DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/14/2026 has been entered.
Response to Arguments
Applicant argues in the response filed 04/14/2026 that the amendments would overcome the previous 102 and 103 rejections. The rejections have been withdrawn. The double patenting rejection has also been withdrawn based on the claim amendments.
New claim objections, 112 rejections, 102 and 103 rejections have been made below.
Further limitations with respect to how the needle holder arm is attached to the cap can overcome the prior art of record.
Claim Objections
Claim 18 is objected to because of the following informalities: For clarity and consistency purposes, line 3 should read “…with respect to the endoscope or guide member…”. 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 14, 16, 20 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 limitation "the needle is configured to be releasably inserted into an end of the needle holder arm " in lines 1-2. Claim 14 is dependent off of claim 7 which recites a distal end of the needle holder arm is configured to hold the needle. It is unclear if “the end” of claim 20 is supposed to be the distal end or another distinct end. For examination purposes, the end of the needle holder arm of claim 14 will be interpreted to be the distal end of the needle holder arm.
Claim 16 recites the limitation "the needle holder arm has a first end pivotably coupled with respect to the cap and a second end configured to hold the needle " in lines 2-3. Claim 16 is dependent off of claim 15 which recites proximal and distal ends of the needle holder arm coupled to the cap and adapted to hold the needle respectively. It is unclear if the first and second ends of the needle holder arm are supposed to be the same or different than the proximal and distal ends of the needle holder arm. For examination purposes, the first end of the needle holder arm will be interpreted to be the proximal end and the second end of the needle holder arm is interpreted to be the distal end.
Claim 20 recites the limitation "the needle is configured to be releasably inserted into an end of the needle holder arm " in lines 1-2. Claim 20 is dependent off of claim 15 which recites a distal end of the needle holder arm is adapted to hold the needle. It is unclear if “the end” of claim 20 is supposed to be the distal end or another distinct end. For examination purposes, the end of the needle holder arm of claim 20 will be interpreted to be the distal end of the needle holder arm.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claims 15-18, 20 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by U.S. Patent Publication 2007/0162052 to Hashimoto.
As to claim 15, Hashimoto discloses a treatment device for use with an endoscope or guide member (2) having an instrument channel with an axis and a distal end face (figure 1, paragraph 35), said treatment device comprising: a cap (6) configured to position the treatment deice over the distal end face of the endoscope or guide member and having a wall extending around and surrounding a distal end of the endoscope or guide member (figure 6, the proximal part of 6), a needle (9) having a needle tip (tip of 9); and a needle holder arm (3/8) having a proximal end ( the end of 3 that connects to the cap via the pin, the end can be the proximal end depending on the rotation of the arm and is the end that is more accessible to the user) mounted on the cap (figure 1, paragraph 35, via the pins) and pivotable about an axis which extends axially along the wall of the cap (figure 18) and a distal end adapted to hold said needle (figure 1, 18, 19, the end can that holds the needle 9 can be the needle tip as it is closer to the tissue, based on the rotation of the needle and placement of the device), wherein the needle is pivotable in a first direction toward the distal end face of the endoscope to case the needle to puncture a tissue (figure 1, 18) and in a second direction opposite the first direction (figure 18-19), wherein when the needle is moved in the first direction the needle is moved from a first position (just after the needler holder arm rotates from the position in figure 1) in which the needle tip is positioned over and angled away from the distal end face of the endoscope or guide member, across the distal end face of the endoscope or guide member, and to a second position (figure 18) in which the needle tip is directed at an opening (where 12 is located ) of the instrument channel along the distal end face of the endoscope or guide member and coaxial with the instrument channel axis (figure 18).
As to claim 16, Hashimoto discloses the needle holder arm has a first end (figure 1, 18, 19, where the holder arm rotates with about the pin) pivotably coupled with respect to the cap and a second end (where the needle is attached) configured to hold the needle (figure 1, 18, 19), when the needle is in the second position, the first end of the needle holder arm intersects an axis intersecting the endoscope or guide member (figure 18), and when the needle is moved in the first direction, the second end of the needle holder arm is directed at the opening of the instrument channel so that the needle tip is moved closer to the instrument channel to be transferrable to a device in the instrument channel (figure 1, 18, 19).
As to claim 17, Hashimoto discloses the needle holder arm is curved and coupled with respect to the periphery of the distal end face of the endoscope or guide member to hold the needle tip over the distal end of the endoscope or guide member when the needle holder arm is in an open configuration (figure 1).
As to claim 18, Hashimoto discloses the cap is configured to extend around a periphery of the endoscope or guide member, and said needle holder arm is pivotably coupled with respect to the endoscope at a position laterally away from the endoscope instrument channel and moves the needle tip in the first direction to be closer to the instrument channel (figure 1, 18, 19).
