Medtronic, Inc.

UNITED STATES PATENT AND TRADEMARK OFFICE

UNITED STATES DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

Address: COMMISSIONER FOR PATENTS P.O. Box 1450

Alexandria, Virginia 22313-1450 www.uspto.gov

APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.

16/186,967 11/12/2018 Subham Ghosh C0008584.US01DIV 7500

10723 7590 07/02/2025 EXAMINER

Medtronic Inc. (CRDM/MRG)

710 Medtronic Parkway NE

TEJANI, ANKIT D

MS LC-340

Minneapolis, MN 55432-5604

ART UNIT PAPER NUMBER

3796

NOTIFICATION DATE DELIVERY MODE

07/02/2025 ELECTRONIC

Please find below and/or attached an Office communication concerning this application or proceeding.

The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es):

ptodocketing@mrgs.com

rs.patents.two@medtronic.com

PTOL-90A (Rev. 04/07)

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UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE PATENT TRIAL AND APPEAL BOARD

Ex parte SUBHAM GHOSH

Appeal 2024-002869

Application 16/186,967

Technology Center 3700

Before STEFAN STAICOVICI, BENJAMIN D. M. WOOD, and LEE L. STEPINA, Administrative Patent Judges. STEPINA, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE

Pursuant to 35 U.S.C. § 134(a), Appellant¹appeals from the Examiner's decision to reject claims 59-67 and 72.²We have jurisdiction under 35 U.S.C. § 6(b).

We affirm.

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Appeal 2024-002869 Application 16/186,967

CLAIMED SUBJECT MATTER

Appellant's disclosure relates to "[c]ardiac resynchronization therapy (CRT) [as] a treatment for heart failure patients in which one or more heart chambers are electrically stimulated (paced) to restore or improve heart chamber synchrony." Spec. 1:14-16.

Independent claim 59, reproduced below, with emphases added, is illustrative of the claimed subject matter.

59. A method for adjusting multisite pacing to effectively capture cardiac tissue by an implantable medical device, the method comprising:

selecting a first cathode and a first anode to form a first pacing vector;

selecting a second cathode and a second anode to form a second pacing vector;

delivering cardiac resynchronization therapy (CRT) to improve heart chamber synchrony by simultaneously delivering a first pacing pulse to the first pacing vector positioned at a first pacing site along a heart chamber and a second pacing pulse to the second pacing vector positioned at a second pacing site along the heart chamber within a single cardiac cycle; determining whether each of the first and second pacing pulses individually effectively captured cardiac tissue at the first and second pacing sites, respectively;

in response to determining ineffective capture, selecting a first action to achieve effective capture for the first and second pacing pulses being delivered simultaneously, and in response to determining effective capture, delivering simultaneous multisite pacing using the first and second pacing vectors.

Appeal Br. (Claims App. 1).

REFERENCES

The prior art relied upon by the Examiner is:

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Appeal 2024-002869 Application 16/186,967

REJECTIONS

I. Claims 59, 60, 66, and 67 are rejected under 35 U.S.C. § 103 as unpatentable over Ryu 2012.

II. Claims 61-64 are rejected under 35 U.S.C. § 103 as unpatentable over Ryu 2012 and Sommer.

III. Claims 65 and 72 are rejected under 35 U.S.C. § 103 as unpatentable over Ryu 2012 and Ryu 2013.

OPINION

Rejection I (Ryu 2012) Claims 59, 60, 66, and 67 Appellant argues for the patentability of the claims subject to the first ground of rejection, i.e., claims 59, 60, 66, and 67, as a group. Appeal Br. 6-14. We select claim 59 as representative of the group, and claims 60, 66, and 67 stand or fall with claim 59. 37 C.F.R. § 41.37(c)(1)(iv). The Examiner finds that Ryu 2012 discloses many of the process steps recited in claim 59, including the step of determining whether each of the first and second pacing pulses individually effectively captured⁴cardiac

3 For consistency, we adopt nomenclature similar to that used by Appellant.

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Appeal 2024-002869 Application 16/186,967 tissue at the first and second pacing sites, respectively (hereinafter, the

"determining" step), but does not explicitly disclose that the therapy it delivers via its first and second pacing vectors is cardiac resynchronization therapy (CRT). Final Act. 7-8. However, the Examiner finds that Ryu 2012 discloses, in paragraph 30, that its device may be a CRT device. See id. at 8. The Examiner reasons that it would have been obvious to incorporate Ryu 2012's disclosed method of adjusting multisite pacing for effectively capturing cardiac tissue into a CRT device to perform CRT, in order to allow

"the underlying method to be used for a larger amount of cardiac therapies."

Id.

Appellant first argues that the Examiner erred in finding that Ryu 2012 discloses the determining step. See Appeal Br. 6-10; Reply Br. 2-4. Appellant contends that the capture confirmation disclosed in paragraphs 10 and 65 Ryu 2012 and the detection of evoked responses disclosed in paragraph 12 of Ryu 2012 are merely general descriptions of capture confirmation. See Appeal Br. 7-9. According to Appellant, such general confirmation of tissue capture does not qualify as disclosure of capture confirmation for each of the first and second pacing pulses as individually capturing cardiac tissue at the first and second pacing sites, respectively. See Appeal Br. 7-9. For example, Appellant contends that, "at best, paragraph [65] of Ryu '2012 describes that capture may be determined using multiple sensing sites but is silent as to whether individual pacing pulses effectively captured pacing sites." Id. at 9.

positioned at endocardial, epicardial, or intravenous locations or any combination thereof." Spec. 11:26-30.

