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 .
Claims 1-18 are pending and have been considered on the merits.
Priority
The earliest filing date of the instant application is the filing date of the US provisional application, 62/711,808, which is 7/30/2018.
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.
Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature, judicial exception, without significantly more. The claim(s) recite(s) a composition comprising naringenin, a buffering system comprising a synthetic biological buffer, and a sugar. Under the broadest reasonable interpretation of the composition, a citrus fruit comprising naringenin, sodium citrate and sugar such as glucose, fructose and sucrose, and thus, the naturally occurring counterpart of the claimed composition is a citrus fruit or a juice of the citrus fruit (e.g. orange juice). The term “synthetic” is considered as a product-by-process limitation directed to the biological buffer, and there is no limitation to the types of biological buffer. Thus, sodium citrate in the citrus fruit, which is well known as a buffer, is considered the same as synthetic sodium citrate buffer.
The dependent claims disclose additional ingredients/components in the claimed composition including naturally occurring elements such as sodium ions, calcium ions, chloride ions, etc. (claims 8-9), insulin/transferrin/sodium selenite (claims 10-11), penicillin or streptomycin (claims 12-13). There is no naturally occurring counterpart to the claimed combination, so the combination is compared to the individual components as they occur in nature. As discussed above, the main ingredients of the composition disclosed in claim 1 are considered naturally occurring products. There is no indication in the specification that the additional naturally occurring elements would provide any characteristics (structural, functional or otherwise) that are different to the naturally occurring counterparts (i.e. citrus fruit or citrus fruit juice). Thus, the combination of the naturally occurring elements as claimed does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. There are claims disclosing additional elements that are not naturally occurring (e.g. alanyl-glutamine; 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid; DMSO). For the additional elements that are not naturally occurring, the same analysis is applicable to determine if such combination of the naturally occurring counterpart with the additional non-naturally occurring elements would render the naturally occurring counterpart significantly different. There is no indication in the instant specification that these elements would change the characteristic of the composition comprising naringenin, sodium citrate and sugar. Accordingly, the claims are directed to an exception (Step 2A:YES).
This judicial exception is not integrated into a practical application because there is no additional element that would integrate the judicial product into any improvement in their function or applying or using the judicial exception in some other meaningful way. It is noted that the intended purpose or use does not constitute as an integration into a practical application. MPEP2106.04(d)(2) states “…it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.” Thus, the judicial exception is not integrated into a practical application (STEP 2A Prong Two: NO).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements as discussed above do not add significantly more to the judicial exception.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Einset (1978, Plant Physiol.).
Einset teaches the use of 10% orange juice added to the basal medium in the method of culturing citron explant cultures (Abstract). It is extremely well known in the art that orange juice contains naringenin, sodium citrate (a buffer) and sugar. Thus, the orange juice taught by Einset would meet the limitation of claim 1.
Regarding the intended purpose of transporting or cryopreserving cells or tissue, the limitation does not provide any structure to the claimed product and thus, they do not provide any weight in determining patentability of the claimed product. However, as the orange juice is utilized for culturing the citron explant (containing cells and tissues), it is considered that the orange juice or the culture medium comprising orange juice is capable of being used for the purpose of transportation or cryopreservation.
Thus, the reference anticipates the claimed invention.
Claim(s) 1-6 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Madaan et al. (2017, Am. J. Dermatol. Venereol.; IDS ref.) as evidenced by DMEM (2016, Sigma-Aldrich)
Madaan et al. teach a culture medium comprising DMEM, FBS, Penicillin/Streptomycin, and naringenin for culturing DPC cells or HaCaT cells (Materials and Methods; Fig. 1).
Regarding a sugar component of claim 1, Madaan et al. do not particularly teach the sugar, however, it is considered that the DMEM inherently contains 4.5 g/L of glucose according to DMEM formulation, which is 25mM. Thus, the DMEM of Madaan et al. contain D-glucose at the concentrations as claimed in claim 6.
Regarding claims 2-3 directed to the concentration of naringenin, Madaan et al. teach that the final concentration of naringenin used in the culture medium is 0.001 up to 10 mM (Fig. 1).
Regarding claims 4-5, the DMEM of Madaan et al. inherently contains NaHCO3 (sodium bicarbonate; a.k.a. hydrogen bicarbonate) at the concentration of 3.7 g/L, which is 44 mM (as MW of NaHCO3 is 84.01 g/mol), thus, this teaching would meet the about 15-45 mM of the synthetic biological buffer.
Regarding claim 16, the wherein clause of the claim is directed to the intended purpose of claim 1 but does not provide any structure to the composition. As the culture medium of Madaan et al. is capable of culturing DPC cells or HaCaT cells, it is considered that the culture medium of Madaan et al. is capable of using for cells derived from human hair follicles.
