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 .
Disposition of Claims
Claims 1-12, 15-20, 22, and 25 are pending.
Claims 13-14, 21, 23-24, and 26-50 are cancelled.
Election/Restrictions
Applicant’s election without traverse of Species AI: Figure 3 in the reply filed on 12/23/2025 is acknowledged.
Applicant’s election without traverse of Species BI: Figure 5 in the reply filed on 12/23/2025 is acknowledged.
Claims 7, 17-20, and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species AII and nonelected Species BII-BV, there being no allowable generic or linking claim.
Specification
The use of the terms Bluetooth, Infrared Data Association (IrDA), Digital Enhanced Cordless Telecommunications (DECT), and ZigBee, which is a trade name or a mark used in commerce, have been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 limitations are:
“a sensor system configured to determine position information for the rigidizable section relative to a distal portion of the delivery device” in claim 1 as described in Para. [0029] of Applicant’s specification.
“the selective rigidization system … is configured to transition a portion of the rigidizable section of the instrument from a bendable state to a rigid state” in claim 1 as described in Paras. [0030-0031] and [0036] of Applicant’s specification.
“a pneumatic system configured to apply a vacuum to the rigidizable section” in claim 17 as described in Para. [0045] of Applicant’s specification.
“a hydraulic system configured to apply a pressurized fluid to the rigidizable section” in claim 18 as described in Para. [0045] of Applicant’s specification.
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12, 15-20, 22, and 25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 3-4, and 9-11 recite the limitation "the delivery device" in l. 8 of claim 1, l. 2 of claim 3, l. 2 of claim 4, l. 2 of claim 9, l. 2 of claim 10, and l. 2-3 of claim 11. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the delivery device” is being interpreted as “the flexible delivery device.”
Claims 1, 3-4, 9-11, and 25 recite the limitation "the instrument" in l. 10 of claim 1, l. 2 of claim 3, l. 2 of claim 4, l. 2 of claim 9, l. 2 of claim 10, l. 2-3 of claim 11, and l. 3 of claim 25. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the instrument” is being interpreted as “the elongated instrument.”
Claim 11 recites the limitation “a distal end face of the delivery device” in line 3. It is unclear if the applicant is referring to the distal end face of the delivery device introduced previously in claim 11 or an additional distal end face of the delivery device. For the purposes of examination, “a distal end face of the delivery device” is being interpreted as “the distal end face of the delivery device.”
Claim 25 recites the limitation “a bendable state” in line 3. It is unclear if the applicant is referring to bendable state introduced in claim 1 or an additional bendable state. For the purposes of examination, “a bendable state” is being interpreted as “the bendable state.”
Claims 2, 5-8, 12, 15-20, and 22 are rejected as being dependent upon claims previously rejected under 35 USC § 112(b).
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.
Claims 1-3, 5-6, 8-12, 16, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Appl. Publ. No. 2020/0030575 A1 to Bogusky et al. (“Bogusky ‘575”).
Regarding claim 1, Bogusky ‘575 discloses a system (medical system 100; Fig. 1, paragraph 0053) comprising:
a flexible delivery device including tool channel extending therethrough (elongate device 226 can include a working lumen or channel 221 sized and shaped to receive a medical instrument 242; Fig. 2A-B, paragraph 0063);
an elongated instrument configured to extend within the tool channel (in other examples, the elongate device 202 may be housed within the working lumen 221 of medical instrument 226; paragraph 0071), the elongated instrument including a flexible section (the elongate sheath 202 may include a flexible body 216 having a distal end 218, a proximal end 217, a lumen 241 extending therebetween, and a plurality of segments 224 dividing a portion of or the entire length of the flexible body 216; Fig. 2C, paragraph 0067) and a rigidizable section (a stiffening mechanism may be positioned in each of a plurality of the segments 224 along flexible body 216 for individually rigidizing each of the plurality of segments 224, providing for controllably variable stiffness along the length of the flexible body; Fig. 2C, paragraph 0068);
a selective rigidization system at least partially extending within the elongated instrument (a stiffening mechanism may be positioned in each of a plurality of the segments 224 along flexible body 216 for individually rigidizing each of the plurality of segments 224, providing for controllably variable stiffness along the length of the flexible body; Fig. 2C, paragraph 0068); and
a sensor system configured to determine position information for the rigidizable section relative to a distal portion of the delivery device (the elongate device 202 may include sensor systems, such as … position sensor 220 in the form of a plurality of EM sensors distributed along the length of the flexible body 216; Fig. 2A, paragraph 0070) (tracking system 230 may optionally and/or additionally track distal end 228 using a position sensor system 220. Position sensor 220 may be a component of an EM sensor system; Fig. 2A, paragraph 0062),
wherein the selective rigidization system, responsive to the position information, is configured to transition a portion of the rigidizable section of the instrument from a bendable state to a rigid state (the stiffening mechanisms may use information from the sensor systems to inform the control system 112 which then controls formation and holding of a shape of the flexible body 216; paragraph 0069-0070).
