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 .
General Information
The examiner would like to note that the applicant is given 3-months to reply then has to
purchase an extension of time after the 3 months but is limited to 6 months from this office
action. The reply must be sent in on or before 6 months.
It appears the inventor(s) filed the current application pro se (i.e., without the benefit of representation by a registered patent practitioner). While inventors named as applicants in a patent application may prosecute the application pro se, lack of familiarity with patent examination practice and procedure may result in missed opportunities in obtaining optimal protection for the invention disclosed. The inventor(s) may wish to secure the services of a registered patent practitioner to prosecute the application, because the value of a patent is largely dependent upon skilled preparation and prosecution. The Office cannot aid in selecting a patent practitioner.
A listing of registered patent practitioners is available at https://oedci.uspto.gov/OEDCI/. Applicants may also obtain a list of registered patent practitioners located in their area by writing to Mail Stop OED, Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Examiner’s Notes
All references relied up on and not cited in the current Form 892 may be found in previous 892's or IDS'.
Response to Amendment
Applicant’s Amendments, filed 1/2/2026, to claims 1-5 acknowledged by Examiner. Additionally, applicant added claims 6-11.
The previous 112b rejections have been withdrawn.
The previous claim objections have been withdrawn.
Claims 1-11 are now pending.
Response to Arguments
With regards to Applicant’s arguments that the prior art does not disclose the field claims. Applicant's arguments with respect to the claims have been considered but are moot because the rejection has been changed below, necessitated by Applicant's amendments. However, considering that applicant appears to be pro se, Examiner has provided further response to inventor’s arguments.
Applicant’s arguments appear substantially tied that the references used in the rejection mailed 11/26/2025 do not explicitly teach the non-adherent central region overlying a radiation-affected area of a female breast and an adherent border only contacting the skin surrounding the radiation-affected area. Examiner believes Applicant has a fundamental misunderstanding on how functional language works in apparatus/device claims. Functional language’s patentable weight lies in the requiring structure/construction itself of the apparatus as a result of needing to be configured to do this function. As long as the prior art, in this case the primary prior art being Von Wolff has a central non-adherent region and an adhesive border region that is capable of being placed over a radiation affected area of a patient with the border only adhering to intact skin in this case then Von Wolff discloses the invention as claimed. Unless Applicant proves that this functional language requires structure/construction that Von Wolff does NOT have then the argument will not be persuasive and Von Wolff is not required to explicitly recite the function herein. If the independent claim 1 was a method claim instead of an apparatus claim that provided steps of placing a non-adherent pad over a radiation-affected area of a patient then a different argument may be had; however, Applicant has already elected by original presentation an apparatus claim nor is it clear if the current state of Applicant’s disclosure supports such a method claim. And even further Von Wolff provides in [0057] that the fabric layer 4 (being a central pad, Fig. 1-2) is non-adherent to the skin and overall recites “This layer is intended to lie in direct contact with the wound when the dressing is worn. The fabric layer is generally non-adherent to the skin. It is also preferred that this layer develops low or non-adherence to the wound bed during wearing, in order to minimize pain and damage to newly created healing tissue during dressing removal”, wherein this directly states a non-adherent area is laid over the wound wherein wound is generic over Applicant’s use of a “radiation-affected area” which is simply a form of “wound”.
Thus, Examiner does not find Applicant persuasive on why the references of previous record would not disclose the invention of the present application.
Regarding Applicant’s new claim language, see the updated rejections below. Note, Applicant’s arguments regarding the new claims 6-11 appear to be replete with arguments relying on disclosure and reasons NOT present within the present application especially as considering the amendment’s themselves contain numerous new matter as discussed in the 112a rejections below. Furthermore, none of the Applicant’s arguments actually appear to discuss the differences between the cited apparatus and the actual rejection as written by the Examiner and the claimed invention. Arguments are thus unpersuasive.
Also, further for Applicant, Examiner provides MPEP 2112.01(I) which states “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”, wherein the structure of Von Wolff is substantially identical to the actual structures of the claims, wherein thus any functions/properties/intended use is presumed to be inherent and implicit when considering such aspects.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “a polyester-rayon blend, a cotton-polyester blend, and a nylon-polyester blend” (claim 5, requires antecedent basis in the specification, considering the original claim set had these blends listed, not a new matter issue).
