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
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 Request for Continued Examination (RCE) filed July 10, 2026, with the submission filed on June 10, 2026, that includes a response to the Final Office Action mailed December 10, 2025, has been entered. Claims 25-27 have been amended; and claims 1-24, 28, and 29 have been canceled. Claims 25-27 are under examination.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 25-27 are 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 25 now recites “organic contaminants”, which is not disclosed anywhere at all in the original specification and claims.
Claim 26 now recites “wet environmental conditions” and “contaminated environmental conditions”, and “a persistent physical barrier against reinfection”, which are not disclosed anywhere at all in the original specification and claims.
Claim 27 recites “substantially similar” and “volumetric proportions”, and thus “substantially similar volumetric proportions”; “cohesive” and “non-flowable”, and thus “a cohesive, non-flowable packing mass”; “sprayable coating”; and “curing after application”, which are not disclosed in the original specification and claims.
While it is noted that the background of the specification, in describing the prior art, refers to U.S. Pat. No. 8,505,162, for describes a method of treating thrush by utilizing an adherent, rapidly curing synthetic organic resin, which thus requires curing the synthetic organic resin, this is not deemed to be adequate support for the claimed limitation of “the composition is retained in the treated area without requiring drying or curing after application”. Applicant did not contemplate or describe curing a composition to retain it in a treated area, and even if one points to the background reference to U.S. Patent No. 8,505,162, the claims are not necessarily directed to curing a synthetic organic resin.
Moreover, the original specification and claims, in addition to not adequately disclosing “substantially similar volumetric proportions” and “a cohesive, non-flowable packing mass”, as just noted, do not disclose a direct cause/effect relationship between “substantially similar volumetric proportions” and “a cohesive, non-flowable packing mass”, and how “substantially similar” is “sufficient” for this “cohesive, non-flowable packing mass”.
Finally, Applicant has not pointed to specifically where these newly added limitations are found in the original specification and claims.
This constitutes new matter.
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 25-27 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.
Claims 25 and 26 are indefinite for the following reasons:
1. Claims 25 and 26 are directed to methods of “treating or preventing” a microbial infection. However, the claim requires “administering a therapeutically effective amount” of the recited composition, which implies “treating”, not “preventing”. For “prevention”, there is no microbial infection that even exists, so there is no “effective therapeutic treatment” to speak of. Further for claim 26, the claim actually expressly states that application of the composition “provides…a persistent physical barrier against reinfection”, thus openly referring to the treatment of an existing infection. Hence, one of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
2. Claims 25 and 26 stipulate that the composition being administered is “non-liquid”. The limitation “non-liquid” is not formally defined by the claim. It is noted that the claim does stipulate that the composition must be “form holding”, but the specification defines “form holding” merely as “the ability to adhere to the infected area”. Indeed, even liquids could be said to be “form-holding” if they adhere to a substrate they come in direct contact with. Hence, one of ordinary skill in the art cannot definitively ascertain whether “non-liquid” refers more broadly to the composition as a whole being “non-liquid” in character, despite including constituent elements, like water, that, by themselves, are normally liquid under ambient conditions. Or, rather, does “non-liquid” more strictly stipulate that the composition does not contain any constituent elements, like water, that, by themselves, are normally liquid under ambient conditions? Or what? One of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
***For examination at this time, since Applicant’s specification provides examples of “packing compositions” that can contain constituents, such as water, that are normally liquid under ambient conditions, the term “non-liquid” is being interpreted as the composition as a whole must be “non-liquid” in character, despite being open to the inclusion of constituent elements, like water, that, by themselves, are normally liquid under ambient conditions. In other words, the recited “non-liquid” composition does not necessarily exclude liquid constituent elements, such as water.
3. Claim 25 stipulates in a wherein clause that “the composition is capable of being packed into a nail bed, claw, or hoof”, and claim 26 stipulates in a wherein clause that “the composition is packable into a nail, claw, or hoof”. One of ordinary skill in the art cannot definitively ascertain whether the composition is necessarily administered by the active step of “packing” into a nail, claw, or hoof, and indeed what constitutes “packing”. Does “packing” simply mean that the composition is “form holding” and forms a physical barrier? Or, rather, is the wherein clause merely describing the composition only as “capable of being packed” or as “packable”, but there is no required active step to pack the composition into a nail, claw or hoof?
***Since the claims merely require that the recited composition is “administered”, and never definitively stipulates that the method necessarily requires the active step of packing into a nail, claw, or hoof, the claims are being interpreted as the administration can be by any means, e.g. packing or non-packing means. Further, it is noted that the stipulation that the composition provides a “physical barrier” is being interpreted as a free-standing limitation not necessarily dependent on whether or not the composition is administered by the active step of packing.
