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 .
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 1-12 of U.S. Patent No. 11020157.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the only difference between the claims of the present application and the patented claims is that the patented claims include more elements and are thus more specific. Thus, the invention of the patented claims is in effect a “species” of the “generic” invention of the claims of the present 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 the claims of the present application are anticipated by the patented claims, they are not patentably distinct from the patented claims.
All of the structural elements of the pending claims are present in the patented claims defined with either identical or equivalent language. Features of the pending claims not found in the patented claims would be readily obvious to one of ordinary skill in the art based on the field of the invention and the interaction of the structural elements recited in the patented claims.
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.
Claims 1-20 are 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.
In claim 1, “the proximal thread” lacks antecedent basis. It appears Applicant intended to recite “the proximal thread segment” and is understood in that manner for the purpose of examination.
Appropriate correction is required.
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 1-9 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 7537596) in view of James et al. (US 20060149265 A1).
Regarding claims 1-2, 8, 11-15 and 17, Jensen discloses a screw 110 wherein the shank 114 of screw 110 has a proximal portion with a first thread turn or segment and a distal portion with a distal thread turn or segment (Fig. 5); a head or head portion 112 of screw 110 extending from the proximal end of the shaft portion and wherein a diameter of the head portion 112 is greater than a diameter of the shaft portion and the head portion has a head thread 116 that has the same pitch as the shaft thread 134 to have the same pitch or a different pitch (interpreted to mean “separate”) that is either constant or variable; and the shaft can be divided into two portions, a first proximal portion and a second distal portion of equal length (Figs. 5 and 6, col. 2, lines 64-67, and cols. 3-16).
Regarding claim 20, Jensen discloses the screw to be cannulated with an axial bore (col. 6, lines 18-25).
Jensen discloses all elements of the claimed invention except for a proximal portion of the shaft located proximate to the head portion to taper distally in a direction from the proximal end to the distal end.
Regarding claims 1 and 16, James et al. also disclose screw 400 to have a variable minor diameter as in Fig. 1, i.e. a shaft portion that tapers distally in a direction from the proximal end to the distal end (paras [0011] and [0036]).
Regarding claims 3-4 and 18, James et al. disclose a surgical screw 400 with a shank 401 having multiple segments, each segment having a different pitch, the pitch decreasing incrementally from the distal end to the proximal end (Figs. 4-7 paras [0007], [0013], [0023] and [0026]-[0041]).
Regarding claim 6, James et al. disclose the pitch of the shaft thread to change at intervals of equal length (Fig. 4).
Regarding claim 7, James et al. disclose the pitch to change along only a portion of the shaft thread (Fig. 4).
Regarding claim 9, James et al. disclose the pitch to change along a length of the shaft thread (Fig. 4).
It would have been obvious to one of ordinary skill in the art to have provided a variable minor diameter to the threads in the shaft portion for greater engagement and resistance to pull out in the bone.
Regarding claims 5 and 19, the screw of the combination of Jensen and James et al. is configured to create compression across fractured bone because they are capable of being used with a bone plate to apply compressive force to a fractured bone.
In the alternate, claims 1-2, 10-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 7537596) in view Ferrante et al. (US 6565573).
Regarding claims 1-2 and 10-17, Jensen discloses a screw 110 wherein the shank 114 of screw 110 has a proximal portion with a first thread turn or segment and a distal portion with a distal thread turn or segment (Fig. 5); a head or head portion 112 of screw 110 extending from the proximal end of the shaft portion and wherein a diameter of the head portion 112 is greater than a diameter of the shaft portion and the head portion has a head thread 116 that has the same pitch as the shaft thread 134 to have the same pitch or a different pitch (interpreted to mean “separate”) that is either constant or variable; and the shaft can be divided into two portions, a first proximal portion and a second distal portion of equal length (Figs. 5 and 6, col. 2, lines 64-67, and cols. 3-16).
Regarding claim 20, Jensen discloses the screw to be cannulated with an axial bore (col. 6, lines 18-25).
Jensen discloses all elements of the claimed invention except for a proximal portion of the shaft located proximate to the head portion to taper distally in a direction from the proximal end to the distal end.
Ferrante et al. disclose providing a uniform taper to the shaft of a screw such that the minor diameter continually decreases from the proximal end to the distal end of the shaft. Ferrante et al. also discloses providing three sections to shank 36 wherein the minor diameter of the trailing end is greater than a minor diameter of the intermediate section such that the taper widens in the direction of the trailing end or screw head.
Therefore it would have been recognized by one of ordinary skill in the art that applying the known technique of providing a minor diameter that decreases towards the longitudinal axis from the proximal end to a location intermediate the proximal end and the distal end to the Jensen screw would have yielded the predictable result of a wedge fit when the screw is seated in bone.
Claims 3-5, 7-8, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 7537596) and Ferrante et al. (US 6565573), as applied to claim 1, in view of Huebner (US 6030162).
The combination of Jensen and Ferrante et al. discloses all elements of the claimed invention except for: (1) the pitch to decrease incrementally from the distal end to the proximal end of the shaft portion; (2) the distal thread segment to have a pitch that is larger than a pitch of the proximal thread segment; and (3) the pitch to change incrementally along only a portion of a length of the shaft thread.
Huebner discloses varying the pitch of a screw to generate and/or maintain axial compression between threads in the leading and trailing sections of the screw. The pitch of the threads in the leading section (distal thread segment) is larger than the pitch of the threads in the trailing section (proximal thread segment) and the pitch of the shaft thread decreases in a direction from the distal end towards the proximal end (Figs. 1-4, col. 3, lines 29-67, cols. 4-8 and col. 9, lines 1-58).
Therefore, it would have been recognized by one of ordinary skill in the art that applying the known technique of varying the pitch of a screw, as taught by Huebner, to the screw of the combination of Jensen and Ferrante et al. would have yielded predictable results, i.e., improved compression for fracture fixation.
Regarding claims 5 and 19, the screw of the combination of Jensen, Ferrante et al. and Huebner, is configured to create compression across fractured bone because they are capable of being used with a bone plate to apply compressive force to a fractured bone.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anu Ramana whose telephone number is (571)272-4718. The examiner can normally be reached 8:00 am-5:00 pm.
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, 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.
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.
July 24, 2026
/Anu Ramana/Primary Examiner, Art Unit 3775
Prosecution Insights