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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/28/2025 has been entered. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This action is in response to the papers filed on October 28, 2025. Pursuant to amendment filed October 28, 2025, claims 1-12, 18-28, and 35 have been canceled. Claims 13 and 33 are currently amended. Claims 36-42 are newly added.
Therefore claims 13-17, 29-34, and 36-42 are currently examined.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2017/039066, filed on June 23, 2017. Applicants' claim for the benefit of a prior-filed application parent provisional applications 62/354,627, filed June 24, 2016, and 62/354,629 filed June 24, 2016, under 35 U.S.C. 119(e) or under 35 U.S.C. 120,121, or 365(c) is acknowledged.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 112 as follows:
The later-filed application must be an application for a patent for an invention that is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later -filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. Specifically, the instant claim 13 is drawn to electrode assembly positioned to not penetrate a layer of mitral/tufted (M/T) cells and memory storing instructions for numeric concentration outputs is not supported by the earlier specification filed June 24, 2016. Should the applicant disagree, the applicant is encouraged to point out with particularity by page and line number where such support might exist in each intervening document. In order to properly claim priority, the support for each of the claim limitations must exist in each of the intervening documents.
Thus, the earliest possible priority for the instant application is June 24, 2016.
Specification Objection
The disclosure is objected to because of the following informalities: The specification references color drawings, specifically referring to a representative blue line for the average profile in Fig. 7; see [0022]. Necessary correction is required. Applicant may obviate the objection by filing the petition for color drawings.
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show color designated and as described in the specification, see Fig. 7. The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawings will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
Additionally, any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim interpretation
The claims recite the phrase “configured to” in the context of multiple structural and physical features. This language is understood by the ordinary artisan as describing the intended function or purpose of the component, rather than imposing distinct structural limitations, unless accompanied by explicit supporting structure or operational context in the specification. For instance, in the absence of corresponding structure, algorithm, or clear definition in the specification explaining how the components are “configured” to perform the recited functions, such as receive a signal, receive a raw signal, receive signals from a location within a layer, these recitations are interpreted as reciting general capability or intended use. Therefore, during examination, these phrases are interpreted as non-limiting functional language that does not restrict the claims to specific implementations or configurations beyond what is expressly stated.
Furthermore, independent claim 13 recites an apparatus including electrodes, an olfactory system, and generic processors executing instructions to receive signals, determine signatures, and output concentration values. These limitations describe the operation and intended function of the system but do not impose structural distinctions over the prior art sensor systems that similarly acquire neural signals and process them using generic computing components. Thus, patentability is determined by the structural limitation expressly recited in the claims, because functional language describing capabilities or results of operation does not impose additional structural limitations under the broadest reasonable interpretation.
Withdrawn Claim Rejection- 35 USC§ 102
In view of Applicants’ amendments to the instant claims, reciting the positioning of the electrode assembly not penetrating a layer of mitral/tufted (M/T) cells, the rejection under 35 U.S.C. 102(a)(l) as being anticipated by Dong et al. (Biosens Bioelectron. 2013 Nov 15:49:263-9. Epub 2013 May 29. 2013; see IDS 06/03/2021) has been withdrawn. Applicants’ arguments are moot in view of the withdrawn rejection. Applicants’ arguments are moot in view of the withdrawn rejection.
Withdrawn Claim Rejections - 35 USC § 103
In view of Applicants amendment to the instant claims, the rejection under 35 USC § 103 to claims 13-17 and 29-35 as being unpatentable over Zhuang et al. (Biosens Bioelectron. 2015 May 15:67:694-9. Epub 2014 Oct 28), in view of Guo et al. (Sensors and Actuators B: Chemical, Volume 225, 2016, Pages 34-41, ISSN 0925-4005) has been withdrawn. Applicants’ arguments are moot in view of the withdrawn rejection. A response to Applicant’s arguments pertinent to a new or remaining rejection can be found below.
