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 12/06/2023 has been considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities:
Par. [0024], line 15: There is a mention of a “Table 3” in the specification, but no Table 3 included in the specification or the drawings. The factor loading that is mentioned along with Table 3 appears to correspond to the contents of Fig. 5.
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 1-8 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.
Claim 1 recites the limitation "the assessment contents of the main scale" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the frequency of the neuropathy" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the assessment contents of the subscale" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the most severe symptom" in line 6. There is insufficient antecedent basis for this limitation in the claim.
The limitation “the scoring formula is
S
=
T
1
-
t
m
a
x
+
t
m
a
x
x
T
2
renders claim 8 indefinite. It is unclear from the claim what the variables S, T1, tmax, and T2 represent. It is also noted that using proper order of operations, this equation would result in completing the “tmax x T2” step first, and then combining the T1, -tmax, and (tmax x T2) terms together. Is this the correct and intended way to use this formula? Please consider providing parentheses around tmax x T2 if this is a correct interpretation of the scoring formula. It is noted that there is no example to follow in the Applicant’s instant specification. Please consider providing proper correction and/or explanation.
*All other claims are rejected due to their dependency on a rejected claim.
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 1-8 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a patient-reported assessment tool which would not be considered as one of the four statutory categories of invention (i.e., process, machine, manufacture, or composition of matter). The Applicant’s claims are instead directed to a product that does not have a physical or tangible form, such as information (i.e., data per se) (please see MPEP 2106.03(I)), which is an example of claims that are not directed to any of the statutory categories.
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.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Inoue, et al. (“Discrepancy between the NCI-CTCAE and DEB-NTC scales in the evaluation of oxaliplatin-related neurotoxicity in patients with metastatic colorectal cancer”, 2011) in view of Kanda, et al. (“Development and validation of the comprehensive assessment scale for chemotherapy-induced peripheral neuropathy in survivors of cancer”, 2019). “FACT-G (Version 4)” and “FACT-G Scoring Guidelines” from FACIT.org is relied upon as evidence (please see attached).
Regarding claim 1, Inoue teaches a patient-reported assessment tool dedicated for assessment of oxaliplatin-induced peripheral neuropathy (OIPN) (Abstract – the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) and the Neurotoxicity Criteria of Debiopharm (DEB-NTC), the commonly used oxaliplatin-specific scales, in the evaluation of peripheral neurotoxicity; Introduction), comprising a main scale (Introduction – Main scale and grading of NCI-CTCAE and DEB-NTC shown in Table 1), and a scoring formula (Introduction and Table 1 – Grades 1-5 for NCI-CTCAE and Grades 1-3 for DEB-NTC; Discussion (Page 346) – Some oxaliplatin-specific scales other than DEB-NTC have been proposed. De Gramont et al. evaluated peripheral neurotoxicity as a factor affecting the patient’s quality of life (QOL) using QOL scores), wherein the assessment contents of the main scale contain symptoms of body organs and are graded based on patient's subjective feelings about the frequency of the neuropathy, corresponding to relative scores (Introduction, Table 1, Discussion (Page 346) – evaluation of the duration of peripheral neuropathy, a subjective variable that can only be described by the patients themselves, by DEB-NTC might be able to contribute to QOL improvement of the patients given oxaliplatin-based chemotherapy). Inoue does not explicitly teach the limitations of instant claim 1, that is wherein the assessment tool comprises a subscale with assessment contents that contain location, duration and influence of the most severe symptom.
Kanda teaches the development and validation of the comprehensive assessment scale for chemotherapy-induced peripheral neuropathy in survivors of cancer (Title, Abstract). Kanda teaches the limitations of instant claim 1, that is wherein the assessment tool comprises a subscale with assessment contents that contain location, duration and influence of the most severe symptom (Questionnaire structure (Page 4) – in addition to the final version of the CAS-CIPN, questionnaires for the following existing scales were used to investigate participants’ attributes. Such scales of GOG-Ntx, FACT-G, and CCRS are considered to be and include subscales and have scoring systems.; Table 2 (Page 7) – CAS-CIPN, along with the various subscales previously mentioned, shows questions regarding location, duration, and influence of the most severe symptom. For instance, the patient is asked about dysesthesia of palms and soles).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Inoue’s patient-reported assessment tool dedicated for assessment of oxaliplatin-induced peripheral neuropathy (OIPN) with Kanda’s comprehensive assessment scale for chemotherapy-induced peripheral neuropathy, because doing so would be an example of combining prior art elements according to known methods to yield predictable results. Kanda demonstrates that multiple assessment tools can be used together for patient evaluation (see Questionnaire structure (Page 4)) and Inoue encourages the use of DEB-NTC together with NCI-CTCAE for the evaluation of neurotherapy (see Discussion (Page 346)). One of ordinary skill in the art would have found it obvious to combine well-known assessment tools in order to optimize understanding of a patient’s oxaliplatin-induced peripheral neuropathy (OIPN) status.
Therefore, claim 1 is unpatentable over Ionue, et al. and Kanda, et al.
