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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed February 6, 2025 is being considered by the examiner.
Election/Restrictions
Claims 3, 6-9, and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 27, 2026.
Applicant asserts that claims 2 and 11-13 are encompassed in the elected species, however the examiner respectfully disagrees. Claim 2 is dependent on claim 1, which recites in lines 14-18 wherein the first articulation member includes a first bend distal to a first distal face defining a distal end of the first channel, and the second articulation member includes a second bend distal to a second distal face defining a distal end of the second channel. This appears to describe a structure similar to that seen in Applicant’s Fig. 4A & 4B, also in Fig. 10A. Claim 2 recites wherein a proximal face of the first distal member abuts the first distal face of the core and wherein a proximal face of the second distal member abuts the second distal face of the core. Without considering the limitation of claim 1, claim 2 appears to describe a structure similar to that seen in Applicant’s Fig. 12A & 12C, also described in paragraph [0101] of specification. However, the elected Species comprising Applicant’s Figs. 10A-10C and Figs. 12A-12D does not includes both a first bend distal to a first distal face and a second bend distal to a second distal face and wherein a proximal face of the first distal member abut the first distal face of the core and a proximal face of the second distal member abuts the second distal face of the core. Therefore, claims 2 and 11-13 are withdrawn.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “969A” has been used to designate both first bend and third bend in Fig. 10B and 10C. It appears that third bend is intended to be labeled as “969C”. Further, reference character “969B” has been used to designate both second bend and fourth bend in Figs. 10B and 10C. It appears that fourth bend is intended to be labeled as “969D”. 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. 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 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 10 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.
In claim 10, line 5 recites “receives a portion of the second articulation member after the first bend”. The Examiner believes it should read “receives a portion of the second articulation member after the second bend” since the first bend only exists along the first articulation wire. For the purpose of examination, the examiner is interpreting “the first bend” in line 5 of claim 10 as “the second bend”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 5, 10, 18-20 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Qvist (US2023/0263375).
Regarding claim 1, Qvist discloses a medical device comprising: a handle (handle 4 [0049]); an insertion portion extending distally from the handle (insertion cord 6 comprising insertion tube 8, bending section 10 and distal tip unit 12 [0049]), wherein a first articulation member and a second articulation member each extend longitudinally from the handle through the insertion portion (steering wire that comprises steering wire portion 58 is analogous to applicant’s first articulation member, steering wire that comprises steering wire portion 60 is analogous to applicant’s second articulation member; steering wire portions 58 and 60 may be two separate steering wires instead of the illustrated intermediate portion 59 in Fig. 6 [0069]), and wherein the insertion portion defines a first lumen (intermediate sections 26 of the bending section 22 comprises channel lumen 34 [0059]); and a distal tip at a distal end of the insertion portion (distal tip unit 12 at distal end of insertion cord 6 [0049]), wherein the distal tip includes: a light source (camera or light emitting diodes provided in the distal tip unit 12 [0065]); an imaging device (camera or light emitting diodes provided in the distal tip unit 12 [0065]); and a core including a first channel that receives a distal portion of the first articulation member (distal end segment 28 comprises steering wire lumen 36 receives a distal end of the steering wire comprising steering wire portion 58 [0059, 0069]), a second channel that receives a distal portion of the second articulation member (steering wire lumen 38 receives a distal portion of the steering wire comprising steering wire portion 60 [0059, 0069]), and a second lumen between the first channel and the second channel (Figs. 2 & 6: channel lumen 34 extends through the distal end segment 28), the second lumen being in communication with the first lumen of the insertion portion (Figs. 2 & 6: channel lumen 34 extends through the entire bending section 22 including the intermediate segments 26 and the distal end segment 28); wherein each of the first articulation member and the second articulation member terminates proximal to a distalmost end of the core (Fig. 6: wires comprising portions 58 and 60 may be separate, each having proximal ends and distal ends that are not connected to each other, removing intermediate portion 59 [0069], in such a situation, the distal ends of the wires terminate into the wall portion, proximal of the distal end of the distal end segment 28); and wherein the first articulation member includes a first bend distal to a first distal face defining a distal end of the first channel (Annotated Fig. 6: first bend is distal to a first distal face, which is defined by a distal end of the steering wire lumen 36 [0069], first distal face is more clearly illustrated in Fig. 3 in which the steering wires are not shown, providing an illustration of the distal faces on which the steering wires are looped back into the wall portion or into the page), and the second articulation member includes a second bend distal to a second distal face defining a distal end of the second channel (Annotated Fig. 6: second bend is distal to a second distal face, which is defined by a distal end of the steering wire lumen 38 [0069], second distal face is more clearly illustrated in Fig. 3 in which the steering wires are not shown, providing an illustration of the distal faces on which the steering wires are looped back into the wall portion or into the page).