Reason Why Affidavit or Declaration Under 37 CFR 1.132 Is Insufficient: Conclusion
The declaration under 37 CFR 1.132 filed October 28, 2025 is insufficient to overcome the rejection of claims 13-17, 29-34, and 36-42. Claims 36-42 are newly presented and were not previously rejected; therefore, the Declaration is moot with respect to the prior rejection under 35 USC § 103, which has been withdrawn.
With respect to the newly applied rejections under 35 USC § 103 set forth in the present Office Action, the Declaration fails to address the specific teachings of the applied references or to rebut the articulated obviousness rationales. When all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness. Additionally, the declaration primarily includes statements which amount to an affirmation that the claimed subject matter functions as it was intended to function. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof, see MPEP § 716. Furthermore, the Declaration evidence does not establish a nexus between the asserted performance advantages and the structural limitations recited in the claims, which broadly define a biological/electrical interface for receiving LFP signals and determining numeric odorant concentration. Obviousness is evaluated based on what the prior art teaches or suggests to one of ordinary skill in the art, before the effective filing date of the instant application, not whether the prior art explicitly demonstrated identical performance metrics. In view of the referenced prior art, the ordinary artisan would have found it obvious to optimize non-penetrating or surface proximal electrode positioning or placements with a reasonable expectation that odor-dependent information could be extracted.
Claim Rejections - 35 USC § 112(a) – new matter
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.
Claim 13 is newly 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
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 new matter rejection necessitated by
amendment filed October 28, 2025.
37 CFR 1.118 (a) states that "No amendment shall introduce new matter into the disclosure of an application after the filing date of the application".
Claim 13 is directed to a chemical sensor comprising: an electrode assembly comprising a plurality of electrodes positioned on an outer surface of one or more olfactory bulbs and not penetrating a layer of mitral/tufted (M/T) cells. The amendment to claim 13 constitutes new matter. This is seen in part to the specification having no support for any disclosure of an electrode assembly positioned to not penetrate a layer of mitral/tufted (M/T) cells. The specification only discloses positioning within, positioning the electrode in communication with glomeruli, positioning on the surface of the olfactory bulb, positioned on the surface of the mouse OB ([0033-0034]; [0037]; [0040]). Furthermore, the specification does not disclose new amendments, such as the memory storing instructions for numeric concentration outputs. The entirety of the disclosure does not provide any support for this claim element and is thus considered new matter.
MPEP §2163.06 notes:
If new matter is added to the claims, the examiner should reject the claims under 35
U.SC. 112, first paragraph - written description requirement. In re Rasmussen, 650 F2d 1212, 211 USPQ 323 (CCPA 1981).
MPEP §2163.02 teaches that:
Whenever the issue arises, the fundamental factual inquiry is whether a claim defines an invention that is clearly conveyed to those skilled in the art at the time the application was filed. If a claim is amended to include subject matter, limitations, or terminology not present in the application as filed, involving a departure from, addition to, or deletion from the disclosure of the application as filed, the examiner should conclude that the claimed subject matter is not described in that application.
MPEP §2163.06 further notes:
When an amendment is filed in reply to an objection or rejection based on 35 U.SC. 112, first paragraph, a study of the entire application is often necessary to determine whether or not ''new matter" is involved. Applicant should therefore specifically point out the support for any amendments made to the disclosure. (Emphasis added).
New Claim Rejections - 35 USC § 103
Claims 13-17, 29-34, and 36-42 are newly rejected under 35 USC § 103 as being unpatentable over Dong et al. (Biosens Bioelectron. 2013 Nov 15:49:263-9. Epub 2013 May 29. 2013; see IDS 06/03/2021), in view of Zhuang et al. (Biosens Bioelectron. 2015 May 15:67:694-9. Epub 2014 Oct 28), and Guo et al. (Sensors and Actuators B: Chemical, Volume 225, 2016, Pages 34-41, ISSN 0925-4005.
