DETAILED ACTION
This action is in reply to papers filed 8/15/2023. Claims 22-40 are pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20230357723A1, Published 11/9/2023.
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 22,25 and 32 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 22 recites, inter alia, “…wherein the cell hibernation medium comprises Hibernate®E.” The® (R in a circle) symbol, recited after the term ‘Hibernate’ is used to denote registered trademarks. Per MPEP 2173.05 (u), if the 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 the 35 U.S.C. 112, second paragraph. Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). This is because the claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. In fact, the value of a trademark would be lost to the extent that it became descriptive of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to identify or describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name. Appropriate correction is required.
Claim 25, which depends on claim 22, refers to “or the analog dipeptide.” The recitation ‘the analog dipeptide’ lacks antecedent basis. This is because claim 22 recites ‘an analog thereof’ and not an analog dipeptide thereof. Appropriate correction is required.
Claim 32 is drawn to a cell recovery medium comprising: the cell preservation medium
of claim 22, and Ml99, DMEM, glucose or other sugar based energy source, glutamine or an analog thereof, and one or more of ascorbic acid, albumin, or insulin, wherein the cell recovery medium has about 45% to about 55% cell preservation medium, wherein the cell recovery medium has about 10% to about 15% M199 and about 35% to about 40% DMEM.
For completeness, claim 22 is drawn to a cell preservation medium comprising: cell hibernation medium and L-glutamine or an analog thereof, and one or more of ascorbic acid, albumin, or insulin.
At issue here is that claim 32 comprises the cell preservation medium of claim 22 and Ml99, DMEM, glucose or other sugar based energy source, glutamine or an analog thereof, and one or more of ascorbic acid, albumin, or insulin. This is problematic because the cell preservation medium already recites each of the components in bold font. Thus, the metes and bounds of the cell recovery medium of claim 32 are unclear.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 29-30 and 34-35 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 29 is drawn to the medium of claim 22 further comprising cells. Claim 30 limits those cells to cardiomyocytes. Similarly, claim 34 is drawn to the medium of claim 33 further comprising cells. Claim 35 limits the cells of claim 34 to cardiomyocytes.
For completeness, claim 22 is drawn to a cell preservation medium comprising: cell hibernation medium and L-glutamine or an analog thereof and one or more of ascorbic acid, albumin, or insulin.
For completeness, claim 33 is drawn to a cell culture medium comprising: Ml99, DMEM, L-glutamine or analog thereof, glucose or other sugar based energy source, one or more of ascorbic acid, albumin, or insulin, wherein the medium has about 20% to to about 30% M199 , about 70% to 80% DMEM, and about 2 g/L to about 8 g/L glucose or other sugar.
The subject matter of claim 22 is a cell preservation medium. Arora (MATER METHODS 2013; 3: 175) teaches a culture medium is a liquid or gel designed to support the growth of microorganisms, cells, or small plants. Cell culture media generally comprise an appropriate source of energy and compounds which regulate the cell cycle. A typical culture medium is composed of a complement of amino acids, vitamins, inorganic salts, glucose, and serum as a source of growth factors, hormones, and attachment factors (Pg. 1, para. 1). A cell culture medium does not comprise cells. As such, claims 29-30 fail to further limit the subject of claim 22. This analysis extends to claims 34 and 35.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Prior Art Rejection 1
Claim(s) 22-23, 25, 29 and 37 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steketee et al. (Proc Natl Acad Sci U S A. 2011 Nov 7;108(47):19042–19047).
Claim interpretation: Claim 22 is drawn to a cell preservation medium. The term ‘preservation’ is interpreted as an intended use of the medium, as delineated by the body of claim 1. The Courts have consistently held that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Steketee et al. is drawn to functionalizing super magnetic particles to be used as a platform to study subcellular organelle localization and to deliver nanotherapeutics to treat injury or disease in the central nervous system (Abstract). Towards this end, Steketee et al. teach retinal ganglion cells (as in claim 29 and claim 37) were purified from embryonic day 20 to postnatal day 8 Sprague–Dawley rats to >99% purity by immunopanning, cultured on poly-d-lysine and 2 μg/mL laminin-coated glass bottom dishes in H-SATO containing Hibernate-E (as in claim 22 (in-part) and claim 23) with 5 mg/mL insulin (as in claim 22 (in-part)), 1 mM sodium pyruvate, 1 mM l-glutamine as in (as further in claim 22 and as in claim 25), 40 ng/mL triiodo-thyronine, 5 mg/mL N-acetyl cysteine, B27, with or without 50 ng/mL BDNF, 10 μg/mL ciliary neurotrophic factor, and 5 μM forskolin. Stektee et al. teach DRGs were dissected from P4 Sprague–Dawley rats and cultured as above with the addition of 25 ng/mL NGF (Pg. 19046, Col. 1, para. 2).
