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 .
Response to Arguments
Applicant's arguments filed 6/25/26 have been fully considered but they are not persuasive.
Applicant argues the prior art fails to disclose a single device that is delivered and deployed as a single unit from a working channel of the delivery device in a compressed delivery configuration. In contrast to Sharkawy and Cole that become “unitary” when multiple pieces become coupled during or after deployment.
However, Examiner respectfully disagrees. The language as currently claimed including being “unitary” does not require the limitation that the device is delivered as a single piece together within the deliver device. The language only requires a unitary otomy control device having a structure formed of the distal and proximal flange comprising a central channel extending therethrough and delivered through the delivery device and being unitary. “Unitary” is defined as “of or relating to a unit” and “having the character of a unit: undivided, whole”– Merriam Webster.com. A “unit” being defined as “any group of things or persons regarded as an entity” -Merriam Webster.com. The otomy control device, after delivery, may be considered unitary as the units or distal flange, proximal flange and central channel are joined as an entity making up the device. Therefore, the amendment does not overcome the prior art.
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 15, 26-33 and 35-44 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 15 discloses “a unitary otomy control device” on line 3. This is unclear as to whether it is the same or different otomy control device on line 1 in the preamble. Examiner is interpreting the language as an otomy control device comprising a unitary control device.
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) 15 and 36-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharkawy et al. US 7938841 in view of Cole 6352543.
Regarding claim 15, Sharkawy et al. discloses an otomy control device comprising:
an annular distal flange 36 and an annular proximal flange 12 separated and connected by a central tube 18 forming a unitary control device having a hollow tubular central channel extending through the annular distal flange and the annular proximal flange (channel within tubular member 18 to receive portion 10, figure 1A, 2B, see annotated figure 2A, 2B below; coupled as shown in figure 2B to form a unitary device, Examiner notes “Unitary” is defined as “of or relating to a unit” and “having the character of a unit: undivided, whole” and a “unit” being defined as “any group of things or persons regarded as an entity” -Merriam Webster.com, the otomy control device, after delivery, may be considered unitary as the units or distal flange, proximal flange and central channel are coupled forming an entity making up the device), with the hollow tubular central channel circumferentially supporting the otomy from within the otomy when delivered from the working channel in a fully deployed configuration (figure 2B), further comprising at least one magnet incorporated into only one of the flanges, wherein the at least one magnet is situated about the central channel (column 5, lines 62-67; Examiner notes components 38 and 40 making up distal flange 36 may comprise a magnet for attaching the components together, the distal flange and proximal flange may be connected by a magnetic force or non-magnetic force to secure flanges together, resulting in a magnet in only the distal flange).
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Sharkawy et al. fails to disclose wherein the distal flange and the proximal flange of the unitary otomy control device are configured to compress to fit the unitary otomy control device within a working channel of an access or delivery device in a delivery configuration.
Cole teaches wherein the distal flange and the proximal flange are configured to compress to fit the otomy control device within a working channel of an access or delivery device in a delivery configuration (figure 5, column 6, lines 21-39, flange 40 is comprised of a material to be partially or completely collapsed for delivery through a small incision or port, trocar, catheter, or cannula by folding).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Sharkawy et al. a material to be partially or completely collapsed, as taught by Cole, for delivering the device flanges through a small incision or port, trocar, catheter, or cannula by folding.
Regarding claims 36 and 37, Sharkawy et al. discloses wherein the at least one magnet is incorporated into the distal flange or the proximal flange (may consider either flange 12 or 36 to be the proximal or distal flange).
Regarding claim 38, Sharkawy et al. discloses wherein at least one of the flanges is shaped or configured to assist with positioning of a magnetic compression anastomosis device around the otomy control device (figures 2A, 2B, may consider member 38 to be a magnetic compression anastomosis device around the device to assist with positioning between flanges 12 and flange 36, may consider just portion 40 to be the distal flange as it is still connected to the proximal flange 38 by hollow tubular central passage within 18).
Regarding claim 39, Sharkawy et al. discloses the device flanges essentially as claimed as discussed above, but fails to disclose wherein at least one of the flanges is tapered.
Cole et al. discloses a variety of flange shapes that may be varied (for example,
column 5, lines 49-65; figures 2-5), including a flange comprising a tapered leading edge for easier
introduction (column 5, lines 46-47).
Therefore, it would have been obvious matter of design choice to provide a circular or oval or
tapered flange, as taught by Sharkawy et al., to provide at least one flange comprising a tapered leading edge for easier introduction, or a shape that may be desirable for particular applications.
Regarding claim 40, Sharkawy et al. discloses wherein the flanges have the same configuration (flange 14 annular shape placed on one side of opening 48, flange annular shape portion 40 placed on the opposite sides of the opening, placed flat; Examiner note the same configuration does not require the same size or shape).
Regarding claim 41, Sharkawy et al. discloses wherein the flanges have the different configurations (flange 14 comprising a single annular portion, flange 36 has a configuration with two annular portions 38 and 40).
Regarding claim 42, Sharkawy et al. discloses wherein the proximal flange is shaped or configured to mate with a proximal flange of another otomy control device (figures 2A, 2B, may consider member 38 to be a second otomy control device, and just portion 40 to be the distal flange as it is still connected to the proximal flange 38 by hollow tubular central passage within 18, Examiner further notes the flange portion 40 is also sized and shaped to be mated with another device, as it is flat surface which may be mated with another device even if not explicitly disclosed).
