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 .
Claim Status
Claims 29-43 are pending and have been examined on 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.
Claim 41 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.
In claim 41 (at lines 4-5), the claim contains the trademark/trade names: F-68® and TWEEN 80® (phrased as “F-64 Registered Trademark” and “Tween 80 Registered Trademark”, respectively). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe the material sold under the tradename TWEEN 80®, however, without identifying the actual product itself, and, accordingly, the identification/description is indefinite. Appropriate correction is required.
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.
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 29-32, 34-37, and 41-43 are rejected under 35 U.S.C. 103 as being unpatentable over Kattman et al (WO 2013/019661 A1; IDS).
The instant claims are as of record, drawn to a method comprising culturing cells in a media containing:
a mixture of a lipid mixture, taurine, creatine, and carnitine (see claims 29+), including:
a lipid mixture, optionally 0.01-05 pg/ml (see claims 29-43) of one or more of: linolenic acid, linoleic acid, and palmitic acid (see claim 30), or further with arachidonic acid, myristic acid, oleic acid, palmitoleic acid, and stearic acid (see the combinations as claimed in part in cl. 41,for example);
a taurine compound, optionally 2-7mM thereof (cl. 29+, esp. cl. 29, 35) ; and
a creatine compound, optionally 2-7mM thereof (cl. 29+, esp. cl. 29,36);
carnitine (cl. 36) in an amount of 0.5-3.5 mM or 1.5-2.25 mM (cl. 29+, esp. cl. 29,34);
and further optionally:
insulin, transferrin and selenium (cl. 37) in respective amounts of 5-15, 3-8, and 0.005-0.0075 mg/m (cl. 42)l;
polyvinyl alcohol (PVA) in an amount of 0.1-10 mg/ml (cl. 38 for example)
serum-free (cl. 29+)
triiodothyronine T3, DITPA, a thyroid hormone-like compound, in an amount of 25-150 ng/ml (cl. 49-40 for example); and
cholesterol (cl. 33).
The claims are, in part, distinguished from Kattman et al (WO 2013/019661 A1, see entire document) in that the reference does not teach or suggest (vi, vii, ix) providing polyvinyl alcohol (PVA) or triiodothyronine T3, DITPA, or cholesterol. However, the balance of the claims are obvious in light of the ‘661 reference which teaches the following (note: superscripted roman numerals are added, for clarity of comparison to corresponding claimed components above). ‘661 teaches culturing stem cells to maturity in a culture media, specifically “stem cell-derived cells which are grown in certain media to promote them to a later stage of differentiation, including a later stage of cardiomyocyte differentiation, for example”, and the cells include “cardiomyocytes [which] are derived from embryonic stem cells or induced pluripotent stem cells,…grown from induced pluripotent stem cells, human embryonic stem cells, or human induced pluripotent stem cells…the resultant cardiomyocytes mature by decreasing the expression of "fetal" genes…and increasing adult genes/proteins” [0006]. The reference additionally teaches “contacting stem cell-derived cells with a medium that has one or more of…is essentially free of serumvii; …that comprises one or more fatty acidsi; ...L-carnitineiv;…creatineiii;… taurineii; “ [0006] (see also e.g. [0010-0016,00190,0024,0047-0060]). The one or more fatty acids may include one or mixtures of “myristoleic acid, palmitoleic acid, .., oleic acid, .., linoleic acid, .., alpha-linolenic acid, arachidonic acid, ... Examples of saturated fatty acids include .., myristic acid, palmitic acid, stearic acid, ..” [0048-0060]. The culturing media may further include “ITS-A (Gibco cat #:51300-044: a combination of insulin, transferrin, and seleniumv… of any level so long as it promotes aerobic respiration in favor of glycolysis” [0055]. ’661 further teaches measured viability at extended periods of time, including “at days 7 and 14” [00138] and “for any suitable period of time to allow metabolic maturity” including “for at least two, three, four, five, six, seven, eight, nine, ten, or more days”.
It would have been obvious to one of skill at the time of the instant invention effective filing to have provided for the intended use with cultured fetal-like cells to maturity including by culture media as claimed because, as itemized by Kattman et al ‘661 (and as enumerated above), each of the instantly claimed cells and component cell culturing materials (as enumerated and identified above) and effective amounts therefor were known as taught by the reference. Kattman et al ‘661 is relied upon for the reasons discussed above. If not expressly taught thereby, based upon the overall beneficial teaching provided by this reference with respect to the cells useful therein, the components of the culture media useful therein and the amounts and or effects elicited thereby in the culturing, in the manner disclosed therein (see also at [0046-0066]), then the adjustments of particular conventional working conditions (e.g., determining one or more suitable component from among the known components and the ranges (including amounts, concentrations, and proportions thereamong), in which to provide such a composition or use in performing cell maturity-inducing and -maintaining culturing), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Double Patenting
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 29-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent Nos. 10,696,947 (claims 1-25) and 12,043,846 (claims 1-43).
Although the claims at issue are not identical, they are not patentably distinct from each other because each of the instant ‘048 and conflicting patent (‘947 and ‘846 reference) claims are drawn to compositions method of use of the composition specially adapted therefor, wherein the composition (and composition in the method) contains combinations of components as mutually claimed (and/or supported by the disclosure), in the amounts claimed, as useful therein within the “comprising” compositions. For example, each recites inclusion of materials from among lipid mixture, cholesterol, linoleic acid, oleic acid, linolenic acid, palmitic acid, arachidonic acid, myristic acid, palmitoleic acid, stearic acid; a taurine compound; and a creatine compounds. Consequently, practicing at least one of the instant invention as claimed or that of the conflicting reference patents, as claimed, would have at least rendered obvious the other, and as such are not patentably distinguished.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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/AARON J KOSAR/Primary Examiner, Art Unit 1655
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