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 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.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/14/2026 has been entered.
Previous Rejections
Applicant’s arguments, filed 8/14/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 54-56 are newly added.
Claims 3-4, 25, 29, and 48-51 are cancelled.
Claims 1-2, 5-24, 26-28, 30-47, and 52-56 are pending.
Claims 9-15, 37-38, 44, 47, and 52-53 are withdrawn
Claims 1-2, 5-8, 16-24, 26-28, 36, 39-43, 45-46, and 54-56 are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejections
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.
Note that the rejections have been necessarily recast in response to applicant’s amendment dated 8/14/2026.
1) Claims 1-2, 5-8, 16-24, 26-28, 30-34, 39-43, 45-46, and 54-55 are rejected under 35 U.S.C. 103 as being unpatentable over Dyar (US 2015/0343112 A1; of record), in view of Lyczak (US 2013/0095184 A1; of record), Raghuvaran (“Zinc Oxide Nanoparticles: Opportunities and Challenges in Veterinary Sciences,” Immunome Res 2015; of record), and Gardner (US 1,918,804, published 7/18/1933).
Dyar teaches a method for forming a liquid bandage (Abstract). The bandage is comprised of a solvent (pg 1, [0008]) and a film former such as shellac (pg 1, [0010]). Dyar teaches the addition of an antimicrobial agent (pg 2, [0012]); pg 4, claim 11). Dyar teaches the addition of an oil such as clove oil or eugenol is optional (pg 1, [0011]; pg 2, [0013]; pg 4, claim 1). Dyar teaches the composition forms a barrier that is critical to bandages (pg 2, [0009]).
For claim 2, Dyar teaches the addition of an antimicrobial element and further teaches the composition is useful for treating a wound (pg 4, [0021]).
For claim 5, Dyar teaches the addition of silica is optional ([0009]).
For claim 6, Dyar teaches the presence of alcohol as an antimicrobial ([0012]). Alcohols such as ethyl alcohol (pg 4, claim 6) are known in the art as antibacterials and anti-fungals.
For claim 23, Dyar teaches the amount of shellac is from about 5 wt% and about 40 wt% (pg 1, [0010]), overlapping the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 (I). For claim 24, Dyar teaches the method can comprise ethanol, propanol or isopropanol (pg 1, [0009]).
For claims 25 and 26, Dyar teaches the method may comprise a copper compound ([0139]).
For claim 33, since Dyar teaches a method in which the amount of shellac and the composition overlaps with, or is identical to the composition of the claimed method, one of ordinary skill could manipulate the composition to be resistant to high pH environments. Furthermore, the claim does not specify a time frame; as such, the invention of Lowndes would only have to be resistant for an infinitesimally short time period to meet the claim limitations.
For claim 34, Dyar teaches an embodiment that “may include a film former from at least one polymer or resin” (pg 3, [0017]).
Dyar does not teach the presence of a metal active that is anti-infective, or a metal based active that increases viscosity.
Lyczak, Raghuvaran, and Gardner teach the missing element of Dyar.
Lyczak teaches a composition comprising a metal active such zinc in the form or a nanocrystalline zinc oxide, or copper compounds (pg 19, [0139]). Lyczak teaches the composition in the form of a suspension (pg 28, claim 30), a solution (pg 13, [0112]), a strip, or a bandage (pg 11, [0094]).
For claims 16-18, Lyczak teaches the composition is useful for treating non-human subjects such as “a dog, a cat, a horse, a bird, a reptile, an amphibian, a fish, a turtle, a guinea pig, a hamster, a rodent, a cow, a pig, a goat, a primate, a monkey, a chicken, a turkey, a buffalo, an ostrich, a sheep, a llama” (pg 21, [0141]), and may be in the form of a topical for administration to the skin (pg 14, [0117]).
For claim 19, Lyczak teaches a viscosity under 45,000 cPs, overlapping the claimed range.
For claim 20, Lyczak teaches the metal-containing composition can be applied in the form of a spray (pg 3, [0038]). Regarding the viscosity claimed in claim 20, one of ordinary skill in the art would have had a reasonable expectation of success in adjusting the thickness of the composition to between 10 cP and 3000 cP to obtain a liquid dressing that was sprayable by manipulating the amount of solvent in the composition.
For claim 27, Lyczak teaches nano zinc oxide, as discussed supra.
For claim 28, Lyczak teaches a concentration of from 100 to 20000 μg per ml (pg 7, [0061]). As calculated by the Examiner, this range is from 1.2 mM to 246 mM, overlapping the claimed range.
For claim 29, since Lyczak teaches the claimed amount of metal in the composition, as well as the viscosity, one of ordinary skill would understand that the addition of a solid to a solution would increase the thickness of the composition.
