DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 13 February 2026. The Examiner acknowledges the amendments to claims 1, 8, 13, and 17, as well as the cancelation of claims 2 and 12. Claims 1, 3-11, and 13-20 are pending, with claims 18-20 standing as previously withdrawn.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “216” [Fig. 6], “268” [Figs. 7-8].
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
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.
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) 1, 3-6, 8-11, 13, and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US-20190021640-A1) [which the Examiner notes is not the same as the previously presented Burkholz ‘346 reference].
Regarding claim 1, Burkholz teaches
A blood draw device for use with a peripheral intravenous catheter (PIVC) comprising:
a catheter having a proximal end, a distal end, and a sidewall therebetween defining a lumen [the instrument 12 may include the proximal end and the distal tip 42. In some embodiments, the distal tip 42 may include one or more holes 44, which may be inlet and/or outlet holes (Burkholz ¶0055); the extension 10 may include a blood collection device, which may be used to obtain a blood sample (Burkholz ¶0041); the extension 10 may include an adapter 36, which may be coupled to a proximal end of the instrument 12 (Burkholz ¶0053); the adapter 36 may include a cavity configured to receive, for example, a syringe and/or blood collection tube (Burkholz ¶0054), wherein the instrument 12 defining inlet holes and being fluidically coupled to adapter 36, which is configured to enable blood withdrawal, is considered to read the claimed catheter (instrument 12)];
an introducer having a proximal end, a distal end, and a sidewall therebetween defining an inner volume configured to movably receive the catheter, the introducer defining a longitudinal axis [the instrument 12 may be at least partially disposed or housed within the housing 28. In some embodiments, the housing 28 may at least partially surround the instrument (Burkholz ¶0051, Fig. 2B); in response to movement of the adapter 36 along the slot 34 from the proximal position to the distal position, the instrument 12 is advanced beyond the distal end of the housing 28 (Burkholz ¶0053), wherein a length of the introducer may define the claimed longitudinal axis]; and
an actuator movably coupled to the introducer and connected to the catheter, the actuator having a first portion disposed outside of the introducer and a second portion disposed in the inner volume of the introducer [the proximal end of the instrument may include an instrument hub, which may facilitate coupling with the adapter. In some embodiments, the instrument hub may include the curved or angled portion and/or may extend through the slot 34… For clarity, in some embodiments, the proximal end of the instrument 12 may extend through the slot 34 via either the instrument hub extending through the slot 34 or another portion of the instrument 12 extending through the slot 34 (Burkholz ¶0058), wherein the instrument hub being extending through the slot 34 and being coupled to the proximal end of the instrument 12 (catheter) is considered to respectively read on the claimed “first portion” and “second portion”; the extension may include an advancement tab 46, which may be coupled to the proximal end of the instrument 12 and/or the adapter 36. In some embodiments, the clinician may pinch or grasp the advancement tab 46 to move the instrument 12 to the proximal position and/or the distal position (Burkholz ¶0060), wherein the Examiner notes that as the advancement tab 46 being coupled to the proximal end of the instrument 12 to advance the instrument 12, the advancement tab 46 is understood to be coupled to the instrument hub (actuator)],
wherein the actuator is configured to move relative to the introducer to move the catheter between a first position, in which the catheter is disposed within the introducer, and a second position, in which the distal end of the catheter is disposed beyond the distal end of the introducer [in response to movement of the adapter 36 along the slot 34 from the distal position to the proximal position, the instrument 12 may be withdrawn into the housing 28 (Burkholz ¶0053); the instrument 12 is advanced beyond the distal end of the housing 28 when the adapter 36 is disposed in the distal position (Burkholz ¶0060, Figs. 2B, 2D), wherein the Examiner notes that Fig. 2B is considered to depict the first position, wherein the distal tip 42 of the instrument 12 (catheter) is disposed within the housing 28 (introducer), and Fig. 2D depicts the second position, and wherein as the instrument hub is coupled to the proximal end of the instrument 12, the instrument 12 moves as the instrument hub moves], and wherein, when the catheter is in the first position, the catheter has a first portion extending parallel to the longitudinal axis of the introducer and a second portion extending oblique to the longitudinal axis of the introducer [wherein as depicted in at least Fig. 2B, at least a portion of the instrument 12 (catheter) extends parallel to the longitudinal axis of the housing 28 (introducer); the proximal end of the instrument 12 may include a curved or angled portion, which may extend through the slot 34 and/or may be coupled to the adapter 36 or another device… In some embodiments, the instrument hub may include the curved or angled portion and/or may extend through the slot 34 (Burkholz ¶0058), wherein the curved/angled portion of the proximal end of the instrument 12 is considered to define the claimed second portion extending oblique to the longitudinal axis of the introducer].
