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.
Information Disclosure Statement
The information disclosure statement filed 09/19/2022 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the lined-through information referred to therein has not been considered.
Election/Restrictions
Applicant’s election without traverse of Invention I and specie b. (claims 1-3, 6, 7, and 10-12) in the reply filed on 12/15/2025 is acknowledged.
Claims 4, 5, 8, 9, and 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or specie, there being no allowable generic or linking claim. Accordingly, claims 1-3, 6, 7, and 10-12 are currently under consideration.
Claim Objections
Claim 7 is objected to because of the following informalities: the recitation of “based on the calculated based on the air” should instead read –based on the air--.
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: “information acquisition unit” in claims 1, 7, 10, and 12.
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 (e.g. for “information acquisition unit,” a smartphone camera as described).
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 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.
Claim 11 is 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation “physiological attribute,” and the claim also recites a number of narrower attributes following the term “preferably.” The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Further regarding claim 11, the acronym “BMI” is unclear because it has not been defined.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US Patent Application Publication 2012/0046568 (“Soatto”).
Regarding claim 1, Soatto discloses [a] system for generating an indicator of chronic obstructive pulmonary disease, COPD, in a subject (Fig. 2, ¶ 0003, via spirometry), the system comprising: an elasticated bag configured for inflation by exhalation of the subject (Fig. 2, expandable disposable volume spirometry apparatus 102a or 102b, ¶¶s 0034 and 0035); an information acquisition unit configured to detect a change in a measurable characteristic of the elasticated bag responsive to the subject exhaling into the elasticated bag (Fig. 2, remote non-contact sensor/camera 104, ¶ 0037); and a processor configured to analyze the detected change in the measurable characteristic (Fig. 2, computer 106, ¶ 0037), and to generate, based on the analysis, an indicator of COPD in the subject (¶ 0003, via spirometry).
Regarding claim 2, Soatto discloses all the features with respect to claim 1, as outlined above. Soatto further discloses wherein the measurable characteristic comprises a visual characteristic (¶¶s 0037, 0073, 0074, etc. – the position of salient point features on the inflatable element, or the profile of the grid).
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 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2012/0046568 (“Soatto”) in view of US Patent Application Publication 2016/0022240 (“Yamagata”).
Regarding claim 3, Soatto teaches all the features with respect to claim 2, as outlined above. Soatto further teaches wherein the visual characteristic comprises a spatially distributed graphical pattern on an outer surface of the elasticated bag, and wherein analyzing the detected change comprises determining a volume of air … in the elasticated bag based on a detected change in the size or shape of the spatially distributed graphical pattern (¶¶s 0022, 0035, 0073-0075, 0077, 0078, etc., a pattern including salient point features or a grid, that can be converted to a 3D volume and volume change).
Soatto does not appear to explicitly teach determining a rate of change of volume of air (although volume change is contemplated as indicated above).
Yamagata teaches determining a change rate of a size of an area as being relevant to COPD evaluation (claim 14).
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 determine rate of change of the volume of air (or of the bag) in Soatto as in Yamagata (and as already contemplated by Soatto), for the purpose of more comprehensively evaluating COPD in the patient (Yamagata: claim 14, ¶¶s 0003-0006).
Regarding claim 10, Soatto teaches all the features with respect to claim 1, as outlined above. Soatto further teaches wherein the information acquisition unit is configured to detect the change in the measurable characteristic of the elasticated bag from a full inhalation state of the subject to a full exhalation state of the subject (¶ 0003, measuring the amount of air that can be inhaled and exhaled), but does not appear to explicitly teach wherein analyzing the detected change comprises analyzing a rate of change of the measurable characteristic (although ¶¶s 0022, 0035, 0073-0075, 0077, 0078, etc., describe a pattern including salient point features or a grid, that can be converted to a 3D volume and volume change).
Yamagata teaches determining a change rate of a size of an area as being relevant to COPD evaluation (claim 14).
