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 .
Status of Claims
Claims 1-24 are currently pending and under consideration.
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-15, drawn to a catheter tool for heart valve treatment comprising a catheter body, clamshell-shaped tool, and a LASER array, classified in A61B2018/0016.
II. Claims 16-24, drawn to a method of remodeling a cusp of a heart valve of a patient in need thereof, classified in A61B2018/00839.
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 catheter tool for heart valve treatment can be utilized in methods other than the method described in Invention II. For example, another method of using the catheter tool, outside of remodeling a cusp of a heart valve, would be for diagnostic testing through a coronary angiography.
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.
A telephone call was made to Susan Oiler on 08/26/2026 to request an oral election to the above restriction requirement, and claims 1-15 were elected without traverse.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4, 10, and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “clamshell-shaped” in claims 1 and 15 is a relative term which renders the claim indefinite. The term “clamshell-shaped” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Thus, the shape of the catheter body is rendered indefinite by this term. The examiner will interpret the term “clamshell-shaped” to mean any hinged structure with two portions that is capable of grasping an object, or in this case - tissue.
The term “apical” in claims 4 and 10 is a relative term which renders the claim indefinite. The term “apical” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although it is understood in the art that apical means to be located at the top or highest point of a structure, it is unclear what the Applicant is regarding as the top point of the LASER array, thus the positioning of the first LASER array as recited in claims 4 and 10 is rendered indefinite.
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.
Claims 1, 5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Francis et. al, (US 20240041524 A1, published 02/08/2024, hereinafter known as Francis).
Regarding claim 1, Francis discloses a catheter tool for heart valve treatment (“catheter cutting apparatus is configured to excise valve leaflets and prepare the site for valve replacement” [0017]) comprising:
a catheter body (hollow tube (catheter) 40 as shown in annotated Figure 1. below, [0021]) comprising a main channel extending the operative length (sheath 50 as shown in Fig. 2, [0025]) thereof and terminating with a clamshell-shaped tool (accessory tool 20 as shown in annotated Fig. 1 below, [0022]) configured to define a compartment shaped to receive a leaflet of a heart valve (“outer sheath of the catheter is pulled back, exposing the grasping catheter to grab the leaflet tissue” [0017]),
wherein the tool has an aortic shell and a ventricular shell (grasping elements 22 and 24 as shown in annotated Fig. 1 below, [0022]) operatively openable relative to one another about a hingepoint (as shown in annotated Fig. 1 below, [0022]) proximate the distal end of the catheter body (“direction is generally, from the perspective of the distal tip of the catheter 5” as shown in annotated Fig. 1 below, [0021]) and are operatively expandable to fan outward at their respective distal ends to form the compartment (accessory body including the grasping elements “protrudes outward from the catheter” as shown in annotated Fig. 1 below, [0022]);
wherein the main channel is operatively open into the compartment formed by the clamshell-shaped tool while open and while closed (main channel 50 as shown in Fig. 2, [0025]).
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It would have been an obvious matter of design choice to make the different portions of the grippers of whatever form or shape was desired or expedient (i.e., a clamshell shape as claimed in the present invention). A change in shape from the grippers as disclosed in Francis to the clam-shell shaped tool as claimed in the present invention both achieve the device’s goal of valve resection. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. See MPEP 2144.04 Part IV Example B.
Regarding claim 5, Francis discloses the catheter tool of claim 1, wherein the aortic shell and the ventricular shell each have a perimeter flange extending toward one another and shaped to sealing mate to define a closed, expanded position for the compartment (as shown in Fig. 2, the teeth disposed on the distal end of the grasping elements 22 and 24 extend from the catheter body 40 towards one another, grasping elements are coupled through a hinge, during treatment the two members close and seal together using the teeth of the grasping elements to grasp onto the tissue [0026]).
Regarding claim 8, Francis discloses the catheter tool of claim 1, wherein the distal end face of each of the aortic shell and the ventricular shell comprise a LASER positioned for operative separation of adherent adjacent cusp fibrous tissue (“outer sheath of the catheter is pulled back, exposing the grasping catheter to grab the leaflet tissue”, [0017]). It would be commonly understood in the art that because Francis reads on the device as claimed in the present invention, the device of Francis is capable of the intended use of the claimed invention.
Claims 2-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Francis as applied to claim 1 above, and further in view of Nathan et. al, (US 20210307771 A1, published 10/07/2021, hereinafter known as Nathan).
