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 .
Election/Restrictions
Applicant's election with traverse of Group I (Claims 1, 3-5, and 11-13) in the reply filed on 09/22/2025 is acknowledged. The traversal is on the grounds that the prior art reference Ben Arie (US20210113197) fails to teach or suggest each and every feature recited by claims 1 and 6. This is not found persuasive because the prior art (Ben Arie) does not need to teach each and every feature found in claims 1 and 6 to prove lack of unity of invention but rather only features shared between claims 1 and 6. Because Ben Arie teaches each and every feature found in at least claim 1 (as evidenced below under 35 USC §102), Ben Arie therefore teaches any features shared between claims 1 and 6. Moreover, Applicant fails to explicitly point out which specific feature(s) is/are not taught or suggested by Ben Arie.
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application is a 371 of PCT/US2022/072408 filed 05/18/2022 which claims benefit from provisional application 63/189,933 filed 05/18/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted was filed on 11/18/2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character not mentioned in the description: reference number 11 in figure 10. In addition, reference number 20 in figure 22 should be corrected to reference number 2220 to correctly indicate the corresponding component as the inner tube 2220. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
Specification
The disclosure is objected to because of the following informalities:
In ¶ [0064] of the Specification filed 11/18/2023, method step 2608 does not match the corresponding reference number 2608 in figure 26 (2608 in the specification should be corrected to 2610).
Method step 2608 in figure 26 is missing from ¶ [0064]
In ¶ [0064], “to a the proximal lumen port” should be corrected to:
“to the proximal lumen port”
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities:
“EUS endoscope” should be corrected to:
“endoscopic ultrasound system (EUS) endoscope”
3 instances of “said ultrasound endoscope assembly” corrected to:
“said ultrasound endoscope needle assembly”
Claims 3-5 are objected to because of the following informalities:
“The endoscope assembly of claim…” should be corrected to:
“The gastroscope conversion assembly of claim…”
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.
Claims 1 and 3-5 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 1 recites the limitation “said first needle”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, it will be interpreted for “said first needle” to refer to the recited lengthwise needle. Furthermore, the term “first” seems to imply there may be a second needle, third needle, and so on. It is unclear whether the invention further includes more needles than just a first needle.
Claim 4 recites “on said distal end” and “at said proximal end”. It is unclear which distal and proximal ends are being referred to respectively. The gastroscope, tubular extension, and needle are all positively recited to have a distal end. Moreover, both the gastroscope and tubular extension are recited to have a proximal end. For purposes of examination, it will be interpreted for “on said distal end” to mean “on the distal end of the tubular extension” and for “at said proximal end” to mean “at the proximal end of the tubular extension”.
Claims 3 and 5 are rejected by virtue of dependency on rejected claim 1.
Claim Rejections - 35 USC § 102
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.
Claims 1, 4-5, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben Arie (US20210113197).
