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 .
Claim Rejections - 35 USC § 101
Claims 1-7 are rejected under 35 U.S.C. 101 because :
The claimed invention is directed to natural phenomenon and abstract ideas without significantly more.
Specifically, claim 1 is directed towards a biomarker composition comprising “decanoylcarnitine and octanoylcarnitine as effective ingredients”, wherein these compounds are simply natural compounds involved in a natural phenomenon (i.e. diagnosis of oral cancer using these natural compounds).
In addition, claim 4 is directed towards a composition comprising “ an agent for measuring levels of decanoylcarnitine and octanovlcarnitine”, wherein decanoylcarnitine and octanoylcarnitine are natural compounds involved in a natural phenomenon (i.e. diagnosis of oral cancer using these natural compounds).
Finally, claim 6 is directed towards an abstract idea without significantly more as it recites “comparing the levels of decanoylcarnitine and octanoylcarnitine with corresponding levels in a control group sample”, which is an abstract idea related to determining whether a subject has oral cancer.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims 1 and 4 are just directed to natural compounds involved in a natural phenomenon (i.e. diagnosis of oral cancer using these natural compounds). Furthermore, claim 6 only additionally recites “measuring levels of decanoylcarnitine and octanovlcarnitine in plasma isolated from a subject suspected of having oral cancer”, which is just mere data gathering.
Furthermore, the above described judicial exceptions (i.e. natural phenonmen/compounds and abstract ideas) are not integrated into a practical application because these limitations recite abstract ideas (i.e. invoke a judicial exception) and this judicial exception is not integrated into a practical application because the above cited limitations are both directed to an abstract idea, which could be performed by a mental step or with the use of a black box computer.
Furthermore, it is noted that data gathering to be used in the abstract idea is insignificant extrasolution activity, and not a particular practical application. See MPEP 2106.05(g).
In addition, the examiner notes that office policy (per the July 2015 Interim Eligibility Guidance with regards to USC 101 rejections) states that abstracts ideas may be ideas themselves and that one specific example of an abstract idea is the idea of comparing new and stored information (such comparing the measured levels of decanoylcarnitine and octanovlcarnitine in plasma isolated from a subject suspected of having oral cancer) and using rules to identify options (such as whether or not the subject should be diagnosed with oral cancer).
In addition, the examiner notes that following the procedure outlined in Mayo
Collab. Svcs. v. Prometheus Labs (SCOTUS) 101 USPQ2d 1961, 132 S. Ct. 1289 (2012) that claim 1 (and therefore their dependent claims as well) would be ineligible since in step 1 it is noted even if the claims are directed towards one of the statutory categories (i.e. a method of providing information for diagnosis of oral cancer ), while in step 2a it is noted that the claim is directed to a judicial exception (an abstract idea, as described above as the comparison step in claim 6) and in step 2b it is noted that the claims do not recite additional elements that amount to significantly more than the judicial exception since the additional measuring step is simply a mere data gathering step.
Therefore claims 1-7 are ineligible.
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.
Claim(s) 1, 2, and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al (CN 112198270), cited in the IDS, in view of Perkins et al (US PGPub S 2018/0320233).
Regarding Claim 1, Zhao et al teaches a biomarker composition for diagnosis of oral cancer, comprising an acyl carnitine metabolite as an effective ingredient, wherein the acyl carnitine metabolite comprises decanoylcarnitine (see [0006]-[0007]).
However, Zhao et al does not explicitly disclose that the biomarker composition also includes octanoylcarnitine, and that the biomarker composition is found in plasma isolated from a subject suspected of having oral cancer.
However, in the analogous art of genomics-based medicine platforms for detecting undiagnosed medical conditions, Perkins et al teaches methods and systems for detecting hidden, latent or subsymptomatic cancers (such as oral cancer) using plasma samples (see [0034] and [0067]), wherein greatly elevated medium chain acyl-carnitines, hexanoylcarnitine, octanoylcarnitine and decanoylcarnitine (Z-scores above 97.5.sup.th percentile) were detected suggestive of reduced MCAD activity (see [0026] and [0067]). It would have been obvious to one of ordinary skill in the art to incorporate both octanoylcarnitine and decanoylcarnitine in the biomarker composition (in plasma) for the benefit of effectively indicating that the subject has oral cancer and/or reduced MCAD activity (which would indicate likelihood or subject having oral cancer).
Regarding Claim 2, the combination of Zhao et al and Perkins et al teaches that the biomarker composition further includes hexanoylcarnitine (see [0067] of Perkins et al).
Regarding Claim 4, Zhao et al teaches a composition for diagnosis of oral cancer, comprising an agent (such as the agent used in the Orbitrap HRMS analysis platform) for measuring the level of an acyl carnitine metabolite (wherein the metabolite is decanoylcarnitine) as an effective ingredient (see [0046]).
