DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I claims 1-17 in the reply filed on 05/26/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 18-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subcombination, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/26/2026.
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 12-17 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 12 recites “wherein the open end extends along the central longitudinal axis from a proximal end to a distal end” in lines 12-13 and is unclear which proximal end and distal end the open end extends along from. It is unclear if this is the proximal end and distal end of the tubular introducer as previously introduced, the proximal end and distal end of the actuator as previously introduced, or if this is a new proximal end and distal end needing to be introduced. For the purposes of examination, the Office will interpret the claim to mean a proximal end and a distal end of the open end. Claims 13-17 are rejected due to their dependency on claim 12.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4 and 6-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taylor et al. (US PGPub 2011/0087235), hereinafter known as “Taylor.”
With regards to claim 1, Taylor discloses (Figures 1-9; although directed towards different embodiments, paragraph 111 discloses “it will be understood by those skilled in the art that the present inventions extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Further, the various features of these inventions can be used alone, or in combination with other features of these inventions other than as expressly described above” and thus the tissue retrieval bag 20’ of figures 7-9 is used in place of the tissue bag 20 of figures 1-4A) a tissue retrieval system 10 comprising:
a tubular introducer 3 having a proximal end and a distal end and defining a central longitudinal axis between the proximal end and the distal end, the tubular introducer 3 having a lumen extending between the proximal end and the distal end (paragraph 36);
an actuator 7 longitudinally slidable within the lumen of the introducer 3, the actuator having a proximal end and a distal end (paragraph 36);
a pair of support arms 40 extending distally along the central longitudinal axis from the distal end of the actuator 7 (pair of support arms 40 extend distally along the central longitudinal axis when inside the introducer 3 as disclosed in paragraphs 53 and 61 in the retracted configuration);
a tissue retrieval bag 20’ removably coupled to the support arms 40 (paragraph 58 – tissue retrieval bag is releasable attached to the actuator 7, thus also the support arms 40), the tissue retrieval bag 20’ having an open end (figures 7-8 – open end is the end that cord 32 makes a loop through cuff 30) and a closed end opposite the open end, the tissue retrieval bag 20’ comprising:
a cuff 30 extending longitudinally at the open end between a proximal end of the open end and a distal end of the open end (figures 7-8), the cuff 30 configured to receive the pair of support arms 40 (paragraph 57); and
an upper proximal portion positioned at the proximal end of the cuff 30 and extending transversely to the longitudinal axis in a direction longitudinally proximally and away from the closed end (see annotated figure 8 below); and
a bead 50 coupled to the upper proximal portion, the bead 50 configured to slidably receive the pair of support arms 40 (paragraph 58).
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With regards to claim 2, Taylor discloses wherein the tissue retrieval bag 20’ comprises a distal edge extending from the open end at the distal end of the cuff 30 to the closed end (see annotated figure 8 below).
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With regards to claim 3, Taylor discloses wherein the distal edge comprises a folded edge (paragraph 48 – “Advantageously, such a geometry can facilitate folding and rolling of the tissue retrieval bag 20' to a relatively low diameter configuration for installation in a trocar” – thus the distal edge comprises a folded edge due to the folding of the tissue retrieval bag 20’ to a relatively low diameter configuration).
With regards to claim 4, Taylor discloses wherein the tissue retrieval bag 20’ comprises a proximal edge extending from the open end at the proximal end of the cuff 30 to the closed end (see annotated figure 8 below).
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With regards to claim 6, Taylor discloses wherein the upper proximal portion comprises an upper edge and a lower edge opposite the upper edge (see annotated figure 8 below).
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With regards to claim 7, Taylor discloses wherein the lower edge is colinear with the proximal edge (see two previous annotated figure 8s above – lower edge and proximal edge extend along the same line).
With regards to claim 8, Taylor discloses wherein the upper edge comprises a radiused profile (see annotated figure 8 below).
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With regards to claim 9, Taylor discloses wherein the radiused profile has a first radiused portion having a first radius, a second radiused portion having a second radius, and a transition profile (see annotated figure 8 above).
With regards to claim 10, Taylor discloses wherein the first radius is larger than the second radius (see annotated figure 8 above – first radius is wider than the second radius).
