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 .
Election/Restrictions
Applicant’s election without traverse of Species B in the reply filed on 1/21/2026 is acknowledged.
Claim Objections
Claim 2 is objected to because of the following informalities: “formed form” in line 2 should read “formed from”. 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 15-20 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.
Claim 15 includes “the needle” in line 8, which lacks clear antecedent basis as only a “needle tube” (line 7) has been previously recited. It is unclear if the needle in line 8 refers back to the previously recited needle tube, or if the needle is being claimed in addition to the previously recited needle tube. As best understood, the needle is meant to refer back to the previously recited needle tube, and thus is being interpreted as though “the needle” in line 15 reads “the needle tube”.
Claim 20 recites “the distal end coil tube” which lacks clear antecedent basis. It is unclear if the distal end coil tube is meant to refer back to the previously recited distal end coil sheath, or if the distal end coil tube is being claimed in addition to the previously recited distal end of the distal coil sheath. For purposes of claim interpretation, as best understood in view of the specification, “the distal end coil tube” is being treated as though it reads “the distal end coil sheath”.
Regarding claim 18: Claim 15 recites a second stopper and a second position. Claim 18, which depends from claim 15, also recites a second stopper and a second position. Claim 18 then recites “the second position” in line 4, which lacks clear antecedent basis since it is unclear which previously recited second position is being referenced (second position introduced in claim 18, or second position introduced in claim 15). Noting that both claim 15 and 18 read “a second stopper fixing the inner sheath at a second position where the inner sheath is fully retracted relative to the outer sheath”, the second stopper of claim 15 and the second stopper of claim 18 appear to be one and the same, though not clearly claimed as such. For purposes of claim interpretation, claim 18 is being treated as though “wherein the outer sheath further includes a second stopper…retracted relative to the outer sheath, and” has been deleted from claim 15, noting that this passage merely repeats limitations already present in claim 15.
Claims 16, 17, and 19 are rejected as being indefinite by virtue of their dependence from claim 15.
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) 1-3 and 5 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Clancy et al. (US 2013/0006144). Clancy discloses a puncture device inserted into an endoscope channel ([0018]; [0028]) comprising an outer sheath (112; fig. 2), an inner sheath (123; fig. 2, 3) inserted into the outer sheath, the inner sheath comprising a coil sheath (123 comprises cable tubing 131 which is coiled; see [0024]) and a needle tube (124) located at a distal end of the coil sheath (fig. 4), a connecting portion (overlapping region 127 where needle tube and coil sheath are adhered, soldered, or welded together; [0027]) connecting the needle tube and the coil sheath, and a cover (heath shrink or other coating that extends along length 137; [0027]) covering the coil sheath and the connection portion (fig. 4). Since claim 1 includes the language “A puncture device inserted into an endoscope channel” (emphasis added), the endoscope channel is being positively recited and the claim requires that the puncture device is in an endoscope channel.
Regarding claim 2, the cover is engaged on an unevenness (e.g. taper, resulting in uneven diameter along the length) formed on the connection portion ([0027] – taper a result of cable tube being ground down; cover is applied over the tapered cable tube).
Regarding claim 3, the cover is engaged on a step formed from the needle tube to the coil sheath (the taper results in a change in diameter, which is considered a step in diameter; see fig. 2, 3;)
Regarding claim 5, the cover includes a heat-shrinkable tube ([0027]).
Claim(s) 1-3, 8 and 9 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Wang et al. (US 2005/0090764). Wang discloses a puncture device inserted into an endoscope channel ([0031]) comprising an outer sheath (12; fig. 2), an inner sheath (220/224) inserted into the outer sheath, the inner sheath comprising a coil sheath (220/224), a needle tube (18) located at a distal end of the coil sheath, a connecting portion connecting the needle tube and the coil sheath (see portion of needle 18 that extends into coil sheath and includes adhesive or solder connecting it to the coil sheath ([0030]), and a cover (coupling member crimped over proximal end 242 of needle 18 and distal end of coil sheath 220/224, not illustrated but disclosed in [0030]) covering the coil sheath and the connection portion (fig. 4). Since instant claim 1 includes the language “A puncture device inserted into an endoscope channel” (emphasis added), the endoscope channel is being positively recited and the claim requires that the puncture device is in an endoscope channel.
