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 .
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being anticipated by claims 1-20 of U.S. Patent 12102312. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include many more elements and are thus much more specific as shown below (see underlined text for item-to-item matching):
Invention: 18/815984
US Patent 12102312
1. An expandable device configured to expand within a body lumen, the device comprising a plurality of interconnected segments each having a proximal terminal end and a distal terminal end; wherein the segments are interconnected to have a generally elongated delivery configuration in which the interconnected elements are arranged generally linearly with respect to one another with terminal ends not fixedly engaged with one another, and a tensioned configuration in which terminal ends of adjacent interconnected elements contact one another to shift the shape of the device from an elongated delivery configuration to an expanded helical configuration for holding open the body lumen.
Claims 1-15:
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(note that the filament, projective and receptive portions interconnect the segments)
2. The expandable device of claim 1, wherein the plurality of interconnected segments are interconnected to form a predetermined shape when in the tensioned configuration.
Claims 1-15- see underlined sections of claim 1 above
3. The expandable device of claim 1, wherein segments of the plurality of segments abut adjacent segments of the plurality of segments to form the expanded helical shape in the tensioned configuration.
Claims 1-15- see underlined sections of claim 1 above
4.The expandable device of claim 1, further comprising a filament extending through the plurality of segments, wherein the tensioned configuration is achieved by proximally translating the filament with respect to a stop member disposed about the filament to thereby press segments of the plurality of segments against adjacent ones of the plurality of segments.
Claim 3:
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5. The expandable device of claim 1, wherein segments of the plurality of
segments comprise:
a middle portion; a projection portion extending from an end of the middle portion; and a receptive portion configured to receive the projection portion.
Claims 1-15- see underlined sections of claim 1 above
6.The expandable device of claim 5, wherein the projection portion tapers
away from the middle portion, and the receptive portion comprises a cavity
complementing the shape of the projection portion.
Claims 1-15- see underlined sections of claim 1 above
7.The expandable device of claim 1, further comprising a filament extending through the plurality of segments, and an end portion disposed at the distal end of the filament, the end portion comprising a larger dimension than a dimension of the aperture of each of the plurality of segments.
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8.The expandable device of claim 1, further comprising a filament engaging at least one of the plurality of segments in the tensioned configuration.
Claims 1-15- see underlined sections of claim 1 above
9. The expandable device of claim 1, further comprising a filament
extending through the plurality of segments, wherein a distal end of the filament is adhered to a distalmost segment of the plurality of segments.
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10.The expandable device of claim 1, wherein the device comprises an
arc shape in the tensioned configuration.
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11. The expandable device of claim 1, further comprising a suture coupled to an aperture defined through at least one of the plurality of segments.
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12. An expandable device configured to expand within and to expand a body lumen, the device comprising: a tubular base having a proximal terminal end and a distal end, and defining a lumen therethrough along a longitudinal axis; and a plurality of self-expanding leaves extending from the distal end of the tubular base, each of the plurality of self-expanding leaves having a proximal end associated with the distal end of the tubular base and a distal end; wherein: the plurality of self-expanding leaves are shiftable between a delivery configuration oriented substantially parallel with the longitudinal axis for delivery into the body lumen, and an expanded deployed configuration in which the distal ends of the plurality of self-expanding leaves curl toward the proximal terminal end of the tubular base in a deployed configuration holding open the body lumen; wherein the device in the expanded deployed configuration is configured to establish a scaffold working area from accessing target tissue independent of an endoscope
Claims 16-20: (see claim 16 below)
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*note that this device is capable of performing this function
13. The expandable system of claim 12, wherein the distal end of each of the plurality of self- expanding leaves is configured to curl outwardly away from the lumen in the tubular base when in the deployed configuration.
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14. The expandable system of claim 12, wherein each of the plurality of self-expanding leaves comprises an end configured to curl toward a proximal end of the longitudinal axis in the deployed configuration.
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15. The expandable system of claim 12, wherein the distal end of each of the at least one of the plurality of self-expanding leaves comprises an aperture configured to receive a suture, the suture having a tissue-engaging portion for engaging tissue and for applying tension to the tissue via the associated self-expanding leaf.
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16. The expandable system of claim 12, wherein said plurality of self-expanding leaves are shiftable from the deployed configuration to the delivery configuration for retrieval and/or repositioning.
Claims 16-20 (see claim 16 above- paragraphs 3 and 5 and note that this device is capable of performing this function.
17. An expandable device configured to expand within a body lumen, the device comprising: a plurality of interconnected segments each having a proximal terminal end and a distal terminal end; wherein the segments are interconnected to have a generally elongated delivery configuration, and an expanded helical configuration for holding open the body lumen.