For claims 30-32, Lyczak teaches the addition of a non-metal antibiotic to the composition (pg 15, [0125]).
For claims 35 and 36, Lyczak teaches the composition of the method can comprise cellulosic fibers (pg 24, [0159]).
For claim 43, Lyczak teaches the method of the composition can be anti-inflammatory (pg 7, [0063]) or comprise an anti-inflammatory agent (pg 16, [0133]).
Raghuvaran teaches the use of zinc oxide nanoparticles are more effective than non-nanoparticulate zinc oxide (pg 1, right column). Raghuvaran further teaches: “E. coli is a gram-negative bacterium responsible for coliform mastitis in ruminants, white scours in calves and coli granuloma in birds. ZnO NPs have strong antibacterial activity against E. coli (pg 2, bottom of left column):
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See pg 2, top of left column.
As such, Raghuvaran teaches the limitations of claims 7, 8, 16, and 21.
Gardner teaches shellac-pigment compositions comprising commercial, bleached shellac (reading on claim 22), solvent, and pigments such as zinc oxide (Example 1, pg 1). For the limitation of an increase in viscosity upon addition of zinc compound to shellac, Gardner teaches:
When a basic oxide such as zinc oxide is added to a shellac solution in the preparation of a white shellac paint, it will be noted that after a few hours the paint becomes very viscous, and in a short time the whole may become solid. Similar behavior is encountered when metals such as aluminum are incorporated in bleached shellac solutions.
See pg 1, lines 9-16.
For claims 54-55, Gardner teaches a method of manipulating the viscosity of the zinc oxide-shellac mixture. As such, one of ordinary skill can control the droplet size by adjusting the amount of zinc oxide thickener in the mixture as a routine optimization process. As set forth in MPEP 2144.05(II)(A), “"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation."[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In the instant case, Gardner provides a roadmap demonstrating an amount of zinc oxide required to thicken the formulation, and one of ordinary skill can utilize a trial-and-error method to optimize the percentage of zinc oxide.
The skilled artisan would have expected success in substituting zinc oxide for the antimicrobial agents taught by Dyar (pg 2, [0012]) since Lyczak teaches the method wherein zinc oxide nanoparticles (or copper compounds) is/are effective antimicrobials when administered in the form of a topical such as a suspension, solution, strip, or bandage for treating non-human subjects such as a dog, cat, horse, cow, pig, and goat, and Raghuvaran teaches zinc oxide nanoparticles are effective in treating infections in cattle and ruminants caused by E. coli.
The skilled artisan would have likewise expected success in a method of increasing the viscosity of a composition comprising shellac and zinc oxide since Gardner teaches a method wherein addition of zinc oxide to a solution of shellac in alcohol provides an increase in the viscosity of the composition. Furthermore,
The skilled artisan would have predicted that varying the amount of zinc oxide in the shellac-alcohol solution would have yielded the viscosity preferred for an applied liquid dressing.
2) Claims 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Dyar (cited above), in view of Lyczak (cited above), Raghuvaran (cited above), Gardner (cited above), and Kabara (“Fatty Acids and Derivatives as Antimicrobial Agents,” Antimicrobial Agents and Chemotherapy, July 1972, p. 23-28; of record).
The teachings of Dyar, Lyczak, Raghuvaran, and Gardner are discussed above.
The combination of Dyar, Lyczak, Raghuvaran, and Gardner does not teach the presence of decanoic acid (also known as capric acid), claimed as a hydrophobic barrier enhancing agent or a buffering agent, in the method.
Kabara teaches the missing element of the combination of Dyar, Lyczak, Raghuvaran, and Gardner.
Kabara teaches capric acid is an effective antimicrobial against a number of bacteria, including Pneumococci, Streptococcus Group A, Corynebacteria, Candida, S. aureus, and S. Epidermis (pg 24, Table 1). It is noted that Lyczak teaches the method wherein both shellac and stearic acid, a fatty acid, are compatible in a topical antimicrobial composition (Lyczak, pg 29, claims 40 and 51).
The person of ordinary skill would have had a reasonable expectation of success in selecting decanoic acid as an additive to the dressing composition method of Lowndes comprising shellac and nanoparticulate zinc oxide for the treatment of infection and/or wounds. The skilled artisan would have been motivated to add decanoic acid to the method of Lowndes because Kabara teaches the compound as an effective antimicrobial agent and, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Regarding claim 40, it is noted that Kabara teaches decanoic acid for an intended use that is not recited in the claims. However, as set forth in MPEP 2144(IV), a “reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” As such, while Kabara teaches a different reason for adding decanoic acid to the method of the combination of Dyar, Lyczak, and Raghuvaran, the addition of decanoic acid as taught by Kabara solves a different problem, namely the expectation of an enhancement of antimicrobial effectiveness of the method claimed in claim 1.