Accordingly, Steketee anticipates the claimed invention.
Prior Art Rejection 2
Claim(s) 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (Biochim Biophys Acta. 2012 Sep;1817(9):1628-34.).
Li et al. teach freshly isolated rat hepatocytes (as in claim 34) were grown in DMEM medium (as in claim 32, in-part) containing 4.5g/l glucose (as in claim 32, in-part) supplemented with 25% M199 (as in claim 32, in-part), 10% SVF, 0.2 mg/ml BSA (as in claim 32, in-part), 10μg/ml insulin (as in claim 32, in-part), 2 mM glutamine, (as in claim 32, in-part) and antibiotics (Pg. 1629, paragraph bridging Col. 1 and Col. 2).
Accordingly, Li et al. anticipates the claimed invention.
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.
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.
Prior Art Rejection 3
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Steketee et al. (Proc Natl Acad Sci U S A. 2011 Nov 7;108(47):19042–19047) as applied to claims 22-23, 25, 29 and 37 and further in view of Nilsang et al. (Biotechnol Prog. 2008 Sep-Oct;24(5):1122-31.).
The teachings of Steketee et al. are relied upon as detailed above. However, Steketee et al. fails to teach L-alanyl-L-glutamine (as in claim 24).
Before the effective filing date of the claimed invention, for understanding cell behavior and to achieve high cell density and mAb productivity, Nilsang et al. explored the effect of basal medium on hybridoma cell culture was studied by using three different culture medium; (1) D-MEM with 4 mM L-glutamine (available commercially); (2) D-MEM containing the dipeptide L-alanyl-L-glutamine (3.97 mM) substituted on a molar equivalent basis for L-glutamine (commercial name GlutaMAX) (available commercially); and (3) D-MEM with L-glutamine and was supplemented in our experiments with 2 mM α- ketoglutarate; pH 7.2. Nilsang notes he kinetics of cell growth in basal medium containing L-glutamine + α-ketoglutarate was similar to cells grown on GlutaMAX containing medium, whereas D-MEM containing L-glutamine showed lower productivity. With the maximal viable cell density (6.85 × 106 cells mL−1) and highest specific mAb production rate (3.9 μg mL−1 10−4 viable cell day−1), D-MEM-GlutaMAX was further selected for 3D cultivation (Abstract; paragraph bridging Pg. 1123 and 1124).
When taken with the teachings of Steketee et al., one of ordinary skill in the art would have found it prima facie obvious to substitute the L-glutamine in the medium of Steketee with the L-alanyl-L-glutamine of Nilsang because Nilsang observed better cell growth in medium containing L-alanyl-L-glutamine when compared to medium containing L-glutamine. Thus, the substitution would have been prima facie obvious.
Prior Art Rejection 4
Claims 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Steketee et al. (Proc Natl Acad Sci U S A. 2011 Nov 7;108(47):19042–19047) as applied to claims 22-23, 25, 29 and 37 and further in view of Richard et al. (Eur J Neurosci. 2005 Nov;22(9):2145-58).
The teachings of Steketee et al. are relied upon as detailed above. However, Steketee et al. fails to teach the preservation medium further comprises ascorbic acid (as in claim 26), albumin (as in claim 27) and the insulin concentration is 1 ug.ml to about 20 ug/ml (as in claim 28).
Before the effective filing date of the claimed invention, Richard et al. taught olfactory epithelium explants were prepared from E14 rat embryos. Specifically, Richard teaches explants were transferred onto cover-slips coated with poly-l-lysine and laminin. Explants were then placed in a humidified incubator at 37 °C, 5% CO 2 for 1 h, without culture medium, in order to facilitate their adherence to the cover-slip. Medium was then added to cover explants and was changed after 48 h. Culture medium contain gentamicin (100 ug ⁄ mL), glucose (6 mg ⁄ mL), insulin (5 ug ⁄ mL) (as in claim 28), glutamin (2 mm), bovine serum albumin (1%) (as in claim 27), holo-transferrin (10 ug ⁄ mL), putrescine (0.1 mm), ascorbic acid (40 um) (as in claim 28) and sodium selenite (30 m) diluted in DMEM and HAM F12 media (1 : 1 mixture) (Pg. 2147, Col. 1, last paragraph).
