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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/02/2026 has been entered.
Priority
The earliest priority date for this application is its filing date 02/17/2021.
Status of Claims
Claims 1, 4-10, 12, 14-16, and 18-22 are pending.
Claims 2, 3, 11, 13, and 17 have been cancelled.
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 plate like nanostructure of the independent claims must be shown or the feature(s) canceled from the claim(s). (The disclosure refers to Figure 15A as showing a plate like nanostructure, but there is nothing in Figure 15A that is platelike) 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.
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 1, 4-10, 12, 14-16, and 18-20 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 defines a mineral coated surface marker on the outer surface of the implant, which renders the claim indefinite because if it is coated then it cannot be on an outer surface of the implant. The surface coatings including the mineral coating are part of the implant. Therefore the outer surface must be the top of the mineral coating. The applicant is advised to delete the phrase “on the outer surface of the implant” from line 11 and use the following lines to better define its location.
Claim 1 has been amended to further define the radiographic layer as being disposed between an uncoated portion of the plurality of lyophilized porous macroparticles and the mineral coated surface marker, which renders the claim indefinite. First, it is unclear how the there can be an uncoated surface portion of the plurality of lyophilized porous macroparticles, when they are covered with the mineral coating. Second it is unclear how the radiographic layer can be between the mineral coated surface marker, when the claim defines the radio graphic layer as part of the mineral coated surface marker in the previous lines. Finally, the claims now define the radiographic layer in relation to other portions of the implant making it a distinct component, but the original disclosure defines the macro and nano particles having recesses that form radiographic markers not a true layer. In its current form the claims essentially require a distinct layer of the markers, but there does not appear to be any markers other than defined by the macro and nanoparticles. The applicant is advised to amend this phrase to better define the markers as being at the intersection of the macro and nanoparticles.
The applicant has amended independent claim 1 to define the plate-like nanostructure comprising nanoparticles having a size range from 10 to 100 nanometers, but claim 7 depends upon claim 1 and still defines the range as being from about 100 to about 200 nanometers. Therefore claim 7 is rendered indefinite because the dependent claim does not further define the original range. The ranges are separate meaning the nanoparticles cannot be consistent with both recitations. The applicant is advised to cancel claim 7 as was done to similar claim 17.
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, 15, 16, and 18-22 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 mineral coated surface marker comprising a radiographic layer disposed between an uncoated portion of the plurality of lyophilized porous macroparticles and the mineral coated surface marker to allow a measurement to be taken of 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 patterned layout and distinct 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. Additionally, as explained in the 112 rejection above, the applicant’s own invention does not clearly disclose the radiographic layer and its position. Grinberg discloses the projections and recesses (Figures 5A-C) defining an outer radiographic layer (Figures 5A-C appear to use radiography to show them), which when modified below according to Jong will be positioned between the macro and nano particles of the mineral coating.
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 plate-like nanostructure ([0029] discloses the mineral coating is plate like) comprising a nano-sized feature comprising a carbonate-substituted, calcium-deficient hydroxyapatite component (see abstract and paragraph [0029]) having a size range from 10 to 100 nanometers (see [0022], which discloses about 100 nanometers which include 100 nanometers as well as numerous sizes under 100 nanometers because of the “about” recitation) 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).
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 comprising a plate-like nanostructure comprising nanoparticles having a size range from 10 to 100 nanometers (Jong [0029] [0022]), 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 radiographic layer positioned an uncoated portion of the plurality of lyophilized porous macroparticles and the mineral coated textured surface marker that allows a measurement to be taken of bone growth within or bone growth adjacent to the bone implant from the radiographic layer, it is still considered to be an intended use because the step is not positively claimed. 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).
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]).
21. Grinberg in view of Jong disclose all the components of the implant as explained with respect to claim 1 above. Grinberg in view of Jong discloses a bone implant 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 plurality of lyophilized porous macroparticles coated with a mineral coating (Jong [0029] [0022]), the mineral coating comprising a nano-sized feature comprising a carbonate-substituted, calcium-deficient hydroxyapatite component (see Jong abstract and paragraph [0029]), the bone implant comprising a plurality of recesses, projections or a combination thereof (see projections and recesses of Grinberg Figures 5A-C), wherein the mineral coating comprises a plate-like nanostructure comprising nanoparticles having a size range from 10 to 100 nanometers (Jong [0029] [0022]).
