DETAILED ACTION
This action is in response to applicant's amendments filed 09/12/25.
The examiner acknowledges the amendments to the claims and specification.
Claims 1-21, 23-27 are pending in this application.
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 with respect to claim(s) 1-27 have been considered but are moot in view of the new grounds of rejection set forth below and necessitated by the claim amendments.
Claim Objections
Claim 20 is objected to because of the following informalities: in line 2 it reads “the shape” and should instead read as --a shape--. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: in line 3 it reads “the deploying device” and should instead read as --a deploying device--. Appropriate correction is required.
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 1-21 and 23-27 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 1 recites the limitation "the closing device" in the following instances. It is unclear if “the closing device” is one of the previously recited “one or more closing devices” (Claim 1, lines 5-6), or is referring to another closing device. For examination purposes, in Claim 1 the limitation will be read as –the one or more closing devices--.
Claim 1, line 9
Claim 1, line 11
Claim 12 recites the limitation "a closing device". It is unclear if “a closing device” is one of the previously recited “one or more closing devices” (Claim 1, lines 5-6), or is referring to another closing device. For examination purposes, in Claim 12 the limitation will be read as –the one or more closing devices including a closing device--.
Claims 1 and 25 recite the limitation "the closing devices" in the following instances. It is unclear if “the closing devices” is one of the previously recited “one or more closing devices” (Claim 1, lines 5-6), or is referring to additional closing devices. For examination purposes, in Claims 1 and 25 the limitation will be read as –the one or more closing devices--.
Claim 1, line 21
Claim 25, line 15
Claim 25, lines 17-18
Claim 25, line 20
Claim 1, line 21 recites the limitation "the bars". It is unclear if this is referring to the previously recited “one or more bars or other protrusions” (in Claim 1, lines 19-20). For examination purposes, the limitation will be read as --the one or more bars or other protrusions--.
Claims 12, 20, 21, 23 recite the limitation "the closing device holder" and Claim 25 recites “a closing device holder” in the following instances. It is unclear if these instances are referring to one of the previously recited “closing device holders” (Claim 1, line 5) or is another closing device holder. For examination purposes, the limitation in Claims 12, 20, 23, 25 will be read as –one of the closing device holders--, and the limitation in Claim 25, line 15 will be read as --inserting one of the closing device holders--.
Claim 12, line 2
Claim 20, line 2
Claim 21, lines 1-2
Claim 21, line 4
Claim 23, line 4
Claim 25, line 15
Claim 25, line 17
Claim 25, line 18
Claim 27, lines 6-8 recites “a self-expanding shape memory section within a closing device holder in a stressed state”. It is unclear if this limitation is positively reciting “a closing device holder”, or is only functionally reciting the closing device holder. For examination purposes, the recitation will be read as a functional limitation: –a self-expanding shape memory section configured to be positioned within a closing device holder in a stressed state--.
Claims 2-11, 13-19, 24, 26 are rejected due to their dependency on claim 1.
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.
Claims 1-10, 12-18, 21, 23, 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Harris et al., hereinafter “Harris” (U.S. Pub. No. 2008/0319455) in view of Flanagan et al., hereinafter “Flanagan” (U.S. Pub. No. 2018/0085101).
