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 .
Status of Claims
Claims 1-11 and 15-19 are pending and examined below
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.
(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) 1-10, 15, 16, and 18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2019/118983 (Krizan)
Regarding claim 1, Krizan discloses a biocompatible polymeric material (¶0049, wherein “silicone rubber” corresponds to a biocompatible polymeric material) having a textured surface with an arithmetical mean height value (Sa) below in a range of 0.1 to 10 µm (see annotated Table 1 below, wherein 0.132787 fall within the claimed range) and a developed interfacial area ratio (Sdr) above 1.0 (see annotated Table 1 below), determined according to ISO 25178 using a Gaussian low pass S-filter with a nesting index value of at least 0.25 pm (examiner note: the ISO standard and low pass filter limitations are not being given patentable weight as the claimed structure is not limited by the steps used to measure it, see MPEP 2114)
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Regarding claim 2, Krizan further discloses wherein the textured surface comprises a density of peaks (Spd) above 1x106 peaks/mm2 (see Table 1 below, wherein 1,015,401 is above 1x106 peaks/mm2)
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Regarding claim 3, Krizan further discloses wherein the textured surface has a texture aspect ratio (Str) above 0.6 (see Table 1, wherein 0.978388 is above 0.6)
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Regarding claim 4, Krizan further discloses wherein the textured surface has a maximum height value (Sz) below 60 µm (see Table 1 below, wherein 12.2927 is below 60 µm)
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Regarding claim 5, Krizan further discloses wherein the biocompatible polymeric material comprises a polyester, a polyurethane, an organosilicon, or a polyolefin (¶0049, wherein “silicone rubber” corresponds to an organosilicon)
Regarding claim 6, Krizan discloses a process for preparing the biocompatible polymeric material (¶0050, wherein “silicone rubber” corresponds to a biocompatible polymeric material) according to claim 1 (see the rejection of claim 1), the process comprising:
a) providing a microstructured template (Fig. 1, wherein 15 and 17 together form a microstructured template) having a textured surface with an arithmetical mean height value (Sa) in a range of 0.1 to 10 µm (see annotated Table 1 below, wherein 0.132787 fall within the claimed range) and a developed interfacial area ratio (Sdr) above 1.0 (see annotated Table 1 below, wherein 1.294387 is above 1.0), determined according to ISO 25178 using a Gaussian low pass S-filter with a nesting index value of at least 0.25 pm (examiner note: the ISO standard and low pass filter limitations are not being given patentable weight as the claimed structure is not limited by the steps used to measure it, see MPEP 2114)
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b) covering the textured surface of the microstructured template with a biocompatible polymeric material as a solid or with a liquid polymerizable mixture (Fig. 1, wherein a layer of PTFE corresponds to a solid biocompatible polymeric material)
c) conforming the biocompatible polymeric material to the textural contours of the microstructured template using, in combination or separately, elevated temperature, pressure, or vacuum (¶0054, wherein the “compression molding step” corresponds to a combination of elevated temperature and pressure)
d) when provided as the liquid polymerizable mixture, solidifying the biocompatible polymeric material (see rejection of step b above, wherein 16 is a solid), and
e) separating the biocompatible polymeric material and the microstructured template (¶0058, wherein “piston 11 is removed from the first mold 14” corresponds to separating the biocompatible polymeric material and the microstructured template)
Regarding claim 7, Krizan further discloses wherein the template has a textured surface with an arithmetical mean height value (Sa) in a range of 0.1 to 10µm (see annotated Table 1 below, wherein 0.132787 falls within the claimed range) and a developed interfacial area ratio (Sdr) above 1.0 (see annotated Table 1 below, wherein 1.294387 falls within the claimed range), determined according to ISO 25178 using a Gaussian low pass S-filter with a nesting index value of at least 0.25 pm (examiner note: the ISO standard and low pass filter limitations are not being given patentable weight as the claimed structure is not limited by the steps used to measure it, see MPEP 2114)
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Regarding claim 8, Kirzan further discloses wherein the textured surface has a density of peaks (Spd) above 1x106 peaks/mm.
