DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This Office action is responsive to an amendment filed February 26, 2026. Claims 23-41 are pending. Claims 1-22 have been canceled. Claims 23 & 30-31 have been amended.
Terminal Disclaimer
The terminal disclaimer filed on February 26, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent Number 11,607,115 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Specification
The substitute specification filed February 26, 2026 has been entered.
Claim Interpretation
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an attachment portion configured to couple the endoscopic medical device thereto so that the endoscopic medical device moves and rotates with the proximal segment” in claims 23 & 31; the term “portion” is a placeholder coupled to a function “to couple the endoscopic medical device thereto so that the endoscopic medical device moves and rotates with the proximal segment,” the specification discloses a tubular portion comprising internal threading for engaging a threaded outer wall of a proximal end of an endoscope (see at least par 0017); and “an attachment portion for coupling the endoscopic medical device thereto so that the endoscopic medical device moves and rotates with the proximal segment” in claim 31. The term “portion” is a placeholder coupled to a function “coupling the endoscopic medical device thereto so that the endoscopic medical device moves and rotates with the proximal segment.” The specification describes a corresponding keyed portion of the lumen of the proximal segment or corresponding structure that prevents relative rotation between the endoscopic medical device and the proximal segment (see par 0011 of the original publication).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 23-27 & 29-41 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Surti (US 2005/0228312) in view of Hardia et al. (US 2004/0260199) (“Hardia” hereinafter).
In regards to claim 23, Surti discloses a telescoping handle for a medical device, comprising:
a proximal segment 22 including a proximal lumen extending longitudinally therethrough, the proximal lumen being sized and shaped to receive an endoscopic medical device 32 therein;
a medial segment 64 rotatably received within a distal portion of the proximal segment 22 and slidable within the distal portion of the proximal segment 22, the medial segment 64 defining a medial lumen extending therethrough open to the proximal lumen; and
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a distal segment 16 slidable axially within a distal portion of the medial segment 64 and defining a distal lumen extending therethrough open to the medial lumen, the medial and distal lumens being sized and shaped to permit sliding and rotation of the endoscopic medical device 32 therein relative to the medial and distal segments (16, 64) (see at least abstract, fig. 2A and par 0022 & 0028).
Surti discloses a handle, as described above, that fails to explicitly teach a handle with the proximal segment including an attachment portion configured to couple the endoscopic medical device thereto so that the endoscopic medical device moves and rotates with the proximal segment.
However, Hardia teaches that it is known to provide a handle with the proximal segment 118 including an attachment portion 100 configured to couple the endoscopic medical device 30 thereto so that the endoscopic medical device (30, 300) moves and rotates with the proximal segment 118 (see at least figs. 14A-B and par 0062-0063 & 0076).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the handle of Surti with the proximal segment including an attachment portion configured to couple the endoscopic medical device thereto so that the endoscopic medical device moves and rotates with the proximal segment as taught by Hardia since such a modification would amount to applying a known technique (i.e., as taught by Hardia) to a known device (i.e., as taught by Surti) ready for improvement to achieve a predictable result such as preventing rotational and axial movement of the stylet relative to the proximal handle (see par 0063 of Hardia), doing so would facilitate rotational manipulation of the stylet, brush or other endoscopic device via the proximal handle--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 24, Surti discloses the handle of claim 23, further comprising a proximal movement limiting mechanism 66 being configurable by a user to select a maximum amount of movement of the medial segment 64 into the proximal segment 22 (see at least fig. 2A and par 0027).
In regards to claim 25, Surti discloses the handle of claim 24, wherein the proximal movement limiting mechanism is configured to frictionally engage an outer wall of the medial segment 64 (see at least fig. 2A and par 0027).
In regards to claim 26, Surti discloses the handle of claim 25, that fails to explicitly teach a handle further comprising a distal movement limiting mechanism configurable by the user to lock the distal segment in a desired position relative to the medial segment. However, Hardia teaches that it is known to provide a handle further comprising a distal movement limiting mechanism 113 configurable by the user to lock the distal segment 120 in a desired position relative to the medial segment 112 (see at least fig. 5 and par 0067). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the handle of Surti further comprising a distal movement limiting mechanism configurable by the user to lock the distal segment in a desired position relative to the medial segment as taught by Hardia since such a modification would amount to applying a known technique (i.e., as taught by Hardia) to a known device (i.e., as taught by Surti) ready for improvement to achieve a predictable result such as selectively fixing a relative axial position between the intermediate segment and distal segment so as to thereby fix the relative position of the needle and sheath--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 27, Surti discloses the handle of claim 25, wherein the proximal movement limiting mechanism 66 is slidably positioned over a target portion of the medial segment 64 so that only a portion of the medial segment located proximally thereof is retractable into the proximal segment 22 (see at least fig. 2A and par 0027).