Regarding claim 1, Harris discloses a medical apparatus (Figures 29A-32C, 35A-35C, [0184]; it is noted that the applicator devices in these figures may be combined and integrated into a single unitary device having substantially the same features, actuation mechanisms and operational characteristics, and therefore are cited together even though they appear as different embodiments) capable of closing an aperture (such as gap within tissue fold 3135), an incision, a puncture, a passage through tissue and/or a communication with a blood vessel or other body lumen of a tissue of a patient, the medical apparatus comprising
- a closing device holder (lumen of 2920 or 3004 or U-shaped groove of insertion guides 2936 in cross section view A-A; Figures 29A-29B, 30A-30B), for releasably receiving one or more closing devices (such as self-reconfiguring or self-actuating fasteners 1600/2600/3024), wherein each of the one or more closing devices comprises a staple or a clip made at least partly of a deformable shape memory alloy and/or having a self-expanding shape memory section ([0177]; self-reconfiguring or self-actuating clip such as fastener 2600 is produced from shape memory or superelastic material such as NiTi alloy) within the closing device holders in a stressed state ([0178]) such that when the one or more closing devices is manipulated to exit a distal end of the respective closing device holder during use of the medical apparatus, the one or more closing devices releases its stress, or part of it (Id.); and
- a retracting unit (including movable arms 2922 or 3020; Id.) configured to come into contact with opposite sides of the aperture and retracting the opposite sides of the aperture and/or for spreading the aperture causing the aperture to change its shape into a slit (due to the movable arms capable of engaging opposite sides of the tissue aperture), wherein a multitude of arms are provided to act as the retraction unit or as part thereof (Id.);
wherein the medical apparatus comprises one or more bars or other protrusions (insertion guides 2636 or 3026; Id.) that are arranged between or adjacent to an opening of the closing device holder for discharging the one or more closing devices, the one or more bars or other protrusions being arranged to protrude over an opening area of the opening (Id.).
However, Harris does not disclose the apparatus including another closing device holder such that there are closing device holders each for releasably receiving the one or more closing devices.
Flanagan teaches a medical apparatus 500 for closing an aperture 66 (Figures 13-14) including closing device holders (multiple parallel staplers/stapler heads; [0067]) each for releasably holding one or more closing devices (staples). Having the multiple parallel closing device holders may allow for simultaneous deployment of the one or more closing devices into a tissue aperture (Id.).
Harris acknowledges in [0084] that the apparatus may allow simultaneous placement of multiple tissue fasteners. It would have been obvious to one of ordinary skill before the effective filing date to modify Harris such that there are multiple closing device holders, as taught by Flanagan, in order to allow for simultaneous deployment of the one or more closing devices (Id.) to efficiently close the tissue aperture (see Figure 4 of Flanagan).
Regarding claim 2, Harris as modified teaches the retracting unit comprising:
- at least one retracting device holder (outer tube 2920 or longitudinal tube assembly 3004; Harris, Figures 29B, 30B); and
- at least one retracting device (such as applicator tube 2928; [0182]-[0183]), at least partially received in the at least one retracting device holder,
wherein the retracting device is preferably at least partially releasably received in the retracting device holder (Id.);
wherein the at least one retracting device is arranged in a moveable or slidable
manner with respect to the at least one retracting device holder (to move retraction arms 2922 or 3020; Id.).
Regarding claim 3, Harris as modified teaches the retracting unit comprising at least
- a retracting device 2928 (Figure 29B; Harris) having at least one of:
a first side and an opposite second side,
the multitude of arms comprising or consisting of a first arm and a second arm 2922,
a first retracting device and a second retracting device,
a first retracting device holder and a second retracting device holder and
a first engaging device and a second engaging device; and
- a mechanism 3008 (Figure 30A; [0184]) for moving the first side apart or away from the second side, the first arm apart or away from the second arm (Id.), the first retracting device a part or away from the second retracting device, the first retracting device holder apart or away from the second retracting device holder and/or the first engaging device apart or away from the second engaging device.
Regarding claim 4, Harris as modified teaches closing device holders are arranged to remain, at least in parts, parallel to each other throughout the closing of the aperture (multiple parallel closing device holders 2920/3004; Flanagan, [0067]) or to part or deviate from each other when being advanced towards the aperture and/or out of a closing member.
Regarding claim 6, Harris as modified teaches at an outer or lateral sides of a closing member 2930 of the closing device holders or of the delivery support bumpers or spacers are arranged (Harris, Figure 29A-29B; at lateral sides of closing member [pusher 2930] of the closing device holder [lumen of 2920] spacers [see cross section view A-A showing spacers or U-shaped grooves formed by semi-circular guides 2936] are arranged; it is noted when in combination with Flanagan there are multiple closing device holders).
Regarding claims 7-8, Harris as modified teaches a handle member 3002 (Harris; Figure 30A), wherein the handle member comprises a sleeve or another element having a guide slot (that receives and guides actuating means 3012).
However, Harris does not expressly disclose the handle member, a knob or the sleeve itself comprises an elastic element, a spring arranged to guide a pin through a turning point of the guide slot.
