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 .
Status of the Application
Claims 39-44 and 53-65 are pending and are under current examination.
Amendment necessitated new claim rejection as set forth below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claim(s) 57 is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The subject matter of the instant claim 57, is not properly described in the application as filed. In particular, there was no indication in original specification as filed or in canceled claims that “chitosan ----is free of ethanol” and therefore raise doubt as to possession of the claimed invention at the time of filing.
Applicant is required to cancel the new matter in the reply to this Office Action.
Therefore, this limitation is not considered for this rejection.
Claim Rejections - 35 USC § 103
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.
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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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. 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 39-44 and 53-57 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (WO2014/126370 A1; as provided by the applicant on IDS dated 08/03/2022) as evidenced by Pubmed (pubchem.ncbi.nlm.nih.gov/compound/tyrothricin, downloaded on 03/24/2026) and Rautenbach (Biochimie, 130, 2016, 122-131).
Determining the scope and contents of the prior art
Kim discloses a method of treating wound or promoting wound healing, such as burn wound, abrasion wound, closed wound etc. on any area with example of skin area using an antimicrobial and/or anti-inflammatory composition in form of liquid, ointment or a gel applied directly to affected area with several examples comprising chitosan 0.4-20wt% with respect to total weight of the composition (which can be obtained from crustaceans) with % of deacetylation as 80%, 82%, 84%, 86%, 90% or higher (thus reads on limitation of 70-100%) (paragraph 37), purified water, lactic acid 0.2-20wt% with respect to total weight of the composition (encompasses 50% of the weight of the chitosan based on the total weight of non- water components); optionally may have preservative such as benzyl alcohol and optionally may contain plasticizer such as propylene glycol; polyol, such as propylene glycol, glycerin (92g/mol), polyethylene glycol PEG (with molecular weight of at least 90g/mol); essential oils, such as olive oil (extracted from plant material); iodophore (for example povidone-iodine (same compound and iodophore as described in the instant specification), wherein the composition is applied topically thereby forming a film on affected area (paragraphs 17, 23, 26, 29, 30-34, 37, 42-44, 55-61, claims and Examples, paragraphs 66 -104). The cited prior art further discloses MW of chitosan as 100,000D or less or 100,000D-2,000,000 D (encompass 500,000D) or less (paragraphs 70-71).
PNG
media_image1.png
532
748
media_image1.png
Greyscale
PNG
media_image2.png
773
771
media_image2.png
Greyscale
Examples 1-4, 6-20 (paragraphs 66 -92) discloses % by weight of chitosan based on the weight of the formulation as 10% (example 4), 0.5% (example 7), 3% (example 13), 2% (examples 9, 11, 12 and 14), 4% (examples 1-3, 6, 10, 15-19), 1% (example 8, 20) along with water (at least 80wt% of the formulation in examples (7-10) and lactic acid.
For example (pages 13-14, paragraphs 64-69), example 1 consists: Chitosan 4g, lactic acid 2 g and water 100g-6g-(2.5-0.1-1-0.05-1=4.65g) =89.35g were dissolved making a composition. Thus chitosan 4/95.35 (89.35+2g+4g=95.35g) x100=4.19 % (example 1) and acid 2/4x100=50% of chitosan. As evidenced by Pubmed and Rautenbach, tyrothricin has antifungal activity.
PNG
media_image3.png
537
745
media_image3.png
Greyscale
Importantly, examples 17 and 20 (pages 17-18, paragraphs 89-92). For instance, example 17 comprises no antibiotic or any of the negative limitations of the claims: Chitosan 4g (MW 100,000-2,000,000 or less), lactic acid 2 g, 1g Centella asiatica extract (anti-inflammatory, antioxidant), 5 g polysorbate 80 (stabilizer), 0.05 g cetylpyridinium chloride (preservative), +additional components (5g+5g+1g=11g) and water 100g-(4+2+1+5+0.05=12.05g +additional components 11g) =76.95g. Thus, chitosan 4/96 x100=4.16 % of total composition; and acid 2/4x100=50% of chitosan (reads on all limitations of the instant claims).
PNG
media_image4.png
684
796
media_image4.png
Greyscale
With regard to limitation of viscosity of chitosan, viscosity of chitosan containing solution -since the cited prior art teaches same chitosan as in the instant claims, the chitosan of the cited prior art is also expected to possess same viscosity under same conditions as in the instant claims. This is because substances are inseparable from their physical and chemical properties.
With regard to the limitation in instant claim, “sprayable”, since the cited prior art teaches same composition as in instant claims, the composition of the prior art must be capable of being sprayable, whether or not realized by the cited prior art. Further, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) (“where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation”); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000).
Ascertaining the differences between the prior art and the claims at issue
Kim teaches a method of treating wound or promoting wound healing, such as burn wound, abrasion wound, closed wound etc. on any area with example of skin area using an antimicrobial and/or anti-inflammatory composition with several examples for wound healing comprising chitosan (which can be obtained from crustaceans) with % of deacetylation as 80%, 82%, 84%, 86%, 90% or higher with MW 100,000 or less-2,000,000 or less, purified water, lactic acid, pharmaceutically active substance, such as antibiotic, disinfectant, sanitizer, local anesthetic, wound healing accelerant, for example povidone-iodine (same compound and iodophore as described in the instant specification) with optional components preservative such as benzyl alcohol, plasticizer such as glycerin (glycerol) propylene glycol, polyethylene glycol with several benefits such as dissolution of active substances, preventing destruction of film etc. However, the cited prior art does not provide specific example of composition, wherein the composition has iodophores, composition has polyol with MW 90-100g/mol, and applying comprises spraying.
