CTFR 18/233,204 CTFR 90834 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. Response to Arguments Applicant’s arguments, filed 05 March 2026, with respect to the rejection(s) of the claims under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. Specifically, the claims now recite a coil-reinforced tubular body which overcomes the previous prior art. However, upon further consideration, a new ground(s) of rejection is made in view of McNamara. Claim Rejections - 35 USC § 112 07-36 AIA The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 07-36-01 AIA Claim 30 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitation of 30 is already recited in claim 1 . Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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 Claim s 1, 3, 6, 15-17, 26-32, 34-35 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by McNamara (US 9757107) . Regarding claim 1, McNamara discloses a medical device, comprising: an elongated member (figure 36, see annotated figure below) having a first end (see annotated figure below), a second end (see annotated figure below), and a coil-reinforced tubular body (tubular body with the coil 3601) extending between the first end and the second end, and a lumen (lumen inside 3203) extending through the tubular body between the first end and the second end configured to provide a channel for transportation of fluid (col 48, lines 45-64); a first anchor (anchors 3205) coupled to the first end of the elongated member comprising a braided element (col 42, lines 38-47, flanges of plurality of segments see for example figure 1 which shows how the anchors would look which comprises braided elements, see also col 22, lines 54-67) configured to assume a delivery configuration when the braided element is contained in a delivery device and to assume a deployed configuration when the braided element is outside the delivery device (col 49, lines 38-57); and a second anchor (anchors 3205) coupled to the second end of the elongated member (figure 36, col 48, lines 45-64); The device of McNamara is capable of performing the intended use operation/function of wherein the elongated member is configured for placement across an abdominal wall of a fetus, and wherein the elongated member is elastically stretchable to accommodate for a growing thickness of the abdominal wall of the fetus (the elongated member can be stretched, col 49, lines 20-25). PNG media_image1.png 587 493 media_image1.png Greyscale Regarding claim 3, McNamara discloses the materials used include stainless steel (col 48, lines 65-67) which is kink-resistant. Regarding claim 6, McNamara discloses wherein the braided element is configured to expand radially when outside the delivery device (col 49, lines 38-57). Regarding claim 15, McNamara wherein at least a part of the medical device comprises echogenic enhancements (col 26, lines 42-50). Regarding claim 16, McNamara is capable of performing the intended use of wherein the first anchor is configured for placement inside a patient, and the second anchor is configured for placement outside the patient (shunt can be implanted to move material including the intended use of moving material outside the patient). Regarding claim 17, McNamara discloses wherein the elongated member is configured to couple to a drainage container (the delivery catheter, figure 35, would naturally need to be hooked to a disposal outlet at the end of the delivery catheter). Regarding claim 26, McNamara discloses wherein the tubular body comprises a thin wall made from an elastic material (col 46, lines 40-55). Regarding claim 27, McNamara discloses wherein tubular body comprises a superelastic nitinol coil covered by the thin wall (col 46, lines 40-55 and col 48, lines 65-67). Regarding claim 28, McNamara discloses wherein the tubular body is made from PET, polyurethane (col 24, lines 55-60), or silicone including a reinforcement layer. Regarding claim 29-30, McNamara discloses wherein the tubular body is elastic in its axial direction to allow the tubular body to undergo sufficient strain in order to accommodate fetal movement or growth of the fetus (the elongated member can be stretched and can perform the intended use of accommodating the anatomy, col 49, lines 20-25). Regarding claim 31, McNamara discloses wherein the second anchor comprises a braided anchor (col 42, lines 38-47, flanges of plurality of segments see for example figure 1 which shows how the anchors would look which comprises braided elements, , see also col 22, lines 54-67). Regarding claim 32, McNamara discloses wherein, in the delivery configuration inside the delivery device the anchors are stretched or compressed to have a low profile in the delivery configuration and, after the shunt is delivered, the anchors assume an expanded profile in the deployed configuration (col 49, lines 38-57). Regarding claim 34, McNamara discloses a medical device, comprising: an elongated member (figure 36, see annotated figure) having a first end (see annotated figure), a second end (see annotated figure), and a coil-reinforced tubular body (tubular body with the coil 3601) extending between the first