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 . Claims 1-17 of the claim set received 10/10/2023 are pending.
Information Disclosure Statement
The information disclosure statements filed 1/17/2025 and 4/19/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Drawings
New drawings are required under PCT Rule 11. The drawings are necessary to understand the construction of the second embodiment of the driving mechanism discussed in para. 0071 and claimed in claim 17 which is not captured in any drawing.
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: “driving mechanism” in claim 1 and “driving member”, “first driven member”, “second driven member” of claim 2.
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 corresponding structure to the driving mechanism is a driving member and to a first driven member and a second driven member. The driving member corresponds to one or two bevel gears. The first driven member corresponds to a bevel gear and the second driven member corresponds to a
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.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Humphrey (US 2019/0117937).
Regarding Claim 1, Humphrey discloses in Fig. 1, a deflectable catheter, comprising: a sheath 14 having a bendable section 18; a first traction wire 20 anchored to the bendable section of the sheath; a second traction wire 22 anchored to the bendable section of the sheath at a location circumferentially different from that of the first traction wire 20 (see also Figs. 2-3A); and a driving mechanism 38 (see Fig. 5) connected to both the first traction wire and the second traction wire, wherein the driving mechanism pulls and releases the first traction wire and the second traction wire, and when the driving mechanism pulls any of the first traction wire and the second traction wire, the driving mechanism will synchronously release the other one of the first traction wire and the second traction wire (read para. 0076).
Regarding Claim 2, Humphrey discloses in Fig. 5, wherein the driving mechanism comprises a driving member 44, a first driven member 40 linked with the driving member, and a second driven member 42 linked with the driving member, and wherein the first driven member is connected to the first traction wire 20, the second driven member is connected to the second traction wire 22, and the driving member drives one of the first driven member and the second driven member to pull the traction wire connected thereto and synchronously drives the other one of the first driven member and the second driven member to release the traction wire connected thereto (read e.g. para. 0076).
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.
Claims 3-7 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Humphrey (US 2019/0117937) in view of Kimmel (US 2022/0054800).
Regarding Claim 3, Humphrey discloses the claimed invention as discussed above. Humphrey does not disclose wherein the driving member is a driving bevel gear, the first driven member is a first driven bevel gear meshing with the driving bevel gear, the second driven member is a second driven bevel gear meshing with the driving bevel gear, the first driven bevel gear is connected to the first traction wire, the second driven bevel gear is connected to the second traction wire, the driving bevel gear drives one of the first driven bevel gear and the second driven bevel gear to pull the traction wire connected thereto and synchronously drives the other one of the first driven bevel gear and the second driven bevel gear to release the traction wire connected thereto. However, Humphrey discloses the driving mechanism comprises a gear train and that any gear train can be used in the driving mechanism (para. 0061).
Kimmel discloses in Figs. 3-5, a first traction wire 34 and a second traction wire 36 of a deflectable catheter similar to that disclosed by Humphrey (read paras. 0048-0051). Kimmel discloses the driving mechanism comprising wherein the driving member is a driving bevel gear 38, the first driven member is a first driven bevel gear 24 meshing with the driving bevel gear, the second driven member is a second driven bevel gear 26 meshing with the driving bevel gear, the first driven bevel gear is connected to the first traction wire 34, the second driven bevel gear is connected to the second traction wire 36, the driving bevel gear drives one of the first driven bevel gear and the second driven bevel gear to pull the traction wire connected thereto and synchronously drives the other one of the first driven bevel gear and the second driven bevel gear to release the traction wire connected thereto (read para. 0049).
It would have been obvious to one of ordinary skill in the art at the time of filing to have modified Humphrey to include the differential/driving mechanism taught by Kimmel because of Humphrey’s teaching that any differential can be used in order to have a simple design that is easy to manipulate and assemble (read e.g. para. 0074).
