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.
Response to Amendment
This Office Action is responsive to the amendment filed 01/27/2026 (“Amendment”). Claims 1-3, 5-7, and 11-13 are currently under consideration. The Office acknowledges the amendments to claims 1-3 and 5-7, as well as the cancellation of claims 4 and 8-10 and the addition of new claims 12 and 13.
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under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
The Amendment is entered in part. All amendments are entered except for those made to the drawings, since they include new matter.
Drawings
The drawings are objected to because the new Figure 7 contains new matter. There is no clear support for much of the text added to the figure, and no explanation for why one of the directional arrows has changed direction. The old Figure 7 contains unreadable text. Thus, 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 Objections
Claim 1 is objected to because of the following informalities: the “and” at the end of lines 3 and 12 and in the middle of line 10 should be deleted. Further, the recitation of “10-B0pg/mm2” should be changed to --10-30µg/mm2--.
Appropriate correction is required.
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: “VOC enrichment module” and “moisture removal module” in claim 1.
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 § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3, 5-7, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2015/0295562 (“Agarwal”) in view of US Patent Application Publication 2007/0048180 (“Gabriel”).
Regarding claim 1, Agarwal teaches [a] non-invasive device for monitoring and/or detection of diabetes in the breath of a subject (Fig. 1, ¶ 0053), comprising: a. a carbon nanotube (CNT) based sensor array (¶¶s 0015, 0053); and b. a printed circuit board (¶¶s 0034, 0067); and c. at least one of a VOC enrichment module, and a moisture removal module (¶ 0068, a filter for preventing dust, smoke, and bigger air-borne particles from entering the air chamber 113), wherein the printed circuit board is in the form of a cassette (Fig. 16), and the CNT based sensor array is adapted to be mounted within said cassette (Fig. 16, ¶¶s 0067 and 0068, etc., PCB 107 supporting sensor array 90), wherein the CNTs are functionalized with at least one of COOH, NH3, and OH (¶¶s 0015, 0058, carboxylic acid), wherein the CNTs reversibly bind with at least one Volatile Organic Compound (VOC) present in the breath of the subject (Fig. 14 and ¶¶s 0051, 0052, 0062), … , and wherein the device is configured to detect an amount of the at least one VOC bound to the CNT based sensor array (¶¶s 0052, 0053, 0057, VOC concentrations, etc.), and wherein a sensitivity of the device for detection of the at least one VOC bound to the CNT based sensor array is 1 part per billion (PPB)(¶¶s 0053, 0057, and Table 1, showing measurements in 1 and even 0.1 ppb increments. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to achieve a sensitivity as in Table 1, since this sensitivity is shown as being possible and is of diagnostic value, which diagnostic value Agarwal achieves (Abstract, ¶ 0057, etc., identifying hypoglycemia via breath)).
Agarwal does not appear to explicitly teach wherein the CNT density per unit area in the CNT based sensor array is in the range of 10-30µg/mm2.
Gabriel teaches that a nanotube density can be changed as desired to provide a desired degree of conductivity (¶ 0063). This means that it is a results-effective variable.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a density as claimed, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 2, Agarwal-Gabriel teaches all the features with respect to claim 1, as outlined above. Agarwal-Gabriel further teaches at least one of a humidity and temperature sensor; and a flow sensor (Agarwal: ¶ 0061, temperature, pressure, and humidity sensors; Gabriel: ¶ 0091, compensating for temperature, pressure, and humidity. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use temperature and humidity sensors in the combination for the purpose of compensating for these factors – Gabriel: ¶ 0091).
Regarding claim 3, Agarwal-Gabriel teaches all the features with respect to claim 13, as outlined herein. Agarwal-Gabriel further teaches wherein said at least one VOC is at least one of acetone, and isoprene (Agarwal: ¶¶s 0015, 0059, Table 1, etc.).
Regarding claim 5, Agarwal-Gabriel teaches all the features with respect to claim 3, as outlined above. Agarwal-Gabriel further teaches wherein binding of acetone equal to or more than 2 parts per million (PPM) is indicative of diabetes condition, and wherein binding of isoprene equal to or more than 1 PPM is indicative of diabetes condition (Agarwal: Table 1 – 1,880 ppb of acetone is ~2 ppm).
Regarding claim 6, Agarwal-Gabriel teaches all the features with respect to claim 1, as outlined above. Agarwal-Gabriel further teaches wherein an accuracy of detection of the at least one VOC bound to the CNT based sensor array is in the range of 95-98% (Gabriel: ¶¶s 0021, 0089, 0117, maximizing accuracy).
Regarding claim 7, Agarwal-Gabriel teaches all the features with respect to claim 1, as outlined above. Agarwal-Gabriel further teaches a software module capable of connecting with a network over wired or wireless media (Agarwal: Abstract).
Regarding claim 11, Agarwal-Gabriel teaches all the features with respect to claim 1, as outlined above. Agarwal-Gabriel further teaches [a] non-invasive device as claimed in claim 1 (see above) for use in detecting and measuring at least a Volatile Organic Compound (VOC) in the breath of a subject for monitoring and/or diagnosis of diabetes (Agarwal: ¶¶s 0053-0055, etc.).
Regarding claim 12, Agarwal-Gabriel teaches all the features with respect to claim 1, as outlined above. Agarwal-Gabriel further teaches wherein the CNT density per unit area of the CNT based sensor array is in the range of 10-20 µg/mm2 (Gabriel teaches that a nanotube density can be changed as desired to provide a desired degree of conductivity (¶ 0063). This means that it is a results-effective variable. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a density as claimed, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges through routine experimentation is not inventive. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)).
Regarding claim 13, Agarwal-Gabriel teaches all the features with respect to claim 1, as outlined above. Agarwal-Gabriel further teaches wherein binding of at least one VOC to the CNTs induces a detectable and measurable change in the electrical conductance of the array (Agarwal: ¶ 0053).
Response to Arguments
Applicant’s arguments filed 01/27/2026 have been fully considered.
The Office agrees that the “VOC enrichment module” and “moisture removal module” are physical features. But, the scope of these features is based on interpretation under 35 USC 112(f).
As outlined above, Agarwal describes the diagnostic concentrations of acetone and isoprene, and also teaches that sensitivity of 1 ppb is relevant and achievable.
The claims do not describe the cassette as having e.g. a top surface, bottom surface, a slot therebetween, etc., for accepting a removable sensor array.
Agarwal teaches functionalization with carboxylic acid, which meets the claim language (¶¶s 0015, 0058, etc.).
Agarwal also has teachings on sensitivity, as noted above. These teachings are relevant because they indicate the requirements for diagnostic value. Then, Gabriel teaches the results-effective nature of nanotube density. Even if a particular density is not mentioned, Gabriel teaches that the density can be optimized to achieve a desired degree of conductivity. Agarwal already contemplates sufficient sensitivity, and there is nothing to suggest that the particular density would not have been obvious to achieve in view of the teachings of the combination. Applicant’s disclosure does not include any reasoning as to why 10-30µg/mm2 is particularly relevant, except that VOCs can be detected. But, the art already contemplates a configuration that enables detection of the relevant VOCs.
Thus, all claims remain rejected in light of the prior art.
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 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