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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 procedure tool module” in claim 1. The examiner notes that this limitation is interpreted to mean a housing and driven gear, and functional equivalents thereof, as set forth in paragraph 170 of the published application.
“second procedure tool module” in claim 1. The examiner notes that this limitation is interpreted to mean a housing and driven gear, and functional equivalents thereof, as set forth in paragraph 177 of the published application.
“first transferring portion” in claims 2 and 5. The examiner notes that this limitation is interpreted to mean a transferring nut, and functional equivalents thereof, as set forth in paragraph 129 of the published application.
“second transferring portion” in claims 2 and 5. The examiner notes that this limitation is interpreted to mean a transferring nut and motor, and functional equivalents thereof, as set forth in paragraphs 130-131 of the published application.
“third procedure tool module” in claim 4. The examiner notes that this limitation is interpreted to mean a housing and a driven gear, and functional equivalents thereof, as set forth in paragraph 190 of the published application.
“third transferring portion” in claim 5. The examiner notes that this limitation is interpreted to mean a transferring nut and motor, and functional equivalents thereof, as set forth in paragraphs 132-133 of the published application.
“rotation power generating portion” in claim 8. The examiner notes that this limitation is interpreted to mean a motor, and functional equivalents thereof, as set forth in paragraph 147 of the published application.
“power transmitting portion” in claim 8. The examiner notes that this limitation is interpreted to mean a gear, and functional equivalents thereof, as set forth in paragraph 243 of the published application.
“supporting members” in claims 11 and 19. The examiner notes that this limitation is interpreted to mean a chain assembly, and functional equivalents thereof, as set forth in paragraph 204 of the published application.
“engaging portion” in claim 12. The examiner notes that this limitation is interpreted to mean a pair of engaging wheels, and functional equivalents thereof, as set forth in paragraph 207 of the published application.
“splitting portion” in claim 15. The examiner notes that this limitation is interpreted to mean a member having a wedge shape, and functional equivalents thereof, as set forth in paragraph 251 of the published application.
“transfer module driving portion” in claim 20. The examiner notes that this limitation is interpreted to mean a pair of engaging wheels, and functional equivalents thereof, as set forth in paragraph 207 of the published application. The examiner notes that this limitation is interpreted to mean a lead screw, motor, and frame slider, and functional equivalents thereof, as set forth in paragraph 119 of the published application.
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, 8, 9, 10, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yi (US 20180168751).
Regarding claim 1, Yi discloses a vascular intervention procedure device, comprising:
a base frame extending in a front and rear direction (base part 310 in fig. 10);
a transfer module (transfer unit 300 in fig. 10) including a transfer frame coupled to the base frame so as to be transferred in the front and rear direction along the base frame (fig. 10 shows a frame which supports components of transfer unit 300 contacting base 310);
a first procedure tool module coupled to the transfer module so as to be transferred with respect to the base frame in the front and rear direction and configured to rotate a first procedure tool, which is a catheter, about a rotation axis of the front and rear direction (the examiner notes that this limitation is interpreted to mean a housing and a driven gear as noted above; rotation cover 135 and gear 135 in fig. 10; paragraph 78); and
a second procedure tool module coupled to the transfer module so as to be transferred with respect to the base frame in the front and rear direction independently of the first procedure tool module and configured to support a second procedure tool which is a guide wire or a micro catheter inserted into the catheter (the examiner notes that this limitation is interpreted to mean a housing and a driven gear as noted above; guidewire supply unit 210 forms a housing in fig. 10 and gear 123).
Regarding claim 2, Yi discloses the transfer module includes:
a first transferring portion disposed in the transfer frame and configured to be coupled to the first procedure tool module and to transmit rotation power for rotating the first procedure tool to the first procedure tool module (the examiner notes that this limitation is interpreted to mean a transmitting nut; middle gear 115 in fig. 10 is a functional equivalent since it transfers rotational movement of motor 110 to the top gear 115); and
a second transferring portion disposed in the transfer frame so as to be transferred independently of the first transferring portion in rear of the first transferring portion, and coupled to the second procedure tool module (the examiner notes that this limitation is interpreted to mean a nut and a motor as noted above; motor 221 and middle gear 223 in fig. 10).
