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 .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-3, and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Seo et al. (A molecular approach to an electrocatalytic hydrogen evolution reaction on single-layer graphene).
Regarding claims 1 and 5, Seo discloses a medical device comprising:
a graphene sensor component (Fig. 1) comprising:
a graphene layer (see: graphene);
at least one self-assembled monolayer disposed on an outer surface of the graphene layer through π-π stacking interactions (pg. 3971/Monolayer formation of porphyrin on graphene: in situ electrochemical scanning tunneling microscopy (EC-STM), see: π-π stacking); and
a readout circuit (pg. 3978/Electronic characterization; pg. 3978/Electrochemical characterization, see: 4200 Keithley semiconductor characterization system) that, in operation, detects changes in capacitance of the graphene sensor component upon binding of an analyte and outputs a signal indicative of the change in capacitance (Keithley 4200-SCS User Manual/pg. 27, see: “Measurement functions” includes “capacitance”);
wherein the self-assembled monolayer provides a Langmuir theta value of at least 0.9 (see:2H-TPP, 2H-TPyP, 2H-TAPP);
wherein the self-assembled monolayer is a porphyrin compound (pg. 3971/col. 1, see: 5,10,15,20-tetraphenyl-21H,23H-porphine; Fig. 1, see: porphyrin structures).
Although the prior art does not disclose the Langmuir theta value of the self-assembled monolayer, the claimed properties are deemed to be inherent to the structure in the prior art since the prior art reference teaches an invention with a substantially similar structure and chemical composition as the claimed invention. Products of identical structure and composition cannot have mutually exclusive properties. The burden is on the Applicants to prove otherwise.
Regarding limitations in claim 1, directed towards the intended use of the instantly claimed medical device for detecting the binding of an analyte, it is the position of the Examiner that the prior art device disclosed by Seo is fully capable of performing the instantly recited function. This interpretation is supported by Saxena et al. (Metal-tetraphenylporphyrin functionalized carbon nanotube composites as sensor for benzene, toluene and xylene vapors), which teaches the use of analogous Metal-tetraphenylporphyrin functionalized carbon nanostructures for the electrical based sensing of benzene, toluene and xylene vapors.
Regarding claims 2 and 3, Seo further discloses the self-assembled monolayer comprising a tetraphenylporphyrin comprising the formula recited in claim 3 (pg. 3971/col. 1, see: 5,10,15,20-tetraphenyl-21H,23H-porphine; Fig. 1, see: porphyrin structures).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (A molecular approach to an electrocatalytic hydrogen evolution reaction on single-layer graphene).
Regarding claims 6 and 7, Seo does not explicitly disclose the self-assembled monolayer provides coverage over the graphene from 99% to 120% by surface area.
As the adsorptive capacity and detection limits are variables that can be modified, among others, by adjusting said coverage, with said adsorptive capacity increasing and detection limits decreasing as the coverage is increased, the precise coverage would have been considered a result effective variable by one having ordinary skill in the art, before the effective filing date of the claimed invention. As such, without showing unexpected results, the claimed coverage cannot be considered critical. Accordingly, one of ordinary skill in the art, before the effective filing date of the claimed invention, would have optimized, by routine experimentation, the coverage of the self-assembled monolayer in the apparatus of Seo to obtain the desired balance between adsorptive capacity and detection limits (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (A molecular approach to an electrocatalytic hydrogen evolution reaction on single-layer graphene), in view of Saxena et al. (Metal-tetraphenylporphyrin functionalized carbon nanotube composites as sensor for benzene, toluene and xylene vapors).
Regarding claim 19, Seo discloses a medical device comprising:
a graphene sensor component (Fig. 1; Fig. 5) comprising:
one or more gate electrodes (pg. 3978/Electronic characterization; pg. see: back gate);
a contact electrode (pg. 3978/Electronic characterization; pg. see: Au source and drain electrodes);
a graphene layer (see: graphene);
a self-assembled monolayer disposed on an outer surface of the graphene layer through π-π stacking interactions (pg. 3971/Monolayer formation of porphyrin on graphene: in situ electrochemical scanning tunneling microscopy (EC-STM), see: π-π stacking);
reading circuitry that, in operation, detects a differential response in capacitance of the graphene sensor component due to the binding of one or more analytes (pg. 3978/Electronic characterization, see: 4200 Keithley semiconductor characterization system);
wherein the self-assembled monolayer provides a Langmuir theta value of at least 0.9 (see:2H-TPP, 2H-TPyP, 2H-TAPP); and
wherein the self-assembled monolayer is a porphyrin compound (pg. 3971/col. 1, see: 5,10,15,20-tetraphenyl-21H,23H-porphine; Fig. 1, see: porphyrin structures).
Although the prior art does not disclose the Langmuir theta value of the self-assembled monolayer, the claimed properties are deemed to be inherent to the structure in the prior art since the prior art reference teaches an invention with a substantially similar structure and chemical composition as the claimed invention. Products of identical structure and composition cannot have mutually exclusive properties. The burden is on the Applicants to prove otherwise.
Seo does not explicitly disclose a housing and a sensor element chamber.
Saxena teaches an analogous Metal-tetraphenylporphyrin functionalized carbon nanostructures (Fig. 1) for the electrical based sensing of benzene, toluene and xylene vapors, arranged within an experimental setup or sensing chemical vapors comprising a gas sensor chamber (Fig. 4). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the graphene nanocomposite disclosed by Seo, into the experimental setup taught by Saxena, in order to reduce background effects in increase experimental reproducibility in order to validate the electrochemical properties of the graphene nanocomposite.
