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 .
Priority
The earliest priority date for this application is its filing date 02/17/2021.
Status of Claims
Claims 1, 4-10, 12, and 14-20 are pending.
Claims 2, 3, 11, and 13 have been cancelled.
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, 5-10, 12, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Grinberg et al (Grinberg) US 2017/0319750 A1 in view of Jongpaiboonkit et al (Jong) US 2020/0384154 A1.
1. Grinberg discloses a bone implant and methods of making/using it (see paragraph [0020]) comprising a plurality of lyophilized porous macroparticles comprising ceramic material and collagen (see paragraph [0035]; the porous collagen component and porous calcium ceramic granules are considered porous macroparticles, which are mixed and delivered into a mold and lyophilized to form the implant),
the bone implant comprising a plurality of recesses, projections or a combination thereof (fenestrations, which are considered recesses; see paragraph [0036]), wherein the plurality of recesses, projections or a combination thereof form square, cylindrical, corrugated, notches, curve, waffle, or hexagonal honeycomb shapes in a pattern or randomly about the bone implant such that the plurality of recesses, projections or a combination thereof are configured to form identification markers (see Figures 5A-5B illustrating waffle, square, and cylindrical shaped fenestrations/recesses which are readily locatable based on their shape and location to act as identification markers).
In regards to the requirement for these recesses, projections or combination thereof to be a surface marker comprising a reference point in a radiographic layer that allows measuring bone growth within or bone growth adjacent to the bone implant, is considered to be an intended use. The claim recitations defining how and where the applicant’s invention is used are considered to be intended use limitations. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. A recitation of the intended use of the claimed 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. Additionally, Grinberg discloses that the healing and progress of spinal fusion (bone ingrowth) is monitored after implantation using radiographic and computed tomography (CT) imaging [0040]. Grinberg does not specifically disclose that his recesses are used as reference points to measure this ingrowth, but it is inherent that every surface is made up of an infinite number of reference points. For example the center of the surface, the midpoint of each edge, the intersection of any two lines, the center of each recess, or the center of each projection. These markers and points are fully capable of “allowing” the operator for tracking the progression and measuring change. A person of ordinary skill in the art would recognize that the uniform layout and pattern of the fenestrations of Grinberg have a consistent position with known spacing, which would allow them to be used as reference points to measure the bone growth when it was being monitored by radiography and tomography imaging.
Although Grinberg discloses the implant, which includes the plurality of lyophilized porous macroparticles, may be coated, Grinberg fails to specifically disclose a mineral coating, the mineral coating comprising a nano-sized feature comprising a carbonate-substituted, calcium-deficient hydroxyapatite component.
Jong also discloses a scaffold that can be used as a bone implant (see paragraphs [0070] and [0075]). Jong teaches the implant is coated with a mineral coating, the mineral coating comprising a nano-sized feature comprising a carbonate-substituted, calcium-deficient hydroxyapatite component (see abstract and paragraph [0029]) in order to provide a surface that is similar in composition to bone tissue, promotes favorable interactions with natural bone, and is osteoconductive, thereby capable of inducing new bone formation in vivo (see paragraphs [0006] and [0009]).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Grinberg’s bone implant, which includes the plurality of lyophilized porous macroparticles, with a mineral coating along the entire outer surface including the all recesses and projections, the mineral coating comprising a nano-sized feature comprising a carbonate-substituted, calcium-deficient hydroxyapatite component, as taught by Jong. Doing so would provide the implant with a surface that is more similar in composition to bone tissue, thereby promoting favorable interactions with natural bone and inducing new bone formation.
5 and 18. The combination of Grinberg and Jong disclose an implant made of the same materials as the applicant’s invention which results in it inherently being rollable in the same manner as the applicant’s invention. However, the combination does not disclose the final surface area of the implant. It is old and well known bone defects and injuries come in all shapes and sizes. It would have been obvious to one of ordinary skill in the art of bone implants to form the implant of Grinberg to have a surface area of at least about 2 m2/g to about 100 m2/g in order to fit many commonly known bone defects.
6 and 15. Grinberg discloses the bone implant has pores (i) from about 50 microns to about 500 microns for bone growth (300 microns disclosed within claim 1).
7 and 17. Jong discloses the mineral coating comprises nanostructure comprising nanoparticles having a size range from about 100 to about 200 nanometers [0022].
