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 .
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.
Notice of Amendment
In response to the amendment(s) filed on 11/20/25, amended claim(s) 1-10 and 13-20, and new claims) 11-12 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Election/Restrictions
Newly submitted claim(s) 11-12 is/are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The invention of claims 1-10 and 13-20 and the invention of claims 11-12 are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus as claimed can be used to practice another and materially different process such as, for example, drug delivery with advancement of the stiffener prior to coupling of the access system to the base catheter system.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 11-12 is/are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 5, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2008/0009784 to Leedle et al. (hereinafter “Leedle”) in view of U.S. Patent Application Publication No. 2019/0312590 to Burkholz et al. (hereinafter “Burkholz”).
For claim 1, Leedle discloses an access system (Abstract) for use with a base catheter system (Examiner’s Note: functional language/intended use, i.e., capable of) (as can be seen in Fig. 1), the access system comprising:
a housing (30) (Fig. 1) (para [0048]) comprising an extension at a distal end thereof that is insertable (Examiner’s Note: functional language/intended use, i.e., capable of) into a removable from a hub of a base catheter system (as can be seen in Fig. 1), the housing defining an opening (unlabeled, but as can be seen in Fig. 5 next to reference numeral “12”);
an access catheter (50) (Fig. 5) (para [0048]) of which a first portion (first portion of 50) is positioned within the housing (as can be seen in Fig. 5) and a second portion (second portion of 50) extends out of the housing through the opening (as can be seen in Fig. 5) when the access catheter is in a retracted position (as can be seen in Fig. 3), the access catheter being configured to (Examiner’s Note: functional language, i.e., capable of) move relative to the housing from the retracted position (see Fig. 3) to an extended position (see Fig. 5A);
a stiffener (17) (Fig. 1) (para [0049]) encompassing at least a portion of the second portion of the access catheter (as can be seen in Fig. 1), the stiffener being graspable (Examiner’s Note: functional language/intended use, i.e., capable of) at an exterior of the housing for application of force thereto to advance the access catheter from the retracted position to the extended position (as can be seen in Fig. 1) (also see para [0051]); and
a fitting (15) (Fig. 1) (para [0056]) coupled to the second portion of the access catheter (as can be seen in Fig. 1),
wherein the first portion of the access catheter is advanceable through the extension of the housing as the access catheter is advanced to the extended position (as can be seen in Figs. 3 and 5A).
Leedle does not expressly disclose a base catheter system that includes a base catheter and a hub at a proximal end of the base catheter; wherein, when the extension of the housing is inserted into the hub of the base catheter system, the first portion of the access catheter is advanceable through the extension of the housing, through the hub, and through at least a portion of the base catheter as the access catheter is advanced to the extended position.
However, Burkholz teaches a base catheter system (Examiner’s Note: made up of the elements that it includes) that includes a base catheter (54/55) (Fig. 5A) (para [0057]) and a hub at a proximal end of the base catheter (62) (Fig. 5A) (para [0057]); wherein, when an extension (66) (Fig. 5A) (para [0058]) of a housing (72) (Fig. 5A) (para [0058]) is inserted into the hub of the base catheter system (as can be seen in Fig. 5A), a first portion of an access catheter is advanceable (Examiner’s Note: functional language/intended use, i.e., capable of) through the extension of the housing, through the hub, and through at least a portion of the base catheter as the access catheter is advanced to the extended position (para [0059]).
It would have been obvious to a skilled artisan to modify Burkholz to include a base catheter system that includes a base catheter and a hub at a proximal end of the base catheter; wherein, when the extension of the housing is inserted into the hub of the base catheter system, the first portion of the access catheter is advanceable through the extension of the housing, through the hub, and through at least a portion of the base catheter as the access catheter is advanced to the extended position, in view of the teachings of Burkholz, for the obvious advantage of having an indwelling catheter in addition to an access catheter for ready gdeployment of hemodialysis.
For claim 2, Leedle further discloses wherein the access catheter is configured to (Examiner’s Note: functional language/intended use, i.e., capable of) be returned from the extended position to the retracted position by direct application of force to the stiffener (para [0051]).
For claim 5, Leedle does not expressly disclose wherein a hardness of the stiffener is greater than a hardness of the second portion of the access catheter (Examiner’s Note: inherent, see para [0049], if element 17 was softer than element 16, then there’s no scenario where element 17 could clamp element 16).
