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
This action is in response to the papers filed September 19, 2024.
Claim Listing
The instant claims are the original claims filed on 09/19/2024.
Claims 1-9 are pending and under examination.
Priority
The instant application 18890553 was filed on 09/19/2024. This application claims priority based on U.S. Provisional Patent Application 63/539,297 filed 09/19/2023.
Double Patenting
Applicant is advised that should claim 2 be found allowable, claim 3 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Objections
The claims are objected to because of the following informalities:
In claim 1, step (b), the phrase “Cluster of Differentiation (CD Marker)” should be “Cluster of Differentiation (CD) Marker” instead.
In claim 1, step (g), the phrase “the DMD patient” should be “the Duchenne Muscular Dystrophy (DMD) patient” instead.
In claim 2, the phrase “Fibroblast Growth Factor (FGF) 21” should be “Fibroblast Growth Factor 21 (FGF21)” instead.
In claim 3, the phrase “Fibroblast Growth Factor (FGF) 21” should be “Fibroblast Growth Factor 21 (FGF21)” instead.
In claim 4, the phrase “method pf Claim 1” should be “method of Claim 1” instead.
In claim 5, the term “CD 133” should be “CD133” instead.
In claim 8, the term “patients” should be “patient’s” instead.
In claim 8, the term “FGF 21” should be “FGF21” instead.
Applicant should carefully review the claims and correct any typographical errors which would be undesirable should the claim proceed to issue. Appropriate action is required. Any amendments to the claims must not include new matter.
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 1-19 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.
The claims are generally narrative and indefinite, replete with grammatical and idiomatic errors. The claims are found to be indefinite for at least the following reasons:
Claim 1, step (a), recites “patient's mesenchymal stem cells (HSMCs).” It is unclear what “HSMC” means, or how the parenthetical further limits the “patient's mesenchymal stem cells,” if at all.
The limitation “the MSCs” in claim 1, step (b), lacks sufficient antecedent basis. Generally, it is unclear whether “the MSCs” refers to the earlier recitation of “patient's mesenchymal stem cells (HSMCs)” or the later recitation of “viable HMSCs.”
The limitation “HMSCs” in steps (e) and (g) of claim 1, lines 1 and 2 of claim 6, and line 1 of claim 9 is unclear. The term lacks sufficient antecedent basis, and the term is neither defined by the claims nor specification. Generally, it is unclear the “HMSCs” is intended to refer to the earlier recitation of “HSMCs” and/or MSCs.”
Claim 1, step (e) recites the limitation “a special growth medium.” The limitation is indefinite. The term “special growth medium” is not a term of art, and neither the claims nor specification provide a definition. Generally, it is unclear how the modifier “special” changes the scope of the claimed growth medium, and one of ordinary skill in the art would not be reasonably apprised of the difference between a “special” growth medium and a growth medium that is not “special.”
Claim 1, step (e), recites expansion to “a concentration of at least 60 million cells.” The limitation is indefinite because “60 million cells” is not a “concentration” but rather the total number of cells. Reciting a “concentration” requires defining the unit of volume, e.g., 60 million cells per microliter.
The limitation “the DMD patient” in step (g) of claim 1 and in claim 6 lacks sufficient antecedent basis. The claims do not previously describe any patient having DMD. Generally, it is unclear if “ the DMD patient” refers to the same patient of the preamble of claim 1.
The limitation “one or more a metabolic respiratory chain ("RTCs") functions, capacities or performance is improved in function generally when damaged or dysfunctional from disease” is indefinite. The term “metabolic respiratory chain” is not a term of art, and the term is neither defined by the claims nor specification. It is also unclear what the parenthetical “RTCs” means, or how the parenthetical further limits “metabolic respiratory chain,” if at all. In addition, it is unclear what the phrase “generally when damaged or dysfunctional from disease” means, e.g., it is unclear how “generally when” is different from “when.” For example, “generally when” appears to suggest there is additional scope to the claim outside of conditional limitation “when damaged or dysfunctional from disease,” but the claims fails to describe that additional scope.
The limitation “Canver growth and disease” in claim 5 is indefinite. The term is not a term of art, and the term is neither defined by the claims nor specification. In addition, the limitation “cells expressing CD 133 and related cells” is indefinite because it is unclear what criteria or standard defines a cell “related” to cells expressing CD133. In addition, the term “HMAC expanded cells” is not a term of art, and the term is neither defined by the claims nor specification.
The limitation “the intramuscular injections” in claim 7 lacks sufficient antecedent basis. No step of intramuscular injection is previously recited.
Claim 8 recites “injections are administered to a patients muscles, nerves, or organs that have a likelihood of mitochondrial or FGF 21 deficit.” The limitation is indefinite because “injections” lacks antecedent basis, and it is generally unclear what therapeutic is being injected into the patient. In addition, the term “likelihood” is a relative term which renders the claim indefinite. The term is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For example, the claim provide no criteria or test to determine “likelihood,” and a “likelihood” determination may be found using one standard and not found using another standard.
For these reasons, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Dependent claims are included in the basis of the rejection because they do not correct the deficiencies of the claim upon which they depend. Applicant should carefully review the claims and correct any grammatical and idiomatic errors. Any amendments to the claims must not include new matter.
Claim Rejections - 35 USC § 102
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.
Claims 1-6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2014/203267 A2 to Totey et al.
As set forth under 35 U.S.C. 112(b), the claims are generally narrative and indefinite, replete with grammatical and idiomatic errors. The claims are found to be unpatentable over the prior art for at least the following reasons:
Totey discloses methods for isolation, purification and expansion of human adipose tissue-derived mesenchymal stem cells (MSCs) for treating Duchenne muscular dystrophy (DMD). See, Abstract.
