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 .
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.
Response to Amendment
This Action is responsive to the Reply filed on 10 June 2025 (“Reply”). As directed in the Reply:
no claims have been amended;
no claims have been and/or remain cancelled; and
no claims have been added.
Thus, Claims 1-31 are presently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1-25, and species A, Claims 1-13, in the Reply is acknowledged.
Claims 14-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply.
Drawings
The drawings are objected to because of the following informalities:
Fig. 3 must include cross-hatching of solid elements;
Fig. 5 should be labeled as two separate figures, e.g., 5A and 5B, and the Specification updated accordingly - Applicant may, however, jointly refer to the subfigures as Fig. 5 when appropriate;
Figs. 6 and 7 should each be bracketed to include their subparts; and
Section lines 3-3 (Fig. 2), 6-6, and 7-7 (Fig. 5) are not discussed in the Specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The Abstract of the Disclosure (“Abstract”) is objected to because it includes self-evident language (line 1: “are disclosed”). A corrected Abstract is required. See MPEP § 608.01(b). Any replacement Abstract must commence on a separate sheet, apart from any other text, 37 C.F.R. §§ 1.52(b)(4), 1.72(b), and include markings to show added and deleted text, 37 C.F.R. § 1.121(b)(2).
The disclosure is objected to because of the following informalities (referencing the Specification’s paragraph numbers):
[0054], line 5, text should refer the reader to Figs. 6, 7 to see ref. no. 114;
[0060], lines 3-5 are inaccurate, as Figs. 2 and 3 show lumens 120, 122 empty and the device 102 in lumen 124.
Appropriate correction is required.
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.
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.
(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.
Claims 1-4, 6-9, 12 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. 2005/0228274, by Böse et al. (“Böse”).
Böse describes a system as claimed by Applicant, as follows.
Claim 1: A system (Fig. 1), comprising:
an elongate medical device (2) including:
a tubular body (2); and
a lumen (12a, 12b) terminating proximal of a distal end of the medical device (Fig. 2, showing closed distal ends of the lumens), the lumen configured to contain a fluid therein (lumens can contain fluid); and
a fluid-pressurizing means for pressurizing the fluid and, thereby, inducing a curve in at least a distal portion of the medical device under control of a user for steering the medical device through an anatomical lumen or a network of anatomical lumens (5; [0023], [0025]).
Claim 2: (The system of claim 1,) wherein the fluid-pressurizing means is also for depressurizing the fluid and, thereby, softening or reducing the curve in at least the distal portion of the medical device under the control of the user for the steering of the medical device through the anatomical lumen or the network of anatomical lumens ([0034], discussing depressurization).
Claim 3: (The system of claim 2,) wherein the fluid-pressurizing means is a pneumatic or hydraulic pump station including a pump configured to pressurize and depressurize the fluid ([0025], indicating that the fluid can be liquid or gas, and thus that the control device 5 is pneumatic or hydraulic).
Claim 4: (The system of claim 3,) wherein the pump station is configured with a processor, memory, and associated logic configured to pressurize the fluid along a continuum for a corresponding continuum of curvature in at least the distal portion of the medical device under the control of the user ([0031]-[0033], discussing recording, and thus a memory; ‘assigning’ a section of the catheter, thus indicating a processor to do the assigning and logic upon which the processor bases the assignment; ‘determining,’ indicating the same).
Claim 6: (The system of claim 1,) wherein the fluid is a gas ([0025]).
Claim 7: (The system of claim 1,) wherein the fluid is a liquid (id.).
Claim 8: (The system of claim 1,) wherein the lumen is offset from a central axis of the medical device to allow tension along a side of the medical device including the lumen and compression along an opposite side of the medical device from the lumen when the fluid is pressurized for inducing the curve in at least the distal portion of the medical device (see Fig. 3, showing lumena 12a-f offset from the center of lumen 14).
