DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-20 are pending and have been considered on the merits.
Claim Objections
Claims 1 and 3-4 are objected to because of the following informalities:
Claims 1 and 4 disclose the term “anti-oxidant” in line 4 and line 1, respectively. It would be more appropriate as “antioxidant” instead.
Claim 3 discloses the term “adenosine triphosphatemagnesium chloride”. There should be a hyphen between “triphosphate” and “magnesium”.
Claim 12 discloses “insulin-growth factor”. It appears that this term is a typographical error for “insulin-like growth factor”.
Appropriate correction is required.
Improper Markush Grouping Rejection
Claims 3, 5-6 and 10 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of “anti-apoptotic compounds” of claim 3 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: The species “tissue extract”, “transferrin”, “selenium”, “adenosine triphosphate-magnesium chloride”, “L-cysteine” or “L-leucine” does not share a common use as anti-apoptotic compounds known in the art. There is no known anti-apoptotic property for these species in the art based on the brief search whereas the rest of the species are known to have an anti-apoptotic effect.
The Markush grouping of “stem cell enhancer compound” of claims 5-6 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: erythropoietin, CD34-positive cell and retinoic acid as claimed do not share any structural similarity or a common use of alleged “stem cell enhancer.” CD34-positive cell, which includes hematopoietic stem/progenitor cells and it, is not a commonly known function that CD34-positive cell is used to enhance the reprogramming of a stem cell or differentiation of a stem cell into a desired tissue type as defined in paragraph [0047] of the instant specification.
The Markush grouping of “extracellular matrix compound” in claim 10 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: one of the listed species “platelet rich plasma” (PRP) is not generally considered as an extracellular matrix (ECM), and PRP is not known to share a structural similarity and a common use with other well-known ECM molecules as listed in the claims (i.e. laminin, collagen, heparan sulfate or chondroitin sulfate).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims disclose “differentiation inducing factor” present in the composition. The term “differentiation inducing factor” is defined in the instant specification as “a compound that is capable of inducing differentiation of a mesenchymal stem cell, such as a hair follicular stem cell, into a different, desired, cell type, such as neural cell, photoreceptor cell, cardiomyocytes, smooth muscle cells, epithelial cells, and the like.” (para. [0050] of PGPub)
The scope of “differentiation inducing factor” in the instant claims is particularly limited to differentiate the hair follicular stem cells into nerve cells, and thus, the scope is limited to the factor to the differentiation into nerve cells.
The instant specification discloses only a single specie for the genus of “differentiation inducing factor” as claimed. The specification discloses nerve growth factor as a differentiation inducing factor for nerve cell (para. [0135]; Example 7). The specification discloses other differentiation inducing factor (i.e. other growth factors), however, there is no other species for inducing nerve cell differentiation. Since differentiation of hair follicular stem cells into nerve cells is not well known in the art, the showing of a single species, i.e. nerve growth factor, would not sufficiently provide written description for the entire scope of the claimed invention at the time of filing.
M.P.E.P. §2163 recites, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus…when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.”
Furthermore, claim 12 discloses various growth factors and yet except nerve growth factor, the rest of the growth factors listed in the claim is not particularly disclosed in detail in the instant specification for differentiating the hair follicular stem cell into nerve cells.
Still further, claim 13 discloses that the differentiation inducing factor is epithelial growth factor. The instant specification does not disclose any embodiment that epithelial growth factor is capable of differentiating the hair follicular stem cells into nerve cells.
Thus, it is considered that the instant specification fails to provide sufficient written description to a person skilled in the art to determine that the inventors had possession on the entire scope of the claimed invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 discloses that the composition of claim 1 further comprises at least one degranulating agent. The specification does not provide any definition for the term “degranulating agent” or the scope of the term for the method as claimed. The term “degranulating agent” is interpreted as the term “degranulation” being implicated in the response of mast cells to wounds, releasing the granules and its contents. Thus, broadly, the term is interpreted as an agent that release granules [from mast cells]. While it is understood that degranulation is known cellular phenomenon, however, the claimed “degranulating agent” in the context of the method utilizing hair follicular stem cells is not fully described in the specification. The instant specification discloses only one example of the “degranulating agent”, which is Compound 48/80.
Thus, the scope of the “degranulating agent” is not clear and the instant specification fails to provide sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus of “degranulating agent”.