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Appeal 2024-002869 Application 16/186,967 A preponderance of the evidence supports the Examiner's finding of fact regarding Ryu 2012's disclosure of the determining step. Paragraph 10 of Ryu 2012 discloses the capture confirmation process. Paragraphs 12 and 65 of Ryu 2012 disclose capture confirmation and multiple pacing sites. sites. We agree with the Examiner that, in Ryu 2012, "[t]he individual pacing pulses are the entity that caused the detected capture" and "[t]here is a direct connection between the pacing pulses and the capture events, because the pacing pulses caused the capture events." Ans. 4. Additionally, the Examiner finds that, "[w]ithin the context of [Ryu 2012's] disclosure, there cannot be a capture event without there first being a pacing pulse."

Id. (emphasis added). Appellant does not explain how, absent the occurrence of a pacing pulse, tissue capture may occur. The Examiner finds that Ryu 2012 further discloses that its pacing electrodes may also be used as sensing electrodes, creating a one-to-one relationship between the electrodes and sensors. See Ans. 6 (discussing paragraph 31 of Ryu 2012). In other words, Ryu 2012 discloses that its pacing electrodes and sensing electrodes may be the same electrodes (see Ryu 2012 ¶ 31), that is, the pacing electrodes and sensing electrodes may be located in exactly the same place. Thus, a person of ordinary skill in the art would understand that the determination of tissue capture performed by Ryu 2012 determines whether a given pacing pulse has individually captured cardiac tissue at that location. Appellant next contends:

The Examiner clearly failed to identify any portion of Ryu '2012 that teaches or suggests delivering cardiac

resynchronization therapy (CRT) to improve heart chamber synchrony by simultaneously delivering a first pacing pulse to the first pacing vector positioned at a first pacing site along a heart chamber and a second pacing pulse to the second pacing

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Appeal 2024-002869 Application 16/186,967 vector positioned at a second pacing site as recited in independent claim 59 as required for a prima facie case of obviousness.

Appeal Br. 11. According to Appellant, "[s]imply because Ryu '2012 mentions that the device 10 could be a CRT device, among others, does not necessarily mean that all processes and methods described therein can then be utilized when delivering CRT." Id. at 12; see also Reply Br. 6 (asserting that the Examiner fails to provide evidence that the steps disclosed in Ryu 2012 steps could be used in CRT).

The Examiner has the better position because Ryu 2012 explicitly discloses that its device may be a CRT device. Ryu 2012 ¶ 30 ("The device 10 may be a pacing device, a pacing apparatus, a cardiac rhythm management device, an implantable cardiac stimulation device, an implantable cardioverter/defibrillator (ICD) and/or a cardiac resynchronization therapy (CRT) device."). Thus, Ryu 2012 at least suggests the use of its disclosed method with CRT. Appellant apprises us of no reason the determining step disclosed by Ryu 2012 would be incompatible with CRT, which is also disclosed by Ryu 2012 by virtue of Ryu 2012's disclosure of a CRT device.

Appellant next argues that the Examiner's proposed modification to Ryu 2012 would change its principle of operation. See Appeal Br. 13-14; Reply Br. 7. According to Appellant, "[t]he principle of operation of Ryu is antitachycardia pacing therapy."⁵Appeal Br. 13 (emphasis omitted). Appellant states, "[s]ince the principle of operation of Ryu '2012 is antitachycardia pacing therapy and the Examiner's modification would be

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Appeal 2024-002869 Application 16/186,967 eliminate the antitachycardia pacing therapy in Ryu '2012, the Examiner's proposed modification of Ryu '2012 is clearly changing the principle of operation of Ryu '2012." Id. at 13-14.

Appellant's argument does not identify Examiner error. First, Appellant's characterization of the principle of operation in Ryu 2012 is unreasonably narrow. Ryu 2012 delivers electrical pulses to different locations in cardiac tissue to evoke a response. The particular therapy provided by this process is not Ryu 2012's principle of operation. Second, even assuming, as Appellant contends, that the type of therapy provided by Ryu 2012 equated to Ryu 2012's principle of operation, Ryu 2012 discloses multiple types of therapy, including CRT. See Ryu 2012 ¶ 30. In the rejection of claim 59, "[t]he Examiner is merely proposing incorporating the steps of determining effective capture of pacing pulses into a device that delivers cardiac resynchronization therapy [CRT]." Ans. 9. Thus, the Examiner's proposed modification is to provide one of the multiple types of therapy Ryu 2012 already discloses. The Examiner explains that the rejection of claim 59 does not eliminate APT from Ryu 2012 in general. Ans. 9.

We have considered all of Appellant's arguments in support of the patentability of claim 59, but find them unavailing. Accordingly, we affirm Rejection I as to claim 59. Claims 60, 66, and 67 fall with claim 59. Rejections II (Ryu 2012 and Sommer) and III (Ryu 2012 and Ryu 2013) Claims 61-65 and 72

Appellant does not make arguments for the patentability of claims 61- 65 and 72 aside from those discussed above regarding claim 59. See Appeal Br. 15. Accordingly, for the same reasons, we sustain Rejections II and III.

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Appeal 2024-002869 Application 16/186,967

CONCLUSION

The Examiner's decision to reject claims 59-67 and 72 is affirmed.

DECISION SUMMARY

In summary:

TIME PERIOD FOR RESPONSE

No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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