CTNF 18/410,346 CTNF 91212 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. Priority 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Claim Objections 07-05-05 Applicant is advised that should claims 1 and 2 be found allowable, claims 9 and 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). 07-30-03-h AIA Claim Interpretation 07-30-03 AIA The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 07-30-05 The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. 07-30-06 This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “drive unit configured to drive”, “imaging unit configured to acquire…image”, “control unit configured to control”, “display unit configured to display”, “detection unit configured to detect”, “reaction force measurement unit configured to detect a reaction force”, and “outer tube holding unit configured to fix” in claims 1-20. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 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. Claims 1, 9, 13, and all dependent claims thereof recite the limitation “…one or more of a movement distance and a puncture angle of the drive unit based on information on the cross- sectional image and a separation distance between the distal end of the inner needle and a distal end of the outer tube.” This is a list of three elements without punctuation. It is unclear how to interpret one or more of [element A] and [element B] and [element C]. For example, this could be interpreted as being one or more of [element A], one or more of [element B], and one or more of [element C]. It could also be interpreted as one or more elements from the group comprising [element A], [element B], and [element C]. It could further be interpreted as one or more elements from the group comprising [element A] and [element B], and also [element C]. It is not possible to reasonably determine which elements from the list (“a movement distance and a puncture angle of the drive unit based on information on the cross- sectional image and a separation distance between the distal end of the inner needle and a distal end of the outer tube”) are required and which, if any, are optional. For the purposes of further examination this limitation will be interpreted as one or more element from the group comprising a movement distance, a puncture angle of the drive unit based on information on the cross- sectional image, and a separation distance between the distal end of the inner needle and a distal end of the outer tube. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 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. 07-15-aia AIA Claim(s) 1, 3, 7, 9-11, 13, and 15 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Burkholz et al. (US 2020/0230391 A1, Jul. 23, 2020) (hereinafter “Burkholz”) . Regarding claim 1, as best understood based on limitations which are indefinite: Burkholz discloses a vascular puncture device that punctures a blood vessel, the vascular puncture device comprising: an inner needle including a needle tip (fig. 3, needle 215 with distal end 205, [0067]); an outer tube that is flexible and configured to cover the inner needle (fig. 3, catheter 213, [0067]); a drive unit configured to move the inner needle and the outer tube (drive mechanisms 201 and 825, [0107], [0110]-[0111]); an imaging unit configured to acquire a cross-sectional image of a human body in contact with a skin surface and visualize a distal end of the inner needle (ultrasound probe 175, [0039], [0043] - cross section of the vein, coronal plane 140, transverse plane 120, see at least fig. 2); a control unit configured to control movement of the drive unit ([0045] - processor, [0057] - processor, [0088]-[0090] - processor 602 and blood vessel detection system processor, [0102], [0109]-[0110] - processor 805); and wherein the control unit is configured to calculate one or more of a movement distance and a puncture angle of the drive unit based on information on the cross- sectional image and a separation distance between the distal end of the inner needle and a distal end of the outer tube ([0076]-[0083], [0107], [0111]), and move the drive unit to set the drive unit at one or more of the calculated movement distance and the calculated puncture angle ([0076]-[0083], [0107], [0111]). Regarding claim 3: Burkholz discloses the vascular puncture device according to claim 1, further comprising: a display unit configured to display relative positions of the blood vessel and the distal end of the outer tube (display device 110). Regarding claim 7: Burkholz discloses the vascular puncture device according to claim 1, further comprising: an outer tube holding unit configured to fix a position of the outer tube independently of the inner needle ([0107] - the drive mechanism 201 can move, or not move, the needle and the catheter independently). Regarding claim 9: Burkholz discloses a vascular puncture system comprising: an inner needle including a needle tip (fig. 3, needle 215 with distal end 205, [0067]); an outer tube that is flexible and configured to cover the inner needle (fig. 3, catheter 213, [0067]); a drive unit configured to move the inner needle and the outer tube (drive mechanisms 201 and 825, [0107], [0110]-[0111]); an imaging unit configured to acquire a cross-sectional image of a human body in contact with a skin surface and visualize a distal end of the inner needle (ultrasound probe 175, [0039], [0043] - cross section of the vein, coronal plane 140, transverse plane 120, see at least fig. 2); a control unit configured to control movement of the drive unit ([0045] - processor, [0057] - processor, [0088]-[0090] - processor 602 and blood vessel detection system processor, [0102], [0109]-[0110] - processor 805); and wherein the control unit is configured to calculate one or more of a movement distance and a puncture angle of the drive unit based on information on the cross- sectional image and a separation distance between the distal end of the inner needle and a distal end of the outer tube ([0076]-[0083], [0107], [0111]), and move the drive unit to set the drive unit at one or more of the calculated movement distance and the calculated puncture angle ([0076]-[0083], [0107], [0111]). Regarding claim 10: Burkholz discloses the vascular puncture system according to claim 9, wherein the drive