DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/10/26 has been entered.
Claims 1-3, 6, 11-12, 18-19, 21, 24 and 26 have been amended. Claim 25 was previously canceled. Currently, claims 1-24 and 26-30 are pending and under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.
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 1-24, 26 and 30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The claims are directed to a naturally occurring correlation between the levels of the recited lipids in a subject at risk to develop one or more complications of cardiovascular disease (CVD) or the levels in subjects being treated for one or more complications of CVD.
Step 2A, Prong 2
The additional elements of spiking with a synthetic non-endogenous ceramide (Cer) and/or phosphatidylcholine (PC) internal standard and quantifying concentrations of the one or more lipids does not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
With respect to the recitation “determining a lipid profile…..”, assigning the subject as being at risk of developing one or more complications of CVD based on the lipid profile. The “determining” and assigning statements at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the recited lipid levels being correlated one or more complications of CVD. No active method steps are invoked or clearly required; the “determining” and “assigning” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself. Also, with respect to the comparison to a control. Comparison is an abstract idea which can be performed mentally and therefore does not apply, rely on or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
With regard to claims 2, 3 and 26, determining effective treatment in a subject resembles to the Prometheus scenario (Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012) where a treatment was administered to the patient followed by measuring related drug-metabolite. This administering step does not provide a significant weight to the claim amounting more than law of nature. It is because this step is not one that applies, relies on, or uses the judicial exception (Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals (2018)). The step of treating the subject is merely part of data-gathering process. One clinician cannot determine how a treatment works unless administering the treatment to the subjects followed by measuring the biomarkers (MPEP 2106.05(a)). In another word, the initial treatment testing here is not the step one clinician does in response to the law of nature, i.e. identified different lipid metabolites or ratios thereof in patient and treating the identified patient accordingly (See Vanda holding). Overall, the law of nature is at the end of the instant claim, i.e. correlating the levels, i.e. decreased of biomarkers to the phenomena (improved) of organic acidemia. Note, the term “treatment” in claims 20-22 does not specify any particular therapeutic or agent, therefore simply “rest” can be considered under broadest reasonable interpretation and thus patentable weight is given. No additional element adds to the claim amounting significantly more than mere judicial exception.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
Using internal standard for quality assurance is well-known and commonly practiced in the field. For instance, Meikle (III)(US 20080233655) teaches using Cer(ceramide) and PC (phosphatidylcholine) as internal standard for analysis lipid metabolites (section 0084). In addition, Shi (US 20070111316) teaches analyzing lipid metabolites using PC as internal standard (section 0193). Moreover, Watkins (US 20040143461) also teaches using PC as an internal standard for analysis for analyzing lipid metabolites (section 0086). Note, the above Ceramide and PC are non-endogenous synthetic, and administering (spiking) to the samples for quality of the lipid metabolites quantitation. Using these internal standards can be considered part of the assay to ensure quality of the assay. It is not a practical application. Assuming arguendo the internal standard is a practical application, nevertheless it still falls into “well-known, common and routine practice in the field” (see below)
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
Claims 13-15 and 18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed a method of preventing (cl. 13) and prevented (cl. 18) one or more complications of CVD in a subject identified to be at risk from one or more complications of CVD.
The specification on page 1, line 19 discloses that this invention relates to methods and uses involving lipid levels to diagnose, predict, prevent and/or treat atherosclerosis or cardiovascular disease. The specification on page 39, lines 11-13 discloses that the antibody may be used for preventing or treating atherosclerosis or CVD and/or one or more of the above complications in a subject. However, the specification does not provide any data, graphs, examples, experiments to show the prevention of one or more complications of CVD in a subject identified to be at risk from one or more complications of CVD. The term “prevent” (recited in claim 13) is interpreted as implying an absolute and complete prevention of the appearance/onset of complications of CVD, i.e., not any overt symptom or pre-symptomatic marker or damage may be present at any level. The specification fails to reasonably provide written description for prophylaxis (prevention) of complications of CVD in a subject identified to be at risk from one or more complications of CVD . It is recommended to delete the term from the claims.