Regarding claim 2, the cover (coupling member discussed in [0030]) is engaged on an unevenness formed on the connection portion. For example, consider the external surface formed by 242 in the connection portion, which is considered an unevenness due to its undulating outer surface, over which the cover is crimped.
Regarding claim 3, the cover is engaged on a step formed from the needle tube to the coil sheath tube (see [0030], coupling member crimpled over proximal end 242 of needle 18 and distal end of coil sheath 224, which have different diameters as illustrated in fig. 2).
Regarding claim 8, the outer sheath includes a first stopper (208) fixing the inner sheath at a first position where the inner sheath is fully advanced relative to the outer sheath (position shown in fig. 3), and a second stopper (stop band 502; fig. 5) fixing the inner sheath at a second position where the inner sheath is fully retracted relative to the outer sheath ([0040]), wherein when the inner sheath is arranged at the first position, the needle tube protrudes from the outer sheath (see fig. 3) and wherein when the inner sheath is arranged at the second position, the needle tube is accommodated in the outer sheath (fig. 2).
Regarding claim 9, the outer sheath includes a rigid tube (hard tip 14 is considered rigid; [0029]) at the distal end and when the inner sheath is arranged at the second position, the distal end of the needle tube is arranged at a position surrounded by the rigid tube (fig. 2). For purposes of claim 9, the first stopper may be considered the proximal threaded portion of 14 having proximal end surface 208 thereon, while the rigid tube is considered the radially enlarged distal, unthreaded portion of 14.
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clancy in view of Gordon (US 2016/0331358). Clancy discloses the invention substantially as stated above including that the connecting portion (127) includes a part connected by welding ([0027]), but does not expressly disclose the use of laser welding or the cover being caught on the one or more laser-welding marks.
Gordon discloses another puncture device comprising a needle tube (270; fig. 3C) located at a distal end of a coil sheath (273). A connection portion connecting the needle tube to the coil sheath includes a part connected by laser welding (note: connection portion is considered portion where 270 is laser-welded to 273 as per [0089]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Clancy to form the connecting portion by laser-welding the needle tube to the coil sheath as taught by Gordon, instead of other forms of welding, soldering or adhesive as disclosed by Clancy, for the predictable result of providing an alternative suitable connection between the needle tube and the coil sheath, wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success. Since Clancy discloses a cover (heat-shrink tube) extending over the connection portion between the needle tube and the coil sheath as discussed above, and the connection portion comprises one or more laser welding marks as taught by Gordon, the cover (heat-shrunk tube) of Clancy as modified by Gordon is considered “caught on” the one or more welding marks formed by the laser welding since it cannot move in relation to the entire overlapping portion, which includes the welding marks.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clancy in view of Kadamus (US 2021/0045720). Clancy discloses the invention substantially as stated above including that the needle tube includes a concave portion with a recessed outer surface (any one of proximal-most dimples shown in fig. 4; [0023]), but does not expressly disclose that the cover covers, or is engaged on, the concave portion.
Kadamus discloses another puncture device (figs. 1b, 1c) having a tube (350) located at a distal end of a coil sheath (20) (see fig. 10, [0065]), and further teaches that, by engaging and covering a portion with a recessed outer surface on the tube (e.g., areas between barbs and distal lip of collar of anchor 350, which may be rounded as per [0060]), a heat shrinkable cover (210) is better anchored to the tube via the purchase provided by the recessed portion ([0066]). It would have been obvious to one of ordinary skill in the art to have extended the cover of Clancy such that it is engaged with and covers the concave portion (e.g. any one of the proximal-most dimples) in view of the teachings of Kadamus in order to provide purchase to the heat shrink tube, thus improving anchoring of the heat shrink tube to the remaining structure of the puncture device.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Scarfone et al. (US 6,770,053). Wang discloses a puncture device inserted into an endoscope channel ([0031]) comprising an outer sheath (12), an inner sheath (220/224) inserted into the outer sheath, the inner sheath comprising a coil sheath (220/224), a needle tube (18) located at a distal end of the coil sheath, a connecting portion connecting the needle tube and the coil sheath (see portion of needle 18 that extends into coil sheath and includes adhesive or solder ([0030]), and a cover (coupling member crimped over proximal end 242 of needle 18 and distal end of coil sheath 220/224, not illustrated but disclosed in [0030]) covering the coil sheath and the connection portion (fig. 4). Wang fails to disclose that the outer sheath (12) includes a distal end coil sheath, intermediate coil sheath, proximal end coil sheath, first and second connecting portions and the claimed locations of the first and second stoppers.