Regarding claim 1, Ben Arie teaches a gastroscope conversion assembly (10) (Fig. 1, [0039], [0042], “For example, tool 12 and device 10 may be advanced into the gastrointestinal tract and used to obtain a sample of a tissue of the gastrointestinal tract, or tissue proximal to the gastrointestinal tract”, figure 1 shows wherein endoscope 12 comprises a gastroscope for examining the gastrointestinal tract, [0043], [0046], [0048], device 10 comprising an adapter 17 configured for use with endoscope 12 of varying lengths by adjusting the length of a sheath 16 of the device 10 housing multiple needles comprises a gastroscope conversion assembly, converting the gastroscope 12 into a device for performing endoscopic ultrasound fine-needle aspiration [EUS-FNA]), comprising:
a) a gastroscope (12), having a proximal and a distal end, and defining a lumen, and having a proximal lumen port (Luer-lock), configured to permit entry of a lengthwise needle into said lumen, wherein said first needle comprises a first length (Fig. 1, [0039], “FIG. 1 is a view of device 10 being used with a guiding tool 12, such as an endoscope, e.g., an ultrasonic endoscope”, [0042], “For example, tool 12 and device 10 may be advanced into the gastrointestinal tract and used to obtain a sample of a tissue of the gastrointestinal tract, or tissue proximal to the gastrointestinal tract”, [0043], “Sheath 16 may be arranged to house multiple inner needles”, [0048], “Typically, a distal end of adapter 17 (shown by example to be generally cone shaped) may be arranged to fit the Luer-lock of the endoscope while sheath 16 extends through the lumen of the endoscope towards the target tissue within the body of the patient”); and
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b) a tubular extension (11), having a proximal and distal end (17), and having said distal end (17) affixed to said proximal lumen port (Luer-lock) (Fig. 3A, [0046], “In some embodiments, device 10 comprises an adapter 17 disposed at a distal portion of shaft 11”, [0048], “Typically, a distal end of adapter 17 (shown by example to be generally cone shaped) may be arranged to fit the Luer-lock of the endoscope”),
c) an ultrasound endoscope needle assembly (14; 21, 22) attached to proximal end of said tubular extension (11) (Fig. 3A, [0042], “”For example, guiding tool 12 may be a steerable ultrasonic endoscope”, [0045], “Reference is now made FIGS. 3A-B, which are a closer view of needle-control housing 14 coupled to the proximal portion of sheath 16”, [0050], “Control slide member 21 is attached to a first elongate needle 32a”) and having:
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i. a proximal handle (14; 21, 22) (Figs. 7A-7B, [0058], “For example, in the illustrated example, it is envisioned that a physician may manipulate device 10 at needle control housing 14 using a single hand”); and
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ii. a needle (32a) having a distal end, extending distally out of said handle (14; 21, 22) (Figs. 2, 4-6, & 8A-8D, [0050], “Control slide member 21 is attached to a first elongate needle 32a, such that sliding of slide member 21 with respect to housing 14 (along axis X) slides needle 32a through sheath 16, such that a distal tip of the needle moves with respect to opening 30a (e.g., the tip moves through the opening, such as out of the opening)”, [0053], “Distal advancement of slide member 21 causes central main needle 32a to extend beyond tip 77 of sheath 16”); and
d) wherein said needle (32a) of said ultrasound endoscope assembly (14; 21, 22) comprises a diameter compatible with-said lumen defined by said gastroscope (12) ([0042], “For example, guiding tool 12 may be a steerable ultrasonic endoscope, and sheath 16 may be advanceable through a working channel of the endoscope”, [0053], “central main needle 32a to extend beyond tip 77 of sheath 16”, [0065], “These are fine hollow needle with a sharpened piercing tip (e.g., 19 gauge or smaller, and typically 22-25 gauge)”, wherein the sheath 16 being positioned within the gastroscope 12 and housing needle 32a comprises the diameter of the needle 32a being compatible with the lumen of the gastroscope 12) and
a length incompatible with said lumen defined by said gastroscope (12) ([0046], “Adapter 17 is used to configure device 10 for use with guide tools 12 (e.g. endoscopes) of varying lengths by adjusting an effective length of sheath 16”, [0052], “e.g., subsequently to adapting device 10 to different endoscope lengths”, wherein using an adapter 17 to adjust the length of the sheath 16 containing needle 32a for different endoscopes [i.e. gastroscope] comprises the needle having a length incompatible with said lumen of the gastroscope), and
