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 .
Claim Status
Claims 1-30 are cancelled.
Claims 31-51 are pending. Applicant’s amendment has necessitated modification of the existing rejections. Accordingly, this Action is FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/20/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn rejections
Applicant's amendments and arguments filed 8/12/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 31-33, 35-46 and 48-51 are rejected under 35 U.S.C. 103(a) as being unpatentable over Williams et al. (US20080262633) and Anderson et al. (US20150011947) and Peterson et al. (US20150231183) as evidenced by VitaCyte Clzyme AS ([online] retrieved on 5/6/25 from: https://www.vitacyte.com/products/shop/cizyme-as-005-1090/; 14 pages).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Applicant claims, for example:
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Examiner’s comment: The “cell types” are named in the claim and therefore the term “type” does not rise to a level of indefiniteness.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a tissue engineering research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from tissue engineering including bone grafts and implant compositions, components, natural bone cells and their physiological function and biochemical assays— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claim 31 and 36, Williams et al. teach methods of determining the number of live cells from a bone graft material by combining demineralized cortical bone components with a cancellous bone component, by taking samples from a bone product produced in Example 1 [0054], thereby producing a test sample from the bone graft material, and contacting the test sample with an enzyme formulation collagenase treatment (Example 2, [0055-0056] and evaluating cell types and determining quantities with a viability of at least 70% and a cell density of at least 1X103 cells/cc [0061-0062]. Evaluation of viable cells including chondrocytes, osteocytes, chondroblasts, chondrocytes was performed (Abstract; [0095-0100]). Williams et al. teach implanting the bone samples [0088], thus providing the bone graft material to implant in a subject.
Regarding claim 32, Williams et al. teach using a combination of collagenase and trypsin and lipase [0009].
Regarding claim 35, Williams et al. teach washing the bone sample prior [0048-0049], which implicitly removes native cells and is prior to contacting with the enzyme formulation [0050].
Regarding claims 31 and 36-38, the bone material of Williams et al. naturally comprises viables cells including osteocytes, mesenchymal stem cells (MSCs), leukocytes, erythrocytes, or any combination thereof, including CD44+ osteocytes, CD90+ MSCs and CD45+ leukocytes. The limitation of at least 50% MSC and less than 5% leukocytes and/or less than 5% erythrocytes appears to be an implicit result of performing the method and washing away leukocytes and erythrocytes and leaving the MSCs within the bone component.
Regarding claims 39-40, Williams et al. report the optimal bone material has 70% cancellous bone chips and 30% cortical bone chips [0135]. Williams et al. also teach: “wherein said bone implant includes at least 50 vol. % of said cancellous bone, from about 5 vol. % to about 40 vol. % of said cortical bone particles” (Claim 20).
Regarding claims 41, 43-46, 48-51, Williams et al. teach preparing a bone product from a single donor and frozen at -80°C and then thawed after 17 days [0054-0055]. The samples were then contacted with collagenase solution [0056-0058]. 10% DMSO is used as a cryopreservative [0053] but also contain glycerol [0023]. The amount of cryoprotectant in terms of vol/vol% is readily determined by the ordinary artisan to achieve cryoprotection. The same amount of the same cryoprotectant implicitly results in less than 80% and/or less than 50% and/or less than 10% toxicity to the total number of cells present in the bone graft material.”
Regarding claim 31, Peterson et al. teaches that the artisan is aware of enzymatic digestion methods employing a combination of enzymes including a collagenase and a neutral protease and commercially available as Vitacyte [0076], such as Vitacyte Clzyme AS [0140, 0319]. As evidenced by VitaCyte, Clzyme AS contains 60% class I and 40% class II collagenase pre-mixed with neutral protease.
Regarding claim 31, Anderson et al. is directed to mixtures of cortical and cancellous bone ([0059]; claims 1-25) and methods of treating bone defects with the bone repair composition ([0053]; claim 26). Anderson et al. teach that it is known that: “If the bone was non-demineralized and frozen or freeze dried then the osteoinductive properties would not be degraded and a loss of osteoinductive activity could be avoided.” [0006] Andersen et al. teach: “The particulate bone preparations of this invention are unique because they avoid entirely the need for harsh chemical treatments and extractions, which alter inherent native properties of bone.” [0058] Thus, the bone preparation has optimal osteoconductivity [0058].
