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 .
Claims 1-14 are pending and under examination.
Claim Objections
Claims 4, 6 are objected to because of the following informalities: .
It is noted that last line of claim 4 recites measure an “S-parameter” based on the RF biosignal. Claim 5 recites the “S-parameter” with definition in the wherein clause. Since claim 4 is an earlier claim, it is suggested that applicants recite the wherein clause in claim 4 for clarity.
As to claim 6, it is noted wherein clause recite “the reflection coefficient and the transmission coefficient” but there is no such coefficient in claim 1 but the terms appear in claim 5. It is suggested that applicants replace dependency of claim 6 to claim 5 for clarity.
Appropriate correction is required.
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 1-14 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.
As to claim 1, line 5, the term “interconnector” is not clear. From Figure 1, component 30 is the interconnector where samples of β-amyloid can be placed thereupon for detection.
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Based upon the function of component 30, the “interconnector” is not merely an electrical connector to the electrodes (component 21, 22 and 23), the “interconnector” also serves as a “sample” input component for contacting samples. Without this feature, it is not known how one can detect radio frequency for the β-amyloid. For clarification of function. It is suggested the feature of “a reduced graphene oxide as an interconnector for placing and detecting samples containing β-amyloid thereupon and electrically connecting to the signal electrode” (see below).
As to claim 5, the “S-parameter” is defined in the claim, i.e. “wherein the S-parameter is a ratio of reflected/transmitted voltage measured at the output probe to reflected/transmitted voltage measured at the input probe and comprises a reflection coefficient calculated using a signal reflected from the input probe and a transmission coefficient calculated using a signal transmitted from the output probe” (note, as suggested above the “S-parameter” should be in an earlier claim 4)(emphasis added). The issue here is that there is no nexus between the “S-parameter” and the “monomeric” or “oligomeric” β-amyloid. The nexus is important because the diagnosis model for AI learning module is based on the “correlation between the reflection coefficient and the transmission coefficient”. Does the reflection as well as the transmission coefficients have relation to the β-amyloid? Moreover, what are the “probes” of input and output refer to? Is there any connection between the probes with β-amyloid? It is suggested reciting and incorporating the feature of step (c ) in claim 10 with more detailed on monomeric as well as oligomeric measurements as recited in claim 1 for clarity.
As to claim 10, it is an independent claim. This claim is free of prior art but subject to the following clarification, including feature of step (c ) in claim 10 with more detailed on monomeric as well as oligomeric measurements as recited in claim 1 for clarity.
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, 3-14 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 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.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, the court clearly states “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. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification needs “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision.
University of California v. Eli Lilly., 119 F.3d 1559, 43 USPQ2d 1398, the court held that a ‘representative number” of species is required possession of the genus - “structural features common to the members of the genus, which features constitute a substantial portion of the genus.” Enzo Biochem, Inc. V. Gen-Probe Inc, 1567, 43 USPQ2d at 1405, the court adopted the standard that “the written description requirement can be met by ‘show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics ....i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “
The issue here is the term “interconnector electrically connected to the signal electrode to detect β-amyloid”. The specification only states using one species, i.e. reduced graphene oxide (section 0011, 0048, 0064-0066). Applicants also discuss the functional requirements of the interconnector in terms of detecting suitability in section 0066-0065. For instance, if the graphene oxide remains in the oxidized form instead of reduced form, this will cause deterioration in electrochemical properties inherent to graphene. As has been discussed by Chen et al. that several materials, such as gold, carbon nanotube, or iron oxide are not suitable for radio frequency detection due to weak signals (Nat Nanotechnol. 2021 16:717-1724; page 3, first paragraph). Taken together, thus far applicants only show one interconnector material, i.e. reduced graphene oxide, which is less sufficient in justifying in possession of a whole genus.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Min (RSC Adv. 2017 7:574-580).
The current invention directs to a PRODUCT, i.e. radio-frequency biosensor, having a silicon substrate, a signal electrode disposed on the silicon substrate and an interconnector electrically connected to the electrode and a radio-frequency analyzer.
Min teaches radio-frequency biosensing system. Min teaches coating silk protein on silicon substrate where the area of the silk film is considered an interconnector for contacting samples, and the system is connected to signal electrodes for receiving radio-frequency (section 2.2 “Fabrication Process”, and Figure 1).
Figure 1 shows that the silicon based silk film is used for biological detection.
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As to the functionality of the current invention, namely measuring the degrees of amyloid-β in both monomeric and oligomeric form, MPEP §2112 concerning PRODUCT states “[Where] the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)(emphasis added). Although Min does not explicitly teach that the biosensor of his team can be used for analyzing oligo/mono forms of amyloid- β, nevertheless inherently the sensor of Min’s can still perform the same function because of the same components and/or structures. Similarly, reflection and transmission coefficient can also be detected inherently.
The following literatures have been considered as pertinent to the current invention but are not cited as prior art.
Hasim “Structural and Optical Properties of Zinc Oxide Film Prepared Using RF-Sputtering Techniques for Glucose Biosensor” (Int. J. Electrochem. 2012 7:11876-11883).
Chen “Ultra-High Frequency-Radio-Frequency-Acoustic Molecular Imaging with Saline Nanodroplets in Living Subjects” (Nat. Nanotechnol. 2021 16:717-724).
Conclusion
No claim is allowed.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/ Primary Examiner, Art Unit 1678