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 .
Status of Claims
Claims 1-23 are pending and are currently under consideration for patentability under 37 CFR 1.104. Previous 35 USC 112 Rejections have been withdrawn in light of Applicant’s amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-23 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.
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: “an image capture device” in claim 12.
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
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) 1-9, 12-13, and 18-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wiltshire (US 2004/0138529).
Regarding claim 1, Wiltshire discloses an endoscope system (see figure 2) comprising: a control handle (22, figure 1); a primary scope (10, figure 2) extending from the control handle to a distal portion (14, figure 2) and configured for insertion into a passage of a patient (patient’s body [0082]), the primary scope defining a working channel (26, figures 1-2) extending therethrough; an auxiliary scope (see tool 40 with end effector 48, figure 1 | secondary scopes [0141]) located at least partially within the working channel and movable to extend from the primary scope (see figures 1-2); and a guide (30, figures 1-2) extendable from the distal portion of the primary scope to guide extension of the auxiliary scope from the primary scope (see figure 2), the guide configured to conform to a shape of the auxiliary scope when the guide is extended from the primary scope and when the auxiliary scope extends from the primary scope along the guide (tool arm 30…distal end is steerable [0110] | manipulation of the tool 40…used to steer the arm 30 [0136] | also, best seen with figure 20).
Regarding claim 2, Wiltshire further discloses the guide is extendable from the working channel and engageable with the auxiliary scope to guide extension of the auxiliary scope from the primary scope (see 34 of 30 and it guides 48 of 40, figures 1-2).
Regarding claim 3, Wiltshire further discloses an arm (96, figure 21d) pivotably connected (see pivot/curve of 30, figure 21d) to the distal portion of the primary scope (tether to the fixation point 104…[0124]), the arm engageable with the guide to guide extension of the guide from the primary scope (see figure 21d).
Regarding claim 4, Wiltshire further discloses the arm is engageable with the auxiliary scope to guide extension of the auxiliary scope from the primary scope (see figure 21d | the auxiliary scope would be engaged with the arm 96 through guide 30).
Regarding claim 5, Wiltshire further discloses a guide wire (tools may be passed through auxiliary lumens…[0150] | tools…not limited [0019]) extendable from the primary scope (figures 37-40), the guide engageable (functional language) with the guidewire to guide extension of the guide wire from the primary scope (used in conjunction with the arms 30 and/or tools 40 inserted through the arms [0148]; see figures 37-40).
Regarding claim 6, Wiltshire further discloses the arm (96, figure 21d) is engageable (functional language) with the guide wire to guide extension of the guide wire from the primary scope (used in conjunction…[0148]).
Regarding claim 7, Wiltshire further discloses the guide wire is extendable from a second channel (auxiliary lumens 58 [0148]) located near the working channel (see figures 37-40).
Regarding claim 8, Wiltshire further discloses the guide is tapered from a proximal portion to a distal portion (best seen with 30, figure 37a).
Regarding claim 9, Wiltshire further discloses a distal portion of the guide is configured to deliver energy to ablate tissue (end effectors…electrosurgical…laser [0019]).
Regarding claim 12, Wiltshire further discloses an image capture device (this element is interpreted under 35 USC 112f as a sensor, lens, chip, or processor [0041] | main body 10…visualization elements…[0096]; CCD [0108]) connected to an outer portion of the primary scope (visualization element would be close to the outer portion/surface of the primary scope | see 10, figure 1) and angled with respect to a longitudinal axis of the primary scope (see the angled surface of 16, figure 1).
Regarding claim 13, Wiltshire further discloses the primary scope is a duodenoscope (ERCP…[0094] | interpreted the primary scope to be a duodenoscope because it can be in the duodenum) and the auxiliary scope is a cholangioscope (secondary scopes [0141] | ERCP…[0094] | interpreted the auxiliary scope to a cholangioscope to perform ERCP).
Regarding claim 18, Wiltshire discloses an endoscope system (see figure 2) comprising: a primary scope (10, figure 2) extending from a proximal portion (see proximal portion of 20, figure 2) to a distal portion (14, figure 2) and configured for insertion into a passage of a patient (patient’s body [0082]), the primary scope defining a working channel (26, figures 1-2) extending therethrough; an auxiliary scope (see tool 40 with end effector 48, figure 1 | secondary scopes [0141]) located at least partially within the working channel and movable to extend from the primary scope (see figures 1-2); and a guide (30, figures 1-2) extendable from the distal portion of the primary scope to direct advancement of the auxiliary scope from the primary scope (see figure 2), the guide configured to conform to a shape of the auxiliary scope when the guide is extended from the primary scope and when the auxiliary scope extends from the primary scope along the guide (tool arm 30…distal end is steerable [0110] | manipulation of the tool 40…used to steer the arm 30 [0136] | also, best seen with figure 20).
Regarding claim 19, Wiltshire further discloses the guide is extendable from the working channel and engageable with the auxiliary scope to guide extension of the auxiliary scope from the primary scope (see 34 of 30 and it guides 48 of 40, figures 1-2).
