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 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) 50,52-54,56-58 are rejected under 35 U.S.C. 103 as being unpatentable over Deslauriers et al. (8337497) in view of Bezwada et al. (2016/0250374). Deslauriers et al. disclose (col. 10, lines 49-65) a homogenous putty composition (HPC), such that a composition can comprise:20-30 wt % of a polyurethane or polyurethane urea copolymer, see col. 5, lines 37-40. It is also noted that Deslauriers et al. also teach (col. 5, lines 40,41) that an additive be included with the mixture in an amount that can be 10%. However, Deslauriers et al. did not state the composition has 60-75 wt % of two or more particulate materials, the two or more particulate materials are selected from β-tricalcium phosphate (β- TCP), hydroxyapatite (HA), and hydroxyapatite/beta tricalcium phosphate, and wherein the one or more additive components are selected from calcium stearate, triacetin, tocopheryl acetate, and triethanolamine. Bezwada et al. teach that a polyurethane putty include 60-75 wt % of two or more particulate materials, see paragraph 16. Bezwada et al. also teach (paragraph 119) the particulate can be a hydroxyapatite (HA) or hydroxyapatite/beta tricalcium phosphate. Bezwada et al. also teach (paragraph 105) the additive can be triethanolamine at an amount of 10%. It would have been obvious to one of ordinary skill in the art to select particulates such as hydroxyapatite (HA) or hydroxyapatite/beta tricalcium phosphate to include in an amount of 60-75 wt% and also the additive of triethanolamine at an amount of 10% as taught by Bezwada et al. in the polyurethane putty of Deslauriers et al. such that the appropriate hardening or solid form is achieved when placed in the body, see paragraph 114 of Bezwada as finding optimal setting capability only involves routine skill in the art.
Regarding claim(s) 52,57,58 Deslauriers et al. did not disclose the incorporation of an antibiotic or local anesthetic. Bezwada et al. teach (paragraphs 123,145) the incorporation of an antibiotic with the polyurethane putty and it can be one of gentamicin, clindamycin, erythromycin, ampicillin, cephalosporin. It would have been obvious to one of ordinary skill in the art to utilize an antibiotic including one of gentamicin, clindamycin, erythromycin, ampicillin, cephalosporin as taught by Bezwada et al. in the polyurethane composition of Deslauriers et al. such that it prevents infection. Further, Bezwada et al. teach (paragraphs 124,146) the incorporation of a local anesthetic with the polyurethane putty and it can be one of lidocaine, bupivacaine, tetracaine, ropivacaine. It also would have been obvious to one of ordinary skill in the art to utilize a local anesthetic including one of lidocaine, bupivacaine, tetracaine, ropivacaine as taught by Bezwada et al. in the polyurethane composition of Deslauriers et al. such that it prevents any pain at the site of placement. With respect to claim 53, Deslauriers did not disclose the HPC is fully or partially biodegradable, bioabsorbable under physiological conditions, or both fully or partially biodegradable and bioabsorbable under physiological conditions. Bezwada et al. teach (paragraphs 31,41) the HPC is fully or partially biodegradable, bioabsorbable under physiological conditions, or both fully or partially biodegradable and bioabsorbable under physiological conditions. It would have been obvious to one of ordinary skill in the art to provide the HPC to be fully or partially biodegradable, bioabsorbable under physiological conditions, or both fully or partially biodegradable and bioabsorbable under physiological conditions as taught by Bezwada et al. with the composition of Deslauriers et al. such that it allows natural tissue to replace the implantable material. Regarding claim 54, Deslauriers did not disclose the two or more particulate materials comprises β-tricalcium phosphate (β-TCP) and hydroxyapatite/beta tricalcium phosphate. Bezwada et al. teach (paragraph 119, see Table 1) the two or more particulate materials comprises β-tricalcium phosphate (β-TCP) and hydroxyapatite/beta tricalcium phosphate. It would have been obvious to one of ordinary skill in the art to select particulates and use two or more particulate materials such as β-tricalcium phosphate (β-TCP) and hydroxyapatite/beta tricalcium phosphate as taught by Bezwada with the composition of Deslauriers such that it has the suitable properties for support of the bone and similar to its makeup. With respect to claim 56, Deslauriers did not disclose one or more additive materials comprises a colorant. Bezwada et al. teach (paragraphs 16,149) a colorant can be used as an additive. It would have been obvious to one of ordinary skill in the art to utilize a colorant as the additive taught by Bezwada et al. in the composition of Deslauriers et al. such that it assists the surgeon in accuracy of the application of the putty.
