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 with traverse of Group I, claims 1-10, in the reply filed on 12/17/2025 is acknowledged. The traversal is on the ground(s) that there is not a serious search and examination burden because, as asserted by Applicant, prior art that discloses the product of group I would have disclosed or taught methods of using the product, and method of its manufacture. This is not found persuasive because not all prior art documents that disclose a product also disclose the method of manufacturing that product, or methods of use for the product. As noted in the restriction requirement mailed 10/21/2025, there would be a serious search or examination burden if restriction were not required because of the different fields of search for each group including different classification searches (group I – A61B 17/221; group II – A61B 17/24; Group III – A61B 2017/00526, noting that this is indented under A61B17/00234 and thus requires a search of A61B 17/00234). Additionally, the two groups require the use of different search terms (“method”, “esophagus”, “attaching”, “integrating” not required for the product claims). Furthermore, the examination burden is not limited exclusively to a prior art search but also that effort required to apply the art by making and discussing all appropriate grounds of rejection. Multiple inventions, such as those in the present application, normally require additional reference material and further discussion for each additional invention examined. Concurrent examination of multiple inventions would thus typically involve a significant burden even if all searches were coextensive. The searches and examination of the method of manufacture, the method of use, and the apparatus are indeed different and burdensome.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 1-4, 6-7 and 10 are objected to because of the following informalities:
Claim 1: in line 2, “the area” should read “an area” as this is its first recitation.
Claim 1: in line 2, “coupled to and cover” should read “coupled to and covering”.
Claim 1: in line 4, it appears that “loop contains” should read “loop that contains”.
Claim 1: in line 5, “said distal end of said tube” should read “a distal end of said tube” as this is its first recitation.
Claim 1: in line 7, “a distal end of said control wire” should read “said distal end of said control wire” since it has been previously recited.
Claim 2: in line 3, “a distal end of said tube” should read “said distal end of said tube” since it has been previously recited.
Claim 3: “the outermost point” should read “an outermost point” as this is its first recitation.
Claim 4: “having a center folded having an angle” should read “having a center folded
Claim 6: “said expanded state” should read “an expanded state” as this is its first recitation.
Claim 7: the limitation in claim 7 is understood to be drawn to an intended use of the device. In order to avoid any potential 35 USC 101 issues with respect to the positively reciting the device in combination with a part of a human body, “is perpendicular to” must be amended to read “is configured to be perpendicular to”.
Claim 10: “mesh material” should read “a material of said mesh” as the mesh material of claim 10 is understood to refer back to the material of the previously recited mesh. 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 6 and 9 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 6 recites the limitation of the loop and mesh having a configuration “similar to a clam shell” which is considered indefinite, as it is not clear what applicant intends to cover (i.e., what is and isn’t “similar to” a clam shell). In other words, the metes and bounds of the limitation “similar to a clam shell” is unclear. See MPEP 2173.05(b), III, C. For purposes of claim interpretation, the claim is being treated as though it has been amended to read “to form an enclosure…”.
Regarding claim 9, the phrase "such as" (“biocompatible material such as stainless steel or titanium”) renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For purposes of claim interpretation, the claim is being treated as though “such as stainless steel or titanium” has been deleted from the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Teague et al. (US 2005/0119668) in view of Dennis (US 2005/0043743). Teague discloses an endoscopic snare net retrieval device comprising: a snare loop (125g; fig. 18); a mesh (128g) securely coupled to and cover the entirety of the area within the snare loop ([0102]); a tube (sheath; [0100]) having a lumen configured and arranged therein; a control wire or cable (110g; considered a control wire, noting “wire” is given its broadest reasonable interpretation of a thin filament, and may be hollow) that is disposed within the lumen of the tube (similar to arrangement shown in fig. 1), such that the snare loop that contains the mesh thereon is located at the distal end of the tube (as understood in view of fig. 1) and is attached to the distal end of the control wire or cable (110g); and a drive member (104; fig. 1) coupled to a proximal end of the control wire or cable and exposed at a proximal end of the tube, such that an actuation of the drive member moves the snare loop via the control wire or cable, to fully retrieve the snare loop within the lumen of the tube at the distal end of the tube (similar to figs. 4-6; see also claim 27 of Teague), or to release and to expand the snare loop ([0079]) and the mesh coupled thereon at the distal end of the tube away from the tube such that the snare loop is about 90° apart from the distal end of the tube (configuration shown in fig. 18 considered 90 degrees in the same manner as the instant invention – i.e., tip of snare is disposed along a line perpendicular to the longitudinal axis of the control wire and tube; see examiner-annotated fig. 18 of Dennis below, noting dotted perpendicular lines).
PNG
media_image1.png
329
447
media_image1.png
Greyscale
PNG
media_image2.png
356
334
media_image2.png
Greyscale
Teague fails to expressly disclose an external string or suture that has a first end coupled to a distal end of the control wire or cable, and a second end that anchors the snare loop away from the distal end of the tube.
