DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Applicant’s election without traverse of Group A Species I (Fig. 1a-6c) and Group B Species ii (Fig. 7c-d) in the reply filed on 5/21/26 is acknowledged.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the suture passer passing through the proximal and distal openings which are aligned at an acute angle and passing through the first gap must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Note that the first gap and the two opening at an acute angle are found in the drawing with the suture passing only through the distal and proximal openings at an acute angle however the drawings do not show nor does it appear capable of having the suture passer than pass through the first gap as claimed.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: on page 1 Lines 4-5, the corresponding patent number for the parent application must be added.
Appropriate correction is required.
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the claimed limitations “the first gap defined by the expandable member is longitudinally aligned with the first distal opening such that the suture passer, when extended through the first proximal and distal openings with the expandable member in the expanded position, passes through the first gap extending between the first and second collapsible arms, is spaced from the expandable member along the length of the expandable member.”
The specification does not state how the suture passer when passed through the distal and proximal openings at an acute angle would also pass through the first gap. The drawings and specification show that the suture passer goes through an angle in the barrel and exits at an angle which would not allow it to go through the gap as claimed.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,274,426. Although the conflicting claims are not identical, they are not patentably distinct from each other because each of the structural limitation recited in the claims of the instant application are also recited in claims 1-18 of U.S. Patent No. 12,274,426. The difference in the terminology used would be obvious to one of ordinary skill in the art.
Specifically, the claimed limitations of claims 1-3 are found in claims 1-3 of U.S. Patent No. 12,274,426, respectively. The claimed limitations of claim 4 are found in the combination of claims 4 and 5 of U.S. Patent No. 12,274,426. The claimed limitations of claims 5-17 are found in claims 1 and 6-17 of U.S. Patent No. 12,274,426, respectively. The claimed limitations of claim 18 are found in the combination of claim 1 and 16 of U.S. Patent No. 12,274,426. The claimed limitation of claims 19 and 20 are found in claims 9 and 18 of U.S. Patent No. 12,274,426, respectively.
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 1-20 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 states that the suture passer extends through the proximal and distal openings at an acute angle and it extends through the first gap which is aligned with the distal opening, however it is unclear to the examiner how the suture passer would extend through the two openings and the first gap as claimed and in view of the specification; hence the claim is indefinite.
In order to advance prosecution, the examiner will interpret the limitation as the suture passer extending through the proximal and distal openings at an acute angle and passing radially adjacent through the first gap which is aligned with the distal opening.
Claim 18 states that the suture passer extends through the proximal and distal openings at an acute angle and it extends through the first gap which is aligned with the distal opening, however it is unclear to the examiner how the suture passer would extend through the two openings and the first gap as claimed and in view of the specification; hence the claim is indefinite.
In order to advance prosecution, the examiner will interpret the limitation as the suture passer extending through the proximal and distal openings at an acute angle and passing radially adjacent through the first gap which is aligned with the distal opening.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-4, 9-15, and 17-19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Riza (5,716,369) in view of Foster et al. (5,290,249).
Riza discloses a suture passer guide comprising: a barrel (270) having a longitudinal axis (Fig. 16-17); wherein the barrel defines a first proximal opening (see figure below) and a first distal opening (see figure below) that are substantially aligned with one another (see figure below and Fig. 16-17) such that a suture passer (80) (Fig. 14) can be extended through the first proximal and distal openings at an acute angle relative to the longitudinal axis of the barrel (Fig. 14 where the embodiment of Fig. 16-17 is capable of performing this function).
Riza further discloses that the barrel defines a second proximal opening (see figure below) and a second distal opening (see figure below) that are substantially aligned with one another (see figure below and Fig. 16-17) such that the suture passer (80) (Fig. 14) can be extended through the second proximal and distal openings at an acute angle relative to the longitudinal axis of the barrel (Fig. 14 where the embodiment of Fig. 16-17 is capable of performing this function); wherein the first proximal and distal openings are defined by respective portions of the barrel that are circumferentially spaced by about 180 degrees (Fig. 16-17 and figure below); that a shaft of the barrel defines a first guide passage (see figure below), that extends from the first proximal opening to the first distal opening (see figure below), and a second guide passage (see figure below), that extends from a second proximal opening to a second distal opening (see figure below).
