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 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 3 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 3, the term of degree “small enough” combined with the term of degree “even a thin” renders the claim indefinite because it is not clear what size value or range is contemplated by the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 12 recites an electrode and any conceivable element that can be called an “electrode” is capable of delivering pulsed field or RF ablation energy such that claim 13 does not further limit claim 12. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-6, 8, 9, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (US 5,471,982) in view of Shiber (US 5,007,896).
Regarding claims 1-6, 8, 12 and 13, Edwards discloses a catheter with a shaft (62, fig. 26), an expandable assembly (70) and an assembly (154, figs. 26-27) for holding a guidewire (152) connecting the proximal and distal ends of the expandable assembly. The assembly (where “assembly” can include any number of elements) is the only direct coupling between the ends of the expandable assembly (fig. 26). The expandable assembly comprises a plurality of electrodes for ablation (22 which can be used for sensing or ablation, col. 10 lines 14-24). Edwards does not disclose the assembly is a coil-spring assembly with two, lefthanded/righthanded, nested coil springs. However, the fact that Edwards does not describe the construction of the assembly at all suggests that it is a matter for a person of ordinary skill in the art to determine. Further, it has been held that the simple substitution of one known element for another is an obvious modification (MPEP 2141(III)), where in this case the “known element” is simply a type of tube. Shiber discloses a medical system that a deflectable tube (relative to a longitudinal axis) can be made by using two, lefthanded/righthanded, nested coil springs that together form a circular passageway (fig. 10). It is also noted that Shiber teaches that a polymer sheath (63) can be provided, but is not necessary (col. 5 line 65 to col. 6 line 8). These nested coils springs have gaps (fig. 10) that would prevent some sized “elongated element” from passing through the gaps. Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to modify the catheter of Edwards to use any commonly known assembly construction to provide a guidewire lumen between proximal and distal ends of an expandable assembly, including a coil-spring assembly with two, lefthanded/righthanded, nested coil springs forming a circular passageway such as taught by Shiber, that would produce the predictable result of a catheter usable to perform the various procedures disclosed by Edwards.
Regarding claim 9, the catheter of Edwards as modified does not include a coil-spring assembly integrally formed with the expandable assembly. However, it has been held that making elements integral is an obvious modification (MPEP 2144.04(V)(B)). Further, “assembly” is a broad term that can encompass an arbitrary number of elements. Finally, the fact that Applicant has claimed mutually exclusive structures (cf. claim 10) suggests neither produces unexpected result (within the meaning of MPEP 716.02(a)). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to make any elements of Edwards integral, including the “coil-spring assembly” and the “expandable assembly” that would produce the predictable result of a functional catheter.
Claims 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards and Shiber, further in view of Cajamarca (US 2015/0119859).
Regarding claims 7 and 11, Edward does not disclose that the coil-spring assembly is made from nitinol (nitinol is an art-recognized term for nickel-titanium alloy). It is noted that claim 11 also includes a product-by-process limitation. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Use of nitinol for spring coils is common in the art and there is no evidence that using such a commonly known material produces an unexpected result (within the meaning of MPEP 716.02(a)). Cajamarca discloses a medical device and teaches that spring coils can be made out of several materials including nitinol ([0056]). Therefore, before the application was filed, it would have been obvious to make the coil-spring assembly of Edwards out of any commonly known material including nitinol as taught by Cajamarca that would produce the predictable result of catheter having desired properties useful for a medical procedure. It is noted that the coil-spring assembly as modified will be both compressible and extensible given sufficient force.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards and Shiber, further in view of Bakos (US 2014/0039491).