Regarding claim 3, Burkholz teaches
The blood draw device of claim 1, further comprising a secondary catheter having a proximal end, a distal end, and a sidewall therebetween defining a lumen, the secondary catheter connected to the actuator [a distal end of an extension tube 49 coupled with the proximal end of the instrument 12, according to some embodiments. In some embodiments, the proximal end of the extension tube 49 may be coupled with the adapter 36 or another device (Burkholz ¶0061), wherein the Examiner notes that as Figs. 2A-F are considered to depict exemplary connections between the instrument 12, adapter 36, instrument hub (see ¶0058), and extension tube 49 (as opposed to structurally/functionally different embodiments), reference to any of Figs. 2A-F are considered to be applicable, as there is no disclosure or depiction between the exemplary embodiments depicted in Figs. 2A-F that would preclude connection between the instrument 12, adapter 36, instrument hub (see ¶0058), and extension tube 49].
Regarding claim 4, Burkholz teaches
The blood draw device of claim 3, wherein the proximal end of the secondary catheter comprises a coupler [the proximal end of the extension tube 49 may include a coupling mechanism, such as, for example, a luer fitting (Burkholz ¶0061)].
Regarding claim 5, Burkholz teaches
The blood draw device of claim 1, wherein the actuator comprises a main body and an extension portion, the main body of the actuator extends parallel to the longitudinal axis of the introducer, the extension portion of the actuator receives the catheter and extends oblique to the longitudinal axis of the introducer [Burkholz ¶0058, Fig. 2B, wherein the Examiner notes that as ¶0058 discloses that the instrument hub (actuator) may comprise the curved/angled portion of the proximal end of the instrument 12 (catheter), the instrument hub may be considered to define a main body and an extension portion separated by where the instrument 12 is curved/angled, wherein the main body of instrument hub may comprise the portion of the proximal end of the instrument 12 that is depicted as being parallel to the longitudinal axis, and wherein the extension portion of the instrument hub may comprise the portion of the proximal end of the instrument 12 that is depicted as oblique to the longitudinal axis].
Regarding claim 6, Burkholz teaches
The blood draw device of claim 1, wherein the introducer defines a groove extending in a direction extending from the proximal end of the introducer to the distal end of the introducer, the groove positioned within the inner volume of the introducer and configured to receive a portion of the catheter during use of the blood draw device [Burkholz ¶0051, Fig. 2B, wherein the housing 28 (introducer) defining an enclosure around the instrument 12 is considered to define the claimed groove].
