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 .
In the event the determination of the status of the application as subject to AIA 35
U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any
correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will
not be considered a new ground of rejection if the prior art relied upon, and the rationale
supporting the rejection, would be the same under either status.
Claim Status
Applicant’s amendment of 08/11/2026 is acknowledged. Claims 1-3, 7-9, 12-15, and 17-20 are amended. Claims 1-20 are currently pending.
Priority
The instant application is a 371 of PCT/US2023/018031 filed on 04/10/2023 and claims domestic benefit to U.S. Application No. 63/350,963 filed on 06/10/2022 as reflected in the filing receipt dated on 08/19/2025.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/10/2024 and 07/22/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-17, in the reply filed on 08/11/2026 is acknowledged. The traversal is on the ground(s) that independent claim 18 is amended to recite that the aerogel wound dressing includes a sensing component, which is not disclosed by Zheng. This argument was not found persuasive in view of Kane et al. (US20100178203A1; published: 07/15/2010; PTO-892) and in view of Jose et al. (Carbohydrate Polymers, vol. 287, pg. 1-10; published: 03/12/2022; PTO-892), which individually anticipate the instantly claimed aerogel as discussed in detail in the prior art rejections below. Because the technical feature of an aerogel wound dressing including a sensing component does not make a contribution over the prior art, it is not a special technical feature. Therefore, Groups I and II lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 are pending in the application. Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/11/2026. Accordingly, claims 1-17 are being examined on the merits herein.
Specification
The use of the term “Kevlar” (see paragraphs 0022, 0031, and 0089), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112(b)
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.
Claims 9 and 17 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.
Claim 9 recites the limitation “the wound exudate”. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends from claims 1 and 8, which do not recite a wound exudate. Therefore, it is unclear to which wound exudate the claim refers.
Claim 17 recites the broad limitation “cellulose” followed by “cellulose nanocrystals” (see lines 2 and 4), which is the narrower statement of the limitation. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 17 contains the trademark/trade name Kevlar in lines 2 and 4. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a material which can be used to form the aerogel layer(s) and, accordingly, the identification/description is indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 5 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Kane et al. (US20100178203A1; published: 07/15/2010; PTO-892).
Kane discloses a non-invasive, colorimetric infection detector and bandage containing the same [claims; abstract]. The colorimetric infection detector comprises: (a) a substrate; and (b) an indicator composition, which is disposed on, encapsulated within, or covalently linked with the substrate, that senses gaseous oxides of nitrogen and acids formed therefrom emanating from a proximal wound upon infection and exhibits a color change in response [claim 1].
Regarding claim 1: Kane teaches that the substrate is comprised of one or more of aerogels, xerogels, and zeolites [claim 7]. Therefore, an ordinarily skilled artisan could readily envision an embodiment wherein the substrate, which includes a sensing component (e.g., the indicator composition), is an aerogel.
Regarding claims 2 and 3: Kane teaches that the indicator composition has a pKa of from about 1 to about 6.5, which allows for selective protonation by nitric acid emanating from an infected wound and results in a persistent color change [claims 10-11; 0075-0076]. Thus, the indicator composition is adapted to change color because of a change in pH of a wound exudate absorbed by the aerogel. This is further evidenced by several of Kane’s exemplary embodiments, wherein the indicator composition is specifically denoted as a pH indicator [0094, example 2; 0096-0097, examples 4-5].
Regarding claim 5: The patentability of a product-by-process claim is based on the product itself and does not depend on its method of production. Note: MPEP 2113(I). Because the aerogel disclosed by Kane is structurally the same as the product of instant claim 5, then it meets the claim. In further support, several of Kane’s exemplary colorimetric infection detectors are formed by directly incorporating the indicator composition into a solution of substrate polymer by mixing (i.e., during formation of the substrate) [0093, example 1; 0095, example 3].
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jose et al. (Carbohydrate Polymers, vol. 287, pg. 1-10; published: 03/12/2022; PTO-892) as evidenced by Pan et al. (J. Mater. Chem. B, vol. 7, pg. 2626-2633; published: 03/05/2019; PTO-892).