3) Claims 42 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Dyar (cited above), in view of Lyczak (cited above), Raghuvaran (cited above), Gardner (cited above), Doxey (US 9,855,211), and Wiechers (“Formulating at pH 4-5: How Lower pH Benefits the Skin and Formulations,” Cosmetics &Toiletries, July 3, 2013, 1-18).
The teachings of Dyar, Lyczak, Raghuvaran, and Gardner are discussed above.
The combination of Dyar, Lyczak, Raghuvaran, and Gardner does not teach the presence of a diacid buffering agent in the method.
Doxey and Wiechers teach the missing element of the combination of Dyar, Lyczak, Raghuvaran, and Gardner.
Doxey teaches an antimicrobial method comprising a composition comprising viscosity increasing agents, at least one polyhydric alcohol, at least one buffering agent, at least one preservative, at least one organic solvent, and at least one active pharmaceutical ingredient, wherein the composition is buffered to a pH of about 3 to about 8 (col 1: 28-34). It is noted that the instant method recites the same pH range as the instant invention (see the Specification, pg 12, lines 1-7). Doxey teaches the diacids succinic acid, malic acid, and tartaric acid may be used to buffer the composition (col 6: 5-24).
Doxey also teaches the skin surface has a pH of between 5 and 6 (col 20: 5-7).
Wiechers teaches the pH of the surface of skin is from 4.5 to 7 (pgs 2-3), depending on the method of testing. Wiechers also teaches “Staphylococcus aureus grows best at pH 7.5 but continues to proliferate slowly at pH 5.0 to 6.0. The acidic pH of the SC [stratum corneum] restricts colonization by pathogenic flora and encourages the persistence of normal microbial flora”. See pg 8, second full paragraph.
The skilled artisan would have expected success in substituting a diacid such as succinic acid, malic acid, or tartaric acid for the buffer acids taught by Lyczak (pg 11, [0095]) since Doxey teaches the diacids are useful for achieving a pH close to skin pH of 5-6, reducing the possibility of skin irritation, and Wiechers teaches reducing the population of Staphylococcus aureus on the skin and encouraging the return of normal skin microflora.
4) Claims 45 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Dyar (cited above), in view of Lyczak (cited above), Raghuvaran (cited above), Gardner (cited above), and Larsen (US 2011/0021964 A1; of record).
The teachings of Dyar, Lyczak, Raghuvaran, and Gardner are discussed above.
The combination of Dyar, Lyczak, Raghuvaran, and Gardner does not teach the presence of a hemostatic agent in the method.
Larsen teaches the missing element of the combination of Dyar, Lyczak, Raghuvaran, and Gardner.
Larsen teaches a method of promoting homeostasis and/or wound healing (Abstract) comprising a composition comprising shellac (pg 6, [0081]) and zeolite as a hemostatic agent “being explored for use in sealing severe injuries quickly” (pg 17, [0192]).
The person of ordinary skill would have had a reasonable expectation of success in selecting a zeolite hemostatic agent as an additive to the dressing composition of method of Dyar, Lyczak, Raghuvaran, and Gardner comprising shellac and nanoparticulate zinc oxide for the treatment of infection and/or wounds. The skilled artisan would have been motivated to add the zeolite since Larsen teaches addition of the zeolite promotes homeostasis and/or wound healing and zeolite may be useful in sealing severe injuries quickly.
Examiner’s Reply to Attorney Arguments dated 8/14/2026
1. Rejection of claims 1, 2, 5-8, 16-36, 39-2, 43, 45, and 46 over Dyar, Lyczak and Raghuvaran
The applicant argues that claim1 has been amended to further require that the addition of the anti-infective metal-based active increases the viscosity of the composition relative to a corresponding composition comprising shellac alone. The applicant argues that neither Dyar, Lyczak, nor Raghuvaran teach a shellac-metal composition or method comparable to the instant invention so as to increase the viscosity of the combination.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. In view of applicant’s amendment to claim 1 reciting the increase of viscosity of the shellac formulation upon addition of zinc oxide, the Examiner has added the prior art of Gardner to the rejection. The prior art of Gardner, filed in 1930, teaches that addition of metals such as zinc oxide and copper to a commercial bleached, de-waxed shellac solution, increases the viscosity. Gardner also teaches that after a period of time, the composition becomes gelatinous or even solid. Gardner teaches that a zinc soap forms between the zinc oxide and the acids in the shellac composition, causing the increase in viscosity (pg 1: 21-35). Regarding the formation of a self-supporting barrier, the teaching of Gardner provides support for a method of forming a solid barrier from the shellac-alcohol-zinc oxide composition.
