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 .
Previous Action Withdrawn/Suspended
The notice to applicant regarding non-compliance dated 05/28/2026 is hereinafter withdrawn.
Election/Restrictions
Applicant’s election without traverse of species I (Figs. 1C-D) and Species IV (Claims 17-18) in the reply filed on 03/24/2026 is acknowledged.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventive species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/24/2026.
Claim Objections
Claim 10 is objected to because of the following informalities: Line 1 reading “wherein sheath portion” should read --wherein the sheath portion--. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: Line 4 reading inhibit lateral separation” should read --inhibit a lateral separation--. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: Line 2 reading “to define needle tract” should read --to define a needle tract--. Appropriate correction is required.
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 4 is 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 4 recites the limitation “the needle tract” in Line 2. There is insufficient antecedent basis for this limitation in the claims.
Claim 9 is 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 9 recites the limitations "the sharp tip", “the back edge” and “the back wall”. There is insufficient antecedent basis for these limitations in the claims.
Claim 12 is 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 12 recites the limitation “the deliberate action” in Line 5 and again in Line 6. There is insufficient antecedent basis for this limitation in the claims.
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.
Claims 1-9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Ingold et al. (USPGPub 2013/0197558) in view of Howell (USPGPub 2023/0201539).
Re Claim 1, Ingold teaches a tissue-cutting device (100) (Ingold Fig. 2), comprising: a body defining a distal end (104) and a proximal end (112), the body including: a channel wall defining a channel (150) extending along a length of the body (as seen in Ingold Fig. 3); one or more protrusions (114) extending laterally away from the channel wall adjacent the proximal end (112) (Ingold ¶ 0031); and a sheath portion (106) extending proximally away from the distal end (104), the sheath portion (106) disposed in line with the channel (150) (Ingold Fig. 3); and a blade (102) attached to the body along a medial portion of the body, the blade (102) extending laterally away from the channel wall so that a cutting edge of the blade (102) is disposed opposite the channel (150) (Ingold ¶ 0030-0031), wherein: the channel (150) is configured to receive an elongate medical device (50) therein so as to inhibit lateral movement of the elongate medical device (50) from the channel (150) (as seen in Ingold Figs. 5A-5C; Claim 1; ¶ 0032), and the cutting edge is disposed at an angle with respect to the channel (150) so that a distal portion of the cutting edge is disposed closer to the channel (150) than a proximal portion of the cutting edge (as seen in Ingold Fig. 2).
However, Ingold fails to teach the channel is configured to selectively allow lateral removal of the elongate medical device from the channel. Howell teaches a tissue-cutting device (100) comprising a channel (152), said channel (152) configured to selectively allow lateral removal of an elongate medical device (30) from the channel (152) for ease and quick disconnection of the elongate medical device from the tissue-cutting device during a medical procedure (Howell ¶ 0043). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the channel of the tissue-cutting device of Howell to be configured to selectively allow lateral removal of the elongate medical device from the channel as disclosed by Howell for ease of and quick disconnection from the elongate medical device from the tissue-cutting device during a medical procedure (Howell ¶ 0015-0016, 0043).
Re Claim 2, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold teaches wherein the device (100) is slidably displaceable along the elongate medical device (50) (as seen in Ingold Figs. 5A-5C).
Re Claim 3, Ingold in view of Howell tach all of the limitations of Claim 1. In the present case, the limitation “wherein the device is configured for insertion along a needle tract extending between a skin surface and a blood vessel wall of a patient” has been determined to be a functional limitation and an inherent characteristic of prior art Ingold in view of Howell. The structure of prior art Ingold in view of Howell possesses the structure to carry out the function of insertion along a needle tract extending between a skin surface and a blood vessel wall of a patient (See MPEP 2114).
Re Claim 4, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold teaches wherein the one or more protrusions (114) provide an insertion stop for the device (100) during insertion of the device (100) along a needle tract (Ingold ¶ 0031; Figs. 5A-5C).
Re Claim 5, Ingold in view of Howell tach all of the limitations of Claim 4. Ingold teaches wherein the insertion stop defines a depth of cut for the blade (102) in accordance with the angle of the blade (102) (Ingold ¶ 0031; Figs. 5A-5C).
Re Claim 6, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold teaches wherein: the blade (102) includes a sharp tip at a distal end of the blade (102) (Ingold ¶ 0030; as seen in Fig. 3), and the sharp tip is disposed between an outside surface of the channel wall and an inside surface of the channel wall (Ingold ¶ 0030).
Re Claim 7, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold teaches wherein a proximal edge of the blade (102) is encapsulated within at least one of the one or more protrusions (114) (as seen in Ingold Figs. 2 and 3).
Re Claim 8, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold teaches all of the limitations of Claim 1. Ingold further teaches wherein the blade is formed of a stainless steel (Ingold ¶ 0031).
Re Claim 9, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold teaches wherein, the body is formed of a thermo-plastic material via an injection molding process, and the blade (102) is insert molded into the body so that a sharp tip is molded into the channel wall and a back edge is molded into the back wall (Ingold ¶ 0031; Fig. 3).
Re Claim 10, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold teaches wherein the sheath portion (106) includes a taper so that a diameter of the sheath portion (106) adjacent the distal end of the body is less than a diameter of the sheath portion (106) adjacent the blade (102) (as seen in Ingold Fig.3).
