DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s Response to Election/Restriction Filed, Amendment, and Arguments/Remarks, filed 29 July 2026, have been entered. Claims 1-18, 75, and 84-85 were previously pending in the application. Applicant canceled claims 10, 75, and 84-85. Claims 1-9 and 11-18 are currently pending. Claim 1 is an independent claim.
Additionally, applicant’s election of the following species:
Markers expressed: ALPL, ITGA9, PDGFRA, RSPO4, and SOX18;
Reprogramming factors: EBF agent and TWIST agent;
Permeant domains: deleted from claims and rendered moot;
in a reply filed 29 July 2026; is acknowledged. While Applicant has not indicated whether these elections of species have been made with or without traverse, Applicant has not provided any arguments traversing the election of species requirement(s). Therefore, the election of species 1) markers expressed: ALPL, ITGA9, PDGFRA, RSPO4, and SOX18; and 2) reprogramming factors: EBF agent and TWIST agent; is considered to have been made without traverse.
Claims 1-9 and 11-18 are currently pending in the application and under examination to which the following grounds of rejection are applicable. An action on the merits follows.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2022/078422, filed 20 October 2022, which claims priority to 63/257,752, filed 20 October 2021.
Thus, the earliest possible priority for the instant application is 20 October 2021.
Information Disclosure Statement
The information disclosure statement filed 29 February 2024 has been considered by the Examiner.
Specification
The use of the terms “Triton-X 100” on page 30 line 13, “TrypLE” on page 31 line 19, “Alexa Flour” (which appears to be a misspelling of “Alexa Fluor”) on page 31 lines 24-25, “Attune NxT Flow Cytometer” on page 31 line 29, which are trade names or a marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore, the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
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.
Note that the specification has not been inspected sufficiently to identify all instances of trade names and/or marks used in commerce. It is Applicant’s responsibility to ensure complete compliance.
Claim Objections
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.
Claim 14 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Claim 14 is dependent on any one of claims 11 to 13. However, claims 13 is dependent on 11 or 12. Accordingly, claim 14 has not been further treated on the merits.
Claims 2-4, 6, 8-9, and 11-12 are objected to because of the following informalities: claim 2 recites a “,” (comma) following “marker(s)” in line 2 which appears to be a typographical error. Appropriate correction is required.
Claim 3 recites a “fivefold” in line 2 which appears to be a typographical error for “five-fold”. Appropriate correction is required.
Claim 4 recites a “as” in line 2 which appears to be a typographical error. Appropriate correction is required.
Claim 6 recites a “,” (comma) in line 3 following “cytometry” within a list of two options which appears to be a typographical error. Similarly, claims 8-9 and 11-12 each recites a “,” (comma) in line 2 following “polypeptide” within a list of two options which appears to be a typographical error. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-9, 11-13, and 15-18 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. Claims 8-9, 11-13, and 15-18 are included due to their dependence on independent claim 1.
Independent claim 1 recites, “EBF agent” and “TWIST agent” in lines 7-8, which is indefinite because it is unclear what constitutes an “EBF agent” or a “TWIST agent”. The terms “EBF agent” and “TWIST agent” or “agent” alone are not defined in the claim nor in the specification. The terms “EBF agent” and “TWIST agent” are not used in the relevant art. For example, it is unclear whether “agent” is meant to me limited to being an EBF (or TWIST) protein and/or nucleic acid encoding an EBF (or TWIST) protein or whether “agent” is meant to encompass any component which targets an EBF (or TWIST) protein, such as small molecule inhibitors or agonist, siRNAs, or any other modulatory treatment. As such, the metes and bounds of the claim cannot be determined.
