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 . Claims 1-3, 5-6, & 8-13 are pending and examined below. Claims 14-24 is/are withdrawn.
Response to Arguments
Applicant's arguments filed 10/08/2025 have been fully considered but they are not persuasive. Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 6) and that the dependent claims rise and fall with the same arguments (pages 7-8). Applicant's arguments are moot due to the additional references applied to the newly added limitations, as detailed in the rejection below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5-6, 8, & 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arcaro et al. (US 20190091014 A1) hereinafter, Arcaro, in view of Langer et al. (US 20130231412 A1) hereinafter, Langer.
Regarding claim 1, Arcaro teaches
a leaflet (104, Fig. 1 Arcaro) for a heart valve replacement, wherein the leaflet is free of a textile (¶0246, Arcaro).
Arcaro does not teach the leaflet comprising poly(glycerol sebacate) urethane. However, Langer teaches compositions and methods for an elastomeric cross-linked polyester material (abstract, Langer) wherein
the leaflet comprising poly(glycerol sebacate) urethane (¶0078 & ¶0112, Langer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arcaro by incorporating the teaching above as taught by Langer in order to allow efficient encapsulation and controlled delivery of bioactive macromolecules (¶0130, Langer).
Regarding claim 2, Arcaro teaches a leaflet but does not specify the leaflet consists of poly(glycerol sebacate) urethane. However, Langer teaches
wherein the leaflet consists of poly(glycerol sebacate) urethane (¶0078 & ¶0112, Langer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arcaro by incorporating the teaching above as taught by Langer in order to allow efficient encapsulation and controlled delivery of bioactive macromolecules (¶0130, Langer).
Regarding claim 3, Arcaro teaches
wherein the leaflet comprises a leaflet substrate material (¶0246, Arcaro) and a coating on the leaflet substrate material (¶0246, Arcaro). Arcaro does not teach the coating comprising poly(glycerol sebacate) urethane. However, Langer teaches
the coating comprising poly(glycerol sebacate) urethane (¶0117, Langer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arcaro by incorporating a coating as taught by Langer in order to allow efficient encapsulation and controlled delivery of bioactive macromolecules (¶0130, Langer).
Regarding claim 5, the combination of Arcaro and Langer teaches
wherein the coating conforms to the leaflet substrate material (¶0118 & 0130, Langer).
Regarding claim 6, the combination of Arcaro and Langer teaches
wherein the coating has a smooth, flat surface obfuscating the substrate (smooth, non-porous films, ¶0139, Langer).
Regarding claim 8, Arcaro does not disclose a poly(glycerol sebacate) resin. However, Langer teaches
wherein the poly(glycerol sebacate) urethane is formed from a poly(glycerol sebacate) resin having a weight average molecular weight in the range of 14,000 Da to 20,000 Da (20,000 Da, ¶0136, Langer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arcaro by incorporating a molecular weight as taught by Langer as that is a known value in the art.
Regarding claim 10, Arcaro teaches
a heart valve replacement comprising a plurality of leaflets (Fig. 1, Arcaro).
Regarding claim 11, Arcaro teaches
further comprising a heart valve frame (102, Fig. 1, Arcaro) having a valve opening (Fig. 1, Arcaro), wherein the plurality of leaflets extend from the heart valve frame to cover the valve opening (Fig. 1, Arcaro).
Regarding claim 12, Arcaro does not teach crosslinking density. However, Langer teaches
wherein at least one of the plurality of leaflets comprises a first portion having a first crosslinking density and a second portion having a second crosslinking density different from the first crosslinking density (¶0127, Langer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arcaro by incorporating different crosslinking densities as taught by Langer in order to form an elastomeric cross-linked polyester material that contains one or more urethane crosslinks (¶0076, Langer).
Regarding claim 13, Arcaro teaches
wherein at least a portion of the heart valve replacement comprises a coating (¶0246, Arcaro). Arcaro does not disclose a coating of poly(glycerol sebacate) urethane. However, Langer teaches
wherein at least a portion of the heart valve replacement comprises a coating of poly(glycerol sebacate) urethane (¶0117, 0130 & 0144, Langer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arcaro by incorporating a coating as taught by Langer in order to allow efficient encapsulation and controlled delivery of bioactive macromolecules (¶0130, Langer).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arcaro in view of Langer, and further in view of Goldstein et al. (US 20190290802 A1) hereinafter, Goldstein.
Regarding claim 9, Arcaro and Langer does not teach the leaflet is storable for at least 6 months at room temperature. However, Goldstein teaches
wherein the leaflet is storable for at least 6 months at room temperature and room humidity without storage in a fixative without detrimentally impacting performance (¶0127, Goldstein).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Arcaro and Langer by incorporating the teaching above as taught by Goldstein in order to have a dry, easy to store, and ready to use sheet (membrane) (¶0126, Goldstein).
Conclusion
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 KIA XIONG WHITE whose telephone number is (703)756-4773. The examiner can normally be reached 0830-1630 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, Jerrah Edwards can be reached at (408) 918-7557. 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.
/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774