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 .
Information Disclosure Statement
The information disclosure statement filed 04/03/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Non-patent literature reference “Japanese Patent Office Action issued July 28, 201”, which has been lined through, has been placed in the application file but the information referred to therein has not been considered, since no translation was provided.
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 1-19 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.
Regarding claim 1, which sets forth the parameter of “thereby providing multiple limbs having multiple slits”, on lines 8-9; however this parameter is found to be confusing since it is not clear how many slits are actually provided in each limb. Specifically, the parameter seems to recite that each limb has multiple slits, however this contradicts what is set forth on lines 7-8 which states each limb has “a slit”, i.e. one slit; therefore, it is unclear if each limb has a/one slit or multiple slits. Moreover, if the above mentioned parameter is actually setting forth that there are multiple limbs and each limb has a/one slit, then the parameter is found to be redundant (since this is already set forth on lines 7-8), not adding any additional structural limitation(s) to the claim, and just unnecessarily causes confusion. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 15, which, on lines 3-5, sets forth the parameter of “a capture element at the distal end region of the elongated flexible rod for releasable attachment to the furcated stent at the proximal end region which and…” (emphasis added); however, this parameter is found to be confusing. Specifically, it is set forth that the capture element is at the distal end region of the elongated flexible rod, however, it is further stated that the capture element attaches to the furcated stent “at the proximal end region” (which is the proximal end region of the elongated flexible rod, as set forth in the claim(s)); therefore, it is unclear how the capture element, which is at the distal end region of the elongated flexible rod, can also releasably attach to the furcated stent at the proximal end region of the elongated flexible rod. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite. For the purpose of examination, as can best be gleaned from the originally filed disclosure, the above mentioned parameter shall be interpreted as “a capture element at the distal end region of the elongated flexible rod for releasable attachment to a proximal end of the furcated stent”, however it is to be noted that the furcated stent is not actually actively claimed.
Examiner’s Notes
It is to be noted that claims 1-11 and 15-19 do not actively claim the “furcated stent”; therefore, the furcated stent/any structure associated with the furcated stent does not hold patentable weight and will only be considered to the extent that it further defines the structure of the claimed invention/device.
It is further to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight; intended use/functional language and/or method of manufacturing is considered to the extent that it/they further define(s) the claimed structure of the final device (see MPEP 2113 & 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-12 and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blaeser et al. (US Patent No. 6,514,281), as disclosed in the IDS dated 04/03/2024, hereinafter Blaeser.
Regarding claims 1-4, 8, 10-12 and 19, Blaeser discloses a delivery system/kit (20), illustrated in Figures 2A-2D and 2F, comprising a furcated stent (210a), which is self-expanding or non-self-expanding, having a stem (216a) and two arms (214a & 212a), illustrated in Figure 2F (Column 10, Lines 7-17); a delivery catheter (22) comprising an elongated first tube (24), having proximal and distal ends, and a tubular furcated part (26 & 28) at the distal end configured to accommodate the two arms (214a & 212a); wherein tubular furcated part (26 & 28) includes two limbs (26 & 28), each limb provided with a slit (30 & 32), wherein the slits (30 & 32) together form a passageway for passage therethrough of the furcated stent (210a), wherein the tubular furcated part (26 & 28) is configured to constrain radially the two arms (214a & 212a) when the passageway in the narrowed state and resist expansion of the furcated stent (210a) when the passageway in the narrowed state; the passageway has a narrowed state and a widened state, is biased in the narrowed state, and is configured for repeatable transition between the narrowed state and the widened state which is actuated by application of mechanical force between the passageway and the furcated stent, illustrated in Figures 2A-2D (Column 3, Lines 8-56 & Column 4, Lines 15-44); and further comprising an access catheter/guide catheter (156) configured for an over-the-wire, example illustrated in Figure 10A, including an elongated second tube having proximal and distal end regions provided with a second lumen adapted to slidably accommodate the first tube (24/142), and configured to control a gradual opening or folding of the tubular furcated part of the first tube responsive to slidable relative displacement of the first and second tubes, example illustrated in Figure 10A (Column 4, Lines 14-15; Column 8, Lines 60-63; Column 8, Line 64 – Column 9, Line 1 & Column 9, Lines 22-24 and 30-35).
Regarding claims 5 and 6, Blaeser discloses the delivery system according to claim 1, wherein each slit (30 & 32) extends from each limb (26 & 28) in a proximal direction from a distal terminal end of the limb, and connects at its proximal end to at least one other slit to form the passageway, and the slit (30 & 32) has edges that are always detached from each other, illustrated in Figures 2A and 2D.
