DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Remarks, filed 10 March 2026, in the matter of Application N° 18/142,026. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No additions, amendments, or cancellations have been made to the previously filed claims of 15 September 2025. No new matter has been added.
Thus, claims 34-40 and 42-50 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Drawings
The Examiner acknowledges Applicants’ submission of a Replacement Sheet for Figures 1a and 1b, received on 10 March 2026.
These drawings are not entered because they add new matter that is not described in the originally-filed disclosure. In the case of Figure 1b, an entirely new Figure has been submitted that contains information that was 1) not present in the original Figure and 2) not discussed or defined in the originally filed disclosure. A side-by-side comparison of the two Figures 1b is shown below:
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Original Fig. 1b (05/02/2023) Replacement Fig. 1b (03/10/2026)
Among the information that is new to the Figure and not described in the originally-filed disclosure is:
Title of “Day 4 Snapshot” as well as the dashed line connecting Figure 1b to the approximated fourth day of new Figure 1a;
The p-values indicating statistical significance; and
The delineated copper ion species and concentrations tested.
Similarly, Replacement Figure 1a also contains changes that were not originally discussed or described. The Examiner notes that the scale of the y-axis has been changed and the x-axis labeled and more granularly defined (i.e., every five days). However, the legend identifying the two different plots has, for instance, renamed “Wound Control” to “Burn Control”, and the error bars for at least the first three data points on the Naïve Control plot are definitively wider in margin. Also, as mentioned above, there now exists a dashed line connecting an approximation of Day 4 to Replacement Figure 1b.
In view of the foregoing, the Examiner respectfully submits that the drawings are not entered on the ground that they introduce new matter.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 14 January 2026 since the art that was previously cited continues to read on the previously recited limitations.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 34-40 and 42-50 are rejected under 35 U.S.C. 103 as being unpatentable over Dagger et al. (WO 2019/012068 A1; IDS/ISR reference of record) further in view of Borkow (Current Chemical Biology; 2014; herein referred to as “Borkow CCB”) and Borkow et al. (Wound Repair Regen; 2010; herein referred to as “Borkow WWR”).
As previously presented, the invention set forth in claim 34 recites:
A method for reducing post-operative scar formation on a skin of a patient, said method comprises applying a material to a postoperative wound under compression or under continuous peripheral pressure to a surgical incision and surrounding inflamed tissue,
wherein the application of the material:
reduces the secretion of Transforming Growth Factor- β (TGF-β) at the postoperative wound compared to a postoperative wound treated with a material lacking said particles, which in turn:
selectively promotes migration of epidermal keratinocytes while not promoting proliferation of dermal fibroblasts,
thereby reducing inflammatory response, improving wound healing, reducing wound complications, and thus improving resulting in improved scar formation, wherein said material is either:
(1) impregnated or coated with about 0.1-10% w/w water-insoluble copper containing particles, or composite particles thereof, or
(2) comprises about 0.1-10% w/w water-insoluble copper containing particles, or composite particles thereof, said particles are in a powdered form embedded inside said material, wherein a portion of said particles being exposed and protruding from the surface of the material.
Dagger discloses an antimicrobial material or device that is sealed in moisture and/or microbe impermeable packaging (see e.g., claim 29). Claims 1 and 14 define the material as being a flexible porous hydrophilic polymer foam or fibrous matrix comprising a powder charge comprising antimicrobial additive and/or wound dressing additive. The fibrous matrix is further defined in claim 14 as being selected from woven or non-woven absorbent and super-absorbent fibers.
Claim 15 further defines the antimicrobial additive as being selected from various forms of silver including: silver complexes, silver chloride, silver oxide, silver nitrate, and combinations thereof. Paragraph [0120] adds further adds alternative suitable antimicrobial additives as comprising such as copper salts and complexes thereof. Paragraph [0182] discloses that the additive is included in the matrix material in an amounts ranging from trace to 99 wt%, and in more specific amounts and ranges such as from 3.8 wt% to 10 wt%.
Such is considered to teach the limitations of the composition recited in claim 50.
