CTNF 18/990,992 CTNF 96175 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. 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 Claim(s) 7 and 19 is/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 7 recites the limitation "the at least two extensions" and there is insufficient antecedent basis for this limitation in the claim as no “two extensions” have been previously introduced or defined within claim 1, from which claim 7 depends. As no “two extensions” are shown/labeled in the included drawings and are not recited in the specification aside from a cursory mention in Para. [0027], the examiner cannot determine the meets and bounds and/or scope of the claimed feature. For the purposes of examination, the “two extensions” are interpreted to refer to protruding features extending outward from the dilator hub housing as shown in Fig. 5D of the claimed invention (see Specification Para. [0087]). Claim 19 recites the limitation "the protruding feature" and there is insufficient antecedent basis for this limitation in the claim as no “protruding feature” have been previously introduced or defined within claim(s) 15 or 17, from which claim 19 depends. For the purposes of examination, the “protruding features” are interpreted to refer to any features protruding outward from the dilator hub housing as shown in Fig. 5D of the claimed invention (see Specification Para. [0087]). 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. 07-21-aia AIA Claim (s) 1-4, 6-10, 12-13, 15-17 and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan (US 2013/0204206 A1) . Regarding claim 1, Morgan discloses: An adaptable dilator for use with a crossing device (see Figs. 1A-1B and 7A-7B), the adaptable dilator comprising: a dilator hub housing (hub member 200, see Figs. 1A-1B) defining a distal end and a proximal end (see Fig. 1A); a dilator body extending distally from the dilator hub housing (catheter body 270, see Fig. 1A-1B and 7A-7B); and a locking feature (projections 250, see Figs. 2A-2B) disposed adjacent the proximal side of the dilator hub housing (see Figs. 2A-2B); wherein the locking feature is movable between a neutral position defining a first diameter, wherein the locking featured defines an engaged position between the neutral position and the second position, wherein the engaged position of the locking feature defines an engaged diameter, wherein the engaged diameter is variable, such that in the engaged position the locking feature is configured to engage an inner diameter of a therapy sheath hub (see Para. [0032], [0034] and [0050]-[0053] mentioning wherein the projections 250 are configured to transition from a maximum diameter state (i.e., when a user is pulling the opposing projections away from one-another) to a compressed state when the projections are being inserted through the cavity of proximal hub 300 before transitioning to a third “engaged” state in which the projections re-expand within apertures 334 to secure the hub member 200 to proximal hub 300). Regarding claim 2, Morgan discloses the invention of claim 1, Morgan further discloses wherein the locking feature comprises at least one arm extending from a proximal side of the dilator hub housing wherein the at least one arm extends beyond the proximal side of the dilator hub housing (see Figs. 1A-2B showing two projections 250 in the form of arms extending proximally from the hub member 200). Regarding claim 3, Morgan discloses the invention of claim 2, Morgan further discloses wherein the at least one arm extends away from the dilator hub housing (see Figs. 1A-2B). Regarding claim 4, Morgan discloses the invention of claim 4, Morgan further discloses wherein dilator hub housing further comprises a shaft extension extending from the proximal side (see Examiner’s Diagram of Fig. 1A below designating a “Shaft Extension” of the hub member 200 which extends proximally from the distal-most end of the hub member), wherein the locking feature is formed integral to the shaft extension (see Examiner’s Diagram of Fig. 1A below showing this integral connection). PNG media_image1.png 373 761 media_image1.png Greyscale Examiner’s Diagram of Fig. 1A Regarding claim 6, Morgan discloses the invention of claim 4, Morgan further discloses wherein the locking feature is at least two protrusions radially spaced about the shaft extension (see Figs. 1A-2B showing wherein projections 250 are a pair of protrusions extending proximally from the hub member 200). Regarding claim 7 (see 112(b) rejection above), Morgan discloses the invention of claim 1, Morgan further discloses wherein the at least two extensions are two protruding features diametrically opposed about the shaft extension (see Figs. 1A-2B). Regarding claim 8, Morgan discloses the invention of claim 4, Morgan further discloses wherein the locking feature is configured to form a friction fit with the therapy sheath hub (see Para. Para. [0032], [0034] and [0050]-[0053] mentioning wherein the projections 250, once inserted within the cavity of proximal hub 300, are configured to re-expand within apertures 334 and be against an abutting surface of the cavities which would form a friction fit due to the abutting contact preventing the projections from being withdrawn from the proximal hub 300 until a user depressed the