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 .
Election/Restrictions
The restriction requirement of clip arrangements, as set forth in the Office action mailed on 10/24/25, has been reconsidered in view of the amendment submitted 12/30/25. The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of species for clip arrangements on a coaptive device is withdrawn.
Newly submitted claims 51-70 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the new claims are to apparatus or product claims, whereas the prior claims (now cancelled) were directed to a method of treatment to a mitral valve, with new claims specifically defining a coaptation assistance element for treating mal-coaptation of a heart valve in a heart. Please note that upon receipt of the current office action applicant is advised, this invention now claimed has been constructively elected by original presentation for prosecution on the merits. No further switching inventions/species is permitted.
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.
Claims 52-55 are 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.
Claim 52 recites the limitation "the commissures of the valve leaflets" in line 2 of the claim. Please note limitations or implied features are not read into claims. Thus it is not evident if the recited “commissures of the valve leaflets” is intended to be of the native valve or of a prosthetic valve. There is insufficient antecedent basis for this limitation in the claim. Dependent claims carry the problem of the claim they depend on.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 51,52,54-57,60,62,65-69 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mohl (2020/0268512). Figs. 3,4 show a coaptation assistance element 21 for treating mal-coaptation of a heart valve of a heart (see abstract), the coaptation assistance element comprising: a first surface 28 and an opposed second surface faces backside element 24. Please note all three dimensional objects have numerous sides and it is inherent the coaptation element of Mohl has a first lateral edge, a second lateral edge, an inferior edge or region defined by element 22, and a superior edge 23, and an adaptive coaptation element 29 configured to inflate in systole and deflate in diastole, paragraph 88. Regarding claims 52,67,68 Mohl further shows (Fig. 5) implant wings 27 configured to seal on the commissure of the valve leaflets and can be seen they extend along the first lateral edge and the second lateral edge as they extend outward. Additionally as best seen (Fig. 3) the wings extend less than the entire height of the coaptation assistance element as they are solely in the upper part of the device. Regarding claim 54, it can be seen (Fig. 3) the implant wings are configured to cover an opening during upward and downward motion of the coaptation assistance element as they extend out and form a ledge to cover the area about the annulus and cover any gap when placed in the native valve. Regarding claim 55, it can be seen (Fig 3) the implant wings 27 extend along a transition from a horizontal oriented section of the coaptation assistance element to a vertically oriented section of the coaptation assistance element. Regarding claim 56, Mohl discloses (paragraph 18) the adaptive coaptation element inflates by the increase in left ventricle pressure and blood flow toward the left atrium, and wherein the adaptive coaptation element deflates by the decrease in left ventricle pressure and blood flow toward the left ventricle. Regarding claim 57, Mohl further disclose (paragraph 22) the coaptation assistance element is configured to be fixed at one or more locations in the annulus, and wherein the coaptation assistance element is configured to move upward and downward during the cardiac cycle. Regarding claim 60, it can be construed (Fig. 3) the adaptive coaptation element comprises a fixed superior edge, fixed lateral edges, and a free inferior edge with all elements affixed together to not allow separation of components. Regarding claim 62, it can be construed the adaptive coaptation element is configured to fill to greater thickness as the heart condition worsens as Mohl disclose the pockets are flexible. Regarding claim 65, it can be seen (Fig. 3) the adaptive coaptation element extends the entire width between lateral edges of the coaptation assistance element as the pockets extend about the entire circumference. Regarding claim 66, Fig. 3 shows wherein the adaptive coaptation element extends less than the entire height of the coaptation assistance element. Regarding claim 69, Mohl discloses (paragraph 92) the adaptive coaptation element is configured to inflate to any thickness over a range of thickness until the adaptive coaptation element is stopped by an anterior leaflet.