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 .
Election/Restrictions
Applicant’s election without traverse of Group 1 (claims 1-15) and Species II, in the reply filed on 09/09/2025 is acknowledged.
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 and second opposed members...” in claim 2 and all dependent claims thereof.
“first and second sub-assemblies...” in claim 5, and all dependent claims thereof.
“mounting member” in claim 13, and all dependent claims thereof.
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 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (US 2020/0230360; hereinafter Yu).
Regarding claim 1, Yu discloses an active drives for robotic catheter manipulators. Yu shows a guide unit (see par. [0102], [0113], [0171]; fig. 1, 4, 6, 27) for an elongate flexible medical instrument steerable by an operator handle (see fig. 2), comprising a guide base fixedly securable in an operative position to define a reference datum relative to an orifice into which the flexible medical instrument is in-use to be inserted (see fig. 1-2; par. [0007]-[0009]); the guide base supporting a guide assembly engageable in-use with the flexible medical instrument to selectively inhibit lengthwise axial movement of the flexible medical instrument relative to the guide base (see fig. 1, 4, 6 and 27; par. [0007]-[0009]), and the guide assembly being moveable relative to the guide base to allow rotation of the flexible medical instrument about its axis while inhibiting said lengthwise axial movement (see par. [0105], [0112]).
Regarding claim 2, Yu shows wherein the guide assembly includes first and second opposed members to frictionally engage in-use with the flexible medical instrument (see 56 and 48 in fig. 4; 140 and 142 in fig. 13; and 308A and 308B in fig. 27).
Regarding claim 3, Yu shows wherein the first and second opposed members are or include first and second rotatable members (see par. [0174]).
Regarding claim 4, Yu shows wherein the first and second opposed members are moveable away from and towards one another (see 308a and 308b in fig. 29, 30, 31 and 32).
Regarding claim 5, Yu shows wherein the guide base and guide assembly are formed in first and second sub-assemblies which are moveable away from and towards one another (see fig. 1, 4, 13-14, and 29-30).
Regarding claim 6, Yu shows wherein the first and second sub-assemblies are pivotally coupled to one another (see fig. 1, 4, 13-14, and 29-30).
Regarding claim 7, Yu shows wherein the first and second sub-assemblies present a cover surface to one another (see fig. 1, 4, 13-14, and 29-30).
Regarding claim 8, Yu shows wherein the first and second sub-assemblies are lockable in abutment with one another (see par. [0181], fig. 37).
Regarding claim 9, Yu shows wherein at least one of the first and second opposed members is driven by an actuator whereby in-use the flexible medical instrument is selectively moveable in a lengthwise axial direction relative to the guide base (see actuator 404 and 390; par. [0190]).
Regarding claim 10, Yu shows wherein one of the guide unit or the guide assembly is selectively moveable in a direction parallel to a lengthwise axial direction of a flexible medical instrument guided in- use thereby (see par. [0016], [0127], fig. 4 and 25a-d).
Regarding claim 11, Yu shows wherein the guide assembly is or includes a turntable which is rotatable relative to the guide base (see par. [0171], fig. 27, 35, 37).
Regarding claim 12, Yu shows wherein one or more of the guide base and the guide assembly, as well as any sub- assemblies or parts thereof, are selectively completely separable from one another (see par. [0171]-[0176]; fig. 31-32).
Regarding claim 13, Yu shows further including a mounting member to fixedly secure the guide base in its operative position (see fig. 2).
Regarding claim 14, Yu shows wherein the mounting member houses one or more of at least one power cable to supply power to the guide unit, and at least one control cable to permit control of the guide unit (see fig. 1).
Regarding claim 15, Yu shows a method of using a guide unit according to claim 1, comprising the steps of: fixedly securing the guide base in an operative position to define a reference datum relative to an orifice into which a flexible medical instrument is to be inserted (see fig. 1-2; par. [0007]-[0009]); engaging the guide assembly with the flexible medical instrument (see par. [0105], [0112]); and steering the flexible medical instrument using an operator handle (see fig. 2; see par. [0105], [0112]).
Response to Arguments
The previous objections to claims 2-15 have been withdrawn in view of Applicant’s amendments to the claims.
The previous rejections under 35 USC 112 (b) to claims 10 and 15 have been withdrawn in view of Applicant’s amendments to the claims.
Applicant's arguments filed 12/22/2025, with respect to prior art rejection of claim 1, have been fully considered but they are not persuasive.
In response to Applicant’s arguments on pages 9-10, with respect to prior art rejection of claims 1 and 11, the examiner respectfully disagrees. The examiner maintains that prior art Yu does disclose all the claim limitations set forth in claim 1, particularly the claim limitation of that the guide assembly being moveable relative to the guide base to allow rotation of the flexible medical instrument about its axis while inhibiting said lengthwise axial movement. The examiner notes that claim 1 does not recite and limit how the guide assembly is being moveable relative to the guide base, and the term “moveable” under broadest interpretation can be interpreted as rotation movement, axial movement or any other movements. Yu does show a guide base fixedly securable in an operative position to define a reference datum relative to an orifice into which the flexible medical instrument is in-use to be inserted (see fig. 1-2; par. [0007]-[0009]), and the guide assembly being moveable relative to the guide base to allow rotation of the flexible medical instrument about its axis while inhibiting said lengthwise axial movement (par. [0105], [0112] and fig. 1, 27-29, 31 and 39 show allowing rotation of the flexible medical instrument using guide assembly and different gripping pads).
With respect to claim 11, the applicant argues that Yu shows gripping pads to move the catheter linearly, not rotationally, however, claim 11 does not recite anything regards to the movement of the catheter. Claim 11 is merely directed to the guide assembly including a turntable which is rotatable relative to the guide base and Yu does show the guide assembly is or includes a turntable which is rotatable relative to the guide base (par. [0171], fig. 27, 35, 37 show the guide base is rotatable relative to the guide base).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Noonan et al. (US 2019/0365201) disclose detecting endoluminal buckling of flexible instruments.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAHDEEP MOHAMMED whose telephone number is (571)270-3134. The examiner can normally be reached Monday to Friday, 9am to 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, Anne M Kozak can be reached at (571)270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAHDEEP MOHAMMED/ Primary Examiner, Art Unit 3797