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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“friction adjusting mechanism” in claims 1 and 18 will be interpreted as any mechanism that increases frictional force for locking a wire as disclosed in para. [0008] that includes a fastening member as disclosed by para. [0048].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1-9, 12-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dejima et al. (US 2020/0352422 A1).
Regarding claim 1, Dejima discloses an endoscope treatment tool (para. [0004]) comprising: a distal end part (Fig. 3) that is provided with an openable and closable grip part 30 (Figs. 3-4); a bendable part 25 that is provided to be adjacent to the distal end part (Figs. 6-7) and that is bendable (Fig. 6); an operating part 22 (Fig. 2) into which an operation of closing the grip part and an operation of bending the bendable part are input (para. [0072]); and an operation wire 27 that transmits the operations at the operating part respectively to the grip part (para. [0076]) and the bendable part (para. [0076]), wherein the operating part includes an operating part body 58 that movably holds a wire holding part 58b (i.e., at least since 58b is movable upon actuation of 51 that translates to 57) to which the operation wire is connected (Fig. 11), and an operation handle 51 that moves the wire holding part (para. [0092]), and has a friction adjusting mechanism (i.e., 58a is being interpreted as a friction adjusting mechanism and includes a fastening member (i.e., pin) as disclosed above with regard to 112f) that increases a frictional force for locking the wire holding part to correspond to an increase in a pulled amount of the operation wire which is caused by the wire holding part interlocked with an operation of the operation handle (para. [0092]), wherein the bendable part includes a plurality of bending pieces 42, and an outer coat 43, wherein the friction adjusting mechanism is provided at a rotational movement support shaft part 50, 52 that supports the operation handle to be movable rotationally, (para. [0089]) and the rotational movement support shaft part comprises a cam part 58c that is capable of changing a contact pressure to correspond to a rotation angle about a shaft of the rotational movement support shaft part (para. [0093] i.e., the contact pressure changes by the rotation between the slider 56 and link 57 such that 58c generates a friction force by movement of 57 (and thereby 56) such that the angle of 57 changes during the sliding mechanism and the friction force affects the contact pressure during sliding).
Regarding claim 2, Dejima discloses the endoscope treatment tool according to claim 1. Dejima also discloses wherein the operation handle is swingably provided to overhang from the operating part body and moves the wire holding part through swinging (para. [0090]; see also Fig. 11).
Regarding claim 3, Dejima discloses the endoscope treatment tool according to claim 1. Dejima also discloses wherein the operation handle is coupled to the wire holding part to be slidably movable via a link member 57 (para. [0093]; i.e., see Fig. 11 such that moving 57 slides 58b).
Regarding claim 5, Dejima discloses the endoscope treatment tool according to claim 1. Dejima also discloses wherein the cam part is provided at the wire holding part in the operating part body (Fig. 11).
Regarding claim 6, Dejima discloses the endoscope treatment tool according to claim 5. Dejima also discloses wherein the rotational movement support shaft part is provided with a fastening member 172 that penetrates the rotational movement support shaft part (i.e., at least as shown in Fig. 11 to be at least inside 52, but also 50), and a fastening force of the rotational movement support shaft part is configured to be adjustable (para. [0094]; i.e., ay least since it generates a frictional force based on the movement of body 50).
Regarding claim 12, Dejima discloses the endoscope treatment tool according to claim 1. Dejima also discloses wherein as a movement amount by which the operation wire is pulled increases, a force pulling in a direction of restoring the operation wire increases (para. [0076] i.e., by pulling and then by pushing also as disclosed by para. [0076], i.e., see also paras. [0083]-[0084]).
Regarding claim 13, Dejima discloses the endoscope treatment tool according to claim 12. Dejima also discloses wherein the bendable part that is bent by pulling of the operation wire has an elastic force in a direction returning from a bent state to a linear state (para. [0082]-[0085]) .
Regarding claim 14, Dejima discloses the endoscope treatment tool according to claim 13. Dejima also discloses wherein an outer coat of the bendable part is made of an elastic member (para. [0081], [0084]).
Regarding claim 15, Dejima discloses the endoscope treatment tool according to claim 13. Dejima also discloses wherein a member inside an outer coat of the bendable part is made of an elastic material (para. [0084] i.e., at least the wire 27).
Regarding claim 16, Dejima discloses an endoscope device 1 comprising: a first treatment tool 20 that is the endoscope treatment tool according to claim 1 (para. [0072]); a second treatment tool 60; and an endoscope 2 that has a first treatment tool channel 13 into which the first treatment tool is insertable (para. [0072]) and a second treatment tool channel 15 into which the second treatment tool is insertable (para. [0068]).
Regarding claim 17, Dejima discloses a treatment method comprising: by using the endoscope device according to claim 16, disposing the distal end part of the first treatment tool at a lesion part in a body through the first treatment tool channel of the endoscope (para. [0096]); gripping the lesion part with the grip part of the first treatment tool (paras. [0097]-[0098]); lifting, in a state where the lesion part is gripped, the lesion part by bending the bendable part of the first treatment tool (para. [0098]); and treating, in a state where the lesion part is lifted, a lower part of the lesion part with the second treatment tool inserted into the second treatment tool channel of the endoscope (para. [0099]).
Claims 18- are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee (US 20080294191 A1).
