CTNF 18/810,922 CTNF 87146 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-fti AIA The present application is being examined under the pre-AIA first to invent provisions. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claim 11 is 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. Claim 11 recites “various extremity locations” and it is unclear what the term “various” adds to such recitation and thus the claim is indefinite. For example, “various” could mean “more than one” or it could mean “different from one another” (i.e., alternative extremity locations), which results in differing claim interpretations. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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 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. 07-20-fti The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made. 07-20-02-fti This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a). 07-21-fti Claim s 1-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yang et al. (US 2010/0075162 A1; published 25 March 2010) in view of Rathenow et al. (US 2005/0079200 A1; published 14 April 2005) and Boyden et al. (US 2010/0262239 A1; published 14 October 2010) . Yang et al. teach an implant consisting of a biodegradable magnesium-based alloy or partially applied with the magnesium-based alloy, and a method for manufacturing the same. The implant is biodegradable, in which its biodegradation rate can be easily controlled, and the implant has excellent strength and interfacial strength to an osseous tissue (abstract). The biodegradable magnesium-based alloy is represented by Formula MgaCabXc wherein X comprises one or more selected from the group consisting of zirconium (Zr), molybdenum (Mo), niobium (Nb), tantalum (Ta), titanium (Ti), strontium (Sr), chromium (Cr), manganese (Mn), zinc (Zn), silicon (Si), phosphorus (P), nickel (Ni) and iron (Fe) wherein a, b, and care a molar ratio of each component, satisfying the following conditions: a.) is 50-100% and b and c are between 0-40% (see claims 1-3 and [0010] of Yang et al.). Impurities may be 45 ppm iron and nickel (see [0050]). The implant is an orthopedic, dental, plastic surgical or vascular implant (see claim 4 of Yang et al.). In the molding step, Yang et al. Teach that a method for molding in the shape of implant can be performed by using a metal processing method known in the related art wherein the implant can have a rod or sheet shape (see [0041]). Regarding the claimed amounts and ratio of magnesium, calcium and strontium, Yang et al. tech that their biodegradable magnesium-based alloy is represented by Formula MgaCabXc wherein X comprises one or more selected from the group consisting of zirconium (Zr), molybdenum (Mo), niobium (Nb), tantalum (Ta), titanium (Ti), strontium (Sr), chromium (Cr), manganese (Mn), zinc (Zn), silicon (Si), phosphorus (P), nickel (Ni) and iron (Fe) wherein a, b, and c are a molar ratio of each component, satisfying the following conditions: a.) is 50-100% and b and c are between 0-40% (see claims 1-3 and [0010] of Yang et al.). Yang et al. teach a biodegradable magnesium-based alloy for use in an implant as instantly claimed. Thus, it would have been obvious to one of ordinary skill in the art at the time of the invention to select any point within the ranges taught by Yang et al. In addition, according to the MPEP, "It is to be presumed also that skilled workers would as a matter of course, if they do not immediately obtain desired results, make certain experiments and adaptations, within the skill of the competent worker." (MPEP 716.07). From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. One difference between the invention of the instant application and that of Yang et al. is that Yang et al. do not expressly teach that the implant is inserted into the spine and the use of an osteogenic growth factor, hormone, nucleic acid sequence or drug. However, Rathenow et al. teach a biocompatibly coated implantable medical device wherein the device is an orthopedic bone prosthesis or joint prosthesis, a bone substitute or a vertebra substitute in the breast or lumbar region of the spine and is loaded with at least one active principle such as drugs or hormones (see claims of Rathenow et al.). A second difference between the invention of the instant application and that of Yang et al. is that Yang et al. do not expressly teach that the implant is a cage, dowel or wedge and that the structure is selected from the group consisting of: cannulated screw for femoral head fixation, fracture fixation screw and plate system for use in various extremity locations, suture anchor, interference screw, surgical clip, and vascular stent. However, Boyden et al. teach an orthopedic implant is described including at least one adjustment mechanism configured for securing