DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 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.
Priority
The application is filed as a divisional; however, the was no restriction requirement in the parent application, 17/459276. Thus, the status of divisional is incorrect and should be changed to a continuation.
The application will be examined as if being a continuation.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/459276 provides adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority benefit date of 8/27/2021.
Specification
The disclosure is objected to because of the following informalities: amend the first paragraph to accurately reflect the application as a continuation and not a divisional.
Appropriate correction is required.
Claim Objections
Claim 6 is objected to because of the following informalities: amend “the distal-tail” to -the respective distal-tail- in ll. 1. Appropriate correction is required.
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(s) 1-7 is/are rejected under 35 U.S.C. 3 as being unpatentable over Beeckler et al. (2017/0311829) in view of Zhang et al. (2020/0085497) and Salahieh et al. (2014/0357956).
Concerning claim 1, as illustrated in at least Figs. 1-3 & 5, Beeckler et al. disclose a catheter (balloon catheter 24; [0063]), comprising:
a probe having a lumen with an inner diameter (catheter balloon 24 has a probe 20 with a lumen with an inner diameter; [0063]);
a shaft disposed in the lumen (tubular shaft 70 is disposed in probe 20; [0067]);
a catheter balloon disposed in the lumen, the catheter balloon having a membrane including a proximal end and a distal end (inflatable balloon 80 is disposed in probe 20 and has a membrane 26 including a proximal and distal; [0068]);
a plurality of substrates disposed about the membrane that each extend to the distal end of the membrane, each of the plurality of substrates including a respective distal tail having a distal-tail portion of a form (membrane 26 supports and carries flex circuit assembly 84 comprises radiating leaves/strips 30 of a resilient sheet substrate 34 having respective proximal 31P and distal 31D tails, the distal tails 31D terminating at respective distal tips disposed proximal to a distal end of membrane 26; [0070-0071]); and
an adhesive disposed between each of the plurality of substrates and the membrane (adhesive is applied to entire inner surface 37 of substrate 34 to adhere the flex circuit electrode assembly 84 to membrane 26; [0100]).
Beeckler et al. fail to disclose the inner diameter of the probe to be about 13.5 French. However, Zhang et al. discloses a balloon catheter (24) comprising a probe (82) having a lumen, the probe (82) can measure 10.5 F (French) with a 13.5 F maximum outer diameter around a balloon (80) when the balloon is in its fully collapsed state ([0421]). It would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Beeckler et al. by making the inner diameter of the probe to be about 13.5 French as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Beeckler et al. in view of Zhang et al. fail to disclose the shaft having a first shaft portion and a second shaft portion partially disposed within the first shaft portion in a telescoping relationship with the first shaft portion, the proximal end of the membrane connected to the first shaft portion and the distal end of the membrane connected to the second shaft portion. However, Salahieh et al. disclose a catheter (10) comprising a probe (51) having a lumen (50), a shaft (55) disposed in the lumen (50), the shaft (55) having a first shaft portion (55) and a second shaft portion (54) partially disposed within the first shaft portion (55) in a telescoping relationship with the first shaft portion (55), a proximal end of a membrane (22) connected to the first shaft portion (55) and the distal end of the membrane connected to the second shaft portion (54). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Beeckler et al. in view of Zhang et al. such that the shaft has a first shaft portion and a second shaft portion partially disposed within the first shaft portion in a telescoping relationship with the first shaft portion, the proximal end of the membrane connected to the first shaft portion and the distal end of the membrane connected to the second shaft portion in order to provide the benefit of allowing for the shape of the balloon to be changed and assisting in transitioning the catheter balloon to a collapsed configuration as taught by Salahieh et al. ([0068-0069], [0071], [0073]; Fig. 1- 3)
Beeckler et al. in view of Zhang et al. and Salahieh et al. fail to disclose the distal-tail portion to be of a serpentine form. However, Zhang et al. further teach that a serpentine configuration of an element allows for increased flexibility. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Beeckler et al. in view of Zhang et al. and Salahieh et al. such that the distal-tail portion is of a serpentine form in order to provide the benefit of a configuration that allows for increased flexibility ([0440]) and since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Concerning claims 2-5, Beeckler et al. in view of Zhang et al. and Salahieh et al. fail to disclose the serpentine form comprises a square wave that includes rounded corners, a curved wave, or comprises between about three and about ten periods. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Beeckler et al. in view of Zhang et al. and Salahieh et al. such that the serpentine form comprises a square wave that includes rounded corners, a curved wave, or comprises between about three and about ten periods is of whatever desired or expedient form or shape, since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Further, Applicant places no criticality on the claimed specific shapes (square wave, square wave including rounded corners, curved wave, or shape having about three and ten periods), indicating merely the “serpentine pattern may comprise a square wave 106a, which may also have rounded corners, whereas, as reflected in FIG. 11B, the serpentine pattern may comprise a curved wave 106b. The serpentine pattern may also extend over about 3 to about 10 periods. For example, square-wave pattern 106a is reflected as comprising nearly four periods, while curved-wave pattern 106b is reflected as having five periods”.