Regarding claim 8, Yi discloses the first transferring portion includes a rotation power generating portion generating rotation power for rotating the first procedure tool (the examiner notes that this limitation is interpreted to mean a motor as noted above; motor 110 in fig. 10), and a power transmitting portion configured to be connected to the rotation power generating portion, to be coupled to the first procedure tool module, and to transmit the rotation power for rotating the first procedure tool (the examiner notes that this limitation is interpreted to mean a gear as noted above; gear 115 coupled to motor 110 in fig. 10, paragraph 78).
Regarding claim 9, Yi discloses the first transferring portion is disposed in the transfer frame so as to be transferable in the front and rear direction (middle gear 115 in fig. 10 is shown to be in the frame of transfer unit 300), and wherein the transfer module is configured to transfer the first transferring portion and the second transferring portion simultaneously or independently (paragraph 84 discloses that transfer unit 300 can move relative to base unit 310 via a rack and pinion).
Regarding claim 10, Yi discloses the second procedure tool module is configured to rotate the second procedure tool about the rotation axis (paragraph 80), and wherein the second transferring portion is configured to transmit rotation power for rotating the second procedure tool to the second procedure tool module (paragraph 82 discloses that the gear 223 and motor 221 rotates the guidewire).
Regarding claim 20, Yi discloses a transfer module driving portion transferring the transfer module with respect to the base frame in the front and rear direction (the examiner notes that this limitation is interpreted to mean a pair of wheels as noted above; pinions 355 in fig. 10), wherein the transfer module is slidably coupled to the base frame by the transfer module driving portion (paragraph 84).
Claim(s) 1 and 4 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Clark (US 20220233820).
Regarding claim 1, Clark discloses a vascular intervention procedure device (fig. 3), comprising:
a base frame extending in a front and rear direction (linear member 60 in fig. 3 extends along the X-axis, equated to the claimed directions);
a transfer module (stages 62, brackets 78 and drive mechanisms 68 form the “transfer module” in fig. 10) including a transfer frame coupled to the base frame (housing of stages 62 each forms a frame) so as to be transferred in the front and rear direction along the base frame (paragraph 93);
a first procedure tool module coupled to the transfer module so as to be transferred with respect to the base frame in the front and rear direction and configured to rotate a first procedure tool, which is a catheter, about a rotation axis of the front and rear direction (the examiner notes that this limitation is interpreted to mean a housing ad a driven gear as noted above; cassette 66a in fig. 3 comprises a cassette housing 316 and a driven gear 322; paragraphs 94 and 110 discloses rotating a EMD); and
a second procedure tool module coupled to the transfer module so as to be transferred with respect to the base frame in the front and rear direction independently of the first procedure tool module and configured to support a second procedure tool which is a guide wire or a micro catheter inserted into the catheter (the examiner notes that this limitation is interpreted to mean a housing ad a driven gear as noted above; cassette 66b in fig. 3 comprises a cassette housing 316 and a driven gear 322; paragraph 93 discloses that each stage 62 is independently movable so that the cassette 66b is independently movable relative to cassette 66a).
Regarding claim 4, Clark discloses the second procedure tool module is a micro catheter module configured to support the micro catheter (the examiner notes that the “micro catheter” is functional and that cassette 66b is capable of supporting a micro catheter), and wherein the vascular intervention procedure device further comprises a third procedure tool module coupled to the transfer module so as to be transferred with respect to the base fame in the front and rear direction and configured to rotate a third procedure tool, which is a micro guide wire inserted into the micro catheter, about the rotation axis (the examiner notes that this limitation is interpreted to mean a housing ad a driven gear as noted above; cassette 66c in fig. 3 comprises a cassette housing 316 and a driven gear 322; paragraph 93 discloses that each stage 62 is independently movable so that the cassette 66c is independently movable relative to cassettes 66a/b).
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(s) 3, 4, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yi, as applied to claims 1 and 2 above, and further in view of Clark.
Regarding claim 3, Yi discloses all of the claimed limitations set forth in claims 1 and 2, as discussed above, and further discloses the transfer module includes a rack and pinion to transfer the second transferring portion (paragraph 84 discloses the rack/pinion transfers the entire transfer unit 300, which includes the second transferring portion).
However, Yi does not teach or disclose the module includes a module transferring lead screw a module transferring lead screw disposed along the front and rear direction and coupled to the second transferring portion so as to transfer the second transferring portion through screw motion.
Clark teaches a transfer module which includes a module transferring lead screw a module transferring lead screw disposed along the front and rear direction (drive mechanism 76 in fig. 3; paragraph 93 discloses the drive mechanism can be a lead screw) and coupled to the second transferring portion so as to transfer the second transferring portion through screw motion (fig. 3 shows the second transferring portion 64b coupled to drive mechanism 76 via screwing).
