CTNF 18/679,019 CTNF 95793 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Specification The abstract of the disclosure is objected to because “again lateral movement” should be –against lateral movement--. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Claim Objections 07-29-01 AIA Claim 43 is objected to because of the following informalities: "the protrusions" should be --the plurality of protrusions-- and "the radial projections" should be --the plurality of radial projections --. Appropriate correction is required. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-12-aia AIA (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15-aia AIA Claim(s) 31-32 and 4 4 is/are re jected under 35 U.S.C. 102(a)(1) an d (a)(2) as being a nticipa ted by Suzuki (U S 6110127 A). Regardin g claim 31 , Suzuki discloses a method for obtaining a target tissue, comprising: inserting a distal portion of a biopsy forceps assembly (medical instrument 1) to a target area within a living body (Col. 1, line 5-10 and Col. 8, line 29-37-- to be inserted into a patient's body through the … for cutting living tissues continuously and collecting a plurality of living-tissue samples.), the distal portion including: a control member extending from a proximal end to a distal end (operation wire 12, Fig. 1B); an end effector including first and second jaws (forceps tips 24, 25; Fig. 4-7) movable between an open configuration in which the first and second jaws are separated from one another to receive the target tissue therebetween (Col. 6, lines 18-41—forceps tips 24 and 25 are connected to the distal ends of the elastic arms 24a and 25a…the edges 24e and 25e meet each other when the blades 24b and 25b are moved into their closed position…the elastic arms 24a and 25a are so biased that the blades 24b and 25b are spaced apart from each other; Col. 7, lines 15-36—as the tube 11 and wire 12 move, the blades 24b and 25b are moved into the opened positions or the closed positions; Fig. 4, 6A, 6C, 7), and a closed configuration, in which cutting edges of the first and second jaws are moved toward one another to cut the target tissue away from surrounding tissue (Col. 6, lines 18-41; Col. 7, lines 15-36—as the tube 11 and wire 12 move, the blades 24b and 25b are moved into the opened positions or the closed positions. When moved into the closed position, the blades 24b and 25b clamp and cut a living tissue; Col. 8, lines 28-46; Fig. 5, 6A-6B), the first and second jaws defining a tissue receiving space therebetween to house the target tissue (opening between forceps tips 24 and 25 that receives tissue H; as best seen in Fig. 4-7); moving the control member distally relative to the first and second jaws (Col. 7, line 7-22—the inner tube 11 and the operation wire 12 have their proximal ends secured to the slider 8…when the slider 8 is moved in the axial direction…the operation wire 12 move with respect to the outer tube 10 in the same direction as the slider 8. As the tube 11 and wire 12 move, the blades…are moved into the opened positions or the closed positions; Col. 8, line 37-52—when the sampling means 13 reaches the mucous membrane, the doctor moves the slider 8 forward…) to move a yoke coupled between the control member and the first and second jaws (coupling 23, Fig. 1B) distally so that a distal projection (distal frame 27; Fig. 4-7) of the yoke contacts the target tissue (Fig. 6A; col. 8, lines 46-51—setting the distal frame 27 into contact with the mucous membrane; Col. 10, line 10-24), the yoke being coupled to the first and second jaws (forceps tips 24, 25 secured to the coupling 23; Fig. 4-7; Col. 6, lines 19-23 and 35-41—forceps tips 24 and 25 are connected to the distal ends of elastic arms 24a and 25a…ends of the arms 24a and 25a are secured to the outer circumference of the coupling 23) so that distal movement of the yoke moves the first and second jaws to the open configuration (Fig. 6A-6C demonstrate that distal movement of coupling 23 via distal movement of the operation wire 12 moves the forceps tips 24 and 25 distally to an open configuration; Col. 7, lines 15-36; col. 8, lines 37-52; Col. 10, line 10-24;), moving the control member proximally relative to the first and second jaws to move the jaws to the closed configuration so that the cutting edges of the first and second jaws sever the target tissue from the surrounding tissue (Col. 7, lines 15-36—when the slider 8 is moved toward the proximal end of the operation section 3, the inner tube 11 and the operation wire 12 pull the distal unit 15 and both elastic arms 24a and 25a into the distal pipe 14. As the arms 24a and 25a are pulled into the distal pipe 14, they bend toward the axis of the instrument…the blades 