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 .
REJECTIONS WITHDRAWN
There are no rejections withdrawn.
REJECTIONS REPEATED
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 14-33 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,779,716 in view of Jinks et al. (US 2017/0152396).
Claims 1-13 of U.S. Patent No. 11,779,716 recite a coated component for a medicinal delivery device comprising a component; a base layer comprising a polysulphone, wherein the base layer is intermediate the component and a fluorine-containing coating.
Claims 1-13 of U.S. Patent No. 11,779,716 do not recite wherein the fluorine-containing coating comprises two layers, a first polyfluoropolyether-containing layer comprising polyfluoropolyether silane entities of the following Formula Ib which shares at least one covalent bond with a second non-fluorinated layer comprising entities of the following Formula IIb.
Jinks discloses wherein the fluorine-containing coating comprises two layers, a first polyfluoropolyether-containing layer comprising polyfluoropolyether silane entities of the following Formula Ib which shares at least one covalent bond with a second non-fluorinated layer comprising entities of the following Formula IIb in a dose inhaler for the purpose of providing improved surface properties (paragraphs [0003], [0007], [0017-0063], [0070-0071], [0077-0084], [0172], [0180], [0194], [0199-0205]).
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided wherein the fluorine-containing coating comprises two layers, a first polyfluoropolyether-containing layer comprising polyfluoropolyether silane entities of the following Formula Ib which shares at least one covalent bond with a second non-fluorinated layer comprising entities of the following Formula IIb in claims 1-13 of U.S. Patent No. 11,779,716 in order to provide improved surface properties as taught or suggested by Jinks.
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) 14-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Britto (US 6,149,892, cited by applicant) in view of Jinks et al. (US 2017/0152396).
Britto discloses a coated component for a medicinal delivery device comprising a component; a base layer comprising a polysulphone, wherein the base layer is intermediate the component and a fluorine-containing coating (column 1, lines 10-20, column 1, lines 59-67, column 4, lines 20-61, column 5, lines 54-61).
Britto does not recite wherein the fluorine-containing coating comprises two layers, a first polyfluoropolyether-containing layer comprising polyfluoropolyether silane entities of the following Formula Ib which shares at least one covalent bond with a second non-fluorinated layer comprising entities of the following Formula IIb.
Jinks discloses wherein the fluorine-containing coating comprises two layers, a first polyfluoropolyether-containing layer comprising polyfluoropolyether silane entities of the following Formula Ib which shares at least one covalent bond with a second non-fluorinated layer comprising entities of the following Formula IIb in a dose inhaler for the purpose of providing improved surface properties (paragraphs [0003], [0007], [0017-0063], [0070-0071], [0077-0084], [0172], [0180], [0194], [0199-0205]).
Therefore it would have been obvious to one of ordinary skill in the art at the time applicant’s invention was made to have provided wherein the fluorine-containing coating comprises two layers, a first polyfluoropolyether-containing layer comprising polyfluoropolyether silane entities of the following Formula Ib which shares at least one covalent bond with a second non-fluorinated layer comprising entities of the following Formula IIb in Britto in order to provide improved surface properties as taught or suggested by Jinks.
Britto discloses claims 20, 24, 27, 30 (column 1, lines 10-20, column 1, lines 59-67, column 4, lines 20-61, column 5, lines 54-61).
Jinks discloses claims 15-29, 21-23, 25-26, 28-29 and 31-33.
NEW REJECTIONS
There are no new rejections.
ANSWERS TO APPLICANT’S ARGUMENTS
Applicant’s arguments of 12/23/25 have been carefully considered but are deemed unpersuasive. Applicant’s desire to hold the double patenting rejection in abeyance is acknowledged.
Applicant argues, “Applicant respectfully submits that a person of ordinary skill in the art would neither have been motivated to combine Britto and Jinks in the manner asserted by the Examiner nor would have had a reasonable expectation of success in doing SO. Accordingly, a prima facie case of obviousness has not been established for claims 14-33.
In the Non-Final Office Action, the Examiner asserts that Britto teaches or suggests a base layer that includes a polysulphone and a fluorine-containing coating for application to a medical device component. The Examiner further asserts that Jinks teaches or suggests a coating that includes a first silane- and polyfluoropolyether-containing, layer of Formula Ib and a second non-fluorinated layer of Formula Ilb. The Examiner concludes that a person of ordinary skill in the art would have been motivated to substitute fluorine-containing coating layer of Britto with the two-layer coating system of Jinks to provide improved surface properties as taught by Jinks. Applicant respectfully disagrees.
