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 Species 44, Fig. 54 in the reply filed on 5/6/26 is acknowledged.
Claims 6, 8, 11, 14, 15, 19-30, and 38-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim, as discussed below. Election was made without traverse in the reply filed on 5/6/26.
Claim 6 discloses wherein each flange includes multiple support wires that are connected to each other, wherein the connections are contained within the flexible outer covering. This is directed toward Species 42, Fig. 49.
Claim 8 discloses wherein the at least one support wire of the first flange is directly connected to the at least one support wire of the second flange. Paragraph 0173 discloses the support wires of the elected species are indirectly coupled, not directly coupled as indicated for alternative embodiments.
Claim 11 discloses wherein the flanges are rotationally asymmetric about an axis of the central channel. This is directed to Species 20, Fig. 25, the flanges being asymmetric with petals.
Claim 14 discloses wherein the flexible outer covering of the central channel includes a concentric bellows configuration including one or more circumferential folds/ridges/pleats to allow the central channel to expand and contract longitudinally in the direction of a central axis of the central channel. This is directed to Species 46, Fig. 56.
Claim 15 discloses wherein the flexible outer covering of the central channel includes a vertical bellows configuration. This is directed to Species 49, Fig. 59.
Claim 19 discloses wherein each flange includes a plurality of non- concentric lobes, with each lobe including a lobe support wire along and supporting an outer edge of the lobe. This is directed to Species 42, Fig. 51. Claims 23-30 are dependent upon claim 19.
Claim 20 discloses each flange includes two lobes, a first lobe of the first flange and a corresponding first lobe of the second flange being supported by a first support wire that extends through the central channel, a second lobe of the first flange and a corresponding second lobe of the second flange being supported by a second support wire that extends through the central channel. This is directed to Species 42, Fig. 50. Claims 21 and 22 are dependent upon claim 20.
Claim 38 discloses wherein each flange includes a star wave outer perimeter. This is directed to Species 50, Fig. 60. Claims 39 and 40 are dependent upon claim 38.
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 5, 13, 31, 32 and 34 is 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 5 discloses “optionally where the one or more variations are formed by griding the wire” on lines 2-3. This language indefinite as the one or more variations are optional, therefore does not clearly define the scope of the claimed subject matter.
Claim 13 discloses “one flange” and “the other flange” on lines 1-2. There is insufficient antecedent basis for the limitations in these claims. Examiner notes the language is unclear as to whether the first flange is the “one flange” or “the other flange” or if it may be either flange.
Claim 31 recites the limitation "at least one flange" in 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 discloses “optionally where in the flexible outer covering is tapered downward from the central channel toward an outer tangency of the flange or rounded to engage tangentially” on lines 4-6. This language indefinite as the flexible outer covering is tapered downward from the central channel toward an outer tangency of the flange or rounded to engage tangentially is optional, therefore does not clearly define the scope of the claimed subject matter.
Claim 34 recites the limitation “wherein only one flange is shaped” on line 1. This language is indefinite as it is unclear how the flange would not inherently have a shape.
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) 1-5, 10, 12, 13, 16, 18 and 31- 37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al. US 2015/0313599.
Regarding claim 1, Johnson et al. discloses an otomy control device (for example, 200, 2200, 2300, figures 2A, 16A-17C) comprising: a flexible outer covering (for example, fig. 2A, covering material 210; figure 16B, covering material 2214; figure 17A, covering material 2314) forming a first flange (for example, 120, 2220 or 2320) and a second flange (for example, 130, 2230 or 2330) connected by a central channel (for example, figure 1B, channel though 140; figure 16A-16C, channel 2244 through connecting region 2240, paragraph 0167, figure 17A, central aperture 2350); and an inner framework (for example, frame 100 formed by elongate member 110, 2210 formed by elongate member 2212 or frame 2310 formed by elongate member 2312) encompassed at least partially within the flexible outer covering and including, for each flange, at least one support wire along and supporting an outer edge of the flange (figure 16C, 17C; elongate member 2212 defines petals 2222 and 2232 or elongate member 2312 of frame 2310 supporting each flange, Examiner notes petals extend along the center of the flange out and along the outer edges).
Regarding claims 2 and 3, Johnson et al. discloses wherein the flanges and inner framework are configured to allow the flanges to compress and elongate to fold to fit the otomy control device within a working channel of an access or delivery device in a delivery configuration (figure 13B) and to expand and unfold on opposite sides of an otomy formed through a single wall of a body lumen to secure the otomy from opposite sides of the wall when delivered from the working channel into a fully deployed configuration (paragraph 0137; figure 13A; for example similar device 1600 or other embodiments can be configured to be folded one or more times to fit within sheath or delivery configuration for delivery), wherein the flanges are configured to be folded in one or more planes to be compressed for delivery (paragraph 0137, figure 13A, 13B, configured to be folded one or more times or crushed within sheath).
Regarding claim 4, Johnson et al. discloses wherein the wires are shape-memory (e.g. nitinol) wires (paragraph 0063; 0166, 0167; elongate member frame may be materials as discussed in reference to elongate member 110, such as nitinol or shape-memory).
Regarding claim 5, Johnson et al. discloses wherein at least one of the wires is configured to have one or more variations in wire diameter along its length, optionally where the one or more variations are formed by griding the wire (paragraph 0068; framework elongate members may be of various cross-sectional shape and/or size).
Regarding claim 10, 12 and 13 , Johnson et al. discloses a frame 100 with a first flange 1020, a second flange 1030 and an outer covering 1110 (paragraph 0114, 0115) wherein the flanges are asymmetric with respect to one another (for example, figure 8A, paragraph 0115, mirror imagery is not required, first flange 1020 may be dissimilar to second flange 1030) , wherein the flanges have different diameters or circumferences wherein the flanges have different diameters or circumferences (figure 8B, flange), wherein one flange is configured to nest inside the other flange when the otomy control device is compressed (figure 8B, flange 1030 is nested within flange 1020).
