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
Applicant’s election without traverse of Group I, claims 1-17 in the reply filed on 2/10/2026 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/10/2026.
Claim Objections
Claim 10 is objected to because of the following informalities:
“The blood pressure is detect using” in line 1 should read, “the blood pressure is detected using”
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 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to mental processes without significantly more. Claim 1 recites, “A method for determining pacing attributes for a patient.” Claim 13 recites, “A system for determining pacing attributes for a patient.” Both the method and system involve receiving physiological data and determining use of beta blockers with ISA. One could determine the pacing attributes for a patient by analyzing the data and reading the medical records of the patient, and by meeting with the patient periodically to discuss their medication history. This judicial exception is not integrated into a practical application because the language of claim 1 describes determining pacing attributes without reciting any structure that is completing said tasks, which could also be done in one’s mind. This judicial exception is not integrated into a practical application because the language of claim 13 describes using a memory, one or more processors, and processor-readable instructions to determine pacing attributes, which could also be done in one’s mind. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the memory and one or more processors are being used simply as tools to perform abstract ideas.
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.
Claims 1-4 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boileau et al. (U.S. Patent No. 7,142,911).
Regarding claim 1, Boileau teaches a method for determining pacing attributes (Fig. 12, Col. 26, lines 36-39) for a patient (Col. 26, line 37), the method comprising: determining use of (Col. 3, lines 62-64) a beta blocker with intrinsic sympathomimetic activity (ISA) (Table 1, Acebutolol) by the patient; receiving a current physiological input (Col. 17, lines 23-24); and determining pacing attributes (Col. 26, lines 59-62) based on the determining use of the beta blocker with ISA (Col. 26, lines 63-64) and the current physiological input (Col. 27, lines 12-16).
Regarding claim 2, Boileau teaches the method (Fig. 12, Col. 26, lines 36-39) of claim 1, further comprising outputting the pacing attributes (Fig. 12, Col. 26, lines 43-47).
Regarding claim 3, Boileau teaches the method (Fig. 12, Col. 26, lines 36-39) of claim 1, further comprising causing a cardiac pacing device (Fig. 1, Col. 6, lines 8-9) to generate pacing outputs (Col. 6, lines 10-11) based on the pacing attributes (Col. 26, lines 51-53).
Regarding claim 4, Boileau teaches the method (Fig. 12, Col. 26, lines 36-39) of claim 1, wherein the pacing attributes (Col. 26, lines 59-62) are further determined based on one or more of a type (Col. 16, lines 25-28 and Col. 26, lines 47-55) or a quantity (Col. 11, lines 18-24) of the beta blocker with ISA (Table 1, Acebutolol).
Regarding claim 9, Boileau teaches the method (Fig. 12, Col. 26, lines 36-39) of claim 1, wherein the current physiological input (Col. 17, lines 23-24) is a blood pressure (Col. 17, line 24).
Regarding claim 10, Boileau teaches the method (Fig. 12, Col. 26, lines 36-39) of claim 9, wherein the blood pressure (Col. 17, line 24) is detect using a blood pressure measuring device selected from a cuff-less device (Col. 10, lines 50-51) or a photoplethysmography (PPG) device (Col. 10, lines 50-51). Although not explicitly disclosed by Boileau, it would be well known by a person of ordinary skill in the art that blood pressure can also be measured with a cuff device.
Regarding claim 11, Boileau teaches the method (Fig. 12, Col. 26, lines 36-39) of claim 1, wherein the pacing attributes (Col. 26, lines 59-62) include one or more of a pacing rate (Col. 9, line 10), a pacing amplitude (Col. 9, line 9), a pacing acceleration (Col. 26, lines 66-67), or a pacing deceleration (Col. 27, lines 1-2).
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.
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 5-6 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Boileau et al. (U.S. Patent No. 7,142,911) in view of Yomtov et al. (WIPO Pub. No. 2004/033036).
Regarding claim 5, Boileau teaches the method (Fig. 12, Col. 26, lines 36-39) of claim 1 that comprises determining use (Col. 3, lines 62-64) of the beta blocker with ISA (Table 1, Acebutolol). Boileau does not teach that determining use of the beta blocker with ISA comprises: sensing a body part property; and identifying a chemical associated with the beta blocker with ISA.