However, Harris teaches in another embodiment (Figures 7A-7G, [0101], [0118]) extendible members or arms can be actuated by an actuating mechanism including a spring, wherein the actuating mechanism is accessible to an operator at handle assembly 706. In a different embodiment shown in Figures 9A-9B, [0129], a handle 828 having a guide slot 834 has a spring 832 arranged to guide a pin 822 through a turning point (proximal opening) of the guide slot.
It would have been obvious to one of ordinary skill before the effective filing date to modify Harris as modified with a spring and guide pin as claimed, as taught by the embodiment of Figures 7A-7G and 9A-9B of Harris, in order to facilitate actuation of the retracting device (Harris; [0127]-[0130]), and the modification would be substitution of one known actuation mechanism for another, which would yield predictable results, namely facilitating deploying and retracting a retracting device by a user. See MPEP 2143.
Regarding claim 9, Harris as modified teaches at least one of the multitude of arms comprises two legs 2922 or 3022 (Harris; Figures 29A-29B, 30A-30B) surrounding or circumscribing at least one opening or middle opening between them.
Regarding claim 10, Harris as modified teaches at least one opening of the retracting unit through which at least one of the multitude of arms 2922 or 3022 exit (Id.) in use of the medical apparatus has a width and length.
However, Harris does not teach that the width of the opening is smaller than its length. In a different embodiment shown in Figure 11A of Harris, an opening (longitudinal slot 852) through which arms 818 exit has a width that is smaller than its length (the slots may have a rectangular cross-section in which a width is smaller than its length).
It would have been obvious to one of ordinary skill before the effective filing date to modify the opening such that the width is smaller than its length, as taught by the embodiment of Figure 11A of Harris, in order to accommodate a shape of the arms that has a width that is smaller than its length which may provide sufficient lateral rigidity that prevents undesirable bending (0133] of Harris).
Regarding claims 12-13, Harris as modified teaches the one or more closing devices includes a closing device (one of fasteners 1600/2600/3024 in Harris) comprised in one of the closing device holders (lumen of 2920/3004; Figures 29A-29B, 30A-30B), wherein the closing device has two arms 2610 (Figures 26A-26B), wherein at least one of the arms has a or one first bending direction and a or one second bending direction (each arm have downward bending directions in Figure 26B, or opposite bending directions in deployed state in Figure 26A).
Regarding claim 14, Harris as modified teaches in a closed state of the closing device or the aperture, the end or tip of a first one of the arms points away from a second one of the arms, whereas the end or tip of the second arm points away from the first arm (in Figure 26A, Harris teaches the ends or tips of the arms [see overlapped ends 2620] point away from each other in a closed state).
Regarding claim 15, Harris as modified teaches a deploying device 2930 (Harris; Figures 29A-29B, [0182]) configured to be at least partially releasably received in a lumen of the at least one retracting device holder 2920.
Regarding claim 16, Harris as modified teaches the at least one retracting device 2928 (Id.) is positioned at the distal tip, distal end or distal end section of the at least one retracting device holder 2920, wherein the at least one retracting device and the at least one retracting device holder are designed integrally with each other (as a unit within the apparatus) and/or connected to each other in a non-releasable manner.
Regarding claim 17, Harris as modified teaches the at least one retracting device comprises the multitude of arms that comprises or consists of a first arm and a second arm 2922 or 3022 (Harris; Figures 29A-29B, 30A-30B), the first arm and the second arm being positioned or provided parallel to each other (multiple parallel staplers/stapler heads; Flanagan, [0067]), at least while or before positioning the retracting unit into the aperture.
Regarding claim 18, Harris as modified teaches the first arm and the second arm 2922 or 3022 are arranged at a (distal) surface of a deploying device 2928 and/or in contact with it while advancing the at least one retracting device 2928 to the aperture (Harris; [0182], to move arms outwardly), and wherein the first arm and the second arm are expanded, in a passive manner and/or without using a motor, manual assistance and/or a mechanism, to a retracting state for retracting the aperture after pulling the deploying device 2928 out from the at least one retracting device holder (outer tube 2920 or longitudinal tube assembly 3004), since Harris teaches arms 2922 operate in a manner as “described previously” ([0182]) such as in [0100], where arms 720 and 724 may be expanded outside of holder 702 via the at least one retracting device due to their superelastic, shape change material.
