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 .
Response to Amendment
In response to the amendment filed on 12/09/2025, Claims 11-12, 14, 16, 24-30 have been cancelled, and Claims 1-10, 13, 15, 17-22, 23, 31 and 32 are pending.
Election/Restrictions
Applicant’s election WITHOUT traverse of GROUP I in the reply filed on 12/09/2025 is acknowledged. Claim 31 has been withdrawn from further consideration and Claims 1-10, 13, 15, 17-22, 23, and 32 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-10, 13, 15, 17-22, 23, and 32 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding Claim 1, the limitations “an external fixation disposed on the outside of the vessel wall; a scaffold disposed on the inside of the vessel wall and interfacing with the external fixation, with at least a portion of the scaffold disposed through an aperture in the vessel wall; and a patch disposed on the inside of the vessel wall and sandwiched between the external fixation and the scaffold, with the patch substantially covering the full area of the aperture, thereby sealing the aperture.” are directed to and encompass a human organism “the vessel wall” and “an aperture in the vessel wall”. In order to obviate this rejection, Applicant must claim these limitations functionally such that the implantable device is not defined by a positive recitation of these human organisms. For example, the claims are suggested to read “an external fixation configured to be disposed on the outside of the vessel wall; a scaffold configured to be disposed on the inside of the vessel wall and interfacing with the external fixation, with at least a portion of the scaffold configured to be disposed through an aperture in the vessel wall; and a patch configured to be disposed on the inside of the vessel wall and sandwiched between the external fixation and the scaffold, with the patch capable of substantially covering the full area of the aperture, thereby sealing the aperture.”
Regarding Claim 17, the limitation “a longitudinal axis of the patch is aligned with a longitudinal axis of the blood vessel.” encompasses a human organism. The claim is suggested to read “a longitudinal axis of the patch is capable of being aligned with a longitudinal axis of the blood vessel.”
Regarding Claim 22, the limitations “an external fixation disposed on the outside of the vessel wall; a scaffold disposed on the inside of the vessel wall and interfacing with the external fixation, with at least a portion of the scaffold disposed through an aperture in the vessel wall; and a patch disposed on the inside of the vessel wall and sandwiched between the external fixation and the scaffold, the patch substantially covering the full area of the aperture, thereby sealing the aperture” encompass a human organism. The claims are suggested to read “an external fixation configured to be disposed on the outside of the vessel wall; a scaffold configured to be disposed on the inside of the vessel wall and interfacing with the external fixation, with at least a portion of the scaffold configured to be disposed through an aperture in the vessel wall; and a patch configured to be disposed on the inside of the vessel wall and sandwiched between the external fixation and the scaffold, with the patch capable of substantially covering the full area of the aperture, thereby sealing the aperture.”
Claims 2-10, 13, 15, 17-21, 23, and 32 are rejected for incorporating errors from the parent claim by dependency.
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 9 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 9 recites the limitation "the protrusion" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 32 recites the limitation "the scaffold neck" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
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 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/735,726 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding Present Claim 1, Claim 2 of App ‘726 discloses an implantable device for sealing an aperture in a wall of a body vessel (Preamble of claim 1 of which Claim 2 depends upon), the implantable device comprising (Claim 2, Line 2):
an external fixation disposed on the outside of the vessel wall (Claim 2, lines 3-4);
a scaffold disposed on the inside of the vessel wall and interfacing with the external fixation, with at least a portion of the scaffold disposed through an aperture in the vessel wall (Claim 2, Lines 4-7); and
a patch disposed on the inside of the vessel wall and sandwiched between the external fixation and the scaffold, with the patch substantially covering the full area of the aperture, thereby sealing the aperture (Claim 2, Lines 8-12).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 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) 1-8, 10, 13, 17-19, 21, 23 and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGoldrick (US PGPub 2019/0021710).
Regarding Claim 1, McGoldrick teaches an implantable device for sealing an aperture in a wall of a body vessel (abstract), the implantable device (Figures 1A-1B and Figure 75) comprising:
an external fixation (126; Figure 1A-1B) disposed on the outside (116; Figure 1B) of the vessel wall (110; as seen in Figure 1B; Paragraph 0053) (see also Figures 75-76C; Paragraph 0110 which states that this element is on the outside of the vessel);
a scaffold (120; Figure 1B) disposed on the inside (108) of the vessel wall (110) and interfacing with the external fixation (126; Figure 1B) (see also Figures 75 in which the scaffold is the bottom plate), with at least a portion of the scaffold (120) disposed through an aperture (112; Figure 1B) in the vessel wall (110; as disclosed in Paragraph 0048); and
a patch (106) disposed on the inside (108) of the vessel wall (110) and sandwiched between the external fixation (126; Figures 1A-1B) and the scaffold (104), with the patch (106) substantially covering the full area of the aperture (112; Figures 1B), thereby sealing the aperture (112; Paragraph 0046 and 0084).
