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 .
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to the apparatus for testing breath samples with a gas sensor, and Species A, embodiment drawn to Figure 1, in the reply filed on 5/14/26 is acknowledged.
Claims 19-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/14/26.
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “at least one user identification device” of claims 15-16 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
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:
“a wireless communication module” in claim 13;
“at least one user identification device” in claim 15; and
“at least two user identification devices” in claim 16.
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 Objections
Claims 2-18 are objected to because of the following informalities: the positive recitation of “a substance” in line 2 should apparently read “the substance”, or the like, for consistent antecedent with the preamble of claim 1. Appropriate correction is required.
Claims 2-18 are objected to because of the following informalities: the positive recitation of “a substance in a sample” should apparently read “the substance in the sample”, or the like, for consistent antecedent with claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
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 11-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 positively recites “a feedback means”.
Claim 12 positively recites “the feedback means”.
Claim 13 positively recites “a wireless communication module”.
For the claimed “feedback means” and “wireless communication module”, the instant Specification while reciting the terms verbatim [0021-0023, 0056-0060] appears to fail to disclose and/or describe any structure(s) that may correspond to either the “feedback means” or the “wireless communication module”. The claimed “feedback means” and “wireless communication module” are a black box with regard to any corresponding disclosed structure(s) such that possession does not appear established. Given the lack of corresponding structure, let alone with any example or specificity, the claimed “feedback means” and “wireless communication module” lack written description. One of ordinary skill in light of the instant Specification would not be apprised of possession of the invention given the lack of written description therefor.
Claim Rejections - 35 USC § 112(b)
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 11-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 positively recites “a feedback means”.
Claim 12 positively recites “the feedback means”.
Claim 13 positively recites “a wireless communication module”.
For the claimed “feedback means” and “wireless communication module”, the instant Specification while reciting the terms verbatim [0021-0023, 0056-0060] appears to fail to disclose and/or describe any structure(s) that may correspond to either the “feedback means” or the “wireless communication module”. The claimed “feedback means” and “wireless communication module” are a black box with regard to the corresponding disclosed structure(s). Given the lack of corresponding structure, let alone with any example or specificity, the claimed “feedback means” and “wireless communication module” appear indefinite because, particularly in the absence of corresponding disclosed structure, the scope of the claim is indeterminate with respect to what may be required and/or excluded to be considered a “feedback means” or a “wireless communication module”. One of ordinary skill in light of the instant Specification would not be apprised of the metes and bounds of the claimed invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ahmad et al. (US 2018/0056302 A1, hereinafter Ahmad).
For claim 1, Ahmad discloses an apparatus for testing for a substance (220) in a sample of breath (Fig 33) ([0345-0346]), comprising inter alia:
a blow tube (250) for receiving a sample of breath (Fig 33 and 36) ([0345-0346]),
a gas sensor (sensor within sensor housing 226) for detecting the substance (Fig 33) ([0345-0346]), and
a filter (filter 224) positioned between the blow tube and the gas sensor (Figs 33) ([0345-0346]).
For claim 2, Ahmad discloses the apparatus according to claim 1, wherein the filter comprises a hydrophobic filter of 5 micron or less (moisture filter 224 may contain desiccant that filters airborne water molecules 3 angstroms in size) ([0200]).
For claim 3, Ahmad discloses the apparatus according to claim 1, further comprising:
an inlet (interior inlet of mouthpiece 221) at an interface between the blow tube and a housing (sensor housing 226) containing the gas sensor (Fig 33) ([0345-0346]),
the inlet having a lesser diameter than the diameter of the blow tube (Fig 33) ([0345-0346]).
For claim 4, Ahmad discloses the apparatus according to claim 1, wherein the blow tube further comprises at least one pressure relief port (223) configured to release pressure in the blow tube caused by the sample of breath entering the inlet (Fig 33) ([0345-0346]).
For claim 5, Ahmad discloses the apparatus according to claim 1, further comprising:
a first pressure sensor ([0087-0122, 0239-0244, 0345-0346, 0379-0400]);
a second pressure sensor ([0087-0122, 0239-0244, 0345-0346, 0379-0400]); and
a flow restrictor (222),
wherein the first pressure sensor is positioned before the flow restrictor, and the second pressure sensor positioned after the flow restrictor ([0087-0122, 0239-0244, 0345-0346, 0379-0400]).
For claim 6, Ahmad discloses the apparatus according to claim 1, wherein a rate of flow of the sample of breath is calculated as a function of a first measurement of absolute pressure measured by the first pressure sensor and a second measurement of absolute pressure measured by the second pressure sensor ([0087-0122, 0239-0244, 0345-0346, 0379-0400]).
For claim 7, Ahmad discloses the apparatus according to claim 6, further comprising:
a pump (225),
wherein: the rate of flow of the sample of breath is calculated as a function of a difference in the first measurement of absolute pressure and the second measurement of absolute pressure that differs by more than a predetermined value ([0087-0122, 0239-0244, 0345-0346, 0379-0400]); and the pump is controlled to vary the rate of flow of the sample of breath ([0087-0122, 0239-0244, 0345-0346, 0379-0400]).
For claim 8, Ahmad discloses the apparatus according to claim 1, wherein the gas sensor is configured to determine a presence of a volatile organic compound in the sample of breath ([0087-0122, 0239-0244, 0345-0346, 0379-0400]).
For claim 9, Ahmad discloses the apparatus h according to claim 1, wherein the gas sensor comprises a photo-ionization detector ([0153]).
For claim 10, Ahmad discloses the apparatus according to claim 1 further comprising an outlet for the sample of breath (Fig 35).
For claim 11, Ahmad discloses the apparatus according to claim 1 further comprising a feedback means (27) configured to indicate a parameter of the sample of breath ([0087-0122, 0239-0244, 0345-0346, 0379-0400]).
For claim 12, Ahmad discloses the apparatus according to claim 11, wherein the feedback means provides a tactile feedback or a visual feedback (27) ([0087-0122, 0239-0244, 0345-0346, 0379-0400]).
For claim 13, Ahmad discloses the apparatus according to claim 1 further comprising a wireless communication module (27) configured to submit data concerning an analysis of the sample of breath to a remote device ([0087-0122, 0239-0244, 0345-0346, 0379-0400]).
For claim 14, Ahmad discloses the apparatus according to claim 1 further comprising a display screen (27) ([0087-0122, 0239-0244, 0345-0346, 0379-0400]).
For claim 15, Ahmad discloses the apparatus according to claim 1 further comprising at least one user identification device (user 1) ([0082]).
For claim 16, Ahmad discloses the apparatus according to claim 15, wherein the at least one user identification device comprises at least two user identification devices (other user 1) ([0082]).
For claim 17, Ahmad discloses the apparatus according to claim 1, wherein the substance to be identified comprises an alcohol (Table 1).
For claim 18, Ahmad discloses the apparatus according to claim 1, wherein the substance to be identified comprises a disulfiram (Table 1 includes acetaldehyde which increases in a patient consuming alcohol while taking disulfiram).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for providing a breath analyzer for substance detection.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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