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.
Claim Objections
Claim 1 is objected to because of the following informalities: line 9 should be amended to -channel extending to and terminating at an opening at [[the]] an end face of the distal tip-. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: line 9 should be amended to - the channel extending to and terminating at an opening at [[the]] an end face of the distal tip-. 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.
Claim(s) 1, 3-9 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:
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).
AAPA fails to disclose:
A channel formed in the circumferential sidewall and extending along the lumen, the channel extending to and terminating at an opening at the end face of the distal tip;
wherein the channel is located along the tapered portion of the tubular member.
wherein a fluid is movable through the channel irrespective of the presence of an elongated device located within the lumen.
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 in the circumferential side wall located in the distal end/tapered portion of the tubular member at the opening 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).
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Figure 1 – figure 3a of AAPA, annotated by the examiner
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 1, 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 1, 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:
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 wherein the channel (see the plurality of channels of Yamamoto incorporated into the AAPA) extends from the lumen (305 of the AAPA) to the opening (end of the tubular member 300 of the AAPA) through the end face of the distal tip (as already taught in Yamamoto where the channel 6b extend to the end of the tubular member 2 (via tip 6) and incorporated into the AAPA accordingly).
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
the 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 within the lumen (205).
AAPA fails to disclose:
A channel formed in the circumferential sidewall adjacent to and extending along the lumen, the channel being located along the tapered portion of the tubular member, and the channel extending to and terminating at an opening at the end face of the distal tip;
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 within the lumen.
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 in the circumferential side wall located in the distal end/tapered portion of the tubular member at the opening 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:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 15 by the AAPA and Yamamoto:
The kit of claim 15, wherein the tubular member (300) forms a dilator (as shown in figure 3a and as indicated in ¶0007 of the AAPA) including at least one additional channel (see the plurality of channels of Yamamoto incorporated into the AAPA).
Response to Arguments
Applicant's arguments filed 7/8/26 have been fully considered but they are not persuasive.
Regarding the 35 USC 103 claim rejections:
The applicant has argued that the above amendments overcome the rejections of the claims however the office is not persuaded. The applicant has argued that the AAPA does not teach the channels (see page 6 of the remarks). The office agrees with this argument but as indicated in the remarks the structure is incorporated from Yamamoto.
The applicant also argues that the groove in Yamamoto is located in a cylindrical tip structure at the end of the tubular member and further the cylindrical tip structure does not include tapered edges around the channels or on the cylindrical tip structure (see page 7 of the remarks). For this reason, its combination with the AAPA (primary reference) would not yield the structure as required by the claim. The applicant further argues that the up structure in Yamamoto is separate from the tubular member and therefore the combination with the AAPA would not include adding the channels to the tubular member in the AAPA. However, the office is not persuaded by this argument. First, the fact that the tip structure and the tubular member are one unitary piece in the AAPA and they are separate structures in Yamamoto does not render it not obvious to add the channels taught in the tip structure of Yamamoto with the tip structure in the AAPA. Both the AAPA and Yamamoto have tips (or distal ends) and in the case of Yamamoto the tips (or distal end) includes channels to allow fluid to flow forward out of the end of the tubular member (and around the electrode) and its combination with the AAPA would add the channels to the tip of the tubular member to allow fluid to flow around the electrode and directly ahead of the tubular member. This would have been obvious to do for the motivations indicated above. Second, in regards to the tapered structure, this is already taught by the AAPA and with the addition of the channels located and the distal end of the tubular member (from Yamamoto) the structure required by the claim with the channels located at the opening and at the tapered portion is taught by the combination.
The applicant also argues that adding the channels form Yamamoto to the AAPA at the tapered end of the tubular member would amount to modifying the AAPA in a manner not disclosed by Yamamoto (see page 7 of the remarks). However, the office is not persuaded by this since the channels of Yamamoto would be located at the same position in the AAPA. The applicant has attempted to argue that the channels in Yamamoto would not be located in the tubular member of the AAPA but as indicated this is not the case. Structurally, the combination of the tip structure and the tubular member in the Yamamoto reference is the same as the tubular member in the AAPA. In the case of the AAPA, the distal tip structure and the tubular member is one unitary piece while the same structures in Yamamoto are two separate parts. For this reason, the channels of Yamamoto would be incorporated in the same location of the AAPA which would be in the distal end portion of the tubular member with the tapered portion.
The applicant argues that adding the channels to the AAPA in the location claimed would undermine the structure in Yamamoto and therefore the combination would be incorrect (see page 7 of the remarks). However, as indicated above, the channels of Yamamoto are located at the distal tip of the tubular member/tip structure and the combination would add these channels to the same location in the AAPA (distal tip of the tubular member/tip structure). For this reason, the combination would not invalidate the Yamamoto reference since it is placing the channels in the same location.
For these reasons, the above combinations are maintained.
Regarding the 35 USC 112(b) claim rejections:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn.
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 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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