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 .
Response to Amendment
The preliminary amendment filed November 9, 2023 has been entered. Claims 1-11 and 22-23 are currently pending.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-11, drawn to an assembly including an outer catheter, guidewire, and navigation tool assembly, classified in A61M25/0662.
II. Claims 22-23, drawn to a method of avoiding a ledge effect while delivering an outer catheter through a vasculature, classified in A61M25/0662.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process of using that product including delivering through the outer catheter through a single vessel lumen not including a ledge.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: the inventions have acquired a separate status in the art due to their recognized divergent subject matter and/or the inventions require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Raymond Sun on December 9, 2025 a provisional election was made without traverse to prosecute the invention of Group II, claims 22-23, drawn to a method of avoiding a ledge effect while delivering an outer catheter through a vasculature. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-11 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections - 35 USC § 103
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 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) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable Ho (US 2017/0028170, hereinafter “Ho”).
Regarding claim 22, Ho discloses the invention substantially as claimed including a method of avoiding a ledge effect while delivering an outer catheter through a vasculature, comprising the steps of:
providing an outer catheter (20) having a shaft with a lumen extending therethrough, and a distal end;
extending a guidewire (22) or a microcatheter through the lumen and into a part of the human vasculature adjacent a ledge (para [0056]; Fig 4);
providing a navigation tool assembly (10) having: a delivery wire (18) having a distal end and a proximal end; and a guide sleeve (12) having a tapered distal end (14) and a proximal end that is attached to the distal end of the delivery wire (para [0049, 0052-0053]; Fig 1A); and
wrapping the guide sleeve around the guidewire or the microcatheter and retaining the guide sleeve inside the lumen at the distal end of the shaft of the outer catheter (para [0055-0056]; Fig 5).
Ho teaches advancing the outer catheter (20) to a ledge and advancing the guidewire (22) or microcatheter beyond the ledge (see annotated Fig 5 below). However, Ho does not specifically teach using the tapered distal end of the guide sleeve as a transition to guide the outer catheter past the ledge. Ho teaches the guide sleeve (extension catheter 12) is inserted within the outer catheter (20) to guide past additional ledges or bifurcated areas of the vasculature. “The minimal leading diameter of the extension catheter 12, due to its tapered distal tip 14, and curling inward from the longitudinal slit 13, allows the extension catheter 12 to be easily maneuvered through the coronary artery, while minimizing the possibility of injuring the artery. Once the extension catheter 12 is positioned properly, the interventional cardiology device 24, such as a balloon catheter 26, is advanced through the extension catheter lumen 28 (as shown in FIG. 6) until being positioned properly within the surgical site 36 (as shown in FIG. 7), at which point the surgeon can proceed to treat the patient.” (para [0056]). Therefore, it would have been obvious to one of ordinary skill in the art to try modifying Ho to include the step of using the tapered distal end of the guide sleeve as a transition to guide the outer catheter past the ledge since Ho recognizes the tapered distal end of the guide sleeve allows for easy maneuverability through the coronary artery, while minimizing the possibility of injuring the artery and thus would also be able to serve as a transition to guide the outer catheter past other ledges when navigating the tortuous vasculature to minimize the possibility of injuring the artery, as a person with ordinary skill has good reason to pursue the known options within his or her technical grasp and since it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success.
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Regarding claim 23, Ho teaches the method further includes providing the guide sleeve (12) with a slit (13) that extends from the proximal end of the guide sleeve to the distal end of the guide sleeve so that the guide sleeve can wrap around the guidewire or the microcatheter (para [0051]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Chou (US 2020/0289136) additionally teaches a navigation tool assembly (catheter advancement element 300) insertable within an outer catheter (200) and using the tapered distal end of the guide sleeve of the navigation tool assembly as a transition to guide the catheter past a ledge. “The catheter advancement element 300 can be positioned through the lumen of the catheter 200 such that its distal tip 346 extends beyond a distal end of the catheter 200. The distal tip 346 of the catheter advancement element 300 eliminates the stepped transition between the inner member and the outer catheter 200 thereby avoiding issues with catching on branching vessels within the region of the vasculature such that the catheter 200 may easily traverse the multiple angulated turns of the carotid siphon CS.” (para [0213]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771