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 Interpretation - 35 USC § 112
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
Specification
The disclosure is objected to because of the following informality: On page 1, under “CROSS-REFERENCE TO RELATED APPLICATIONS,” U.S. Pat. No. 11,986,405 is not cited as being issued from U.S. Pat. App. No. 17/847,583.
Appropriate correction is required.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it recites “are described” and “are also disclosed,” which are phrases that can be implied. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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-disThe 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 1-8, 11, and 12 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 5, 9, and 11 of U.S. Patent No. 11,986,405. Although the claims at issue are not identical, they are not patentably distinct from each other because claims of the present application claim subject matter encompassed by claims of the patent according to the table below.
Claims 9, 10, and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9 of U.S. Patent No. 11,986,405 in view of Kim et al. (2007/0050008). See the table below. The patent claims the subject matter of claims of the present application substantially, but does not claim that the composition comprises at least one substance that is injectable into a space between a surface of the stent and a vascular wall or comprises a filler substance that is not a therapeutic agent; nor does the patent claim that at least one of the aneurysm stabilizing substances is a non-phenolic molecule. Kim et al. teach, in figure 5 and para. [0029]-[0031], a composition (1) comprising at least one substance (e.g., a sponge structure of medical grade polymers or collagen) that is injectable into a space between a surface of the stent and a vascular wall or comprises a filler substance (e.g., medical grade polymers) that is not a therapeutic agent; nor does the patent claim that at least one of the aneurysm stabilizing substances is a non-phenolic molecule (e.g., medical grade polymers, collagen). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Kim et al., to modify the composition or aneurysm stabilizing substance of the patent as claimed. Such a modification would allow a barrier between the aneurysm wall and pressurized blood.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,986,405 in view of Khosravi et al. (6,231,562). See the table below. The patent claims the subject matter of claims of the present application substantially, but does not claim that at least one of the inlet and the outlet is comprised of an expandable toroidal balloon or a mechanical basket. Khosravi et al. teach, in figure 2 and col. 5, lines 6-44; a stent-like structure including an inlet and an outlet that comprise an expandable toroidal balloon (20). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Khosravi et al., to modify the stent of the patent, so that at least one of the inlet and the outlet is comprised of an expandable toroidal balloon. Such a modification would allow improvement of the sealing between the stent and necks of the aneurysm.
Claims of U.S. Pat. App. No. 18/669,221
Claims of U.S. Pat. No. 11,986,405
1
1
2
10
3
2
4
4
5
11
6
5
7
9
8
9
9
9 (in view of Kim et al.)
10
9 (in view of Kim et al.)
11
1
12
9
13
9 (in view of Kim et al.)
14
9 (in view of Kim et al.)
15
9 (in view of Kim et al.)
20
1 (in view of Khosravi et al.)
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.
Claims 1-3, 5, 7, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Duggal et al. (2010/0106240) in view of Leynov et al. (2007/0233224). Duggal et al. disclose the invention substantially as claimed. Duggal et al. disclose, at least in figures 2A-4 and para. [0059] and [0062]-[0068]; a method of intravascular treatment of an aneurysm (8), the method comprising: providing a device comprising a stent (20) in communication with an insertion catheter (a microcatheter, according to para. [0064]), the stent comprising an inlet operable to receive blood flow at a first end thereof and an outlet operable to allow an egress of blood flow at a second end thereof; inserting the device into an artery (2) comprising an aneurysm; expanding at least a portion of the stent; allowing blood to flow unimpeded through at least the expanded portion of the stent for a predetermined amount of time; wherein inserting the device comprises: providing the first end of the device at a cephalic location (an intracranial location, according to para. [0059]) relative to a renal artery; wherein the stent comprises a composition (at 30) including at least one aneurysm stabilizing substance (e.g., hydrogel, according to para. [0066]) for treating an aneurysm; wherein the composition comprises at least one substance (e.g., gel and/or foam) that is injectable into a space between a surface of the stent and a vascular wall (according to para. [0068]); and wherein the composition comprises a filler substance that is not a therapeutic agent (e.g., nylon or other polymer, according to para. [0066]).
However, Duggal et al. do not explicitly disclose contracting at least the expanded portion of the stent; and removing the device. Leynov et al. teach, in para. [0046], contracting (by re-sheathing) at least an expanded portion of a stent (12) and removing the stent. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Leynov et al., to modify the method of Duggal et al., so that at least the expanded portion of the stent is contracted and the device is removed. Such a modification would allow repositioning the stent as needed and/or replacement of the stent with a stent of a larger or smaller expanded diameter.
However, Duggal et al. in view of Leynov et al. do not explicitly disclose that the predetermined amount of time comprises a period of time between approximately sixty seconds and approximately ninety minutes. Nevertheless, It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to choose a predetermined amount of time as desired, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimal or workable ranges (e.g., of time) involves only routine skill in the art. In re Aller.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Duggal et al. (2010/0106240) in view of Leynov et al. (2007/0233224), and further in view of Chobotov et al. (11,439,497). Duggal et al. in view of Leynov et al. disclose the invention substantially as claimed, but do not explicitly disclose performing a scanning and/or imaging step to confirm that the stent is in a desired position. Chobotov et al. teach, in col. 23, line 49 to col. 24, line 5; performing a scanning and/or imaging step of a deployed stent (e.g., a graft). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Chobotov et al., to modify the method of Duggal et al. in view of Leynov et al., so that a step of scanning and/or imaging of a deployed stent is performed. Such a modification would not only allow verification of the position of the stent, it would allow detection of leakage or undesirable flow of material from the stent.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Duggal et al. (2010/0106240) in view of Leynov et al. (2007/0233224), and further in view of Boyle et al (2005/0186241). Duggal et al. in view of Leynov et al. disclose the invention substantially as claimed, but do not explicitly disclose that the at least one aneurysm stabilizing substance is selected from therapeutic agents listed in claim 8. Boyle et al. teach, in para. [0014], a stent that may comprise a composition that is a therapeutic agent, wherein, for example, the therapeutic agent may include antioxidants. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, in view of Boyle et al., to modify the method of Duggal et al. in view of Boyle et al., so that the stent comprises a composition that is a therapeutic agent. Such a modification would allow the stent to facilitate a healing response within a damaged region of a blood vessel.
Allowable Subject Matter
Claims 16-19 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.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
Any inquiry concerning this communication should be directed to Julian W. Woo at telephone number (571)272-4707. Normal office hours are: M-Th, 8-5:30 ET, 1st Fri. of biweek OFF; 2nd Fri., 8-4:30 ET.
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/JULIAN W WOO/Primary Examiner, Art Unit 3771