For claim 13, Leedle further discloses wherein the opening defined by the housing is at a proximal end of the housing (as can be seen in Fig. 5), and wherein the access catheter is advanced through a distal end of the housing (as can be seen in Fig. 5).
Claim(s) 3-4 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leedle in view of Burkholz, and further in view of U.S. Patent Application Publication No. 2018/0339131 to Muse et al. (hereinafter “Muse”).
For claim 3, Leedle and Burkholz do not expressly disclose wherein the stiffener encompasses no less than 50 percent of a portion of the access catheter that is external to the housing when the access catheter is in the retracted position.
However, Muse teaches wherein a stiffener (106) encompasses no less than 50 percent of a portion of an access catheter (104) that is external to a housing (152) when the access catheter is in the retracted position (as can be seen in Fig. 4D) (also see para [0113]).
It would have been obvious to a skilled artisan to modify Leedle wherein the stiffener encompasses no less than 50 percent of a portion of the access catheter that is external to the housing when the access catheter is in the retracted position, in view of the teachings of Muse, for the obvious advantage of shielding the access catheter before it is deployed.
For claim 4, Leedle and Burkholz do not expressly disclose wherein the stiffener is overmolded onto the access catheter.
However, Muse teaches wherein a stiffener (841) is overmolded onto an access catheter (802) (para [0187]).
It would have been obvious to a skilled artisan to modify Leedle wherein the stiffener is overmolded onto the access catheter, in view of the teachings of Muse, because overmolding is a suitable fixing technique that would lead to the predictable result of coupling the stiffener to the access catheter.
For claim 14, Leedle and Burkholz do not expressly disclose wherein the opening defined by the housing comprises a track that extends longitudinally at a side of the housing.
However, Muse teaches wherein an opening defined by a housing comprises a track (156) (Fig. 1) (see para [0112]) that extends longitudinally at a side of the housing (as can be seen in Fig. 1).
It would have been obvious to a skilled artisan to modify Leedle wherein the opening defined by the housing comprises a track that extends longitudinally at a side of the housing, in view of the teachings of Muse, as another arrangement by which to be able to advance the access catheter via the stiffener that would lead to the predictable result of moving the position of the access catheter.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leedle in view of Burkholz, and further in view of U.S. Patent Application Publication No. 2019/0351182 to Chou et al. (hereinafter “Chou”).
For claim 6, Leedle and Burkholz do not expressly disclose wherein the first portion of the access catheter is softer than the second portion of the access catheter.
However, Chou teaches wherein the first portion of the access catheter is softer than the second portion of the access catheter (para [0127]).
It would have been obvious to a skilled artisan to modify Leedle wherein the first portion of the access catheter is softer than the second portion of the access catheter, in view of the teachings of Chou, for the obvious advantage of giving the access catheter good pushability while also being kink resistant (see para [0127] of Chou).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leedle in view of U.S. Patent Application Publication No. 2017/0326339 to Bailey et al. (hereinafter “Bailey”).
For claim 7, Leedle and Burkholz do not expressly disclose a junction that joins the first and second portions of the catheter together.
However, Bailey teaches a junction (6/106) that joins the first and second portions of the catheter together (as can be seen in Figs. 4C-D).
It would have been obvious to a skilled artisan to modify Leedle to include a junction that joins the first and second portions of the catheter together, in view of the teachings of Bailey, for the obvious advantage of “keep[ing] a lumen or lumens open between the tubes” (see para [0071] of Bailey).
For claims 8-9, Leedle and Burkholz do not expressly disclose wherein the stiffener is attached to the junction, wherein the stiffener and the junction are overmolded onto the access catheter.
However, Bailey teaches wherein a stiffener is attached to the junction (part of 6 that can be grasped as can be seen in Figs. 4C-D) (also see “a harder or more rigid polymer or plastic material,” para [0071]), wherein the stiffener and the junction are overmolded onto the access catheter (para [0071]).
It would have been obvious to a skilled artisan to modify Leedle wherein the stiffener is attached to the junction, wherein the stiffener and the junction are overmolded onto the access catheter, in view of the teachings of Bailey, for the obvious advantage of ease of manufacturing as well as keeping production costs low.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leedle in view of Burkholz, and further in view of U.S. Patent No. 6,190,371 to Maginot et al. (hereinafter “Maginot”).