Regarding the recited methods of claims 34 and 44, the reference discloses a method of treating a wound comprising placing a wound dressing comprising a loaded wound dressing layer into or over the wound, wherein the loaded wound dressing layer comprises a porous matrix and a powder charge of micronized antimicrobial release additive loaded within the matrix (see e.g., claim 33). The claim additionally teaches that the antimicrobial release additive is activated for the release of an antimicrobial agent into the wound from the wound dressing upon contact with moist or aqueous medium (i.e., wound exudate). Claim 44 discloses that the wound dressing will have negative pressure applied to it, while claim 71 discloses that such a wound dressing may have a fluidic connector configured to connect the cover layer of the dressing to a source of negative pressure. See also ¶[0332] which discusses Figures 12A-12D depicting a dressing which may be placed over a wound, connected to a fluidic connector which may be used to provide negative pressure applied from a vacuum source, to the wound.
Regarding the disclosure of treating a wound, the reference defines a “wound” as not only having its broad ordinary meaning, but also includes any body part of a patient that may be treated using negative pressure. See ¶[0155]. Further, examples of wounds treated by the practiced composition and method include incisional wounds, acute wounds, burns, traumatic wounds, flaps and skin grafts, lacerations, and surgical wounds. Such is considered to teach the treatment of wounds whereby the treated patient would incur a scar due to the mending of the affected or sutured skin. See also ¶[0222].
Paragraph [0157] states further that the incorporation of negative pressure in the method for wound therapy will facilitate and promote healing of the wound.
Based on the foregoing guidance in the reference, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited methods of treatment. As mentioned, the Examiner acknowledges that the reference does not specifically teach the reduction of post-operative scar formation on the skin of a patient. However, in lieu of this, the reference does expressly disclose treating wounds that are defined as causing scar-inducing trauma, such as through surgery or procedures that are understood in the art as being used to repair injuries incurred to the skin (i.e., incisional wounds, lacerations, burns, etc.). As such, the Examiner respectfully submits that use of the practiced antimicrobial-loaded, wound-healing matrices wound present a person of ordinary skill in the art with a reasonable expectation of reducing scar formation through the application of such devices that will wick away wound exudate and promote healing through the reduction of inflammation.
The Examiner further acknowledges that Applicants’ recited functional limitations are not expressly disclosed by Dagger. Similarly, the Examiner acknowledges that the disclosure of the antimicrobial release additive while seemingly preferring silver-based compounds, also teaches and suggests that copper salts and complexes may be selected from a rather abundant list of known antimicrobial alternatives. The teachings of Borkow are considered to remediate these perceived deficiencies.
Borkow CCB is a publication that reports on the use of copper as an agent to improve the well-being of skin and notes that there are two key properties that are being exploited in both consumer and medical device products: 1) copper has potent biocidal properties, and 2) copper is involved in numerous physiological and metabolic processes critical for the appropriate functioning of almost all tissues in the human body (see Abstract).
The Abstract further discloses that the paper focuses on showing how the use of textile consumer and medical device products, embedded with microscopic copper particles provides such improvements as the reduction of facial fine line and wrinkles, as well as enhancement of wound healing, using copper particle infused-pillowcases and wound dressings, respectively.
The reference additionally discloses that copper has historical uses which include the use of malachite (basic cupric carbonate) for healing postoperative wounds and “gauzes soaked in a copper sulfate solution to ‘disinfect’ surgical wounds” (see paragraph bridging pp. 92-93).
As mentioned above, the article discusses the testing of copper oxide in both pillowcase textiles for the reduction of wrinkles (see pg. 94), and in wound dressing products for the purposes of wound healing (see pp. 96-98). Both disclosures appear to incorporate copper oxide as impregnated particles within their respective fabrics (see e.g., Fig. 4). With respect to the wound dressing format, the Examiner acknowledges that the reference does not appear to expressly disclose that the “wounds” being treated are either “surgical” or “postoperative”. However, what is expressly discussed is that Borkow CCB states that “the wounds healed statistically significantly faster (p<0.01) than wounds treated with control wound dressings without copper or with wound dressing[s] containing silver.”
Based on the combined guidance in the art, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of successfully achieving the instantly claimed method of reducing scar formation through the application of the antimicrobial additive-loaded compositions disclosed by Dagger. Though Dagger appears to prefer applying a wound dressing using silver-containing forms of the additive, the Examiner again submits that copper salts or complexes are also taught as alternative forms of antimicrobial additives that may be used in the practice of the invention.