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 determine rate of change of the volume of air (or of the bag, or of the measurable characteristic) in Soatto as in Yamagata (and as already contemplated by Soatto), for the purpose of more comprehensively evaluating COPD in the patient (Yamagata: claim 14, ¶¶s 0003-0006).
Claims 6 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2012/0046568 (“Soatto”) in view of US Patent Application Publication 2017/0273597 (“Schuelke”).
Regarding claim 6, Soatto teaches all the features with respect to claim 1, as outlined above. Soatto further teaches wherein generating the indicator of COPD comprises: determining a vital capacity of the subject based on the analysis of the detected change in the measurable characteristic (¶¶s 0003, 0051, the amount of air that can be inhaled and exhaled, forced vital capacity), but does not appear to explicitly teach comparing the calculated vital capacity to a predetermined vital capacity; and determining the indicator of COPD based on the comparison.
Schuelke teaches using spirometers to diagnose COPD by comparing measurements to standards, the measurements including e.g. FVC (¶ 0159).
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 compare the FVC of Soatto to a standard, as in Schuelke, to aid in diagnosing COPD (Schuelke: ¶ 0159).
Regarding claim 11, Soatto teaches all the features with respect to claim 1, as outlined above. Soatto does not appear to explicitly teach wherein generating the indicator of COPD is further based on at least one physiological attribute of the subject, and preferably wherein the at least one physiological attribute of the subject comprise at least one of: an age, a sex, a height, a weight, a BMI, present medical conditions, a medical history, an exposure to air pollution, and a smoking history.
Schuelke teaches using spirometers to diagnose COPD by comparing measurements to standards, the measurements including e.g. FVC, and the standards being based on an individual’s age, height, sex, and race/ethnicity (¶ 0159).
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 base the indicator of COPD in Soatto on a physiological attribute of the subject, as in Schuelke, for the purpose of making the indicator more accurate with respect to different populations, etc. (Schuelke: ¶ 0159).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication 2012/0046568 (“Soatto”) in view of US Patent Application Publication 2016/0186123 (“Nanba”) and US Patent Application Publication 2010/0050735 (“Varney”).
Regarding claim 12, Soatto teaches all the features with respect to claim 1, as outlined above. Soatto does not appear to explicitly teach wherein the elasticated bag further comprises a colorimetric sensor suitable for determining a CO2 concentration of the gas within the elasticated bag, and wherein the information acquisition unit is further configured to receive the CO2 concentration of the exhaled gas within the elasticated bag responsive to the subject exhaling into the elasticated bag, and wherein the indicator of COPD is further based on an analysis of the CO2 concentration.
Nanba teaches using a colorimetric sensor to measure carbon dioxide concentration inside a bag based on optical means (¶ 0010).
Varney teaches the importance of evaluating carbon dioxide concentration in determining extent and/or progress of COPD (¶ 0002).
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 colorimetric sensor into the bag of Soatto, and to detect CO2 concentration optically using Soatto’s camera, as in Nanba, for the purpose of being able to evaluate extend and/or progress of COPD (Varney: ¶ 0002), including in a continuous, sterile, and non-contact manner (Nanba: ¶ 0010).
Allowable Subject Matter
Claim 7 is allowable over the prior art, but is objected to as being dependent upon rejected base claims. Therefore, it will be allowed if the 35 USC 112(b) rejections are overcome, and if rewritten in independent form including all of the limitations of the base claims and any intervening claims.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements (i.e., the claim objection) or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to teach or fairly suggest the elasticated bag comprising a pressure sensor whose measurement the information acquisition unit can use, together with a compliance of the elasticated bag, to calculate vital lung capacity, in combination with all other recited limitations.
Although it is generally known that volume can be determined from pressure and compliance, and US Patent Application Publication 2018/0160970 (“Khoury”) teaches determining compliance in the context of a breath bag (Fig. 1, Abstract, ¶ 0034, etc.), this is with respect to pulmonary/lung compliance, and not necessarily compliance of an elasticated bag. Further, the volume is not necessarily vital capacity.
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