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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The abstract of the disclosure is objected to because it is unclear if the definition of C1 mandates that the diamine contain at least one sterically hindered secondary amine group; the current language could be reasonably interpreted to apply only to the amino alcohol or to both the amino alcohol and the diamine. 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).
The disclosure is objected to because of the following informalities:
(Page 21, line 9) “each R2 is independently selected form monovalent, bulky, saturated or unsaturated, aliphatic or alicyclic radicals with 1 to 10 carbon atoms” contains a typographical error.
(Page 21, line 12) “R1 is selected form C1-C10-alkylene and C4-C10-cycloalkylene radicals” contains a typographical error.
(Page 21, line 13) “each R2 is independently selected form 1,1-dimethyl-substituted, saturated or unsaturated C1-C6-alkyl radicals and 1-methyl-substituted C3-C6-cycloalkyl radicals” contains a typographical error.
(Page 21, line 15) “and in particular form radicals of Formula (II)” contains a typographical error.
Appropriate correction is required.
Claim Objections
Claim 20 is objected to because of the following informalities: “R1 is selected form bivalent” contains a typographical error. 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.
Claims 16-30 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.
Regarding claim 16, it is unclear if the definition of C1 mandates that the diamine contain at least one sterically hindered secondary amine group; the current language could be reasonably interpreted to apply only to the amino alcohol or to both the amino alcohol and the diamine. For examination purposes, this limitation has been interpreted to apply to both the diamine and the amino alcohol. Dependent claims 17-30 are similarly rejected by their dependence on indefinite claim 16.
Additionally regarding claim 26, the definition of "each of the diamine" is also not clearly understood. Dependent claims 17-30 are similarly rejected by their dependence on indefinite claim 16.
Regarding claim 20, Formula (II) pertains to the diamine bonded through reaction with isocyanate groups. As such, it is not clear how the specific linkage could be a urethane group. Dependent claim 21 is similarly rejected by its dependence on indefinite claim 20.
Additionally regarding claim 20, with respect to the definition of R2 in claim 20, it is unclear what constitutes “bulky” in terms of structural requirement. Dependent claim 21 is similarly rejected by its dependence on indefinite claim 20.
Regarding claim 21, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 21 recites the broad recitation “C1-C10-alkylene”, and the claim also recites “C4-C10-cycloalkylene radicals”, “C2-C6-alkylene”, and “C5-C6-cycloalkylene radicals” which are narrower statements of the preceding ranges/limitations. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, these ranges have been interpreted as exemplary embodiments and therefore are not required.
Regarding claim 25, it is unclear if “a solution of the TPUU of Formula (I) in hexafluoroisopropanol” is the same solution as the solution recited in claim 24 or a new, secondary solution. For examination purposes, these have been interpreted to be the same solution.
Additionally, the method of claim 25 is indefinite as “using” does not constitute a definitive process step.
Regarding claim 26, it is unclear if “a solution of a mixture of the TPUU of Formula (I)” is the same solution as the solution recited in claim 24 or a new, secondary solution. For examination purposes, these have been interpreted to be the same solution. Dependent claims 27, 28, and 29 are similarly rejected by their dependence on indefinite claim 26.
Additionally, the method of claim 26 is indefinite as “using” does not constitute a definitive process step. Dependent claims 27, 28, and 29 are similarly rejected by their dependence on indefinite claim 26.
Regarding claim 27, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 27 recites the broad recitation “at least 10% by weight”, and the claim also recites “at least 30% by weight” and “at least 50% by weight” which are narrower statements of the preceding ranges/limitations. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, these ranges have been interpreted as exemplary embodiments and therefore are not required.
Additionally, the method of claim 27 is indefinite as “using” does not constitute a definitive process step.
Regarding claim 28, the method of claim 28 is indefinite as “using” does not constitute a definitive process step. Dependent claim 29 is similarly rejected by its dependence on indefinite claim 28.
Regarding claim 29, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, these have been interpreted as exemplary embodiments and therefore are not required.
Additionally, the method of claim 29 is indefinite as “using” does not constitute a definitive process step.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16-23 and 30, are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 20200108550 A1) in view of Chun et al (US 20170340463 A1).
Regarding claims 16, 18-23, and 30, Chen discloses an additive manufacturing process useful in vascular surgery, including as stents, fibres, or catheters ([0002], [0010], [0302], [0368]). Chen discloses the use of 2-(tert-butylamino)ethyl methacrylate (TBAEMA) which contains a sterically hindered amino group [0255] as well as other diisocyanate derivatives such as toluene diisocyanate (TDI), methylene diphenyl diisocyanate (MDI), hexamethylene diisocyanate (HDI), isophorone diisocyanate (IPDI), hydrogenated MDI (HMDI), para-phenyl diisocyanate (PPDI) [0256], a photoinitiator such as phenylbis(2,4,6-trimethylbenzoyl)phosphine oxide (PPO) [0253], polyols such as polyethers (particularly polytetrahydrofuran [0256]), polypropylene glycols, polyesters, and polycarbonates with a molecular weight of 500-6000 g/mol [0256], and chain extenders such as diols, diamines, triols, triamines, combinations thereof, and others [0255], corresponding to the repeat units I, M, and C2 of formula (I) with n>3 and a and c>1, to prepare thermoplastic poly(urethane-urea) (TPUU) [0257].
Chen does not particularly disclose preparation of said TPUU with an electrospinning process.
In the same field of endeavor, Chun (US 20170340463 A1) discloses bioabsorbable and biodegradable polymers (Abstract), including stents and catheters [0038], including PUU produced by an electrospinning process [0068]. Chun further discloses that electrospinning is a well-established method for producing polymeric micro- and nano-fibers [0068].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the preparation method of Chen with electrospinning as disclosed by Chun with a reasonable expectation of success.
