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 .
Response to Amendment
This action is entered in response to Applicant's amendment and reply of 1/28/26. The claims 8-12, 19-23 are pending. The claims 8, 12, 19-21 are amended. Claims 1-7, 13-18 are cancelled. Claims 22 and 23 are new.
Response to Arguments
Applicant’s arguments, filed 1/28/26 with respect to the rejections of claims 8-11, 18-21 under 35 U.S.C. 103 as being unpatentable over Foster (US2018/0140323) in view of Berry (US1255577) have been fully considered but they are not persuasive. Applicant has amended claim 8 to be in independent form and include the limitations of cancelled claim 1. Applicant argues with respect to independent claims 8 and 12, the Berry reference is non-analogous art, since Berry is directed to a flexible pipe coupling. Examiner disagrees, in response to applicant's argument that the reference Berry is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the pipe of Berry is reasonably pertinent to the problem of a flexible conduit design having to ability to flex for navigation or guidance. Since Berry has discrete segments that achieve flexibility in a tube.
With regard to claim 12, Applicant further argues Foster in view of Berry does not disclose or suggest a proximal portion of one segment disposed within a frustoconical portion of the channel of an adjacent segment. Examiner disagrees, as addressed in annotated Fig. 3 of the rejection of claim 12 below.
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 8-11 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.
Claim 8 recites the limitation "the distal portion" in claim 8, line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation “a distal portion” in claim 8, line 15. It is unclear if the “distal portion” is the same or a different structure than the previously recited “distal portion”.
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 8-12, 19-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Foster (US2018/0140323) in view of Berry (US1255577).
Regarding claims 8-11, Foster discloses a system for delivering an implantable medical device to an implant location ([0046]), the system comprising:
a control handle portion (18);
a catheter portion (outer sheath 12) coupled to the control handle portion at a proximal end of the catheter portion (see Fig. 1), the catheter portion comprising an outer shaft (outer sheath 12 is a shaft), wherein the outer shaft comprises:
an inner shaft (inner catheter 14) extending from the control handle portion to the distal portion (see Fig. 1); and
a distal portion coupled to a distal end of the outer shaft (distal end of outer sheath 12, see Fig. 1); the distal portion being configured to receive the implantable medical device (see Fig. 1, [0046]).
Foster, in the embodiment of Fig. 1, does not explicitly disclose the outer shaft comprises a plurality of segments arranged in an axial direction to form the outer shaft of the catheter portion, each of the plurality of segments being configured to move relative to one another. Foster according to embodiments teaches the outer sheath 12 can include a portion of example shaft 20 (Fig. 7, [0049]). The shaft 20 including an inner liner 22 (inner shaft) and exoskeleton 24 including a plurality of articulating links, such as bead members 26 and barrel members 28 configured to move relative to each other ([0059]). It would have been obvious to one having ordinary skill in the art before the effective fling date of the claimed invention to have incorporated the plurality of segments and inner liner as a portion of the outer shaft as taught by Foster in Fig. 7 to the embodiment of Fig. 1, in order to increase the compression resistance, the tension resistance, or both of the outer shaft while also affording a desirable amount of flexibility and kink resistance such that the shaft can be navigated through the anatomy ([0050]).
Foster does not explicitly disclose wherein each of the plurality of segments comprises: a body portion having a proximal end and a distal end and forming an inner cavity between the proximal end and the distal end, wherein the inner cavity of one of the plurality of segments is configured to receive the proximal end of an adjacent one of the plurality of segments, wherein the body portion comprises a lip portion formed at the distal end and wherein an outer surface of the body portion tapers from the lip portion to the proximal end, wherein the inner cavity has a frustoconical shape and the lip portion has a circular cross-section, a plurality of washers coupled to the inner shaft, wherein a washer from the plurality of washers is coupled between adjacent segments of the plurality of segments. Berry teaches a flexible pipe composed of a number of coupling units (plurality of segments) (Page 1, lines 81-83). Where the plurality of segments comprises: a body portion (see Fig. 3) having a proximal end and a distal end and forming an inner cavity between the proximal end and the distal end (see Fig. 3), wherein the inner cavity of one of the plurality of segments is configured to receive the proximal end of an adjacent one of the plurality of segments (see Fig. 3), wherein the body portion comprises a lip portion formed at the distal end (see annotated Fig. 3) and wherein an outer surface of the body portion tapers from the lip portion to the proximal end (see Fig. 3), wherein the inner cavity has a frustoconical shape (see annotated Fig. 3) and the lip portion has a circular cross-section (Page 1, line 66), a plurality of washers (stop ring and bearing H, Page 2, lines 19-25, see Fig. 3), wherein a washer from the plurality of washers is coupled between adjacent segments of the plurality of segments (the stop ring and bear H is between every coupling unit of the series of coupling units, Page 1, line 98). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the plurality of segments of Foster for the plurality of segments of Berry since the substitution would have yielded the same predictable result of providing segments/coupling units for articulating a flexible tube. Where the modified invention of Foster/Berry further teaches the plurality of washers (stop ring and bearing H, Page 2, lines 19-25, see Fig. 3) coupled to the inner shaft (coupled to the inner shaft of the modified invention by the coupling of the plurality of segments to the inner shaft/inner liner of Faster).
