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 .
Priority
This application has PRO 63/464,007 05/04/2023 is acknowledged.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 75-88, drawn to an endoscopic apparatus, classified in A61B17/0469.
II. Claims 89-90, drawn to a securing system for use with an endoscope, classified in A61B17/0469.
III. Claims 91-94, drawn to a method of coupling a cap assembly of an endoscopic apparatus to an endoscope, classified in A61B17/0469.
The inventions are independent or distinct, each from the other because:
Inventions Groups I, II and III are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the product as claimed can be used in a materially different process such as using the product beating stick.
Inventions II and I are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination Group II does not required at least one hook, could be more than one hook, for patentability. The subcombination has separate utility such as using the subcombination as hooking device .
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
(a) the inventions have acquired a separate status in the art due to their
recognized divergent subject matter;
(b) the prior art applicable to one invention would not likely be applicable to
another invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Karen Horowitz on 02/26/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 75-88. Affirmation of this election must be made by applicant in replying to this Office action. Claims 89-94 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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) 75, 83, 88 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2019/0209160 to Mitelberg et al. (Mitelberg).
Mitelberg teaches:
Claim 75: An endoscopic apparatus for use with an endoscope having a proximal end and a distal end, the endoscopic apparatus comprising:
a) a proximal handle assembly (24, Fig. 2);
b) a distal cap assembly (50, Fig. 3) defining a recess (Fig. 6, the endoscope access the recess through opening 92, para. 0039) in which the distal end of the endoscope is received and including at least one hook (the edge of arm 94 of clip 90 can be considered a hook, Fig. 6) at one side of the recess for receiving a tensile member that wraps around a portion of the cap assembly and the endoscope (the tensile member has not positively recited yet); and
c) a central portion (between the handle 24 and cap 50, Fig. 2) adapted to extend along the endoscope between the handle assembly and the cap assembly.
Claim 83: The cap assembly (50, Fig. 4) is a suturing assembly including a movably mounted needle holder (83, Fig. 4), and operation of the proximal handle assembly moves the needle holder on the cap assembly (para. 0034).
Claim 88: The distal cap assembly (50, Fig. 4) includes a resilient clip (90, Fig. 6) that defines the recess (Fig. 6, the endoscope access the recess through opening 92, para. 0039).
Claim(s) 75, 77 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 8876701 to Surti et al. (Surti).
Surti teaches:
Claim 75: An endoscopic apparatus for use with an endoscope having a proximal end and a distal end, the endoscopic apparatus comprising:
a) a proximal handle assembly (inherently, there’s a handle for operating the endoscope and the suturing assembly in Fig. 1);
b) a distal cap assembly (26, Fig. 1) defining a recess (cavity 40, Fig. 2) in which the distal end of the endoscope is received and including at least one hook (the guide body 42, Fig. 2, comprises distal and proximal guide flanges 48, 50, these guides can be considered hooks) at one side of the recess for receiving a tensile member that wraps around a portion of the cap assembly and the endoscope (the tensile member has not positively recited yet); and
c) a central portion (between the endcap 26 and the proximal end handle of endoscope 22, Fig. 2) adapted to extend along the endoscope between the handle assembly and the cap assembly.
Claim 77: The at least one hook includes two longitudinally spaced apart hooks (the guide body 42, Fig. 2, comprises distal and proximal guide flanges 48, 50, these guides can be considered hooks that are longitudinally spaced apart).
(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.
Claim(s) 75, 76, 84 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2023/0027249 to Adhikarath Balan et al. (Balan).
Balan teaches:
Claim 75: An endoscopic apparatus for use with an endoscope having a proximal end and a distal end, the endoscopic apparatus comprising:
a) a proximal handle assembly (inherently, there’s a handle for operating the endoscope in Fig. 1);
b) a distal cap assembly (108, Fig. 1) defining a recess (lumen where endoscope 104 is inserting into, Fig. 1) in which the distal end of the endoscope is received and including at least one hook (teeth 122 of jaws 114, Fig. 1) at one side of the recess for receiving a tensile member that wraps around a portion of the cap assembly and the endoscope (the tensile member has not positively recited yet); and
c) a central portion (between the endcap 108 and the proximal end handle of endoscope 104, Fig. 1) adapted to extend along the endoscope between the handle assembly and the cap assembly.
Claim 76: The at least one hook (teeth 122 of jaws 114, Fig. 1) is identified with a contrasting color relative to a majority of the cap assembly (the cap 108 is a transparent material, para. 0007, and the clip 102 is made of metal alloy, para. 0059).
Claim 84: The at least one hook includes two longitudinally spaced apart hooks (proximal and distal ends of clip 102 are considered hooks for being raised above the outer surface of cap 108) each identified by a contrasting color relative to a color of a majority of the cap assembly (the cap 108 is a transparent material, para. 0007, and the clip 102 is made of metal alloy, para. 0059).
Allowable Subject Matter
Claims 78-82 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.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 78, none of the prior art disclose the distal stop including indicia relative to which a feature of the endoscope is intended to be rotationally aligned. Claims 79-82 objected for depending on objected claim 78. Regarding claim 85, none of the prior art disclose two longitudinally spaced apart hooks each identified by different hook indicia. Claims 86-87 objected for depending on objected claim 85.
The prior art Mitelberg disclose the current invention but fails to discloses the contrasting colors or indicia for the hooks and indicia for the distal stop. Contrasting colors, indicators or indicia are used to differentiate different areas by visualization and well-known. However, there is no motivation for the rejected “hook” limitation above to have different colors, indicator or indicia relative to the rest of the cap assembly.
The prior art Balan discloses the current invention with cap and clip having different materials which makes different contrasting colors. However, this prior fails to disclose indicia on the distal stop or different hook indicia as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHONG SON DANG whose telephone number is (571)270-5809. The examiner can normally be reached Mon-Fri 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, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771
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