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 .
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 29-37 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 29 recites the limitation "a corresponding apex of the plurality of apices of the ring" in line 7 of the claim. There is insufficient antecedent basis for the limitation “the plurality of apices” in the claim since only a plurality of apices of the end ring is introduced in line 3. The examiner interprets the limitation to be “a corresponding valley of the plurality of peaks and valleys of the at least three rings”
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.
Claims 21-26, 29, 30, 32, 35-37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bales et al (US 20040044401).
Regarding claim 21, Bales discloses a stent, comprising: a main body (12) comprising a plurality of rings that form a helix (18, figure 1), a ring of the plurality of rings comprising a plurality of apices;
an end ring shaped to have a plurality of apices (see image below); and
a transition region (see image below); wherein the transition region includes a plurality of struts (32, 34) that each connect a corresponding apex of the plurality of apices of the end ring to a corresponding apex of the plurality of apices of the ring;
wherein the transition region includes a first gap and a second gap; wherein the first gap is between a first apex of the plurality of apices of the end ring and a second apex of the plurality of apices of the ring; wherein the second apex is opposing to the first apex, a direct distance between the first apex and the second apex defines a length of the first gap; wherein the second gap is between a third apex of the plurality of the apices of the end ring and a fourth apex of the plurality of apices of the ring; wherein a direct distance between the third apex and the fourth apex defines a length of the second gap; and wherein the length of the first gap is different from the length of the second gap (see image below).
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Regarding claim 22, Bales discloses all of the limitations set forth in claim 21, wherein a length of a second strut of the plurality of struts is longer than a length of a first strut of the plurality of struts (see image below).
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Regarding claim 23, Bales discloses all of the limitations set forth in claim 22, wherein a length of a third strut of the plurality of struts is longer than the length of a second strut of the plurality of struts (see image above).
Regarding claim 24, Bales discloses all of the limitations set forth in claim 23, wherein a distance between the first strut and the second strut is shorter than a distance between the second strut and the third strut (see image above).
Regarding claim 25, Bales discloses all of the limitations set forth in claim 21, further comprising: a plurality of connecting struts for connecting a particular ring of the plurality of rings of the main body with an adjacent ring of the plurality of rings of the main body (see image below).
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Regarding claim 26, Bales discloses all of the limitations set forth in claim 25, wherein each of the plurality of connecting struts extends from a corresponding peak of a plurality of peaks of the particular ring to a corresponding valley of a plurality of valleys of the adjacent ring (see image above).
Regarding claim 29, Bales discloses a stent, comprising: a main body (12) comprising a plurality of rings (18a, 18b, 18c) that form a helix (figure 2), at least three rings (18a, 18b, 18c) of the plurality of rings comprising a plurality of peaks and valleys (at 20, 26, figure 2); an end ring (38, winding, paragraph 00359) shaped to have a plurality of apices; and a transition region (16); wherein the transition region includes a plurality of struts (32, 34, 94, 96, 98,90, 92) that each connect a corresponding apex of the plurality of apices of the end ring to a corresponding valley of the plurality of peaks and valleys of the at least three rings (figure 3); a first plurality of connecting struts (56) for connecting a particular ring of the plurality of rings of the main body with a first adjacent ring of the plurality of rings of the main body (See image below); and a second plurality of connecting struts (50, 52, 54) for connecting the particular ring with a second adjacent ring of the plurality of rings of the main body (see image below); wherein each of the first plurality of connecting struts extends from a corresponding peak of a plurality of peaks of the particular ring to a corresponding valley of a plurality of valleys of the first adjacent ring; and wherein each of the second plurality of connecting struts extends from a corresponding valley of a plurality of valleys of the particular ring to a corresponding peak of a plurality of peaks of the second adjacent ring (see image below).
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Regarding claim 30, Bales discloses all of the limitations set forth in claim 29, wherein a particular connecting strut (52) of the second plurality of connecting struts is equidistant from a corresponding two connecting struts of the first plurality of connecting struts that are nearest to the particular connecting strut (see image below).
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Regarding claim 32, Bales discloses all of the limitations set forth in claim 29, wherein the main body further comprises a second plurality of rings that form a second helix.
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Regarding claim 35, Bales discloses all of the limitations set forth in claim 29, further comprising: a second end ring positioned to an opposite side of the main body from the end ring; wherein each of the plurality of rings of the main body is angled with respect to the end ring and the second end ring (figure 1).
Regarding claim 36, Bales discloses all of the limitations set forth in claim 35, wherein a width direction of an end of the end ring and a width direction of an end of the second end ring are perpendicular to a longitudinal axis of the stent (figure 1).
Regarding claim 37, Bales discloses all of the limitations set forth in claim 35, further comprising: a second transition region for connecting the second end ring to the main body (figure 1).
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.
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.
Claims 27-28 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Bales et al (US 20040044401) as applied to claim 21 above, and further in view of Zadno-Azizi et al (US5907893) and Nakano et al (US 20040102834).
