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 office action is responsive to the amendment filed on 7/30/26. As directed by the amendment: no claims have been amended, claims 1-15 and 25-35 been cancelled, and new claims 36-41 have been added. Thus, claims 16-24 and 36-41 are presently pending in this application.
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 21 and 41 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 21, it is unclear how the sharp distal end can be both covered via the access cannula, as recited in parent claim 16, and protrude distally from the access cannula, as recited in dependent claim 21; claim 21 is therefore indefinite.
Regarding claim 41, it is unclear what the relationship is between “a spacing” and “two or more different distances”, whether the distances are the spacing itself or distances relative to the spacing. It is further unclear, in the first instance above, how “a spacing” can alternate between two distances as claimed.
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 21 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 21, as worded, fails to include all the limitations of claim 16 on which it depends, and specifically fails to include the sharp distal end being covered via the access cannula as recited in claim 1, instead broadening the limitation so that the sharp distal end is not covered and protrudes distally. 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 § 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.
Claim(s) 16, 19, 20, 22, 23, and 36-41 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adams (US 2847995).
Regarding claim 16, Adams discloses a system for accessing a biliary duct (system illustrated in fig. 5-8, fully capable of accessing a biliary duct via puncture with the tip as illustrated), comprising: an access cannula 41 extending along a longitudinal axis from a proximal end to a distal end (distal end toward sharp tip and proximal end toward hub) and including a channel 42 extending longitudinally therethrough, a distal portion of the access cannula including a laser cut pattern (pattern formed by elements 43, which are a product fully capable of formation via a laser cut pattern process of making that product) including a plurality of slots 43 extending through a wall thereof (see fig. 8; 43 are slots that extend through at least a portion of the wall diameter) so that the access cannula is movable between a biased non-compressed configuration (fig. 5, 6, or 8) and a compressed configuration (fig. 7), in which the access cannula is compressed along the longitudinal axis (see fig. 7); and a needle 47 extending longitudinally from a proximal end to a sharp distal end (see fig. 5-8), the needle housed within the channel of the access cannula (see fig. 5, 6, and 8) so that, when the access cannula is in the non-compressed configuration, the sharp distal end is covered via the access cannula (see fig. 5, 6, and 8) and, when the access cannula is in the compressed configuration, the sharp distal end is exposed to puncture a wall of one of an organ and a target duct (see fig. 7).
Regarding claim 19, Adams discloses the laser cut pattern is selected to achieve a desired level of compressibility for the access cannula (desired compressibility achieved as illustrated in fig. 7), the desired level of compressibility including a compressive force required to move the access cannula from the non-compressed configuration toward the compressed configuration and length by which the access cannula is shortened when moved from the non-compressed configuration toward the compressed configuration (See fig. 5-8).
Regarding claim 20, Adams discloses the desired level of compressibility achieved via the laser cut pattern is based on one of a number of slots per row, dimensions of each of the slots, a rotation angle between corresponding slots in adjacent rows, and a distance between rows (compressibility of 41 is achieved at least via the dimensions of slots and distance between rows as illustrated in fig. 5-8).
Regarding claim 22, Adams discloses when the access cannula is moved from the non-compressed configuration to the compressed configuration, the access cannula is shortened via a distance corresponding to the sharp distal end of the needle (distance corresponding to the sharp tip of the needle is uncovered during transition from configuration to configuration as claimed, comparing fig. 5/6 to fig. 7).
Regarding claim 23, Adams discloses a length of the sharp distal end of the needle that is exposed when the access cannula is in the compressed configuration is smaller than the target duct such to prevent a through and through puncture (structure of fig. 5-8 is fully capable of performing this claimed function, at least by compressing only to expose a desired length).
Regarding claim 36, Adams discloses each of the plurality of slots corresponds in length along the longitudinal axis and width around a circumference of the distal portion along which the slot extends (see fig. 8).
Regarding claim 37, Adams discloses each of the plurality of slots has a variable dimension configured to form the laser cut pattern to achieve a desired level of compression (variable depth along length, see fig. 8).
Regarding claim 38, Adams discloses each row is separated from an adjacent one of the rows by a desired distance along a length of the access cannula (distance between deepest point of each row, for example; see fig. 8).
