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
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 3 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 3 of prior U.S. Patent No. 12,029,459. This is a statutory double patenting rejection.
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, 4-7, 10-11, 13-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chiquillo Perez (US 9,763,717).
Regarding claim 1, Chiquillo Perez discloses a screw (1, FIGS. 6-7) for orthopedic surgery at an anatomical target site in a human patient, comprising: a head (31), a shank (41), and a neck (9A) extending between said head and said shank, wherein said head, neck and shank are colinear along a longitudinal axis extending between a proximal end (3) of said head and a distal end (4) of said shank; said head including: a reverse frustroconical cross-sectional shape defined by a narrow base (proximal most end of head) at said proximal end of said head, a wide base (distalmost end of head at 2A) at a distal end of said head, a minor diameter that increases from said narrow base to said wide base (FIGS 6-7), and a curved lateral surface extending between said narrow base and said wide base that is tapered relative to said longitudinal axis to define at a reverse taper angle (FIGS. 6-7); at least one helical thread extending from said narrow base of said head to said wide base of said head and having a diameter that defines a major diameter of said head (FIGS. 6-7), said helical thread capable to contact a bone forming part of said anatomical target site when said head is implanted during use to thereby enhance the purchase of said head into said bone, said at least one helical thread having at least one pitch (inherent); and a drive feature (proximal socket) dimensioned to cooperate with an instrument such that said head, shaft, and neck may be rotated about said longitudinal axis in order to drive said shaft, neck and head into an anatomical target of a patient; and said shank including: a curved lateral surface having at least one helical thread extending from a proximal end of said shank towards said distal end of said shank (FIGS. 6-7), said at least one helical thread including at least one pitch (inherent).
Regarding claim 4, Chiquillo Perez discloses the screw for orthopedic surgery of claim 1, wherein said reverse taper angle of said head is between approximately 5 and 15 degrees (FIGS. 6-7).
Regarding claim 5, Chiquillo Perez discloses the screw for orthopedic surgery of claim 1, wherein said pitch of said at least one helical thread of said head is in the range of 0.5 mm to 2.5 mm (col. 6 ll. 20-35).
Regarding claim 6, Chiquillo Perez discloses the screw for orthopedic surgery of claim 1, wherein said pitch of said at least one helical thread of said head is approximately equal to the pitch of said at least one helical thread of said shank such that said screw is a compression neutral screw in use (col. 6 ll. 20-35, pitch ranges overlap so can be “approximately equal”).
Regarding claim 7, Chiquillo Perez discloses the screw for orthopedic surgery of claim 1, wherein said pitch of said at least one helical thread of said head is at least one of: (a) not approximately equal to the pitch of said at least one helical thread of said shank such that said screw is a compression screw in use; and (b) of varying pitch including a first pitch at said narrow base and a second pitch at said wide base such that said screw is a compression screw in use (col. 6 ll. 20-35).
Regarding claim 10, Chiquillo Perez discloses the screw for orthopedic surgery of claim 1, wherein said minor diameter of said head is within the range of 1.75 mm to 9 mm (col. 6 ll. 53-56).
Regarding claim 11, Chiquillo Perez discloses the screw for orthopedic surgery of claim 1, wherein said major diameter of said head is in the range of 2 mm to 10 mm (col. 6 ll. 53-56).
Regarding claim 13, Chiquillo Perez discloses the screw for orthopedic surgery of claim 1, wherein said curved lateral surface of said shank has a diameter that defines a minor diameter of said shank, and said at least one helical thread of said shank has a diameter that defines a major diameter of said shank (FIGS. 6-7).
Regarding claim 14, Chiquillo Perez discloses the screw for orthopedic surgery of claim 13, wherein said major diameter of said shank is less than a minimum value of said major diameter of said head (at distal end).
Regarding claim 15, Chiquillo Perez discloses the screw for orthopedic surgery of claim 13, wherein said minor diameter of said shank is in the range of between 1.0 mm and 7.5 mm (col. 6 ll. 53-56).
Regarding claim 16, Chiquillo Perez discloses the screw for orthopedic surgery of claim 13, wherein said major diameter of said shank is in the range of between 1.5 mm to 8 mm (col. 6 ll. 53-56).