Regarding claim 21, Harris as modified teaches one of the closing device holders (U-shaped grooves of insertion guides 2936 in cross section view A-A; Harris, Figure 29B,) is, at least partially releasably, received in the retracting device holder 2920/3004, translationally movable in a longitudinal direction of the closing device holder (U0shaped rooves slide as the insertion guides 2936 slide; [0183]).
Regarding claim 23, Harris as modified teaches a connector 3010 (Harris; Figure 30A, [0184]) to be connected, or an integral part of, the at least one retracting device holder 2920/3004, providing an opening for advancing the deploying device 2930 ([0182]) and/or one of the closing device holders into the inner lumen of the at least one retracting device holder.
Regarding claim 25, Harris as modified teaches a method (Harris; see [0185], [0189], Figures 31A-32C, 35A-35C, similar to embodiment shown in Figures 7D-7G; also see [0184] which indicates applicator devices in these figures may be combined and integrated into a single unitary device having substantially the same features, actuation mechanisms and operational characteristics, and therefore are cited together even though they appear as different embodiments) for closing an aperture of a tissue (gap within tissue fold 3135), encompassing the steps:
- providing a medical apparatus according to claim 1 (as discussed above, and including 3100, 3200, 3500), comprising a retracting device holder (outer tube 2920 or longitudinal tube assembly 3004; Harris, Figures 29B, 30B), a retracting device (such as deployment tube 2928; [0182]-[0183]) comprising the multitude or arms comprising or consisting of a first arm and a second arm 2922/3022/3115/3125, wherein the retracting device is positioned at the distal tip, end or end section of the retracting device holder (Id.) or attached to the latter;
- inserting the deploying device (pusher 2930/3152/3205/3505) into a lumen of the retracting device holder 2920/3004 (initially inserted when assembled).
- inserting one of the closing device holders (U-shaped groove of insertion guides 2936 in cross section view A-A; Figure 29B) having one or more closing devices (such as 1610) into the lumen of the retracting device holder 2920 (initially inserted when assembled), so that the distal opening or openings of one of the closing device holders for discharging one or more of the closing devices from one of the closing device holders is/are positioned at the aperture ([0183]).
- pushing out, releasing or bringing out the one or more closing devices 3210/3300 for closing the aperture (Figure 32C, 35C, [0186], [0189]).
However, Harris as modified does not expressly teach the pushing forward or pulling steps.
In another embodiment, Harris teaches:
- pushing forward both the deploying device 720 and the retracting device holder 702 comprising the retracting device up to the aperture until at least parts of the first arm and the second arm are positioned inside the aperture (Figures 7E-7F; also see Figures 5F and 6B):
- pulling the deploying device back ([0121]; retracted via plunger 714) and out of the lumen ([0119]; pushed distally and out of holder 702) of the retracting device holder (it is noted that the limitation does not indicate an order of the pulling back/pushed distally steps);
It would have been obvious to one of ordinary skill before the effective filing date to further modify Harris as modified with the above steps in order to facilitate securement of tissue and closure of the tissue aperture (Id.).
Regarding claim 26, Harris as modified teaches a method (Harris; see [0185], [0189], Figures 31A-32C, 35A-35C, similar to embodiment shown in Figures 7D-7G; also see [0184] which indicates applicator devices in these figures may be combined and integrated into a single unitary device having substantially the same features, actuation mechanisms and operational characteristics and therefore are cited together even though they appear as different embodiments) for closing an aperture of a tissue ((gap within tissue fold 3135), encompassing the steps:
- providing a medical apparatus according to claim 1 (as discussed above, and including 3100, 3200, 3500);
- closing the aperture by means of the medical apparatus (Figure 32C, 35C, [0186], [0189]).
