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 .
Detailed Action
Summary
This is the Non-Final Office action based on the 18/689552 filed 03/06/2024.
Claims 1-20 are pending.
This case has been examined as part of the PBA program.
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 1-20 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.
With respect to Claim 1, the claim is unclear as to whether what is being claimed is a method or a solution/composition, or if instead the claims are a product by process claim (which they are not since the claimed use doesn’t really relate to the formation of a product). Therefore, it is unclear if applicant is claiming one of the statutory categories of invention or not—and it is also unclear what “use,” “for conservation, preservation or/and fixation,” means as not actual method involving these things is claimed. Further- the “use,” is “characterized in that,” and then only solution components are listed. Characterized reads similarly to “comprises,” so therefore, as the claimed “use of a solution for the conservation, preservation or/and fixation of at least one eukaryotic cell, in particular of tumor cells and circulating tumor cells in a blood sample or another body fluid, or of cells from cell culture or of cells in tissue samples,” is the preamble and preambles are not limiting--- the claim body reads a composition/solution claim, and the “use,” is read as intended use. See MPEP 2173.05 (g) “Use,” Claims.
With respect to Claim it is further unclear due to the claiming of “in particular,” if the claim is limited to circulating tumor cells or tumor cells of the blood or body fluid or cells from call culture or not. In particular alludes to that the claim is open to other options. Therefore, what applicant is intending to be limiting for optional is unclear.
Further for Claim 1, step a) “of such carboxylic acids,” is unclear as to what is meant by this. Everyone could interpret this differently. Further for step a) what is meant by “is present as an acid/base system,” is unclear. All acids and bases are part of an acid/base system- so what is meant by “is present as?”
With respect to Claim 1, step b), it is unclear what is meant “free of,” “such amounts,” “which destroy morphological integrity.” First of all “destroy,” is a relative term that would mean different things to different people and therefore what is meant by this in the claim is unclear. Further, it is unclear what “such amounts,” would be to do this since “destroy,” is relative.
With respect to Claim 1, step c), “maintains,” is a relative term that would mean different things to different people and therefore what is meant by this in the claim is unclear.
With respect to Claim 1, step d), it is unclear what the claimed pH value would/could be since it is unclear what the cells on in Claim 1 preamble as shown above. Correction is required.
With respect to Claim 2, “acidic acid,” is claimed and it is assumed that the first “acidic,” is a typo and acetic acid is meant instead. However, it is unclear what is meant by an “acetate system.” Many different things could be considered to be an acetate system and therefore, this is a relative term and it’s unclear in the claims.
With respect to Claim 3, the acid/base system is unclear for Claim 3 as it was in Claim 1. Further, it is unclear when applicant is claiming concentrations in Claim 3--- for what component of a system, these concentrations are present for. Even further for Claim 30 “preferably,” and “particularly preferably,” is claimed, and therefore it is unclear if these concentrations are really required, or if instead they are optional. Right now as claimed- Claim 3 includes the claiming of a broad limitation with that or a narrow limitation, which makes the claims unclear.
With respect to Claim 4, the acid/base system is unclear for Claim 4 as it was in Claim 1. Further, it is unclear when applicant is claiming concentrate in Claim 4--- what is meant by the systems are “configured as,” and if this is eliciting any structure or not. As claimed, it seems not. Further- it is not clear what is meant by a “2-20-fold multiple concentrate,” or “5-fold concentrate,” and it is also not clear if the “particularly preferably,” concentrate is required or just option. Right now, the claim 4 includes the claiming of a broad limitation with that or a narrow limitation, which makes the claims unclear.
With respect to Claim 5, includes the claiming of a broad limitation with that or a narrow limitation, which makes the claims unclear. The narrow part follows the “preferably,” and the broad part is ahead of the “preferably,” in the claim. Further for Claim 5, “strong,” is a relative term and not defined by the claim so therefore is unclear.
With respect to Claim 6, the claim mentions a pH, “after mixing,” “at 20 degrees Celsius, “however what is claimed is not a method. Since no method steps are claimed, it is unclear if the pH “after mixing,” is limiting or not. Further--- claim 6 contains the limitations “preferably,” “particularly preferably.” Therefore, Claim 6 also includes the claiming of a broad limitation with that or a narrow limitation, which makes the claims unclear as to what if any of that is limiting in the claim.