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
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Riza teaches all the claimed limitations discussed above however, Riza does not disclose an expandable member secured to the barrel as claimed.
Foster teaches an expandable member (17) (Fig. 1-3) secured to a distal end region of the barrel (13) (Fig. 1-2), the expandable member configured to be positioned in an expanded position in which the expandable member extends radially beyond the barrel (Fig. 2-3), the expandable member comprising a first collapsible arm (18, see figure below) and a second collapsible arm (18, see figure below) that are spaced around a circumference of the expandable member (Fig. 2-3), the expandable member defining a first gap (see figure below) that extends between the first and second collapsible arms around the circumference of the expandable member (see figure below), and the first gap being open and uncovered (Fig. 1-3); wherein a first end region (proximal end of the arms connected to the barrel) of each of the collapsible arms is secured to the distal end region of the barrel (Fig. 2 where the end is at the proximal end closer to the tissue wall and it is connected to the distal end of the barrel), a second end region (distal end of the arm connected to 38 as seen in Fig. 1-3) of each of the collapsible arms is secured to a base (38) that is axially moveable relative to the barrel (Fig. 1-2 where it moves proximally in order to expand the expandable member), and a middle region (region between the two ends as seen in Fig. 2-3) of each of the collapsible arms is secured to the first and second end regions of each of the collapsible arms (Fig. 2-3); wherein axial movement of the base distally relative to the barrel causes the expandable member to collapse (Fig. 2-1 where the base moved distally in order to collapse the expandable member), and axial movement of the base proximally relative to the barrel causes the expandable member to expand (Fig. 1-2 where it moves proximally in order to expand the expandable member); wherein the expandable member comprises one or more additional collapsible arms that are spaced around the circumference of the expandable member (Fig. 2-3); wherein the first and second collapsible arms are in first and second groups of collapsible arms that are spaced apart around the circumference of the expandable member (see figure below); wherein the first gap is defined between two consecutive groups of collapsible arms (see figure below).
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It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Riza to have an expandable member, as taught by Foster, in order to secure the barrel to the tissue which would prevent it from moving during the procedure.
The combination of Riza in view of Foster would have the first gap defined by the expandable member of Foster longitudinally aligned with the first distal opening of Riza such that it would be capable of having a suture passer, when extended through the first proximal and distal openings with the expandable member in the expanded position, passes radially adjacent to through the first gap extending between the first and second collapsible arms, is spaced from the expandable member along the length of the expandable member (the combination would be capable of performing this function).
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
With respect to claims 2-3, the combination of Riza in view of Foster would be capable of having the suture passer guide configured to be passed through a lumen of an endoscopic port when the expandable member is positioned in a collapsed position (the device could be capable of performing this function); and wherein the expandable member is configured so that when the suture passer guide is positioned within an endoscopic port site wound and the expandable member is in the expanded position within a body cavity adjacent the endoscopic port site wound, the suture passer guide can be pulled proximally to apply an outward force to a wall forming the body cavity on either side of the endoscopic port site wound (the device could be capable of performing this function).
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
With respect to claim 12, Foster discloses the claimed expandable member except for the first gap between the first and second collapsible arms extending about 30 to about 180 degrees around a circumference of the barrel. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the gap extend about 30 to about 180 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim 1-4, 9-15, and 17-19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Riza (5,716,369) in view of Green (5,203,773).
Riza discloses a suture passer guide comprising: a barrel (270) having a longitudinal axis (Fig. 16-17); wherein the barrel defines a first proximal opening (see figure below) and a first distal opening (see figure below) that are substantially aligned with one another (see figure below and Fig. 16-17) such that a suture passer (80) (Fig. 14) can be extended through the first proximal and distal openings at an acute angle relative to the longitudinal axis of the barrel (Fig. 14 where the embodiment of Fig. 16-17 is capable of performing this function).
