DETAILED 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 .
Response to Amendment
Applicant’s amendment filed 01/30/2026 is acknowledged. Claims 1, 3, 7 and 12 are amended and claims 15-19 are new.
Claims 1, 3, 7, 12 and 15-19 are under examination.
Claim Interpretation
Claim 1 is amended to add “to determine risk of cardiovascular disease”, followed by steps for measuring physiological and pathological adiponectin. The amended phrase is interpreted as a mental step; determining risk of cardiovascular disease encompasses diagnosis.
Objection/Rejection Withdrawn
Specification
The objection to the disclosure for informalities is withdrawn in response to Applicant’s amendment filed 01/30/2026. Specifically, the specification now has sufficient clarity and contrast between the paper and the writing thereon to permit the direct reproduction of readily legible copies in any number by use of photographic, electrostatic, photo-offset, and microfilming processes and electronic capture by use of digital imaging and optical character recognition as required by 37 CFR 1.52(a) and (b).
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1, 3, 7 and 12 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in response to Applicant’s amendment of claim 1 to add active method steps.
New Rejections – Necessitated by Amendment
Claim Rejections - 35 USC § 112(b)
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, 3, 7 and 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. Applicant’s amendment adds active measuring steps; however, the claim, which recites determining risk of cardiovascular disease, is not clear with respect to how the risk determination is carried out.
Claim Rejections - 35 USC § 112(a)
Claim 15 is 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
New claim 15 depends from claim 1 and recites further comparing
(i) the quantified amount of physiologically active adiponectin,
(ii) the quantified amount of pathologically active adiponectin, or
(iii) both (i) and (ii),
to respective reference values established by measuring amounts of adiponectin having physiological activity and amounts of adiponectin having pathological activity in patients and healthy individuals, and determining disease risk based on the comparison, wherein risk is considered increased when the quantified amount of physiologically active adiponectin is below its reference value or the quantified amount of pathologically active adiponectin is above its reference value.
There is implicit support for parts (i)-(iii) in the claims as originally filed in at least paragraphs [0011], [0041], [0047] and [0048]. There is also implicit support for comparing to reference values of amount of adiponectin having physiological activity or pathological activity in patients and healthy individuals at least at paragraph [0041] and for determining increased risk disease risk based upon a quantified amount of pathologically active adiponectin is above its reference value at least at paragraph [0052]. There is no apparent explicit, implicit or inherent support, however, for determining increased risk when the quantified amount of physiologically active adiponectin is below its reference value in the application as originally filed.
While it may appear obvious that levels of physiologically active adiponectin below a reference value indicates increased cardiovascular disease risk, a patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. See Genentec, Inc, v. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997). The Federal Circuit has pointed out that, under United States law, a description that merely renders a claimed invention obvious may not sufficiently describe the invention for the purposes of the written description requirement of 35 U.S.C. 112 (see Eli Lilly, 119 F.3d at 1567, 43 USPQ2d at 1405). It is noted that obviousness is not the standard for the addition of new limitations to the disclosure (or claims) as filed, but would be obvious over what is expressly disclosed. Lockwood v.American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977). See MPEP 2163.02, which cites Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977).
Lockwood argues that the district court erred by looking solely at the applications themselves. We do not agree. It is the disclosures of the applications that count. Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed. It extends only to that which is disclosed. While the meaning of terms, phrases, or diagrams in a disclosure is to be explained or interpreted from the vantage point of one skilled in the art, all the limitations must appear in the specification. The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date
sought. See Martin v. Mayer, 823 F.2d 500, 504, 3 USPQ2d 1333, 1337 (Fed.Cir. 1987) (stating that it is “not a question of whether one skilled in the art might be able to construct the patentee's device from the teachings of the disclosure…Rather, it is a question whether the application necessarily discloses that particular device.”) (quoting Jepson v. Coleman, 314 F.2d 533, 536, 136 USPQ 647, 649-50 (CCPA 1963)). Lockwood argues that all that is necessary to satisfy the description requirement is to show that one is “in possession” of the invention. Lockwood accurately states the test, see Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed.Cir. 1991), but fails to state how it is satisfied. One shows that one is “in possession” of the invention by describing the invention, with all its claimed limitations, not that which makes it obvious. Id. (“[T]he applicant must also convey to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.”) (emphasis in original). One does that by such descriptive means as words, structures, figures, diagrams, formulas, etc., that fully set forth the claimed invention. Although the exact terms need not be used in haec verba, see Eiselstein v. Frank, 52 F.3d 1035, 1038, 34 USPQ2d 1467, 1470 (Fed.Cir. 1995) (“[T]he prior application need not describe the claimed subject matter in exactly the same terms as used in
the claims...”), the specification must contain an equivalent description of the claimed subject matter. A description which renders obvious the invention for which an earlier filing date is sought is not sufficient.
Applicant cited support for the amendments at p. 6, 1st paragraph of the Remarks filed 01/30/2026, however a careful review of the specification and drawings did not provide support for determining risk is increased when the quantified amount of physiologically active adiponectin is below its reference value. Applicant is invited to specifically point out in the application as originally filed where this limitation is supported. See MPEP § 714.02 and §2163.06.
Rejection Maintained
Claim Rejections - 35 USC § 112(a)
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.
The rejection of claims 1, 3, 7 and 12 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is maintained for reasons of record and the following.
