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 with traverse of Species I: Claims 6-15 in the reply filed on 7/29/2026 is acknowledged. However, because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been now treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/06/2024 and 12/09/2025 have being considered by the examiner.
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 1-15 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. Claim limitation “release mechanism” as cited in claim 1, invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The limitation “release mechanism” is reasonably interpreted as invoking 35 U.S.C. § 112(f) because it is expressed in functional language and does not recite sufficient definite structure to perform the claimed function. The claimed function is moving at least one of the outer sheath and the inner member an initial distance in a controlled manner to break friction between the expandable device and the outer sheath prior to deployment. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
6. For purposes of the prior art rejection, the recited “release mechanism” is construed broadly to encompass actuator (175, 174), which is disclosed as performing the claimed release function.
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)(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) 1-3, 5, and 6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated Andreas et al. (US 20050149159 A1).
Claim 1: Andreas et al. disclose an endoluminal prostheses delivery system comprising:
an outer sheath (38) comprising a distal end region, a proximal end region and a lumen extending along a longitudinal axis between the proximal end region and the distal end region;
an expandable device (30)
an inner member (32/36) extending through the lumen of the outer sheath (38), at least a portion of the inner member configured to support the expandable device within the lumen near the distal end region of the outer sheath (Paragraphs 59-60; and
a release mechanism (54/58) inherently configured to move at least one of the outer sheath and the inner member an initial distance in a controlled manner to break friction between the expandable device and stent valve (50) of the outer sheath prior to deployment of the expandable device from the lumen (paragraph 60-61).
Claim 2: Andreas et al. disclose the delivery system of claim 1, wherein the release mechanism is configured to retract the outer sheath the distance (paragraphs 59-61).
Claim 3: Andreas et al. disclose the delivery system of claim 1, wherein the release mechanism is configured to advance the inner member the distance (paragraphs 59-61).
Claim 5: Andreas et al. disclose the delivery system of claim 1, wherein the release mechanism comprises an actuator (54/58) configured to be toggled between at least a first position and at least a second position (paragraph 62).
Claim 6: Andreas et al. disclose the delivery system of claim 5, wherein the actuator is toggled by rotation around longitudinal axis of the outer sheath (paragraph 62).
Claim(s) 1-3, and 5-8 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated Gunderson et al. (US 7967829 B2).
Claim 1: Gunderson et al. disclose an endoluminal prostheses delivery system comprising: an outer sheath (130) comprising a distal end region, a proximal end region and a lumen extending along a longitudinal axis between the proximal end region and the distal end region; an expandable device (150), an inner member (140) extending through the lumen of the outer sheath (130), at least a portion of the inner member (140) configured to support the expandable device within the lumen near the distal end region of the outer sheath (Fig. 6A), a release mechanism (240) configured to move at least one of the outer sheath (130) and the inner member (140) an initial distance in a controlled manner to break friction between the expandable device (150) and the outer sheath prior to deployment of the expandable device from the lumen (Figs. 6A-C, Col. 5 to 6).
Claim 2: Gunderson et al. disclose the delivery system of claim 1, wherein the release mechanism is configured to retract the outer sheath the distance (Col. 5 to Col. 6).
Claim 5: Gunderson et al. disclose the delivery system of claim 1, wherein the release mechanism comprises an actuator (240) configured to be toggled between at least a first position and at least a second position.
Claim 6: Gunderson et al. disclose the delivery system of claim 5, wherein the actuator is toggled by rotation around longitudinal axis of the outer sheath (Figs. 6A-C, Col. 5 to 6).
Claim 7: Gunderson et al. discloses the claimed subject matter of claim 6, wherein the delivery system includes a release mechanism having a threaded internal component (250) coupled to a proximal end region of the inner member (140), the threaded internal component (250) being in threaded engagement with a corresponding thread on an internal surface of the actuator (240, fig. 6A).