Regarding claim 2, Ionue, in view of Kanda, renders obvious, the patient-reported assessment tool dedicated for assessment of oxaliplatin-induced peripheral neuropathy (OIPN) according to claim 1, as indicated hereinabove. Ionue, in view of Kanda, also renders obvious the limitation of instant claim 2, that is wherein the symptoms of body organs include a total of 17 items: tingling, numbness, and oversensitivity or pain of hands or fingers; tingling, numbness, and oversensitivity or pain of feet or toes; tingling and numbness around mouth; cramps and weakness of hands or arms; cramps and weakness of feet or legs; contraction sense in throat; difficulty in writing or buttoning; difficulty in holding or grabbing; difficulty in standing balance; and difficulty in walking or ascending steps (Ionue – Discussion – Other oxaliplatin-specific scales, along with NCI-CTCAE and DEB-NTC, cover this grouping of symptoms, Kanda – Background (Page 2) – the main symptoms are numbness, pain, ache, and similar physical sensory disturbances on the hands and feet; Table 2 (Page 7), Questionnaire Structure (Page 4) – CAS-CIPN, along with GOG-Ntx, FACT-G, and CCRS, cover this grouping of symptoms).
Therefore, claim 2 is unpatentable over Ionue, et al. and Kanda, et al.
Regarding claim 3, Ionue, in view of Kanda, renders obvious the patient-reported assessment tool dedicated for assessment of oxaliplatin-induced peripheral neuropathy (OIPN) according to claim 1, as indicated hereinabove. wherein the grades include 4 levels: not at all, a little bit, quite a bit, very much (Kanda, Questionnaire Structure (Page 4) – FACT-G (version 4) – as evidenced by FACT-G (version 4), grades of not at all, a little bit, quite a bit, and very much are seen (please see attached)).
Therefore, claim 3 is unpatentable over Ionue, et al. and Kanda, et al.
Regarding claim 4, Ionue, in view of Kanda, renders obvious the patient-reported assessment tool dedicated for assessment of oxaliplatin-induced peripheral neuropathy (OIPN) according to claim 1, as indicated hereinabove. Kanda teaches the limitation of instant claim 4, that is wherein the scores include 0, 1, 2 and 3 (Questionnaire Structure (Page 4) – GOG-Ntx – each item is scored from 0 to 4 points – FACT-G and CCRS use a four point Likert scale).
Therefore, claim 4 is unpatentable over Ionue, et al. and Kanda, et al.
Regarding claim 5, Ionue, in view of Kanda, renders obvious the patient-reported assessment tool dedicated for assessment of oxaliplatin-induced peripheral neuropathy (OIPN) according to claim 1, as indicated hereinabove. Kanda also teaches the limitations of instant claim 5, that is wherein the location of the most severe symptom is divided into 4 grades: nowhere, limited to fingers or toes, extending to wrist or ankle, above wrist or ankle (Table 2 – Factor 4 – Dysesthesia of palms and soles is separated based on different levels that correspond with the grades of the instant claim (e.g., see Kanda’s Factor 4 “Discomfort spreads from my palms and soles throughout the body”)).
Therefore, claim 5 is unpatentable over Ionue, et al. and Kanda, et al.
Regarding claim 6, Ionue, in view of Kanda, renders obvious the patient-reported assessment tool dedicated for assessment of oxaliplatin-induced peripheral neuropathy (OIPN) according to claim 1, as indicated hereinabove. Ionue teaches the limitation of instant claim 6, that is wherein the duration is divided into 4 grades: 0, ≤1 week, ≤3 weeks, and >3 weeks (Table 1 (Page 342) – DEB-NTC broken up into different grades of within 7 days and more than 7 days, along with functional impairment interfering with ADL which could correspond with >3 weeks).
Therefore, claim 6 is unpatentable over Ionue, et al. and Kanda, et al.
Regarding claim 7, Ionue, in view of Kanda, renders obvious the patient-reported assessment tool dedicated for assessment of oxaliplatin-induced peripheral neuropathy (OIPN) according to claim 1, as indicated hereinabove. Kanda teaches the limitation of instant claim 7, that is wherein the influence of the most severe symptom is divided into 4 grades: no, mild, limited tool-using, and limited self-care (Questionnaire Structure (Page 4) – FACT-G measures cancer-specific health-related QOL on a scale of 1-4 (see attached FACT-G), which corresponds to the 4 grades as claimed, which are used in determining a patient’s quality of life).
Therefore, claim 7 is unpatentable over Ionue, et al. and Kanda, et al.
Regarding claim 8, Ionue, in view of Kanda, renders obvious the patient-reported assessment tool dedicated for assessment of oxaliplatin-induced peripheral neuropathy (OIPN) according to claim 1, as indicated hereinabove. Kanda also renders obvious the limitation of instant claim 8, that is wherein the scoring formula is S=T1-tmax+tmax×T2 (Questionnaire Structure (Page 4) – FACT-G – Please see attached FACT-G scoring sheet, which is relied upon as evidence. While the formula shown here is not exactly the same as claimed, the formula shown is representative of a formula that achieves the similar goal of corresponding scores with an indication of a patient’s well-being.).
Therefore, claim 8 is unpatentable over Ionue, et al. and Kanda, et al.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Hausheer (U.S. PGPub No. 2008/0193498)
Olde, et al. (U.S. PGPub No. 2024/0306916)
Takigiku, et al. (U.S. PGPub No. 2024/0316146)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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/MICHAEL T. HOLTZCLAW/Examiner, Art Unit 3796