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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/14/26 has been entered.
Claims 60, 63, 64, 66, and 67 have been amended. Claim 82 has been added. Claims 1-59, 62, 65, and 81 have been canceled. Claims 60, 61, 63, 64, 66-80, and 82 are pending.
Claims 74-79 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/12/24.
Claims 60, 61, 63, 64, 66-73, 80, and 82 are under examination.
Withdrawn Rejections
The rejection of claims 60, 61, 63-64, 66-73, and 80-81 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn. See paragraph 9, page 17 of the previous Office action.
The rejection of claim 81 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn in light of Applicant’s cancelation of the claims. See paragraph 11, page 19 of the previous Office action.
New Rejection Necessitated by Applicant’s Amendment
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 60, 61, 63, 64, 66-73, 80, and 82 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 MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
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, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, 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 Applicants were in possession of the claimed genus.
The claims are drawn to a polynucleotide encoding a chimeric cytokine receptor polypeptide, wherein the polynucleotide comprises:
a first nucleic acid encoding an IL-7, wherein the IL-7 comprises the amino acid sequence encoded by the nucleotide sequence of SEQ ID NO:02 having 0-8 conservative amino acid substitutions,
a second nucleic acid encoding a tether;
a third nucleic acid encoding an extracellular IL-7 receptor (IL-7R) domain, wherein the IL-7 is linked to the extracellular IL-7R receptor domain via the tether;
a fourth nucleic acid encoding an IL-7R transmembrane domain, wherein the extracellular IL-7R domain and the transmembrane IL-7R domain together comprise the nucleotide sequence of SEQ ID NO:04 having 0-13 conservative amino acid substitutions; and
a fifth nucleic acid encoding an intracellular IL-21 receptor (IL-21R) domain, wherein the transmembrane domain links the extracellular IL-7R domain to the intracellular IL-21R domain, wherein the intracellular IL-21R domain comprises the nucleotide sequence of SEQ ID NO: 05 having 0-14 conservative amino acid substitutions.
The specification teaches that the term “IL-7” is mammalian, such as human. The specification teaches that the first nucleic acid comprises a nucleotide sequence having a percentage identity with the nucleotide sequence of SEQ ID NO: 2, and in some embodiments, the percentage identity is greater than 80%, 85% 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99%, or is 100% or is within a range defined by any two of the aforementioned percentages.
The specification teaches that the tether can have a length greater than or equal to two amino acids and less than or equal to 50 amino acids, greater than or equal to 5 amino acids and less than or equal to 40 amino acids, greater than or equal to 10 amino acids and less than or equal to 35 amino acids, greater than or equal to 10 amino acids and less than or equal to 30 amino acids, or greater than or equal to 15 amino acids and less than or equal to 25 amino acids. The specification teaches that in some embodiments, the second nucleic acid comprises a nucleotide sequence having a percentage identity with the nucleotide sequence of SEQ ID NO:03. The specification teaches that in some such embodiments, the percentage identity is greater than 80%, 85%, 90%, 91%, 92%,93%, 94%, 95%, 96%, 97%, 98%, 99% or is 100% or is within a range defined by any two of the aforementioned percentages.
The specification teaches that the extracellular IL-7 receptor domain is mammalian, such as human. The specification teaches that in some embodiments, the third nucleic acid comprises a nucleotide sequence having a percentage identity with the nucleotide sequence of SEQ ID NO:04. The specification teaches that in some such embodiments, the percentage identity is greater than 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or is 100% or is within a range defined by any two of the aforementioned percentages.