8. Jong discloses the nano-sized feature of the coating comprises a nanoparticles [0199] [0210].
9. Jong discloses (i) the mineral coating comprises a calcium- containing mineral, the calcium-containing mineral is hydroxyapatite [0137].
10. Grinberg in view of Jong disclose all the components of the implant as explained with respect to claim 1 above. Grinberg and Jon further disclose the method of making such an implant (Grinberg Example 1) comprising the steps of providing the macroparticles (Grinberg [0022]) coating them with a mineral coating (Jong [0029]), and adding the macroparticles to a slurry to form a mixture (Grinberg [0035]) that forms the implant, wherein the mineral coating comprising a nano-sized feature comprising a carbonate-substituted, calcium-deficient hydroxyapatite component, and lyophilizing the mixture to form the mineral coating on the outer surface of the implant (see Jong abstract and paragraph [0029]).
In regards to the requirement for these recesses, projections or combination thereof to be a surface marker comprising a reference point in a radiographic layer that allows measuring bone growth within or bone growth adjacent to the bone implant, it is still considered to be an intended use. The claim recitations defining how and where the applicant’s invention is used are considered to be intended use limitations. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. A recitation of the intended use of the claimed 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. As explained above the combination applied the mineral coating to all outer portions and surfaces of the implant forming the textured surface including the recesses/projections, inherently includes a plethora of reference points which can be used in the claimed intended use or as claimed ”allows measurement”.
As explained above, Grinberg discloses that the healing and progress of spinal fusion (bone ingrowth) is monitored after implantation using radiographic and computed tomography (CT) imaging [0040]. Grinberg does not specifically disclose that his recesses are used as reference points to measure this ingrowth, but it is inherent that some markers and points must have been used by the operator for tracking the progression and measuring change. A person of ordinary skill in the art would recognize that the fenestrations of Grinberg have a consistent position with known spacing, which would allow them to be used as reference points to measure the bone growth when it was being monitored by radiography and tomography imaging.
12. Grinberg discloses the plurality of recesses, projections or a combination thereof are etched into the implant (Fenestrations may be generated after molding using etching processes such as punching or cutting [0036]).
16. Grinberg discloses the bone implant has pores from about 500 microns to about 5 mm for vascularization (Claim 7).
19. Grinberg in view of Jong disclose all the components of the implant and its material characteristics as explained with respect to claim 1 above. Grinberg and Jon further disclose the method of using such an implant comprising the steps of implanting the implant into a defect (Grinberg Example 2).
In regards to the requirement for these recesses, projections or combination thereof to be a surface marker comprising a reference point in a radiographic layer that allows measuring bone growth within or bone growth adjacent to the bone implant, within a method of use claim it is given more weight. It is noted that the claims do not actively require the step of measuring or determining the reference points. The claims merely define the reference point as allowing for measurement. Every identifiable point on the surface of the implant of Grinberg is inherently capable of allowing for measurement of growth within or adjacent to it. As long as a point is identifiable and visible the ability to measure ingrowth requires no special feature or property.
Regardless, Grinberg discloses that the healing and progress of spinal fusion (bone ingrowth) is monitored after implantation using radiographic and computed tomography (CT) imaging [0040]. Grinberg does not specifically disclose that his recesses are used as reference points to measure this ingrowth, but it is inherent that some markers and points must have been used by the operator for tracking the progression and measuring change. Without reference points a precise measurement of the growth cannot be obtained. A person of ordinary skill in the art would recognize that the fenestrations of Grinberg have a consistent position and shape, with known spacing, which would allow them to be used as reference points to measure the bone growth when it was being monitored by radiography and tomography imaging. The preexisting fenestrations of Grinberg have no structural difference than any other marker when merely being used to measure distance.
20. Jong teaches the bone implant should be hydrated with fluid comprising bone marrow aspirate, saline, sterile water, blood for injection, phosphate buffered saline, dextrose, sodium lactated solution, or a combination thereof before, during or after the bone implant is implanted into the bone defect (Jong discloses the use of a modified simulated body fluid to hydrate the implant comprising phosphates and blood plasma [0103] [0104]).
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Grinberg in view of Jong (Combination 1) as applied to claims 1, 5-10, 12, and 15-20 above, and further in view of Zihlmann et al (Zihlmann) US 2020/0390934 A1.
