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 . 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 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.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/25/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed 02/25/2026 (“Amendment”). Claims 56-62 and 64-66 are currently under consideration. The Office acknowledges the amendments to claim 56, as well as the addition of new claim 67.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Election/Restrictions
Newly submitted claim 67 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The inventions are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the processes for using the product as claimed can be practiced with a materially different product, such as one which does not have a closed loop channel assembly or a pump. The product as claimed can be used in a materially different process, such as one which does not require the step of connecting the sample collecting chamber to the at least one sensor assembly.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 67 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “data processing unit” in claim 56.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 56-62 and 64-66 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.
Regarding claim 56, it 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, claim element “data processing unit” invokes 35 USC 112(f). However, the written description fails to disclose the corresponding structure, material, or acts for the claimed functions. It is unclear what the structure that receives, processes, and communicates data is. See the 35 USC 112(b) and 35 USC 112(f) analysis herein.
Further regarding claim 56, there is no support for the recitation of “data processor” at least because the disclosure does not describe any device which performs the functions associated with this element.
Regarding claims 57-62 and 64-66, they are rejected because they depend on rejected claims.
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 56-62 and 64-66 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 pre-AIA the applicant regards as the invention.
Regarding claim 56, claim limitation “data processing unit” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. It is unclear what the structure that receives, processes, and communicates data is.
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 57-62 and 64-66 are rejected because they depend on rejected claims.
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 56-58, 61, 62, and 64-66 are rejected under 35 U.S.C. 103 as being unpatentable over non-patent publication Pantalei, Simone, et al. "Improving sensing features of a nanocomposite PEDOT: PSS sensor for NO breath monitoring." Sensors and Actuators B: Chemical 179 (2013): 87-94 (“Pantalei”) in view of US Patent Application Publication 2022/0039690 (“Rigas”) and US Patent Application Publication 2019/0285570 (“Levaray”).
Regarding claim 56, Pantalei teaches [a] hand-held device for determining presence of a volatile compound (VC) or the content thereof in at least one gaseous sample (see the reference to "NO breath monitoring" via "an actual handheld device" in abstract), the device comprising: at least two … parts, a first of said at least two … parts comprising a sample collecting chamber (Fig. 4, part of the tubing of the circulation path) and a second of said at least two … parts comprising at least one sensor assembly (see the mention of "a nanocomposite PEDOT:PSS sensor" – also see the sensor of Fig. 4), wherein the sample collecting chamber and the at least one sensor assembly are connected by a closed loop channel assembly to be in gaseous communication (as in Fig. 4 – also see the description, which explains that the measurement chain can be closed in a ring), …; a pump configured, when the sample collecting chamber containing a gaseous sample is associated with the sensor assembly, to direct said sample from the sample collecting chamber to the at least one sensor assembly through the closed loop channel assembly and to circulate said sample from the sample collecting chamber over the at least one sensor assembly over a period of time, wherein the circulation is continuous back to and from the collection chamber and over the sensor assembly to maintain a continuous measurement (see above, e.g. Fig. 4, maintaining recirculation until necessary); a data processor that is in data communication with the sensor assembly (evident from the calculations and figures) …; … .
Pantalei does not appear to explicitly teach the device comprising at least two detachable parts, the data processor storing data relating to a control data set, said data processor being configured to receive from the sensor assembly information relating to presence of VCs or pattern thereof, compare the control data set to the information relating to presence of VCs or pattern thereof to determine a result, and provide a real-time output indicating the presence or absence of one or more VCs and disease state in response and in accordance with the result; and a data user interface unit being in data communication with the output provided by the data processing unit, wherein said at least one sensor assembly comprises a plurality of sensing regions, each of the plurality of sensing regions being provided with a plurality of nanoparticles (although Pantalei does suggest real-time measurement when it describes recirculating a sample to achieve adequate sensor response – see § 2.2, describing the desire to increase sensor response time for real time breath analysis and § 4, overcoming the problem of sensor response time via e.g. the recirculation strategy).
Rigas teaches a device made of detachable parts (¶¶s 0093, 0094, a removable/replaceable sensor). It also teaches a user interface in data communication with a processor (and therefore the output of the processor - Figs. 1-3, etc.), the processor comparing stored control data with sensor information to output information related to VOC presence and disease state (¶¶s 0046, 0154, 0162, 0175, etc., comparison with stored baseline levels, ¶ 0033, VOCs indicative of asthma, ¶ 0068, VOCs indicative of e.g. IBD, etc.). It further teaches the sensor assembly comprising a plurality of sensing regions provided with a plurality of nanoparticles (Fig. 16, ¶¶s 0187, 0261, 0262, etc.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a device like the one of Rigas in Pantalei (e.g. having removable/replaceable components, a plurality of sensing regions, etc.), for the purpose of implementing an easy-to-use configuration (Rigas: ¶¶s 0044, 0083, handheld, portable). It would have been obvious to measure VOCs, compare them to a control/baseline value, and obtain a diagnosis, as in Rigas, for the purpose of being able to achieve reliable and self-administered point of care diagnosis (Rigas: ¶ 0041), including based on many markers other than NO (Rigas: ¶ 0262).
