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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “first engaging element includes a window extending therethrough” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Examiner notes that FIG 8 shows a window (170’) extending through the deformable tab (116’) but not the first engaging element (148).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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: “first engaging element” and “engaging feature” in claim 36. The disclosed structure of the first engaging element is a radially inward extending end of the tab ([0015, 0021], FIGs 4-7). The disclosed structure of the engaging feature is a notch or recess ([0034]). These elements and their structural equivalents will be interpreted as satisfying the limitation in the prior art rejection below.
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.
Claim(s) 36, 38-49, 51-53, and 55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by King et al. (US 2018/0153552).
Regarding claim 36, King et al. discloses a reloadable clipping system for treating tissue (100, FIG 1), comprising: a clipping assembly (102) including a pair of clip arms (114, [0035], FIG 1), a capsule (108, 106) configured to receive proximal ends of the clip arms therein (FIG 1 shows the proximal ends of the clip arms received within 108), and a first deformable tab (one of 152) extending proximally from a proximal end of the capsule (FIG 1), the first deformable tab including a first engaging element extending radially inward from a proximal end of the first deformable tab (proximal protrusion at 158 which extends radially inward, See annotated FIG 1 below); and an applicator (104, [0034]) having a distal end (Distal end of 110 shown in FIG 1) including an engaging feature (The radial groove on the distal end of 110 formed in between 162 and 170) configured to receive the first engaging element of the first deformable tab therein in a locked configuration (See FIG 1 where the radially inward protrusion at the proximal end of 106 is received and locked within the groove of 110), the distal end of the applicator being configured so that, when the first deformable tab is pulled proximally beyond the engaging feature, the first deformable tab is bent ([0044] discloses the process of the distal end of applicator applying a force to the first deformable tab such that it bends radially outward; “deflecting the arms 152 radially outward to disengaging the coupler 106 from the catheter 110”) and plastically deformed ([0044] discloses that deflection of the arms 152 may cause the coupler 106 to fracture, thereby releasing the catheter 110 therefrom. Fracture is understood to comprise plastic deformation) so that the first deformable tab is fixed radially outward out of engagement with the distal end of the applicator (Upon plastic deformation approaching fracture, the arms are bent radially outward in a fixed manner such that 110 can be released therefrom, [0044]. “Fixed” is interpreted as a point in which the deformation is permanent and the tab will no longer elastically return to its initial structure).
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Regarding claim 38, King discloses the distal end of the applicator includes a bushing (The distal end 160 shown in FIG 1 is interpreted as a bushing) and the engaging feature is formed on the bushing (The groove is formed in this region as shown in FIG 1), the engaging feature being configured to receive the first engaging element of the first deformable tab therein (FIG 1 and to plastically deform the first engaging element when the first engaging element is pulled proximally beyond the engaging feature ([0044] discloses that when arms 152 are retracted further proximally, they can engage a shoulder 170 formed at the proximal end of the groove and result in plastic deformation).
Regarding claim 39, King discloses the distal end of the applicator includes a first ramped surface (See annotated FIG below) along which the first engaging element is configured to slide without plastic deformation ([0041] “The arms 152 deflect away from one another as the engaging features 162 at the distal end 160 are being inserted therebetween. Once the engaging features 162 are received within the grooves 154, however, the arms 152 snap inward under their natural bias so that the grooves 154 and the engaging features 162 engage one another, coupling the catheter 110 to the coupler 106”), the engaging feature being formed as a slot extending proximally of the first ramped surface into which the first engaging element is configured to snap into the locked configuration (FIG 1, the feature is a slot) and a second ramped surface (170) extending proximally of the engaging feature (FIG 1), the second ramped surface being configured so that, when the first engagement element slides proximally thereover, the first deformable tab is plastically deformed ([0044]; sliding the engagement elements over ramp 170 results in plastic deformation of the tab).
