DETAILED ACTION
Claims 1-20 are currently pending and under examination.
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 without traverse of Species C in the reply filed on 01/05/2026 is acknowledged.
Applicant has elected species C wherein a specific election in each of species A, B, C and D were required. However, upon further consideration the species election has been withdrawn.
Priority
The instant application claims priority to provisional application 63/313,376, filed 02/24/2022.
Information Disclosure Statement
No Information Disclosure Statement has been filed in the instant application. Applicants are reminded of their duty to disclose all information known to them to be material to patentability as defined in 37 C.F.R. 1.56.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 contains the limitation “DMB-gelatin” in the second to last line which appears to be a typographical error for DBM-gelatin. 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 9-10 and 12-16 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 9 contains the limitation of packaging the implant in a “sterile hydration container”. Sterile hydration container is not known in the art or described in the instant specification. It is unclear if the hydrate container includes a liquid to hydrate, is capable of holding liquids already present in the graft or capable of liquid being applied to ‘hydrate’. The metes and bound of what a hydration container includes is ambiguous. Dependent claim 10 is additionally rejected as not clarifying the ambiguity of claim 9.
Claim 10 contains the limitation securing the DMB gelatin allograft implant between two portions of severed bone to promote bone growth. Claims 1 and 8-9 from which claim 10 dependents, are directed to methods of making a bone graft including packaging in a sterile container. Claim 10 appears to be directed to using said bone graft between bone. Mixing of method of making claims and method using claims leads to unclear scope and metes and bounds of the claim as to what is required.
Regarding claim 12, the term “low-moisture” in claim 12 is a relative term which renders the claim indefinite. The term “low-moisture” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The instant claim has unclear metes and bounds as ‘low moisture collagen carrier’ and ‘firm implant’ are relative terms, it is unclear the scope of ‘low moisture’ and ‘firm’, as compared to what? Claim 13 is further rejected as being deponent on claim 12 and not clarifying the ambiguity.
Claim 13 contains the limitation “packaging the firm implant in a saline hydration container”. Saline hydration container is not known in the art or described in the instant specification. It is unclear if the saline hydration container includes saline to hydrate, capable of holding saline already present in the graft or capable of liquid being applied to hydrate. It is unclear if saline is provided in the container how the implant would maintain “low moisture” as is required by instant claim 12. Thus the metes and bounds of the instant claim are ambiguous.
Regarding claims 14 and 16, the term “high-moisture” in claim 14 and 16 is a relative term which renders the claim indefinite. The term “high-moisture” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The instant claim has unclear metes and bounds as ‘high moisture collagen carrier’ is a relative term, it is unclear the scope of ‘high moisture’, as compared to what? Claims 15-16 are further rejected as being dependent on claim 14 and not clarifying the ambiguity.
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 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 4,472,840.
Regarding claim 1, the limitation of a method of forming a bone graft, the method comprising forming a demineralized bone matrix from an initial bone material, mixing in a solution the DBM with a gelatin carrier to form a DBM-gelatin solution and performing a crosslinking reaction with the DBM-gelatin solution to form a DBM-gelatin matrix allograft material is met by the ‘840 patent teaching allogenic bone material was obtained from human cadavers, cleaned, pulverized, milled and sieved into bone powder. Demineralized bone powder was prepared. Collage-DBP conjugates were prepared by forming collagen, adding DBP slowly to the collagen dispersion. Glutaraldehyde crosslinking is taught to include mechanical strength (column 3, line 50 to column 4, line 10).
Regarding claim 5, the limitation of wherein the DBM is mixed with the gelatin carrier to form the DBM-gelatin solution at a DMB:gelatin carrier ratio of 20% to 50% is met by the ‘840 patent teaching preferably DBP is present from 5-35%, most preferably from about 10 to about 20 weight percent, balance collagen (column 3, lines 30-40).
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.
The factual inquiries 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.
Claim(s) 1-5 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4,472,840 in view of US 2017/0304494 and US 6,911,212.
Regarding claims 1 and 18, the limitation of a method of forming a bone graft, the method comprising forming a demineralized bone matrix from an initial bone material, mixing in a solution the DBM with a gelatin carrier to form a DBM-gelatin solution and performing a crosslinking reaction with the DBM-gelatin solution to form a DBM-gelatin matrix allograft material is met by the ‘840 patent teaching allogenic bone material was obtained from human cadavers, cleaned, pulverized, milled and sieved into bone powder. Demineralized bone powder was prepared. Collage-DBP conjugates were prepared by forming collagen, adding DBP slowly to the collagen dispersion. Glutaraldehyde crosslinking is taught to include mechanical strength (column 3, line 50 to column 4, line 10).
