DETAILED ACTION
This action is in response to applicant's amendments filed 02/03/26.
The examiner acknowledges the amendments to the claims.
Claims 2-19 are pending in this application.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
In light of Applicant’s amendments to the claims, the prior art rejection of claims 2-4 has been withdrawn. However, new grounds of double patenting rejections are set forth below necessitated by the amendments.
Applicant’s arguments with respect to claim(s) 5-19 have been considered but are moot in view of the new grounds of rejection set forth below.
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.
Claims 5-15 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kahle et al., hereinafter “Kahle” (U.S. Pub. No. 2007/0088370) in view of Spaeth et al., hereinafter “Spaeth” (U.S. Patent No. 5,354,303).
Regarding claims 5-6, Kahle discloses a tissue retrieval system comprising:
an introducer 3 (Figures 1-5) having a proximal end, a distal end, and a lumen formed therein extending from the proximal end to the distal end ([0035]);
an actuator rod 7 having a proximal end and a distal end, at least a portion of the actuator rod being slidable within the lumen of the introducer (Id., [0037]);
a tissue retrieval bag 21 deployable by the actuator rod (Id.) and removably coupled to the actuator rod ([0038]-[0039]), the tissue retrieval bag comprising:
a rim (portion of bag 21 surrounding open end 21a) extending from a proximal end to a distal end, the proximal end and distal end of the rim defining a rim axis therebetween;
an opening 21a at the rim;
a closed end 21b opposite the opening (Figure 3);
a first edge (distal portion of cuff 51; Figure 8, [0067]) extending from the distal end of the rim between the opening and the closed end;
wherein the tissue retrieval bag is formed of a sheet material (“film”; Id.) and wherein the first edge comprises a folded edge (the cuff 51 is formed by folding over a top edge of the sheet material; Id.).
However, Kahle does not disclose the sheet material comprising a laminated material or the tissue retrieval bag closed end comprises a sealed edge.
In Figures 12c-12d, Spaeth teaches a tissue retrieval bag 14 that is formed of a laminated material (including multiple layers 44/46/48; Figures 13a-13b, col. 9, lines 3-35), and wherein a closed end of the tissue retrieval bag comprises a sealed edge (Id.; the materials for closed end 41 can be heat sealed).
It would have been obvious to one of ordinary skill at the time of invention to modify Kahle with a laminated material and sealed edge in the closed end as claimed, as taught by Spaeth, in order to strengthen the bag and prevent stretching or tearing (Id.).
Regarding claims 7 and 9, Kahle as modified teaches a closure member 25 (Kahle, Figure 4; [0038]) at the opening of the tissue retrieval bag 21, the closure member removably coupled to the actuator rod 7 ([0039]), wherein the closure member is usable to cinch the opening of the tissue retrieval bag ([0038]).
Regarding claim 8, Kahle as modified teaches the actuator rod 7 comprises a retaining slot 7a (Kahle, Figure 6; [0039]) positioned thereon, and wherein the closure member is removably coupled to the retaining slot of the actuator rod (Id.).
Regarding claim 10, Kahle as modified teaches the actuator rod 7 is slidable relative to the introducer 3 to position the tissue retrieval bag in one of a stowed configuration and a deployed configuration (Kahle, Figures 1, 3; [0037]).
Regarding claim 11, Kahle as modified teaches the actuator rod 7 comprises two support arms 23a, b (Kahle, Figure 3; [0037]) extending from the distal end thereof, the two support arms removably coupled to the opening of the tissue retrieval bag ([0038]).
Regarding claim 12, Kahle as modified teaches the two support arms 23a, b (Id.) support the opening of the tissue retrieval bag with the tissue retrieval bag in the deployed position (Figure 3).
Regarding claim 13, Kahle as modified teaches the tissue retrieval bag further comprises a cuff 51 (Kahle, Figure 8; [0041]-[0042]) positioned at the opening, and wherein the two support arms are removably positioned within the cuff ([0038]).
Regarding claims 14-15, Kahle as modified teaches the introducer 3 comprises a handle assembly 5 positioned at the proximal end thereof (Kahle; [0035]), wherein the actuator rod 7 comprises a handle 9 positioned at the proximal end thereof (Id.).
Claims 16-17, 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kahle (U.S. Pub. No. 2007/0088370) in view of Spaeth (U.S. Patent No. 5,354,303), as applied to claim 5 above, and further in view of Zwolinski et al., hereinafter “Zwolinski” (U.S. Pub. No. 2009/0306683).
Regarding claims 16-17, 19, Kahle as modified teach the claimed invention, as discussed above, including the actuator rod 7 being slidable from an initial configuration in which the tissue retrieval bag is in a stowed configuration, the bag having a diameter configured to fit within the lumen of the introducer 3 (Kahle, Figures 1, 3; [0037]), except for the tissue retrieval bag being rollable about a rim axis to the stowed configuration and a thickness of the sheet of material defines an outer diameter of the tissue retrieval bag in the stowed configuration.
Zwolinski teaches a tissue retrieval bag 110 being rollable about a rim axis to a stowed configuration [0064] having a diameter configured to fit within a lumen of an introducer 108 (Id.), a thickness of the sheet of material defines an outer diameter of the tissue retrieval bag in the stowed configuration. (Id.)
It would have been obvious to one of ordinary skill before the effective filing date to modify Kahle as modified with the above features, as taught by Zwolinski, in order to maintain a low profile of the tissue retrieval bag, therein facilitating introduction as well as removal from the patient’s body.
Claim 18 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kahle (U.S. Pub. No. 2007/0088370) in view of Spaeth (U.S. Patent No. 5,354,303) and Zwolinski (U.S. Pub. No. 2009/0306683), as applied to claim 16 above, and further in view of Taylor et al., hereinafter “Taylor” (U.S. Pub. No. 2008/0234696).