The spacing of the lines of the specification is such as to make reading difficult. New application papers with lines 1 1/2 or double spaced (see 37 CFR 1.52(b)(2)) on good quality paper are required.
A substitute specification including the claims is required pursuant to 37 CFR 1.125(a) because the specification amendments on 7/1/2025 appear to be missing fundamental disclosure of the invention disclosed in the specifications field 2/3/2025 and 11/21/2024. After so many filed amended substitution sheets, the actual full specification is unclear. For examining purposes, the specifications in the file will be relied on holistically.
A substitute specification must not contain new matter. The substitute specification must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. 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. An accompanying clean version (without markings) and a statement that the substitute specification contains no new matter must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
Content of Specification
(a) TITLE OF THE INVENTION: See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be placed at the top of the first page of the specification unless the title is provided in an application data sheet. The title of the invention should be brief but technically accurate and descriptive, preferably from two to seven words. It may not contain more than 500 characters.
(b) CROSS-REFERENCES TO RELATED APPLICATIONS: See 37 CFR 1.78 and MPEP § 211 et seq.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT: See MPEP § 310.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT. See 37 CFR 1.71(g).
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM: The specification is required to include an incorporation-by-reference of electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application. See 37 CFR 1.77(b)(5) and MPEP § 608.05. See also the Legal Framework for Patent Electronic System posted on the USPTO website (https://www.uspto.gov/sites/default/files/documents/2019LegalFrameworkPES.pdf) and MPEP § 502.05
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR. See 35 U.S.C. 102(b) and 37 CFR 1.77.
(g) BACKGROUND OF THE INVENTION: See MPEP § 608.01(c). The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled “Technical Field.”
(2) Description of the Related Art including information disclosed under 37 CFR 1.97 and 37 CFR 1.98: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant’s invention. This item may also be titled “Background Art.”
(h) BRIEF SUMMARY OF THE INVENTION: See MPEP § 608.01(d). A brief summary or general statement of the invention as set forth in 37 CFR 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
(j) DETAILED DESCRIPTION OF THE INVENTION: See MPEP § 608.01(g). A description of the preferred embodiment(s) of the invention as required in 37 CFR 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described, and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i) - (p).
(l) ABSTRACT OF THE DISCLOSURE: See 37 CFR 1.72 (b) and MPEP § 608.01(b). The abstract is a brief narrative of the disclosure as a whole, as concise as the disclosure permits, in a single paragraph preferably not exceeding 150 words, commencing on a separate sheet following the claims. In an international application which has entered the national stage (37 CFR 1.491(b)), the applicant need not submit an abstract commencing on a separate sheet if an abstract was published with the international application under PCT Article 21. The abstract that appears on the cover page of the pamphlet published by the International Bureau (IB) of the World Intellectual Property Organization (WIPO) is the abstract that will be used by the USPTO. See MPEP § 1893.03(e).
(m) SEQUENCE LISTING: See 37 CFR 1.821 - 1.825 and MPEP §§ 2421 - 2431. The requirement for a sequence listing applies to all sequences disclosed in a given application, whether the sequences are claimed or not. See MPEP § 2422.01.
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the applicant’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility application should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase “Not Applicable” should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A READ-ONLY OPTICAL DISC, AS A TEXT FILE OR AN XML FILE VIA THE PATENT ELECTRONIC SYSTEM.
(f) STATEMENT REGARDING PRIOR DISCLOSURES BY THE INVENTOR OR A JOINT INVENTOR.
(g) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art including information disclosed under 37 CFR 1.97 and 1.98.
(h) BRIEF SUMMARY OF THE INVENTION.
(i) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(j) DETAILED DESCRIPTION OF THE INVENTION.
(k) CLAIM OR CLAIMS (commencing on a separate sheet).
(l) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(m) SEQUENCE LISTING. (See MPEP § 2422.03 and 37 CFR 1.821 - 1.825). A “Sequence Listing” is required on paper if the application discloses a nucleotide or amino acid sequence as defined in 37 CFR 1.821(a) and if the required “Sequence Listing” is not submitted as an electronic document either on read-only optical disc or as a text file via the patent electronic system.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “central, non-adherent wound-contacting pad” (claims 1), the dressing having a low-profile and placed under garments (claim 6), “absorbent layer” (claim 8) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-11 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.
