DETAILED ACTION
In application filed on 04/17/2023, Claims 1, 3 and 5-8 are pending. The claim set submitted on 03/11/2026 is considered because this is the most recent claim set. Claims 1, 3 and 5-8 are considered in the current office 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 (IDS) submitted on 11/23/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 1 and 5 are objected to because of the following informalities:
Claim 1 recites “the indicator” in line 13. It appears that these limitations should be recited as “the lipid based indicator” as recited in line 2 of the claim.
Consistent language should be used and for the purpose of expedited prosecution, Examiner interprets “the indicator” as “the lipid based indicator”.
Appropriate correction is required.
Claim 5 recites “raman signatures” in line 5. It appears that this limitation should be recited as first unique raman signature and second unique raman signature” for the purpose of consistency.
Appropriate correction is required.
Claim 5 further recites “amplified signatures” in line 6. It appears that this limitation should be recited as “the amplified signatures” for the purpose of consistency, to align the recitation of “the amplified signatures” in Claim 1, line 9.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 3 and 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 3 recites the limitation "the raman signature". There is insufficient antecedent basis for this limitation in the claim.
It is not clear which of the first unique raman signature or second unique raman signature is being referred to.
For the purpose of expedited prosecution, the limitation "the raman signature" is interpreted by the Examiner as “the first unique raman signature” and “the second unique raman signature”.
Claim 8 recites the limitation "the source". There is insufficient antecedent basis for this limitation in the claim.
It is not clear which of “a first source” or “a second source” is being referred to.
For the purpose of expedited prosecution, the limitation "the source" is interpreted by the Examiner as “the first source” and/or “the second source”.
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, 3 and 5-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims have been analyzed for eligibility in accordance with their broadest reasonable interpretation. All claims are directed to statutory categories, i.e., a method (Claims 1, 3 and 5-8) (Step 1: YES).
Analysis:
Claim 1: Ineligible.
Step 1:
The claim recites a series of steps or acts, including “method of obtaining a lipid based indicator for cardiovascular disorder using Raman spectroscopy”. Thus, the claim is directed to a method, which is one of the statutory categories of invention (Step 1: YES).
Step 2A Prong 1:
Claim 1 recites “transforming each of the first lipid Raman signatures and second lipid Raman signatures to obtain amplified signatures; comparing the amplified signatures to obtain a first ratio; and repeating the abovementioned steps at least one more time to obtain a second ratio” (math step)”. Therefore, the claim is directed towards an abstract idea, and more specifically to the abstract idea group of a math process since claim 1 relates to using a math or calculations to “transform each of the first lipid Raman signatures and second lipid Raman signatures to obtain amplified signatures; compare the amplified signatures to obtain a first ratio; and repeating the above mentioned steps at least one more time to obtain a second ratio”. (Step 2A, Prong 1: YES).
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application.
Once the “comparing and the repeating” are done, the step of “wherein, alteration in the first ratio and the second ratio provides the indicator for cardiovascular disorder” is performed. This limitation appear to be insignificant post solution activities as they amount to just “data gathering” or “applying it” – both held as not practical applications (MPEP 2106.05f, MPEP 2106.05g).
In addition, it appears that the steps of “capturing a first unique Raman signature with respect to a first lipid component; capturing a second unique Raman signature with respect to a second lipid component” are recited at a high level of generality that they amount to mere data gathering (insignificant extra-solution activity). See MPEP 2106.05(g).
The courts have held that there must be some meaningful limit on the judicial exception rather than a drafting effort to monopolize it (2106.05e) (Step 2A, Prong 2: NO).
Step 2B:
Furthermore, the courts have found that limitations adding insignificant extrasolution activity to the judicial exception, such as mere data gathering in conjunction with a law of nature or abstract idea, are limitations found not to be enough to qualify as ‘significantly more’ when recited in a claim with a judicial exception (see the 2014 Interim Guidance on Patent Subject Matter Eligibility of the Federal Register dated December 16, 2014; and MPEP 2106.05(I)(A)). Note that mere data gathering is not significantly more than the abstract idea. See MPEP 2106.05(g).
