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 .
DETAILED ACTION
This action is in response to Applicant’s amendment filed August 25, 2025 in reply to the First Office Action on the Merits mailed March 24, 2025. Claims 25-27 have been amended; claims 1-24, 28, and 29 have been canceled; and no claims have been newly added. Claims 25-27 are under examination.
Withdrawal of Prior Claim Objections
Claim 27 has been satisfactorily amended. Therefore, the objection to claim 27 presented in the First Office Action on the Merits mailed March 24, 2025 is hereby withdrawn.
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 25 and 27 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 pre-AIA the applicant regards as the invention.
Claim 25 requires administering a composition comprising the recited elements “sufficient for said treating or preventing”. Presumably, the term “sufficient for” denotes an amount of the composition that is administered. However, the term “sufficient for” appears to perhaps be narrower in scope and more nuanced than a more customarily employed term like e.g. “effective for” (i.e. “an effective amount of”). While on the one hand, the term “sufficient for” could merely be equivalent to “an effective amount of”, on the other hand “sufficient for” could be reasonably interpreted to mean the minimal effective amount, i.e. the minimal amount that satisfies being “enough” of the composition to achieve the desired effect, but which excludes higher amounts that may be “effective” but are beyond the scope of being “sufficient”. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 27 is indefinite for the following reasons:
1. Claim 27, as now amended, provides for treating “bacterial infections of a mammal’s skin, nails, claws and/or hooves”. The new phrase “a mammal’s” would be understood to mean only one mammal. However, “bacterial infections” is plural. One of ordinary skill in the art thus cannot definitively ascertain whether the requisite subject mammal being treated must necessarily be one with two or more different types of bacterial infections; or one having the same bacterial infection at two or more separate locations on the skin, nails, claws, or hooves; or what? Furthermore, one of ordinary skill in the art cannot definitively ascertain whether “preventing” requires simultaneously preventing two or more bacterial infections. In such a scenario, preventing e.g. merely S. aureus infection alone would not read on the claim, as two or more bacterial infections must be prevented simultaneously. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
2. Claim 27 stipulates that the composition comprises copper sulfate, clay, and sodium bicarbonate “in approximately equal amounts”, which renders the claim indefinite for the following reasons:
i) First, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of “approximately equal”, and whether “approximately equal” necessarily includes or excludes “equal”, and how equal is “approximately equal”. In other words, does “approximately equal” thus necessarily exclude “precisely exactly equal” (i.e. “approximately equal” cannot be “exactly equal”), or can “approximately equal” include within its purview “precisely exactly equal” (i.e. “approximately equal” can be “exactly equal”).
ii) Moreover, by “approximately equal amounts”, one of ordinary skill in the art, in light of the original specification and claims, would understand this to mean “approximately equal volume amounts”. However, one of ordinary skill in the art cannot definitively ascertain whether the “equal volume amounts” is intended to necessarily limit the concentrations of copper sulfate, clay, and sodium bicarbonate, and if so, how? If the volume of each is the variable “x”, the total volume is another variable, “3x”. Yet, no valid information can be discerned about the actual concentration of each element in each respective volume. For example, a volume “x” could contain anywhere from a very high to a very low concentration of copper sulfate. Likewise for clay and sodium bicarbonate in their respective “x” volumes. The actual final composition thus contains a total volume of 3x, but the concentrations of copper sulfate, clay, and sodium bicarbonate in this total volume are not limited and could be just about anything. Hence, for example, despite the “approximately equal volume” limitation, the copper sulfate concentration in the final composition could be high, while the clay concentration is low, or vice versa. Hence, one of ordinary skill in the art cannot definitively ascertain how the “approximately equal volumes” stipulation translates into any meaningful limits on the actual concentrations of the constituent elements in the composition. Since there is not even any actual limits on the volume x, one of ordinary skill in the art cannot definitively ascertain how this “approximately equal volumes” stipulation even limits the composition in any meaningful way at all.
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, 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.
Claims 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (U.S. Patent Application Pub. No. 2004/0175433), in view of Buttermore-Baca et al. (U.S. Patent Application Pub. No. 2015/0150908).
Applicant Claims
Applicant claims a method of treating a microbial infection in a mammal’s skin, nails, claws and/or hoof comprising administering a composition comprising copper sulfate, clay, and sodium bicarbonate; wherein the composition can further comprise acetic acid.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Thomson discloses a method of treating or preventing a microbial infection (e.g. including scald and other bacterial infections) affecting the hoof of an animal comprising administering to the hoof of the animal a composition comprising e.g. copper sulfate, an organic acid comprising 2-10 carbon atoms, an alkali metal salt, and a colloid former, e.g. a clay; wherein the constituents can be present in the composition in equal amounts (abstract; paragraphs 0001, 0007, 0010, 0012, 0014, 0016-0019, 0035, 0036, 0039-0041, 0043, and 0044).
Buttermore-Baca et al. disclose a method for treating or preventing e.g. a bacterial infection in an animal comprising topically administering to the animal a composition comprising e.g. sodium bicarbonate, an alkali metal salt, and an organic acid, e.g. acetic acid, wherein the composition can further comprise a thickening agent, e.g. magnesium aluminum silicate, i.e. a clay (abstract; paragraphs 0004, 0006, 0007, 0011, 0012, 0014, 0016, 0019).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Thomson does not explicitly disclose that the alkali metal salt includes sodium bicarbonate, and that the organic acid is acetic acid. These deficiencies are cured by the teachings of Buttermore-Baca et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Thomson and Buttermore-Baca et al., outlined supra, to devise Applicant’s claimed method.
