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
Claim 7 is objected to because of the following informalities: line 1 “any of” should be removed”. Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, and 7-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) a mental process of comparing data and determining an adjusted physiologic pacing rate. This judicial exception is not integrated into a practical application because the memory and processor are generically recited computer elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because memory and processor are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification in published paragraph [0073], disclose the instructions may be stored in a memory of the computer system. A processor may be a central processing unit (CPU), a graphics processing unit (GPU), or any suitable types of processing unit. Accordingly, in light of Applicant’s specification, the claimed term memory and processor is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the memory and processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
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.
Claim(s) 1-5, and 12-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stahmann et al (US Publication 2011/0144712).
Referring to Claim 1, Stahmann et al teaches a method for determining an adjusted physiologic pacing rate (e.g. Paragraph [0049] discloses pacing pulse delivery can be adjusted, hereby inducing the production and release of atrial natriuretic hormones), the method comprising: receiving one or more biomarker levels, wherein the biomarker levels indicate levels of at least one of atrial natriuretic peptide (ANP), B-type natriuretic peptide (BNP), N-terminal pro b-type natriuretic peptide (NT-proBNP), or C-type natriuretic peptide (CNP) (e.g. Figure 2, Element 216 and Paragraph [0053] and [0074] discloses measuring one or more natriuretic peptides); comparing the one or more biomarker levels to a target biomarker level (e.g. Paragraph [0077] discloses increasing atrial natriuretic hormone when the one or more natriuretic peptides is below a threshold value); determining an adjusted physiologic pacing rate based on comparing the one or more biomarker levels to the target biomarker level (e.g. Paragraphs [0049] and [0077] discloses based on the comparison to the threshold triggering operation to adjust the timing of pacing to induce the production and release of atrial natriuretic hormone).
Referring to Claim 2, Stahmann et al teaches the method of claim 1, further comprising determining of at least one of the ANP, the BNP, the NT-proBNP, or the CNP based on the one or more biomarker level (e.g. Paragraphs [0002] and [0077]).
Referring to Claim 3, Stahmann et al teaches the method of claim 1, further comprising: receiving one or more physiological inputs (e.g. Figure 2, Elements 214, 202 and 206); comparing the one or more physiological inputs to a threshold physiological input (e.g. Figure 5, Element 506/508 and Paragraph [0078]); determining an adjusted physiologic pacing rate further based on comparing the one or more physiological inputs to the threshold physiological input (e.g. Paragraphs [0078]-[0079]).
Referring to Claim 4, Stahmann et al teaches the method of claim 1, further comprising outputting the adjusted physiological pacing rate (e.g. Paragraph [0079]).
Referring to Claim 5, Stahmann et al teaches the method of claim 1, further comprising causing a pacing device to pace based on the adjusted physiological pacing rate (e.g. Paragraph [0079]).
Referring to Claim 12, Stahmann et al teaches the method of claim 1, wherein the adjusted physiological pacing rate causes stimulation of a heart, wherein the stimulation of the heart causes a release of hormones (e.g. Paragraph [0049]).
Referring to Claim 13, Stahmann et al teaches the method of claim 12, wherein the released hormones treat a heart condition (e.g. Paragraph [0049]).
Referring to Claim 14, Stahmann et al teaches a system for determining an adjusted physiologic pacing rate, the system comprising: at least one memory storing instructions (e.g. Figure 2, Element 218); at least one processor executing the instructions to perform a process (e.g. Figure 2, Element 212), the at least one processor configured to: receiving one or more biomarker levels, wherein the biomarker levels indicate levels of at least one of atrial natriuretic peptide (ANP), B-type natriuretic peptide (BNP), N-terminal pro b-type natriuretic peptide (NT-proBNP), or C-type natriuretic peptide (CNP) (e.g. Figure 2, Element 216 and Paragraph [0053] and [0074] discloses measuring one or more natriuretic peptides); comparing the one or more biomarker levels to a target biomarker level (e.g. Paragraph [0077]); determining an adjusted physiologic pacing rate based on comparing the one or more biomarker levels to the target biomarker level (e.g. Paragraphs [0049] and [0077]).
Referring to Claim 15, Stahmann et al teaches the system of claim 14, the process further comprising: receiving one or more physiological inputs (e.g. Figure 2, Elements 214, 202 and 206); comparing the one or more physiological inputs to a threshold physiological input (e.g. Figure 5, Element 506/508 and Paragraph [0078]); determining an adjusted physiologic pacing rate further based on comparing the one or more physiological inputs to the threshold physiological input (e.g. Paragraphs [0078]-[0079]).
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(s) 6-8, 16 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al (US Publication 2011/0144712) in view of Sarkar et al (US Publication 2021/0093254).
Referring to Claim 6, Stahmann et al teaches the method of claim 1, further comprising except causing a compound reservoir to release a compound based on one or both of the one or more biomarker level or the determined adjusted physiologic pacing rate.
Sarkar et al teaches that it is known to use a compound reservoir to release a compound based on one or both of the one or more biomarker level or the determined adjusted physiologic pacing rate as set forth in Paragraphs [0156] and [0260] to provide improved treatment by delivering a therapeutic agent to the patient. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Stahmann et al, with a compound reservoir to release a compound based on one or both of the one or more biomarker level or the determined adjusted physiologic pacing rate as taught by Sarkar et al, since such a modification would provide the predictable results of improved treatment by delivering a therapeutic agent to the patient.
Referring to Claims 7, 8 and 16, Stahmann et al teaches the claimed invention, except wherein the adjusted physiologic pacing rate is output by a trained machine learning model; and wherein the trained machine learning model is trained based on one or more of historical biomarker levels, historical target biomarker levels, a patient medical history, a patient medication history, a patient demographic, or patient vitals.