NOTE: Examiner adds warning being a pro se Applicant that attempting to amend the specification with rejected claim language would only lead to more new matter issues therein.
Claim 1 recites “breast dressing for covering a radiation-affected area of a female breast, comprising: a central, non-adherent wound-contacting pad having a curvature configured to conform to a female breast and sized to overlie the radiation-affected area, and a peripheral adhesive border integrally formed with the central pad and defining extended edges at a top region, a bottom region, and first and second side regions of the pad, wherein the peripheral adhesive border is configured to adhere to intact skin surrounding the radiation-affected area while the central non-adherent pad remains substantially non-adherent to the radiation-affected area”. There is no written disclosure towards the invention have a central, non-adherent wound contacting pad and any intervening disclosure therein. There is no disclosure towards a peripheral adhesive border integrally formed with a central pad nor the border being at the top, bottom, and side regions of such a central pad. There is no disclosure of the adhesive border being configured to secure to “intact skin surrounding the radiation-affected area while the central non-adherent pad remains substantially non-adherent to the radiation-affected area. As such, the entire claim appears to be entirely new matter based on the original specification, the drawings only provide for the external facing structure of the dressing with not enough clarity on each piece of the dressing as claim 1 is attempting to do.
Claim 2 recites “wherein a silicone gel adhesive is disposed along a top rim, the first and second side edges, and a bottom rim of the peripheral adhesive border”, wherein the disclosure does provide for “The back of the dressing/bandage incorporates silicone gel adhesive around its edges”. However, the “peripheral adhesive border” as noted above is new matter as written depending on claim 1.
Claim 3 recites “breast dressing is provided in a plurality of sizes corresponding to standard bra cup sizes to provide conformal coverage for different breast volumes”, wherein there is no discussion in the disclosure towards the bra cup sizes being to provide conformal coverage for different breast volumes. Claim 3 is new matter.
Claim 4 recites “the central non-adherent pad comprises at least one non-adherent material”, wherein the disclosure only provides for the dressing have a non-adherent material with no discussion towards a central pad as defined in claim 1 and 4. Claim 4 is new matter.
Claim 6 recites “the breast dressing has a low-profile, breast-conforming contour configured to lie smoothly under a bra or other clothing so as to reduce visible bulk”, there is no disclosure of the dressing being low-profile nor any discussion of a literal dressing contour (only discussed that the dressing is “contoured” and “molded” being verbs not structure when applying the device to a breast), nor is there any discussion on how the dressing is configured to be under a bra or clothing smoothly or to reduce visible bulk. Claim 6 is new matter.
Claim 7 recites “wherein the peripheral adhesive border is dimensioned and configured to contact intact skin substantially around the radiation-affected area such that the breast dressing remains substantially immobile on the breast during normal daily activities and sleep”, there is no discussion of the peripheral border of the dressing being dimensioned to “contact intact skin substantially around the radiation-affected area” nor that the dressing remains “substantially immobile on the breast during normal daily activities and sleep”. Claim 7 is new matter.
Claim 8 recites “wherein the central non-adherent pad comprises an absorbent layer configured to retain wound exudate and prevent fluid from leaking onto or staining a garment worn over the breast dressing”, there is no discussion of any absorbent layer especially an absorbent layer being part of a central non-adherent pad and even further no discussion of any layer retaining wound exude and preventing fluid from leaking onto or staining a garment. Claim 8 is new matter.
Claim 9 recites “wherein the breast-conforming curvature and the extended peripheral adhesive border are configured to distribute contact pressure over a broad surface of the breast to improve comfort for the wearer as compared to flat, non-conforming dressings”, there is no discussion at all of an adhesive border distributing contact pressure over a broad surface of the breast nor any comparison of comfort between this invention and other “flat, non-conforming dressings”. Claim 9 is new matter.
Claim 10 recites “wherein selection of a size corresponding to a wearer's standard bra cup size and the breast-conforming curvature enable intuitive placement of the breast dressing by the wearer without professional assistance”, there no discussion of size selection enabling intuitive placement without professional assistance. Claim 10 is new matter.