to at least one orthopedic structure of a subject, and at least one motor operatively connected to the at least one adjustment mechanism, wherein the at least one motor is configured to move the at least one adjustment mechanism in at least three degrees of freedom (abstract). The at least one motor can include, but is not limited to, at least one of an electronic motor, electrostrictive motor, piezoelectric motor, ultrasonically-activated motor, shape memory alloy actuator ([0007,0049,0050]). The at least one adjustment mechanism including one or more fixation screws such as a cannulated screws, or interference screws ([0039]). In addition, Boyden et al. teach that a plate and screw orthopedic device can be used for anterior cervical spine fusion with a cage device filled with bone allograft ([0052]). The teachings of Yang and Rathenow et al. are directed to implantable medical devices that comprise alloy compositions. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to combine the teachings Yang and Rathenow et al. to arrive at an implant that is inserted into the spine and the use of an osteogenic growth factor, hormone, nucleic acid sequence or drug at the time of the instant invention, with a reasonable expectation of success. Yang et al. teach that the desired corrosion rate of an alloy can be obtained by controlling processes according to extrusion or the like, impurity concentration, and the amount of Ca as an additional element ([0061]). Rathenow et al. teach that coating the surfaces of medical implants in a suitable manner increases the biocompatibility of the materials used and prevents defense and/or rejection reactions ([0007]). Thus, the combination of the references would have been obvious with the expectation of providing coated medical implants which are capable of liberating in a targeted and, if necessary, controlled manner applied pharmacologically effective substances after insertion of the implant into the human body as well as increase the biocompatibility of the materials used (see [0018-0022] of Rathenow et al.) wherein a desired corrosion rate is obtained. The teachings of Yang, Boyden et al. are directed to implantable medical devices that comprise alloy compositions. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to combine the teachings Yang and Boyden et al. to arrive at an implant that is a cage, dowel or wedge and that the structure is selected from the group consisting of: cannulated screw for femoral head fixation, fracture fixation screw and plate system for use in various extremity locations, suture anchor, interference screw, surgical clip, and vascular stent, with a reasonable expectation of success. Boyden et al. teach that the use of alloys, cannulated screws, interference screws and cage devices in the orthopedic implant art was known at the time the instant invention was made. Thus, the combination of the references would have been obvious with the expectation of providing an implant for use in various extremity locations and low corrosion rate of the alloy. In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a) . Double Patenting 08-33 AIA 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 1-2 and 4-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-14 of U.S. Patent No. 9,629,873. Although the claims at issue are not identical, they are not patentably distinct from each other because the concentrations overlap and the instant claims merely additionally recite impurity and the properties are inherent. Citation of Pertinent Prior Art 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Fischer (U.S. Patent No. 2,073,515; issued 09 March 1937) discloses an alloy wherein about 0.5 to 4.5 percent of alkaline earth metals calcium, barium, and/or strontium are added to magnesium (column 1 lines 20-31), but is not relied upon herein as it is redundant art in view of the current obviousness rejection . Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time. 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, Sue Liu can be reached on (571)272-5539. 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. /MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617 Application/Control Number: 18/810,922 Page 2 Art Unit: 1617 Application/Control Number: 18/810,922 Page 3 Art Unit: 1617 Application/Control Number: 18/810,922 Page 4 Art Unit: 1617 Application/Control Number: 18/810,922 Page 5 Art Unit: 1617 Application/Control Number: 18/810,922 Page 6 Art Unit: 1617 Application/Control Number: 18/810,922 Page 7 Art Unit: 1617 Application/Control Number: 18/810,922 Page 8 Art Unit: 1617 Application/Control Number: 18/810,922 Page 9 Art Unit: 1617 Application/Control Number: 18/810,922 Page 10 Art Unit: 1617 Application/Control Number: 18/810,922 Page 11 Art Unit: 1617
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