Response to Arguments
Applicant argues at p. 7 of the Remarks filed 01/30/2026 enablement “does not require statistically significant clinical outcomes or definitive diagnostic thresholds”, citing MPEP 2107.03 and In re Brana, 51 F.3d 1560, 1566 (Fed. Cir. 1995). Further, Applicant argues that “post-filing references cannot impose a higher enablement standard than required at the time of filing; they merely confirm operability of the disclosed principles.” Applicant concludes that a later study reporting “undetectable MAC levels in some samples does not negate the operability of the claimed method, nor does it retroactively render the original disclosure non-enabling.”
These arguments have been fully considered, but are not found persuasive. First, MPEP 2107.03 and In re Brana concern situations where the invention is deemed to be wholly inoperative (i.e., “‘incredible’ utility”), a rejection the examiner did not make. Rather, the examiner stated that the guidance set forth in the specification is insufficient to allow the skilled artisan to determine the nexus between the quantity of physiological and pathological adiponectin and determining risk of cardiovascular disease. The MPEP 2164 concerns the enablement requirement. Second, while post-filing date references generally should not be used to demonstrate non-enablement, exceptions to this rule could occur if a later-dated reference provides evidence of what one skilled in the art would have known on or before the effective filing date of the patent application (see MPEP 2164.05(a)).
If a publication demonstrates that those of ordinary skill in the art would find that a particular invention was not enabled years after the filing date, the publication would be evidence that the claimed invention was not possible at the time of filing. See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513-14 (Fed. Cir. 1993) (The court found that an article published 5 years after the filing date of the application adequately supported the examiner’s position that the physiological activity of certain viruses was sufficiently unpredictable so that a person skilled in the art would not have believed that the success with one virus and one animal could be extrapolated successfully to all viruses with all living organisms. Accordingly, the court held that the applicant’s earlier-filed claims not limited to the specific virus or the specific animal were non-enabled).
In the instant case, the post-filing date art of Sasaoka et al. provides evidence of the lack of nexus (i.e., the complexity and lack of predictability) between the quantity of physiological and pathological adiponectin and determining risk of cardiovascular disease.
Applicant argues at pages 7-8 that the claims recite a method for “quantifying adiponectin species, not for guaranteeing a clinical diagnosis”. Applicant argues further that “the specification provides sufficient technical guidance for one skilled in the art to practice the claimed invention”, and how to detect “physiological adiponectin via T-cadherin and pathological adiponectin via LOX-1 interaction a form of adiponectin, which can serve as biomarkers for cardiovascular risk, citing paragraphs [0065]-[0071] and [0086]-[0098] and Figures 6 and 7.
These arguments have been fully considered, but are not found persuasive. First, claim 1 is not limited to quantifying adiponectin species, rather the goal of the claim is to determine cardiovascular risk. Indeed, Applicant argues that the physiological and pathological adiponectin species can serve as biomarkers for cardiovascular risk. The examiner is not questioning the ability or utility of the method steps to detect physiological and pathological adiponectin. Rather, the issue is that the specification does not provide a nexus between levels of physiological and pathological adiponectin and determining cardiovascular disease risk.
Applicant argues at p. 8 of the Remarks filed 01/30/2026 that the examiner’s assertion that the claimed immunoassay was “not well-understood, routine or conventional” at filing “supports novelty rather than lack of enablement.”
To clarify the record, the examiner did not argue that the claimed immunoassay was not well-understood, routine or conventional when making the enablement rejection. Rather, the examiner stated at p. 4 that because the quantification step was particular and not routine at the time of the filing of the invention, no issues needed to be raised under 35 USC 101 (“Because claim 1 encompasses a particular immunoassay that was not routinely performed at the time of filing, any judicial exceptions, such as diagnosis and prognosis, are integrated into a practical application”). See p. 4, 1st paragraph of the Office action mailed 10/01/2025.
Applicant argues that the reference by Sasaoka and colleagues “confirms the principle that modified LDL-adiponectin complexes can be measured and have clinical relevance, even if their study design limits interpretation. Enablement is judged as of the filing date and does not require exhaustive clinical validation.” Applicant also argues that determining risk of cardiovascular disease does not constitute diagnosis or prognosis. Applicant argues that “risk assessment is a recognized application of biomarker quantification and does not demand definitive clinical thresholds” and that “the predictability of immunoassay techniques in the biochemical field weighs heavily in favor of enablement.”
These arguments have been fully considered but are not found persuasive. The examiner raised no issue with regard to the principal that modified LDL-adiponectin complexes can be measured, nor is there any requirement for exhaustive clinical validation. Nevertheless, the assertion that determining risk of cardiovascular disease does not constitute diagnosis is not persuasive. The examiner raised the issue that the specification does not provide a nexus between the biomarkers (physiological and pathological adiponectin) and the determining the risk of cardiovascular disease. For instance, Pischon et al. (Atherosclerosis, 2011; 219: 322-329) teach a study which found “[h]igh levels of total and [high molecular weight] HMW adiponectin, and HMW/total adiponectin ratio are associated with a lower risk of CHD among women” (see abstract). The plain meaning of using biomarkers to determine risk requires some type of correlation between the biomarkers and the presence or absence of disease. Definitive clinical thresholds are not required but determination of risk does require some correlation between biomarkers and presence of disease.
Conclusion
Claims 1, 3, 7, 12 and 15 are rejected and claims 16-19 are allowed.
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 CHRISTINA M BORGEEST whose telephone number is (571)272-4482. The examiner can normally be reached M-F 9-5:30 EDT.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675