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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 11/13/2025 is acknowledged.
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 1-3, 11 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 “a sensor on a guidewire” in line 3, and further “a sensor” in line 5, and “a guidewire” in line 6. It appears that these limitations are intended to recite a first sensor on a first guidewire and a second and a second guidewire, however the claim language is unclear. the examiner suggests a clarifying amendment such a first sensor/guidewire, second sensor/guidewire, or a mapping sensor/guidewire, and a delivery guidewire, or something to that effect.
Claims 2 and 3 inherit the deficiencies of claim 1.
Claim 11 recites “wherein the position of the blood pump is tracked while the patient is ambulatory.” This is interpreted to be a method step within a device claim which renders the scope of the claim unclear. it is recommended that Applicant amend this claim to be a functional recitation rather than an explicit method step.
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.
Claim(s) 4, 5, 7-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osadchy et al (US 2018/0271402).
Regarding claim 4, Osadchy discloses a system for delivering a catheter to a patient (fig. 1; abstract). Osadchy does not disclose that fluoroscopy or contrast medium is used, and that delivery is based on a sensed location of the catheter rather than an imaged location and therefore it is understood that the delivery is fluoro-less. The limitation “for delivering a catheter-based blood pump” is interpreted to be an intended use limitation wherein the catheter-based blood pump is not positively recited. Osadchy discloses a system for delivering a catheter and therefore is capable of delivering any catheter-based device including a catheter-based blood pump. Osadchy discloses that the system comprises an introducer sheath 26 with a sensor 20 configured to provide feedback regarding bidirectional axial movement and/or rotation of a catheter through an internal lumen configured and dimensioned to slidably receive the catheter (page 2, para. 0036), and at least one processor 36 configured to receive the feedback and determine a linear position and/or orientation of the catheter along a pre-mapped pathway within a patient's vasculature based on the feedback (page 2, para. 0035- 0037; fig. 1). Note: as discussed above, the limitations “configured to provide feedback regarding the… catheter comprising a blood pump” and “configured to … determine a linear position of the blood pump along a pre-mapped pathway…” are a functional limitations wherein the catheter comprising a blood pump is not positively recited.
Regarding claim 5, Osadchy discloses a display 38 (fig. 1), and wherein the at least one processor is further configured to send at least one image comprising the pre-mapped pathway and at least an indication for a location and/or orientation of the blood pump along the pre-mapped pathway to the display (fig. 1; page 2, para. 0035-0037).
Regarding claim 7, Osadchy discloses that the at least one processor is further configured to store a value representing the position of the blood pump after the blood pump has been fully inserted (page 2, para. 0032: the catheter may be used for mapping which necessarily includes storing values representing the position of the catheter after insertion).
Regarding claim 8, as discussed above with regard to claim 7, Osadchy discloses that the catheter is used for mapping which necessarily includes representing the position of the blood pump comprises three-dimensional coordinates.
Regarding claim 9, Osadchy discloses that the value representing the position of the blood pump comprises a value representing a linear distance the catheter has moved along the pre-mapped pathway (page 2, para. 0035).
Regarding claim 10, Osadchy discloses that the processor is further configured to receive feedback regarding bidirectional axial movement and/or rotation of the catheter after the blood pump has been fully inserted (page 2, para. 0036, 0037), and a position of the blood pump is tracked over a period of time (page 2, para. 0034-0037: tracking during insertion is provided which necessarily happens over a period of time).
Regarding claim 11, the limitation “wherein the position of the blood pump is tracked while the patient is ambulatory” is interpreted to be an intended use limitation. Because the system of Osadchy includes only the single catheter insertion point, the patient need not be immobilized and therefore is capable of being used on an ambulatory patient.
Regarding claim 12, Osadchy discloses that further comprises a wired transceiver coupled to the at least one processor (page 2, para. 0037: cable 30).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osadchy in view of Richer et al (US 2018/0099125).
Claim 6 differs from Osadchy in calling for a guidewire, the guidewire comprising a sensor configured to provide information to the at least one processor, wherein the at least one processor is further configured to generate a three-dimensional pathway of the guidewire based on the information, and then use the generated three-dimensional pathway of the guidewire as the pre-mapped pathway. Richer teaches a guidewire comprising a sensor that us used to map the vasculature of a patient for subsequent use in catheter delivery (page 1, para. 0005; page 3, para. 0023; page 4, para. 0034). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Osadchy to include a guidewire having a sensor that maps the vessels and then uses the map as the predetermined pathway as taught by Richer to improve the safety of the system as the user can be sure that that catheter remains on the predetermined pathway and immediately recognize any divergence.
Allowable Subject Matter
Claims 1-3 are allowable over the prior art of record but for the 112(b) rejections above.
Claims 13, 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 1, the prior art fails to teach or fairly suggest the method as claimed. As discussed in detail above, Osadchy teaches tracking of catheter insertion similar to the claimed invention, however, fails to teach or fairly suggest the catheter including a catheter-based blood pump.
Regarding claim 13 and 14, the prior art fails to teach or fairly suggest that the processor is configured to determine a difference between a current position of the blood pump and the position of the blood pump when it had first been fully inserted and/or a most recently determined position and generate a warning or alert if the difference is greater than a predetermined threshold, in combination with the features of the invention, substantially as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783