Regarding claim 8, Burkholz teaches
A blood draw device for use with a peripheral intravenous catheter (PIVC) comprising:
a catheter having a proximal end, a distal end, and a sidewall therebetween defining a lumen [the instrument 12 may include the proximal end and the distal tip 42. In some embodiments, the distal tip 42 may include one or more holes 44, which may be inlet and/or outlet holes (Burkholz ¶0055); the extension 10 may include a blood collection device, which may be used to obtain a blood sample (Burkholz ¶0041); the extension 10 may include an adapter 36, which may be coupled to a proximal end of the instrument 12 (Burkholz ¶0053); the adapter 36 may include a cavity configured to receive, for example, a syringe and/or blood collection tube (Burkholz ¶0054), wherein the instrument 12 defining inlet holes and being fluidically coupled to adapter 36, which is configured to enable blood withdrawal, is considered to read the claimed catheter (instrument 12)];
a secondary catheter having a proximal end, a distal end, and a sidewall therebetween defining a lumen [a distal end of an extension tube 49 coupled with the proximal end of the instrument 12, according to some embodiments. In some embodiments, the proximal end of the extension tube 49 may be coupled with the adapter 36 or another device (Burkholz ¶0061)];
an introducer having a proximal end, a distal end, and a sidewall therebetween defining an inner volume configured to movably receive the catheter, the introducer defining a longitudinal axis [the instrument 12 may be at least partially disposed or housed within the housing 28. In some embodiments, the housing 28 may at least partially surround the instrument (Burkholz ¶0051, Fig. 2B); in response to movement of the adapter 36 along the slot 34 from the proximal position to the distal position, the instrument 12 is advanced beyond the distal end of the housing 28 (Burkholz ¶0053), wherein a length of the introducer may define the claimed longitudinal axis]; and
an actuator movably coupled to the introducer, the actuator having a first portion disposed outside of the introducer and a second portion disposed in the inner volume of the introducer, the actuator comprising a catheter connection connected to the catheter and a secondary catheter connection connected to the secondary catheter [the proximal end of the instrument may include an instrument hub, which may facilitate coupling with the adapter. In some embodiments, the instrument hub may include the curved or angled portion and/or may extend through the slot 34 (Burkholz ¶0058); the extension may include an advancement tab 46, which may be coupled to the proximal end of the instrument 12 and/or the adapter 36. In some embodiments, the clinician may pinch or grasp the advancement tab 46 to move the instrument 12 to the proximal position and/or the distal position (Burkholz ¶0060), wherein the Examiner notes that as the advancement tab 46 being coupled to the proximal end of the instrument 12 to advance the instrument 12, the advancement tab 46 is understood to be coupled to the instrument hub (actuator)],
wherein the actuator is configured to move relative to the introducer to move the catheter between a first position, in which the catheter is disposed within the introducer, and a second position, in which the distal end of the catheter is disposed beyond the distal end of the introducer [in response to movement of the adapter 36 along the slot 34 from the distal position to the proximal position, the instrument 12 may be withdrawn into the housing 28 (Burkholz ¶0053); the instrument 12 is advanced beyond the distal end of the housing 28 when the adapter 36 is disposed in the distal position (Burkholz ¶0060, Figs. 2B, 2D), wherein the Examiner notes that Fig. 2B is considered to depict the first position, wherein the distal tip 42 of the instrument 12 (catheter) is disposed within the housing 28 (introducer), and Fig. 2D depicts the second position, and wherein as the instrument hub is coupled to the proximal end of the instrument 12, the instrument 12 moves as the instrument hub moves], and
wherein, when the catheter is in the first position, the catheter and the secondary catheter each extend parallel to the longitudinal axis of the introducer, with the catheter offset a distance from the secondary catheter [the proximal end of the instrument 12 may include a curved or angled portion, which may extend through the slot 34 and/or may be coupled to the adapter 36 or another device… the proximal end of the instrument may include an instrument hub, which may facilitate coupling with the adapter. In some embodiments, the instrument hub may include the curved or angled portion and/or may extend through the slot 34. In some embodiments, the instrument hub may be bonded to a distal portion of the instrument 12 via mechanical, adhesive, solvent, ultrasonic, or