DETAILED ACTION
This action is in response to the amendment filed 1/2/2026. Currently, claims 1, 3 and 6-21 are pending in the application. Claims 8 and 12-20 are withdrawn and not examined at this point. Claims 2, 4 and 5 are cancelled by Applicant.
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 Arguments
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “the skin contacting layer at the skin contacting surface comprising 80% to 99% by weight of the silicone-based material,” which is a claim limitation lacking proper antecedent basis in the specification. This is not an issue of new matter. Applicant should amend the specification to include the cited language to avoid this error. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “an antipruritic agent” in line 8 of the claim should be amended to recite ---the antipruritic agent---. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “means for reducing and/or preventing dermal scarring” in claim 1
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Applicant’s specification teaches the following corresponding structure(s) as performing the claimed function: an antipruritic agent dispersed throughout a skin contacting layer.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 6, 7 and 21 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. Claim 1 recites “the skin contacting surface comprising means for reducing and/or preventing dermal scarring.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure teaches the scar management dressing itself functioning for reducing and/or preventing dermal scarring (see original claim 1 and the abstract), and does not teach the skin contacting layer including a distinct means for reducing and/or preventing dermal scarring (and including this “means” in addition to the antipruritic agent and the silicone-based material), as claimed. Claims 3, 6, 7 and 21 depend on claim 1 and therefore, include the same error.
Claims 1, 3, 6, 7 and 21 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. Claim 1 recites the dressing with “the skin contacting surface comprising means for reducing and/or preventing dermal scarring” and “an antipruritic agent dispersed throughout the skin contacting layer.” No support is provided for this disclosure in Applicant’s specification as originally filed. Applicant’s original disclosure does not teach the dressing including means for reducing and/or preventing dermal scarring and a separate and distinct antipruritic agent dispersed throughout the skin contacting layer, as claimed. As detailed in the interpretation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph presented above, Applicant’s original disclosure teaches the means for reducing and/or preventing dermal scarring being an antipruritic agent dispersed throughout a skin contacting layer. Thus, Applicant’s original disclosure teaches the means for reducing and/or preventing dermal scarring and the antipruritic agent dispersed throughout the skin contacting layer being the same structure, and not distinct structures as claimed. Claims 3, 6, 7 and 21 depend on claim 1 and therefore, include the same error.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3, 7, 9 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Satoda et al. (US 2008/0149277 A1).
In regards to claim 1, Satoda et al. teaches in Figure 1, the abstract, [0010], [0034], [0049-0050], [0053], [0060-0061] and [0117]
a skin contacting layer (adhesive layer 2; capable of being positioned in contact with a user’s skin), the skin contacting layer (adhesive layer 2) comprising a sheet ([0034] teaches “adhesive layer [or, sheet] 2” that comprises adhesive sheet 3) of a silicone-based material (silicone rubber and liquid component; [0034] teaches “adhesive layer 2 further comprises an adhesive and a liquid component;” [0060] teaches that the adhesive can be a rubber adhesive; [0061] teaches “examples of the rubber adhesive include adhesives containing silicone rubber”), the skin contacting layer (adhesive layer 2) having a skin contacting surface (exterior surface capable of being positioned in contact with a user’s skin), and the skin contacting surface (exterior surface of adhesive layer 2, capable of being positioned in contact with a user’s skin) comprising ([0010] teaches the adhesive layer 2 being “a combination of a drug liquid, an adhesive and a liquid component;”) means for reducing and/or preventing dermal scarring (drug liquid 4; [0049] teaches “the drug concentration of a drug liquid;” [0050] teaches that the drug can be an “analgesic antipruritic astringent-anti-inflammatory drug;” [0117] teaches “the drug liquid broken into small parts gradually soaking into the adhesive layer in the traveling section for impregnation”), and
and an antipruritic agent (drug liquid 4; [0049] teaches “the drug concentration of a drug liquid;” [0050] teaches that the drug can be an “analgesic antipruritic astringent-anti-inflammatory drug”) dispersed throughout ([0117] teaches “the drug liquid broken into small parts gradually soaking into the adhesive layer in the traveling section for impregnation”) the skin contacting layer (adhesive layer 2),
the skin contacting layer (adhesive layer 2) at (throughout and therefore, at) the skin contacting surface (exterior surface of adhesive layer 2, capable of being positioned in contact with a user’s skin) comprising 80% to 99% by weight of the silicone-based material (silicone rubber and liquid component; [0034] teaches “adhesive layer 2 further comprises an adhesive and a liquid component;” [0060] teaches that the adhesive can be a rubber adhesive; [0061] teaches “examples of the rubber adhesive include adhesives containing silicone rubber;” [0053] teaches “the drug is preferably contained in a proportion of about 1-40 wt %, more preferably 1-20 wt %, most preferably 5-20 wt %, of an adhesive layer;” [0010] teaches the adhesive layer 2 being “a combination of a drug liquid, an adhesive and a liquid component;” therefore, the remaining 80-99 wt % of the adhesive layer 2 must comprise the silicone rubber and liquid component (corresponding to the claimed silicone-based material)),
the skin contacting layer (adhesive layer 2) comprising 1% to 20% by weight antipruritic agent ([0050] teaches that the drug can be an “analgesic antipruritic astringent-anti-inflammatory drug;” [0053] teaches “the drug is preferably contained in a proportion of about 1-40 wt %, more preferably 1-20 wt %, most preferably 5-20 wt %, of an adhesive layer”), and
the silicone-based material (silicone rubber and liquid component) comprising silicone, polydimethylsiloxane, polyorganosiloxane, silicone gel, or a silicone elastomer (silicone rubber is a known silicone elastomer).