Clark teaches that the lead screw is an alternative to a rack and pinion arrangement (paragraph 93). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the rack and pinion to be a module transferring lead screw and nut as taught by Clark as Cleark teaches this is a suitable alternative to providing longitudinal movement.
Regarding claim 4, Yi discloses all of the claimed limitations set forth in claim 1, as discussed above, and further discloses the second procedure tool module is a micro catheter module configured to support the micro catheter (the micro catheter is functional so that the module 200 is configured to support a micro catheter).
However, Yi does not teach or disclose the vascular intervention procedure device further comprises a third procedure tool module coupled to the transfer module so as to be transferred with respect to the base fame in the front and rear direction and configured to rotate a third procedure tool, which is a micro guide wire inserted into the micro catheter, about the rotation axis.
Clark teaches a similar vascular intervention device (fig. 3) which comprises a third procedure tool module (the examiner notes that this limitation is interpreted to mean a housing ad a driven gear as noted above; cassette 66c in fig. 3 comprises a cassette housing 316 and a driven gear 322) so as to be transferred with respect to the base fame in the front and rear direction and configured to rotate a third procedure tool, which is a micro guide wire inserted into the micro catheter, about the rotation axis (paragraphs 92 and 93 discloses the cassette 66c can move and rotate the device independently of the other devices).
Since Yi teaches that the second procedure tool module is configured to be transferred with respect to the base frame in a front/rear direction and is configured to rotate (paragraph 80), it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have modified the transfer module of Yi (300 in fig. 10) to comprise a third procedure tool module which comprises all of the components of the second procedure tool module (200 in fig. 10). Clark teaches that it is known to have a system comprising more than two elongate, concentric medical devices (fig. 10) which can increase the utility of the device of Yi.
Regarding claim 5, in the modified device of Yi, Yi discloses the transfer module further includes:
a first transferring portion disposed in the transfer frame and configured to be coupled to the first procedure tool module and to transmit rotation power for rotating the first procedure tool to the first procedure tool module (the examiner notes that this limitation is interpreted to mean a nut as noted above; middle gear 115 in fig. 10 is considered a functional equivalent since it receives and transfers rotational movement from motor 110) ;
a second transferring portion disposed in the transfer frame so as to be transferred independently of the first transferring portion in rear of the first transferring portion, and coupled to the second procedure tool module (the examiner notes that this limitation is interpreted to mean a nut and motor as noted above; middle gear 223 and motor 213 in fig. 10); and
a third transferring portion disposed in the transfer frame so as to be transferred in the front and rear direction independently of the first transferring portion and the second transferring portion in rear of the second transferring portion (the examiner notes that this limitation is interpreted to mean a motor and nut as noted above; in modified Yi, the third transferring portion would comprise the same components of the second transferring portion), and configured to be coupled to the third procedure tool module and to transmit rotation power for rotating the third procedure tool to the third procedure tool module (in modified Yi, the gear and motor would be coupled to the third procedure tool module to enable linear and rotational motion to the tool).
Allowable Subject Matter
Claims 6, 7, and 11-19 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:
Regarding claim 6, the closest prior art is Yi, as discussed above, which does not teach or disclose the transfer module includes a module transferring lead screw disposed along the front and rear direction and coupled to the second transferring portion and the third transferring portion so as to transfer the second transferring portion and the third transferring portion through screw motion, wherein the second transferring portion includes a second transferring nut coupled to the module transferring lead screw so as to be transferred through screw motion, and a second transferring motor configured to rotate the second transferring nut, and 64 wherein the third transferring portion includes a third transferring nut coupled to the module transferring lead screw so as to be transferred through screw motion, and a third transferring motor configured to rotate the third transferring nut.
Regarding claims 11 and 19, this closest prior art is Yi and Clark as discussed above, which does not teach or disclose a pair of supporting members, as interpreted above, configured to be drawn into or drawn out from the guide housing so as to have a variable length in the guide section according to a length change of the guide section in the front and rear direction, and configured to sandwich the first procedure tool or the second procedure tool by being engaged with each other.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Weitzner (US 20070060879) teaches a device comprises three different procedure tool modules which are configured to translate in a front/rear direction and rotate relative to each other (fig. 3).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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, BHISMA MEHTA can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