Regarding Claim 4, Humphrey in view of Kimmel teaches the claimed invention as discussed above. Kimmel teaches the driving mechanism of the combination including wherein the first traction wire 34 is wound on the first driven bevel gear 24 in a first direction, the second traction wire 26 is wound on the second driven bevel gear 36 in a second direction, and the first direction is in the same direction as the second direction (see Fig. 7); the driving bevel gear 38 drives the first driven bevel gear and the second driven bevel gear to rotate simultaneously, and rotation directions of the first driven bevel gear and the second driven bevel gear are opposite (see Fig. 5).
Regarding Claim 5, Humphrey in view of Kimmel teaches the claimed invention as discussed above. Kimmel teaches the driving mechanism of the combination including as shown in Fig. 4, wherein the first driven bevel gear 24 and the second driven bevel gear 26 are arranged symmetrically with respect to at least one axial plane of the driving bevel gear.
Regarding Claim 6, Humphrey in view of Kimmel teaches the claimed invention as discussed above. Kimmel teaches the driving mechanism of the combination including wherein, as shown in Fig. 4, the first driven bevel gear 24 and the second driven bevel gear 26 are located at circumferentially different positions of the driving bevel gear 38, the rotational central axis of the first driven bevel gear is arranged coaxially with that of the second driven bevel gear, and the rotational central axes of the first driven bevel gear and the second driven bevel gear are both perpendicular to the central axis of the driving bevel gear (all as shown in the figure).
Regarding Claim 7, Humphrey in view of Kimmel teaches the claimed invention as discussed above. Kimmel teaches the driving mechanism of the combination including wherein the driving mechanism further comprises a support frame comprising a first rotary shaft and a second rotary shaft which are arranged collinearly and located in the same radial plane of the sheath (see annotation of Fig. 4 below), the first driven bevel gear 24 is rotatably arranged on the first rotary shaft, and the second driven bevel gear 26 is rotatably arranged on the second rotary shaft.
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Regarding Claim 9, Humphrey in view of Kimmel teaches the claimed invention as discussed above. Humphrey further discloses in Figs. 3A and 3B, wherein the first traction wire 24 and the second traction wire 26 are located in the same axial plane of the sheath.
Regarding Claim 10, Humphrey in view of Kimmel teaches the claimed invention as discussed above. Kimmel teaches the driving mechanism of the combination including, as best shown in Fig. 5, wherein the driving mechanism further comprises an adjusting member 14 comprising an adjusting tube 14 having an end connected to the driving bevel gear 38 and an adjusting component (the ridged portion) connected to the other end of the adjusting tube, wherein the sheath 12 extends through the adjusting tube 14, and the adjusting component drives the adjusting tube to rotate and drives the driving bevel gear to rotate (as shown in Fig.5).
Regarding Claim 11, Humphrey in view of Kimmel teaches the claimed invention as discussed above. Humphrey further discloses a handle housing 12 having an accommodating cavity. Kimmel teaches the driving mechanism of the combination including wherein the driving mechanism is located in the accommodating cavity of the handle housing 20 (see Fig. 3), at least two limiting members are provided on the adjusting tube to axially limit the adjusting tube, limiting rib plates corresponding to and bearing against the two limiting members are provided on an inner wall of the handle housing 12 (see annotation of Fig. 7 below), the two limiting members are located between the two limiting rib plates, or the two limiting rib plates are located between the two limiting members.
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Regarding Claim 12, Humphrey in view of Kimmel teaches the claimed invention as discussed above. Kimmel teaches the driving mechanism of the combination including wherein the limiting members (as defined above) protrude from an outer surface of the adjusting tube 14, the adjusting member further comprises a sleeve (the portion of 20 in which the defined limiting rib plates are located as shown in Fig. 1) surrounding the limiting members, and an axial length of the limiting members is less than an axial length of the sleeve.
