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 .
Response to Arguments
Applicant's arguments filed 05/14/26 have been fully considered but they are not persuasive.
On pages 7-8 regarding claim objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws outstanding objections. Please see the objections below which have arisen out of amendments.
On pages 8-9 regarding 112 rejections Applicant argues amendments overcome the 112 rejections.
The Examiner respectfully disagrees, noting amendments do not appear to address the rejections of record. Additionally, please see the 112 rejections below which have been added due to claim amendments.
On pages 9-10 Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first section, the second section, the hollow central region, the first region of the bone, the second region of the bone, the length of the first section, thickness of the first section, length of the second section, thickness of the second section, the location of the stress shielding of the bone, a first location of reduced bone thickness, a second location of the bone, the first location of quality peripheral bone, the implant being stemmed, the implant being stemless must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the first region of the bone, the second region of the bone, the location of stress shielding of the bone, the first location of reduced bone thickness, the second location of the bone, the first location of quality peripheral bone, the first location of quality bone.
Claim Objections
Claims 11, 16-18, 30 are objected to because of the following informalities:
Claim 11 is objected to for referring both to “a part of a bone” and also “a first region of the bone” and “a second region of the bone” when it is unclear how, if at all, the “part” of the bone and the first and second regions relate to one another.
Claim 16 is objected to for having improper antecedent basis for “the location of stress shielding of the bone”.
This claim is further unclear for referring to “a first location of reduced bone thickness” and “a second location of the bone” when it is unclear how these relate, if at all, to the previously claimed “first region of the bone”, “second region of the bone”, and “part of a bone”.
The claim is further unclear for claiming “the location of stress shielding of the bone corresponds to a first location of reduced bone thickness compared to a second location of the bone”. It is unclear how a location of stress shielding corresponds to a first location of “reduced bone thickness” as compared to a “second location” of the bone. It is unclear how a location corresponds to one location compared to another. For example, a location of stress shielding could correspond to a first location, and that location could have a reduced bone thickness as compared to the thickness of a second location of bone, but as the claim is worded, it compares a location to two other locations which are compared.
Claim 17 is objected to for referring to “a first location of quality peripheral bone” and “a second location of the bone” when it is unclear how, if at all, these relate to the previously claimed “part of a bone”, “first region of the bone”, and “second region of the bone”. It is likewise unclear how the “quality peripheral bone” refers to the previously referred to “bone” of the patient.
Claim 18 is objected to for referring to “a first location of quality peripheral bone” and “a second location of the bone” when it is unclear how, if at all, these relate to the previously claimed “part of a bone”, “first region of the bone”, and “second region of the bone”. It is likewise unclear how the “quality bone” refers to the previously referred to “bone” of the patient.
Claim 30 is objected to for referring to “implant fixation” with improper antecedent basis. It is unclear how, if at all, the implant fixations are related to one another.
The claim is further objected to for referring to “stress shielding” multiple times with improper antecedent basis.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-30, 38-40 are rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 11-30, 38-40 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 11 is rejected for positively claiming a part of the human body. It states “the first section [of the device] is located in the first region of the bone and the second section [of the device] is located in the second region of the bone.” This positively claims the device within the bone of a human.
Remaining claims are rejected for depending on a claim which claims part of the human body.
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.
Claims 11-30, 38-40 are 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 11 is rejected for having new matter for claiming the central region is “hollow” when the originally filed disclosure fails to teach a device having a hollow central region. There is no support anywhere in the specification for the device’s center region being hollow.
There is likewise no support in the originally filed disclosure for the first section of the device being located in the first region of the bone and the second section of the device being located in the second region of the bone. The regions of bone are not discussed or shown anywhere in the disclosure, making this new matter.
Claim 16 is rejected for having new matter for claiming the location of stress shielding of the bone corresponds to “a first location of reduced bone thickness compared to a second location of the bone”. The originally filed specification does not refer to there being a first location of reduced bone thickness compared to a second location of the bone, making this new matter.
Claims 17-18 are rejected for having new matter for claiming the length of the first section is configured to engage with a first location compared to a second location. There is no support for this in the originally filed disclosure.
Remaining claims are rejected for depending on a claim with new matter.
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 11-30, 38-40 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 11 is indefinite for claiming “the first section and the second section are configured to reduce stress shielding in the bone by matching a first region of the bone and a second region of the bone with more uniform stress distribution compared to a symmetric implant, when the first section is located in the first region of the bone and the second section is located in the second region of the bone”. It is unclear what it means to “match” the two regions of the bone with “more uniform stress distribution”, since it isn’t understood how a bone region can “match” with stress distribution. It is further unclear because it states the reduction in stress shielding is done by “matching” the two sections with the more uniform stress distribution “compared to a symmetric implant” but it isn’t clear how one matches sections to a stress distribution compared to a different implant. The Examiner is unable to understand the language of this claim.
Claim 17 is indefinite for claiming the “length of the first section is configured to engage with a first location of quality peripheral bone compared to a second location of the bone”. It is unclear how the length engages with a location of bone compared to a second location. The Examiner is unsure how to interpret this claim.