Regarding claim 27, Harris discloses a closing device (such as self-reconfiguring or self-actuating fasteners 1600/2600/3024) capable of closing an aperture (such as gap within tissue fold 3135), an incision, a puncture, a passage through tissue and/or a communication with a blood vessel or other body lumen of a tissue of a patient, the closing device comprising two, at least two or more arms 2610 (Figure 26A) for penetrating the tissue ([0177]), wherein the closing device comprises a staple or a clip made at least partly of a deformable shape memory alloy and/or having a self-expanding shape memory section ([0177]; self-reconfiguring or self-actuating clip such as fastener 2600 is produced from shape memory or superelastic material such as NiTi alloy) configured to be positioned within a closing device holder in a stressed state ([0178]) such that when the one or more closing devices is manipulated to exit a distal end of the respective closing device holder during use of the medical apparatus, the one or more closing devices releases its stress, or part of it (Id.);
Claims 11, 19-20, 24 are rejected under 35 U.S.C. 103 as being unpatentable over Harris (U.S. Pub. No. 2008/0319455) in view of Flanagan (U.S. Pub. No. 2018/0085101), as applied to claim 1 above, and further in view of Zhu et al., hereinafter “Zhu” (U.S. Patent No. 6,287,322).
Regarding claim 11, Harris as modified teaches the claimed invention, as discussed above, except for at least one of the at least one opening of the retracting unit through which the at least one of the multitude of arms exits has an oval opening area or cross section.
However, Harris does teach in another embodiment shown in Figure 11A, an elongate opening (longitudinal slot 852) through which arms 818 exit has a width that is smaller than its length (the slots may have a rectangular cross-section) in order to accommodate an elongate (rectangular) shape of the arms which may provide sufficient lateral rigidity that prevents undesirable bending ([0133]).
In the same field of art, namely medical devices for closing a tissue aperture, Zhu teaches in col. 21, lines 57-64 that an oval cross-section of a device advantageously conforms to an elongated incision formed in the blood vessel, which facilitates closure.
It would have been obvious to one of ordinary skill before the effective filing date to modify the at least one opening such that it has an elongate, or oval opening area or cross section, as taught by Harris and Zhu, in order to accommodate an elongated arm that may provide sufficient lateral rigidity (Harris, [0133]) and to conform to a tissue aperture formed in the body to facilitate closure (Zhu; col. 21, lines 57-64).
Regarding claims 19-20, Harris as modified teaches the claimed invention, as discussed above, including the at least one retracting device holder (outer tube 2920 or longitudinal tube assembly 3004; Harris, Figures 29B, 30B) or its lumen exhibits, assumes or shows a first shape or a first cross section (generally round or circular proximal cross-section), being a circular cross-section with a cross section diameter (Dr), while positioning the retracting unit into the aperture, except for the retracting holder or its lumen exhibits a second shape or a second cross section, being an oval cross section with a main axis length (Dn), larger than the cross section diameter (Dr) and being an elliptical cross section with two symmetry axes, main axis and minor axis, after pulling the deploying device, partly or completely, out of the at least one retracting device holder, or wherein a shape of one of the closing device holders or of its cross section assumes mainly the second shape or features the second cross section, corresponds to it and/or has an oval cross section.
Harris does teach in another embodiment shown in Figure 11A, an elongate opening (longitudinal slot 852) through which arms 818 exit has a width that is smaller than its length (the slots may have a rectangular cross-section) in order to accommodate an elongate (rectangular) shape of the arms which may provide sufficient lateral rigidity that prevents undesirable bending ([0133]).
In the same field of art, namely medical devices for closing a tissue aperture, Zhu teaches in col. 21, lines 57-64 that an oval cross-section of a distal end of the device advantageously conforms to an elongated incision formed in the blood vessel, which facilitates closure.
It would have been obvious to one of ordinary skill before the effective filing date to modify the at least one retracting holder or its lumen, as well as one of the closing device holders, such that they have a second, elongated or oval opening area or cross section, as taught by Harris and Zhu, in order to accommodate an elongated arm that may provide sufficient lateral rigidity (Harris, [0133]) and to conform to a tissue aperture formed in the body to facilitate closure (Zhu; col. 21, lines 57-64).
Regarding claim 24, Harris as modified teaches the claimed invention, as discussed above, including at least one of the inner lumen of the at least one retracting device holder, or of a cross section thereof (cross section of outer tube 2920 or longitudinal tube assembly 3004; Harris, Figures 29B, 30B), and the opening area of the opening comprise sections that delimit an at least partially round shape (generally round or circular proximal cross-section), however not sections that delimit an at least partially oval shape.