22. Grinberg in view of Jong discloses the recesses, projections or a combination thereof form square, cylindrical, corrugated, notches, curve, waffle, hexagonal honeycomb shapes in a pattern or randomly about the bone implant (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).
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, 15, 16, and 18-22 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 04/02/2026 have been fully considered but they are not persuasive.
The applicant argues that the surface marker is an integration of the surface feature, mineral coating and radiographic layer, which is structurally different from the fenestration in Grinberg. This explanation is consistent with why the claims are rendered indefinite. If the surface marker is an integration of these components how can they be separately claimed. How can there be a radiographic layer between them if it is part of them.
The applicant goes on to argue that a surface marker is not some arbitrary point that is subjectively determined when conducting a computed tomography (CT) imaging as in Grinberg. The surface markers in the mineral coating is disposed between the uncoated graft and the coated graft such that this geographical location allows accurate measurement from such surface marker to determine the bone growth. A clinician would not rely on unclear subjective judgment of where the bone growth starts by mere fenestrations as in Grinberg but in the current application is able to determine the exact growth using the radiographic layer. This is not persuasive because a surface marker is just that, an arbitrary point that the operator decided to rely on. As explained above there are numerous surface markers in Grinberg that can be specifically identified such as intersections of surfaces, midpoints, and endpoints. These points are positioned and identifiable on the base structure of the implant before applying the mineral coating of Jong, which will result in the same structure as the applicant’s invention. They are not unclear or subjective. The points can be readily defined and located using standard imaging.
The applicant further argues that the fenestration of Grinberg do not generate a uniform radiographic layer and the positions are not consistent due to the growth of bone repairs. This is not persuasive because the claims do not require nor does the current application disclose a uniform radiographic layer. They merely require a layer which is part of the mineral coated surface marker. As well as the numerous points identified above that can function as surface markers, the highest and lowest point of each peak and valley would also be readily identifiable as surface markers defining the radiograph surface extending along them. Then CT imaging would allow for the operator to determine the change in height or depth of the peaks and valleys to measure the amount of ingrowth. The CT imaging does not need to clearly depict every part of the bone implant, it only needs to depict a single point. This point is among an infinite number of identifiable points along the surface of the implant. Grinberg already discloses numerous points in peaks and valleys of Figures 5B-C as well as measurable midpoints, intersections, and endpoints in Figure 5A. Furthermore if standard CT imaging is not capable of identifying the initial surface features of an implant prior to ingrowth, then how could it possibly identify the specific surface of the ingrowth surface features. Certainly if it can be used to accurately identify the surface growth of the applicant’s implant after growth has occurred, it would be capable of accurately identifying both the initial and final surface features of the prior art combination.
The applicant then argues that their proposed uncertainty of Grinsberg is not the case with their invention because of the claimed nano-sized mineral coating comprising a plate-like nanostructure comprising nanoparticles having a size range from 10 to 100 nanometers. This is not persuasive because Jong has been relied upon to teach this exact configuration. Therefore if this clause supports the elimination of uncertainty, the prior art combination does not have the applicant’s proposed uncertainty.
With respect to Jong the applicant argues that this reference is silent on forming surface markers for radiographic identification or measurement. This argument is misplaced because the office action does not rely on Jong for forming the markers or taking measurements. The markers are inherently present because of the base structure of Grinberg. Adding the coating of Jong merely defines the markers between the two components in the same manner as the applicant’s own invention.
The applicant further argues that Grinberg gives no specific reason to apply the specific coating of Jongpaiboonkit to the implant. This argument is misplaced because if Grinberg did provide such a reason the rejection would have been a 102 rejection without the teachings of Jong. How could a base reference in a 103 rejection be expected to teach the same feature that has been identified as missing?
The applicant further argues that there is no indication that such coating is applied as part of the s surface marker on the exterior s surface of the implant, so that it can act as a reference point. This is not persuasive because as explained above the claims only require the presence of a reference point, which every solid object inherently has. Neither the apparatus nor the method claims positively define any step of taking measurements. They merely require the points to allow for measurements to be taken based on them, which again every solid object inherently can.
With regards to claim 21, this limitation has been addressed clearly above (See Jong [0029] [0022].
With respect to Zihlmann, that applicant’s arguments are moot because Grinberg and Jong already disclose these claimed elements.
Conclusion
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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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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