Claims 1-3 and 5 are rejected above as anticipated by Kane et al. The claims are further rejected herein to demonstrate that claim 4 is also anticipated by the prior art.
Jose discloses a wound healing 3D porous aerogel comprising nanocellulose/sodium alginate incorporated with curcumin [abstract; pg. 2, “2.2. Fabrication of 3D porous CNF/SA/Curcumin aerogels”; fig. 2].
Curcumin is known to exhibit an obvious pH-dependent color change from yellow to red brown when wound pH shifts to an alkaline infected state, as evidenced by Pan [abstract; pg. 2626, “Introduction”].
Regarding claims 1-4: Because the aerogel of Jose incorporates curcumin, which is a known pH indicator, it reads on the instantly claimed aerogel comprising a sensing component and is also necessarily adapted to change color because of the change in pH of a wound exudate absorbed by the aerogel. Note: MPEP 2145. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979); In re Baxter Travenol Labs., 952 F.2d 388, 21 USPQ2d 1281 (Fed. Cir. 1991); see also In re Woodruff, 919 F.2d 1575, 1577-78 (Fed. Cir. 1990) (obviousness rejection affirmed where using claimed elements in the manner suggested by the prior art necessarily resulted in claim-recited effect). Since nothing in the instant claims or specification indicates how the structure of the aerogel wound dressing of Jose differs from the instant claims, the instant claims are not distinguished from the prior art.
Regarding claim 5: The patentability of a product-by-process claim is based on the product itself and does not depend on its method of production. Note: MPEP 2113(I). Because the aerogel disclosed by Jose is structurally the same as the product of instant claim 5, then it meets the claim. In further support, Jose teaches that the curcumin is mixed in homogenous suspensions of nanocellulose and sodium alginate prior to lyophilization to form the porous aerogel [pg. 2, “2.2. Fabrication of 3D porous CNF/SA/Curcumin aerogels”].
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.
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. Applicant is 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 1-3 and 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kane et al. (US20100178203A1; published: 07/15/2010; PTO-892) in view of Kassal et al. (Sensors and Actuators B, vol. 246, pg. 455-460; published: 02/20/2017; PTO-892).
Kane teaches the invention(s) of claims 1-3 and 5 as discussed in detail above and further incorporated herein.
However, Kane does not expressly teach that the sensing component comprises a probe connected to an external sensing device as recited in instant claim 6.
Kassal teaches that optical wound pH sensing is limited to an unquantifiable readout by the naked eye of the color of an indicator dye; however, incorporation of a miniature optoelectronic probe can be used to wirelessly transfer data to a computer or smartphone to more accurately determine the pH of a colorimetric pH-sensitive hydrogel wound dressing in a non-invasive manner [abstract; pg. 456, l. col.; fig. 1-2].
Regarding claim 6: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the colorimetric infection detector of Kane by incorporating the optoelectronic probe of Pusta to create an improved sensing component having a more accurate readout of the color change produced by the indicator composition and, thus, the precise pH detected. This would prompt a more appropriate response from a healthcare provider. Because the optoelectronic probe is wirelessly connected to a computer or smartphone which retrieves the optical data, it meets the limitation of a probe connected to an external sensing device, as there is no requirement that the claimed “connection” is a physical connection. One of ordinary skill in the art would have a reasonable expectation of success because Kassal demonstrates that the technology is compatible with a gel-based wound dressing comprising a pH indicator dye, and the approach is non-invasive, which is consistent with the goals of Kane.
Claims 1-3, 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Kane et al. (US20100178203A1; published: 07/15/2010; PTO-892) in view of Chartier et al. (International Journal of Biological Macromolecules, vol. 202, pg. 215-223; published: 01/14/2022; PTO-892).
Kane teaches the invention(s) of claims 1-3 and 5 as discussed in detail above and further incorporated herein.
However, Kane is silent as to the wound exudate absorption capacity of the aerogel substrate and, thus, does not expressly teach that the aerogel is adapted to absorb 10 times or greater of a wound exudate by weight per weight of the aerogel as recited in instant claim 7.