Examiner notes that although Richard does not teach the albumin and ascorbic acid are added to the medium at an amount as claimed, MPEP 2144.05 states that "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). Experimentation to determine the optimum concentration of growth factors to be added to the wound healing device in order to obtain a therapeutic effect in vivo was well known in the art of wound repair and regeneration. Thus, obtaining the resulting composition to function as claimed would require only routine experimentation for one of ordinary skill in the art. Therefore, given that the combination of the claimed components has been previously described, without specific evidence that the indicated concentrations are critical to the invention; the identification of these properties will not render the subject matter patentable.
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and G are applicable. Before the effective filing date of the claimed invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Steketee et al., whereby Steketee et al. teaches a culture medium comprising insulin for disassociating explants with the teachings of Richard et al., whereby Richard et al. teaches a culture medium comprising insulin, ascorbic acid and albumin for disassociating explants. That is, one of ordinary skill in the art would have found it prima facie obvious to modify the disassociating medium of Steketee such that said medium further contained ascorbic acid and albumin, as taught in Richard. That is, the skilled artisan would have found it prima facie obvious to combine albumin, insulin and ascorbic acid in a disassociating medium to isolate neurons because Richard observed success in olfactory epithelium explants were prepared from E14 rat embryos .
Thus, the combination would have been prima facie obvious.
Prior Art Rejection 5
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Steketee et al. (Proc Natl Acad Sci U S A. 2011 Nov 7;108(47):19042–19047) as applied to claims 22-23, 25, 29 and 37 and further in view of Das et al. (Biomaterials. 2004 Nov;25(25):5643-7.).
The teachings of Steketee et al. are relied upon as detailed above. However, Steketee et al. fails to teach the cells are cardiomyocytes (as further in claim 22).
Before the effective filing date of the claimed invention, and with respect to claim 30, Das et al. teach a method of purifying cardiomyocytes from embryonic day 14 (E14) embryos. Specifically, Das teaches disassociating cardiomyocytes from the E14 embryos (Pg. 5644, Col. 2, para. 2). With respect claim 31, the recitation “….wherein the cells are iPSc derived cardiomyocytes”, this recitation is being interpreted as a product-by-process limitation. Per MPEP §2113, "Even though product-by process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In this regard, absent evidence to the contrary the cardiomyocyte of Das et al. is the same or obvious over an IPSc derived cardiomyocyte.
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationale B is applicable. Before the effective filing date of the claimed invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Steketee et al., whereby Steketee et al. teaches a disassociating medium for disassociating retinal ganglion cells from rat embryos with the teachings of Das et al., whereby Das et al. teaches a disassociating medium for disassociating cardiomyocytes from rat embryos. That is, one of ordinary skill in the art would have found it prima facie obvious to substitute the disassociating medium of Das et al. with the disassociating medium of Steketee et al. in order to determine which disassociating medium was more efficient. It is well settled that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipate success, it is likely that product not of innovation but of ordinary skill and common sense."
Thus, the substitution would have been prima facie obvious.
Prior Art Rejection 5
Claims 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Vukadinovic-Nikolic et al. (Tissue Eng Part A. 2014 Feb;20(3-4):799-809.), Thavandiran et al. (Proc Natl Acad Sci U S A. 2013 Dec 3;110(49):E4698-707.) and Cao et al. (Cell Res. 2011 Dec 6;22(1):219–236.)
Vukadinovic-Nikolic et al. teach neonatal rat heart cells (as in claim 34 and claim 35) were isolated from 1- to 3-day old Sprague–Dawley rats. Isolates were cultivated for 1 h in culture medium and humidified at 37°C in an atmosphere with 5% CO2 in DMEM:M199 in ratio 1:4 (as in claim 33, in-part) supplemented with 10% fetal calf serum (PAA), 5% horse serum (Gibco), 2 mM L-Glutamin (as in claim 33,in-part), 100 U/mL penicillin, and 100 μg/mL streptomycin (Pg. 800, paragraph bridging Col. 1 and Col. 2).