Scope of Enablement Rejection
Claim 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for nerve growth factor in differentiating the hair follicular stem cell into nerve cells, does not reasonably provide enablement any other growth factors including those listed in claims 12-13. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
The instant claims are directed to a method of differentiating hair follicular stem cell into nerve cells by contacting the hair follicular stem cell with a composition comprising a physiologically acceptable vanadium compound, an antioxidant compound, a stem cell enhancer compound, an ECM compound, and a differentiation inducing factor.
The specification discloses various components belonging to each of the compound present in the composition, and most of the factors disclosed and claimed appear to be for proliferation of the hair follicular stem cells. However, for the differentiation of specific cell type, Example 5 specifically discloses that the cell type and/or tissue-type specific differentiation inducing factor. According to this disclosure (para. [0120]), for generating neural cell and/or tissue, bFGF is added referring Example 6; to generate keratinocyte cell and/or tissue, EGF is added referring Example 7, and then to generate neural cell and/or tissue, NGF is added referring Example 8. However, Example 6 of the instant specification does not disclose any nerve cell differentiation. Example 6 is directed to the generation of keratinocyte cell using EGF. The use of bFGF and VEGF are for endothelial lineage differentiation according to paragraph [0078]. Example 7 discloses the step of generating nerve cell and/or tissue, and the paragraph [0125] disclose the use of nerve growth factor (NGF) to differentiate the hair follicular stem cells into nerve cells.
Thus, the disclosure of the specification with regard to the differentiation of nerve cells from the hair follicular stem cells is limited to use NGF rather than any other growth factors. However, the scope of claims as disclosed is broader to encompass any differentiation inducing factor including bFGF, IGF and EGF cannot be supported by the instant specification. Rather the specification specifically points out that other factors would not differentiate hair follicular stem cells into nerve cells.
In the presence of clear disclosure that other differentiation inducing factors than NGF are inducing other types of cells rather than nerve cells, it is considered that the instant specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for triiodothyronine, estradiol, progesterone, insulin, or adenosine triphosphate-magnesium chloride as anti-apoptotic compounds does not reasonably provide enablement for tissue extract, transferrin, selenium, L-cysteine, or L-leucine. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
The claim discloses that the composition of claim 1 further comprising one or more anti-apoptotic compounds selected from the group of triiodothyronine, estradiol, progesterone, insulin, tissue extract, transferrin, selenium, L-cysteine, adenosine triphosphate-magnesium chloride, and L-leucine.
Thus, the species listed in the Markush group in claim 3 should have known anti-apoptotic effect to the cells.
However, while some of the listed species in the claim are known to act as an anti-apoptosis in the art (e.g. triiodothyronine, estradiol, progesterone, insulin), however, “transferrin”, “selenium”, “L-cysteine” or “L-leucine” is not known in the art at the time of filing that their known function includes an anti-apoptotic effect. There is no disclosure in the instant specification that these compounds are anti-apoptotic compounds. The specification merely listed these compounds as anti-apoptotic compounds.
For example, selenium is known to induce apoptosis according Sanmartin et al. (2012, Int. J. Mol. Sci.). Sanmartin et al. teach that selenium is an essential trace mineral for human and animals and Se induces apoptosis (see Abstract).
Regarding the tissue extract, the scope of the tissue extract as claimed is extremely broad since there is no particular tissue indicated. According to the instant specification, bovine pituitary extract (BPE) is exemplified. It is known in the art that BPE provides protection against oxidative stress in human prostate epithelial cells (Kent et al. 2003). According to Kent et al., BPE contains growth hormone, which is known to protect cardiomyocytes against H2O2-induced apoptosis (see Introduction). Thus, it appears that BPE would be considered as an anti-apoptotic compound. However, the broadly claimed “tissue extract” would not necessarily provide the claimed anti-apoptotic effect.
There is no known use of adenosine triphosphate-magnesium chloride, L-cysteine or L-leucine as an anti-apoptotic compound in the art.
In the absence of any evidence or embodiments showing that the above mentioned species have anti-apoptotic effect or no known prior art on the species for the alleged functionality in the art, it is highly unpredictable that the claimed species (i.e. “transferrin”, “selenium”, “L-cysteine” or “L-leucine”) possess the alleged anti-apoptotic effect without undue experimentations.