Regarding limitations in claims 19 and 21, directed towards the intended use of the instantly claimed medical device for detecting one or more analytes in a gaseous breath sample, it is the position of the Examiner that the prior art device disclosed by Seo is fully capable of performing the instantly recited function. This interpretation is supported by Saxena et al. (Metal-tetraphenylporphyrin functionalized carbon nanotube composites as sensor for benzene, toluene and xylene vapors), which teaches the use of analogous Metal-tetraphenylporphyrin functionalized carbon nanostructures for the electrical based sensing of benzene, toluene and xylene vapors.
Regarding claim 20, Seo discloses a medical device comprising:
a graphene sensor component (Fig. 1) comprising:
one or more gate electrodes (pg. 3978/Electronic characterization; pg. see: back gate);
a contact electrode (pg. 3978/Electronic characterization; pg. see: Au source and drain electrodes);
a graphene layer (see: graphene);
a self-assembled monolayer disposed on an outer surface of the graphene layer through π-π stacking interactions (pg. 3971/Monolayer formation of porphyrin on graphene: in situ electrochemical scanning tunneling microscopy (EC-STM), see: π-π stacking);
reading circuitry that, in operation, detects a plurality of capacitance measurements across a range of voltages, and further detects a change in the plurality of capacitance measurements across the range of voltages due to the binding of one or more analytes (pg. 3978/Electronic characterization, see: 4200 Keithley semiconductor characterization system);
wherein the self-assembled monolayer provides a Langmuir theta value of at least 0.9 (see: Ni-TPyP, Zn-TPyP, Ni-TAPP, Zn-TAPP, Ni-TPP, Zn-TPP); and
wherein the self-assembled monolayer comprises a metallotetraphenylporphyrin described by the claimed formula (see: Ni-TPyP, Zn-TPyP, Ni-TAPP, Zn-TAPP, Ni-TPP, Zn-TPP).
Seo does not explicitly disclose the metal atom of the claimed formula being selected from the group comprising: aluminum, calcium, magnesium, manganese, iron, cobalt, ruthenium, palladium, or derivatives thereof.
Saxena teaches the use of analogous Metal-tetraphenylporphyrin (Fig. 1) functionalized carbon nanostructures (Fig. 4) for the electrical based sensing of benzene, toluene and xylene vapors, wherein the metal comprises cobalt (Table 1). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to select cobalt as the metal for the metallotetraphenylporphyrin in the device disclosed by Seo, as taught by Saxena, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Although the prior art does not disclose the Langmuir theta value of the self-assembled monolayer, the claimed properties are deemed to be inherent to the structure in the prior art since the prior art reference teaches an invention with a substantially similar structure and chemical composition as the claimed invention. Products of identical structure and composition cannot have mutually exclusive properties. The burden is on the Applicants to prove otherwise.
Seo does not explicitly disclose a housing and a sensor element chamber.
Saxena teaches an analogous Metal-tetraphenylporphyrin functionalized carbon nanostructures (Fig. 1) for the electrical based sensing of benzene, toluene and xylene vapors, arranged within an experimental setup or sensing chemical vapors comprising a gas sensor chamber (Fig. 4). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to incorporate the graphene nanocomposite disclosed by Seo, into the experimental setup taught by Saxena, in order to reduce background effects in increase experimental reproducibility in order to validate the electrochemical properties of the graphene nanocomposite.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (A molecular approach to an electrocatalytic hydrogen evolution reaction on single-layer graphene), in view of Singh et al. (Flexible Graphene-Based Wearable Gas and Chemical Sensors)
.Regarding claim 22, Seo does not explicitly disclose a passive sensor circuit configured to function as an LRC resonator circuit, wherein the resonant frequency of the LRC resonator circuit changes upon binding of the analyte, wherein the readout circuit is configured to detect electrical properties of the passive sensor circuit.
Singh teaches a plurality of graphene based gas and chemical sensor configurations, including an RFID based sensor tag (Figure 16). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to configure the device disclosed by Seo into a passive wireless configuration, as taught by the RFID based sensor tag of Singh, since such a modification would have provided for increased flexibility and mechanical stability (Singh: pg. 34559/col. 2/para. 1) and the advantages provided by wireless communication (Singh: pg. 34574/col. 1/para. 1).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 5-7, and 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-5 of U.S. Patent No. 11,079,371 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the narrower scope of the instantly claimed medical device of U.S. Patent No. 11,079,371 B2 would be fully encompassed by the instant claims (varactor vs. reading circuitry; metallotetraphenylporphyrin vs. tetraphenylporphyrin).
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive.
The Examiner respectfully disagrees with the Applicant’s assertion that claim amendments filed 12/18/2025 distinguish the claims from the previously presented claims filed 08/26/2025.
The Examiner respectfully disagrees with the Applicant’s assertion that the instantly claimed functional language has been dismissed as merely non-limiting statements of intended use.
The amendments which claim that the readout circuit performs the recited functions “in operation” has been interpreted as a statement of intended use as they are literally claimed as the functions performed when the device is “in operation”.
A recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform.
In this particular case, the 4200 Keithley semiconductor characterization system disclosed by the prior art and being interpreted as analogous to the instantly claimed “readout circuit” is fully capable of performing the recited functions since the Keithley 4200-SCS User Manual explicitly discloses it includes a capacitance measuring function (pg. 27, see: “Measurement functions” includes “capacitance”).
The Applicants are advised, further defining the “readout circuit” as comprising a “non-transitory memory” which is “programmed to execute” the instantly recited functions and/or reciting additional functional capabilities would advance prosecution of the Application.
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 ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
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/ROBERT J EOM/ Primary Examiner, Art Unit 1797