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 .
Election/Restrictions
Applicant's election with traverse of Group I method claims in the reply filed on February 2, 2026 is acknowledged. The traversal is on the ground(s) that the claims as currently presented are all up for examination. The Examiner agrees as all the claims are directed towards the elected method.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 20 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 20 requires the orientation of the screw holes to not be changed during fixation to the bone. The written specification never mentions this feature. It might not be the case all the time. If the screws are placed through the holes on a curved bone, the force from driving the screws would most likely cause some twisting of the plate resulting in the holes pointing slightly different directions than it was prior to installation. There does not seem to be support for this limitation and seems nearly impossible to guarantee this limitation would always be met when using the plate of the current Application.
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 1-10, 14-18, and 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.
Claim 1, lines 10-11 require the screw holes in the middle section to each have a more anterior to posterior trajectory than the screw hole. As in the parent case 17222332, it should be the screw holes have a more anterior to posterior trajectory than the screw hole above it.
Claim 3 requires on of the screw holes in the middle section to be oval. It is unclear what the middle section is. None of the drawings point out where each section starts and ends. It seems that oval/oblong holes 56 and 44 either belong to the top section or the lower section.
Claim 6, “the four screws” lacks antecedent basis.
Claim 10, line 3, “the locking screws” lacks antecedent basis.
Claim 14, “the head of the bone” lacks antecedent basis in the claim.
Claim 18, “the screws” lacks antecedent basis. Originally called “an upper screw” in claim 1.
Claim Objections
Claims 3-10 and 12-13 are objected to because of the following informalities:
Claim 3, line 1, “the screw holes” should be --the plurality of screw holes--.
Claim 6, “the four holes” should be --the four screw holes--.
Claim 12, line 1, “the screw holes” should be --the plurality of screw holes--.
Claim 12, line 2, Microsoft word is suggesting “comprise” be --comprises--.
Claim 13, line 3, “the screw above it” should be –the screw hole above it--.
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) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gonzalez-Hernandez (US 2014/0172020; “Hernandez”).
Claim 1, Hernandez discloses a method of promoting healing of a fracture of a bone (abstract), comprising: fixing a fracture plate (Fig. 4) to the bone (Fig. 5), wherein the fracture plate comprises: (a) an upper section (section that 88 points towards) having at least one screw hole (130, 132) for receiving an upper screw (any hole can receive a screw), the trajectory of the screw hole is a lateral to medial orientation (we can define D1 to D2 the lateral to medial direction); (b) a middle section (where 90 generally points) having a plurality of screw holes (all the holes in the middle section can receive screws) capable of receiving a plurality of middle screws (Fig. 4; any hole can receive a screw), the middle section integral with the upper section (Fig. 4), the plurality of screw holes therethrough the middle section having an oblique trajectory relative to the trajectory of the screw hole of the upper section (Fig. 4; note how the plate has a bend in it so even the holes on the side that 94 points towards will be at a different angle of trajectory, and the holes on the 92 side will definitely be at a different angle than the upper section) and configured to match an anatomy of the bone (Fig. 5) wherein one or more of the plurality of screw holes therethrough the middle section each have a more anterior to posterior trajectory than the screw hole therethrough the middle section above it (Fig. A below; “hole 2” is true anterior posterior while “hole 1” is more lateral to medial); and, (c) a lower section (section that 82 points towards) having at least one screw hole (130, 132, and 134 are all capable of being screw holes) for receiving a lower screw (Fig. 4; all the holes can receive screws), the trajectory of the screw hole having an oblique trajectory relative to the trajectory of the plurality of screw holes of the middle section (Fig. 4; note how the plate bends so the holes will be at different angles compared to the rest of the plate), the lower section integral with the middle section (Fig. 4).
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Fig. A: Annotated Fig. 4 of Hernandez to show how claim limitations are met.
Claim 2, Hernandez discloses the method of claim 1, wherein the at least one screw hole of the upper section is a plurality of screw holes (Fig. 4).
Claim 3, Hernandez discloses the method of claim 2, wherein the plurality of screw holes of the middle section comprises at least one oval screw hole suitable to receive a middle screw (Fig. 4; the hole just above and to the right of where 94 points), the at least one screw hole sized to permit the fracture plate to be positioned to not project above the top of the bone (Figs. 4 and 5).
