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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 22 July 2026 has been entered.
The Examiner acknowledges the amendments to claims 1, 4, 9, and 14, as well as the cancelation of claims 2-3, 6, 8, and 15-17. Claims 1, 4-5, 9-11, and 14 are pending.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “with rotation of the wheel member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one pair of opposing proximal clip portions; wherein the locking member comprises a sleeve member sized and configured to extend over at least a portion of the pair of opposing clips when the wheel member is rotated to the second position” [emphasis applied; as the Examiner notes that while Applicant’s Figs. 9-10 appear to depict a sleeve member (212) that “extends over” (or “surrounds” based at least on Applicant’s Specification ¶0099) “distal” clip portions 215A, 215B, the Applicant’s Figures fail to specifically depict the locking member/sleeve member being positioned to prevent “actuation” of a ”proximal” clip portion, as the distal clip portions (which appear to define the entirety of the opposing clips) are depicted as being prevented from being “actuating”/flexing outwards; the Examiner further notes that the configuration as depicted in Figs. 9-10 appear to depict a particular pair of opposing clips that function differently from opposing clips in other Figures (wherein opposing clips in other Figures are specifically defined as comprising “proximal” and “distal” clip portions] must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 Objections
Claim(s) 1 and 9 is/are objected to because of the following informalities:
Claim 1 should read “based on a direction of rotation of the wheel member” [lines 8-9].
Claim 1 should read “wherein the probe is in a retracted position when the wheel is in the first position” [line 9].
Claim 9 should read “wherein the probe is in a retracted position when the wheel is in the first position” [line 9].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 14 is/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 14 recites the limitations “pair of opposing clips” [lines 11, 19] and “pair of opposing proximal clip portions” [line 17, emphasis applied], which is considered indefinite, as it is not clear whether the recited limitations are intended to refer to the same structural element or not. Based at least on ¶0078 of the Applicant’s Specification and Applicant’s Fig. 2, the recited “pair of opposing proximal clip portions” is understood to refer to a portion of the recited “pair of opposing clips”, such that for examination purposes, the Examiner has interpreted claim 14 to define wherein each opposing clip of the pair of opposing clips to respectively comprise opposing proximal clip portions.
Claim 14 recites the limitation “wherein the locking member is configured to prevent disconnection of the connector member from the needleless access connector when the wheel member is rotated to a second position and to allow disconnection of the connector member when the wheel member is rotated to a first position, with rotation of the wheel member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions” [lines 12-17, emphasis applied], which is considered indefinite, as it is not clear how the wheel member being in the first position allows BOTH disconnection of the connector member and prevents actuation of the at least one of the pair of opposing proximal clip portions by the locking member, as based on the broadest reasonable interpretation of the Applicant’s Specification, the locking member is configured such that rotation of the wheel member to the second position causes a distal linear movement of the locking member to a position that prevents actuation of the at least one pair of opposing clips, wherein rotation of the wheel member to the first position causes a proximal linear movement of the locking member to a position that allows for disconnection of the connector member [See Applicant’s Specification ¶¶0098-0100, Figs. 9-10]. For Examination purposes, the Examiner has interpreted the indefinite limitation to read “wherein the locking member is configured to prevent disconnection of the connector member from the needleless access connector when the wheel member is rotated to a second position and to allow disconnection of the connector member when the wheel member is rotated to a first position, with rotation of the wheel member to the [[first]] second position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions”.
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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harding (US-20210290264-A1, previously presented) in view of Koch (US-20110288533-A1, previously presented).