The specification teaches that the transmembrane domain comprises an IL-7 receptor transmembrane domain, or an IL-21 receptor transmembrane domain. The specification teaches that in some embodiments, the transmembrane domain comprises an IL-7 receptor transmembrane domain. The specification teaches that in some embodiments, the IL-7 receptor transmembrane domain is mammalian, such as human. The specification teaches that in some embodiments, the third and fourth nucleic acids together encode the extracellular IL-7 receptor domain and the IL-7 receptor transmembrane domain, and comprises a nucleotide sequence having a percentage identity with the nucleotide sequence of SEQ ID NO:04. The specification teaches that in some such embodiments, the percentage identity is greater than 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or is 100% or is within a range defined by any two of the aforementioned percentages. The specification teaches that in some embodiments, a polynucleotide can include a fifth nucleic acid encoding an intracellular IL-21 receptor domain. The specification teaches that the intracellular IL- 21 receptor domain is mammalian, such as human. The specification teaches that in some embodiments, the fifth nucleic acid comprises a nucleotide sequence having a percentage identity with the nucleotide sequence of SEQ ID NO:05. The specification teaches that in some such embodiments, the percentage identity is greater than 80%, 85%, 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97%, 98%, 99% or is 100% or is within a range defined by any two of the aforementioned percentages.
The claims encompass a genus of polynucleotides encoding a chimeric cytokine receptor polypeptide that are not adequately described. Although the claims are inclusive of polynucleotide encoding a chimeric cytokine receptor polypeptides comprising a first nucleic acid encoding an IL-7 having the amino acid sequence of SEQ ID NO: 2, a second nucleic acid encoding a tether, a third nucleic acid encoding an extracellular IL-7R domain, a fourth nucleic acid encoding an IL-7 receptor transmembrane domain, wherein the extracellular IL-7R domain and the transmembrane IL-7R domain together comprise the amino acid sequence set forth in SEQ ID NO: 4, and a fifth nucleic acid encoding an intracellular IL-21 receptor domain having the amino acid sequence set forth in SEQ ID NO: 5, the claims also broadly encompass polynucleotides encoding variants of IL-7 set forth in SEQ ID NO: 2 having 0-8 conservative substitutions, variants of extracellular IL-7 receptor domain/IL-7R transmembrane domain set forth in SEQ ID NO: 4 having 0-13 conservative amino acid substitutions, and variants of IL-21 receptor domain set forth in SEQ ID NO: 5 having 0-14 conservative amino acid substitutions. The claims also encompass sequences having 95% sequence identity to the claimed sequences. Thus, the terms “IL-7”, “IL-7 receptor domain”, and “IL-21 receptor domain” each encompass variants that differ from the corresponding full-length protein. A variance of 8 amino acids, for example, in an IL-7 polypeptide that is 177 amino acids in length translates into 8 residues that may be added, deleted, substituted, or otherwise mutated anywhere throughout the entire length of the 456 nucleic acid sequence, which corresponds to 152 amino acid residues. To give an idea of the breadth of the claims, there are an almost unfathomable number of ways which 1 to 8 amino acids (i.e., the sum of results for 1 change, 2 changes, 3 changes…8 changes) can be selected from the 152 residues, without any other limitation in the independent claims, each particular residue can be substituted with any of the other 19 naturally occurring amino acids and still meet the limitation. For example, for just 1 change, there would be 152 unique sequences, but because the change at each residue can be substituted with any one of the other 19 naturally occurring amino acids, then the actual number of unique sequences encompassed is 2,888 (i.e. a sequence having a substitution at, for example residue 33 with cysteine, would be structurally distinct from a sequence having a substitution at residue 33 with tryptophan; and 152*19=2,888). Yet, the claims allow for up to 8 unrestricted changes, anywhere along the length of SEQ ID NO: 2, so with the order of selection not important and repetition not allowed, the equation is X = 19* [n!/(r!(n -r)!)], which for 8 changes, results in a number having more than 40 zeros (i.e. a trillion only has 12 zeros). As a result, there are potentially trillions of variant permutations that could be made and still maintain a variance of 0-8 amino acid substitutions. It should be noted that this example is for only one portion of the chimeric cytokine receptor polypeptide (i.e., IL-7 nucleic acid), and consideration of the other portions of the chimeric cytokine receptor polypeptide would exponentially increase the breadth of the claims. Therefore, these structures (i.e., IL-7, tether, IL-7 receptor domain, and IL-21 receptor domain sequence variants) are claimed only by their functional characteristics and the specification fails to provide a sufficient correlation between the claimed function characteristics (i.e., having IL-7, IL-7 receptor domain, and IL-21 receptor domain activity) and the necessary structural components (i.e., critical domain within the sequence).