The method comprises:
(a) harvesting the patient's mesenchymal stem cells (MSCs) from that patient's adipose tissue obtained by a liposuction procedure (pg. 4, ll. 16-33; pg. 8, ll. 31-34);
(b) separating the MSCs having a specified CD marker from the adipose environment (pg. 4, ll. 24-26; pg. 5, ll. 1-6);
(c) cryofreezing the MSCs to a state where metabolic activity has ceased (pg. 9, ll. 25; pg. 13, ll. 3-10; pg. 15, ll. 1-6; pg. 19, ll. 13-16);
(d) recovering by a gradual warming protocol of MSCs to viability (pg. 13, ll. 13; pg. 15, ll. 9-12; pg. 19, ll. 18);
(e) expansion of viable MSCs in a growth medium to a concentration of at least 60 million cells (pg. 5, ll. 7-12; pg. 13, Table 1);
(f) preparing the expanded MSCs for administration (pg. 5, ll. 17-19; pg. 9, ll. 6-10); and
(g) administrating the MSCs to the patient, wherein the patient has DMD (pg. 5, ll. 17-19; pg. 9, ll. 6-10).
The MSCs are administered intravenously and to multiple subjects (pg. 20, ll. 1-2; pg. 21, Table 4; pg. 23, ll. 28-30; pg. 24, ll. 7-19).
The claims further recite that the method increases the number and lifespan of a patient's mesenchymal stem cells by administration of laboratory expanded autologous mesenchymal stem cells (claim 1, preamble), FGF21 is increased in the patient’s serum, organs or tissue cells by reasons of increased bodily generation, increased circulation and changed properties of utilization in the patient’s body (claims 2-3), one or more metabolic respiratory chain or “RTCs” functions, capacities or performance is improved in function when damaged or dysfunctional from disease (claim 4), cells expressing CD133 and related cells associated with Canver growth or disease are suppressed in the patient’s serum, organs or tissue cells by increased volume of HMAC expanded cells (claim 5), and the patient’s muscles, nerves or organs have a likelihood of mitochondrial or FGF21 deficit (claim 8).
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003). See, MPEP 2112.
In this case, the above limitations describe an intended result or functional property of performing the process steps (manipulative actions) positively recited in claim 1. A recitation of an intended result or functional property of the claimed process must result in a manipulative difference between the claimed process and the cited prior art in order to patentably distinguish the claimed process from the cited prior art. If the prior art process is capable of performing the intended result, or if the functional property naturally flows from the prior art process, then the prior art reads on the intended result or functional property recitation. There is no requirement that the cited prior art expressly teach or suggest the intended result or functional property recitation, but only that the subject matter is, in fact, present in the cited prior art. As outlined above, the manipulative actions positively recited by the claims are anticipated by the cited prior art. In particular, Totey discloses a process of obtaining and expanding a population of human adipose tissue-derived mesenchymal stem cells (MSCs) and administering the cell population to a patient having DMD, as claimed in claim 1. Therefore, the intended results and/or functional properties of the claims would have naturally flowed from performing the process steps taught by Totey. Accordingly, absent evidence to the contrary, the intended result and functional property recitations are not found to patentably distinguish the claimed invention from the cited prior art.
For these reasons, Totey anticipates the process of claims 1-6 and 8.
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.
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/203267 A2 to Totey et al., as applied to claims 1-6 and 8 above; in further view of Dai et al. (2018) “Efficacy of stem cell therapy in ambulatory and nonambulatory children with Duchenne muscular dystrophy–Phase I–II” Degenerative Neurological and Neuromuscular Disease, 63-77.
Claim 7 recites intramuscular injections are administered in a series of 8 injections, and claim 9 recites repeated intravenous injection at a minimum interval of 45 days.
Totey teaches intravenous administration (pg. 20, ll. 1-2; pg. 23, ll. 28-30), administering 1-3 doses (pg. 9, ll. 9), and administering at regular intervals (pg. 25, ll. 32, through pg. 26, ll. 1; pg. 29, ll. 18-20).
Totey does not teach intramuscular injection, a series of 8 injections or regular administrations at a minimum interval of 45 days, as instantly claimed.
Dai is relevant prior art for disclosing the administration of mesenchymal stem cells (MSCs) to human patients having Duchenne muscular dystrophy (DMD). Cellular therapies were administered in a series of 8 injections, including both intramuscular and intravenous, and the 8 cycles of stem cell therapy were given every 2 weeks for a total of 4 months. Increased gene expression, muscle strength and pulmonary function is reported. See, Abstract; pg. 64-65; pg. 75, Table S1.
"[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). MPEP 2144.05.
In this case, the general conditions of the claims are found in the prior art. In particular, Totey discloses a process of obtaining and expanding a population of human adipose tissue-derived mesenchymal stem cells (MSCs) and administering the cell population to a patient having DMD, as claimed in claim 1. Further, one of ordinary skill in the art would have recognized that the dosing regimen, including the route of administration, the number of administrations and the interval between administrations, are result-effective variables effecting the efficacy of treatment. Indeed, Dai provides a clinical study with a dosing regimen similarly including intramuscular injection, 8 cycles of injection and a 4-week interval between intravenous injections. Therefore, absent a secondary consideration, the instantly claimed dosing regimens of claims 7 and 9 would have been prima facie obvious over the prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES J GRABER whose telephone number is (571)270-3988. The examiner can normally be reached Monday-Thursday: 9:00 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James D Schultz can be reached at (571)272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES JOSEPH GRABER/Examiner, Art Unit 1631
