DETAILED ACTION
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.
Election/Restrictions
Applicant’s election without traverse of Species A (claims 1-9 and 15-16) in the reply filed on 3/19/26 is acknowledged.
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 1-9 and 15-16 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 1:
The claim is unclear because of the limitation “a channel coaxial with the lumen” (emphasis added by the examiner) in line 6 is unclear. The claim indicates the channel is coaxial with the lumen which is not the case for any of the channels (402, 501 or 605) in the embodiments shown in any of the figures. The plurality of the channels maybe arranged concentrically to the lumen but a single channel is not. Further, the claim raises a question of if the applicant considers the whole hole for receiving the puncturing device (205/608) on the distal end of the lumen as the channel or just the channels (402/501/605) as described in the specification. If the hole whole/bore for receiving the puncturing device would not normally be interpreted as a channel since it is a bore and not a channel. This clarity issue makes it hard to determine what the applicant interprets as a channel and unclear what would read on the claim. For the sake of examination, the office has interpreted consistently with the disclosure which would require the channels to be something separate from the bore for receiving the puncturing device and that the plurality of the channels are arranged concentrically to the lumen. However, the applicant should amend the claim to clarify.
Claims 2-9 are rejected due to their dependence on claim 1.
Regarding claim 7:
The claim limitation “a tapered portion” in line 1 is unclear. The limitation is unclear because of the earlier recitation of the limitation “tapered portion” in line 3 of claim 1 (on which this claim depends) which raises a question of if two of tapered portions are required by the claim 2 or only one. For the sake of examination, the office has assumed that only one tapered portion is required by the claim.
Regarding claim 7:
The claim limitation “wherein the channel extends between a hub connected to the tubular member and the distal tip of the tubular member” (emphasis added by the examiner) in lines 1-2 is unclear. The limitation is unclear since it refers to embodiment not selected by the applicant as indicated in the election filed 3/19/26. The embodiment where the channel extends to the hub is the embodiment shown in figures 5a and 5b as indicated in ¶0054 of the specification and as shown in figure 5a. The embodiment elected in figure 4a/4b only shows the channels extending to the lumen. For the sake of examination, the office has assumed that the applicant is attempting to claim the channel extends to the lumen which is consistent with the disclosure and the applicants elected embodiment.
Regarding claim 15:
The claim limitation “tubular member” in line 4 is unclear. The limitation is unclear because of the earlier recitation of the limitation “tubular member” in line 2 of the claim which raises a question of if two of tubular members are required by the claim or only one. For the sake of examination, the office has assumed that only one tubular member is required by the claim.
The claim is unclear because of the limitation “a channel coaxial with the lumen” (emphasis added by the examiner) in line 9 is unclear. This limitation is unclear for the same reason identified in the claim 1 rejection above. The office has taken the same interpretation however the applicant should amend the claim to clarify.
Claims 16 is rejected due to its dependence on claim 15.
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) 1-9 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant admitted prior art (AAPA, figures 3a/3b filed 8/7/23 identified as prior art) in view of WO 2016021230 A1 to Yamamoto et al. (Yamamoto)(see English language machine translation attached to this or a previous office action).
Regarding claim 1 (as best understood by the examiner, see the 35 USC 112(b) rejection above for the claim interpretation):
AAPA discloses:
An apparatus (figure 3a/3b) for fluid transfer (301/303), the apparatus comprising:
a tubular member (300) having a circumferential sidewall (see the sidewall as shown in figure 3a), the circumferential sidewall including a tapered portion (see the tapered portion A in figure 1 below) with an outer diameter that is tapered towards a distal tip (304) of the tubular member (300) (as shown in figure 1 below);
a lumen (305) for fluid transfer through (as shown in figure 3a as 301 and 303) the distal tip (304), the lumen (305) centrally located within the circumferential sidewall (as shown in figure 3a); and
wherein a fluid (301/303) is movable irrespective (301 flows around 205 and becomes 303) of the presence of an elongated device (205).
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Figure 1 – figure 3a of AAPA, annotated by the examiner
AAPA fails to disclose:
A channel coaxial with the lumen and located at least at a distal region of the tubular member.
wherein a fluid is movable through the channel irrespective of the presence of an elongated device located adjacent the channel.
Yamamoto teaches:
An apparatus for fluid transfer (see figures 1-10) that includes a tubular member (2) surrounding a lumen (2a) with a distal end (6c). further. A plurality of channels (6b as shown in figures 2 and 3) that allows fluid (“C” as shown in figure 3) to flow past an elongated device (3). The channels allow the fluid to flow despite the position of the elongated device and allow the fluid to flow either directly ahead of the tubular member (translation, page 4, “And a part of the outer side in the radial direction of the groove 6b is exposed without being blocked”) and prevents the fluid flow from being blocked (translation, page 3, “And a part of the outer side in the radial direction of the groove 6b is exposed without being blocked”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify AAPA to further include channels arranged concentrically with the lumen located in the distal end/tapered portion of the tubular member as taught by Yamamoto to prevent fluid flow from being blocked and to allow it to flow directly ahead of the apparatus and the elongated devices (Yamamoto, translations page 3 and 4).
Regarding claim 2:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by the AAPA and Yamamoto:
The apparatus of claim 1, wherein the channel (see the one of the plurality of channels of Yamamoto incorporated into the AAPA) is located along a tapered portion (see the tapered portion A in figure 1 above of the AAPA) of the tubular member (300 of the AAPA).