Regarding claim 14, Harding teaches
A fluid transfer device for needle-free delivery of a probe to a patient's vascular system, the fluid transfer device comprising:
a housing [housing 104 (Harding Figs. 1A-B)];
a distal introducer portion positioned at a distal end portion of the housing and configured to penetrate a needleless access connector of a vascular access device [cannula 132 (Harding Figs. 1A-B, 3-8); the distal end 108 of the housing 104 may include the lever lock 130 to couple the housing 104 to the catheter assembly. The lever lock 130 may include a cannula 132 (Harding ¶0069); In some embodiments, in operation, the cannula 132 may penetrate a luer connector of the catheter assembly to access the fluid pathway of the catheter assembly (Harding ¶0070)];
a translation member movable with respect to the housing, wherein the translation member is operably coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of movement of the translation member [advancement tab 112 (Harding Figs. 1A-B); In some embodiments, the advancement tab 112 may be configured to move linearly along the slot 110 between a retracted position 114 and an advanced position 116. In some embodiments, the advancement tab 112 may be coupled to a proximal end 120 of the instrument 102, such that moving the advancement tab 112 linearly along the slot 110 may cause the instrument 102 to move in a same direction as the advancement tab 112 relative to the housing 104 (Harding ¶0054)];
a connector member positioned proximate the distal introducer portion and configured for releasable connection to at least one surface of the needleless access connector, wherein the connector member comprises a pair of opposing clips [at least two of the lever lock arms 128a, b (Harding Figs. 1A-B); In some embodiments, proximal ends of the lever lock arms 128a, b may be biased inwardly towards the longitudinal axis of the housing 104 to snap to or otherwise couple to the luer connector. In this manner, the lever lock arms 128a, b may automatically secure the cannula 132 to the luer connector. In some embodiments, the luer connector of the catheter assembly may include one or more recesses configured to receive one or more protrusions of the lever lock arms 128a, b. In some embodiments, the lever lock arms 128a, b may engage the protrusions of the lever lock arms 128a, b to secure the housing 104 to the catheter assembly (Harding ¶0070)]; and
a locking member, wherein the locking member is configured to prevent disconnection of the connector member from the needleless access connector when the translation member is moved to a second position and to allow disconnection of the connector member when the translation member is moved to a first position, with rotation of the wheel member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions [the lock element 900 may include a locking member 902 configured to interact with the lever lock arms 128a, b (Harding ¶0074, Figs. 9-10); in response to the instrument 102 being in the advanced position 116, the locking member 902 may be disposed in a locked position between the housing 104 and the lever lock arms 128a, b. In this position, the locking member 902 may prevent depression of the lever lock arms 128a, b and thus prevent release of the catheter assembly from the housing 104. In response to the instrument 102 being in the retracted position 114, the locking member 902 may be disposed proximal to the lever lock arms 128a, b in an unlocked position, thereby enabling the lever lock arms 128a, b to depress and to thus release the catheter assembly from the housing 104 (Harding ¶0075, Figs. 9-10); see corresponding § 112(b) rejection and interpretation above, wherein the rotation of the wheel member to the second position is configured to cause the distal linear movement of the locking member as claimed];
wherein the locking member comprises a sleeve member sized and configured to extend over at least a portion of the pair of opposing clips when the translation member is moved to the second position [wherein as depicted in Harding Figs. 9-10, the locking member 902 is considered ring-like to read on the broadest reasonable interpretation of a “sleeve member”, and as the locking member 902 is of a length that extends in the distal/proximal direction and physically interfaces with the lever lock arms 128a, b (Harding ¶0075, Figs. 9-10), the locking member 902 is considered to extend over at least a portion of the pair of opposing clips].
However, Harding fails to explicitly disclose wherein the translation member is a wheel member rotatable with respect to the housing, wherein the wheel member is operably coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of rotation of the wheel member; wherein the locking member is configured to prevent disconnection of the connector member from the needleless access connector when the wheel member is rotated to a second position and to allow disconnection of the connector member when the wheel member is rotated to a first position, with rotation of the wheel member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions [see corresponding § 112(b) rejection and interpretation above, wherein rotation of the wheel member to the second position causes the claimed distal linear movement]; wherein the sleeve member is configured to extend over at least a portion of the pair of opposing clips when the wheel member is rotated to the second position.