Regarding claim 43, Sharkawy et al. discloses wherein at least one flange includes a single loop or lobe (single loop or lobe 14, figure 2A).
Regarding claim 44, Sharkawy et al. discloses wherein the at least one flange includes a plurality of loops or lobes (plurality of loops or lobes 38, 42 of second flange 36, figure 2A).
Claim(s) 26-28 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharkawy et al. US 7938841 in view of Cole 6352543 in view of Kopelman US 2019/0216460.
Regarding claims 26-28, Sharkawy et al. in combination discloses wherein the distal flange and the proximal flange are configured to compress to fit the unitary otomy control device within a working channel of an access or delivery device as discussed above, but fails to disclose wherein each flange comprises a shape-memory material, wherein the shape-memory material includes a nitinol shape-memory material, wherein the shape-memory material includes a spring material.
Kopelman discloses an otomy control device (paragraph 0067, 0068; device penetrating tissue
walls to position anastomosis device) comprising: a distal flange (for example, 202 figure 2B, 406,
figures, 4B, 4C, or 602, figure 6B, ) and a proximal flange (for example, 203, figure 2B, 408, figures 4B,
4C, or 603, figure 6B) separated and connected by a central channel (for example, channel between
tissue portions 400, 402, figures 4A-4C, or between tissue portions 620, 622, figures 6A, 6B) wherein the
distal flange and the proximal flange are configured to compress to fit the otomy control device within a
working channel of an access or delivery device in a delivery configuration (paragraph 0224, compressed
into a straight configuration for inserted into a delivery tube) wherein each flange comprises a shape-
memory material (paragraph 0086, 0224, magnetic and/or shape memory material) the shape-memory
material includes a nitinol shape-memory material or spring material (paragraph 0124, 0163, 0222,
formed of an elastic material such as nitinol or other shape memory material which may be considered a
spring material as it springs back to the pre-defined shape once released from the delivery tube).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective
filing date of the invention to modify Sharkawy et al. with a shape memory material including nitinol or a spring material, as taught by Kopelman and known in the art, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 35, Sharkawy et al. in combination discloses a device essentially as claimed as discussed above, but fails to disclose the flanges are inflatable.
Kopelman discloses an otomy control device (paragraph 0067, 0068; device penetrating tissue
walls to position anastomosis device) wherein the flanges are inflatable (paragraphs 0005, 130), the
flanges being controlled by inflation pressure (paragraph 0006) to create pressure or compression on
the tissue (paragraph 0119, 0124).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective
filing date of the invention to modify Sharkawy et al. with inflatable flanges, as taught by Kopelman, to be able to control the compression or pressure on the tissue.
Claim(s) 29-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sharkawy et al. US 7938841 in view of Cole 6352543 in view of Gray et al. US 2018/0361127.
Regarding claims 29-33, Sharkawy et al. in combination discloses the device essentially as claimed, but fails to disclose wherein each flange comprises an inner framework and an external covering encompassing some or all of the inner framework wherein the external covering includes a biocompatible material, wherein the external covering includes a flexible material, wherein the flexible material includes at least one of plastic, rubber, urethane, or polymer, wherein the external covering is an injection molded external covering over the inner framework.
Gray et al. teaches an otomy control device 100 comprising: a distal flange 114 and a proximal
flange 124 separated and connected by a central channel (figure 1, through region 128, figure 1),
wherein the distal flange and the proximal flange are configured to compress to fit the otomy control
device within a working channel of an access or delivery device in a delivery configuration (figures 2A,
2B) each flange comprises an inner framework and an external covering encompassing some or all of the
inner framework to provide a flow passage therethrough (paragraph 0042, body formed of a woven,
knitted or braided wire elements and may further include a membrane or coating), wherein the external covering includes a biocompatible material (paragraph 0042, may comprise a variety of non-degradable
and biocompatible polymeric materials), wherein the external covering includes a flexible material
including at least one of plastic, rubber, urethane, or polymer (paragraph 0042, may comprise silicones,
rubbers, or polyethylene such that the covering may conform to the device).
Gray et al. teaches wherein the external covering is over the inner framework. Although the
reference does not explicitly disclose "wherein the external covering is an injection molded", it is noted
that "[E]ven though product-by-process claims are limited by and defined by the process, determination
of patentability is based on the product itself. The patentability of a product does not depend on its
method of production. If the product in the product-by-process claim is the same as or obvious from a
product of the prior art, the claim is unpatentable even though the prior product was made by a
different process", In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Furthermore,
"although produced by a different process, the burden shifts to applicant to come forward with
evidence establishing an unobvious difference between the claimed product and the prior art product",
In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. r.1983). See MPEP 2113.2. Therefore, Gray
et al. disclosing an external covering over an inner framework meets the claim requirements.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Sharkawy et al. in combination with each flange comprising an inner framework and an external covering encompassing some or all of the inner framework and proving a passage for flow therethrough, wherein the external covering includes a biocompatible material, wherein the external covering includes a flexible material including at least one of plastic, rubber, urethane, or polymer, and wherein the external covering is an injection molded external covering over the inner framework, as taught by Gray et al. since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
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