With respect to Claim 7, it claims “further buffer substances,” but no buffers were claimed prior to this. Therefore, it is unclear what is meant by, “further buffer systems.”
With respect to Claim 8, it is rejected by virtue of being dependent on and not fixing errors in a claim which it is dependent on.
With respect to Claim 9, it includes the claiming of a broad limitations with that or a narrow limitations, which makes the claims unclear. The narrow part follows the “preferably,” and the broad part is ahead of the “preferably,” in the claim for both the sugar and amino acid.
With respect to Claim 10, it includes the claiming of a broad limitations with that or a narrow limitation, which makes the claims unclear. The narrow part follows the “preferably,” and the broad part is ahead of the “preferably.” It is unclear if the claim is limited to the narrow limitation or not.
With respect to Claim 11, it includes the claiming of a broad limitations with that or a narrow limitation, which makes the claims unclear. The narrow part follows the “preferably,” and the broad part is ahead of the “particularly preferably.” It is unclear if the claim is limited to the narrow limitation or not.
With respect to Claim 12, it includes the claiming of a broad limitations with that or a narrow limitation, which makes the claims unclear. The narrow part follows the “preferably,” and the “in particular,” and the broad part is ahead of the “particularly preferably.” It is unclear if the claim is limited to the narrow limitation or not.
With respect to Claims 13-14, they are rejected by virtue of being dependent on and not fixing errors in a claim which it is dependent on.
With respect to Claim 15, it includes the claiming of a broad limitations with that or a narrow limitation, which makes the claims unclear. The narrow part follows the “preferably,” and the broad part is ahead this. It is unclear if the claim is limited to the narrow limitation or not. Further it is unclear what “this vessel,” is in the claims since no “vessel,” was mentioned prior to this. Even further, is unclear if mixing the solution is limiting or not since in Claim 1, the use and whether it is a method or not is unclear.
With respect to Claim 16, it is unclear what is meant by “substantially intact,” as two different people could take this term to be drastically different things. Therefore, “substantially,” is a relative term as claimed, and unclear in the claims. Further, if using for transciptome analysis is limiting or not since in Claim 1, the use and whether it is a method or not is unclear.
With respect to Claim 17, it is unclear if using for transciptome analysis or a morphological analysis is limiting or not since in Claim 1, the use and whether it is a method or not is unclear.
With respect to Claim 18, it is unclear if the steps a) and f) are limiting or not since no actual method is claimed in claim 1 from which is depends. Further, a step a) was already claimed in Claim 1. Therefore it is unclear if this is the same or a different step. Further with respect to the claimed “Cells,” it use unclear if they refer back to the same cells in Claim 1 or not, since “the,” or “Said,” cells is not used, and since transciptome analysis or a morphological analysis is limiting or not since in Claim 1, the use and whether it is a method or not is unclear.
Further, for Claim 18, it is written as dependent on Claim 1, but also seemingly on Claims 1-4. Therefore, it is unclear which the claim is really dependent on.
With respect to Claim 19, it is unclear if step b) is a new step or if instead is further limiting for the initial step b) in Claim 1. The same applies for steps c) and d). Further, it is unclear if the steps b) and c) d) and e) are limiting or not since no actual method is claimed in claim 1 from which is depends.
With respect to Claim 20, it is unclear what “they,” refers to since it only one of a sample tube, a blood collection syringe, or blood collection tube is required. Further the same comments about the preamble in Claim 1 apply to Claim 20, since it is mostly the same preamble.
Correction is required for all of the issues above.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The claim(s) 1-20 does/do not fall within at least one of the four categories of patent eligible subject matter because they are drawn towards a “use,” which is not one of the statutory categories of invention. It is assumed that applicant intends to claim either a composition/solution or a method, which are statutory categories of invention, or instead a products (composition or solution, achieved through a specific process). If applicant amends the claim to be one of the four statutory categories of invention, which are a machine, a manufacture, a composition or a method/process, they should be able to overcome the 101 rejection. See MPEP 2173.05 (g) and MPEP 2106.03.
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 non-obviousness.
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.
Claims 1-10, 15-20 are rejected under U.S.C. 103 as being obvious by SHE in WO2018064976 in view of VINCEK in US 20030211452.