Here, there are no additional elements which are significantly more than the abstract idea in Claim 1. The limitation of “capturing a first unique Raman signature with respect to a first lipid component; capturing a second unique Raman signature with respect to a second lipid component; and wherein, alteration in the first ratio and the second ratio provides the indicator for cardiovascular disorder” in independent Claim 1, appear well-understood, routine, and conventional (WURC) in the field of Clinical diagnostics, as evidenced by Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006.) (Step 2B: NO).
Therefore, Claim 1 is ineligible.
Moreover, Claim 3 and 5-8 are rejected by virtue of their dependency on Claim 1.
Claims 3 and 5-8: Ineligible.
Step 2A, Prong One and Two: Claims 3 and 5-8 further define the data gathering steps which appear to be generic and WURC.
Step 2B: The claims do not recite any elements which are significantly more. Therefore, Claims 3 and 5-8 are ineligible.
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, 3 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006.).
Regarding Claim 1, Alfano teaches a method of obtaining a lipid based indicator for cardiovascular disorder using Raman spectroscopy (See Abstract… An apparatus and method of use for detecting vulnerable plaque (VP) in arterial walls is provided. The method includes measuring whether the Raman spectrum of adipose (lipid) tissue signal is present in a Raman signal from aortic intimal wall tissue) , the method comprising:
capturing a first unique Raman signature (See Para 0038… FIG. 4 shows a Raman Ratio Meter useful for detecting and processing calcified plaque and VP signals in regions of an artery) with respect to a first lipid component (‘the lipid bands ‘)(See Para 0055… calcified plaque is detected by measuring a signal at about 957 cm−1; See Claim 12… detecting calcified plaque regions, wherein step b) comprises detecting Raman scatter at three or more wavenumbers, wherein one of the three or more wavenumbers is about 1435 cm−1, about 2850 cm−1, or about 2892 cm−1…; See Para 0025… the lipid bands at 1435 cm−1, 2850 cm−1 and 2892 cm−1) from a first source (referred to as calcified plaque [Page 0055]);
capturing a second unique Raman signature (See Abstract…Raman vibration modes for VP are strong bands at about 1435 cm−1, about 2850 cm−1, and about 2892 cm−1; See Para 0038… FIG. 4 shows a Raman Ratio Meter useful for detecting and processing calcified plaque and VP signals in regions of an artery.) with respect to a second lipid component (‘main lipid C—H vibration bands’) (See Para 0005… These three Raman modes, which are the main lipid C—H vibration bands, have sharp spectrum, strong features and high stability with varied environments including temperature, and can be used as a fingerprint of VP.) from a second source (referred to as vulnerable plaques (VP) [Para 0055]);
transforming (‘normalized peak Raman intensity’) each of the first unique Raman signature (‘Spectroscopic information’) and second unique Raman signatures (‘Spectroscopic information’) to obtain amplified signatures (See Para 0065… Spectroscopic information also includes the normalized peak Raman intensity; Examiner, under BRI, submits that peak normalization amplifies spectra in spectroscopy);
comparing (ratioed’) the amplified signatures to obtain a first ratio (See Para 0055… When calcified plaque is detected by measuring a signal at about 957 cm−1, this signal may be ratioed with the signal from the VP)
“repeating (‘assessing several regions’) the abovementioned steps at least one more time to obtain a second ratio (See Para 0037… the Raman spectroscopic information to determine whether the cardiovascular tissue sample contains at least one region of VP; See Para 0038…Fig. 4 shows a Raman Ratio Meter useful for detecting and processing calcified plaque and VP signals in regions of an artery; Examiner submits that several regions 1-5 were assessed for or detecting and processing calcified plaque and VP signals in regions of an artery).
While Alfano teaches that several regions of artery were assessed for VP and calcified plaque (See Fig. 4; Para 0038, 0043), where there ratios were calculated (See Para 0055), Alfano does not explicitly teach “wherein, alteration in the first ratio and the second ratio provides the indicator for cardiovascular disorder”.
