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:
Resilient member in claim 10 is being interpreted according to para. [0027] as any structure capable of biasing the beak of a work element in an open position.
Resilient section in claims 17-20 are being interpreted according to para. [0027] as any structure capable of biasing the beak of a work element in an open position.
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 1-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vetter (US 2013/0096459 A1).
Regarding claim 1, Vetter discloses a device to cut tissue (Figs. 1, 20-23b), comprising: a work element 13 (i.e., the rotatable element), configured to cut tissue and formed from a single tube of material (i.e., Fig. 20) and comprising a plurality of cuts to define a single articulable beak (para. [0092]; Fig. 23a), the work element being configured such that the single articulable beak is biased in an open configuration (para. [0047]) and is selectively configured to assume a closed configuration (para. [0048]); a rigid trough portion (i.e., along the second element 13b; see para. [0060] as well), configured such that the single articulable beak, in the closed configuration, contacts and presses against a facing surface of the rigid trough portion (Fig. 23b); and a handle 12 comprising an actuating lever 30 operatively coupled to the work element to selectively cause the single articulable beak to assume the open configuration or the closed configuration (para. [0062]).
Regarding claim 2, Vetter discloses the device of claim 1. Vetter also discloses wherein the rigid trough portion is an integral part of the work element (Figs. 20-23b i.e., integral being defined as essential to completeness as disclosed by merriam-webster).
Regarding claim 3, Vetter discloses the device of claim 1. Vetter also discloses wherein the rigid trough portion is separate from work element and is configured to be positioned within tissue in advance of the work element (Figs. 20-23b i.e., the work element is not actuated to sever tissue).
Regarding claim 4, Vetter discloses the device of claim 1. Vetter also discloses wherein the work element is configured to rotate (para. [0048]; i.e., to close) while the rigid trough portion is configured to be non-rotating (para. [0048]).
Regarding claim 5, Vetter discloses the device of claim 1. Vetter also discloses wherein the work element is configured to stop rotating at a point where single articulable beak presses against the rigid trough portion (i.e., to be in the closed position).
Regarding claim 6, Vetter discloses the device of claim 1. Vetter also discloses wherein the single articulable beak, in the open configuration, creates an opening for tissue with the rigid trough portion and, in the closed configuration, occludes the opening, cuts and parts off any tissue engaged in the opening (para. [0062]).
Regarding claim 7, Vetter discloses the device of claim 1. Vetter also discloses wherein the handle further comprises a ramp structure against which the actuating lever acts to impart a twisting motion to the single articulable beak (i.e. with 107 to 105 as disclosed in para. [0062]).
Regarding claim 8, Vetter discloses the device of claim 1. Vetter also discloses wherein the handle further comprises: a first dog element (i.e., gear component; i.e., or purposes of this Office Action, Examiner is interpreting a “dog” to be any kind of bearing or circular support), wherein the actuating lever is configured to act upon the first dog element to selectively cause the at least one articulable beak to assume the open or closed configuration (i.e., as disclosed in para. [0063]), and wherein the ramp structure is further configured to act to rotate the first dog element and to correspondingly impart the twisting motion to the work element (paras. [0062]-[0063]).
Regarding claim 9, Vetter discloses the device of claim 8. Vetter also discloses wherein the first dog element is removable and replaceable (i.e., at least during assembly and disassembly para. [0062]).
Regarding claim 10, Vetter discloses the device of claim 8. Vetter also discloses wherein the handle further comprises a second dog element (i.e., second gear component as disclosed by paras. [0062]-[0063]; for purposes of this Office Action, Examiner is interpreting a “dog” to be any kind of bearing or circular support) and wherein the device further includes further a resilient member coupled to the first dog element and to the second dog element (i.e., tab 105 as disclosed in para. [0062] is being interpreted as the resilient member according to 112f above), the resilient member being configured to urge the at least one articulable beak in the open configuration (para. [0062]).
Regarding claim 11, Vetter discloses the device of claim 10. Vetter also discloses wherein the second dog element comprises a ramp against which a portion of the actuating lever acts to rotate the second dog element and correspondingly twist the work element (para. [0062]).
