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 .
Acknowledgments
In the reply, filed on February 3, 2026, Applicant amended claims 8, 13-14, 52-53, 56-57, 63, 65, 68, and 75-76.
Applicant cancelled claim 12.
Applicant added new claims 77-84.
In the non-final rejection of November 3, 2025, Examiner noted that the information disclosure statement filed December 23, 2021, fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Applicant submitted a new information disclosure statement on February 4, 2026. Concern is withdrawn.
Examiner objected to the Disclosure. Applicant amended the Specification. Objection is withdrawn.
Examiner objected to claims 8 and 14. Applicant amended claims 8 and 14. Objection is withdrawn.
Currently, claims 8-11, 13-14, 16, and 77-84 are under examination.
Claim Objections
Claim 82 is objected to because of the following informalities:
In regards to claim 82, line 2, “an elongated medical device” should be changed to “the elongated medical device”.
Appropriate correction is required.
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.
Claims 79-82 are 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.
In regards to claim 79, lines 2-3 recite: “wherein the gear is disposed in the cradle”; however, such is new matter not described in the Specification. Claims 80-82 are rejected by virtue of being dependent upon claim 79.
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 8-11, 13-14, 16, and 77-84 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Falb et al (US 2016/0271368).
In regards to claim 8, Falb et al teaches a cassette (Figures 1-33, cassette 222) for use in a robotic drive of a catheter-based procedure system (paragraph [0002]: guide catheter control in a robotic catheter system), the cassette comprising:
a housing (222) having a distal end and a proximal end
a device support (216) having a lengthwise slit (286), a distal end and a proximal end, wherein a section of the device support is positioned within the housing (Figure 1), a path of the device support passing along a first side of a guide (Figure 1)
a connector (256) attached to the distal end of the device support
a splitter (paragraph [0062]: flexible track 216 has sufficient rigidity to maintain slit 286 in the open position, that is the two portions of the outer surface of flexible track 216 that define slit 286 remain separated during movement of the flexible track 216 as described herein and do not collapse onto one another such that no opening is present)(298) positioned at the distal end of the housing of the cassette at an entry point for an elongated medical device into the device support
wherein the connector is movable between a first position (Figure 2)(Figure 14) and a second position (Figure 10)(Figure 15)
wherein in the first position, the connector is retracted onto a second side of the guide (Figure 2)(Figure 14)
wherein the second side of the guide is opposite the first side of the guide (Figure 1)
wherein the first position is configured to enable loading of the elongated medical device into the device support (Figure 2)
wherein in the second position, the connector is located distal to the entry point (Figure 10)(Figure 15)
In regards to claim 9, Falb et al teaches wherein the distal end of the housing comprises a recess (Figure 2).
In regards to claim 10, Falb et al teaches wherein the first position is a retracted position and in the first position, the connector is located in the recess (Figure 2)(Figure 14).
In regards to claim 11, Falb et al teaches wherein the splitter is positioned in the recess (Figure 2)(Figure 11).
In regards to claim 13, Falb et al teaches wherein the splitter is configured to hold open the lengthwise slit of the device support as the connector and the device support are moved over the splitter (Figures 14-15)(paragraph [0062]).
In regards to claim 14, Falb et al teaches wherein the splitter is configured to hold open the lengthwise slit of the device support on both a proximal side of the entry point (Figures 14-15) and a distal side of the entry point (Figure 15).
In regards to claim 16, Falb et al teaches wherein in the first position the connector is off axis to a longitudinal axis of the elongated medical device (Figure 4).
In regards to claim 77, Falb et al teaches a channel (270) configured to receive the device support, the channel being at an angle with respect to a longitudinal axis of the elongated medical device (Figure 7).
In regards to claim 78, Falb et al teaches a gear (241) configured to interface with a coupler of a drive module of the robotic drive, wherein the cassette is configured to be releasably attached to the drive module (Figure 1).
In regards to claim 79, Falb et al teaches a cradle configured to receive the elongated medical device, wherein the gear is disposed in the cradle (Figures 2-4).
In regards to claim 80, Falb et al teaches a rigid portion (238), wherein the cradle is floating with respect to the rigid portion (Figure 3).
In regards to claim 81, Falb et al teaches a midsection distal to the cradle (Figure 2).
In regards to claim 82, Falb et al teaches wherein the midsection is configured to receive an adapter for an elongated medical device (Figure 2).
In regards to claim 83, Falb et al teaches wherein the device support is disposed between the splitter and the guide in the second position (Figure 10)(Figure 15).
In regards to claim 84, Falb et al teaches wherein the splitter is located within the path (Figure 11).
Response to Arguments
Applicant's arguments filed February 3, 2026, have been fully considered but they are not persuasive:
In regards to claim 8, Applicant argued: The sheath clip 256 of Falb does not retract into the cassette 222 and thus does not retract onto an element that has a first side that is along a path of a device support. Thus, the system of Falb cannot describe at least "a path of the device support passing along a first side of a guide" and "wherein in the first position the connector is retracted onto a second side of the guide," as recited in amended claim 8 (Remarks, page 11). Examiner disagrees. First, the claim does not require the connector to retract “into the cassette”, as argued by Applicant. The claim instead requires “the connector is retracted onto a second side of the guide”. Second, Falb et al teaches a path of the device support (216) passing along a first side of a guide (Figure 1), and wherein in the first position, the connector (256) is retracted onto a second side of the guide (Figure 2)(Figure 14). And it is noted that “a guide” is not a positively recited element of “a cassette”, as claimed, and thus Falb et al only has to teach a cassette with the ability to interact with a guide, as claimed.
In regards to claims 9-10, Applicant argued: There is no recess defined or described in Falb and there is no description in the Office Action of a feature of Falb that is being interpreted as being a recess. A sheath clip 256 located at a distal end of a cassette 222 cannot describe a cassette 222 that includes a recess such that a connector is located within a recess in a first, retracted position as recited in claims 9 and 10 (Remarks, page 11). Examiner disagrees. At minimum, attachment portion 260 of connector 256 is located in collar 250 having a recess (Figure 9), thus teaching the claimed connector located in the recess of the housing.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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