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 of invention II (claims 11-19, 30) in the reply filed on 12/10/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-8, 10, 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/10/25.
Claim Objections
Claims 11, 14, 15, 30 are objected to because of the following informalities:
Claim 11 is objected to for missing a word after “device” in line 5.
Claim 14 is objected to for referring to “stress shielding” when it is unclear if this is the same “stress shielding” referred to in claim 11 or not.
Claim 15 is objected to for referring to “the surface of the device” with improper antecedent basis.
Claim 30 is objected to for referring to “a region of the bone” with improper antecedent basis.
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.
Claims 16-18, 30 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 pre-AIA the applicant regards as the invention.
Claim 16 is indefinite for referring to “a location of reduced bone thickness” but I is unclear what “reduced bone thickness” means, and what the bone thickness is reduced compared to (e.g. Is it reduced thickness compared to another person? Compared to another area of bone? Compared to an area of healthy bone? etc.). Without context that specifies exactly that the reduction is and what is compared to, the Examiner cannot understand the meaning of the term. Further, the specification does not refer to “reduced bone thickness” anywhere, meaning the Examiner cannot find guidance or context in the specification regarding the term. Since the Examiner cannot understand the meaning of the term, the boundaries of the claim cannot be determined, and the claim is indefinite.
Claim 17 is indefinite for referring to “quality peripheral bone”. First, it is unclear whether or not the “peripheral bone” is related to the previously claimed “bone” of claim 11. Further however, the Examiner is unclear on what “quality” peripheral bone is.
Paragraph [0048] states that bone scores can be qualified on a scale of 1-10, with 1 being “low” and 10 being “high”, but it is unclear whether “quality” bone includes “low” scores, and also where the delineation is between not quality and quality. Paragraphs [0067]-[0070] also describe how certain implants are used for “better” or “poorer” bone quality, but this still does not guide a person of ordinary skill as to what limits or qualities must be present in the bone to be considered to meet the limitations of the claim. While discussions of quality of bone are made throughout the specification (e.g. [0045] discusses determining the quality of a bone, [0044] discusses quantifying the quality of a bone), but no part of the specification creates a boundary between what would be considered “quality” and what would be considered “not quality”. This means the Examiner cannot determine what bone would or would not meet the requirements of this claim.
Claim 18 is indefinite for the same reasons as claim 17 regarding “quality bone”, and being unclear whether or not the “bone” referred to in the claim is the same or different bone than was referenced in claim 11.
Claim 30 is indefinite for claiming the two sections are configured to “improve implant fixation to a region of the bone” when it is unclear what it means to “improve” fixation of the implant. It appears an “improvement” would require a comparison (e.g. improve fixation as compared to…), but the claim does not indicate what the improvement is based against. The specification states that the implant fixation can be improved via the implant shape ([0046]), but it isn’t clear what the improved fixation is compared to. Further, the specification states that long-term fixation can be improved by decreasing stress shielding ([0042]), but the claim does not mention long-term fixation, and also does not mention what improvement is compared to. Without understanding with the improvement is compared to, the Examiner cannot understand the boundaries of the claim.
Claim Rejections - 35 USC § 102
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 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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11-13, 19, 30 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bandoh et al. (US 20080234833 A1) hereinafter known as Bandoh.
Regarding claim 11 Bandoh discloses a device for repairing a part of a bone in a subject (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Bandoh was considered capable of performing the cited intended use. See, for example [0173] which indicates how the device is used as an implant to connect joints which have been damaged) comprising:
a first section (Figure 2a-b item 10) having a first material property (this is considered to be inherent),
a second section (Figure 2a-b item 11) having a second material property (this is considered to be inherent),
wherein the first section is connected to the second section at a central region of the device (Figure 2a-b shows the two sections connected at a region which is considered a central region, [0121]), thereby forming an asymmetric implant (Figure 2a-b shows how the implant is asymmetric),
wherein the first section and second section are configured to reduce stress shielding to a region of the bone (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Bandoh discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0154]).
Regarding claim 12 Bandoh discloses the device of claim 11 substantially as is claimed,
wherein Bandoh further discloses the first material property includes thickness (Figure 2a-b shows how the first material 10 includes a thickness).
