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 .
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.
Claim Objections
Claim 1 objected to because of the following informalities:
The Examiner respectfully suggests Applicant amend line 5 of the claim to read as “a fiber Bragg grating (FBG);”.
Appropriate correction is required.
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 1-10 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.
Regarding claim 1, lines 9-10 of the claim recites “transmitting strain data from the optical interrogator … the processing circuitry correlating the strain data” therein. Line 8 of the claim has previously set forth “obtaining strain data” therein. The Examiner is of the position that the noted recitations in lines 9-10 of the claim render the scope of the claim as indefinite because it is unclear if the strain data associated with the optical interrogator is the same strain data as associated with the optical element. The scope is further indefinite because, if referring to different strain data, it is then unclear what “strain data” the recitation of “the strain data” in line 10 refers to. The Examiner respectfully suggests Applicant amend claim 1 to further the relationship between the strain data in each of lines 8 and 9 to either establish that such are the same data, or to distinguish that such are directed to different data. Claims 2-10 are rejected due to their dependency on claim 1. 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.
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.
Claims 1, 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US Pat. No. 2009/0076476 A1) further in view of Leo et al. (US Pat. Pub. 2006/0200049 A1).
Regarding claim 1, Barbagli provides for a method of quantifying a force exerted by a medical device against an area of tissue, the method comprising: placing a distal portion of the medical device in contact with the area of tissue (placing the distal end 20 of the device 18 against tissue; see at least [0102] disclosing the tissue surface contact), the medical device including an optical element, the optical element having an optical fiber with fiber Bragg grating (FBG) (see [0008], [0060] and [0086] as well as figure 16 with the optical system including the Bragg grating),
advancing the medical device such that the distal portion of the medical device exerts a force against the area of tissue (see [0102] discussing the distal end of the device to be advanced to contact tissue to exert a force),
obtaining strain data from the optical element with an optical interrogator (in view of [0086], the obtaining of the data from the optical sensors 1802/1804 with such being passed through some manner of processing circuity to provide for use of the data),
transmitting strain data from the optical interrogator to processing circuitry (again via the transmission of the strain data through the system for processing and use as in [0086]), the processing circuitry correlating the strain data to a pressure value (via the strain data of the optical sensors via the Bragg grating being indicative of a pressure value in the fiber itself), and
repositioning the medical device when the distal portion of the medical device is not located at target tissue (via the utilization of the optical/Bragg system being used for shaping/positioning sensing (See [0060] and [0086]).
While repositioning is provided for in Barbagli as above, Barbagli fails to specifically provides that the pressure value specifically indicates the distal portion of the medical device is in contact with non-target tissue. Leo discloses a similar system as that of Barbagli and specifically contemplates the utilization of at least one optical fiber in the form of an FBG to determine force relative to the contacting of the distal end of the device with tissue (See [0124] and [0139]).
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 the optical fiber sensing including the FBG’s of Barbagli to provide for distal tip force sensing as in Leo to provide for the additional determination of the repositioning of the distal portion of the medical device if the device is in contact with non-target tissue. Specifically, the combined arrangement of the FBG positioning and distal portion contact sensing would ensure that the user can ensure that the distal portion is in contact with tissue at a desired target location and reposition the distal portion if such is in contact with non-target tissue based on the pressure value associated with the contact of the distal portion with that non-target tissue.
Regarding claim 7, in view of the combination with Leo in the rejection of claim 1 above, the combined medical device is configured to puncture septal tissue, the medical device further including a lumen extending between a proximal portion and the distal portion (a lumen through 18 for passing the optical fiber therethrough), a first portion of the optical element being external to an elongate body of the medical device (portion external to 30 as in figure 2) and a second portion of the optical element being within the lumen (portion within the lumen of 18), the first portion including the FBG (the portion external to 30 would contain the FBG at the tip at 20).
Regarding claim 10, Barbagli further provides for comparing the strain data to an image of the area of tissue performed by an imaging system in communication with the processing circuitry (see [0078]-[0082] providing for the processing system to both image and collect force/strain data; and to determine based on the comparison if wall contact is made), and determining whether the pressure value indicates that the distal portion of the medical device is in contact with non-target tissue based on the comparison (see, for example, [0095] providing for the displaying o the image/force mapping on the display at the time when the device is in contact with non-target tissue).
Claims 5, 6, 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Barbagli et al. (US Pat. No. 2009/0076476 A1) in view of Leo et al. (US Pat. Pub. 2006/0200049 A1) as applied to claim 1 above, and further in view of Sara (US Pat. Pub. 2017/0105780).
