DETAILED ACTION
Applicant’s preliminary amendment, filed February 21, 2025, are fully acknowledged by the Examiner. Currently, claims 43-52 are pending with claims 1-42 cancelled, and claims 43-52 newly added. The following is a complete response to the February 21, 2025 communication.
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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the RF catheter of claim 44 including an RF generator must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 44 is 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.
Regarding claim 44, the claim recites the requirement that “the electrode is connected to an RF generator and functions to transfer RF energy and to sense a myocardial electrical signal or apply pacing”. The Examiner is of the position that the positive requirement of the electrode to be connected to an RF generator renders the scope of the claim as indefinite because each of claims 43 and 44 are directed to an “RF catheter” and not a system (or some other broader structure). Accordingly, it is unclear to the Examiner if the RF generator can be included as structure of the RF catheter or if, alternatively, the catheter is configured to connect to the generator. The Examiner respectfully suggests Applicant amend claim 44 to recited “wherein the electrode is configured to connect[[ed]] to an RF generator” to correct the issue. Appropriate correction is required.
Regarding each of claims 44, 47 and 48, each claim recites the limitation of “the electrode” therein. The Examiner is of the position that the scope of each claim is indefinite given that parent claim 43 sets forth “one more electrodes” and none of claims 43 or 44, or claims 43 and 47, or claims 43 and 48 have positively narrowed the claim to only include a single electrode. The Examiner respectfully suggests that Applicant amend each of claims 44, 47 and 48 to recite “the one or more electrodes” to correct the issue. Appropriate correction is required.
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 43-44, 46-48, 50 and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schaer (US Pat. No. 6,002,956).
Regarding claim 43, Schaer provides for an RF catheter for treating hypertrophic cardiomyopathy, the RF catheter device 10) comprising a body part constituting a catheter body made of a flexible and soft material (shaft 11, see col. 5; 6-17 providing for the materials of construction; see further col. 8; 1-9 providing for PEBAX), and
an intraseptal insertion part provided at a distal part of the body part and having one or more electrodes (part at 12 having 17 as an electrode; such can further include one or more of electrodes 18 thereon), a tapered tip gradually becoming thinner toward an end thereof (tip at 17), and a guidewire lumen therein, into which a guidewire is inserted (lumen formed at 14 through which 31 is inserted),
wherein the guidewire lumen is provided from a tip hole (from port 34), which is an end of the tapered tip (as shown in the figures), to a side hole provided at a middle part of the catheter (via a hole at 30as in figure 3, or 38 as in figure 5), or is provided in an entirety of the catheter from the tip hole to a proximal part of the catheter (via 14 extending to the proximal end of 11),
wherein the body part has a cooling channel independent of the guidewire lumen (see figure 3, with the channels formed through 30; see figure 5 with the channels formed at 35),
and wherein when a coolant is injected into the guidewire lumen, the coolant flows reversely and is discharged through the side hole of the guidewire lumen (via the capability of fluid to flow through 14 to the proximal end of 33 as shown in either figures 3 or 5 and then to pass through one of 30 in figure 3 or 38 as in figure 5).
The Examiner further notes that the limitation set forth in claim 43 of “so that during hypertrophic cardiomyopathy treatment, the intraseptal insertion part is inserted into the interventricular septum along the guidewire” is being interpreted as a functional recitation of the intended use of the claimed invention. It is well established that such a functional recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the Examiner fails to find that the claimed functionality would define over the device 10 of Schaer given that Schaer is capable of being inserted within the body through vasculature.
Regarding claim 44, Schaer provides that the electrode is connected to an RF generator and functions to transfer RF energy and to sense a myocardial electrical signal or apply pacing (17 or 18 are capable of connecting to a generator and/or sensing system via the conductors 16 to connector 22; see col. 5; 19-37).
Regarding claim 46, Schaer provides for a tip lumen has an inner diameter smaller than an inner diameter of a body lumen provided in the body part (see figures 3 and 5 where the lumen formed through 17 is smaller in diameter than the lumen formed in 14; see col. 7; 39-46).
Regarding claim 47, Schaer provides that the intraseptal insertion part has a spiral coil wire or a braided wire provided therein, the wire being insulated from the electrode (16 is not electrically connected to any of 17 or 18).
Regarding claim 48, Schaer provides that the intraseptal insertion part comprises a hydrophilic polymer coating layer formed on a surface except for a surface of the electrode (via the outer jacker formed of a hydrophilic polymer in the form of PEBAX as in col. 7; 59 – col. 6; 9).
