DETAILED ACTION
The amendment filed on 02/03/2026 has been entered and fully considered. Claims 1-2, 4-5, 7-8, 10, 12, 14, 16, 18, 20-21, 24-25, 27, 31 and 33-34 are pending, of which claim 1 is amended.
Response to Amendment
In response to amendment, the examiner maintains rejection over the prior art established in the previous 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 .
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-5, 7-8, 10, 12, 14, 24-25, 27, 31 and 33-34 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Auner et al. (Cancer and Metastasis Reviews, 2018, IDS) (Auner).
Regarding claim 1, Auner teaches a method for screening for and/or diagnosing a disease in a subject (abstract), the method comprising:
(i) generating a spectroscopic profile of the subject's sample or comparing a
spectroscopic profile of the subject's sample with one or more reference spectroscopic profiles (Fig. 4, page 692, par 2; page 701, par 3), wherein the spectroscopic profile, the one or more spectroscopic profiles, or both, comprise components (signal of biomarkers including proteins, lipids, and DNA) (page 701, par 3),
(ii) generating one or more component scores by comparing the components of the spectroscopic profile with corresponding components in at least one of the one or more reference spectroscopic profiles using a computer-implemented algorithm, wherein the one or more component scores are used to calculate a general score of the spectroscopic profile (Fig. 4, page 701, par 3), and
(iii) providing a diagnosis, prognosis, or both, of the disease based on the general score (page 701, par 3; page 702, par 2).
Auner describes Raman spectroscopic analysis in which spectral features are processed using multiple quantitative analysis techniques. Specifically, Auner teaches that:
“Multiple methods were employed for analysis including discriminating algorithms, score of factor, Mahalanobis distance, spectral residuals, and the limit test.” (Auner, page 701)
The disclosed “score of factor” analysis demonstrates that Auner derives quantitative score values from spectral components. Because Raman spectra comprise discrete spectral features corresponding to molecular components of the sample, the factor scores generated from such analysis correspond to the claimed “component scores.”
Further, Auner teaches that these quantitative analytical outputs are used in classification and diagnostic determination of diseased versus normal tissue. The combination of quantitative factor scores within discriminant or classification models inherently produces an overall diagnostic metric or classification result, which reasonably corresponds to the claimed “general score of the spectroscopic profile.”
Regarding claim 4, Auner teaches that wherein the general score is obtained by summing the one or more component scores optionally using the computer-implemented algorithm (page 701, par 3), wherein when only one component score is available, the general score is that component score (page 701, par 3).
Regarding claim 5, Auner teaches that wherein the spectroscopic profile of the subject's sample, and the one or more reference profiles are generated using data from a spectroscopic technique that applies a frequency scan between about 14,000 cm-1 and about 4000 cm-1, or between about 4,000 cm-1 and about 400 cm-1 (Fig. 4).
Regarding claim 7, Auner teaches that wherein the spectroscopic profile of the subject's sample, and the one or more reference profiles are generated using data from a spectroscopic technique comprising field-resolved spectroscopy (such as field-resolved infrared spectroscopy), frequency-resolved spectroscopy, Fouriertransform infrared spectroscopy, Raman spectroscopy, infrared attenuated total reflectance, diffuse reflectance spectroscopy, and combinations thereof (Fig. 4, page 701, par 3).
Regarding claim 8, Auner teaches that wherein the spectroscopic technique comprises vibrational spectroscopy (Fig. 4, page 695, par 4).
Regarding claim 10, Auner teaches that wherein:
(i) the components of the spectroscopic profile of the subject's sample contain vibrational frequencies (Fig. 4, page 695, par 4), or
(ii) the components of at least one of the one or more reference spectroscopic profiles contain vibrational frequencies (Fig. 4, page 695, par 4).
Regarding claim 12, Auner teaches that wherein:
(i) at least one of the one or more reference spectroscopic profiles is generated using a non-diseased sample (Fig. 4, page 695, par 3), or
(ii) at least one of the one or more reference spectroscopic profiles is generated using a diseased sample (Fig. 4, page 695, par 3).
