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 .
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.
Claim 10 is 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.
It appears the limitations of claim 10 “… wherein the support comprises filter paper” have been incorporated into claim 1. Claim 10 lacks proper antecedent basis and is not clear if the “filter paper” is the same “a filter paper support” in claim 1. Clarification can be achieved by the cancelation of claim 10.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sporty et al., Ozbal et al. and Babu et al.
See the appropriate paragraphs of the 2/5/24 non-final office action and the 10/3/25 Decision by the patent Trial and Appeal Board.
The amendments adding “human blood” have incorporated the subject matter of previously rejected dependent claim 13 into claim 1. Additionally, the limitations of “a filter paper support” has been previously addressed in the rejection of claim 10. These amendments do not merit further discussion as these limitations are addressed in the 2/5/26 office action and the Decision by the patent Trial and Appeal Board.
The rejection of Sporty et al., Ozbal et al. and Babu et al. are silent to the NAD “… is detected at a limit of quantitation (LOQ) concentration as low as 5 micromoles …”.
The 10/3/25 Decision by the patent Trial and Appeal Board make the interpretation in the paragraph bridging pages 4-5 , the claim language covers concentrations of NAD over 5 micromoles and the cited art clearly teaches measurements of NAD over 5 micromoles:
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The broadest reasonable interpretation of this claim language is the method detects NAD concentrations at and over 5 micrograms which is met by the 35 USC 103 rejections of record over Sporty et al., Ozbal et al. and Babu et al.
Response to Amendment
The 5/5/26 amendments have been considered, but do not overcome the rejections of record.
On page 4 of Applicant’s remarks state “none of the cited referenced describe or even suggest, a dried human blood on a filter paper support. These issues were addressed under 35 USC 103 as within the skill of the art as articulated by the 10/3/25 Patent Trial and Appeal decision.
The 5/5/26 37 CFR 1.132 declaration by Dr. Sara Smith has been consider and is insufficient to overcome the rejection of claims 1-12 based upon 35 USC 103 as set forth in the last Office action because:
The 5/5/26 37 CFR 1.132 declaration by Dr. Sara Smith states the cited references taken alone or in any combination do not teach or suggest all aspects of independent claim 1. The declaration has not provided any object, factual evidence to support these statements. In the absence of factual evidence, the declaration has been considered the “opinion” of the declarant and is not convincing to overcome the 35 USC 103 rejections of record.
Further, the declaration states the claims are now directed to “a limited of quantitation (LOQ) concentration as low as 5 micromoles …” which has a greater precision/accuracy and is not suggested by the prior art. It is not clear what is unexpected by using the “LOQ” measurement of NAD compared to any other type of concentration measurement and there is no evidence of unexpected results.
Conclusion
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 LYLE A ALEXANDER whose telephone number is (571)272-1254. The examiner can normally be reached M,W-8:30-5; T,thur-6:30am-7pm; off Fri.
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/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797
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