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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 2-20 is/are pending. Claim(s) 1 is/are canceled.
Information Disclosure Statement
The information disclosure statement filed 4/9/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the lined through citations (NPL numbers 15 and 71) were not provided in the instant Application or in the parent Application. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
All non-lined through citations were considered.
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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. 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 USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 2-6 and 8-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 16 of U.S. Patent No. 11,723,783. Although the claims at issue are not identical, they are not patentably distinct from each other because the following prior claims contain the limitations claimed by the current Application as indicated in the following table.
Current Application
Prior ‘783 Patent
2, 13, 15, 18, 19
1
3
2
4
3
6
4
5
5
14
6
8
7
9
8
10
9
11
10
12
11
13
12
16
13
17
14
20
16
Claims 2, 5, 6, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 11,497,503. Although the claims at issue are not identical, they are not patentably distinct from each other because the following prior claims contain the limitations claimed by the current Application as indicated in the following table.
Current Application
Prior ‘503 Patent
2, 5, 6, 13
3
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 19 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.
Claim 19 recites “the first end of the first end of the radially expandable frame”. It is unclear what end is referred to as there is only one “first end” introduced in claim 2. For purposes of examination the Examiner considers this language to be for the first end of claim 2 (i.e. the second recitation of “the first end” is a typo).
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.
Functional and intended use language is presented in italicized font.
Claim(s) 2-8 and 11-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fogarty, et al (Fogarty) (US 5,824,037).
Regarding Claim 2, Fogarty teaches a flow modifying apparatus (e.g. abstract, Figures 3, 3A-D) comprising:
a plurality of struts coupled together to form a radially expandable frame (e.g. Figure 3B) having a first end portion and a second end portion (e.g. Figure 3, #s 66, 62 axially beyond #74 toward end #68; collapsed configuration of the shown end portions), wherein the first end portion and the second end portion are radially expandable into expanded first and second end portions (e.g. column 8, lines 49-60; expanded configuration see in Figure 3), respectively, wherein the flow modifying apparatus extends from a first end of the radially expandable frame to a second end of the radially expandable frame (e.g. Figure 3);
a reduced diameter portion of the expandable frame (e.g. Figure 3, at region #74 of element #64) disposed between the first end portion and the second end portion (e.g. Figure 3), wherein the reduced diameter portion comprises a fluid flow through passage (e.g. abstract, column 9, lines 9-14), wherein when the first and second end portions have expanded into the expanded first and second end portions, the first and second expanded end portions each comprise flared portions that flare outwardly from the reduced diameter portion toward the first and second ends, respectively, of the radially expandable frame (e.g. Figure 3; column 9, lines 45-54); and
a cover covering at least a portion of the flared portion of the first end portion (e.g. column 1, lines 6-12; graft material), wherein the cover is spaced from the reduced diameter portion (e.g. Figure 3, by the portions of #64 between #74 and #76), wherein the reduced diameter portion modifies fluid flow therethrough immediately upon implantation thereof and forms a pressure gradient between the first end and the reduced diameter portion of the expandable frame (these functions inherently result from the shape of the apparatus per fluid mechanics principles; specifically, fluid flow velocity inherently increases when a tube narrows and there is a pressure gradient per Bernoulli’s equation for a narrowed tube relative to a larger diameter tube).
Regarding Claim 3, the pressure gradient is greatest between the first end of the apparatus and the reduced diameter portion (e.g. Figure 3, the first end is considered that at #66, which is the largest diameter section; thus the difference between the largest cross-section and the smallest (which is at the reduced diameter portion, Figure 3, # 74) is the pressure gradient with the greatest value).
Regarding Claim 4, a velocity of the fluid flow is greatest in the reduced diameter portion (e.g. Figure 3, the reduced diameter portion has the smallest diameter and therefore the highest velocity, which is inherently present, see Bernoulli’s principle).
Regarding Claim 5, the cover is disposed over an outer surface of the radially expandable frame (e.g. column 4, lines 41-56).
Regarding Claim 6, the cover is disposed over an inner surface of the radially expandable frame (e.g. column 4, lines 41-56).
Regarding Claim 7, there is a second cover covering at least a portion of the flared portion of the second end portion (e.g. column 1, lines 6-12; graft material), wherein the second cover is spaced from the reduced diameter portion (e.g. Figure 3, as broadly claimed, the second cover on #62 is radially spaced from the reduced diameter portion of #64).