Written Description
Claims 1-24 and 27-30 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are directed to methods for determining whether a subject is at risk to develop one or more complications of CVD, evaluating the effectiveness of prophylactic treatment for the complications of CVD and detecting a lipid concentrations in a sample from a subject identified to be at risk from one or more complications of CVD by detecting the concentration of the one ore more lipids in any and all samples from any and all subjects. The limitation 'subject’ represents a genus and encompasses human and non-human including mouse, monkey, dog, rat, pig, insects, kangaroo, horse, canine and snake to name a few. The limitation ‘sample’ represents a genus and encompasses tears, semen, liver, urine, kidney, brain, peritoneal fluid, sputum, synovial fluid, lung tissues and vomit to name a few. However, there is inadequate written description in the instant specification for a method of such broad scope as claimed currently.
In order to fulfill the written description requirements set forth under 35 U.S.C § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, each member correlated with the requisite function, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicants have possession the claimed invention. Applicants have not described and established structure-function correlation for a representative number of species within the broad genus of at least the recited ‘subject’, and ‘sample’ such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the full scope of the claimed invention at the time the application was filed.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. When there is substantial structural variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
A review of the instant specification indicates the following. The specification on page 5, lines 15-18 discloses the detection of lipids in a blood sample. The specification on page 7 discloses that the present invention provides novel lipidomic markers for predicting the development of atherosclerosis or cardiovascular disease (CVD). Specifically, it has been found that the lipid molecules, lipid-lipid ratios and lipid-clinical concentration ratios provided herein, when displaying an increased or decreased level -- as the case may be -- in samples from atherosclerotic or CVD patients (which appear to be human), are useful lipidomic markers for the methods and uses in accordance with the present invention. The specification on page 9, lines 18-25 discloses that the sample from the subject and the control sample is preferably a blood sample, more preferably a blood plasma sample or also preferably a blood serum sample. A blood sample can be prepared and plasma or serum, or fractions thereof, can be separated therefrom with techniques well known to the person skilled in the art. Alternatively, both the sample from the subject and the control sample may also be a tissue sample, e.g., artery tissue, such as carotid artery tissue, or artery plaque material, such as carotid artery plaque material. The specification on page 36 discloses that the sample can be a serum sample for determining increases and decreases in the sample. Example 1 on pages 43-44 discloses the use of a blood sample. Page 45, lines 18-25 discloses that to identify biomarkers for coronary artery disease (CVD) risk by analyzing molecular lipid species in human serum, plasma and carotid artery plaques and quantifying the lipids in the sample to show a correlation with CVD. Page 47 of the specification discloses lipid extraction from human samples and discloses that the sample is serum, plasma or carotid artery plaques. The specification does not provide data, testing or examples with a showing that any all and all samples from any and all subjects provide the recited biomarkers and at levels which can be specifically correlated with risk of developing one or more complications of CVD. Also, Torzewski et al, (Hindawl Publishing Corporation, Mediators of Inflammation, Vol 2014, Articles ID 683598, pages 1-7) teaches for example that CRP (biomarker) is an acute phase reactant in humans but not an acute phase reactant in a mouse (e.g. page 1). Van Der Vekens et al., (Cardiovascular Endocrinology, 2013, Vol 2, No. 4,pages 67-76) teaches that markers between human and equine show important species differences, which can be explained by variations in physiology or pathophysiology and also teaches pathological differences in the species (e.g. abstract).
The only examples utilized in the specification appears to be limited to patients that are human and the quantification of the recited lipids in blood, serum, plasma or carotid artery plaques from the patients for determining a patient at risk to develop complications of CVD. The specification does not disclose that the recited biomarkers which appear in blood, serum, plasma or carotid artery plaques also appear in samples such as stool, tears lung tissue, brain tissue, sputum, plural fluid etc. or that such lipids would be expected to be shed, excreted into or found in these samples and correlated with risk of complications of CVD. As stated supra the specification appears to be limited to patients that are human and the quantification of the recited lipids in blood, serum, plasma or carotid artery plaques from the patients for determining a patient at risk to develop complications of CVD
The specification also fails to provide for a correlation of the recited lipids in all patients such as dogs, cats, cows, monkey, horse, rabbit squirrel and mice (as shown supra by Torzewski and Van Der Vekens different species of mammal have different expression of biomarkers and do not correlate to the same condition/disease) The specification also fails to provide that the recited lipids exist in samples such as lung tissue, kidney tissue, stool, saliva, tears, sputum, CSF or liver tissue or that a correlation of these lipids exist in such patients with risk of complications of CVD. Further, it is not well known in the art that these samples provide for the recited lipids and that a correlation exists between such lipids in the samples to risk to develop one or more complications of CVD. The examples in the specification appear to be limited to patients that are human and the quantification of the recited lipids in blood, serum, plasma or carotid artery plaques from the patients for determining a patient at risk to develop complications of CVD. The purpose of the ‘written description; requirement is broader than to merely explain how to ‘make and use’, Applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.