another suitable type of bonding. For clarity, in some embodiments, the proximal end of the instrument 12 may extend through the slot 34 via either the instrument hub extending through the slot 34 or another portion of the instrument 12 extending through the slot 34 (Burkholz ¶0058, Fig. 2B); In some embodiments, the adapter 36 may be angled with respect to the housing, as illustrated, for example, in FIG. 2A. In some embodiments, the adapter 36 may be oriented parallel to the longitudinal axis of the housing 28, as illustrated, for example, in FIG. 2B (Burkholz ¶0059, Fig. 2B); In some embodiments, the proximal end of the extension tube 49 may be coupled with the adapter 36 or another device. In some embodiments, the proximal end of the extension tube 49 may include a coupling mechanism, such as, for example, a luer fitting that may be compatible with a luer fitting of the adapter 36 and/or the other device (Burkholz ¶0061), wherein the Examiner notes that as Figs. 2A-F are considered to depict exemplary connections between the instrument 12, adapter 36, instrument hub (see ¶0058), and extension tube 49 (as opposed to structurally/functionally different embodiments), reference to any of Figs. 2A-F are considered to be applicable, as there is no disclosure or depiction between the exemplary embodiments depicted in Figs. 2A-F that would preclude connection between the instrument 12, adapter 36, instrument hub (see ¶0058), and extension tube 49; the Examiner further notes that as depicted in Fig. 2B, the instrument 12 and adapter 36, which is understood to be couplable to extension tube 49 (see ¶0061; depicted in at least Fig. 2Fas extending longitudinally), are each considered to extend parallel to a longitudinal axis defined by the length of the housing 28 (introducer); and wherein the Examiner also notes that the disclosure of ¶¶0058-0059 regarding an instrument hub that may angle the instrument 12 from the adapter 36 (see at least Fig. 2B), as coupled to extension tube 49, is considered to anticipate the instrument 12 being offset a distance from the extension tube].
Regarding claim 9, Burkholz teaches
The blood draw device of claim 8, wherein the catheter connection is offset from the secondary catheter connection via an angled body portion [Burkholz ¶¶0058-0059, Fig. 2B; see Examiner’s analysis of claim 8 above].
Regarding claim 10, Burkholz teaches
The blood draw device of claim 8, wherein the actuator comprises a main body having a top surface and a bottom surface positioned opposite from the top surface, and wherein the catheter connection extends from the bottom surface of the main body of the actuator [Burkholz ¶0058, wherein the instrument hub (main body of the actuator) extending through the slot 34 may define a bottom surface disposed within the housing 28 and a top surface disposed outside the housing on the portion of the instrument hub that extends through slot 34, such that as the proximal end of the instrument 12 is coupled to the instrument hub and is disposed within the housing 28, the claimed catheter connection is considered to extend from the bottom surface of the bottom surface of the main body of the actuator (See Annotated Fig. 1)].
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Annotated Fig. 1. The Examiner has annotated Burkholz Fig. 2B, which is considered to depict the offset between the catheter and the secondary catheter [the Examiner acknowledges the as depicted in Fig. 2B, the adapter 36 is coupled to a cannula 38, but based on at least ¶0061, the adapter 36 may be coupled to an extension tube 49], and is considered to depict structure based on the disclosed instrument hub of Burkholz [see Burkholz ¶¶0058-0059]. The structure considered to be the disclosed instrument hub has been annotated to identify the portions considered to read on the claimed top surface and bottom surface of a main body of the actuator.
Regarding claim 11, Burkholz teaches
The blood draw device of claim 10, wherein the secondary catheter connection extends between the top surface and the bottom surface of the main body of the actuator [see Annotated Fig. 1].
Regarding claim 13, Burkholz teaches
The blood draw device of claim 8, wherein the introducer defines a groove extending in a direction extending from the proximal end of the introducer to the distal end of the introducer, the groove positioned within the inner volume of the introducer and configured to receive a portion of the catheter during use of the blood draw device [Burkholz ¶0051, Fig. 2B, wherein the housing 28 (introducer) defining an enclosure around the instrument 12 is considered to define the claimed groove].
Regarding claim 15, Burkholz teaches
The blood draw device of claim 8, wherein the catheter is offset downward from the secondary catheter [Burkholz ¶¶0058-0059, Fig. 2B, see Examiner’s analysis of claim 8 above].