projections radially-inward). Regarding claim 9, Morgan discloses the invention of claim 1, Morgan further discloses wherein the first diameter is larger than the second diameter (the “first diameter” is interpreted to be a state in which the pair of projections are pulled radially away from one-another, resulting in a larger diameter configuration). Regarding claim 10, Morgan discloses the invention of claim 4, Morgan further discloses wherein the locking feature is an expandable membrane (see Para. [0032], [0034] and [0050]-[0053] mentioning wherein the projections 250 are expandable and compressible) disposed about an exterior surface of the shaft extension (see Examiner’s Diagram of Fig. 1A above). Regarding claim 12, Morgan discloses the invention of claim 10, Morgan further discloses wherein the first diameter is smaller than the second diameter (the “first diameter” may be interpreted to be the state in which the projections are compressed radially-inward during insertion into the cavity of proximal hub 300, resulting in the projections being in their smallest-diameter configuration). Regarding claim 13, Morgan discloses the invention of claim 1, Morgan further discloses wherein the locking feature in the engaged position maintains one or more of the axial or radial position of the dilator hub housing. (see Para. [0032], [0034] and [0050]-[0053]). Regarding claim 15, Morgan discloses: An assembly for facilitating access to a patient’s heart, the assembly comprising: an adaptable dilator (catheter 270 and hub member 200; see Figs. 1A-1B and 7A-7B), the adaptable dilator comprising: a dilator hub housing (hub member 200, see Fig. 1A) defining a distal end and a proximal end (see Fig. 1A); a dilator body (catheter 270, see Figs. 1A-1B) extending distally from the dilator hub housing (see Figs. 1A-1B); and a locking feature (projections 250, see Figs. 2A-2B) disposed adjacent the proximal side of the dilator hub housing (see Figs. 2A-2B); wherein the locking feature is movable between a neutral position defining a first diameter and a second position defining a second diameter, wherein the locking featured defines an engaged position between the neutral position and the second position (see Para. [0032], [0034] and [0050]-[0053] mentioning wherein the projections 250 are configured to transition from a maximum diameter state (i.e., when a user is pulling the opposing projections away from one-another) to a compressed state when the projections are being inserted through the cavity of proximal hub 300 before transitioning to a third “engaged” state in which the projections re-expand within apertures 334 to secure the hub member 200 to proximal hub 300); a therapy sheath hub (proximal hub 300, see Figs. 1A and 7A) defining an inner diameter (diameter of cavity 318, see Fig. 7A; see also Para. [0032], [0034] and [0059]), wherein the engaged position of the locking feature defines an engaged diameter (see Fig. 7B and 8 showing the “engaged position” of the projections 250 within apertures 334 of the proximal hub 300 which is between a maximum-diameter configuration in which the projections are pulled away from one-another and a minimum diameter when the projections are passing through the cavity 318 of the proximal hub 300 before engagement with apertures 334), and wherein the engaged diameter is variable, such that in the engaged position the locking feature is configured to engage the inner diameter of the therapy sheath hub (see Figs. 7B and 8; see also Para. [0032], [0034] and [0050]-[0053]). Regarding claim 16, Morgan discloses the invention of claim 15, Morgan further discloses wherein the locking feature comprises at least one arm extending from a proximal side of the dilator hub housing wherein the at least one arm extends beyond the proximal side of the dilator hub housing (see Figs. 1A-2B showing two projections 250 in the form of arms extending proximally from the hub member 200). Regarding claim 17, Morgan discloses the invention of claim 15, Morgan further discloses wherein dilator hub housing further comprises a shaft extension extending from the proximal side (see Examiner’s Diagram of Fig. 1A below designating a “Shaft Extension” of the hub member 200 which extends proximally from the distal-most end of the hub member), wherein the locking feature is formed integral to the shaft extension (see Examiner’s Diagram of Fig. 1A below showing this integral connection). PNG media_image1.png 373 761 media_image1.png Greyscale Examiner’s Diagram of Fig. 1A Regarding claim 19 (see 112(b) rejection above), Morgan discloses the invention of claim 17, Morgan further discloses wherein the locking feature is an expandable membrane disposed about an exterior surface of the protruding feature (see Examiner’s Diagram of Fig. 1A above showing wherein the projections 250 are disposed about a radially-outwardly positioned portion of the hub member 200). Regarding claim 20, Morgan discloses: A method of engaging an adaptable dilator and a therapy sheath, the method comprising: providing an adaptable dilator (catheter 270 and hub member 200, see Figs. 1A-1B and 7A-8), the adaptable dilator comprising: a dilator hub housing (hub member 200, see Figs. 1A-1B) defining a distal end and a proximal end (see Figs. 1A-1B); a dilator body extending