PNG
media_image1.png
472
568
media_image1.png
Greyscale
Regarding claim 4, Qvist discloses the medical device of claim 1, wherein each of the first bend and the second bend is approximately 90 degrees to approximately 180 degrees (first and second bends appear to be approximately 90 degrees).
Regarding claim 5, Qvist discloses the medical device of claim 1, wherein the first bend is in a first direction, and the second bend is in a second direction, opposite the first direction (Annotated Fig. 6 above: second bend occurs in a second direction, into the page, which is a different and opposite to the first direction of the first bend, which is coming out of the page).
Regarding claim 10, Qvist discloses the medical device of claim 1, wherein the core further includes: a third channel adjacent to the first channel, wherein the third channel receives a portion of the first articulation member after the first bend; and a fourth channel adjacent to the second channel, wherein the fourth channel receives a portion of the second articulation member after the second bend (Annotated Fig. 3 & 6: third channel is adjacent to steering wire lumen 36 and fourth channel is adjacent to steering wire lumen 38, the third channel and the fourth channel receiving a portion of the separate steering wires after the first and second bends, see Annotated Fig. 6 attached to claim 1 [0069]).
PNG
media_image2.png
464
494
media_image2.png
Greyscale
Regarding claim 18, Qvist discloses a medical device comprising: a handle (handle 4 [0049]); an insertion portion extending distally from the handle to a distal tip and defining a first lumen (insertion cord comprising insertion tube 8, bending section 10 and distal tip unit 12 [0049]; Figs. 2 & 6: channel lumen 34 extends through the bending section 22), wherein a first articulation member and a second articulation member each extend from the handle through the insertion portion (steering wire that comprises steering wire portion 58 is analogous to applicant’s first articulation member, steering wire that comprises steering wire portion 60 is analogous to applicant’s second articulation member; steering wire portions 58 and 60 may be two separate steering wires instead of the illustrated intermediate portion 59 in Fig. 6 [0069]), wherein the distal tip includes: a light source (camera or light emitting diodes provided in the distal tip unit 12 [0065]); an imaging device (camera or light emitting diodes provided in the distal tip unit 12 [0065]); and a core including a first channel that receives a distal portion of the first articulation member (steering wire lumen 36 receives a distal end of the steering wire comprising steering wire portion 58 [0059, 0069]) and a second channel that receives a distal portion of the second articulation member (steering wire lumen 38 receives a distal portion of the steering wire comprising steering wire portion 60 [0059, 0069]), wherein the first channel defines a first distal face and the second channel defines a second distal face (first distal face and second distal face are more clearly illustrated in Fig. 3 in which the steering wires are not shown, providing an illustration of the distal faces on which the steering wires are looped back into the wall portion or into the page); wherein each of the light source and the imaging device is distal to the distal portion of each of the first articulation member and the second articulation member (although the light emitting diodes and camera [0065] do not appear to be illustrated in the drawings, it is highly suggested that the light emitting diodes and camera would be distal of the steering wires, as electrical wire lumen 40 accommodating the electrical wires and cables for the camera and light emitting diodes passes through the bending section portion 22 illustrated in Figs. 3 and 6); and wherein the first articulation member includes a first bend distal to the first distal face and the second articulation member includes a second bend distal to the second distal face (Annotated Fig. 6: first bend is distal to a first distal face, which is defined by a distal end of the steering wire lumen 36 [0069]; second bend is distal to a second distal face, which is defined by a distal end of the steering wire lumen 38 [0069]).
PNG
media_image3.png
472
568
media_image3.png
Greyscale
Regarding claim 19, Qvist discloses the medical device of claim 18, further disclosing wherein each of the first bend and the second bend is approximately 90 degrees to approximately 180 degrees (first and second bends appear to be approximately 90 degrees).
Regarding claim 20, Qvist discloses the medical device of claim 18, further disclosing wherein the core further includes: a third channel adjacent to the first channel, wherein the third channel receives a portion of the first articulation member after the first bend; and a fourth channel adjacent to the second channel, wherein the fourth channel receives a portion of the second articulation member after the first bend (Annotated Fig. 3 & 6: third channel is adjacent to steering wire lumen 36 and fourth channel is adjacent to steering wire lumen 38, the third channel and the fourth channel receiving a portion of the separate steering wires after the first and second bends, see Annotated Fig. 6 attached to claim 18 [0069]).
PNG
media_image2.png
464
494
media_image2.png
Greyscale
Claims 15 and 16 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable by Sato (US2023/0016068).