However, Zhao et al does not explicitly disclose that the biomarker composition also includes octanoylcarnitine, and that the biomarker composition is found in plasma isolated from a subject suspected of having oral cancer.
However, in the analogous art of genomics-based medicine platforms for detecting undiagnosed medical conditions, Perkins et al teaches methods and systems for detecting hidden, latent or subsymptomatic cancers (such as oral cancer) using plasma samples (see [0034] and [0067]), wherein greatly elevated medium chain acyl-carnitines, hexanoylcarnitine, octanoylcarnitine and decanoylcarnitine (Z-scores above 97.5.sup.th percentile) were detected suggestive of reduced MCAD activity (see [0026] and [0067]). It would have been obvious to one of ordinary skill in the art to incorporate both octanoylcarnitine and decanoylcarnitine in the biomarker composition (in plasma) for the benefit of effectively indicating that the subject has oral cancer and/or reduced MCAD activity (which would indicate likelihood or subject having oral cancer).
Regarding Claim 5, the combination of Zhao et al and Perkins et al teaches a kit for diagnosis of oral cancer, comprising the composition of Claim 4 (see [0014] and [0058] of Zhao et al and [0071] of Perkins et al).
Regarding Claim 6, Zhao et al teaches a method of providing information for diagnosis of oral cancer, the method of providing information comprising:(a) measuring a level of an acyl carnitine metabolite (wherein the metabolite is decanoylcarnitine) of a sample isolated from an oral cancer patient; (b) comparing the level of the acyl carnitine metabolite with a level of a control group sample; and (c) determining oral cancer when the level of the acyl carnitine metabolite of the sample isolated from the oral cancer patient is lower than the level of the control group sample (see [0041] and [0046]).
However, Zhao et al does not explicitly disclose that levels of octanoylcarnitine are also measured , and that the octanoylcarnitine is found in plasma isolated from a subject suspected of having oral cancer.
However, in the analogous art of genomics-based medicine platforms for detecting undiagnosed medical conditions, Perkins et al teaches methods and systems for detecting hidden, latent or subsymptomatic cancers (such as oral cancer) using plasma samples (see [0034] and [0067]), wherein greatly elevated medium chain acyl-carnitines, hexanoylcarnitine, octanoylcarnitine and decanoylcarnitine (Z-scores above 97.5.sup.th percentile) were detected suggestive of reduced MCAD activity (see [0026] and [0067]). It would have been obvious to one of ordinary skill in the art to measure the levels of both octanoylcarnitine and decanoylcarnitine in plasma (as taught be Perkins et al) for the benefit of effectively indicating that the subject has oral cancer and/or reduced MCAD activity (which would indicate likelihood or subject having oral cancer).
Claim(s) 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al and Perkins et al as applied to claims 1 and 6 above, and further in view of Yang et al (CN 113804901 A).
Regarding Claims 3 and 7, the combination of Zhao et al and Perkins et al does not explicitly disclose that the biomarker composition further includes glycerophosphorylcholine or measuring a level of glycerophosphorylcholine.
However, in the analogous art of markers for early non-invasive diagnosis of Oral squamous cell carcinoma, Yang et al teaches a serum lipid marker for early non-invasive diagnosis of oral squamous cell carcinoma and application thereof. Specifically, the invention claims a characteristic lipid molecule compound capable of detecting by CPSI-MS proposition mass spectrometry, comprising Arginyl-methionine (spermine acyl-methionine), phosphocholine (glycerophosphorylcholine), Propionylcholine (propionyl choline), more than three lipid markers down-regulated expression, it indicates that the subject is oral squamous cell carcinoma patient or potential oral squamous cell carcinoma patient (see abstract). It would have been obvious to one of ordinary skill in the art to additionally measure the levels of glycerophosphorylcholine (as taught by Yang et al) for the benefit of enabling the determination of whether a patient/subject has oral squamous cell carcinoma patient or potential oral squamous cell carcinoma when glycerophosphorylcholine levels have down-regulated expression.
Response to Arguments
Applicant’s arguments, see pages 1-2 of remarks, filed 7/28/2026, with respect to the rejection(s) of claim(s) 1-7 under Zhao et al have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Zhao et al in view of Perkins et al (see above)(for claims 1, 2 and 4-6) and Zhao et al, Perkins et al and Yang et al (see above)(for claims 3 and 7).
Furthermore, it is noted that based on the 7/28/26 amendments a 35 USC 101 rejection on claims 1-7 is also being presented above, as claims 1-7 are directed towards the judicial exceptions of natural phenomenon/natural compounds and abstract ideas.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797
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