Pantalei-Rigas does not appear to explicitly teach the nanoparticles associated to a surface of each of the plurality of sensing regions, the nanoparticles being surface-associated with a plurality of VC interacting ligand molecules.
Levaray teaches using nanoparticles with a sensing region, the nanoparticles being surface-associated with a plurality of VOC interacting ligand molecules (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use nanoparticles and ligand molecules in the combination as in Levaray, for the purpose of improving sensor sensitivity and selectivity (Levaray: Abstract).
Regarding claim 57, Pantalei-Rigas-Levaray teaches all the features with respect to claim 56, as outlined above. Pantalei-Rigas-Levaray further teaches wherein the sample is a breath sample (Pantalei: Title, Abstract).
Regarding claim 58, Pantalei-Rigas-Levaray teaches all the features with respect to claim 57, as outlined above. Pantalei-Rigas-Levaray further teaches wherein the breath sample is obtained from a subject and is received through an inlet provided in the sample collecting chamber (Pantalei: Fig. 4, e.g. the inlet of V3).
Regarding claim 61, Pantalei-Rigas-Levaray teaches all the features with respect to claim 56, as outlined above. Pantalei-Rigas-Levaray further teaches wherein one or more of said at least two detachable parts is disposable (Rigas: the removeable/replaceable component is disposable).
Regarding claim 62, Pantalei-Rigas-Levaray teaches all the features with respect to claim 56, as outlined above. Pantalei-Rigas-Levaray further teaches wherein the VCs are associated with the metabolism, presence and/or growth of at least one pathogen or involved in the pathogenesis of a disease or disorder (Rigas: ¶ 0033, VOCs indicative of asthma, ¶ 0068, VOCs indicative of IBD, ¶¶s 0007 and 0215, a profile of metabolomics).
Regarding claim 64, Pantalei-Rigas-Levaray teaches all the features with respect to claim 56, as outlined above. Pantalei-Rigas-Levaray further teaches wherein the VC profile differentiates one disease over another, provides an indication of a disease state or progression thereof, identifies onset of a disease at a stage before symptoms develop and/or determines success of a therapeutic treatment (as above in Rigas, the profile differentiates e.g. IBD).
Regarding claim 65, Pantalei-Rigas-Levaray teaches all the features with respect to claim 56, as outlined above. Pantalei-Rigas-Levaray further teaches wherein the sample collecting chamber is configured to receive a gaseous sample while disconnected from the at least one sensor assembly (e.g. when the sensor of Rigas is removed).
Regarding claim 66, Pantalei-Rigas-Levaray teaches all the features with respect to claim 56, as outlined above. Pantalei-Rigas-Levaray further teaches wherein the closed loop channel assembly has at least one outlet operable to exhaust the sample upon demand (Pantalei: Fig. 4, the outlet in the bottom-right, via V4).
Claims 59 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Pantalei-Rigas-Levaray in view of US Patent Application Publication 2007/0261472 (“Flaherty”).
Regarding claims 59 and 60, Pantalei-Rigas-Levaray teaches all the features with respect to claim 57, as outlined above. Pantalei-Rigas-Levaray does not appear to explicitly teach two or more sample collecting chambers, wherein one or more of the sample collecting chambers is an environment testing chamber adapted with one or more sensors providing an initial reading of environmental parameters, wherein the one or more sensors is configured for providing a reading relating to any one of gas composition, carbon dioxide presence and concentration, humidity and sample temperature.
Flaherty teaches using a separate channel to detect ambient/noise conditions that include interfering gases (¶¶s 0036, 0037).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a separate collecting chamber into the combination to collect and test an environmental sample, for the purpose of detecting a noise signal that can be used to correct the breath sample measurement (Flaherty: ¶ 0036).
Response to Arguments
Applicant’s arguments filed 02/25/2026 have been fully considered.
Regarding the amendment of “data processing unit” to “data processor” (in all instances except for the very end of claim 56), it is noted that “data processor” has similar issues of not being discussed anywhere in the specification. Disclosure of an algorithm alone is insufficient because there is no structure to carry out the algorithm.
In response to the arguments regarding the rejections under 35 USC 103, they are not persuasive. Pantalei teaches both a sample collecting chamber and a closed loop channel assembly. One is e.g. part of the tubing of Fig. 4, and the other is e.g. part of the tubing and/or valves of Fig. 4. There is nothing requiring the sample collecting chamber to be the device shown in e.g. Applicant’s Fig. 2B. As for the “detachable” language, the Office notes that e.g. a detachable sensor, as described in Rigas, means that as combined, the sensor assembly of Pantalei is detachable from the sample collecting chamber and the sample collecting chamber is detachable from the sensor assembly. Thus, there are two detachable parts. The claims do not require detachment at e.g. a tube or gaseous pathway (although this is also suggested by Fig. 4 of Pantalei, since the sensor is not necessarily formed integrally with the recirculation path). Regarding Levaray, it is unclear to the Office which claim elements it does not teach that it was cited for. All claims remain rejected in light of the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson, can be reached at telephone number (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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