DETAILED ACTION
Claim Objections
Claim 10 is objected to because of the following informalities. In line 3, “one of one of two lengths” should be - - one of two lengths - - to correct a minor typographical error. Appropriate correction is required.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8 and 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-9, 11-12, 14 and 16-19 of U.S. Patent No. 10245086.
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.
Claims 13-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-29 and 31-33 U.S. Patent No. 10245086.
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.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-13 of U.S. Patent No. 11344347.
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.
Claims 13-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-18 U.S. Patent No. 11344347.
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.
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.
Claims 1-4, 6-9 and 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Huebner (US 8231662).
Regarding claim 1, Huebner discloses a kit (cols. 9-10) in a sterile or sterilizable condition, the kit capable of being used for a foot or ankle orthopedic procedure including: a sterile or sterilizable package or container; one or more fasteners or unicortical bone plate fasteners included in the sterile or sterilizable container; and a plurality of bone plates (interpreted to mean any number greater than one) wherein the bone plates may substantially be the same in size and/or shape, or may be different in size, shape, handedness (e.g., a left bone plate and a right bone plate), and/or pre-bent profile, among others, wherein each bone plate includes: a body having a top surface and a bone facing surface opposite the top surface; and a first fixation hole extending through the body from the top surface to the bone facing surface and configured for receiving one of the plurality of fasteners or unicortical bone plate fasteners included in the sterile container (Figs. 1-10, col. 9, lines 61-67 and col. 10, lines 1-24). Any kit can be thrown away after a single use based on the kit user’s inclination to do so. Thus, the Huebner kit is considered to be disposable. Regarding the recitation “unicortical fasteners,” the qualifier “unicortical” is directed to function rather than structure. Any fastener can function as a unicortical fastener depending on the size of the underlying bone and the fastener placement as decided by the surgeon to avoid damage to surrounding soft tissues.
Regarding claims 2-3, the various recitations of “tarsal-metatarsal joint”, “plantar region of the first metatarsal to a medial region of the medial cuneiform,” “first metatarsal and a medial cuneiform,” Huebner discloses “The bone plate may be structured for use with a strut and for use on any suitable bone, such as a distal portion of a radius bone, among others [underline, emphasis added].” Huebner also discloses “A bone(s) to be fixed may be selected. The bone(s) may have any suitable injury, such as a fracture, a cut, a malunion, a nonunion, a developmental error, and/or the like. In some examples, the bone(s) selected may be two or more bones that articulate with one another through an anatomical joint. Any suitable anatomical joints may be selected, including the scapholunate joint, the acromioclavicular joint, the wrist, etc. Any suitable bone(s) may be selected for fixation, including a bone(s) of the hand (e.g., phalanges, metacarpals), wrist (e.g., carpal bones), arm (e.g., radius, ulna, humerus), foot (e.g. phalanges, metatarsals, tarsals).” Thus, the Huebner plate is fully capable of being placed across a tarsal-metatarsal joint.
Regarding claim 4, Huebner disclose each plate to have a proximal and distal region, each of the regions having two fixation holes (Figs. 1 and 3).
Regarding claims 6 and 7, Huebner disclose any suitable number bone screws may be placed into the underlying bone for fracture fixation (col. 13, lines 17-46).
Regarding claims 8, Huebner discloses a T-shaped plate (Fig. 2). The width of the body is greater at the location along the central longitudinal axis where a fixation hole (for e.g. 76 is situated, see Fig. 2) than at a location remote from the fixation hole (for e.g. the region containing hole 80) (col. 10, lines 44-67 and col. 11, lines 1-4).
Regarding claims 9 and 11, Huebner discloses a bending tool or attachment member 110 that is partially received in a fixation hole (for e.g. 76, Fig. 8).
Regarding claim 11, Huebner discloses a bending tool or manipulation instrument 110 that is partially received in a fixation hole (for e.g. 76, Fig. 8).
Regarding claim 12, Huebner discloses drills or bone preparation instruments for placing the fasteners (col. 9, lines 61-67 and col. 10, lines 1-8).
Huebner discloses “The kits optionally may include (1) one or more bone plates, (2) one or more struts, (3) one or more fasteners for connecting the strut(s) to the bone plate, (4) fasteners for securing the bone plate(s) to bone, (5) drills and/or drivers for installing the fasteners (6) one or more tools for bending the bone plate(s) and/or strut(s) on bone and/or off bone, (7) a gauge for measuring the angular bend of the bone plate (and/or strut), and/or (8) instructions for use. Some or all of the components of the kit may be packaged in a sterile and/or sterilizable (e.g., autoclavable) condition. In some examples, components of the kit, such as the bone plate(s) and strut(s), may be intended for single use. In some examples, components of the kit, such as drills and/or drivers, may be intended or suitable for repeated use. (col. 9, lines 61-67 and col. 10, lines 1-24).”
Huebner discloses all elements of the claimed invention except for: (1) no more than four plates; (2) number of the fasteners to be greater than or equal to the number of fixation holes; (3) number of fasteners to be equal to the total number of fixation holes of the bone plates in the sterile container plus at least one and no more than four; (4) at least one and no more than three plate manipulation instruments; and (5) at least one and no more than ten bone preparation fixation pins included in the sterile container.