Regarding claim 7, Blaeser discloses the delivery assembly of claim 1, wherein the two limbs (26 & 28) are joined at a joint and spread apart as the limbs extend in a distal direction, illustrated in Figures 2A and 2D.
Regarding claim 9, Blaeser discloses the delivery assembly of claim 1, wherein the tubular furcated part (26 & 28) is formed of a compliant material (34) that provides the bias of the passageway in the narrowed state and the repeatable transition between the narrowed state and widened state, illustrated in Figures 2A-2D (Column 3, Lines 21-25, 52-56 & Column 4, Lines 20-27).
Regarding claims 17 and 18, Blaeser discloses the delivery system according to claim 1, wherein the delivery catheter (22) is for a bodily vessel (12/14/16), specifically an artery or vein, illustrated in Figures 1, 2A, 2C and 2D (Column 1, Lines 5-9).
Regarding claim 20, Blaeser discloses a delivery assembly, illustrated in Figures 2A-2D and 2F, comprising a furcated stent (210a) including a stem (216a) and first arms (214a & 212a), illustrated in Figure 2F (Column 10, Lines 7-17); a delivery catheter (22) comprising an elongated first tube (24), having proximal and distal ends, and a tubular furcated part (26 & 28) proximate the distal end of the first tube (24), wherein the tubular furcated part (26 & 28) includes second tubular arms (26 & 28), which are configured to receive the first arms (214a & 212a) of the furcated stent (210a); and each second tubular arm (26 & 28) includes a slit (30 & 32) extending substantially the length of the tubular second tubular arm, each slit (30 & 32) contacting at least one other slit thereby forming a passageway, wherein the tubular furcated part (26 & 28) is formed of a material (34) having a native state that both applies a bias to the furcated stent resisting expansion of the furcated stent and allows forward and reverse passage of the furcated stent through the passageway, wherein the passageway has a narrowed state during which the second tubular arms (26 & 28) extend circumferentially around a majority of the circumference of each of the first arms (214a & 212a), and wherein the second tubular arms are biased in the narrowed state, and a widened state formed by first arms forcing the passageway apart and the second arms extending circumferentially each of the first arms less than in the narrowed state, illustrated in Figures 2A-2D (Column 3, Lines 8-56 & Column 4, Lines 15-44). discloses a delivery assembly, illustrated in Figures 2A-2D and 2F, comprising a furcated stent (210a) including a stem (216a) and first arms (214a & 212a), illustrated in Figure 2F (Column 10, Lines 7-17); a delivery catheter (22) comprising an elongated first tube (24), having proximal and distal ends, and a tubular furcated part (26 & 28) proximate the distal end of the first tube (24), wherein the tubular furcated part (26 & 28) includes second tubular arms (26 & 28), which are configured to receive the first arms (214a & 212a) of the furcated stent (210a); and each second tubular arm (26 & 28) includes a slit (30 & 32) extending substantially the length of the tubular second tubular arm, each slit (30 & 32) contacting at least one other slit thereby forming a passageway, wherein the tubular furcated part (26 & 28) is formed of a material (34) having a native state that both applies a bias to the furcated stent resisting expansion of the furcated stent and allows forward and reverse passage of the furcated stent through the passageway, wherein the passageway has a narrowed state during which the second tubular arms (26 & 28) extend circumferentially around a majority of the circumference of each of the first arms (214a & 212a), and wherein the second tubular arms are biased in the narrowed state, and a widened state formed by first arms forcing the passageway apart and the second arms extending circumferentially each of the first arms less than in the narrowed state, illustrated in Figures 2A-2D (Column 3, Lines 8-56 & Column 4, Lines 15-44).
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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Blaeser as applied to claim 12 above, and in view of Penn et al. (US Patent No. 5,755,771), as disclosed in the IDS dated 04/03/2024, hereinafter Penn.
Regarding claim 13, Blaeser discloses the delivery system according to claim 12, but does not specifically teach the furcated stent is provided with an elutable active pharmaceutical ingredient.
However, Penn teaches a furcated stent, in the same field of endeavor, which is provided with an elutable active pharmaceutical ingredient, in order to reduce thrombogenicity and/or provide anticoagulation (Column 4, Lines 61-67).
In view of the teachings of Penn, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the furcated stent, of the delivery system of Blaeser, to be provided with an elutable active pharmaceutical ingredient, in order to reduce thrombogenicity and/or provide anticoagulation, as taught by Penn.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Blaeser as applied to claim 12 above, and in view of McHugo (US PG Pub. 2011/0313505).