In the analogous art of the visible RR (VRR) technique for directly distinguishing and classifying vulnerable plaques with various states of atherosclerosis development and different cap thicknesses in human aorta tissues using RR spectral molecular fingerprints in a wide frequency region, Liu teaches “wherein, alteration in the first ratio and the second ratio (See Page 127006-6…Figure 2 shows a comparison (‘ratios’) of normal arterial fat tissue versus three types lesions of atherosclerotic plaques corresponding to their RR spectra, thereby teaching at least a first , second and third ratio) provides the indicator for cardiovascular disorder (See Conclusion , Section 4, Page 127006-7… we have successfully demonstrated that the changes in components and conformation of three states of VPs identified using RR molecular fingerprints and the 2895-cm−1 vibrational mode can be detected and identified for lipids that are under the thin intimal wall of the plaque’s cap region. The RR spectral findings revealed that these molecular fingerprints can identify the vascular calcification process of atherosclerosis and may provide higher accuracy and sensitivity, thereby teaching “provides the indicator for cardiovascular disorder”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Alfano to provide a step of “wherein, alteration in the first ratio and the second ratio provides the indicator for cardiovascular disorder”, as taught by Liu for the benefit of using the RR spectral findings to reveal that these molecular fingerprints can identify the vascular calcification process of atherosclerosis and may provide higher accuracy and sensitivity (Liu, Section 4, Conclusion), allowing for the provision of a visible RR (VRR) technique for directly distinguishing and classifying vulnerable plaques with various states of atherosclerosis development and different cap thicknesses in human aorta tissues using RR spectral molecular fingerprints in a wide frequency region (Liu, Page 127006-2, Section 1, Introduction).
Regarding Claim 3, the method of claim 1 is obvious over Alfano in view of Liu.
Alfano teaches that the Raman signature (interpreted as “the first unique raman signature” and “the second unique raman signature” in light of the 112b rejection above) ((See Para 0038… FIG. 4 shows a Raman Ratio Meter useful for detecting and processing calcified plaque and VP signals in regions of an artery; (See Abstract…Raman vibration modes for VP are strong bands at about 1435 cm−1, about 2850 cm−1, and about 2892 cm−1; See Para 0038… FIG. 4 shows a Raman Ratio Meter useful for detecting and processing calcified plaque and VP signals in regions of an artery) is obtained with an electromagnetic radiation (referred to as the monochromatic light [Para 0049]) having a wavelength in a range of 442 nm to 830 nm (See Para 0049…, the monochromatic light is from a laser source having an excitation source at, for example, 633 nm, 785 nm, 800 nm, or 632 nm).
Regarding Claim 6, the method of claim 1 is obvious over Alfano in view of Liu.
Alfano teaches each of the first lipid component (‘the lipid bands ‘)(See Para 0055… calcified plaque is detected by measuring a signal at about 957 cm−1; See Claim 12… detecting calcified plaque regions, wherein step b) comprises detecting Raman scatter at three or more wavenumbers, wherein one of the three or more wavenumbers is about 1435 cm−1, about 2850 cm−1, or about 2892 cm−1…; See Para 0025… the lipid bands at 1435 cm−1, 2850 cm−1 and 2892 cm−1) and the second lipid component (‘main lipid C—H vibration bands’) (See Para 0005… These three Raman modes, which are the main lipid C—H vibration bands, have sharp spectrum, strong features and high stability with varied environments including temperature, and can be used as a fingerprint of VP).
Alfano does not explicitly teach that each of the first lipid component and the second lipid component is at least one of phospholipids, carotenoids, total lipid of low density lipoproteins, and total lipid of high density lipoproteins from a same or distinct source.