With respect to Claim 1, SHE teaches of a cryopreservation composition comprising:
(1) about 2 ％ (w/v) to about 40 ％ (w/v) of a permeating cryoprotectant；
(2) about 0.1 M to about 1 M of a saccharide； and
(3) about 1 ％ (w/v) to about 10 ％ (w/v) of a macromolecule,
wherein the unit of ％ (w/v) and the unit of M are based on the total volume of the cryopreservation composition (abstract). SHE further teaches that the solution is used or preserve tumor cells, which are eukaryotic (paragraph 0027), which can be obtained from blood (paragraph 0194, 0196).
SHE further teaches that the solution is aqueous (paragraph 0071, 0063).
SHE teaches that the solution/composition can have a pH of about 6.0, which also reads on the claimed “less than 6,” (paragraph 0069).
SHE teaches that the cells can be treated with an enzyme or detergent (meaning the solution does not require a detergent) ( paragraph 0130) and also the solution can use a polyvinylalcohol, but also does not require it to be used as the cyroprotectant, so it can also be used without polycinylalcohol (paragraph 0089, 0109, 0113, 0124).
SHE teaches of making the cells morphologically viable and of inspecting the morphology (paragraph 0184, 0185).
SHE teaches of using amino acid derivatives in the composition which can be organic acid salts including carboxylic acid salts which include citrate salt, acetate salt, and lactate salt (paragraph 0113)---- lactic acid, is a C3 carboxylic acid--- so lactate salt is a C3 carboxylic acid salt. The system forms a pH in the range of around pH of 6, which is in the acidic range as claimed. SHE further teaches that glutamic acid can be used (paragraph 0112), which is a C4 dicarboxylic acid, which reads on the claimed cell-permeable proton carrier.
The claimed preservation of cellular morphology is a material property of the solution, used and SHE teaches of a solution as claimed as shown above. However, due to the 112 issues above, and since it is not clear what exactly is being claimed with respect to a composition or method, VINCEK is used to teach of preserving morphological features as claimed to expedite compact prosecution.
VINCEK teaches of a solution for preservation and or storage of a call or tissue (abstract). VINCEK further teaches of the solution being used for preservation of a cell or tissues and that the composition allows the cell or tissue to maintain it’s morphological features (paragraph 0002). VINCEK further teaches of the tissue being a tumor or cell suspensions of a tumor (paragraph 0017). VINCEK further--- does not teach that the solution does not include DMSO (there is no mention of it) and it is not required to use other detergents ( as claimed), but only that that “may,” be used (paragraph 0049), and that alcohols are also not always used (paragraph 0021) and therefore when not using the morphological integrity is not destroyed per what is claimed. Further—it is noted that while methanol is used (see Claim 1), which is an alcohol, it is specifically noted that morphological integrity is not destroyed, therefore meeting the claim language of being “free,” of “alcohols,” “which destroy morphological integrity.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to preserve morphological integrity as is done in VINCEK in the method of SHE due to fact that solutions for preserving cellular morphology are needed (VINCEK, paragraph 0004).
With respect to Claim 2, SHE teaches of the preservation composition including an amino acid or derivative such as an acetate salt (paragraph 0113, 0112) being present in the composition solution.
With respect to Claim 3, SHE teaches of the preservation composition including an amino acid or derivative such as an acetate salt (paragraph 0113, 0112) being present in the composition solution in 0.01-10.0％by weight amount/concentration. Especially, as the claimed concentration required is unclear, and what the acid/base system is, is unclear, it would have been obvious to one of ordinary skill in the art to adjust the concentration to the claimed range of 1 mM to 100 mM through routine optimization. See MPEP 2144.05. Routine Optimization.
With respect to Claim 4, SHE teaches of the preservation composition including an amino acid or derivative such as an acetate salt (paragraph 0113, 0112) being present in the composition solution in 0.01-10.0％by weight amount/concentration. Especially, as the claimed concentration required is unclear, and what the acid/base system is, is unclear, it would have been obvious to one of ordinary skill in the art to adjust the concentration to the claimed range of 1 mM to 100 mM through routine optimization. See MPEP 2144.05. Routine Optimization.
With respect to Claim 5, SHE teaches of the composition and adjusting the solution of a pH of “about,” 6.0 (paragraph 0069) and of using phosphoric acid buffer to do this (paragraph 0066). Phosphoric acid, is considered a “strong acid,” as instantly claimed, since “strong,” is a relative term.