Regarding claim 15, Sato discloses a medical device comprising: a distal tip (distal end portion 10 and bending section 11) that includes: a light source (illumination unit 202 [0247]); an imaging device (image pickup unit 201 [0247]); a first articulation member, wherein a distal end of the first articulation member is fixed to a first ferrule (top wire 30 illustrated in Fig. 30, with a distal end of the top wire 30 attached to a first top sleeve 102); a second articulation member, wherein a distal end of the second articulation member is fixed to a second ferrule (bottom wire 30 illustrated in Fig. 30, with a distal end of the bottom wire 30 attached to a second bottom sleeve 102); and a core defining a lumen extending along a longitudinal axis of the core (Fig. 30: end bending piece 101A comprises a center lumen extending along a longitudinal axis of the piece 101A), a first channel configured to receive a first articulation member (Annotated Fig. 30: first channel receives the top wire 30), and a second channel configured to receive a second articulation member (Annotated Fig. 30: second channel receiver the bottom wire 30), wherein: the first channel is parallel to the lumen and at least one of a first distal face or a first proximal face defined by the first channel is transverse to the lumen (Annotated Fig. 30: the first channel is parallel to the center lumen; first distal face is transverse the center lumen, first proximal face, opposing side of the first distal face, is also transverse the center lumen); and the second channel is parallel to the lumen and at least one of a second distal face or a second proximal face defined by the second channel is transverse to the lumen (Annotated Fig. 30: the second channel is parallel to the center lumen; second distal face is transverse the center lumen, second proximal face, opposing side of the second distal face, is also transverse the center lumen).
PNG
media_image4.png
602
742
media_image4.png
Greyscale
Regarding claim 16, Sato discloses the medical device of claim 15, further disclosing wherein a proximal end of the first ferrule abuts the first distal face and a proximal end of the second ferrule abuts the second distal face (Annotated Fig. 30: proximal end of first top sleeve 102 abuts the first distal face, proximal end of the second bottom sleeve 102 abuts the second distal face).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Sato in view of Potter (US2009/0163917).
Regarding claim 17, Sato discloses the medical device of claim 15, further comprising: a handle (Fig. 1: operation section 3 [0076]); and an insertion portion extending distally from the handle (Fig. 1: insertion section 2 extends from operating section 3 [0076]); wherein each of the first articulation member and the second articulation member extends from the handle through the insertion portion to the distal tip (wires towed from the operation section [0009]; proximal end of wires 30 extend to pulley and turned by the bending lever 15, at the operation section 3 [0115]), but fails to disclose wherein the first articulation member includes a first bend distal to the first distal face, and the second articulation member includes a second bend distal to the second distal face. In the same field of endeavor, Potter teaches a substantially similar medical device comprising: a distal tip (Fig. 1: distal tip 30 [0017]) that includes: a first articulation member (pull wire 73); a second articulation member (pull wire 74); and a core defining a first channel configured to receive a first articulation member (Fig. 4: axial guide channel 65 through which wire 73 passes through distal portion 63), and a second channel configured to receive a second articulation member (Fig. 4: axial guide channel 66 through which wire 74 passes through distal portion 63), wherein: the first channel is parallel to a longitudinal axis and at least one of a first distal face or a first proximal face defined by the first channel is transverse to the longitudinal axis (Annotated Fig. 4: first distal face and first proximal face, appearing to be the distal and proximal face of flange 64 defines the first channel which is transverse the longitudinal axis); and the second channel is parallel to the longitudinal axis and at least one of a second distal or a second proximal face defined by the second channel is transverse to the longitudinal axis (Annotated Fig. 4: second distal face and second proximal face defines the first channel which is transverse the longitudinal axis).
Potter further teaches the medical device comprising a handle (Fig. 1: handle actuator 120 [0017]); and an insertion portion extending distally from the handle (Fig. 1: catheter 20 extends from handle actuator 120 [0017]); wherein each of the first articulation member and the second articulation member extends from the handle through the insertion portion to the distal tip (Fig. 4: pull wires extend from the pull ring, loop back through the guide channels 65, 69 and 66, 70 to the handle actuator [0021]), and wherein the first articulation member includes a first bend distal to the first distal face, and the second articulation member includes a second bend distal to the second distal face (Fig. 4: a first bend occurs in the pull wire 73 distal to the first distal face, a second bend occurs in the pull wire 74 distal to the second distal face).
In view of Potter, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the first bend and the second bend distal to the first distal face and the second distal face, respectively, as taught by Potter, to the medical device of Sato, as the bends provides a pull ring interlock that additionally helps anchors the pull wires, relieving some of the forces applied to the primary anchoring mechanism for effective articulation of the steerable catheter [0009].
PNG
media_image5.png
412
550
media_image5.png
Greyscale
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See referenced cited in PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI-TING SONG whose telephone number is (571)272-5771. The examiner can normally be reached 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LI-TING SONG/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
09/05/26
Prosecution Insights