Regarding claim 10, Edwards does not disclose the use of cylindrical or funnel-shaped members, although the ends of coil-spring assembly are coupled to the ends of the expandable assembly (fig. 26). However, there are a wide range of couplers common in the art and the fact that Applicant has claimed mutually exclusive structures (cf. claim 9) suggests neither produces unexpected result (within the meaning of MPEP 716.02(a)). Bakos discloses a medical device that employs a coil spring assembly coupled with proximal and distal cylindrical members (54, 56, fig. 6) to the rest of the device. Therefore, before the application was filed, it would have been obvious to couple any of the parts of the device of Edwards together, including the coil-spring assembly and the expandable assembly, using any commonly known structures including the cylindrical members as taught by Bakos, to produce the predictable result of a medical device that does not fall apart during use.
Claim 14-17, 19 and 20 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards and Shiber, further in view of Govari (US 2018/0160936).
Regarding claim 14, the catheter of Edward does not include position/orientation sensors. However, position/orientation sensors are common in the art. Govari discloses a basket catheter similar to Edwards and teaches that the expandable assembly can be provided with position/orientation sensors (62, fig. 4B, [0031]). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the catheter of Edwards to have position/orientation sensors on the expandable assembly as taught by Govari that would produce the predictable result of allowing the position/orientation of the expandable assembly to be tracked.
Regarding claim 15-17 and 20, Edwards further discloses that the expandable assembly includes a plurality of resilient splines (76) that can be compressed or not by a delivery sheath between radially bowing and constrained in a relationship to the longitudinal axis (68, see e.g. col. 14 lines 38-55). The assemblies move distally, at least relative to some frame of reference, when the delivery sheath is retracted relative to the assemblies. The electrodes are arranged on every spline such that a circumferential lesion could be produced (fig. 26). Edwards does not specifically disclose that the splines are aligned parallel to the longitudinal axis when compressed. However, compressing splines in parallel is a common configuration for introducing an expandable assembly into the body, such as taught by Govari (fig. 2 vs fig. 3). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the catheter of Edwards to have a collapsed configuration in which the splines are parallel to the longitudinal axis, such as taught by Govari, that would produce the predictable result of allowing the expandable assembly to be delivered to a target region of the body in a desired manner.
Regarding claim 19, the embodiment of Edwards as discussed above does not disclose a proximal coupler. However, a different embodiment of Edwards does disclose a proximal coupler (72, fig. 12) which couples the proximal end of an assembly (240) to the proximal end of the expandable assembly (70) to the distal end of the shaft (62). Therefore, before the application was filed, it would have been obvious to one of ordinary skill in the art to further modify the catheter of Edwards to have any of the elements disclosed in the other parts of Edwards, including a proximal coupler for coupling the various proximal ends of assemblies to the distal end of the shaft, to produce the predictable result of a device that can be used as desired by an operator.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards, Shiber and Govari, further in view of Bakos.
Regarding claim 18, Edwards does not disclose the use of cylindrical or funnel-shaped members, although the ends of coil-spring assembly are coupled to the ends of the expandable assembly (fig. 26). However, there are a wide range of couplers common in the art and the fact that Applicant has claimed mutually exclusive structures (cf. claim 9) suggests neither produces unexpected result (within the meaning of MPEP 716.02(a)). Bakos discloses a medical device that employs a coil spring assembly coupled with proximal and distal cylindrical members (54, 56, fig. 6) to the rest of the device. Therefore, before the application was filed, it would have been obvious to couple any of the parts of the device of Edwards together, including the coil-spring assembly and the expandable assembly, using any commonly known structures including the cylindrical members as taught by Bakos, to produce the predictable result of a medical device that does not fall apart during use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Regarding expandable elements with spring elements within them, see fig. 2 of US 2020/0054859 to Keyes. Regarding other devices that use multiple counter-wound coils for tubes, see fig. 14 and paragraph [0045] of US 2014/0114287 to Beasley and fig. 3 of US 4,951,677 to Crowley.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL WAYNE FOWLER whose telephone number is (571)270-3201. The examiner can normally be reached Monday-Friday (9-5).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL W FOWLER/Primary Examiner, Art Unit 3794
Prosecution Insights