Regarding claims 5 and 8, while Barbagli provides for a treatment element in the form of electrodes (606/608/610/612), or in the form of a needle/knife (1402), Barbagli fails to provide that the treatment element is cryotreatment element in the form of an expandable element defining a maximum outer diameter, and a distal tip that is distal to the expandable element. Barbagli further fails to provide that the method further comprises automatically preventing, by the processing circuitry, circulation of a coolant through the treatment element that is configured to lower a temperature of the treatment element to a temperature that is sufficient to cryoablate tissue. Sara discloses a similar treatment device as that of Barbagli that includes a expadnable cryotreatment element configured to cryoablate tissue and that includes a FBG sensing for sensing tissue contact/force (see the catheter 12 with the cryoballoon 26 and the fiber sensors 30). Sara further provides that its processing circuitry function to automatically preventing, by the processing circuitry, circulation of a coolant through the treatment element that is configured to lower a temperature of the treatment element to a temperature that is sufficient to cryoablate tissue (see [0041] providing for 62 functioning to automatically control the delivery of the cryogen).
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 treatment element configured to cryoablate tissue as in Sara as the treatment element of Barbagli. Sara readily provides that the cryoablation treatment element readily funcitons to ablate tissue within the heart. Further, the automatic control of the delivery of the cryogen would have been further obvious in view of the teaching of Sara in order to control the delivery of the cryogen in the manner described as in [0041] of Sara. Such would ensure only a desired amount of cryogen would be delivered to the treatment element so as to create a desired area of ablation within the tissue.
Regarding claim 9, in view of the combination in the rejection of claim 8 above, the optical element is on the maximum outer diameter of the expandable element see figure 12 with the portion at 108A on the maximum outer diameter of the balloon at 26A).
Regarding claim 6, while Barbagli provides for a treatment element in the form of electrodes (606/608/610/612), or in the form of a needle/knife (1402), Barbagli fails to specifically provide that the treatment element defines an equator wherein the optical element is on the equator of the treatment element. Barbagli further fails to provide the step of placing a distal portion of the medical device in contact with an area of tissue including placing a portion of the equator of the treatment element in contact with an area of tissue.
Sara discloses a similar treatment device as that of Barbagli that includes a expadnable element that defines an equator and for an optical element in the form of an FBG sensor for sensing tissue contact/force (see the catheter 12 with the cryoballoon 26 and the fiber sensors 30 located at the equator). Sara further provides for placing a portion of the equatoe in contact with an area of tissue (see figure 12 with the portion of 26A contacting tissue).
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 an expandable treatment element as in Sara as the treatment element of Barbagli to provide for a known alternative element for treating tissue of heart that includes optical fiber sensing. Sara readily provides that the expandable treatment element readily functions to ablate tissue within the heart in the same manner that the treatment element of Barbagli. Further, the provision of the FBG at the equator of the expandable element would ensure that contact with target or non-target tissue can be accurately determined such that treatment is only provided with the device is in contact with tissue of the heart.
Allowable Subject Matter
Claims 2-4 are 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.
Claims 11-20 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: During the search of the prior art, prior art such as Barbagli, Leo and Sara were identified as the closest prior art to the instant claims for the reasoning set forth in the rejections above. The Examiner has also reviewed Agrawal et al (US Pat. Pub. 2014/0336637 A1) as being particularly pertinent to the instant claims. The Examiner, however, has failed to find any reference or combination of references that would disclose each and every limitation required by either dependent claim 2 or independent claim 11.
With respect to dependent claim 2, neither Barbagli nor Leo (as relied upon in the rejection of claim 1) disclose, fairly suggest or otherwise render obvious the additional step of automatically preventing the advancement of the puncture element from the elongate body and through the area of tissue when the pressure value indicated the distal portion of the medical device is in contact with non-target tissue. Barbagli, while contemplating a puncture device is the form of a needle or knife at 1402 and further contemplating the navigating of the device to a location for treatment (see [0090] providing for “where or how close the surgical instrument is located to the spot where the operation has to be executed”), fails to provide that determination of the non-target location is via a pressure value or that any manner of movement of the puncture device is automatically controlled by the circuitry of the system to prevent the advancement of the puncture element from the elongate body at the non-target location. Leo fails to cure this deficiency in Barbagli given that such is concerned with the determination of a pressure value on the distal portion of a surgical device and makes no mention of the automatic prevention of the advancement of any manner of puncture device as claimed.
With respect to independent claim 11, the Examiner notes that substantially similar rationale is equally applicable as set forth above regarding claim 2. Claim 11 specifically requires a combination of limitations where the determination of contact of the distal portion of the elongate body with non-target tissue is based on the comparison between the force exerted on the area of tissue to an image of the area of tissues, and then that the subsequent automatic prevention of operation of the medical device occurs when the determination is made that the medical device is in contact with non-target tissue. Barbagli, while contemplating both force-based mapping within the body and imaging within the body, fails to specifically provide that the feedback from the imaging and force feedback are compared as claimed to then result in the automatic prevention of the operation of the medical device as claimed. Neither Leo nor Sara nor the noted Agrawal reference cure this deficiency in Barbagli.
Thus, it is for at least the reasoning set forth above that the Examner finds that each of claims 2-4 and 11-20 contain allowable subject matter.
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