Regarding claims 13 and 17, Dong teaches a bio-electronic chemical sensor comprising a multichannel electrode assembly in communication with the olfactory bulb (OB) of male Sprague-Dawley rats for the purposes of odor detection and classification (Abstract; Fig. 2). Dong employs normal, Sprague-Dawley rats, which are non-human mammals possessing natural glomerular structures in the olfactory bulb. The chemical sensor is taught to comprise microwire electrode array, or an electrode assembly, configured to receive signals from the dorsal olfactory bulb. Activity was observed across the mitral cell layer, and distributed across the dorsal, ventral, medial, and lateral positions of the olfactory bulb, to minimize sampling bias (pg. 62, Section 2.2). Dong additionally teaches a 95% accuracy rate where,
“Extracellular potentials of mitral/tufted (M/T) cells in olfactory bulb (OB) were recorded by implanted 16-channel microwire electrode arrays (Abstract).”
Dong teaches the signals data from individual electrodes were amplified and filtered in two separate frequency bands one from 1–300 Hz and another from 200–5000 Hz. This is consistent with the applicant’s own description (instant specification, [0041]). Dong teaches the electrodes are lowered into the OB and are in contact with superficial structures, such as the glomerular layer, where the mitral/tufted cell layer lies deeper within the olfactory bulb. The glomerular layer lies exterior to the M/T layer, and Dong teaches the positioning of electrodes to record odor-evoked activity at the surface and within the dorsal OB structures. Dong teaches the signals or activities were recorded, and filtered to “obtain local field potential (LFP)”, explicitly teaching that the system is configured to acquire LFP signals (pg. 264, column 1, para. 2).
Furthermore, it is no more than routine experimentation for one of ordinary skill in the art
to discover an optimum value for a result effective variable (MPEP 2144.05). That is to say that
the particular parameter was taught and known to affect the result. In the instant case, electrode placement, distance, or positioning, relative to the olfactory bulb and M/T cell layer was an established result effective variable for odorant stimulative signal acquisition. The ordinary artisan would have recognized that electrode positioning relative to the olfactory bulb layers is adjustable and affects signal acquisition, thereby identifying electrode depth and placement as result-effective variables, further in view of the teachings of Zhuang and Guo.
Zhuang teaches a bio-hybrid olfactory sensor system integrating a microelectrode array with an array of mitral/tufted cells (M/Ts) olfactory bulb tissue to detect and classify multiple odorants (Abstract; Fig. 1). The system is taught to record extracellular potentials, including local field potentials (LFPs), from the olfactory bulb (pg. 696, Section 2.4). Zhuang teaches the placement of electrodes where the depth was adjusted at or near the level of M/T cell layer (pg. 695, column 2, para. 1; pg. 699, column 1, last para.; Fig. 1-2). Moreover, the ordinary artisan would have recognized that precise spatial positioning of electrodes relative to olfactory bulb microanatomy was both feasible and advantageous for enhancing signal specificity and odor stimuli classification accuracy, further in view of Guo. Guo teaches that spatial distributed odor-specific neural responses can be effectively discriminated using surface microelectrode arrays positioned across the dorsal olfactory bulb, and that high-resolution spatiotemporal features of the LFP signal enable odor classification with improved reliability (Fig. 1-6; pg. 35-36, bridging para. and Sections 2.1-2.3). Zhuang teaches bio-hybrid olfactory sensor system with adjustable electrode depth for monitoring odor-evoked potentials, while Guo demonstrates that surface-level electrode arrays across the dorsal olfactory bulb can spatially resolve odor-specific local field potential patterns.
In view of Zhuang’s teachings on depth-dependent signal optimization and Guo’s demonstration of effective surface recordings of odor classification, the ordinary artisan would have been motivated to optimize electrode depth or positioning, such as those taught by Dong, as a predictable and functionally advantageous configuration, yielding a chemical sensor biohybrid system, with a reasonable expectation of success. Hence before the effective filing date, the ordinary artisan would have found it obvious to optimize electrode positioning in the olfactory bulb for odor detection by placing the electrodes to enhance signal specificity and classification accuracy. It would have been obvious to a person of ordinary skill in the art to modify Dong’s olfactory sensor by adjusting electrode placement toward surface-proximal locations exterior to the M/T layer, as taught by Guo, and motivated by Zhuang’s teaching that electrode placement affects signal quality.