Regarding claim 3, the limitation of wherein forming the DBM from the initial bone material includes demineralizing a bone powder via three incubations of one hour with 0.5 N HCl to create an initial DBM material, washing the initial DBM material with water until reaching a pH of 7.4 to form washed DBM material is met by the ‘840 patent teaching demineralized bone powder was prepared by extracting the previously prepared bone powder particles with 0.5M HCl for 3 hours at room temperature followed by six washes in sterile distilled water to remove all acids and calcium, followed by four sequential 60 minute washed in absolute ethanol. The limitation “three incubations” at one hour is met by the ‘840 patent teaching extracting the bone powder of HCl for 3 hours at room temperature, three incubations is not defined in the claims or instant specification, therefore one extraction for the full time period of 3 hours is deemed to meet the instant claim limitations. The 3 total hours reads on performing 3-1hr incubations.
Regarding claim 5, the limitation of wherein the DBM is mixed with the gelatin carrier to form the DBM-gelatin solution at a DMB:gelatin carrier ratio of 20% to 50% is met by the ‘840 patent teaching preferably DBP is present from 5-35%, most preferably from about 10 to about 20 weight percent, balance collagen (column 3, lines 30-40). As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
Regarding claim 19, the limitation of drying the DBM-gelatin matrix allograft a predetermined time period to reach a predefined moisture content, the predefined moisture content corresponding to a type of allograft is met by the ‘840 patent teaching drying the specification to obtain a semi-rigid foam to form a bone graft (title, abstract, Example 1). The predefined time, moisture content are not specified therefore the drying time and moisture content taught by the ‘840 patent meets the instant claim limitation resulting in the allograft.
Regarding claim 20, the limitation of wherein the type of allograft is at least one of a gel or an implant is met by the ‘840 patent teaching a foam (example I) which is to be implanted (column 3, lines 1-10).
The ‘840 patent does not specifically teach forming the DBM from the initial bone material includes milling or griding cut bone pieces to form a bone powder having 200-1000 um particles and sieving the bone powder for 400-800 um particles (claim 2).
The ‘840 patent does not specifically teach a pH of 7.4 (claim 3).
The ‘840 patent does not specifically teach freezing the washed DBM material at -80 degrees C for 48 hours to form a frozen DBM material and lyophilizing the frozen DBM material for 48 hours (claim 3).
The ‘840 patent does not specifically teach bovine-based collagen (claims 4 and 18).
The ‘494 publication teaches demineralized bone composition consists of cortical bone wherein the bone is cut and freeze dried. The bone particles are mixed with gelatin to form a malleable putty or paste (abstract). The bone particles are cut into pieces having a width, length and thickness from 1 to 4mm, freeze died and ground to form the cortical ground particles that are less than 1,000 microns and greater than 100 microns and sieved to a first range of 125 to 200 microns or 300 to 500 microns [0006], reading on claim 2. The cortical bone is cut, morselized or shaved, ground, sieved at different sizes, demineralized and freeze dried to obtain cortical bone particles [0027]. After rinsing with water, the bone particles are placed in a metal cube, stored at -80 degrees C and then freeze dried. The freeze-drying cycle is set to fun for 33 hours 50 minutes. It is understood the timing, ratios and volumes can vary based on the equipment and procedures used and the above is preferred process for the inventor’s equipment [0029].
