DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-17 are pending and currently under consideration for patentability under 37 CFR 1.104
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed applications (PCT/US2022/018356 filed on March 1, 2022; and 63/154997 filed on 3/1/2021) are acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on September 1, 2023 has/have been considered by the examiner.
Claim Rejections - 35 USC § 112
Claim 6 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 6 contains the trademark/trade name Tedlar®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark is used to identify/describe the bag or other receptacle and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a method of detecting stage one lung cancer in a subject. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“…analyzing the breath sample to detect at least one of Acetoin, Dodecane, and p-Cymene…”
These limitations describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“…receiving a breath sample from the subject… initiating a follow-up plan for the subject, if the at least one of Acetoin, Dodecane, and p- Cymene is detected.”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, i.e., mere data gathering steps necessary to perform the identified judicial exception and outputting do not integrate a judicial exception into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they pertain to widely-understood, routine, and conventional techniques for obtaining data. Moreover, “receiving a breath sample from the subject” is highly generalized.
Independent claim 11 is also not patent eligible for substantially similar reasons.
Dependent claims 2-10 and 12-17 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1-17 are not patent eligible under 35 USC 101.
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 1-5 and 7-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hanada et al. (US PG Pub. No. 2018/0275131 A1) (hereinafter “Hanada”).
Hanada was cited in applicant’s IDS filed on September 1, 2023.
With respect to claims 1 and 11, Hanada teaches a method of detecting stage one lung cancer in a subject (par.0305-0306) comprising: receiving a breath sample from the subject (par.0306); analyzing the breath sample to detect at least one of Acetoin, Dodecane, and p-Cymene (par.0087, 0328);
Although Hanada does not explicitly teach initiating a follow-up plan for the subject, if the at least one of Acetoin, Dodecane, and p- Cymene is detected, further modification to incorporate this feature would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for several reasons. First, Hanada discloses calculating an assessment score from results of the received exhaled air sample, concentrations of plurality of types of target components, etc. (see par.0342). Moreover, it is widely known to provide targeted therapy/treatment recommendations based on the patient’s assessment score, diagnostic result, etc. Therefore, PHOSITA would have had predictable success modifying Hanada when the invention was filed to further incorporate initiating a follow-up plan in the manner recited for the purposes tailoring subsequent therapy/treatment to the particular cancer-stricken patient, as suggested by Hanada and is widely known in the art.
With respect to claims 2 and 12, Hanada teaches further comprising receiving multiple breath samples from the subject (par.0024,0026).
With respect to claims 3 and 13, Hanada teaches using a device for analysis of the VOCs in the breath (par.0028, 0030, 0110-0111).
With respect to claims 4 and 14, Hanada does not explicitly teach further comprising using the device more than once, in order to confirm results. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed for several reasons. First, Hanada teaches uses a device (e.g. chromatograph) to analyze the components (par.0027-28). Moreover, it is widely known, in diagnostics, to confirm results, get a second opinion (especially when cancer is the potential diagnosis) based on obtained data, etc. Therefore, PHOSITA would have had predictable success modifying Hanada to use the device more than once, in order to confirm results in order to provide more accuracy in the cancer diagnosis, as evidence by Hanada, and generally known in the art.
With respect to claim 5, Hanada teaches collecting the breath sample in a bag or other receptacle (collecting device 8 in Fig. 3).
With respect to claims 7 and 15, Hanada does not explicitly teach further comprising analyzing the breath sample within 24 hours of collection. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed for several reasons. First, Hanada inherently teaches analyzing the breath sample within some time period (abstract “assessed in short time”). Accordingly, PHOSITA would have had predictable success modifying Hanada to analyze the breath sample within 24 hours of collection since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claims 8 and 16, Hanada does not explicitly teach further comprising analyzing the breath sample within 2 hours of collection. However, such a modification would have been prima facie obvious to PHOSITA when the invention was filed for several reasons. First, Hanada inherently teaches analyzing the breath sample within some time period (abstract “assessed in short time”). Accordingly, PHOSITA would have had predictable success modifying Hanada to analyze the breath sample within 2 hours of collection since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
With respect to claims 9 and 17, Hanada teaches further comprising using a gas chromatograph for analysis of the breath sample (par.0027).
With respect to claim 10, Hanada does not explicitly teach wherein the follow up plan further comprises additional testing, treatment, preventative and/or lifestyle changes. However, further modification to include additional testing, treatment, preventative and/or lifestyle would have been prima facie obvious to PHOSITA when the invention was filed for several reasons. First, Hanada discloses calculating an assessment score from results of the received exhaled air sample, concentrations of plurality of types of target components, etc. (see par.0342). Moreover, it is widely known to provide targeted therapy/treatment recommendations based on the patient’s assessment score, diagnostic result, etc. Therefore, PHOSITA would have had predictable success modifying Hanada when the invention was filed to further incorporate initiating additional testing, treatment, preventative and/or lifestyle changes for the purposes tailoring subsequent therapy/treatment to the particular cancer-stricken patient, as suggested by Hanada and is widely known in the art.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hanada in view of Hanna et al. (US PG Pub. No. 2020/0378973 A1) (hereinafter “Hanna”).
Hanna was cited in applicant’s IDS filed on September 1, 2023.
With respect to claim 6, Hanada teaches a method of detecting stage one lung cancer in a subject.
However, Hanada does not teach the limitations further recited in claim 6.
Hanna teaches wherein the bag or other receptacle comprises a Tedlar® bag or other film bag (par.0083).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Hanada to incorporate a Tedlar® bag or other film bag as this would be a simple substitution allowing for obtaining VOCs from exhaled breath in an alternate manner that has been set forth in the art, as evidence by Hanna (par.0083).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791