Claims 1-15 (see claim 1 below):
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(note that the filament, projective and receptive portions interconnect the segments)
18. The expandable device of claim 17, wherein the terminal ends of the plurality of interconnected segments are shaped to engage one another to define the expanded helical configuration.
Claims 1-15 (see claim 1 above and note projection and receptive portions)
19. The expandable device of claim 17, wherein segments of the plurality of interconnected segments are spaced apart from one another when in the elongated delivery configuration, and engage one another to form the expanded helical configuration.
Claims 1-15 (see claim 1 above and note the last paragraph)
20. The expandable device of claim 17, further comprising a filament extending through the plurality of segments, and translatable to shift the interconnected segments between the delivery configuration and the expanded helical configuration.
Claims 1-15 (see claim 1 above)
Thus, the invention of US Patent 12102312, claims 1-20, respectively, are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
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.
Claim(s) 12-16 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Albrecht (US 20120289785).
With respect to claim 12, Albrecht discloses an expandable device (e.g., 220 or 200) configured to expand within and to expand a body lumen (see fig. 27-29 below and para. 81-84), the device comprising: a tubular base (220 or 200) having a proximal terminal end and a distal end (see fig. 27-29 below and para. 81-84), and defining a lumen therethrough along a longitudinal axis (see fig. 27-29 below); and a plurality of self-expanding leaves (224, see para. 84) extending from the distal end of the tubular base (see fig. 27-29 below), each of the plurality of self-expanding leaves having a proximal end (closer to 220) associated with the distal end of the tubular base and a distal end (see fig. 27-29 below); wherein: the plurality of self-expanding leaves are shiftable between a delivery configuration oriented substantially parallel with the longitudinal axis for delivery into the body lumen (see fig. 27 below), and an expanded deployed configuration (see fig. 28-29 below) in which the distal ends of the plurality of self-expanding leaves curl toward the proximal terminal end of the tubular base in a deployed configuration holding open the body lumen (see fig. 28-29 below) wherein the device in the expanded deployed configuration is configured to establish a scaffolded working area for accessing target tissue independent of an endoscope (see fig. 27-29 below and para. 81-84).
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As for claim 13, Albrecht further discloses the expandable system of claim 12, wherein the distal end of each of the plurality of self- expanding leaves is configured to curl outwardly away from the lumen in the tubular base when in the deployed configuration (see fig. 28-29 above, para. 84).
As for claim 14, Albrecht further discloses the expandable system of claim 12, wherein each of the plurality of self-expanding leaves comprises an end configured to curl toward a proximal end of the longitudinal axis in the deployed configuration (see fig. 28-29 above, para. 84)
As for claim 15, Albrecht further discloses the expandable system of claim 12, wherein the distal end of each of the at least one of the plurality of self-expanding leaves comprises an aperture (e.g., 240) configured to receive a suture (e.g., 234), the suture having a tissue-engaging portion (e.g., end portion) for engaging tissue and for applying tension to the tissue via the associated self-expanding leaf (note that this device is capable of performing this function and the suture is not positively recited).
As for claim 16, Albrecht further discloses the expandable system of claim 12, wherein said plurality of self-expanding leaves are shiftable from the deployed configuration to the delivery configuration for retrieval and/or repositioning (see para. 84).
Reasons for Allowance
The following is a statement of reasons for the indication of allowable subject matter:
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1. In particular, none of the cited references teach or suggest a plurality of interconnected segments each having a proximal terminal end and a distal terminal end; wherein the segments are interconnected to have a generally elongated delivery configuration in which the interconnected elements are arranged generally linearly with respect to one another with terminal ends not fixedly engaged with one another and a tensioned configuration in which terminal ends of adjacent interconnected elements contact one another to shift the shape of the device from an elongated delivery configuration to an expanded helical configuration for holding open the body lumen as required by claims 1-11.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 17. In particular, none of the cited references teach or suggest a plurality of interconnected segments each having a proximal terminal end and a distal terminal end; wherein the segments are interconnected to have a generally elongated delivery configuration and an expanded helical configuration for holding open the body lumen, as required by claims 17-20.
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.”
Response to Arguments
The amendment entered on 2/24/2026 overcomes the USC 102a1 rejection of claims 1-11 and 17-20.
The Double Patenting rejection is maintained and updated in view of the amendment entered on 2/24/2026.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tara Carter whose telephone number is (571) 272-3402. The examiner can normally be reached on M-F 7am-3pm.
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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773