end and the second end, and a lumen (lumen inside 3203) extending through the tubular body between the first end and the second end configured to provide a channel for transportation of fluid (col 48, lines 45-64); a first anchor (anchors 3205) coupled to the first end of the elongated member comprising a braided element (col 42, lines 38-47, flanges of plurality of segments see for example figure 1 which shows how the anchors would look which comprises braided elements, see also col 22, lines 54-67) configured to assume a delivery configuration when the braided element is contained in a delivery device and to assume a deployed configuration when the braided element is outside the delivery device (col 49, lines 38-57); and a second anchor (anchors 3205) coupled to the second end of the elongated member (figure 36, col 48, lines 45-64); Regarding claim 35, the device of McNamara is capable of performing the intended use operation/function of wherein the elongated member is configured for placement across an abdominal wall of a fetus, and wherein the elongated member is elastically stretchable to accommodate for a growing thickness of the abdominal wall of the fetus (the elongated member can be stretched, col 49, lines 20-25) . 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. 07-21-aia AIA Claim s 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over McNamara (US 9757107) in view of Finch (US 2011/0071623) . Regarding claim 10-13, McNamara does not disclose the medical device comprising a one-way valve coupled to the elongated member (claim 10). wherein the one-way valve is located in a lumen of the elongated member (claim 11), wherein the one-way valve is located closer to the first end than to the second end, or vice versa (claim 12), wherein the one-way valve is configured to open in response to pressure that is above a certain threshold (claim 13). Finch discloses a shunt device relatively pertinent to problem posed by Applicant of controlling flow through an anatomical structure. Finch teaches a one-way valve (104, figure 2, [0164], [0090], duckbill valves are one way valves) coupled to the elongated member, wherein the one-way valve is located in a lumen of the elongated member (figure 2-3), wherein the one- way valve is located closer to the first end than to the second end, or vice versa (figures 2-3), wherein the one-way valve is configured to open in response to pressure that is above a certain threshold ([0090], valves have crack pressure especially duckbill valves). Finch provides a valve in order to control the movement of material through the shunt ([0177]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify McNamara by incorporating a valve in order to control the pressure differential as taught by Finch . 07-21-aia AIA Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over McNamara in view of Finch further in view of Levi (US 2015/0039084) . Regarding claim 14, McNamara and Finch do not teach the device further comprising a pressure sensor, wherein the one-way valve is configured to open based on input provided by the pressure sensor. Levi discloses a shunt device comprising a pressure sensor ([0305]), wherein the one-way valve (138) is configured to open based on input provided by the pressure sensor ([0305-0306]). Levi provides valve and sensor arrangement in order to properly control flow of material ([0310]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify McNamara with the sensor arrangement of Levi in order to obtain a pressure differential and control the valve with greater degree as taught by Levi . 07-21-aia AIA Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over McNamara . Regarding claim 32, McNamara does not disclose wherein the tubular body has a nominal unstretched length L and is stretchable to reach a total length that is at least 1.2L, 1.3L, 1 .4L, 1.5L, 1.6L, or 1.7L. However, McNamara discloses the length and stretching to be a result effective variable in that changing the length of the body affects expansion of the stent (col 50, lines 20-47). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the McNamara to have a flexible length within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filling date to modify the device of McNamara making the length of the stent stretchable to 1.2L, 1.3L, 1 .4L, 1.5L, 1.6L, or 1.7L as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Conclusion 07-40 AIA 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 KAI H WENG whose telephone number is (571)272-5852. 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, Rebecca Eisenberg can be reached at (571) 270-5879. 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. /KAI H WENG/Primary Examiner, Art Unit 3781 Application/Control Number: 18/233,204 Page 2 Art Unit: 3781 Application/Control Number: 18/233,204 Page 3 Art Unit: 3781 Application/Control Number: 18/233,204 Page 4 Art Unit: 3781 Application/Control Number: 18/233,204 Page 5 Art Unit: 3781 Application/Control Number: 18/233,204 Page 6 Art Unit: 3781 Application/Control Number: 18/233,204 Page 7 Art Unit: 3781 Application/Control Number: 18/233,204 Page 8 Art Unit: 3781
Prosecution Insights