Regarding claim 2, Francis discloses the catheter tool of claim 1, wherein the catheter contains a first LASER array (ring of fibers 32 in a plurality of arrangements of an entirety, a circle of the circumference of the catheter distal end to ablate tissue of the aortic valve leaflet…a power source is connected at a proximal end of the catheter to energize a laser (via the fibers)” Fig. 1, (Francis [0024])).
However, Francis does not disclose wherein the interior shell surface of each of the aortic shell and the ventricular shell comprise a LASER.
Nathan teaches a surgical system that includes a robotic manipulator, a first surgical instrument removably mountable to the robotic manipulator and maneuverable within a body cavity by the robotic manipulator (Abstract). Other examples within the scope of this disclosure may include…the use of diagnostic tools such as catheters to deliver radiopaque materials to targeted tissue [0024]. Tools used for laser ablation may be inserted into the working channel to perform ablation on the tissue grasped within the jaws, as shown in Fig. 4 [0016].
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the laser structure of Nathan with the catheter tool of Francis because the jaws may protect other tissue from the laser, reducing the risk of harming adjacent tissue (Nathan [0016]).
Regarding claim 3, Francis in view of Nathan discloses the catheter tool of claim 2, wherein the first LASER array comprises a circumferentially arranged array (lasers 32 are positioned circumferentially around the face of the catheter as shown in Fig. 1, Francis [0024]) and a radially arranged array (lasers 32 are positioned radially around the face of the catheter as shown in Fig. 1, Francis [0024]).
Francis discloses the present invention as claimed with the exception of the radially disposed lasers being inside the clamshell.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to dispose the lasers within a clamshell instead of around, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. See MPEP 2144.04, Section 6, Example C.
Regarding claim 4, Francis in view of Nathan discloses the catheter tool of claim 3, wherein the first LASER array comprises an apical array positioned for alignment with the leaflet's nodule of Arantius (one of the lasers 32 is positioned apically (at the highest point) along the face of the catheter as shown in Fig. 1, Francis [0024]).
Regarding claim 6, Francis in view of Nathan discloses the catheter tool of claim 2.
However, Francis does not disclose wherein at least longitudinal portions of each perimeter flange comprise a second LASER array.
Nathan teaches tools used for laser ablation may be inserted into the working channel to perform ablation on the tissue grasped within the jaws, as shown in Fig. 4 [0016].
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to duplicate the laser configuration of Nathan (See MPEP 2144.04 part VI example B) and include this in the catheter tool of Francis because this allows for the lasers to ablate more tissue during treatment.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Francies in view of Nathan as applied to claim 2 above, and further in view of Sirhan et. al, (US 20220183843 A1, published 06/16/2022, hereinafter known as Sirhan).
Regarding claim 7, Francis in view of Nathan disclose the catheter tool of claim 2.
However, Francis in view of Nathan does not disclose wherein the perimeter flanges are configured to sealing mate using an electromagnetic seal.
Sirhan teaches a catheter system for delivering an anchor to a valve annulus in a heart valve includes a locating catheter and an anchor delivery catheter (Abstract). The present invention relates systems and methods for access heart valves for treatment, repair, or replacement [0002]. The channels or other features of the device shaft may be configured to position an interventional tool, such as a tissue resection device [0042]. At least one of the locating catheter and the anchor delivery catheter will comprise at least one magnetic element, typically near a distal end thereof…magnetic elements will usually comprise…including electromagnets [0025]. The distal end of the anchor delivery catheter magnetically couples to the distal end of the locating catheter [0014].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the electromagnets disposed on the end of the elongate device with the catheter tool of Francis and Nathan to magnetically couple to the distal end of the elongate device across the mitral valve (Sirhan, [0019]).
Claims 9, 11, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Francis as applied to claim 1 above, and further in view of Mee et. al, (US 20210030467 B2, published 02/04/2021, hereinafter known as Mee).
Regarding claim 9, Francis discloses the catheter tool of claim 1.
However, Francis does not disclose wherein the interior shell surface of each of the aortic shell and the ventricular shell comprise a multi-faceted array comprising an array of outlets configured to release a medical treatment material and a first LASER array.
Mee teaches a method of delivering a membrane enclosed preparation to a target cell in a subject [0316]. The target cell or tissue is modified by…tissue resection [0323]. Compositions of fusosomes may be generated from cells in culture…such as stem cells [0297]. The fusosome compositions described herein can be used to treat a subject [0332]. A variety of perforation devices and perforation chambers can be used…the perforation devices can be lasers [0113].
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the stem cell treatment and laser array of Mee with the catheter tool of Francis because the medical treatment material composition can be delivered to an ex-vivo transplant (e.g… heart valves)…the composition improves viability, respiration, or other function of the transplant (Mee, [0331]).