unit includes: a first linear movement portion configured to linearly move the inner needle with respect to the outer tube along an extending direction of the inner needle ([0047], [0107] - linear motors move needle and catheter independently, [0110], [0118]); and a second linear movement portion configured to integrally and linearly move the inner needle and the outer tube along the extending direction of the inner needle ([0047], [0107] - linear motors move needle and catheter independently, [0110], [0118]). Regarding claim 11: Burkholz discloses The vascular puncture system according to claim 9, wherein the inner needle and the outer tube are connectable to each other (fig. 3). Regarding claim 13: Burkholz discloses a method for puncturing a blood vessel, the method comprising: acquiring a cross-sectional image of a human body in contact with a skin surface and visualizing a distal end of an inner needle, the inner needle including a needle tip (fig. 10, step 1005); calculating one or more of a movement distance and a puncture angle based on information on the cross-sectional image and a separation distance between the distal end of the inner needle and a distal end of an outer tube, the outer tube covering the inner needle (fig. 10, step 1010; [0076]-[0083]); and setting a drive unit at one or more of the calculated movement distance and the calculated puncture angle, the drive unit configured to move the inner needle and the outer tube (fig. 10, step 1020; [0076]-[0083], [0107], [0111]). Burkholz discloses the method according to claim 13, further comprising: displaying relative positions of the blood vessel and the distal end of the outer tube ([0043] - "...show the movement of the VAD passing into the blood vessel 125.", [0059]; where the VAD includes both the catheter and the needle) . Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 2, 6, 12, 14, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Yarmush et al. (US 2021/0378627 A1, Dec. 09, 2021) (hereinafter “Yarmush”) . Regarding claims 2, 12, and 14: While Burkholz discloses that the purpose of the disclosed invention is to properly place a catheter at a target location, and that the guidance is provided based on a center-point (“center of gravity”) of the vessel ([0071], [0080]-[0081]), Burkholz does not explicitly describe aligning the distal end of the catheter with the center point of the vessel. With respect to the limitation “…separated by the separation distance in a proximal direction from the distal end of the inner needle along an axial center of the inner needle…”, this appears to be nothing more than a description of the location of the tip of the catheter. Positioning the tip of the catheter at the desired location would satisfy this limitation. Yarmush, in the same field of endeavor, discloses automated placement of the distal end of an instrument (which can be a catheter, a needle, or another cannulation instrument - [0133]) such that the position of the tip of the catheter is coincident with a position of a center of gravity of the blood vessel calculated from the information on the cross-sectional image when puncture of the blood vessel is completed ([0083]-[0084], [0099], [0123], [0128]). It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to make the position of the tip of the catheter of Burkholz coincident with a position of a center of gravity of the blood vessel calculated from the information on the cross-sectional image when puncture of the blood vessel is completed as taught by Yarmush in order to ensure an accurate placement within the vessel in view of the teachings of Burkholz and Yarmush. Regarding claim 6: Burkholz discloses the puncture device according to claim 1 but is silent on a reaction force measurement unit configured to detect a reaction force acting on the inner needle during puncture. Yarmush, in the same field of endeavor, discloses a puncture device comprising a reaction force measurement unit configured to detect a reaction force acting on the puncturing instrument during puncture ([0029], [0056], [0061]). Yarmush further discloses that this force measurement provides feedback to confirm vessel wall puncture and/or detect conditions such as vessel rolling which may require repositioning of the instrument to correct for vessel motion for a successful puncture ([0111]-[0113]). It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Burkholz by providing a force sensor as taught by Yarmush in order to provide feedback of vessel wall puncture or vessel rolling/motion to assist in achieving a successful puncture. Regarding claim 18: Burkholz and Yarmush disclose the method of claim 14. Yarmush further discloses detecting a reaction force acting on the puncturing instrument during puncture ([0029], [0056], [0061]). Yarmush further discloses that this force measurement provides feedback to confirm vessel wall puncture and/or detect conditions such as vessel rolling which may require repositioning of the instrument to correct for vessel motion for a successful puncture ([0111]-[0113]). It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Burkholz and Yarmush by providing a force measurement as taught by Yarmush in order to provide feedback of vessel wall puncture or vessel rolling/motion to assist in achieving a successful puncture. Regarding claim 19: Burkholz and Yarmush disclose the method according to claim 14. Burkholz further discloses fixing a position of the outer tube independently of the inner needle (this is implicitly disclosed because the needle of Burkholz is withdrawn/retracted - [0009], [0053] - while the catheter remains indwelling in order to provide treatment - [0045], [0050], [0061], [0127]) . 