Regarding claim 2, Bogusky ‘575 discloses the system according to claim 1. Bogusky ‘575 further discloses wherein the flexible section remains in a flexible state when the rigidizable section is in the rigid state (each of the plurality of segments 224 is configurable, either on an individual basis or as part of a group of segments, between a rigid state and a flexible state based on actuation of a corresponding stiffening mechanism; 2C, paragraph 0068-0069).
Regarding claim 3, Bogusky ‘575 discloses the system according to claims 1-2. Bogusky ‘575 further discloses wherein when the rigidizable section is in the rigid state, the instrument is axially movable relative to the delivery device (during motion of the elongate device drive unit 204a and the medical device drive unit 204b toward the reference location 408a, the elongate device drive unit 204a configures actuation of one or more stiffening mechanisms of the elongate device 202 to transition from a rigid state to a flexible state (e.g. become more flexible); Fig. 4A-B, paragraph 0076). The proximal portion of the elongate device is rigid and the distal portion of the elongate device is flexible during axial motion of the elongate device (Fig. 4A-B; paragraph 0074).
Regarding claim 5, Bogusky ‘575 discloses the system according to claim 1. Bogusky ‘575 further discloses wherein the sensor system includes an optical fiber shape sensor (the elongate device 202 may include sensor systems, such as shape sensor 222 in the form of an optical fiber; paragraph 0070).
Regarding claim 6, Bogusky ‘575 discloses the system according to claim 1. Bogusky ‘575 further discloses wherein the sensor system includes an encoder (actuator position sensors such as resolvers, encoders, potentiometers, and other mechanisms may provide sensor data to medical system 100 describing the rotation and orientation of the motor shafts. This position sensor data may be used to determine motion of the objects manipulated by the actuators; Fig. 1, paragraph 0056).
Regarding claim 8, Bogusky ‘575 discloses the system according to claim 1. Bogusky ‘575 further discloses wherein the sensor system includes an optical sensor (medical system 100 may include a sensor system 108 with one or more sub-systems for receiving information about the instruments of manipulator assembly 102. Such sub-systems may include … a visualization system for capturing images from the distal end of medical instrument 104; Fig. 1, paragraph 0057).
Regarding claim 9, Bogusky ‘575 discloses the system according to claim 1. Bogusky ‘575 further discloses wherein the portion of the rigidizable section includes an entire length of the instrument distal of the distal portion of the delivery device (A drive unit (e.g. drive unit 204 configures actuation of one or more stiffening mechanisms in a first segment 506 of the elongate device 202 to be maintained in a rigid state while the steerable end 502 of the medical instrument 226 navigates the section of patient anatomy; Fig. 5A-C, paragraphs 0083-0085). As disclosed by Bogusky ‘575, the distal segment of the elongate device located distal of the distal portion of the medical instrument is in a rigid state while the medical device transitions from its position in Fig. 5B to its position in Fig. 5C.
Regarding claim 10, Bogusky ‘575 discloses the system according to claim 1. Bogusky ‘575 further discloses wherein the portion of the rigidizable section includes a partial length of the instrument distal of the distal portion of the delivery device (A drive unit (e.g. drive unit 204 configures actuation of one or more stiffening mechanisms in a first segment 506 of the elongate device 202 to be maintained in a rigid state while the steerable end 502 of the medical instrument 226 navigates the section of patient anatomy; Fig. 5A-C, paragraphs 0083-0085). As disclosed by Bogusky ‘575, the distal segment of the elongate device located distal of the distal portion of the medical instrument is in a rigid state while the medical device transitions from its position in Fig. 5B to its position in Fig. 5C.
Regarding claim 11, Bogusky ‘575 discloses the system according to claim 1. Bogusky ‘575 further discloses wherein the portion of the rigidizable section includes a portion of the instrument distal to a distal end face of the delivery device and includes a portion of the instrument proximal to a distal end face of the delivery device device (A drive unit (e.g. drive unit 204 configures actuation of one or more stiffening mechanisms in a first segment 506 of the elongate device 202 to be maintained in a rigid state while the steerable end 502 of the medical instrument 226 navigates the section of patient anatomy; Fig. 5A-C, paragraphs 0083-0085). As disclosed by Bogusky ‘575, the distal segment of the elongate device located distal of the distal portion of the medical instrument and a proximal segment of the elongate device located proximal of the distal portion of the medical instrument is in a rigid state while the medical device transitions from its position in Fig. 5B to its position in Fig. 5C.