Claims 2-4 each recite wherein the population of iDPCs have at least a two-fold (claim 2), five-fold (claim 3), or ten-fold (claim 4) increased expression of one or more markers selected from the group consisting of ALPL, ITGA9, PDGFRA, RSPO4, and SOX18, as compared to the population of non-dermal papilla cells, which is unclear in that 2-fold, 5-fold, and 10-fold increases encompass values which conflict with the requirement of claim 1 which recites that the population of iDPCs express one or more of the recited markers. For example, the instant specification discloses wherein the expression levels of ITGA9, PDGFRA, RSPO4, and SOX18 in the population of non-dermal papilla cells- the epithelial cells- have undetectable levels of ITGA9, PDGFRA, RSPO4, and SOX18 [Figures 1, 3]. As such 2-fold, 5-fold, and 10-fold levels of expression in the iDPCs compared to an expression level of 0 in the non-DCs is still 0 expression in the iDPCs, which conflicts with claim 1 requiring a non-zero expression of the recited markers within the iDPCs. Accordingly, the metes and bounds of the claim cannot be determined.
Claims 5 and 6 each recite, “selected from the group consisting of … or …” wherein the recited lists are joined by the linker word “or” instead of “and”. Therefore, is it unclear which options are meant to be part of the lists from which selections are to be made. As such, the metes and bounds of the claim cannot be determined.
Claim 7 recites the term “maintained” in line 2, which is a relative term which renders the claim indefinite. The term “maintained” is not defined by the claim, 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. It is unclear whether the term “maintained” is meant to indicate that the same level of expression exists with the iDPCs over at least one cell passage or whether “maintained” is meant to encompass any level of (non-zero) expression existing within the iDPC population over the at least one cell passage. As such, the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 112(a)- Scope of Enablement
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 1-9, 11-13, and 15-18 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:
A composition comprising:
a population of cultured human non-dermal papilla (DP) cells;
a population of induced dermal papilla cells (iDPCs) expressing one or more markers selected from the group consisting of ALPL, ITGA9, PDGFRA, RSPO4, and SOX18; and
a dermal papilla cell reprogramming (DPCR) system comprising a nucleic acid encoding tetracycline-inducible EBF1 and a nucleic acid encoding tetracycline-inducible TWIST2;
wherein the DPCR system causes trans-differentiation of one or more non-DP cells into one or more iDPC when cultured in the presence of tetracycline; and
wherein the non-DP cells are cultured human epithelial cells;
does not reasonably provide enablement for:
A composition comprising:
a population of any non-dermal papilla (DP) cells;
a population of induced dermal papilla cells (iDPCs) expressing one or more markers selected from the group consisting of ALPL, ITGA9, PDGFRA, RSPO4, and SOX18; and
a dermal papilla cell reprogramming (DPCR) system comprising any EBF agent and any TWIST agent;
wherein the DPCR system causes trans-differentiation of any one or more non-DP cells into one or more iDPC.
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 and use the invention commensurate in scope with these claims.
This rejection comprises three (3) separate issues: 1) the absence of an enabling disclosure for a dermal papilla cell reprogramming (DPCR) system which causes trans-differentiation of any non-dermal papilla cell (non-DP) into one or more induced dermal papilla cells (iDPCs); 2) the absence of an enabling disclosure for a dermal papilla cell reprogramming (DPCR) system which comprises any EBF agent and any TWIST agent other than a nucleic acid encoding tetracycline-inducible EBF1 and a nucleic acid encoding tetracycline-inducible TWIST2; and 3) the absence of an enabling disclosure for a dermal papilla cell reprogramming (DPCR) system lacking tetracycline to induce expression of EBF1 and TWIST2 in the non-DP cells.
These issues were identified by the Office after analysis of the disclosure provided by the specification. The Office has analyzed the specification in direct accordance to the factors outlined in In re Wands, namely 1) the nature of the invention, 2) the state of the prior art, 3) the predictability of the art, 4) the amount of direction or guidance present, and 5) the presence or absence of working examples, and presented detailed scientific reasons supported by publications from the prior art for the finding of a lack of enablement for the scope of the instant methods. The Wands analysis and supporting specific evidence are presented below for each of the identified issues.
Note that the term “trans-differentiation” has been given its broadest reasonable interpretation consistent with the regular meaning in the art to indicate the direct reprogramming of somatic cells into other somatic cell types without intermediate de-differentiation into induced pluripotent cell types.
As a first issue (1), the specification does not provide an enabling disclosure for a dermal papilla cell reprogramming (DPCR) system which causes trans-differentiation of any non-dermal papilla cell (non-DP) into one or more induced dermal papilla cells (iDPCs) other than cultured human epithelial cells.