Claim 4, Hernandez discloses the method of claim 3, wherein at least one of the screw holes of the middle section comprises a circular or oval screw hole (Fig. 4; it has both types) capable of receiving the middle screw (Fig. 4; all the holes can receive screws), wherein the middle screw received by the circular screw hole is a locking screw or a compression screw (Fig. 4; the holes can receive any type of screw, as long as the shank fits through the hole).
Claim 5, Hernandez discloses the method of claim 4, wherein the at least one screw hole of the upper section is four screw holes (Fig. 4; there are at least 4 holes depending on where you call the stopping point of the upper section it could be 5 or 6 holes).
Claim 6, Hernandez discloses the method of claim 5, wherein the four screw holes of the upper section are each configured to receive one of the four screws (Fig. 4; all the holes can receive screws).
Claim 7, Hernandez discloses the method of claim 6, wherein the four screw holes are symmetrically disposed along the longitudinal axis of the upper section (Fig. 4; all the holes are right along the center of the plate).
Claim 8, Hernandez discloses the method of claim 7, wherein the at least one screw hole of the lower section is another plurality of screw holes (Fig. 4; there are as many as 10 holes in the lower section).
Claim 9, Hernandez discloses the method of claim 8, wherein the another plurality of screw holes of the lower section is selected from the group consisting of three screw holes, four screw holes, or five screw holes (Fig. 4; it has from 1 to 10 depending on what is considered the lower section and which holes are considered screw holes).
Claim 10, Hernandez discloses the method of claim 9, wherein the another plurality of screw holes of the lower section are configured to receive a locking screws (Fig. 5).
Claim 11, Hernandez discloses the method of claim 1, wherein the middle section is anteriorly curved and conforms to the lateral cortex of the bone (Figs. 4 and 5).
Claim 12, Hernandez discloses the method of claim 11, wherein the plurality of screw holes therethrough the middle section comprises two screw holes (Fig. 4 and Fig. A above).
Claim 13, Hernandez discloses the method of claim 1, wherein each of the plurality of screw holes therethrough the middle section having a more anterolateral to posteromedial trajectory than the screw hole above it (Fig. 4 and Fig. A above; just search “bend” in Hernandez to see how all the portions are bendable, so the plate can be bent in a manner where it looks very similar to Applicant’s plate).
Claim 14, Hernandez discloses the method of claim 1, wherein the upper section is capable of conforming to the anatomy of a head of the bone (Fig. 4; the plate is bendable and the head of the bone could be a variety of shapes).
Claim 15, Hernandez discloses the method of claim 14, wherein the at least one screw hole of the upper section is a plurality of screw holes (Fig. 4).
Claim 16, Hernandez discloses the method of claim 15, wherein the screw holes of the upper section have parallel trajectories (Figs. 1-4; the plate is bendable, so it could be perfect flattened so all the holes have the same trajectory).
Claim 17, Hernandez discloses the method of claim 15, wherein the screw holes of the upper section have non-parallel trajectories (Fig. 4).
Claim 18, Hernandez discloses the method of claim 17, wherein the screws configured for fastening the upper section of the plate to head of the bone are in different planes (Fig. 4; the plate is bendable so each hole can be at the same trajectory or a different trajectory).
Claim 19, Hernandez discloses the method of claim 1, wherein the fracture plate is precontoured such that the screw holes of the fracture plate are not deformed during fixation of the fracture plate to the bone so as to compromise screw fixation to the bone (Figs. 1-4; the plate is bendable so it could be bent to perfectly match the shape of the bone).
Claim 20, Hernandez discloses the method of claim 1, wherein the orientation of the screw holes therethrough are not changed during fixation to the bone so as to compromise fracture fixation (Figs. 1-4; the plate is bendable so it could be bent to perfectly match the shape of the bone prior to and the shape shown in Fig. 4 could be the perfect shape to match the bone it is going to be placed on).
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. 10238438 in view of Gonzalez-Hernandez (US 2014/0172020; “Hernandez”).
The patent has claims geared towards the same embodiment. Any missing features from the patent claims are taught by Hernandez as noted above.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10966766 in view of Gonzalez-Hernandez (US 2014/0172020; “Hernandez”).
The patent has claims geared towards the same embodiment. Any missing features from the patent claims are taught by Hernandez as noted above.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12023077 in view of Gonzalez-Hernandez (US 2014/0172020; “Hernandez”).
The patent has claims geared towards the same embodiment. Any missing features from the patent claims are taught by Hernandez as noted above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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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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/Zade Coley/Primary Examiner, Art Unit 3775