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 Arguments
Applicant’s arguments, see Remarks, pages 1-2, filed August 3rd, 2026, with respect to the rejection(s) of claim(s) 1-14 under 35 USC § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of a newly found prior art reference, in combination with previous applied references.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8-11, 13, and 14 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Walder et al. (US Patent No. 5064415 A, herein, Walder) in view of Bickoff et al. (US Pub No. 20090275815 A1, herein, Bickoff) and further in view of Ross (US Pub No. 20100069855 A1).
Regarding claim 1, Walder discloses an obturator assembly comprising:
a hub (12 – Fig.1) forming a central passage (44 – Fig.1); and
an obturator (32 – Fig.1) movably positionable within a lumen (46 – Fig.1) of a catheter (10 – Fig.1) operatively coupled to the hub (Fig.1), the obturator movable within the lumen (“manipulating and feeding the obturator rod to and through the lumen in catheter in order to occlude completely lumen” – Col. 4, lines 59-63) between a first position (Fig.1) and a second position (Fig.2), the obturator comprising:
a distal end having a tip portion and an opposing proximal end (See Annotated Fig.1 below);
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However, Walder does not expressly disclose wherein the obturator comprises a sensor at the distal end of the obturator and wherein, an outer diameter of the tip portion is approximately the same as an inner diameter of the catheter such that when the obturator is in the first position, the tip portion seals the lumen, wherein an outer diameter of a reduced-diameter portion of the obturator proximal and proximate the tip portion is less than the outer diameter of the tip portion, wherein when the obturator is in the second position, the reduced-diameter portion is distal to the lumen such that fluid is configured to flow around the reduced-diameter portion and into the lumen.
Bickoff teaches a sensor (60 – Fig.4) at the distal end of an obturator (40a – Fig.3).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the obturator of Walder to comprise a sensor at the distal end of the obturator as taught by Bickoff to provide the obturator of Walder with an analyte sensor for optimal treatment of the patient.
Ross teaches an obturator assembly (Fig.11) comprising: an obturator (1106 – Fig.11) comprising wherein, an outer diameter of a tip portion (1116 – Fig.11) is approximately the same as an inner diameter of a catheter (1102 – Fig.11)(“The second exterior diameter… is substantially equal to the interior diameter of the cannula” – Para [0055]) such that when the obturator is in a first position (Fig.11), the tip portion seals a lumen (1104 – Fig.11)(“slidably positioned so that the head is within the interior surface of the cannula, fluid flow is prevented through the cannula” – Para [0055]) wherein an outer diameter of a reduced-diameter portion (1112 – Fig.11) of the obturator proximal and proximate the tip portion is less than the outer diameter of the tip portion (Fig.11, “The second exterior diameter of the stylet is greater than the first exterior diameter of the stylet” – Para [0055]), wherein when the obturator is in a second position (Fig.12), the reduced-diameter portion is distal to the lumen such that fluid is configured to flow around the reduced-diameter portion (Fig.12, “The separation of the head from the cannula opens a fluid path through the interior of the cannula” – Para [0056]).
Ross teaches another obturator assembly embodiment (Fig.9, Fig.10) comprising: an obturator (914 – Fig.9) comprising wherein, an outer diameter of a tip portion is approximately the same as an inner diameter of a catheter (“outer diameter of the stylet is substantially equal to the interior diameter of the tip” – Para [0054]) such that when the obturator is in a first position (Fig.10), the tip portion seals a lumen (Fig.10, “biological material is advantageously prevented from passing into the tip” – Para [0054]).
The limitation, “configured to flow around the reduced-diameter portion and into the lumen” is interpreted to be a functional limitation (the obturator assembly of Ross is capable of performing these functions since the assembly comprises all the elements provided above and allows for a fluid path through the interior of the cannular (Para [0056]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the obturator of Walder to comprise two different diameters, wherein the tip portion’s diameter allows for the sealing of the lumen and the reduced-diameter portion allows for fluid flow through the lumen as taught by Ross since Ross teaches alternative embodiments for selectively restricting and permitting the fluid flow through the lumen. Ross teaches alternative obturator embodiments, including one embodiment having portions of different diameters and another embodiment having a uniform diameter, similar to Walder’s obturator, for performing the flow-control function. Thus, the different-diameter embodiments represent alternative structural arrangements for achieving the known function of selectively restricting and permitting fluid flow though the lumen.
Regarding claim 2, Walder, as modified, discloses an obturator assembly as set forth above, but Walder does not expressly disclose the obturator further comprising a locking collar operatively coupled to the hub, the locking collar configurable in a locked configuration to prevent movement of the obturator within the lumen and in an unlocked configuration to allow movement of the obturator within the lumen.
However, Walder teaches another embodiment of an obturator assembly comprising a locking collar (108 – Fig.8), the locking collar configurable in a locked configuration to prevent movement of the obturator within the lumen and in an unlocked configuration to allow movement of the obturator within the lumen (“allow moving the distal end of rod forward to occlude, or rearward to allow fluid passage” – Col.6, lines 47-48).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the obturator of Walder to comprise a locking collar as taught by the second embodiment of Walder and to couple it directly to the hub of the first embodiment of Walder to allow controlled movement of the obturator within the lumen for optimal control of the obturator.