With regards to claim 11, Taylor discloses wherein the tissue retrieval bag 20’ is operable between a stowed position in which the tissue retrieval bag 20’ is positioned within the introducer 3 and a first deployed position in which the tissue retrieval bag 20’ is deployed from the introducer 3 and coupled to the support arms 40 such that longitudinal movement of the actuator 7 within the lumen repeatably actuates the tissue retrieval bag 20’ between an open configuration and a closed configuration (paragraphs 7-9, 40 and 57).
With regards to claim 12, Taylor discloses (Figures 1-9; although directed towards different embodiments, paragraph 111 discloses “it will be understood by those skilled in the art that the present inventions extend beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Further, the various features of these inventions can be used alone, or in combination with other features of these inventions other than as expressly described above” and thus the tissue retrieval bag 20’ of figures 7-9 is used in place of the tissue bag 20 of figures 1-4A) a tissue retrieval system 10 comprising:
a tubular introducer 3 having a proximal end and a distal end and defining a central longitudinal axis between the proximal end and the distal end, the tubular introducer 3 having a lumen extending between the proximal end and the distal end (paragraph 36);
an actuator 7 longitudinally slidable within the lumen of the introducer 3, the actuator having a proximal end and a distal end (paragraph 36);
a pair of support arms 40 extending distally along the central longitudinal axis from the distal end of the actuator 7 (pair of support arms 40 extend distally along the central longitudinal axis when inside the introducer 3 as disclosed in paragraphs 53 and 61 in the retracted configuration);
a tissue retrieval bag 20’ removably coupled to the support arms 40 (paragraph 58 – tissue retrieval bag is releasable attached to the actuator 7, thus also the support arms 40), the tissue retrieval bag 20’ having an open end (figures 7-8 – open end is the end that cord 32 makes a loop through cuff 30) and a closed end opposite the open end and defining a depth axis extending from the open end to the closed end orthogonally to the central longitudinal axis (see annotated figure 8 below), wherein the open end extends along the central longitudinal axis from a proximal end to a distal end, the tissue retrieval bag 20’ comprising:
a distal edge extending from the distal end of the open end to the closed end (see annotated figure 8 below);
a proximal edge extending from the proximal end of the open end to the closed end, the proximal edge extending transversely to the central longitudinal axis (see annotated figure 8 below); and
an upper proximal portion positioned at the proximal end of the cuff 30 and extending transversely to the longitudinal axis in a direction longitudinally proximally and away from the closed end (see annotated figure 8 below); and
a bead 50 coupled to the upper proximal portion, the bead 50 configured to slidably receive the pair of support arms 40 (paragraph 58).
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With regards to claim 13, Taylor discloses wherein the tissue retrieval bag 20’ is formed of a sheet of material (paragraph 46).
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 5 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Taylor in view of Kessler et al. (US PGPub 2017/0224321), hereinafter known as “Kessler.”
With regards to claims 5 and 14, Taylor discloses the tissue retrieval system as claimed in claims 4 and 13, respectively. Taylor is silent wherein the proximal edge comprises a welded seam (claims 5 and 14).
However, in a similar field of endeavor of tissue retrieval systems, Kessler teaches (Figures 57-59) wherein the proximal edge 326 comprises a welded seam 326 (paragraph 337).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal edge of Taylor to comprise a welded seam as taught by Kessler for the purpose of providing a strong, leak-proof seal while collecting tissue.
With regards to claim 15, Taylor further discloses wherein the upper proximal portion comprises an upper edge and a lower edge opposite the upper edge (see annotated figure 8 below).
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With regards to claim 16, the combination discloses wherein the lower edge (of Taylor) comprises a welded seam (welded seam taught by Kessler) that is colinear with the proximal edge (Taylor: see annotated figure 8 below - lower edge and proximal edge extend along the same line).
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With regards to claim 17, Taylor further discloses wherein the upper edge comprises a radiused profile (see annotated figure 8 below).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMED S ADAM whose telephone number is (571)272-8981. The examiner can normally be reached 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMED S ADAM/Examiner, Art Unit 3771 06/23/2026