In the analogous art of the visible RR (VRR) technique for directly distinguishing and classifying vulnerable plaques with various states of atherosclerosis development and different cap thicknesses in human aorta tissues using RR spectral molecular fingerprints in a wide frequency region, Liu teaches that each of the first lipid component (See Page 127006-2…high-density lipoprotein (HDL), and low-density lipoprotein (LDL) from human plasma; See Section 3.1…Figure 3 (c) shows the RR spectra of liquid HDL and LDL obtained from human plasma) and the second lipid component (See Page 127006-5, Section 3.4… Calcified and Ossified Plaques; Figure 4(c) shows a typical RR spectrum for the third set of lesions where calcification has evolved into ossification) is at least one of phospholipids, carotenoids, total lipid of low density lipoproteins, and total lipid of high density lipoproteins from a same or distinct source (See Section 3.4, Para 127006-5…This indicates that, in this state, the main components may be … phospholipids; See Section 2.3…powder, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) from human plasma ; See Section 3.2… in HDL/LDL powder and normal aortic fat, the presence of a sharp methylene (─CH2) peak is observed at 2854 cm−1; Under BRI Examiner submits that the first lipid component and the second lipid component may be from the same or different sources).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Alfano and Liu to provide that each of the first lipid component and the second lipid component is at least one of phospholipids, carotenoids, total lipid of low density lipoproteins, and total lipid of high density lipoproteins from a same or distinct source, as taught by Liu for the benefit of determining that the main components of the calcified and ossified plaques may be crystalline cholesterol, cholesteryl esters, and phospholipids (Liu, Page 127006-6, Section 3.4) and determining that in the lesions in the fibrolipid plaques, the Raman spectral molecular fingerprints arises from the macromolecules of lipids and lipoproteins (Liu, Page 127006-4, Section 3.2), allowing for the provision of a visible RR (VRR) technique for directly distinguishing and classifying vulnerable plaques with various states of atherosclerosis development and different cap thicknesses in human aorta tissues using RR spectral molecular fingerprints in a wide frequency region (Liu, Page 127006-2, Section 1, Introduction).
Regarding Claim 7, the method of claim 1 is obvious over Alfano in view of Liu.
Alfano teaches that the first lipid component (‘the lipid bands ‘) (See Para 0055… calcified plaque is detected by measuring a signal at about 957 cm−1; See Claim 12… detecting calcified plaque regions, wherein step b) comprises detecting Raman scatter at three or more wavenumbers, wherein one of the three or more wavenumbers is about 1435 cm−1, about 2850 cm−1, or about 2892 cm−1…; See Para 0025… the lipid bands at 1435 cm−1, 2850 cm−1 and 2892 cm−1) and the second lipid component (‘main lipid C—H vibration bands’) (See Para 0005… These three Raman modes, which are the main lipid C—H vibration bands, have sharp spectrum, strong features and high stability with varied environments including temperature, and can be used as a fingerprint of VP) are identical or distinct (Under BRI, Examiner submits that the first lipid component and the second lipid component may be identical or distinct).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006.) as applied to claim 1 above, and further in view of Puppels et al. (US20060139633A1).
Regarding Claim 5, the method of claim 1 is obvious over Alfano in view of Liu.
Alfano teaches wherein the transformation (‘normalized peak Raman intensity’) of the of the first unique Raman signature (‘Spectroscopic information’) and second unique Raman signatures (‘Spectroscopic information’) to obtain amplified signatures (See Para 0065… Spectroscopic information also includes the normalized peak Raman intensity; Examiner, under BRI, submits that peak normalization amplifies spectra in spectroscopy) include steps;
eliminating at least one baseline shifts of the first unique Raman signature and second unique Raman signatures (See Para 0065… Spectroscopic information also includes the normalized peak Raman intensity).
The combination of Alfano and Liu does not teach the steps of:
eliminating at least one baseline shifts of the first unique Raman signature and second unique Raman signatures; dimensionally reducing the base line shifted Raman signatures; and resolving the dimensionally reduced signatures to obtain amplified signatures.
