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 .
Specification
The use of the term PLASMA-LYTE, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 8 is objected to because of the following informalities:
The claim set contains two claims numbered claim “8” (hereinafter, “8a” and “8b”)
Claim 8a, line 3, “Isolating MSC from the tissue source” should be amended to recite “isolating MSC from the tissue source;”
Claim 10, line 1, “secret” should be amended to recite “secrete”
Appropriate correction is required.
Claim Interpretation
Claim 1 is drawn to a “formulation of mesenchymal stem cells (MSC) for cosmetic use comprising a solvent and MSC.” The recitation of “for cosmetic use” was interpreted herein as an intended use. This limitation, while fully considered, was given no patentable weight, and the claims were interpreted herein to encompass any formulation comprising a solvent and MSC, which was understood to be suitable for the intended cosmetic use.
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 2-13 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 2 recites “[t]he formulation of claim 1 comprising: a balanced salt solution, an
anticoagulant, and a human serum albumin.” The relationship between these components and the “solvent” of claim 1 is unclear. In particular, it is unclear if these components are intended to further limited the solvent, or are additional components distinct from the solvent. The dependent claims do not add additional clarity and, therefore, are also indefinite. For purposes of compact prosecution and applying prior art, claim 2 was interpreted herein to require a solvent comprising a balanced salt solution, an anticoagulant, and a human serum albumin.
Claim 3 recites “0.9% saline (sodium chloride).” The recitation of “(sodium chloride)” renders the claim indefinite because it is unclear if “(sodium chloride)” was meant to expand the claim to encompass any sodium chloride solvent, or was intended as an alternative designation for “saline.” For purposes of compact prosecution and applying prior art, the recitation of “0.9% saline (sodium chloride)” was interpreted herein to only mean 0.9% saline.
Claims 9 and 10 depend from “claim 8,” but, as discussed above, the claim set contains two claims numbered “8.” As such, the scope of claims 9 and 10 is unclear. For purposes of compact prosecution and applying prior art, claims 9 and 10 were interpreted herein to depend from claim 8a.
Claim 10 requires that “the MSC formulation has the ability to secret[e] at least 1μg/106 cells/24 hours total collagen or 100 ng/106 cells/24 hours Type I collagen.” It is unclear how a formulation, i.e., a liquid composition, can secrete collagen. For purposes of compact prosecution and applying prior art, claim 10 was interpreted such that the MSCs in the formulation have the ability to secrete at least 1μg/106 cells/24 hours total collagen or 100 ng/106 cells/24 hours Type I collagen.
Claim 11 is drawn to a “method for apply the MSC formulation to a subject.” There is insufficient antecedent basis for “the MSC formulation” in the claim. It is also unclear if “a subject” in the preamble is the same as “a subject in need thereof” in line 2 of the claim. The term “apply” also renders the claim indefinite because it is unclear if the claim encompasses applying, administering, etc. It is unclear how “apply the MSC formulation to a subject” in the preamble relates to “administering to a subject in need thereof a MSC product” within the body of the claim. The dependent claims do not add additional clarity and, therefore, are also indefinite. Indeed, claim 13 limits the “MSC formulation,” and not the “MSC product.”
For purposes of compact prosecution and applying prior art, claim 11 was interpreted herein to encompass administering to a subject in need thereof an MSC formulation comprising MSCs and a solvent, wherein the solvent comprises a balanced salt solution, an anticoagulant, and a human serum albumin.
Claim 13 recites “wherein the MSC formulation is delivered to the skin locally to the dermal layer or subcutaneous tissue at between 1x105 to 1x107 cells per injection site.” The claim appears to require injecting the MSC formulation, but broadly recites “delivered,” which encompasses, e.g., topical administration. For purposes of compact prosecution and applying prior art, claim 13 was interpreted herein to injecting the MSC formulation into the skin locally to the dermal layer or subcutaneous tissue at between 1x105 to 1x107 cells per injection site.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
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 1-3 and 7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106.04 for analysis parameters.
The instant claims are drawn to a formulation of mesenchymal stem cells (MSCs) for cosmetic use comprising a solvent and MSCs, which is a statutory category of invention (Step 1: YES).
As evidenced by the Specification, MSCs are naturally occurring adult stem cells, originated from mesoderm, present, e.g., in bone marrow, adipose tissues, blood, amniotic fluid, dental pulp and placenta (Specification, as published, ¶¶ 0010, 0019). Likewise, human serum albumin (HSA) is a naturally occurring human protein. Absent evidence to the contrary, placing naturally occurring MSCs, alone or in combination with HSA, into a formulation would not, absent evidence to the contrary, result in any markedly different characteristics with respect to structure, function, or any other property to distinguish the MSCs and/or HSA from their naturally occurring counterparts.
Moreover, the broadest reasonable interpretation of “solvent” includes water and sodium chloride (see claim 2 “0.9% saline”). As such, the instant claims are drawn to a judicial exception (“JE” | natural phenomenon) in the form of naturally occurring MSCs, HSA, and natural solvents such as water, salt water, etc. (Step 2A, Prong 1: YES).
While the claims recite a formulation for “cosmetic use,” this is merely an intended use, i.e., the instant claims are drawn solely to the JE—not a method of using the JE for, e.g., a specific treatment or prophylaxis. As such, the claims do not recite any additional elements that integrate the JE into a practical application (Step 2A, Prong 2: NO).
Since the claims are limited to the JE, the claims do not include any additional elements that are sufficient to amount to significantly more than the JE. Moreover, as evidenced below, it was well-understood, routine, and conventional to formulate MSCs and HSA together with solvents (Step 2B: NO).
In view of foregoing, the claimed invention does not constitute patent eligible subject matter.
Claim Rejections - 35 USC §§ 102/103
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.