wherein said tubular extension (11) can be adjusted to render said length of said needle (32a) of said ultrasound endoscope assembly (14; 21, 22) compatible with lumen of said gastroscope (12) (Figs. 3A & 4, [0047], “Adapter 17 is configured to slide axially with respect to shaft 11 in the distal or proximal directions over sheath 16 (i.e. while the sheath remains substantially fixed in place) and by that shorten or lengthen, respectively, the length that sheath 16 extends away from the from adapter 17”, [0052], “In some embodiments, (e.g., subsequently to adapting device 10 to different endoscope lengths), stopper 18 is used to stop the movement of slide members 21 and 22 and hence the needles may be maneuvered along shaft 11 to define a distal extent that the first and second slide members 21, 22 (and their respective needles 32a and 32b) may extend distally beyond the distal tip 77 of sheath 16”),
by enabling said needle (32a) of said ultrasound endoscope assembly (14; 21, 22) to be positioned so that said distal end is within said lumen but can be extended out of said lumen by manipulation of said handle (14; 21, 22), thereby structurally converting said gastroscope (12) for use as an EUS endoscope (Figs. 4-5, [0038], “independent control over the two needle groups (central and outer) is achieved through a single handle”, [0039], “Device 10 is used for obtaining one or more tissue samples (e.g., biopsy samples) in a fine-needle aspiration biopsy (FNAB) procedure, and is typically advanced through a guiding tool 12 (such as an ultrasonic endoscope) in an FNA procedure such as an EUS-FNA procedure”, [0052], “In FIG. 4, slide members 21, 22 have yet to be advanced distally and thus no needles extend beyond tip 77”, [0053], “Distal advancement of slide member 21 causes central main needle 32a to extend beyond tip 77 of sheath 16”, [0042], “For example, guiding tool 12 may be a steerable ultrasonic endoscope, and sheath 16 may be advanceable through a working channel of the endoscope. For example, tool 12 and device 10 may be advanced into the gastrointestinal tract and used to obtain a sample of a tissue of the gastrointestinal tract, or tissue proximal to the gastrointestinal tract”).
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Regarding claim 4, Ben Arie teaches the invention as claimed above in claim 1.
Ben Arie further teaches wherein said tubular extension (11) has a receptive endoscope proximal lumen port connector (17) on said distal end, and an insertive endoscope proximal lumen port connector (P2) at said proximal end (Figs. 5 & 7A, [0056], wherein figure 5 shows port P2 for insertion/connection of a syringe and therefore port P2 comprises an insertive endoscope proximal lumen port connector, [0046], “In some embodiments, device 10 comprises an adapter 17 disposed at a distal portion of shaft 11. Adapter 17 is used to configure device 10 for use with guide tools 12”, and wherein figure 7A shows the adapter 17 for reception/connection of endoscope 12 and therefore adapter 17 comprises a reception endoscope proximal lumen port connector, and wherein the entire device 10 is configured to be connected to endoscope 12).
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Regarding claim 5, Ben Arie teaches the invention as claimed above in claim 1.
Ben Arie further teaches the invention further including a first adapter (17) positioned between said distal end of said tubular extension (11) and said proximal lumen port (Luer-lock) (Figs. 1 & 7A, [0048], “Typically, a distal end of adapter 17 (shown by example to be generally cone shaped) may be arranged to fit the Luer-lock of the endoscope”).
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Regarding claim 11, Ben Arie teaches a tubular extension (11) for a make of gastroscope (12), having a proximal and distal end, and wherein said distal end has a receptive connector (17) for an endoscope proximal lumen port insertive connector (17) for said make of gastroscope (12) and wherein said proximal end has an endoscope proximal lumen port insertive connector (P2) (Figs. 1, 3A, 5, & 7A, [0042], “For example, tool 12 and device 10 may be advanced into the gastrointestinal tract”, [0045], “In FIG. 3A, housing 14 is shown comprising a main shaft 11”, [0056], wherein figure 5 shows port P2 for insertion/connection of a syringe and therefore port P2 comprises an insertive endoscope proximal lumen port connector, [0046], “In some embodiments, device 10 comprises an adapter 17 disposed at a distal portion of shaft 11. Adapter 17 is used to configure device 10 for use with guide tools 12”, and wherein figure 7A shows the adapter 17 for reception/connection of endoscope 12 and therefore adapter 17 comprises a reception endoscope proximal lumen port connector, and wherein the entire device 10 is configured to be connected to endoscope 12).
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Regarding claim 13, Ben Arie teaches the invention as claimed above in claim 11.