Regarding claim 50, Schaer provides that wherein in the catheter, a cooling channel into which a coolant is injected is provided from a proximal part of the catheter to the intraseptal insertion part, with an end of the cooling channel communicating with the guidewire lumen (via the lumen formed through the portion indicated at 13 as in figure 1 being a cooling channel, and such communicating with the lumen in 14 in the insertion part as in figures 2/3/5).
Regarding claim 51, Schaer provides that a cooling tube into which the coolant is injected is inserted into the guidewire lumen from a proximal part of the guidewire lumen to the intraseptal insertion part, with an end of the cooling tube being open.
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.
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 45 is rejected under 35 U.S.C. 103 as being unpatentable over Schaer (US Pat. No. 6,002,956) as applied to claim 43 above, and further in view of Carmel et al. (US Pat. Pub. 2015/0359998 A1).
Regarding claim 45, Schaer provides for a tip lumen provided in the tapered tip is in close contact with the guidewire (portion of the lumen within 17 as in the figures, see col. 5; 56- col. 6; 2). Schaer fails to that there is no space therebetween the guidewire and the tip lumen. Carmel discloses a manner of utilizing a lumen with a guidewire therein to direct fluid through a surgical device. Carmel further provides for the guidewire (3310 to be in close contact with a tip lumen such that there is no space between the guidewire and the tip lumen (see figure 3A with the seal 3320 being in contact with the guidewire to form a seal as in at least [0059]). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a seal 3310 as in Carmel to the tip lumen of Schaer to provide for an exemplary manner of sealing fluid flow through the tip lumen. Such would result in there being no space between the lumen and the guidewire.
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Schaer (US Pat. No. 6,002,956) as applied to claim 43 above, and further in view of Carmel et al. (US Pat. Pub. 2015/0359998 A1).
Regarding claim 49, Schaer provides for a length of the tapered tip great than 2mm (see col. 7; 54-55), for a thickness of a side opposite to the end of the tapered tip to be in the range of 3 to 6Fr (via the outer diameter being in the range of 0.89mm – 1.5mm as in col. 7; 39) and for a thickness of an end of the tapered tip to be less than that of the above defined side off the end of the tapered tip thereof. Schaer, while providing for general features and sizes of various portions of the tapered tip and related structure (see col. 7; 29-58), fails to specifically recited that the length of the tapered tip is between 5mm and 20mm, and that the thickness of the end of the tapered tip is between 1.2 – 1.4Fr.
Mirza provides for a similar fluid delivering device as that of Schaer and specifically provides for an upper limit of a tapered tip in the range 1 mm to 4 cm (per [0038]). Mirza further provides for the a size of the end of a tapered tip to be between 1.2-1.4 Fr (See [0038] providing for an outer diameter of 0.4mm – 1.5mm and [0039] providing for 0.4mm to 1.35mm). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a tip length and end diameter as in Mirza to the treatment tip of Schaer to provide for a known alternative size for a tapered, fluid-delivering tip of a treatment device. Schaer already provides for an open-ended length range that overlaps with the claimed length and Mirza further provides that such a range is known within a bounded range of tip lengths. Similarly, while Schaer provides for relative diameters near/close to the claimed tip diameter, Mirza readily provides that tapered to such a diameter around a tip opening is known in the art. The Examiner further notes that the selection of a value within the claimed ranges for the device of Schaer in view of Mirza would have further been obvious given that it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see In re Aller, 105 USPQ 233).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Schaer (US Pat. No. 6,002,956) as applied to claim 43 above, and further in view of Jonkman. (US Pat. No. 6,120,494).
Regarding claim 52, Schaer provides that the body part is thicker than the intraseptal insertion part (for example, the shaft at 13 is thicker than portions of the tip tapered at 17), and wherein the body part has a grounding-device lumen such that a grounding device is inserted thereinto from a proximal part of the grounding-device lumen to the tapered connect part (lumen formed through the body to pass 23 therethrough). Schaer fails to provide for a tapered connect part is provided between the body part and the intraseptal insertion part. Jonkman discloses a similar devices for placing a device within the body including a guidewire and specifically contemplates the use of a tapered connecting part between a body part and a tapered distal tip of the device (see figure 4 with the taper at 38). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a tapered connecting part between the body part and the intraseptal insertion part of Schaer in view of the teaching of Jonkman. Such would provide a more gradual transition along the length of the device and allow for a thinner insertion part to be utilized.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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/Ronald Hupczey, Jr./
Primary Examiner, Art Unit 3794
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