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: “a biasing member” in claims 1 and 16 having structural recitation in Applicant’s specification [0044].
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 and 5-19 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by U.S. Patent Application Publication 2016/0227986 to Yasunaga (hereinafter “Yasunaga”). In regards to claims 1-2 and 5-19, Yasunaga discloses a medical device comprising:
In regards to claim 1: a handle (Fig. 1, Element 3) comprising a housing (Fig. 1, Element 8) and an actuator mechanism (entirety of Fig. 2) disposed within the housing, wherein the actuator mechanism includes: a disk (Element 22) rotatable between a first position and a second position ([0051]); and a biasing member (Element 30), wherein a proximal end of the biasing member is coupled to the disk and a distal end of the biasing member is coupled to the housing (see Fig. 3, Element 30 is connected at Element 23 and 24, Figs. 4 and 5 show that orientation of the biasing member is selectable), wherein, in the first position of the disk, the biasing member has a first length and exerts a first distal force on the disk (Fig. 4, Element 30 has a 1st length); and wherein, in the second position of the disk, the biasing member has a second length different from the first length and exerts a second distal force on the disk less than the first distal force (Fig. 2, Element 30 has a 2nd length, [0062]-[0066])
In regards to claim 2, wherein the first length of the biasing member is greater than the second length of the biasing member (Length of Element 30 in Figs. 2 and 4)
In regards to claim 5, wherein the actuator mechanism further includes a lever coupled to the disk (Fig. 2, Element 14)
In regards to claim 6, wherein the lever is coupled to an outer surface of the housing of the handle, the lever being rotatable to drive a corresponding rotation of the disk (see Element 14, Fig. 1, [0048])
In regards to claim 7, wherein the biasing member is fixed to a proximal portion of the disk (Fig. 5 shows connection location is selectable)
In regards to claim 8, wherein the actuator mechanism further comprises first and second control members each coupled to the disk (Elements 17 and 18, respectively)
In regards to claim 9, wherein the first control member (Element 17) is attached to the disk by a first coupler ([0051]), the second control member (Element 18) is attached to the disk by a second coupler ([0051]), and the biasing member is attached to the disk by a third coupler (Element 23), and wherein the third coupler is between the first coupler and second coupler (see Fig. 4)
In regards to claim 10, wherein movement of the disk from the first position to the second position is configured to move the first control member proximally and the second control member distally, and wherein movement of the disk from the second position to the first position is configured to move the first control member distally and the second control member proximally (Figs. 4 and 5, [0051]-[0053])
In regards to claim 11, wherein the biasing member includes a spring (Fig. 3, Element 39)
In regards to claim 12, wherein, in a third position of the disk, the biasing member has a third length and exerts a third distal force on the disk, wherein the third distal force is less than the first distal force ([0068] [0071]-[0082] explains how various levels of lever rotation display different torques on the disk)
In regards to claim 13, wherein the disk is rotatable in a first direction between the first position and the second position, and rotatable in a second direction between the first position and the third position (Figs. 4+5, [0051]-[0053])
In regards to claim 14, wherein the medical device further comprises a shaft (Fig. 1, Element 2) coupled to the handle, the shaft comprising an articulation section (Element 12) operably coupled to the actuator mechanism
In regards to claim 15, wherein movement of the disk from the first position to the second position is configured to move the articulation section of the shaft along a first plane, and movement of the disk from the first position to a third position is configured to move the articulation section of the shaft along a second plane perpendicular to the first plane ([0048], four directions of movement)
In regards to claim 16, a handle (Fig. 1, Element 3) comprising a housing (Fig. 2, Element 8) and an actuator mechanism (entirety of Fig. 2) disposed within the housing, wherein the actuator mechanism includes: a rotatable disk (Element 22, [0051]); a biasing member (Element 30) coupled to, and configured to exert a force on, the disk ([0065] [0066]); a first control member coupled to the disk (Element 17); and a second control member coupled to the disk (Element 18); wherein the handle is configured to rotate from a first configuration to a second configuration by rotation of the disk, and wherein, in the second configuration, the force exerted on the disk is greater than the force exerted on the disk in the first configuration ([0068] [0071]-[0082] explains how various levels of lever rotation display different torques on the disk)
In regards to claim 17, wherein rotating from the first configuration to the second configuration shortens a length of the biasing member ([0064] [0076] [0080])
In regards to claim 18, wherein the actuator mechanism further includes a lever (Element 14) coupled to the disk, the lever configured to be engaged by a user to drive rotation of the disk ([0063])
In regards to claim 19, a shaft (Fig. 1, Element 2) coupled to the handle, the shaft comprising an articulation section (Element 12) operably coupled to the actuator mechanism, wherein movement of the disk is configured to control the articulation section ([0048])
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3-4 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yasunaga in view of U.S. Patent Application Publication 2022/0280021 to Chu (hereinafter “Chu”). Yasunaga discloses a rotatable disk (Element 22), but does not disclose first and second protrusions on the disk. However, Chu discloses an analogous medical device wherein:
In regards to Claim 3, wherein the disk includes a first protrusion on a first side of the disk and a second protrusion on a second side of the disk (Figs. 12 and 14, first protrusion = Elements 253+282, second protrusion = Element 261, [0124] [0135])
In regards to Claim 4, wherein an inner surface of the housing receives the first protrusion on a first side of the handle and the second protrusion on a second side of the handle opposite the first side (Fig. 14, Element 286, housing cap is shown as removed in the Figure, [0135] [0136])
It would have been obvious before the effective filing date of the claimed invention to modify Yasunaga to include first and second protrusions such as that taught by Chu in order to set maximum allowable bending angles such as that suggested by Chu in [0135].
In regards to claim 20, Yasunaga teaches a medical device comprising: a handle (Fig. 1, Element 3) comprising a housing (Element 8) and an actuator mechanism (entirety of Fig. 2) disposed within the housing, wherein the actuator mechanism includes: a disk rotatable between a first position and a second position (Element 22, [0051]); a biasing member (Element 30), wherein a proximal end of the biasing member is coupled to the disk and a distal end of the biasing member is coupled to an internal surface of the housing (Fig. 3, connected to disc at Element 23 and to the housing at Element 24); a first control member coupled to the disk (Element 17); and a second control member coupled to the disk (Element 18). However, Yasunaga does not disclose first and second protrusions on the disk. Chu discloses an analogous medical device wherein the disk includes a first protrusion on a first side of the disk and a second protrusion on a second side of the disk, wherein the housing receives the first protrusion on a first side of the handle and the second protrusion on a second side of the handle opposite the first side (Figs. 12 and 14, first protrusion = Elements 253+282, second protrusion = Element 261, [0124] [0135]).
It would have been obvious before the effective filing date of the claimed invention to modify Yasunaga to include first and second protrusions such as that taught by Chu in order to set maximum allowable bending angles such as that suggested by Chu in [0135].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL JAMES CAREY whose telephone number is (571)270-7235. The examiner can normally be reached Monday-Friday (8am-5pm).
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/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795