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 .
Applicants preliminary amendment filed November 27, 2023 has been received and entered. Claims 8, 12, 15-16, 20, and 26-71 have been canceled. Accordingly, claims 1-7, 9-11, 13-14, 17-19 and 21-25 remain pending in the instant application.
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.
1. Claims 13-14 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.
Claims 13-14 both depend on canceled claim 12. As such, the metes and bounds of the claim are incomplete.
Accordingly, claims 13-14 have been withdrawn from further consideration as incomplete claims.
2. Claim 7 is 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.
Claim 7 recites the limitation "said antigen.” There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
3. Claim(s) 1, 3-6, 10-11, 21-22 and 25 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Astake et al.
The claims are drawn to a method for processing or analyzing a sample from a subject in need thereof, the method comprising:
a) processing said sample using a lateral flow device configured to specifically bind to one or more target analytes associated with a respiratory condition associated with one or more pathogens that can cause Canine Infectious Respiratory Disease Complex (CIRDC) in one or more discrete sections of said lateral flow device, wherein said lateral flow device is configured to produce a detectable signal in said one or more discrete sections upon binding to said one or more target analytes; and
b) analyzing said detectable signal to determine if said subject has said respiratory condition or has an immunity to said respiratory condition.
Astatke et al (US Publication 2020/0040408; filed May 6, 2019, with priority to Feb. 8, 2016) disclose of a method for processing or analyzing a sample from a subject, the method comprising processing a sample using a lateral flow device configured to specifically bind to one or more target analytes. (See paragraph 0026). The immunoassay detection format is a lateral flow detection format that enables chromatographic wicking of a tagged amplicon-Ab complex on a membrane to be detected and visualized at a specific position. (See paragraph 0041; Figure 16). Astatke et al further disclose of detecting Canine Infections Respiratory Disease Complex (CIRDC), specifically Canine coronavirus. (See paragraph 0067). Astatke et al further disclose of analyzing samples of blood. (See paragraph 0056). Astatke et al further disclose comparison to control signals. (See Figure 16).
Accordingly, Astatke et al disclose of each and every limitation of the instantly filed claims.
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.
4. Claim(s) 1, 3-7, 10-11, 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Astake et al in view of Brown et al.
The claims are drawn to a method for processing or analyzing a sample from a subject in need thereof, the method comprising:
a) processing said sample using a lateral flow device configured to specifically bind to one or more target analytes associated with a respiratory condition associated with one or more pathogens that can cause Canine Infectious Respiratory Disease Complex (CIRDC) in one or more discrete sections of said lateral flow device, wherein said lateral flow device is configured to produce a detectable signal in said one or more discrete sections upon binding to said one or more target analytes; and
b) analyzing said detectable signal to determine if said subject has said respiratory condition or has an immunity to said respiratory condition,
wherein the antigen is a virulence factor.
The teachings of Astake et al are set forth above.
Astake et al do not teach of detecting virulence factors.
Brown et al (US Patent Number 5,661,006) teach of canine coronavirus spike proteins (virulence factors) which can elicit protective immunity. (See abstract and claims).
Accordingly, it would have been prima facie obvious to have taken the method of detecting canine coronavirus in a lateral flow device as taught by Astake et al and to have detected the specific virulence factor spike protein of coronavirus as taught by Brown et al, in view of the teaching by Brown et al that the spike protein of coronavirus can elicit an immune response and protection.
5. Claim(s) 1-6, 10-11, 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Astake et al in view of Pronovost et al.
The claims are drawn to a method for processing or analyzing a sample from a subject in need thereof, the method comprising:
a) processing said sample using a lateral flow device configured to specifically bind to one or more target analytes associated with a respiratory condition associated with one or more pathogens that can cause Canine Infectious Respiratory Disease Complex (CIRDC) in one or more discrete sections of said lateral flow device, wherein said lateral flow device is configured to produce a detectable signal in said one or more discrete sections upon binding to said one or more target analytes; and
b) analyzing said detectable signal to determine if said subject has said respiratory condition or has an immunity to said respiratory condition,
wherein the sample is obtained via a swab.
The teachings of Astake et al are set forth above.
Astake et al do not teach of obtaining a sample via a swab.
Pronovost et al (US Patent Number 5,773,234) teach that at the time of the invention it was routine in the art to obtain samples for lateral flow analysis via a swab. (See column 1).
Accordingly, it would have been prima facie obvious to have taken the method of detecting canine coronavirus in a lateral flow device as taught by Astake et al and to have obtained the sample via a swab as taught by Pronovost et al, as it was routine in the art to obtain samples via swab.
6. Claim(s) 1, 3-6, 10-11, 17-19, 22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Astake et al in view of Cantor et al.
The claims are drawn to a method for processing or analyzing a sample from a subject in need thereof, the method comprising:
a) processing said sample using a lateral flow device configured to specifically bind to one or more target analytes associated with a respiratory condition associated with one or more pathogens that can cause Canine Infectious Respiratory Disease Complex (CIRDC) in one or more discrete sections of said lateral flow device, wherein said lateral flow device is configured to produce a detectable signal in said one or more discrete sections upon binding to said one or more target analytes; and
b) analyzing said detectable signal to determine if said subject has said respiratory condition or has an immunity to said respiratory condition,
wherein the condition is tracheobronchitis.
The teachings of Astake et al are set forth above.
Astake et al do not teach of tracheobronchitis.
Cantor (US Publication 2012/0027771) teach of detecting tracheobronchitis via a lateral flow device. (See paragraph 272).
Accordingly, it would have been prima facie obvious to have taken the method of detecting canine coronavirus in a lateral flow device as taught by Astake et al and to detect tracheobronchitis via lateral flow as taught by Cantor, as it was routine in the art to detect tracheobronchitis infection via lateral flow.
7. Claim(s) 1, 3-6, 10-11, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Astake et al in view of Polito et al.
The claims are drawn to a method for processing or analyzing a sample from a subject in need thereof, the method comprising:
a) processing said sample using a lateral flow device configured to specifically bind to one or more target analytes associated with a respiratory condition associated with one or more pathogens that can cause Canine Infectious Respiratory Disease Complex (CIRDC) in one or more discrete sections of said lateral flow device, wherein said lateral flow device is configured to produce a detectable signal in said one or more discrete sections upon binding to said one or more target analytes; and
b) analyzing said detectable signal to determine if said subject has said respiratory condition or has an immunity to said respiratory condition,
wherein the analysis is performed by an algorithm.
The teachings of Astake et al are set forth above.
Astake et al do not teach of analysis via an algorithm.
Polito (US Patent Number 6,136,610) teach of using algorithms to determine the results of a lateral flow assay. (See Figure 7).
Accordingly, it would have been prima facie obvious to have taken the method of detecting canine coronavirus in a lateral flow device as taught by Astake et al and to employ algorithms to determine the results as taught by Polito.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark NAVARRO whose telephone number is (571)272-0861.
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/ALBERT M NAVARRO/Primary Examiner, Art Unit 1645 December 9, 2025