Concerning claim 6, Beeckler et al. in view of Zhang et al. and Salahieh et al. fail to disclose a width of the serpentine form of the distal-tail portion is between about 1/10 to about ½ of a width of the distal tail. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of Beeckler et al. in view of Zhang et al. and Salahieh et al. such that a width of the serpentine form of the distal-tail portion is between about 1/10 to about ½ of a width of the distal tail is of whatever desired or expedient size, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Further, Applicant places no criticality on the claimed width range, indicating merely the “The width w of serpentine form 106a may be between about 1/10 and about ½ of the width W of distal tail 31D.”.
Concerning claim 7, Beeckler et al. disclose the plurality of substrates (30/34) comprise ten substrates (Fig. 3).
Claim(s) 8 is/are rejected under 35 U.S.C. 3 as being unpatentable over Beeckler et al. (2017/0311829) in view of Zhang et al. (2020/0085497) and Salahieh et al. (2014/0357956), as applied to claim 1, in further view of Butler et al. (2004/01222445).
Concerning claim 8, Beeckler et al. in view of Zhang et al., and Salahieh et al. fail to disclose a maximum force required to move the shaft in the lumen is less than about 6 lbf. However, Butler et al. discloses a medical device comprising an expandable basket (18) connected to a shaft (14) disposed in a lumen of a probe (12) where a force of about five pounds to move the shaft (14) within the lumen of the probe (12) is preferred such that the movement of the shaft within the probe is deliberate but not difficult. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Beeckler et al. in view of Zhang et al. and Salahieh et al. such that a maximum force required to move the shaft in the lumen is less than about 6 lbf in order to provide the benefit of movement of the shaft within the probe being deliberate but not difficult as taught by Butler et al. ([0023-0025])
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-11 of U.S. Patent No. 12,114,905 in view of Zhang et al. (2020/0085497). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite a catheter ballon comprising the probe having a 13.5 french inner diameter lumen, a telescoping first and second shaft, a balloon, ten substrates having distal tails and adhesive disposed between the substrates and the balloon. The patent fails to disclose the distal-tail portion to be of a serpentine form. However, Zhang et al. further teach that a serpentine configuration of an element allows for increased flexibility. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the patent such that the distal-tail portion is of a serpentine form in order to provide the benefit of a configuration that allows for increased flexibility ([0440]) and since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. The patent fails to disclose the serpentine form comprises a square wave that includes rounded corners, a curved wave, or comprises between about three and about ten periods. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that the serpentine form comprises a square wave that includes rounded corners, a curved wave, or comprises between about three and about ten periods is of whatever desired or expedient form or shape, since a change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Further, Applicant places no criticality on the claimed specific shapes (square wave, square wave including rounded corners, curved wave, or shape having about three and ten periods), indicating merely the “serpentine pattern may comprise a square wave 106a, which may also have rounded corners, whereas, as reflected in FIG. 11B, the serpentine pattern may comprise a curved wave 106b. The serpentine pattern may also extend over about 3 to about 10 periods. For example, square-wave pattern 106a is reflected as comprising nearly four periods, while curved-wave pattern 106b is reflected as having five periods”. The patent fails to disclose a width of the serpentine form of the distal-tail portion is between about 1/10 to about ½ of a width of the distal tail. It would have been obvious to one having ordinary skill in the art at the time the invention the invention was effectively filed to modify the invention of the patent such that a width of the serpentine form of the distal-tail portion is between about 1/10 to about ½ of a width of the distal tail is of whatever desired or expedient size, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Further, Applicant places no criticality on the claimed width range, indicating merely the “The width w of serpentine form 106a may be between about 1/10 and about ½ of the width W of distal tail 31D.”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
Prosecution Insights