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
Claims 1-3, 5-8 and 31-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 24, 2025.
Claims 9-13 and 33-36 are examined herein.
Claim Rejections - 35 USC § 112
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.
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for generating a respiratory pressure curve and a mediastinal pressure curve, does not reasonably provide enablement for generating at least one of a ventricular pressure curve or an atrial pressure curve. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The test for undue experimentation includes, but is not limited to the following factors articulated in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988):
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The claim is interpreted as requiring the ability to distinguish between at least one of a ventricular pressure curve or an atrial pressure curve by using an amplifier/filter to separate the pressure signals in different frequency bands and by using a single pressure sensor configured to be disposed in the substernal space.
The substernal space is interpreted to mean the area under the sternum between the sternum and the pericardium.
While filtering pressure changes having a relatively lower frequency from those having a relatively higher frequency is a well-known technique for separating pressure due to breathing versus cardiac activity, Examiner is unaware of a pressure sensor capable of distinguishing between ventricular sounds and atrial sounds using only filtering techniques. The frequencies share far too many similar harmonics for them to be easily distinguished from each other using only frequency.
The specification further does not shed light on the techniques employed in carrying out this task. Paragraph [0194] comes close in stating:
“As shown, the pressure signal data 1261 includes and/or reflects relatively high-frequency pressure changes within the anterior mediastinum of the patient, which are associated with and/or indicative of pressure changes as a result of cardiac function (e.g., ventricular pressure changes). In addition, the pressure signal data 1261 includes and/or reflects relatively low-frequency pressure changes within the anterior mediastinum (e.g., shown as the dashed regression line), which are associated with and/or indicative of pressure changes as a result of respiration. The atrial pressure signal data 1262 includes and/or reflects atrial pressure changes, which can be different from and/or can have a frequency, characteristic, and/or waveform that is separate and/or different from the pressure signal data 1261 (e.g., which may reflect ventricular pressure changes).”
But this is not sufficient to inform one of ordinary skill in the art how to distinguish between these different pressures without resort to some other technique that is neither shown nor described. One of ordinary skill in the art, which may include a skilled physician or engineering graduate, would be forced to guess as to how to go about such a task. This amounts to undue experimentation.
For these reasons, this claim is found to lack enablement under Section 112(a).
Claim 10 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.
The rejection of claim for enablement must necessarily result in a rejection under the written description requirement given that the instructions for configuring a processor to perform the recited capabilities are not disclosed.
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 9-13, 33-36 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.
The term “substernal” is indefinite. A plain mean would be simply an area under the sternum. What is the frame of reference for “under?” The spine? The feet? A more medical meaning would be the area under the sternum between the sternum and the pericardium. Given that there are multiple meanings that call into question the metes and bounds of the claims, they must be rejected under Section 112(b).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9-11, 13, and 33-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0161023 A1 to Manicka in view of US 2013/0060149 A1 to Song et al. (“Song”).
As to claim 9, Manicka discloses an apparatus for assessing a health status of a patient, the apparatus comprising:
an electrical sensor configured to be disposed within a substernal space of the patient (see Fig 6B, elements 150 and 172 and Fig 7, element 188), the electrical sensor configured to detect electrical signals radiating from a heart of the patient;
at least one pressure sensor configured to be disposed within the substernal space (see [0240] – “Sensor(s) 190 can include any suitable sensor, including, but not limited to, temperature sensors, accelerometers, pressure sensors, proximity sensors, infrared sensors, optical sensors, and ultrasonic sensors. The information from sensor(s) 190 allows subcutaneous device 100 to sense physiological parameters of a patient. For example, the data from the sensors can be used to calculate heart rate, heart rhythm, respiration rate, respiration waveform, activity, movement, posture, oxygen saturation, photoplethysmogram (PPG), blood pressure, core body temperature, pulmonary edema, and pulmonary wetness.”).
