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 .
Detailed Action
This is the Non-Final Action for application 18/027764 election response filed 04/20/2026.
Claims 8-12 are pending and have fully been considered.
Claims 6-7, 13-16, and 19-20 are cancelled.
Claims 1-5 & 17-18 are withdrawn from prosecution.
Election/Restrictions
Applicant’s election without traverse of Group 1 Claims 8-12 in the reply filed on 04/20/2026 is acknowledged.
Claims 1-5 & 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/20/2026.
Claim Objections
Claim 12 is objected to because of the following informalities:
In Claim 12, “or other sample,” is claimed. While the examiner understands this to be “or other bodily sample,” “or other,” reads more broadly than this and could be any sample. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-12 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.
With respect to Claim 8, it claims things in parentheses including “e.g., plasma,” and “e.g., blood.” It is unclear if the claim is limited to the things in parentheses, or if these are merely optional. Further- “e.g.” is used which means “for example.” This renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further Claim 8 reads as claiming the broad limitations of “bodily sample,” and “subject,” and the narrow limitations of “plasma,” and “human subject,” within the same claim--- therefore making the claims unclear. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
With respect to Claim 9, it claims in parentheses including “e.g., a statin.” It is unclear if the claim is limited to the things in parentheses, or if these are merely optional. Further- “e.g.” is used which means “for example.” This renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 10-12 are rejected by virtue of their dependency on Claim 8.
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 8-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation and abstract idea without significantly more.
Step 1: Independent Claim 8 are directed towards a method.
Step 2A, Prong One: Independent Claim 8 recites the abstract idea, “evaluating,” in the preamble. Though the word “comparing,” is not used the determination of the evaluating is based on a comparison of a first determined level and a second determined level of the claimed biomarker/s. Both evaluating and comparing are mental process or simple math at most. These are abstract idea judicial exceptions. See MPEP 2106.04(a).
Further-though the word “diagnosis,” or diagnosing is not used, the relation of the claimed biomarkers to cardiovascular disease is a law of nature/natural correlation judicial exception.
Step 2A, Prong Two: The abstract idea and natural correlation in independent Claim 8 are not integrated into a practical application. Upon or after the comparison/determining, nothing further is done to practically apply.
Also- no measuring/measurement steps as instantly claimed, and only “determining,” which itself can be interpreted as a mental process/abstract idea. Even if general measuring or detecting was claimed--- this would be and currently is considered data gathering to perform the judicial exceptions. Data gathering is considered to be insignificant extra-solution activity, and does not practically apply the judicial exception. See MPEP 2106.05 (g).
Further- treatment is not positively recited in Claim 8, however even if it were, it seems the claimed treatment is also insignificant extra-solution activity in the instant claims, since it would be done before the second determining step and therefore is used to gather data to accomplish the claimed judicial exception of “evaluating.”
Step 2B: There is nothing in independent Claim 8 which adds something which is non routine and conventional or significantly more to the claimed abstract idea or natural correlation judicial exception.
“Determining,” or measuring, biomarkers especially as generally claimed instantly claimed is well understood routine and conventional (WURC) in the art. This is evidenced by URDEA in US 20170261520 --which teaches in paragraph 0006-0009 of measuring biomarkers in samples, as well known in the background of the invention section.
See MPEP 2106.05(d)- “laboratory techniques as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner.”
The dependent claims are analyzed the same way as above.
Claim 9 recites what the therapeutic agent is. However, an actual treatment step is still not required in the claim and what applicant is claiming here is only specification on what happens outside the boundaries of Claim 8. Even if one or more of the claimed treatments were claimed, the treating in the instant method only seems to be done to gather data for the claimed “evaluating,” of Claim 8. The treatment is not particular and specific to what is being done within the claims, but instead the treatment would be applied in all instances if a treatment step were added into the Claim 8 language. Further, the claimed treatments are WURC in the art. This is evidenced by HAZEN in US 20110152224, which teaches of using direct thrombin inhibitors, ACAT inhibitors and CDTP inhibitors among others including anti-inflammatory agents are commonly used to see if they have effect as is instantly done (paragraph 0093).Therefore, this is not a practical application. See Vanda memorandum. Therefore, this does nothing to practically apply at step 2A/2, nor to add significantly more at step 2B.