Yomtov, however, teaches a system for providing controlled drug delivery to a cardiac patient, wherein the system determines the use (Page 21, lines 14-16) of a beta blocker with ISA (Page 13, line 33). Yomtov also teaches that the system senses a body part property (Page 21, lines 14-15); and identifies a chemical associated with (Page 21, lines 10-11) a beta blocker with ISA (Page 13, line 33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boileau to incorporate the teachings of Yomtov to include that the system determines use of a beta blocker with ISA by: sensing a body part property; and identifying a chemical associated with the beta blocker with ISA. Doing so would ensure body part properties can be detected, and chemicals associated with the beta blocker with ISA can be detected in said body part properties to determine beta blocker with ISA use, as recognized by Yomtov.
Regarding claim 6, Boileau teaches the method (Fig. 12, Col. 26, lines 36-39) of claim 5. Boileau does not teach that the body part is at least one of a body fluid or a body tissue. Yomtov, however, teaches a system for providing controlled drug delivery to a cardiac patient, wherein the sensed body part property (Page 21, lines 14-15) is at least one of a body fluid (Page 21, line 15) or a body tissue (Page 21, line 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boileau to incorporate the teachings of Yomtov to include that the sensed body part property is at least one of a body fluid or a body tissue. Doing so would ensure that both body tissue and body fluids can be detected in order to determine use of the beta blocker with ISA, as recognized by Yomtov.
Regarding claim 13, Boileau teaches a system for determining pacing attributes (Col. 6, line 8 and Col. 11, lines 21-24) for a patient (Col. 26, line 37), the system comprising: a memory (Col. 7, line 35) configured to store (Col. 11, lines 61-62) processor-readable instructions (Col. 11, line 60); and one or more processors (Col. 11, lines 55-57 and Col. 12, lines 27-29) operatively connected to the memory (Col. 11, line 61), and configured to execute the instructions to perform operations (Col. 11, line 60) that include: determining use of (Col. 3, lines 62-64) a beta blocker with intrinsic sympathomimetic activity (ISA) (Table 1, Acebutolol) by the patient; receiving a current physiological input (Col. 17, lines 23-24); and determining pacing attributes (Col. 26, lines 59-62) based on the determining use of the beta blocker with ISA (Col. 26, lines 63-64) and the current physiological input (Col. 27, lines 12-16).
Boileau does not teach that the system operations include: receiving a beta blocker use signal; and determining use of a beta blocker with ISA by the patient based on the beta blocker use signal. Yomtov, however, teaches a system for providing controlled drug delivery to a cardiac patient, wherein the system receives a beta blocker use signal (Page 21, lines 9-12). Furthermore, Yomtov teaches that the system determines the use (Page 21, lines 14-16) of a beta blocker with ISA (Page 13, line 33) based on (Page 21, lines 4-9) the beta blocker use signal.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boileau to incorporate the teachings of Yomtov to specify that the system operations include: receiving a beta blocker use signal; and determining use of a beta blocker with ISA by the patient based on the beta blocker use signal. Doing so would ensure that the system has a means to detect and determine beta blocker with ISA use, as recognized by Yomtov.
Regarding claim 14, Boileau teaches the system (Col. 6, line 8 and Col. 11, lines 21-24) of claim 13 that determines a quantity (Col. 11, lines 18-24) of the beta blocker with ISA (Table 1, Acebutolol). Boileau does not teach that the beta blocker use signal is generated by a sensor configured to detect one or more of beta blocker presence, absence, type, or quality.
Yomtov, however, teaches a system for providing controlled drug delivery to a cardiac patient, wherein the system receives a beta blocker use signal (Page 21, lines 9-12) that is generated by a sensor (Page 21, lines 12-13) and configured to detect (Page 21, line 10) one or more of beta blocker presence (Page 21, line 10), absence (Page 21, line 10), type (Page 21, lines 10-11), or quality (Page 21, lines 10-11).