distally from the dilator hub housing (catheter body 270, see Fig. 1A-1B and 7A-7B); and a locking feature (projections 250, see Figs. 2A-2B) disposed adjacent the proximal side of the dilator hub housing (see Figs. 2A-2B); wherein the locking feature is movable between a neutral position defining a first diameter and a second position defining a second diameter, wherein the locking featured defines an engaged position between the neutral position and the second position (see Para. [0032], [0034] and [0050]-[0053] mentioning wherein the projections 250 are configured to transition from a maximum diameter state (i.e., when a user is pulling the opposing projections away from one-another) to a compressed state when the projections are being inserted through the cavity of proximal hub 300 before transitioning to a third “engaged” state in which the projections re-expand within apertures 334 to secure the hub member 200 to proximal hub 300); providing a therapy sheath hub (proximal hub 300, see Figs. 1A and 7A) defining an inner diameter (diameter of cavity 318, see Fig. 7A; see also Para. [0032], [0034] and [0059]); transitioning the locking feature from the neutral position to the second position (see Para. [0032], [0034] and [0050]-[0053]; the projections 250 transition between a largest-diameter position in which they are pulled away from one-another to a compressed configuration during insertion into the cavity of proximal hub 300); engaging the adaptable dilator with the therapy sheath hub (see Para. [0032], [0034] and [0050]-[0053]; see also Figs. 7A-8 showing projections positioned within and engaging abutting surfaces of apertures 334); releasing the locking feature to transition between the second position and the engaged position (see Para. [0054]), wherein in the engaged position the locking feature is engaged with the inner diameter of the therapy sheath hub (see Figs. 7A-8 showing the projections engaged within apertures 334 in the “engaged position”) . 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. 07-21-aia AIA Claim (s) 5, 11 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan (US 2013/0204206 A1) in view of Juravic (US 2013/0053863 A1) . Regarding claim 5, Morgan discloses all of the limitations of the invention of claim 4. However, Morgan does not expressly disclose wherein the locking feature is in mechanical connection with a trigger, such that the trigger is configured to move the locking feature between the neutral position and the second position. In the field of endeavor of surgical devices comprises radially-expandable and collapsible arms configured to retain the device at a desired location, Juravic teaches a surgical device (see Fig. 1A) comprising a pair of arms (arms 104, see Figs. 1A-1B) configured to expand and compress (see Figs. 1A- 1C; see also Para. [0099]); wherein the expansion and compression of the arms is controlled by a rotatable mechanical knob (see Para. [0099]) which allows a user to manually adjust the amount of expansion imparted to the arms with increased accuracy. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the expansion/compression mechanism for controlling the pair of projections of Morgan to include a rotatable knob located on the hub member configured to control the amount of expansion and/or compression imparted to the pair of projections as taught and suggested by Juravic to, in this case, provide a more accurate expansion control mechanism which would allow a user to have greater control over the amount of expansion and/or compression imparted onto the pair of protrusions, which would allow for a more efficient and easier coupling and decoupling of the hub member 200 and proximal hub 300 (see Juravic Para. [0099]). Regarding claim 11, Morgan discloses all of the limitations of the invention of claim 10. However, Morgan does not expressly disclose wherein the dilator hub housing further comprises a rotatable dial in mechanical connection with the expandable membrane, such that rotation of the rotatable dial transitions the expandable membrane between the neutral position and the engaged position. In the field of endeavor of surgical devices comprises radially-expandable and collapsible arms configured to retain the device at a desired location, Juravic teaches a surgical device (see Fig. 1A) comprising a pair of arms (arms 104, see Figs. 1A-1B) configured to expand and compress (see Figs. 1A-1C; see also Para. [0099]); wherein the expansion and compression of the arms is controlled by a rotatable mechanical knob (see Para. [0099]) which allows a user to manually adjust the amount of expansion imparted to the arms with increased accuracy. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the expansion/compression mechanism for controlling the pair of projections of Morgan to include a rotatable knob located on the hub member configured to control the amount of expansion and/or compression imparted to the pair of projections as taught and suggested by Juravic to, in this case, provide a more accurate expansion control mechanism which would allow a user to have greater control over the amount of expansion and/or compression imparted onto the pair of protrusions, which would allow for a more efficient and easier coupling and decoupling of the hub member 200 and proximal hub 300 (see Juravic Para. [0099]). Regarding claim 18, Morgan discloses all of the limitations of the invention of claim 17. However, Morgan does not expressly disclose wherein the locking feature is in mechanical connection with a trigger, such that the trigger is configured to move the locking feature between the neutral position and the second position. In the field of endeavor of surgical devices comprises radially-expandable and collapsible arms configured to retain the device at a desired location, Juravic teaches a surgical device (see Fig. 1A) comprising a pair of arms (arms 104, see Figs. 1A-1B) configured to expand and compress (see Figs. 1A-1C; see also Para. [0099]); wherein the expansion and compression of the arms is controlled by a rotatable mechanical knob (see Para. [0099]) which allows a user to manually adjust the amount of expansion imparted to the arms with increased accuracy. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the expansion/compression mechanism for controlling the pair of projections of Morgan to include a rotatable knob located on the hub member configured to control the amount of expansion and/or compression imparted to the pair of projections as taught and suggested by Juravic to, in this case, provide a more accurate expansion control mechanism which would allow a user to have greater control over the amount of expansion and/or compression imparted onto the pair of protrusions, which would allow for a more efficient and easier coupling and decoupling of the hub member 200 and proximal hub 300 (see Juravic Para. [0099]) . 07-21-aia AIA Claim (s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan (US 2013/0204206 A1) . Regarding claim 14, Morgan discloses all of the limitations of the invention of claim 1. However, Morgan does not expressly disclose wherein the engaged diameter is between 8 French and 18 French. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the proximal hub 300 of Morgan et al. to have a diameter between projection-engaging apertures 334 of between 8 French and 18 French, causing the projections 250 to expand within the apertures 334 to an “engaged diameter” of between 8 French and 18 French 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 relative 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, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, since Morgan does not disclose a size of either the hub member 200 or proximal hub 300, the device of Morgan et al. would be reasonably modifiable to allow for an “engaged diameter” of the projections 250 to be between 8 French and 18 French by merely changing the size of the proximal hub 300 which would not cause the device of Morgan to operate differently since the size/shape operable portion of the device (i.e., catheter member 270) would remain unchanged. The modification of the hub(s) 200 and 300 to be sized such that the “engaged diameter” of the projections within apertures 334 is understood to be reasonable to one of ordinary skill in the art as Morgan provides no disclosure pertaining to an intended or desired size, merely describing how the projections 250 are configured to engage the hub member 200 with the proximal hub 300 to couple the two components together. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “may” be within the claimed ranges (see Specification Para. [0020], [0034], [0089] and [0103]]). Conclusion 07-96 The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2006/0015086 A1 to Rasmussen, US 2008/0108944 A1 to Woehr, US 2016/0331929 A1 to Lampropoulos, US 2011/0288442 A1 to Reymond, US 2018/0021059 A1 to Dolgin, US 2010/0136501 A1 to Schuetz, US 2018/0015276 A1 to Ueda, US 2019/0070394 A1 to Appling, US 2018/0339146 A1 to Schrauder, US 2007/0120083 A1 to Simpson, US 5935109 A to Donnan, US 8535271 B2 to Fuchs and US 9227012 B2 to Fujii all disclose surgical devices comprising an elongate tubular body capable of dilating a vessel; wherein the dilator devices focus on and discuss alternative methods of coupling a dilator hub to a proximal auxiliary hub device through an expandable connection means located at the proximal end of the dilator hub. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F. 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, Darwin Erezo can be reached at 5712724695. 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. /M.B.H./Examiner, Art Unit 3771 /DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771 Application/Control Number: 18/990,992 Page 2 Art Unit: 3771 Application/Control Number: 18/990,992 Page 3 Art Unit: 3771 Application/Control Number: 18/990,992 Page 4 Art Unit: 3771 Application/Control Number: 18/990,992 Page 5 Art Unit: 3771 Application/Control Number: 18/990,992 Page 6 Art Unit: 3771 Application/Control Number: 18/990,992 Page 7 Art Unit: 3771 Application/Control Number: 18/990,992 Page 8 Art Unit: 3771 Application/Control Number: 18/990,992 Page 9 Art Unit: 3771 Application/Control Number: 18/990,992 Page 10 Art Unit: 3771 Application/Control Number: 18/990,992 Page 11 Art Unit: 3771 Application/Control Number: 18/990,992 Page 12 Art Unit: 3771 Application/Control Number: 18/990,992 Page 13 Art Unit: 3771 Application/Control Number: 18/990,992 Page 14 Art Unit: 3771
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