It would have been obvious to a person of ordinary skill in the art have modified the kit of Huebner to include any number of bone plates, threaded fasteners or pins and tools such as bending tools, drivers and drills in an attempt to provide an adequate number of plates, fasteners and tools for a surgical procedure or multiple procedures on different bones of the same patient, depending on the anatomy of the underlying bone and the condition of the patient, as a person with ordinary skill has good reason to pursue known options (i.e. picking a suitable number of various elements in a kit based on the disclosure of Huebner that kit can have more than one element in the kit) for the predictable result of having options
The method steps of claims 15-17, specifically of removing an appropriate number of plates and fasteners, applying one or more plates by contacting the bone to be fixed, and inserting fasteners through holes in the one or more plates are routine steps employed by an attending surgeon during fracture fixation utilizing the Huebner plate (col. 13, lines 17-67 and col. 14, lines 1-35).
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.
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Huebner (US 8231662) in view of Huebner (US 7578825).
Regarding claims 5 and 10, Huebner discloses fasteners having a head and a shaft (Fig. 6). Further, Huebner discloses placing one or more fasteners 34 into bone (col. 9, lines 9-20 and col. 13, lines 30-35).
Huebner discloses all elements of the claimed invention except for specifically disclosing providing fasteners with different lengths.
It is well known to provide fasteners of different lengths (unicortical or bicortical or cancellous) depending on the support desired by the attending surgeon, as evidenced by Huebner (col. 9, lines 37-63, col. 10 and col. 11, lines 1-25).
Therefore, it would have been obvious to one having ordinary skill in the art to have provided fasteners of different lengths in the Huebner kit, as taught by Huebner, for ease of access by the attending surgeon, for the predictable result of fracture fixation.
Response to Arguments
Applicant's arguments have been fully considered but are not persuasive for the following reasons.
Regarding the double-patenting rejections, claims 1-5, 7-9, 11-12, 14, and 16-19 in US 10245086 recite all the elements of pending claims 1-8 and 10-12 of the instant application as shown below. Identical limitations are underlined and additional limitations in the patented claims are in bold.
1. A disposable single-use surgical kit for a foot or ankle orthopedic procedure comprising:
a sterile container;
a plurality of unicortical bone plate fasteners included in the sterile container; and
at least one bone plate but no more than four bone plates included in the sterile container, each bone plate comprising:
a body having a top surface and a bone facing surface opposite the top surface; and a first fixation hole extending through the body from the top surface to the bone facing surface and configured for receiving one of the plurality of unicortical bone plate fasteners included in the sterile container,
wherein at least one bone plate of the at least one but no more than four bone plates comprises the body extending from a proximal region to a distal region and having a helical curvature between the proximal region and the distal region.
Patented claims 2 and 3 recite all the limitations of pending claims 2 and 3.
Patented claims 4 and 5 recite all the limitations of pending claim 4.
Patented claim 7 recites the same limitations as claim 5 using different language.
Patented claims 8 and 9 recite all the limitations of pending claims 6 and 7.
Patented claim 12 is identical to pending claim 8.
Patented claim 11 is identical to pending claim 9.
Patented claim 14 is identical to pending claim 10.
Patented claims 16 and 17 recite all limitations of pending claim 11.
Patented claims 18 and 19 recite all limitations of pending claim 12.
Regarding the double-patenting rejections, claims 28-29 and 31-33 in US 10245086 recite all the elements of pending claims 13-17 of the instant application as shown below. Identical limitations are underlined and additional limitations in the patented claims are in bold.
28. (Currently Amended) A method for performing a surgical operation, the method comprising the steps of:
removing a plurality of bone plate fasteners from a sterile container, wherein each one of the plurality of bone plate fasteners comprises a head and a shaft, and wherein the shaft of each one of the plurality of bone plate fasteners consists of one of a first length, a second length, a third length, and a fourth length, and further wherein the diameter of each one of the plurality of bone plate fasteners consists of one of a first diameter, a second diameter, a third diameter, or a fourth diameter, and there are no other lengths or diameters of bone plate fasteners within the sterile container;
removing at least one and no more than four bone plates from the sterile container, the at least one and no more than four bone plates each comprising:
a body having a top surface and a bone facing surface opposite the top surface; and a first fixation hole extending through the body from the top surface to the bone facing surface and configured for receiving one of the plurality of bone plate fasteners;
contacting a bone with the at least one and no more than four bone plates removed from the sterile container; and
inserting one of the plurality of bone plate fasteners removed from the sterile container through the first fixation hole and into the bone,
wherein removing at least one and no more than four bone plates comprises removing a bone plate comprising the body extending from a proximal region to a distal region and having a helical curvature between the proximal region and the distal region.
Patented claim 29 recites all limitations of pending claim 14.
Patented claim 31 recites all limitations of pending claim 15.
Patented claim 32 recites all limitations of pending claim 16.
Patented claim 33 recites all limitations of pending claim 17.
