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: “tissue biasing component” in claim 1.
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.
The specification of the present invention discloses in [0031] the tissue biasing component 144 may be, for example, one or more vacuum sources or vacuum ports that transmit a biasing force to draw tissue into the tissue chamber 142 or in [0032] that tissue biasing component may include a tissue apposition tool. For the purpose of examination, either a source of negative pressure, a tissue grasping instrument, of structural equivalents thereof will be interpreted as meeting the limitations of a tissue biasing component.
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.
Claim(s) 1, 2, 4, 12, 14-17, 22, 23, 27, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McLawhorn et al. (US 2011/0152891).
Regarding claim 1, McLawhorn et al. discloses an apparatus (30, FIG 1-3 and 7-10) comprising: a housing (32) including an instrument interface (Proximal interior space 48, [0027]), the instrument interface configured to releasably engage a distal portion of an endoscope ([0027], 48 releasable engages the distal end 24 of endoscope 22); a drive system (44, 46,80 [0028-0029]) coupled to the housing (FIGs 7-10 show 44 and 46 extend into the arms 34, 36 of the housing, [0028]) and configured to releasably engage a drive element extending from the endoscope (There is at least some element at the proximal end of the endoscope which imparts the translational force to 44 and 46. 44,46 are at least configured to be releasably coupled to such an element); an arc-shaped needle (38) coupled to the drive system ([0034] such as when 82 receives the ends 70, 72 of the needle), wherein the drive element is configured to provide motion to the arc-shaped needle when the drive system is engaged with the drive element (examiner notes the drive element is not a positively recited limitations of the claim. The device is at least configured that 44, 46, 80 provide motion to the needle when actuated, [0034-0036, 0038]) ; and a tissue apposition system comprising: a tissue chamber in the housing (Open space between arms 34,36 as shown in FIGS 7-10) across which a trajectory of the arc-shaped needle extends (FIG 8, wherein FIG 3 shows the trajectory 54); and a tissue biasing component (90, [0036-0037]) configured to draw tissue into the tissue chamber (FIG 7).
Regarding claim 2, McLawhorn et al. discloses the drive system is configured to provide bi- directional motion to the arc-shaped needle (FIGs 7-10, [0036-0040]).
Regarding claim 4, McLawhorn et al. discloses a proximal end of the housing includes an attachment feature configured to interface with the endoscope (inner surfaces 48 frictionally fit with the endoscope, [0027]).
Regarding claim 12, McLawhorn et al. discloses the tissue chamber is sized to receive a full thickness fold of a tissue (FIG 7, “T” is interpreted as a full thickness fold of a tissue).
Regarding claim 14, McLawhorn et al. discloses the arc-shaped needle has a needle trajectory that approximately bisects the tissue chamber (FIG 8).
Regarding claim 15, McLawhorn et al. discloses the tissue biasing component includes an aperture through which a vacuum force is applied to draw the tissue into the tissue chamber ([0036] discloses that 90 can be a suction device).
Regarding claim 16, McLawhorn et al. discloses the tissue biasing component comprises a tissue apposition tool (Grasper, [0036]) configured to be advanced to bite onto tissue and retracted to draw the tissue into the tissue chamber (As shown in use in FIGs 7-9, [0036-0037]).
Regarding claim 17, McLawhorn et al. discloses the tissue apposition tool comprises a helical shaped component to engage tissue ([0036] discloses that tool 90 can be a cork screw).
Regarding claim 22, McLawhorn et al. discloses the arc-shaped needle comprises a first pointed end (70) and a second pointed end (72, FIG 4); wherein when the drive system is rotated in a first direction, the first pointed end is a leading end of the arc-shaped needle (when 46 is extended distally, first end 70 is the leading end); and when the drive system is rotated in a second direction opposite to the first direction , the second pointed end is a leading end of the arc-shaped needle (When 44 is extended distally, second end 72 becomes the leading end, FIGs 7-10).
Regarding claim 23, McLawhorn et al. discloses the arc-shaped needle includes an attachment portion for attachment to a suture (FIG 4, [0031] there is a bore in the needle which receives suture 76).
Regarding claim 27, McLawhorn et al. discloses the housing includes a track in which the arc-shaped needle is supported (50 and 52, [0032]).
Regarding claim 28, McLawhorn et al. discloses the arc-shaped needle has a trajectory that remains entirely within the housing (FIGs 7-10), the path of the trajectory is within 50 and 52 of the housing).
Claim(s) 1, 13, 19, 21, 24, 26, and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shelton et al. (US 2006/0282091).
Regarding claim 1, Shelton et al. discloses an apparatus (10, FIG 1) comprising: a housing (14, [0067]) including an instrument interface (Clamp 17), the instrument interface configured to releasably engage a distal portion of an endoscope (endoscope 18, [0072]); a drive system (30, FIG 3-4, [0068-0070]) coupled to the housing (FIG 1 and 3) and configured to releasably engage a drive element extending from the endoscope (There is at least some element at the proximal end of the endoscope, such as 42, [0070], which imparts the driving force. The drive system 30 is at least configured to be releasably coupled to such an element); an arc-shaped needle (28) coupled to the drive system ([0070]), wherein the drive element is configured to provide motion to the arc-shaped needle when the drive system is engaged with the drive element (examiner notes the drive element is not a positively recited limitations of the claim. The device is at least configured that 30 provides motion to the needle when actuated, [0070]); and a tissue apposition system comprising: a tissue chamber in the housing (Vacuum chamber 46/cavity 48, FIG 1, [0073-0074]) across which a trajectory of the arc-shaped needle extends (FIG 1); and a tissue biasing component (50) configured to draw tissue into the tissue chamber ([0073]).