Regarding claim 17, the combination of Chen and Chun discloses all limitations of claim 16. Chen further discloses ester moieties which are thermally cleavable [0225] but does not particularly disclose their cleavage under physiological conditions. However, Chun states that certain poly(urethane urea)s are biocompatible with non-toxic degradation byproducts [0066], which necessitates their cleavage under physiological conditions.
Claims 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (US 20200108550 A1) and Chun (US 20170340463 A1). as applied to claims 16-23 and 30 above, and further in view of Du (WO 2011109712 A2). The discussion with respect to Chen and Chun set forth above is incorporated herein by reference.
Regarding claim 24, Chun discloses an electrospinning process as set forth above but does not particularly disclose the methodology. In the same field of endeavor, Du (WO 2011109712 A2) discloses an electrospinning process for generating a biodegradable scaffold for in vivo use. Particularly, Du discloses electrospinning a polymer-containing solution (such as a poly(ether urethane urea), page 13, lines 12-15) in a reservoir such a needle or pipette tip (syringe) with a metering pump (syringe pump) and a high voltage source, with one electrode placed in electrical contact with the polymer-containing fluid and the other placed in electrical contact with a target, such as rotating mandrel. Following charging and forced ejection, polymer fibers are deposited on the target (page 17, line 26 to page 18, line 18). Du further discloses that electrospinning allows for optimization of the polymer structure for specific applications (page 12, lines 26-32).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the thermoplastic poly(urethane urea) polyadduct disclosed by the combination of Chen and Chun with the electrospinning process disclosed by Du with a reasonable expectation of success, thereby arriving at applicant’s claimed invention.
Regarding claim 25, Du particularly discloses use of hexafluoroisopropanol as solvent and further stated that use of this solvent provided fibers with the best appearance (page 19, lines 15-18). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the thermoplastic poly(urethane urea) polyadduct disclosed by the combination of Chen and Chun with the preferred solvent disclosed by Du with a reasonable expectation of success.
Regarding claim 26, Chen further discloses that the mixture may comprise combinations of a linear thermoplastic polyurethane, polyurea, or copolymer thereof and a cross-linked thermoset polyurethane, polyurea, or copolymer thereof [0257].
Regarding claim 27, Chen does not expressly disclose the claimed weight percentages nor a ratio between the polymers. Nevertheless, the obviousness analysis may “take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). For example, the analysis may “include recourse to logic, judgment, and common sense available to the person of ordinary skill that do not necessarily require explication in any reference or expert opinion.” Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1329 (Fed. Cir. 2009). The Patent Trial and Appeal Board has held that mixing equivalent components in a 1:1 ratio represented no more than application of the “logic, judgment, and common sense available to the person of ordinary skill” in the art. Ex parte Swanzy, Appeal 2017-004875 at 8-9. In this case, Chen discloses “a linear thermoplastic polyurethane, polyurea, or copolymer thereof” and “a cross-linked thermoset polyurethane, polyurea, or copolymer thereof” as equally suitable alternatives to one another and therefore recognizes the equivalence of the two. It would have would have been prima facie obvious, using no more than ordinary creativity, logic, judgment, and common sense, to combine these polymers in equal amounts (i.e. in a 1:1 ratio by weight) based on the fact that both are disclosed in parallel as being equally suitable for use in this capacity. This 1:1 ratio falls within the claimed ratio (1:1 by weight).
Regarding claim 28, the combination of Chen and Chun discloses all claim limitations of claim 26 as set forth above. Chun further discloses polyurethane ureas as biodegradable polymers suitable for stents and catheters [0065] and that certain polyurethane ureas possess good biocompatibility with non-toxic degradation products [0066]. It is prima facie obvious to select a known material based on its suitability for its intended use. See MPEP 2144.07.
Regarding claim 29, Chen particularly discloses polyether urethanes, and particularly those made of polyethers such as polytetrahydrofuran [0256] and diisocyanates such as hexamethylene diisocyanate [0256] in combination with dicarboxylic acid chain extenders [0242].
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 16-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 14-15 of copending Application No. 18/014,081 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claim set, drawn to a method of using the thermoplastic poly(urethane-urea) polyadduct would have been obvious in view of the copending claim set drawn to a method of preparing the equivalent (same) thermoplastic poly(urethane-urea) polyadduct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Hassel (CA 2040910 A1) discloses a thermoplastic poly(urethane-urea) (TPUU) comprising the reaction product of diisocyanatodicyclohexylmethane (I radical), a macrodiol having a molecular weight greater than 400 (M radical), a low molecular weight diol (C2 radical), and a cyclic secondary diamine (C1 radical).
Adhikari (WO 2005089778 A1) discloses a biodegradable TPU/TPUU for use in stents and stent grafts for treatment of coronary heart diseases based on polycaprolactone and HDI as well as a diol-based chain extenders, but not on a component which leads to a sterically hindered urea group.
Tanzi (US 5955560 A) discloses elastomeric, biocompatible materials for use in vascular prostheses as well as the production of PU for use in the stated vascular prostheses, containing a piperazine-based component which does not result in any sterically hindered urea group in a TPUU.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Savannah G Phillips whose telephone number is (571)270-0822. The examiner can normally be reached M-Th 8-6 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Del Sole can be reached at (571)272-1130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SAVANNAH G. PHILLIPS/Examiner, Art Unit 1763
/JOSEPH S DEL SOLE/Supervisory Patent Examiner, Art Unit 1763
Prosecution Insights