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Williams et al. is that Williams et al. do not expressly teach evaluating cell types and determining quantities the number of viable cells for the cell types released from the test sample the cell types released from the test sample comprise mesenchymal stem cells (MSCs), leukocytes, erythrocytes, or any combination thereof, and iii) if the viable cells released from the test sample comprise at least 50% MSCs released and less than 10% leukocytes and/or erythrocytes, providing the bone graft material to implant in a subject. However, it would be obvious to obtain a test sample and determine the type and amount of cells released prior to implanting another sample into a subject for the following reasons. Williams et al. teach that the product produced by the method is free of red blood cells (Claim 1), which are erythrocytes, thus reading on less than 10% erythrocytes and the ordinary artisan would desire the greatest amount of MSCs released in the sample for their desirable properties in the implant. Consequently, it is obvious to evaluate the test sample for viable cells under different conditions such as enzyme concentration and duration (Table 2) and determine the type and amount present and then judicious selection of those samples with greater than 50% MSCs released and 0% red blood cells and then provide the bone graft material, from which the test sample was taken, for implantation into a subject with a reasonable expectation of success.
The difference between the instant application and Williams et al. is that Williams et al. do not expressly teach combining non-demineralized bone component with a cancellous bone component and contacting with an enzyme formulation wherein the enzyme formulation comprises 40% to 60% collagenase and about 40% to 60% neutral protease and wherein about 2.0 x 107 viable cells per gram of bone graft material are released. This deficiency in Williams et al. is cured by the teachings of Anderson et al. and Peterson et al.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine a non-demineralized bone component, as suggested by Anderson et al., with a cancellous bone component of Williams et al. to make a bone graft material and contact the bone graft material with an enzyme formulation as claimed, as suggested by Peterson et al., and obtain about 2.0 x 107 viable cells per gram of bone graft material are released and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because for the following rationale. While Williams et al. teach and suggest demineralized cortical bone for the bone graft material, the art of Anderson et al. suggests that non-demineralized bone is superior because the natural osteoinductive properties have not been degraded by harsh chemical treatment and has optimal osteoinductivity. Consequently, it is desirable to employ the superior non-demineralized bone component in the method of Williams et al. to have those properties and it would simplify the method by eliminating the need to demineralize the bone. The ordinary artisan would do so with a reasonable expectation of success. Regarding the limitation of wherein the enzyme formulation comprises 40% to 60% collagenase and about 40% to 60% neutral protease, the Examiner has this position. Williams et al. teach and suggest using collagenase as well as collagenase in combination with other enzymes. The tissue engineering artisan is well aware through the teachings of Peterson et al. that combinations of collagenase with other enzymes are commercially available such as Vitacyte Clzyme AS, which is a combination of collagenase and neutral protease as evidenced by Vitacyte Clzyme AS. Accordingly it appears to be nothing more than obtaining a commercial product off the shelf to perform the enzymatic digestion step of Williams et al. to determine the number of viable cells in the samples with a reasonable expectation of success. At least a 1:1 ratio of collagenase to neutral protease (50% collagenase and 50% neutral protease) appears to be an obvious amount to utilize in the method with the predictable result of obtaining viable cells from the bone graft material. The ordinary artisan would expect obtain about 2.0 x 107 viable cells per gram of bone graft material since the bone graft materials are of the same source and the non-demineralized bone would be expected to add a greater number of viable cells naturally present.
The difference between the instant application and Williams et al., as modified by Anderson et al. and Peterson et al., is that Williams et al., as modified by Anderson et al. and Peterson et al., do not expressly teach cryopreserving the bone graft material, and wherein the contacting step is performed after the bone graft material has been cryopreserved for a period of time selected from 1 week, 1 month, 1 year, or 5 years and wherein the cryopreserving comprises rate controlled freezing at -1 °C/min. However, the Examiner noted above that Williams et al. teach a cryopreservation time period of 17 days [0054] and suggest that storage can be “at least seventeen days” [0064]. Thus, it is at the discretion of the ordinary artisan how long the bone graft material is frozen such as from 1 week, 1 month, 1 year, or 5 years with a reasonable expectation of success. Concerning the controlled freezing rate, the ordinary artisan in this art can set the freezer to freeze at a desired rate and thus it is merely routine optimization to select a freezing rate of -1 °C/min to reach the desired cryopreservation temperature with no inventive faculty required.
Claim 34 is rejected under 35 U.S.C. 103(a) as being unpatentable over Williams et al. (US20080262633) and Anderson et al. (US20150011947) and Peterson et al. (US20150231183) as evidenced by VitaCyte Clzyme AS ([online] retrieved on 5/6/25 from: https://www.vitacyte.com/products/shop/cizyme-as-005-1090/; 14 pages), as applied to claims 31-33, 35-46 and 48-51 above, in further view of Kim et al. (KR20130127329A with English translation).
