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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 06/25/2026. Claims 1, 4, 6, 8, 21, 24 and 28 are amended. Claims 9-20 are cancelled.
The objection of claims 6 and 28 has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/25/2026, with respect to the rejection(s) of claim(s) 1-8, 21-26 and 28-32 under 35 U.S.C. 102(a)(1) as being anticipated by Yamamoto; and claim 27 under 35 U.S.C. 103 as being unpatentable over Yamamoto, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendment to the claims.
Applicant argues Yamamoto does not disclose the tip cover 80 configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope, because tip cover 80 extends distally beyond the distal end of the endoscope and is not at all associated with the endoscope (Remarks, pg. 7).
In response to applicant’s first argument, it is respectfully submitted the arguments are narrower than the claim limitations. As discussed below, Yamamoto discloses a plate member 221 protruding from tip cover 80 and abutting the distal end surface of endoscope 4 (see fig. 7), such that at least the plate member 221 is considered to extend at least partially around the periphery of the distal end of the endoscope as claimed. Further, the endoscope is not positively recited in the body of the claim. Since the endoscope is only functionally recited in the preamble (see “for use with an endoscope”), further structure directed to the endoscope within the body of the claim is not required by the claim language.
Applicant further argues Yamamoto’s receiving portion 60 does not define throughbores therethrough (Remarks, pg. 7).
In response to applicant’s second argument, it is respectfully submitted receiving portion 60 is not relied upon to teach the first and second throughbores as claimed, therefore applicant’s argument is moot.
Applicant’s argument with respect to the double patenting rejection has been fully considered, and the double patenting rejection has been modified, necessitated by applicant’s amendment, as discussed below.
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.
Claim(s) 1-8, 21-26 and 28-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamamoto (US 2007/0167978 A1) (all references previously of record).
Regarding claim 1, Yamamoto discloses (see abstract; paras. [0044]-[0111]; figs. 1-30) an endoscopic treatment system (fig. 1) for use with an endoscope (4, para. [0044]) having a proximal end and a distal end and a longitudinal axis extending therebetween (fig. 1), the endoscopic treatment system comprising:
a distal cap assembly (tip cover 80 and bridge portion 85, para. [0063]; fig. 6) configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope (see plate member 221 which protrudes from tip cover 80 and abuts the distal end of endoscope 4, such that plate member 221 is considered to extend at least partially circumferentially around the distal end of endoscope 4, para. [0085]; figs. 7-8) and having an end effector (forceps member 115 and needle 120, para. [0068]) rotatable on an axis between open and closed positions (paras. [0070] and [0072]; figs. 16-17), the end effector having a free end (distal end of 120);
a proximal handle assembly (operating portion 13, para. [0045]; fig. 2); and
a first lumen (includes lumen formed by 21 and 41 which 18 extends through, para. [0056]; fig. 9) and a second lumen (includes lumen formed by 22, 42 and 71 which 15 extends through; fig. 17) extending from the distal cap assembly to the proximal handle assembly (figs. 3 and 17) for receiving instruments therethrough (receives operating wires, para. [0048]);
wherein:
the first lumen is in alignment with the free end of the end effector when the end effector is in the closed position (fig. 9); and
the second lumen is positioned between the first lumen and the axis on which the end effector rotates (115 and 120 rotate around pin 116, second lumen depicted as between lumen of 21 and axis of rotation of 116, figs. 9-10).
Regarding claim 2, Yamamoto discloses the endoscopic treatment system according to claim 1. Yamamoto further discloses further comprising a needle assembly having a needle (121, para. [0068]), wherein the needle is removably coupled to the end effector (detachable, para. [0068]).
Regarding claim 3, Yamamoto discloses the endoscopic treatment system according to claim 2. Yamamoto further discloses wherein when the end effector is in the closed position, the needle is oriented parallel to the longitudinal axis of the endoscope (depicted in figs. 1, 6-7 and 9).
