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 .
Claim Objections
Claims 1-13 are objected to because of the following informalities:
Claim 1, line 6: “remote” should be replaced with –remotely–;
Claims 2-7: in the preambles: “a respiration” should be replaced with –the respiration–;
Claim 2, line 2: “providing” should be replaced with –is configured to provide–;
Claim 3, line 2: –are configured to– should be inserted before “communicate”;
Claim 3, line 1: a comma should be inserted after “claim 1”;
Claims 4 and 5: a comma should be inserted after “claim 3”;
Claim 4, line 2: “produces” should be replaced with –is configured to produce”;
Claim 5, line 2: –configured to be– should be inserted before “sent”;
Claim 6, line 2: –configured to be– should be inserted before “sent”;
Claim 8, line 8: “remote” should be replaced with –remotely–;
Claim 9, line 2: “providing” should be replaced with –is configured to provide–;
Claim 10, line 1: a comma should be inserted after “claim 8”;
Claim 10, line 2: –are configured to– should be inserted before “communicate”;
Claim 11, line 2: “produces” should be replaced with –is configured to produce”;
Claim 11, line 2: “said respiration rate” should be replaced with –said at least one respiration parameter–;
Claims 12 and 13: a comma should be inserted after “claim 10”;
Claim 12, line 2: –configured to be– should be inserted before “sent”; and
Claim 12, line 2: –configured to be– should be inserted before “sent”.
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.
“A first communication module” and “a second communication module” in claims 1 and 8 because they a generic placeholder (i.e., “module”) that is coupled with functional language (“communication”) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The specification does not describe any corresponding structure. Therefore, the elements are being given their broadest reasonable interpretation and are being interpreted to correspond to any element for communication.
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 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 1-14 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 8 recites “said respiration parameter” in line 17. Claim 8 also recites “at least one respiration parameter” in line 15. If there are a plurality of respiration parameters, it is unclear which of the plurality is being referred to by “said respiration parameter” in line 17. For the purposes of examination, the recitation in line 17 will be interpreted to be “said at least one respiration parameter”. Claims 9-14 are rejected by virtue of their dependence from claim 8.
Claim limitations “first communication module” and “second communication module” in claims 1 and 8 invoke 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 structures, materials, or acts for performing the entire claimed function and to clearly link the structures, materials, or acts to the function. In this case, the specification is completely devoid of any structure for performing the communication. Therefore, the claims are indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claims 2-7 and 9-14 are rejected by virtue of their dependence from claims 1 and 8, respectively.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 9 recites “The device for monitoring a respiration rate as recited in claim 8” in line 1. However, claim 8 does not include a device for monitoring a respiration rate, so claim 9 fails to further limit the subject matter of the claim upon which it depends and fails to include all the limitations of the claim upon which it depends. Claims 10-14 recite similar limitations, so it is rejected on similar grounds. The Examiner suggests amending the claims to recite “The device for monitoring [[a]] respiration–.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-7, 8-10, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0273626 A1 (MacDonald) in view of US 2021/0330259 A1 (Liu) and US 2009/0112626 A1 (Talbot)
With regards to claims 1 and 8, MacDonald teaches a device for monitoring respiration and a respiration rate in a patient (¶¶ [0016]-[0022] disclose a nasal insert provided with one or more sensors for monitoring nasal respiration; ¶ [0096] discloses the sensor can be used for measuring the rate of breathing), comprising:
(a) a nasal dilator (¶ [0016] discloses a nasal insert for increasing airflow through the nasal passages; Fig. 9 depicts the nasal insert);
(b) a sensor mounted on said nasal dilator (Fig. 9 and ¶ [0112] disclose a sensor insert 60 including a sensor 65 mounted on the nasal insert; ¶ [0097] discloses the sensor comprises one or more bio-sensors);
(c) a first communication module mounted on said nasal dilator and connected to said sensor (¶ [0097] disclose the sensor comprising a communications module; Fig. 9 and ¶ [0112] disclose the sensor 65 is mounted on the nasal insert)
(d) a second communication module mounted remote from said nasal dilator (¶¶ [0019], [0097] disclose a mobile or non-mobile device for receiving and displaying respiratory data, which indicates that the mobile or non-mobile device has a processor);
(f) a display (¶¶ [0019], [0097] disclose a mobile or non-mobile device for receiving and displaying respiratory data),
Wherein a component of the device is configured to determine at least one respiration parameter or respiration rate (¶¶ [0019], [0096]-[0097] disclose determining rate of breathing. The Examiner notes that the rate of breathing is both a respiration parameter and a respiration rate).
MacDonald is silent regarding whether the sensor is a microphone.
In the same field of endeavor of monitoring respiration parameters, Liu teaches a breath sensor being a microphone (¶ [0030] discloses a sensor for measuring breathing rate being a microphone). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the sensor of MacDonald with the microphone of Liu. Because both elements are capable of being used for measuring a breathing rate, it would have been the simple substitution of one known equivalent element for another to obtain predictable results.