Regarding claim 16, Burkholz teaches
The blood draw device of claim 8, wherein the catheter is offset upward from the secondary catheter [Burkholz ¶¶0058-0059, Fig. 2B, see Examiner’s analysis of claim 8 above, wherein the Examiner notes that the housing 28 as depicted in Fig. 2B may be observed in an inverted (upside down) position, such that the instrument 12 (catheter) is considered to be offset upward from the extension tube 49 (secondary catheter)].
Regarding claim 17, Burkholz teaches
The blood draw device of claim 8, wherein the catheter is offset sideways from the secondary catheter [Burkholz ¶¶0058-0059, Fig. 2B, see Examiner’s analysis of claim 8 above].
Claim(s) 7 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz, as applied to claims 6 and 13 above, in view of Ehrenreich (US-20180272107-A1, previously presented).
Regarding claim 7, Burkholz teaches
The blood draw device of claim 6.
However, while Burkholz is considered to depict the introducer as defining a circular groove [based on the circular shape of the housing 28 as depicted in at least Burkholz Figs. 2A-F], Burkholz fails to explicitly disclose wherein the groove is at least one of U-shaped, V-shaped, and squared-shaped.
Ehrenreich discloses blood draw devices comprising an introducer that defines a groove within an inner volume of the introducer configured to receive a portion of a catheter [The inner surface 223 of the first member 220 and the inner surface 233 of the second member 230 collectively define the inner volume 213 of the introducer 210 (Ehrenreich ¶0091, Fig. 20), wherein as depicted in Ehrenreich Fig. 20, the inner volume 213 receives a portion of catheter 260, and wherein the inner volume 213 may be considered to comprise portions that are U-shaped and square-shaped].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz to employ wherein the groove is at least one of U-shaped, V-shaped, and squared-shaped, as this modification would amount to mere simple substitution of one known element for another [shape of introducer that defines a groove positioned within an inner volume of the introducer] with similar expected results [house at least a portion of a catheter] [MPEP § 2143(I)(B)].
Regarding claim 14, Burkholz teaches
The blood draw device of claim 13.
However, while Burkholz is considered to depict the introducer as defining a circular groove [based on the circular shape of the housing 28 as depicted in at least Burkholz Figs. 2A-F], Burkholz fails to explicitly disclose wherein the groove is at least one of U-shaped, V-shaped, and squared-shaped.
Ehrenreich discloses blood draw devices comprising an introducer that defines a groove within an inner volume of the introducer configured to receive a portion of a catheter [Ehrenreich ¶0091, Fig. 20, wherein as depicted in Ehrenreich Fig. 20, the inner volume 213 receives a portion of catheter 260, and wherein the inner volume 213 may be considered to comprise portions that are U-shaped and square-shaped].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Burkholz to employ wherein the groove is at least one of U-shaped, V-shaped, and squared-shaped, as this modification would amount to mere simple substitution of one known element for another [shape of introducer that defines a groove positioned within an inner volume of the introducer] with similar expected results [house at least a portion of a catheter] [MPEP § 2143(I)(B)].
Response to Arguments
Applicant's arguments, see Applicant’s Remarks p. 7, filed 13 February 2026, with respect to the previously presented drawing objections have been fully considered but they are not entirely persuasive.
The Examiner notes that the objections for drawings including reference characters not in the description were not entirely addressed.
Applicant’s arguments, see Applicant’s Remarks p. 7, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The rejection of claim 17 has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 7-10, with respect to the rejection(s) of claim(s) 1, 8, and those dependent therefrom under § 102 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 Burkholz (US-20190021640-A1) [which the Examiner notes is not the same as the previously presented Burkholz ‘346 reference].
