrawn given that claims 1 and 17 have been cancelled. However, see below for the maintenance of these rejections in regards to the newly added claims 29 and 30.
Applicant’s arguments, see the claim amendments and the arguments filed 6/1/2026, with respect to the rejections of claims 1 and 9 under 35 U.S.C. 112(b) as set forth in paragraph 7 of the action mailed 2/3/2026, have been fully considered and are persuasive. The rejection of claims 1 and 9 has been withdrawn. This rejection has been withdrawn given that claim 1 has been cancelled. However, see below for the maintenance of these rejections in regards to the newly added claims 29 and 30 and the alleged “% by weight” proportions of the isocyanate.
Applicant’s arguments, see the claim amendments and the arguments filed 6/1/2026, with respect to the rejections of claim 9 under 35 U.S.C. 112(d) as set forth in paragraph 9 of the action mailed 2/3/2026, have been fully considered and are persuasive. The rejection claim 9 has been withdrawn.
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
Claim 29 is 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 29, the Examiner respectfully reiterates that the recitation that the “(b) an isocyanate of 5% to 7 % by weight” 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 “% by weight” as recited in current claim 29.
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. An AI GOOGLE search characterizes STRATEX Gel Sheet 800-13 as a crosslinked silicone polymer(s).
Claims 30 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 30, see the rejection of claim 29 under the identical statute set forth above, which is identically relevant to the current claims.
Claims 29 is 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 29, 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. See also the rejection of claim 29 under 35 U.S.S.C 112(a) set forth above.
Claims 30 and 21-28 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 30, see the rejection of claim 29 under the identical statute set forth above, which is identically relevant to the current claims.
Claim Rejections - 35 USC § 103
Claim(s) 29 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 previous action, as was the original document.
Regarding claim 29, 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) (flexible substrate film, 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) (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). The polyurethane comprises polyol (A), which is 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/molecule); polyol (B), which is 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/molecule); and (C) an organic polyisocyanate having an average functionality of 2 (2 NCO/molecule); wherein polyol (A) is present at 40 to 90 parts by weight per 100 parts by weight of the combination of polyol (A) and polyol (B) (10 to 60 parts by weight of polyol (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 polyol (A) comprises a polyether polyol and polyol (B) comprises polyether glycols such as, inter alia, polyethylene glycol and polypropylene glycol (para 0022); and wherein compound (C) comprises, inter alia, diphenylmethane diisocyanates (2 NCO/molecule; molecular weight ~ 250 g/mol) (para 0029). Lastly, Adachi teaches that the NCO/OH molar ratio of compounds (polyol (A) and polyol (B))/diisocyanate (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 acknowledges the Applicant’s arguments against the previous numerical analysis, which is updated here to correctly provide the following numerical analysis of the proportions of the compounds (A)/(B) and (C) as disclosed in Adachi. Polyol (A) is present at 40 parts by weight per 100 parts by weight of the combined amounts of polyol (A) and polyol (B), and thus polyol (B) is present at 60 parts by weight per 100 parts by weight of the combined amounts of polyol (A) and polyol (B).
Polyol (A) demonstrates a hydroxyl weight equivalent (Hew) given by:
Hew of polyol (A) = molecular weight (Mw) of polyol (A) ÷ OH functionality
= 12,000 g/mol ÷ 3 OH groups/molecule
= 4,000 g/eq.
Similar calculations yield a Hew of polyol (B) of 500 g/eq, and a Hew of the diphenylmethane diisocyanates (C) of 125 g/eq. The total Hew for the combination of polyol (A) and polyol (B) is:
0.4 × 4,000 g/eq + 0.6 × 500 g/eq =1,900 g/eq,
or 1,900 grams of polyols (A) and (B) provides one (1) mole of -OH functional groups, wherein 125 grams of diisocyanates (C) provides one (1) mole of -NCO functional groups.
As noted above, Adachi discloses an NCO/OH molar ratio of 0.7/1 to 1/1. Therefore, the range of the % by weight of the isocyanate (C) is given by:
0.7(125 g) ÷ (1,900 g + 0.7(125 g) × 100 = 4.40 % by weight, and
1(125 g) ÷ (1,900 g + 1(125 g) × 100 = 6.17 % by weight,
which overlaps that presently claimed (5 to 7% by weight).