Regarding claim 12, Bogusky ‘575 discloses the system according to claim 1. Bogusky ‘575 further discloses wherein the rigidizable section includes predetermined segments and transitioning to the rigid state includes rigidizing one or more of the predetermined segments (a stiffening mechanism may be positioned in each of a plurality of the segments 224 along flexible body 216 for individually rigidizing each of the plurality of segments 224, providing for controllably variable stiffness along the length of the flexible body; Fig. 2C and 5A-5C, paragraphs 0068 and 0083-0084).
Regarding claim 16, Bogusky ‘575 discloses the system according to claim 1. Bogusky ‘575 further discloses wherein the selective rigidization system includes a series of compressible linkages (as the elongate device drive unit 204a continues to advance toward the reference location 408a, the segments 224 is/are able to collapse or compress in the flexible state; Fig. 4A, paragraph 0076-0077).
Regarding claim 25, Bogusky ‘575 discloses the system according to claim 1. Bogusky ‘575 further discloses wherein the selective rigidization system, responsive to the position information, is configured to transition a portion of the rigidizable section of the instrument from the rigid state to a bendable state (various segments 224 along the flexible body 216 may switch from a rigid state to a flexible state as the flexible body navigates through anatomy depending on where the particular segments 224 are positioned within anatomy; paragraphs 0090) (while the elongate device 202 is advanced along the steerable end 502 of the medical instrument, the drive unit 204 configures actuation of one or more stiffening mechanisms in the first segment 506 of the elongate device 202 to transition from the rigid state to a flexible state; Fig. 5A-C, paragraph 0085).
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 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bogusky ‘575 in view of U.S. Patent Appl. Publ. No. 2025/0359736 A1 to Ferrante et al. (“Ferrante”).
Regarding claim 4, Bogusky ‘575 discloses the system according to claims 1-3. However, Bogusky does not explicitly disclose wherein when the rigidizable section is in the rigid state, the instrument is rotationally movable relative to the delivery device.
Ferrante teaches wherein when the rigidizable section is in the rigid state, the instrument is rotationally movable relative to the delivery device (Fig. 20A illustrates rotation, e.g., roll, 2040 of the distal tip of the inner rigidizing device 2010 relative to the distal end of the outer rigidizing device 2000 … The inner rigidizing device 2010 may be in a rigid state; Fig. 20A, paragraph 0194). Ferrante teaches this type of roll of the inner rigidizing device is useful for panning around a structure such as a lumen (paragraph 0194).
Ferrante is considered to be analogous to the claimed invention because it is in the same field of medical instruments with a selective ridigization system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Bogusky ‘575 to incorporate the teachings of Ferrante by rotating the elongate device relative to the medical instrument while the elongate device is in a rigid state. Doing so is useful for panning around a structure such as a lumen, as recognized by Ferrante.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Bogusky ‘575 in view of U.S. Patent Appl. Publ. No. 2021/0268233 A1 to Bugusky et al. (“Bogusky ‘233”).
Regarding claim 15, Bogusky ‘575 discloses the system according to claim 1. However, Bogusky ‘575 does not explicitly disclose wherein the selective rigidization system includes a tendon extending through a coil pipe in the rigidizable section.
Bogusky ‘233 teaches wherein the selective rigidization system includes a tendon extending through a coil pipe in the rigidizable section (for example, a stiffening system or mechanism 500 uses the characteristics of the coil pipe 423 within the control element lumen 412 to stiffen the pose of the flexible body 410. Fig. 5. Is an enlarged schematic showing an example of the conduit or coil pipe 423 within control element lumen 412 extending around the control element 421, such as a pull wire; Fig. 5 and 6A-D, paragraph 0084-0086).
Bogusky ‘233 is considered to be analogous to the claimed invention because it is in the same field of medical instruments with a selective ridigization system. It would have been obvious to one of ordinary skill in the art at the time the invention was made to have substituted the rigidization mechanism of Bogusky ‘575 with the rigidization mechanism of Bogusky ‘233, because the substitution of art recognized equivalents as shown by Bogusky ‘233 is within the level of ordinary skill in the art. In addition, the substitution of one rigidization mechanism for another is likely to be obvious when it does no more than yield predictable results.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Appl. Publ. No. 2011/0106055 A1 to Robertson teaches a stiffening member disposed within a lumen of a flexible elongate member as described in the abstract and following descriptive text.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA G STARKEY whose telephone number is (571)272-3375. The examiner can normally be reached Monday-Friday 8:00-5:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at 5712707235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795