Regarding claim 3, Walder, as modified, discloses an obturator assembly as set forth above, wherein, in the locked configuration, the locking collar is configured to prevent movement of the obturator within the lumen with the obturator in the first position or the second position (“allow moving the distal end of rod forward to occlude, or rearward to allow fluid passage” – Col.6, lines 47-48).
Regarding claim 4, Walder, as modified, discloses an obturator assembly as set forth above, wherein the locking collar comprises a tab (112 – Fig.10) configured to interfere with a depression formed in the obturator with the locking collar in the locked configuration (Figs.10-11, Col. 6, lines 31-48).
Regarding claim 5, Walder, as modified, discloses an obturator assembly as set forth above, but Walder, as modified, does not expressly disclose the obturator further comprising electronic circuitry in the locking collar, the electronic circuitry coupled in signal communication with the sensor.
Bickoff teaches an electronic circuitry (50 – Fig.9) in a hub, the electronic circuitry coupled in signal communication with a sensor (“sensor cable transmit electrical signals generated by the sensor assembly” – Para [0075]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the locking collar of Walder, as modified, to comprise an electronic circuitry and have it coupled in signal communication with the sensor as taught by Bickoff since electronic circuitry coupled with sensors is well-known for processing signals.
Regarding claim 6, Walder, as modified, discloses an obturator assembly as set forth above, but Walder, as modified, does not expressly disclose the obturator further comprising an electrical contact positioned within the obturator, the electrical contact electrically coupled to the sensor; and
an electrical lead wire extending through the obturator electrically coupling the electrical contact with the electronic circuitry.
Bickoff teaches an electrical contact positioned within a hub (65 – Fig.9), the electrical contact electrically coupled to a sensor (Para [0080]); and
an electrical lead wire (62 – Para [0080]) extending through the obturator electrically coupling the electrical contact with an electronic circuitry (50 – Fig.9)(“facilitating connection to a single-sided sensor cable” – Para [0080]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the obturator of Walder, as modified, to comprise an electrical contact position within coupled to the sensor and an electrical wire coupling the electrical contact with the electronic circuitry as taught by Bickoff in order to transmit signals generated by the sensor to the circuitry for processing, as sensors inherently require electrical connections to communicate sensed data.
Regarding claim 8, Walder, as modified, discloses an obturator assembly as set forth above, but Walder, as modified, does not expressly disclose wherein the electronic circuitry comprises a connection port for connecting the electronic circuitry with remote reception circuitry.
Bickoff teaches electronic circuitry comprising (171 – Fig.18) a connection port (172, 176 – Fig.18) for connecting the electronic circuitry with remote reception circuitry (Para [0090]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the electronic circuitry of Walder, as modified, to comprise a connection port as taught by Bickoff since connection ports are well-known to be routinely used to facilitate electrical data between devices.
Regarding claim 9, Walder, as modified, discloses an obturator assembly as set forth above, wherein the obturator has a central axis extending between the distal end and the proximal end of the obturator, at least a portion of the distal end having one of a symmetrical profile with respect to the central axis or an asymmetrical profile with respect to the central axis (Fig.1).
Regarding claim 10, Walder, as modified, discloses an obturator assembly as set forth above, wherein the sensor is configured to measure one or more of the following: a temperature within a body lumen (“temperature sensor” – Para [0018]).
Regarding claim 11, Walder, as modified, discloses an obturator assembly as set forth above, wherein the hub comprises a small-bore connector configured to couple the hub to a tube (42 – Fig.1, Col. 4, lines 53-54).
Regarding claim 13, Walder, as modified, discloses an obturator assembly as set forth above, wherein the catheter comprises a small-bore connector (42 – Fig.1) and the proximal end of the obturator forms a channel (49 – Fig.1) in fluid communication with the lumen (Col.4, lines 47-54), the obturator assembly further comprising a seal positioned about an outer periphery of the proximal end of the obturator and contacting an inner surface of the small-bore connector at a proximal end of the catheter (48, 52, 54 – Fig.1, Col.4, lines 47-56).
Regarding claim 14, Walder, as modified, discloses an obturator assembly as set forth above, wherein the seal is positioned within an annular slot formed in the inner surface of the small-bore connector (12 – Fig.6).
Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Walder in view of Bickoff and Ross as applied to claim 5 above, and further in view of Spotnitz at al. (US Pub No. 20120097174 A1, herein, Spotnitz).
Regarding claim 7, Walder, as modified, discloses an obturator assembly as set forth above, but Walder, as modified, does not expressly disclose the assembly further comprising communication circuitry in the locking collar, the communication circuitry coupled in signal communication with the electronic circuitry for wireless communication with remote reception circuitry.
Spotnitz teaches an assembly comprising communication circuitry (632, Fig.6A) in a hub, the communication circuitry coupled in signal communication with the electronic circuitry (380 – Fig.3A, “One or more sensor wires traverse the stem from the sensor suite to a device end of the obturator to communicate measurements from the sensor” – Para [0096]) for wireless communication with remote reception circuitry (“wireless data transmission is use” – Para [0096]).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the locking collar of Walder, as modified, to comprise communication circuitry coupled in signal communication with the electronic circuitry for wireless communication with remote reception circuitry as taught by Spotnitz since this is a well-known process for being used to transmit data from local circuitry to remote devices.
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 Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISSA TAYLOR/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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