With respect to Claim 6, SHE teaches of the composition and adjusting the solution of a pH of “about,” 6.0 (paragraph 0069) and of using phosphoric acid buffer to do this (paragraph 0066). Phosphoric acid, is considered a “strong acid,” as instantly claimed, since “strong,” is a relative term.
With respect to Claim 7, SHE teaches of the solution containing a buffer (paragraph 0012, 0014, 0035, 0037, 0061, 0064-0067, 0071, 0176).
With respect to Claim 8, SHE teaches of the system having DMSO (paragraph 0088). SHE teaches that in some embodiments the solution is free of DMSO, but than it also can have DMSO of about 4% present (paragraph 0117, 0216).
With respect to Claim 9, SHE teaches of the composition including a saccharide (Claim 1), which is a monosaccharide (paragraph 0093-0084), and amino acids (paragraph 0109-0114).
With respect to Claim 10, SHE teaches of the composition including amino acids and that the amino acids are in a concentration of 0.01-10.0％by weight (paragraph 0109-0114). Especially, since what exactly is being claimed is unclear, it would have been obvious to one of ordinary skill in the art to adjust the concentration to the claimed range of 1 mM to 100 mM through routine optimization. See MPEP 2144.05. Routine Optimization.
With respect to Claim 15, SHE teaches of distributing the solution of the claimed invention into a cryotube (paragraph 0156).
With respect to Claim 16, SHE teaches of isolation of RNA (paragraph 0184), which means the RNA is intact, but does not teach of analyzing transcripts. VINCEK is used to remedy this and does teach of analysis and detection of transcripts (paragraph 0005). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to analyze transcripts as is done in VINCEK in the method of SHE due to the advantage this has for genetic analysis (VINCEK, paragraph 0005).
With respect to Claim 17, SHE teaches of isolation of RNA (paragraph 0184), which means the RNA is intact, but does not teach of analyzing transcripts morphological features. VINCEK teaches of morphological features as shown above for Claim a. VINCEK is used to remedy this and does teach of analysis and detection of transcripts (paragraph 0005). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to analyze transcripts as is done in VINCEK in the method of SHE due to the advantage this has for genetic analysis (VINCEK, paragraph 0005).
With respect to Claim 18, SHE teaches of mixing the cells with the preservation solution (paragraph 0019). SHE teaches of isolation of RNA (paragraph 0184), which means the RNA is intact, but does not teach of analyzing transcripts morphological features. VINCEK teaches of morphological features as shown above for Claim a. VINCEK is used to remedy this and does teach of analysis and detection of transcripts (paragraph 0005). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to analyze transcripts as is done in VINCEK in the method of SHE due to the advantage this has for genetic analysis (VINCEK, paragraph 0005).
With respect to Claim 19, SHE teaches of mixing the cells with the preservation solution (paragraph 0019). SHE teaches of isolation of RNA (paragraph 0184), which means the RNA is intact, but does not teach of analyzing transcripts morphological features. VINCEK teaches of morphological features as shown above for Claim a. VINCEK is used to remedy this and does teach of analysis and detection of transcripts (paragraph 0005). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to analyze transcripts as is done in VINCEK in the method of SHE due to the advantage this has for genetic analysis (VINCEK, paragraph 0005).
With respect to Claim 20, SHE teaches of distributing the solution of the claimed invention into a cryotube (paragraph 0156). SHE teaches of a cryopreservation composition comprising:
(1) about 2 ％ (w/v) to about 40 ％ (w/v) of a permeating cryoprotectant；
(2) about 0.1 M to about 1 M of a saccharide； and
(3) about 1 ％ (w/v) to about 10 ％ (w/v) of a macromolecule,
wherein the unit of ％ (w/v) and the unit of M are based on the total volume of the cryopreservation composition (abstract). SHE further teaches that the solution is used or preserve tumor cells, which are eukaryotic (paragraph 0027), which can be obtained from blood (paragraph 0194, 0196).
SHE further teaches that the solution is aqueous (paragraph 0071, 0063).
SHE teaches that the solution/composition can have a pH of about 6.0, which also reads on the claimed “less than 6,” (paragraph 0069).