Applicant claims:
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Williams et al., Anderson et al. and Peterson et al. are discussed above.
Regarding claim 34, Kim et al. teach that it is known in the art to employ CCK-8 assay to count cells (Example 6) or MTT cell viability assay (Figure 7), which is understood by the artisan in this art to be a 3-( 4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide cell viability assay.
The difference between the instant application and Williams et al., as modified by Anderson et al. and Peterson et al., is that Williams et al., as modified by Anderson et al. and Peterson et al., do not expressly teach wherein the cell viability is determined using a 3-( 4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) cell viability assay or a Cell Counting Kit 8 (CCK-8) assay. This deficiency in Williams et al., as modified by Anderson et al. and Peterson et al., is cured by the teachings of Kim et al.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to determine the cell viability with either a 3-( 4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) cell viability assay or a Cell Counting Kit 8 (CCK-8) assay, as suggested by Kim et al., in the method of Williams et al., as modified by Anderson et al. and Peterson et al., to produce the instant invention. One of ordinary skill in the art would have been motivated to do this because while Williams et al. teach using Trypan Blue for counting cells [0060], the artisan in this art is aware through the teachings of Kim et al. of alternative cell counting techniques to ascertain cell viability. Consequently, it is merely judicious selection of known cell counting assays to determine the number of viable cells by the ordinary artisan with a reasonable expectation of success. See MPEP 2144.07 Art Recognized Suitability for an Intended Purpose 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). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the answer depends on “whether the improvement is more than the predictable use of prior art elements according to their established functions.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). As is the case here, the selection of known means to count viable cells is not inventive without more.
Claims 45-47 are rejected under 35 U.S.C. 103(a) as being unpatentable over Williams et al. (US20080262633) and Anderson et al. (US20150011947) and Peterson et al. (US20150231183) as evidenced by VitaCyte Clzyme AS ([online] retrieved on 5/6/25 from: https://www.vitacyte.com/products/shop/cizyme-as-005-1090/; 14 pages), as applied to claims 31-33, 35-46 and 48-51 above, in further view of Brockbank (US5071741).
Applicant claims:
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Williams et al., Anderson et al. and Peterson et al. are discussed above.
Regarding claims 45-47, Brockbank teach cryoprotective agent compositions for cryopreservation process (Abstract) comprising alginate and DMSO (Claims 1, 3, 4 and 9-14) for bone (Claim 15). Alginate is taught as the sodium salt (Column 4, lines 6-9). Brockbank teach that a variety of protective agents are known to the artisan including polyvinylpyrrolidone, hydroxyethyl starch, monosaccharides, and sugar alcohols (Column 2, lines 37-40).
The difference between the instant application and Williams et al., as modified by Anderson et al. and Peterson et al., is that Williams et al., as modified by Anderson et al. and Peterson et al., do not expressly teach all the cryoprotectant agents claimed or the combination of DMSO and alginate which can be the sodium salt. This deficiency in Williams et al., as modified by Anderson et al. and Peterson et al., is cured by the teachings of Brockbank.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to employ any of the claimed cryoprotectants including DMSO and sodium alginate, as suggested by Brockbank, in the method of Williams et al., as modified by Anderson et al. and Peterson et al., and produce the instant invention. One of ordinary skill in the art would have been motivated to do this because William et al. is not limited to the cryoprotectants to be used and Brockbank reports improved cell viability in cryoprotectant combinations of DMSO + agarose (Table 1; Example 1) and the artisan would expect similar enhanced cell viability from the combination of DMSO + alginate (Claims 3-4, 10-11). The ordinary artisan is motivated to do so for the enhanced cell viability taught by Brockbank. One would have a reasonable expectation of success in so doing.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed 8/12/25 have been carefully considered but are not persuasive.
