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 Objections
Applicant is advised that should claims 4 and 13 be found allowable, claims 11 and 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,318,303. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1-20 of the current application and the invention of claims 1-19 of the patent lies in the fact that the invention of claims 1-19 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-19 of the patent is in effect a "species" of the "generic" invention of claims 1-20 of the current application. It has been held that the generic invention is “anticipated” by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 1-20 are anticipated by claims 1-19, claims 1-20 are not patentably distinct from claims 1-19.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6, 8, 9, 11-13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ainsworth (U.S. Patent 8,088,147).
Ainsworth discloses a method of using a device (for example see Figure 3) comprising:
(claim 1) providing a spinal implant (see Figure 3) including
(claim 1) a body (450, 460, etc.)
(claim 6) wherein the body comprises a plurality of braided strands (column 24 lines 1-15; for example Figure 26)
(claim 12) wherein the body is flexible such that the body stretches and lengthens when a tensile force is applied to the first fitting or the second fitting (the body is disclosed as semi-compliant and is capable of stretching and lengthening when put in tension)
(claim 13) wherein the body is flexible such that the body is self-expanded when a compression force is applied to the first fitting or the second fitting (the body is disclosed as semi-compliant and is capable of expanding outwards when compressed)
(claim 1) a first fitting (340)
(claim 8) securing a first end of each of the plurality of braided strands with the first fitting
(claim 1) a second fitting (344)
(claim 9) securing a second end of each of the plurality of braided strands with the second fitting
(claims 4 and 11) wherein a diameter of a middle portion of the spinal implant (for example 476) is less than a diameter of a first end of the spinal implant (for example the outer diameter of element 340)
(claim 1) embedding the first fitting of the spinal implant in a first vertebral body
(claim 1) embedding the second fitting of the spinal implant in a second vertebral body (for example see Figure 2)
(claim 2) applying a coating to the spinal implant
(claim 3) wherein the coating provides an impervious barrier to liquids from entering an interior cavity of the body (column 24 line 24 to column 25 line 17)
(claim 15) removably coupling the first fitting to a delivery instrument (threads 2313 of delivery tool 2300 engage internal threads of element 340)
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ainsworth (U.S. Patent 8,088,147).
Ainsworth discloses the invention as claimed, see above, except for the diameter of the first end of the spinal implant being the same diameter of the second end of the spinal implant. As discussed above, Ainsworth discloses a method of using a device including a first end having a first diameter (the end including element 340) and a second end having a second diameter (the end including element 344) meeting the general conditions of the claim, wherein the first diameter and the second diameter are not the same. It has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to perform the method of Ainsworth wherein the first diameter and the second diameter on the spinal implant are the same.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ainsworth (U.S. Patent 8,088,147) in view of Hewitt (U.S. Publication 2016/0249934).
Ainsworth discloses the invention as claimed, see above, except for the plurality of braided strands being made from nitinol. Hewitt teaches method of using spinal implant comprising a body (40), a firs fitting (66), a second fitting (68), wherein the body includes a plurality of braided strands (for example see abstract) made from nitinol (paragraph 18). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the invention of Ainsworth wherein the plurality of braided strands are made from nitinol in view of Hewitt, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ainsworth (U.S. Patent 8,088,147) in view of Lee (U.S. Publication 2005/0015150).
Ainsworth discloses the invention as claimed, see above, except for the body having an hourglass shape. Lee teaches a method of using a device including a body (200), wherein the body has an hour-glass shape (for example see abstract). It would have been an obvious matter of design choice to one skilled in the art at the time the invention was filed to perform the method of Ainsworth wherein the body has an hour-glass shape in view of Lee, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of providing a body of a spinal implant. In re Dailey and Eilers, 149 USPQ 47 (1966).
Allowable Subject Matter
Claims 16-20 are allowable over the prior art. However, claims 16-20 are rejected under non-statutory double patenting as discussed above.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 16:
Hestad (U.S. Patent 8,043,381) discloses a method of implanting a spinal implant comprising:
(claim 16) bonding a first coupling (14; column 4 lines 16-19) to a spinal implant
(claim 16) attaching a second coupling (38) to a pusher (is attached to pusher tube 28)
(claim 16) removably coupling the second coupling to the first coupling (for example see Figure 5)
(claim 16) moving the pusher tube so as to advance the spinal implant out of a cannula (66; for example see Figure 7)
(claim 16) positioning the spinal implant between a first vertebral body and a second vertebral body (for example see Figures 7-12)
Hestad fails to disclose the method wherein the second coupling is bonded within a lumen of the pusher tube. The examiner was unable to find a reference or a combination of references that disclose and/or teach all the limitations of claim 16 as presented.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
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