Claim 11 recites “wherein, in use, the central non-adherent pad remains substantially stationary relative to the radiation-affected area such that shear and friction at the wound surface are reduced, thereby promoting healing of the radiation-affected area”, there is no disclosure of the dressing, and even more specifically the undisclosed central pad, remaining substantially stationary and that shear and friction at the wound surface would be reduced thus promoting healing. The only discussed “friction” is related to the dressing blocking clothing friction, which is unrelated to this new claim language. Claim 11 is new matter.
Claim 5 rejected as being dependent to a rejected claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-11 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.
The term “central pad… sized to overlie the radiation-affected area” in claim 1 is a relative term which renders the claim indefinite. The term “sized to overlie the radiation-affected area” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant’s specification in their description of figures appears to have many measurements of sizes of a woman’s human body size, but there is no description on what a size of a radiation-affected area would be nor any description relating to the central pad itself. Thus, it is unclear on what it would mean physically for Applicant’s central pad to be sized for a radiation affected area that would be different from any normal island dressing central pad as a radiation affected area could be literally any size therein based on the radiation injury. As such, the claim will be interpreted loosely in the rejections below.
Claim 2 recites “a silicone gel adhesive is disposed along a top rim, the first and second side edges, and a bottom rim of the peripheral adhesive border”, while claim 1 recites “a peripheral adhesive border integrally formed with the central pad and defining extended edges at a top region, a bottom region, and first and second side regions of the pad”, wherein the claim 2language is unclear if a top rim and a bottom rim of claim 2 for the adhesive border is different or actually the same as the top and bottom region as defined in claim 1. For examining the purposes, “a top rim” and “a bottom rim” will be read as -the top region- and -the bottom region-.
Claim 5 recites the limitation "the group”. There is insufficient antecedent basis for this limitation in the claim.
The term “low-profile” in claim 6 is a relative term which renders the claim indefinite. The term “low-profile” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no provide disclosure on what would be required structurally for a bandage to be considered low-profile.
Claim 9 recites “wherein the breast-conforming curvature and the extended peripheral adhesive border are configured to distribute contact pressure over a broad surface of the breast to improve comfort for the wearer as compared to flat, non-conforming dressings” wherein this claim is completely indefinite as it is unclear as to how the curvature and border of the claim would function differently to improve comfort “as compared to flat, non-conforming dressings” when considering contact pressure from the adhesive.
Claim 10 recites “selection of a size corresponding to a wearer's standard bra cup size and the breast-conforming curvature enable intuitive placement of the breast dressing by the wearer without professional assistance”, wherein the invention being a product claim Examiner is uncertain as to what structure in the invention is providing this function. Is there something specific to the curvature coverage? Something specific to the breast sizing? Further what does “intuitive placement” even require? What is considered not intuitive placement? Nothing of this function appears to be elaborated in the specification. As such, it is unclear to what is being limited by this claim from the previous claim 3 structure of their being a curvature and the bra cup sizing. Also, as this claim 10 depends on claim 3, there is also a lack of clarity regarding antecedent basis on if the size selected is from the “plurality of sizes” defined in claim 3 or a different set of sizes.
Claims 3-4, 6-8, 11 rejected as being depending on a rejected claim.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2, 4-9 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Von Wolff (US 20140236112 A1) in view of Robinson (US 20220211932 A1).
