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 .
Specification
The disclosure is objected to because of the following informalities:
References to the figures, particularly on pages 8-11, are not presented in the specification filed 2/28/23. The references appear as “Error! Reference source not found”.
Appropriate correction is required.
Claim Objections
Claims 4 and 8 are objected to because of the following informalities:
Claim 4 should read “the cellular stabilizing agent includes one or more” for the best clarity in the claim
Claim 8 should read “assist, compliment, or amplify the effects” or something similar for grammatical purposes.
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 4-6, 8-9, and 11 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 4 is rejected for reciting the limitation “the stabilizing agent includes one or more of … destabilizers, and denaturing agents” and it is not clear how a stabilizing agent can include a destabilizer and satisfy the claimed limitation of a stabilizing agent. The specification provides no clarity on the destabilizing agents that can read on a stabilizing agent as claimed. Therefore, the scope of the limitation cannot be determined and the claim is indefinite. For the purpose of examination, it is interpreted the stabilizing agent includes an agent that can function to stabilize or destabilize.
Claim 5 is rejected for being directed towards an improper Markush group. Claim 5 recites “one or more of the additives, the stabilizers, the catalysts, the protectants, the destabilizers, and the denaturing agents includes or more or of … antimicrobial peptides, including peptide fragments of histones, leukocyte lysates, coagulates … peptides … ”. Firstly, the scope of the claim cannot be determined because the nested list of alternatives including antimicrobial peptides does not have a definite closed end to the limitations included in it. What is necessarily included in the list of antimicrobial peptides and what is not should be made clear from the claim.
Claim 5 also recites “other amoebocytes” and the claim does not make clear what amoebocytes are necessarily included and not included in this limitation, and the specification provides no definition either. The scope of the limitation and what is necessarily included in the claim therefore cannot be determined and the claim is indefinite.
Lastly, claim 5 is rejected for including a Markush group which does not recite a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art-recognized class. The claim recites that “additives, stabilizers, catalysts, protectants, destabilizers, and denaturing agents”, all of which are understood as having distinct functions from one another, can include substances from a single list including every listed substance in claim 5, and the claim does not make clear whether the substance is an additive, stabilizer, or destabilizer, for example. In other words, a stabilizer and destabilizer are not recognized as belonging to the same art-recognized class as one another, and the Markush group recites a list of substances that may or may not fall under the category of stabilizer or destabilizer, or other stabilizing agent recited. See MPEP 2117, II(A) The scope of the claim therefore cannot be determined and the claim is indefinite. For the purpose of examination, it is interpreted the stabilizing agent includes one or more of the claimed substances.
Claim 8 is rejected for including what appears to be two claims. It cannot be determined from claim 8 which sentence is intended to be the claim and what the scope of the claim necessarily is. For the purpose of examination, it is interpreted the claim includes those limitations.
Claim 8 is further rejected for reciting “the neutralization of the unwanted cells” and the limitation lacks antecedent basis in the claims. For the purpose of examination, it is interpreted that there are some cells that are unwanted.
Claim 9 is rejected for reciting the limitation “are packaged in the container” where the limitation “the container” lacks antecedent basis in the claim. For the purpose of examination, it is interpreted there is a container the agents are packaged in.
Claim 9 is rejected for reciting “the biological material” and there is a lack of antecedent basis for the limitation in the claim. For the purpose of examination, it is interpreted there is some biological material.
Claim 11 is rejected for reciting “a biological matrix” and it is not clear if the biological matrix is intended to be the same biological matrix as set forth in claim 1 from which claim 11 depends. For the purposes of examination, it is interpreted to be the same matrix or a different one.
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.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over Laugharn (US 2002/0182107) in view of Silverman (US 2020/0146280).
Regarding claim 1, Laugharn (US 2002/0182107) discloses –
A neutralization method (Title, Abstract) comprising the steps of:
adding a stabilizing agent (pars. 31 and 75 discloses adding a protein stabilizing reagent, like amino acids) to a biological matrix (par. 24, the sample includes blood plasma which is an extracellular biological fluid reading on the limitation of a biological matrix, the other examples including a biological sample also read on this) to
subjecting the biological matrix to pressures above 5,000 psi,
while maintaining the temperature of the material at 4° C. or lower (pars. 23, 50 disclose pressure above 5,000 psi, including for example 10,000 psi, while maintaining a lowered temperature of 4 degrees or lower).
Laugharn appears to be silent with regards to the stabilizing agent being specifically a cellular stabilizing agent that is to preserve a predetermined level of desired cells.