Regarding claim 39, Adams discloses each slot extends along a corresponding one of the rows over a selected portion of a circumference of the distal portion (see fig. 8).
Regarding claim 40, Adams discloses the rows are equidistantly spaced from one another along a length of the distal portion (distance between deepest point of each row, for example; see fig. 8).
Regarding claim 41, as best understood, Adams discloses a spacing between the rows alternates between two or more different distances (spacing between rows can alternate between distance illustrated in fig. 8 and distance illustrated in fig. 7).
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.
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) 17 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Aramo (US 3134380).
Regarding claims 17 and 18, Adams discloses the laser cut pattern includes a plurality of rows (each of 43 is one row), each row extending about a periphery of the access cannula (see fig. 8), each of the rows including at least one slot extending along a portion of the row (see fig. 8), wherein each row extends perpendicular to the longitudinal axis of the cannula (see fig. 5-8), except for specifically disclosing the rows extending through the wall such that the channel of the access cannula is open to and in communication with an exterior of the access cannula via the slots. However, Aramo teaches extending a portion of a slot in a compressible sleeve through the wall such that the access cannula is open to the exterior, via 31 (see fig. 6). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to extend at least a portion of each row of Adams through the wall such that the channel is open to the exterior, as taught by Aramo, for the purpose of providing sufficient structure to allow air to escape from the interior to accommodate the collapsing of the cannula (col. 1, ln. 67- col. 2, ln. 27).
Claim(s) 21, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Schwartz (US 3867937).
Regarding claim 21, as best understood, Adams disloses the device as claimed, except for, in the non-compressed configuration, a distal-most tip of the needle protrudes distally of the distal end of the access cannula. However, Schwartz teaches extending a distal tip of a needle past the distal end of the access cannula in the non-compressed configuration (see fig. 1-2). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Adams to extend the distal tip pas the distal end of the access cannula, as taught by Schwartz, for the purpose of providing sufficient structure to allow initial puncture/placement while protecting the majority of the needle with the collapsible sleeve.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Prestidge et al. (US 20040193109).
Regarding claim 24, Adams discloses the device as claimed, except for the access cannula formed of a nitinol hypotube. However, Prestidge et al. teaches forming a collapsible/expandable access cannula 17 from NiTi (see fig. 1-2; par. 0035-0037). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula of Adams to utilize a nitinol hypotube, as taught by Prestidge et al., for the purpose of providing sufficient structure for controlled extension/contraction of the cannula.
Response to Arguments
Applicant's arguments filed 7/30/26 have been fully considered but they are not persuasive.
Applicant argues, on pg. 5 of the Remarks, that claim 21 is definite and does not broaden or fail to further limit parent claim because of an argued interpretation of claims 16 and 21 where claim 16 is not limited to configurations of “the entire sharp distal end” being covered. Examiner respectfully disagrees, noting that the plain meaning of the terminology in both claims at least encompasses the interpretation the Examiner set forth in the rejections, and is additionally worded more closely to the examiner’s interpretations than that set forth by applicant, notably missing any recitation that would hint at partial covering in the initial language of claim 16.
Applicant argues, on pg. 7-8 of the Remarks, that Adams does not disclose a laser cut pattern. Examiner respectfully disagrees, noting again that the language “laser cut” is a product-by-process limitation, and that the claimed pattern is disclosed by Adams.
Regarding Applicant’s arguments on pg. 8-9 of the Remarks directed to the singular citation to element 33 in the previous rejection, Examiner acknowledges that, as Applicant has correctly discerned based on Applicant’s subsequent arguments, citation to element 33 was a typographical mistake where elsewhere in the rejection element 43 was relied upon. The typo has been corrected in the rejection above.
Applicant argues, on pg. 9-10 of the Remarks, that Adams fails to disclose slots “extending through a wall”. Examiner respectfully disagrees. Applicant’s argument appears to be based on interpreting this limitation to require slots that extend fully through the wall, from one side to another, which Examiner notes is not required by the claims. Examiner maintains that elements 43 of Adams extend at least partially through the wall and thus read on the limitation as claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