Regarding claim 14, Auner teaches that wherein at least one of the one or more reference spectroscopic profiles is generated using a cancerous sample (Fig. 4, pae 695, par 3).
Regarding claim 24, Auner teaches that wherein the sample is in vitro or in vivo (Fig. 4, page 695, par 3).
Regarding claim 25, Auner teaches that wherein the disease comprises cancer, diabetes, atherosclerosis, Alzheimer's Disease, Parkinson's Disease, or chronic kidney disease, optionally wherein the sample is selected from the group consisting of cells, blood, spittle/saliva, serum, plasma, urine, sputum, sweat, semen, synovial fluids, lymphatic fluids, cerebrospinal fluids, biopsy, stool, and combinations thereof (abstract).
Regarding claim 27, Auner teaches that wherein:
(i) the subject is asymptomatic of the disease, or
(ii) the diagnosis is performed on the subject presenting symptoms of the disease (diagnosis and treatment evaluation)(abstract).
Regarding claim 31, Auner teaches that wherein the subject is at risk (such as at high risk) of developing breast cancer (page 711, par 3).
Regarding claim 33, Auner teaches that wherein the general score is used to determine whether the subject has breast cancer (abstract).
Regarding claim 34, Auner teaches that wherein the components are ordered by wavenumbers (Fig. 4, page 695, par 4).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 2, 16, 18 and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Auner et al. (Cancer and Metastasis Reviews, 2018, IDS) (Auner).
Regarding claim 2, comparing the general score to a threshold value, wherein the subject is diagnosed as having the disease when the general score is greater than the threshold is conventional.
Regarding claim 16, It would have been obvious to one of ordinary skill in the art to select at least one of the one or more reference profiles is from one or more individuals in the same population as the subject, so that one can compare apple with apples.
Regarding claim 18, it would been convenient to select at least one of the one or more reference spectroscopic profiles is from one or more individuals in a different population than the subject, when the same population reference is not available.
Regarding claim 20-21, Auner teaches range of changes of components between the normal and disease references (page 708, par 2). It would have been obvious to one of ordinary skill in the art to compare the spectroscopic profile with a normal reference spectroscopic profile and a disease reference spectroscopic profile,
wherein:
(i) the first reference spectroscopic profile contains upper bounds of spectroscopic data,
or
(ii) the second reference spectroscopic profile contains lower bounds of spectroscopic data,
in order to quantify the changes of the components.
Response to Arguments
Applicant's arguments filed 02/03/2026 have been fully considered but they are not persuasive.
Applicants argue that Auner fails to disclose generating one or more component scores and using the component scores to calculate a general score of the spectroscopic profile. The arguments are not persuasive.
Auner describes Raman spectroscopic analysis in which spectral features are processed using multiple quantitative analysis techniques. Specifically, Auner teaches that:
“Multiple methods were employed for analysis including discriminating algorithms, score of factor, Mahalanobis distance, spectral residuals, and the limit test.” (Auner, page 701)
The disclosed “score of factor” analysis demonstrates that Auner derives quantitative score values from spectral components. Because Raman spectra comprise discrete spectral features corresponding to molecular components of the sample, the factor scores generated from such analysis correspond to the claimed “component scores.”
Further, Auner teaches that these quantitative analytical outputs are used in classification and diagnostic determination of diseased versus normal tissue. The combination of quantitative factor scores within discriminant or classification models inherently produces an overall diagnostic metric or classification result, which reasonably corresponds to the claimed “general score of the spectroscopic profile.”
Applicants’ argument improperly requires Auner to explicitly label its quantitative outputs as “component scores” and “general score.” However, anticipation does not require identical terminology. Auner’s disclosure of extracting quantitative factor scores from spectral components and using them within diagnostic algorithms teaches the claimed scoring framework.
Accordingly, Auner discloses the disputed limitations and the rejection under 35 U.S.C. 102(a)(1) is maintained.
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 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 XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797