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Regarding claim 9, Krizen further discloses wherein the textured surface has a texture aspect ratio (Str) above 0.6 (see annotated Table 1 below, wherein 0.978388 is above 0.6)
Regarding claim 10, Krizan further discloses the textured surface has a maximum height value (Sz) below 40 µm (see annotated Table 1 below, wherein 12. 2927 µm is below 40 µm)
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Regarding claim 15, Krizan further discloses a medical device (¶0004, wherein “syringe” corresponds to a medical device) comprising: the biocompatible polymeric material according to claim 1 (see rejection of claim 1)
Regarding claim 16, Krizan further discloses wherein an outer surface of the medical device comprises the textured surface (¶0073, wherein the entire surface of 11 comprises the textured surface therefore the outer surface also comprises the texture)
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Regarding claim 17, Krizan further discloses an entire surface of the medical device comprises the textured surface (¶0073, wherein the entire surface of 11 comprises the textured surface therefore the outer surface also comprises the texture)
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) 11 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/118983 (Krizan) in view of US 2005/0178522 (Kurokawa)
Regarding claim 11, Krizan discloses a microstructured template (see rejection of claim 1) but doesn't explicitly teach or disclose a sintered ceramic material
Kurokawa discloses wherein the microstructured template material comprises a sintered ceramic material (¶0140, wherein “tricalcium phosphate” corresponds to a ceramic material, please note “sintered” is being treated as a product-by-process limitation per MPEP 2113 and therefore does not limit the claim)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the micro structured template of Krizan with a ceramic material, as taught by Kurokawa, in order to increase the strength of the mold (¶0140)
Regarding claim 19, Krizan disclose a template (see rejection of claim 1) but doesn't explicitly teach or disclose wherein the sintered ceramic material comprises tricalcium phosphate.
Kurokawa discloses wherein the sintered ceramic material comprises tricalcium phosphate (¶0140, wherein “tricalcium phosphate” corresponds to a ceramic material, please note “sintered” is being treated as a product-by-process limitation per 2113 and therefore does not limit the claim)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the microstructured template of Krizan with tricalcium phosphate, as taught by Kurokawa, in order to increase the strength of the mold (¶0140)
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/118983 (Krizan) in view of WO 2009/006608 (Nunez)
Regarding claim 18, Krizan discloses a medical device (see rejection of claim 15) but doesn't explicitly teach or disclose wherein the medical device is one of a breast implant for a human, a cardiac or cardiovascular implant, a surgical mesh, a neurostimulation lead, an ophthalmic implant, a urological implant, a drug delivery film, and a biosensor.
Nunez discloses a medical device comprising: at least one of a a breast implant for a human, a cardiac or cardiovascular implant (¶0003, wherein a “stent’ corresponds to a cardiovascular implant), a surgical mesh, a neurostimulation lead, an ophthalmic implant, a urological implant, a drug delivery film, and a biosensor.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the medical device of Krizan to be a cardiovascular implant, as taught by Nunez, in order to prevent or limit endothelialization and/or reduce a risk of thrombosis and/or embolism.
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 1-8, 11 and 15-19 rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. US 11,890,394 (Davidson) in view of US 11,110,066 (Ollenrenshaw)
Regarding claims 1-8, 11, and 15-19, the claims at issue are not identical, they are not patentably distinct from each other. The patented claims fully encompass the instant claims except that the instant claims recite “a biocompatible polymeric material” in the preamble rather than the “medical implant” of Davidson.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the medical implant of Davidsion to include a biocompatible polymeric material, as taught by Ollenrenshaw (Claim 1, see also Col. 3, Lines 32-34, wherein biocompatible polymers are included, see MPEP 804), in order to avoid adversely affecting the cells or tissues in the area where it is implanted (Col. 3, Lines 26-30)
Claims of Instant Application 18/546,287
Claims of US 11,890,394 (Davidson) in view of US 11,110,066 (Ollenrenshaw)
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Conclusion
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774