Regarding claim 16, Johnson et al. discloses wherein the flexible outer covering includes one or more features selected from holes, openings, shut-offs, raised elements, and recessed elements (for example, figure 16C, 17C; recessed elements are formed by the cover following the frame structure).
Regarding claim 18, Johnson et al. discloses wherein the central channel includes at least one circumferential support (for example, figure 3B; elongate member extends from first flange to second flange, providing circumferential support there between).
Regarding claim 31, Johnson et al. discloses wherein the shape of the flexible outer covering of at least one flange is configured to cause self-positioning of a magnetic compression anastomosis device around the otomy control device (the shape of the outer covering at least one flange is configured to be positioned as claimed; Examiner notes the magnetic compression anastomosis device is not positively claimed and the claim is functional language, and depending on the configuration it would be configured to cause self-positioning around the otomy control device).
Regarding claim 32, Johnson et al. discloses wherein the flexible outer covering of the at least one flange is configured to tangentially contact the magnetic compression anastomosis device to assist with positioning of the magnetic compression anastomosis device around the otomy control device (Examiner notes the magnetic compression anastomosis device is not positively claimed and the claim is functional language, and depending on the configuration it would be configured to tangentially contact the anastomosis device to assist with positioning of the device around the totmy control device), optionally where in the flexible outer covering is tapered downward from the central channel toward an outer tangency of the flange or rounded to engage tangentially (Examiner notes the claim is optional and not required by the prior art).
Regarding claims 33 and 34, Johnson et al. discloses wherein both flanges (for example, figure 1B, 16C, when deployed flanges are both shaped to be placed on tissue) or shaped or only one flange is shaped (for example, figure 13A, only one flange is expanded and shaped).
Regarding claim 35, Johnson et al. discloses wherein the outside diameter of the flanges is configured to fit entirely within the inside diameter of the magnetic compression anastomosis device (Examiner discloses the magnetic compression anastomosis device is not positively claimed, as the claims are not directed system claims; depending upon the size of the magnetic compression anastomosis device the flange may configured to fit entirely within the inside diameter). Regarding claim 36, Johnson et al. discloses wherein the diameter of the central channel when deployed is configured to be larger than the diameter of the otomy such that the central channel dilates the otomy (Examiner notes this is functional language and would be configured depending upon the size of the otomy as the device has the same claimed structure).
Regarding claim 37, Johnson discloses wherein the outer perimeter of the flanges is configured to be larger than the perimeter of the otomy (Examiner notes this is functional language and would be configured depending upon the size of the otomy as the device has the same claimed structure).
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.
Claim(s) 7 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. US 2015/0313599 in view of Sambandam US 2015/0313597.
Regarding claims 7 and 9, Johnson discloses the device discloses a support wire or elongate member within each flange (frame 100 formed by elongate member 110, 2210 formed by elongate member 2212 or frame 2310 formed by elongate member 2312) and essentially as claimed but fails to disclose wherein the at least one support wire of the first flange is decoupled from the at least one support wire of the second flange, wherein the at least one support wire of the first flange is indirectly connected to the at least one support wire of the second flange via the outer covering of the central channel.
Sambandam discloses a similar otomy control device (for example, figure 2) comprising: a flexible outer covering 212 forming a first flange portion and a second flange portion connected by a central channel (figures 4, channel through device); and an inner framework encompassed at least partially within the flexible outer covering 212 (for example, shown in figure 4A) and including, for each flange, at least one support wire along and supporting an outer edge of the flange (figure 4B shows a plurality of support wires 412, 414, 416, 418, 420 along each flange portion), wherein the at least one support wire of the first flange is decoupled from the at least one support wire of the second flange (each support wire 412, 414, 416, 418, 420 are separate or decoupled), the device may comprise one elongate member or multiple separate elongate members connected by the elongate members (paragraph 0034), the number of elongate members can be varied for the application (paragraph 0036), wherein the at least one support wire of the first flange is indirectly connected to the at least one support wire of the second flange via the outer covering of the central channel (outer covering surrounds and couples the separate elongate members (for example, covering 212 shown covering elongate members in figure 4A).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Johnson with separate or decoupled elongate support wires, the first flange is indirectly connected to the at least one support wire of the second flange via the outer covering of the central channel, as taught by Sambandam as known in the art, as any number of elongate members may be used as necessary for a particular application, the elongate members being coupled by the outer covering. Further, it would have been obvious to provide a single or multiple support wires, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlicnrnan, 168 USPQ 177, 179.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. US 2015/0313599 in view of Das US 2005/0070957.
Regarding claim 17, Johnson et al. discloses the flexible outer covering includes one or more features selected from holes, openings, shut-offs, raised elements, and recessed elements (for example, figure 16C, 17C; recessed elements are formed by the cover following the frame structure), but fails to disclose wherein the one or more features are configured or arranged for the central channel to control variable selective elongation in one or another direction.
Das teaches a similar device having a first flange 102 and second flange 104 comprising an outer covering 127 and framework 110 (paragraph 0034, 0035), the flexible outer covering includes one or more features selected from holes, openings, shut-offs, raised elements, and recessed elements (holes 130) configured or arranged for the central channel to control variable selective elongation in one or another direction (paragraph 0035, holes 130 configured to be coupled with a tether to release or expand the flanges about the central channel; Examiner notes the skeleton or framework extends from the central channel to the flanges, thereby the holes at the distal end of the tines may be considered the central channel controlling the selective elongation).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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