Regarding claim 4, Yamamoto discloses the endoscopic treatment system according to claim 1. Yamamoto further discloses wherein the distal cap assembly includes a mount (116) supporting the end effector (para. [0068]) and defining a first throughbore (throughbore of 86) and a second throughbore (throughbore of 81), and the first and second lumen extend respectively into the first and second throughbores (lumens extend into 86 and 81, depicted in fig. 16).
Regarding claim 5, Yamamoto discloses the endoscopic treatment system according to claim 1. Yamamoto further discloses wherein the first lumen and the second lumen are defined by discrete catheters (depicted in figs. 1, 3 and 9).
Regarding claim 6, Yamamoto discloses the endoscopic treatment system according to claim 5. Yamamoto further discloses further comprising a common sheath (overtube 6) covering at least a portion of both of the discrete catheters (fig. 1).
Regarding claim 7, Yamamoto discloses the endoscopic treatment system according to claim 1. Yamamoto further discloses wherein the first lumen and the second lumen are defined by a common catheter (41 and 42 both defined as coil sheaths, considered to be defined by a common catheter in that 41 and 42 are defined by the same materials, note the claim language does not require the first and second lumens to be located within the same (e.g. single) catheter, and broadest reasonable interpretation encompasses a commonality shared among the lumens defined by a catheter, para. [0056]).
Regarding claim 8, Yamamoto discloses the endoscopic treatment system according to claim 1. Yamamoto further discloses wherein the distal cap assembly comprises a peripheral engagement structure (C-shaped base 61, para. [0059]; fig. 8) configured to extend around the periphery of the distal end of the endoscope (figs. 7-8).
Regarding claim 21, Yamamoto discloses (see abstract; paras. [0044]-[0111]; figs. 1-30) an endoscopic treatment system (fig. 1) for use with an endoscope (4, para. [0044]) having a proximal end and a distal end and a longitudinal axis extending therebetween (fig. 1), the endoscopic treatment system comprising:
a distal cap assembly (tip cover 80 and bridge portion 85, para. [0063]; fig. 6) configured to be mounted around at least a portion of the periphery of the distal end of the endoscope (considered to be mounted around a periphery of the distal end of endoscope 4 via plate member 221, which protrudes from tip cover 80 and abuts the distal end of endoscope 4, para. [0085]; figs. 7-8);
an end effector (forceps member 115 and needle 120, para. [0068]) having a distal free end (distal end of 120);
a first throughbore (throughbore of 86) defined in the distal cap assembly (para. [0063]); and
a second throughbore (throughbore of 81) defined in the distal cap assembly adjacent the first throughbore (figs. 6-7 and 9);
wherein the end effector is movable to move the distal end of the end effector into alignment with the first throughbore (fig. 9-10).
Regarding claim 22, Yamamoto discloses the endoscopic treatment system according to claim 21. Yamamoto further discloses further comprising a needle assembly having a needle (121, para. [0068]), wherein the needle is removably coupled to the end effector (detachable, para. [0068]).
Regarding claim 23, Yamamoto discloses the endoscopic treatment system according to claim 22. Yamamoto further discloses wherein when the end effector is in the closed position, the needle is oriented parallel to the longitudinal axis of the endoscope (depicted in figs. 1, 6-7 and 9).
Regarding claim 24, Yamamoto discloses the endoscopic treatment system according to claim 21. Yamamoto further discloses wherein the distal cap assembly comprises a cap clip (C-shaped base 61, para. [0059]; fig. 8) configured to extend around the periphery of the distal end of the endoscope (figs. 7-8).
Regarding claim 25, Yamamoto discloses the endoscopic treatment system according to claim 21. Yamamoto further discloses further comprising a peripheral engagement structure (C-shaped base 61, para. [0059]; fig. 8) comprising a recess (recess of base 61, fig. 8) and an arm (arm of base 61) movable to receive the distal end of the endoscope within the recess (figs. 7-8).
Regarding claim 26, Yamamoto discloses the endoscopic treatment system according to claim 21. Yamamoto further discloses wherein the first throughbore and the second throughbore are parallel to each other (depicted in fig. 16).
