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 1-14, 16, and 18-22 of the amended claim set received 6/22/2026 are pending. Claims 15 and 17 have been canceled.
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 claims 1 and 22 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.
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, 9, 21 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Golden (US 2009/0287188).
Regarding Claim 1, Golden discloses a deflectable catheter, comprising:
a sheath 24 (Figs. 1 and 2) having a bendable section 38;
a first traction wire 44 anchored to the bendable section of the sheath;
a second traction wire 44 anchored to the bendable section of the sheath at a location circumferentially different from that of the first traction wire (see Fig. 2);
a driving mechanism 70 connected to both the first traction wire 44 and the second traction wire 44;
a handle housing 50 having an accommodating cavity (see Fig. 3), the driving mechanism 70 located in the accommodating cavity of the handle housing (as shown in Fig. 3);
an adjusting member 62 connected to the driving mechanism 70 and comprising an adjusting component 62;
a stop mechanism comprising a first stop 130 and a second stop 96 (see Figs. 7A and 7B), the first stop 84 connected to the adjusting component 62 (as shown in Fig. 3), the second stop 130 remaining stationary relative to the sheath 24 (e.g. when the position of Fig. 7A is held constant);
wherein the driving mechanism 70 pulls and releases the first traction wire 44 and the second traction wire 44, and when the driving mechanism pulls any of the first traction wire and the second traction wire, the driving mechanism 70 will synchronously release the other one of the first traction wire 44 and the second traction wire 44 (see Fig. 4, read para. 0035: pair of wires 44 secured on opposite sides of pulley 70, such that rotation of the pulley pulls one wire while releasing the other); and
wherein the second stop 96 has a plurality of positioning recesses 122B arranged thereon in an annular layout (see Fig. 6), and the first stop 130 is elastically snap-fitted with a corresponding one of the plurality of positioning recesses 122B on the second stop 96 (as shown in Fig. 7B).
Regarding Claim 9, Golden discloses the claimed invention as discussed above and further discloses the first traction wire 44 and the second traction wire 44 are located in the same axial plane of the sheath 24 (see Fig. 2; a plane could be formed which contains any two of the wires 44 shown).
Regarding Claim 21, Golden discloses wherein the stop mechanism 130+96 is arranged opposite to the adjusting component 62 and is configured to maintain the bendable section 38 of the sheath in a corresponding bent state after it is bent to a preset position (the locked position shown in Fig. 7A as described, e.g., in paras. 0050-0052).
Regarding Claim 22, Golden discloses a deflectable catheter, comprising:
a sheath 24 (Figs. 1 and 2) having a bendable section 38;
a first traction wire 44 anchored to the bendable section of the sheath;
a second traction wire 44 anchored to the bendable section of the sheath at a location circumferentially different from that of the first traction wire (see Fig. 2); and
a driving mechanism 70 connected to both the first traction wire 44 and the second traction wire 44, wherein the driving mechanism 70 pulls and releases the first traction wire 44 and the second traction wire 44, and when the driving mechanism pulls any of the first traction wire and the second traction wire, the driving mechanism 70 will synchronously release the other one of the first traction wire 44 and the second traction wire 44 (see Fig. 4, read para. 0035: pair of wires 44 secured on opposite sides of pulley 70, such that rotation of the pulley pulls one wire while releasing the other);
an adjusting member 62 and a handle housing 50 (see Fig. 3);
wherein the adjusting member 62 is configured to adjust the driving mechanism 70 for selecting and adjusting a bending direction and a bending angle of the sheath 24 (read para. 0033), the adjusting member comprises an adjusting component 62 which is at least partially exposed outside the handle housing 50; wherein the deflectable catheter further comprises a stop mechanism 84 arranged opposite to the adjusting component 62 and is configured to maintain the bendable section 38 of the sheath in a corresponding bent state after it is bent to a preset position (the locked position as described in paras. 0050-0052).
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kanemasa (US 2016/0339208).
Regarding Claim 1, Kanemasa discloses a deflectable catheter, comprising:
a sheath 10 (Figs. 1A-1C and 2) having a bendable section DE;
a first traction wire 30a anchored to the bendable section of the sheath;
a second traction wire 30b anchored to the bendable section of the sheath at a location circumferentially different from that of the first traction wire (see Fig. 2);
a driving mechanism 64 connected to both the first traction wire 30a and the second traction wire 30b (read para. 0148);
a handle housing 80+65 having an accommodating cavity (recessed portion of 65 into which driving mechanism 64 positioned as read at para. 0180), the driving mechanism 64 located in the accommodating cavity of the handle housing (as shown in Figs. 4 and 5 and described above);
an adjusting member 61 connected to the driving mechanism 64 and comprising an adjusting component 61;
a stop mechanism comprising a first stop 62a and a second stop 63 (see Fig. 6), the first stop 62a connected to the adjusting component 61 (via fittings 62c and 61c), the second stop 63 remaining stationary relative to the sheath 10 (e.g. when the torque applied by the adjusting component 61 is too great, 62a slips while 63 remains stationary, read paras. 0152-0153);
wherein the driving mechanism 64 pulls and releases the first traction wire 30a and the second traction wire 30b, and when the driving mechanism pulls any of the first traction wire and the second traction wire, the driving mechanism 64 will synchronously release the other one of the first traction wire 30a and the second traction wire 30b (see Fig. 5, read para. 0148); and
wherein the second stop 63 has a plurality of positioning recesses 63b arranged thereon in an annular layout (see Figs. 6 and 8A), and the first stop 62a is elastically snap-fitted with a corresponding one of the plurality of positioning recesses 63b on the second stop 96 (as can be understood looking at Fig. 6 and reading para. 0153).
Regarding Claim 2, Kanemasa discloses wherein the driving mechanism 64 comprises a driving member 64b, a first driven member 66 linked with the driving 64b member, and a second driven member 66 linked with the driving member 64b, and wherein the first driven member 66 is connected to the first traction wire 30a (read para. 00148), the second driven member 66 is connected to the second traction wire 30b, and the driving member 64b drives one of the first driven member 66 and the second driven member 66 to pull the traction wire 30a or 30b connected thereto and synchronously drives the other one 66 of the first driven member and the second driven member to release the traction wire (the other of 30a and 30b) connected thereto (as can be understood looking at Fig. 5).
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.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kanemasa (US 2016/0339208).
Regarding Claim 20, Kenemasa further discloses wherein the first stop 62a is fixed to the adjusting component 61 (via fittings 62c and 61c, as described in para. 0152), and the second stop 63 is opposite to the adjusting component 61 (63 is opposite to 61, relative to 62).
Although the specification and drawings do not clearly show the second stop 63 is spaced apart from the adjusting component 61 as claimed, it is one of two options (a) where there is contact or (b) where there is no contact, either of the two options would equally enable the apparatus to function as intended. It would have been obvious to one of ordinary skill in the art at the time of filing to produce the deflectable catheter of Kenemasa such that the second stop is spaced apart from the adjusting component given that it is one of two viable options and there is a design need to choose one in order to reproduce the invention, see MPEP 2144.05 II B.
Allowable Subject Matter
Claims 18-19 are allowable.
Claims 3-8, 10-14, and 16 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:
Regarding Claim 3, the prior art does not disclose or form a reasonable combination teaching the following in combination with the limitations of the base claim, “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.”
Regarding Claim 18, “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.”
Claims 4-8, 10-14, 16, and 19 are allowable at least by basis on one of the claims discussed above.
Response to Arguments
Applicant’s arguments with respect to prior art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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