The broadest independent claim, claim 1, recites a composition comprising: a) a population of non-DP cells; b) a population of iDPCs expressing one or more markers selected from the groups consisting of ALPL, ITGA9, PDGFRA, RSPO4, and SOX18; and c) a DPCR system comprising an EBF agent and a TWIST agent. Claims 2-9, 11-13, and 15-18 depend on claim 1.
The specification discloses a composition comprising a mixed cell population, wherein a single population of cultured human epithelial cells (ECs) are transduced with lentivirus comprising a nucleic acid encoding tetracycline-inducible EBF1 and a nucleic acid encoding tetracycline-inducible TWIST2, and wherein a subset of the cells transdifferentiate into iDPCs in a culture media comprising tetracycline [Examples 1-2, 0094-0099].
The art at the time of filing does not teach trans-differentiation of any non-DP cells into iDPCs. Gnedeva teaches in vitro derivation of hair-inducing dermal papilla cells from human pluripotent stem cells (PSCs) [Gnedeva et al. 2015, PLOS One, 10(1), e0116892, 1-14, abstract]. Fukuyama teaches in vitro derivation of cell aggregates exhibiting dermal papilla cell properties from hiPSCs, wherein somatic cells are first de-differentiated into iPSCs prior to differentiation into human papilla cells [Fukuyama et al. 2021, Frontiers in Cell & Developmental Biology, 9, 1-15, published 02 August 2021, abstract]. However, the art at the time of filing does not teach the direct reprogramming of non-DP somatic cells into iPDCs in the absence of an intermediate de-differentiation of the non-DP cells into iPSCs prior to differentiation into iPDCs.
Neither the specification nor the art at the time of filing teaches that any somatic cell type can be trans-differentiated into iDPCs by contacting the cells with a dermal papilla reprogramming system comprising an EBF agent and a TWIST agent other than the cultured human epithelial cells disclosed in the instant specification. Thus, in view of the complete lack of teachings in the prior art for transdifferentiation of any cell type into an induced dermal papilla cell, Applicant’s limited disclosure teaching only the transdifferentiation of a single cultured human epithelial cell type into iDPCs, and the breadth of the claims, the skilled artisan would have considered transdifferentiating any cell type into iDPCs by exposure to an EBF agent and a TWIST agent as highly unpredictable. As such, it would have required undue experimentation to practice the scope of Applicant’s invention as claimed.
As a second issue (2), the specification does not provide an enabling disclosure for a dermal papilla cell reprogramming (DPCR) system which comprises any EBF agent and any TWIST agent other than a nucleic acid encoding tetracycline-inducible EBF1 and a nucleic acid encoding tetracycline-inducible TWIST2.
The broadest independent claim, claim 1, recites a composition comprising: a) a population of non-DP cells; b) a population of iDPCs expressing one or more markers selected from the groups consisting of ALPL, ITGA9, PDGFRA, RSPO4, and SOX18; and c) a DPCR system comprising an EBF agent and a TWIST agent. Claims 2-9, 11-13, and 15-18 depend on claim 1.
The specification discloses a composition comprising a mixed cell population, wherein a single population of cultured human epithelial cells (ECs) are transduced with lentivirus comprising a nucleic acid encoding tetracycline-inducible EBF1 and a nucleic acid encoding tetracycline-inducible TWIST2, and wherein a subset of the cultured human epithelial cells transdifferentiate into iDPCs in a culture media comprising tetracycline [Examples 1-2, 0094-0099].
The art at the time of filing does not teach trans-differentiation of any non-DP cells into iDPCs. Gnedeva teaches in vitro derivation of hair-inducing dermal papilla cells from human pluripotent stem cells (PSCs) [Gnedeva et al. 2015, PLOS One, 10(1), e0116892, 1-14, abstract]. Fukuyama teaches in vitro derivation of cell aggregates exhibiting dermal papilla cell properties from hiPSCs, wherein somatic cells are first de-differentiated into iPSCs prior to differentiation into human papilla cells [Fukuyama et al. 2021, Frontiers in Cell & Developmental Biology, 9, 1-15, published 02 August 2021, abstract]. However, the art at the time of filing does not teach the direct reprogramming of non-DP somatic cells into iPDCs in the absence of an intermediate de-differentiation of the non-DP cells into iPSCs prior to differentiation into iPDCs.