Koch discloses a fluid transfer device for delivery of a probe to a patient's vascular system comprising a housing [elongated housing 11 (Koch Fig. 1)], distal introducer portion [Luer Lock extension 15 (Kock Fig. 1)], a wheel member rotatable with respect to the housing, wherein the wheel member is operable coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of rotation of the wheel member [thumb wheel 25 (Koch Fig. 1); The threads on the thumb wheel engage with the grooves on the top surface of the traveller, such that rotating the thumb wheel in a distal direction causes the traveller to move in the proximal direction. In this case, tubular shaft member which is attached to the traveller is moved proximally and will expose the distal tip portion of the inner guidewire. Rotating the thumb wheel in an opposite, in this case proximal, direction causes the traveller to move in the distal direction. Here, tubular shaft member is moved distally on a longitudinal axis and will cause the distal tip portion of the inner guidewire to become enclosed by the tubular shaft member (Koch ¶0011); Traveller 16 moves within inner cavity 12, along the longitudinal axis of elongated housing 11. In a preferred embodiment, movement of traveller 16 in the longitudinal direction is accomplished by thumb wheel 25. In this embodiment, as seen in FIGS. 1 and 2, thumb wheel 25 has a threaded surface 31 and traveller 16 has a grooved upper surface 26. As thumb wheel 25 is rotated, the threaded surface 31 contacts with the grooved upper surface 26 of traveller 16 to cause longitudinal movement of traveller 16 within inner cavity 12 (Koch ¶0018); To control the distal tip 24 of inner guidewire 13, the tubular member 18 is moved in a proximal direction to allow exposure the distal tip 24 of inner guidewire 23. This is accomplished by rotating thumb wheel 25 in a distal direction, thereby causing traveller 16 to slide in a proximal direction (Koch ¶0021)].
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 Harding to employ wherein the translation member is a wheel member rotatable with respect to the housing, wherein the wheel member is operably coupled to the probe to advance and retract the probe through the distal introducer portion based on direction of rotation of the wheel member, as this modification would amount to mere simple substitution of one known element for another with similar expected results [allow for translation of a probe] [MPEP § 2143(I)(B)]; and to have modified the device of Harding to employ wherein the locking member is configured to prevent disconnection of the connector member from the needleless access connector when the wheel member is rotated to a second position and to allow disconnection of the connector member when the wheel member is rotated to a first position, with rotation of the wheel member to the first position causing a distal linear movement of the locking member to a position that prevents actuation of the at least one of the pair of opposing proximal clip portions [see corresponding § 112(b) rejection and interpretation above, wherein rotation of the wheel member to the second position causes the claimed distal linear movement]; wherein the sleeve member is configured to extend over at least a portion of the pair of opposing clips when the wheel member is rotated to the second position, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [rotation of a wheel member to cause linear actuation of elements operably coupled to rotation of the wheel member] [MPEP § 2143(I)(D)].
Subject Matter Not Taught By Prior Art
Regarding claim 1, the closest prior art of record is Harding (US-20210290264-A1, previously presented), Koch (US-20110288533-A1, previously presented), and Tegg (US-20150196736-A1, previously presented), which alone or in combination, fail to disclose, teach, or suggest the amended subject matter regarding “a clocking member rotatable with the wheel member and comprising a first clocking projection that interacts with the proximal end of the arm; and wherein with the wheel in the first position and the probe in the retracted position, the proximal end of the arm is held by the first clocking projection, with the locking member thus positioned to enable actuation of at least one of the pair of opposing proximal clip portions, and wherein with the wheel rotated toward the second position and the probe moved toward the advanced position, the proximal end of the arm is released from the first clocking projection, with the biasing member thus causing the locking member to move distally to a position that prevents actuation of at least one of the pair of opposing proximal clip portions” [emphasis applied]. The Examiner notes that while Koch discloses subject matter regarding a clocking member [Koch ¶¶0011, 0018, 0021, Fig. 1], Koch fails to disclose, teach, or suggest any subject matter regarding a locking member [and was not specifically cited for such claim language], and that Harding was relied upon regarding the structure and functionality of the claimed locking member and Tegg was applied in the previously applied rejection of dependent claim 3 to disclose subject matter regarding a post configured to ride within a cam groove formed in a clocking member [Tegg ¶¶0035, 0039, Fig. 7]. However, Harding, Koch, and Tegg fail to disclose any subject matter regarding a first clocking projection that interacts with the proximal end of the arm and thus also fails to teach the amended claimed subject matter regarding the operative connection and functionality between the wheel, clocking member, first clocking projection, locking member and arm, and the connector member. It would not 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 any of Harding, Koch, or Tegg, alone or in combination, to employ the subject matter identified as not being taught by any of Harding, Koch, or Tegg without the benefit of hindsight. As such, claims 1 and those dependent therefrom are not taught by any prior art reference.
