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 .
This application is in response to Applicant’s response filed July 8, 2025. Claims 61-76 are pending in the application. Claims 61-65 and 72-76 are withdrawn from further consideration as being drawn to nonelected inventions. Claims 66-71 will presently be examined to the extent they read on the elected subject matter of record.
Status of the Claim
The rejection of claim 71 because informalities is withdrawn due to Applicant’s amendment to claim 71.
The rejection of claims 66-71 under 35 U.S.C. 103 as being unpatentable over Koopman et al. (US 2012/0315305) in view of Keiji et al. (US 2011/0263528) is maintained.
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 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.
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 66-71 are rejected under 35 U.S.C. 103 as being unpatentable over Koopman et al. (US 2012/0315305) in view of Keiji et al. (US 2011/0263528). Koopman et al. and Keiji et al. cited by Applicant on the IDS filed May 31, 2022.
Applicant’s Invention
Applicant claims a method of desloughing, debriding or exfoliating a region of skin of a mammal or treating a wound on a mammal, the method comprising applying to the skin region or the wound, a dry powder topical composition consisting of water soluble components, the composition comprising: honey in dry granular form; at least one pharmaceutically acceptable carbonate (CO3-2) and/or bicarbonate (HCO3-1) salt in a dry granular form; and at least one organic acid in a dry granular form.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
Koopman et al. teach a dry powder fibrin sealant for use in the treatment of wounds or for surgical intervention or a topical hemostat (Abstract).
Regarding claims 66 and 68, Koopman et al. teach the carrier particles comprise an effervescent couple. As the powders are applied to a wound, the effervescent components dissolve, and liberate, say, carbon dioxide, thereby increasing the wettability of the hemostatic components (page 4, paragraph 49).
Regarding claims 66 and 68, Koopman et al. teach the composition is administered to the wound or wounds of a subject, including human and mammal (page 5, paragraph 64). Koopman et al. teach a method of treating a wound, comprising administering to the wound a pharmaceutical dry powder (page 11, claim 10).
Regarding claims 66, 68, 70 and 71, Koopman et al. teach the effervescent couple typically comprises citric acid and sodium bicarbonate. A preferred combination of citric acid and sodium bicarbonate represent on a weight basis, a range of 1:1 to 0.3:1 (page 4, paragraph 50).
Regarding claims 67 and 69, Koopman et al. teach the compounds are not activated until they are wetted, e.g. by coming into contact with liquid at a wound site (page 4, paragraph 53).
Koopman et al. teach the powder composition is adapted to form a protective or preventative covering or bandage for cuts, burns, ulcers and other skin injuries (page 5, paragraph 56).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Koopman et al. do not specifically disclose honey in dry granular form. It is for this reason Keiji et al. is added as a secondary reference.
Keiji et al. teach antimicrobial compositions containing methylglyoxal and material with methylglyoxal contained (such as manuka honey). Keiji et al. teach powder compositions (Abstract).
Regarding claims 66 and 68, Keiji et al. teach the material comprising methylglyoxal is manuka honey (page 1, paragraph 11). Keiji et al. teach the method comprises drying manuka honey prior to or during powderising (page 2, paragraph 30).
Keiji et al. teach a method of promoting wound healing, comprising administering to a subject in need thereof a composition comprising methylglyoxal and cyclodextrin. The composition is directly applied to the wound by topical application to the wound, for example by application to bandages, dressings (page 2, paragraphs 36-37).
Keiji et al. teach to promote wound healing the wound may be selected from burns, venous ulcers, surgical wounds, and infected wounds including those resulting from surgery (page 5, paragraph 93).
Finding a Prima Facie Obviousness Rationale and Motivation
(MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Koopman et al. and Keiji et al. and formulate a composition comprising dry honey, at least one pharmaceutically acceptable bicarbonate and at least one organic acid. Koopman et al. teach the effervescent couple typically comprises citric acid and sodium bicarbonate. Koopman et al. teach the composition is administered to the wound or wounds of a subject, such as cuts, burns, ulcers and other skin injuries. Keiji et al. teach the use of dry manuka honey to promote wound healing of burns, ulcers, and other injuries. In view of In re Kerkhoven, 205 USPQ 1069 (C.C.P.A. 1980), it is prima facie obvious to combine two or more compositions each of which is taught by prior art to be useful for the same purpose in order to form a third composition that is to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in prior art, thus claims that requires no more than mixing together two or three dry wound healing components set forth prima facie obvious subject matter.