Regarding Claim 8, the cover comprises a polymer, a fabric, a synthetic material, tissue, or combinations thereof (e.g. column 5, lines 7-15; yarns make a fabric).
Regarding Claim 11, the plurality of struts form a plurality of rectangular slots when the expandable frame is in a collapsed configuration, and wherein the plurality of rectangular slots expand into diamond shapes when the expandable frame is in a radially expanded configuration (e.g. Figure 3B; when collapsed the diamond shapes form rectangular slots), and wherein the diamond shapes have a height and a length (diamond shapes inherently have these dimensions), and wherein the height decreases from the first and second ends toward a center point disposed therebetween (upon expansion the height of each diamond decreases in the axial direction and this from first and second ends and toward the axial center of the overall device because the diamond’s longer dimension is oriented in this direction) .
Regarding Claim 12, the length decreases from the first and second ends toward the center point (discussed supra for claim 11; as the frame is made of diamond shapes the length of the stent decreases as it expands due to these shapes).
Regarding Claim 13, the flow modifying apparatus is self-expanding or balloon expandable (e.g. column 3, lines 30-48).
Regarding Claim 14, the cover extends over up to 40% of a length of the flow modifying apparatus (e.g. Figure 3; the length of #66 is less than 40% of a length of the flow modifying apparatus).
Regarding Claim 15, the cover is spaced from the first end of the radially expandable frame such that the cover is located only on the flared portion of the first end portion (e.g. Figures 3, 3B, the tips of the frame are uncovered).
Regarding Claim 16, the cover forms a continuous conical shape from a first end of the cover that is adjacent the first end of the radially expandable frame to a second end of the cover that is adjacent the reduced diameter portion (e.g. Figure 3, column 9, lines 45-54).
Regarding Claim 17, one of the first and second ends is smaller than the other of the first and second ends (e.g. Figure 3).
Regarding Claim 18, the first portion is an outflow portion of the apparatus and the second portion is an inflow portion of the apparatus (the device is fully capable of being placed in the vessel in the claimed orientation).
Regarding Claim 19, the cover extends up to the first end of the first end of the radially expandable frame (e.g. Figure 3B, the cover is at the terminal end of the frame portions other than the tips and is generally at the “end” of the frame as required by the claim).
Regarding Claim 20, Fogarty teaches a system for delivering a flow modifying implant (e.g. abstract, column 3, lines 29-48), said system comprising: the flow modifying implant of claim 2 (discussed supra for claim 2); and a delivery catheter (e.g. column 3, lines 29-48).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fogarty, et al (Fogarty) (US 5,824,037) as discussed supra, alone.
Regarding Claim 10, the reduced diameter portion comprises a diameter between 2 to 4 mm (e.g. column 9, lines 14-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fogarty such that the reduced diameter portion comprises a diameter between 2 to 4 mm since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fogarty, et al (Fogarty) (US 5,824,037) as discussed supra and further in view of Molaei, et al (Molaei) (US 2005/0197687 A1).
Regarding Claim 9, Fogarty discloses the invention substantially as claimed but fails to teach the cover is configured to prevent or minimize an inflammatory response by a vessel wall.
Molaei teaches a stent graft having a cover that is configured to prevent or minimize an inflammatory response by a vessel wall (e.g. [0052]).
Molaei and Fogarty are concerned with the same field of endeavor as the claimed invention, namely stent grafts.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Fogarty to have the therapeutic agent as taught by Molaei in order to an anti-inflammatory effect (e.g. Molaei, [0052], anti-inflammatory agents).
Relevant Prior Art
US 2015/0374516 A1 to Pereira teaches a stent having multiple band coverings along its axial length (e.g. Figure 4).
US 5,741,333 to Frid teaches a stent graft having tapering ends to a narrowed portion between the ends (e.g. Figure 2).
US 5,876,445 to Anderson, et al teaches a stent having tapering ends to a narrowed portion between the ends and having a covering on at least one end (e.g. Figure 4a).
US 2003/0130611 A1 to Martin teaches a stent having tapering ends to a narrowed portion between the ends (e.g. Figure 3).
US 2003/0070676 A1 to Cooper, et al teaches a stent having tapering ends to a narrowed portion between the ends and having a covering on at least one end (e.g. Figure 14B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571)272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 1/22/2026