In regards to claim 29, Surti discloses the handle of claim 23, that fails to explicitly teach a handle wherein the distal segment includes an attachment sized and shaped to engage a corresponding attachment at a proximal end of an endoscope to which the handle is to be mounted. However, Hardia teaches that it is known to provide a handle wherein the distal segment (120, 360) includes an attachment 80 sized and shaped to engage a corresponding attachment at a proximal end of an endoscope 375 to which the handle 120 is to be mounted (see at least figs. 10, 10A & 13 and par 0059 & 0079-0080). Therefore, since Surti teaches that the distal end 20 of the inner handle member 16 has the ability to be in contact with an endoscope or other medical device (see par 0031 thereof), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the handle of Surti wherein the distal segment includes an attachment sized and shaped to engage a corresponding attachment at a proximal end of an endoscope to which the handle is to be mounted as taught by Hardia since such a modification would amount to applying a known technique (i.e., as taught by Hardia) to a known device (i.e., as taught by Surti) ready for improvement to achieve a predictable result such as selectively allowing attachment of the handle to another medical device (see at least par 0059 of Hardia)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 30, Surti discloses the handle of claim 23, that fails to explicitly teach a handle wherein the distal segment 16 includes a structure configured to engage an endoscope via a luer lock. However, Hardia teaches that it is known to provide a handle wherein the distal segment 120 includes a structure configured to engage an endoscope via a luer lock (see at least figs. 10, 10A & 13 and par 0059 & 0079-0080). Therefore, since Surti teaches that the distal end 20 of the inner handle member 16 has the ability to be in contact with an endoscope or other medical device (see par 0031 thereof), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the handle of Surti wherein the distal segment 16 includes a structure configured to engage an endoscope via a luer lock as taught by Hardia since such a modification would amount to applying a known technique (i.e., as taught by Hardia) to a known device (i.e., as taught by Surti) ready for improvement to achieve a predictable result such as selectively allowing attachment of the handle to another medical device (see at least par 0059 of Hardia)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 31, Surti discloses a telescoping handle for a medical device, comprising:
a proximal segment 22 defining a proximal lumen extending longitudinally therethrough, the proximal lumen being sized and shaped to receive an endoscopic medical device 32 therein;
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a medial segment 64 rotatably received and longitudinally slidable within a distal portion of the proximal segment 22, the medial segment 64 defining a medial lumen extending therethrough open to the proximal lumen;
a distal segment 16 received longitudinally slidable within a distal portion of the medial segment 64 and defining a distal lumen extending therethrough open to the medial lumen; and
a telescoping internal channel extending through the medial and distal segments (16, 64), the telescoping channel including first, second and third sections movable relative to one another upon retraction or expansion of the proximal, medial and distal segments (16, 64) relative to one another, wherein the first section is within the proximal segment 22, the second section is within the medial segment 64 and the third section is within the distal segment 16, wherein the medial and distal lumens are sized and shaped so that rotation of the proximal segment 22 relative to the medial segment 64 rotates the endoscopic medical device 32 relative to the medial and distal segments (16, 64), wherein the medial and distal lumens are sized and shaped to rotate the proximal segment 22 relative to the medial segment 64 (see at least abstract, fig. 2A and par 0022 & 0028).
Surti discloses a handle, as described above, that fails to explicitly teach a handle with the proximal segment including an attachment portion configured to couple the endoscopic medical device thereto so that the endoscopic medical device moves and rotates with the proximal segment; wherein the medial and distal lumens are sized and shaped so that rotation of the proximal segment relative to the medial segment rotates the endoscopic medical device relative to the medial and distal segments and movement of the proximal segment distally longitudinally relative to the medial segment moves the endoscopic medical device axially relative to the medial segment.
