DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 39-40 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 39 recites the limitation "a biocompatible material" in lines 2 and 7 of the claim. It is unclear whether the limitation “a biocompatible material” in line 7 refers to the same biocompatible material in line 2 or an additional biocompatible material. The examiner interprets the limitation in line 7 to be “the biocompatible material” to refer to the same biocompatible material in line 2 for examination purposes.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 21-24, 26-40 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Blaesar (US 6514281).
Regarding claim 21, Blaeser et al (hereafter Blaeser) discloses a method comprising: placing within a patient vessel an endovascular prosthesis comprising: a main tubular body (24) having an open end and an opposed ipsilateral leg and a contralateral leg (42, 40), said ipsilateral leg and contralateral leg each having an open end (figure 2A); the tubular body comprising a bifurcation point between the ipsilateral leg and the contralateral leg (figure 2A), a distal ipsilateral leg portion and a distal contralateral leg portion; and a biocompatible material (22) extending between the ipsilateral leg and the contralateral leg and restraining movement of the contralateral leg with respect to the ipsilateral leg (C:3, L:50-56).
Regarding claim 22, Blaeser discloses all of the limitations set forth in claim 21, further comprising the step of causing at least a portion of the biocompatible material to separate (C:3, L:65-67).
Regarding claim 23, Blaeser discloses all of the limitations set forth in claim 22, wherein a portion of the biocompatible material is separated by application of a displacement force (withdrawal of elongate retaining wire).
Regarding claim 24, Blaeser discloses all of the limitations set forth in claim 23, wherein the biocompatible material comprises a weakened portion (118) that is configured to allow separation of one portion of the biocompatible material from another portion of the biocompatible material (C:7, L:57-62).
Regarding claim 26, Blaeser discloses all of the limitations set forth in claim 21, wherein the biocompatible material between the ipsilateral leg and the contralateral leg increases in a direction extending from the bifurcation point to the distal ipsilateral leg portion or distal contralateral leg portion (figure 9B).
Regarding claim 27, Blaeser discloses all of the limitations set forth in claim 21, wherein the biocompatible material has a distal portion near a distal portion of the ipsilateral leg and near a distal portion of the contralateral leg (104, 106); wherein the biocompatible material has a proximal portion (108) near the bifurcation point of the prosthesis where the ipsilateral leg and the contralateral leg separate from the main tubular body; and wherein the distal portion of the biocompatible material is configured to allow more independent mobility of the distal portions of the ipsilateral leg and the contralateral leg as compared to proximal portions of the ipsilateral leg and the contralateral leg near the bifurcation point (figure 9B, separate branch portions 104, 106 allow more independent mobility).
Regarding claim 28, Blaeser discloses all of the limitations set forth in claim 21, wherein the biocompatible material is configured to restrict the contralateral leg from significant rotational movement so as to prevent misalignment within a bodily lumen (when wrapped around stent in delivery configuration, significant rotational movement is restricted).
Regarding claim 29, Blaeser discloses all of the limitations set forth in claim 28, wherein the biocompatible material comprises a plurality of connections shaped to allow more relative independent movement of distal portions of the ipsilateral leg and the contralateral leg (connection between panel 104, 106 and portion 108).
Regarding claim 30, Blaeser discloses all of the limitations set forth in claim 21, further comprising placement of the contralateral leg and the ipsilateral leg in the patient vessel (figure 2A-2C, placement in bifurcation).
Regarding claim 31, Blaeser discloses a method comprising: placing within a patient vessel an endovascular prosthesis comprising: a main tubular body (24) having an open end and an opposed ipsilateral leg and a contralateral leg (42, 40), said ipsilateral leg and contralateral leg each having an open end; the tubular body comprising a bifurcation point between the ipsilateral leg and the contralateral leg, a distal ipsilateral leg portion and a distal contralateral leg portion; and a biocompatible material (22, 44) extending between the ipsilateral leg and the contralateral leg, wherein the biocompatible restrains movement of the contralateral leg with respect to the ipsilateral leg, and wherein the biocompatible material is substantially triangular-shaped (figure 9B, portions 104, 106 comprise triangular extensions. The limitation ‘substantially triangular-shaped is also sufficiently broad to encompass the shape of 9B).
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Regarding claim 32, Blaeser discloses all of the limitations set forth in claim 31, further comprising the step of causing at least a portion of the biocompatible material to separate (C:7, L:57-62).
Regarding claim 33, Blaeser discloses all of the limitations set forth in claim 32, wherein a portion of the biocompatible material is separated by application of a displacement force (withdrawal of elongate retaining wire).
Regarding claim 34, Blaeser discloses all of the limitations set forth in claim 31, wherein the biocompatible material comprises a plurality of connections (121, 1128, 104, 106, 116, 114).
Regarding claim 35, Blaeser discloses all of the limitations set forth in claim 31, wherein the biocompatible material comprises a web portion (elongate retaining wire threaded through eyelets forms a web, figure 3B).
Regarding claim 36, Blaeser discloses all of the limitations set forth in claim 35, wherein a distal edge of the web portion is curved (44 threaded between eyelets forming loops which are curved) to allow the ipsilateral leg and contralateral leg more relative independent movement as compared to a web without a curved distal edge.
Regarding claim 37, Blaeser discloses all of the limitations set forth in claim 34, wherein each of the plurality of connections comprise a weakened portion (118, configured to allow separation of one portion of the biocompatible material from another portion of the biocompatible material, C:7, L:57-62)
Regarding claim 38, Blaeser discloses all of the limitations set forth in claim 34, wherein each of the plurality of connections is shaped to allow more relative independent movement of distal portions of the ipsilateral leg and the contralateral leg (figure 9B, separate branch portions 104, 106 allow more independent mobility).
Regarding claim 39, Blaesar discloses a method comprising: separating a portion of a biocompatible material (44, 22) which forms a part of an endovascular device, wherein the device comprises: a main tubular body (24) having an open end and an opposed ipsilateral leg and contralateral leg (42, 40) defining a graft wall therein between, said ipsilateral leg and contralateral leg each having an open end; the biocompatible material extending between the ipsilateral leg and the contralateral leg; wherein the biocompatible material restrains movement of the contralateral leg with respect to the ipsilateral leg (C:3, L:50-56)..
Regarding claims 40, Blaeser discloses all of the limitations set forth in claim 39, wherein a portion of the biocompatible material is separated by application of a displacement force (withdrawal of elongate retaining wire).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
Claim 25 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Blaesar (US 6514281) as applied to claim 24 above, and further in view of Mayberry et al (US 20090259298).
Regarding claim 25, Blaeser discloses all of the limitations set forth in claim 24, but does not specifically disclose the weakened portion comprises a tear line. However, Mayberry et al (hereafter Mayberry) teaches it was known in the art at the time of the invention to include a plurality of perforations configured to tear portions of the tubular member of the main branch restraint to deploy the main branch portion when a release wire is proximally retracted (paragraph 0013). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention for the weakened portion to include a tear line in addition to the release wire as a known alternative deployment mechanism for the biocompatible material around the main tubular body at the time of the invention by Mayberry to propagate a tear along the side of the main branch sheath, since it has been held that mere substitution of art-recognized equivalents 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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12336920. Although the claims at issue are not identical, they are not patentably distinct from each other because patent claim 1-15 recites the claimed method comprising the claimed main tubular body and biocompatible material (elongate release wire). Therefore, patent claims 1-15 are in essence a “species” of the generic invention of application claim 21-40. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claim 21-40 are anticipated by patent claims 1-15, it is not patentably distinct from patent claims 1-15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/
Primary Examiner, Art Unit 3771
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