Regarding claim 13, Shelton et al. discloses the arc-shaped needle has a needle trajectory that extends 360 degrees in a plane approximately parallel to a longitudinal axis of the housing (FIGs 5-10 show a needle trajectory that extends 360 degrees and in a plane that is parallel to a longitudinal axis of the housing, FIG 1).
Regarding claim 19, Shelton et al. discloses the housing includes a viewing port configured to align with an imaging system of the endoscope (FIG 1 shows the opening in the frame of 17 that allows for passage of the endoscope having an imaging system).
Regarding claim 21, Shelton et al. discloses the arc-shaped needle extends approximately 270 degrees ([0087] discloses the needle extending along an arc of 240 degrees, which is interpreted as “approximately” 270 degrees).
Regarding claim 24, Shelton et al. discloses the arc-shaped needle includes teeth along an inner diameter of the needle configured to engage the drive system or the arc- shaped needle includes a slotted rack configured to engage the drive system (notches 56 on the surface 54 of the needle is interpreted as a slotted rack which engages the drive system, [0093]).
Regarding claim 26, Shelton et al. discloses the arc-shaped needle includes a releasable suture tag (tag 3676 on needle 3628, FIG 85, [0165]).
Regarding claim 37, Shelton et al. discloses a suture tag mechanism including a suture cartridge (3670, FIG 85, [0164]) and a suture release mechanism ([0185] discloses detachable cartridge 3670 can be removed and replaced with a fresh needle 3628 and suture 3612, therefore there is understood to be at least some mechanism which releases the suture).
Claim(s) 1, 3, and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stefanchik et al. (US 2006/0224184).
Regarding claim 1, Stefanchik et al. discloses an apparatus (FIG 5) comprising: a housing (160, FIG 5, [0042]) including an instrument interface (Inner surface of the tubular proximal end), the instrument interface configured to releasably engage a distal portion of an endoscope (endoscope 130, [0042]); a drive system (30, 50, 40, FIG 6, [0024-0032]) coupled to the housing (FIG 6) and configured to releasably engage a drive element extending from the endoscope (60 is releasable connected to 30, [0030]); an arc-shaped needle (70) coupled to the drive system (FIG 6-11), wherein the drive element is configured to provide motion to the arc-shaped needle when the drive system is engaged with the drive element (examiner notes the drive element is not a positively recited limitations of the claim. [0030] discloses that 60 imparts a rotational force on 30 which ultimately rotates the needle along its trajectory); and a tissue apposition system comprising: a tissue chamber in the housing (162, FIG 6, [0042-0045]) across which a trajectory of the arc-shaped needle extends (FIG 6-11); and a tissue biasing component (141) configured to draw tissue into the tissue chamber ([0042]).
Regarding claim 3, Stefanchik et al. discloses the housing includes a generally transparent material through which a field of view of the endoscope is visible ([0040, 0042-0043]).
Regarding claim 6, Stefanchik et al. discloses the drive system includes a drive input at a proximal end of the housing (engagements of 60 to 32), the drive input configured to releasably engage the drive element extending from the endoscope ([0030] discloses 60 is removably attachable to 32).
Regarding claim 7, Stefanchik et al. discloses the drive element comprises a distal drive head and a drive shaft, the drive element configured to be inserted into a working channel of the endoscope for releasably coupling the distal drive head to the drive input at the proximal end of the housing (as described above is claim 1, the drive element is not positively recited in the claim. However, Stefanchik does teach that 60 has a distal drive head 62, [0030] and a drive shaft- the flexible cable which extends proximally into the endoscope to handle 152, [0040]).
Regarding claim 8, Stefanchik et al. discloses the drive system includes a gear system that interfaces between the drive input and the arc-shaped needle (FIG 6 shows gear 30 and 40 connected by drive belt 50, which operate to rotate the needle, [0028-0031]).
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.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Stefanchik et al. (US 2006/0224184) in view of Litke (US 2024/0206869).
Regarding claim 9, Stefanchik et al. discloses the invention substantially as claimed, as set forth above for claim 8. Stefanchik further discloses the gear system includes at least two drive gears on opposite sides of the tissue chamber (FIG 6 shows 30 and 40 located on opposite sides of 162).
Stefanchik et al discloses the two gears are connected by a driving belt, not a central gear as claimed.
However, Litke teaches a drive system (300, FIGs 5-6) for rotation of an arc shaped needle (308) comprising a gear system (FIG 6) having two drive gears (352, 356) connected by a central gear (354, [0042]), wherein alternatively, the gears 352, 356 could be connected by a belt or chain ([0042]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the gear system of Stefanchik to have a central gear instead of the driving belt, as taught by Litke, for the purpose of substituting one commonly known mechanism for another thereby achieving the predictable result of ensuring the two drive gears move in unison ([0042]).
Claim(s) 29 is rejected under 35 U.S.C. 103 as being unpatentable over McLawhorn et al. (US 2011/0152891) in view of Meade (US 2018/0242967).
Regarding claim 29, McLawhorn et al. discloses the invention substantially as claimed, as set forth above for claim 1.
McLawhorn et al. is silent regarding the arc-shaped needle having a trajectory that extends beyond a distal end of the housing.
However, Meade teaches in the same field of endeavor of arc shaped needle drivers (FIG 1-2B) a device having a housing (56, FIG 5A) and an arc-shaped needle (120), the arc-shaped needle having a trajectory that extends beyond a distal end of the housing (FIG 6A-6B).
Therefore, it would have been an obvious matter of design choice to modify the shape and curvature of the housing of McLawhorn such that the needle has a trajectory that extends beyond a distal end of the housing, as taught by Meade, for the purpose of forming the housing in a manner that still contacts the needle on both ends while the needle passes across the tissue chamber, as desired by McLawhorn ([0032]) while allowing for a larger portion of tissue to be received within the chamber.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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