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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/19/26 has been entered.
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims may be addressed jointly herein when instances of limitations with verbatim or near-verbatim similarity are recited in the body of differently numbered claims and/or when multiple different limitations are clearly addressed by a same/similar citation to/within a reference.
Claim(s) 1-7, 9-10, 12, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin (US 20160278747 A1) in view of Bauer (US 5389089 A).
For claims 1 and 23, Chin teaches A system for cell collection within a vessel [entire disclosure – see at least abstract], the system comprising:
a cannula [10, 20] having with a pathway extending between a first end and a second end of the cannula along a central axis, [pathway created by ports 11, 13; see also unnumbered port shown in Figs. 5A-B which also forms a type of ‘pathway’; consider also channel(s) of 20 in which 10 resides which constitute(s), under BRI, a form of a ‘pathway’]
and a first lumen situated longitudinally within the pathway of the cannula; [central lumen into which 12, 14 is inverted as shown in Figs. 5-6]
a tip at the second end of the cannula and terminating in a free distal end, [either / both of rolled edge of 12 and/or balloon 14 (once everted) constitute(s), under BRI, a form of a tip where ¶64 explicitly establishes that 12 is flexible and 14 is elastic]
the tip being movable by an adjustment mechanism, [inflation in ¶¶62-66] between a first position where the tip extends along the central axis and a second position where the tip curves away from the central axis; [Figs. 4-6]
an inverted balloon [12, 14] situated along the pathway independent of the tip [balloon 12, 14 is along a pathway where there is at least some form of a pathway which is independent of the tip],
a first end of the balloon being coupled to the second end of the cannula and a second end of the balloon being coupled to a rod, [Fig. 5A]
the balloon designed to permit controlled eversion in the presence of positive pressure along a path defined by the tip; [¶¶62-66]
and an inverted sleeve [15, 17] situated within the balloon and an end of the sleeve being attached to the second end of the cannula, such that the sleeve is configured to evert with the balloon along the defined path upon eversion of the balloon from the cannula [Figs. 5-7] and the balloon is configured to inflate to a diameter sufficient to radially push the sleeve into contact with walls of the vessel, [collection in ¶¶60-65 see esp. ¶¶64-65 and ¶68]
wherein the inverted balloon and inverted sleeve are each independently affixed to the cannula. [see annotated Fig(s). 6B of Chin below where clearly shown is a distalmost extent of wall 19 of catheter 10A has independent attachments of each balloon 14 and sleeve 17]
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While Chin can be said (under BRI) to teach a flexible tip at an end of the cannula and, Chin cannot be said to teach (under BRI) a flexible tip which (specifically) extends from the second end of the cannula terminating in a free distal end where the tip is independently affixed to the cannula movable with an adjustment mechanism prior to eversion.
Bauer teaches an eversion cannula for a fallopian tube [abstract] including a flexible tip [end 17 with sleeve 65 and portion 63 forming a tip which is flexible per col. 4 ll. 15-30] extending from an end of the cannula terminating in a free distal end [65 shown overlapping 27 at segment 29 in Figs. 4-7] movable from a first parallel configuration to a second configuration offset from an axis [Figs. 4-5] where the tip is independently affixed to the cannula [65 shown attached to 27 via a proximal extent of 65 as in Fig(s). 4] movable with an adjustment mechanism prior to eversion. [e.g., adjustment mechanism can be one or both of fittings 35 and 49 or blind mandrel with mandrel lumen 59 as in col. 4 onto col. 5]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the flexible tip of Chin to incorporate the rounded tip of Bauer (e.g., adding the distal portion 63 of Bauer onto the everting end of the balloon of Chin) in order to ensure proper positioning of the evertible balloon against the fallopian tube entrance. As motivated by Bauer cols. 1-3.
For claim 2, Chin teaches The system of claim 1, wherein a surface of the inverted sleeve includes at least one of a textured surface [15], an adhesive surface, and an open mesh surface. [¶64]
For claim 3, Chin teaches wherein the balloon is in fluid communication with the pathway and the balloon is configured to receive pressurizing fluid from the pathway for eversion out from the second end of the cannula. [eversion via ports with inflation in ¶¶62-63 ¶71 ¶79; Fig. 2]
For claim 4, Chin teaches The system of claim 1, wherein the sleeve [15, 17] is configured to evert from the second end of the cannula upon pressurization of the balloon. [¶¶64-65]
For claim 5, Chin teaches The system of claim 1, further comprising a second lumen within the cannula, the second lumen configured to receive an endoscope. [channels of hysteroscope 20 shown in Fig. 3 per ¶¶62-63 (i.e., a channel for the imaging element then being the endoscope and another channel for the balloon and eversion sleeve)]
For claim(s) 6, Chin fails to teach in the embodiment of Figs. 5-15 a transparent hood on the second end of the cannula to provide viewing from within the second end of the cannula.
However, Chin does teach in the separate embodiment of Figs. 17-34 a transparent hood [167] at the second end of a cannula [162].
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the cannula of Chin Figs. 5-15 to incorporate the transparent hood 167 of Chin Figs. 17-34 in order to permit viewing of the insertion and eversion process. As motivated by Chin ¶¶79-80.
For claim 7, Chin teaches The system of claim 1, wherein the cannula is sufficiently flexible to be advanced through a vessel in a body. [flexible navigation in ¶¶62-64]
For claim 9, Chin teaches The system of claim 8, wherein the vessel is a Fallopian tube. [Fallopian tube sampling is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Chin, see at least ¶¶60-65]
For claim 10, Chin teaches The system of claim 1, wherein the inverted balloon and the inverted sleeve are configured to move longitudinally within the pathway of the cannula. [longitudinal eversion of 14 and 15,17 from initial inverted position within a ‘pathway’ of 10 as throughout ¶¶60-65]
For claim(s) 12 Bauer (in the motivated combination of claim(s) 1) teaches wherein the distal tip is rounded. [Figs. 2-7]. As motivated in claim(s) 1.
For claim(s) 22, Chin teaches
wherein the adjustment mechanism is an outer sleeve [19] that conforms the tip to the first configuration when disposed over the tip.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin in view of Bauer and Summers (US 5458573 A).
For claim(s) 21, Chin fails to teach the adjustment mechanism being a shape memory alloy.
Summers teaches an everting catheter which includes an everting adjustment mechanism which is a shape memory alloy. [col. 2 ll. 35-45]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the adjustment mechanism of Chin to incorporate the shape memory alloy of Summers in order to aid in ensuring proper navigability within the target anatomy. As motivated by Summers col. 2.
Response to Arguments
Applicant's 2/19/26 arguments with respect to the prior art have been fully considered but they are not persuasive.
Applicant argues in remarks p. 5 that Examiner has relied upon multiple embodiments across Chin Fig(s). 5-7. Chin Fig(s). 5-7 generally encompass a core embodiment of a balloon with an everting sleeve attached to a cannula which is relied upon in the rejection. Chin Fig(s). 5-7 are cited to show the breadth of applicable teachings of Chin to the claimed structure (under BRI) — not as any improper combination of wholly separate embodiments.
Applicant argues in remarks p. 6 that Chin fails to teach balloon 14 independently affixed to the cannula. Examiner respectfully disagrees. Annotated Chin Fig(s). 6 as well as Chin Fig(s). 5 clearly depicts an edge of the balloon attached to the cannula in an ‘independent’ manner under BRI.
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Applicant argues in remarks p. 6-7 that Chin fails to teach a movable tip independently affixed to the cannula. The § 103 rejection does not rely upon Chin to teach such a feature but rather Bauer in combination with Chin.
Conclusion
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/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
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