SHE teaches that the cells can be treated with an enzyme or detergent (meaning the solution does not require a detergent) ( paragraph 0130) and also the solution can use a polyvinylalcohol, but also does not require it to be used as the cyroprotectant, so it can also be used without polycinylalcohol (paragraph 0089, 0109, 0113, 0124).
SHE teaches of making the cells morphologically viable and of inspecting the morphology (paragraph 0184, 0185).
SHE teaches of using amino acid derivatives in the composition which can be organic acid salts including carboxylic acid salts which include citrate salt, acetate salt, and lactate salt (paragraph 0113)---- lactic acid, is a C3 carboxylic acid--- so lactate salt is a C3 carboxylic acid salt. The system forms a pH in the range of around pH of 6, which is in the acidic range as claimed. SHE further teaches that glutamic acid can be used (paragraph 0112), which is a C4 dicarboxylic acid, which reads on the claimed cell-permeable proton carrier.
The claimed preservation of cellular morphology is a material property of the solution, used and SHE teaches of a solution as claimed as shown above. However, due to the 112 issues above, and since it is not clear what exactly is being claimed with respect to a composition or method, VINCEK is used to teach of preserving morphological features as claimed to expedite compact prosecution.
VINCEK teaches of a solution for preservation and or storage of a call or tissue (abstract). VINCEK further teaches of the solution being used for preservation of a cell or tissues and that the composition allows the cell or tissue to maintain it’s morphological features (paragraph 0002). VINCEK further teaches of the tissue being a tumor or cell suspensions of a tumor (paragraph 0017). VINCEK further--- does not teach that the solution does not include DMSO (there is no mention of it) and it is not required to use other detergents ( as claimed), but only that that “may,” be used (paragraph 0049), and that alcohols are also not always used (paragraph 0021) and therefore when not using the morphological integrity is not destroyed per what is claimed. Further—it is noted that while methanol is used (see Claim 1), which is an alcohol, it is specifically noted that morphological integrity is not destroyed, therefore meeting the claim language of being “free,” of “alcohols,” “which destroy morphological integrity.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to preserve morphological integrity as is done in VINCEK in the method of SHE due to fact that solutions for preserving cellular morphology are needed (VINCEK, paragraph 0004).
Claims 11-14 are rejected under U.S.C. 103 as being obvious by SHE in WO2018064976 in view of VINCEK in US 20030211452 and further in view of ROTH in US 20070078113.
With respect to Claim 11, SHE and VINCEK teaches of the invention as shown above. They do not teach of using one of the claimed preservative active ingredients.
ROTH is used to remedy this and teaches of a method and compositions for ensuring statis of cells (abstract).
ROTH further teaches of using imidazolidinyl and urea (paragraph 0325).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to used imidazolidinyl urea as instantly claimed with the solutions and compositions of SHE and VINCEK due to their advantage as an active compound (paragraph 0304, 0325).
With respect to Claim 12, SHE and VINCEK teaches of the invention as shown above. They do not teach of using one of the claimed molality.
ROTH is used to remedy this and teaches of a method and further teaches of an osmolality of 350 mosmol(paragraph 0843).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the claimed osmolare concentration/amount as is done in ROTH with the solutions and compositions of SHE and VINCEK due the fact that this is the optimized concentration (ROTH, paragraph 0843).
With respect to Claim 13, SHE and VINCEK teaches of the invention as shown above. They do not teach of using one inhibiting coagulation.
ROTH is used to remedy this and teaches of using anticoagulants (paragraph 0673).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the claimed anticoagulants as done in ROTH with the solutions and compositions of SHE and VINCEK due the fact that this is the optimized composition and treatment (ROTH, paragraph 0843).
With respect to Claim 14, SHE teaches of the solution containing magnesium sulfate/MgSo4 (paragraph 0064).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
KATO in US 20090197331 teaches of a composition for the cryopreservation of cells according to the present invention at least comprises sericin and one or more components selected from the group consisting of amino acids and saccharides. Further, a method for the cryopreservation of cells according to the present invention comprises the steps of placing target cells in the abovementioned composition for the cryopreservation of cells and cryopreserving them. According to the composition for the cryopreservation of cells of the present invention, cells can be cryopreserved over a long period of time without the use of serum and components derived from serum (abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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