24b and 25b move forward until each saw-tooth edge…abut on each other. If the blades 24b and 25b hold a living tissue between them, they can exert a sufficient cutting force on the living tissue; Col. 8, lines 28-61; Figs. 6B). Regarding claim 32 , Suzuki discloses the method of claim 31. Suzuki additionally teaches inserting the biopsy forceps assembly through a working channel of an endoscope (Col. 1, line 5-11 and Col. 8, line 29-37-- a medical instrument, which is designed, to be inserted into a patient's body through the instrument-guiding channel of an endoscope, already inserted into the patient's body). Regarding claim 44 , Suzuki discloses the method of claim 31. Suzuki additionally teaches wherein the first and second jaws include concave inner surfaces defining a hemispherical cup (Forceps tips 24, 25, Figs. 4-7) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 45-46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Suzuki in view of He (US 20180125596 A1) . Regarding claim 45 , Suzuki discloses the method of claim 31. However, Suzuki does not specifically teach wherein the end effector including the first jaw, the second jaw, and the yoke has a length of less than 4 mm. He, in the same field of endeavor of manipulation devices having an end effector (abstract), teaches wherein the end effector may comprise forceps actuated by actuation wires (Paragraph 0022, 0033-0034), wherein the end effector length may be less than 3mm for use in a small working space (Paragraph 0023, 0030, 0035). It would have been obvious to one having ordinary skill in the art to combine the device of Suzuki with the length teachings of He in order to predictably improve the ability to use the device in very small working spaces, which would allow for use of the device in a greater variety of locations within the body which may require biopsy. Regarding claim 46 , Suzuki discloses the method of claim 44. However, Suzuki does not specifically teach wherein the end effector has a length of no more than 3.5 mm. He, in the same field of endeavor of manipulation devices having an end effector (abstract), teaches wherein the end effector may comprise forceps actuated by actuation wires (Paragraph 0022, 0033-0034), wherein the end effector length may be less than 3mm for use in a small working space (Paragraph 0023, 0030, 0035). It would have been obvious to one having ordinary skill in the art to combine the device of Suzuki with the length teachings of He in order to predictably improve the ability to use the device in very small working spaces, which would allow for use of the device in a greater variety of locations within the body which may require biopsy . 07-21-aia AIA Claim( s) 47 i s/are rejected under 35 U.S.C. 103 as being unpatentable over S uzuki in view of Bencini (US 5172700 A). R egarding claim 47 , Suzuki discloses the method of claim 31. However, Suzuki fails to specifically teach the distal projection is formed as a tissue penetrating spike. Bencini in the same field of endeavor of biopsy forceps including first and second cutting jaws (Abstract), teaches wherein the forceps include a tissue contacting structure formed as a tissue penetrating spike (Spike 96, Fig. 5-5C, or alternatively spike 190, Figs. 8A-8F or spike 206, Figs. 9A-9F or spike 224, Figs. 10A-10F) which is positioned so that, when the yoke and the first and second jaws are moved distally and the first and second jaws move to the open configuration, the tissue contacting structure extends distally to engage a portion of tissue between the first and second jaws to anchor the engaged portion of tissue again lateral movement as the first and second jaws contact the tissue adjacent to the engaged portion of tissue (Col. 7, lines 15-20; Col. 10, lines 38-46; Col. 11, lines 17-19; Col. 11, lines 39-44—when the jaw members open, the spike will be exposed…may be used to stabilize the distal end of the device in tissue to be sampled…may also serve as a skewer to pass through and retain cut tissue samples while the biopsy device continues to take additional tissue samples). It would have been obvious to one having ordinary skill in the art at the time of filing to perform a simple substitution of the tissue contacting structure of Suzuki for the tissue penetrating spike of Bencini which is similarly capable of retaining a tissue sample in order to predictably improve the stability of the device during sampling via anchoring of the distal end of the device in the tissue . Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim s 33-43 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. 