Regarding claims 14-16, the combined teachings of Dong, Zhuang, and Guo render claim 13 obvious. Additionally, Dong teaches the electrode arrays are constructed of 35 μm nichrome wire, which was lowered to the dorsal olfactory bulb, where signals activity was observed approximately 300-400 μm, which is taught to correspond to the average depth of the mitral cell layer of the olfactory bulb (Abstract; pg. 264, Sections 2.1 and 2.2). Given that glomeruli are approximately 60-80 μm in diameter, broadly distributed across the olfactory bulb, and that Dong’s design places electrodes throughout the dorsal, ventral, medial, and lateral OB regions, the reference teach electrode positions within 250 μm of glomeruli, further explicated below.
The electrode assembly is recited as being comprised of electrodes located exterior to or not penetrating a layer of mitral/tufted (M/T) cells of the olfactory bulb. The olfactory bulb, as understood in the art and confirmed by the applicant’s own specification, contains over 2000 glomeruli and layers of mitral/tufted cells (instant specification [0004] and [0036-038]). Dong explicitly teaches that,
“Recording locations were widely distributed across the dorsal, ventral, medial, and lateral OB to minimize bias from sampling a restricted population (pg. 264, Section 2.2),”
Given that glomeruli are approximately 60-80 μm in diameter and Dong describes guiding electrodes based on functional signal outputs, it implicitly teaches positioning electrodes within 250 μm of glomeruli. The size of and inter-glomerular distances related to these non-linear physiological structures is known in the art and supported by the specification (instant specification, [0038] and [0040]). Additionally, Dong teaches a 16-channel array, or a plurality of glomeruli within the OB (Abstract; pg. 264, column 1). Given that multiple electrodes were deployed across the bulb and glomerular structure is fundamentally distributed in a ubiquitously widespread nature, Dong teaches a configuration where the electrodes are within 250 μm of an associated glomerulus, absent any evidence to the contrary.
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Dong further teaches inter-electrode spacing compatible with functional signal discrimination and odor-evoked mapping. Dong teaches the range of electrode spacing and configuration for the use of a dense multi-electrode microwire array implanted into small structures like the olfactory bulb of a rodent. Dong’s design parameters show electrode spacing on this scale for discrete signal resolution, provided in supplementary figures, see supplement Figure 1.
Moreover, Zhuang additionally teaches the specific structural dimensions of the microelectrode microwires of 38 μm coated diameter, where the distance between microwires in a row varied from 200 to 300 μm, and the distance between the rows varied from 300 to 500 μm. (pg. 695, Section 2.1). As Zhuang explicitly teaches the adjustment of the electrode position at or near the M/T cell layer as a variable of electrophysiological monitoring activity, the ordinary artisan would have recognized position of the electrode for signal detection as a result effective variable.
Again, regarding the specific placement or positioning of the electrode relative to the glomerulus of the olfactory system, it is not inventive to find optimal workable ranges by routine experimentation. See In re Aller, 220 F.2d 454,456, 105 USPQ 233,235 (CCPA 1955). In light of the teachings of Zhuang, the ordinary artisan would recognize the positioning of the electrode to the array or layer of mitral/tufted cells (M/Ts) of the olfactory bulb as a variable which achieves a recognized result, odor stimulated signal detection, or result effective variable, and been motivated to optimize such variable. Where a variable disclosed in a range in the prior art is taught, there exists a prima facie case of obviousness based on optimization where the variable was recognized in the prior art to be a result-effective variable. That is to say that the particular parameter was taught and known to affect the result.
