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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/19/2026 has been entered.
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 § 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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. (US 2020/0230360; hereinafter Yu), in view of Destrebecq et al. (US 2019/0038872; hereinafter Destresbecq).
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 (see par. [0105], [0112]).
But, Yu fails to explicitly state that the guide assembly allows rotation of the flexible medical instrument about its elongate axis while inhibiting said lengthwise axial movement.
Destrebecq discloses a module for guiding an elongated flexible medical device and teaches guide assembly allows rotation of the flexible medical instrument about its elongate axis while inhibiting said lengthwise axial movement (see par. [0086], [0148]; fig. 7 and 8).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of guide assembly allows rotation of the flexible medical instrument about its elongate axis while inhibiting said lengthwise axial movement in the invention of Yu, as taught by Destrebecq, to be able to independently rotate and axial movement of the medical device.
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 and the turntable is mounted within the guide base to inhibit movement of the turntable along the elongate axis of the flexible instrument (see par. [0171], fig. 27, 35, 37), and Destrebecq teaches inhibiting movement of turntable along elongate axis of the flexible instrument while allowing said rotation of the flexible medical instrument about its elongate axis (see par. [0086], [0148]; fig. 7 and 8).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing of the claimed invention, to have utilized the teaching of inhibiting movement of turntable along elongate axis of the flexible instrument while allowing said rotation of the flexible medical instrument about its elongate axis in the invention of Yu, as taught by Destrebecq, to be able to independently rotate and axial movement of the medical device.
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
Applicant’s arguments filed on 06/19/2026 with respect to prior art rejection of claim 1 have been considered but are moot because the new ground of rejection does not rely on any rejection applied in the prior office action of record for any teaching or matter specifically challenged in the argument. The examiner has provided new prior art Destrebecq.
Furthermore, the examiner notes that Applicant’s argument on page 8 that claim 1 limits a rotational movement is controlled separately from the longitudinal movement, however, this limitation is not recited in claim 1. Furthermore, the examiner notes that in fig. 28-30, Yu does show that the guide assembly being moveable relative to the guide base.
Conclusion
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
Prosecution Insights