Claim 8: Gunderson et al. disclose a delivery system having a threaded actuator arrangement in which rotation of the actuator (240) about the longitudinal axis from a first position to a second position causes relative axial movement between the actuator and the threaded internal component, as shown in FIGS. 6A–6C. In one mode of operation, when the inner member is held fixed and the outer sheath is not held fixed, rotation of the actuator retracts the outer sheath proximally as the corresponding thread of the actuator translates along the threaded internal component. The recited functional language does not impart any additional structural distinction over the device disclosed by Gunderson et al., because Gunderson et al.’s device is capable of performing the same movement in the same manner.
Claim 9: Gunderson et al. disclose a delivery system having a threaded actuator arrangement in which rotation of the actuator (240) about the longitudinal axis from a first position to a second position causes relative axial movement between the actuator and the threaded internal component, as shown in FIGS. 6A–6C. In one mode of operation, when the proximal end region of the outer sheath is held fixed and the inner member is not held fixed, rotation of the actuator advances the inner member distally as the threaded internal component translates along the corresponding thread of the actuator. The recited functional language does not impart any additional structural distinction over the device disclosed by Gunderson et al., because Gunderson et al.’s device is capable of performing the same movement in the same manner.
Claim Rejections - 35 USC § 103
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 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.
Claim 4 is rejected under 35 U.S.C. § 103 as being unpatentable over Andreas et al. (US 2005/0149159 A1) in view of Gunderson et al. (US 7,967,829 B2)
Andreas et al. discloses an endoluminal prosthesis delivery system including an outer sheath, an inner member, an expandable device disposed therebetween, and a release mechanism configured to move at least one of the outer sheath and the inner member in a controlled manner to expose the expandable device for deployment. See Andreas et al. paragraphs 59–61. Andreas et al. further teaches that the actuator may be configured to move the outer sheath or inner member an initial distance to break friction prior to deployment. See Andreas et al. paragraphs 60–61.
Gunderson et al. discloses a medical device delivery system including an actuator arrangement for controlled relative movement between inner and outer tubular components. See Gunderson et al. paragraphs 7, 23, 26, 30, 42–43. Gunderson et al. teaches that the actuator may provide controlled and incremental movement during retraction of the outer tube. See Gunderson et al. paragraphs 23, 24, 26–27.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the release mechanism of Andreas et al. in view of Gunderson et al. to move the outer sheath or inner member an initial distance of about 5 mm to about 1 cm, because selecting an initial movement distance sufficient to break friction and initiate controlled deployment would have been a predictable optimization of a known result-effective variable. The claimed range merely represents a routine design choice within the skill of the art, and no criticality or unexpected result has been shown for the particular numerical range recited.
Claims 10–15 are rejected under 35 U.S.C. § 103 as being unpatentable over Gunderson et al. (US 7,967,829 B2) in view of Andreas et al. (US 2005/0149159 A1)
Gunderson et al. discloses a medical device delivery system including an inner tube, an outer tube, and an actuator configured to cause relative motion between the inner and outer tubes. See Gunderson et al. paragraphs 7, 20, 23, 26, 30, 42–43. Gunderson et al. further discloses a rotatable actuator arrangement for controlling relative axial movement of the outer tube. See Gunderson et al. paragraphs 26–27.
Andreas et al. discloses positional control and indication features for a delivery system, including stop structures, detents, slots, tactile feedback, audible feedback, and visual indicia. See Andreas et al. paragraphs 17, 19, 22, 34, 36, 44–45, 47, 54–55, 57. Andreas et al. teaches that a stop may limit actuator movement to provide tactile indication, and that detent and ratchet structures may provide tactile and/or audible feedback. See Andreas et al. paragraphs 17, 22, 36, 47, 54–55.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the actuator arrangement of Gunderson et al. in view of Andreas et al. to include the claimed stop, projection, feedback, marking, and additional stop features, because such structures are conventional positional control mechanisms used to define actuator position, provide feedback, and improve user control in medical delivery systems.
Claim 10: Gunderson et al. do not disclose that the actuator comprises a projection on an outer surface configured to be received against or within a first stop on a proximal end region of the outer sheath. Andreas et al. teaches a stop that limits movement of the actuator, and further teaches cooperating positional structures such as detents and slots that define actuator position and provide user feedback. See Andreas et al. paragraphs 17, 19, 22, 36, 54, 57. It would have been obvious to provide a projection on the actuator of Gunderson et al. to cooperate with the stop structure of Andreas et al., because a projection-and-stop arrangement is a conventional and predictable way to define actuator positions and limit movement.
