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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 191-214), drawn to methods of cryopreserving a cadaver bone in the reply filed on Aug. 14, 2026 is acknowledged.
Claims 215 and 216 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 191-214 are examined below.
Priority
The present application is a CON of U.S. Patent Serial App. No. 18/155,657, which is a CON of International Application No. PCT/US2021/042064, filed July 16, 2021. Applicant’s claim for the benefit of a prior-filed parent provisional applications 63/184,109 (filed on May 4, 2019); 63/180,625 (filed April 27, 2021); 63/176,191 (filed April 16, 2021); 63/113,777 (filed Nov. 13, 2020); and 63/053,585 (filed July 18, 2020) under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is July 18, 2020.
Information Disclosure Statement
The information disclosure statement filed May 5, 2025 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. Further, the information disclosure statement filed May 5, 2025 fails to comply with the provisions of 37 CFR 1.97(a) because it lacks the appropriate size fee set forth in 37 CFR 1.17(v). It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
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 191-214 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. Independent claim 191 recites “placing a cadaver bone in a closed container comprising a cryoprotectant solution”. It is unclear how the cadaver bone is placed inside the closed container. Placing would indicate that the container is in a format where the bone can be positioned inside the container (e.g. open). Closed indicates that container is not in a situation where anything could be placed inside the container, without opening the container.
For the purposes of examination the claim will be interpreted as reciting “(a) obtaining a closed container comprising a cadaver bone and a cryoprotectant.”
Claims 192-214 ultimately depend from claim 191 and do not correct the indefiniteness. They are rejected on the same basis as claim 191.
The term “substantially” in claim 206is a relative term which renders the claim indefinite. The term “substantially” 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. Exactly how “intact” must the vertebral body be prior to step (a)? While the vertebral body not having been divided into fragments prior to step (a) being undertaken is definite, the “substantially intact” introduces ambiguity that rises to the level of indefiniteness, as the person of skill in the art might know what an “intact vertebrae” and a “divided vertebrae” are, but whether a vertebrae is “substantially intact” would vary depending on the skilled artisans assessment.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 191-199, 205, and 207 are rejected under 35 U.S.C. 103 as being unpatentable over Temple et al. (U.S. Patent App No. 2020/0054788 A1, cited in IDS filed on May 5, 2025).
Independent claim 191 is directed to a method for cryopreserving a cadaver bone, which includes placing the bone in a closed container with a cryoprotectant solution; reducing the pressure in the closed container, and holding the closed container at a reduced pressure to remove at least a portion of the water present in the cadaver bone; raising the pressure in the closed container and holding the closed container at a raised pressure to allow infiltration of the cryoprotectant solution into the cadaver bone; removing the cadaver bone from the closed container, and chilling the cadaver bone to a temperature less than about 0 C to cryopreserve the bone.
Temple et al. teach cutting cadaverous bone into bone particles (paras. [0007], [0011]); infusing the particles with polyampholyte cryoprotectant by placing the particles under a negative pressure or vacuum to draw the cryoprotectant into the particles, or alternatively, infusing the cryoprotectant into the bone particles using positive pressure (paras. [0007]-[0010], [0015]); and then freeze drying and/or cryopreserving the bone particles. (paras. [0011], [0015], [0018]). The limitation that the bone and cryopreservant are in a closed container with the cryopreservant would be inherently met by the application of positive pressure or a vacuum, as either would require a closed container for doing so.
It would have been obvious for one of ordinary skill in the art at the time of the invention to modify the teachings of Temple et al. to incorporate employing first reducing the pressure and then increasing the pressure of the bone in the closed container with cryoprotectant because it would have been obvious to try this modification as the person of ordinary skill would be choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, as doing so would merely be employing not one, but both, of the methods of infusion taught by Temple et al. As one could be expected to work better than the other (or perhaps both would work better than either single method), trying both in the claimed order constitutes an obvious variation to try. Making this modification would have led to a reasonable expectation of success because Temple et al. teaches both reducing the pressure and raising the pressure are a means of infusing the cryoprotectant in bone particle. Although Temple et al., teach that doing so would only have provided two mechanisms for infusion of cryopreservant (that is, Temple et al. does not explicitly teach that reducing the pressure removes at least a portion of the water in the cadaver bone), practicing this modification would have inherently resulted in removal of at least a portion of the water in the cadaver bone, thereby meeting the claim limitation.
With respect to claim 192, repetition of the steps used to infuse the cryoprotectant would have been obvious to a skill artisan as routine optimization; as such, once the claimed steps are obvious, repetition of those steps would have also been obvious.
With respect to claims 193-196, it would have been obvious to have increased the pressure back to atmospheric (0 - up to 760 mm Hg) (claim 193), to have held the raised pressure for less than 2 hours (claim 194), to have provided a moderate vacuum (between -400 and -800 mmHg) (claim 195) and to have held the container at a reduced pressure for less than 50 minutes (claim 196) as these ranges are all result-effective variables and within ranges that a person of ordinary skill in the art would routinely try when applying the teachings of Temple et al..
With respect to claims 197-198, Temple et al. teach DMSO, glycerol, trehalose, sucrose sand ethylene glycol as cryoprotectants., specifying that the w/w % of cryoprotectant can be 0.1-50%, rendering obvious the claimed range in claim 198. (paras. [0028], [0103]).
With respect to claim 199, Temple et al. teach the cryopreservant solution may include proteins (paras. [0015], [0078]).
With respect to claim 205, Temple et al. teach the bone may be a vertebral body. (paras. [0027], [0056]).
With respect to claim 207, Temple et al. teach the soft tissue can be removed (debridement). (para. [0085])
Claim(s) 209-211 are rejected under 35 U.S.C. 103 as being unpatentable over Temple et al. (U.S. Patent App No. 2020/0054788 A1, cited in IDS filed on May 5, 2025) as applied to claims 191-199, 205 and 207 above, and further in view of Gorantla et al. (Cytotherapy, 2012, cited in IDS filed on May 5, 2025).
Temple et al. does not teach surface sterilization with bleach and hydrogen peroxide.
Gorantla et al. teach surface sterilization with a 10% bleach solution or a 3% hydrogen peroxide solution.
It would have been obvious for one of ordinary skill in the art at the time of the invention to modify the teachings of Temple et al. to incorporate surface sterilize the bone with bleach and hydrogen peroxide in the claimed concentrations because it would have been obvious combine prior art elements according to known methods to yield predictable results. Incorporating this modification would have led to predictable results with a reasonable expectation of success because both Temple et al. and Gorantla et al. are directed to isolation of stem cells from cadaver bone. As both could be expected to work better than either bleach or hydrogen peroxide singly, combining these would have been obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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