Regarding claim 20, Wiltshire further discloses an arm (96, figure 21d) pivotably connected (see pivot/curve of 30, figure 21d) to the distal portion of the primary scope (tether to the fixation point 104…[0124]), the arm engageable with the guide to guide extension of the guide from the primary scope (see figure 21d).
Regarding claim 21, Wiltshire further discloses the arm is engageable with the auxiliary scope to guide extension of the auxiliary scope from the primary scope (see figure 21d | the auxiliary scope would be engaged with the arm 96 through guide 30).
Regarding claim 22, Wiltshire further discloses a guide wire (tools may be passed through auxiliary lumens…[0150] | tool…not limited [0019]) extendable from the primary scope (figures 37-40), the guide engageable (functional language) with the guide wire to guide extension of the guide wire from the primary scope (used in conjunction with the arms 30 and/or tools 40 inserted through the arms [0148]; see figures 37-40).
Regarding claim 23, Wiltshire further discloses the arm (96, figure 21d) is engageable (functional language) with the guide wire to guide extension of the guide wire from the primary scope (used in conjunction with the arms 30 and/or tools 40 inserted through the arms [0148]; see figures 37-40).
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.
Claim(s) 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wiltshire (US 2004/0138529) as applied to claim 1 above, and further in view of Reydel (US 2017/0251917).
Regarding claim 10, Wiltshire discloses all of the features in the current invention as shown above in claim 1. Wiltshire is silent regarding a stabilizer connected to the primary scope and configured to extend therefrom to engage an inner intestinal wall.
Reydel teaches an attachable structure (40d, figure 28a) with one or more flexible appendages (47d, figure 28a) extending outwardly from the outer surface of the body ([0130]). There may be multiple flexible appendages extending outward within the same row (figure 29b; [0134]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the system, specifically the distal portion of the primary scope, of Wiltshire to have an attachable structure (40d, figure 28a) with multiple flexible appendages (47, figures 28a and 29b) extending outward within the same row ([0134]). Doing so would facilitate a forward advance of the endoscope by reducing intestinal looping ([0141]). The modified system would have a stabilizer (47, figures 28a and 29b; Reydel) connected to the primary scope (the modified primary scope would have the attachable structure 40d and flexible appendages 47d, figure 28a) and configured to extend therefrom to engage an inner intestinal wall ([0141]; Reydel).
Regarding claim 11, Reydel further teaches the stabilizer includes a plurality of projections (47, figures 28a and 29b; Reydel) extending from the primary scope, each projection configured to engage the inner intestinal wall ([0141]; Reydel).
Claim(s) 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Wiltshire (US 2004/0138529), in view of Stefanchik (US 2004/0230095).
Regarding claim 14, Wiltshire discloses a method of operating an endoscope system (see figure 2), the method comprising: extending a guide (30, figures 1-2 | insertable through a…[0084]) from a distal portion of a primary scope (10, figure 2) near a working channel (guide lumen 26, figures 2) of the primary scope; extending an auxiliary scope (see tool 40 with end effector 48, figure 1 | secondary scopes [0141]) from the working channel to engage the guide (see 34 of 30 and it guides 48 of 40, figures 1-2); and guiding extension of the auxiliary scope from the working channel by engaging the guide with the auxiliary scope (see 34 of 30 and it guides 48 of 40, figures 1-2). Wiltshire further discloses the guide engaged with an arm (96, figure 21d) connected to the distal portion of the primary scope. Wiltshire is silent regarding extending the guide through an opening of an arm connected to the distal portion of the primary scope.
Stefanchik teaches an endoscope (100, figure 10) with an instrument (168, figure 10) extending from an accessory (50, figure 10). A snare (73, figure 10) extends from a channel of the endoscope, where the snare can be in the form of a looped wire ([0070]). When the instrument extends through the loop in snare, the curvature of the instrument can be increased ([0070]).
It would have been obvious to modify the method of Wiltshire, specifically the arm (96, figure 21d), to use a looped wire in a snare (see 73, figure 10) as taught by Stefanchik. Doing so would provide a method to articulate the guide when it extends through the loop in the snare/arm ([0070]; Stefanchik). The modified method would comprise extending the guide through an opening of an arm (see 73, figure 10; loop in snare [0070]; Stefanchik) connected to the distal portion of the primary scope (see 96, figure 21d; Wiltshire).
Regarding claim 15, Wiltshire and Stefanchik further disclose extending the auxiliary scope through the opening of the arm (the auxiliary scope would extend through the opening of the arm because it extends through guide | see 73, figure 10 of Stefanchik; see 34 of 30 and it guides 48 of 40, figures 1-2 of Wiltshire).
Regarding claim 16, Wiltshire further discloses cannulating a sphincter of Oddi with a tip of the guide (see 34 of 30, figures 1-2 | ERCP…sphincterotomy…[0094] | the distal end 34 is steerable…[0084], can cannulate a sphincter of Oddi).
Regarding claim 17, Wiltshire further discloses extending the auxiliary scope into the sphincter of Oddi following cannulation (tool 40 is advanced…48 emerges…[0085]; see figures 2).
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 PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
July 10, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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