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 .
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-2, 8-9 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 6-7 of U.S. Patent No. 11,554,033. Although the claims at issue are not identical, they are not patentably distinct from each other because all the elements of the application claim(s) 1-2, 8-9 are to be found in patent claim(s) 1, 6-7 (as the application claim(s) 1-2, 8-9 fully encompass patent claim(s) 1, 6-7). The difference between the application claim(s) 1-2, 8-9 and the patent claim(s) 1, 6-7 lies in the fact that the patent claim includes many more elements and is thus much more specific. Thus the invention of claim(s) 1, 6-7 of the patent is in effect a “species” of the “generic” invention of the application claim(s) 1-2, 8-9. It has been held that the generic invention is “anticipated by the “species”. See In re Goodman, 29 USPQ 2d 2010 (Fed. Cir. 1993). Since application claim(s) 1-2, 8-9 is/are anticipated by claim(s) 1, 6-7 of the patent, it is not patentably distinct from claim(s) 1, 6-7 of the patent.
Claim within current application
Claim within 11,554,033
1
1 (column 18, lines 1-9)
2
1 (column 17, lines 38-45)
3
4
5
6
7
8
6
9
7
Claim Objections
Claim(s) 3, 5 is/are objected to because of the following informalities:
Within claim 3, line 3: “the delivery shaft” should be –the delivery shaft (249)-- (in order to maintain consistent claim terminology).
Within claim 5, lines 2-3: the tubular body” should be replaced with --the self-expanding tubular body-- (in order to maintain consistent claim terminology).
Within claim 6, line 2: “(L1)” should be replaced with --(L2)-- (in order to abbreviations consistent with claim 2).
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(s) 2-9 is/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.
Within claim 2, lines 1: Applicant claims, “a self-expanding tubular body”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim. The scope of the claim is determined by the preamble – which is to the delivery system alone; however, the aforementioned claim requirement positively recites the self-expanding tubular body which according the specification is configured to be delivered by the delivery system. As such, it is unclear, if Applicant is trying to claim the delivery system alone (in which case configured to language could be added to claim 2) OR if Applicant if trying to claim a medical system which includes both a delivery system and the self-expanded tubular body (in which case an amendment to the preamble of the claims could be made). Claim(s) 3-9, which depend from claim 2, inherit all the problems associated with claim 2.
Within claim 3, line 4: Applicant claims, “the removable sheath (230,241) is split by pulling on the pull handle (232)”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim. The scope of the claim is determined by the preamble – which is to the delivery system alone; however, the aforementioned claim requirement is positively reciting the splitting of the removable sheath which is a method of use claim requirement. As such, it is unclear, if Applicant is trying to claim the product or the method of using the product. Claim(s) 4-5, which depend from claim 3, inherit all the problems associate with claim 3.
Within claim 4, lines 2-4: Applicant claims, “whereby inflation of the integrated balloon (15, 245) after removal of the removable sheath (230, 241) enables further radial expansion of the stented tubular length portion (L')”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim. The scope of the claim is determined by the preamble – which is to the delivery system alone; however, the aforementioned claim requirement is positively reciting the inflation and further radial expansion which are method of use claim requirements. As such, it is unclear, if Applicant is trying to claim the product or the method of using the product. Claim(s) 5, which depend from claim 4, inherit all the problems associate with claim 4.
Within claim 5, line 1 (and claim 6, line 1; and claim 7, line 1; and claim 8, line 1; and claim 9, line 1): Applicant claims, “the tubular medical device of claim”; it is unclear, and therefore indefinite, what Applicant considers to be the scope of the claim – the preamble oof previous claim(s) 1-4 is to the delivery system alone; however, in the aforementioned claim requirement the preamble is to the tubular medical device (which is distinct from the delivery system); as such, it is unclear, what the scope of claim(s )6-9 are.
Claim 5 recites the limitation "the maximum potential expanded dimension" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Pryor (US 2007/0244540 A1).
With respect to claim 1:
Pryor discloses a delivery system (stent delivery system 200), as can be seen in figs. 2-4 (paragraph [0024]), comprising:
a) an operator handle (220) (handle 212), including a splitter mechanism (224) (keel 216) (paragraph [0028]);
b) a delivery shaft (249) (strain relief 232) extending from the operator handle (220) (handle 212) (paragraph [0032]);
c) a pull handle (232) (sheath knob 224) at the operator handle (220) (handle 212) (paragraph [0039]); and
d) straps (233) (two subsections of sheath 206, proximal to keel 216, on either side of slit 304 in fig. 3) extending from the pull handle (232) (sheath knob 224) (paragraph [0035]).
With respect to claim 2:
Further including a self-expanding tubular body (31, 243) (stent 202) that includes a stented tubular length portion (L') (a proximal subsection of stent 202) that includes self-expanding stents (individual wires/ rings making up the proximal subsection of stent 202), and a crimped tubular length portion (L’) (a distal subsection of stent 202), the crimped tubular length portion (L’) (a distal subsection of stent 202) being secured to the stented tubular length portion (L') (a proximal subsection of stent 202) (paragraph [0025]). (PLEASE NOTE: Applicant has not claimed any structural differences between the stented tubular length portion and the crimped tubular length portion; as such, Examiner is subdividing the stent (202), as disclosed by Pryor, such that a portion thereof is considered the stented tubular length portion – this portion will be made up of some self-expanding structure which Examiner is considering to be the “stents” thereof; the remaining portion of the stent (202), as disclosed by Pryor, is considered by Examiner to be the a crimped tubular length portion which is crimped prior to the deployment process) (paragraph [0030]).