Claim 11: Gunderson et al. do not disclose that the first stop provides tactile and/or auditory feedback regarding position of the actuator relative to the first stop. Andreas et al. expressly discloses that a stop may limit movement of the actuator and thereby provide tactile indication of length. See Andreas et al. paragraphs 17 and 22. Andreas et al. further discloses that detent and slot engagement may provide a tactile “bump,” and that ratchet or detent features may provide an audible “click.” See Andreas et al. paragraphs 36, 47, 54–55. It would have been obvious to configure the stop arrangement in the combined system to provide tactile and/or auditory feedback, because such feedback is the predictable result of cooperating mechanical stop structures.
Claim 12: Gunderson et al. do not disclose that the actuator comprises a projection and the first stop comprises a first surface feature projecting a first distance radially outward from an outer surface of the outer sheath and a second surface feature projecting a second distance radially outward from the outer surface of the outer sheath, the first surface feature projecting further than the second surface feature such that the projection on the actuator can slide over the second surface feature and is prevented from sliding over the first surface feature. Andreas et al. teaches detent and slot structures, including a movable detent engaging a plurality of holes or slots, wherein the engagement of the detent with the structure provides discrete positional stops. See Andreas et al. paragraphs 19, 22, 36, 54–55. These teachings would have suggested to one of ordinary skill in the art the use of stepped or differing-height stop features so that a projection may pass one feature while being blocked by another. Modifying the control features of Gunderson et al. in view of Andreas et al. in this manner would have been an obvious variation of known indexing and stop structures.
Claim 13: Gunderson et al. do not disclose that receipt of the projection between the first and second surface features provides tactile and/or auditory feedback regarding position of the actuator relative to the first stop. As noted above, Andreas et al. discloses that reception of a detent in a hole or slot provides a tactile indication, and that engagement of detent or ratchet structures can provide an audible click and tangible bump. See Andreas et al. paragraphs 19, 22, 36, 47, 54–55. It would have been obvious to configure the stepped stop arrangement of claim 12 so that receipt of the projection between the surface features provides tactile and/or auditory feedback, because such feedback is the predictable result of engagement between cooperating stop structures.
Claim 14: Gunderson et al. do not disclose that one or more markings on the outer surface of the outer sheath relative to the first stop providing information regarding actuator position. Andreas et al. discloses visual indication structures including indicia and indicators that inform the user of actuator or sheath position. See Andreas et al. paragraphs 34, 44–45. Andreas et al. further teaches that visual indicators may be coupled with actuator movement to show length or position. See Andreas et al. paragraphs 17, 22, 44–45. It would have been obvious to provide corresponding markings on the outer surface of the outer sheath relative to a stop structure in the device of Gunderson et al. in order to visually indicate actuator position, because such markings are a routine and predictable manner of displaying device state.
Claim 15: Gunderson et al. do not disclose that a second stop on the proximal end region of the outer sheath located less than 360 degrees around the longitudinal axis relative to the first stop. Andreas et al. teaches multiple positional control structures and stop-like features associated with actuator movement, including detents, slots, ratchet structures, and mechanisms that define discrete positions and user feedback points. See Andreas et al. paragraphs 19, 22, 36, 47, 54–55, 57–58. It would have been obvious to provide a second stop circumferentially offset from the first stop in the delivery system of Gunderson et al. in view of Andreas et al., because multiple stop locations are a known way to define actuator orientation or indexing positions and to improve user control and feedback during actuation. The recited second stop would therefore have been an obvious positional-control variation of the known stop structures taught by Andreas et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAN-UYEN THI HO whose telephone number is (571)272-4696. The examiner can normally be reached Normal Schedule M-F Between 7:00 am and 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, TAN-UYEN T HO can be reached at 7034745263. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAN-UYEN T HO/ Supervisory Patent Examiner, Art Unit 3771
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