Regarding claim 11, Francis in view of Mee disclose the catheter tool of claim 9.
However, Francis does not disclose wherein each LASER of the first LASER array are adjustable to contours of the leaflet by adjusting a distance parameter and/or wavelength of the LASER.
Mee teaches a variety of perforation devices and perforation chambers can be used…the perforation devices can be lasers [0113]. A half wave plate and a polarizing beam splitter are installed in the laser beam path to adjust the laser energy [0217].
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the LASER adjustments of Mee with the catheter tool of Francis to better adapt to cavities of various shapes and sizes.
Regarding claim 12, Francis in view of Mee disclose the catheter tool of claim 11.
However, Francis does not disclose wherein the medical treatment material comprises a biomedical resin and the LASER operatively prints the biomedical resin on the surface of the leaflet.
Mee teaches a method of delivering a membrane enclosed preparation to a target cell in a subject [0316]. The target cell or tissue is modified by…tissue resection [0323]. Compositions of fusosomes may be generated from cells in culture…such as stem cells, [0297] (a biomedical resin can comprise stem cells as described in [0142] of the specification of the present invention). The fusosome compositions described herein can be used to treat a subject [0332].
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the stem cell treatment and laser array of Mee with the catheter tool of Francis because the medical treatment material composition can be delivered to an ex-vivo transplant (e.g… heart valves)…the composition improves viability, respiration, or other function of the transplant (Mee, [0331]).
Regarding claim 14, Francis in view of Mee disclose the catheter tool of claim 19, wherein the compartment defines a tray for holding the medical treatment material in contact with the surface of the leaflet for printing thereon (because Francis in view of Mee teaches the configuration of the catheter body as claimed in the present invention, the art also teaches the intended use of the catheter tool as claimed).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Frances in view of Mee as applied to claim 9 above, and further in view of Nathan.
Regarding claim 10, Francis in view of Mee disclose the catheter tool of claim 9, wherein the first LASER array comprises a circumferentially arranged array (lasers 32 are positioned circumferentially around the face of the catheter as shown in Fig. 1, Francis [0024]), radially arranged array (lasers 32 are positioned radially around the face of the catheter as shown in Fig. 1, Francis [0024]), and an apical array positioned for alignment with the leaflet's nodule of Arantius (one of the lasers 32 is positioned apically (at the highest point) along the face of the catheter as shown in Fig. 1, Francis [0024]).
Francis discloses the present invention as claimed with the exception of the radially disposed lasers being inside the clamshell.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to dispose the lasers within a clamshell instead of around, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. See MPEP 2144.04, Section 6, Example C.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Francies in view of Mee as applied to claim 12 above, and further in view of Bowlin et. al, (US 20070225631 A1, published 09/27/2007, hereinafter known as Bowlin).
Regarding claim 13, Francis in view of Mee disclose the catheter tool of claim 12.
Francis in view of Mee does not disclose wherein the medical treatment material further comprises CD/CL1 and/or CD/CL3.
Bowlin teaches sealants for skin and other tissues (Abstract). The tissue sealants are also used as a treatment…including valve repair [0119]. Layering of structures is used in some sealants in which it is desired to mimic more closely the composition of natural materials…providing a sealant with selected amounts of Type I collagen, Type III collagen, and elastin in successive layers is used in some embodiments [0094].
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the profibrotic agents for treatment of Bowlin with the catheter tool of Francis and Mee because these medical treatment materials can mimic gradients or other patterns of distribution across the depth of a structure such as the wall of a blood vessel (Bowlin [0094]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Francis as applied to claim 1 above, and further in view of Tamir et. al, (US 20230077068 A1, published 09/03/2023, hereinafter known as Tamir).
Regarding claim 15, Francis discloses the catheter tool of claim 1.
However, Francis does not disclose wherein the catheter body comprises a plurality of subchannels extending the operative length thereof for communication with the expandable clamshell and/or the environment surrounding the expandable clamshell.
However, Tamir teaches methods and tools for modifying leaflets of an existing valvular structure in a subject (Abstract). FIGS. 3A-3B illustrate a second exemplary tool that can be used to sequentially cut multiple leaflets of an existing valvular structure [0107]. The second tool can also have a multi-channel positioning member disposed at the distal end of catheter…the multi-channel positioning member can have channels through which the first positioning member, second spacing member, and lacerating member respectively extend [0107].
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the subchannel configuration of Sharma with the catheter tool of Francis because this allows for the respective outlets of channels to be reoriented with respect to another leaflet of the existing valvular structure for cutting (Tamir [0107]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/F.M.K./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