Regarding claim 28, Yamamoto discloses (see abstract; paras. [0044]-[0111]; figs. 1-30) an endoscopic treatment system (fig. 1) for use with an endoscope (4, para. [0044]) having a proximal end and a distal end and a longitudinal axis extending therebetween (fig. 1), the endoscopic treatment system comprising:
a distal cap assembly (tip cover 80 and bridge portion 85, para. [0063]; fig. 6) configured to be mounted around at least a portion of the periphery of the distal end of the endoscope (considered to be mounted around a periphery of the distal end of endoscope 4 via plate member 221, which protrudes from tip cover 80 and abuts the distal end of endoscope 4, para. [0085]; figs. 7-8);
an end effector (forceps member 115 and needle 120, para. [0068]) having a first end coupled to the distal cap assembly (via 115 and 116, para. [0068]; fig. 9), and a second free end (distal end of 120); and
a first lumen (includes lumen formed by 21 and 41 which 18 extends through, para. [0056]; fig. 9) and a second lumen (includes lumen formed by 22, 42 and 71 which 15 extends through; fig. 17) extending proximally from the distal cap assembly (figs. 3 and 17);
wherein:
the end effector is movable to move the second free end of the end effector into and out of alignment with the first lumen (figs. 9-10); and
the second lumen is positioned between the first lumen and the first end of the end effector (depicted in figs. 9-10).
Regarding claim 29, Yamamoto discloses the endoscopic treatment system according to claim 28. Yamamoto further discloses wherein the first lumen and the second lumen are defined by discrete catheters (depicted in figs. 1, 3 and 9).
Regarding claim 30, Yamamoto discloses the endoscopic treatment system according to claim 28. Yamamoto further discloses wherein the first lumen and the second lumen are defined by a common catheter (41 and 42 both defined as coil sheaths, considered to be defined by a common catheter in that 41 and 42 are defined by the same materials, note the claim language does not require the first and second lumens to be located within the same (e.g. single) catheter, and broadest reasonable interpretation encompasses a commonality shared among the lumens defined by a catheter, para. [0056]).
Regarding claim 31, Yamamoto discloses the endoscopic treatment system according to claim 28. Yamamoto further discloses wherein the distal cap assembly includes a mount (116) supporting the end effector (para. [0068]) and defining a first throughbore (throughbore of 86) and a second throughbore (throughbore of 81), the first and second lumens extending respectively into the first and second throughbores (lumens extend into 86 and 81, depicted in fig. 16).
Regarding claim 32, Yamamoto discloses the endoscopic treatment system according to claim 28. Yamamoto further discloses further comprising a peripheral engagement structure (C-shaped base 61, para. [0059]; fig. 8) configured to extend around the periphery of the distal end of the endoscope (figs. 7-8).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 27 is rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto.
Regarding claim 27, Yamamoto discloses the endoscopic treatment system according to claim 21.
However, Yamamoto fails to disclose wherein the first throughbore and the second throughbore are obliquely oriented relative to each other.
There is no evidence of record that establishes that changing the orientation of the throughbores to be obliquely oriented relative to each other would result in a difference in function of the device of Yamamoto (claims 8-9 and para. [0039] of the published application, describing the first and second throughbores parallel or obliquely angled relative to each other, which recites alternative orientations of the throughbores and is therefore not critical). Further, a person having ordinary skill in the art, being faced with modifying the device of Yamamoto, would have a reasonable expectation of success in making such a modification, and it appears the device would function as intended being given the claimed orientation. Lastly, applicant has not disclosed that the claimed orientation solves any stated problem (para. [0039] of the published application) and therefore there appears to be no criticality placed on the orientation of the throughbores as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the orientation of the first and second throughbores of Yamamoto to be obliquely oriented relative to each other as an obvious matter of design choice within the skill of the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1-8 and 21-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 22 and 24 of U.S. Patent No. 11,051,800 B2 to Mitelberg in view of Yamamoto.
Regarding claim 1, Mitelberg claims the system of claim 1 (claims 1, 22 and 24), but fails to claim the distal cap assembly configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope.