Regarding claim 1, the Applicant asserts that Ehrenreich fails to disclose “wherein the actuator is configured to move relative to the introducer to move the catheter between a first position, in which the catheter is disposed within the introducer, and a second position, in which the distal end of the catheter is disposed beyond the distal end of the introducer, and wherein, when the catheter is in the first position, the catheter has a first portion extending parallel to the longitudinal axis of the introducer and a second portion extending oblique to the longitudinal axis of the introducer” as amended, wherein the Applicant notes that Ehrenreich fails to disclose that the catheter 370 has a first portion extending parallel to the longitudinal axis of the introducer and a second portion extending oblique to the longitudinal axis of the introducer when the catheter 360 is within the introducer and not advanced outside of the introducer, based on ¶0137 of Ehrenreich, which the Applicant argues discloses that the advancement of the actuator 370 causes the actuator to be non-parallel to the longitudinal axis of the introducer. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Burkholz (US-20190021640-A1) [not the same as the previously applied Burkholz ‘346 reference] is presently applied to teach the argued amended subject matter regarding “when the catheter is in the first position, the catheter has a first portion extending parallel to the longitudinal axis of the introducer and a second portion extending oblique to the longitudinal axis of the introducer” [wherein as depicted in at least Burkholz Fig. 2B, at least a portion of the instrument 12 (catheter) extends parallel to the longitudinal axis of the housing 28 (introducer); the proximal end of the instrument 12 may include a curved or angled portion, which may extend through the slot 34 and/or may be coupled to the adapter 36 or another device… In some embodiments, the instrument hub may include the curved or angled portion and/or may extend through the slot 34 (Burkholz ¶0058), wherein the curved/angled portion of the proximal end of the instrument 12 is considered to define the claimed second portion extending oblique to the longitudinal axis of the introducer].
Regarding claim 8, the Applicant asserts that Burkholz ‘346 fails to disclose “wherein, when the catheter is in the first position, the catheter and the secondary catheter each extend parallel to the longitudinal axis of the introducer, with the catheter offset a distance from the secondary catheter”, as amended, wherein the Applicant notes that the Examiner has combined elements from the embodiment shown in Fig. 7B with the embodiment shown in Figs. 10A-10C, which the Applicant notes depicts different looking and functioning hubs 115, such that the Examiner has failed to establish that a single embodiment of Burkholz ‘346 discloses each and every limitation of claim 8 to establish anticipation by Burkholz; and wherein the Applicant further argues that as shown in Burkholz Fig. 10A, the tubing 102 does not extend parallel to the longitudinal axis of the introducer. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 8 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Burkholz (US-20190021640-A1) [not the same as the previously applied Burkholz ‘346 reference] is presently applied to teach the argued amended subject matter regarding “wherein, when the catheter is in the first position, the catheter and the secondary catheter each extend parallel to the longitudinal axis of the introducer, with the catheter offset a distance from the secondary catheter” [Burkholz ¶¶0058-0059, 0061, Figs. 2B, 2F, wherein the Examiner notes that as Figs. 2A-F are considered to depict exemplary connections between the instrument 12, adapter 36, instrument hub (see ¶0058), and extension tube 49 (as opposed to structurally/functionally different embodiments), reference to any of Figs. 2A-F are considered to be applicable, as there is no disclosure or depiction between the exemplary embodiments depicted in Figs. 2A-F that would preclude connection between the instrument 12, adapter 36, instrument hub (see ¶0058), and extension tube 49; the Examiner further notes that as depicted in Fig. 2B, the instrument 12 and adapter 36, which is understood to be couplable to extension tube 49 (see ¶0061; depicted in at least Fig. 2F as extending longitudinally), are each considered to extend parallel to a longitudinal axis defined by the length of the housing 28 (introducer); and wherein the Examiner also notes that the disclosure of ¶¶0058-0059 regarding an instrument hub that may angle the instrument 12 from the adapter 36 (see at least Fig. 2B), as coupled to extension tube 49, is considered to anticipate the instrument 12 being offset a distance from the extension tube].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Arruego (US-6152901-A) discloses an actuator configured to move relative to an introducer between a first position and a second position, wherein the actuator is connected to a tubular instrument, wherein when the tubular instrument is in the first position, the tubular instrument has a first portion extending parallel to a longitudinal axis of the introducer and a second portion extending oblique to the longitudinal axis of the introducer [Arruego Figs. 1-2]
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 SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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