However, Vukadinovic-Nikolic et al. fails to teach the medium further comprises glucose (as further in claim 33).
Before the effective filing date of the claimed invention, Thavandiran et al. teaches rat neonatal cardiomyocytes were isolated. Specifically, hearts were isolated from 1- to 2-d-old neonatal Sprague–Dawley rat hearts were cultured in high-glucose (4.5 g/L) (as in claim 33) DMEM with l-glutamine supplemented with 10% FBS, 1% (vol/vol) penicillin/streptomycin, and 1% (vol/vol) Hepes (Pg. E4705, paragraph bridging Col. 1 and Col. 2).
However, neither Vukadinovic-Nikolic et al. nor Thavandiran et al. teach the medium further comprises ascorbic acid (as further in claim 32).
To identify suitable inducers for iPSC-CMs (as in claim 36), Cao systematically screened sixteen cytokines and chemical compounds reported to facilitate the cardiac differentiation of ESCs. Cao found that only ascorbic acid (AA) (as in claim 32) robustly and reproducibly enhanced cardiac differentiation of iPSCs even in the lines without spontaneous cardiogenic potential. Optimized treatment of AA led to approximately 7.3-fold (miPSCs) and 30.2-fold (hiPSCs) increases in the relative abundance of cardiomyocytes (Pg. 220, Col. 2, para. 2).
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and B are applicable. Before the effective filing date of the claimed invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Vukadinovic-Nikolic et al. wherein Vukadinovic-Nikolic et al. teaches culturing 1- to 3-day old Sprague–Dawley rats isolates in a culture medium comprising DMEM:M199 in ratio 1:4 supplemented, inter alia, with L-Glutamine with the teachings of Thavandiran et al. wherein Thavandiran et al. teaches culturing 1- to 3-day old Sprague–Dawley rats isolates in a culture medium comprising, inter alia, high-glucose (4.5 g/L) DMEM, with a reasonable expectation of success. That is, one of ordinary skill in the art would have found it prima facie obvious to substitute the generic DMEM of Vukadinovic-Nikolic with the high-glucose DMEM of Thavandiran in order to determine which DMEM was more efficient. It is well settled that "a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipate success, it is likely that product not of innovation but of ordinary skill and common sense." Moreover, the skilled artisan would have found it prima facie obvious to include ascorbic acid in the medium because Cao reported such a medium facilitated cardiac differentiation. Thus, the modification would have been prima facia obvious.
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 32 and 38-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11613732. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Instant claims are drawn a cell recovery medium comprising: the cell preservation medium of claim 22,and Ml99, DMEM, glucose or other sugar based energy source, glutamine or an analog thereof, and one or more of ascorbic acid, albumin, or insulin, wherein the cell recovery medium has about 45% to about 55% cell preservation medium, wherein the cell recovery medium has about 10% to about 15% Ml99 and about 35% to about 40% DMEM.
For completeness, claim 22 is drawn to a cell preservation medium comprising: cell hibernation medium and L-glutamine or an analog thereof, and one or more of ascorbic acid, albumin, or insulin. Claim 38 is drawn to a method of culturing using the medium of claim 32. Claims 39-40 depend on claim 38.
Claim 1 of U.S. Patent ‘732 is drawn to a cell recovery medium comprising: M199, DMEM, glucose or other sugar based energy source, and cell preservation medium, wherein the cell recovery medium has about 45% to about 55% cell preservation medium, wherein the cell recovery medium has about 10% to about 15% M199 and about 35% to about 40% DMEM, wherein the cell preservation medium comprises cell hibernation medium, 0.5 mM to 4 mM L-glutamine or-alanyl-L-glutamine dipeptide, ascorbic acid, albumin, and insulin, wherein the ascorbic acid is 100 μg/mL to 300 μg/mL, the albumin is 200 μg/mL to 700 μg/mL, and the insulin is 1 μg/mL to 20 μg/mL.
It is clear that all the elements of the application claims are to be found in patent claims (as the application claims fully encompasses patent claims). The difference between the application claims and the patent claims lies in the fact that the patent claim includes many more elements and is thus much more specific. For example, patent claims specific ac concentration of ascorbic acid, albumin, insulin and L-glutamine. Thus the invention of claims of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims is anticipated by claims of the patent, it is not patentably distinct from claims of the patent.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632