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.
Claim(s) 30 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 30 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 claim 29, which is equally applicable to the current claims. As noted above in the rejection of current claim 290, 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) (para 0079).
Response to Arguments
Applicant’s arguments, see the claim amendment and the arguments filed 6/1/2026, with respect to the rejections of claims 1 and 9 and claims 17 and 21-28 under 35 U.S.C. 112(a) as set forth in paragraphs 5-6 of the action mailed 2/3/2026, have been fully considered but they are not persuasive.
The Examiner acknowledges the cancelation of claims 1, 9 and 17, and the addition of new claims 29 and 30. Thus, the Examiner’s rebuttal towards the Applicant’s arguments are directed to the updated rejections set forth above. The Examiner respectfully acknowledges the Applicant’s citation of the present specification and its disclosure concerning the isocyanate content. However, the Examiner also respectfully maintains that the specification as originally filed does not provide support for the presently claimed isocyanate content expressed in units of % by weight. The Examiner does not submit that the values relating to the isocyanate are hypothetical values; only that they are disclosed as values without specifying the units of the alleged proportions towards supporting the language of the claimed invention as recited in at least current claim 29 and current claim 30.
Turning now to the Applicant’s assertions towards one of ordinary skill “immediately and unambiguously” recognizing that the presently disclosed values of “5 to 7” would refer to the isocyanate’s weight percentage, the Applicant is respectfully reminded that,
“the arguments of counsel cannot take the place of evidence in the record”, In re Schulze,
346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). It is the Examiner’s position that
the arguments provided by the Applicant regarding the “immediately and
unambiguously” recognition must be supported by a declaration or affidavit. As set forth
in MPEP 716.02(g), “the reason for requiring evidence in a declaration or affidavit form
is to obtain the assurances that any statements or representations made are correct, as
provided by 35 U.S.C. 24 and 18 U.S.C. 1001.”
The Examiner acknowledges that % by weight is a convention for reporting the proportions of the components comprising a resultant polyurethane, but the Examiner further submits that any disclosure of said proportions is not limited only to % by weight. Thus, it is not certain whether one skilled in the art would unambiguously recognize that the presently claimed/disclosed invention intended for the proportions of the isocyanate compounds to be given in % by weight.
The Applicant’s attention is respectfully directed to paragraph 14 of the action mailed 2/3/2026, where it is noted that 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) also cited in said paragraph 14; US 2022/0154055 A1 to Meng et al. (for example, at para 0033 and 0051); US 2021/0207012 A1 to Golombowski et al. (para 0046); and US 2018/0346774 A1 to Chen et al. (see claim 13 therein).
To the Applicant’s second point, there is nothing of record to demonstrate that the presently disclosed numerical values of 5 to 7 are meaningless without assuming that they refer to the % by weight of the associated compounds. Indeed, the above-noted cited references demonstrate the Examiner’s position that units other than % by weight are meaningful. It is also unclear what the Applicant intended via a “batch size,” especially given that the presently claimed/disclosed proportions of the isocyanate are also referenced without the inclusion of a batch size (e.g., mol%, weight%, etc. based on the total weight of the resultant polyurethane). Clarification is requested on this matter.
The Examiner further submits that weight% amounts are also not reported as bare integers unless they lead to the same issues currently disputed. Moreover, the Examiner does not dispute the Applicant’s contention in regards to volume%, but neither does the Examiner conceded the merits of the Applicant’s position towards overcoming the disputed rejection. The Applicant’s position with respect to “typical” values of the NCO index or NCO:OH is not supported by any evidence on the record (see In re Schulze above), nor would the Applicant’s position be persuasive if they were typical as there is also nothing on the record that atypical values are forbidden in the art.