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 1-4, 8a-8b, and 10-11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over CN101210232 (translation cited below, hereinafter “CN232”).
CN232 discloses mesenchymal stem cells (MSCs) in a storage solution comprising MSCs, human serum albumin (HSA), and low-molecular heparin (LMWH) in physiological saline (i.e., 0.9% NaCl) (Claims 1-7). CN232 further teaches the resulting formulation is suitable for administration to a subject (Abstract). CN232 discloses isolating the MSCs from umbilical cord tissue (page 3).
As such, CN232 teaches each and every element of the claimed invention. In the alternative, it would have been prima facie obvious before the effective filing date of the claimed invention to produce the MSC formulation taught by CN232 from MSCs isolated from umbilical cord tissue for administration to a subject because CN232 further teaches the formulation advantageously exhibits stability at 4˚C and is suitable for clinical use (Abstract).
Regarding claim 10, as discussed above, CN232 discloses MSCs isolated from umbilical cord tissue (as well as bone marrow and adipose (page 3) as encompassed by the instant claims, and nothing in the Specification reasonably suggests that the instant MSCs were manipulated/modified to increase collagen production. As such, absent evidence to the contrary, the MSCs taught by CN232, which were formulated in the same solvent, as claimed, would inherently possess the ability to secrete at least 1μg/106 cells/24 hours total collagen or 100 ng/106 cells/24 hours Type I collagen, as claimed. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Accordingly, CN232 anticipates the claimed invention or, in the alternative, renders the claimed invention prima facie obvious.
Claims 5-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over CN232.
As discussed above, claims 1-4, 8a-8b, and 10-11 were anticipated or, in the alternative, rendered prima facie obvious by CN232.
Regarding claims 5 and 7, CN232 further teaches an HSA concentration of 0.01%-20% and a LMWH concentration of 1-5000 IU/ml (page 2; claim 1). 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 re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claims 5, 7, and 9, at a minimum, it would have been a matter of routine experimentation using standard laboratory techniques available at the time of filing to determine the optimal concentration of each component and number of MSCs in the formulation taught by CN232 to maximize MSC stability and desired clinical application(s) with a reasonable expectation of success. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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).
Regarding claim 6, CN232 further teaches that EDTA was well-known to prevent MSC aggregation and, as such, provides a clear teaching, suggestion, and motivation to further add EDTA to the MSC formulations disclosed within the reference with a reasonable expectation of success (pages 1-2, Technical Field).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claims 1-4 and 11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over CN108651442 (translation cited below, hereinafter “CN442”).
Regarding claims 1-4, CN442 discloses mesenchymal stem cells (MSCs) in a storage solution comprising EDTA, human serum albumin (HSA), and heparin in lactated Ringer’s solution (Abstract; page 3; claims 1-5). Regarding claim 11, CN442 discloses administering the resulting formulation to mice (Example 5).
As such, CN442 teaches each and every element of the claimed invention. In the alternative, it would have been prima facie obvious before the effective filing date of the claimed invention to produce the MSC formulation taught by CN442 because CN442 further teaches the formulation advantageously exhibits stability at 4˚C allowing for ease of short-distance transportation (Abstract).
Accordingly, CN442 anticipates the claimed invention or, in the alternative, renders the claimed invention prima facie obvious.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over CN442
As discussed above, claims 1-4 were anticipated or, in the alternative, rendered prima facie obvious by CN442.
Regarding claim 6, CN442 teaches EDTA at a concentration of 0.01 to 0.4 mg/ml (claim 2).
Regarding claim 7, CN442 teaches HSA at a concentration of 0.5 to 5% (claim 2).
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 re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). At a minimum, it would have been a matter of routine experimentation using standard laboratory techniques available at the time of filing to determine the optimal concentration of each component in the formulation taught by CN442 to maximize MSC stability with a reasonable expectation of success.
Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over CN442 as applied to claims 1-4 and 11 above, and further in view of CN232.
As discussed above, claims 1-4 and 11 were anticipated or, in the alternative, rendered prima facie obvious by CN442. While the reference teaches the use of heparin, the reference does not explicitly teach that the heparin is low molecular weight heparin (LMWH). However, CN232 that LMWH has, inter alia, longer half-life and higher activity compared to unfractioned heparin (page 2). It would have been prima facie obvious before the effective filing date of the claimed invention to utilize the LMWH taught by CN232 in the MSC storage solution taught by CN442 due to its longer half-life and high activity with a reasonable expectation of success.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over CN232 as applied to claims 1-4, 8a-8b, and 10-11 above, and further in view of Kim et al. (WO 2007/069813, hereinafter “Kim”).
As discussed above, claims 1-4, 8a-8b, and 10-11 were anticipated or, in the alternative, rendered prima facie obvious by CN232. The reference does not teach that the formulation is administered to locally to the dermal layer or subcutaneous tissue at between 1x105 to 1x107 cells per injection site for the various cosmetic applications in claim 12.
However, Kim teaches isolating MSCs with increased Type I collagen production from adipose tissue, which can be formulated into injectable compositions to treat skin defects of dermis or subcutaneous tissues, including wrinkles scars, via dermal or subcutaneous injection (Abstract; page 2, lines 16-24; page 6, lines 17-21; page 8, lines 20-21).
It would have been prima facie obvious before the effective filing date of the claimed invention to formulate the MSCs isolated according to Kim in the storage solution taught by CN232 in order to advantageously stabilize the MSCs prior to use with a reasonable expectation of success.
Moreover, regarding claim 13, it would have been a matter of routine experimentation using standard laboratory techniques available at the time of filing to determine the optimal concentration of MSCs per injection to maximize the therapeutic outcome, e.g., reduction in wrinkles, scarring, etc., with a reasonable expectation of success. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
CN 101919380 A
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/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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