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Regarding claim 40, King discloses a proximal end of the slot comprises a wall (The second ramped surface forms a part of the wall) configured to engage and plastically deform the first engaging element as the first engaging element is pulled proximally out of the slot ([0044]).
Regarding claim 41, King discloses a diameter of the distal end of the applicator at a proximal end of the first ramped surface is greater than a diameter of the distal end of the applicator at the distal end of the second ramped surface (See annotated FIG above).
Regarding claim 42, King discloses the first deformable tab is elastically deformable as the first engaging element is slid along the first ramped surface so that, when the first engaging element moves proximally beyond the proximal end of the first ramped surface, the first engaging element snaps into the slot to couple the capsule to the applicator ([0041] “The arms 152 deflect away from one another as the engaging features 162 at the distal end 160 are being inserted therebetween. Once the engaging features 162 are received within the grooves 154, however, the arms 152 snap inward under their natural bias so that the grooves 154 and the engaging features 162 engage one another, coupling the catheter 110 to the coupler 106”).
Regarding claim 43, King discloses the first deformable tab moves to a deployed configuration when the first deformable tab and the first engaging element are plastically deformed as the first deformable tab is moved proximally out of the slot and over the second ramped surface ([0044]; this position is interpreted as a deployed configuration because the tabs are fixed radially outward such that the applicator can be released), the first deformable tab being fixed radially outward out of engagement with the distal end of the applicator in the deployed configuration (Because they are fractured/plastically deformed, the tabs are in a fixed radially outward configuration relative to the distal end of the applicator).
Regarding claim 44, King discloses in the locked configuration, the first engaging element extends substantially perpendicular to a longitudinal axis of the capsule (FIG 1 shows the engaging elements extend radially inward, perpendicular relative to a longitudinal axis of 108/106).
Regarding claim 45, King discloses the first engaging element of the first deformable tab includes a stamped boss extending, in the locked configuration, inward, toward the longitudinal axis of the capsule (In light of the specification of the present invention and the mechanical definition as understood by one of ordinary skill in the art, a “boss” is interpreted as a projection or protruding feature extending form a surface. The engaging features of the connecting tabs in the device as modified are interpreted as projections or protruding features extending form a surface. Furthermore, “stamped” is a product-by-process limitation wherein the final product disclosed is identical to a product wherein the boss was created by stamping).
Regarding claim 46, King discloses each of the first and second ramped surfaces defines a conically shaped portion of the distal end of the applicator (Although only shown in cross section in FIG 1, the first and second ramped surfaces extend radially around the longitudinal axis of the system and therefore form conically shaped portions of the applicator), each of the first and second ramped surfaces tapering toward the distal end of the applicator (FIG 1).
Regarding claim 47, King discloses the clipping assembly includes at least one further deformable tab extending proximally from the proximal end of the capsule (A second one of the arms 152), the at least one further deformable tab including a further engaging element extending radially inward from a proximal end of the at least one further deformable tab (Identical to what is described above in relation to the first deformable tab).
Regarding claim 48, King discloses the engaging feature is configured to deflect and plastically deform the further engaging element when the further deformable tab is moved proximally beyond the engaging feature so that the at least one further deformable tab is fixed radially outward out of engagement with the distal end of the applicator (Identical to what is described above in relation to the first deformable tab).
Regarding claim 49, King discloses the proximal ends of the clip arms are connected to one another via a yoke (102, [0035]) coupleable with an enlarged distal end (122) of a control member (112, [0037]) extending through an elongated flexible member of the applicator (Not shown, [0042]).
