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 1 (claims 1-10) in the reply filed on 09/08/2026 is acknowledged.
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.
Claims 1-2, 5-6 and 10 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Chu (US 2021/0378740).
Regarding claim 1, Chu discloses a system for removing fragmented remains of a bodily mass from an anatomical site within a patient (abstract), said system comprising: a first sheath (fig.20A; scope 1207) defining a first lumen (fig.20A-B; working channel 1210) therethrough and having an inner surface ( inner surface of working channel 1210) and an outer surface (outer surface of working channel 1210); a tubular elongate member (fig.20A; sheath 1211) extending through the first lumen (fig.20A), said tubular elongate member defining a distal inlet channel therethrough (fig.20A) and having an inner surface (inner surface of sheath 1211) and an outer surface (outer surface of sheath 1211); and a biasing member (fig.20A-B; laser 1208) within said first lumen maintaining spacing between the inner surface of said first sheath and said outer surface of said tubular elongate member (fig.20A-B); wherein: said first lumen is fluidly couplable with a suction source to define an outlet channel between the inner surface of said first sheath and said outer surface of said tubular elongate member [0117]; and said biasing member is insertable into said first lumen independently of said tubular elongate member (the laser housing 626 is inserted into the channel 610 during the making process and laser 608 extend within that (fig. 20A-B, see also [0117]).
Regarding claim 2, Chu discloses the system of claim 1, wherein said first sheath, said tubular elongate member, and said biasing member are movable with respect to one another to adjust the relative positions of distalmost ends thereof with respect to one another (fig.20C, see also [0117]).
Regarding claim 5, Chu discloses the system of claim 1, further comprising a sensor insertable into said first lumen independently of said tubular elongate member and said biasing member (fig.20A, [0118]).
Regarding claim 6, Chu discloses the system of claim 1, wherein said tubular elongate member is a medical scope with a working channel defining the distal inlet channel (fig.20A-B).
Regarding claim 10, Chu discloses the system of claim 1, further comprising a fluid management system operatively associated with at least one of the first lumen or the distal inlet channel to control pressure and/or temperature conditions at the anatomical site [0119].
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.
Claims 4, 7-8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US 2021/0378740).
Regarding claim 4, Chu discloses sensor being disposed at different locations [0007]. However, Chu does not specifically disclose wherein said biasing member includes a sensor. It would have been obvious to one having ordinary skill in the art at the time the Application was effectively filed to have the sensor being disposed anywhere including on the biasing member, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 7, Chu, in this embodiment, does not disclose a second sheath defining a second lumen therethrough and having an inner surface and an outer surface, said first sheath positionable within the second lumen defined through said second sheath, wherein a proximal inlet channel is defined between the inner surface of said second sheath and the outer surface of said first sheath. In another embodiment (fig.8), Chu discloses the system of claim 1, further comprising a second sheath (sheath 402) defining a second lumen (lumen 404) therethrough and having an inner surface (inner surface of lumen 404) and an outer surface (outer surface of 404), said first sheath (in this embodiment lumen of 407) positionable within the second lumen defined through said second sheath (fig.8), wherein a proximal inlet channel (suction channel 410)is defined between the inner surface of said second sheath and the outer surface of said first sheath (fig.8, see also [0089]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the first embodiment (fig.20A-C) with a second sheath defining a second lumen therethrough and having an inner surface and an outer surface, said first sheath positionable within the second lumen defined through said second sheath, wherein a proximal inlet channel is defined between the inner surface of said second sheath and the outer surface of said first sheath as taught by the second embodiment (fig.12A-B) for the purpose of having additional suction area.
Regarding claim 8, Chu, in this embodiment (fig.20A-C), does not disclose a fragmenting device extendable through said tubular elongate member. Chu teaches various arrangement of the fragmenting device in the disclosure. For example, in another embodiment (fig.12A-B), fragmenting device extendable through said tubular elongate member (fig.12A, see also [0097]). In this embodiment, Chu teaches a sperate laser housing to maintain the laser housing to one side of the suction channel, thus allowing a larger area for fragments removal [0097]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the first embodiment (fig.20A-C) with fragmenting device extendable through said tubular elongate member as taught by the second embodiment (fig.12A-B) for the purpose of maintaining the laser in one side and create more space.
Regarding claim 9, Chu discloses the system of claim 8, wherein said fragmenting device is movable with respect to said first sheath and said tubular elongate member between a position distal to a distalmost end of said first sheath and a position proximal to the distalmost end of said first sheath and within the first lumen (fig.12A).
Allowable Subject Matter
Claim 3 is 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: the examiner failed to find any reference which that, either alone or in combination discloses, suggests or renders obvious of wherein said first sheath has a distalmost end advanceable distal to a distalmost end of said tubular elongate member to create a funnel within a distal end of said first sheath within said first lumen and between the distalmost end of said first sheath and the distalmost end of said tubular elongate member while teaching each and every limitation set forth in independent claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nir et al. (US 20090227992) teaches method for removing deposits from an in vivo tissue, such as removing calcified plaque from a calcified aortic valve by removing the deposits with the help of shock waves produced by a light-source such as a laser in an aqueous liquid in proximity of the tissue as well as a shock-wave generating device useful in implementing the method. Disclosed is a minimally invasive valve-sparing treatment of calcific aortic stenosis (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794
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