DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The action is in response to the application filed on 04/12/2024. Claims 1-18 are pending and examined below.
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.
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:
Gas sampling unit in claim 1
Chemical isolation unit in claim 1
Processing unit in claim 1
Display unit in claim 1
Communication unit in claim 2
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.
“The gas sampling unit” is described as a chamber for receiving a patient’s breath in paragraph [0023] in the PGPub US 20240341623 A1.
“the chemical isolation unit” is described as “include a filter that filters out all non-essential organic compounds from the breath” in paragraph [0023] in the PGPub US 20240341623 A1.
“the processing unit” is not structurally defined in the Specification of the Instant Application.
“the display unit” is not structurally defined in the Specification of the Instant Application.
“the communication unit” is not structurally defined in the Specification of the Instant Application.
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 limitations “processing unit”, “display unit”, and “communication unit” invokes 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 structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The disclosure is devoid of any structure that performs the function of the above limitations in the claims. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
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.
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.
Claim(s) 1-4, 7, 15-16, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20120011918 A1 (hereinafter referred to as “Bacal”) in view of US 20220160297 A1 (hereinafter referred to as “Wu”).
Regarding claim 1, Bacal teaches a congestive heart failure biomarker detector (abstract) comprising the following:
a gas sampling unit adapted to collect a gas sample for evaluating congestive heart failure (as shown in Figures 9-10); and
a chemical isolation unit adapted to selectively isolate a biomarker of interest from the gas sample to a predetermined level of accuracy (The means for extracting and capturing said biomarker (5) have a high chemical affinity with acetone; paragraph [0050]).
Bacal does not explicitly teach a processing unit configured to determine a level of the isolated biomarker of interest; and a display unit configure to display the determined level of the isolated biomarker of interest.
However, Wu teaches a processing unit configured to determine a level of the isolated biomarker of interest (706; paragraph [0172]; Figure 7); and a display unit configure to display the determined level of the isolated biomarker of interest (710; paragraph [0182]; Figure 7). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bacal, to have a processor and display, as taught by Wu, because doing so provides an electronic implementation for determining a gas in a user’s breath and displaying results.
Regarding claim 2, Bacal does not explicitly teach a communications unit configure to communicate the determined level of the isolated biomarker of interest to a computing device.
However, Wu teaches a communications unit configure to communicate the determined level of the isolated biomarker of interest to a computing device (708; paragraph [0181]; Figure 7). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bacal, to have a communications unit, as taught by Wu, because doing so allows a user to share information.
Regarding claim 3, Bacal, in view of Wu, teaches wherein the gas sample comprises a breath gas sample from a patient diagnosed with or experiencing the symptoms of heart failure (paragraphs [0038], [0064]; as taught by Bacal).
Regarding claim 4, Bacal, in view of Wu, teaches wherein the gas sampling unit comprises a portable breath analyzer (“Said device is portable, easy to handle and fast to collect, being compatible with sufferers of heart decompensation”; paragraph [0064]; as taught by Bacal).
Regarding claim 7, Bacal, in view of Wu, teaches wherein the biomarker of interest is acetone (“The biomarker of said diagnosis method is acetone”; paragraph [0063]; as taught by Bacal).
Regarding claim 15, Bacal teaches A method for monitoring acetone levels in a patient diagnosed with congestive heart failure using a portable breath analyzer (paragraph [0038]), comprising:
selectively isolating acetone from each collected breath sample in the plurality of breath samples to a predetermined level of accuracy (paragraph [0050]); and
determining a level of acetone isolated from each collected breath sample in the plurality of breath samples (paragraph [0039]).
Bacal does not explicitly teach collecting a plurality of breath samples from the patient over a predetermined time period; and communicating the determined level of the acetone isolated from each collected breath sample in the plurality of breath samples to the patient and/or a patient caregiver.
However, Wu teaches collecting a plurality of breath samples from the patient over a predetermined time period (paragraph [0173]); and communicating the determined level of the acetone isolated from each collected breath sample in the plurality of breath samples to the patient and/or a patient caregiver (paragraphs [0172]-[0174], [0181]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bacal, to perform repeated measurements and communicate there results, as taught by Wu, because doing so allows for serial quantize monitoring of the same acetone biomarker over time and provides the resulting measurements to health care professionals.
Regarding claim 16, Bacal does not explicitly teach creating a care regime for the patient based at least in part on the determined levels of acetone isolated from each collected breath sample in the plurality of breath samples.
Wu teaches creating a care regime for the patient based at least in part on the determined levels of acetone isolated from each collected breath sample in the plurality of breath samples (paragraphs [0028], [0030], [0032]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bacal to have a care regime as taught by Wu, because doing so provides health care options for a user.
Regarding claim 18, Bacal, in view of Wu, teaches wherein the communicating step comprises displaying the determined level of the acetone isolated from each collected breath sample in the plurality of breath samples (paragraph [0182]; as taught by Wu).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bacal, in view of Wu, as applied to claim 1 above, and further in view of US 20160270704 A1 (hereinafter referred to as “DeTurk”).
Regarding claim 5, Bacal, in view of Wu, does not explicitly teach wherein the gas sample comprises a gas sample emitted from an area of skin of a patient diagnosed with or experiencing the symptoms of heart failure.
