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 Objections
Claim 19 is objected to because it includes reference characters which are not enclosed within parentheses.
Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m).
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 1-5, 7-12, 14-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pacetti US 6,663,664 (hereafter referred to as Pacetti; cited in IDS).
Regarding claim 1, Pacetti discloses a stent device comprising: a main stent body 20 configured to expand when placed in a treatment site of a patient, the main stent body configured to expand to a first diameter at a first time and a second diameter at a later second time (col. 7, lines 40-50; col.12, lines 15-43; col.15, lines 16-42), wherein the second diameter is greater than the first diameter and wherein the main stent body is constrained to the first diameter by a bioabsorbable material 25, 90, 94 (figs. 1-2, 7-8, and 17-18).
Regarding claims 2 and 8, see col.10, lines 15-16 for Nitinol and fig.1 for strut braces and loops forming the stent.
Regarding claims 3-5, and 7, see figs. 17-18 for outer stents 90 and 94 which are biodegradable (col.15, lines 16-27).
Regarding claim 9, see figs.1-2 for the main stent body 20 comprising the bioabsorbable material 25.
Regarding claim 10, see the materials listed in col.9, line 64-col.10, line 14.
Regarding claim 11, Pacetti discloses a stent device comprising: an expandible stent 20 configured to expand to a second diameter, and a bioabsorbable constraint structure 25, 90, 94 (figs. 1-2, 7-8, and 17-18) secured with the expandible stent and constraining the expandible stent to a first diameter that is less than the second diameter, the bioabsorbable constraint structure made of a bioabsorbable material (col. 7, lines 40-50; col.12, lines 15-43; col.15, lines 16-42).
Regarding claim 12, see figs. 17-18 for outer stent 90, 94 and col.15, lines 16-42 for the biodegradable outer stents functioning as claimed.
Regarding claim 14, see fig.7 for bioabsorbable strut 25 of the expandable stent.
Regarding claim 15, see figs. 17-18 for biodegradable loops 90 and 94.
Regarding claim 16, see the materials listed in col.9, line 64-col.10, line 14.
Regarding claim 17, see col.10, lines 15-16 for Nitinol.
Regarding claim 19, Pacetti discloses a stent device comprising: an outer stent 90, 94 comprising a bioabsorbable material configured to expand to a first diameter (figs. 17-18; col.15, lines 16-42), and an inner stent 20 disposed within the outer stent and configured to expand to a second diameter; wherein the second diameter is greater than the first diameter (col.15, lines 16-42).
Regarding claim 20, see col.10, lines 15-16.
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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Pacetti. Pacetti discloses the stent device of claim 11 as discussed above. Pacetti further discloses bioabsorbable helical spring 94 in fig.18 but Pacetti does not disclose a plurality of springs. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add another bioabsorbable helical spring to the stent device of Pacetti fig.18 since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960), MPEP 2144.04 VI B). In the instant case, a second spring would provide the expected result of greater control over the expansion of the stent device.
Claims 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Pacetti as applied to claims 4 and 11 above, and further in view of Skousen et al. US 2020/0330250 (hereafter referred to as Skousen). Pacetti discloses the stent device of claims 4 and 11 as discussed above including embodiments wherein the stent comprises both non-absorbable material (nitinol) and bioabsorbable material 25 (figs. 1 and 7; col.6, line 66-col.7, line 4). Pacetti does not specifically disclose a combination of the embodiment of figs. 1 and 7 with the embodiment of figs. 17-18 and therefore does not disclose that biodegradable material of the main/inner stent has a longer bio-absorption time than the biodegradable material of the outer stent.
Skousen teaches a stent device, in the same field of endeavor, wherein the stent device comprises a stent 502 comprising non-absorbable and absorbable 502 materials (fig.5; pars.45 and 49). Skousen teaches an embodiment wherein a stent 402 is coated with a bioabsorbable coating 404 that restrains the stent in a compressed state until the outer coating absorbs (par.47). Skousen further teaches a combination of spot welds of expansion stops in combination with an outer coating for the purpose of providing a double expansion stop mechanism (par.48) and teaches designing the stent to be tailored to achieve a desired expansion profile (par.41).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the embodiments of Pacetti figs. 1 or 7 comprising a stent with biodegradable portions with the embodiment of Pacetti figs. 17-18 comprising a bioabsorbable outer stent in order to provide a double expansion stop mechanism as taught by Skousen. It would have been further obvious to select a longer bio-absorption time for the inner stent in order to achieve a desired expansion profile as taught by Skousen. Given that the outer stent of Pacetti is in direct contact with the tissue of the body lumen thereby rapidly degrading (Pacetti col.15, lines 38-42), it would have been further obvious to provide the inner stent with a longer bio-absorption time to maintain some expansion control after the outer stent absorbs.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sumanasinghe et al. US 2018/0325651, Berglund US 9,060,891, Jantzen et al. US 8,764,813, and Nielsen US 2014/0074221 each disclose a stent device comprising a bioabsorbable material, the stent device configured for multiple stage expansion. Weber et al. US 2010/0292776 discloses inner and outer biodegradable stents.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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