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(s) (IDS) submitted on 6/23/2025 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
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.
Currently no claims are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-20 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 1 (and thereby dependent claims 2-11) recites the limitation "said expanded diameter" in line 13. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 12 (and thereby dependent claims 13-18) recites the limitation "said expanded diameter" in line 15. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim 19 (and thereby dependent claim 20) recites the limitation "said expanded diameter" in line 16. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
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) 1-5 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Saeed (US 2008/0255656).
Saeed discloses (see Figs. 1-10) a method for implanting a bifurcated endovascular prosthesis comprising the following claim limitations:
(claim 1) A method of locating and securing a branch graft (10, Fig. 1) in two separate conduits (aorta 16 and iliac artery, as shown in Fig. 4) comprising: positioning a first end (14, Fig. 1) of a branch graft (10) into an opening of a first conduit (i.e., aorta 16) by a first insertion length so that a second end (18, Fig. 1) of the branch graft (10) extends from the first conduit (16) opening (as expressly shown in Figs. 4-6; [0079]; trunk portion 14 expressly inserted into aorta conduit 16 and first leg portion 18 expressly inserted one of the iliac arteries), the first end (14) being constricted to a first constricted diameter (as shown in Figs. 2a and 4-5); pulling a ripcord (32, Fig. 2a) of the branch graft (10) to deploy the first end (14) of the branch graft (10) within the first conduit (16) from the first constricted diameter (as shown in Figs. 2a and 5-7; [0080]; [0089]); subsequent to positioning the first end (14) of the branch graft (10) into the opening of the first conduit (16), configuring the second end (18) of the branch graft (10) into an opening of a second conduit (i.e., iliac artery) that is separate from the first conduit (16) by a second insertion length (as shown in Fig. 8; [0091]; release string 32 used to position/deploy second end 18 subsequent to trunk portion 14), the second end (18) being constricted to a second constricted diameter (as shown in Fig. 2a; [0080]; [0089]; [0091]); expanding the branch graft (10) to a deployed state (as shown in Fig. 8; [0091]), wherein the branch graft (10) is expanded toward said expanded diameter and is retained within the first conduit (16) and within the second conduit (i.e., iliac artery) so that the branch graft (10) couples the first conduit with the second conduit (as expressly shown in Fig. 8; [0091]);
(claim 2) wherein the ripcord (32) is a serpentine ripcord (as expressly shown in Fig. 2a);
(claim 3) further comprising pulling the ripcord (32) to deploy the second end (18) of the branch graft (10) within the second conduit (i.e., iliac artery) from the second constricted diameter (see Fig. 2a) subsequent to pulling the ripcord (32) of the branch graft (10) to deploy the first end (14) of the branch graft (10) (as shown in Figs. 4-8; [0080]; [0089]; [0091]; two-stage release of opposed ends of branch graft 10 expressly disclosed);
(claim 4) wherein the branch graft (10) is a stent graft (see Abstract and claims 1 and 9; [0022]; deployment of a stent graft prosthesis expressly disclosed);
(claim 5) wherein the branch graft (10) is a self-expanding stent graft (see claim 9; [0010]; [0080]; [0089]; [0091]; self-expansion after removal of a restraint mechanism (i.e., release string) expressly disclosed);
(claim 19) A method of locating and securing a branch graft (10, Fig. 1) in two separate conduits (aorta 16 and iliac artery, as shown in Fig. 4) comprising: positioning a first end (14, Fig. 1) of a branch graft (10) into an opening of a first conduit (i.e., aorta 16) by a first insertion length so that a second end (18, Fig. 1) of the branch graft (10) extends from the first conduit (16) opening (as expressly shown in Figs. 4-6; [0079]; trunk portion 14 expressly inserted into aorta conduit 16 and first leg portion 18 expressly inserted one of the iliac arteries), the first end (14) being constricted to a first constricted diameter (as shown in Figs. 2a and 4-5); pulling a ripcord (32, Fig. 2a) of the branch graft (10) to deploy the first end (14) of the branch graft (10) within the first conduit (16) from the first constricted diameter (as shown in Figs. 2a and 5-7; [0080]; [0089]); subsequent to positioning the first end (14) of the branch graft (10) into the opening of the first conduit (16), configuring the second end (18) of the branch graft (10) into an opening of a second conduit (i.e., iliac artery) that is separate from the first conduit (16) by a second insertion length (as shown in Fig. 8; [0091]; release string 32 used to position/deploy second end 18 subsequent to trunk portion 14), the second end (18) being constricted to a second constricted diameter (as shown in Fig. 2a; [0080]; [0089]; [0091]); subsequent to pulling the ripcord (32) of the branch graft (10) to deploy the first end (14) of the branch graft (10), pulling the ripcord (32) to deploy the second end (18) of the branch graft (10) within the second conduit (i.er., iliac artery) from the second constricted diameter (as shown in Figs. 4-8; [0080]; [0089]; [0091]; two-stage release of opposed ends of branch graft 10 expressly disclosed); expanding the branch graft (10) to a deployed state, wherein the branch graft (10) is expanded toward said expanded diameter and is retained within the first conduit (16) and within the second conduit (i.e., iliac artery) so that the branch graft (10) couples the first conduit (16) with the second conduit (i.e., iliac artery) (as shown in Fig. 8; [0091]); and
(claim 20) wherein the ripcord (32) has a serpentine configuration (as expressly shown in Fig. 2a).
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 12-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12,268,590. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 12,268,590
12
1-12
13
2,11
14
3,12
15
6,8-10
16
1-6,9-10
17
4,10
18
5,7-12
Claims 1-12 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30, 33-37, 40-41, 45 and 52 of U.S. Patent No. 11,504,222. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 11,504,222
1
1-30,33-37,40-41,45,52
2
4-6,35-37
3
4-6,21-30,34-37,40-41,52
4
2,12-13,22-23,33-37,52
5
3,13,23,33-37,52
6
6,37
7
7-9,15-17,25-27,52
8
8,16,26-27
9
9,17,27
10
1-10,18,28,45
11
1-10,31-49
12
10,18,28,45
19
1-10,21-30,33-37,40-41,45,52
20
4-6,35-37
Claims 1-14 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,512,533. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I).
Present Invention
U.S. Pat. No. 10,512,533
1
1-20
2
5-7
3
1-20
4
2-3
5
3
6
7
7
13-15
8
14-15
9
15
10
16
11
12
12
16
13
16
14
16
19
5-7,10-11,16
20
5-7
Allowable Subject Matter
Claims 6-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. It is noted that claims 6-11 remain subject to both 112 rejections and double patenting rejections (see above) that must be resolved before these claims can be rewritten into proper condition for allowance.
Claims 12-18 contain allowable subject matter. It is noted that claims 12-18 remain subject to both 112 rejections and double patenting rejections (see above) that must be resolved before these claims can be in proper condition for allowance. The following is an examiner’s statement of reasons for allowance: the art of record does not teach or render obvious a method of locating and securing a branch graft in two separate conduits as claimed that includes, in combination with the claim(s) as a whole, pulling on a first end and a second end of the ripcord to remove the locating sheath. The closest prior art appears to be Saeed (US 2008/0255656) disclosing a similar method for implanting a bifurcated stent graft, but failing to disclose or teach the step of pulling both first and second ends of a ripcord to remove a locating sheath.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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