Neither the specification nor the art at the time of filing teaches that any somatic cell type can be trans-differentiated into iDPCs by contacting the cells with a dermal papilla reprogramming system comprising any EBF agent and any TWIST agent other than a nucleic acid encoding tetracycline-inducible EBF1 and a nucleic acid encoding tetracycline-inducible TWIST2 as disclosed in the instant specification. Thus, in view of the complete lack of teachings in the prior art for transdifferentiation of any cell type using any reprogramming system into an induced dermal papilla cell, Applicant’s limited disclosure teaching only the transdifferentiation of a single cultured human epithelial cell type into iDPCs using only lentivirally-transduced tetracycline-inducible EBF1 and TWIST2, and the breadth of the claims, the skilled artisan would have considered transdifferentiating any cell type into iDPCs by exposure to any EBF agent and any TWIST agent as highly unpredictable. As such, it would have required undue experimentation to practice the scope of Applicant’s invention as claimed.
As a third issue (3), the specification does not provide an enabling disclosure for a dermal papilla cell reprogramming (DPCR) system lacking tetracycline to induce expression of EBF1 and TWIST2 in the non-DP cells.
The broadest independent claim, claim 1, recites a composition comprising: a) a population of non-DP cells; b) a population of iDPCs expressing one or more markers selected from the groups consisting of ALPL, ITGA9, PDGFRA, RSPO4, and SOX18; and c) a DPCR system comprising an EBF agent and a TWIST agent. Claims 2-9, 11-13, and 15-18 depend on claim 1.
The specification discloses a composition comprising a mixed cell population, wherein a single population of cultured human epithelial cells (ECs) are transduced with lentivirus comprising a nucleic acid encoding tetracycline-inducible EBF1 and a nucleic acid encoding tetracycline-inducible TWIST2, and wherein a subset of the cultured human epithelial cells transdifferentiate into iDPCs in a culture media comprising tetracycline [Examples 1-2, 0094-0099]. Therefore, the specification teaches wherein the non-DP cells comprise the nucleic acids encoding tetracycline-inducible EBF1 and TWIST2 and wherein the DPCR comprises tetracycline for inducing the expression of EBF1 and TWIST2 within the non-DP cells to initiate transdifferentiation of the non-DP cells into iDPCs.
The art at the time of filing does not teach trans-differentiation of any non-DP cells into iDPCs. Gnedeva teaches in vitro derivation of hair-inducing dermal papilla cells from human pluripotent stem cells (PSCs) [Gnedeva et al. 2015, PLOS One, 10(1), e0116892, 1-14, abstract]. Fukuyama teaches in vitro derivation of cell aggregates exhibiting dermal papilla cell properties from hiPSCs, wherein somatic cells are first de-differentiated into iPSCs prior to differentiation into human papilla cells [Fukuyama et al. 2021, Frontiers in Cell & Developmental Biology, 9, 1-15, published 02 August 2021, abstract]. However, the art at the time of filing does not teach any direct reprogramming of non-DP somatic cells into iPDCs in the absence of an intermediate de-differentiation of the non-DP cells into iPSCs prior to differentiation into iPDCs.
Neither the specification nor the art at the time of filing teaches that any somatic cell type can be trans-differentiated into iDPCs by contacting the cells with a dermal papilla cell reprogramming system comprising any EBF agent and any TWIST agent other than a DPCR system comprising a lentivirally transduced nucleic acid encoding tetracycline-inducible EBF1, and a lentivirally transduced nucleic acid encoding tetracycline-inducible TWIST2, and tetracycline for inducing the expression of EBF1 and TWIST2, as disclosed in the instant specification. Thus, in view of the complete lack of teachings in the prior art for transdifferentiation of any cell type using any reprogramming system into an induced dermal papilla cell, Applicant’s limited disclosure teaching only the transdifferentiation of a single cultured human epithelial cell type into iDPCs using only lentivirally-transduced tetracycline-inducible EBF1 and TWIST2 combined with tetracycline administration to induced expression of EBF1 and TWIST2 proteins, and the breadth of the claims, the skilled artisan would have considered transdifferentiating any cell type into iDPCs by exposure to a tetracycline-inducible EBF1 and a tetracycline-inducible TWIST2 agent in the absence of tetracycline as highly unpredictable. As such, it would have required undue experimentation to practice the scope of Applicant’s invention as claimed.
