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 .
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.
Examiner notes: for brevity, economy, and clarity of reading, select of the claims are 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) 1-5, 11-14, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chin (US 20160278747 A1).
For claim(s) 1, 3, 11, and 19, Chin teaches
A system for collection and analysis of cells from a body lumen of a patient, [entire disclosure – see at least abstract] comprising:
a diagnostics device [preferably Fig. 23A and Fig. 24] including a tube [126] having a distal end and a proximal end,
a balloon [130] having a first end coupled to the distal end of the tube,
a plurality of markers disposed along a length of the tube and incrementally spaced apart in known predetermined distances from each other, the markers being in the form of bands of material, [absent further structural language limiting the marker, the marker on balloon of Figs. 33-34 when everted or inverted constitutes a marker which is disposed on the tube (via the balloon)][more generally, absent further language which limits the structure of the marker, any variety of physical structure in the embodiments of the tube of Figs. 23-33 could (under BRI) constitute a “retraction marker” as claimed — such as the distal-most edge of the tube, a proximal hub structure, the filaments of Figs. 27-28, or even the curve show Fig. 22C],
the balloon being disposed in the tube in a first, inverted position and movable to a second, everted position, [Figs. 5-6]
and a push wire [134/175] having a distal end coupled to a second end of the balloon,
wherein the balloon is movable from the first inverted position to the second everted position with actuation of the push wire; [¶¶79-83]
one or more receptacles for processing a balloon sample; [end of ¶72 and ¶82]
and at least one of a sample preparation fluid, a sample preservation liquid, or both; [end of ¶72 and ¶82]
wherein the balloon sample is preparable for cytological analysis. [end of ¶72 and ¶82]
wherein the diagnostics device further includes a sheath [162] coaxial with the tube and slidably adjustable relative to the tube to cover in at least a partially everted position at least a first length of the balloon extending outward from the distal end of the tube,
wherein at least a portion of the sheath is transparent such that the markers are visible through the sheath, [¶80 ¶99]
and wherein the retraction marker is positioned to allow the user to visualize and confirm that the balloon is protected by the sheath. [e.g., markings of balloon of Figs. 33-34 would not be visible once balloon is retracted or, in the case of a transparent tube as suggested in some embodiments of ¶99, the change in the position / orientation of the markings could also indicate the balloon is inverted and protected by the sheath / tube][to wit: any marker that is used to confirm eversion can thereby be used to confirm inversion by its respective absence / reversal from view];
For claim(s) 2 and 12, Chin teaches
wherein in the second, everted position a surface of the balloon is contactable with an inner surface of the body lumen to collect a plurality of cells, the balloon and the collected cells being separable from the diagnostics device for the balloon sample. [¶64 ¶¶81-83]
For claim(s) 4 and 13, Chin teaches
wherein the diagnostics device further includes a filament extendable distally of the first end of the balloon. [Figs. 9A-B, Figs. 11A-B, Figs. 14A-B, Figs. 17A-18]
For claim(s) 5 and 14, Chin teaches
wherein the balloon and/or the filament is/are separable into the one or more receptacles for processing the balloon sample and/or a filament sample for cytological analysis of the collected cells. [end of ¶72 and ¶82]
For claim(s) 20, Chin teaches
wherein the balloon is separable from the diagnostics device to provide the balloon sample and wherein one or more of the markers disposed on the balloon that indicate potential locations to separate the balloon. [a number of structural features on the body of the balloon can constitute(s), under BRI, a form of a marker of a ‘potential’ location for cutting the balloon such as a proximal end near sheath luer 164 or a tip of the balloon near end of wire 175 — see also Figs. 30-31 where the additional structures could ‘mark’ where to cut the balloon]
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 are 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) 6-10 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin in view of Jovanovich (US 20190212233 A1).
For claim(s) 6-10 and 16-18, Chin fails to teach the system comprising a cell library.
Jovanovich teaches a sampling system comprising a cell library. [¶¶25-29]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the system of Chin to incorporate the cell library of Jovanovich in order to aid in analytical and diagnostic processes for more targeted therapies (i.e., as a result of the sampled tissue). As motivated by Jovanovich ¶¶6-12. (Where then, for claim(s) 6-10 and 16-18, the cells in the library of Chin in view of Jovanovich would be capable of the claimed compiling and analyses in the intended use(s) of claim(s) 6-10 and 16-18).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chin in view of Strickland (US 5191899 A).
For claim(s) 15 Chin fails to teach spinning the receptacle in the centrifuge. However, Chin does teach at the end of ¶61 and the end of ¶72 the cell sample is prepared for a microscope slide.
Strickland teaches a system and method of collecting and preparing cells [abstract] including a step of preparing a cell sample from cells on an instrument portion by spinning a receptacle in a centrifuge. [abstract, col. 2 ll. 55-60, col. 4 ll. 45-50, col. 8 ll. 60-68].
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the system of Chin to incorporate the centrifuge as taught by Strickland in order to ensure a good microscopic sample is prepared. As motivated by Strickland cols. 2, 4, and 8.
In consideration of Examiner’s interpretation and citation for the ‘marker’ limitations in the amendments, and in earnest and good faith advancement of prosecution, claim(s) 1, 11, and 19 (and their dependent claim(s) thereby) is/are alternately rejected under 35 U.S.C. 103 as being unpatentable over Chin in view of Woker (US 5163927 A ).
If (arguendo) Chin fails to teach the markers on the tube as claimed, then:
Woker teaches an everting medical device [abstract] for fallopian tube operations [col. 2 ll. 10-15] comprising a tube [15] with a series of (including thereby one) retraction markers [53] disposed thereon [per Figs. 1 and 2A] where a length of eversion (including both insertion and retraction) of an elastic [per col. 5 ll. 24-30] everting element [17] is confirmed (in a method of the device’s use) to be protected by a sheath [13] by using the retraction marker to visualize and confirm the protection of the everting element [17] in the sheath [insertion and retraction control via use of markers per col. 5 l. 60 – col. 7 l. 60].
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the tube and corresponding method steps of Chin to incorporate the retraction marker disposed on a tube as taught by Woker (i.e., to modify the tube of Chin to have a retraction marker disposed on and around the tube) in order to aid in the precise positioning of the everting element (the balloon of Chin) to prevent injury during operation. As motivated by Woker cols. 1-2 and Chin ¶99.
Response to Arguments
Applicant's 12/31/25 arguments with respect to the prior art have been fully considered but they are not persuasive.
Applicant generally asserts that the cited reference(s) do not teach the claim(s). Examiner respectfully disagrees and directs attention to the rejections above which specifically detail which passages of the references teach each limitation.
In the alternate, in earnest advancement of prosecution, Applicant’s arguments with respect to the prior art have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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/BENJAMIN S MELHUS/ Primary Examiner, Art Unit 3791
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