Silverman (US 2020/0146280) discloses a method of treating biological product at very low temperatures (par. 31) similar to the blood product treatment of Laugharn as set forth above, where the method includes the addition of a cellular stabilizing agent to the biological product for the purpose of protecting and preserving the cells during treatment (par. 28). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Laugharn such that the stabilizing agent is specifically a cellular stabilizing agent and the method is applied to blood including cells to arrive at the claimed invention. One would have been motivated to do so to successfully neutralize a biological product in need of neutralization such as blood product and to do so without damaging the biological product to arrive at an improved biological treatment method.
Regarding claim 2, modified Laugharn further teaches one or more of parameters of pressure, temperature, and time is varied in one or more of a waveform, sawtooth pattern, an ascending waveform, a square-waveform, a polynomial waveform, a sine waveform, a rectangular waveform, a resonant frequency waveform, pulsing waveforms, and hold and relax times (pars. 23, 82 discloses a uniform cycle time of a 1:1 or 2:1 ratio where the pressure is cycled at a frequency of 2 Hz, which reads on the limitation of at least a sine or rectangular waveform, and par. 43 discloses pulses reading on a pulse waveform).
Regarding claim 3, modified Laugharn teaches a post process including membrane or porous filtering (par. 75 discloses the stabilizer being removed by dialysis, filtration, or chromatography, dialysis being membrane filtration and chromatography involving porous filtration anticipating the limitation or at least making it obvious).
Regarding claim 4, modified Laugharn further teaches the stabilizing agent includes one or more of additives, stabilizers, catalysts, protectants, destabilizers, and denaturing agents (Laugharn teaches amino acids are added as a stabilizer, and Silverman, who is relied upon for teaching the cellular stabilizing agent, discloses dimethyl sulfoxide; both of these agents are at least stabilizers and/or protectants; par. 28 of Silverman, par. 75 of Laugharn).
Regarding claim 5, modified Laugharn further teaches the one or more of the additives, stabilizers, catalysts, protectants, destabilizers, and denaturing agents includes one or more of DMSO and amino acids (par. 28 of Silverman, par. 75 of Laugharn).
Regarding claim 6, modified Laugharn further teaches the additives, stabilizers, catalysts, protectants, destabilizers, denaturing agents are added prior to, during or after the material is subjected to the neutralization method (par. 28 of Silverman, par. 75 of Laugharn; the stabilizer and/or protectant are added before the neutralization proceeds).
Regarding claim 7, Laugharn appears to be silent with regards to a gas-impermeable coating or a chemical shell applied to the desired cells to withstand the neutralization method.
Silverman further teaches phosphate is added to the biological matrix (par. 27), which according to the last two paragraphs on page 8 of the instant specification is a material suitable to perform the function of forming a gas-impermeable coating or chemical shell to withstand the neutralization method. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Laugharn such that phosphate is added to the biological matrix to form a gas-impermeable coating or chemical shell as taught by Silverman to arrive at the claimed invention. One would have been motivated to protect and preserve the desired cells throughout the neutralization method to arrive at an improved neutralization method for biological products.
Regarding claim 8, modified Laugharn further teaches a catalyst, destabilizing agent or electrical charge is applied to the biologic matrix to assist, compliment, or amplify the effects of the neutralization of the unwanted cells (par. 55 discloses a catalyst added to accelerate phase change, which would at least compliment the destruction of cells that are unwanted), and wherein the method is applied to flexible packaging of specific dimensions, form, geometry, materials and material properties, and made using specific methods to form a container that transmits pressure without rupture (par. 34 disclosed hermetically sealed flexible plastic that transmits pressure without rupture).
Regarding claim 9, modified Laugharn further teaches the stabilizer is added to the container neutralization (pars. 31, 34) and the addition before a biological material is a modification that would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as the mere change in sequence of adding ingredients is prima facie obvious in the absence of new or unexpected results. See MPEP 2144IV(C).
Regarding claim 10, modified Laugharn further teaches a headspace including one or a combination of ambient air, inert gas, CO2, the volume of which is metered, controlled, or measurable (par. 52 discloses an air or inert nitrogen headspace in the sample, the amount of which inherently measurable through known and existing means, as a volume of gas is necessarily able to be measured and thus is measurable as claimed).
Regarding claim 11, modified Laugharn discloses the method reduces unwanted cells in a biologic matrix (par. 32 discloses the neutralization of cells, the designation of which as unwanted being arbitrary and this method step being a natural result of the performing of the neutralization method).
Conclusion
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/BRENDAN A HENSEL/Examiner, Art Unit 1758