Claim 10 recites that the subject has been diagnosed as having CVD of cardiovascular thrombosis. Diagnosis/diagnosing based on biomarkers is a natural correlation/law of nature judicial exception. Therefore, this does nothing to practically apply at step 2A/2, nor to add significantly more at step 2B.
Claim 11 recites that the subject has been diagnosed as being at risk of having CVD of cardiovascular thrombosis. Diagnosis/diagnosing based on biomarkers is a natural correlation/law of nature judicial exception. Therefore, this does nothing to practically apply at step 2A/2, nor to add significantly more at step 2B.
Claim 12 recites that bodily sample is plasma, blood, serum, urine, or other. In the instant claims, the sample is just used to gather data to perform the judicial exception. Further, using bodily samples such as blood are WURC in the art. This is evidenced by URDEA in US 20170261520 --which teaches in paragraph 0006-0009 of measuring biomarkers in samples, as well known in the background of the invention section. Therefore, this does nothing to practically apply at step 2A/2, nor to add significantly more at step 2B.
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 8-12 are rejected under 35 U.S.C. 103 as being obvious over URDEA in US 20170261520 in view of HAZEN in US 20110152224.
With respect to Claim 1, URDEA teaches of methods of identifying subjects with arteriovascular disease and methods of differentially diagnosing diseases associated with arteriovascular disease from other diseases or within sub-classifications of arteriovascular disease, and methods of evaluating the effectiveness of treatments in subjects with arteriovascular disease, and methods of selecting therapies for treating arteriovascular disease (abstract).
URDEA teaches that the disease can be cardiovascular disease (CVD) (paragraph 0011, 0038), and that a sample is investigated which is one of serum, blood, plasma (paragraph 0023, 0220).
URDEA teaches that the arterior risk markers can include 13-HODE in plasma (See Table 2, which is right before paragraph 0217). The “arteriorriskmarkers,” as they are referred to in URDEA to determine patients in a population who are at risk of developing or have arteriorvascular disease or are at risk of an arteriorvascular event (paragraph 0211-0217 & including Table 2).
URDEA teaches that the biomarker level in a sample is compared to that in a reference sample (paragraph 0122-0123).
URDEA further does not teach of measuring the biomarker before and after treatment.
HAZEN is used to remedy this. HAZEN teaches of diagnostic tests for characterizing an individual's risk of developing or having a cardiovascular disease (Abstract). HAZEN teaches that HODE and HETE’s can be the biomarkers that are detected in the diagnostic tests (paragraph 0012, 0083). HAZEN further teaches of monitoring the levels of the biomarkers or risk factors before and after treatment or therapy and that a decreased in the level after therapy is indicative of a positive effect of the therapy in the subject (paragraph 0014).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to monitor biomarkers and/or risk factors before and after therapy/treatment as is done in HAZEN in the method of URDEA due to the advantage this gives for determining if the therapy is having an effect or not (HAZEN, paragraph 0014, 0093).
With respect to Claim 9, URDEA teaches of the invention as shown above, but does not teach of the claimed treatments for CVD.
HAZEN is used to remedy this and teaches of using direct thrombin inhibitors, ACAT inhibitors and CDTP inhibitors among others including anti-inflammatory agents (paragraph 0093).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use and monitor before the therapies/treatments as is done in HAZEN in the method of URDEA due to the advantage this gives for determining if the therapy is having an effect or not (HAZEN, paragraph 0014, 0093).
With respect to Claim 10, URDEA teaches that the patient has been diagnosed with CVD (paragraph 0120, 0097, 0204).
With respect to Claim 11, URDEA teaches that the patient has been diagnosed with risk of CVD (paragraph 0120, 0097, 0204).
With respect to Claim 12, URDEA teaches of the body sample being blood, serum, plasma, or urine (paragraph 0023, 0112).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
BUCHANAN in US 20040115749 teaches of measuring plasma 13-HODE is a useful maker to assess i) the severity or burden of coronary artery disease and ii) the risk of thrombotic events in patients undergoing medical and/or surgical procedures for revascularization (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel, can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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