The teachings of Borkow CCB are not only considered to provide added motivation to select copper salts and complexes from the list of alternative antimicrobial additives disclosed in ¶[0120], but also to modify the wound healing device of Dagger to incorporate particulate copper (e.g., copper oxide) for the express purposes of facilitating wound healing. As mentioned above, Borkow CCB expressly discloses that copper demonstrated “statistically significantly faster” healing as compared to dressings containing silver.
The Examiner notes that Borkow CCB does not expressly define what type of wounds are inflicted on the test subjects prior to testing the wound dressings. However, Dagger’s definitions for the scope of wounds to be treated continues to be of record as being inclusive of surgical wounds. See ¶[0155], ¶[0222], and ¶[0285]. Borkow CCB discloses that the application of the copper-based wound dressing improves wound healing (see Fig. 8), increases integrins, PLGF, TGF-β, and are directly involved in scar formation.
The teachings of Borkow WRR are considered to offer additional contributions to the teachings of Dagger and Borkow CCB such that a person of skill in the art would have had a reasonable expectation of success in achieving the claimed method.
Therein, Borkow WRR, as discussed in the attached affidavit, speaks to copper oxide’s ability to influence the expression of TGF-beta. In the case of the cited reference, the Examiner acknowledges that the test subjects are surgically wounded and then treated with copper oxide-loaded wound dressings in order to evaluate the ability for copper oxide to enhance dermal wound repair (see e.g., Abstract; Table 1). Table 1 reports on the size of the treated wounds over two experiments. The first experiment pits copper-loaded dressings against a control in which it is shown that after 17 days, a smaller wound area is achieved with copper. The second experiment adds a silver-treating group for added comparison. As with the first experiment, after 17 days, the smallest wound area was again achieved using copper.
The Examiner acknowledges that this showing does not specifically speak to the reduction TGF-beta. However, in terms of reducing the potential for scar formation, it is advanced that a person of skill in the art would expect that reducing the wound area would also contribute to minimizing the dermal surface area over which a scar may form (see also Figure 2).
Figure 4 and Table 2 are also mentioned in the filed response as being instrumental in demonstrating the reduction of TGF-beta expression. The former charts 84 different genes at the wound site. However, Table 2 is considered to more clearly demonstrate TGF-beta expression that mimics Applicants’ claimed property. Consistent with discussion provided in passages 5-6 of the declaration and as it appears in Figs 1a and 1b, the expression of TGF-betas 1-3 and the receptor, appear to reduce at day one, upregulate by day five, and then down-regulate at different rates between days 5-17.
Thus, contrary to the assertions made in the attached Declaration, the recited reduction in TGF-beta expression at the postoperative wound site is not unexpected and in view of both of the Borkow teachings, the Examiner respectfully maintains that the ordinarily skilled artisan, practicing the treatment methods of Dagger, would have had a reasonable expectation of success in achieving the instantly claimed method.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 34-40 and 42-50 under 35 USC 103(a) as being unpatentable over the combined teachings of Dagger et al., Borkow et al. (WRR), and Borkow (CCB) have been fully considered, but they are not persuasive.
Applicants initially traverse the rejection on the grounds that the down-regulation of TGF-β at certain time points are late-stage events that occur after an initial spike.
The Examiner, in response, respectfully submits that the argument is not commensurate in scope with the method as presently claimed. Therein, the overall effect of the administered copper oxide does, by Applicants’ own admission, eventually provide a down-regulation in TGF-β. Furthermore, Applicants’ argument that the instant method avoids the initial spike (i.e., “the fire”) is also not commensurate in scope, notably as the combined teachings of the references teach and suggest the positively recited method (i.e., Dagger). The guidance provided by both of the Borkow articles is relied upon to motivate the skilled artisan to replace the preferred silver active with copper, specifically copper oxide, even teaching that it is improved over silver.
Applicants’ reliance upon the data provided in Figures 1a and 1b is based upon the Replacement Figures newly submitted. The Examiner submits that this is not commensurate in scope with the method as currently claimed and, as discussed above, presents a showing of new matter. Thirdly, discussion of the Figures focuses on the criticality of using CuI and Cu2O to treat burn wounds, as opposed to post-operative trauma, the latter of which is relied upon and taught in the cited art.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615