However, DeTurk teaches wherein the gas sample comprises a gas sample emitted from an area of skin of a patient diagnosed with or experiencing the symptoms of heart failure (paragraph [0025]; Figures 1-11). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bacal, in view of Wu, to obtain gas samples from a user’s skin, as taught by DeTurk, because doing so provides a source suitable for wearable monitoring.
Regarding claim 6, Bacal, in view of Wu and DeTurk, teaches wherein the gas sampling unit comprises a portable skin gas analyzer (paragraph [0015]-[0017], [0025]; as taught by DeTurk).
Claim(s) 8 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bacal, in view of Wu, as applied to claims 1 and 15 above, and further in view of US 20190391099 A1 (hereinafter referred to as “Jung”).
Regarding claims 8 and 17, Bacal, in view of Wu, does not explicitly teach wherein the predetermined level of accuracy is 50 parts per billion (ppb).
However, Jung teaches wherein the predetermined level of accuracy is 50 parts per billion (ppb) (paragraph [0021]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bacal, in view of Wu, to have the predetermined level of accuracy is 50 parts per billion (ppb), as taught by Jung, because doing so improves sensitivity for detection of low acetone concentrations.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bacal, in view of Wu, as applied to claim 1 above, and further in view of US 20160231309 A1 (hereinafter referred to as “Ahemd”).
Regarding claim 9, Bacal, in view of Wu, does not explicitly teach wherein the display unit comprises a color indicator for displaying the level of the isolated biomarker of interest.
Ahmed teaches wherein the display unit comprises a color indicator for displaying the level of the isolated biomarker of interest (paragraph [0287]; Figure 20). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of to employ colored indicator presentation, as taught by Ahmed, because doing so helps the user distinguish between data points.
Regarding claim 10, Bacal, in view of Wu, does not explicitly teach wherein the display unit comprises a display configured to show trend information for the determined level of the isolated biomarker of interest, including showing whether the level has been increasing or decreasing on a daily and/or moving average basis.
However, Ahmed teaches wherein the display unit comprises a display configured to show trend information for the determined level of the isolated biomarker of interest, including showing whether the level has been increasing or decreasing on a daily and/or moving average basis (paragraphs [0150], [0163]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bacal, in view of Wu, display the historical/daily trends, as taught by Ahmed, because doing so allows the user to see trends over time.
Claim(s) 11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeTurk in view of Bacal.
Regarding claim 11, DeTurk teaches a method for monitoring acetone levels in a patient using a portable skin gas analyzer (abstract), the method comprising the following:
collecting a plurality of gas samples from an area of skin of the patient over a predetermined period of time (paragraphs [0025], [0028], [0050], [0053]; Figures 1-4C);
selectively isolating acetone from each collected skin gas sample in the plurality of skin gas samples to a predetermined level of accuracy (paragraphs [0025]-[0025], [0029]-[0030], [0034], [0036]);
determining a level of the acetone isolated from each collected skin gas sample in the plurality of skin gas samples (paragraphs [0013], [0025]-[0026], [0034]; Figures 1-2A); and
communicating the determined level of the acetone isolated from each collected skin gas sample in the plurality of skin gas samples to the patient and/or a patient caregiver (paragraphs [0013], [0025]-[0026], [0034]-[0035], [0041]-[0044]; Figures 2A and 5).
DeTurk does not explicitly teach that the patient is diagnosed with congestive heart failure or selectively isolating acetone from each collected skin gas sample to a predetermined level of accuracy.
Bacal teaches that the patient is diagnosed with congestive heart failure (paragraphs [0062]-[0066]) and selectively isolating acetone from each collected skin gas sample to a predetermined level of accuracy (The means for extracting and capturing said biomarker (5) have a high chemical affinity with acetone; paragraph [0050]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of DeTurk, to diagnose congestive heart failure and isolating acetone, as taught by Bacal because doing so provides the additional functionality of measuring congestive heart failure based on acetone (which DeTurk already teaches measuring).
Regarding claim 14, DeTurk, in view of Bacal, teaches wherein the communicating step comprises displaying the determined level of the acetone isolated from each collected skin gas sample in the plurality of skin gas samples (paragraphs [0013], [0025]-[0026], [0034]-[0035], [0041]-[0044]; Figures 2A and 5; as taught by DeTurk).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeTurk, in view of Bacal, as applied to claim 11 above, and further in view of Wu.
Regarding claim 12, DeTurk, in view of Bacal, does not explicitly teach creating a care regime for the patient based at least in part on the determined levels of acetone isolated from each collected skin gas sample in the plurality of skin gas samples.
Wu teaches creating a care regime for the patient based at least in part on the determined levels of acetone isolated from each collected skin gas sample in the plurality of skin gas samples (paragraphs [0028], [0030], [0032]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Bacal to have a care regime as taught by Wu, because doing so provides health care options for a user.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over DeTurk, in view of Bacal, as applied to claim 11 above, and further in view of Jung.
Regarding claim 13, Deturk, in view of Bacal, does not explicitly teach wherein the predetermined level of accuracy is 50 parts per billion (ppb).
However, Jung teaches wherein the predetermined level of accuracy is 50 parts per billion (ppb) (paragraph [0021]). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Deturk, in view of Bacal, to have the predetermined level of accuracy is 50 parts per billion (ppb), as taught by Jung, because doing so improves sensitivity for detection of low acetone concentrations.
Conclusion
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/ABID A MUSTANSIR/Examiner, Art Unit 3791