However, Hardia teaches that it is known to provide a handle with the proximal segment 118 including an attachment portion 100 configured to couple the endoscopic medical device 30 thereto so that the endoscopic medical device (30, 300) moves and rotates with the proximal segment 118; wherein movement of the proximal segment 118 distally longitudinally relative to the medial segment 112 moves the endoscopic medical device 30 axially relative to the medial segment 112 (see at least figs. 14A-B and par 0062-0063 & 0076).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the telescopic handle of Surti with the proximal segment including an attachment portion configured to couple the endoscopic medical device thereto so that the endoscopic medical device moves and rotates with the proximal segment, as taught by Hardia; wherein the medial and distal lumens of Surti are sized and shaped so that rotation of the proximal segment thereof relative to the medial segment thereof rotates the endoscopic medical device, as suggested by Hardia, relative to the medial and distal segments thereof and movement of the proximal segment thereof distally longitudinally relative to the medial segment thereof moves the endoscopic medical device axially relative to the medial segment as taught by Hardia since such a modification would amount to applying a known technique (i.e., as taught by Hardia) to a known device (i.e., as taught by Surti) ready for improvement to achieve a predictable result such as preventing rotational and axial movement of the stylet relative to the proximal handle (see par 0063 of Hardia), doing so would facilitate rotational manipulation of the stylet, brush or other endoscopic device via the proximal handle--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 32, Surti discloses the handle of claim 31, wherein the medial segment 64 is telescopically movable into and out of a portion of the proximal segment 22 and wherein the distal segment 16 is telescopically movable into and out of a portion of the medial segment 64 (see at least fig. 2A).
In regards to claim 33, Surti discloses the handle of claim 31, wherein the proximal retraction of the distal segment 16 into the medial segment 64 retracts the third section into the second section (see at least fig. 2A).
In regards to claim 34, Surti discloses the handle of claim 31, wherein the proximal retraction of the medial segment 64 into the proximal segment 22 retracts the second section into the first section (see at least fig. 2A).
In regards to claim 35, Surti discloses the handle of claim 31, wherein the third section has an outer diameter smaller than an inner diameter of the second section (see at least fig. 2A).
In regards to claim 36, Surti discloses the handle of claim 35, wherein the second section has an outer diameter smaller than an inner diameter of the first section (see at least fig. 2A).
In regards to claim 37, Surti discloses the handle of claim 31, further comprising a proximal movement limiting mechanism 66 configurable by a user to set a maximum amount of movement of the medial segment 64 into the proximal segment 22 (see at least fig. 2A and par 0027).
In regards to claim 38, Surti discloses the handle of claim 37, wherein the proximal movement limiting mechanism 66 frictionally engages an outer wall of the medial segment 64 (see at least fig. 2A and par 0027).
In regards to claim 39, Surti discloses the handle of claim 37, that fails to explicitly teach a handle further comprising a distal movement limiting mechanism operable by the user to lock a position of the distal segment relative to the medial segment. However, Hardia teaches that it is known to provide a handle further comprising a distal movement limiting mechanism 113 operable by the user to lock a position of the distal segment 120 relative to the medial segment 112 (see at least fig. 5 and par 0067). Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the handle of Surti further comprising a distal movement limiting mechanism operable by the user to lock a position of the distal segment relative to the medial segment as taught by Hardia since such a modification would amount to applying a known technique (i.e., as taught by Hardia) to a known device (i.e., as taught by Surti) ready for improvement to achieve a predictable result such as selectively fixing a relative axial position between the intermediate segment and distal segment so as to thereby fix the relative position of the needle and sheath--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 40, Surti discloses the handle of claim 31, that fails to explicitly teach a handle wherein the distal segment includes an attachment sized and shaped to engage a corresponding attachment at a proximal end of an endoscope to which the handle is to be mounted. However, Hardia teaches that it is known to provide a handle wherein the distal segment (120, 360) includes an attachment 80 sized and shaped to engage a corresponding attachment at a proximal end of an endoscope 375 to which the handle 120 is to be mounted (see at least figs. 10, 10A & 13 and par 0059 & 0079-0080). Therefore, since Surti teaches that the distal end 20 of the inner handle member 16 has the ability to be in contact with an endoscope or other medical device (see par 0031 thereof), it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the handle of Surti wherein the distal segment includes an attachment sized and shaped to engage a corresponding attachment at a proximal end of an endoscope to which the handle is to be mounted as taught by Hardia since such a modification would amount to applying a known technique (i.e., as taught by Hardia) to a known device (i.e., as taught by Surti) ready for improvement to achieve a predictable result such as selectively allowing attachment of the handle to another medical device (see at least par 0059 of Hardia)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
In regards to claim 41, Surti discloses the handle of claim 37, wherein the proximal movement limiting mechanism 66 is slidably positionable by the user over a target portion of the medial segment 64 so that only a portion of the medial segment 64 located proximally thereof is retractable into the proximal segment 22 (see at least fig. 2A and par 0027).