The ‘212 patent teaches Malleable bone putty and flowable paste for a bone defect site comprising demineralized lyophilized allograft bone material of the size 100 to 800 microns. The compristion has a pH of 6.8-7.4 (abstract). Demineralized allograft bone is usually available in lyophilized or freeze dried and sterile form to provide extended shelf life (column 2, lines 55-67). It is important to maintain any surgical implant which is in intimate contact with blood at a biocompatible condition of about pH 7.2 to 7.4 (column 9, lines 1-10). It is important to neutralize the acid used to demineralize bone so as to assure that there is not residue of this very strong acid which could overwhelm the buffer compacity of the carrier, the pH is adjusted to 7.2 to 7.4 (column 9, lines 10-30). Bovine and Human collagen are taught to be used in the formulation of allograft bone particles in collagen (column 5, lines 1-15).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to freeze and lyophilize the DBM particles taught by the ‘840 patent because the ‘840 patent teaches formation of demineralized bone particle though exposing to acid and washing with water to form a sponge to be implanted to induce bone formation and the ‘494 publication teaches method obtaining demineralized bone particles which includes treatment and washing followed by freezing for storage and lyophilization before addition with gelatin and water to form the final product. Thus it was known to one of ordinary skill in the art before the filing date of the claimed invention to freeze and lyophilize DBM before addition to a gelatin solution to form a bone implant. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to freeze dry the DBM as it is known to provide extended shelf life and be easily manipulated (‘212, column 2, lines 55-67). One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘494 publication and the ‘212 patent teach that it known to lyophilize DBM particle before use in bone formulations. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to optimize the time of the freezing and lyophilizing as the ‘494 publication teaches the timing to be an optimizable parameter based on the inventor’s equipment. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use bovine or human collagen as the ‘840 patent teaches the use of collagen wherein bone for the composition is obtained from humans, and the ‘212 patent teaches that it is known to use both bovine and human collagen in bone particle containing compositions. Thus it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known sources of collagen as taught by the ‘212 patent for the collagen taught as used in the compositions of the ‘840 patent.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the size ranges of the DBM particles taught by the ‘494 publication in the composition taught by the ‘840 patent because the ‘840 patent teaches forming the DBM particles through pulverizing, milling and sieving to be used in a bone graft material and the ‘494 publication teaches a range of DBM bone particle sizes used in the steps of grinding and sieving to obtain the desired size ranges for DBM to be used in bone compositions. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known size ranges of DBM to be combined with gelatin for a bone composition as the ‘840 patent and the ‘494 publication are both directed to DBM particles to be used with gelatin for a bone composition. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a pH of 7.2-7.4 after washing of the DBM particles as the ‘840 patent teaches the desire to remove all acidic material using water and the ‘212 patent teaches a specific pH range desired through washing and removal of acids used in DBM processing. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to obtain the pH range of 7.7-7.4 as the ‘212 patent teaches it is important to maintain any surgical implant which is in intimate contact with blood at a biocompatible condition of about pH of 7.2 to 7.4 (column 9, lines 1-10).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4,472,840 in view of US 2017/0304494 and US 6,911,212 as applied to claims 1-5 and 18-20 above, and further in view of US 2007/0087059.
As mentioned in the above 103 rejection, all of the limitations of claims 1-5 and 18-20 are taught by the combination of the ‘840 patent, the ‘494 publication and the ‘212 patent.
The combination of references does not specifically teach performing the crosslinking reaction includes adding to the DBM-gelatin solution a solution NHS/ED (claim 6) at a solution ratio of between 1:10 and 5:10 (claim 7).
The ‘059 publication teaches bioactive delivery matrix compositions (abstract) wherein the bioactive substance is demineralized bone matrix [0007]. The invention includes crosslinking agent. Preferred crosslinking agents are oxidizing agents wherein no external energy source is required [0035]. Bovine collagen discs are taught to be subjected to treatment with N-hydroxysuccinimide (NHS) and an equal concentration of N’-(3-dimethylaminopropyl)-N-ethylcarbodiimide (EDC) ([0027], [0069]).
It would have been obvious to one of ordinary skill in the art to substitute a first crosslinking agent as taught by the ‘840 patent with a second crosslinking agent, NHS/EDC, as taught by the ‘059 publication with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06.
One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success in using NHS/EDC to crosslink the compristion of the ‘840 patent because the ‘840 patent and the ‘059 publication are both directed to composition of collagen and DBM particles which are crosslinking, thus rending it obvious to substitute one crosslinking agent for another known crosslinking agent for collagen in the DBM collagen composition.
Claim(s) 11-14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4,472,840 in view of US 2017/0304494 and US 6,911,212 as applied to claims 1-5 and 18-20 above, and further in view of Clyde (Clyde, Weslee, Everything You Need to Know About Electromagnetic Sieve Shakers, 09/05/2019, pgs. 1-8).
As mentioned in the above 103 rejection, all of the limitations of claims 1-5 and 18-20 are taught by the combination of the ‘840 patent, the ‘494 publication and the ‘212 patent.
Regarding claims 11 and 17, the limitation of a method of forming a bone graft, the method comprising forming a demineralized bone matrix from an initial cut bone portion by using a bone grinder followed by a sieve shaker, mixing the DBM with an animal based gelatin carrier to form a DBM-gelatin solution and forming a crosslinking reaction with the DBM gelatin solution to form a DBM gelatin matrix allograft material is met by the ‘840 patent teaching allogenic bone material was obtained from human cadavers, cleaned, pulverized, milled and sieved into bone powder. Demineralized bone powder was prepared. Collage-DBP conjugates were prepared by forming collagen, adding DBP slowly to the collagen dispersion. Glutaraldehyde crosslinking is taught to include mechanical strength (column 3, line 50 to column 4, line 10). The ‘212 patent teaches Bovine and Human collagen are taught to be used in the formulation of allograft bone particles in collagen (column 5, lines 1-15).