Dennis discloses another endoscopic snare retrieval device, the device comprising a snare loop (152; fig. 1, 4), a tube (132), and a control wire or cable (134) disposed within the lumen of the tube. The device further comprises an external string or suture (160; [0038]) that has a first end (162) coupled to a distal end of the control wire or cable (at 162, via their common connection to tube 132) and a second end (164) that anchors the snare loop away from the distal end of the tube (fig. 4; radially away). Actuation of a drive member (122/128; fig. 1) moves the loop via the control cable (134) to fully retrieve the snare loop within the lumen of the tube (see fig. 5), or to release and expand the loop and the external string at the distal end of the tube away from the tube such that the snare is about 90 degrees apart from the distal end of the tube (figs. 5-8; [0041]). This configuration is disclosed as a known alternative to a snare loop that, instead of using an external string or suture to cause curvature of the loop, is biased into a curved shape via the material of the loop (fig. 11; [0047]).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Teague to include an external suture or string having a first end coupled to a distal end of the control wire or cable, via the tube, and a second end that anchors the snare loop away from the distal end of the tube to control curvature of the loop in view of Dennis’s teaching that providing such an external string or suture coupled to the snare loop in order to control curvature of the loop is a known alternative to a loop that is merely biased by its material into its curved shape. Such a modification can be considered a substitution of one mechanism for curving the snare loop (material of loop biased to expand into an outwardly curved shape when not within a sheath) for another (tether that provides tension to outwardly curve snare loop), wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Regarding claim 2, as taught by Dennis, the first end of the external string or suture (160 of Dennis) is coupled to a distal end of the control wire or cable via the outer wall of a distal end of the tube (see fig. 4 of Dennis; at 162).
Regarding claim 3, the second end of the external string or suture anchors the snare loop at the outermost point (at 164 in fig. 4 of Dennis) away from the distal end of the tube (see fig. 4 of Dennis; radially outermost point).
Regarding claim 4, the limitation “the anchoring of the snare loop by the second end of the external string or suture allows the snare loop to be configured as an at least partially folding loop having a center folded angle of between 30° to 90° formed by the anchoring” corresponds to the angle “α” in fig. 3 as understood in view of the specification of the instant application (see [022]). The angle formed within the loop at the distal free end of the snare loop of Teague (and of Dennis; fig. 8), which corresponds to the angle α of the instant application, is clearly less than 90 degrees in both the prior art of Teague and the prior art of Dennis, but it is unclear whether or not it falls within the claimed range of between 30 and 90 degrees. However, such a modification to the prior art of Teague in view of Dennis would have been considered obvious to one of ordinary skill in the art since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984, cert. denied, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, both the claimed device and the prior art of Teague in view of Dennis provide a center folded angle that allows the snare loop to fold back toward the distal end of the tube to form an enclosure to trap an undesirable growth or foreign object.
Regarding claim 5, as taught by Dennis, the external string or suture is partially or fully extended away from the distal end of the tube (at least in the configuration shown in fig. 4 of Dennis).
Regarding claim 6, in the expanded state, the loop and the mesh are positioned by the external string or suture to have a configuration to form an enclosure to capture a bolus, undesirable growth, or foreign object as taught by Dennis (see fig. 18 of Teague, which has been modified to include a string or suture holding the loop in this fully expanded configuration as taught by Dennis).
Regarding claim 7, the expanded snare loop is configured to be (noting claim objection above) perpendicular to the axis of an internal cavity or esophagus of a patient ready to capture bolus, undesirable growths, or objects, noting that the degree at which the snare loop bends is controlled by the degree at which the control wire or cable is moved relative to the tube to which the external string or suture is coupled as taught by Dennis (see [0041] of Dennis – noting “any degree of deformation” of loop can be achieved by moving cable 134 distally relative to tube according to Dennis).
Regarding claim 8, the expanded snare loop has a diameter of between 0.5cm to 5cm. Noting that Teague discloses an expanded diameter of 1.5 to 2.5cm for the configuration shown in fig. 3 ([0084]), it would have been obvious to one of ordinary skill in the art to similarly size the diameter of the loop shown in fig. 18 of Teague with a reasonable expectation of success since it is used for the same purpose – to expand across the body lumen to assist in capturing, for example, a calculi within the urinary tract of a patient.
Regarding claim 9, the snare loop is formed from a high-grade, biocompatible metal such as stainless steel or titanium ([0081] of Teague).
Regarding claim 10, the mesh material is selected from the group consisting of polypropylene, polyester, ePTFE and mixtures thereof. In particular, Teague discloses that the mesh may comprise any biocompatible fabric or material (see [0102]) and further discloses that ePTFE may be used in the construction of sheaths, elongate members, or “other structures of the devices” ([[0081]) and thus it would have been considered obvious to one of ordinary skill in the art to have constructed the mesh of Teague from ePTFE, wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2002/0095171 to Belef discloses a loop having a net mesh attached thereto and a string or suture attached to a distal end of the loop in order to tension the distal end of the loop toward the distal end of the tube through which the loop passes (see figs. 3A-3F).
US 2010/0042107 to Merrifield discloses a loop having a control wire or cable (51) attached thereto and a member (60) attached to a distal end of the loop in order to tension the distal end of the loop toward the distal end of the tube through which the loop passes (see figs. 2a, 2b).
US 2013/0184739 to Brady et al. discloses a loop having a net mesh attached thereto and a string or suture (343; figs. 15-17) attached to a distal end of the loop in order to tension the distal end of the loop toward the distal end of the tube through which the loop passes (see figs. 15-17).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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.
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.
KSH 1/22/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771