Chartier, also drawn to porous aerogels for wound dressings, teaches that higher porosity in chitosan aerogels results in higher absorption of wound exudate ranging from approximately 200% to 600% absorption based on the sample’s initial weight, which allows for healing of moist wounds where fluid absorption is necessary to limit bacterial proliferation [abstract; pg. 218, formula (7); pg. 221, fig. 8; pg. 222, “3.5. Absorption of simulated wound exudate”].
Regarding claim 7: While Kane is silent as to the wound exudate absorption capacity of the aerogel, which may in fact be capable of absorbing the instantly claimed amount of wound exudate, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the porosity of the aerogel substrate, according to the teachings of Chartier, to achieve a higher absorption of wound exudate. One would have been motivated to increase the aerogel’s wound exudate absorption capacity because Chartier teaches that adequate fluid absorption is necessary to limit bacterial proliferation. There is a reasonable expectation of success because Chartier teaches that porosity is routinely manipulated to improve fluid absorption in aerogel wound dressings, and Kane teaches that chitosan, among other biocompatible polymers, is a suitable material for forming its porous substrate [claim 8].
Claims 1-3, 5, 8-9, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kane et al. (US20100178203A1; published: 07/15/2010; PTO-892) in view of Yahiaoui et al. (US20100198177A1; published 08/05/2010; PTO-892).
Kane teaches the invention(s) of claims 1-3 and 5 as discussed in detail above and further incorporated herein.
Kane further teaches that the colorimetric infection detector may further comprise an adhesive or elastic attachment means in communication with the substrate, means operable to attach the sensor to a patient [claim 13].
However, Kane does not expressly teach a second aerogel layer as required by instant claims 8-9 and 12-17.
Yahiaoui teaches an absorbent article containing a skin adhesive and absorbent gel composition comprising an aerogel absorbent core, which adheres the article directly to a wearer and absorbs bodily fluids, including bodily exudates and blood [abstract; 0019; 0133; claims 1 and 5]. The aerogel is formed by drying a hydrogel under supercritical conditions to preserve its porous structure [0141; 0148].
Regarding claim 8: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Kane and Yahiaoui by using the adhesive and absorbent aerogel article of Yahiaoui as the adhesive attachment means in communication with the sensing aerogel substrate of Kane in order to attach the sensor to a patient. Together, these would provide an aerogel wound dressing wherein the second aerogel layer is removable. Since all of the claimed elements were known in the prior art, one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A). While Kane does not limit its adhesive portion so long as it can adhere the bandage to the area of the wound, there is an additional expectation of success because Yahiaoui teaches that combining multiple gel layers is useful to aid in the capturing and holding of bodily fluid [0064].
Regarding claim 9: Because the adhesive aerogel layer (i.e., second aerogel layer) of the wound dressing taught by the combination of Kane and Yahiaoui is in communication with the sensing aerogel substrate layer (i.e., first aerogel layer) and is also designed to absorb bodily exudates, it is reasonably adapted to absorb at least a portion of the wound exudate first absorbed by the first aerogel layer.
Regarding claim 12: It would have been obvious to further include an indicator composition in the adhesive aerogel layer (i.e., second aerogel layer) of the wound dressing taught by the combination of Kane and Yahiaoui since the adhesive layer would obstruct visualization of the color change in the sensing aerogel substrate layer (i.e., first aerogel layer). Since the adhesive aerogel layer is in communication with the sensing aerogel substrate layer, one would reasonably expect that it would also absorb wound exudate. By including an indicator composition in this layer, it would be easier to detect onset of infection without removing the adhesive aerogel layer and disturbing the wound.
Regarding claim 13: Since Yahiaoui teaches that the adhesive aerogel layer (i.e., second aerogel layer) of the wound dressing taught by the combination of Kane and Yahiaoui is designed to be removed and reapplied [0053], it meets the limitation of being adapted to be replaceable upon saturation and removal.
