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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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: “computing device” in claim 17.
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 “computing device,” the device electronics package including CPU 201, etc., as in Fig. 1).
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.
Claims 1-21 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 claims 1 and 20, there is insufficient antecedent basis for the recitation of “the wall of said hollow volume.”
Regarding claim 2, it is unclear how the cylinder is distinct from the tube, since the cylinder being a hollow volume is a tube.
Regarding claim 5, it is unclear how the mouthpiece can be an opening for connection to the nose, or a breathing mask. Those are not mouthpieces.
Regarding claim 8, antecedent basis for the recitation of “a port” is unclear, since claim 1 already recites a port. Is this the same or a new/different port than the one already recited? For purposes of examination, it will be interpreted as a different port.
The term “secure” in claims 15 and 16 is a relative term which renders the claims indefinite. The term “secure” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically, it is unclear what makes the server secure, or what degree of measures is considered “secure.”
Regarding claim 21, antecedent basis for the second recitation of “a memory” is unclear, since one has already been recited. Is this the same or a new/different memory?
Claims 2-19 are rejected because they depend on rejected claims.
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 1-9, 11-13, 17-19, and 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by International Application Publication WO 2021/119305 (“Starr”).
Regarding claim 1, Starr discloses [a] system for measuring pulmonary neuromuscular metrics of a patient comprising: a hollow volume having two ends (Fig. 4, flow chamber 230) with a mouthpiece constructed at one end (Fig. 4, mouthpiece 490), a resistance at the opposite end (Figs. 3 and 4, distal end opening 235 being narrower – also see ¶¶s 00121 and 00122, describing the use of flow restrictor 237 to alter a restriction of a flow path), and a port in the wall of said hollow volume located between said ends (Figs. 3 and 4, port 242); and an electronic device having a first sensor, said sensor connected to said port in said wall (Figs. 3 and 4, sensors 455 and/or 250 connected to the port, the sensors associated with an electronic device as shown in Figs. 2-4), whereby pulmonary neuromuscular metrics for said patient exhaling or inhaling at said mouthpiece are provided for reading by said patient's medical professional (Fig. 14B, PEF, FEV1, FVC, etc. being reported to a healthcare provider).
Regarding claim 21, Starr discloses [a] method for measuring pulmonary neuromuscular metrics for a patient comprising the steps of: powering on an electronic device (the device of Figs. 2-4, etc., powered on via PSUPP 264); initializing an ambient air pressure sensor resident in said electronic device having access to ambient air (Fig. 3, pressure sensor 250 obtaining ambient air pressure via port 246 - ¶ 00107); initializing an air pressure sensor resident in said electronic device having access to air in a hollow volume having a mouthpiece at a proximal end (Fig. 3, pressure sensor 250 obtaining air pressure of flow chamber 230 via port 242 - ¶ 00107; also see mouthpiece 490 in Fig. 4); exhaling by said patient into said mouthpiece (Fig. 15B); measuring the differential air pressure between the ambient air pressure and the air pressure in said hollow volume (¶¶s 00106, 00107, 00109, etc.), said tube having a resistance to air flow at a distal end (Figs. 3 and 4, distal end opening 235 being narrower – also see ¶¶s 00121 and 00122, describing the use of flow restrictor 237 to alter a restriction of a flow path); recording said differential air pressure by said electronic device (Fig. 2, memory 258, ¶¶s 0093, 0095, 00102, etc.); storing said recording in a memory (Fig. 2, memory 258, ¶¶s 0093, 0095, 00102, etc.); analyzing said stored recordings using an algorithm (Fig. 14B, calculating metrics – also see ¶¶s 00191-00194 and claim 40), storing said analysis in a memory (Fig. 2, memory 258, ¶¶s 0093, 0095, 00102, 00193, 00194, etc.); and displaying said analysis whereby pulmonary neuromuscular metrics for said patient are provided for reading by said patient's medical professional (Fig. 14B, PEF, FEV1, FVC, etc. being reported to a healthcare provider).
Regarding claim 2, Starr discloses all the features with respect to claim 1, as outlined above. Starr further discloses in which said hollow volume is selected from the group comprising: a tube, a cylinder, a sphere, and an ovoid spheroid (¶ 00105, cylindrical flow chamber 230).