Yamamoto teaches a distal cap assembly (tip cover 80 and bridge portion 85, para. [0063]; fig. 6) configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope (see plate member 221 which protrudes from tip cover 80 and abuts the distal end of endoscope 4, such that plate member 221 is considered to extend at least partially circumferentially around the distal end of endoscope 4, para. [0085]; figs. 7-8), for the purpose of providing a restriction part in the insertion direction of the endoscope (para. [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the distal cap assembly configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope, in order to provide a restriction part in the insertion direction of the endoscope, based on the teachings of Yamamoto (para. [0085]).
Regarding claim 2, Mitelberg (as modified) claims the system of claim 2 (claim 2).
Regarding claim 3, Mitelberg (as modified) claims the system of claim 3 (claim 3).
Regarding claim 4, Mitelberg (as modified) claims the system of claim 4 (claim 4).
Regarding claim 5, Mitelberg (as modified) claims the system of claim 5 (claim 7).
Regarding claim 6, Mitelberg (as modified) claims the system of claim 6 (claim 8).
Regarding claim 7, Mitelberg (as modified) claims the system of claim 7 (claim 9).
Regarding claim 8, Mitelberg (as modified) claims the system of claim 8 (claims 1 and 22).
Regarding claim 21, Mitelberg claims the system of claim 1 (claim 4), but fails to claim the distal cap assembly configured to be mounted around at least a portion of the periphery of the distal end of the endoscope.
Yamamoto teaches a distal cap assembly (tip cover 80 and bridge portion 85, para. [0063]; fig. 6) configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope (considered to be mounted around a periphery of the distal end of endoscope 4 via plate member 221, which protrudes from tip cover 80 and abuts the distal end of endoscope 4, para. [0085]; figs. 7-8), for the purpose of providing a restriction part in the insertion direction of the endoscope (para. [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the distal cap assembly configured to be mounted around at least a portion of the periphery of the distal end of the endoscope, in order to provide a restriction part in the insertion direction of the endoscope, based on the teachings of Yamamoto (para. [0085]).
Regarding claim 22, Mitelberg (as modified) claims the system of claim 22 (claim 4), but fails to claim a needle assembly having a needle, wherein the needle is removably coupled to the end effector.
Yamamoto teaches further comprising a needle assembly having a needle (121, para. [0068]), wherein the needle is removably coupled to the end effector (detachable, para. [0068]), for the purpose of providing a structure to be inserted deep into tissue (para. [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim a needle assembly having a needle, wherein the needle is removably coupled to the end effector, in order to provide a structure to be inserted deep into tissue, based on the teachings of Yamamoto (para. [0070]).
Regarding claim 23, Mitelberg (as modified) claims the system of claim 23 (claim 4), but fails to claim wherein when the end effector is in the closed position, the needle is oriented parallel to the longitudinal axis of the endoscope.
Yamamoto teaches wherein when the end effector is in the closed position, the needle is oriented parallel to the longitudinal axis of the endoscope (depicted in figs. 1, 6-7 and 9), for the purpose of aligning the needle appropriately with the endoscope (para. [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein when the end effector is in the closed position, the needle is oriented parallel to the longitudinal axis of the endoscope, in order to align the needle appropriately with the endoscope, based on the teachings of Yamamoto (para. [0059]).
Regarding claim 24, Mitelberg (as modified) claims the system of claim 24 (claim 4).
Regarding claim 25, Mitelberg (as modified) claims the system of claim 25 (claim 4), but fails to claim the peripheral engagement structure comprising a recess and an arm movable to receive the distal end of the endoscope within the recess.
Yamamoto teaches a peripheral engagement structure (C-shaped base 61, para. [0059]; fig. 8) comprising a recess (recess of base 61, fig. 8) and an arm (arm of base 61) movable to receive the distal end of the endoscope within the recess (figs. 7-8), for the purpose of holding the endoscope (para. [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the peripheral engagement structure comprising a recess and an arm movable to receive the distal end of the endoscope within the recess, in order to hold the endoscope appropriately (para. [0059]).