In regards to claim 3, Satoda et al. teaches the apparatus of claim 1. Satoda et al. teaches in [0050] and [0053] the skin contacting layer (adhesive layer 2) comprising 10% by weight antipruritic agent ([0050] teaches that the drug can be an “analgesic antipruritic astringent-anti-inflammatory drug;” [0053] teaches “the drug is preferably contained in a proportion of about 1-40 wt %, more preferably 1-20 wt %, most preferably 5-20 wt %, of an adhesive layer”).
In regards to claim 7, Satoda et al. teaches the apparatus of claim 1. Satoda et al. teaches in [0049-0050] the antipruritic agent (drug liquid 4; [0049] teaches “the drug concentration of a drug liquid ;” [0050] teaches that the drug can be an “analgesic antipruritic astringent-anti-inflammatory drug”) comprising topical steroids, counterirritants ([0050] teaches that the drug can be an “analgesic antipruritic astringent-anti-inflammatory drug;” an anti-inflammatory drug functions to reduce irritation by reducing inflammation), and/or local anesthetics.
In regards to claim 9, Satoda et al. teaches in Figure 1, [0010], [0034], [0049], [0061], [0095], [0105] and [0117]
mixing an antipruritic agent (drug liquid 4; [0049] teaches “the drug concentration of a drug liquid ;” [0050] teaches that the drug can be an “analgesic antipruritic astringent-anti-inflammatory drug”) into a silicone formulation (adhesive layer 2; [0060] teaches that the adhesive can be a rubber adhesive; [0061] teaches “examples of the rubber adhesive include adhesives containing silicone rubber”) to form a mixture thereof ([0117] teaches “the drug liquid broken into small parts gradually soaking into the adhesive layer in the traveling section for impregnation”),
the silicone formulation (materials forming adhesive layer 2; [0060] teaches that the adhesive can be a rubber adhesive; [0061] teaches “examples of the rubber adhesive include adhesives containing silicone rubber”) comprising polyorganosiloxane, silicone, silicone gel, silicone elastomer (silicone rubber is a known silicone elastomer), or polydimethylsiloxane,
applying the mixture onto a carrier (support sheet 1) to form a layer of the mixture thereon ([0105] teaches “after passing a drug liquid application part and a traveling section for impregnation, a sheet such as a release liner, a support sheet and the like, which is necessary for completing a product, is appropriately layered thereon;” [0115] teaches “an adhesive layer (containing a liquid component) 2 supported by a support sheet 1 (or a release liner);” steps also shown in Figure 1), and
curing the layer of the mixture ([0095] teaches “In order to provide appropriate coagulation power for application to the skin of a human and the like, it is preferable to perform a crosslinking treatment to an adhesive layer.”) to form a skin contacting layer (adhesive layer 2; capable of being positioned in contact with a user’s skin) comprising a sheet ([0034] teaches “adhesive layer [or, sheet] 2” that comprises adhesive sheet 3) of a silicone-based material having an antipruritic agent dispersed throughout the silicone-based material ([0010] teaches the adhesive layer 2 being “a combination of a drug liquid, an adhesive and a liquid component;” [0060] teaches that the adhesive can be a rubber adhesive; [0061] teaches “examples of the rubber adhesive include adhesives containing silicone rubber;” [0049] teaches “the drug concentration of a drug liquid;” [0050] teaches that the drug can be an “analgesic antipruritic astringent-anti-inflammatory drug;” [0117] teaches “the drug liquid broken into small parts gradually soaking into the adhesive layer in the traveling section for impregnation”).
In regards to claim 11, Satoda et al. teaches the method of claim 9. Satoda et al. teaches in [0049-0050] the antipruritic agent (drug liquid 4; [0049] teaches “the drug concentration of a drug liquid ;” [0050] teaches that the drug can be an “analgesic antipruritic astringent-anti-inflammatory drug”) comprising topical steroids, counterirritants ([0050] teaches that the drug can be an “analgesic antipruritic astringent-anti-inflammatory drug;” an anti-inflammatory drug functions to reduce irritation by reducing inflammation), and/or local anesthetics.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 6 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Satoda et al. (US 2008/0149277 A1) in view of STHENGEL et al. (US 2021/0170068 A1).