In the analogous art of an instrument and the use thereof for measuring a Raman signal of a tissue, comprising a laser, a signal detection unit, and a fiber optic probe, Puppels teaches:
dimensionally reducing the base line shifted Raman signatures (See Para 0114… First, PCA was performed on the Raman spectra, to orthogonalize and reduce the number of parameters needed to represent the variance in the spectral data set.); and
resolving the dimensionally reduced signatures to obtain amplified signatures (‘normalized first derivatives of the spectra’) (See Para 0114… In brief, the analysis was carried out on normalized first derivatives of the spectra (2700 to 3100 cm−1) in order to diminish any influence of variations in the absolute intensity of the Raman signal and to correct for a slight slowly varying signal background due to slight autofluorescence from the tissue, thereby teaching “dimensionally reducing the base line shifted Raman signatures”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Alfano and Liu to provide a step of “eliminating at least one baseline shifts of the first unique Raman signature and second unique Raman signatures; dimensionally reducing the base line shifted Raman signatures; and resolving the dimensionally reduced signatures to obtain amplified signatures”, as taught by Puppels for the benefit conducting Raman Data processing to determine the heterogeneity in Raman spectra within each tissue sample, in a non-subjective way and without assuming prior knowledge of the morphology and composition of the artery samples (Puppels, Para 0113-0114), allowing for the provision of provision of an instrument that enables ex vivo, in vitro and in vivo analysis and diagnosis of atherosclerotic plaque and detection of tumor tissue with great advantages over current state-of-the-art technology (Puppels, Abstract).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006.) as applied to claim 1 above, and further in view of Swagemakers et al. (US20110059089A1).
Regarding Claim 8, the method of claim 1 is obvious over Alfano in view of Liu.
Alfano teaches that the source (interpreted by the Examiner as “the first source” and/or “the second source” in light of the 112b rejection of Claim 8) (referred to as calcified plaque [Page 0055] and/or (referred to as vulnerable plaques (VP) [Para 0055])) includes samples (See Para 0057…patient’s artery; See Para 0022-0023… arterial walls, arteries) from individual (‘patient’) having the cardiovascular disorder (See Para 0007… a method of treating a patient comprising detecting vulnerable plaque as defined above and targeting said vulnerable plaque for treatment; See Para 0060… the patient may be suffering from atherosclerotic vascular disease or suspected of being at risk of experiencing a plaque rupture and/or an occlusive thrombotic event).
The combination of Alfano and Liu does not explicitly teach that the source (interpreted by the Examiner as “the first source” and/or “the second source” in light of the 112b rejection of Claim 8) includes samples from healthy individuals and individual having the cardiovascular disorder.
In the analogous art of a method for predicting the risk of a subject developing a cardiovascular event comprising detecting at least one biomarker in (a sample of) the cardiovascular system from said subject, Swagemakers teaches that the source (interpreted by the Examiner as “the first source” and/or “the second source” in light of the 112b rejection of Claim 8) includes samples from healthy individuals (See Para 0117-0118…a samples taken from two different subjects, e.g., from a test subject or patient having (a risk of developing) a particular medical condition, such as cardiovascular events, compared to a comparable sample taken from a control subject (e.g., a subject not having (a risk of developing) a particular medical condition; a normal or healthy subject; Also See Para 0161-0162 yping of atherosclerotic plaque involves taking a sample from a subject at risk of developing a medical condition, and a sample from a control subject not at risk of developing said condition).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Alfano and Liu to provide that the source (interpreted by the Examiner as “the first source” and/or “the second source” in light of the 112b rejection of Claim 8) includes samples from healthy individuals and individual having the cardiovascular disorder, as taught by Swagemakers for the benefit of providing a method for predicting the risk of a test subject developing a medical condition comprising the steps of typing atherosclerotic plaque (Swagemakers, Para 0057) to identify a biomarker associated to the medical condition, and b) detecting said biomarker in (a sample of) atherosclerotic plaque from said test subject, wherein said test subject is at risk of developing said medical condition when said biomarker is present in said (sample of) atherosclerotic plaque (Swagemakers, Para 0159), allowing for the provision of more reliable biomarkers for predicting the risk to major cardiovascular events (Swagemakers, Para 0005).
Response to Arguments
Applicant's arguments filed on 03/11/2026, with respect to the objections on the drawings have been fully considered and are persuasive.
Applicant has submitted Figures with improved resolution.
Examiner respectfully agrees and the Drawing objection is withdrawn.
Applicant's arguments filed on 03/11/2026, with respect to the objections on claims 1 and 3-5 have been fully considered and are persuasive.