Manicka fails to disclose
an amplifier/filter coupled to the at least one pressure sensor, the amplifier/filter configured to amplify and filter pressure signal data received from the at least one pressure sensor into pressure signals in different frequency bands; and
a processor configured to execute instructions stored in a memory that cause the processor to:
receive the pressure signals in the different frequency bands;
generate at least one pressure curve based on the pressure signals in different frequency bands;
receive, from the electrical sensor, data associated with the electrical signals radiating from the heart;
correlate the at least one pressure curve to the data associated with the electrical signals; and
determine a health status of the patient based on the correlation.
In a related invention, Song discloses
an amplifier/filter coupled to the at least one pressure sensor, the amplifier/filter configured to amplify and filter pressure signal data received from the at least one pressure sensor into pressure signals in different frequency bands (see Fig 5 and [0056]-[0062]); and
a processor configured to execute instructions stored in a memory that cause the processor to:
receive the pressure signals in the different frequency bands (see [0071]-[0072]);
generate at least one pressure curve based on the pressure signals in different frequency bands (see [0071]-[0072] and Fig 6, element 414 – the pressure “curve” is taken to mean a waveform, which is a time series of pressure data);
receive, from the electrical sensor, data associated with the electrical signals radiating from the heart (see Fig 6, element 416);
correlate the at least one pressure curve to the data associated with the electrical signals (see Fig 6 – the correlation is whether both respiratory and cardiac data fulfill certain requirements); and
determine a health status of the patient based on the correlation (see Fig 6, element 430).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the teachings of Manicka and Song in order to achieve the predictable result of improving the health of the user having, for example, heart failure.
As to claim 10, Song further discloses wherein the at least one pressure curve includes a respiratory pressure curve, a mediastinal pressure curve, and at least one of a ventricular pressure curve or an atrial pressure curve (all of these pressures are inherently present to some extent in the filtered signals of Song).
As to claim 11, Song further discloses wherein n the processor is further configured to execute instructions stored in the memory that cause the processor to:
generate a notification associated with the health status; and
send, via a network, the notification to a compute device (see [0024]-[0027]).
As to claim 13, wherein the apparatus is a diagnostic/treatment device, the processor further configured to execute instructions stored in the memory that cause the processor to:
control, based on the health status of the patient, a generator of an implantable cardioverter defibrillator (ICD) implanted in the patient to generate treatment energy, the ICD including a lead configured to implanted in the substernal space and to apply the treatment energy to the heart of the patient (see [00248]).
As to claim 33, Manicka further discloses wherein the processor is configured to control the generator of the ICD to generate the treatment energy when a degree of the correlation between the at least one pressure curve and the data associated with the electrical signals is above a threshold degree of correlation (see [0072]).
As to claim 34, Song further discloses wherein the treatment energy includes at least one of low-power treatment energy for cardiac pacing or high-power treatment energy for shock therapy (see [0072] and [0076]-[0081]).
As to claim 35, Song further discloses wherein the processor is further configured to control the generator of the ICD such that treatment energy is not generated when the correlation between the at least one pressure curve and the data associated with the electrical signals is below the threshold degree of correlation (see [0090] – apnea therapy is only turned on when apnea is detected, Examiner notes that the changes are made to claims 9 and 33, mutatis mutandis, for the health status being apnea versus heart failure).
As to claim 36, Manicka further discloses wherein the data associated with the electrical signals includes at least one of electrocardiogram signal data or cardiac electrogram signal data (see [0248]).
Claim(s) 12 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Manicka in view of Song as applied to claim 9 above, and further in view of US 2022/0296906 A1 to Westphal et al. (“Westphal”).
As to claim 12, neither Manicka nor Song discloses wherein the processor is further configured to execute instructions stored in the memory that cause the processor to:
provide data associated with the at least one pressure curve and data associated with electrical signals as input into a machine learning model; and
execute the machine learning model to correlate the data associated with the at least one pressure curve and data associated with electrical signals.
However, such machine learning was a well-known tool before the effective filing date of the claimed invention as shown by Westphal (see [0145]-[0147]). It would have been obvious to one of ordinary skill in the art to provide the data of Song with the machine learning of Westphal as the advantages of such models were known for their ability to identify complex relationships between clinical data and patient outcomes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-F, 830am-5pm.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791