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.
Previous Rejections
Applicant’s arguments, filed 8/13/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 52-53 are newly added.
Claims 3-4 and 48-51 are cancelled.
Claims 1-2, 5-47, and 52-53 are pending.
Claims 9-15, 37-38, 44, and 48-51 are withdrawn. Upon further consideration, claim 47 is withdrawn in view of the election of a non-elected spray formulation. In addition, newly added claims 52 and 53 are hereby withdrawn as being dependent on a withdrawn claim.
Claims 1-2, 5-8, 16-36, 39-43, and 45-46 are examined on the merits in this prosecution.
It is noted that the applicant elected the presence of a flexibilizer or plasticizer in the response dated 10 November 2024, and has presently amended claim 1 to recite the absence of a flexibilizer. In view of the desire of the Office to maintain compact prosecution, the Examiner withdraws the elected requirement of the absence of a flexibilizer.
CLAIM REJECTIONS
Failure to further limit a previous claim
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS: Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 25 and 26 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 is drawn to the limitation of “wherein the metal active is an anti-infective metal active selected from one or more of Cu, Zn, Fe, Al, Mo, and Ca….” Dependent claim 25 recites “Ag, Cu, Zn, Fe, Se, Al, Cr, Mo, Ga, Co, Bi, Sb, Li, Ge, Ti, and/or Ce, or a metal active selected from one or more of Ag, Cu, Zn, Fe, Se, Al, Cr, Mo, Ga, Co, Bi, Sb, Li, Ge, Ti, Ce, Na, K, Rb, Be, Mg, Ca, Sr, Sc, Ti, Zr, Hf, V, Nb, W, Mn, Re, Ru, Ir, Pd, Pt, In, La, Pr, Nd, Sm, Eu, Gd, Tb, Dy, Ho, and/or Er”, and dependent claim 26 recites “wherein the metal active comprises one or more of Cu, Zn, Ag, Fe, Se and/or Mo.” As such, each of claims 25 and 26 recite metal actives that are not recited in the parent claim, and therefore claims 25 and 26 do not further limit the subject matter of the parent claim.
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
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.
1) Claims 1-2, 5-8, 16-36, 39-42, 43, and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Dyar (US 2015/0343112 A1), in view of Lyczak (US 2013/0095184 A1) and Raghuvaran (“Zinc Oxide Nanoparticles: Opportunities and Challenges in Veterinary Sciences,” Immunome Res 2015).
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.
Lyczak and Raghuvaran 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):
PNG
media_image1.png
262
428
media_image1.png
Greyscale
See pg 2, top of left column.
As such, Raghuvaran teaches the limitations of claims 7, 8, 16, and 21.
2) Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Dyar (cited above), in view of Lyczak (cited above), Raghuvaran (cited above) and Clapp (US 3,142,622).
The teachings of Dyar, Lyczak, and Raghuvaran are discussed above.
The combination of Dyar, Lyczak, and Raghuvaran does not teach the type of shellac used in the composition.
Clapp teaches the missing element of the combination of Dyar, Lyczak, and Raghuvaran.
Clapp teaches a shellac-containing formulation that is useful as a hairspray (col 1: 9-12). Clapp teaches the formulation comprises bleached and dewaxed shellac (col 1: 18-24).
The skilled artisan would have expected success in substituting Clapp's dewaxed and bleached (decolorized) shellac for the generic shellac in Dyar's composition since Clapp teaches the dewaxed and decolorized shellac is safe to apply to the skin or scalp.
3) Claims 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Dyar (cited above), in view of Lyczak (cited above), Raghuvaran (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, and Raghuvaran are discussed above.
The combination of Dyar, Lyczak, and Raghuvaran 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, and Raghuvaran.
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).
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, 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 solves a different problem, namely the expectation of an enhancement of antimicrobial effectiveness of the method claimed in claim 1.
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), and Larsen (US 2011/0021964 A1).
The teachings of Dyar, Lyczak, and Raghuvaran are discussed above.
The combination of Dyar, Lyczak, and Raghuvaran does not teach the presence of a hemostatic agent in the method.
Larsen teaches the missing element of the combination of Dyar, Lyczak, and Raghuvaran.
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, and Raghuvaran 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 8/13/2025
1. Rejection of claims 1-4, 6, 19, 20, 22-27, 29-32, and 39 under 35 U.S.C. §102 over Lowndes.
and
2. Rejection of claims 33, 34, 43, 45, and 47 under 35 U.S.C. §103 over Lowndes.
The Applicant argues that Lowndes requires a flexibilizer in the composition.
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on the prior rejection of record (Lowndes) for any teaching or matter specifically challenged in the argument.
3. Rejection of claims 7 and 8 under 35 U.S.C. §103 over Lowndes and Sirelkhatim.
The Applicant argues the deficiencies of Lowndes are not cured by Sirelkhatim.
The Examiner acknowledges the arguments presented, but does not consider them persuasive since the current rejection detailed above does not depend on the prior art of Lowndes.
4. Rejection of claims 16-18 and 21 under 35 U.S.C. §103 over Lowndes and Raghuvaran
The Applicant argues the deficiencies of Lowndes are not cured by Raghuvaran.
The Examiner acknowledges the arguments presented, but does not consider them persuasive since the current rejection detailed above does not depend on the prior art of Lowndes.
5. Rejection of claims 28 and 46 under 35 U.S.C. §103 over Lowndes and Kumar.
The Applicant argues the deficiencies of Lowndes are not cured by Kumar.
The Examiner acknowledges the arguments presented, but does not consider them persuasive since the current rejection detailed above does not depend on the prior art of Lowndes.
6. Rejection of claims 35 and 36 under 35 U.S.C. §103 over Lowndes and Glenn
The Applicant argues the deficiencies of Lowndes are not cured by Glenn, and that Glenn does not teach a film comprising shellac.
The Examiner acknowledges the arguments presented, but does not consider them persuasive since the current rejection detailed above does not depend on the either the prior art of Lowndes nor that of Glenn.
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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, Frederick Krass can be reached on (571)272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
Prosecution Insights