Claims 28 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Surti (US 2005/0228312) in view of Hardia (US 2004/0260199) further in view of Mugan et al. (US 2010/0081965).
Surti as modified by Hardia discloses the handle of claim 23, that fails to explicitly teach a handle wherein the endoscopic medical device is a needle.
However, Mugan teaches that it is known to provide a handle wherein the endoscopic medical device is a needle 22 (see at least abstract, fig. 1 and par 0056-0057).
Therefore, it would have been obvious to one of ordinary skill in the art at the time Applicant’s invention was filed to provide the handle of Surti as modified by Hardia wherein the endoscopic medical device is a needle as taught by Mugan since such a modification would amount to applying a known technique (i.e., as taught by Mugan) to a known device (i.e., as taught by Surti) ready for improvement to achieve a predictable result such as providing a handle that is adapted to accommodate needles of various diameters for use in endoscopic procedures (see at least par 0009-0010 of Mugan)--See KSR, 550 U.S. at___, 82 USPQ2d at 1396 (See MPEP § 214 3 for a discussion of the rationale(s) listed above. See also MPEP § 2144 - §2144.09 for additional guidance regarding support for obviousness determinations).
Response to Arguments
Applicant's arguments filed February 26, 2026 have been fully considered but they are not persuasive. Applicant contends that the combination of Surti and Hardia fails to disclose that "the medial segment being rotatably received within a distal portion of the proximal segment and slidable within the distal portion of the proximal segment," wherein the medial and distal lumens are "sized and shaped to permit sliding and rotation of the endoscopic medical device therein relative to the medial and distal segment," as recited in claim 23. The Office respectfully traverses.
First, the Office notes that the medial segment 64 of Surti is inherently rotatably and slidably disposed within the proximal segment 22 by virtue of the fact that the respective segments (16, 22, 64) of Surti are round tubes, without more, as clearly shown in fig. 2A thereof. In fact, Surti clearly teaches that a user can even twist (e.g., rotate) the distal end 20 of the distal segment 16, see par 0028, thereby further suggesting that the segments are merely round tubes that are rotatably and slidably disposed within each other, without the addition of linear tracks or railings to facilitate linear motion of the segments, which Surti never discloses in the embodiments of figs. 1 & 2A contrary to the Applicant’s inference. As such, telescoping round tubes as shown in fig. 2A of Surti are inherently rotatable and slidable with respect to the each other.
Moreover, Surti discloses an endoscopic medical stylet 32 that is clearly sized and shaped (see at least fig. 5 thereof) to permit sliding and rotation thereof inside the lumens of the medial and distal segments (16, 64) (see at least fig. 3 thereof).
Applicant further contends that Surti and/or Hardia discloses or suggests any "attachment portion for coupling the endoscopic medical device thereto so that the endoscopic medical device moves and rotates with the proximal segment," as recited in claim 23. The Office respectfully traverses. For example, Hardia clearly discloses in par 0063 thereof, that the endoscopic medical stylet 30 thereof is prevented from rotational and axial movement against the proximal segment 18 thereof, which means that the proximal segment 18 and stylet 30 rotate together, see also figs. 14A-B thereof. The Office submits that it would have been obvious to a skilled artisan to modify the device of Surti such that the stylet thereof also is prevented from rotational and axial movement against the proximal segment 22 thereof.
In view of the foregoing, the rejections over at least Surti and Hardia are maintained.
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 RENE T TOWA whose telephone number is (313)446-6655. The examiner can normally be reached Mon-Fri, 9:00 AM-5:00 PM.
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/RENE T TOWA/ Primary Examiner, Art Unit 3791
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