Regarding claims 29-30, the combined teachings of Dong, Zhuang, and Guo render claim 13 obvious. Additionally, Dong teaches the electrode array receives raw, unprocessed signals directly from neural elements within the OB, including those evoked by odor stimulation (Abstract; pg. 264, Section 2.4). The 16-channel array is implanted such that signal capture occurs at the site of odor-evoked activity, thereby capturing raw signals directly from glomeruli.
Regarding claim 31, the combined teachings of Dong, Zhuang, and Guo render claim 13 obvious. The claim is to a chemical sensor, and the state of the animals as conscious/awake or unconscious/asleep, as recited in the ‘wherein’ clause is not a limiting structural feature. Additionally, Dong teaches that the method of signals analysis can be effective in awake rats, and this is a function of data processing (pg. 268, column 1, para. 3). Hence, Dong reasonably conveys possession of a chemical sensor operable in either physiological state, and the awake condition does not impart any structural distinction to the claimed apparatus.
Regarding claim 32, the combined teachings of Dong, Zhuang, and Guo render claim 13 obvious. Additionally, Dong teaches the electrodes in the plural, a 16-channal microwire electrode array, which implicitly has a surface and are brought into contact with the surface of a cellular layer.
Regarding claim 33, the combined teachings of Dong, Zhuang, and Guo render claim 13 obvious. Dong additionally teaches the electrodes receive signals from the glomeruli stating,
“We have known all olfactory receptor neurons expressing the same ORs converge onto the same glomeruli in the OB, where terminal axons of ORNs make excitatory synapses with apical dendrites of M/T cells, the output elements of the OB. Odors are ultimately represented through the action potential activity of M/T cells, whose selectivity and tuning to odorant molecules are therefore fundamental determinants of OB olfactory coding. Taking advantage of this mechanism, we measured neural responses of M/T cells to different odorants in vivo by implanted 16-channel microwire electrode arrays and then assessed the smell by neural decoding methods based on population vector similarity. (pg. 264, column 1, para. 1)”
Regarding claim 34, the combined teachings of Dong, Zhuang, and Guo render claim 13 obvious. The claim merely requires the probe is ‘configured’ to be inserted into the olfactory bulbs, and the parent claim recites the electrodes are positioned on the outer surface of the olfactory bulbs. Dong teaches the use of a probe suitable for and able to be inserted into the OB, describing construction for such purposes, such as the electrode arrays being constructed with 35 μm nichrome wire and an impedance of 300–500 kΩ at 1 kHz.
Regarding claims 36-39 and 42, the combined teachings of Dong, Zhuang, and Guo render claim 13 obvious. Dong teaches spatial mapping of odor identities of over two, three or four odors (pg. 266, column 1, para. 2). Generating multiple odor-specific spatial representations from multichannel olfactory bulb recordings would be an expected result of applying known neural decoding techniques of spatial LFP mapping, such as those taught by Dong, Zhuang, and Guo. Additionally, the ordinary artisan would have recognized extending such mapping or signature determination to additional odorants as a routine and established application of the same techniques and additional inputs.
The recitations that the first and second odorants are structurally similar, structurally dissimilar, or enantiomers merely describe properties or relationships of the odorants being sensed and do not impose structural limitations of the claimed sensor apparatus. Additionally, regarding the wherein clauses found throughout the instant claim set, it is noted that the claim scope is not limited by claim language that does not limit a claim to a particular structure. Examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are “adapted to” or “adapted for” clauses, “wherein” clauses, and “whereby” clauses. A “whereby” clause that merely expresses the intended result of a process step without positively reciting the step in itself. Ex parte Attig, 7 USPQ2d 1092 (Bd. Pat. App. & Inter. 1986). MPEP 2173.05 III E. A "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003).
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby” clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. See M.P.E.P. § 2111.04.