Regarding claim 18, Lee discloses an endoscope treatment tool (para. [0004]) comprising: a distal end part that is provided with an openable and closable grip part 16 (para. [0061]); a bendable part (20 or alternatively 18 in combination with 14) that is provided to be adjacent to the distal end part (Figs. 5, 6, 7, 12) and that is bendable (para. [0053]); an operating part (Fig. 1; i.e., proximal end of tool) into which an operation of closing the grip part and an operation of bending the bendable part are input (para. [0053], [0061]); and an operation wire 100, 38 that transmits the operations at the operating part respectively to the grip part (i.e., via 38 and 100) and the bendable part (para. [0053]), wherein the operating part includes an operating part body 12 that movably holds a wire holding part (i.e., conical wedge 180 and paras. [0070]-[0071]) to which the operation wire is connected (para. [0061], [0070]-[0071]), and an operation handle 22 that moves the wire holding part (para. [0061]), and has a friction adjusting mechanism (155 is substantial in structure including a shaft as disclosed above with regard to 112f) that increases a frictional force for locking the wire holding part (para. [0070]-[0071]) to correspond to an increase in a pulled amount of the operation wire (i.e., via the movement of wedge member 180 such that the wire is pulled both distally and proximally as disclosed in para. [0070]) which is caused by the wire holding part interlocked with an operation of the operation handle (paras. [0070]-[0071]; i.e., see also Figs. 1 and 2), wherein the bendable part includes a plurality of bending pieces 18, 20, and an outer coat 14, wherein the friction adjusting mechanism includes the wire holding part that slidingly moves with respect to the operating part body (para. [0067], [0069]-[0071]), and a sliding portion 154 that is slidingly contactable with the wire holding part by a movement of the wire holding part (para. [0071]), and at least a part of the sliding portion has an inclined structure (i.e., wedge as shown in Fig. 2) that increases a contact pressure on the wire holding part to correspond to an increase in the pulled amount of the operation wire (paras. [0069]-[0071] by virtue of wedging when 155B is depressed).
Regarding claim 19, Lee discloses the endoscope treatment tool according to claim 18. Lee also discloses wherein the sliding portion includes a first sliding portion i.e., in contact with 155A as shown in Fig. 2), of which the contact pressure with respect to the wire holding part is substantially constant (i.e., such that it is released as disclosed in para. [0071]), and a second sliding portion having the inclined structure (i.e., wedged piece connected to 155B), of which the contact pressure with respect to the wire holding part increases (i.e., during the wedging) to correspond to the increase in the pulled amount of the operation wire (i.e., such that the wire may be locked when in a pulled configuration; see para. [0061]).
Regarding claim 20, Lee discloses the endoscopic treatment tool according to claim 19. Lee also discloses wherein the first sliding portion is set to have a frictional force smaller than a frictional force of the second sliding portion (para. [0071] at least since it is in the unlocked state vs the locked, wedged state).
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.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Smith et al. (US 20150099928 A1).
Regarding claim 23, Lee discloses an endoscope device comprising: a first treatment tool that is the endoscope treatment tool according to claim 18 for use in an endoscope (see para. [0004]).
Lee doesn’t directly disclose a second treatment tool; and an endoscope that has a first treatment tool channel into which the first treatment tool is insertable and a second treatment tool channel into which the second treatment tool is insertable.
In the same field of endeavor, namely endoscopic surgical devices, Smith discloses a system including several treatment tools to be used through endoscope 70. Smith also discloses a second treatment tool (i.e., electrocautery snare as disclosed in para. [0040]); and an endoscope 70 that has a first treatment tool channel into which the first treatment tool is insertable and a second treatment tool channel into which the second treatment tool is insertable (Fig. 8 shows multiple channels).
Regarding claim 24, Lee and Smith disclose a treatment method comprising: by using the endoscope device according to claim 23, disposing the distal end part of the first treatment tool at a lesion part in a body through the first treatment tool channel of the endoscope (i.e., according to para. [0040] of Smith and using Lee’s grasping device as disclosed above); gripping the lesion part with the grip part of the first treatment tool (i.e., the resulting device of Smith and Lee would accomplish this; i.e., see also para. [0040] of Smith); lifting, in a state where the lesion part is gripped (para. [0040] of Smith), the lesion part by bending the bendable part of the first treatment tool (i.e., the resulting device of Smith and Lee would accomplish this; i.e., see also para. [0040] of Smith); and treating, in a state where the lesion part is lifted, a lower part of the lesion part with the second treatment tool inserted into the second treatment tool channel of the endoscope (para. [0040] of Smith).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Lee by using an endoscopic device and a second treatment tool as disclosed by Smith for the purpose of introducing multiple treatment devices to a site to be treated such that the treatment is a removal of a lesion (para. [0040], [0054]).
Allowable Subject Matter
Claims 21-22 are 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.
Regarding claim 21, Lee discloses the endoscope treatment tool according to claim 19. Lee also discloses wherein the second sliding portion has a piston (i.e., shaft as shown in Fig. 2) that is provided at one end part of the wire holding part (Fig. 2), and a ring-shaped elastic member 142.
Lee doesn’t disclose a cylinder that movably accommodates the piston in an axial direction of the piston, or that the ring is provided on an outer periphery of the piston and that is in contact with an inner wall surface of the cylinder.
The device of Lee could not be modified to include a cylinder that movably accommodates the piston in an axial direction of the piston, or that the ring is provided on an outer periphery of the piston and that is in contact with an inner wall surface of the cylinder without significantly altering the function of the device or completely re-designing the device.
Claim 22 is allowable for its dependency on claim 21.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument at least because of the reinterpretation as discussed above.
Applicant's arguments filed October 29, 2025 with regard to claim 18 have been fully considered but they are not persuasive. Applicant argues that Lee doesn’t disclose: the wire holding part that slidingly moves with respect to the operating part body. Examiner disagrees. Examiner notes that Applicant correctly cited paragraph [0071] of Lee which discloses that conical wedge 180 may be moved by means of a button arrangement that includes the lock button 155 but incorrectly argues that as such the conical wedge 180 does not have relative movement with respect to handle 12. The handle 12 and the button 155 are independent and as such, movement of 180 may occur independently of 12.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771