DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 11-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 of U.S. Patent No. 12,064,342 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the Patent discloses:
Regarding Claim 11, the Patent discloses a self-assembly member for assembling a valve module of a modular prosthetic valve device after deployment from a delivery device (column 20, lines , said self-assembly member having a delivery configuration and a preset configuration (column 20, lines 25-26 and 30-32), and wherein when in said preset configuration said self-assembly member comprises a split ring and a plurality of masts (column 20, lines 25-26 and column 20, lines 61-63), and in said delivery configuration said split ring extends in a generally linear direction along the longitudinal axis of said delivery device (column 20, lines 61-63), and said masts are oriented generally parallel to the split ring in said delivery configuration (column 20, lines 35-36) and oriented perpendicularly to said split ring of said self-assembly member in said preset configuration (column 20, lines 33-36).
Regarding claim 12, the Patent discloses wherein the mast in said delivery configuration revert to said pre-set configuration after deployment (column 20, lines 33-35).
Regarding claim 13, the Patent discloses wherein said self-assembly member comprises a first self-assembly member and a second self-assembly member, said first self-assembly member comprising in said preset configuration said split ring (column 20, lines 60-63) and said second self-assembly member comprising a mast oriented parallel to the longitudinal axis of said delivery device in said delivery configuration (column 20, lines 35-37) and having at least a portion oriented perpendicularly to said split ring in said preset configuration (column 20, lines 33-35).
Specification
The disclosure is objected to because of the following informalities: the reference number 1025 as seen in Figure 10 is not described in the specification.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 13 and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 13 further limits claim 11 to have a self-assembly member comprises a first self-assembly member and a second self-assembly member, said first self-assembly member comprising in said preset configuration said split ring and said second self-assembly member comprising a mast oriented parallel to the longitudinal axis of said delivery device in said delivery configuration and having at least a portion oriented perpendicularly to said split ring in said preset configuration. However, claim 11 already established a self-assembly member having a split ring and a plurality of masts, therefore it is unclear if the first and second self-assembly member is additional structure in addition to the self-assembly member claimed in claim 11. For examination purposes the examiner interprets the prior art discloses a split ring and a plurality of posts to meet said “first self-assembly member” and “second self-assembly member.”
Claim 14 limits the self-assembly member of claim 11 to further include a post, the post is orientated parallel to the longitudinal axis of said delivery device in said delivery configuration and oriented perpendicularly to said split ring or said self-assembly member in said pre-set configuration to engage a support structure. However, the specification provides support for a mast or post (see specification, paragraph [0039], [0056]), there are no descriptions showing a distinct mast and post useable together. Furthermore, the drawings only show a post or mast not two distinct structures representing a mast and post. For examination purposes the examiner interprets as the specification describes, the mast and post is interchangeable referring to the same structure.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
21
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 11-14 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Kheradvar et al. U.S. Publication 2008/0275550 A1.
Regarding Claim 11, Kheradvar et al. discloses a self-assembly member for assembling a valve module of a modular prosthetic valve device 25B after deployment from a delivery device 22, said self-assembly member having a delivery configuration and a preset configuration (as seen in Figures 1-4, 10-13), and wherein when in said preset configuration said self-assembly member comprises a split ring 12 and a plurality of masts 13, 31, 14A, 14B (see Figures 1-4 and paragraph [0074]), and in said delivery configuration said split ring 12 extends in a generally linear direction along the longitudinal axis of said delivery device (see Figures 1-4, 10-13 and paragraphs [0075] and [0095]), and said masts 31 are oriented generally parallel to the split ring 12 in said delivery configuration and oriented perpendicularly to said split ring of said self-assembly member in said preset configuration (as seen in Figures 11-13).
Regarding Claim 12, Kheradvar et al. discloses wherein the mast 13, 31, 14A, 14B in said delivery configuration revert to said pre-set configuration after deployment (see Figures 10-13).
Regarding Claim 12, Kheradvar et al. discloses wherein said self-assembly member comprises a first self-assembly member 12 and a second self-assembly member 13, 31, 14A, 14B, said first self-assembly member 12 comprising in said preset configuration said split ring (as seen in Figures 1-4 and paragraphs [0071], [0075]) and said second self-assembly member comprising a mast 13, 31, 14A, 14B oriented parallel to the longitudinal axis of said delivery device in said delivery configuration (as seen in Figures 1-4 and 10-13) and having at least a portion oriented perpendicularly to said split ring in said preset configuration (as seen in Figure 13).
Regarding Claim 12, Kheradvar et al. discloses wherein said self-assembly member further comprises a post 13, 31, 14A, 14B, said post oriented parallel to a longitudinal axis of said delivery device in said delivery configuration (see Figures 1-4, 10-13 and paragraphs [0075] and [0095]) and oriented perpendicularly to said split ring or said self-assembly member in said pre-set configuration to engage a support structure (as seen in Figures 12-13 and paragraph [0095]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (571) 272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
Prosecution Insights