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 Final Action for application 18/027764 response filed 08/05/2026.
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Claims 1-5 & 17-18 are withdrawn from prosecution.
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 is unclear in steps b) and d) if the “a CVD therapeutic agent,” and “a treatment comprising a CVD therapeutic agent,” are the same thing or not. As claimed, they seem like the same thing, and that the use in step d) does not have proper antecedent basis back to the use of “a CVD therapeutic agent,” used in steps c) and b). If instead, the agents in steps b) and d) are the same thing, just administered at different times- this needs to be made clear in the claims as it is not currently clear.
Further with respect to Claim 8, the preamble claims “evaluating,” while claim steps a)-d) only require a series of measuring and administering steps. Therefore, it is unclear what if any evaluating is occurring.
Claims 9-12 are rejected by virtue of being dependent 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 is directed towards a method.
Step 2A, Prong One: Independent Claim 8 recites the abstract idea, “evaluating,” in the preamble. “Evaluating,” is a mental process which is an abstract idea judicial exception. See MPEP 2106.04(a).
Further-though no positive diagnostic step is claimed in Claim 8, the level of a biomarker, 12 (S) the relation of the claimed biomarkers to cardiovascular disease is a law of nature/natural correlation judicial exception, and is still implicitly in the claims.
Even further, though the comparison step is no longer a claimed step, it is also still implicitly claimed since there is no claimed step d) without it. (One cannot determine if there is a “not decreased,” level without a comparison.) As claimed, it is not just two measurement and two administration steps occurring, but the second administration step in step d) can only occur based on a comparison, and conditionally at that, since “when,” is claimed. Therefore, the comparison step is also still implicitly in the claim. Comparison is a mental process judicial exception.
Step 2A, Prong Two: The abstract ideas and natural correlation in independent Claim 8 are not integrated into a practical application. Upon or after the comparison/determining of a “not decreased,” level, there is no particular practical application.
The measurement by liquid chromatography mass spectrometry is just done to gather data to perform the judicial exception. Data gathering is considered to be insignificant extra-solution activity and does not practically apply the judicial exception. See MPEP 2106.05 (g).
With respect to the two claimed treatment steps, the first treatment step as claimed is done for data gathering and is insignificant extra-solution activity as claimed. The second treatment only happens conditionally, “when,” so does not even always occur within the boundaries of the claim.
Further- the claimed treatments of “administering a CVD therapeutic,” as claimed are not a particular treatment, but instead seem to just be saying to “apply,” the judicial exception.
See MPEP 2016.04(d)(2)a. See quoted section specifying the difference between particular treatment and not. “The claim also recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and “administering a suitable medication to a patient.” This administration step is not particular, and is instead merely instructions to “apply” the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application.”
Step 2B: There is nothing in independent Claim 8 which adds significantly more to the claimed judicial exceptions.
which adds something which is non routine and conventional or significantly more to the claimed abstract idea or natural correlation judicial exception.
“Measuring,” the claimed biomarkers especially as generally claimed using liquid chromatography mass spectrometry, is well understood routine and conventional (WURC) in the art.
This is evidenced by SQUELLERIO in Liquid chromatography-tandem mass spectrometry for simultaneous measurement of thromboxane B2 and 12(S)-hydroxyeicosatetraenoic acid -- SQUELLERIO is used to remedy this and teaches of a method of measuring 12(S)-hydroxyeicosatetraenoic acid (12(S) HETE) by liquid chromatography tandem mass spectrometry (abstract). SQUELLERIO teaches that the 12-LOX products, which include 12(S) HETE are associated with CVD (Page 257, column 1, paragraph 3). SQUELLERIO further teaches of making multiple measurements over time to the 12(S) HETE (Page 259, figure 2).
For the claimed general treatments in Claims 8 and 9, HAZEN teaches of using direct thrombin inhibitors, ACAT inhibitors and CDTP inhibitors among others including anti-inflammatory agents specifically as treatment for CVD (paragraph 0093) and that more aggressive therapy can require administering more medication (so dosing twice)(paragraph 0005, 0093), including anti-inflammatory agents are commonly used to see if they have effect as is instantly done (paragraph 0093).