4. Claim 25 stipulates in a wherein clause that the composition “inhibits moisture and organic contaminants from contacting the area of administration”. First, “organic contaminants” is not defined by the claim or the specification (i.e. “organic contaminants” never appears in the specification at all), and one of ordinary skill in the art cannot definitively ascertain the metes and bounds of “organic contaminants”, and which organic compounds are “contaminants” and which are not. Moreover, one of ordinary skill in the art cannot definitively ascertain whether the composition itself being administered necessarily excludes “moisture”, presumably water, and “organic contaminants”, since the composition inhibits these from contacting the area of administration. Again, one of ordinary skill in the art cannot definitively ascertain which organic compounds are “contaminants” and which are not. Presumably, since the composition contains copper sulfate, clay, and sodium bicarbonate, these are not “contaminants”. From these, one of ordinary skill in the art cannot extrapolate which organic materials are “contaminants” and which are not. Presumably all dirt, soil, and sand, like clay, are not contaminants?
5. Claim 26 stipulates in a wherein clause that the applied composition “remains in place under wet or contaminated environmental conditions”, which are arbitrary, subjective, and not defined by the claim or the specification. What constitutes a “wet” environmental condition, e.g. a relative humidity of greater than 95%? Or 100%? Heavy rain? Or what? What constitutes a “contaminated environmental condition”? Nuclear fallout? Oil spill? Locusts? Presence of asbestos particles in the air? Hot day, e.g. temperature over 95F with UV index over 8? Or what? One of ordinary skill in the art cannot make heads or tails out of the claimed subject matter.
Claim 27 is indefinite for the following reasons:
1. Claim 27, which depends from claim 25, stipulates that the composition comprises copper sulfate, clay, and sodium bicarbonate “in substantially similar volumetric proportions”, which renders the claim indefinite. “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 “substantially similar”, and whether “substantially similar” necessarily includes or excludes “similar”, and how similar is “substantially similar”, not to mention how “similar” is “the very same”. Applicant amended the claim from “approximately equal”, which was indefinite enough, to “substantially similar”, which is even more fuzzy and indefinite. One of ordinary skill in the art cannot make heads or tails out of the claimed subject matter.
ii) As one of ordinary skill in the art would readily understand, the composition as a whole is but one volume, not three separate volumes. For a solution or dispersion, the constituents are distributed in the total volume of the composition. Because there are not three, separate volumes, the whole notion of “substantially similar volumetric proportions” not only appears to be an abstraction of merely diving the total volume into three equal parts, with each part containing all of one element and none of the others, but says nothing at all about the actual concentrations of the constituents in the composition. If the total volume of the composition could be imagined to be divided into three “substantially similar” sub-volumes, each denoted by the variable “1/3x”, the total volume is another variable, “x”. Even of one imagines all the copper sulfate is in one of the sub-volumes, “1/3x”, and all of the clay is in another sub-volume, and all of the sodium bicarbonate is in another sub-volume, no valid information can be discerned about the actual concentration of each element in each respective volume or in the composition as a whole. For example, the first sub-volume “1/3x” could contain anywhere from a very high to a very low concentration of copper sulfate. Likewise for clay and sodium bicarbonate in their respective sub-volumes. The actual final composition thus contains a total volume of x, 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 “substantially similar volumetric proportions” 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 “substantially similar volumetric proportions” stipulation translates into any meaningful limits on the actual concentrations of the constituent elements in the composition. Indeed, there is not even any actual limit on the volume x. One of ordinary skill in the art thus cannot definitively ascertain how this “substantially similar volumetric proportions” stipulation even limits the actual composition as a whole in any meaningful way.
Claim 27 is also indefinite for depending from an indefinite claim.
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 e.g. a mud-like 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, and wherein the composition can be administered by footbath, i.e. having the animal step in or on the composition (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 e.g. a mud-like 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 June 10, 2026 have been fully considered but they are not persuasive.
i) Applicant contends that “Thomson’s compositions are over 80% water…and are only applied in thin layers to limit the amount of drying time”, and “given the thin layer applied, a POSA would understand that the Thomson compositions do not provide a physical barrier from moisture and organic material”, and “Thomson teaches away from thick, persistent application”; that “the only example in Buttermore-Baca shows a water content of 54.5%” and “Buttermore-Baca relies on synthetic polymer thickeners to produce an aqueous solution, a salve, a balm, a lotion, a cream, an ointment, a paste, or a gel” and thus “neither teaches nor suggests to a POSA a…formulation capable of being packed and retained”, and “the formulations disclosed in Buttermore-Baca do not create a physical barrier to external environmental conditions”; however, the amended claims “require a non-liquid, form holding composition” that “does not dry or dissipate into a wet, dirty stall”, require “that the composition be packed into the hooves, nails or claws of a mammal” and “also require that the composition be retained in the hoof, claw, etc. after application”.
