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 .
Information Disclosure Statement
The information disclosure statement filed January 5, 2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Additionally, for the NPL references listed on the IDS dated January 5, 2024 only one contained a date for the reference. Therefore, the four references without dates have not been considered.
Claim Objections
Claim 10 is objected to because of the following informalities: the word “based” in line 4 appears to be a typographical error. 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 12 and 13 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. It is unclear what constitutes a “low risk” risk assessment and what constitutes a “high risk” risk assessment.
Claims 14, 15, and 16 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. It is unclear what constitutes a “low risk” risk assessment, what constitutes a “high risk” risk assessment, and what constitutes a “severe” risk assessment.
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.
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 9-16 are rejected under 35 U.S.C. 103 as being unpatentable over CIOPYK et al. (US 2021/0207194 A1, hereinafter Ciopyk) in view of Harris et al. (US 2016/0138089 A1, hereinafter “Harris), in further view of Kim (US 2017/0367297 A1), in further view of Crusoe (“Crusoe the Dachshund: How I brush Crusoe’s teeth – copy provided on IDS dated April 25, 2024), in further view of Swanson (“How Long Do I Have to Wait to Eat After Brushing My Teeth?” – copy provided on IDS dated April 25, 2024).
Regarding Claim 9, Ciopyk discloses a method of determining a treatment plan for disease (abstract) that is guided by the presence or absence of DNA of an organism ([0053]) and discloses that a DNA biological sample can be obtained via buccal swab ([0063]). (Original) Ciopyk further discloses placing the DNA sample in a preservative for DNA analysis ([0121] describes DNA analysis via reagents and primers and [0145] discloses that the reagent can contain a preservative) and analyzing the swab for bacteria (determining the presence of bacteria is described in [0106]). Ciopyk further discloses determining and modifying a treatment protocol in response to the detection of SNP’s (single nucleotide polymorphisms) within the DNA ([0284]).
Ciopyk fails to disclose that the DNA testing is performed on a canine and obtained via a swab of a canine’s gum line. In the similar art of assaying the dental bacteria present in a canine, Harris teaches evaluation of the dental health of canines by DNA sequencing samples taken from the oral cavity of the canine ([0019]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the buccal swab technique for obtaining a DNA sample (which would be taken on the buccal side of the tooth and therefore also be a swab of the gum line) of Ciopyk with performing the procedure on a canine as is taught by Harris in order to provide the needed sampling for analysis of the DNA when treating a dog as opposed to a human.
Ciopyk in view of Harris discloses the invention substantially as claimed, but fails to teach a method of cleaning the canine's gums by applying treatment gel to the canine with the application of gel comprising the steps of placing a finger applicator on the dominant finger of the user and applying treatment gel to the finger applicator. In the art of pet dental care, Kim teaches the use of a fingertip toothbrush (Figure 1) for a pet in which a fingertip is placed [0044]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to execute the treatment of the bacterial in the canine oral cavity as determined by Ciopyk in view of Harris with the finger applicator of Kim in order to effectively reach the teeth and gums of the canine in a gentle manner.
Ciopyk in view of Harris in further view of Kim however fails to teach applying the treatment gel to the outer surface of the canine's teeth and gums. In the art of dog tooth brushing, Crusoe teaches brushing a dog's teeth using toothpaste and a toothbrush (bristles) by putting the toothpaste (gel) on the toothbrush and applying it to the outer surface of the canine’s teeth or gums ([0:03]-[5;01]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to utilize the technique for dog tooth brushing as taught by Crusoe with the method of treating and cleaning a canine’s gums as taught by Ciopyk in view of Harris in further view of Kim in order to thoroughly and gently treat the canine.
Ciopyk in view of Harris in further view of Kim in further view of Crusoe discloses the invention substantially as claimed, but fails to teach preventing canine from ingesting food or water for a one-hour period after treatment. In the same art of dental treatment, Swanson recommends waiting to eat or drink after brushing teeth. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to apply the guidance of Swanson of waiting to eat or drink at least 30 minutes after brushing, and preferably longer, to the treatment protocol of Ciopyk in view of Harris in further view of Kim in further view of Crusoe in order to prevent dilution and ingestion of the treatment substance (i.e. toothpaste).
Ciopyk in view of Harris in further view of Kim in further view of Crusoe in further view of Swanson discloses the invention substantially as claimed, and Harris further discloses performing a second swab of a canine's gum line and placing the swab in a preservative for DNA analysis, analyzing the second swab for bacteria, and analyzing the effectiveness of the method (comparison trials to measure the prevention and treatment of the oral health of an animal are described in ([0053]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the treatment plan of Ciopyk in view of Harris in further view of Kim in further view of Crusoe in further view of Swanson with the comparison trials of Harris in order to determine the outcomes of the treatment plan.
Regarding Claim 10, Ciopyk in view of Harris in further view of Kim in further view of Crusoe in further view of Swanson discloses the method of Claim 9 substantially as claimed, and Harris further discloses the steps of determining the concentration of bacteria in the first swab, determining the systemic risk to the canine's gums based, the systemic risk corresponding directly to the type of bacteria present in the first swab and consisting of either a mild, high, or severe risk; and determining a risk assessment based on the systemic risk and concentration of bacteria in the first swab, wherein the risk assessment is either a high risk or low risk ([0053] and [0088]). ]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the treatment plan of Ciopyk in view of Harris in further view of Kim in further view of Crusoe in further view of Swanson with the comparison trials of Harris in order to assess risk and modify the treatment plan.