Resolving the level of ordinary skill in the pertinent art
With regard to the above difference of composition with iodophore – Kim teaches that the composition may use disinfectant, sanitizer, local anesthetic, wound healing accelerant, with example povidone-iodine, Centella asiatica etc. Thus, with the guidance provided by Kim, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that wound healing accelerant in chitosan containing compositions provided by the cited prior art may be substituted with another wound healing accelerant, such as, povidone-iodine as suggested and taught by the cited prior art for using in process of treating inflammation or microbial contamination of wound.
Further, Case law has established that it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007). Most importantly, the predictable result is also taught and suggested by the cited prior art.
With regard to the above difference of “applying comprises spraying”- Although Kim is silent about spraying, Kim teaches that the composition can be in the form of liquid, gel and ointment and is applied topically directly to the affected area, wherein the solvent of the composition volatizes forming a film. Based on the guidance provided by Kim of direct topical application of the composition, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that the chitosan containing compositions may be applied topically in any manner, such as spraying. Thus, the cited prior art meets limitation of the instant claims.
With regard to the above difference of “polyol with MW 90-100g/mol”- Kim teaches that the composition may have polyol, such as propylene glycol, glycerin (92g/mol), polyethylene glycol PEG (with molecular weight of at least 90g/mol) and give examples with propylene glycol. Based on the guidance provided by Kim, it would have been prima facie obvious to a person of ordinary skill in the art with a reasonable expectation of success that polyol, such as propylene glycol, glycerin (92g/mol), polyethylene glycol PEG (with molecular weight of at least 90g/mol) as taught by the cited prior may be useful in making the composition and for treating inflammation. Thus, the cited prior art meets limitation of the instant claims.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Kim teaches a method of treating wound or promoting wound healing, such as burn wound, abrasion wound, closed wound etc. on any area with example of skin area using an antimicrobial and/or anti-inflammatory composition with several examples for wound healing comprising chitosan (which can be obtained from crustaceans) with % of deacetylation as 80%, 82%, 84%, 86%, 90% or higher, purified water, lactic acid, preservative such as benzyl alcohol, plasticizer such as glycerin (glycerol) propylene glycol, polyethylene glycol with several benefits such as dissolution of active substances, preventing destruction of film etc.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that that wound healing accelerant in chitosan containing compositions provided by the cited prior art may be substituted with another wound healing accelerant, such as, povidone-iodine as suggested and taught by the cited prior art for using in process of treating inflammation or microbial contamination of wound.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to practice process with a reasonable expectation of success.
Response to Arguments
Applicants’ remarks, affidavit and amendment, filed 07/23/2026 have been fully considered but not found persuasive.
Applicant files affidavit and argue over that specification excludes compounds that form insoluble complexes with chitosan or induce precipitation of chitosan (e.g., ethanol) and introduction of new claim with such limitation. Applicants argue over rejection under 103 with similar argument that claim 39 excludes compounds that form insoluble complexes with chitosan or induce precipitation of chitosan (e.g., ethanol), bioadhesive polymer.
This is not found persuasive and the instant claims are rejected under 103. This is because (1) applicant’s excluded compounds, solvents etc. that form insoluble complexes with chitosan or induce precipitation of chitosan is in fact new matter; (2) Further, applicant’s composition essential component, water, also form insoluble precipitates with chitosan. In fact, chitosan is insoluble in water (see instant specification also paragraphs 0044-0046) in absence of acid. Ethanol might be reducing solubility so is water.
With regards to applicant’s argument that bioadhesive polymer other than chitosan is excluded in the instant claims and is included in Kim’s composition is again not found persuasive. This is because (1) instant claims are broad and include any thickener, plasticizer, adjuvant, preservative etc., with overlapping definition of bioadhesive polymers; (2) applicant only argued but provided no reference where the argued components of examples of Kim are in fact bioadhesive polymers and are not covered under thickener, plasticizer, adjuvant, preservative etc., which according to the broad language of claims are all included; (3) Importantly, components, such poloxamer, hydroxypropyl cellulose are optional and not necessarily needs to be present in the composition of Kim;(4) Kim teaches composition with and without bioadhesive polymer, such as examples 4, 10 and 17-20.
Applicant argued over optional component polyol with molecular weight 90-1000g/mol.
Applicant argument is moot in view of new rejection as set forth above.
Applicant argued over exclusion of antibiotic from the instant claims.
This is not found persuasive as Kim teaches that the composition may optionally contain antibiotic, antifungal agent, iodophore etc. Importantly Kim teaches example of a composition without any antibiotic. Kim’s other examples with antibiotics don’t preclude its teaching without antibiotic.
Allowable Subject Matter
Claims 58-65 presents allowable subject matter over the cited prior art.
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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PANCHAM BAKSHI whose telephone number is (571)270-3463. The examiner can normally be reached M-Thu 7-4.30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Milligan Adam can be reached on 571-2707674. 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.
/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623
Prosecution Insights