To the Applicant’s third point, the Examiner does not dispute that the data of Fig. 4 represents the isocyanate content (i.e., a compositional parameter) as discussed in Vas-Cath Inc. v. Mahurkar. Indeed, this is presently disclosed in at least paragraph 0020. However, there is nothing is said specification that specifies that the “5 to 7” compositional parameter was intended to convey % by weight. Lastly, the above-noted cited references, including Adachi, are clear indications that the Examiner has conspicuously identified alternative descriptions to % by weight proportions of polyurethanes that would be “physically meaningful” to polyurethane adhesive chemistry.
Thus, the rejections are maintained and repeated above.
Applicant’s arguments, see the claim amendment and the arguments filed 6/1/2026, with respect to the rejection of claims 1 and 9 under 35 U.S.C. 112(b) as set forth in paragraph 7 of the action mailed 2/3/2026, have been fully considered but they are not persuasive.
The Examiner acknowledges the cancelation of claims 1 and 9, and the addition of new claims 29 and 30. Thus, the Examiner’s rebuttal towards the Applicant’s arguments are directed to the updated rejections set forth above, which said rebuttal is adequately treated in the Examiner’s response to the Applicant’s arguments against the rejection under 35 U.S.C. 112(a). Thus, the rejections are maintained and repeated above.
Applicant’s arguments, see the claim amendment and the arguments filed 6/1/2026, with respect to the rejections of claims 1 and 9 and claims 17 and 21-28 over Tinius in view of Adachi under 35 U.S.C. 103 as set forth in paragraphs 10-11 of the action mailed 2/3/2026, have been fully considered but they are not persuasive.
The Examiner acknowledges the cancelation of claims 1, 9 and 17, and the addition of new claims 29 and 30. Thus, the Examiner’s rebuttal towards the Applicant’s arguments are directed to the updated rejections set forth above. In regards to Item (I) of the Applicant’s arguments against the prior art rejections, the Examiner respectfully directs the Applicant’s attention to the updated prior art rejections of current claim 29 and current claims 30 and 21-28 set forth above, which is a fair and complete response to the Applicant’s position with the respect to Tinius/Adachi teaching or rendering obvious the presently claimed proportions (i.e., 5 to 7 % by weight) of the recited (b) isocyanate.
In regards to Item (II), Adachi teaches the presently claimed % by weight for the recited (b) isocyanate, and thus Adachi does not teach a “high isocyanate content” if the Applicant’s intention was to argue that the presently claimed isocyanate content of 5 to7 % by weight is considered high.
Turning now to Item (III) of the Applicant’s arguments, as acknowledged by the Applicant, Adachi was only employed to remedy Tinius’ silence to the presently claimed content of the isocyanate. Both Tinius and Adachi are directed to PSAs that comprise polyurethane as a component, wherein both polyurethanes comprises polyols and isocyanates forming its structural backbone. Further, it is respectfully submitted that the,
"test for obviousness is not whether the features of a secondary reference may be bodily
incorporated into the structure of the primary reference... Rather, the test is what the
combined teachings of the references would have suggested to those of ordinary skill in
the art", In re Keller, 642 F.2d 413,208 USPQ 871,881 (CCPA 1981) and that
"combining the teachings of references does not involve an ability to combine their
specific structures", In re Nievelt, 482 F.2d 965, 179 USP 224, 226 (CCPA).
In addition, as set forth above, not only does Adachi remedy Tinius in regards to the claimed proportions of the isocyanate component, Adachi provides the motivation for adjusting the isocyanate component of the Tinius polyurethane.
Further, as previously cited, while Tunius teaches that the thickness is typically 60 m, Tunius does not dissuade one skilled in the art from the thickness(es) identical to that presently claimed. Complimenting Tinius, and further apprising one of ordinary skill, Adachi instructs that the adhesive strength can be adjusted based on the thickness of the adhesive layer with thickness values ranging from 5 to 100 mm. Lastly, there is no requirement that the prior art teach a thickness of 100 to 384 mm in order to teach or render obvious the presently claimed thickness. Tinius/Adachi conspicuously provide the skilled artisan with both overlapping thicknesses with that presently claimed as well as salient motivation towards the same.
Conclusion
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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/FRANK D DUCHENEAUX/Primary Examiner, Art Unit 1788 7/13/2026
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