Regarding claim 18, Kahle as modified teaches the claimed invention, as discussed above, including the sheet of material comprises a laminated nylon material that resists tearing (Spaeth; col. 9, lines 10-18), but does not expressly teach ripstop material.
In [0065], [0068], Taylor teaches a tissue retrieval bag may include laminated rip-stop nylon.
It would have been obvious to one of ordinary skill before the effective filing date to modify the laminated nylon material to be ripstop, since the material has a substantially higher puncture strength than other commonly used tissue pouch materials (Id.) and 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.
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 2-3, 5, 7-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9 of U.S. Patent No. 11,191,557 in view of Kahle (U.S. Pub. No. 2007/0088370). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that the patent claims encompass the limitations of the application claims (see corresponding claims in the chart below), including a folded edge portion distal the distal end of the rim and distal each support arm (extending distally of opening of rim and cuff that receive the support arms in claims 1 and 9), and a folded sheet of material (in claim 1) laminated ripstop material (in claim 3), except lack features that are merely obvious. For instance, Kahle teaches a tissue retrieval bag 21, as discussed above, being removably coupled to at least one support arm 23a, b ([0038]) and a cuff 51 (Figure 8; [0041]-[0042]) comprising a reinforced cuff section at the distal end of the rim ([0042]). Additionally, Kahle teaches actuator rod 7 is slidable relative to introducer 3 to position the tissue retrieval bag in one of a stowed configuration and a deployed configuration (Figures 1, 3; [0037]), and the introducer 3 comprises a handle assembly 5 positioned at the proximal end thereof (Kahle; [0035]), wherein the actuator rod 7 comprises a handle 9 positioned at the proximal end thereof (Id.). It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims with the above features, as taught by Kahle, in order to facilitate deployment of the bag and cinching the bag to a fully closed configuration without disrupting or disturbing the bag or contents within the bag, as well as to counteract tension or force applied to the cord loop during manipulation or closure of the bag and to avoid unintended separation of the bag from the cord loop (Id.).
Application No. 18/619,630 claims
U.S. Pat. No. 11,191,557 claims
2
1, 9
3
1, 9
4
1, 9
5
1, 3
6
1, 3
7
1, 3
8
1, 3
9
1, 3
10
1, 3
11
1, 3
12
1, 3
13
1, 3
14
1, 3
15
1, 3
16
1, 3
17
1, 3
18
3
19
1, 3
Claims 4 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 9 of U.S. Patent No. 11,191,557 in view of Kahle (U.S. Pub. No. 2007/0088370), as applied to claims 3 and 5 above, and further in view Spaeth (U.S. Patent No. 5,354,303). Regarding claims 4 and 6, the patent claims as modified teach the claimed invention, as discussed above, except for the tissue retrieval bag is formed of a first sheet of material, and wherein the reinforced section comprises a second sheet of material joined to the first sheet of material, or wherein the tissue retrieval bag closed end comprises a sealed edge.
In Figures 12c-12d Spaeth teaches a tissue retrieval bag 14 that is formed of a first sheet of material (44 or 46; Figures 13a-13b, col. 9, lines 3-35), and a reinforced section at a closed end 41 comprises a second sheet of material 48 joined to the first sheet of material, or wherein the tissue retrieval bag is formed of a sheet of material 44/46/48 and wherein the closed end comprises a sealed edge (Id.; the materials for closed end 41 can be heat sealed). It would have been obvious to one of ordinary skill at the time of invention to modify the patent claims as modified such that the tissue retrieval bag has material sheets in the reinforced section or closed end as claimed, as taught by Spaeth, in order to prevent the bag from stretching or tearing (Id.).
Claims 16-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 of U.S. Patent No. 11,191,557 in view of Kahle (U.S. Pub. No. 2007/0088370), as applied to claim 5 above, and further in view of Zwolinski (U.S. Pub. No. 2009/0306683). Regarding claims 16-19, the patent claims as modified teach the claimed invention, as discussed above, except for a tissue retrieval bag being rollable about a rim axis to a stowed configuration having a diameter configured to fit within a lumen of an introducer, the tissue retrieval bag moves from the stowed configuration to a deployed configuration wherein a thickness of the sheet of material defines an outer diameter of the tissue retrieval bag in the stowed configuration.
Zwolinski teaches a tissue retrieval bag 110 being rollable about a rim axis to a stowed configuration [0064] having a diameter configured to fit within a lumen of an introducer 108 (Id.), the tissue retrieval bag moves from the stowed configuration to a deployed configuration wherein a thickness of the sheet of material defines an outer diameter of the tissue retrieval bag in the stowed configuration. (Id.) It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims as modified with the above features, as taught by Zwolinski, in order to maintain a low profile of the tissue retrieval bag, therein facilitating introduction as well as removal from the patient’s body.
Although patent claim 3 does not recite the laminated ripstop material being nylon, Kahle teaches in [0050] nylon fibers having an advantageous tensile strength. It would have been obvious to one of ordinary skill before the effective filing date to modify the laminated ripstop material to be nylon, 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.
Allowable Subject Matter
Claims 2-4 would be allowable if a Terminal Disclaimer was filed to overcome the double patenting rejections set forth in this office action.
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 tissue retrieval system including, inter alia, a tissue retrieval bag comprising at least one support arm extending distally from a distal end of an actuator rod, a rim extending from a proximal end to a distal end, the proximal end and the distal end defining a rim axis therebetween, the tissue retrieval bag comprising an elongate profile defined by a folded edge portion being positioned distal the distal end of the rim and distal each support arm of the at least one support arm relative to the rim axis, as in claim 2.
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 DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DIANE D YABUT/Primary Examiner, Art Unit 3771
Prosecution Insights