The above combination is silent regarding a processor connected to said second communication module, a display connected to said processor; said first communication module being configured to receive electrical signals from said microphone and transmit data signals based on said electrical signals to said second communication module; said processor being configured to use said data signals from said second communication module to determine at least one respiration parameter or a respiration rate for said patient; and said display being configured to display said respiration parameter or respiration rate determined by said processor.
In a system relevant to the problem of transmitting and analyzing sensor signals, Talbot teaches a processor connected to a second communication module (Fig. 3 and ¶ [0044] depict an ambulatory telemetry device 300 which includes a processing architecture 316 connected to a wireless/wired data communication module(s) 302), a display connected to said processor (Fig. 3 and ¶ [0044] depict a display 306 connected to said processing architecture 316); said first communication module being configured to receive electrical signals from a sensor and transmit data signals based on said electrical signals to said second communication module (Fig. 2 and ¶ [0042] depict a sensor/transmitter unit 200 comprising a sensor transmitter 204 configured to wirelessly transmit a raw unprocessed electrical sensor signal from sensor 202; ¶ [0048] discloses the wireless and/or wired data communication modules 302 is configured to support data communication between device 300 and sensor transmitter 204); said processor being configured to use said data signals from said second communication module to determine at least one biological parameter for said patient (¶ [0045] discloses the SSP 322 of the processing architecture 316 has the same characteristics and functionality of SSP 208; ¶ [0041] discloses the SSP 208 processes the data signals into sensor signals that convey measured glucose values); and said display being configured to display said biological parameter determined by said processor (¶ [0052] discloses a display element 306 is configured to display information such as measured values of the physiological characteristic). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the above combination to incorporate, based on the teachings of Talbot, a processor connected to said second communication module, a display connected to said processor; said first communication module being configured to receive electrical signals from said microphone and transmit data signals based on said electrical signals to said second communication module; said processor being configured to use said data signals from said second communication module to determine at least one respiration parameter or a respiration rate for said patient; and said display being configured to display said respiration parameter or respiration rate determined by said processor. The motivation would have been to provide the system with elements for effectively transmitting, processing, and communicating the sensor parameters.
With regards to claims 2 and 9, the above combination is silent regarding a rechargeable power source mounted on said nasal dilator, said power source providing electrical power to said microphone and said first communication module.
In a system relevant to the problem of transmitting and analyzing sensor signals, Talbot teaches a sensor/transmitter unit comprising a rechargeable power source, said power source providing electrical power to a sensor and said first communication module (Fig. 2 and ¶ [0040] disclose a power unit 206 which may be a rechargeable battery for providing operating power for physiological characteristic sensor 202 and sensor transmitter 204). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor unit mounted on the nasal dilator of MacDonald of the above combination to incorporate a rechargeable power source, said power source providing electrical power to a sensor and said first communication module as taught by Talbot. The motivation would have been to provide the sensor with a power unit, thereby improving the ease of use of the device.
With regards to claims 3 and 10, the above combination teaches or suggests said first and second communication modules communicate using radio signals (¶¶ [0048]-[0049] of Talbot depict the wireless communication being RF, BLUETOOTH, ZigBee, etc.).
With regards to claims 5 and 12, the above combination teaches or suggests said radio signals are sent using a BLUETOOTH format (¶¶ [0048]-[0049] of Talbot depict the wireless communication being RF, BLUETOOTH, ZigBee, etc.).
With regards to claims 6 and 13, the above combination teaches or suggests said radio signals are sent using a ZIGBEE format (¶¶ [0048]-[0049] of Talbot depict the wireless communication being RF, BLUETOOTH, ZigBee, etc.).
With regards to claims 7 and 14, the above combination teaches or suggests said first and second communication modules are connected by a wire (¶ [0048] of Talbot discloses the communication modules supporting wired data communication between device 300 and sensor transmitter 204).
Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over MacDonald in view of Liu and Talbot, as applied to respective claims 1 and 8, and further in view of US 2020/0281523 A1 (Maidel).
With regards to claims 4 and 11, the above combination is silent regarding whether the processor produces an alarm signal when said respiration rate increases beyond a defined threshold.
In the same field of endeavor of monitoring respiratory parameters of a patient, Maidel teaches a processor configured to produce an alarm signal when said respiration rate increases beyond a defined threshold (¶ [0012] discloses a computer processor configured to generate an alert if the sensor signal indicates that the physiological parameter of the subject exceeds the threshold for a given percentage of time, wherein the physiological parameter includes a respiration rate of the subject). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of the above combination to incorporate the processor produces an alarm signal when said respiration rate increases beyond a defined threshold as taught by Maidel. The motivation would have been to alert the user of a potentially dangerous respiratory condition (see ¶ [0009] of Maidel).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C KIM whose telephone number is (571)272-8637. The examiner can normally be reached M-F 8:00 AM - 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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