Applicant has amended claims 1 to recite a single sentence;
In claim 3 the term "the range" has been amended to "a range";
Claim 4 has been canceled, rendering the objection to that claim moot;
Claim 5 has been amended to replace each of the terms "signatures" with " the first unique Raman signature and second unique Raman signature".
It is believed that all the objections have been addressed appropriately and Reconsideration of the claims is respectfully requested.
Examiner respectfully agrees and the claims objections are withdrawn.
However, new issues are raised regarding the objections on amended Claims 1 and 5 (See Claim objection paragraph (Supra).
Applicant's arguments filed on 03/11/2026, with respect to the 35 U.S.C. §112 (b) rejections on Claims 2-4 and 6 have been fully considered and are persuasive.
Applicant has initially noted that claims 2 and 4 have been canceled, rendering the rejection of these claims moot.
In claim 3, the limitation "the electromagnetic radiation" has been amended by Applicant to "an electromagnetic radiation".
In claim 6, the limitation "the lipid component" has been amended to "each of the first lipid component and the second lipid component".
It is believed that claims 3 and 6 are clearly defined under 35 U.S.C. 112(b).
Examiner respectfully agrees and the claims rejections are withdrawn.
However, new issues are raised regarding the rejections on amended Claim 3 and Claim 8 (Supra).
Applicant's arguments filed on 03/11/2026, with respect to the 35 U.S.C. §101 rejections on Claims 1-7 (Claims 2 and 4 are canceled) have been fully considered and are not persuasive.
Applicant respectfully disagrees.
In the analysis, the Office Action states - with regards to Step 2A prong 1 - that the steps of transforming...; comparing...; and repeating... are limitations that are directed "towards an abstract idea, and more specifically to the abstract idea group of a math process since claim 1 relates to using a math or calculations to "transform each of the first lipid signatures and second lipid signatures to obtain amplified signatures; compare the amplified signatures to obtain a first ratio; and repeating the above mentioned steps at least one more time to obtain a second ratio"."
Applicant strongly disagrees. The concept of obtaining unique signature from various lipid components using Raman Spectroscopy is not an abstract idea. The signatures obtained have been collected and analysed to provide an indicator for Cardiovascular Disorders. The lipid components are measured using samples collected from both healthy and individuals having the metabolic syndrome.
The step of analysis in transforming the data obtained through unique signatures is possible only subsequent to the physical collection of the data through a system involved. The method cannot be performed without physical collection of sample, analysis and extraction of the data.
Therefore, Step 2A, Prong 1 is "No".
Applicant’s arguments with respect to amended claim 1, 3 and 5-8 has been considered and Examiner respectfully disagrees.
Examiner assertively identifies the judicial exception (abstract idea) in Claim 1 as “transforming each of the first unique Raman signature and second unique Raman signature to obtain amplified signatures; comparing the amplified signatures to obtain a first ratio; and repeating the abovementioned steps at least one more time to obtain a second ratio” as a mental or mathematical step (Step 2A Prong One) and found that the additional elements “capturing a first unique Raman signature with respect to a first lipid component; capturing a second unique Raman signature with respect to a second lipid component; and wherein, alteration in the first ratio and the second ratio provides the indicator for cardiovascular disorder” do not integrate the exception into a practical application (Step 2A Prong Two), as these additional elements appear to be insignificant post solution activities as they amount to just “data gathering” or “applying it” – both held as not practical applications (MPEP 2106.05f, MPEP 2106.05g).
In response to the statement “once the determination is done”, Examiner clarifies that the “determination” was provided to convey the “comparing and repeating” steps, which has submitted in the Step 2A, Prong 2 section of the 101 rejection (Supra).
Further these additional elements do not amount to significantly more than the exception (Step 2B) because they are well-understood, routine and conventional activities in the field of clinical diagnostics (See 101 rejection Supra). These elements are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity: See MPEP 2106.05(d), previously known in the field of clinical diagnostics as evidenced by Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006).
Examiner further submits that the prior art of record shows that the “method of obtaining a lipid based indicator for cardiovascular disorder using Raman spectroscopy” is disclosed by Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006.).