Regarding claim 12, the limitation of drying the DBM-gelatin matrix allograft material a period of time to form a firm implant having a low moisture collagen carrier is met by the ‘840 patent teaching the composition to be freeze dried to form a semi-rigid foam (Example 1). As noted above in the 112(b) rejection ‘firm” and “low moisture” are not defined, therefore the dried foam meets the instant claim limitation.
Regarding claim 13, the limitation of packaging the firm implant in a saline hydration container is met by the ‘840 patent teaching wherein the sponge is placed in a sealed, sterile container of sterile normal saline (Example 1).
Regarding claim 14, the limitation of drying the DBM-gelatin matrix allograft material a period of time to forma gel having a high moisture content is met by the ‘840 patent teaching drying the composition to form a semi-rigid foam (Example 1) wherein the composition may be in the form of a gel (column 2, lines 45-50) As noted in the 112(b) rejection above the limitation of “high moisture” is an ambiguous relative term, therefore the drying to obtain a semi-rigid foam wherein gel compositions are also taught meets the instant claim limitations.
The combination of references does not specifically teach an electromatic sieve shaker (claim 11).
Clyde teaches sieve shakers have been around for a long time (page 2). Electromagnetic shaker was created as a refreshed version of mechanical sieve shakers (page 2). Sieve shakers separate particles and are used in labs for quality control. Both shakers, mechanical and electromagnetic will yield consistent repeatable results and choosing is based on preferences such as space, noise, custom settings and price ranges (pages 3-4).
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use the electromatic shaker taught by Clyde for the sieve taught by the ‘840 patent as the ‘840 patent teaches the desire to sieve particles to obtain a desired particle size and Clyde teaches shaker are well known sieves and wherein electromagnetic sieves are well known to be used in the lab for quality control and based on preference. Thus one of ordinary skill in the art would be motivated to use an electromatic shaker sieve for the process taught by the ‘840 patent as Clyde teaches the use of electromagnetic shakers are well known.
Claim(s) 8-10 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 4,472,840 in view of US 2017/0304494 and US 6,911,212 as applied to claims 1-5 and 18-20 above, and further in view of WO 00/54821.
As mentioned in the above 103 rejection, all of the limitations of claims 1-5 and 18-20 are taught by the combination of the ‘840 patent, the ‘494 publication and the ‘212 patent.
Regarding claim 10, the ‘840 patent teaches implantation in osseous defects (abstract).
The combination of references does not specifically teach crosslinking in a cast to form a DBM-gelatin allograft implant with a shape predetermined by the cast (claim 8).
The ‘821 publication teaches an implant for repair of a bone defect or void (abstract). The allograft material that is molded, machined, cast or otherwise formed into the shapes for use (page 7, lines 5-15). The device is taught as a pre-formed shape or molded to fit precisely into an implant site (page 15, lines 5-15). Gelatin and demineralized bone are taught as mixed to form a paste then molded into desired shapes which are stored in a sealed sterile pouches or containers (page 19, line 25 to page 20, line 10). The ‘821 publication teaches a wide variety of supplemental constituents maybe included in the composition including antibiotics (page 8, lines 25-30). The ‘821 publication teaches the device comprising nested pair of tubes to form the device to repair large defects (Figure 5, lines 15-25), thus teaching multiple layers of a device to repair large defects, reading on claim 15.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to include antibiotics in the composition taught by the ‘840 patent as the ‘821 publication that it was known at the time of the invention to include for example growth factors and antibiotics in the composition containing BMP and gelatin and the ‘840 patent teaches a compristion comprising DBM and gelatin. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to do so as the ‘840 patent teaches inclusion of additional ingredient such as BMP in the composition and the ‘821 publication teaches ingredients include BMP and antibiotics, thus are interchangeable to be used as additional ingredients in the bone graft matrix.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to form the matrix of the ‘840 patent in to a specific molded shape as the ‘821 publication teaches that it was known to form preformed shapes of the allograft materials and the ‘840 patent teaches an allograft material. It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to form the shape in a mold prior to crosslinking as the ‘840 patent teaches the lyophilization of the gelatin DBM mixture into a sponge structure with crosslinking after, thus teaching the crosslinking may be performed before forming the structure or after. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘840 publication and the ‘821 publication are both directed to composition containing gelatin and DBM, thus providing an expectation of success of use in a mold for the DBM gelatin composition of the ‘840 patent as taught by the ‘821 publication.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a multilayered device as taught by the ‘821 publication in order to fill large defects as the ‘821 publication teaches multilayered device comprising DBM and gelatin to fill large defects as the ‘840 patent teaches filling in bone defects.
Conclusion
No claims are allowed.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613