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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 15/939981, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 15/939981 fails to provide support for “magnesium phosphate” in claim 2 and the limitations of claims 3-5, 16 and 17. Therefore, the present application will be examined as having an effective filing date of 07/24/2020 as support for such limitations is provided in Application No. 16/937974.
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.
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.
Claim(s) 2, 3 and 6-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al., U.S. PG-Pub 2018/0280589 in view of Diaz et al. U.S. PG-Pub 2019/0125420.
Regarding claim 2, Morris et al. discloses a method of manufacturing a bone-implantable device, the method comprising: providing an uncured osteostimulative material into a desired shaped of a body (100) of the bone-implantable device, wherein the osteostimulative material comprises KH2PO4 in an amount between 20-70 dry weight percent, MgO in an amount between 10-50 dry weight percent, and a calcium containing compound; and curing the osteostimulative material into the desired shape of the body of the bone-implantable device (Figs. 1-8 and paragraphs [0039, [0066], [0067]).
Morris et al. does not disclose the osteostimulative material having magnesium phosphate.
Diaz et al. discloses a bone-implantable device having magnesium phosphate as such further allows the implantable device to be absorbed in-vivo and absorb faster into the body (paragraph ]0021]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the osteostimulative material of Morris et al. to include magnesium phosphate in view of Diaz et al. to further permit the bone-implantable device to be absorbed in-vivo and absorb faster into the body of a patient.
Regarding claim 3, Morris et al. discloses wherein the osteostimulative material further comprises a bioactive therapeutic agent (paragraph [0035]).
Regarding claim 6, Morris et al. discloses wherein the body (100) includes an interior cavity (110) and one or more openings (112) connecting the interior cavity to an exterior surface, wherein at least a portion of the interior cavity and at least a portion of the one or more openings includes the osteostimulative material (106) (Figs. 3-6).
Regarding claims 7-9, Morris et al. wherein the body (100) includes a plurality of grooves (108 or threads of portion 118), and wherein the osteostimulative material (106) is positioned in one or more of the plurality of grooves (Figs. 1-4); wherein the bone-implantable device comprises a bone screw including a head portion (116), and wherein the plurality of grooves (118) comprises a threaded portion (118) of the bone screw (Figs. 1-2); and wherein the bone-implantable device comprises an inter-vertebrate implant, wherein the plurality of grooves (108) comprises a top grooved surface (120) and a bottom grooved surface (122) of the inter-vertebrate implant, and wherein at least a portion of each of the top grooved surface and the bottom grooved surface includes the osteostimulative material (106) (Figs. 3-4 and paragraph [0033]).
Regarding claim 10, Morris et al. discloses wherein the bone-implantable device comprises a joint implant including a stationary component (124) coupled to a rotatable elongated member (126), and wherein at least a portion of an exterior surface of the stationary component and at least a portion of the rotatable elongated member includes the osteostimulative material (106) (Figs. 7-8).
Regarding claims 11 and 12, Morris et al. discloses wherein the body (100) includes titanium, polyetheretherketone (PEEK), polyurethane or bone; and wherein an entirety of the body comprises the osteostimulative material (paragraphs [0030]-[0031].
Regarding claim 13, Morris et al. discloses wherein an exterior surface of the body (100) includes a plurality of pores (114), and wherein the osteostimulative material is positioned in one or more of the plurality of pores (Figs. 1-2 and paragraph [0032]).
Regarding claims 14 and 15, Morris et al. discloses wherein the osteostimulative material (106) is osteoconductive and osteoinductive (paragraph [0030]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al., U.S. PG-Pub 2018/0280589 in view of Diaz et al. U.S. PG-Pub 2019/0125420 as applied to claim 3 above, and further in view of Sardesai, U.S. PG-Pub 2013/0304032.
Regarding claim 4, Morris et al. discloses the invention essentially as claimed except for wherein the bioactive therapeutic agent comprises one of one of amikacin, butirosin, dideoxykanamycin, fortimycin, gentamycin, kanamycin, lividomycin, neomycin, netilmicin, ribostamycin, sagamycin, seldomycin and epimers thereof, sisomycin, sorbistin, spectinomycin and tobramycin.
Sardesai discloses a bone implantable device having a bioactive therapeutic agent of neomycin or tobramycin as such help promote healing or treatment of a disease condition (paragraph [0011]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bioactive therapeutic agent of Morris et al. to include one of neomycin and tobramycin further in view of Sardesai to permit helping promote healing and treatment of a disease condition.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al., U.S. PG-Pub 2018/0280589 in view of Diaz et al. U.S. PG-Pub 2019/0125420 as applied to claim 2 above, and further in view of Meredith, U.S. PG-Pub 2014/0172028.
Regarding claim 5, Morris et al. discloses wherein the osteostimulative material further comprises a sugar (paragraph [0039]).
Morris et al. does not disclose the sugar comprising one of sugar alcohols, sugar acids, amino sugars, sugar polymers glycosaminoglycans, glycolipids, sugar substitutes and combinations thereof.
Meredith discloses a bone implantable device having sugar alcohol (paragraph [0017]) as such can improve the hydrophilicity or wettability of the device and ensure that the appearance of the surface of the device is maintained during storage (paragraph [0013]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sugar of Morris et al. to comprise sugar alcohol further in view of Meredith to permit improving the hydrophilicity or wettability of the device and ensure that the appearance of the surface of the device is maintained during storage.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al., U.S. PG-Pub 2018/0280589 in view of Diaz et al. U.S. PG-Pub 2019/0125420 as applied to claim 2 above, and further in view of Preiss-Bloom et al., U.S. PG-Pub 2017/0246356.
Regarding claims 16 and 17, Morris et al. discloses the invention essentially as claimed except for injection molding the uncured osteostimulative material into the desired shape or performing an additive-manufacturing process with the uncured osteostimulative material into the desired shape.
Preiss-Bloom et al. discloses forming a bone implantable by injection molding or additive-manufacturing (3-D printing) as such permit homogeneity of material throughout the implant (paragraph [0018]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the body of Morris et al. by injection molding or additive-manufacturing further in view of Preiss-Bloom to permit homogeneity of material throughout the implant.
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.
Claim 2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 10,722,280 in view of Diaz et al., U.S. PG-Pub 2019/0125420.
Claim 13 of U.S. Patent No. 10,722,280 recites the claimed invention except for the osteostimulative material comprising magnesium phosphate.
Diaz et al. discloses a bone-implantable device having magnesium phosphate as such further allows the implantable device to be absorbed in-vivo and absorb faster into the body (paragraph ]0021]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the osteostimulative material of claim 13 of U.S. Patent No. 10,722,280 to include magnesium phosphate in view of Diaz et al. to further permit the bone-implantable device to be absorbed in-vivo and absorb faster into the body of a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571) 272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
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