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 § 112
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.
Claim 4 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 4 states that “the passageway in the body defines an angle for the fastener that is perpendicular to the long axis of the body.” The previous mention of passageway is with regard to a blind longitudinal passageway which Examiner assumes in element 16 of the current application. Thus, it is unclear how that passageway defines a perpendicular angle for a fastener in reference to the long axis of the body. For the purposes of Examination the Examiner will assume that Applicant is referring to the through hole 17 for fastener 18.
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 20-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,682,168. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claims 1, 5-13, 23-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10, 13, 14 of U.S. Patent No. 11,596,457. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus much specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claims 1, 5-1 of the application map to claims 1, 2-6, 8-10 of the patent.
Claim 13 of the application map to claims 1, 3-7 of the patent.
Claims 23-27 of the application map to claims 13, 14 of the patent.
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.
Claim(s) 1, 6-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Orbay et al. (U.S. Publication No. 2002/0143337).
Orbay et al. discloses, an implant (10) for use in a long bone osteotomy surgical procedure comprising: a plate (14) defining one or more through holes (34, 36, 38) suitable for accepting a fastener; and a body (12) having a tapered first end (54) and a second end (16) spaced-apart by a contoured surface (20, 22) configured to lodge within an intramedullary channel of the long bone so as to impede rotation of the body within the intramedullary channel and about the osteotomy site (Figure 12-14), the second end forming a plate portion of an integral two-member implant (Figure 1).
Regarding claim 6, the plate includes two through holes and two fasteners (Figure 6).
Regarding claim 7, the through holes are locking through holes and the fasteners are locking fasteners (paragraph 28, “The plate portion 14 also includes three longitudinally displaced, threaded peg holes 34, 36, 38, each of which-is adapted to orient a peg (preferably having a threaded head portion) in a different orientation from the others”).
Regarding claim 8, the plate is joined to the body in advance of the surgery (as seen in figures 11-14, the plate is joined to the body before surgery).
Regarding claim 9, the plate is offset from the long axis of the body (Figure 1).
Regarding claim 10, the implant further comprising a through hole (34) defined in the plate portion that is off-set from a long axis of the body (Figure 2, it can be seen that hole 34 is set to the side of the long axis of the body).
Regarding claim 11, a bottom surface (32) of the plate has a longitudinal axis and a radius of curvature along the longitudinal axis configured to match a long bone surface (Figure 3, paragraph 28).
Regarding claim 12, the plate comprises a contour that is defined by a portion of a cylinder (Figure 2, 3, Paragraph 28).
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) 1-5, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundquist et al. (U.S. Publication No. 2016/0354127) in view of Orbay et al. (U.S. Publication No. 2002/0143337).
Lundquist et al. discloses an implant (101) for use in a long bone osteotomy surgical procedure comprising: a plate (103) defining one or more through holes (104) suitable for accepting a fastener; and a body (102) having a first end (end opposite plate, Figure 2) and a second end (end adjacent plate) spaced-apart by a contoured surface configured to lodge within an intramedullary channel of the long bone so as to impede rotation of the body within the intramedullary channel and about the osteotomy site (Figure 3), the second end forming a plate portion of an integral two-member implant (Figure 2). Lundquist et al. fails to disclose that the first end is tapered. Orbay et al. teaches an implant having a body (12) and a plate portion (14) where the first end of the body portion is tapered. This helps the surgery be minimally invasive (Paragraph 10). It would have been obvious to one skilled in the art to construct the device of Lundquist et al. with a tapered first end in view of Orbay et al. in order to aid in minimally invasive surgery.
The following claims are unpatentable over Lundquist in view of Orbay, however reference is made to Lundquist unless otherwise stated.
Regarding claim 2, the body defines a blind longitudinal passageway (106) that communicates with the second end.
Regarding claim 3, the implant further includes fastener for the plate portion and a fastener for the body portion (Figure 6).
Regarding claim 4, the passageway in the body defines an angle for the fastener (116) that is perpendicular to the long axis of the body (Figure 6).
Regarding claim 5, the first end includes a counterbore (106).
Regarding claim 23, Lundquist et al. disclosed an implant for a long bone osteotomy comprising: a plate (103) defining one or more through holes (104) suitable for accepting a fastener; and a body (102) having a first end (end opposite plate, Figure 2) and a second end (end adjacent plate) spaced-apart by a contoured surface and configured to lodge within an intramedullary channel of the long bone in the absence of rotation of the body within the intramedullary channel and about the osteotomy site (Figure 4), a longitudinal passageway (106) that communicates with the second end wherein the second end includes a plate. Lundquist et al. fails to disclose that the first end is tapered. Orbay et al. teaches an implant having a body (12) and a plate portion (14) where the first end of the body portion is tapered. This helps the surgery be minimally invasive (Paragraph 10). It would have been obvious to one skilled in the art to construct the device of Lundquist et al. with a tapered first end in view of Orbay et al. in order to aid in minimally invasive surgery.
Claim(s) 24-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lundquist et al. (U.S. Publication No. 2016/0354127) in view of Orbay et al. (U.S. Publication No. 2002/0143337) and further in view of Eli Running et al. (U.S. Publication No. 2007/0083202) .
Lundquist et al. and Orbay disclose the claimed invention except for the contoured surface comprises a plurality of grooves arranged so as to impede rotation of the body within the intramedullary channel. Eli Running teaches an implant (10) having a body portion (200) and a plate portion (100). The body portion has grooves (204) to provide rotational control of the device (paragraph 39). It would have been obvious to construct the device of Lundquist et al. as modified by Orbay et al. with grooves on the body further in view of Eli Running so as to provide rotational control of the implant in the medullary canal.
The following claims are obvious of Lundquist, Orbay and Eli Running, however, reference is made only to Eli Running unless otherwise stated.
Regarding claim 25, it is not taught by Eli Running that the plurality of grooves defines a spiral along the length of the body arranged so as to impede rotation of the body within the intramedullary channel. However, it would have been an obvious matter of design choice to one skilled in the art to construct the grooves of Eli Runing, 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 an anti-rotation element. In re Dailey and Eilers, 149 USPQ 47 (1966).
Regarding claim 26, the plurality of grooves are arranged in parallel relation to the passageway arranged so as to impede rotation of the body within the intramedullary channel. It can be construed that the combination would be as such when viewing the figures of Lundquist, Orbay, and Eli Running together.
Regarding claim 27, the contoured surface comprises at least one of an outwardly projecting plurality of flanges and plurality of flutes (as seen in figure 1 of Eli Running, the grooves are essentially made from flanges and flutes).
Allowable Subject Matter
Claims 14-19 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.
The following is a statement of reasons for the indication of allowable subject matter: Independent claim 13 is only rejected under Double Patenting. Claim 13 includes that the implant having a plate and a body such that the system has two plates for selective assembly to the body. Such subject matter is not disclosed by the prior art alone or in combination. Thus a Terminal disclaimer will place claim 13 in condition for allowance or including one of the dependent claims 14-19.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached 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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/ANDREW YANG/Primary Examiner, Art Unit 3775