Thus, the reference anticipates the claimed invention.
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 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) 1-9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madaan et al. (supra) in view of DMEM (supra)
Madaan et al. teach the subject matter of claims 1-6 and 16, and thus, render them obvious (see above).
Regarding claim 7, Madaan et al. do not teach the concentration of D-glucose being about 9-15 mM. While DMEM of Madaan et al. do not particularly teach the concentration of D-glucose, however, based on DMEM composition containing 4.5 g/L of D-glucose (i.e. 25 mM) was discussed above. It is also noted that DMEM can be supplemented with 1.0 g/L of D-glucose according to DMEM from Sigma, and the concentration of 1.0g/L of D-glucose can be converted to 5.5 mM. Thus, it would have been obvious to a person skilled in the art to use DMEM with lower glucose contents as an alternative option for the high glucose DMEM with a reasonable expectation of success.
Regarding claims 8-9 directed to various ions (sodium, calcium, potassium, magnesium ions) and their concentration, it is considered that the DMEM of Madaan et al. contain these ions. While the teaching of Madaan et al. and DMEM-Sigma show these ions, however, they don’t show the concentration. However, it is considered that the concentration of ions in the culture medium would be a parameter that can be modified by routine optimization in the absence of any criticality of the claimed concentrations.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madaan et al. in view of DMEM as applied to claims 1-9 and 16 above, and further in view of ITS supplement (2014, Gibco)
Regarding claims 10-11 directed to insulin, transferrin and/or sodium selenite, Madaan et al. do not teach the limitation.
It is extremely well known in the art that insulin/transferrin/selenium (ITS) is supplemented to DMEM for many adherent cell types according to ITS supplement (p.1).
It would have been obvious to a person skilled in the art to use the ITS as a supplement to the DMEM of Madaan et al. as it is well known supplement to DMEM.
Regarding the concentration of sodium selenite, ITS supplement teaches 0.00067 g/L of sodium selenite at 100x, which would be 38.7 nM, and thus, meet the claimed range.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madaan et al. in view of DMEM as applied to claims 1-9 and 16 above, and further in view of Da Pozzo et al. (2017, Oxidative Medicine and Cellular Longevity; IDS ref.)
Regarding claims 12-13 directed to the concentration of penicillin, Madaan et al. do not teach the limitation.
Da Pozzo et al. teach the use of 100 units/ml of penicillin for DMEM.
It would have been obvious to a person skilled in the art to use the concentrations of antibiotics known in the art as taught by Da Pozzo et al. with a reasonable expectation of success.
It would have been obvious to a person skilled in the art to use the concentration for penicillin known in the art with a reasonable expectation of success.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madaan et al. in view of DMEM as applied to claims 1-9 and 16 above, and further in view of Andreasen et al. (US11,484,025)
Regarding the limitation directed to dextran 40, sucrose and/or DMSO, and their concentration, Madaan et al. do not teach the limitation.
Andreasen et al. teach that dextran, sucrose and DMSO are all considered as cryoprotectants (col. 21). Andreasen et al. teach dextran can be dextran with average MW 40,000 (i.e. dextran 40) (col. 38, Example 9). Andreasen et al. teach 10% of DMSO (Fig. 1). Andreasen et al. teach the cryoprotectants are included in a culture medium (e.g. DMEM) (col. 21-22).
While Madaan et al. do not teach the process of cryopreserving the cultured cells, however, it would have been obvious to a person skilled in the art that any mammalian cells in culture would be cryopreserved for some point of culturing. Thus, one skilled in the art would utilize the well-known cryoprotectant to cryopreserve the cultured cells as it is extremely well known procedure in the art.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 10 is/are rejected under 35 U.S.C. 101 as claiming the same invention as that of claim 1 of prior U.S. Patent No. 12,058,997. This is a statutory double patenting rejection.
Claim 1 of the ‘997 patent disclose identical scope as claim 10.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-9 and 11-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,058,997. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘997 patent teach all the ingredients and their concentration within or overlapping with the claimed concentrations. Thus, the claims of the ’997 patent render the claims of the instant application obvious.
Allowable Subject Matter
It is noted that claims 17-18 disclose “about 10-15 mM of hydrogen phosphate. While hydrogen phosphate (Na2HPO4) is present in DMEM/F-12 or RPMI media, however, the concentration is lower than the claimed concentration. PBS is known to contain up to 10 mM Na2HPO4, however, PBS does not contain other claimed ingredients for cell culture. Thus, the presence of 10-15 mM Na2HPO4 (hydrogen phosphate) in the claimed composition would render the claims free of prior art.
Conclusion
No claims are allowed.
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/TAEYOON KIM/ Primary Examiner, Art Unit 1631
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