It must be noted that "[t]he applicant must . . . convey to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention." Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir.1991). The invention, is for purposes of the ‘written description’ inquiry, whatever is now claimed.” See page 1117. The specification does not describe the claimed embodiments in sufficient detail to convey to a person skilled in the art that Applicants were in possession of the full scope of the claimed invention at the time of filing. The Written Description Guidelines state: There is an inverse correlation between the level of predictability in the art and the amount of disclosure necessary to satisfy the written description requirement. For example, if there is a well-established correlation between the structure and function in the art, one skilled in the art will be able to reasonably predict the complete structure of the claimed invention from its function. Furthermore, the written description provision of 35 U.S.C § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. The Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, paragraph 1, ‘Written Description’ Requirement (66 FIR 1099-1111, January 5,2001) state, ‘[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the Applicant was in possession of the claimed invention’ (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. Factual evidence of an actual reduction to practice has not been disclosed in the instant specification, nor has Applicant shown the invention was ‘ready for patenting’. The Guidelines further state, ‘[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus' (Id. at 1106). For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. Instant claims are viewed as not meeting the written description provision of 35 U.S.C § 112, first paragraph. The specification fails to disclose the detection of the recited lipids in any and all samples from any and all subjects wherein the lipids are at levels which provide for the quantification of the lipids and at specific concentrations in each sample being correlated with one or more complications of CVD.
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 1-24 and 27-30 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 1, lines 18-19 is indefinite in reciting improper Markush language in reciting “one or more lipids having increased concentration values is (are) selected from:..” because it appears to intend to limit the scope of the lipids recited in the claims but improperly defines it as such. Perhaps, Applicant intends, “one or more lipids having increased concentration values are selected from the group consisting of”.
Claim 1, lines 22-23 is indefinite in reciting improper Markush language in reciting “one or more lipids having decreased concentration values is (are) selected from:..” because it appears to intend to limit the scope of the lipids recited in the claims but improperly defines it as such. Perhaps, Applicant intends, “one or more lipids having decreased concentration values are selected from the group consisting of”.
Claim 2, lines 19-20 is indefinite in reciting improper Markush language in reciting “one or more lipids having decreased concentration values is (are) selected from:..” because it appears to intend to limit the scope of the lipids recited in the claims but improperly defines it as such. Perhaps, Applicant intends, “one or more lipids having decreased concentration values are selected from the group consisting of”.
Claim 2, lines 22-23 is indefinite in reciting improper Markush language in reciting “one or more lipids having increased concentration values is (are) selected from:..” because it appears to intend to limit the scope of the lipids recited in the claims but improperly defines it as such. Perhaps, Applicant intends, “one or more lipids having increased concentration values are selected from the group consisting of”.
Claim 3, lines 20-21 is indefinite in reciting improper Markush language in reciting “one or more lipids having increased concentration values is (are) selected from:..” because it appears to intend to limit the scope of the lipids recited in the claims but improperly defines it as such. Perhaps, Applicant intends, “one or more lipids having increased concentration values are selected from the group consisting of”.
Claim 3, lines 23-24 is indefinite in reciting improper Markush language in reciting “one or more lipids having decreased concentration values is (are) selected from:..” because it appears to intend to limit the scope of the lipids recited in the claims but improperly defines it as such. Perhaps, Applicant intends, “one or more lipids having decreased concentration values are selected from the group consisting of”.
Claim 6, lines 2-3 is indefinite in reciting improper Markush language in reciting “one or more lipids having increased concentration values is (are) selected from:..” because it appears to intend to limit the scope of the lipids recited in the claims but improperly defines it as such. Perhaps, Applicant intends, “one or more lipids having increased concentration values are selected from the group consisting of”.