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 58,59,63,64 are rejected under 35 U.S.C. 103 as being unpatentable over Mohl (2020/0268512) in view of McLean et al. (2022/0192822). Mohl is explained supra. However, Mohl did not explicitly disclose there is an edge to edge device and it is configured to clip the anterior leaflet to the coaptation assistance element to reduce the backflow of blood. McLean et al. teach that an edge to edge device or clip 220 which is configured to clip the anterior leaflet to the coaptation assistance element (paragraphs 48,49) to reduce the backflow of blood, see Figs. 2,4D, note would couple to anterior leaflet since coaptation device 214 extends into the mitral valve towards the anterior. It would have been obvious to one of ordinary skill to use an edge to edge coupling clip to secure with the coaptation device as taught by McLean et al. and incorporate with the coaptation assistance element of Mohl to assure the element stays at the valve site. Regarding claim 63, Mohl did not disclose one or more struts having one end terminating at an annular hub and having the other end extending radially outwardly. McLean et al. teach (Fig. 3B) one or more struts 322 having one end terminating at an annular hub 321 and having the other end extending radially outwardly. It would have been obvious to one of ordinary skill in the art to utilize an annular hub as taught by McLean et al. with the coaptation device of Mohl in order to effective place the implant in the valve site. Regarding claim 64, Mohl did not disclose an annular hub. McLean et al. teach (Fig. 3B) an annular hub 321 coupled with the implantable coaptation device to assist with positioning, paragraph 42. It would have been obvious to one of ordinary skill in the art to utilize an annular hub as taught by McLean et al. with the coaptation device of Mohl in order to effective place the implant in the valve site.
Claim(s) 53,70 are rejected under 35 U.S.C. 103 as being unpatentable over Mohl (2020/0268512) in view of van der Burg et al. (2016/0106437). Mohl is explained supra. However, Mohl did not explicitly disclose material of wings is ePTFE or the adaptive coaptation element comprises a material having a porosity between 10 microns and 200 microns. van der Burg et al. teach (paragraph 88) the material of covering can be ePTFE. It would have been obvious to one of ordinary skill in the art to select a known material such as ePTFE as taught by van der Berg for the wings of the coaptive device of Mohl to provide a suitable biocompatible covering. van der Burg et al. also teach (paragraph 90) an assist element (Fig. 38) for a heart in the form of a membrane material having a porosity between 10 microns and 200 microns. It would have been obvious to one of ordinary skill in the art to select the appropriate material and provide the porosity between 10 microns and 200 microns as taught by van der Burg et al. with the coaptation device of Mohl and use such material for the adaptive coaptation element in order to provide the properties needed.
Claim(s) 61 is rejected under 35 U.S.C. 103 as being unpatentable over Mohl (2020/0268512). Mohl is explained supra. However, Mohl did not explicitly disclose the adaptive coaptation element comprises a thickness at the coaptation surface when inflated between 1 mm and 15 mm. It would have been obvious to one of ordinary skill in the art to select the appropriate dimensions to seal or have the valve leaflet coapt with the pocket or adaptive coaptation element of Mohl and finding dimensions or thickness between 1-15mm only involves routine skill in the art.
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 51,64 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8,12,15 of U.S. Patent No. 10478303. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim scope overlaps despite a different terminology used. Current claims of the application use broader terminology. It must be noted that narrower claims anticipate broader claims. See In re Goodman. Claim 8 of US recites a coaptation assistance element for treating mal-coaptation of a heart valve of a heart, the coaptation assistance element comprising: a first surface and an opposed second surface, a first lateral edge, a second lateral edge, an inferior edge, and a superior edge, and a leaflet (recited limitation of pending claim 51 to an adaptive coaptation element is analogous) configured to expand (recited limitation of pending claim 51 to inflate is analogous) in systole and deflate in diastole. Regarding claim 64 reciting “an annular hub” is recited and anticipated by claim 12 of US ‘303. Also note, the recited function of “configured to inflate and deflate” of claim 51, is further anticipated by claim 15 reciting the same function.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799