Claim Rejections - 35 USC § 112(a)- Written Description
Claims 8-9, 11-12 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.
Claims 8 and 11 each depend on claim 1 and recite, “an EBF polypeptide, or functional fragment thereof” in lines 1-2 and 2, respectively. Similarly, claims 9 and 12 each depend on claim 1 and recite, “a TWIST polypeptide, or functional fragment thereof” in lines 1-2 and 2, respectively.
The specification recites generically, “In some embodiments, the EBF agent is an EBF polypeptide, or functional fragment thereof, fused to a permeant domain. In some embodiments, the EBF agent is a nucleic acid encoding an EBF polypeptide, or functional fragment thereof. In some embodiments, the TWIST agent is a TWIST polypeptide, or functional fragment thereof, fused to a permeant domain. In some embodiments, the TWIST agent is a nucleic acid encoding a TWIST polypeptide, or functional fragment thereof.” [0011].
The specification also generically recites, “In some embodiments of a method provided herein, the EBF agent is an EBF polypeptide, or functional fragment thereof, fused to a permeant domain. In some embodiments, the EBF agent is a nucleic acid encoding an EBF polypeptide, or functional fragment thereof. In some embodiments, the TWIST agent is a TWIST polypeptide, or functional fragment thereof, fused to a permeant domain. In some embodiments, the TWIST agent is a nucleic acid encoding an TWIST polypeptide, or functional fragment thereof.” [0017].
The specification does not recite any limiting definition for “functional fragment”; nor does the specification recite any particular functions which are necessary to be retained within the functional fragment of EBF or TWIST. The specification does not teach the structural limitation for fragments which retain the necessary function(s). The specification does not provide guidance as to the amino acids which could be modified such that the sequence would retain the necessary function(s), nor does the specification teach a minimum size or minimal region(s) necessary to retain the necessary function(s).
The examples in the specification teach lentiviral delivery and tetracycline-induced expression of nucleic acids encoding EBF1 and TWIST2 to produce EBF1 and TWIST2 proteins [Examples 1-4, 0094-00102]. The examples do not teach any fragments for EBF1 nor TWIST2, nor for any other EBF or TWIST polypeptides.
The following guidance provided in MPEP 2163 is informative. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. 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 (see i)(A) above), reduction to drawings (see i)(B) above), 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 (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. In other words, describing a composition by its function alone typically will not suffice to sufficiently describe the composition. See for example Eli Lilly, 119 F.3 at 1568, 43 USPQ2d at 1406 (Holding that description of a gene’s function will not enable claims to the gene "because it is only an indication of what the gene does, rather than what it is."); see also Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991)). An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that "[w]ithout such disclosure, the claimed methods cannot be said to have been described."). Furthermore, written description issues may also arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996). While it has been held that what is conventional or well known to one of ordinary skill in the art need not be disclosed in detail, for inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession.
The specification, as discussed in detail above, provides generic guidance for the instantly claimed functional fragments of EBF or TWIST polypeptides. At best, the specification discloses a single EBF polypeptide (i.e., EBF1) and a single TWIST polypeptide (i.e., TWIST2), but fails to provide sequence information for either of these polypeptides or for the nucleic acids encoding either of these polypeptides.
Therefore, a written description for functional fragments of an EBF polypeptide or a TWIST polypeptide is lacking within the application as filed. As such, claims 8-9 and 11-12 fail to comply with the written description requirement and do not reasonably convey to one skilled in the relevant art that the inventor or a join inventor, at the time the application was filed, had possession of the claimed invention.
Conclusion
No claim is allowed.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
