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 .
Status of the Claims
This action is in response to the communication of 11/7/2023
Claims 1-17 are pending.
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.
Claim 17 is 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 17 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. Claim 17 recites a method of using the composition of claim 13, but does not recite any concrete steps for the claimed method. Thus, the claim is indefinite. A suggested remedy to the claim language could be “A method of preventing or treating cancer, an immune disease, or an infectious disease in a subject in need thereof, comprising administering a composition comprising NK cells from the NK cell cryopreservation formulation of claim 13 to a subject.” The claim was interpreted to read as such for purposes of examination.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Larichaudy
Claims 1-2, 5-9, and 12-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by:
Larichaudy (US20190000070A1) (Provided in IDS of 11/07/2023)
Regarding claim 1, Larichaudy teaches a composition comprising a physiologically acceptable medium/ base solution, human serum albumin, DMSO (Larichaudy [0001], claim 13), at least one saccharide selected from trehalose and sucrose (Larichaudy claim 16), and cells for therapeutic purposes, which includes NK cells (Larichaudy claim 19, [0052]). Larichaudy teaches that this composition may be used in a process for the cryopreservation of cells for therapeutic purposes, including NK cells (Larichaudy claim 21, [0052]). Larichaudy teaches a cryopreservation method using this composition, which includes a freezing step (Larichaudy claim 21).
Regarding claim 2, Larichaudy teaches that their “Physiologically acceptable medium” may include salts of sodium, potassium, magnesium, and/or calcium, with anions of chloride, carbonate, hydroxide or caprylate type. (Larichaudy [0037]).
Regarding claim 5, Larichaudy teaches that the concentration of DMSO is preferably between 2% and 15%. (Larichaudy [0050])
Regarding claim 6, Larichaudy does not teach that their composition comprises HEPES or HES. (Larichaudy [0082])
Regarding claim 7, Larichaudy teaches 4% human serum albumin. (Larichaudy [0082])
Regarding claim 8, 9 and 12, Larichaudy teaches that the composition may include a saccharide that may be glucose or trehalose (Larichaudy [0042]), and that the final concentration of the saccharide may be between 0.05M and 0.5M (Larichaudy [0045]). (%wv = (Molarity (M) x Molar Mass (g/mol) )/ 10 = 0.05M x 180.156 g/mol /10 = 0.9%. Larichaudy teaches a %w/v of the saccharide (glucose or trehalose) to be between 0.9% to 9%.
Regarding claim 13, When reading the preamble in the context of the entire claim, the recitation “An NK cell cryopreservation formulation” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention' s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
However, Larichaudy teaches that their composition may be used in a process for the cryopreservation of cells for therapeutic purposes, including NK cells (Larichaudy claim 21, [0052]). Larichaudy teaches a cryopreservation method using their composition, which includes a freezing step (Larichaudy claim 21).
Regarding claim 14, Larichaudy teaches that their composition may be used in a process for the cryopreservation of cells for therapeutic purposes, including NK cells (Larichaudy claim 21, [0052]). Larichaudy teaches a cryopreservation method using this composition, which includes a freezing step (Larichaudy claim 21).
Regarding claim 15-16, Larichaudy teaches the composition of claim 15 and 16.
When reading the preamble in the context of the entire claim, the recitations “An immune cell therapeutic agent…” and “A pharmaceutical composition for preventing or treating cancer, or an infectious disease…” are not limiting because the body of their respective claims describe a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention' s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Wang
Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Wang (CN108064840A) (Provided in IDS of 11/07/2023)
Regarding claim 1 and 8, Wang teaches a NKT cell cryopreservation solution and a preparation method thereof. Wang’s composition comprises a base solution (saline), human serum albumin, DMSO, and polyethylene glycol (Wang, Abstract).
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.
Larichaudy
Claims 1-9, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over:
Larichaudy (US20190000070A1) (Provided in IDS of 11/07/2023),
Claims 1-2, 5-9, and 12-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by: Larichaudy (US20190000070A1) (Provided in IDS of 11/07/2023) as described above.
Regarding claim 3, Larichaudy does not specifically teach that the pH of their base solution, which they call a physiologically acceptable medium, is between 4.0 and 8.0. Larichaudy does teach that the medium is “physiologically acceptable” (Larichaudy [0037]), that they intend to cryopreserve cells in this medium, and that they intend to at least be able to buffer the pH of their composition (Larichaudy [0038]).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
In this case, the selection of a pH of the base solution would be the result of routine optimization because the skilled artisan selecting a “physiologically acceptable” medium would be motivated to use a “physiologically acceptable” pH, which would at least in some cases between 4 and 8.
Regarding claim 4, Larichaudy does not specify the osmolarity of their base solution, but Larichaudy does teach that “Physiologically acceptable medium” is intended to mean an aqueous medium comprising electrolytes. Electrolytes are, for example, salts of sodium, potassium, magnesium, and/or calcium, with anions of chloride, carbonate, hydroxide or caprylate type. The physiologically acceptable medium is preferably an aqueous medium comprising sodium chloride and sodium caprylate. (Larichaudy [0037]).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
In this case, the selection of a certain osmolarity of the base solution would be the result of routine optimization because the skilled artisan selecting a “physiologically acceptable” medium would be motivated to use a “physiologically acceptable” osmolarity of the various dissolved components, salts, electrolytes, etc.