The claim is further indefinite for referring to “quality peripheral bone” since 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 claiming the “length of the first section is configured to engage with a first location of quality bone compared to a second location of the bone”. It is unclear how the length engages with a location of bone compared to a second location. The Examiner is unsure how to interpret this claim.
The claim is further indefinite for referring to “quality bone” since the Examiner is unclear on what “quality” 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 30 is indefinite for referring to “implant fixation” but it is unclear what an implant, let alone its fixation, has to do with the claimed “device”.
The claim is further indefinite for claiming the two sections are configured to “improve implant fixation to the first region of the bone” when it is unclear what it means to “improve” fixation of the implant (assuming that “implant” is referring to the claimed “device”). 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 38 is indefinite for claiming “the asymmetric implant is formed due to asymmetry…by matching...the first region…and the second region of the bone with more uniform stress distribution compared to the symmetric implant”. It is first unclear what it means to form an implant “due to asymmetry”. It is likewise unclear what it means to form an implant due to symmetry by matching regions. The Examiner is unsure on how to interpret this claim.
Remaining claims are rejected for depending on an indefinite claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 11-13, 17-19, 30, 38-40 is/are rejected under 35 U.S.C. 103 as being unpatented over Bandoh et al. (US 20080234833 A1) hereinafter known as Bandoh in view of in view of Sperling (US 20190105169 A1).
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 and second section each extend outwardly from a central region of the device (Figures 2a-b show the two sections extending outwardly from a central region of the device),
wherein the device comprises an asymmetric implant due to asymmetry of the first material property and the second material property (Figures 2a-b show the implant being asymmetric),
wherein the first and second section are configured to reduce stress shielding in 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])) by matching a first region of the bone and a second region of the bone with more uniform stress distribution compared to a symmetric implant, when the first section is located in the first region of the bone and the second section is located in the second region of the bone (this appears to depend upon the bone into which the regions are implanted, as opposed to materially changing the structure of the claimed device itself),
but is silent with regards to the central region being hollow.
However, regarding claim 11 Sperling teaches that bone implants can have a hollow center ([0177]). Bandoh and Sperling 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 so that there is a hollow center in the device as is taught by Sperling in order to further decrease stress shielding of the device.
Regarding claim 12 the Bandoh Sperling Combination teaches the device of claim 11 substantially as is claimed,
wherein Bandoh further discloses the first material property includes thickness of the first section (Figure 2a-b shows how the first material 10 includes a thickness).
Regarding claim 13 the Bandoh Sperling Combination teaches the device of claim 11 substantially as is claimed,
wherein Bandoh further discloses the second material property includes thickness of the second section (Figures 2a-b shows how the second material 11 includes a thickness).
Regarding claim 17 the Bandoh Sperling Combination teaches the device of claim 11 substantially as is claimed,
wherein Bandoh further discloses the first material property includes a length of the first section (Figures 2a-b), and the length of the first section is configured to engage with a first location of quality peripheral bone compared to a second location of the bone (the length of the first section is considered able to engage with a first location of bone when implanted, if desired.).
Regarding claim 18 the Bandoh Sperling Combination teaches the device of claim 11 substantially as is claimed,
wherein Bandoh further discloses the first material property includes a thickness of the first section (Figure 2a-b), and the thickness of the first section is configured to engage with a first location of quality bone compared to a second location of the bone (the thickness of the first section is considered able to engage with a first location of bone when implanted, if desired).
Regarding claim 19 the Bandoh Sperling Combination teaches 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 the Bandoh Sperling Combination teaches 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 the first and second region of the bone by reducing stress shielding (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]).
Regarding claim 38 the Bandoh Sperling Combination teaches the device of claim 11 substantially as is claimed,
wherein Bandoh further discloses the asymmetric implant is formed due to asymmetry of the two material properties by matching, from two bone quality scores, the two regions of the bone with more uniform stress distribution compared to the symmetric implant (this appears to be a product-by-process claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. See MPEP 2113. In this case, the cited limitations failed to distinguish the claimed structure from Bandoh, since all the structural limitations of the claim appear to be met.).
Regarding claims 39-40 the Bandoh Sperling Combination teaches the device of claim 11 substantially as is claimed,
Bandoh further discloses the asymmetric implant is stemmed (Figure 2a), and Sperling further teaches stemless and stemmed implants are known, non-restrictable, obvious alternatives in the art (Abstract).
Claims 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bandoh and Sperling as is applied above, further in view of Berchem et al. (US 5150304 A) hereinafter known as Berchem.
Regarding claim 14 the Bandoh Sperling Combination teaches 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 the Bandoh Sperling Combination 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 Sperling Berchem Combination teaches the device of claim 14 substantially as is claimed,
wherein Berchem further teaches the surface coating treatment is asymmetric on a surface of the device (Column 3 lines 22-23 different thicknesses of coating).
Regarding claim 16 the Bandoh Sperling 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 first location of reduced bone thickness compared to a second location of the bone (this appears to depend on the physical structure of the bone as opposed to materially altering the structure of the device itself).
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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 05/26/26
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