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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Notice of Amendment
In response to the amendment(s) filed on 10/24/25, amended claim(s) 1-2 and 6, canceled claim(s) 3, 5, and 15-20, and new claim(s) 21-26 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Election/Restrictions
Newly submitted and amended claims 1-2, 4, 6, and 21-26 is/are directed to an invention that is independent or distinct from the invention of claims 7-10 and the invention of claims 11-14 originally claimed for the following reasons:
This application contains claims directed to the following patentably distinct species:
Species A: bone plate; Figs. 1-2; claims 1-2, 4, 6, and 21-26;
Species B: intramedullary nail; Fig. 3; claims 7-10; and
Species C: lag screw; Figs. 4A-B; claims 11-14.
The species are independent or distinct because they are mutually divergent structures for securing to a bone of a patient. In addition, these species are not obvious variants of each other based on the current record. Currently, no claims are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: the inventions or groupings of patentably indistinct inventions have acquired a separate status in the art in view of their different classification; the inventions or groupings of patentably indistinct inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or the inventions or groupings of patentably indistinct inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim(s) 7-14 is/are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 23 is objected to because of the following informalities: “the second sensor and configured to” (lines 2-3) appears that it should be “the second sensor configured to.”
Appropriate correction is required.
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(s) 1-2, 4, 6, and 21-26 is/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.
For claim 1, the claim term “the bone plate” (line 5) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 21, the claim term “the bone plate” (line 4) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 22, the claim term “a bone plate” (line 1) is ambiguous. Claim 21, from which claim 22 depends, already recites a “bone plate.” Therefore, it is unclear whether the same bone plate is being referred to or whether this is a different bone plate. The claim is examined under the former interpretation.
Dependent claim(s) 2, 4, 6, and 22-26 fail to cure the ambiguity of independent claim(s) 1 and 21, thus claim(s) 1-2, 4, 6, and 21-26 is/are rejected under 35 U.S.C. 112(b).
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) 1-2, 4, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2006/0052782 to Morgan et al. (hereinafter “Morgan”).
For claim 1, Morgan discloses a system for detecting nonunion or malunion fractures (Abstract), the system comprising:
an implant (10) (Fig. 1) (para [0028]) securable (Examiner’s Note: functional language, i.e., capable of) to a bone of a patient in a location near a fracture of the bone (as can be seen in Fig. 2), the implant including a plurality of bores (30) (Fig. 1) (para [0028]) therein each bore configured to (Examiner’s Note: functional language, i.e., capable of) receive a bone fastener therethrough to secure the bone plate to the bone (as can be seen in Fig. 2) (para [0028]);
a sensor (50) (Fig. 1) (para [0028]) connectable to the implant (as can be seen in Fig. 2) and configured to produce (Examiner’s Note: functional language, i.e., capable of) a sensor signal based on a condition of the implant near the fracture (para [0028] and [0031]-[0033]), the sensor positionable in any bore of the plurality of bores (as can be seen in Fig. 2) (para [0028]);
a second sensor (another one of 50) (Fig. 1) (para [0028]) positionable in any bore of the plurality of bores (as can be seen in Fig. 2), the second sensor configured to produce a second sensor signal based on a second condition of the implant near the fracture (para [0028] and [0031]-[0033]), the sensor locatable in a first bore of the plurality of bores on a first side of the fracture (as can be seen in Figs. 1-3) and the second sensor is locatable in a second bore of the plurality of bores on a second side of the fracture (as can be seen in Figs. 1-3); and
a controller (40) (Fig. 1) (para [0028]) configured to determine (Examiner’s Note: functional language, i.e., capable of) a nonunion or malunion of the fracture based on the sensor signal and the second sensor signal (para [0035]) (also see para [0028] and [0040]).
For claim 2, Morgan further discloses wherein the implant is a bone plate securable to an outer surface of the bone, spanning the fracture (as can be seen in Fig. 2).
For claim 4, Morgan further discloses wherein the controller is configured to determine the nonunion or malunion of the fracture based on the sensor signal and the second sensor signal (para [0040]) (also see para [0041]).
For claim 6, Morgan further discloses wherein the sensor is configured to produce a signal based on a strain applied to the bone plate (para [0008]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 21-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morgan in view of U.S. Patent Application Publication No. 2022/0160301 to Ferrante et al. (hereinafter “Ferrante”).