Regarding claims 27 and 28, Bales discloses all of the limitations set forth in claim 21, but does not disclose at least one apex of the end ring is an apex of a tear drop shaped element. Zadno-Azizi et al (hereafter Zadno-Azizi) teaches radially expansible stents, wherein it was known in the art at the time of the invention to make stents comprise lozenge or tear drop shaped elements to form a ring of a stent (23, figure 2) , wherein the tear drop shaped element includes first and second v-shaped elements, wherein the legs (24) of the first v-shaped element are a same length and the legs of a second v-shaped element is a same length, and wherein the legs of the first v-shaped element are longer than the legs of the second v-shaped element such that the v-shaped elements form a tear drop shaped element (C:6, L:55-60, also shown in the embodiment of figure 3), in order to provide a ring that can be compressed radially and at the same time provide outwardly facing radial forces to maintain the patency of the lumen of the vessel of a human body in a manner known to those skilled in the art (C:7, L:1-5). Zadno-Azizi further discloses it was within the level of one with ordinary skill in the art at the time of the invention to utilize a variety of close peripheral structures in order to expand in width to accommodate expansion of the resulting cylindrical stent structure (C:7, L:6-12). Nakano et al (hereafter Nakano) also establishes that it was known in the art at the time of the invention for one with ordinary skill in the art at the time of the invention to make circumferential end rings of a stent comprise a plurality of patterns forming more or less polygonal shapes surrounded by struts lined up in the circumferential direction, wherein the shapes include lozenge shapes, oblong shapes, parallelogram shapes, pentagonal shapes and any other polygonal shapes, wherein more or less polygonal shapes includes shapes in which the corners are not sharp corners, but rather have a curved rounding (paragraph 0210, 0219). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the end ring of Bales further comprise tear drop shaped elements, such as those taught in Zadno-Azizi, wherein the legs of the first v-shaped elements forming the tear drop shaped elements are the same length and the legs of a second v-shaped element forming the tear drop shaped elements are the same length, and further wherein the legs of the first v- shaped element are longer than the legs of the second v-shaped element, since Nakano teaches it was well known in the art at the time of the invention to form any variety “more or less polygonal shapes” with the openings of an end ring and it has been held that a change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Regarding claims 33 and 34, Bales discloses all of the limitations set forth in claim 29, wherein the transition region connects an apex of a the end ring to the main body, but does not disclose the end ring comprises a plurality of tear drop shaped elements. Zadno-Azizi et al (hereafter Zadno-Azizi) teaches radially expansible stents, wherein it was known in the art at the time of the invention to make stents comprise lozenge or tear drop shaped elements to form a ring of a stent (23, figure 2) , wherein the tear drop shaped element includes first and second v-shaped elements, wherein the legs (24) of the first v-shaped element are a same length and the legs of a second v-shaped element is a same length, and wherein the legs of the first v-shaped element are longer than the legs of the second v-shaped element such that the v-shaped elements form a tear drop shaped element (C:6, L:55-60, also shown in the embodiment of figure 3), in order to provide a ring that can be compressed radially and at the same time provide outwardly facing radial forces to maintain the patency of the lumen of the vessel of a human body in a manner known to those skilled in the art (C:7, L:1-5). Zadno-Azizi further discloses it was within the level of one with ordinary skill in the art at the time of the invention to utilize a variety of close peripheral structures in order to expand in width to accommodate expansion of the resulting cylindrical stent structure (C:7, L:6-12). Nakano et al (hereafter Nakano) also establishes that it was known in the art at the time of the invention for one with ordinary skill in the art at the time of the invention to make circumferential end rings of a stent comprise a plurality of patterns forming more or less polygonal shapes surrounded by struts lined up in the circumferential direction, wherein the shapes include lozenge shapes, oblong shapes, parallelogram shapes, pentagonal shapes and any other polygonal shapes, wherein more or less polygonal shapes includes shapes in which the corners are not sharp corners, but rather have a curved rounding (paragraph 0210, 0219). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make the end ring of Bales further comprise tear drop shaped elements, such as those taught in Zadno-Azizi, such that the transition region connects an apex of a tear drop shaped element of the plurality of tear drop shaped elements of the end ring to the main body, since Nakano teaches it was well known in the art at the time of the invention to form any variety “more or less polygonal shapes” with the openings of an end ring and it has been held that a change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Claims 31 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Bales et al (US 20040044401) as applied to claims 21 and 29 above, and further in view of Armstrong et al (US 20130197617).