Claim 6, lines 5-6 is indefinite in reciting improper Markush language in reciting “one or more lipids having decreased concentration values is (are) selected from:..” because it appears to intend to limit the scope of the lipids recited in the claims but improperly defines it as such. Perhaps, Applicant intends, “one or more lipids having decreased concentration values are selected from the group consisting of”.
Claim 8 is indefinite in reciting improper Markush language in reciting “said complications are selected from:..” because it appears to intend to limit the scope of the complications recited in the claim but improperly defines it as such. Perhaps, Applicant intends, “said complications are selected from the group consisting of”.
Claim 12 is indefinite in reciting improper Markush language in reciting “the CVD complications are selected from:..” because it appears to intend to limit the scope of the complications recited in the claim but improperly defines it as such. Perhaps, Applicant intends, “said complications are selected from the group consisting of”.
Claim 23, steps (a-c) is indefinite in reciting improper Markush language in reciting “one or more are selected from:..” because it appears to intend to limit the scope of the lipids recited in the claim but improperly defines it as such. Perhaps, Applicant intends, “said one or more lipid(s)s… are selected from the group consisting of”.
Claim 27, is indefinite in reciting improper Markush language in reciting “one or more lipids… are selected from:..” because it appears to intend to limit the scope of the lipids recited in the claim but improperly defines it as such. Perhaps, Applicant intends, “said one or more lipids… are selected from the group consisting of”.
Claim 29, step (a), is indefinite in reciting improper Markush language in reciting “one or more lipids… are selected from:..” because it appears to intend to limit the scope of the lipids recited in the claim but improperly defines it as such. Perhaps, Applicant intends, “said one or more lipids… are selected from the group consisting of”.
Claim 29, step (b), is indefinite in reciting improper Markush language in reciting “one or more lipid-lipid ratios is (are) selected from:..” because it appears to intend to limit the scope of the lipids recited in the claim but improperly defines it as such. Perhaps, Applicant intends, “said one or more lipids… are selected from the group consisting of”.
Claim 29, step (c), is indefinite in reciting improper Markush language in reciting “one or more lipid-clinical concentraion ratios is (are) selected from:..” because it appears to intend to limit the scope of the lipids recited in the claim but improperly defines it as such. Perhaps, Applicant intends, “said one or more lipids… are selected from the group consisting of”.
Response to Arguments
Applicant's arguments filed 07/10/26 have been fully considered but they are not persuasive.
101 Rejections:
Applicant argues that the claims are directed to improvement in the operation of a technology. Applicant states that similarly to the claims at issue in McRO, not only does the present specification teach how the claimed methods improve a technology, but independent claims 1-3 and 26, when considered as a whole, describe a particular way of determining lipid concentrations using synthetic non-endogenous internal standards, which, as taught in the specification, enables improved quantitation and a reduction in false positives, rather than merely describing disease risk. The claimed methods are therefore directed to a defined analytical technique for generating the lipid measurements used to assess risk, rather than to the correlation itself.
This argument and statements are not found persuasive because as stated above the additional element of spiking the sample with CER and/or PC internal standards are well known and conventional and the use of well-known standard laboratory techniques such as internal standards Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1355, 1362 USPQ2d 1081, 1082-83, 1088 (Fed Cir. 2017) are not sufficient to show an improvement or gathering and analyzing information using conventional techniques and displaying the results, TLI Communications, 823 F.3d at 612-613, 118 USPQ2d at 1747-48 are not sufficient to show an improvement. As stated supra the recited steps of “determining” “assigning” and “comparing” all involve categorizing and/or analyzing information. It has been settled that “[i]nformation as such is an intangible” and “that collecting information, including when limited to particular content (which does not change its character as information),” analyzing it and presenting the results of the collection and analysis without more are patent ineligible abstract concepts, See, e.g. Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1353-54 (Fed Cir. 2016). Thus, the steps in addition to the judicial exception(s) do not do more than describe the judicial exception(s) with general instructions.
Allowable Subject Matter
Claims 1-24 and 26-30 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(a), and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and 35 U.S.C. 101 set forth in this Office action. The prior art of record does not teach nor fairly suggest determining the risk of complications of cardiovascular disease as currently recited.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678
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