Regarding claim 1, Von Wolff discloses a breast dressing for covering a radiation-affected area of a female breast (Figures 1-2, [0010, 0057], see [0033] dressing may be in any desired shape and size over an portion of a human, thus when used on a breast the dressing would be a “breast dressing” and is capable of covering any wound thus including covering a radiation-affected area of a female breast), comprising:
a central, non-adherent wound-contacting pad 4 (Fig. 1-2 and [0057], fabric layer 4 forms a central wound contacting pad 4 wherein the fabric layer 4 is non-adherent) sized to overlie the radiation-affected area (see [0057] fabric layer 4 lays over a wound bed, wound bed being generic to a specific injury of a radiation-affected area, see 112b above, thus being sized to overlie a wound that may be a radiation-affected area), and
a peripheral adhesive border 7 (Fig. 1-2 and [0037,0057] adhesive layer 7 is only present at the edges of the dressing, forming a peripheral adhesive border 7) integrally formed with the central pad 4 (Fig. 1, all one constructed invention, thus the adhesive 7 being integral with the central pad 4) and defining extended edges at a top region, a bottom region, and first and second side regions of the pad 4 (Fig. 2, dressing is in a square shape with extended edges therein at a top, two sides, and a bottom edge),
wherein the peripheral adhesive border 7 is configured to adhere to intact skin surrounding the radiation-affected area (see [0063] adhesive border 7 renders the border adherent to the skin surrounding the wound, depending on the size of the wound the peripheral adhesive border 7 is capable of only contacting skin) while the central non-adherent pad 4 remains substantially non-adherent to the radiation-affected area (see [0057] fabric layer 4 lays over a wound bed non-adherently, wound bed being generic to a specific injury of a radiation-affected area).
Von Wolff does not disclose the central, non-adherent wound contacting pad 7 having a curvature configured to conform to a female breast.
However, Robinson teaches an analogous dressing 100 (Fig. 1-5) wherein the dressing 100 may be molded to anatomical shapes including a breast for a best fitting bandage thus the dressing and any of its components having a formed curvature that would conform therein (see [0039]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have molded the dressing and its components including the central pad 4 therein of Von Wolff to have a curvature and conform to a shape of a breast as taught by Robinson in order to make a best fitting and comfortable bandage (Robinson [0039]) especially as Von Wolff also in conjunction provides that dressing may be in any desired shape and size over an portion of a human, thus when used on a breast the dressing would mold, conform and have a curvature and thus be shaped to a breast of a user (Von Wolff [0033]). Furthermore, changing the shape of the dressing to be molded after a breast would be obvious as changes in shape have been held to be a matter of design choice absent persuasive evidence that the particular configuration of the claimed shape was significant. See MPEP 2144(IV)(B) and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 2, Von Wolff in view of Robinson discloses the invention of claim 1 above.
Von Wolff further discloses wherein a silicone gel adhesive is disposed along a top rim, the first and second side edges, and a bottom rim of the peripheral adhesive border 7 ([0037] adherent facing layer 7 is a silicone gel adhesive; [0063] and Fig. 1-2, the adhesive layer is along the borders of the dressing thus being along its top rim (top region), sides of the dressing, and along a bottom rim (bottom region) of the dressing, see 112b of claim 2).
Regarding claim 4, Von Wolff in view of Robinson discloses the invention of claim 1 above.
Von Wolff further discloses the central non-adherent pad 4 comprises at least one non-adherent material (see [0057] the fabric layer 4 of the dressing/bandage is non-adherent).
Regarding claim 5, Von Wolff in view of Robinson discloses the invention of claim 4 above.
Von Wolff further discloses the at least one non-adherent material is selected from the group consisting of hydro cellular foam, non-adherent silicone, a polyester-rayon blend, a cotton-polyester blend, and a nylon-polyester blend (see [0005] the non-adherent fabric layer may be formed of a mixture/blends of cotton, polyester, and nylon, further [0059] rayon is also provided).
Regarding claim 6, Von Wolff in view of Robinson discloses the invention of claim 1 above.
Von Wolff in view of Robinson further discloses the breast dressing has a low-profile, breast-conforming contour (see combination in claim 1, wherein Von Wolff combined with Robinson has a breast-conforming/body conforming contour) (Von Wolff Fig. 1 and [0048], the thickest part of the dressing is the absorbent core 3 wherein the core 3 may be 0.5 mm in thickness, thus the dressing is very flat thus may be called “low-profile”) configured to lie smoothly under a bra or other clothing so as to reduce visible bulk (Von Wolff Fig. 1, being flat and low-profile would allow one to wear the dressing under clothing smoothy and without visible bulk).
Regarding claim 7, Von Wolff in view of Robinson discloses the invention of claim 1 above.
Von Wolff further discloses wherein the peripheral adhesive border 7 is dimensioned and configured to contact intact skin substantially around the radiation-affected area ([0004] the adhesive layer can be configured to only contact the peri-wound skin of the wearer during use, and not the wound surface) such that the breast dressing remains substantially immobile on the breast during normal daily activities and sleep ([0063-0064] adhesion power holds dressing in place for “sufficient time”, thus being immobile during use including during daily activities and sleep, also as the adhesive being silicone adhesive is the same as the instant application then all the functionality between the two would be the same without evidence otherwise).
