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 the species of Figs. 26-28 in the reply filed on 12 June 2025 is acknowledged.
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.
Claims 1-7 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ostrovsky et al (US 2008/0287741).
Regarding claim 1, Ostrovsky discloses:
A medical device (10; Fig. 2) comprising: a tubular member (12; Fig. 3) having a proximal end (end with cam 52), a distal end (54), an outer surface, an inner surface (see Fig. 3), a longitudinal axis along a length of the tubular member (12), a passage extending from the proximal end to the distal end extending along the longitudinal axis, and a cross-section perpendicular to the longitudinal axis; wherein the tubular member (12) includes: i) a plurality of axial support components (individual links 12) in a stacked arrangement (Fig. 3) including at least a first axial support component and a second adjacent axial support component (adjacent links 12 seen in Fig. 3) located above the first axial support component in the proximal direction, wherein each axial support component has a top edge surface (18) facing the proximal end and a bottom edge surface facing the distal end (16), wherein a first portion (32) of the top edge surface of the first axial support component contacts a first portion (20) of the bottom edge surface of the second axial support component (¶0033), and a second portion (28) of the top edge surface of the first axial support component is spaced apart from the bottom edge surface (16) of the second axial support component (see gaps in Fig. 3), wherein the first and second portions of the top edge surface are at different locations along the circumference of the first axial support component (Fig. 3); and ii) one or more lateral support components (46, 50) in contact with the axial support components (12) for reducing lateral movement of adjacent axial support components relative to each other (¶0036).
Regarding claim 2, Ostrovsky discloses:
The device of claim 1, wherein the first axial support component (12) and the second axial support component (12) have the same shape (¶0031).
Regarding claim 3, Ostrovsky discloses:
The device of claim 1, wherein the first axial support component (12) rocks back and forth relative to the second axial support component (12) (Fig. 5; ¶0036).
Regarding claim 4, Ostrovsky discloses:
The device of claim 1, wherein the first axial support component (12) bends relative to the second axial support component (12) in a first direction away from the longitudinal axis and in an opposing second direction away from the longitudinal axis (¶0036).
Regarding claim 5, Ostrovsky discloses:
The device of claim 4, wherein the first axial support component (12) is connected to the second axial support component (12) at a connection region (20, 32) that comprises alternating ridges and valleys (each link 12 comprises alternating ridges and valleys around the circumference, and opposite ridge 20 and valley 32 abut one another at the connection region).
Regarding claim 6, Ostrovsky discloses:
The device of claim 5, wherein the first axial support component and the second axial support component are formed of the same material (¶0031).
Regarding claim 7, Ostrovsky discloses:
The device of claim 6, wherein the connection region is formed of the same material as the first axial support component and the second axial support component (¶0031).
Regarding claim 12, Ostrovsky discloses:
The device of claim 1, wherein the one or more lateral support components (46, 50) have a wall thickness that is less than a wall thickness of the axial support components (12) (Fig. 3 – the lateral supports 46, 50 are held in lumens in the wall of the axial supports 12 and are therefore thinner than the thickness of the wall that holds them).
Regarding claim 13, Ostrovsky discloses:
The device of claim 1, wherein the device includes about 10 or more stacked axial support components (Fig. 5 – figure shows at least 12 supports).
Regarding claim 14, Ostrovsky discloses:
The device claim 1, wherein the device (10) includes one or more control components (44, 48) extending the length of the tubular member (12) for controlling a direction of bend of the proximal end of the tubular member (¶0036).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 11, and 15 of U.S. Patent No. 10,441,748. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims anticipate the instant claims as follows:
Instant
Patent 10441748
1. A medical device comprising:
a tubular member having a proximal end, a distal end, an outer surface, an inner surface, a longitudinal axis along a length of the tubular member, a passage extending from the proximal end to the distal end extending along the longitudinal axis, and a cross-section perpendicular to the longitudinal axis;
wherein the tubular member includes:
i) a plurality of axial support components in a stacked arrangement including at least
a first axial support component and a second adjacent axial support component located above the first axial support component in
the proximal direction,
wherein each axial support component has
a top edge surface facing the proximal end and a bottom edge surface facing the distal end,
wherein a first portion of the top edge surface of the first axial support component contacts a first portion of the bottom edge surface of the second axial support component, and
a second portion of the top edge surface of the first axial support component is spaced apart from the bottom edge surface of the second axial support component,
wherein the first and second portions of the top edge surface are at different locations along the circumference of the first axial support component; and
ii) one or more lateral support components in contact with the axial support components for reducing lateral movement of adjacent axial support components relative to each other.
1. A medical device comprising:
a tubular member having a proximal end, a distal end, an outer surface, an inner surface, a longitudinal direction along a length of the tubular member, a passage extending from the proximal end to the distal end extending along the longitudinal direction, and a cross-section perpendicular to the longitudinal direction;
wherein the tubular member includes
i) a plurality of helical axial support components in a stacked arrangement including at least
a first axial support component and a second axial support component located adjacent to and above the first axial support component in
the distal direction, (examiner notes that because one support is stacked on top of one another, the axial components are stacked both in the proximal and the distal direction)
wherein each of the plurality of helical axial support components has
a top edge surface facing the proximal end and a bottom edge surface facing the distal end,
the top edge surface of the first axial support component has a first portion, a second portion, a third portion, and a fourth portion in sequential order around a circumference of the top edge surface of the first axial support component, the bottom edge surface of the second axial support component has a corresponding first portion, a corresponding second portion, a corresponding third portion, and a corresponding fourth portion in sequential order around a circumference of the bottom edge surface of the second axial support component,
wherein the first and third portions of the top edge surface of the first axial support component contacts the corresponding first and third portions of the bottom edge surface of the second axial support component
so that an axial force is translated between the adjacent first and second axial support components, and
the second and fourth portions of the top edge surface of the first axial support component are spaced apart from the corresponding second and fourth portions of the bottom edge surface of the second axial support component
a first portion, a second portion, a third portion, and a fourth portion in sequential order around a circumference of the top edge surface of the first axial support component
so that the axial direction can bend between the adjacent first and second axial support components; and
ii) one or more lateral support components in contact with the plurality of helical axial support components for reducing lateral movement between adjacent pairs of the plurality of helical axial support components.