Regarding claim 26, Mitelberg (as modified) claims the system of claim 26 (claim 5).
Regarding claim 27, Mitelberg (as modified) claims the system of claim 27 (claim 6).
Regarding claim 28, Mitelberg claims the system of claim 1 (claims 1, 22 and 24), but fails to claim the distal cap assembly configured to be mounted around at least a portion of the periphery of the distal end of the endoscope.
Yamamoto teaches a distal cap assembly (tip cover 80 and bridge portion 85, para. [0063]; fig. 6) configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope (considered to be mounted around a periphery of the distal end of endoscope 4 via plate member 221, which protrudes from tip cover 80 and abuts the distal end of endoscope 4, para. [0085]; figs. 7-8), for the purpose of providing a restriction part in the insertion direction of the endoscope (para. [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the distal cap assembly configured to be mounted around at least a portion of the periphery of the distal end of the endoscope, in order to provide a restriction part in the insertion direction of the endoscope, based on the teachings of Yamamoto (para. [0085]).
Regarding claim 29, Mitelberg (as modified) claims the system of claim 29 (claim 7).
Regarding claim 30, Mitelberg (as modified) claims the system of claim 30 (claim 9).
Regarding claim 31, Mitelberg (as modified) claims the system of claim 31 (claim 4).
Regarding claim 32, Mitelberg (as modified) claims the system of claim 32 (claims 1, 22 and 24).
Claims 1-8 and 21-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 22 and 24 of U.S. Patent No. 12,478,367 B2 to Mitelberg in view of Yamamoto.
Regarding claim 1, Mitelberg claims the system of claim 1 (claim 1), but fails to claim the distal cap assembly configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope, and the first lumen in alignment with the free end of the end effector when the end effector is in the closed position.
Yamamoto teaches a distal cap assembly (tip cover 80 and bridge portion 85, para. [0063]; fig. 6) configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope (see plate member 221 which protrudes from tip cover 80 and abuts the distal end of endoscope 4, such that plate member 221 is considered to extend at least partially circumferentially around the distal end of endoscope 4, para. [0085]; figs. 7-8), for the purpose of providing a restriction part in the insertion direction of the endoscope (para. [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the distal cap assembly configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope, in order to provide a restriction part in the insertion direction of the endoscope, based on the teachings of Yamamoto (para. [0085]).
Mitelberg (as modified) still fails to claim the first lumen in alignment with the free end of the end effector when the end effector is in the closed position.
Yamamoto teaches a first lumen (includes lumen formed by 21 and 41 which 18 extends through, para. [0056]; fig. 9) in alignment with the free end of the end effector (distal end of 120) when the end effector is in the closed position (depicted in fig. 9), for the purpose of providing a casing that does not damage tissue (para. [0077]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the first lumen in alignment with the free end of the end effector when the end effector is in the closed position, in order to protect the needle and prevent tissue from getting damaged when desired, based on the teachings of Yamamoto (para. [0077]).
Regarding claim 2, Mitelberg (as modified) claims the system of claim 2 (claim 2).
Regarding claim 3, Mitelberg (as modified) claims the system of claim 3 (claim 3).
Regarding claim 4, Mitelberg (as modified) claims the system of claim 4 (claim 4).
Regarding claim 5, Mitelberg (as modified) claims the system of claim 5 (claim 7).
Regarding claim 6, Mitelberg (as modified) claims the system of claim 6 (claim 8).
Regarding claim 7, Mitelberg (as modified) claims the system of claim 7 (claim 9).
Regarding claim 8, Mitelberg (as modified) claims the system of claim 8 (claim 1).
Regarding claim 21, Mitelberg claims the system of claim 21 (claim 4), but fails to claim the distal cap assembly configured to be mounted around at least a portion of the periphery of the distal end of the endoscope.