Regarding claim 14, Blaeser discloses the delivery system according to claim 12, but does not specifically teach the furcated stent is prepared by laser cutting or braiding.
However, McHugo teaches a furcated stent, in the same field of endeavor, which is prepared by laser cutting or braiding/weaving, illustrated in Figure 3 ([0028]).
In view of the teachings of McHugo, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the furcated stent, of the delivery system of Blaeser, to be prepared by laser cutting or braiding/weaving, since these are well-known ways, in the art, of forming stents/furcated stents, as taught by Hugo.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Blaeser as applied to claim 1 above, and in view of Jordan et al. (US PG Pub. 2008/0262592), hereinafter Jordan.
Regarding claim 15, Blaeser discloses the delivery system according to claim 1, but does not specifically teach a pusher having an elongated flexible rod and a capture element.
However, Jordan teaches a delivery system (100), in the same filed of endeavor, comprising a first tube (120); a pusher (160) including an elongated flexible rod (162) having proximal and distal end regions, and a capture element (140) at the distal end region of the elongated flexible rod (162) for releasable attachment to a proximal end of a stent (20), wherein the capture element (140) is radially self-expanding to adopt an open or folded configuration, such that the folded configuration is configured for passage within a first lumen of the first tube (120) and peripheral edges of the capture element (140) are closer together to grip a proximal end of the stent (20), and the open configuration is configured for release of the stent (20), illustrated in Figures 1-5, the pusher system aiding in moving, retrieving, adjusting and/or repositioning a stent in a vessel ([0030]; [0033]; [0034], Lines 1-6 & [0038], Lines 1-5).
In view of the teachings of Jordan, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the delivery system of Blaeser to further comprising a pusher including an elongated flexible rod having proximal and distal end regions, and a capture element at the distal end region of the elongated flexible rod for releasable attachment to a proximal end of the furcated stent, wherein the capture element is radially self-expanding to adopt open and folded configurations, such that the folded configuration is configured for passage within a first lumen of the first tube and peripheral edges of the capture element are closer together to grip the proximal end of the furcated stent, and the open configuration is configured for release of the furcated stent; such a pusher system aids in moving, retrieving, adjusting and/or repositioning the furcated stent in a vessel, as taught by Jordan.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Blaeser as applied to claim 1 above, and in view of Hebert et al. (US PG Pub. 2016/0206419), hereinafter Hebert.
Regarding claim 16, Blaeser discloses the delivery system according to claim 1, but does not specifically teach a loader for loading of the furcated stent into the delivery catheter.
However, Hebert teaches a delivery system, in the same filed of endeavor, comprising a stent/micrograft (10), a delivery catheter/microcatheter, and a loader (136), for loading the stent/micrograft (10) into the delivery catheter/microcatheter, the loader (136) comprising an elongated third tube (138) having a proximal end, a distal end, and a lumen, adapted to slidably accommodate the stent/micrograft (10) in a folded configuration, wherein the distal end of the third tube (138) is configured to couple with a proximal end of the delivery catheter/microcatheter such that a lumen of the delivery catheter and the lumen of the elongated third tube (138) are connected to form a continuous passage for advancement of the stent/micrograft (10) in the folded configuration from the loader (136) to the delivery catheter/microcatheter, illustrated in Figure 9 ([0197] & [0199], Last 5 Lines).
In view of the teachings of Hebert, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the delivery system of Blaeser to further comprising a loader comprising an elongated third tube having a proximal end, a distal end and a third lumen adapted to slidably accommodate the furcated stent in a folded configuration, wherein the distal end of the third tube is configured to couple with a proximal end of the delivery catheter such that a first lumen of the delivery catheter and the third lumen are connected to form a continuous passage for advancement of the furcated stent in the folded configuration from the loader to the delivery catheter, in order to load the furcated stent into the delivery catheter, as taught by Hebert.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 17-20 of U.S. Patent No. 11,229,538, and claims 1-19 and 23-28 of U.S. Patent No. 11,974,933. Although the claims at issue are not identical, they are not patentably distinct from each other because all sets of claims disclose a delivery system comprising a delivery catheter comprising an elongated first tube having proximal and distal ends, and a tubular furcated part at the distal end configured to accommodate arms of a furcated stent; wherein tubular furcated part includes two or more limbs, each limb provided with a slit, the multiple slits together form a passageway for passage therethrough of the furcated stent; the passageway has a narrowed state and a widened state, is biased in the narrowed state, and is configured for repeatable transition between the narrowed state and the widened state.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DINAH BARIA/Primary Examiner, Art Unit 3774 05/29/2026
Prosecution Insights