Ben Arie teaches the invention further including an adapter (17) at its distal end, thereby forming said receptive connector (17) for said endoscope proximal lumen port insertive connector (P2) for said make of gastroscope (12), by being fit onto a connector (Luer-lock) that would not mate with said endoscope proximal lumen port insertive connector (P2) ([0046], [0048], “In some embodiments, device 10 is lockable to endoscope 12, e.g., via a Luer-type lock fitting that mates with a counterpart fitting on the endoscope. Typically, this fitting is coupled to (or defined by) offset adapter 17. Typically, a distal end of adapter 17 (shown by example to be generally cone shaped) may be arranged to fit the Luer-lock of the endoscope”, [0056], “A second port P2 for communicating between a syringe and the secondary needles 32”, wherein port P2 being configured for insertion/connection of a syringe and being a female-type connector would not mate with a similarly female-type Luer-lock connector of an endoscope 12 as shown in figures 5 and 7a below).
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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.
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.
Claims 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Ben Arie (US20210113197) in view of Folan (US20190313887).
Regarding claim 3, Ben Arie teaches the invention as claimed above in claim 1.
However, Ben Arie fails to teach wherein said tubular extension is comprised of two tubes in telescoping arrangement, thereby permitting said tubular extension to be length adjusted.
In an analogous device for extending a working channel of an endoscope field of endeavor, Folan teaches such a feature. Folan teaches an extension device (200, 300) for an endoscope (230) (Figs. 2-3, [0029], [0031]). Folan teaches the extension device (200, 300) comprising a tubular extension has a tubular inner member (202, 302) and a tubular outer member (204, 304), each including a lumen (Figs. 2-3, [0029], [0031]). Folan teaches the outer member (204, 304) and inner member (202, 302) are slidable relative to each other in a telescoping fashion for adjusting a length of the extension device (200, 300) (Figs. 2-3, [0029], [0031]). Folan therefore teaches wherein a tubular extension (200, 300) is comprised of two tubes (202, 204 or 302, 304) in telescoping arrangement permitting the tubular extension to be length adjusted.
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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 invention of Ben Arie to have the tubular extension comprise telescoping tubes as taught by Folan (Figs. 2-3, [0029], [0031]). The telescoping tubes may allow for an additional and/or easier way to adjust the length of a medical device such that the length of the medical device attached to an endoscope may become compatible with the length of the endoscope as recognized by Folan ([0003-0004], [0029], [0031]).
Regarding claim 12, Ben Arie teaches the invention as claimed above in claim 11.
However, Ben Arie fails to teach wherein said tubular extension is comprised of two tubes in telescoping arrangement, thereby permitting said tubular extension to be length adjusted.
In an analogous device for extending a working channel of an endoscope field of endeavor, Folan teaches such a feature. Folan teaches an extension device (200, 300) for an endoscope (230) (Figs. 2-3, [0029], [0031]). Folan teaches the extension device (200, 300) comprising a tubular extension has a tubular inner member (202, 302) and a tubular outer member (204, 304), each including a lumen (Figs. 2-3, [0029], [0031]). Folan teaches the outer member (204, 304) and inner member (202, 302) are slidable relative to each other in a telescoping fashion for adjusting a length of the extension device (200, 300) (Figs. 2-3, [0029], [0031]). Folan therefore teaches wherein a tubular extension (200, 300) is comprised of two tubes (202, 204 or 302, 304) in telescoping arrangement permitting the tubular extension to be length adjusted.
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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 invention of Ben Arie to have the tubular extension comprise telescoping tubes as taught by Folan (Figs. 2-3, [0029], [0031]). The telescoping tubes may allow for an additional and/or easier way to adjust the length of a medical device such that the length of the medical device attached to an endoscope may become compatible with the length of the endoscope as recognized by Folan ([0003-0004], [0029], [0031]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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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.
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/TOMMY T LY/ Examiner, Art Unit 3797
/ANH TUAN T NGUYEN/ Supervisory Patent Examiner, Art Unit 3795
10/15/2025