On page 15 of remarks, Applicant asserts: “Williams does not disclose the cell types or the quantities of viable cells that are released from a bone graft material in order for the bone graft material to qualify as an acceptable implant. In fact, Williams does not mention MSCs, leukocytes, or erythrocytes at all, much less requiring that the viable cells in a bone graft material comprise "at least 50% MSCs and less than 10% leukocytes and/or erythrocytes." Respectfully, the Examiner has a different perspective. As discussed above, Williams et al. teach that the product is free of red blood cells, which are erythrocytes. Free means that no red blood cells are present and the only way to determine that is to evaluate the type and quantity of the cells. In this art, the ordinary artisan is well-aware that white blood cells and red blood cells are undesirable while MSCs are desirable. (This common knowledge in the art is taught for example by Govil et al. (WO2011071766) teaching (Examiner added emphasis): “The harvested cancellous bone is exposed to water to selectively lyse undesired cells types such as red blood cells, white blood cells, etc” [0086] And: “The desired cells, such as mesenchymal stem cells, bone marrow stromal cells, progenitor cells, etc., remain viable in porous bone structure and on bone surface.” [0087].) Consequently, it is entirely obvious to evaluate the type and quantity of cells present and employ the test samples with at least 50% MSCs and less than 10% leukocytes and/or erythrocytes and then provide bone graft material, from which the test sample was taken, for implantation into a subject.
On page 15 of remarks, Applicant argues that Williams produces test samples with cells adhered to them which is opposite of claim 31 which determines the viability of cells that are released from bone. Respectfully, the Examiner does not agree with Applicant’s analysis and has a different perspective. While it is correct that the partial digestion of the components of the bone matrix of Williams et al. loosens but does not release osteogenic cells thereby making them more available for their osteogenic function [0018, 0020], this simply means that the bone graft materials of Williams et al. are loaded with osteogenic cells including MSCs. The instantly claimed method merely tests for the amount of MSCs present in the bone test sample. In Example 2 Williams et al. teach and suggest contacting the bone samples with an enzyme formulation (37°C for 15±1 minute [0058]) and evaluating the viability and cell density [0061-0064]. In Example 4, Williams et al. state: “Two collagenase-treated cancellous bone samples were prepared as described in Example 1, and collagenase released (CR) cells from such samples were obtained as described in Example 2.” [0074] And: “collagenase released (CR) cells from such samples were obtained as described in Example 2.” [0129] The Examiner notes that Williams et al. treat bone samples with collagenase at a concentration of 0.5, 1.5 and to 3 mg/mL for 3 hours and even 24 hours (Table 2) and the instant specification teaches 1 mg/ml collagenase for 3 hours [0162]. The only reasonable conclusion is that the bone test samples contacted with an enzyme formulation for 3 hours or 24 hours of Williams et al. do ultimately release cells, implicitly including MSC cells, and an indication of at least 50% MSCs and less than 10% leukocytes and/or erythrocytes released simply confirms that the bone graft materials of Williams et al. are loaded with MSCs and clean of undesirable cells such as leukocytes and erythrocytes. The Examiner cannot test the bone graft material of Williams et al. for released MSCs. In this regard, see MPEP 2112.01(I): Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Accordingly, because Williams et al. employ the same concentration of enzyme (1.5 mg/mL) and the same duration (3 hours) at the same temperature (37° C) on the bone graft material as Applicant [0162], then the same amount of MSCs are released and it remains the Examiner’s position that the bone graft test samples of Williams et al. release at least 50% MSCs upon contact with an enzyme formulation and less than less than 10% leukocytes and/or erythrocytes because those have already been cleaned/removed from the bone sample.
On pages 15-16, Applicant asserts that Anderson, Peterson, KR20130127329, VitaCyte and Brockbank do not remedy the deficiencies in Williams. However, the Examiner is relying upon those references as described in the rejection and not as characterized by Applicant. Respectfully, Applicant’s arguments are not persuasive.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after review of all the facts, Applicant’s arguments are not persuasive. The Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts, which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and representative of the ordinary artisan’s knowledge. Govil, AP (US20100152863) teaches methods of making osteoinductive implants (Abstract; Figures 1-11; claims 1-20) with release of bioactive materials from the harvested bone (Abstract) including “removal of certain cellular components while retaining other cellular components. Selective lysing or removal can be accomplished physically by methods described above. As can be appreciated, certain cells can be resistant to various lysing mechanisms. As a non-limiting example, mesenchymal stem cells (MSC) are resistant to cytolysis and osmotic lysis due to their resistant cell walls and ineffective cells volumes. Accordingly, to accomplish selective lysing, osmotic lysis can be used to lyse red and white blood cells from blood or bone marrow. Once the non-resistant cells are lysed, the resulting solution is an enriched MSC population.” [0025] And: “The desired cells, such as mesenchymal stem cells, bone marrow stromal cells, progenitor cells, etc., remain viable in porous bone structure and on bone surface.” [0056]
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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613