Regarding Claim 2, McGoldrick teaches the device of claim 1, wherein the scaffold (120) further comprises:
a base plate (310 and 312; Figure 5; Paragraph 0057); and
a neck (122) extending externally at an angle from the base plate (see Figure 1B; but also seen in Figures 70A-10B), the neck comprising at least one lumen disposed therethrough (Figures Figure 3A; 70A-70B, 75-76C).
Regarding Claim 3, McGoldrick teaches the device of claim 1, wherein the scaffold neck (122; Figure 1B) (7401; Figure 74A) comprises at least two retaining tabs (7403), wherein the retaining tabs (7403/7402) are disposed circumferentially around an exterior of the scaffold neck (7401) and extend radially away from the scaffold neck (7401; Figures 74A-74C), and wherein the retaining tabs (7403/7402) interface with a collar (7302) of the external fixation (7301), thereby causing the external fixation (7301) to be coupled to the scaffold (as shown in Figures 76C), with the patch sandwiched between the base plate of the scaffold and the external fixation (as seen in Figure 76C).
Regarding Claim 4, McGoldrick teaches the device of claim 3, wherein the external fixation (7301) comprises:
the collar (see annotated Figure 75 provided below);
a base ring (see annotated Figure 75 provided below);
an anterior rib connecting the collar and the base ring (see annotated Figure 75 provided below); and
a posterior post connecting the collar and the base ring (see annotated Figure 75 provided below).
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Regarding Claim 5, McGoldrick teaches the device of claim 4, wherein the external fixation further comprises a tab disposed at an angle from the collar, the tab comprising a protrusion (see annotated Figure 89D below).
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Regarding Claim 6, McGoldrick teaches the device of claim 2, wherein the scaffold comprises a threaded portion (1900) at the base of the neck, the threads of the threaded portion (1900) interacting with the opening of the patch (106) to hold the patch (106) against the upper surface of the base plate of the scaffold (as shown Figures 20A-20D; Paragraph 0095)
Regarding Claim 7, McGoldrick teaches the device of claim 2, further comprising a closure pin (YY) disposed within the scaffold neck for sealing the at least one lumen after a guidewire is removed from the guidewire lumen, wherein distally pushing the closure pin into the scaffold neck causes the closure pin to seal the at least one lumen (as disclosed Paragraph 0094 and shown in Figure (118A, but appears to be element 318).
Regarding Claim 8, McGoldrick teaches the device of claim 7, wherein the closure pin comprises:
a cylindrical body (see annotated Figure 17B below);
a tip disposed at the distal end of the cylindrical body that comprises at least one of an angled tip and a stepped tapered tip (see annotated Figure 17B below); and
a substantially cylindrical head disposed at the proximal end of the cylindrical body (see annotated Figure 17B below).
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Regarding Claim 10, McGoldrick teaches the device of claim 7, wherein the closure pin (Figure 17B) comprises at least one of a pair of first and second distally extending arms, a rupture portion, an offset bore, an angled pin, a slidable rod, and an L-shaped closure pin (Figure 17B see annotated Figure 17B above).
Regarding Claim 13, McGoldrick teaches the device of claim 2, wherein the scaffold neck (122) comprises at least one of an internal taper, a gradual tapered portion, a ramp portion, a sleeve portion, an angled surface, and a partial bore (Figure 3A).
Regarding Claim 17, McGoldrick teaches the device of claim 1, wherein the aperture (112) is located in a blood vessel (110; Figure 1B), and a longitudinal axis of the patch is aligned with a longitudinal axis of the blood vessel (110; as seen in Figure 1A-1B; furthermore, this is an intended use and the patch can be delivered in any radial configuration).
Regarding Claim 18, McGoldrick teaches the device of claim 1, wherein a longitudinal dimension of the patch is within a range of about 6 to about 29 mm and a lateral dimension of the patch is within a range of about 4 mm to about 22 mm (Paragraph 0084 states that the patch is sized larger than the diameter of the aperture and gives a range of 12F to 30F which is 4mm to 10mm, which is a range within the claimed range and thus anticipated the claim).
Regarding Claim 19, McGoldrick teaches the device of claim 1, wherein an average thickness of the patch (106) is within a range of 100 pm to 500 pm (Paragraph 0084).
Regarding Claim 21, McGoldrick teaches the device of claim 2, wherein the patch comprises an opening (2004; Figure 20A) disposed at the center of the patch (106), the scaffold neck (122) passing through the opening in the patch (106; see Figure 1A-1B and Figures 20A-20B).
