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 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 1-16 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 1 recites the preamble “[a] portable interface for a temporary external pacemaker.” It is unclear if the “temporary external pacemaker” is being positively or functionally recited. For the purposes of examination, the “temporary external pacemaker” will be considered functionally recited, as it is not tied into any portion of the body of the claim. If Applicant wishes to positively claim the temporary external pacemaker it should be positively recited in the body of the claim.
Claim 1 recites the phrase “for communicating with a pacemaker generator.” It is unclear if this pacemaker generator is related to the “temporary external pacemaker” of the preamble or if it is a separate pacemaker generator. For the purposes of examination the “pacemaker generator” is taken to be separate from the “temporary external pacemaker” and, as such, is not required to be external or temporary.
Claim 7 recites the limitation “further comprising a device-calculated threshold derived from an average threshold computed during routine intervals over a defined period.” It is unclear how this device calculated threshold is calculated or obtained and what portion of the temporary interface interacts with the threshold.
Claim 8 recites the limitation “further comprising a recommended output comprising an averaged range calculated based on ongoing output measurements taken at regular intervals over a specific period of time.” It is unclear how this recommended output is calculated and what portion of the temporary interface interacts with the output.
Claim 9 recites the limitation “further comprising a recommended sensitivity range comprising an averaged range calculated from ongoing sensitivity measurements taken by the device at regular intervals over a specific duration.” It is unclear how this recommended sensitivity range is calculated and what portion of the temporary interface interacts with the output.
Claim 12 recites the limitation “and a portable generator.” It is unclear if this is the same or different generator than “the pacemaker generator” claimed in claim 1.
Claim Rejections - 35 USC § 102
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 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, 3-6, 12-13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Werner (US 2001/0031927).
Regarding claim 1, Werner discloses a portable interface for a pacemaker comprising:
a housing (e.g. programmer housing 202 as shown in Figure 6);
a communication module disposed in or on the housing for communicating with a pacemaker generator (e.g. analyzer 210 which communicates with IMD 10 as disclosed in [0066]; and
a display coupled to the housing (e.g. display 206), the display having a graphical interface to visualize a patient's heart rhythm and a sensitivity overlay that correlates with a sensitivity setting (e.g. ECG and sensitivity threshold line 270 as shown in Figure 11).
Regarding claim 3, Werner additionally discloses wherein the sensitivity overlay comprises a partially transparent overlay that offers a visual representation in millivolts of the current sensitivity setting (e.g. overlay as shown in Figure 11).
Regarding claim 4, Werner additionally discloses wherein the sensitivity overlay comprises an upper bound, a lower bound, and a shaded region between the upper bound and the lower bound (e.g. overlay as shown in Figure 11).
Regarding claim 5, Werner additionally discloses wherein the lower bound is 0 mV (e.g. overlay as shown in Figure 11).
Regarding claim 6, Werner additionally discloses wherein the upper bound represents a user-selected sensitivity setting (e.g. “chosen sensitivity threshold” as disclosed in [0010]).
Regarding claim 12, Werner additionally discloses the portable interface of claim 1 (e.g. as disclosed above); and a portable generator (e.g. pacer timing and control 63 as shown in Figure 5). Examiner notes that the IMD of Werner is “portable”.
Regarding claim 13, Werner additionally discloses the portable generator comprises a negative atrial lead connector port, a positive atrial lead connector port, a negative ventricle lead connector port and a positive ventricle lead connector port (e.g. four ports as shown in the housing connector 12 of Figure 4 connecting the leads to the housing)
Regarding claim 16, Werner additionally discloses wherein the portable generator comprises a display showing a set pacemaker rate control (e.g. pacemaker adjustment button as shown in Figure 9).
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.
Claims 7-9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Werner.
Regarding claims 7-9, as best the claims can be understood, Werner discloses the claimed invention but does not disclose expressly a device-calculated threshold derived from an average threshold computed during routine intervals over a defined period (claim 7), a recommended output comprising an averaged range calculated based on ongoing output measurements taken at regular intervals over a specific period of time (claim 8), or a recommended sensitivity range comprising an averaged range calculated from ongoing sensitivity measurements taken by the device at regular intervals over a specific duration (claim 9). It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the interface as taught by Werner with the above limitations, because Applicant has not disclosed that such limitations provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with sensitivity thresholds as taught by Werner, because it provides a reliable sensitivity threshold and since it appears to be an arbitrary design consideration which fails to patentably distinguish over the prior art. Therefore, it would have been an obvious matter of design choice to modify Werner to obtain the invention as specified in the claims.
Regarding claim 15, Werner additionally discloses displaying two different graphs for ventricular and atrial waveforms (e.g. as shown in Figure 9) but does not expressly disclose two displays reflecting a ventricular output sensitivity setting and an atrial output sensitivity setting.
It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the two displays as taught by Werner to both include the sensitivity threshold, because Applicant has not disclosed that the two graphs provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the single graph as taught by Werner because it provides a reliable display of a sensitivity threshold and since it appears to be an arbitrary design consideration which fails to patentably distinguish over the prior art Therefore, it would have been an obvious matter of design choice to modify Werner to obtain the invention as specified in the claims.
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Werner in view of Matos (US 2021/0138254).
Regarding claims 2 and 14, Werner discloses the claimed invention except the express mention of using Bluetooth for communication between devices. Matos discloses that it is well known in the art for medical devices to communicate through Bluetooth (e.g. as disclosed in [0121]). It would have been obvious to one having ordinary skill in the art to include the Bluetooth of Matos in the interface of Werner since such a modification would provide the system with the predictable results of a reliable means of communication.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Werner in view of Roberto (US 10,918,877).
Regarding claim 10, Werner discloses the claimed invention except the express mention of a wired connection port for communicating with the pacemaker generator. Roberto discloses that it was well known in the external temporary pacemaker art (e.g. wearable device can be pacing-enabled as taught in Col. 10, lines 40-50), to have a wired connection port for communicating with the pacemaker generator (e.g. medical device controller 120 is connected to treatment electrodes 114a via wired connection pod 130 as shown in Figure 1B). It would have been obvious to one having ordinary skill in the art to include the external pacemaker and wired connection Roberto in the interface device of Werner since such a modification would provide the system with the predictable results of a reliable means of communication between the external device and the programmer.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Werner in view of Jackson (US 2023/0346510).
Regarding claim 11, Werner discloses the claimed invention except the express mention of a clamp coupled to the housing and mountable on a pole. Jackson discloses that it was well known in the art of equipment management to include a clamp coupled to a monitor to couple the monitor to a pole (e.g. as shown in Figure 1). It would have been obvious to one having ordinary skill in the art to include the pole mounting of Jackson in the device of Werner since such a modification would provide the system with the predictable results of a reliable means of keeping the device close to the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792