Regarding claim 17, Chiquillo Perez discloses the screw for orthopedic surgery of claim 1, wherein at least one of said at least one helical thread of said head includes at least one of a cutting flute and a reverse cutting flute (at 41, FIGS. 6-7).
Regarding claim 18, Chiquillo Perez discloses the screw for orthopedic surgery of claim 1, wherein said at least one of said at least one helical thread of said shank includes a cutting flute (at 41, FIGS. 6-7).
Claim(s) 1, 12, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zander et al. (US 2018/0185076), hereinafter “Zander”.
Regarding claim 1, Zander discloses a screw (1, FIGS. 6-7) for orthopedic surgery at an anatomical target site in a human patient, comprising: a head (31), a shank (41), and a neck (9A) extending between said head and said shank, wherein said head, neck and shank are colinear along a longitudinal axis extending between a proximal end (3) of said head and a distal end (4) of said shank; said head including: a reverse frustroconical cross-sectional shape defined by a narrow base (proximal most end of head) at said proximal end of said head, a wide base (distalmost end of head at 2A) at a distal end of said head, a minor diameter that increases from said narrow base to said wide base (FIGS 6-7), and a curved lateral surface extending between said narrow base and said wide base that is tapered relative to said longitudinal axis to define at a reverse taper angle (FIGS. 6-7); at least one helical thread extending from said narrow base of said head to said wide base of said head and having a diameter that defines a major diameter of said head (FIGS. 6-7), said helical thread capable to contact a bone forming part of said anatomical target site when said head is implanted during use to thereby enhance the purchase of said head into said bone, said at least one helical thread having at least one pitch (inherent); and a drive feature (proximal socket) dimensioned to cooperate with an instrument such that said head, shaft, and neck may be rotated about said longitudinal axis in order to drive said shaft, neck and head into an anatomical target of a patient; and said shank including: a curved lateral surface having at least one helical thread extending from a proximal end of said shank towards said distal end of said shank (FIGS. 6-7), said at least one helical thread including at least one pitch (inherent).
Regarding claim 12, Zander discloses the screw for orthopedic surgery of claim 1, wherein said at least one helical thread of said shank extends in a clockwise direction from said proximal end of said shank towards said distal end of said shank (¶32).
Regarding claim 19, Zander discloses the screw for orthopedic surgery of claim 1, wherein said at least one helical thread of said shank is a dual helix screw thread (¶32).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiquillo Perez.
Regarding claim 2, Chiquillo Perez discloses the screw for orthopedic surgery of claim 1, except wherein said at least one helical thread of said head extends from said narrow base of said head to said wide base of said head in a clockwise direction. Clockwise head threads are well known in the art; it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to form the head with clockwise threads to produce predictable results.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chiquillo Perez in view of Elleby et al. (US 2016/0015438), hereinafter “Elleby”.
Regarding claims 8-9, Chiquillo Perez discloses the screw for orthopedic surgery of claim 1, except wherein said head further comprises a beveled surface extending from said narrow base of said head to a predetermined location along said curve lateral surface of said head, wherein said beveled surface is angled relative to an upper surface of said head that is perpendicular to said longitudinal axis to define a bevel angle in the range of between 1 and 60 degrees. Elleby teaches a screw (10) for orthopedic surgery comprising a head (14) and a shank (21) wherein said head further comprises a beveled surface (31) extending from said narrow base of said head to a predetermined location along said curve lateral surface of said head, wherein said beveled surface is angled relative to an upper surface of said head that is perpendicular to said longitudinal axis to define a bevel angle in the range of between 1 and 60 degrees (¶35). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention, to combine the beveled surface of Elleby with the head of Chiquillo Perez, for the purpose of achieving a flush surface with the bone. In this case, one would form the proximal head surface of Chiquillo Perez comprising a beveled surface as per Elleby so that the screw would be flush with the bone surface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA C CHANG whose telephone number is (571) 270-5017. The examiner can normally be reached Monday-Friday, 7:30AM-5:00PM.
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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/OLIVIA C CHANG/Primary Examiner, Art Unit 3775