Regarding claim 9, the closest prior art of record is Devgon (US-20210052851-A1, previously presented), Harding (US-20210290264-A1, previously presented), and Tegg (US-20150196736-A1, previously presented), which alone or in combination, fail to disclose, teach, or suggest the amended subject matter regarding “wherein with the wheel in the first position and the probe in the retracted position, a proximal end portion of the proximal arm member is aligned with the slot, such that actuation of at least one of the pair of opposing proximal clip portions causes a proximal movement of the locking member, with the proximal end portion of the proximal arm member entering the slot, thereby enabling a full actuation of the proximal clip portions, and wherein with the wheel in the second position and the probe in the advanced position, the proximal end portion of the proximal arm member is out of alignment with the slot, such that a proximal movement of the locking member is prevented, thereby preventing actuation of at least one of the pair of opposing proximal clip portions” [emphasis applied]. The Examiner notes that Devgon and Tegg fail to disclose, teach, or suggest any subject matter regarding a locking member [and were not specifically cited for such claim language], and that Harding was relied upon regarding the structure and functionality of the claimed locking member. However, Harding teaches away from the claimed functionality of the locking member with respect to the claimed pair of opposing proximal clip portions, as Harding explicitly discloses wherein when the probe and the locking member are in a retracted position, the locking member does not operatively interface or interact with the opposing proximal clip portions [Harding ¶0075, Figs. 9-10], as opposed to the claimed interfacing between at least one of the pair of opposing proximal clip portions being operatively connected to the locking member to cause a proximal movement of the locking member. It would not 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 any of Devgon, Harding, and Tegg to employ the subject matter identified as not being taught by an of Devgon, Harding, or Tegg without the benefit of hindsight. As such, claim 9 and those dependent therefrom are not taught by any prior art reference.
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 6-10, filed 22 July 2026, with respect to the previously applied rejections of claims 1, 9, and those dependent therefrom under § 103 have been fully considered and are persuasive. The rejections of claims 1, 9, and those dependent therefrom under § 103 have been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 6-10, with respect to the previously applied rejection of claim 14 under § 103 have been fully considered but they are not persuasive.
Regarding claim 14, the Applicant asserts that neither Harding or Koch discloses a locking member that comprises a sleeve member sized and configured to extend over at least a portion of the pair of opposing clips when the wheel member is rotated to the first position [the Examiner notes that the Applicant’s Remarks say “rotated to the first position”, but claim 14 recites “rotated to the second position”], as the Applicant directs attention to locking member 902 of Harding being positioned under the lever lock arms 128a, b to prevent depression thereof [Harding Fig. 10]. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that the claim language “extend over at least a portion of the pair of opposing clips” [emphasis applied] is broadly recited, such that as the locking member 902 of Harding having a length that extends in a distal/proximal direction and physically interfaces with the lever lock arms 128a, b [Harding ¶0075, Figs. 9-10], the locking member 902 is considered to extend over at least a portion of the pair of opposing clips. The Examiner further notes that cited Fig. 10 of the Applicant’s disclosure and corresponding language in at least ¶¶0098-0100 of the Applicant’s Specification further defines/depicts the sleeve member as at least partially surrounding the distal clip portions 215A, 215B.
Conclusion
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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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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