DETAILED ACTION
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 .
Priority
This application repeats a substantial portion of prior Application No. 17/314,484, filed 5/7/21 and application 16/129,673, filed 9/12/18 and Provisional application 62/579,752 filed 10/31/17, and adds disclosure not presented in the prior application (for example see the limitations of claim 4-5, 10 etc.). Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: There is no mention in the specification for the limitations of claim 4 specifically “wherein, within the lumen, a lateral space is present between the first and second leaflets at the interior surface of the conduit.”
There is no mention in the specification for the limitations of claim 5 specifically “The valved conduit of claim 2, wherein a lateral connector slit connects the first and second slits. Para [0072] discloses that the slits are not connected.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 8-9, 11-13, 20 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,186,182 (hereafter ‘182). Although the claims at issue are not identical, they are not patentably distinct from each other. For example current claim 1 recites:
“1. A valved conduit comprising: a conduit having and an exterior surface and an interior surface defining a lumen, the conduit having formed therein a first slit covering a circumferential segment of the conduit; and a first leaflet including a first base portion attached to the exterior surface of the conduit and a first edge portion passing through the first slit and disposed at least partially within the lumen of the conduit.”
Pat. ‘182 claims 1 and 16 recite:
“1. A valved conduit comprising: a conduit having and an exterior surface and an interior surface defining a lumen; and at least one leaflet extending through an opening in the conduit to define an external portion extending along the exterior surface of the conduit and an internal portion extending into the lumen of the conduit, wherein the internal portion is operable as a one-way valve that opens to permit blood to flow through the lumen and closes to occlude blood flow through the lumen, wherein the external portion is nonmechanically and suturelessly attached to the exterior surface of the conduit by an adhesive film.”
16. The valved conduit of claim 1, wherein the at least one leaflet comprises a plurality of leaflets and the opening in the conduit comprises a plurality of U-shaped slits in the conduit, wherein each of the at least one leaflet extends through one of the plurality of U-shaped slits.”
It is obvious to one having ordinary skill in the art that the term “film” equates to the term cover as disclosed in the specification (see 2:15-30 and 7:10-22). The film acts as a covering. Further it is obvious that the conduit has a first slit covering a circumferential segment of the conduit because claim 16 states that a plurality of U-shaped slits are in the conduit and that leaflets extent through the slits, thus the slit extend to the exterior including the cover.
7. Regarding claims 2-3 because claim 16 of pat. ‘182 recites that there are a plurality of u-shaped slits, it is obvious that a second slit is formed in the conduit that is circumferentially offset relative to the first slit; and a second leaflet including a second base portion attached to the exterior surface of the conduit and a second edge portion passing through the second slit and disposed at least partially within the lumen of the conduit because of the u-shaping of the slits.
8. Regarding claim 8, pat. ‘182 recites “…and at least one leaflet extending through an opening in the conduit to define an external portion extending along the exterior surface of the conduit…that the external portion is nonmechanically and suturelessly attached to the exterior surface of the conduit by an adhesive film, thus it would be obvious that a base portion is present on the leaflet and attached by the adhesive film.
9. Regarding claim 9, see pat. ‘182 claim 7.
10. Regarding claims 11, see pat. ‘182 claims 13-15.
11. Regarding claim 12, see pat. ‘182 claim 14.
12. Regarding claims 13-14, 17 recites:
13. A valved conduit comprising: a tubular conduit having and an outer surface and an inner surface defining a lumen; a first curved opening formed in the tubular conduit; and
a first leaflet that passes through the first curved opening, the first leaflet including a first outer portion attached to the outer surface of the tubular conduit and a first inner portion disposed at least partially within the lumen of the tubular conduit.”
pat. ‘182 claim 14 recites:
“14. A valved conduit comprising: a conduit having and an exterior surface and an interior surface defining a lumen; and at least one leaflet extending through an opening in the conduit to define an external portion extending along the exterior surface of the conduit and an internal portion extending into the lumen of the conduit, wherein the internal portion is operable as a one-way valve that opens to permit blood to flow through the lumen and closes to occlude blood flow through the lumen, wherein the external portion is attached to the exterior surface of the conduit by adhesive, thermal bonding, or chemical bonding; wherein: the external portion of the at least one leaflet comprises two or more tabs coupled to the exterior surface of the conduit; and the two or more tabs are folded in an alternating pattern towards a conduit proximal portion and towards a conduit distal portion.”
It is obvious to one having skill in the art that “at least one” equates to the limitation of “a first leaflet” and that conduit has a round/curved shape and thus has a first curved portion.
13. Regarding claim 17, see pat. ‘182 claims 1-7 which recites the use of an adhesive film.
14. Regarding claims 19-20, see pat. 182 claim 14 which recites the use of tabs.
15. Claims 3-4 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,186,182 (hereafter ‘182) in view of U.S patent 11,039,919 (hereafter ‘919), claims 1-17.
Patent ‘182 has been disclosed supra however does not recite that the first and second slits are separated by a circumferential gap. Pat. ‘919 claims 12-13 state:
“12. The valved conduit of claim 11, wherein the plurality of leaflets includes three leaflets.
13. The valved conduit of claim 12, wherein the commissure gaps separating the leaflets at the attachment section of each of the three leaflets to form the gaps between the three leaflets within the interior surface of the conduit.
It is obvious to one having skill in the art that that the conduit is circumferential and it is further obvious that claim 13 states that gaps are formed within the interior of the conduit. Regarding claim 4, due to lack or written disclosure as best interpreted it would be obvious that a lateral space is present based upon the formation of the gaps between the three leaflets within the interior surface of the conduit.
Allowable Subject Matter
Claims 5-7, 10, 14-16 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is disclosed supra however the prior art does not teach or disclose in combination with claim 1 “a lateral connector slit connects the first and second slits; wherein the conduit is separable into two pieces along the first slit, the second slit, and the lateral connector slit; wherein the first base portion is attached to the exterior surface of the conduit by one or more sutures that do not penetrate the interior surface of the conduit; wherein: the conduit includes an axial medial segment that is denser than axial end segments of the conduit; and the first slit and the first edge portion are disposed within bounds of the axial medial segment.
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 August 20, 2026
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