Regarding claim 3:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by the AAPA and Yamamoto:
The apparatus of claim 2, further including at least one additional channel (see the plurality of channels of Yamamoto incorporated into the AAPA).
Regarding claim 4:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by the AAPA and Yamamoto:
The apparatus of claim 3, wherein each channel (see the plurality of channels of Yamamoto incorporated into the AAPA) is separated from one another by an arc length (see the spacing (arc length) of the channels 6b as shown in figure 2 of Yamamoto and incorporated into the AAPA accordingly) around a periphery of the lumen (305).
Regarding claim 5:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by the AAPA and Yamamoto:
The apparatus of claim 4, wherein the arc length (see the spacing (arc length) of the channels 6b as shown in figure 2 of Yamamoto and incorporated into the AAPA accordingly) separating each channel is equidistant (see page 6 of Yamamoto which indicates the channels/grooves 6b can be arranged equally (equidistant) or unequally).
Regarding claim 6:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by the AAPA and Yamamoto:
The apparatus of claim 2, wherein the lumen (305 of the AAPA) is at least partially occluded (as shown in figure 3a of the AAPA where 305 is partially occluded by 205) by the elongated device (205 of the AAPA) located adjacent the channel (see the plurality of channels of Yamamoto incorporated into the AAPA).
Regarding claim 7 (as best understood by the examiner, see the 35 USC 112(b) rejection above for the claim interpretation):
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by the AAPA and Yamamoto:
The apparatus of claim 6, wherein the channel (see the plurality of channels of Yamamoto incorporated into the AAPA) extends between a hub (as indicated in the 35 USC 112(b) rejection above, the office has interpreted this limitation to require the channel to extend to the lumen and to be fluidly connected to the hub via the lumen which would be the case with the combination with Yamamoto) connected to the tubular member (300 of the AAPA) and the distal tip (304 of the AAPA) of the tubular member (300 of the AAPA).
Regarding claim 8:
AAPA discloses:
The apparatus of claim 7, wherein the tubular member (300) is a dilator (as shown in figure 3a and as indicated in ¶0007).
Regarding claim 9:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by the AAPA and Yamamoto:
The apparatus of claim 8, wherein the channel (see the plurality of channels of Yamamoto incorporated into the AAPA) is open (the channels 6b of Yamamoto are connected to the lumen 2a as shown in figure 3 and would be incorporated into the AAPA accordingly) to the lumen (305 of the AAPA).
Regarding claim 15:
AAPA discloses:
A kit forming an apparatus (figure 3a/3b) for fluid transfer (301/303), the kit comprising:
an elongated device (205) capable of insertion (as shown in figure 3a) into a tubular member (300) for accessing tissue of a patient (puncturing device as indicated in the AAPA in ¶0007); and
a tubular member (300) capable of accepting (as shown in figure 3a) the elongated device (205), the tubular member (300) having
a circumferential sidewall (see the sidewall as shown in figure 3a), the circumferential sidewall including a tapered portion (see the tapered portion A in figure 1 above) with an outer diameter that is tapered towards a distal tip (304) of the tubular member (300);
a lumen (305) capable of fluid transfer through (as shown in figure 3a as 301 and 303) the distal tip (304), the lumen (305) centrally located within the circumferential sidewall (as shown in figure 3a); and
wherein, upon insertion of the elongated device (205) into the tubular member (300), a fluid (301/303) is capable of movement irrespective (301 flows around 205 and becomes 303) of the presence of the elongated device (205).
AAPA fails to disclose:
A channel coaxial with the lumen and located at least at a distal region of the tubular member;
wherein, upon insertion of the elongated device into the tubular member, a fluid is capable of movement through the channel irrespective of the presence of the elongated device located adjacent the channel.
Yamamoto teaches:
An apparatus for fluid transfer (see figures 1-10) that includes a tubular member (2) surrounding a lumen (2a) with a distal end (6c). further. A plurality of channels (6b as shown in figures 2 and 3) that allows fluid (“C” as shown in figure 3) to flow past an elongated device (3). The channels allow the fluid to flow despite the position of the elongated device and allow the fluid to flow either directly ahead of the tubular member (translation, page 4, “And a part of the outer side in the radial direction of the groove 6b is exposed without being blocked”) and prevents the fluid flow from being blocked (translation, page 3, “And a part of the outer side in the radial direction of the groove 6b is exposed without being blocked”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify AAPA to further include channels arranged concentrically with the lumen located in the distal end/tapered portion of the tubular member as taught by Yamamoto to prevent fluid flow from being blocked and to allow it to flow directly ahead of the apparatus and the elongated devices (Yamamoto, translations page 3 and 4).
Regarding claim 16:
AAPA discloses:
The kit of claim 15, wherein the tubular member (300) forms a dilator (as shown in figure 3a and as indicated in ¶0007) including at least one additional channel (see the plurality of channels of Yamamoto incorporated into the AAPA).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20140206987-A1
Urbanski
See the tapered portion at the distal end 801
US-20100222677-A1
Placek
See the channel 108a
US-6551313-B1
Levin
See the tapered portion 42
WO-2012042984-A1
ITOH
See the channel 34
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (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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/WESLEY G HARRIS/Examiner, Art Unit 3783
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