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 .
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, optical fiber cores (claim 7) and imaging optical fiber cores (claim 7) 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.
Claims 8 and 25 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.
Claims 8 and 12 recite “a number of illuminating optical fiber cores” and “a number of imaging optical fiber cores”. Figure 1 demonstrates an elongate medica device 105 which can be an optical fiber however in no way does figure 1 demonstrate both illuminating optical fiber cores as well as imaging optical fiber cores. It is unclear how these are different and it is further unclear and indefinite what applicant specifically intends imaging optical fiber cores to be. The language is further indefinite in that each of the two fiber types are stated to be configured differently. The illuminating optical fiber cores propagate light distally, which is known in the art and standard to fiber illumination. However the imaging optical fiber cores are configured to propagate imaging light proximally, this language is indefinite. It is further indefinite how the imaging light is received at the distal end of the elongate medical light in response to light propagating proximally. It is not clear how imaging can be received at the distal end. For the purpose of examination it will be assumed that optical fibers can propagate light in this manner.
Claim Objections
Claim 1 is objected to because of the following informalities: line 9 recites “the elongate medical”, this should read “the elongate medical device”.
Claim 13 recites “the catheter” in line 4, this language lacks proper antecedent basis and should recite “a catheter”.
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 1-4, 6, 12-21 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wiesman US 2022/0280746.
Regarding claims 1-4, 12, 15-16, 19-21 and 30: Wiesman discloses a medical device assembly 10 (figure 1), comprising: a tubular member 9 (“catheter”, figure 8) for insertion into a patient (“urethra”, paragraph 0025) and defining a lumen (“interior lumen extending through tubular catheter body”, paragraph 0025) which extends from a proximal end to a distal end; an elongate medical device 155 (figure 60) disposed within the lumen, once within the lumen the distal end of the device 155 is within the distal end of the lumen of the catheter (paragraph 0253); and a cap 2 (figures 1-3) covering the distal end (figure 1) of the tubular member 9 (figure 1), the cap configured to prevent contamination of the elongate medical device prior to insertion (paragraph 0176 the cap maintains a lubricant within the system and is thus considered to be fluid tight which would inherently reduce contamination prior to cap removal as well as prevent microbial ingress). Regarding the method of claim 19, as can be seen in figure 3 the cap is removed that the catheter 5 is advanced forward into the body.
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Regarding claim 13: Wiesman discloses a cap body defining a proximal and distal end, a cavity extending into the cap body from the proximal end, the cavity configured to receive the catheter (as is shown in figure 3 the catheter 5 can be contained within introducer tip 2, the cap operably covers introducer tip 2) and the cap is configured to prevent contamination of the medical device disposed within a lumen of the catheter (paragraph 0176 the cap maintains a lubricant within the system and is thus considered to be fluid tight which would inherently reduce contamination prior to cap removal).
Regarding claim 6: Wiesman discloses that the elongate medical device includes a surgical fiber (paragraphs 0207, 0214).
Regarding claims 17-18: Weisman discloses that the cavity is tapered and the cap includes a bullnose shape.
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 5, 7-11 and 22-29 are rejected under 35 U.S.C. 103 as being unpatentable over Wiesman US 2022/0280746 in view of Ramamurthy et a US 8,864,655.
Regarding claims 5 and 23: Weisman discloses the claimed invention including the elongate medical device 155 (figure 60) however Weisman does not disclose that the elongate medical device 155 is enabled for tracking the location of the elongate medical device within the patient, it is noted that the elongate medical device 155 is an optical fiber (paragraph 0207). Ramamurthy however teaches of an optical fiber which includes strain sensors for tracking the device within a body (column 7, lines 24-36). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Weisman to include strains sensors for tracking the device within a body, as taught by Ramamurthy, in order to determine a position of the device.
Regarding claims 7 and 24: Weisman discloses the claimed invention however Weisman does not specifically disclose a multicore optical fiber with a plurality of gratings along the length with the gratings enabling shape sensing. Ramamurthy however teaches of an optical fiber which can include multiple sub-cores (column 11, lines 8-9). The fibers include Fiber Bragg Gratings (FBGs 302, figures 3B and 3C) formed within or written into the core. The FBGs provide accurate shape and position data (column 8, lines 2-4). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Weisman to include a multicore fiber with FBG’s, as taught by Ramamurthy, in order to provide accurate shape and position data.
Regarding claims 8 and 25 as understood: Weisman discloses the claimed invention however Weisman does not specifically disclose a number of illuminating fiber cores which propagate light distally along the device and imaging optical fiber cores used. Ramamurthy however teaches of an optical fiber which can include multiple sub-cores (column 11, lines 8-9). The fibers include Fiber Bragg Gratings (FBGs 302, figures 3B and 3C) formed within or written into the core. The FBGs provide accurate shape and position data (column 8, lines 2-4). As is known in the art the light is propagated distally. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Weisman to include a multicore fiber with FBG’s, as taught by Ramamurthy, in order to provide accurate shape and position data.
Regarding claims 9-10 and 26-28: Weisman discloses the claimed invention however Weisman does not specifically discloses magnetic elements disposed along the length used for magnetic tracking. Ramamurthy however teaches of using electromagnetic coils (column 14, line 52), an electromagnetic localizing sensor can be placed on each Bragg Fiber to obtain three-dimensional coordinates (column 20, lines 27-35). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Weisman to include an electromagnetic localizing sensor can be placed on each Bragg Fiber to obtain three-dimensional coordinates, as taught by Ramamurthy, in order to establish absolute position (Ramamurthy column 20, line 31). Specifically regarding claims 10 and 27-28, the language found in claim 10 is considered to be intended use and/or functional language. Applicant is reminded that it makes no difference if the devices of the prior art are used in a different way since a 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. In this instance, the prior art is capable of meeting the claimed intended use recitations since the device comprises the required magnetic elements.
Regarding claims 11, 22 and 29: Weisman discloses the claimed invention including the elongate medical device 155 (figure 60) however Weisman does not disclose that the elongate medical device 155 is an intravascular catheter. Ramamurthy however teaches of an intravascular system (column 8, line 56) which uses a guide catheter (column 8, line 12) which is considered to be an intravascular catheter based on figure 2A. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Weisman to include an intravascular catheter, as taught by Ramamurthy, in order to treat cardiac tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796