First, in view of Britto, a person of ordinary skill in the art would not have been
motivated to substitute the fluorine-containing polymers expressly disclosed in Britto with the two-layer coating system of Jinks. Britto specifically identifies the fluorine-containing polymers suitable for use in its invention, stating:
‘Fluorocarbon polymers for use in the invention include fluorocarbon polymers which are made of multiples of one or more of the following monomeric units: tetrafluoroethylene (TFE; which is used to prepare polytetrafluoroethylene (PTFE)), per fluorinated ethylene propylene (FEP; which is perfluorinated ethylene propylene copolymer, which is a copolymer of TFE and hexafluoropropylene (HFP)), (PFA; which is a perfluoroalkoxy fluorocarbon polymer which is prepared using a perfluoroalkyl vinyl ether monomer), ethylene tetrafluoroethylene (ETFE; ethylene-tetrafluoroethylene copolymer), vinylidene fluoride (PVDF; polyvinylidene fluoride), and chlorinated ethylene tetrafluoroethylene (a copolymer made by copolymerizing chlorinated ethylene and tetrafluoroethylene) (Emphasis added; Britto col. 4, lines 22 to 36).’
Because Britto explicitly identifies the fluorocarbon polymers for the fluorine-containing layer "for use in the invention" of Britto, a person of ordinary skill in the art would not have been motivated to substitute these polymers with a materially different coating system, let alone the two-layer system of Jinks. Furthermore, a person of ordinary skill in the art would not have been motivated to substitute the fluorine-containing polymers of Britto with those of Jinks because the polymers are of fundamentally different chemical types. Britto's fluorine-containing layer includes
fluorocarbon polymers. In contrast, the fluorine-containing polymers of Formula Ib in Jinks are not fluorocarbon polymers, as they include silane functionalities and ether linkages, chemical features absent from the fluorocarbon polymers of Britto.”
However, there is no specific teaching in Britto that other materials can’t be used. In fact, Britto discloses that the fluorinated polymer can be blended with other polymers (column 4, lines 39-46). Furthermore, Britto discloses the use of perfluoroalkyl vinyl ethers (column 4, lines 22-39) and Jinks discloses the use of perfluoroalkyl vinyl ethers (paragraphs [0035-0036]).
Applicant argues, “Second, the Examiner has failed to provide a factual basis establishing that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the polysulphone polymer of Britto with the two-layer coating system of Jinks in the claimed manner. The Non-Final Office Action merely states, in conclusory fashion, that it would have been obvious to substitute the fluorine-containing polymer of Britto with the two-layer coating system of Jinks, without explaining why a person of ordinary skill in the art would expect that such a substitution would yield predictable results.”
Predictable results would be expected because Britto discloses the use of perfluoroalkyl vinyl ethers (column 4, lines 22-39) and Jinks discloses the use of perfluoroalkyl vinyl ethers (paragraphs [0035-0036]) and Jinks provides improved surface properties (paragraph [0007]).
Applicant argues, “Third, in view of Britto and Jinks, a person of ordinary skill in the art would not have had a reasonable expectation of success in substituting the fluorine-containing polymer of Britto with the two-layer coating system of Jinks for use with the polysulfone polymer of Britto. As discussed above, the fluorine-containing polymers disclosed in Britto and Jinks are chemically distinct. In addition, the coating of Jinks includes non-fluorinated layer containing functional groups, such as silicon-containing groups, that are neither disclosed nor suggested in Britto. Accordingly, a person or ordinary skill in the art would not have had a reasonable expectation that the combination of the polysulfone of Britto with the two layer coating system of Jinks would result in a useable medical component coating, much less yield a coating with desirable properties.”
There is an expectation of success because Britto discloses the use of perfluoroalkyl vinyl ethers (column 4, lines 22-39) and Jinks discloses the use of perfluoroalkyl vinyl ethers (paragraphs [0035-0036]) and Jinks provides improved surface properties (paragraph [0007]). Furthermore, there is no direct teaching in Britto away from the inclusion of additional layers or the use of perfluoroalkyl vinyl ethers with moieties containing silicone.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL C MIGGINS whose telephone number is (571)272-1494. The examiner can normally be reached Monday-Friday, 1-9 pm EST.
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/MICHAEL C MIGGINS/Primary Examiner, Art Unit 1782
MCM
February 5, 2026