Regarding claim 3, 4, 6, and 7, Starr discloses all the features with respect to claim 1, as outlined above. Starr further discloses in which said sensor measures air pressure, in which said sensor measures air temperature (¶¶s 0004, 0075, 0096, etc.), in which the output of said sensor is data relating to pulmonary neuromuscular metrics, in which the output of said sensor is data relating to pulmonary neuromuscular metrics (¶¶s 0075 0096, etc., temperature, breath rate, PEF, etc. of the user).
Regarding claim 5, Starr discloses all the features with respect to claim 1, as outlined above. Starr further discloses in which said mouthpiece is selected from the group comprising: an opening for connection to the mouth of said patient (Figs. 4 and 15B); an opening for connection to the nose of said patient; an opening for connection to the mouth and the nose of said patient; and a breathing mask.
Regarding claims 8 and 9, Starr discloses all the features with respect to claim 1, as outlined above. Starr further discloses in which said device additionally comprises: a port (Fig. 3, pressure sensor 250 obtaining ambient air pressure via port 246 - ¶ 00107); a second sensor (¶ 00107, the ambient pressure sensor); a central processing unit (Fig. 2, processor 210); a power supply (Fig. 2, PSUPP 264); a memory (Fig. 2, memory 258), and a wireless transmitter (Fig. 2, communication 262), whereby said second sensor has access to ambient air through said port (¶ 00107), in which said memory has resident therein an application program (¶ 00102, storing operating instructions).
Regarding claim 11, Starr discloses all the features with respect to claim 1, as outlined above. Starr further discloses in which said pulmonary neuromuscular metrics are selected from a group comprising: tidal volume (TV) (¶¶s 00182, 00232, etc.); inspiratory reserve volume (IRV); expiratory reserve volume (ERV); inspiratory capacity (IC); vital capacity (VC) (¶ 00211, etc.); max inspiratory pressure against a calibrated orifice (MIPCO); max expiratory pressure against a calibrated orifice (MEPCO); power of breathing against a calibrated orifice (POWCO) max inspiratory power of breathing against a calibrated orifice (MIPOWCO); max expiratory power of breathing against a calibrated orifice (MEPOWCO); average sustained inspiratory power of breathing against a calibrated orifice (SIPOWCO); average sustained expiratory power of breathing against a calibrated orifice (SEPOWCO); average sustained tidal inspiratory power (TIPOWCO); average sustained tidal expiratory power (TEPOWCO); average sustained work of breathing per liter against a calibrated orifice (WOBCO); minute ventilation (MINUTEV); and cumulative energy expended forcing air through resistance (CEEFR).
Regarding claims 12 and 13, Starr discloses all the features with respect to claim 8, as outlined above. Starr further discloses in which said device additionally comprises at least one light emitting diode (¶ 00101), in which said device additionally comprises a display screen (¶ 00101).
Regarding claim 17, Starr discloses all the features with respect to claim 1, as outlined above. Starr further discloses in which said pulmonary neuromuscular metrics are transmitted to a computing device having a display screen in the possession of said medical professional (Fig. 1, healthcare provider interface 112 or portal 110 including UI 126, ¶ 0086, etc.).
Regarding claim 18, Starr discloses all the features with respect to claim 1, as outlined above. Starr further discloses at least one additional sensor selected from the group comprising: an air pressure sensor; an air temperature sensor; a humidity sensor; a carbon dioxide sensor; and an oxygen sensor (Figs. 2 and 3, capnograph 260 including a CO2 sensor 261, ¶ 00104).
Regarding claim 19, Starr discloses all the features with respect to claim 8, as outlined above. Starr further discloses at least one additional sensor selected from the group comprising: an air pressure sensor; an air temperature sensor; a humidity sensor; a carbon dioxide sensor; and an oxygen sensor (Figs. 2 and 3, capnograph 260 including a CO2 sensor 261, ¶ 00104).
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.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over International Application Publication WO 2021/119305 (“Starr”) in view of US Patent Application Publication 2019/0110714 (“O’Brien”).