As a result, Examiner submits that the claims do not amount to significantly more that the judicial exception. The 101 rejection is maintained.
Applicant’s arguments, see Page 8, filed 03/11/2026, with respect to the rejection(s) of claim(s) 1-2, 4 and 6-7 under 35 U.S.C. §103 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 for Claim 1 by Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006.)
Applicant has amended claim 1 to presently recites features including: "A method of obtaining a lipid based indicator for cardiovascular disorder using Raman spectroscopy", "capturing a first unique Raman signature with respect to a first lipid component from a first source", "capturing a second unique Raman signature... from a second source", and "transforming each of the first unique Raman signature and second unique Raman signature to obtain amplified signatures"…
Since the combination of Liu and Meikle fails to render amended independent claim 1 obvious under 35 USC § 103 for the reasons presented above, claims 6 and 7, dependent from claim 1, are also not rendered obvious by the aforementioned combination, for at least the same reasons. Claims 6 and 7 further distinguish the invention over the cited art.
Applicant’s arguments with respect to amended claim 1 has been considered and Examiner respectfully disagrees.
Examiner submits that the limitations of amended Claim 1 is taught as disclosed in the rejection of Claim 1 (Supra) by Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006).
Applicant’s arguments, see Page 9, filed 03/11/2026, with respect to the rejection(s) of claim(s) 3 under 35 U.S.C. §103 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 for Claim 3 by Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006.)
Applicant asserts that Claim 3 depends from amended independent claim 1, which has been discussed above. That discussion is applicable here.
Liu and Meikle have been discussed above. Those discussions are applicable here…Other wavelengths can be employed to optimize the diagnostic information depending upon the particular type of tissue and the type and stage of disease or abnormality.
As such, Rava fails to cure any of the deficiencies of Liu and Meikle and therefore adds nothing to this combination.
Since the combination of Liu, Meikle and Rava fails to render amended independent claim 1 obvious under 35 USC § 103, claim 3, dependent from claim 1, is likewise not rendered obvious by the combination.
Applicant’s arguments with respect to amended claim 3 has been considered and Examiner respectfully disagrees.
Examiner submits that the limitations of amended Claim 3 is taught as disclosed in the rejection of Claim 3 (Supra) by Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006).
Applicant’s arguments, see Page 10, filed 03/11/2026, with respect to the rejection(s) of claim(s) 5 under 35 U.S.C. §103 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 for Claim 5 by Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006.) as applied to claim 1 above, and further in view of Puppels et al. (US20060139633A1).
Applicant asserts that Claim 5 depends from amended independent claim 1, which has been discussed above. That discussion is applicable here.
Liu and Meikle have been discussed above. Those discussions are applicable.
Clarke is directed to a non-invasively, in vivo blood analysis in near infrared spectrum (1620-1820 nm,2200-2400 nm). Clarke makes use of optical fiber technology for measuring cholesterol, not specific to CVD related biomarkers.
Clarke analyses electrical signals to derive a ratio for the data and reference wavelengths and compares that ratio to a predetermined value to detect the presence of cholesterol in said blood.
However, none of these features, or other features in Clarke, cure any of the deficiencies of Liu and Meikle and therefore add nothing to that combination.
Since the combination of Liu, Meikle and Clarke fails to render amended independent claim 1 obvious under 35 USC § 103, claim 5, dependent from claim 1, is likewise not rendered obvious by the combination.
Applicant’s arguments with respect to amended claim 5 has been considered and Examiner respectfully disagrees.
Examiner submits that the limitations of amended Claim 5 is taught as disclosed in the rejection of Claim 5 (Supra) by Alfano et al. (US20100317974A1) in view of Alfano et al. (US20100317974A1) in view of Liu et al. ("Vulnerable atherosclerotic plaque detection by resonance Raman spectroscopy." Journal of biomedical optics 21.12 (2016): 127006-127006.) as applied to claim 1 above, and further in view of Puppels et al. (US20060139633A1).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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.
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/OYELEYE ALEXANDER ALABI/Examiner, Art Unit 1797
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