Although, detecting quality of a beta blocker is not explicitly discloses in Yomtov, Yomtov does teach that the type of beta blocker can be detected by said system (Page 21). It would be well understood by a person of ordinary skill in the art that if the type of beta blocker being used is known, one could determine the quality of said beta blocker based on its type.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boileau to incorporate the teachings of Yomtov to specify that the system operations include: receiving a beta blocker use signal that is generated by a sensor configured to detect one or more of beta blocker presence, absence, type, quality, or quantity. Doing so would ensure that the system has a means to detect and determine beta blocker with ISA use, as recognized by Yomtov.
Regarding claim 15, Boileau teaches the system (Col. 6, line 8 and Col. 11, lines 21-24) of claim 13, further comprising a pacemaker (Fig. 3, Col. 11, lines 40-41) configured to: receive the pacing attributes (Col. 26, lines 43-47); and generate pacing outputs (Col. 6, lines 10-11) based on the pacing attributes (Col. 26, lines 51-53).
Claims 7-8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Boileau et al. (U.S. Patent No. 7,142,911) as applied to claim 1 above, and further in view of Sipe et al. (U.S. PGPub No. 2020/0305713).
Regarding claim 7, Boileau teaches the method (Fig. 12, Col. 26, lines 36-39) of claim 1 that comprises determining use (Col. 3, lines 62-64) of the beta blocker with ISA (Table 1, Acebutolol). Boileau does not teach that the method comprises receiving a user input indicating use of the beta blocker with ISA. Sipe, however, teaches a method for providing drug prescription information with monitored cardiac information, where a user input (Paragraph 0164, lines 6-8) indicating use of the beta blocker with ISA (Paragraph 0162, lines 13-16) is received.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boileau to incorporate the teachings of Sipe to specify that the method comprises receiving a user input indicating use of the beta blocker with ISA. Doing so would ensure that the user can input information in order to determine the use of the beta blocker with ISA, as recognized by Sipe.
Regarding claim 8, Boileau teaches the method (Fig. 12, Col. 26, lines 36-39) of claim 1, that includes determining use (Col. 3, lines 62-64) of the beta blocker with ISA ((Table 1, Acebutolol). Boileau does not teach that the method includes receiving electronic medical records associated with a user; analyzing the electronic medical records; and determining use of the beta blocker with ISA based on analyzing the electronic medical records.
Sipe, however, teaches a method for providing drug prescription information with monitored cardiac information that comprises: receiving electronic medical records (Paragraph 0328, lines 3-8) associated with a user (Paragraph 0328, line 6); analyzing the electronic medical records (Paragraph 0257, lines 1-4); and determining use of the beta blocker with ISA based on analyzing the electronic medical records (Paragraph 0328, lines 9-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boileau to incorporate the teachings of Sipe to specify that the method comprises: receiving electronic medical records associated with a user; analyzing the electronic medical records; and determining use of the beta blocker with ISA based on analyzing the electronic medical records. Doing so would ensure that all prior patient history data can be used and analyzed to determine the use of a beta blocker with ISA, as recognized by Sipe.
Regarding claim 12, Boileau teaches the method (Fig. 12, Col. 26, lines 36-39) of claim 1, further comprising: determining pacing attributes (Col. 26, lines 59-62) based on the determining use of the beta blocker with ISA (Col. 26, lines 63-64) and the current physiological input (Col. 27, lines 12-16). Boileau does not teach that the method comprises: receiving an updated physiological input based on continuous monitoring of a physiological input corresponding to the continuous physiological input or the updated physiological input; and determining updated pacing attributes based on the determining use of the beta blocker with ISA and the updated physiological input.
Sipe, however, teaches a method for providing drug prescription information with monitored cardiac information that comprises: receiving an updated physiological input (Paragraph 0060, lines 12-13) based on continuous monitoring (Paragraph 0177, lines 19-22) of a physiological input (Paragraph 0177, line 20) corresponding to the continuous physiological input or the updated physiological input.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boileau to incorporate the teachings of Sipe to specify that the method comprises: receiving an updated physiological input based on continuous monitoring of a physiological input corresponding to the continuous physiological input or the updated physiological input. Doing so would ensure that physiological inputs can be updated in real time, as recognized by Sipe.