Regarding Claim 22, McGoldrick teaches a vascular closure system for sealing an aperture in a tissue of a body vessel (abstract), the system comprising:
an implantable device comprising:
an external fixation (126; Figure 1A-1B) disposed on the outside (116; Figure 1B) of the vessel wall (110; as seen in Figure 1B; Paragraph 0053) (see also Figures 75-76C; Paragraph 0110 which states that this element is on the outside of the vessel);
a scaffold (120; Figure 1B) disposed on the inside (108) of the vessel wall (110) and interfacing with the external fixation (126; Figure 1B) (see also Figures 75 in which the scaffold is the bottom plate), with at least a portion of the scaffold (120) disposed through an aperture (112; Figure 1B) in the vessel wall (110; as disclosed in Paragraph 0048); and
a patch (106) disposed on the inside (108) of the vessel wall (110) and sandwiched between the external fixation (126; Figures 1A-1B) and the scaffold (104), with the patch (106) substantially covering the full area of the aperture (112; Figures 1B), thereby sealing the aperture (112; Paragraph 0046 and 0084).
and
a device delivery system (2202),
wherein the implantable device (106/118) is stowed within the delivery system (2202; Figure 22) with the patch (106) in a rolled configuration prior to delivery of the implantable device (2202) to the aperture in the tissue of the body vessel (Paragraph 0093; Figure 22).
Regarding Claim 23, McGoldrick teaches the system of claim 22, wherein the delivery system comprises:
an introducer sheath (introducer catheter; Figure 22; Paragraph 0090 and 0093) ;
a guidewire (202) disposed through the introducer sheath (Paragraph 0094; see also Figure 1B);
a pusher shaft for facilitating closure of a guidewire lumen (Paragraph 0093 incorporates US 2014/0345109 by reference);
a delivery shaft (504) for delivering the external fixation (Figure 1B; see also Paragraph 0090; see Figure 5; Paragraph 0067);
a loading cannula (2106) for facilitating loading of the implantable device (Figure 21A; Paragraph 0090);
a receiving funnel (2102) for receiving the implantable device from the loading cannula (Paragraph 0090);
an outer shaft for delivering the implantable device to the aperture (see Figure 1B which shows and inner catheter and outer catheter); and
a handle for actuating components of the delivery system (inherent in a delivery system yet not shown; shown in Figure 52 of US 2014/0345109 which is incorporated by reference in Paragraph 0093).
Regarding Claim 32, McGoldrick teaches the system of claim 22, the scaffold neck (122; Figure 1B) (7401; Figure 74A) comprises at least two retaining tabs (7403), wherein the retaining tabs (7403/7402) are disposed circumferentially around an exterior of the scaffold neck (7401) and extend radially away from the scaffold neck (7401; Figures 74A-74C), wherein the external fixation comprises a collar, a base ring, an anterior rib connecting the collar and the base ring, and a posterior post connecting the collar and the base ring (see annotated Figure 75 below and rejection of Claim 4 above), and wherein the retaining tabs (7403/7402) interface with a collar (7302) of the external fixation (7301), thereby causing the external fixation (7301) to be coupled to the scaffold (as shown in Figures 76C), with the patch sandwiched between the base plate of the scaffold and the external fixation (as seen in Figure 76C).
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Claim Rejections - 35 USC § 103
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 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) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McGoldrick (US PGPub 2019/0021710). as applied to claim 1 above, and further in view of McGoldrick (US 2016/0166241; now referred to as McGoldrick-2)
Regarding Claim 20, McGoldrick teaches the device of claim 1, but fails to explicitly teach wherein the patch comprises:
a base layer having a thickness within a range of 190-220 micron; and
an electrospun layer having a thickness within a range of 20-80 micron,
wherein a total thickness of the patch is within a range of 210-300 micron.
McGoldrick-2 discloses:
a base layer (104; Figure 1A-1B) having a thickness within a range of 190-220 micron (Paragraph 0089); and
an electrospun layer (102; Figure 1A-1B) having a thickness within a range of 20-80 micron (Paragraph 0089),
wherein a total thickness of the patch is within a range of 210-300 micron (Paragraph 0089).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the patch taught by McGoldrick with the patch as taught by McGoldrick-2 since it has been held that where the general conditions of a claim are disclosed in the prior art, the substitution of one known element for another yields predictable results to one of ordinary skill in the art; both prior art references discloses patches for sealing a vessel puncture.
Furthermore, would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the base layer, the electrospun layer, or the total thickness of the patch of the McGoldrick references to be as recited in Claim 20 as Applicant appears to have placed no criticality on the claimed range (see pp. [0206] indicating the angle “may” be between 50-500 microns and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Allowable Subject Matter
Claim 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. This includes Claims 8, 7, 5, 4, 3, 2 and 1. Claim 5 and its dependents are included for proper antecedent basis and to obviate the 112(b) rejection.
Claim 15 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. This includes Claims 3, 2 and 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 270-5953. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771