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 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.
Claims 1-20 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 claims 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, at the time the application was filed, had possession of the claimed invention.
See MPEP 2163.03 V where a circumstance where an original claim is not sufficiently described and a written description issue arises. Specifically, “An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved.”
In the current application, the term “resonator assembly” introduced in claims 1 and 12 is not fully described and is only disclosed to be corresponding to sensor 926 [see in Specification pg. 15, lines 3-4]. The claims and the Specification appear to set out a desired functional result, which is to receive and return a signal with enough dielectric sensitivity to be able to noninvasively detect target analyte levels, of the “resonator assembly”, without sufficiently identifying how the invention achieves the claimed functional result. See Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 692 (Fed. Cir. 2015) (see also Ariad, 598 F.3d at 1349). The Specification provides no guidance or example as to what is necessary in order to provide “the resonator assembly” having the functional capability of non-invasively detecting analyte levels. Without any such guidance or example in the Specification as to what structure achieves the functional limitation, the Specification does not demonstrate that Applicant possessed the functionally-defined “resonator assembly” recited in the claims. Claims 1-20 are thus rejected under 35 U.S.C. § 112, first paragraph, as failing to meet the written description requirement.
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 1-20 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 recites “a signal level” in line 3. It is unclear if the difference is based on range or based on a simple value. Claim 1 also recites “provide the same” in line 6. It is entirely unclear if the “same” refers back to the previously mentioned OFDM signal. Examiner suggests to explicitly state “the orthogonal frequency division modulation signal.” Claim 1 further recites “back to the digital signal” in line 8. As written, “back to the digital signal” is interpreted as the OFDM signal being converted back to the original digital signal introduced in line 2 of the claim. Examiner suggests amending “back to the digital signal” to “to a returned digital signal,” to align with the claimed “returned digital signal” in line 9 of claim 1. The same clarity issues raised for claim 1 are applicable to claim 12.
Claim 9 recites the limitation "the peak determinator" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 refers to “The method of device 15” in the preamble, but device 15 has not been mentioned in the prior claims. Examiner is interpreting the preamble to mean “the method of claim 15.”
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.
Claims 1 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Margon (US 9035775 B2 – Cited by Applicant) in view of Edmonson et al. (Edmonson PJ, Hunt WD, Stubbs DD, Lee SH. Analogies between digital radio and chemical orthogonality as a method for enhanced analysis of molecular recognition events. Int J Mol Sci. 2008 Feb;9(2):154-168.), hereinafter Edmonson.
Regarding claim 1, and substantially similar limitations in claim 12, Margon discloses a device for driving an electromagnetic sensor, the device comprising: a signal generator configured to generate a digital signal in which a signal level of at least one frequency band among a plurality of frequency bands is different from a signal level of another frequency band [a signal that is generated by a pseudo-random generator, see in Col. 4, lines 48-49]; a converter configured to convert the generated digital signal to an orthogonal frequency division modulation (OFDM) signal [a quadrature amplitude modulation with orthogonal frequency-division multiplexing signal transmitter, see in Col. 2, lines 64-66], to provide the same to a resonator assembly of the electromagnetic sensor, and to convert a signal returned from the resonator assembly back to the digital signal [The step of processing the modulated signal and the return signal to monitor a physiological function comprises the steps of: demodulating the modulated signal and the return signal to recover in-phase and quadrature channels; converting the recovered in-phase and quadrature channels to a digital domain, see in Col. 2, lines 46-51]; a peak detector configured to detect a peak from the returned digital signal [processing of the recovered in-phase and quadrature channels are in the digital domain, see in Col. 2, lines 51-55; see in Figs. 8 and 9; see in Col. 9, lines 57-61]; and a processor [see in Col. 16, lines 63-65].
Margon fails to disclose that the processor is configured to determine an analyte level of a target based on the peak. Examiner notes that Margon only broadly discloses the step of detecting a peak from the returned digital signal and mentions how peaks are relevant to distinct events during a heart period, as Margon pertains to using OFDM signals to monitor heart rate and motion, rather than targeted analyte levels.
However, Edmonson discloses using OFDM with surface acoustic wave (SAW) biosensors, in the context of analyte detection [see on pg. 162, ¶ 2]. Examiner notes that since the present invention failed to disclose details of the “resonator assembly” and corresponding sensor [see above under Claim Rejections - 35 USC § 112], it is interpreted that any resonant sensor can be utilized in the present invention.
Margon and Edmonson are both analogous to the claimed invention because they are in the same field of using OFDM signals for biosensing. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Margon to incorporate the teachings Edmonson to include the use of SAW biosensors as the resonator assembly to for detection of analytes using OFDM signals, as the SAW biosensors can detect analytes with minimal cross reactivity between channels through the use of OFDM signals [see in Edmonson, pg. 162].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
• Abreu (US 20150094914 A1)
• Gupta et al. (US 20200000386 A1)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HY KHANH DOAN whose telephone number is (703)756-5434. The examiner can normally be reached Monday - Friday 8:00 a.m. - 5 p.m..
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/HY KHANH DOAN/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791