Regarding the limitations of desloughing, debriding or exfoliating a region, the method comprises applying the dry topical composition to the skin region or the wound, Koopman et al. and Keiji et al. teach application of the dry formulations directly to the wounds. As such, following the prior art teachings that if dry citric acid and bicarbonate, as taught by Koopman et al. and dry manuka honey, as taught by Keiji et al., are applied to wounds to promote healing, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, i.e., desloughing, debriding, and exfoliating a region of skin, without evidence to the contrary.
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicant's arguments filed July 8, 2025 have been fully considered but they are not persuasive. Applicant argues the Office has not articulated any reason or motivation for a combination of Koopman and Keiji to be made apart from stating that such idea “flows logically”. Applicant argues that Koopman is specific to a hemostatic composition and not one for the use recited in the pending claimed and that the composition taught is specific to urgent care situation and makes no reference to wound healing. Applicant argues that Keiji is directed to an antimicrobial composition and makes no reference at all to bleeding or any hemostatic activity. In response to Applicant’s argument, the instant claims are directed to a method wherein the method comprises applying to the skin region or the wound, a dry powder topical composition consisting of water soluble components. While the outcome cited in the intended purpose is desloughing, debriding, or exfoliating, the method is application of the composition to the skin region or the wound. Koopman et al. teach the composition is administered to the wound or wounds of a subject, including human and mammal. Koopman et al. teach a method of treating a wound, comprising administering to the wound a pharmaceutical dry powder. Koopman et al.’s composition is the effervescent couple typically comprises citric acid and sodium bicarbonate. Keiji et al. teach antimicrobial compositions containing methylglyoxal and material with methylglyoxal contained (such as manuka honey). Keiji et al. teach powder compositions. Keiji et al. teach a method of promoting wound healing, comprising administering to a subject in need thereof a composition comprising methylglyoxal and cyclodextrin. The composition is directly applied to the wound by topical application to the wound, for example by application to bandages, dressings. Koopman et al. and Keiji et al. each teach the wounds that are treated include burns, ulcers and other skin injuries. Based on these teachings, wherein both compositions (effervescent comprising citric acid and sodium bicarbonate) and powder compositions comprising methylglyoxal (manuka honey) and cyclodextrin, are used to treat wounds by the application of the compositions to wounds, which include burns and ulcers. As such, following the prior art teachings that if dry citric acid and bicarbonate, as taught by Koopman et al. and dry manuka honey, as taught by Keiji et al., are applied to wounds to promote healing, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, i.e., desloughing, debriding, and exfoliating a region of skin, without evidence to the contrary. In addition, 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. In re Kerkhoven, 205 USPQ 1069 (C.C.P.A. 1980).
Applicant argues that honey is known to increase clotting, which is contradictory to the stated purpose of Koopman. Applicant further references Ahmed et al., which states the inhibitory effect of natural honey on platelet aggregation and blood coagulation and that it is known in the art that the use of honey is clearly contraindicated where blood coagulation is required. In response to Applicant’s argument, Ahmed et al., cited by Applicant, teaches that the effect of coagulation time is observed at higher concentrations (>/=15%) of honey (Abstract). Therefore, Ahmed et al. does not teach away from application of honey for the purposes of hemostasis but guides that no more than 15% of a composition should include honey in an effect on coagulation time is to be avoided. Therefore, the effect Koopman et al. intended with its composition would not be altered. Ahmed et al. does not teach or suggest that coagulation would be blocked if honey is combined, but only suggests that coagulation would be slowed.
Applicant argues that the combination of Koopman and Keiji advanced by the Office is inappropriate, as there in no motivation, express or implied, to combine the references, let alone combine them in such a way as to result in the claimed invention. As indicated herein above, Koopman et al. and Keiji et al. each teach the wounds that are treated include burns, ulcers and other skin injuries. Based on these teachings, wherein both compositions (effervescent comprising citric acid and sodium bicarbonate) and powder compositions comprising methylglyoxal (manuka honey) and cyclodextrin, are used to treat wounds by the application to of the compositions to the wounds, which include burns and ulcers. As such, following the prior art teachings that if dry citric acid and bicarbonate, as taught by Koopman et al. and dry manuka honey, as taught by Keiji et al., are applied to wounds to promote healing, the skilled artisan would expect to obtain a result that necessarily flows with the intended purpose and properties, i.e., desloughing, debriding, and exfoliating a region of skin, without evidence to the contrary. In addition, 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. In re Kerkhoven, 205 USPQ 1069 (C.C.P.A. 1980).
Applicant submits that the proposed combination is the result of improper hindsight analysis based on the present specification. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The claims remain rejected.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 Andriae M Holt whose telephone number is (571)272-9328. The examiner can normally be reached Monday-Friday, 8:00 am-4:30 pm EST.
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/ANDRIAE M HOLT/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614