Regarding Claim 13, Humphrey in view of Kimmel teaches the claimed invention as discussed above. Kimmel teaches the driving mechanism of the combination including, as shown in Fig. 8, further comprising a stop mechanism comprising a first stop 50 and a second stop 56, one 50 of the first stop and the second stop is connected to the driving bevel gear and rotates synchronously with the driving bevel gear, the other one 56 of the first stop and the second stop remains stationary relative to the sheath, there is a stop force between the first stop and the second stop, and the stop force enables the first stop and the second stop to limit each other circumferentially (see Figs. 10 and 11), a torque generated by the stop force on the driving bevel gear is A1, and when the sheath is in a bent state, a torque generated by a pull-back force of the sheath on the driving bevel gear is A2, wherein A1 is greater than or equal to A2 (these forces are variable and there can be a case where the pull-back force is minimal, i.e. not much friction, and the stop force great if the user is applying a large amount of force A1).
Regarding Claim 14, Humphrey in view of Kimmel teaches the claimed invention as discussed above. Kimmel teaches the driving mechanism of the combination including wherein the first stop 50 and the second stop rotate relative 56 to each other when a torque acting on the driving bevel gear (transmitted through the handle 14) is greater than A1 (if a large torque, larger than a variable A1, is applied to the handle 14, the stops rotate relative to each other as shown in Figs. 9-11).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Humphrey (US 2019/0117937) in view of Kimmel (US 2022/0054800) and further in view of Shirota (US 5,368,572)
Regarding Claim 8, Humphrey in view of Kimmel teaches the claimed invention as discussed above. Kimmel teaches the driving mechanism of the combination but does not explicitly teach including wherein rotatably contacting surfaces of the first rotary shaft with the first driven bevel gear are smooth surfaces, and rotatably contacting surfaces of the second rotary shaft with the second driven bevel gear are smooth surfaces.
Shirota discloses a medical instrument in Figs. 3 and 4, and teaches the instrument comprising a driven bevel gear G2 rotatably arranged on a rotary shaft 61 wherein rotatably contacting surfaces of the rotary shaft and the driven bevel gear are smooth surfaces (col. 4, ll. 31-47; 61 is a simple support shaft on which the bevel gear G2 rotates, it will have a smooth outer surface mating with a smooth outer surface of the bevel gear).
It would have been obvious to one of ordinary skill in the art at the time of filing to have modified Humphrey in view of Kimmel further such that the contacting surfaces of the bevel gears and shafts are smooth surfaces as taught by Shirota because of an art recognized suitability for the smooth surface in applications of bevel gears allowing the gears to rotate freely (Shirota col. 4, ll. 31-47).
Allowable Subject Matter
Claims 15-17 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not disclose or form a reasonable combination teaching the following in combination -
Regarding Claim 15, “wherein the first stop is connected to the driving bevel gear, the first stop rotates synchronously with the driving bevel gear, the second stop has a plurality of positioning recesses arranged thereon in an annular layout, and the first stop rotates synchronously with the driving bevel gear and is elastically snap-fitted with a corresponding one of the plurality of positioning recesses on the second stop.”
Regarding Claim 17, “wherein the driving member comprises a first driving bevel gear and a second driving bevel gear, the first driven member is a first driven bevel gear meshing with the first driving bevel gear, the second driven member is a second driven bevel gear meshing with the second driving bevel gear, the first traction wire is wound on the first driven bevel gear in a first direction, the second traction wire is wound on the second driven bevel gear in a second direction, the first direction is opposite to the second direction, and rotation directions of the first driven bevel gear and the second driven bevel gear are the same.”
Claim 16 is allowable at least by basis on claim 15.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure can be found in the attached Notice of References Cited.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENE D FORD whose telephone number is (571)272-8140. The examiner can normally be reached on M-F 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Phutthiwat Wongwian can be reached on (571) 270-5426. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.D.F/Examiner, Art Unit 3741
/PHUTTHIWAT WONGWIAN/Supervisory Patent Examiner, Art Unit 3741