The applicant argues Raghuvaran also fails to disclose or suggest a shellac-based liquid dressing; does not disclose or suggest incorporating ZnO or another claimed metal active into shellac to form the presently claimed self-supporting hydrophobic barrier; and does not teach modulation of shellac viscosity by the metal active,
The Examiner acknowledges the arguments presented, but does not consider them persuasive. The prior art of Raghuvaran teaches zinc oxide as an antimicrobial additive in veterinary applications; the prior art of Dyar, Lyczak, and Gardner teach the shellac-zinc oxide formulation. As discussed in MPEP 2145(IV), “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.” As further set forth in MPEP 2145(IV), “Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually.” In the instant argument, the applicant is improperly arguing that Raghuvaran fails to teach each and every element of the claim, while the rejection under obviousness actually recites four references.
The applicant argues the Faria Declaration provides direct experimental evidence that the claimed result was not predictable. The applicant further argues that the thickening of the shellac composition was the result of a chemical interaction.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. While the Faria Declaration demonstrates that addition of zinc oxide to a shellac solution increases the viscosity, this result is predictable and expected based on the teachings of Gardner, as discussed above.
2. Rejection of claim 23 under 35 U.S.C. §103 over Dyar, Lyczak, Raghuvaran, and Clapp.
Applicant' s arguments have been considered but are moot because of the new ground of rejection of claim 23 set forth above that does not recite the Clapp prior art.
3. Rejection of claims 39-42 under 35 U.S.C. §103 over Dyar, Lyczak, Raghuvaran, and Kabara.
The applicant argues that Kabara does not cure the alleged failure of Dyar, Lyczak, and Raghuvaran to teach the claimed functional relationship between shellac solutions and the anti-infective metal.
The applicant argues that Kabara does not teach decanoic (a.k.a. capric) acid as a hydrophobic barrier enhancing agent, or a buffering agent.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. The applicant acknowledges that Kabara teaches decanoic acid as an anti-infective agent. As set forth in MPEP 2144(IV), a rationale different from the applicant’s is permissible in the modification of a reference. In this case, the composition is an anti-infective, and it is prima facie obvious to add a second anti-infective such as decanoic acid to the method. As set forth in MPEP 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." The fact that decanoic acid has multiple utilities does not make it improper to utilize the compound for all of the advantages that it can confer to the claimed method.
4. Rejection of claims 45 and 46 under 35 U.S.C. §103 over Dyar, Lyczak, Raghuvaran, and Larsen.
The applicant agrees that Larsen teaches zeolites as known hemostatic materials, but argues that Larsen does not supply the alleged limitations missing from the underlying Dyar/Lyczak/Raghuvaran combination.
The Examiner acknowledges the argument presented, but does not consider it persuasive. As discussed in detail above, the newly added limitation of claim 1, “wherein the addition of the anti-infective metal-based active increases at least one of (i) the viscosity of the composition” is taught by the newly added prior art of Gardner.
Examiner’s Reply to the Declaration of Inventor Nino Faria dated 8/14/2026
Inventor Nino Faria argues that the prior art of Dyar “fails to suggest using metal actives to thicken shellac.” Inventor Faria has also provided experimental evidence of the curing of the shellac film comprising zinc oxide that he describes as “unexpected” and states that “ the claimed metal-based actives do not merely retain their previously known antimicrobial function when placed in a shellac formulation. Rather, they unexpectedly interact with the shellac system to modify the rheology of the liquid composition and the physical durability of the resulting barrier. See items 12 and 13 of the Declaration.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. The combined teachings of Dyar, Lyczak, and Raghuvaran provide the basis for the rejection of a method for treating or inhibiting infection and/or wounds in a subject comprising a composition containing shellac, a solvent, and a metal such as zinc oxide. The rheological change or thickening of the composition appears from the newly cited prior art of Gardner to be an inherent property of the composition since the thickening is due to the formation of a zinc soap between the zinc oxide and the acids naturally present in shellac, some of which are shown below. Note that the structures come from Lu (“Sesquiterpene acids from Shellac and their bioactivities evaluation,” Fitoterapia, 2013, pg 65).
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In order to demonstrate a surprising or unexpected result, applicant must compare the instant invention with the closest prior art regarding the formulation, namely that of Gardner. See MPEP 716.02(e):
An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978)
In the Faria Declaration, the applicant has failed to provide the required comparison with the closest prior art, and has therefore not demonstrated a surprising or unexpected result that is necessary to overcome a prima facie case of obviousness.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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