Scarfone discloses another puncture device comprising an outer sheath (12), an inner sheath (22) inserted into the outer sheath, and a needle tube (30) located at a distal end of the inner sheath (figs. 2-3). Scarfone discloses that the outer sheath 12 is coiled (figs. 2,3), such that it comprises a distal end coil sheath located at the distal end of the outer sheath, an intermediate coil sheath located on a proximal side of the distal end coil sheath, a proximal end coil sheath located on a proximal end side of the intermediate coil sheath, a first connecting portion connecting the distal end coil sheath and the intermediate coil sheath, and a second connecting portion connecting the intermediate coil sheath and the proximal end coil sheath. See the annotated figure below, noting that the phrase “connecting portion” does not necessitate any particular structure beyond a segment or part that connects other elements.
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Scarfone discloses that the first connecting portion is located on a first stopper (66, particularly proximal face which abuts 62 in advanced position) that fixes the inner sheath at a first position where the inner sheath is fully advanced relative to the outer sheath (fig. 3). The second connecting portion is located on a second stopper (64) that fixes the inner sheath at a second position where the inner sheath is fully retracted relative to the outer sheath (fig. 2). Scarfone discloses such a coiled arrangement as an alternative to other flexible plastic outer sheaths (col. 5, ll. 45-60).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Wang to include the outer sheath (12) and its associated stoppers (64, 66) taught by Scarfone (see annotated figure above) in place of the outer sheath (12) and its associated stoppers (208,520) disclosed by Wang, as such a modification can be considered a substitution of one known outer sheath configuration that includes a mechanism for limiting advancement and retraction of a needle relative to the outer sheath for another, wherein the results of such a modification are predictable and one skilled in the art would have had a reasonable expectation of success.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang in view of Scarfone as applied to claim 12 and further in view of Kadamus. Wang in view of Scarfone discloses the invention substantially as stated above except for the distal end coil sheath being made from a flat wire thinner than the proximal end coil sheath, noting Scarfone teaches a coiled outer sheath made of round wire.
Kadamus discloses that it is known to use a flat wire when forming a coiled sheath for a puncture needle (see fig. [0050]), and further discloses that flat wire advantageously provides good column strength in a small diameter package as compared to a coiled sheath made of round wire ([0052]). It would have been obvious to have further modified the prior art of Wang in view of Scarfone to form the outer sheath, which includes the distal end coil sheath, from a flat wire, so that it too may have good column strength in a small-diameter package. Since the outer sheath of Wang as modified by Scarfone and Kadamus includes an outer coating along its entire length (Scarfone: 20 in fig. 2; Kadamus: 200//210 in fig. 10), it is understood that the flat wire forming the distal end coil sheath is thinner than the proximal end coil sheath. That is to say, the flat wire forming the outer sheath has a thinner cross-section than the cross-section of the proximal end coil sheath since the cross-section thickness of the proximal end coil sheath (or any portion of the outer sheath) includes the wire and the outer coating (20 of Scarfone).
Allowable Subject Matter
Claims 15-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action. The closest prior art of Wang in view of Scarfone (see discussion of claim 8 and 12 above) fails to disclose or fairly suggest, in combination with the remaining limitations of claim 15, that a length from the first stopper to a proximal opening of the outer sheath is shorter than a length of the channel of the endoscope.
Claims 10-11 and 14 are 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 closest prior art of Wang (see discussion of claim 8), or Wang in view of Scarfone (see discussion of claim 12), fails to disclose or fairly suggest, in combination with the other claim limitations of claim 8 or claim 12, the additional limitations of claims 10-11 or claim 14.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 3/16/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771