Regarding Claims 11 and 12, Ciopyk in view of Harris in further view of Kim in further view of Crusoe in further view of Swanson discloses the method of Claim 10 substantially as claimed, and Harris further discloses application of the gel solution to the canine once daily for 21 days if the risk assessment is a low risk and application of the gel solution to the canine twice daily for 21 days if the risk assessment if a high risk (long term comparison trials to measure the prevention and treatment of the oral health of an animal are described in ([0053]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the treatment plan of Ciopyk in view of Harris in further view of Kim in further view of Crusoe in further view of Swanson with the comparison trials of Harris in order to determine treatment length and effectiveness and modify the treatment plan.
Regarding Claim 13, Ciopyk in view of Harris in further view of Kim in further view of Crusoe in further view of Swanson discloses the method of Claim 9 substantially as claimed, and Crusoe further discloses that the step of applying the treatment gel to the outer surface of the canine's teeth and gums comprises the steps of lifting the upper lip on a first side of the canine's mouth to grant visibility and access to the upper teeth and gums of the canine, gently pressing the treatment gel at the gum line of the tooth furthest from the front of the canine's mouth, moving the applicator in a circular and counterclockwise direction while maintaining gentle pressure on the canine's tooth, wherein the path of movement is an "Upper Rotation" comprising the following steps: (a) starting from the gum line and moving slightly downward and in the direction of the next tooth towards the front of the canine's mouth,(b) moving to the pointed end of the tooth being cleaned and away from the gum line,(c) moving slightly upward and toward the back edge of the tooth being cleaned and away from the front of the mouth, and(d) returning back to the gum line of the tooth being cleaned, moving the applicator to the adjacent tooth in the direction of the front of the mouth, continuing to apply the treatment gel, using the Upper Rotation, to each tooth on the first side of the canine's upper jaw, stopping application of the treatment gel to the upper teeth of the first side of the canine's mouth after applying the gel to the upper front teeth of the canine, lifting the upper lip on a second side of the canine's mouth to grant visibility and access to the upper teeth and gums of the canine, gently pressing the applicator at the gum line of the tooth furthest from the front of the canine's mouth, moving the applicator using the Upper Rotation to clean each tooth on the second side of the canine's upper jaw, stopping application of the treatment gel to the upper teeth on the second side of the canine's mouth after applying the gel to the front upper teeth of the canine; lifting the upper lip and on the first side of the canine's mouth to grant visibility and access to the lower teeth and gums of the canine; gently pressing the treatment gel at the gum line of the tooth furthest from the front of the canine's mouth, moving the applicator in a circular and counterclockwise direction while maintaining gentle pressure on the canine's tooth, wherein the path of movement is a "Lower Rotation" comprising the following steps: (a) starting from the gum line and moving slightly upward and in the direction of the next tooth towards the front of the canine's mouth,(b) moving to the pointed end of the tooth being cleaned and away from the gum line,(c) moving slightly downward and toward the back edge of the tooth being cleaned and away from the front of the mouth, and(d) returning back to the gum line of the tooth being cleaned, moving the applicator to the adjacent tooth in the direction of the front of the mouth, continuing to apply the treatment gel, using the Lower Rotation, to each tooth on the first side of the canine's lower jaw; stopping application of the treatment gel to the lower teeth of the first side of the canine's mouth after applying the gel to the lower front teeth of the canine, lifting the upper lip on a second side of the canine's mouth to grant visibility and access to the lower teeth and gums of the canine, gently pressing the applicator at the gum line of the tooth furthest from the front of the canine's mouth, moving the applicator using the Lower Rotation to clean each tooth on the second side of the canine's lower jaw, and stopping application of the treatment gel to the lower teeth on the second side of the canine's mouth after applying the gel to the front upper teeth of the canine (see Crusoe at [0:03]-[5;01]).
Regarding Claims 14, 15, and 16, Ciopyk in view of Harris in further view of Kim in further view of Crusoe in further view of Swanson discloses the method of Claim 9 substantially as claimed, but do not specifically disclose that the average reduction in bacteria concentration for a mild risk assessment bacteria is approximately 72 percent, the average reduction in bacteria concentration for a high risk assessment bacteria is approximately 2 percent, and the average reduction in bacteria concentration for a severe risk assessment bacteria is approximately 74 percent. However, the Examiner notes that the specific reduction in bacterial concentration is a result effective variable dependent on the treatment plan used for the particular canine. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to expect results such as the average reduction in bacteria concentration for a mild risk assessment bacteria is approximately 72 percent, the average reduction in bacteria concentration for a high risk assessment bacteria is approximately 2 percent, and the average reduction in bacteria concentration for a severe risk assessment bacteria is approximately 74 percent as these values represent the optimization of a result effective variable, which has been held to be within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results (see MPEP 2144.05 (II)(A)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE L NELSON whose telephone number is (571)270-5368. The examiner can normally be reached M - F 9-5 ET.
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/CHRISTINE L NELSON/Examiner, Art Unit 3772
/EDWARD MORAN/Primary Examiner, Art Unit 3772
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