Yamamoto teaches a distal cap assembly (tip cover 80 and bridge portion 85, para. [0063]; fig. 6) configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope (considered to be mounted around a periphery of the distal end of endoscope 4 via plate member 221, which protrudes from tip cover 80 and abuts the distal end of endoscope 4, para. [0085]; figs. 7-8), for the purpose of providing a restriction part in the insertion direction of the endoscope (para. [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the distal cap assembly configured to be mounted around at least a portion of the periphery of the distal end of the endoscope, in order to provide a restriction part in the insertion direction of the endoscope, based on the teachings of Yamamoto (para. [0085]).
Regarding claim 22, Mitelberg (as modified) claims the system of claim 22 (claim 4), but fails to claim further comprising a needle assembly having a needle, wherein the needle is removably coupled to the end effector.
Yamamoto teaches further comprising a needle assembly having a needle (121, para. [0068]), wherein the needle is removably coupled to the end effector (detachable, para. [0068]), for the purpose of providing a structure to be inserted deep into tissue (para. [0070]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim a needle assembly having a needle, wherein the needle is removably coupled to the end effector, in order to provide a structure to be inserted deep into tissue, based on the teachings of Yamamoto (para. [0070]).
Regarding claim 23, Mitelberg (as modified) claims the system of claim 23 (claim 4), but fails to claim wherein when the end effector is in the closed position, the needle is oriented parallel to the longitudinal axis of the endoscope.
Yamamoto teaches wherein when the end effector is in the closed position, the needle is oriented parallel to the longitudinal axis of the endoscope (depicted in figs. 1, 6-7 and 9), for the purpose of aligning the needle appropriately with the endoscope (para. [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim wherein when the end effector is in the closed position, the needle is oriented parallel to the longitudinal axis of the endoscope, in order to align the needle appropriately with the endoscope, based on the teachings of Yamamoto (para. [0059]).
Regarding claim 24, Mitelberg (as modified) claims the system of claim 24 (claim 4).
Regarding claim 25, Mitelberg (as modified) claims the system of claim 25 (claim 4), but fails to claim the peripheral engagement structure comprising a recess and an arm movable to receive the distal end of the endoscope within the recess.
Yamamoto teaches a peripheral engagement structure (C-shaped base 61, para. [0059]; fig. 8) comprising a recess (recess of base 61, fig. 8) and an arm (arm of base 61) movable to receive the distal end of the endoscope within the recess (figs. 7-8), for the purpose of holding the endoscope (para. [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the peripheral engagement structure comprising a recess and an arm movable to receive the distal end of the endoscope within the recess, in order to hold the endoscope appropriately (para. [0059]).
Regarding claim 26, Mitelberg (as modified) claims the system of claim 26 (claim 5).
Regarding claim 27, Mitelberg (as modified) claims the system of claim 27 (claim 6).
Regarding claim 28, Mitelberg claims the system of claim 28 (claims 1, 22 and 24), but fails to claim the distal cap assembly configured to be mounted around at least a portion of the periphery of the distal end of the endoscope.
Yamamoto teaches a distal cap assembly (tip cover 80 and bridge portion 85, para. [0063]; fig. 6) configured to extend at least partially circumferentially around the periphery of the distal end of the endoscope (considered to be mounted around a periphery of the distal end of endoscope 4 via plate member 221, which protrudes from tip cover 80 and abuts the distal end of endoscope 4, para. [0085]; figs. 7-8), for the purpose of providing a restriction part in the insertion direction of the endoscope (para. [0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to claim the distal cap assembly configured to be mounted around at least a portion of the periphery of the distal end of the endoscope, in order to provide a restriction part in the insertion direction of the endoscope, based on the teachings of Yamamoto (para. [0085]).
Regarding claim 29, Mitelberg (as modified) claims the system of claim 29 (claim 7).
Regarding claim 30, Mitelberg (as modified) claims the system of claim 30 (claim 9).
Regarding claim 31, Mitelberg (as modified) claims the system of claim 31 (claim 4).
Regarding claim 32, Mitelberg (as modified) claims the system of claim 32 (claims 1, 22 and 24).
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.
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/BRIGID K BYRD/Examiner, Art Unit 3771
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