Thomson discloses a method of treating or preventing a microbial infection (e.g. a bacterial infection) affecting the hoof of an animal comprising administering to the hoof of the animal a composition comprising e.g. copper sulfate, an organic acid comprising 2-10 carbon atoms, an alkali metal salt, and a clay; wherein the constituents can be present in the composition in equal amounts. Since Buttermore-Baca et al. disclose that a composition comprising e.g. sodium bicarbonate, an organic acid such as acetic acid, and a thickening agent such as a clay is surprisingly effective at treating skin wounds, including bacterial infections, one of ordinary skill in the art would thus be motivated to include sodium bicarbonate (e.g. as one of the alkali metal salts) in the Thomson composition, along with e.g. acetic acid, with the reasonable expectation that the resulting composition will be highly effective at treating and preventing topical skin/hoof infections in a mammal.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed August 25, 2025 have been fully considered but they are not persuasive.
i) Applicant contends that “the abstract of Buttermore-Baca…makes no mention of an organic acid”, but “Buttermore-Baca…states that the composition may further comprise an acid” in e.g. paragraphs [0004], [0007], [0012], [0022], and [0027]; that Buttermore-Baca discloses that that the purpose of the acid “is to adjust the pH”; that “there is no disclosure in Thompson for the need to adjust the pH”; that “what Thompson does disclose is that an organic acid can be used as an active ingredient alone or in combination with zinc sulphate, copper sulphate, or an alkali metal salt” and “Thompson also discloses that citric acid is the preferred acid and the acid disclosed in each of the examples”; and thus “a POSA would not find it desirable to add acetic acid”.
The Examiner, however, would like to point out the following:
1. First, claims 25 and 27 do not even require acetic acid at all. Only claim 26 requires acetic acid. The arguments thus appear to apply to claim 26 only.
2. Thomson, the cited primary reference, discloses a method of treating or preventing a microbial infection affecting the hoof of an animal comprising administering to the hoof of the animal a composition that can comprise an organic acid. Buttermore-Baca, likewise, discloses a method for treating or preventing e.g. a bacterial infection in an animal comprising topically administering to the animal a composition that can comprise an organic acid, e.g. acetic acid. Without any question whatsoever, it would thus be obvious in view of the cited prior art to treat or prevent a microbial infection by administering a composition comprising an organic acid. It is of no consequence whatsoever that Buttermore-Baca does not expressly mention an organic acid in their abstract. As Applicant points out, Buttermore-Baca discloses an organic acid in e.g. paragraphs [0004], [0007], [0012], [0022], and [0027]. This is adequate disclosure to make the point that the composition can contain an organic acid, and the organic acid can be acetic acid.
3. Thomson expressly teaches that “the organic acid suitably comprises 2 to 10 carbon atoms” (see paragraph [0014]). As anyone of ordinary skill in the art would immediately recognize, this would thus include acetic acid, which is an organic acid having 2 carbon atoms. Moreover, it has long been common knowledge in the art, and among many laypersons as well, that acetic acid is an excellent antimicrobial compound, and that acetic acid is effective against a wide range of bacteria, including those that form biofilm, and is routinely employed as a disinfectant in household cleaners, including vinegar, and also for wound treatment. Hence, in stark contrast to Applicant’s assertion, one of ordinary skill in the art would certainly find it most desirable to add acetic acid as the organic acid, or as part of the organic acid element, in the Thomson composition. Indeed, Thomson is not limited to the specific examples or even the preferred embodiments, and these do not constitute a teaching away from the broader disclosure and the non-preferred embodiments. Again, Thomson expressly teaches that “the organic acid suitably comprises 2 to 10 carbon atoms” (see paragraph [0014]).
4. Buttermore-Baca discloses that their composition can comprise an organic acid, e.g. acetic acid, and that the organic acid will adjust the pH. Based on this disclosure, Applicant attempts to make the case that Thomson somehow excludes acetic acid since Thomson does not explicitly say anything about adjusting the pH. This statement, however, appears to ignore a lot of basic facts that would be clear to anyone of ordinary skill in the art. First, Thomson expressly provides for the inclusion of an organic acid, and that “the organic acid suitably comprises 2 to 10 carbon atoms”. This would, without question, include acetic acid, which is widely known to be an excellent antimicrobial. Second, as anyone of ordinary skill in the art would undoubtedly recognize, the Thomson composition has a pH, whether Thomson explicitly mentions it or not. Third, if the Buttermore-Baca composition pH is adjusted by adding an organic acid, the Thomson composition pH, as anyone of ordinary skill in the art would reasonably expect, is also adjusted by adding an organic acid, even if Thomson does not explicitly state this fact. Therefore, contrary to Applicant’s assertion, Thomson does not exclude acetic acid at all, or otherwise teach away from adjusting their pH by adding an organic acid.
5. Regardless, one of ordinary skill in the art, in view of the cited prior art, could arrive at the subject matter of claim 26 with a reasonable expectation of success even if they employed e.g. citric acid as the antimicrobial organic acid as taught in Thomson and acetic acid as the organic acid to adjust pH as taught in Buttermore-Baca. Claim 26 merely requires the presence of acetic acid, and does not limit the amount of acetic acid that is necessarily present, and does not necessarily exclude the presence of other organic acids.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
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.
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/DAVID BROWE/Primary Examiner, Art Unit 1617