DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-11, 13-15, 17-22 are pending.
This action is Non-Final.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 claimed features of additional sensor and sensor, with details of leads, and measurement coil (included in claims 15, 17-21) 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 Objections
Claim 9 is objected to because of the following informalities: claim 9 limitations of “the first portion ,” has an extra space. 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 3-4, 7-11, 13-15, 17-21 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 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the features bear no patentable weight.
Regarding claim 7, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, the features bear no patentable weight.
Regarding claim 21, the limitations “The guidewire according to claim 20, wherein the at least one further sensor comprises a measurement coil, and wherein the measurement coil is directly wound onto a portion of the guidewire” (emphasis added) is indefinite in view of he requirements of claim 20 including “The guidewire according to claim 15, wherein the sensor comprises a measurement coil, and wherein the measurement coil is directly wound onto a portion of the guidewire.” (emphasis added). Claim 21 further limits an element with the same features and designations as an element in claim 20. This makes it unclear if these are the same or different features being limited which renders the claim indefinite. At least claim 21 needs should be amended to make clear this is an additional measurement coil by whatever preferred designation applicant chooses.
The dependent claims are rejected for depending on a rejected claim.
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 1-3, 5, 7, 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davies et al. (Davies, US 2016/0175009).
Regarding claim 1, Davies teaches a guidewire for placing a medical device into a patient's body (see at least Figures 5a-b), the guidewire comprising:
an elongated main body having a distal axial end and a proximal axial end (see at least Figures 5a-b, 202 and 206),
wherein the elongated main body comprises a first portion having a first stiffness and a second portion having a second stiffness (seat least Figure 5b, [0088], [0093] can be any two portions), and
wherein the first stiffness of the first portion is different from the second stiffness of the second portion (see at least [0088], [0093], [0106]-[0108] can be any two portions with different stiffness).
Regarding claim 2, Davies teaches wherein the first portion extends from the distal axial end in a direction of the proximal axial end, and wherein the second portion is adjacent to the first portion and extends in a direction of the proximal axial end (see at least Figures 5a-b, [0088], [0093]).
Regarding claim 3, Davies teaches wherein the first stiffness comprises a first axial stiffness and the second stiffness comprises a second axial stiffness, wherein the first axial stiffness is different from the second axial stiffness, and wherein the first axial stiffness is preferably smaller than the second axial stiffness (see at least [0093] where differing stiffness reads on the axial stiffness).
Regarding claim 5, Davies teaches wherein the first stiffness comprises a first lateral stiffness and the second stiffness comprises a second lateral stiffness, and wherein a range of the first lateral stiffness is different from a range of the second lateral stiffness (see at least [0093]-[0094] where differing stiffness reads on the lateral stiffness).
Regarding claim 7, Davies teaches wherein the first portion comprises an atraumatic tip extending from the distal axial end, and wherein the atraumatic tip is preferably a J-tip (see at least [0103], [0153]).
Regarding claim 22, Davies teaches wherein the elongated main body further comprises at least one cardiac echo marker (see at least [0083]-[0084], [0104] marker 210).
Claims 1, 7, 9-11, 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voeller et al. (Voeller, US 2014/0081244).
Regarding claim 1, Voeller teaches a guidewire for placing a medical device into a patient's body (see at least title and abstract), the guidewire comprising:
an elongated main body having a distal axial end and a proximal axial end (see at least Figures, [0004]-[0008]),
wherein the elongated main body comprises a first portion having a first stiffness and a second portion having a second stiffness (see at least [0081]), and
wherein the first stiffness of the first portion is different from the second stiffness of the second portion (see at least [0081]).
Regarding claim 7, Voeller teaches wherein the first portion comprises an atraumatic tip extending from the distal axial end, and wherein the atraumatic tip is preferably a J-tip (see at least Figures, [0037]).
Regarding claim 9, Voeller teaches wherein the guidewire further comprises a sensor, wherein the sensor is disposed in or next to the first portion , and wherein the sensor is disposed in a region between the atraumatic tip and the second portion (see at least Figures 2-6, 9, 17, sensors).
Regarding claim 10, Voeller teaches further comprising a lead arrangement, wherein the lead arrangement is attached to the sensor, wherein the lead arrangement extends in axial direction to the proximal axial end of the elongated main body, and wherein the lead arrangement is coated or covered (see at least Figure 5 with sensors and leads which are covered inside the unit, [0039], [0051]).
Regarding claim 11, Voeller teaches wherein the elongated main body comprises a hollow portion, wherein the lead arrangement is disposed within the hollow portion (see at least Figure 5).
Regarding claim 13, Voeller teaches wherein the sensor is disposed in a magnetically permeable housing, the housing comprising a plastic material (see at least [0083] plastic sheath).
Regarding claim 14, Voeller teaches wherein the sensor is disposed within an extruded protection layer (see at least Figure 5 diaphragm 442).
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 4, 6, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Davies et al. (Davies, US 2016/0175009).