Larichaudy and Schmidt
Claims 1-2, 5-9, and 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over:
Larichaudy (US20190000070A1) (Provided in IDS of 11/07/2023), and
Schmidt S, Tramsen L, Rais B, Ullrich E, Lehrnbecher T. Natural killer cells as a therapeutic tool for infectious diseases - current status and future perspectives. Oncotarget. 2018 Apr 17;9(29):20891-20907
Claims 1-2, 5-9, and 12-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by: Larichaudy (US20190000070A1) (Provided in IDS of 11/07/2023)
Regarding claim 17, Larichaudy teaches that the cells to be cryopreserved in their composition are for therapeutic purposes, and that the cells may originate from the patient to be treated, and that the cells, once cryopreserved and thawed, will be administered to the same patient. (Larichaudy [0066]). Larichaudy teaches that the cells may be NK cells (Larichaudy claim 21, [0052]). Thus, Larichaudy teaches the treatment of a subject with autologous NK cells that were cryopreserved with their composition.
Larichaudy does not specifically teach that the administration of their cryopreserved NK cells would prevent or treat a cancer, immune disease or infectious disease.
Schmidt teaches that autologous NK cells may be used to treat cancer and infectious disease. (Schmidt, “Anti-cancer immunotherapy with NK cells – clinical aspects“ section). Regarding cryopreservation, Schmidt notes that NK cell products which are standardized, well characterized and cryopreserved would be ideal. Schmidt teaches that it has been demonstrated that NK cells maintain their cytotoxic activity against the leukemia cell line K562 after cryopreservation, but at the same time, standard methods of cryopreservation seem to have a negative impact on cell expansion in vivo. In any event, Schmidt teaches that before the EFD of the invention, it was known in the art that NK cells, including cryopreserved NK cells, may be used in a method of preventing of treating cancer.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to use cryopreserved NK cells to treat a subject as taught by Larichaudy, and more specifically to treat or prevent cancer in a subject in need thereof as taught by Schmidt. One of ordinary skill in the art would have been motivated to do so, since Larichaudy teaches the claimed cryopreservation method for NK cells among other cells, and teaches that these cells are intended for therapeutic use. Schmidt then specifically teaches that NK cells, including cryopreserved NK cells, may be used to treat cancer.
One of ordinary skill in the art would have had a reasonable expectation of success, since teaches that cryopreserved NK cells may be used to treat cancer.
Wang and Jang
Claims 1, 8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over:
Wang (CN108064840A) (Provided in IDS of 11/07/2023)
Jang (Jang TH, Park SC, Yang JH, Kim JY, Seok JH, Park US, Choi CW, Lee SR, Han J. Cryopreservation and its clinical applications. Integr Med Res. 2017 Mar;6(1):12-18. doi: 10.1016/j.imr.2016.12.001. Epub 2017 Jan 10)
Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (CN108064840A)
Regarding claim 10, Wang teaches wide ranges of volume ratios for the components of human albumin injection, dimethyl sulfoxide, polyethylene glycol, glucose injection, and normal saline injection. (Wang, pg. 2, “contents of the invention” paragraph 3, Examples 1 and 2). However, Wang does not specify exactly what the average molecular weight of the PEG cryoprotectant used.
Jang’s article reviews cryopreservation and its clinical applications, and teaches that PEG with a molecular weight between 200 and 9500 Da (g/mol) was a commonly known cryoprotectant before the effective filing date of the invention. (Jang, section 2.3.3. Polymers). Thus, it would be reasonable that Wang‘s selected PEG for cryopreservation was within this known molecular weight range for PEG that was known to be effective for cryopreservation as taught by Jang, which teaches a wide overlapping range which encompasses the claimed range (400g/mol to 2000g/mol). If that were the case, Wang alone teaches a PEG with the claimed molecular weight. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
However, even if Wang can’t reasonably be said to teach the claimed PEG, it would still have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to use Jang’s PEG as the PEG component of Wang ‘s NK cryopreservation solution. One of ordinary skill in the art would have been motivated to do so, since Wang does not specify the average molecular weight of the PEG they use, but Jang teaches that PEGs of a wide range of molecular weights were known in the art to be an effective cryoprotectant, which would yield the predictable result of a cryoprotectant solution comprising PEG within the claimed molecular weight range. Thus, this combination is combining prior art elements according to known methods to yield predictable results. (MPEP 2143 (I)(A)).
One of ordinary skill in the art would have had a reasonable expectation of success, since Wang teaches the claimed composition and Jang teaches that PEG in the claimed range is an effective cryoprotectant.
Wang
Claims 1, 8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over:
Wang (CN108064840A) (Provided in IDS of 11/07/2023).
Claims 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (CN108064840A)
Regarding claim 11, Wang teaches wide ranges of volume ratios for the components of human albumin injection, dimethyl sulfoxide, polyethylene glycol, glucose injection, and normal saline injection. (Wang, pg. 2, “contents of the invention” paragraph 3, Examples 1 and 2). However, Wang does not specify exactly the final concentration of the polyethylene glycol in their cryoprotectant solution.
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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 experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In this case, Wang teaches compositions with varying concentrations of different components of their cryopreservation solution, including varying the amount of PEG. This suggests that Wang anticipated the need to optimize the PEG concentration in their cryopreservation solution.
Thus, it is reasonable that the skilled artisan would be motivated to optimize the workable PEG concentration in Wang’s solution.
Conclusion
Claims 1-17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS RUSSE AMICK whose telephone number is (571)272-5474. The examiner can normally be reached 7:30-5 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS R. AMICK/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638