Claim 9: (The system of claim 8,) wherein the medical device further includes a signal-conducting means for conducting a signal along a length of the medical device, the signal-conducting means offset from the central axis of the medical device in the opposite side of the medical device from the lumen (signal conductors 15a-e; Fig. 3, showing a signal-conductor opposite each of the lumena).
Claim 12: (The system of claim 1,) wherein the medical device is a stylet, the tubular body of the stylet configured to be disposed in a lumen of another elongate medical device (device 2 is fully capable of being used as a stylet, e.g., having another interventional catheter mounted over it for insertion into a body cavity).
Claim 13: (The system of claim 12,) wherein the other elongate medical device is an intravenous catheter (same; the catheter is not claimed).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Böse as applied to Claim 2 above, and further in view of U.S. Patent No. 4,909,787, granted to Danforth (“Danforth”).
Böse describes a device substantially as claimed by Applicant; see above. It does not, however, expressly describe the exact nature of the subcomponent that provides the pressure to the fluid in its lumena 12a-f, and thus does not disclose that its fluid-pressurizing means is a syringe or bulb configured to pressurize and depressurize the fluid.
Danforth relates to catheters which can be steered by the application of fluid pressure to a closed offset lumen and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Danforth teaches that the fluid-pressurizing means of such a device can be a syringe (47) configured to pressurize and depressurize the fluid, which a person of ordinary skill in the art understands is a simple, cost-effective, commonly commercially available option for applying fluid pressure to a lumen of a catheter.
It 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, to construct Böse‘s device such that its fluid-pressurizing means is a syringe or bulb configured to pressurize and depressurize the fluid, because Danforth teaches doing so in closely related device, which a person of ordinary skill in the art understands is a simple, cost-effective, commonly commercially available option for applying fluid pressure to a lumen of a catheter.
Claim 10 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Böse.
Böse describes a device substantially as claimed by Applicant; see above. Claim 10 further requires that the signal-conducting means is a wire configured to conduct electrical signals. Böse does not specify the exact nature of its bending sensors 15a-f; however, because it describes the controller 5 operating on signals from those sensors, including the aforementioned assigning and determining functions, a person of ordinary skill in the art would understand that of the several types of sensors that are permitted to be used in interventional medical devices (i.e., FDA approvable), those that conduct electricity through a wire are an industry accepted, inexpensive, and very old and commonplace form for the sensor, and its conductor, to take. Thus, it appears that Böse inherently discloses wire conductors.
Alternatively, it 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, to make the signal-conducting means of Böse’s device to be a wire configured to conduct electrical signals, because such is a well-known, FDA approvable, and industry accepted form of a signal conductor in interventional medical devices.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Böse as applied to Claim 9 above, and further in view of U.S. Patent App. Pub. No. 2021/0268233, by Bogusky et al. (“Bogusky”).
Böse describes a device substantially as claimed by Applicant; see above. It does not, however, describe that:
its signal-conducting means is a wire configured to conduct electrical signals (Claim 10); or
the signal-conducting means is an optical fiber configured to conduct optical signals (Claim 11).
Bogusky relates to interventional medical devices the stiffness of which can be changed using fluid pressure and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Bogusky teaches that the signal conductor for the bend sensors of such a device can be constructed with an optical fiber configured to conduct optical signals (Abstract: “a shape sensor (222, 314, 426) in the form of an optical fiber”), and that the sensor system can be constructed as EM sensors with conductive coils, i.e., wires ([0063]), so that the device can also be used to feed back to the user the shape of the distal end of the device when in use.
It 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, to construct the device and system of Böse such that signal-conducting means is a wire configured to conduct electrical signals or optical fiber configured to conduct optical signals, because Bogusky teaches that such a device can be constructed with either of these element so that the device can also be used to feed back to the user the shape of the distal end of the device when in use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. No. 2007/0100235 describes a device very similar to Applicant’s, which is also read on by some of the current claims, but a redundant rejection has not been made.
The balance of the documents cited with this Office Action relate generally to interventional medical devices which are steerable by the application of fluid pressure to a closed lumen in the device.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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 on 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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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783