DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
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.
Claim 4 is 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.
The word “structure” makes the claim indefinite. The Examiner is not clear what does the Applicant’s representative means with the word “structure”. The word “structural” is so broad that it seems like the claim is incomplete because it is omitting essential structural cooperative relationship of elements, such omission amounting to a gap between the necessary structural connections of the device. Correction is required.
Claim Objections
Claims 4, 7 and 8 are objected to because of the following informalities: the words: “structure”, “mesh” and “Nitinol mesh” should be preceded by the letter: ---a---. For example: “a structure”, “a mesh”, “a Nitinol mesh”. Appropriate correction is required.
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 –
(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.
Claims 2-10 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Bailey et al US Patent 6,458,153B1.
NOTE: The phrase “configured to” has been identified as an intended use limitation because is typical of claim limitations which may not distinguish over prior art according to the principle. It has been held that the recitation that an element is “configured to” performing a function is not a positive limitation but only requires the ability to so perform. Additionally, the claims also disclose functional limitations that has been examined but have not been given patentable weight. These expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim. Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969).
Bailey et al discloses a device (50, see Figs. 13-17) comprising a body (12) adapted and configured to self-expand from a radially collapsed configuration to an expanded configuration. The device (12) comprising a first flange (56). A second flange (58), and a central portion (20) extending between the first and second flanges. The first and second flanges (56 & 58) each having diameters that gradually increase with distance from the central portion (See Fig. 16). The body (12) is capable of being delivered percutaneously to a patient's heart. The body (12) is also capable of being inserted in an opening in a septum of the heart to dispose the first flange (56) in the left atrium, the second flange (58) in the right atrium. Additionally, the central portion (20) is capable of permit blood to flow through the body from the left atrium to the right atrium.
Regarding claim 3, see Fig. 16 showing the leaflets (26).
Regarding claim 4, the Examiner interpreted the “structure” as element (11b).
Regarding claim 5, it is inherent that heart valve implants are biased to a closed position, in this reference elements (24) create the biased position.
Regarding claim 6, the Bailey et al reference is capable of having a pressure differential higher than 2 mm Hg, since, the natural occurring heart valves of an adult open at a higher pressure of 2 mm Hg. Therefore, it is inherent to design a prosthetic heart valve that open at those pressure differentials.
Regarding claim 7, the broadest meaning in the Merriam-Webster dictionary is: ---a weblike pattern---. Therefore, see Fig. 13 disclosing the weblike structure.
Regarding claim 8, see col. 8, lines 33-35.
Regarding claim 9, the flanges are capable of being in contact with the septum when the body is in the expanded position.
Regarding claim 10, the weblike pattern and diamond open cells shown in Fig. 13 makes the body being in the elongated configuration when the body is in the collapsed configuration.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,690,609B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both cases disclose a device comprising a self-expandable body, the device comprising a first flange, a second flange, and a central portion extending between the first and second flanges. The first and second flanges each having diameters that gradually increase with distance from the central portion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 1/8/26