The Examiner, however, would like to point out the following:
1. First, in stark contrast to Applicant’s assertion, the claims do not necessarily require that the composition be packed into the hooves, nails or claws of a mammal. On the contrary, the claims merely require that the composition is “administered”, and the composition is administered for the purpose of “treating or preventing a microbial infection of a mammal’s skin, nails, claws, and/or hooves”. A human is a mammal, and the composition could be administered e.g. to the skin of a human’s arm, or to the skin a human’s face, and this would fall within the purview of the claims. Claim 25 merely states that the composition “is capable of being packed into a nail bed, claw, or hoof”, and claim 26 merely states that “the composition is packable into a nail, claw, or hoof”. None of the claims necessarily requires the active step of packing into a nail, claw, or hoof, or even administration of the composition in any manner to a nail, claw, or hoof. As just noted, the composition could be administered to ordinary skin by a non-packing means and still fall within the purview of the claims. And as noted in the 112 rejection, supra, since the claims merely require that the recited composition is “administered”, and never definitively stipulates that the method necessarily requires the active step of packing into a nail, claw, or hoof, the claims are being interpreted as the administration can be by any means, e.g. packing or non-packing means. Further, it is noted that the stipulation that the composition provides a “physical barrier” is being interpreted as a free-standing limitation not necessarily dependent on whether or not the composition is administered by the active step of packing.
2. In stark contrast to Applicant’s assertion, the Thomson composition is not intended to be a liquid at all, even if it does contain water, even over 80% water. On the contrary, Thomson specifically differentiates their composition from a liquid composition. In the background section, Thomson discusses the disadvantages of employing a liquid composition (see, e.g. paragraph 0004). Then Thomson discloses that their composition is a “viscous composition” as opposed to a “liquid composition” (see paragraphs 0005). In other words, Thomson discloses that their composition is a non-liquid. Specifically, Thomson describes their composition as “mud-like” (see e.g. paragraphs 0010, 0053). As anyone of ordinary skill in the art, and indeed most laypersons as well, would immediately recognize, mud is a semi-solid and is very packable. Indeed, mud gets readily packed into horses and other animal’s hooves all the time, whether they want it there or not. Moreover, Thomson discloses that their composition adheres to the surface to which it is applied, e.g. it sticks well to hooves (see e.g. paragraphs 0008, 0010, 0039, 0055, 0057), and is thus, without question, “form holding”. Moreover, the Thomson composition adheres to the hoof upon application, even before drying (see e.g. paragraph 0010). Hence, the Thomson composition does not require drying or curing to adhere to the hoof.
3. All in all, then, one of ordinary skill in the art would understand that the Thomson composition is non-liquid, form holding, capable of being packed, adheres to the hoof without the need for drying, and is retained thereon. Thomson also expressly makes clear that a therapeutically beneficial amount of the active ingredient is bound to the hoof (see e.g. paragraph 0039). Obviously, it is self-evident and plain for all to see that with this antimicrobial composition adhered to the animal’s hoof, the composition thus forms a physical barrier with the environment and protects against reinfection. Applicant’s assertion that “Thomson’s compositions do not provide a physical barrier from moisture and organic material” is baseless and incongruous.
4. Even assuming, arguendo, that the claims did require that the composition is packed into hooves, Applicant is directed to Figure 1 of Thomson, and to paragraph 0041, which discloses that a suitable means for application of the composition is by having the animal walk though the composition. As anyone of ordinary skill in the art, and most laypersons, would immediately understand, if an animal such as a horse walks through thick mud, the mud is going to readily pack into the hooves. Again, everyone knows that mud is very packable.
5. Buttermore-Baca is merely a secondary reference cited for teaching 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, and thus motivating one of ordinary skill in the art to include the combination in the Thomson composition for the benefits it affords. There is nothing in Buttermore-Baca that teaches away from a non-liquid, form holding, packable composition at all. Indeed, as Applicant points out, Buttermore-Baca disclose e.g. an ointment, and e.g. a paste, and e.g. a gel, which are non-liquid in character and are very packable. Certainly, the antimicrobial effect of the Buttermore-Baca composition is not somehow dependent on it being a liquid.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
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/DAVID BROWE/Primary Examiner, Art Unit 1617