Although Boileau does not explicitly disclose that the method includes determining updated pacing attributes based on the updated physiological input, Boileau does teach that pacing attributes are adjusted (Col. 26) in response to physiological inputs (Col. 27). Furthermore, Sipe teaches receiving updated physiological inputs [0060]. Therefore, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boileau to incorporate the teachings of Sipe to specify that the method comprises: determining updated pacing attributes based on the updated physiological input. Doing so would ensure that updated physiological inputs can be used further to update pacing attributes in real time, as recognized by Sipe.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Boileau et al. (U.S. Patent No. 7,142,911) in view of Yomtov et al. (WIPO Pub. No. 2004/033036) as applied to claim 13 above, and further in view of Sipe et al. (U.S. PGPub No. 2020/0305713).
Regarding claim 16, Boileau teaches the system (Col. 6, line 8 and Col. 11, lines 21-24) of claim 13 that comprises determining use (Col. 3, lines 62-64) of the beta blocker with ISA (Table 1, Acebutolol). Boileau does not teach that the determining the use of beta blockers with ISA comprises one or more of identifying a chemical associated with the beta blocker with ISA, receiving a user input indicating use of the beta blocker with ISA, or analyzing an electronic medical record.
Yomtov, however, teaches a system for providing controlled drug delivery to a cardiac patient, wherein the system determines the use (Page 21, lines 14-16) of a beta blocker with ISA (Page 13, line 33). Yomtov also teaches that the system identifies a chemical associated with (Page 21, lines 10-11) a beta blocker with ISA (Page 13, line 33).
Sipe, however, teaches a system for providing drug prescription information with monitored cardiac information, that determines use (Paragraph 0149, lines 1-3) of a beta blocker with ISA (Paragraph 0146, line 14). Sipe teaches that this is done by receiving a user input (Paragraph 0164, lines 6-8) indicating use of the beta blocker with ISA (Paragraph 0162, lines 13-16). Furthermore, Sipe teaches analyzing an electronic medical record (Paragraph 0257, lines 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boileau to incorporate the teachings of Yomtov and Sipe to specify that determining the use of beta blockers with ISA comprises one or more of identifying a chemical associated with the beta blocker with ISA, receiving a user input indicating use of the beta blocker with ISA, or analyzing an electronic medical record. Doing so would ensure that chemicals associated with the beta blocker with ISA can be detected, the user can input information, and medical records can be used to determine beta blocker with ISA use, as recognized by Yomtov and Sipe.
Regarding claim 17, Boileau teaches the system (Col. 6, line 8 and Col. 11, lines 21-24) of claim 13, wherein the operations include: determining pacing attributes (Col. 26, lines 59-62) based on the determining use of the beta blocker with ISA (Col. 26, lines 63-64) and the current physiological input (Col. 27, lines 12-16). Boileau does not teach that the operations further include: receiving an updated physiological input based on continuous monitoring of a physiological input corresponding to the continuous physiological input or the updated physiological input; and determining updated pacing attributes based on the determining use of the beta blocker with ISA and the updated physiological input.
Sipe, however, teaches a system for providing drug prescription information with monitored cardiac information that comprises: receiving an updated physiological input (Paragraph 0060, lines 12-13) based on continuous monitoring (Paragraph 0177, lines 19-22) of a physiological input (Paragraph 0177, line 20) corresponding to the continuous physiological input or the updated physiological input.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boileau to incorporate the teachings of Sipe to specify that the system operations comprise: receiving an updated physiological input based on continuous monitoring of a physiological input corresponding to the continuous physiological input or the updated physiological input. Doing so would ensure that physiological inputs can be updated in real time, as recognized by Sipe.
Although Boileau does not explicitly disclose that the system includes determining updated pacing attributes based on the updated physiological input, Boileau does teach that pacing attributes are adjusted (Col. 26) in response to physiological inputs (Col. 27). Furthermore, Sipe teaches receiving updated physiological inputs [0060]. Therefore, it also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boileau to incorporate the teachings of Sipe to specify that the system operations comprise: determining updated pacing attributes based on the updated physiological input. Doing so would ensure that updated physiological inputs can be used further to update pacing attributes in real time, as recognized by Sipe.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: U.S. PGPub No. 2005/0137626, U.S. PGPub No. 2009/0092964, U.S. Patent No. 8,043,215, and U.S. Patent No. 11,612,352.
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/H.A.H./Patent Examiner , Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796