Regarding claim 31, Bales discloses all of the limitations set forth in claim 29, but does not disclose a ring of the plurality of rings comprises a plurality skewed v-shaped elements that each have a first leg and a second leg that is longer than the first leg. Armstrong discloses a stent, comprising: a main body (100) comprising a plurality of rings (120) that form a helix (helical turns 121, 122, paragraph 0062), an end ring (111d, 111p), and a transition region, wherein it was known in the art at the time of the invention to have a ring of the plurality of rings comprise a plurality skewed v-shaped elements that each have a first leg and a second leg that is longer than the first leg (Table 2, figure 4B, long strut, short strut), and wherein the first leg and the second leg of each of the plurality of skewed v-shaped elements of each of the plurality of rings have respective lengths such that there is a group of v- shaped elements that have corresponding apices aligned with each other in a direction that is parallel to a longitudinal axis of the stent (figure 6b, apices aligned). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to substitute the main body of the device of Bales with the main body of Armstrong, such that a ring of the plurality of rings comprise a plurality skewed v-shaped elements that each have a first leg and a second leg that is longer than the first leg and wherein the first leg and the second leg of each of the plurality of skewed v-shaped elements of each of the plurality of rings have respective lengths such that there is a group of v- shaped elements that have corresponding apices aligned with each other in a direction that is parallel to a longitudinal axis of the stent, as a known art-recognized equivalent configuration for a stent main body comprising helical windings at the time of the invention and it has been held that mere substitution of art-recognized equivalents at the time of the invention involves routine skill in the art.
Regarding claim 38, Bales discloses all of the limitations set forth in claim 21, further comprising: a plurality of connecting struts (50, 52, 54, 56) extending between rings of the plurality of rings, but does not disclose each of the plurality of connecting struts arranged parallel to a longitudinal axis of the stent. However, Armstrong teaches it was known in the art at the time of the invention for stents having a main body comprising a plurality of rings that form a helix to comprise a plurality of connecting struts (125) extending between rings of the plurality of rings (122), each of the plurality of connecting struts arranged parallel to a longitudinal axis of the stent (Figure 2A, paragraph 0066) as an art-recognized equivalent connecting strut to join adjacent rings of the helix. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to substitute the plurality of connecting struts of Bales with the plurality of connecting struts of Armstrong, such that each of the plurality of connecting struts arranged parallel to a longitudinal axis of the stent, as an art recognized equivalent connecting strut for connecting adjacent helical windings at the time of the invention and it has been held that mere substitution of art-recognized equivalents involves routine skill in the art.
Claim 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Bales et al (US 20040044401) as applied to claim 21 above, and further in view of Bales et al (US 20110166641).
Regarding claim 39, Bales discloses all of the limitations set forth in claim 21, wherein the length of the gap changes and increases, but does not specifically disclose the length of the gap is less than a length of a third strut and greater than a length of a second strut; and the gap is between the second strut and the third strut. However, Bales et al (US 20110166641; hereafter Bales ‘641) teaches a highly flexible stent, wherein the transition region includes struts (461) and a gaps gradually increasing in distance between the apices of a ring of the plurality of rings that form the helix (420a) and the apices of the end ring (64, figure 13) between the struts, such that length of the gap is less than a length of a third strut and greater than a length of a second strut; and the gap is between the second strut and the third strut. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make substitute the transition region of Bales ‘401 with the transition and end ring of Bales ‘641, since it has been held that mere substitution of art-recognized equivalents at the time of the invention involves routine skill in the art.
Regarding claim 39, Bales discloses all of the limitations set forth in claim 21, wherein the length of the gap changes and increases, but does not specifically disclose the length of the gap is less than a length of a second strut and greater than a length of a first strut; and the gap is between the first strut and the second strut. However, Bales et al (US 20110166641; hereafter Bales ‘641) teaches a highly flexible stent, wherein the transition region includes struts (461) and a gaps gradually increasing in distance between the apices of a ring of the plurality of rings that form the helix (420a) and the apices of the end ring (64, figure 13) between the struts, such that length of the gap is less than a length of a second strut and greater than a length of a first strut; and the gap is between the first strut and the second strut. Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make substitute the transition region of Bales ‘401 with the transition and end ring of Bales ‘641, since it has been held that mere substitution of art-recognized equivalents at the time of the invention 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 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 12,070,400. Although the claims at issue are not identical, they are not patentably distinct from each other because Patent 12070400 claims 1 and 9 recite the limitations found in claims 1 and 29. Therefore patent claims 1 and 9 of Patent 12070400 is in essence a “species” of the generic invention of application claims 21 and 29. 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 and 29 are anticipated by patent claims 1 and 9, they are not patentably distinct from patent claims 1 and 9.
Claims 21 and 29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 11497635. Although the claims at issue are not identical, they are not patentably distinct from each other because Patent 11497635claims 1 and 9 recite the limitations found in claims 1 and 29. Therefore patent claims 1 and 9 of Patent 11497635is in essence a “species” of the generic invention of application claims 21 and 29. 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 and 29 are anticipated by patent claims 1 and 9, they are not patentably distinct from patent claims 1 and 9.
Conclusion
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/ANH T DANG/Primary Examiner, Art Unit 3771