Regarding claim 13 Bandoh discloses the device of claim 11 substantially as is claimed,
wherein Bandoh further discloses the second material property includes thickness (Figures 2a-b shows how the second material 11 includes a thickness).
Regarding claim 19 Bandoh discloses the device of claim 11 substantially as is claimed,
wherein Bandoh further discloses the bone is a humerous and a joint that includes the bone is a shoulder (this does not appear to materially affect the structure of the claimed device; however see also [0173] which indicates how the invention can be for use within a shoulder joint).
Regarding claim 30 Bandoh discloses the device of claim 11 substantially as is claimed,
wherein Bandoh further discloses the first and second section are configured to improve implant fixation to a region of the bone (this is stated as a functional limitation of the first and second section (see the explanation regarding “functional limitations” above. See also [0154] in which it is discussed how stress shielding is controlled, which the Examiner understands as improving implantation fixation (see the specification [0042]).
Claim Rejections - 35 USC § 103
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 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bandoh as is applied above in view of Berchem et al. (US 5150304 A) hereinafter known as Berchem.
Regarding claim 14 Bandoh discloses the device of claim 11 substantially as is claimed,
but is silent with regards to the first or second material property including a surface coating.
However, regarding claim 14 Berchem teaches a device for repairing part of a bone of a subject (Column 1 lines 15-16) which includes a first or second section which includes a surface coating treatment of the device which corresponds to a location of stress shielding of the bone (Column 3 lines 21-29). Bandoh and Berchem are involved in the same field of endeavor, namely bone implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Bandoh by including a surface treatment as is taught by Berchem in order to create a coating that encourages ingrowth into the bone, thus improving long term fixation after implantation.
Regarding claim 15 the Bandoh Berchem Combination teaches the device of claim 14 substantially as is claimed,
wherein Berchem further teaches the surface coating treatment is asymmetric on the surface of the device (Column 3 lines 22-23 differenty thicknesses of coating).
Regarding claim 16 the Bandoh Berchem Combination teaches the device of claim 14 substantially as is claimed,
wherein the Combination further teaches the location of stress shielding of the bone corresponds to a location of reduced bone thickness (this appears to depend on the physical structure of the bone as opposed to materially altering the structure of the device itself).
Claims 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bandoh as is applied above in view of Sperling (US 20190105169 A1).
Regarding claim 17 Bandoh discloses the device of claim 11 substantially as is claimed,
but is silent with regards to the first or second material property including a fin length.
However, regarding claim 17 Sperling teaches a device for repairing part of a bone of a subject (Abstract) which includes a first section (Figure 3b, one side of the implant delineated by item 104) having a first fin length (Figure 3a-c shows fins which have a length in the first section) and a second section (Figure 3b, the other side of the implant delineated by item 104) having a second fin length (Figure 3a-c shows fins which have a length in the first section),
wherein the fin length is configured to engage with quality peripheral bone (this is stated as an “intended use” of the fin (see the explanation regarding “intended use” statements above. The length of the fin is understood to be capable of engaging with any bone). Bandoh and Sperling are involved in the same field of endeavor, namely joint implant devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Bandoh so that the first and second material properties include a fin (which inherently includes a length) as is taught by Sperling in order to create an anchoring feature into which bone can grow during healing after implantation, thus improving long-term fixation.
Regarding claim 18 Bandoh discloses the device of claim 11 substantially as is claimed,
but is silent with regards to the first or second material property including a fin thickness.
However, regarding claim 18 Sperling teaches a device for repairing part of a bone of a subject (Abstract) which includes a first section (Figure 3b, one side of the implant delineated by item 104) having a first fin thickness (Figure 3a-c shows fins which have a thickness in the first section) and a second section (Figure 3b, the other side of the implant delineated by item 104) having a second fin thickness (Figure 3a-c shows fins which have a thickness in the first section),
wherein the fin thickness is configured to engage with quality bone (see the explanation regarding “intended use” statements above. The thickness of the fin is understood to be capable of engaging with any bone). Bandoh and Sperling are involved in the same field of endeavor, namely joint implant devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Bandoh so that the first and second material properties include a fin (which inherently includes a thickness) as is taught by Sperling in order to create an anchoring feature into which bone can grow during healing after implantation, thus improving long-term fixation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 01/05/25