Thus, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims without undue experimentation.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claims 1-11, 14-15 and 17-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gho (US 6,399,057; Gho’057 hereinafter) in view of Gho et al. (2004, British Journal of Dermatology; Gho2004 hereinafter), McGrew (US 6,974,681), Mignone et al. (2007, Cell Cycle), Lee (US2006/0121016), Kang et al. (2010, Journal of Dermatological Science) and Mishra (US 2007/0122906)
Gho’057 teaches a method of culturing hair follicle cells from plucked human hair in the anagen phase from one or more donor regions and culturing them in a culture medium, multiplying/proliferating and differentiating the cells (col. 2, lines 16-41). The culture medium suitable for the proliferating the hair follicle cells is a serum-free keratinocyte culture medium which is supplemented with human autologous CD34+ cells (col. 2, lines 33-36; col. 5, lines 56-65; col. 6, lines 20-41). The culture medium of Gho includes a degranulating agent, Compound 48/80 (col. 4, lines 1-23; col. 6, lines 45-49) (RE: claims 8-9).
Gho’057 does not particularly teach hair follicular stem cells in the method (claim 1).
However, Gho2004 teach that there are hair follicular stem cells in the plucked human hair and follicular cell culture (see entire document).
Thus, it is expected that the follicular cells of Gho’057 which are obtained by plucking the hair would inherently contain hair follicular stem cells according to Gho2004. These teachings of Gho’057 in view of Gho2004 would meet the limitation of claims 1, 14-15 and 17.
Gho’057 does not teach a physiologically acceptable vanadium compound (claim 1). It is noted that the limitation directed to “a physiologically acceptable” is interpreted as suitable for cell or tissue culture, and thus, the vanadium compound utilized in a cell culture would meet the limitation.
Regarding the vanadium compound (claim 1) and the vanadium compound being oxovanadium (claim 2), Gho’057 does not teach the limitation. However, it is known in the art that orthovanadate (i.e. orthovanadium) is used in a mammalian cell culture medium for improve cell viability according to McGrew (Abstract; col.2, lines 11-20 and 51-54; col. 5, lines 50-54).
It would have been obvious to a person skilled in the art to use orthovanadium in the culture medium of Gho’057 because McGrew teaches the benefit of orthovanadium or any derivatives of vanadate (vanadium) in enhancing cell survival, and any mammalian cell would be benefit from the use of vanadate in a cell culture medium (col. 2, lines 11-20). Thus, one skilled in the art would recognize the benefit of using orthovanadium in a cell culture medium of the keratinocyte culture medium in the method of Gho’057 with a reasonable expectation of success.
Regarding the differentiation inducing factor for differentiating the hair follicular stem cells into nerve cells (claims 1 and 12), Gho’057 in view of Gho2004 and McGrew do not teach the limitation. However, it would have been obvious to a person skilled in the art to differentiate the hair follicular stem cells into nerve cells. A person of ordinary skilled in the art would have been motivated to do so because it is known in the art that hair follicular stem cells can be differentiated into nerve cells according to Mignone et al. (see entire document).
Regarding claim 3 directed to the anti-apoptotic compounds, Gho’057 teach BPE (tissue extract), insulin supplemented in the culture medium (col. 3, lines 32-37), while they are not particularly named as anti-apoptotic compounds in Gho’057, however, since they are exemplified as anti-apoptotic compounds in claim 3, they are inherently the anti-apoptotic compound as claimed.
Regarding claims 1 and 4 directed to the antioxidant (claim 1) being vitamin C (claim 4), Gho’057 in view of Gho2004, McGrew and Mignone et al. do not teach the limitation.
Lee teaches that ascorbate or Vitamin C, Vitamin E as an antioxidant (para. 101).
It would have been obvious to a person skilled in the art to use an antioxidant, e.g. vitamin C, in order to eliminate reactive oxygen intermediates and enhances metabolism of free radical in the culture medium of Gho’057 in view of Gho2004, McGrew and Mignone et al. This is because one skilled in the art would recognize that any ingredients that provides enhanced survival of the cells in the culture would be desired in the cell culture medium with antioxidants such as vitamin C as taught by Lee are beneficial to the cells in the cell culture of Gho’057 in view of Gho2004, McGrew and Mignone et al. to recover from any damages caused from the preparation with a reasonable expectation of success.
Regarding the stem cell enhancer (claim 1) and erythropoietin (EPO) (claims 5-7), Gho’057 in view of Gho2004, McGrew, Mignone et al. and Lee do not teach the limitation.
Kang et al. teach that EPO increased proliferation of matrix keratinocytes in culture human hair follicles (see Abstract).
It would have been obvious to a person skilled in the art to use EPO in the method of Gho’057 in view of Gho2004, McGrew, Mignone et al. and Lee in order to enhance proliferation of hair follicle cells comprising hair follicular stem cells with a reasonable expectation of success. This is because Kang et al. teach EPO enhances proliferation of hair follicular cells in the culture of human hair follicles.