Furthermore, Applicants have not shown possession of a representative number of species. The specification adequately describes only one complete polynucleotide encoding a chimeric cytokine receptor, identified as CCRIL21, possessing the claimed functions. It should be noted that the exemplified species comprises the full-length IL-7, tether, IL-7 receptor domain, and IL-21 receptor domain amino acid sequences set forth in SEQ ID NO: 2, SEQ ID NO: 3, SEQ ID NO: 4, and SEQ ID NO: 5, respectively. However, the specification does not describe any other polynucleotide comprising nucleic acids encoding variant sequences of the IL-7, tether, IL-7 receptor domain, and IL-21 receptor domain. Thus, the genus has substantial variation because of the numerous alternatives and combinations permitted. There is no description of the structure common to the members of the genus such that one of skill in the art can visualize or recognize the members of the genus. Therefore, only a single species has been described and this is not considered to be representative of the breadth of the genus.
MPEP §2163 states that for a generic claim, the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has a substantial variance (as in the instant case), the disclosure must describe a sufficient variety of species to reflect the variation within that genus. Although the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number to adequately describe a broad genus. The courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus (e.g., see In re Gostelli, 872, F. 2d at 1012, 10 USPQ2d at 1618).
Further, the disclosure of only one or two species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the genu[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.") (MPEP 2163). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when… the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
Accordingly, the specification also does not provide adequate written description to identify the broad genus of the claimed, claimed only be a function characteristic(s) and not structures per se, because inter alia, it does not describe a sufficient number and/or a sufficient variety of representative species to reflect the breadth and variation within the claimed genus. Consequently, based on the lack of information within the specification, there is evidence that a representative number and a representative variety of the numerous polynucleotides had not yet been identified and thus, the specification represents little more than a wish for possession. Therefore, one of skill in the art would not conclude that Applicant was in possession of the broad and highly variable genus of polynucleotides claimed only by a partial structure and functional characteristic(s).
Vas-Cath Inc. v. Mahurkar, 19 U5PQ2d 1111, makes clear that
"applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.)The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
With the exception of a polynucleotide encoding a chimeric cytokine receptor polypeptides comprising a first nucleic acid encoding an IL-7 having the amino acid sequence of SEQ ID NO: 2, a second nucleic acid encoding a tether, a third nucleic acid encoding an extracellular IL-7 receptor domain and an IL-7 receptor transmembrane domain having the amino acid sequence set forth in SEQ ID NO: 4, and a fifth nucleic acid encoding an intracellular IL-21 receptor domain having the amino acid sequence set forth in SEQ ID NO: 5, the skilled artisan cannot envision the detailed chemical structure of the encompassed polynucleotides, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The nucleic acid and/or protein itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481,1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404. 1405 held that:
...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines Inc., 107 F.3d 1565,1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (" [T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d 1966.
In Ariad Pharrns., Inc. v. Eh Lilly & Co., 598 F.3d 1336,1351 (Fed. Cir. 2010), the court held that a “sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize’ the members of the genus." Ariad, 598 F.Bd at 1350.
“[A]n adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials,” Id. Although “functional claim language can meet the written description requirement when the art has established a correlation between structure and function," "merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials constituting the genu and showing that one has invented a genus and not just a species.”Id.
Protein chemistry is probably one of the most unpredictable areas of biotechnology. Consequently, the effects of sequence dissimilarities upon protein structure and function cannot be predicted. Punta et al. (PLoS Comput Biol 4(10): e1000160, 2008) teach that homology (both orthology and paralogy) does not guarantee conservation of function (See page 2). Punta et al. teach that relatively small difference in sequence can sometimes cause quite radical changes in functional properties, such as a change of enzymatic action, or even loss or acquisition of enzymatic activity itself (See page 2). Punta et al. teach that it is also apparent that there is no sequence similarity threshold that guarantees that two proteins share the same function (see page 2). Punta et al. teach that homology between two proteins does not guarantee that they have the same function, not even when sequence similarity is very high (including 100% sequence identity) (See page 2 and table 2). Punta et al. teach that proteins live and function in 3D, and therefore structural information is very helpful for predicating function (See page 4). However, as with sequence, two proteins having the same overall architecture, and even conserved functional residues, can have unrelated functions (See page 4). Punta et al. teach that still; structural knowledge is an extremely powerful tool for computational function prediction (See page 5).