Regarding claim 8, Von Wolff in view of Robinson discloses the invention of claim 1 above.
Von Wolff further discloses wherein the central non-adherent pad 4 comprises an absorbent layer 3 (Fig. 1-2 and [0034]) configured to retain wound exudate and prevent fluid from leaking onto or staining a garment worn over the breast dressing (see [0031] dressing with absorbent core 3 absorbs exudate, thus implicitly preventing would fluid from leaking onto or staining garments worn on a user over the dressing).
Regarding claim 9, Von Wolff in view of Robinson discloses the invention of claim 1 above.
Von Wolff in view of Robinson further discloses wherein the breast-conforming curvature and the extended peripheral adhesive border 7 are configured to distribute contact pressure over a broad surface of the breast to improve comfort for the wearer as compared to flat, non-conforming dressings (Von Wolff [0064] adhesive border 7 providing the adhesion on skin being contact pressure avoids causing excessive pain thus improving comfort for the user) (Von Wolff combined with Robinson in claim 1 provides the dressing having a breast-conforming curvature thus not being a flat, non-conforming dressing).
Regarding claim 11, Von Wolff in view of Robinson discloses the invention of claim 1 above.
Von Wolff in view of Robinson further discloses wherein, in use, the central non-adherent pad 4 remains substantially stationary relative to the radiation-affected area such that shear and friction at the wound surface are reduced, thereby promoting healing of the radiation-affected area (Fig. 1-2 and [0057], the central pad 4 is surrounded by the adhesive 7, thus when applied the pad 4 would be stationary relative to the wound it is placed over including a radiation-affected area being a form of wound, thus shear and friction would not be present thus promoting healing).
Claim(s) 3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Von Wolff (US 20140236112 A1) in view of Robinson (US 20220211932 A1), in further view of Stuart (US 20240225910 A1).
Regarding claim 3, Von Wolff in view of Robinson discloses the invention of claim 1 above.
Von Wolff in view of Robinson does not disclose the breast dressing is provided in a plurality of sizes corresponding to standard bra cup sizes to provide conformal coverage for different breast volumes.
However, Stuart teaches an analogous dressing being a breast dressing (Fig. 1) wherein the analogous dressing is used on a breast for absorbing blood (see [0055]), wherein the dressing is provided in a plurality of sizes corresponding to standard bra cup sizes to provide conformal coverage for different breast volumes (see [0056], “The absorbent article may be shaped and sized to cover at least a portion of a breast of a person. The size and shape of the absorbent article may correspond to bra cup sizes, including, but not limited to, AA, A, B, C, D, DD, DDD, E, F, G, H, or the like”, would implicitly provide for different breast volumes being related to breast size).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the sizing of the dressing/bandage of Von Wolff in view of Robinson to be provided in a plurality of sizes corresponding to standard bra cup sizes to provide conformal coverage for different breast volumes as taught by Stuart in order to ensure the bandage would best fit and coverage to the size of the user’s breast when using the bandage on a breast to absorb fluids such as blood (Stuart [0055-0056]).
Regarding claim 10, Von Wolff in view of Robinson and Stuart discloses the invention of claim 3 above.
Stuart as combined further discloses wherein selection of a size corresponding to a wearer's standard bra cup size and the breast-conforming curvature enable intuitive placement of the breast dressing by the wearer without professional assistance (see Stuart [0056], “The absorbent article may be shaped and sized to cover at least a portion of a breast of a person. The size and shape of the absorbent article may correspond to bra cup sizes, including, but not limited to, AA, A, B, C, D, DD, DDD, E, F, G, H, or the like”, would implicitly provide for different breast volumes being related to breast size”, thus for the user the size being provided in known sizes would implicitly enable intuitive placement as desired, furthermore the bandage of Von Wolff shown in Fig. 1-2 is a typical known island dressing that would not require any form of professional assistance).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O'Neill (US 20090299252 A1) – [0016] provides for a breast conforming curvature
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