Regarding claim 14: Since the aerogel layers of the wound dressing taught by the combination of Kane and Yahiaoui are not physically bonded and are emersed in fluid, an ordinarily skilled artisan would reasonably conclude that the first aerogel layer is adapted to remain in place upon the removal of the second aerogel layer.
Regarding claim 15: The claim is obvious for the same reasons as discussed in relation to claim 12 above.
Regarding claim 16: Kane teaches that substrates with hydrophilic nature are highly permeable to water vapor but impermeable to microorganisms [0074]. Since the sensing aerogel substrate layer (i.e., first aerogel layer) of the wound dressing taught by the combination of Kane and Yahiaoui is in direct contact with the wound, it would have been obvious to one of ordinary skill in the art to ensure that the layer has sufficient hydrophilicity to form an effective pathogen barrier, thereby preventing wound contamination or spread of an onset infection.
Regarding claim 17: Kane teaches that the substrate layer is comprised of one or more of a limited list of hydrophilic polymers, including cellulose and chitosan [claim 8; 0071]. The adhesive portion may also be comprised of one or more polymers selected from a limited list of polymers, including cellulose [0046]. Thus, it would have been obvious to form either, or both, aerogel layer(s) of the wound dressing taught by the combination of Kane and Yahiaoui with cellulose, as it is known in the art to be a useful material for making each portion of the wound dressing and could save manufacturing time and costs by using the same naturally-derived polymer material. There is a reasonable expectation of success because Yahiaoui does not limit the structure of the aerogel core in the adhesive article and teaches that cellulose is a particularly useful adhesion modifier for forming the hydrogel precursor of the aerogel core [0154-0155].
Claims 1-3, 5, 8-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kane et al. (US20100178203A1; published: 07/15/2010; PTO-892) in view of Yahiaoui et al. (US0100198177A1; published 08/05/2010; PTO-892), as applied to claims 1-3, 5, 8-9, and 12-17 above, and further in view of Ghafari et al. (International Journal of Biological Macromolecules, vol. 136, pg. 796-803; published: 06/18/2019; PTO-892)..
The combination of Kane and Yahiaoui teaches the invention(s) of claims 1-3, 5, 8-9, and 12-17 as discussed in detail above and further incorporated herein.
While each aerogel layer of the wound dressing taught by the combination of Kane and Yahiaoui includes a plurality of pores, the prior art combination does not expressly teach that the plurality of pores within each layer are interconnected as recited in instant claim 10, or that the average pore size of the first plurality of pores is larger than that of the second plurality of pores as recited in instant claim 11.
Ghafari, also drawn to cellulose-based aerogels as scaffolds and wound dressings, teaches that two aerogel layers each with interconnected pores and having distinct pore sizes can better mimic the dermis and epidermis of the skin [abstract; pg. 796, “1. Introduction”, r. col.; fig. 4]. For example, having a larger pore size in the bottom contact layer, which can resemble the dermis layer, provides a higher capacity for exudate absorption at the injury site, whereas a lower pore size in the upper layer, which can recapitulate the dermis, prevents dehydration and microorganism penetration of the lower layer [pg. 799, “3.2.1. Bulk density and water uptake” and “3.2.3. Porosity and pore sizes”].
Regarding claims 10 and 11: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to manipulate the pore size and interconnectivity of pores within each layer of the wound dressing taught by the combination of Kane and Yahiaoui by increasing the pore size of the sensing aerogel substrate layer (i.e., first aerogel layer) and decreasing the pore size of the adhesive aerogel layer (i.e., second aerogel layer) because Ghafari teaches this structure improves exudate uptake while preventing wound moisture loss and contamination. One of ordinary skill in the art would have a reasonable expectation of success because Ghafari teaches that aerogel pore size is routinely manipulated by adjusting polymer concentration, and cellulose is particularly advantageous for producing layers with different porosities [pg. 798, “3.1. Scaffold fabrication”; pg. 797, “1. Introduction”, l. col.]. While Ghafari teaches a continuous scaffold, it is within the skillset of an ordinarily skilled artisan to vary the concentration of polymer between two individual layers with a reasonable expectation that the relevant properties would be maintained since the two porous layers are in direct communication with each other.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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