Re Claim 11, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold fails to teach wherein the channel is configured to: allow lateral separation of the device from the elongate medical device in response to a deliberate action by a clinician, and inhibit lateral separation the device from the elongate medical device in the absence of the deliberate action by the clinician. Howell teaches wherein the channel (152) is configured to: allow lateral separation of the device (100) from the elongate medical device (30) in response to a deliberate action by a clinician, and inhibit lateral separation the device (100) from the elongate medical device (30) in the absence of the deliberate action by the clinician, the configuration for ease of and quick disconnection from the elongate medical device from the tissue-cutting device during a medical procedure (Howell ¶ 0015-0016, 0043).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the channel of Ingold in view of Howell to allow lateral separation of the device from the elongate medical device in response to a deliberate action by a clinician, and inhibit lateral separation the device from the elongate medical device in the absence of the deliberate action by the clinician, the configuration as disclosed by Howell for ease of and quick disconnection from the elongate medical device from the tissue-cutting device during a medical procedure (Howell ¶ 0015-0016, 0043).
Re Claim 12, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold fails to teach wherein, the channel wall defines a gap extending along the channel, the gap having a width less than a diameter of the elongate medical device; the channel wall is deflectable so as to allow the gap to widen in response to the deliberate action; and the deliberate action includes displacing the elongate medical device laterally out of the channel through the gap. Howell teaches wherein the channel (152) comprising a channel wall (155), the channel wall (155) defining a gap (158) extending along the channel (152), the gap (158) having a width less than a diameter of the elongate medical device (30) (Howell ¶ 0043); the channel wall (155) is deflectable so as to allow the gap (158) to widen in response to a deliberate action (Howell ¶ 0043); and the deliberate action includes displacing the elongate medical device (30) laterally out of the channel (152) through the gap (158) for preventing inadvertent lateral displacement of the elongate medical device from the channel during a medical procedure (Howell ¶ 0043).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the channel of Ingold in view of Howell to define a gap extending along the channel, the gap having a width less than a diameter of the elongate medical device; the channel wall is deflectable so as to allow the gap to widen in response to the deliberate action; and the deliberate action includes displacing the elongate medical device laterally out of the channel through the gap, the configuration as disclosed by Howell for preventing inadvertent lateral displacement of the elongate medical device from the channel during a medical procedure (Howell ¶ 0043).
Re Claim 17, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold teaches wherein the elongate medical device (50) is a needle (Ingold ¶ 0031-0032).
Re Claim 18, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold teaches wherein; the elongate medical device (50) is a needle (Ingold ¶ 0031-0032), and the sheath portion (106) includes a sheath length such that a total length of the device (100) is sufficient to extend between a bevel portion of a needle tip (58) and a needle hub (52) (Ingold Figs. 5A-5C).
Re Claim 19, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold teaches wherein the body includes a connecting hub (256) disposed at the proximal end of the device (100), the connecting hub (256) configured to couple with the needle hub (Ingold Figs. 5A-5C, 7A-7B).
Re Claim 21, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold teaches a needle assembly (50) comprising: a needle (56) and the tissue-cutting device (100) disposed over a shaft of the needle (56) (Ingold Figs. 5A-5C). With regard to the limitation “a needle configured to define a needle tract between a skin surface of a patient and a blood vessel of the patient,” examiner has determined this limitation is a functional limitation and an inherent characteristic of prior art Ingold in view of Howell. The structure of prior art Ingold in view of Howell possesses the structure to carry out the function of the needle defining a needle tract between a skin surface of a patient and a blood vessel of the patient (See MPEP 2114).
Re Claim 22, Ingold in view of Howell tach all of the limitations of Claim 21. Ingold further teaches wherein a connecting hub (256) of the device (100) is coupled with a needle hub (Ingold Figs. 5A-5C, 7A-7B).
Re Claim 23, Ingold in view of Howell tach all of the limitations of Claim 22. Ingold teaches wherein the distal end of the device (100) is disposed adjacent the bevel of the needle (56) (Ingold Figs. 5A-5C).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ingold et al. (USPGPub 2013/0197558) in view of Howell (USPGPub 2023/0201539) as applied to Claim 1 above, and further in view of Rehnke (USPGPub 2007/0288043).
Re Claim 16, Ingold in view of Howell tach all of the limitations of Claim 1. Ingold in view of Howell fail to teach wherein the sheath portion defines a length between about 1 cm and 2 cm. Rehnke teaches a tissue-cutting device (Rehnke Fig. 1) comprising a sheath portion (20) having a 1 cm length (Rehnke ¶ 0079). Prior art which teaches a range within, overlapping, or touching the claimed range anticipates if the prior art range does not substantially deviate from the claimed range. Perricone v. Medicis Pharmaceutical Corp., 77 USPQ 1321, 1327 (Fed. Cir. 2005)(anticipation found even where prior art range was not identical to claimed ranges); see also MPEP 2131.03 and Ex parte Lee, 31 USPQ2d 1105 (Bd. Pat. App. & Inter. 1993). In the present case, the prior art teaching of a sheath portion having a 1 cm length substantially overlaps and thus anticipates the claimed range of about 1 cm and 2 cm.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Ingold et al. (USPGPub 2013/0197558) in view of Howell (USPGPub 2023/0201539) as applied to Claim 19 above, and further in view of Horst et al. (USPGPub 2021/0290913).
Re Claim 20, Ingold in view of Howell tach all of the limitations of Claim 19. Ingold in view of Howell fail to teach wherein the connecting hub includes a Luer taper portion configured to couple with a corresponding Luer taper portion of the needle hub. Horst teaches a connecting hub (22) and a needle hub (32), wherein the connecting hub (22) includes a Luer taper portion (28) configured to couple with a corresponding Luer taper portion (38) of the needle hub (32), for a fluid tight, releasable connection (Horst ¶ 0089; Figs. 4c-4D). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the connecting hub and needle hub of Ingold in view of Howell wherein the connecting hub includes a Luer taper portion configured to couple with a corresponding Luer taper portion of the needle hub, the configuration as disclosed by Horst for a fluid tight, releasable connection (Horst ¶ 0089; Figs. 4c-4D).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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