DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
Claims 31-32, 34, and 36 are objected to because of the following informalities: the claim recites the term “constraint state” instead of “constrained state”, which finds antecedent basis in the preamble of claim 31. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: the claim recites the term “structs” instead of “struts” in line 3. Appropriate correction is required.
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 45 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.
Regarding claim 45, the claim recites that each of the plurality of first resilient struts both a) comprises two or more enlarged longitudinal sections, and b) comprises only one of the enlarged longitudinal sections. These are conflicting conditions rendering the claim indefinite, because it is unclear whether the struts comprise only one enlarged longitudinal section or require two or more enlarged longitudinal sections.
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.
Claim(s) 31-50 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US 2001/0047198 A1 to Drasler et al. (hereinafter “Drasler”).
Regarding claim 31, Drasler discloses (see abstract; Figs. 3-9D; and [0135]-[0176]) a self-expanding (see [0141]/[0144]) cylindrical stent (245, see Figs. 9A-D) having a constrained state (Fig. 9A) and a relaxed expanded state (Fig. 9B), comprising: a proximal end; a distal end; and a plurality of first resilient struts (370) configured to exert an outward radial force in the constrained state (see [0141]), each of the plurality of first resilient struts comprising an enlarged longitudinal section which is enlarged in a circumferential orientation relative to a longitudinal axis of the stent (portion of struts 370 having width 430 as compared to width 440, see Fig. 9C and [0143]) and configured to stabilize the plurality of first resilient struts (see [0141]-[0143]), wherein the enlarged longitudinal sections of two adjacent resilient struts of the plurality of first resilient struts contact each other in the constraint state (see [0142], "(t)he interstrut openings 375 between the struts 370 in a circumferential direction 403 in a nondeployed state can be negligible and the struts 370 can be in direct contact with each other").
Drasler further discloses (claim 32) wherein the enlarged longitudinal section of a first resilient strut of the plurality of first resilient struts contacts the enlarged longitudinal sections of two second resilient struts of the plurality of resilient structs in the constraint state (see Figs. 9A/C and [0142]); (claim 33) wherein the enlarged longitudinal section of one of the plurality of first resilient struts comprises one or more flat sides (see Fig. 9C and [0143]); (claim 34) wherein the enlarged longitudinal sections of the two adjacent resilient struts circumferentially interfere with each other as the enlarged longitudinal sections of the two adjacent resilient struts contact each other in the constraint state (see Figs. 9A/C and [0142]); (claim 35) wherein the enlarged longitudinal sections of the two adjacent resilient struts are axially coextensive (see Figs. 9A-C); (claim 36) wherein in the constraint state, the enlarged longitudinal sections of the plurality of first resilient struts are compressed to a radial diameter that is no greater than a radial diameter of a remaining part of the stent (see Fig. 9A and [0141]); (claim 37) further comprising a plurality of second resilient struts (380, Figs. 9A/11D), configured to exert an outward radial force in the constrained state, each of the plurality of second resilient struts comprising a body (365, Figs. 9A/11D) and a barbed section (250) that extends from the body (see Fig. 11D and [0172]; Figs. 11A-D are the same structure as Figs. 9A-D plus the presence of barbs); (claim 38) wherein locations and orientations of the barbed sections of two adjacent resilient struts of the plurality of second resilient struts are asymmetric about a dimension that extends across the plurality of second resilient struts (see Fig. 11C); (claim 39) wherein each of the plurality of second resilient struts comprises a section, wherein the barbed section has a first flat surface (outer top surface of barb 250, Fig. 11D), and the enlarged section comprises a second flat surface (see Fig. 11D, portion of 365 adjacent barb 250); (claim 40) wherein a first flat surface of a first resilient strut of the plurality of second resilient struts faces a second flat surface of a second resilient strut of the plurality of second resilient struts (see Fig. 11A); (claim 41) wherein locations of the barbed sections of the plurality of second resilient struts are alternating across the plurality of second resilient struts (see Figs. 11A-D); (claim 42) wherein one of the plurality of first resilient struts is adjacent to one of the plurality of second resilient struts (see Figs. 11A-D); (claim 43) wherein the plurality of first resilient struts do not comprise barbed portion (see Figs. 9A-C); (claim 44) wherein a transverse dimension of the enlarged longitudinal section of one of the plurality of first resilient struts is 1.5 times to 3 times a nominal transverse dimension of the one of the plurality of first resilient struts in the circumferential orientation (see Fig. 9C and [0143]); (claim 45) wherein each of the plurality of first resilient struts comprises two or more of the enlarged longitudinal sections; each of the plurality of first resilient struts comprises only one of the enlarged longitudinal section (see Figs. 9A-C); (claim 46) wherein a location of the enlarged longitudinal section of a first one of the two adjacent resilient struts of the plurality of first resilient struts is offset from a location of the enlarged longitudinal section of a second one of the two adjacent resilient struts of the plurality of first resilient struts, along an axial dimension of the two adjacent resilient struts (see Fig. 9C); (claim 47) wherein a cross-section of a body of one of the plurality of first resilient struts has a trapezoidal shape (see Figs. 9A/C); (claim 48) wherein a cross-section of a body of one of the plurality of first resilient struts has an oval or round shape (see Figs. 9A/C); (claim 49) wherein a cross-section of a body of one of the two adjacent resilient struts and a cross-section of a body of another one of the two adjacent resilient struts are complementary (see Figs. 9A/C and [0143]); and (claim 50) wherein at least one of the plurality of first resilient struts comprises a taper having an offset radius, an elliptical apex radius, or a circular apex radius (see Fig. 9C and [0143]).
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 31, 33, 34, 37, and 42-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 5 of U.S. Patent No. 11,109,989 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims are broader than and thus are “anticipated by” the claims of the ‘989 patent with reference to the column and line numbers of the issued patent below:
Regarding current claim 31, ‘989 patent claim 1 recites a self-expanding cylindrical stent (C22L56) having a constrained state and a relaxed expanded state (C22L56-57), comprising: a proximal end; a distal end; and a plurality of first resilient struts configured to exert an outward radial force in the constrained state (C23L5-7), each of the plurality of first resilient struts comprising an enlarged longitudinal section which is enlarged in a circumferential orientation relative to a longitudinal axis of the stent (C23L22-25) and configured to stabilize the plurality of first resilient struts (C23L9-12), wherein the enlarged longitudinal sections of two adjacent resilient struts of the plurality of first resilient struts contact each other in the constraint state (C23L26-31).
Further, there is correspondence between dependent claims of the current application and claims of the ‘989 patent as follows:
Current application claim #
33
34
37
42
43
44
45
‘989 patent claim #
2
1
1
1
1
5
1
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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, 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.
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.
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
Prosecution Insights