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 is a continuation of U.S. patent application Ser. No. 17/654,512, filed Mar. 1, 2022, now U.S. Pat. No. 12,090,036, which is a continuation of application Ser. No. 16/447,530, filed Jun. 20, 2019, now U.S. Pat. No. 11,273,024, which in turn is continuation of, and incorporates by reference, U.S. patent application Ser. No. 15/364,670, filed Nov. 30, 2016, now U.S. Pat. No. 10,357,351, which in turn claims the benefit of, and incorporates by reference, U.S. Provisional Patent Application No. 62/263,540, filed Dec. 4, 2015.
Information Disclosure Statement
The information disclosure statement, filed August 16, 2024, was received and entered into the record. However, it is impractical for the examiner to review the references thoroughly with the number of references cited in this case. By initializing each of the cited references on the accompanying 1449 forms, the examiner is merely acknowledging the submission of the cited references and indicating that only a cursory review has been made of the cited references.
MPEP § 2004.13 states: It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant's attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aft 'd, 479 F.2d 1338, 178 USPQ 577 (Sth Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Specification
The disclosure is objected to because of the following informalities: paragraph [0151] recites “nitanol.” The “nitanol” should be amended to read “nitinol.” Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,090,036 (hereinafter “the patent”) in view of Badis et al. (US 2014/0343670, which is cited in the Information Disclosure Statement filed August 16, 2024, hereinafter “Bakis”).
Referring to claim 2, claim 1 of the patent discloses a prosthetic valve delivery device, comprising: a storage tube, the storage tube comprising a housing defining an internal chamber configured to receive a prosthetic valve, the storage tube further defining a first locking member; and a nose cone cap, the nose cone cap defining an internal chamber comprising an enclosed distal end and an open proximal end, the open proximal end configured to receive a nose cone such that a distal end of the nose cone is proximate the enclosed distal end of the internal chamber and a proximal end of the nose cone is proximate the open proximal end of the internal chamber, the nose cone cap further defining a second locking member selectively couplable to the first locking member. Examiner notes that the delivery device of claim 1 of the patent inherently discloses a prosthetic valve.
Referring again to claim 2, claim 1 of the patent discloses the invention substantially as claimed except for disclosing a prosthetic valve comprising a frame comprising a retaining arm, the retaining arm defining an aperture and a valve retaining mechanism comprising an elongate prong, the elongate prong comprising a distal bend portion located proximate the aperture of the retaining arm, the distal bend portion of the prong being bent radially inwardly towards a longitudinal axis of the delivery device compared with a proximal portion of the elongate prong.
Referring still to claim 2, however, in the same field of endeavor, which is a prosthetic valve delivery device, Bakis disclose a prosthetic valve delivery device includes a prosthetic valve 10 (FIG. 1) comprising a frame 12 comprising a retaining arm 30, the retaining arm defining an aperture 32 and a valve retaining mechanism (prongs 136 of inner fork 132, prongs 134, which includes opening 140, as shown in FIGS. 20-22) comprising an elongate prong 136, the elongate prong comprising a distal bend portion located proximate the aperture 32 of the retaining arm 30, the distal bend portion of the prong being bent radially inwardly towards a longitudinal axis of the delivery device compared with a proximal portion of the elongate prong (FIG. 20). In view of Bakis’ teaching it would have been obvious to one of ordinary skill in the art, before the effective fling date of the application, to have provided the prosthetic valve and valve retaining mechanism as suggested by Bakis to the prosthetic delivery device of claim 1 of the patent to ensure that the prosthetic valve is still fully secured to the delivery device while the prosthetic valve is radially expand to allow the surgeon to position the valve at the desired location or retrieve the valve to reposition the valve at a desired location before the valve is fully deployed and relieved from the delivery device.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of U.S. Patent No. 12,090,036 (hereinafter “the patent”) in view of Badis et al. (US 2014/0343670, which is cited in the Information Disclosure Statement filed August 16, 2024, hereinafter “Bakis”).