Regarding claim 10, Starr teaches all the features with respect to claim 9, as outlined above. Starr further teaches in which said application program is comprised of … a data transfer subroutine (to perform the transfer to e.g. UD 102-1 – see ¶¶s 0093 and 0094, etc.), a data analysis subroutine (Fig. 14B, calculating metrics – also see ¶¶s 00191-00194 and claim 40), and an algorithm for translating sensor readings of said first sensor and said second sensor into pulmonary neuromuscular metrics (Fig. 14B, calculating metrics – also see ¶¶s 00191-00194 and claim 40, as well as ¶¶s 00106, 00109, etc.), but does not appear to explicitly teach that the program includes a start up subroutine or a run-loop subroutine (although these may be implied).
O’Brien teaches a similar device that has a routine which includes a start up subroutine, a run-loop subroutine, and other subroutines (¶¶s 0114 and 0128, Fig. 31A).
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 the subroutines of O’Brien into Starr for the purpose of initializing the device, running different procedures based on different states, and continuously processing new data as appropriate (O’Brien: ¶¶s 0114 and 0128, Fig. 31A ).
Claims 14-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of International Application Publication WO 2021/119305 (“Starr”).
Regarding claim 14, Starr teaches all the features with respect to claim 13, as outlined above. Starr does not appear to explicitly teach in which said pulmonary neuromuscular metrics are mapped graphically on said display screen as a function of time (although Starr is not explicit that the device with the sensor displays this on its screen, it teaches in ¶¶s 0056, 0074, etc. displaying parameters over time (also see Fig. 14B, rendering results on a user device (1441), Fig.15C and ¶ 00207), and ¶ 00101 explains that the UI 256 of the electronic device can display instructions, test results, etc. Therefore, 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 display the metrics over time on the WFM 225 itself (Fig. 2), for the purpose of making the device more standalone, and as already contemplated in ¶ 00101).
Regarding claims 15 and 16, Starr teaches all the features with respect to claims 6 and 7, as outlined above. Starr further teaches in which said data is transmitted wirelessly to a secure computer cloud server running an algorithm that generates said pulmonary neuromuscular metrics (Fig. 1, server 106. Although it is not explicit, ¶ 0051 mentions that a “computing device” can be a server, that a server may be part of a “system,” etc., ¶¶s 0064 and 0065 mention that the server can perform operations in response to sensor inputs, ¶ 0069 mentions that the server can store code to perform disclosed functions, ¶ 0071 mentions a secure database, etc. – also see Fig. 14B, calculating metrics; and ¶¶s 00191-00194 and claim 40. Thus, 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 the server for carrying out the algorithm, as already contemplated, for the purpose of being able to distribute functionality (¶¶s 0064, 0067, etc.), and for more centrally interfacing with a number of devices in an overall system (Fig. 1, ¶ 0064, etc.)).
Regarding claim 20, Starr teaches [a] system for use by a patient in performing therapeutic pulmonary exercises comprising: a hollow volume (Fig. 4, flow chamber 230) having a mouthpiece (Fig. 4, mouthpiece 490), a resistance to air flow (Figs. 3 and 4, distal end opening 235 being narrower – also see ¶¶s 00121 and 00122, describing the use of flow restrictor 237 to alter a restriction of a flow path), and a port in the wall of said hollow volume located between said mouthpiece and said resistance (Figs. 3 and 4, port 242); and an electronic device having at least one sensor and a display screen, said sensor connected to said port in said wall of said hollow volume (Figs. 3 and 4, sensors 455 and/or 250 connected to the port, the sensors associated with an electronic device as shown in Figs. 2-4; note Fig. 2, UI 256 as described in ¶ 00101), whereby said patient is prompted by directions displayed on said display screen (although Starr is not explicit that the device with the sensor displays this on its screen, it teaches in Figs. 15A-15E and 16 prompting a patient with displayed directions (also see Fig. 14B, rendering results on a user device (1441), Fig.15C and ¶ 00207), and ¶ 00101 explains that the UI 256 of the electronic device can display instructions, test results, etc. Therefore, 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 display instructions for prompting the user on the WFM 225 itself (Fig. 2), for the purpose of making the device more standalone, and as already contemplated in ¶ 00101) for performing therapeutic pulmonary exercises by exhaling or inhaling at said mouthpiece (¶¶s 00174, 00177, 00183, etc.) with the result that pulmonary neuromuscular metrics for said patient exhaling or inhaling at said mouthpiece are provided for reading by said patient's medical professional (Fig. 14B, PEF, FEV1, FVC, etc. being reported to a healthcare provider).
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