Contrary to Applicant’s arguments, the nonstatutory double patenting rejection is based on an anticipation analysis. The patented claims are directed to a species and thus anticipate the generic claims in the instant application (see MPEP 804 and 2131.02).
Regarding the double-patenting rejections, claims 1-7 and 9-13 in US 11344347 recite all the elements of pending claims 1-12 of the instant application as shown below. Identical limitations are underlined and additional limitations in the patented claims are in bold.
1. A disposable single-use surgical kit for a foot or ankle orthopedic procedure comprising:
a sterile container;
a plurality of unicortical bone plate fasteners included in the sterile container; and
at least one bone plate but no more than four bone plates included in the sterile container, each bone plate comprising:
a body having a top surface and a bone facing surface opposite the top surface, the body further comprising a pad extending out from a side surface between the top surface and the bone facing surface, the pad being monolithically formed with the body; and
a first fixation hole extending through the body from the top surface to the bone facing surface and configured for receiving one of the plurality of unicortical bone plate fasteners included in the sterile container.
Patented claims 2 and 3 recite all the limitations of pending claims 2 and 3.
Patented claim 4 recites all the limitations of pending claim 4.
Patented claim 5 recites all the limitations of pending claim 5.
Patented claim 6 recites all the limitations of pending claim 6.
Patented claim 7 recites all the limitations of pending claim 7.
Patented claim 9 recites all the limitations of pending claim 8.
Patented claim 10 recites all the limitations of pending claim 9.
Patented claim 11 recites all the limitations of pending claim 10.
Patented claim 12 recites all the limitations of pending claim 11.
Patented claim 13 recites all the limitations of pending claim 12.
Regarding the double-patenting rejections, claims 14-18 in US 11344347 recite all the elements of pending claims 13-17 of the instant application as shown below. Identical limitations are underlined and additional limitations in the patented claims are in bold.
14. A method for performing a surgical operation, the method comprising the steps of:
removing a plurality of bone plate fasteners from a sterile container, wherein each one of the plurality of bone plate fasteners comprises a head and a shaft, and wherein the shaft of each one of the plurality of bone plate fasteners consists of one of a first length, a second length, a third length, and a fourth length, and further wherein the diameter of each one of the plurality of bone plate fasteners consists of one of a first diameter, a second diameter, a third diameter, or a fourth diameter, and there are no other lengths or diameters of bone plate fasteners within the sterile container;
removing at least one and no more than four bone plates from the sterile container, the at least one and no more than four bone plates each comprising:
a body having a top surface and a bone facing surface opposite the top surface, the body further comprising a pad extending out from a side surface between the top surface and the bone facing surface, the pad being monolithically formed with the body; and
a first fixation hole extending through the body from the top surface to the bone
facing surface and configured for receiving one of the plurality of bone plate fasteners;
contacting a bone with the at least one and no more than four bone plates removed from the sterile container; and
inserting one of the plurality of bone plate fasteners removed from the sterile container through the first fixation hole and into the bone.
Patented claim 15 recites all the limitations of pending claim 14.
Patented claim 16 recites all the limitations of pending claim 15.
Patented claim 17 recites all the limitations of pending claim 16.
Patented claim 18 recites all the limitations of pending claim 17.
Contrary to Applicant’s arguments, the nonstatutory double patenting rejection is based on an anticipation analysis. The patented claims are directed to a species and thus anticipate the generic claims in the instant application (see MPEP 804 and 2131.02).
Regarding the rejections under 35 USC 103 over Huebner, Applicant’s arguments are not persuasive with respect to claims 1-9 and 11-17. As discussed in this action, Huebner discloses all elements of Applicant’s claimed invention. Huebner discloses a range for the number of specific elements in a kit, for e.g. more than one that encompasses Applicant’s claimed range of the number of elements in a kit, more than one but less or equal to a finite number, rendering the claimed invention obvious (see MPEP 2144.05(I) and (II)).
Regarding the recitation “unicortical fastener” implies a fastener having a suitable length based on the anatomy of the bone that is configured to be inserted through a fixation hole of a bone plate and through bone so that the plate is secured to bone. Applicant’s disclosure does not provide screw shaft lengths or thread diameters to distinguish the claimed fastener from screws typically used to secure a bone plate to underlying bone, which include unicortical as well as bicortical screws based on the surgeon’s choice (see for e.g. US 7578825). Applicant’s disclosure merely suggests that “a unicortical bone plate fastener may be configured (e.g. sized) to be inserted through one cortical surface of the bone but not an opposed cortical surface.” Huebner discloses “fasteners 34, such as bone screws, to position the bone plate in a spanning relationship to a fracture 36 of the radius bone (or other suitable bone) (col. 3, lines 15-23).” If the bone is small, common sense would predicate the use of short length screws to avoid soft tissue injury. The functional recitation “unicortical” does not impose any structural limitation on the claimed fastener since the recitation is not supported by recitation of structure to distinguish the claimed fastener from the Huebner screw which may be cortical or bi-cortical depending on the size of the underlying bone, i.e. specific anatomy of the underlying bone.
New grounds of rejection have been made in this office action.
Conclusion
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June 14, 2024
/Anu Ramana/Primary Examiner, Art Unit 3775