07-21-aia AIA Claim (s) 4, 5, 16, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Lackey et al. (US 2022/0023591 A1, Jan. 27, 2022) (hereinafter “Lackey”) . Regarding claim 4: Burkholz discloses the puncture device according to claim 1. Burkholz further discloses a detection unit configured to detect the exposed portion of the inner needle ([0043], [0054]-[0055], [0059], [0109]) but is silent on detecting a position of the distal end of the outer tube with respect to the distal end of the inner needle. Lackey, in the same field of endeavor, discloses a puncture device comprising a catheter and an inner needle, where the distance between the distal end of the catheter and the distal end of the inner needle is called the “lie distance” and must be known in order to ensure proper placement of the catheter within the vessel ([0041]). It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Burkholz to include determining the position of the distal end of the outer tube with respect to the distal end of the inner needle, based on the detection unit of Burkholz, in order to calculate the lie distance to ensure proper placement of the catheter within the vessel in view of the teachings of Lackey. Regarding claim 5: Burkholz and Lackey disclose the vascular puncture device according to claim 4. Burkholz further discloses wherein the control unit is configured to receive a detection result from the detection unit ([0054]-[0055]). Regarding claim 16: Burkholz discloses the method according to claim 13. Burkholz further discloses detecting the exposed portion of the inner needle ([0043], [0054]-[0055], [0059], [0109]) but is silent on detecting a position of the distal end of the outer tube with respect to the distal end of the inner needle. Lackey, in the same field of endeavor, discloses a puncture device comprising a catheter and an inner needle, where the distance between the distal end of the catheter and the distal end of the inner needle is called the “lie distance” and must be known in order to ensure proper placement of the catheter within the vessel ([0041]). It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Burkholz to include determining the position of the distal end of the outer tube with respect to the distal end of the inner needle, in order to calculate the lie distance to ensure proper placement of the catheter within the vessel in view of the teachings of Lackey. Regarding claim 17: Burkholz and Lackey disclose the method of claim 16. Burkholz further discloses receiving a detection result ([0054]-[0055]) . 07-21-aia AIA Claim (s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz in view of Yarmush and Lackey . Regarding claim 8: Burkholz discloses the puncture device of claim 1, where the control unit generates the trajectory (including the movement distance and/or puncture angle) based on various inputs including the cross-sectional image and a detection result of the exposed portion of the needle ([0046], [0069], [0077]). Burkholz is silent on a machine-learned model configured to receive inputs of the information and output the movement distance and/or the puncture angle of the drive unit. Yarmush, in the same field of endeavor, discloses the use of a machine-learned model to calculate the likely success of the trajectory and make adjustments if necessary, using information including image data and instrument pose data ([0130]-[0132]). It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Burkholz by providing a machine-learned model to predict success and adjust the trajectory as taught by Yarmush (where an adjusted trajectory would include outputting an updated movement distance and/or puncture angle) in order to improve the likelihood of a successful procedure and improve patient outcome. Further regarding claim 8: While Burkholz discloses detecting the exposed portion of the inner needle ([0043], [0054]-[0055], [0059], [0109]), Burkholz and Yarmush are silent on obtaining and using a separation distance between the distal end of the inner needle and the distal end of the outer tube. Lackey, in the same field of endeavor, discloses a puncture device comprising a catheter and an inner needle, where the distance between the distal end of the catheter and the distal end of the inner needle is called the “lie distance” and must be known in order to ensure proper placement of the catheter within the vessel ([0041]). It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Burkholz and Yarmush to include information regarding the lie distance as taught by Lackey in order to improve the prediction of success and/or trajectory adjustment in view of the teachings of Lackey that the lie distance is a critical factor in the success of a puncture procedure . 07-22-aia AIA Claim (s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz and Yarmush as applied to claim 14 above, and further in view of Lackey . Burkholz and Yarmush disclose the method of claim 14. Yarmush further discloses the use of a machine-learned model to calculate the likely success of the trajectory and make adjustments if necessary, using information including image data and instrument pose data ([0130]-[0132]). It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Burkholz and Yarmush by providing a machine-learned model to predict success and adjust the trajectory as taught by Yarmush (where an adjusted trajectory would include outputting an updated movement distance and/or puncture angle) in order to improve the likelihood of a successful procedure and improve patient outcome. Further regarding claim 20: Burkholz and Yarmush are silent on obtaining and using a separation distance between the distal end of the inner needle and the distal end of the outer tube. Lackey, in the same field of endeavor, discloses a puncture method comprising a catheter and an inner needle, where the distance between the distal end of the catheter and the distal end of the inner needle is called the “lie distance” and must be known in order to ensure proper placement of the catheter within the vessel ([0041]). It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Burkholz and Yarmush to include information regarding the lie distance as taught by Lackey in order to improve the prediction of success and/or trajectory adjustment in view of the teachings of Lackey that the lie distance is a critical factor in the success of a puncture procedure . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Peterson et al. (US 2022/0304652 A1, Sep. 29, 2022) - discloses a vascular puncture device and method. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday. 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, Chris Koharski can be reached at (571) 272-7230. 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. /CAROLYN A PEHLKE/ Primary Examiner, Art Unit 3799 Application/Control Number: 18/410,346 Page 2 Art Unit: 3799
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