In the same field of art, namely medical devices for closing a tissue aperture, Zhu teaches in col. 21, lines 57-64 that an oval cross-section of a device advantageously conforms to an elongated incision formed in the blood vessel, which facilitates closure.
It would have been obvious to one of ordinary skill before the effective filing date to modify the inner lumen of the at least one retracing device holder, or of a cross section thereof such that it comprises sections that delimit an oval shape to conform to a tissue aperture formed in the body to facilitate closure (Zhu; col. 21, lines 57-64).
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 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7 and 27 of U.S. Patent No. 12,035,899 in view of Harris (U.S. Pub. No. 2008/0319455) and Flanagan (U.S. Pub. No. 2018/0085101). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that elements of the application claims are encompassed by the patent claims, except for features that are merely obvious.
Harris teaches a closing device holder (lumen of 2920 or 3004 or U-shaped groove of insertion guides 2936 in cross section view A-A; Figures 29A-29B, 30A-30B), for releasably receiving one or more closing devices (such as self-reconfiguring or self-actuating fasteners 1600/2600/3024), wherein each of the one or more closing devices comprises a staple or a clip made at least partly of a deformable shape memory alloy and/or having a self-expanding shape memory section ([0177]; self-reconfiguring or self-actuating clip such as fastener 2600 is produced from shape memory or superelastic material such as NiTi alloy) within the closing device holders in a stressed state ([0178]) such that when the one or more closing devices is manipulated to exit a distal end of the respective closing device holder during use of the medical apparatus, the one or more closing devices releases its stress, or part of it (Id.); and
one or more bars or other protrusions (insertion guides 2636 or 3026; Id.) that are arranged between or adjacent to an opening of the closing device holder for discharging the one or more closing devices, the one or more bars or other protrusions being arranged to protrude over an opening area of the opening.
Flanagan teaches a medical apparatus 500 for closing an aperture 66 (Figures 13-14) including closing device holders (multiple parallel staplers/stapler heads; [0067]) each for releasably holding one or more closing devices (staples). Having the multiple parallel closing device holders may allow for simultaneous deployment of the one or more closing devices into a tissue aperture (Id.). Harris acknowledges in [0084] that the apparatus may allow simultaneous placement of multiple tissue fasteners.
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with the above features, as taught by Harris, to facilitate securely closing a tissue aperture. Additionally, it would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims such that there are multiple closing device holders, as taught by Flanagan, in order to allow for simultaneous deployment of the one or more closing devices (Id.) to efficiently close the tissue aperture (see Figure 4 of Flanagan).
Allowable Subject Matter
Claim 5 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
None of the prior art of record, alone or in combination, teaches or renders obvious a medical apparatus for closing an aperture of tissue of a patient including, inter alia, closing device holders, each for releasably receiving one or more closing devices, wherein each of the one or more closing devices comprises a staple or a clip made at least partly of a deformable shape memory alloy and/or having a self-expanding shape memory section within the closing device holders in a stressed state and releases its stress when exiting a distal end of the closing device holder, a retracting unit configured to come into contact with opposite sides of the aperture and to change the aperture shape into a slit, wherein a multitude of arms are provided to act as the retraction unit or as part thereof, one or more bars or other protrusions arranged to protrude over an opening area of at least one of openings of the closing device holders, wherein a delivery support for assuring - or assisting in - that the closing device holders deviate or part from each other when being advanced toward the aperture and/or out of a closing member is provided.
It is noted that if claim 1 is amended such that the allowable subject matter of claim 5 is incorporated into claim 1, claim 4 would be considered indefinite as it recites “closing device holders are arranged to remain, at least in parts, parallel to each other throughout the closing of the aperture or to part or deviate from each other when being advanced towards the aperture and/or out of a closing member”. The closing device holders remaining parallel to each other throughout the closing of the aperture is contrary to the allowable subject matter of the closing device holders deviate or part from each other when being advanced toward the aperture and/or out of a closing member, and therefore the claim would be rendered indefinite.
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.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771