With respect to claim 3:
Further including a removable sheath (230, 241) (subsection of sheath 206 distal to keel 216) radially constricting the stented tubular length portion (L') (proximal subsection of stent 202) that extends through the operator handle (handle 212), wherein the delivery shaft (strain relief 232) extends to (surrounds) the removable sheath (230,241) (subsection of sheath 206 distal to keel 216), whereby the removable sheath (230,241) (subsection of sheath 206 distal to keel 216) is configured to be split (at the breakaway 302) by pulling on the pull handle (232) (sheath knob 224) (paragraphs [0035, 0039-0042]).
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pryor (US 2007/0244540 A1) in view of Pelton (US 2003/0191520 A1).
Pryor discloses the invention substantially as claimed, as discussed above. However, Pryor does not disclose the delivery system (stent delivery system 200) to further including an integrated balloon (15, 245) within the self-expanding tubular body (31, 243) (stent 202), such that inflation of the integrated balloon (15, 245) after removal of the removable sheath (230, 241) (subsection of sheath 206 distal to keel 216) enables further radial expansion of the stented tubular length portion (L') (a proximal subsection of stent 202) of the self-expanding tubular body (31, 243) (stent 202) (as required by claim 4).
Pelton teaches a self-expanding prosthesis (stent 10), as can be seen in fig. 1, delivered by a delivery system including both an integrated balloon (balloon 20) and a removable sheath (delivery sheath 16) (paragraph [0033]), such that inflation of the integrated balloon (15, 245) (balloon 20) after removal of the removable sheath (230, 241) (delivery sheath 16) enables further radial expansion of the self-expanding tubular body (31, 243) (stent 10) to improve seating within the artery wall (paragraph [0033]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the integrated balloon (balloon 20), as taught by Pelton, within the delivery system (stent delivery system 200), as disclosed by Pryor, such that the self-expanding tubular body (31, 243) (stent 202) (and sub-portions thereof) may be further radially expanded after being allowed to self-expand after removal of the sheath to improve seating within the artery wall, as taught by Pelton.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pryor (US 2007/0244540 A1) in view of Case et al. (US 2005/0228472 A1).
Pryor discloses the invention substantially as claimed, as discussed above. However, Pryor is silent with respect to the structure of the self-expanding tubular body (31, 243) (stent 202) – specifically, that the stented tubular length portion (L') (proximal subsection of stent 202) of the self-expanding tubular body (31, 243) (stent 202) includes: an internal valve/ introducer seal (as required by claims 6-7).
Case et al. teaches a prosthesis (medical device 700), as can be seen in fig. 7, for the treatment of incompetent venous valve (paragraph [0080]) using a self-expanding tubular body (31, 243) (frame 704) with the stented tubular length portion (L') (a proximal subsection of stent graft prosthesis) including an internal valve/ introducer seal (valve members) (valve members maybe positioned at any point along the self-expanding tubular body (31, 243) (frame 704)) (paragraphs [0082-0083, 0090]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to include the internal valve/ introducer seal (valve members), as taught by Case et al., within the stented tubular length portion (L') (proximal subsection of stent 202) of the self-expanding tubular body (31, 243) (stent 202), as disclosed by Pryor, such that the self-expanding tubular body (31, 243) (stent 202) may additionally be used to treat vessels/ aneurysms at points where there are incompetent venous valves (so that the prosthesis can be mimic the native anatomy which includes a valve in that region). (PLEASE NOTE: With respect to claim 7: Applicant has failed to claim any structure defining the “introducer seal”, as such the internal valve, as taught by Case et al., is considered an “introducer seal” as currently claimed.)
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pryor (US 2007/0244540 A1) in view of McDonald et al. (US 2014/0121761 A1).
Pryor discloses the invention substantially as claimed, as discussed above. However, Pryor is silent with respect to the structure of the self-expanding tubular body (31, 243) (stent 202) – specifically, that the stented tubular length portion (L') (proximal subsection of stent 202) of the self-expanding tubular body (31, 243) (stent 202) includes: saddle-shaped ring stents (244), each of which has peak (252) and valley portions (253) (as required by claim 8) nor a lining of a polytetrafluoroethylene (PTFE) (as required by claim 9).
McDonald et al. teaches a stent graft prosthesis for the treatment of vascular aneurysms (paragraphs [abstract, 0049]) using a self-expanding tubular body (31, 243) (stent graft prosthesis) with the stented tubular length portion (L') (proximal subsection of stent graft prosthesis) including saddle-shaped ring stents (244) (saddle shaped rings within the proximal subsection of stent graft prosthesis), each of which has peak (252) and valley portions (253) and a lining of a polytetrafluoroethylene (PTFE) (PTFE) (paragraphs [0027-0035]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use the structure of the self-expanding tubular body (31, 243) (stent graft prosthesis) (including all the portions/ substructures thereof – including the saddle shaped rings therein and the inclusion of a PTFE graft), as taught by McDonald et al., for the self-expanding tubular body (31, 243) (stent 202), as disclosed by Pryor, as both structures are used for the same purpose (to treat vascular aneurysms); as such, the structures would be obvious substitutes for each other.
Allowable Subject Matter
Claim(s) 5 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Examiner can find no references alone nor in combination which render obvious:
With respect to claim 5:
A delivery system (as required by claim(s) 1-4) wherein the integrated balloon (which is configured to be used to further expand an already at least partially self-expanded tubular body) is undersized in relation to a maximum potential expanded dimension of the self-expanding tubular body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1.
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/REBECCA S PRESTON/Examiner, Art Unit 3774