DETAILED ACTION
Status of the Claims
Claims 1-20 are currently pending and are examined herein.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election Requirements
Claims 11-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/30/2026.
Applicant's election with traverse of Invention I (claims 1-10 and 17-20) in the reply filed on 01/30/2026 is acknowledged. The traversal is on the ground(s) that “claims 17 to 20 are in fact directed to a method for identifying a potential biomarker, similar to claim 1”. In light of this, claims 17-20 have been added to Invention I. However, Applicant’s assertion that “examining all of the claims together would not provide an undue burden on the Examiner” is not persuasive for at least the reasons detailed in the Restriction Requirement of 10/02/2025, namely, that the claims of Invention II have acquired a separate status in the art in view of their different classification and divergent subject matter, and would require a different field of search.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections – 35 U.S.C. 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Arvizo et al.
Claims 1-3, 5-7, and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arvizo et al. (PLoS ONE, 2012, 7(3):e33650, cited in IDS of 10/04/2023).
Regarding claim 1, Arvizo discloses a method for identifying a potential biomarker from a plurality of biological samples, comprising:
(a) providing a plurality of biological samples comprising a plurality of proteins in the plurality of biological samples, wherein a first subset of biological samples in the plurality of biological samples is associated with a first biological state, and a second subset of biological samples in the plurality of biological samples is associated with a second biological state (e.g., cell lysate from cancerous and non-cancerous ovarian cell lines as per the Cell Lysates section on p. 5);
(b) incubating the plurality of biological samples with a plurality of particles to form a plurality of protein coronas on the plurality of particles (e.g., as per the Corona Formation section on p. 5);
(c) performing mass spectrometry using the plurality of protein coronas to generate a plurality of protein identifications and a plurality of protein levels (e.g., as per the Mass Spectrometry sections on p. 6);
(d) determining (i) a first difference in the presence of a protein identification in the plurality of protein identifications between the first subset of biological samples and the second subset of biological samples and (ii) a second difference in a protein level in the plurality of protein levels between the first subset of biological samples and the second subset of biological samples (e.g., as per Fig. 3 and the Bioinformatics section and Supporting Information sections on pp. 6-7); and
(e) identifying the first difference, the second difference, or both as the potential biomarker when the first difference, the second difference, or both are statistically significant (e.g., as per the Bioinformatics section and Supporting Information sections on pp. 6-7).
Regarding claim 2, Arvizo discloses the above method, wherein the determining comprises determining (i) the first difference in the presence of at least two protein identifications in the plurality of protein identifications between the first subset of biological samples and the second subset of biological samples and (ii) the second difference in at least two protein levels in the plurality of protein levels between the first subset of biological samples and the second subset of biological samples (e.g., as per the Bioinformatics section and Supporting Information sections on pp. 6-7).
Regarding claim 3, Arvizo discloses the above method, wherein the first biological state comprises a cancerous state and the second biological state comprises a non-cancerous state (e.g., cell lysate from cancerous and non-cancerous ovarian cell lines as per the Cell Lysates section on p. 5).
Regarding claim 5, Arvizo discloses the above method, wherein the plurality of particles comprises at least 2 particle types comprising different physicochemical properties (e.g., positive or negative AuNP as per the Particle synthesis section on p. 5).
Regarding claim 6, Arvizo discloses the above method, wherein the plurality of protein identifications and the plurality of protein levels are stratified based on a particle type of the at least 2 particle types (e.g., as per the Bioinformatics section and Supporting Information sections on pp. 6-7).
Regarding claim 7, Arvizo discloses the above method, wherein the mass spectrometry comprises liquid chromatography-tandem mass spectrometry (LC-MS/MS) (e.g., as per the Mass Spectrometry sections on p. 6).
Regarding claim 9, Arvizo discloses the above method, wherein a protein identification in the plurality of protein identifications comprises an identification of a proteolytically fragmented peptide (e.g., trypsin digest as per the Mass Spectrometry sections on p. 6).
Regarding claim 10, Arvizo discloses the above method, wherein the mass spectrometry generates a plurality of MS spectra, and the plurality of protein identifications are generated by searching a database to match the plurality of MS spectra to the plurality of protein identifications (e.g., as per the Bioinformatics section and Supporting Information sections on pp. 6-7).
Claim Rejections – 35 U.S.C. 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 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.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Arvizo et al. and Rahman et al.
Claims 1-10 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Arvizo et al. (PLoS ONE, 2012, 7(3):e33650, cited in IDS of 10/04/2023) in view of Rahman et al. (Proceedings Volume 9338, Colloidal Nanoparticles for Biomedical Applications X; 93380V (2015) https://doi.org/10.1117/12.2079771, cited in IDS of 02/12/2025).
Arvizo is relied on as above, however, it is noted that the reference is silent to the plurality of biological samples comprising a third subset of biological samples associated with a third biological state, as set forth in claim 4, and wherein the first subset of biological samples and the second plurality of subset samples comprise at least 10 samples, as set forth in claims 8 and 17.
Rahman similarly discloses discovery of biomarkers from proteomic analysis of protein corona (e.g., Abstract), specifically teaching “[a]t least ten patients were considered for each group” (e.g., as per the 2. EXPERIMENTAL section) and also that several groups/conditions could be tested for biomarker discovery (e.g., “such as diseases, medical condition, smoking, pregnancy, genetic, life style, and geographic region” as per the 1. INTRODUCTION section).
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to expand the biomarker discovery process of Arvizo to encompass more groups/conditions of humans with at least ten patients per group as per Rahman. One of ordinary skill in the art would have been motivated to do so since as Arvizo explicitly suggests such an expansion, stating in the Discussion section: “Although we focused on HDGF in this study, extension of similar methods to other protein targets to target other diseases would be valid. Future studies will focus on the evolution, modulation, and identification of protein coronas over time and also on testing this unique system with human patient samples (blood, serum, plasma).”
One of ordinary skill in the art would have had a reasonable expectation of success as of the application’s effective filing date in combining the teachings of the prior art references to arrive at the invention as presently claimed since such a combination would merely involve the repetition of well-established corona-based proteomics analysis to more diverse subjects.
Conclusion
No claims are allowed.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684
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