Sarkar et al teaches that it is known to use a pacemaker and drug delivery device that operates based on sensed signals; obtains a probability based on sensed data and historical and uses the probability to deliver therapy as set forth in Paragraphs [0080], [0110]-[0111], [0139], [0156], [0160], and [0200] to provide improving prediction of adverse health events in order to adjust therapy to minimize risk to the patient. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Stahmann et al, with adjusted therapy is output by a trained machine learning model; and wherein the trained machine learning model is trained based on one or more of historical biomarker levels, historical target biomarker levels, a patient medical history, a patient medication history, a patient demographic, or patient vitals as taught by Sarkar et al, since such a modification would provide the predictable results of improving prediction of adverse health events in order to adjust therapy to minimize risk to the patient.
Referring to Claims 19-20, Stahmann et al teaches a method for determining an adjusted physiologic pacing rate, the method comprising: receiving one or more physiological inputs and one or more biomarker levels, wherein the biomarker levels includes levels of at least one of atrial natriuretic peptide (ANP), B-type natriuretic peptide (BNP), N-terminal pro b-type natriuretic peptide (NT-proBNP), or C-type natriuretic peptide (CNP) (e.g. Figure 2, biomarker sensor 216 and Paragraph [0053] and [0074] and physiologic inputs (e.g. Figure 2, Elements 214, 202 and 206); comparing the one or more biomarker levels to a target biomarker level (e.g. Paragraph [0077]); comparing the one or more physiological inputs to a threshold physiological input (e.g. Figure 5, Element 506/508 and Paragraph [0078]); determining a first adjusted physiologic pacing rate based on comparing the one or more biomarker levels to the target biomarker level (e.g. Paragraphs [0049] and [0077]); determining a second adjusted physiologic pacing rate based on comparing the one or more physiological inputs to the threshold physiological input (e.g. Paragraphs [0049] and [0077]). However, Stahmann et al does not explicitly disclose determining a first weight associated with the first adjusted physiologic pacing rate; determining a second weight associated with the second adjusted physiologic pacing rate; determining an output adjusted physiologic pacing rate based on the first adjusted physiologic pacing rate, the first weight, the second adjusted physiologic pacing rate, and the second weight; and wherein the first weight or the second weight is based on a predetermined priority level.
Sarkar et al teaches that it is known to use weights associated with first and second conditions based on priority level to determine an adjustment in output therapy as set forth in Paragraphs [0080], [0110]-[0111], [0153], [0160] and [0260] to provide improved patient treatment to reduce worsening heart failure. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Stahmann et al, with weights associated with first and second conditions based on priority level to determine an adjustment in output therapy as taught by Sarkar et al, since such a modification would provide the predictable results of improved patient treatment to reduce worsening heart failure.
Claim(s) 9 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al (US Publication 2011/0144712) in view of Ben-David et al (US Publication 2006/0100668).
Referring to Claims 9 and 17, Stahmann et al teaches the claimed invention, except wherein the adjusted physiological pacing rate is further determined based on a magnitude of difference between the biomarker level and the target biomarker level.
Ben-David et al teaches that it is known to use adjusting the stimulation as a function of the difference between the actual and desired levels as set forth in Paragraphs [0074] and [0309] to provide configuring the stimulating current to change the level by an amount sufficient to treat the cardiac condition of the subject. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Stahmann et al, with adjusted physiological pacing rate is further determined based on a magnitude of difference between the biomarker level and the target biomarker level as taught by Ben-David et al, since such a modification would provide the predictable results of configuring the stimulating current to change the level by an amount sufficient to treat the cardiac condition of the subject.
Claim(s) 10 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al (US Publication 2011/0144712) in view of Thakur et al (US Publication 2011/0295084).
Referring to Claims 10 and 18, Stahmann et al teaches the claimed invention, further comprising: determining the target biomarker level based on one or more of the one or more biomarker levels, a change in the one or more biomarker levels, a rate of change in the one or more biomarker levels, one or more physiological inputs, one or more patient symptoms, one or more patient medications, a patient history.
Thakur et al teaches that it is known to use determining the target biomarker level based on one or more of the one or more biomarker levels, a change in the one or more biomarker levels, a rate of change in the one or more biomarker levels, one or more physiological inputs, one or more patient symptoms, one or more patient medications, a patient history as set forth in Paragraphs [0040]-[0042] to provide setting the threshold based on worsening conditions in order to further identify changes in the patient’s condition. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Stahmann et al, with determining the target biomarker level based on one or more of the one or more biomarker levels, a change in the one or more biomarker levels, a rate of change in the one or more biomarker levels, one or more physiological inputs, one or more patient symptoms, one or more patient medications, a patient history as taught by Thakur et al, since such a modification would provide the predictable results of setting the threshold based on worsening conditions in order to further identify changes in the patient’s condition.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann et al (US Publication 2011/0144712) in view of Levin et al (US Publication 2010/0094370).
Referring to Claim 11, Stahmann et al teaches the method of claim 1, except wherein the adjusted physiological pacing rate is one of a sub-threshold pacing rate or a supra-threshold pacing rate. Levin et al teaches that it is known to use subthreshold pacing as set forth in Paragraph [0008] and [0082] to provide reducing side effects by not causing the heart muscle to contract which enhances quality of life of cardiac patients. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Stahmann et al, with adjusted physiological pacing rate is one of a sub-threshold pacing rate or a supra-threshold pacing rate as taught by Levin et al, since such a modification would provide the predictable results of reducing side effects by not causing the heart muscle to contract which enhances quality of life of cardiac patients.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Snider et al (US Publication 2013/0345805) discloses using biomarkers compared to a reference level to evaluate a patient’s response to therapy.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796
