DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 1-19 are pending.
Priority
This application is filed 11/10/2023 and no claims the benefit of domestic priority. Foreign priority claimed with Application as following:
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The priority foreign document is in English and is present in the file.
Information Disclosure Statements
All references have been considered in the Information Disclosure Statement (IDS) filed 11/10/2023.
Claim Interpretation
Claims are interpreted in accordance with the broadest reasonable interpretation (BRI) standard
consistent with the specification (See MPEP 2111).
Claims 1-15 are drawn to a disinfectant composition in powder form are interpreted as follows:
Since the specification does not explicitly define “disinfectant agent”, “amino acid surfactant”, “thickener”, and “anti-caking agent”, the terms are interpreted under the broadest reasonable interpretation and given its plain meaning.
Claims 16-19 are drawn to a use of the claimed composition for method of use of the composition and is interpreted as follows:
The term “a disinfectant kit” is interpreted as a container or packaging containing the components would be considered a kit.
Abstract
The abstract of the disclosure is objected to because the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The current submitted abstract is 48 words. Examiner requests to bring in a general compound structure to satisfy the abstract requirement.
Correction is required. See MPEP § 608.01(b).
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12, “1-2,5%” should read “1-2.5%”
Appropriate correction is required.
Specification
The disclosure is objected to because of the following informalities:
The phase “the anti-caking agent and the thickener in a weight ratio of at least 0.01:1,
more preferably in a weight ratio of anti-caking agent to sorbitol of up to 0.2:1” in page 4, line 20 is not correct referencing as sorbitol is not the thickener.
In page 5, line 12, “1-2,5%” should read “1-2.5%”
In page 11, line 12, the term “8value” is not clear. It needs clarification.
In page 12, line 3, “carried what” should read “carried out”
In page 12, line 18 and line 22, “sealed bad” should read “sealed bag”
Inconsistent use of “liters/litres” “colorant/colour” and “chloramine T/chloramine-T”
Example 2 in page 9, total powder weight of the kit is 99 g, not 100 g.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 10-12 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired.
Claims 10-12 recite “preferably” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. (See MPEP § 2173.05(c) and (d))
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 (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.
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 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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gelmi et al. (EP2730168 A1, cited in the IDS filed 11/10/2023, pub’d 05/14/2014), in view of Bobbert (US 2018/0027812 A1, cited in the IDS as WO2016/124764 A1 filed 11/10/2023, pub’d 02/01/2018).
With respect to independent claim 1, Gelmi teaches a disinfectant composition for post-milking teat disinfection of dairy animals. Gelmi specifically teaches including: (i) a powder disinfectant composition (claim 1 and 13), (ii) comprising chloramine T, thickeners, and sorbitol (claim 1), (iii) specific weight-percent ranges for a disinfectant composition (claim 11-12, and example 1-3 in page 4-5), (iv) reconstitution in water (paragraph [0036]), (v) a dye gives the composition an intense colour with its specific wt% ranges (paragraph [0027]), and (vi) formation of a viscous/gel-like composition for post-milking teat disinfection (claim 13-14 and paragraph [0036]).
However, Gelmi fails to teach the inclusion of an amino acid-based surfactant, its weight ratio, and states “the composition of the invention does not require surfactants of any type” in paragraph [0022].
The specification acknowledges Gelmi as prior art and describes the claimed invention as an improvement over Gelmi, specifically by adding amino acid surfactants to the composition disclosed in Gelmi as follow (specification page 2, line 13):
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The MPEP 2145 states that “a prior art reference that "teaches away" from the claimed invention is a significant factor to be considered in determining obviousness. However, "the nature of the teaching is highly relevant and must be weighed in substance. A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 553, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). The MPEP 2145 further states that “"the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004)”.
The statement of Gelmi that surfactants are “not required” merely indicates that surfactants are optional, not that their use is undesirable or should be avoided. Gelmi does not criticize, discredit, or otherwise discourage the use of surfactants. Therefore, Gelmi does not teach away from the claimed invention within the meaning of MPEP 2145.