In regards to claim 6, Satoda et al. teaches the apparatus of claim 1. Satoda et al. does not teach the antipruritic agent comprising diphenylhydramine HCI, corticosteroids, hydrocortisone, diphenhydramine, mint oil, menthol, camphor, lidocaine, pramoxine, and/or benzocaine.
However, STHENGEL et al. teaches in [0040] an analogous device wherein the antipruritic agent comprising diphenylhydramine HCI, corticosteroids ([0040] teaches “antipruritic agents such as: pH adjusting agent for instance 1-3% ammonia or 1-3% acetic acid, 1-10% calamine lotion, 0.1-5% CaCO.sub.3, antihistamine, corticosteroids, xylocaine or other local anesthetics”), hydrocortisone, diphenhydramine, mint oil, menthol, camphor, lidocaine, pramoxine, and/or benzocaine.
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the antipruritic agent of Satoda et al. to comprise diphenylhydramine HCI, corticosteroids, hydrocortisone, diphenhydramine, mint oil, menthol, camphor, lidocaine, pramoxine, and/or benzocaine as taught by STHENGEL et al. because this element is a known antipruritic agent “used to relieve itching from insect bites or other causes,” as STHENGEL et al. teaches in [0040].
In regards to claim 10, Satoda et al. teaches the method of claim 9. Satoda et al. does not teach the antipruritic agent comprising diphenylhydramine HCl, corticosteroids, hydrocortisone, diphenhydramine, mint oil, menthol, camphor, lidocaine, pramoxine, and/or benzocaine.
However, STHENGEL et al. teaches in [0040] an analogous method with the antipruritic agent comprising diphenylhydramine HCl, corticosteroids ([0040] teaches “antipruritic agents such as: pH adjusting agent for instance 1-3% ammonia or 1-3% acetic acid, 1-10% calamine lotion, 0.1-5% CaCO.sub.3, antihistamine, corticosteroids, xylocaine or other local anesthetics”), hydrocortisone, diphenhydramine, mint oil, menthol, camphor, lidocaine, pramoxine, and/or benzocaine.
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of Satoda et al. to include the antipruritic agent comprising diphenylhydramine HCl, corticosteroids, hydrocortisone, diphenhydramine, mint oil, menthol, camphor, lidocaine, pramoxine, and/or benzocaine as taught by STHENGEL et al. because this element is a known antipruritic agent “used to relieve itching from insect bites or other causes,” as STHENGEL et al. teaches in [0040].
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Satoda et al. (US 2008/0149277 A1) in view of Anderson (US 2020/0405655 A1) (as evidenced by FARMER et al. US 2021/0121597 A1).
In regards to claim 21, Satoda et al. teaches in the abstract, [0049-0050] and [0117] providing (the abstract teaches “the adhesive sheet has at least an adhesive layer”) a skin contacting layer (adhesive layer 2; capable of being positioned in contact with a user’s skin) having a skin contacting side (exterior surface capable of being positioned in contact with a user’s skin), and an antipruritic agent (drug liquid 4; [0049] teaches “the drug concentration of a drug liquid ;” [0050] teaches that the drug can be an “analgesic antipruritic astringent-anti-inflammatory drug”) dispersed throughout ([0117] teaches “the drug liquid broken into small parts gradually soaking into the adhesive layer in the traveling section for impregnation”) the skin contacting layer (adhesive layer 2).
Satoda et al. does not teach applying the skin contacting side of the skin contacting layer of the scar management dressing over and into contact with a closed wound site, and maintaining the scar management dressing over and into contact with the closed wound site for an effective amount of time to reduce and/or prevent dermal scarring and to alleviate pruritis.
However, Anderson teaches in [0005], [0027] and [0087] an analogous method that includes applying the skin contacting side of the skin contacting layer of the scar management dressing ([0005] teaches “the dressing reduces or minimizes scarring”) over and into contact with a closed wound site ([0027] teaches “the dressing is applied directly over an incision that has been sutured or otherwise closed after surgery”), and maintaining the scar management dressing ([0005] teaches “the dressing reduces or minimizes scarring”) over and into contact with the closed wound site ([0027] teaches “the dressing is applied directly over an incision that has been sutured or otherwise closed after surgery”) for an effective amount of time to reduce and/or prevent dermal scarring ([0087] teaches “The incision was covered by the dressing for a total period of about four months. The dressing was removed and a fresh, new dressing was applied as needed. FIG. 2 shows the reduction in scaring after about 17 weeks in an area covered by the dressing.”) and to alleviate pruritic (reduction of scarring is known to “reduce the negative effects of a scar, such as immobility, pain or itching,” as evidenced by [0036] of FARMER et al.).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the method of Satoda et al. to include applying the skin contacting side of the skin contacting layer of the scar management dressing over and into contact with a closed wound site, and maintaining the scar management dressing over and into contact with the closed wound site for an effective amount of time to reduce and/or prevent dermal scarring and to alleviate pruritis as taught by Anderson because this element is known to utilize the scar management dressing to provide “reduction in scaring,” as Anderson teaches in [0087].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 4/21/2026
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