Detailed Office Action
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
2. 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.
3. Claims 1-15 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.
Firstly, with respect to claim 1, it is unclear if the definition of C1 mandates that the diamine contain at least one sterically hindered secondary amine group; as drafted, the language can be reasonably interpreted to apply only to the amino alcohol. Furthermore, with respect to the definition of C1, the language, “each of the diamine” cannot be clearly understood; the language appears to be incomplete.
Secondly, with respect to claim 6, since formula (II) pertains to the diamine and since the diamine is bonded through reaction with isocyanate groups, it is not seen how the specified linkage can be a urethane group. Furthermore, with respect to the definition of R2, it is unclear what constitutes “bulky” in terms of the structural requirements of the residues.
Thirdly, with respect to claim 10, since claim 9 requires at least one of the C2 residues to comprise an ester linkage, the claiming of the non-ester-containing compound, butanediol, within claim 10, dependent from claim 9, is unclear.
Lastly, the method of claims 12-15, as drafted, renders the claims indefinite, because the method of claim 12 does not contain a definitive process step; “using” does not constitute a definitive operation step. Accordingly, claims 12-15 have not been further examined on the merits.
Double Patenting
4. 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.
5. Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-23 of copending Application No. 18/274,707 (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 the thermoplastic poly(urethane-urea) polyadduct would have been obvious in view of the copending method of using the equivalent (same) thermoplastic poly(urethane-urea) polyadduct. One is possession of the method would have been in possession of the polyadduct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Prior Art Rejections
6. 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.
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.
6. Claims 1-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over CA 2,040,910.
CA 2,040,910 discloses thermoplastic poly(urethane-urea) comprising the reaction product of diisocyanatodicyclohexylmethane, yielding applicants’ claimed I residue; a macrodiol having a molecular weight greater than 400, which corresponds to applicants’ claimed diol, yielding applicants’ M residue; a low molecular weight diol, yielding applicants’ claimed C2 residue; and a cyclic secondary diamine, yielding applicants’ claimed C1 residue. See page 3, line 21 through page 6, line 21. Though the reference fails to disclose structures that are precisely represented by applicants’ claimed formulas (I) and (IV), the disclosed thermoplastic polymers encompass such formulas and would have been obvious depending on the desired block structure and the desired hard and soft segment content. Since the functions of the respective reactants and their resulting residues ware known at the time of invention, tailoring the structure of the polymer would have been obvious. Furthermore, regarding claims 6-8, though these claims exclude the secondary diamine from having a piperazine, 2-methylpiperazine, or 2,5-dimethylpiperazine structure, it is noted that the reference allows for the use of other secondary amines, and the position is taken that it would have been obvious to use disclosed diamines having higher alkyl groups to tailor such properties as the steric hindrance or another chemical or physical property of the diamine.
7. Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over CA 2,040,910 in view of WO 2005/089778 A1.
CA 2,040,910 discloses thermoplastic poly(urethane-urea) comprising the reaction product of diisocyanatodicyclohexylmethane, yielding applicants’ claimed I residue; a macrodiol having a molecular weight greater than 400, which corresponds to applicants’ claimed diol, yielding applicants’ M residue; a low molecular weight diol, yielding applicants’ claimed C2 residue; and a cyclic secondary diamine, yielding applicants’ claimed C1 residue. See page 3, line 21 through page 6, line 21. Though the reference fails to disclose structures that are precisely represented by applicants’ claimed formulas (I) and (IV), the disclosed thermoplastic polymers encompass such formulas and would have been obvious depending on the desired block structure and the desired hard and soft segment content. Since the functions of the respective reactants and their resulting residues ware known at the time of invention, tailoring the structure of the polymer would have been obvious. Furthermore, regarding claims 6-8, though these claims exclude the secondary diamine from having a piperazine, 2-methylpiperazine, or 2,5-dimethylpiperazine structure, it is noted that the reference allows for the use of other secondary amines, and the position is taken that it would have been obvious to use disclosed diamines having higher alkyl groups to tailor such properties as the steric hindrance or another chemical or physical property of the diamine.
8. The primary reference fails to disclose the use of ester-containing diisocyanates and chain extenders; however, the use of these reactants within biocompatible and degradable thermoplastic polyurethanes was known at the time of invention as evidenced by the disclosure within pages 11-14 of WO 2005/089778 A1. Accordingly, one seeking to improve the degradability of the polymers of the primary reference would have been motivated to incorporate the disclosed ester-containing reactants of the secondary reference into the polymers of the primary reference. It has been held that it is prima facie obvious to use a known compound for its known function.
Conclusion
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rabon A Sergent whose telephone number is (571)272-1079. The examiner can normally be reached on Monday through Friday from 9:00 AM until 5:00 PM, ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heidi Riviere Kelley, can be reached at telephone number 571-270-1831. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RABON A SERGENT/Primary Examiner, Art Unit 1765