Riza further discloses that the barrel defines a second proximal opening (see figure below) and a second distal opening (see figure below) that are substantially aligned with one another (see figure below and Fig. 16-17) such that the suture passer (80) (Fig. 14) can be extended through the second proximal and distal openings at an acute angle relative to the longitudinal axis of the barrel (Fig. 14 where the embodiment of Fig. 16-17 is capable of performing this function); wherein the first proximal and distal openings are defined by respective portions of the barrel that are circumferentially spaced by about 180 degrees (Fig. 16-17 and figure below); that a shaft of the barrel defines a first guide passage (see figure below), that extends from the first proximal opening to the first distal opening (see figure below), and a second guide passage (see figure below), that extends from a second proximal opening to a second distal opening (see figure below).
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
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Riza teaches all the claimed limitations discussed above however, Riza does not disclose an expandable member secured to the barrel as claimed.
Green teaches an expandable member (14) (Fig. 1-4) secured to a distal end region of the barrel (12) (Fig. 1-4), the expandable member configured to be positioned in an expanded position in which the expandable member extends radially beyond the barrel (Fig. 4), the expandable member comprising a first collapsible arm (16, see figure below) and a second collapsible arm (16, see figure below) that are spaced around a circumference of the expandable member (Fig. 1-4), the expandable member defining a first gap (see figure below) that extends between the first and second collapsible arms around the circumference of the expandable member (see figure below), and the first gap being open and uncovered (Fig. 1-4); wherein a first end region (34) (Fig. 3-4) of each of the collapsible arms is secured to the distal end region of the barrel (Fig. 3-4), a second end region (16)(Fig. 3-4) of each of the collapsible arms is secured to a base (see figure below) that is axially moveable relative to the barrel (Fig. 3-4), and a middle region (18) of each of the collapsible arms is secured to the first and second end regions of each of the collapsible arms (Fig. 3-4); wherein axial movement of the base distally relative to the barrel causes the expandable member to collapse (Fig. 4-3 where the base moved distally in order to collapse the expandable member), and axial movement of the base proximally relative to the barrel causes the expandable member to expand (Fig. 3-4 where it moves proximally in order to expand the expandable member); wherein the expandable member comprises one or more additional collapsible arms that are spaced around the circumference of the expandable member (Fig. 3-4); wherein the first and second collapsible arms are in first and second groups of collapsible arms that are spaced apart around the circumference of the expandable member (see figure below); wherein the first gap is defined between two consecutive groups of collapsible arms (see figure below).
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It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device of Riza to have an expandable member, as taught by Green, in order to secure the barrel to the tissue which would prevent it from moving during the procedure.
The combination of Riza in view of Green would have the first gap defined by the expandable member of Green longitudinally aligned with the first distal opening of Riza such that it would be capable of having a suture passer, when extended through the first proximal and distal openings with the expandable member in the expanded position, passes radially adjacent to through the first gap extending between the first and second collapsible arms, is spaced from the expandable member along the length of the expandable member (the combination would be capable of performing this function).
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
With respect to claims 2-3, the combination of Riza in view of Green would be capable of having the suture passer guide configured to be passed through a lumen of an endoscopic port when the expandable member is positioned in a collapsed position (the device could be capable of performing this function); and wherein the expandable member is configured so that when the suture passer guide is positioned within an endoscopic port site wound and the expandable member is in the expanded position within a body cavity adjacent the endoscopic port site wound, the suture passer guide can be pulled proximally to apply an outward force to a wall forming the body cavity on either side of the endoscopic port site wound (the device could be capable of performing this function).
It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham, 2 USPQ2d 1647 (1987).
With respect to claim 12, Green discloses the claimed expandable member except for the first gap between the first and second collapsible arms extending about 30 to about 180 degrees around a circumference of the barrel. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the gap extend about 30 to about 180 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANNE DORNBUSCH whose telephone number is (571)270-3515. The examiner can normally be reached Monday-Wednesday 9 am-3 pm.
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, Elizabeth Houston can be reached at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DIANNE DORNBUSCH/Primary Examiner, Art Unit 3771
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