Bobbert teaches disinfectant compositions suitable for skin-contact applications. An amino acid-based surfactant is selected from N-acylated amino acids with non-ethoxylated anionic surfactants makes a composition active against the combined set of microorganisms. (paragraph [0006] – [0016]). Bobbert further teaches the definition of non-ethoxylated anionic surfactants and the examples of N-acylated amino acids and their salts including monosodium cocoylglutamate and monosodium lauroylglutamate, and lauroyl sarcosinate (paragraph [0047] – [0048], and [0052]), and their weight ratios (claim 1, 5, and 16) for use in mild, skin-compatible compositions (paragraph [0076] – [0077]).
It would have been obvious to a person having ordinary skill in the art (PHOSITA) at the time of the invention to modify a disinfectant composition for the teats of dairy animals of Gelmi to further include amino acid-based surfactants selected from N-acylated amino acid compositions, as taught by Bobbert. Bobbert further teaches that such amino acid-based surfactants provide antimicrobial activity against additional stains of microorganisms beyond those addressed by conventional disinfections (paragraph [0318]). For example, while Gelmi teaches activity against microorganism Staphylococcus aureus, Streptococcus uberis, and Escherichia coli (paragraph [0056]), the inclusion of the amino acid -based surfactant taught by Bobbert would allow the composition to further provide activity against microorganisms Pseudomonas aeruginosa, and Enterococcus hirae (paragraph [0318] – [0144]), thereby improving the overall disinfect efficacy of the composition. Such a modification would have yielded predictable enhanced disinfectant activities in disinfectant composition for the teats of dairy animals, and would not have required undue experimentation. (se1 MPEP 2141 and 2143).
With respect to the weight ratios of amino acid surfactant to sorbitol, on combination one would be motivated to optimize the amounts of N-acylated amino acid (amino acid surfactant) in order to optimizes the antimicrobial activity.
All references are directed to the same field of endeavor, namely a disinfectant for the teats of dairy animals, and address related problems of antimicrobial efficacy and skin tolerability. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
With respect to claims 2, 3, 6-9, 14, and 16-19, the claims further recite specific components and weight ratio within the powder disinfectant composition. As discussed above, Gelmi teaches the base powder disinfectant compositions, including the disinfectant agent, thickeners, sorbitol, and anti-caking agents, and reconstitution in water with the blue colour dye, while Bobbert teaches amino acid surfactants suitable for such skin-contact disinfectant compositions. Gelmi further teaches reconstitution process of the powder compositions to gel mixture using water in a container (paragraph [0036]). Accordingly, the combined references teach or suggest all of the limitations of claims 2, 3, 6-9, 14, and 16-19.
Applying KSR example rationale (A), it would have been prima facie obvious to such a combination represents the known elements (e.g., of a disinfectant agent, an amino acid surfactant, a thickener, sorbitol, an anti-caking agent, and colour dye) taught by Gelmi and Bobbert and their use according to known methods to yield no more than predictable results (see MPEP 2141).
Therefore, claims 2, 3, 6-9, 14, and 16-19 would be obvious to a person skilled in the art at the time.
With respect to claims 4-5, 10-13 and 15, the claims recite specific wt% ranges and weight ratios for the disinfection compositions. As discussed above, Gelmi teaches overlapping ranges at claims 4-5, 10-13 and 15 for sorbitol, thickeners, and disinfectant agents for the same purpose and use, and Bobbert teaches suitable concentration ranges of amino acid surfactants. Adjusting component proportions to arrive at the claimed ranges constitutes routine optimization of result-effective variables and overlapping range, consistent with MPEP 2144.05.
Conclusion
Claims 1-19 are rejected.
Claim 12 is objected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571) 270-7679. The examiner can normally be reached on 7:00am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621