For claim 21, Morgan discloses a system for determining nonunion or malunion fractures (Abstract), the system comprising:
an implant (10) (Fig. 1) (para [0028]) securable (Examiner’s Note: functional language, i.e., capable of) to a bone of a patient in a location near a fracture of the bone (as can be seen in Fig. 2), the implant including a plurality of bores (30) (Fig. 1) (para [0028]) each bore configured to (Examiner’s Note: functional language, i.e., capable of) receive a bone fastener therethrough to secure the bone plate to the bone (as can be seen in Fig. 2) (para [0028]);
a sensor (50) (Fig. 1) (para [0028]) connectable to the implant (as can be seen in Fig. 2) and configured to produce (Examiner’s Note: functional language, i.e., capable of) a sensor signal based on a condition of the implant near the fracture (para [0028] and [0031]-[0033]), the sensor positionable in any bore of the plurality of bores (as can be seen in Fig. 2) (para [0028]); and
a controller configured to determine a nonunion or malfunction of the fracture based on the sensor signal.
a controller (40) (Fig. 1) (para [0028]) configured to determine (Examiner’s Note: functional language, i.e., capable of) a nonunion or malunion of the fracture based on the sensor signal (para [0035]) (also see para [0040]).
Morgan does not expressly disclose that the sensor is threadably securable.
However, Ferrante teaches a threadably securable sensor (para [0173]).
It would have been obvious to a skilled artisan to modify Morgan such that the sensor is threadably securable, in view of the teachings of Ferrante, because threadably securable is a suitable way to position a sensor to a bone fixation device, which is what Morgan wants to do.
For claim 22, Morgan further discloses wherein the implant is a bone plate securable to an outer surface of the bone, spanning the fracture (as can be seen in Fig. 2).
For claim 23, Morgan further discloses a second sensor (another one of 50) (Fig. 1) (para [0028]) positionable in any bore of the plurality of bores (as can be seen in Fig. 2), the second sensor configured to produce a second sensor signal based on a second condition of the implant near the fracture (para [0028] and [0031]-[0033]).
For claim 24, Morgan further discloses wherein the controller is configured to determine the nonunion or malunion of the fracture based on the sensor signal and the second sensor signal (para [0035]) (also see para [0040]).
For claim 25, Morgan further discloses wherein the sensor locatable in a first bore of the plurality of bores on a first side of the fracture (as can be seen in Fig. 2) and the second sensor is locatable in a second bore of the plurality of bores on a second side of the fracture (as can be seen in Fig. 2).
For claim 26, Morgan further discloses wherein the sensor is configured to produce a signal based on a strain applied to the bone plate (para [0008]).
Response to Arguments
Applicant’s arguments filed 10/24/25 have been fully considered.
With respect to the objection to the drawings, Applicant’s amendments and arguments are persuasive and thus the objection is withdrawn.
With respect to the claim objection, Applicant’s amendments and arguments are persuasive and thus the objection is withdrawn.
With respect to the 112(a) rejection(s), Applicant’s amendments and arguments are persuasive and thus the rejection(s) is/are withdrawn.
With respect to the 112(b) rejection(s), Applicant’s arguments are persuasive and the scope of the claim language will be that the sensors are able to be positioned and able to be located in the bores, not that they actually are located in the boars (consistent with Applicant’s arguments).
With respect to the 1021/103 rejections, Applicant’s arguments have been fully considered. Many of the arguments are moot in view of the amendments causing some of the rejections to be withdrawn. However, Applicant’s arguments regarding Morgan that may still be relevant will be addressed in the order they were presented. With respect to the first argument, there is a lack of evidence that the sensors 50 in Morgan are “fixed.” Instead, Morgan appears to provide evidence of the opposite, disclosing that “sensors 50 may be used in conjunction with any appropriate fixation device known in the art” and that an example of an “appropriate fixation device” may include “screws” (see para [0028] of Morgan). Therefore, if the sensors are used in conjuction with a screw, and a screw can threadinly be rotated into and out of a bone plate, then it appears that the sensors could also be inserted and removed (similar to the screw(s)) and therefore the sensor would not be fixed. Additionally, even if the sensors were fixed in Morgan, nothing the claim language precludes the sensors from being fixed. For example, claim 1 recites “the sensor positionable in any bore of the plurality of bores.” If a sensor is fixed in a bore, then it is positionable in that bore. With respect to the second argument, the claimed “first side” and “second side” are not defined in the claim with respect to the implant. Therefore, the sensor 50 on the right side shown in Fig. 3 and the sensor 50 on the left side shown in Fig. 3 meet the functional language of being on a first side of a fracture and a second side of a fracture because those sensors are spaced apart enough that a fracture could be located between them. With respect to the third argument, even though Morgan doesn’t use the exact same term of “nonunion” or “malunion,” it is describing the exact same concept. The amount of strain measured is proportional to the healing (i.e., the union) of the bone. If a bone is more healed (i.e., more union), then measured strain is lower. If a bone is less healed (i.e., less union), then the measured strain is higher. This is described in the citations provided in the rejection above.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791