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 .
Applicant’s arguments filed in the reply on March 10, 2026 were received and fully considered. Claim 1 was amended. Claims 2, 4, and 5 were cancelled. Please see corresponding rejection headings and response to arguments section below for more detail.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on March 10, 2026 has been entered.
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 and 6 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 obtaining a biomarker for indicating a blood anomaly, wherein the blood anomaly is sepsis or septic shock, using Raman scattering. 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:
“…comparing the first unique Raman signature and the second unique Raman signature to detect a change in the signatures corresponding to the biomarker...”
These limitations describe a mathematical calculation. Furthermore, the limitations also 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:
“capturing a first unique Raman signature from a blood sample, corresponding to the biomarker, wherein the first unique Raman signature is obtained from non-resonance Raman scattering using a wavelength in the range from 500 to 1024 nm; capturing a second unique Raman signature from said blood sample, corresponding to the biomarker, wherein the second unique Raman signature is obtained from resonance Raman scattering using a wavelength in the range from 300 to 600 nm… wherein the first unique Raman signature and the second unique Raman signature are collected in a transmission mode.”
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 fail to integrate the claims 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 relate to widely-understood, routine, and conventional techniques for capturing Raman signatures. See art applied in current and previous office actions, which set forth resonance and non-resonance Raman Scattering is widely known in the art.
Dependent 6 recites wherein the biomarker is selected from Tyrosine Fermi doublet, C-C skeletal stretching in protein, ratio of Alpha helix to random coils in protein, carotenoids, which also fail to add something more to the abstract independent claims as this merely further limits the abstract idea, i.e. does not integrate the claims into a practical application for substantially similar reasons as set forth above and/or does not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1 and 6 are not patent eligible under 35 USC 101.
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 and 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Black et al. (US PG Pub. No. 2015/0185207 A1) (hereinafter “Black”) in view of Claus et al. (US PG Pub. No. 2008/0306346 A1) (hereinafter “Claus”).
With respect to claim 1, Black teaches a method of obtaining a biomarker for indicating a blood anomaly, wherein the blood anomaly is sepsis or septic shock, using Raman scattering (abstract “Raman spectroscopy may be used to distinguish and/or quantify the neutrophils from the other blood components… advance the detection of sepsis”), the method comprising: capturing a first unique Raman signature from a blood sample, corresponding to the biomarker (par.0093 “identify the specific signatures associated with neutrophils from other components in the blood or tissue”), signature are collected in a transmission mode (par.0030 “optical measurements using transmission-mode”; par.0073 “utilizes the changes in… transmittance spectra of light in vivo due to changes in the blood content in tissue”).
However, Black does not teach wherein the first unique Raman signature is obtained from non-resonance Raman scattering using a wavelength in the range from 500 to 1024 nm.
Claus teaches wherein the first unique Raman signature is obtained from non-resonance Raman scattering (par.0070-71 “Non-Resonance Raman”).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Black to incorporate non-resonance Raman scattering in order to identify risk of developing sepsis, as evidence by Claus (see Abstract). Although Claus does not explicitly teach using a wavelength in the range from 500 to 1024 nm, it would have been prima facie obvious for PHOSITA when the invention was filed to utilize the recited wavelength range 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. Lastly, PHOSITA would have had predictable success combining Black and Claus since they both relate to the same narrow field of endeavor, i.e. applying Raman scattering to blood for detecting sepsis.
With respect to claim 6, Claus teaches wherein the biomarker is selected from Tyrosine Fermi doublet, C-C skeletal stretching in protein, ratio of Alpha helix to random coils in protein, carotenoids (par.0082 “tyrosine”). Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to select tyrosine as the biomarker for identifying subjects at risk of developing disease including sepsis, as evidence by Claus (Abstract; par.0082).
Response to Arguments
Applicant's arguments filed with respect to the 35 USC 101 rejections raised in the previous office action have been fully considered, but they are not persuasive. Examiner maintains that the recited “comparing” step amounts to a judicial exception (math and/or mental process) that is not integrated into a practical application. Applicant appears to argue that the additional limitations (utilizing resonance and non-resonance Raman scattering to capture Raman signatures from a blood sample) integrate the claims into a practical application. Examiner respectfully disagrees for the following reasons. First, utilizing resonance Raman scattering and non-resonance Raman scattering with incident light at various wavelengths in order to capture Raman signatures in blood amounts to mere data gathering. See MPEP 2106.05(g). Moreover, these extra-solution limitations also fail to recite significantly more as resonance Raman scattering and non-resonance Raman scattering have been widely established in the prior art of record (see current and previous office actions for example teachings). For at lease these reasons, the 35 USC 101 rejections are maintained.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were persuasive in view of amendment. However, upon further consideration, a new ground of rejection is made in view of newly applied prior art (Black and Claus). Please see prior art section above for more detail, updated citations, updated obviousness rationale, etc.
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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