As to claim 20, Hashimoto discloses the needle is configured to be releasably inserted into an end of said needle holder arm (figure 18, 19).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claims 7-14 are rejected under pre-AIA 35 U.S.C. 102 (e) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over U.S. Patent Publication 2007/0162052 to Hashimoto in view of U.S. Patent Publication 2002/0198542 to Yamamoto.
As to claim 7, Hashimoto discloses a treatment device configured for use with an endoscope extending along a longitudinal axis (paragraph 35, figure 1, the device can be used with an endoscope and/or the sheath 2 can read on the endoscope), the endoscope having a distal end face (figure 1) with an imaging device, wherein the distal end face is surrounded by a periphery and defines, radially inwardly of the periphery, a plurality of channels including an instrument channel (figure 1, where 11 extends), the treatment device comprising a needle (9) having a needle tip (tip of needle, as best seen in figure 19); and a rotatable needle holder arm (3/8) having a proximal end pivotable about an axis (the pin that member 3 rotates about, figure 1, 18, 19, the end can be the proximal end depending on the rotation of the arm and is the end that is more accessible to the user) which extends radially along or tangent to the periphery of the distal end face of the endoscope (figure 1), and a distal end configured to hold the needle (figure 1, 18, 19), and mounted with respect to the endoscope to move the needle over the distal end face of the endoscope (figure 18), wherein the rotatable needle holder arm rotates from a first position (just as the needle holder arm begins to rotate from figure 1, where the needle tip won’t be parallel) in which said needle holder arm holds said needle so that said needle tip is not parallel to the longitudinal axis of the endoscope, and a second position (figure 18) in which said needle holder arm holds the needle so that said needle tip is directed at an opening of the instrument channel along the distal end face of the endoscope (figure 18).
It is to be noted that the endoscope with the imaging device and the distal end face is in the preamble and therefore not given patentable weight. Hashimoto does disclose an endoscope like element 2 and/or that the device can be used with an endoscope. The endoscope will have a distal end that can help define the distal end face as seen best in figure 19. The device is capable of having an imaging device since it can be an endoscope. Therefore the treatment device is capable of being used with an endoscope with an imaging device. However, if it would not be known that the device would be able to be used with an endoscope having an distal end face with an imagine device and a plurality of channels, Yamamoto does teach a similar device (suturing device, abstract) where a treatment device is used with an endoscope (16) having a distal end face with an imaging device (10) and a plurality of channels (6, 7) for the purpose of having the device be able to be deployed into a body cavity to suture the desired location while imaging the location (paragraph 57, 58). It would have been obvious to one of ordinary skill in the art before the effective filing date to have the treatment device of Hashimoto be configured for use with an endoscope having a distal end face with an imagine device and a plurality of channels in order to be able to image and suture tissue at a desired location.
As to claim 8, with the device of Hashimoto and Yamamoto above, Hashimoto discloses said needle holder arm is rotatable in a plane which intersects the distal end face of the endoscope (figure 1, 18, 19), in the first position, the needle holder arm holds the needle over and directed away from the distal end face of the endoscope (the first position which is just after an initial rotation from the configuration of figure 1), and the second position (figure 18), the needle holder arm holds the needle so that the needle tip intersects an axis through the instrument channel of the endoscope.
As to claim 9, with the device of Hashimoto and Yamamoto above, Hashimoto discloses the needle holder arm is rotatable in a plane which intersects the instrument channel of the endoscope (figure 1, 18, 19).
As to claim 10, with the device of Hashimoto and Yamamoto above, Hashimoto discloses the needle holder arm holds the needle so that the needle tip is coaxial with the instrument channel of the endoscope when in the second position to be transferred to a device in the instrument channel of the endoscope (figure 18).
As to claim 11, with the device of Hashimoto and Yamamoto above, Hashimoto discloses the needle holder arm is curved (figure 1, 18, 19) and pivotably coupled with respect to the periphery of the distal end face of the endoscope to hold the needle tip over the distal end of the endoscope when the needle holder arm is in an opening configuration (figure 1).
As to claim 12, with the device of Hashimoto and Yamamoto above, Hashimoto discloses said needle holder arm has a first end pivotably coupled to the periphery of the endoscope and a second end, the second end configured to hold the needle and directed at the opening of the instrument channel when the needle holder arm is in the second position (figure 1, 18, 19).
As to claim 13, with the device of Hashimoto and Yamamoto above, Hashimoto discloses a cap (6) positionable over the distal end face of the endoscope to extend around the periphery of the endoscope (figure 1), wherein the proximal end of the needle holder arm is pivotably mounted on said cap (figure 1). The cover 6 does seem to be able to be positioned over and extend around the periphery of an endoscope. Yamamoto does teach/provide evidence of said caps usable with an endoscope (figure 2, 95, 99, 123) .
As to claim 14, with the device of Hashimoto and Yamamoto above, Hashimoto discloses said needle is configured to be releasably inserted into an end of said needle holder arm (paragraph 18, 19).
Allowable Subject Matter
Claim 19 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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