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Regarding claim 12, 19-21, Foster discloses a catheter for a delivery system for delivering an implantable medical device to an implant location ([0046]), the catheter comprising:
an outer shaft (outer sheath 12); and
an inner shaft (inner catheter 14) extending through the outer shaft (see Fig. 1).
Foster does not explicitly disclose the outer shaft comprising a plurality of segments arranged in an axial direction, each of the plurality of segments comprises: an outer sidewall defining an outer surface of the segment; and an inner sidewall defining a channel of the segment, the channel including a proximal portion and a distal portion, the proximal portion of the channel being substantially cylindrical and the distal portion of the channel being substantially frustoconical;
Wherein a proximal end of the outer surface of a first segment of the plurality of segments is disposed within the distal portion of the channel of the second segment of the plurality of segments disposed proximal of the first segment;
The outer surface comprises a lip portion formed at a distal end of the outer sidewall and wherein the outer surface tapers from the lip portion to the proximal end of the outer surface, wherein the lip portion has a circular cross-section;
further comprising: a plurality of washers coupled to the inner shaft, wherein a washer from the plurality of washers is coupled to the inner shaft between adjacent segments of the plurality of segments.
Berry teaches a flexible pipe composed of a number of coupling units (plurality of segments) (Page 1, lines 81-83). The plurality of segments are arranged in an axial direction (see Fig. 2), each of the plurality of segments comprises: an outer sidewall defining an outer surface of the segment (see Fig. 3); and an inner sidewall defining a channel of the segment (see Fig. 3), the channel including a proximal portion and a distal portion (see annotated Fig. 3), the proximal portion of the channel being substantially cylindrical and the distal portion of the channel being substantially frustoconical (see annotated Fig. 3, where the distal portion includes a portion of the covered by adjacent segment). Berry further teaches wherein a proximal end of the outer surface of a first segment of the plurality of segments is disposed within the distal portion of the channel of the second segment of the plurality of segments disposed proximal of the first segment (see annotated Fig. 3). Berry further teaches the outer surface comprises a lip portion formed at the distal end of the outer sidewall (see annotated Fig. 3), wherein the outer surface tapers from the lip portion to the proximal end of the outer surface (see Fig. 3), the lip portion has a circular cross-section (Page 1, line 66). Berry further teaches a plurality of washers (stop ring and bearing H, Page 2, lines 19-25, see Fig. 3), wherein a washer from the plurality of washers is coupled between adjacent segments of the plurality of segments (the stop ring and bear H is between every coupling unit of the series of coupling units, Page 1, line 98). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the plurality of segments of Foster for the plurality of segments of Berry since the substitution would have yielded the same predictable result of providing segments/coupling units for articulating a flexible tube. Where the modified invention of Foster/Berry further teaches the plurality of washers (stop ring and bearing H, Page 2, lines 19-25, see Fig. 3) coupled to the inner shaft (coupled to the inner shaft by the coupling of the plurality of segments to the inner shaft 12 extending through outer shaft 14).
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Regarding claim 23, Foster/Berry makes obvious the catheter of claim 21, Berry further teaches wherein each washer is disposed within the distal portion of the channel of a corresponding segment of the plurality of segments (distal portion would include the washer interpreted as the stop ring and bearing H, Page 2, lines 19-25, see Fig. 3).
Allowable Subject Matter
Claim 22 is 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.
The following is a statement of reasons for the indication of allowable subject matter: No prior art of record teaches or discloses “wherein the plurality of washers are fixedly attached to the inner shaft” In combination with the other limitations as recited in claims 12 and 21.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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, Thomas Barrett can be reached on (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.M/ /THOMAS C BARRETT/Examiner, Art Unit 3774 SPE, Art Unit 3799
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