In this instance, the claims are drawn to the product of a bio-electric electrode assembly chemical sensor ‘nose’, and recitations of the structural nature of the chemicals being sensed are not material to the claimed apparatus. The recited output of olfactory maps and the requirement of chemical structural similarity, dissimilarity, or enantiomeric relationship among the odorants constitute results of the known olfactory sensing and mapping techniques taught by the prior art and limitations directed to the nature of the sensed chemicals, rather than to the claimed invention itself. The cited references are not limited to detecting or classifying any particular class of chemical structures and span a wide range of molecular relationships.
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Regarding claims 40-41, the combined teachings of Dong, Zhuang, and Guo render claim 13 obvious. Additionally, the terms subdural and epidural are relative language, and the ordinary artisan would interpret this as placement relative to the skull or dura matter, in view of the instant specification [0037]. The claims do not specify relative to which anatomical structure the recited placements are defined. Additionally, Dong teaches the placement relative to the cranial dural matter (Fig. S2). Guo additionally teaches the removal of dura matter (Fig. 2; pg. 35, column 2, last para.).
The terms “subdural placement” and “epidural placement” are interpreted as referring to placement relative to the cranial dural matter, as a customary anatomical reference for such terms in neural electrode placement. Dong teaches implantation of a microwire electrode array through the skull and dura matter into the olfactory bulb, which necessarily results in a subdural placement of the electrodes. Concerning claim 41, the selection between epidural and subdural placement is a known alternative. The ordinary artisan would have been motivated to employ an epidural placement as an obvious variation depending on signal quality, invasiveness, and surgical preference, choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success.
Response to Applicants’ arguments as they apply to rejection of claims 13-17, 29-34, and 36-42 under 35 USC § 103
Applicant’s arguments filed October 28, 2025, have been fully considered but they are not persuasive.
At pages 5-8 of the remarks filed October 28, 2025, Applicants essentially argue the following:
None of the cited references teach the “one or more processors are caused to output a numeric concentration for at least one of the first odorant or the second odorant”, and such capability was unexpected and non-obvious.
This argument is not persuasive because the claims do not recite a particular algorithm or novel signal-processing technique for concentration estimation, but instead recite determining a numeric concentration based on spatiotemporal features of LFP signals. Dong and Zhuang both teach extracting odor-dependent features from electrophysiological signals for odor identification and discrimination, and Guo teaches that high-resolution spatiotemporal LFP features enable reliable odor classification. Thus, the ordinary artisan would find determining concentration as a result of signal analysis techniques applied to odor-evoked neural signals to be an obvious and routine process once the odor-specific signals are acquired. The declaration filed does not demonstrate that the claimed concentration output required a unique signal source or processing approach than those taught in the art.
Additionally, in response to applicant's argument that the claims recite the output of numeric concertation or result not contemplated in the referenced prior art, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues that Dong, Zhuang, and Guo all require penetration to the mitral/tufted cell layer, whereas the claims recite electrodes that do not penetrate the M/T layer. Applicant presents post-filing experimental data to support this position.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, the claims are directed to a product, or apparatus, rather than a method and patentability is determined by the structural limitations of the claimed system, not by statements of intended use or functional results such as odor discrimination, concentration determination, or mapping capability. Accordingly, arguments pertaining to achieving particular results or performance outcomes are not persuasive where the claims do not recite structural features that distinguish the claimed apparatus from the prior art.
Furthermore, this argument is not persuasive because the rejection under 35 USC § 103 does not rely on Dong, Zhuang, or Guo disclosing the claimed electrode placement identically, but rather the combination of references teaching electrode positioning within the olfactory bulb as a result-effective variable. As previously responded to, and stated above, Dong teaches that the electrode array, or plurality of electrodes, was lowered until characteristic large unitary activity was observed. Zhuang teaches adjusting electrode position at or near the M/T layer as a variable of electrophysiological monitoring, demonstrating that electrode depth and placement may be modified to obtain desired neural signals.
Conclusion
Claims 13-17, 29-34, and 36-42 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL D LEVIN whose telephone number is (571)270-0616. The examiner can normally be reached Fulltime Teleworker.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.D.L./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699