For claim 10, Leedle and Burkholz do not expressly disclose a follower positioned within the housing and coupled to the access catheter, the follower being constrained to remain within the housing to prevent removal of the access catheter from the housing.
However, Maginot teaches a follower (72 and/or 74, and optionally to include 70) positioned within a housing (the outside structure within the box labeled with reference numeral “56” in Fig. 3) and coupled to the access catheter (as can be seen in Fig. 8), the follower being constrained to remain within the housing to prevent removal of the access catheter from the housing (col. 9, lines 44-49).
It would have been obvious to a skilled artisan to modify Leedle to include a follower positioned within the housing and coupled to the access catheter, the follower being constrained to remain within the housing to prevent removal of the access catheter from the housing, in view of the teachings of Maginot, for the obvious advantage of defining the positions of the access catheter when it is in its deployed state and retracted state.
Claim(s) 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leedle in view of Burkholz, and further in view of U.S. Patent Application Publication No. 2001/0049503 to Estabrook et al. (hereinafter “Estabrook”).
For claims 15-19, Leedle and Burkholz do not expressly disclose an obturator assembly coupled to the assembly catheter, wherein the obturator assembly comprises a removable obturator that extends through at least the first portion of the access catheter, wherein the obturator extends through the second portion of the access catheter, wherein the obturator assembly further comprises a valve through which the obturator extends, wherein the obturator extends through the opening defined by the housing, and wherein the housing defines a separate additional opening, and wherein the obturator extends through the additional opening of the housing.
However, Estabrook teaches an obturator assembly (20) coupled to an assembly catheter (10), wherein the obturator assembly comprises a removable obturator (106) that extends through at least the first portion of the access catheter (40) (as can be seen in Figs. 2A-B), wherein the obturator extends through the second portion of the access catheter (as can be seen in Figs. 2A-B), wherein the obturator assembly further comprises a valve (52) through which the obturator extends (see Figs. 4A-B) (also see para [0107]), wherein the obturator extends through the opening defined by the housing (see Fig. 2A) (also see para [0100]), and wherein the housing defines a separate additional opening (see Fig. 1B or 9) (also see para [0116]), and wherein the obturator extends through the additional opening of the housing (see Fig. 1B or 9) (also see para [0116]).
It would have been obvious to a skilled artisan to modify Leedle to include an obturator assembly coupled to the assembly catheter, wherein the obturator assembly comprises a removable obturator that extends through at least the first portion of the access catheter, wherein the obturator extends through the second portion of the access catheter, wherein the obturator assembly further comprises a valve through which the obturator extends, wherein the obturator extends through the opening defined by the housing, and wherein the housing defines a separate additional opening, and wherein the obturator extends through the additional opening of the housing, in view of the teachings of Estabrook, for the obvious advantage of “punctur[ing] tissue easily” as well as being able “to open the valve without damaging it” (see para [0036] of Estabrook) so that fluid passageways may be opened before fluid transfer begins.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Leedle in view of Burkholz, and further in view of U.S. Patent Application Publication No. 2006/0016478 to Chantalat.
For claim 20, Leedle and Burkholz do not expressly disclose wherein the second portion of the access catheter comprises a curved region, and wherein the system further comprises a support coupled to the curved region.
However, Leedle does teach wherein the access catheter is flexible and comprises a curved region (para [0046]) (also see Figs. 1 and 5).
Additionally, Chantalat teaches a bending sleeve clamp for controlling fluid flow (10) (Fig. 5A) comprising a flexible tube with a curved region (106) (see Fig. 5A), and wherein the system further comprises a support coupled to the curved region (102/104/105) (Fig. 5A).
It would have been obvious to a skilled artisan to modify Leedle wherein the second portion of the access catheter comprises a curved region, and wherein the system further comprises a support coupled to the curved region, in view of the teachings of Chantalat, for the obvious advantage of being able to control direction of fluid flow while at the same time controlling flow of the fluid itself.
Response to Arguments
Applicant’s arguments filed 11/20/25 have been fully considered.
With respect to the objection to the specification, Applicant’s amendments and arguments are persuasive and thus the objection is withdrawn.
With respect to the claim objections, Applicant’s amendments and arguments are persuasive and thus the objections are withdrawn.
With respect to 102 rejection(s), Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 11/20/25.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791