Regarding the ECM compound being platelet-rich plasma in claims 1 and 10-11, Gho’057 in view of Gho2004, McGrew, Mignone et al., Lee and Kang et al. do not teach the limitation.
Mishra teaches that a cell culture media for the growth and proliferation of all types of cells comprising platelet-rich plasma (PRP) (para. 18). Mishra teaches that the blood concentrate enhances cell growth of cells (para. 18). Mishra teach the cells may be any type of cells including stem cells (e.g. ESCs or adult stem cells), and cells from specific organs including hair follicle (para. 4), and exemplifies keratinocytes (para. 100).
It would have been obvious to a person skilled in the art to use PRP in the culture medium for keratinocyte taught by Gho’057 in view of Gho2004 because Mishra teaches PRP enhances cell growth including those from hair follicles, stem cells or keratinocytes. Thus, one skilled in the art would recognize that PRP could be used for cell growth in the keratinocyte culture medium culturing hair follicle cells of Gho’057 which includes hair follicular stem cells according to Gho2004 with a reasonable expectation of success.
Regarding claim 18, Gho’057 in view of Gho2004, McGrew, Lee, Mignone et al. and Kang et al. do not teach the nerve cells obtained from the method being introduced in a recipient region in a subject. However, it would have been obvious to a person skilled in the art to use the nerve cells differentiated from hair follicular stem cells into the body where the nerve cells are desired with a reasonable expectation of success.
Regarding the CD34+ cells and the plasma-rich plasma being autologous (claim 18), Gho’057 teach that the CD34+ cells are autologous (col. 2, lines 35-36) as discussed above, and Mishra teaches that the PRP may be autologous (para. 45).
Regarding claims 19-20, the limitation does not particularly disclose any active step for the claimed method, rather the limitation is directed to an intended purpose. Thus, the limitation does not provide any patentable weight in determining patentability of the claimed method of differentiating the hair follicular stem cells into nerve cells.
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 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gho’057 in view of Gho2004, McGrew, Mignone et al., Lee, Kang et al. and Mishra as applied to claims 1-11, 14-15 and 17-20 above, and further in view of Hunt et al. (2008, Stem Cells)
Regarding the growth factor differentiating the hair follicular stem cells into nerve cells, i.e. NGF (claim 12), Gho’057 in view of Gho2004, McGrew, Mignone et al., Lee, Kang et al. and Mishra do not teach the limitation.
Hunt et al. teach that the hair follicle dermal papilla of adult skin has neuronal and glial potential and culturing the dermal papilla of the hair follicle in the culture medium comprising NGF and bFGF would be able to generate neuronal cells (Abstract).
It would have been obvious to a person skilled in the art to use NGF and/or bFGF in the culture medium of Gho’057 in view of Gho2004, McGrew and Mignone et al. in order to differentiate the hair follicular cells into nerve cells with a reasonable expectation of success. Consistent with the teaching of Mignone et al. discuss the potential of the hair follicular stem cells to differentiate into nerve cells, Hunt et al. show that the cells present in the dermal papilla of the hair follicle can be differentiated into nerve cells in the presence of bFGF and NGF.
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 16 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Gho’057 in view of Gho2004, McGrew, Mignone et al., Lee, Kang et al. and Mishra as applied to claims 1-11, 13-15 and 17-20 above, and further in view of Mahjour et al. (2012, Tissue Engineering).
Regarding claim 16 directed to the hair follicle being contacted with collagenase IV, Gho’057 in view of Gho2004, McGrew, Kang et al., Lee and Mishra do not teach the limitation.
Mahjour et al. teach dissociation of hair follicle in order to obtain dermal cells using various enzymes including collagenase I, IV or dispase (p.17, “Isolation and Culture of Trichogenic Dermal Cells).
It would have been obvious to a person skilled in the art to use known enzymes including collagenase IV for dissociating hair follicles to obtain cells present in the hair follicles including hair follicular stem cells. This is because Gho2004 teaches the use of dispase to dissociate hair follicles, and one skilled in the art would recognize collagenase IV is an art-recognized alternative to dispase according to Mahjour et al.
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.
It is noted that claim 13 is free of prior art. However, as discussed in the 112(a) rejection, claim 13 is considered not enabled as the specification discloses that the EGF is for differentiating the hair follicular stem cells into keratinocytes.
Conclusion
No claim is allowed.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631