Regarding claim 12, Vetter discloses the device of claim 10. Vetter also discloses wherein at least one of the work element, the first dog element and the second dog element is configured to be removed from the handle and replaced (i.e., at least during assembly and disassembly).
Regarding claim 13, Vetter discloses the device of claim 1. Vetter also discloses further comprising a first and second dog element within the handle, at least the second dog element being configured such that manual manipulation thereof by an operator causes a twisting motion of the work element (para. [0063]; i.e., gear assemblies).
Regarding claim 14, Vetter discloses the device of claim 1. Vetter also discloses wherein the work element is configured to part-off tissue when the single articulable beak assumes the closed configuration and twists (para. [0046], [0050], [0062]).
Regarding claim 15, Vetter discloses the device of claim 1. Vetter also discloses wherein all but a distal edge of the work element has a uniform thickness.
Regarding claim 16, Vetter discloses the device of claim 1. Vetter also discloses wherein the actuating lever is further operatively coupled to the work element to impart a twisting motion to the single articulable beak (para. [0062]).
Regarding claim 17, Vetter discloses a device (Figs. 1, 20-23b), comprising: a work element 13 (i.e., the rotatable element), configured to cut tissue and formed from a single tube of material and comprising a plurality of cuts to define at least one articulable beak (i.e., 13 can be manufactured from a single sheet and attached to pivot or rotate), the work element further comprising a proximal portion, the proximal portion defining a resilient section (i.e., Figs. 20-23b where 13 connects to 13b is being interpreted as the resilient member according to 112f above) that is also formed of the single tube of material and that is configured such that an axially-directed force imposed thereon causes the at least one articulable beak to assume a closed configuration (paras. [0062]-[0063]) and such that when the axially-directed force imposed on the resilient section is released, the at least one articulable beak is configured to assume an open configuration (paras. [0062]-[0063]); and a handle 12 comprising an actuating lever 30 operatively coupled to the work element to selectively cause the single articulable beak to assume the open configuration or the closed configuration (paras. [0062]-[0063]).
Regarding claim 18, Vetter discloses the device of claim 17. Vetter also discloses wherein the resilient section biases the at least one articulable beak in the open configuration (para. [0062]).
Regarding claim 19, Vetter discloses the device of claim 17. Vetter also discloses wherein the resilient section is further configured such that when the axially-directed force is imposed in the proximal direction, the resilient section causes the at least one articulable beak to assume the closed configuration (paras. [0062]-[0063]).
Regarding claim 20, Vetter discloses the device of claim 19. Vetter also discloses wherein the resilient section is further configured such that when the axially-directed force imposed in the proximal direction is released, the resilient section causes the at least one articulable beak to assume the open configuration (paras. [0062]-[0063]).
Regarding claim 21, Vetter discloses a device for cutting tissue samples (Figs. 1, 20-23b), the device comprising: a work element 13 (i.e., the rotatable element), configured to cut tissue and formed from a single tube of material (i.e., 13 can be manufactured from a single sheet and attached to pivot or rotate) that defines an inner surface and an outer surface and comprising a plurality of cuts to define at least one articulable beak (Fig. 21-22) configured to selectively assume an open configuration and a closed configuration (paras. [0062]-[0063]), the work element being configured to be acted upon by differential forces to open cause the at least one articulable beak to assume the open and closed configurations (paras. [0062]-[0063]), the device being free of any structures that act upon the work element to open or close the at least one articulable beak that protrude away from either the inner or outer surfaces of the single tube of material the work element (Fig. 21-22); and a handle 12 comprising an actuating lever 30 operatively coupled to the work element to selectively cause the single articulable beak to assume the open configuration or the closed configuration (paras. [0062]-[0063]).
Regarding claim 22, Vetter discloses the device of claim 21. Vetter also discloses wherein each of the at least one articulable beak comprises a surface defined by a hyperbolic segment of the single tube of material (Fig. 21 shows a hyperbolic shape at the tip).
Regarding claim 23, Vetter discloses the device of claim 21. Vetter also discloses wherein the at least one articulable beak is configured to open wider than a diameter of the single tube of material to thereby enable collection of tissue samples having a diameter that is larger than a diameter of the single tube of material (Figs. 20, 22).
Conclusion
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
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