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 all the time, but only “when,” a “not decreased,” level is found. Even if one or more of the claimed treatments were claimed as required to always happen in step d) within the boundaries of the claim, applicant seems to just be repeating the treatment claimed in step b), and therefore seems to just be done for data gathering for the claimed “evaluating,” of Claim 8, and there would still be no particular practical application based on the comparison. 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 HAZEN which teaches of the body sample being serum, plasma (paragraph 0012). 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 NADLER in US 20130131140 in view of SQUELLERIO in Liquid chromatography-tandem mass spectrometry for simultaneous measurement of thromboxane B2 and 12(S)-hydroxyeicosatetraenoic acid in serum and in further view of HAZEN in US 20110152224.
With respect to Claim 1, NADLER teaches of a method for treatment and for treating or reducing complications associated with increased visceral obesity and inflammation (abstract). More specifically, NADLER teaches that the complication associated with inflammation can be cardiovascular disease (CVD) (paragraph 0004, 0010, 0049, 0051). NADLER even more specifically teaches of measuring 12(S)-HETE activity and testing it against libraries of small molecules or test agents (can be considered administering the claimed CVD therapeutic agent through broadest reasonable interpretation) to screen for/evaluate their ability to inhibit the 12(S)-HETE (inhibit means that they are looking for a decrease is 12(S)-HETE) (paragraph 0056, and Claims 7 & 5). NADLER also teaches of methods for evaluating the treatment of these conditions (paragraph 0051). Further—through broadest reasonable interpretation, any patient, or sample from a person can be considered to be “at risk of developing CVD or cardiovascular thrombosis.”
NADLER does not teach of detecting the 12(S)-HETE by liquid chromatography mass spectrometry, or of treating twice.
SQUELLERIO is used to remedy this and teaches of a method of measuring 12(S)-hydroxyeicosatetraenoic acid (12(S) HETE) by liquid chromatography tandem mass spectrometry (abstract). SQUELLERIO teaches that the 12-LOX products, which include 12(S) HETE are associated with CVD (Page 257, column 1, paragraph 3). SQUELLERIO further teaches of making multiple measurements over time to the 12(S) HETE (Page 259, figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to quantify 12 (S) HETE by LC-MS/MS as is done in SQUELLERIO in the method of NADLER due to the advantage this has for clinical research and in detecting alterations in platelet enzymatic activity (SQUELLERIO, Page 257, column 1, paragraphs 7-8).
NADLER and SQUELLERIO further do not specifically 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 the whole class of HETE’s (which includes 12(S) HETE) 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 during and/or after therapy is indicative of a positive effect of the therapy in the subject (paragraph 0014). During therapy, means that there is more therapy after, so this makes dosing if there is no decrease as claimed obvious as well.
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 methods of NADLER and SQUELLIERO 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, NADLER in view of SQUELLERIO 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 methods of NADLER and SQUELLERIO 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, NADLER and SQUELLERIO teaches of the invention as shown above, but does not teach specifically of diagnosis with CVD of the patient. HAZEN is used to remedy this and teaches that the patient has been diagnosed with CVD (paragraph 0009, 0005, 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 a patient diagnosed with CVD as is done in HAZEN in the methods of NADLER and SQUELLERIO 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 11, NADLER and SQUELLERIO teaches of the invention as shown above, but does not teach specifically of diagnosis with CVD of the patient. HAZEN is used to remedy this and teaches that the patient has been diagnosed with CVD (paragraph 0009, 0005, 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 a patient diagnosed with CVD as is done in HAZEN in the methods of NADLER and SQUELLERIO 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 12, NADLER and SQUELLERIO teaches of the invention as shown above, but does not teach specifically of using serum or blood sample.
HAZEN is used to remedy this and teaches of the body sample being serum, plasma (paragraph 0012). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use a serum or plasma sample as is done in HAZEN in the methods of NADLER and SQUELLERIO due to the advantage characterization of biomarker amounts in such samples has for characterizing the subjects risk of developing CVD (HAZEN, paragraph 0012).
Response to Arguments
Applicant's arguments filed 08/05/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The prior 112b rejections and the prior objections are overcome due to amendments made 08/05/2026. Though this is the case, further 112b rejections are made due to the amendments made 08/05/2026.
The 101 rejections are maintained. As the claims have been significantly amended dated 08/05/2026—the reasons for this are shown in the rejection above.
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).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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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