Regarding claim 51, King discloses a clip device (100, FIG 1, [0034]), comprising: a pair of clip arms (114), each of the clip arms extending from a proximal end (118) to a distal end (116); a capsule (108, 106) configured to receive proximal ends of the clips arms therein (FIG 1, [0034-0035, 0040]); and a first deformable tab (one of 152) extending proximally from a proximal end of the capsule (FIG 1), the first deformable tab including a first engaging element extending radially inward from a proximal end of the first deformable tab toward a longitudinal axis of the capsule (proximal protrusion at 158 which extends radially inward, See annotated FIG 1 above) to engage an engaging feature (The radial groove on the distal end of 110 formed in between 162 and 170) of a distal end of an applicator (104, [0034]), so that, when a proximal force is exerted on the first deformable tab to pull the first deformable tab proximally beyond the engaging feature, the first deformable tab is configured to be bent ([0044] discloses the process of the distal end of applicator applying a force to the first deformable tab such that it bends radially outward; “deflecting the arms 152 radially outward to disengaging the coupler 106 from the catheter 110”) and plastically deformed ([0044] discloses that deflection of the arms 152 may cause the coupler 106 to fracture, thereby releasing the catheter 110 therefrom. Fracture is understood to comprise plastic deformation) so that the first deformable tab is fixed radially outward out of engagement with the distal end of the applicator (Upon fracture, the arms are bent radially outward in a fixed manner such that 110 can be released therefrom, [0044]. “Fixed” is interpreted as a point in which the deformation is permanent and the tab will no longer elastically return to its initial structure).
Regarding claim 52, King discloses in a locked configuration the first engaging element extends substantially perpendicular relative to the longitudinal axis of the capsule (FIG 1 shows the engaging elements extend radially inward, perpendicular relative to a longitudinal axis of 108/106), and wherein in a deployed configuration the first deformable tab and the first engaging element are plastically deformed ([0044]; this position is interpreted as a deployed configuration because the tabs are fixed radially outward such that the applicator can be released), and the first deformable tab is fixed radially outward out of engagement with the distal end of the applicator (Because they are fractured/plastically deformed, the tabs are in a fixed radially outward configuration relative to the distal end of the applicator).
Regarding claim 53, King discloses at least one further deformable tab extending proximally from the proximal end of the capsule (A second one of the arms 152), the at least one further deformable tab including a further engaging element extending radially inward from a proximal end of the at least one further deformable tab (Identical to what is described above in relation to the first deformable tab), so that, when the further deformable tab is pulled proximally beyond the engaging feature, the further engaging element is plastically deformed and the further deformable tab is bent and plastically deformed so that the first deformable tab is fixed radially outward out of engagement with the distal end of the applicator (Identical to what is described above in relation to the first deformable tab).
Regarding claim 55, King discloses the proximal ends of the clip arms are connected to one another via a yoke (102, [0035]) coupleable with an enlarged distal end (122) of a control member (112) of the applicator (0037]).
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 50 is rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2018/0153552), in view of Litscher et al. (US 2005/0107809).
Regarding claim 50, King et al. discloses the invention substantially as claimed, as set forth above for claim 49.
King et al. is silent regarding the yoke including a proximal portion and a distal portion connected to one another at a point configured to separate when a predetermined force is exerted thereon.
However, Litscher et al. discloses a clip (90, FIGs 1-1A) releasably connected to an applicator (100) wherein proximal ends of clip arms (208) are connected to one another via a yoke (206,204, FIG 1A) coupleable with an enlarge distal end (140) of a control member (118, FIG 5 and 9-10) wherein the yoke includes a proximal portion (204) and a distal portion (206, FIGs 9-10) connected to one another at a point configured to separate when a predetermined force is exerted thereon (204 and 206 are connected via separable engagement between 216 and 214, paragraph [0069]. Proximal and distal portions are configured to separate when a predetermined force is exerted on the connection between them, paragraph [0069)).
Therefore, it would have been obvious to one of ordinal skill in the art at the time of filing to modify the connection between the enlarged distal end of the control member and the yoke of King et al. with the connection taught by Litscher et al., for the purpose of substituting a mechanism commonly known in the art for achieving the predictable result of forming a releasable connection between the control member and the yoke such that the clip can be controllably detached from the applicator.
Allowable Subject Matter
Claims 37 and 54 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.
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