2
2
3
11
13
4
14
15
Claims 1, 3, and 12-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9, 11, and 15 of U.S. Patent No. 11,642,495. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims anticipate the instant claims as follows:
Instant
Patent 11642495
1. A medical device comprising:
a tubular member having a proximal end, a distal end, an outer surface, an inner surface, a longitudinal axis along a length of the tubular member, a passage extending from the proximal end to the distal end extending along the longitudinal axis, and a cross-section perpendicular to the longitudinal axis;
wherein the tubular member includes:
i) a plurality of axial support components in a stacked arrangement including
at least a first axial support component and a second adjacent axial support component located above the first axial support component in the proximal direction,
wherein each axial support component has
a top edge surface facing the proximal end and a bottom edge surface facing the distal end,
wherein a first portion of the top edge surface of the first axial support component contacts a first portion of the bottom edge surface of the second axial support component, and
a second portion of the top edge surface of the first axial support component is spaced apart from the bottom edge surface of the second axial support component,
wherein the first and second portions of the top edge surface are at different locations along the circumference of the first axial support component; and
ii) one or more lateral support components in contact with the axial support components for reducing lateral movement of adjacent axial support components relative to each other.
1. A medical device comprising:
a tubular member having a proximal end, a distal end, an outer surface, an inner surface, a longitudinal axis along a length of the tubular member, a passage extending from the proximal end to the distal end along the longitudinal axis, and a cross-section perpendicular to the longitudinal axis;
wherein the tubular member includes
i) a plurality of discrete axial support components in a stacked arrangement including
at least a first axial support component and a second axial support component having the same shape, the second axial support component located adjacent to and above the first axial support component in the proximal direction,
wherein each of the plurality of axial support components has
a top edge surface facing the proximal end, a bottom edge surface facing the distal end,
a first lobe region including a first proximally-extending lobe opposing a first distally-extending lobe, and a second lobe region circumferentially spaced from the first lobe region including a second proximally-extending lobe opposing a second distally-extending lobe,
wherein the first proximally-extending lobe of the first axial support component contacts the first distally-extending lobe of the second axial support component at a first contact point,
wherein the second proximally-extending lobe of the first axial support component contacts the second distally-extending lobe of the second axial support component at a second contact point spaced apart from the first contact point, and
wherein the top edge surface of the first axial support component is spaced apart from the bottom edge surface of the second axial support component between the first and second lobe regions to form first and second circumferentially spaced openings between, the first axial support component and the second axial support component,
wherein each of the plurality of axial support components form the first and second contact points and the first and second circumferentially spaced openings with adjacent one of the plurality of axial support components; and
ii) one or more lateral support components in contact with the plurality of axial support components for reducing lateral movement between adjacent pairs of the plurality of axial support components;
wherein a tilt axis is defined by a line connecting the first and second spaced apart contact points; wherein the first axial support component tilts relative to the second axial support component, about the tilt axis, in a first direction away from the longitudinal axis and in an opposing second direction away from the longitudinal axis; and wherein the first axial support component is symmetrical to the second axial support component about a plane extending through the tilt axis.
3
11
12
9
13
3
14
15
Allowable Subject Matter
Claims 8-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 15-20 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record, Ostrovsky, fails to disclose or make obvious a device as described in claim 15. Specifically, Ostrovsky fails to disclose or make obvious a medical device, in combination with the other elements of the claim, with “a lateral support component connected to the first axial support component and the second axial support component, the lateral support component including one or more hinges that allow for rocking motion between the first and second axial support components.” The device (10; Fig. 2) of Ostrovsky teaches a tubular member (12; Fig. 3) with multiple axial support components (individual links 12) having a stacked arrangement (Fig. 3), a top edge surface (18) facing the proximal end, a bottom edge surface facing the distal end (16), a first portion (32) of the top edge surface of the first axial support component that contacts a first portion (20) of the bottom edge surface of the second axial support component (¶0033), and a second portion (28) of the top edge surface of the first axial support component that is spaced apart from the bottom edge surface (16) of the second axial support component (see gaps in Fig. 3). Ostrovsky further teaches one or more lateral support components (46, 50) in contact with the axial support components (12) for reducing lateral movement of adjacent axial support components relative to each other (¶0036). However, these supports are described as locked pullwires that seem to have a degree of flexibility to allow the device as a whole to be articulated sideways (¶0035-0037). It would not be obvious to a person of ordinary skill in the art to incorporate and thereby complicate the pullwire structure of Ostrovsky to incorporate a hinge without using hindsight reasoning. As such, a prima facie case of obviousness or an anticipation rejection cannot be established with respect to the claimed combination of elements as set forth in claim 15. Claims 16-20 are allowed for incorporating the above limitations due to their respective dependencies on claim 15.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific 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 at (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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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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