Referring to claim 17, claim 10 of the patent discloses a prosthetic valve delivery device, comprising: a storage tube, the storage tube comprising a housing defining an internal chamber configured to receive a prosthetic valve, the storage tube further defining a first locking means for securing the storage tube; and a nose cone cap, the nose cone cap defining an internal chamber comprising an enclosed distal end and an open proximal end, the open proximal end configured to receive a nose cone such that a distal end of the nose cone is proximate the enclosed distal end of the internal chamber and a proximal end of the nose cone is proximate the open proximal end of the internal chamber, the nose cone cap further defining a second locking means for securing the nose cone cap to the first locking means of the storage tube. Examiner notes that the delivery device of claim 1 of the patent inherently discloses a prosthetic valve.
Referring again to claim 17, claim 10 of the patent discloses the invention substantially as claimed except for disclosing a prosthetic valve comprising a frame comprising a retaining arm, the retaining arm defining an aperture and a valve retaining means for engaging the retaining arm of the prosthetic valve frame and resisting proximal movement of the valve frame relative to the nose cone cap and the storage tube.
Referring still to claim 17, however, in the same field of endeavor, which is a prosthetic valve delivery device, Bakis disclose a prosthetic valve delivery device includes a prosthetic valve 10 (FIG. 1) comprising a frame 12 comprising a retaining arm 30, the retaining arm defining an aperture 32 and a valve retaining mechanism (prongs 136 of inner fork 132, prongs 134, which includes opening 140, as shown in FIGS. 20-22) comprising an elongate prong 136, the elongate prong comprising a distal bend portion located proximate the aperture 32 of the retaining arm 30, the distal bend portion of the prong being bent radially inwardly towards a longitudinal axis of the delivery device compared with a proximal portion of the elongate prong (FIG. 20). In view of Bakis’ teaching it would have been obvious to one of ordinary skill in the art, before the effective fling date of the application, to have provided the prosthetic valve and valve retaining mechanism as suggested by Bakis to the prosthetic delivery device of claim 10 of the patent to ensure that the prosthetic valve is still fully secured to the delivery device while the prosthetic valve is radially expand to allow the surgeon to position the valve at the desired location or retrieve the valve to reposition the valve at a desired location before the valve is fully deployed and relieved from the delivery device. Furthermore, the valve retaining mechanism also prevent proximal movement of the valve relative to the nose cone cap and the storage tube before the prongs 136 are withdrawn from aperture 32.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 12,090,036 (hereinafter “the patent”) in view of Bakis et al. (US 2014/0343670, which is cited in the Information Disclosure Statement filed August 16, 2024, hereinafter “Bakis”).
Referring to claim 19, claim 16 of the patent discloses a prosthetic valve delivery device, comprising: a storage tube, the storage tube comprising a housing defining an internal chamber configured to receive a prosthetic valve; and a nose cone cap, the nose cone cap defining an internal chamber comprising an enclosed distal end and an open proximal end, the open proximal end configured to receive a nose cone such that a distal end of the nose cone is proximate the enclosed distal end of the internal chamber and a proximal end of the nose cone is proximate the open proximal end of the internal chamber, wherein the nose cone cap is releasably secured to the storage tube.
Referring again to claim 19, claim 16 of the patent discloses the invention substantially as claimed except for disclosing a prosthetic valve comprising a frame comprising a retaining arm, the retaining arm defining an aperture and a valve retaining mechanism comprising an elongate prong, the elongate prong comprising a distal bend portion located proximate the aperture of the retaining arm, a distal end portion of the prong being bent relative to a longitudinal axis of the delivery device compared with a proximal portion of the prong.
12. Referring still to claim 19, however, in the same field of endeavor, which is a prosthetic valve delivery device, Bakis disclose a prosthetic valve delivery device includes a prosthetic valve 10 (FIG. 1) comprising a frame 12 comprising a retaining arm 30, the retaining arm defining an aperture 32 and a valve retaining mechanism (prongs 136 of inner fork 132, prongs 134, which includes opening 140, as shown in FIGS. 20-22) comprising an elongate prong 136, the elongate prong comprising a distal bend portion located proximate the aperture 32 of the retaining arm 30, the distal bend portion of the prong being bent radially inwardly towards a longitudinal axis of the delivery device compared with a proximal portion of the elongate prong (FIG. 20). In view of Bakis’ teaching it would have been obvious to one of ordinary skill in the art, before the effective fling date of the application, to have provided the prosthetic valve and valve retaining mechanism as suggested by Bakis to the prosthetic delivery device of claim 16 of the patent to ensure that the prosthetic valve is still fully secured to the delivery device while the prosthetic valve is radially expand to allow the surgeon to position the valve at the desired location or retrieve the valve to reposition the valve at a desired location before the valve is fully deployed and relieved from the delivery device.