Claim(s) 51 is rejected under 35 U.S.C. 103 as being unpatentable over Deslauriers et al. (8337497) in view of Bezwada et al. (2016/0250374) as applied to claim 50 above, and further in view of Thagard et al. (WO 96/12619). Deslauriers et al. as modified by Bezwada et al. is explained supra. It is noted Bezwada teaches hardness or curing of the putty is evaluated, similar to Deslauriers in wanting a hardening putty. However, Deslauriers et al. in view of Bezwada et al. did not state the HPC exhibits a stiffness in a range of about 4-6 millimeters for at least about 2 minutes after its formation when subjected to a penetrometer test using a force of about 50 grams applied for about 5 seconds. Please note stiffness is a property of the material and properties of a chemical composition cannot be separated from their inherent characteristics. Thus, since the chemical composition has been addressed by the combined teachings, it must inherently possess the stiffness as claimed. Further Thagard et al. teach (page 7, lines 9-19) that one can use a penetrometer to test for stiffness of a composition. Thus, it would have been obvious to one of ordinary skill in the art to use provide an HPC with a stiffness in the range of 4-6mm for at least two minutes when tested with a penetrometer as taught by Thagard with the composition of Deslauriers as modified with Bezwada since such an evaluation only involves routine skill in the art. Further if the same material is shown in the prior art it must possess the same properties as claimed. Use of the appropriate force only involves routine skill in the art, thus one is fully capable of using 50 grams for about 5 seconds. Note the claim is a product claim and recites an inherent property, it is not a method claim, thus the claim does not necessarily require any testing.
Claim(s) 59 is rejected under 35 U.S.C. 103 as being unpatentable over Pandya (2017/0238985) in view of Deslauriers et al. (8337497) and Bezwada et al. (2016/0250374). Pandya disclose a method for stabilizing a surgical screw, paragraph 47. Pandya further disclose (paragraph 68) providing a first reactive putty and a second reactive putty, the first reactive putty and the second reactive putty are capable of being intraoperatively mixed to form a homogenous putty composition (HPC) that is capable of filling a drilled or tapped hole for the surgical screw to be inserted into, see for example paragraph 67. However, Pandya did not disclose the HPC comprises 20-30 wt % of a polyurethane or polyurethane urea copolymer, 60-75 wt % of two or more particulate materials, and 4-10 wt % of one or more additive materials, wherein the two or more particulate materials are selected from 3-tricalcium phosphate (P- TCP), hydroxyapatite (HA), and hydroxyapatite/beta tricalcium phosphate, and wherein the one or more additive components are selected from calcium stearate, triacetin, tocopheryl acetate, and triethanolamine. Deslauriers et al. teach (col. 5, lines 37-40) an HPC can be provided with 20-30 wt % of a polyurethane or polyurethane urea copolymer. It is also noted that Deslauriers et al. also teach (col. 5, lines 40,41) that an additive be included with the mixture in an amount that can be 10%. It would have been obvious to one of ordinary skill in the art to utilize an HPC having 20-30 wt % of a polyurethane or polyurethane urea copolymer and also an additive be included with the mixture in an amount that can be 10% as taught by Deslauriers et al. in the method of securing a surgical screw by Pandya such that it improves securing of components implanted, see col. 2, lines 12,21, 51,52. Bezwada et al. teach that a polyurethane putty include 60-75 wt % of two or more particulate materials, see paragraph 16. Bezwada et al. also teach (paragraph 119) the particulate can be a hydroxyapatite (HA) or hydroxyapatite/beta tricalcium phosphate. Bezwada et al. also teach (paragraph 105) the additive can be triethanolamine at an amount of 10%. It would have been obvious to one of ordinary skill in the art to select particulates such as hydroxyapatite (HA) or hydroxyapatite/beta tricalcium phosphate to include in an amount of 60-75 wt% and also the additive of triethanolamine at an amount of 10% as taught by Bezwada et al. in the method of securing a surgical screw of Pandya as modified with Deslauriers et al. such that the appropriate hardening or solid form is achieved when placed in the body, see paragraph 114 of Bezwada as finding optimal setting capability only involves routine skill in the art.
Claim(s) 60 is rejected under 35 U.S.C. 103 as being unpatentable over Pandya (2017/0238985) in view of Deslauriers et al. (8337497) in view of Bezwada et al. (2016/0250374) as applied to claim 59 above, and further in view of Thagard et al. (WO 96/12619). Pandya in view of Deslauriers et al. as modified by Bezwada et al. is explained supra. It is noted Bezwada teaches hardness or curing of the putty is evaluated, similar to Deslauriers in wanting a hardening putty. However, Pandya in view of Deslauriers et al. in view of Bezwada et al. did not state the HPC exhibits a stiffness in a range of about 4-6 millimeters for at least about 2 minutes after its formation when subjected to a penetrometer test using a force of about 50 grams applied for about 5 seconds. Please note stiffness is a property of the material and properties of a chemical composition cannot be separated from their inherent characteristics. Thus, since the chemical composition has been addressed by the combined teachings, it must inherently possess the stiffness as claimed. Further Thagard et al. teach (page 7, lines 9-19) that one can use a penetrometer to test for stiffness of a composition. Thus, it would have been obvious to one of ordinary skill in the art to use provide an HPC with a stiffness in the range of 4-6mm for at least two minutes when tested with a penetrometer as taught by Thagard with the use of a putty by Pandya and in view of Deslauriers as modified with Bezwada since such an evaluation only involves routine skill in the art. Further if the same material is shown in the prior art it must possess the same properties as claimed. Use of the appropriate force only involves routine skill in the art, thus one is fully capable of using 50 grams for about 5 seconds. Note the claim is a method of use claim and recites an inherent property, it is not a method of testing claim, thus the claim does not necessarily require any testing.
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 59,60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,048,775. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claim (s) are merely broader in scope. Patent claim 1 of US ‘775 recites the same method with more specificity. Narrower claims anticipate the broader, see In re Goodman. Regarding claim 60, see claim 1 of US ‘775.
Allowable Subject Matter
Claim 55 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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