13-03-01 AIA The following is a statement of reasons for the indication of allowable subject matter: The prior art of the record fails to teach and/or fairly suggest, in combination with all other recited limitations, "wherein the yoke includes radial projections sized to slidably engage an inner surface of the capsule to maintain the yoke and the first and second jaws centered within the capsule” of claim 33 and “wherein a plurality of protrusions at a distal end of the capsule extend radially inward toward a longitudinal axis of the capsule to prevent the first and second jaws from sliding distally out of the capsule" of claim 42. In particular, the applicant's arguments that Suzuki (US 6110127 - previously cited) fails to sufficiently teach the claimed limitation because the screws of Suzuki, in contrast to the claimed limitation, are distinct elements which are not part of the yoke and thus cannot serve as radially projecting portions of the yoke which contact an inner surface of the capsule to center the yoke and jaws within the capsule, nor are the screws part of the capsule and thus the screws cannot alternatively or additionally serve as protrusions of the capsule. Furthermore: Palmer (US 6461310 B1) demonstrates a capsule (cylinder 140) including protrusions which extend radially inward (crimp 141, see Fig. 5-6). However, the reference fails to include any suggestion that a yoke portion such as the base member 152 may include radially projecting portions that contact an inner surface of the capsule, or any suggestion that the protrusions of the capsule should be located at a distal end of the capsule and prevent the first and second jaws from sliding distally out of the capsule (the crimp portion instead prevents further proximal movement of the jaw or distal movement of the cylinder). Banik (US 5871453 A) teaches a sample tube 120 similar to a yoke and a sleeve 124 similar to a capsule, where the sleeve includes radial extensions 147 which are protrusions which extend radially inward (see Fig. 10) and which maintain the axial alignment of the two portions. However, the reference fails to include any suggestion that the yoke portion may include radially projecting portions that contact an inner surface of the capsule to center the yoke and the first and second jaws within the capsule, or any suggestion that the protrusions of the capsule should be located at a distal end of the capsule and prevent the first and second jaws from sliding distally out of the capsule. Fisher (US 6994712 B1) teaches a capsule (cylindrical sleeve 112) including radially inwardly projecting pins (pins 114, 116) which are used to inhibit distal movement of an inner portion out of the capsule (Figs. 30-34). However, the reference fails to include any suggestion of the yoke portion may include radially projecting portions that contact an inner surface of the capsule to center the yoke and the first and second jaws within the capsule, or any suggestion that the protrusions of the capsule should be located at a distal end of the capsule. Chu (US 6176834 B1) teaches an inner cutting tube most similar to the yoke and jaw assembly (Cutting tool 14) and an outer retractor tube most similar to the capsule (Retractor 12) which are coaxial (Fig. 1), where each tube includes a radially protruding ring and where the rings meet to prevent further movement distally (Lip 13 prevents the proximal end of the cutter from sliding beyond the proximal end of the retractor, such that the inner assembly is prevented from sliding distally out of the outer assembly; Fig. 1). However, the reference fails to teach or suggest a plurality of protrusions or projecting portions, that the projecting portion of the yoke contacts an inner surface of the capsule, or that the protrusions of the capsule are placed at a distal end and extend radially inward. For these reasons, claim 33 and 42 and their dependents, claims 34-43 and claim 43, respectively, are indicated as containing allowable subject matter . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST. 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, Alexander Valvis can be reached at (571) 272-4233. 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. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ANNA ROBERTS/Examiner, Art Unit 3791 Application/Control Number: 18/679,019 Page 2 Art Unit: 3791 Application/Control Number: 18/679,019 Page 3 Art Unit: 3791 Application/Control Number: 18/679,019 Page 4 Art Unit: 3791 Application/Control Number: 18/679,019 Page 5 Art Unit: 3791 Application/Control Number: 18/679,019 Page 6 Art Unit: 3791 Application/Control Number: 18/679,019 Page 7 Art Unit: 3791 Application/Control Number: 18/679,019 Page 8 Art Unit: 3791 Application/Control Number: 18/679,019 Page 9 Art Unit: 3791
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