Combination 1 discloses the invention substantially as claimed being described above. Grinberg further discloses the macroparticles may have an average diameter from about 0.1 mm to about 10 mm (Claim 21). However, Combination 1 does not disclose the specific weight percentages of the ceramic and collagen.
Zihlmann teaches the use of a composite matrix comprising 3-40 wt% collagen [0135] and 60-97 wt% [0135] of the remaining bone substitute material in the same field of endeavor for the purpose of optimizing biocompatibility and ingrowth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bone implant of Grinberg to provide the ceramic/collagen in the weight percentages taught by Zihlmann in order to optimize biocompatibility and ingrowth.
Response to Arguments
Applicant's arguments filed 10/28/2025 have been fully considered but they are not persuasive.
The applicant argues that it would not be obvious to use fenestrations of Grinberg as indicia for determining reference points because Grinberg provides no such teaching. This argument is misplaced because the claims never positively require the step of measuring the growth based on the reference points. Furthermore the majority of claims are directed at the implant or a method of making the implant, so a positively claimed step would only be given limited weight because it would be a recitation of intended use.
The applicant then argues that the examiner alleges that the marker is unpatentable intended use. This is a misinterpretation of the prior art rejection. Intended use may be patentable, but it is given limited weight in the circumstances identified above. Furthermore the claims still fail to positively require the step of using the markers or reference points for measuring. They only require the reference point to allow for measuring.
The applicant then identifies Grinberg as disclosing the fenestrations to be used for enhancing ingrowth and separately disclosing the step of monitoring the ingrowth. This is argued as proof that there is no link between the use of fenestrations and the observance/measuring of the ingrowth. This argument is also misplaced because as stated above there is no claimed requirement for the step of measuring the ingrowth. The claims are extremely broad and only require the features to define a reference point that allows measuring of the ingrowth. The fenestrations, projections, and every other part of the surface define an infinite number of reference points. For example the reference points could be at the intersections of portions of the features, at the middle of the feature, at an edge of the feature, at a corner of the feature, at the middle of the entire implant, at a corner of the entire implant, at a corner of the entire implant, or any identifiable point throughout. Additionally, there is no structural or physical property that a reference point needs that would provide it with the ability to allow measuring of ingrowth. As long as the reference point is identifiable and visible with some means then it can be referenced by the user to measure ingrowth. Therefore the implant of the prior art combination inherently has a plethora of reference points that read upon the claimed intended use/functionality.
The applicant further argues that a reference point in a radiographic layer is clearly not disclosed anywhere in Grinbergs fenestrations. It is unclear how the plethora of reference points are not in a radiographic layer of the prior art combination. The implant and coatings of the prior art combination comprise the same claimed materials with the same claimed shapes. There fore the outer layer of the prior art combination is as much a radiographic layer as the applicant’s own invention with, as explained above, a plethora of reference points.
The applicant then argues that these features are no intended use but are a purpose driven configuration. This is not persuasive because it is just a rewording of the clause with the same meaning and the purpose is merely to be a point from which a measurement can be taken. Every identifiable point can have a measurement taken from it. If I place a random stick at any point in my yard it is fully capable of allowing for me to measure the growth of the grass around it. I can place the stick at any point in the yard and call that my reference point. I could be deliberate and place it relative to a divot or bump so that the reference point is more readily identifiable. Or I could place it in the very middle of my yard. Regardless of the location, there are an infinite number of reference points within my yard and every single one of them would allow for measuring the growth of my grass around it. As explained above, the same principle applies the prior art implant.
The applicant argues that the examiner has not supplied any factual evidence to support the functional leap that a reference point of the prior art can allow for measuring ingrowth around it. There is no need for scientific experimentation or factual evidence because this is an extremely simply concept. A person of ordinary skill in the art can easily identify a reference point within the middle of any fenestration of the prior art implant. That reference point inherently allows for measurement of the ingrowth around it.
The applicant then argues that the addition of Jongpaiboonkit and Zihlmann do not provide the prior art combination with a surface layer that is an identification marker or textured surface. This is not persuasive because Grinberg already discloses the implant comprises the fenestrations which are merely coated by the coating of Jong and made using the ranges of Zihlmann. The surface will maintain the textured surface of Grinberg including the fenestrations. As explained above every surface has numerous identifiable reference points which allow for measurements to be taken around them.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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