Regarding claim 4, the limitations are met by Davies, where Davies teaches various stiffness may be used in different sections of metal wire (see at least [0085], [0093]-[0094]), but does not directly teach the limitations wherein the first axial stiffness is in a range of 1.4 mN/mm to 30 mN/mm and/or wherein the second axial stiffness is in a range of 1.4 mN/mm to 30 mN/mm. However, such physical changes in wire would have amounted to obvious engineering in modifying the wire size as desired for the desired stiffness using known materials as suggested in [0107] “As known to one skilled in the art, the stiffness of multi-function guidewire 200 is related to (or a function of) the diameter of wire 212.” In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Regarding claim 6, Davies teaches wherein the range of the first stiffness is 39 mN/mm to 2.28 N/mm, and/or wherein the range of the second lateral stiffness is 1.75 N/mm to 2.28 N/mm (see at least [0093]-[0094]), but in the alternative, the specifics into lateral stiffness are not directly claimed for the full range. However, such physical changes in wire would have amounted to obvious engineering in modifying the wire size as desired for the desired stiffness using known materials as suggested in [0107] “As known to one skilled in the art, the stiffness of multi-function guidewire 200 is related to (or a function of) the diameter of wire 212.” In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Regarding claim 8, the limitations are met by Davies, where Davies teaches various stiffness may be used in different sections of wire 212, but does not directly teach wherein the atraumatic tip has an axial stiffness in a range of 1.4 mN/mm to 30 mN/mm and/or a lateral stiffness of 39 mN/mm to 353 mN/mm. However, such physical changes in wire would have amounted to obvious engineering in modifying the wire size as desired for the desired stiffness using known materials as suggested in [0107] “As known to one skilled in the art, the stiffness of multi-function guidewire 200 is related to (or a function of) the diameter of wire 212.” In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Claim 15, 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Voeller et al. (Voeller, US 2014/0081244) as applied to claim 10 above, and further in view of Glover et al. (Glover, US 2017/0027458).
Regarding claim 15, Voeller teaches wherein the guidewire comprises at least one further sensor (see at least Figures 5-6), but does not directly teach wherein the at least one further sensor is disposed at a certain distance from the distal axial end to the proximal axial end or is disposed a certain distance from the sensor disposed in the region between the atraumatic tip and the second portion or in the atraumatic tip, and wherein the certain distance is 10 cm.
Glover teaches a related system for measuring pressure (see abstract), and teaches that placement of multiple pressure sensors being 10 cm distanced would allow for measuring pressure in known spaced areas of the heart and would reasonably teach the at least one further sensor is disposed at a certain distance from the distal axial end to the proximal axial end or is disposed a certain distance from the sensor disposed in the region between the atraumatic tip and the second portion or in the atraumatic tip, and wherein the certain distance is 10 cm (see at least [0097] The lengthwise spacings (L.sub.2 and L.sub.3) of the optical pressure sensors at locations P1, P2 and P3 described with respect to the multi-sensor catheters of the first and second embodiments, i.e. for measurement of pressure waveforms concurrently in the RA, RV and PA refer to typical spacings required for an adult human heart, where the distance from the RA to the RV is about 10 cm and the distance from the RV to the PA, in a region downstream of the pulmonic valve, is about 10 cm. [0101]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of spacing sensors 10 cm apart in order to allow for sensing pressures at desired locations 10 cm apart.
Regarding claim 17, the limitations are met by Voeller in view of Glover, where Voeller teaches wherein the lead arrangement is attached to the at least one further sensor (see at least Figure 5).
Regarding claim 18, the limitations are met by Voeller in view of Glover, where Voeller teaches wherein the at least one further sensor is disposed in a magnetically permeable housing, the housing comprising a plastic material (see at least [0083] plastic sheath).
Regarding claim 19, the limitations are met by Voeller in view of Glover, where Voeller teaches wherein the at least one further sensor is disposed within an extruded protection layer (see at least Figure 5 diaphragm 442).
Regarding claim 20, the limitations are met by Voeller in view of Glover, where Voeller teaches wherein the sensor comprises a measurement coil, and wherein the measurement coil is directly wound onto a portion of the guidewire (see at least Figure 17, [0071]).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Voeller et al. (Voeller, US 2014/0081244) in view of Glover et al. (Glover, US 2017/0027458) as applied to claim 20 above, and further in view of Eberle et al. (Eberle, US 2013/0317372).
Regarding claim 21, the limitations are met by Voeller in view of Glover, but the limitations of wherein the at least one further sensor comprises a measurement coil, and wherein the measurement coil is directly wound onto a portion of the guidewire are not directly taught.
However, such design of one sensor within a coil measurement area is obvious expedient to the second sensor locations such as in Figure 5, including design teaching of such coil arrangement located proximally from a tip location as seen in Eberle Figure 19 (see at least [0198]-[0199]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include at least 2 coil measurement locations for sensor as such design would allow for flexibility at the pressure sensor locations allowing for bending vessel locations to have pressure measured at different points.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
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