Allowable Subject Matter
Claims 1-21 would be allowable if a terminal disclaimer is filed to overcome the nonstatutory double patenting rejection(s) set forth in this Office action.
Liu et al. (US 2012/0239142, which is cited in the Information Disclosure Statement filed August 16, 2024, hereinafter “Liu”) discloses a prosthetic valve delivery device (Figs. 10, 74-75 and 108-111), comprising: a storage tube 3000 (Figs. 74-75; para [0180]), the storage tube comprising a housing 3004 defining an internal chamber 3006 (Fig. 111; para [0187]) configured to receive a prosthetic valve 10, the storage tube further defining a first locking member (one of slots 3062 as shown in Fig. 74 and Fig. 111 is interpreted as a first locking member); and a nose cone cap 3002 (Fig. 74 and 111), the nose cone cap defining an internal chamber (see Fig. 111) that is capable for receiving a nose cone, the nose cone cap further defining a second locking member (tabs 3060 on arms as shown in Fig. 74, one of the tabs and one of the arm are interpreted as a second locking member; para [0186]) selectively couplable to the first locking member (paragraph [0186] discloses housing 3004 coupled to 3002 by a locking mechanism in the form of slot and tab).
Referring again to Liu reference, Liu further discloses the prosthetic valve delivery device includes a prosthetic valve 10 (FIG. 1) comprising a frame 12 comprising a retaining arm 30, the retaining arm defining an aperture 32 and a valve retaining mechanism (prongs 136 of inner fork 132, prongs 134, which includes opening 140, as shown in FIGS. 20-22. FIGS. 19-20 are preproduced below) comprising an elongate prong 136, the elongate prong comprising a distal bend portion located proximate the aperture 32 of the retaining arm 30, the distal bend portion of the prong being bent radially inwardly towards a longitudinal axis of the delivery device compared with a proximal portion of the elongate prong (FIG. 20).
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There is no art of record alone or in combination that teaches a prosthetic valve delivery device that includes the combination of recited limitation in claims 2, 17 and 19.
As to claim 2, prior art of record alone or in combination did not teach the limitation of a storage tube, the storage tube comprising a housing, the housing defining an internal chamber configured to receive the prosthetic valve, the storage tube further defining a first locking member; a nose cone cap, the nose cone cap defining an internal chamber comprising an open proximal end, the open proximal end configured to receive a nose cone such that a distal end of the nose cone is proximate a distal end of the internal chamber and a proximal end of the nose cone is proximate the open proximal end of the internal chamber, the nose cone cap further defining a second locking member selectively couplable to the first locking member
As to claim 17, prior art of record alone or in combination did not teach the limitation of a storage tube, the storage tube comprising a housing, the housing defining an internal chamber configured to receive the prosthetic valve, the storage tube further defining a first means for securing the storage tube; a nose cone cap, the nose cone cap defining an internal chamber comprising an open proximal end, the open proximal end configured to receive a nose cone such that a distal end of the nose cone is proximate a distal end of the internal chamber and a proximal end of the nose cone is proximate the open proximal end of the internal chamber, the nose cone cap further defining a second locking means for securing the nose cone cap to the first locking means of the storage tube.
As to claim 19, prior art of record alone or in combination did not teach the limitation of storage tube, the storage tube comprising a housing, the housing defining an internal chamber configured to receive the prosthetic valve; a nose cone cap, the nose cone cap defining an internal chamber comprising an open proximal end, the open proximal end configured to receive a nose cone such that a distal end of the nose cone is proximate a distal end of the internal chamber and a proximal end of the nose cone is proximate the open proximal end of the internal chamber, the nose cone cap being releasably secured to the storage tube.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TUAN V NGUYEN whose telephone number is (571)272-5962. The examiner can normally be reached Monday - Friday 8:30 AM - 5:30 PM.
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771