Similarly, Whisstock et al. (Quarterly Reviews in Biophysics. 36(3):307-340, 2007) teach that the prediction of protein function from sequence and structure is a difficult problem (See abstract). Although many families of proteins contain homologues with the same function, homologous proteins often have different functions as the sequences progressively diverge (See page 309). Whisstock et al. teach that moreover, even closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function (See page 309). Further, Whisstock et al. note that in some instances, even sequences that are the same can have different functions. For example, eye lens proteins in the suck are identical in sequence to active lactate dehydrogenase and enolase in other tissues, although they do not encounter the substrates in the eye (See page 310). Whisstock et al. teach that assigning a function to an amino acid sequence based upon similarity becomes significantly more complex as the similarity between the sequence and a putative homologue fall (See page 321). Whisstock et al. teach that while it is hopeful that similar proteins will share similar functions, substitution of a single, critically placed amino acid in an active-site may be sufficient to alter a protein’s role fundamentally (See pages 321-323).
The sensitivity of proteins to alterations of even a single amino acid in a sequence are exemplified by Burgess et al. (J. Cell Biol. 111:2129-2138, 1990) who teach that replacement of a single lysine reside at position 118 of acidic fibroblast growth factor by glutamic acid led to the substantial loss of heparin binding, receptor binding and biological activity of the protein and by Song et al. (Molecular Biology of the Cell, 15:1287–1296, March 2004) who teach that substitution of alanine for aspartate in survivin results in the conversion of survivins’ apoptotic function from anti-apoptotic to proapoptotic and changes in its subcellular localization (See page 1287-1289). Moreover, Defeo-Jones et al. (Molecular and Cellular Biology, Sept. 1989, p. 4083-4086) teach that the conservative substitution of lysine for arginine at position 42 completely eliminated biological activity (See abstract and pages 4084-4085). These references demonstrate that even a single amino acid substitution will often dramatically affect the biological activity and characteristics of a protein.
Additionally, Bork (Genome Research, 2000; 10:398-400) clearly teaches the pitfalls associated with comparative sequence analysis for predicting protein function because of the known error margins for high-throughput computational methods. Bork specifically teaches that computational sequence analysis is far from perfect, despite the fact that sequencing itself is highly automated and accurate (p. 398, column 1). One of the reasons for the inaccuracy is that the quality of data in public sequence databases is still insufficient. This is particularly true for data on protein function. Protein function is context dependent, and both molecular and cellular aspects have to be considered (p. 398, column 2). Conclusions from the comparison analysis are often stretched with regard to protein products (p. 398, column 3). Further, although gene annotation via sequence database searches is already a routine job, even here the error rate is considerable (p. 399, column 2). Most features predicted with an accuracy of greater than 70% are of structural nature and, at best, only indirectly imply a certain functionality (see legend for table 1, page 399). As more sequences are added and as errors accumulate and propagate it becomes more difficult to infer correct function from the many possibilities revealed by database search (p. 399, paragraph bridging columns 2 and 3). The reference finally cautions that although the current methods seem to capture important features and explain general trends, 30% of those features are missing or predicted wrongly. This has to be kept in mind when processing the results further (p. 400, paragraph bridging cols 1 and 2).
Given not only the teachings of Punta et al., Whisstock et al., Song et al., Burgess et al., and Defeo-Jones et al., but also the limitations and pitfalls of using computational sequence analysis and the unknown effects of alternative splicing, post translational modification and cellular context on protein function as taught by Bork, the claimed proteins having the required function(s) could not be predicted based on sequence identity. Clearly, it could not be predicted that a polypeptide or a variant that shares only partial homology with a disclosed protein or that is a fragment of a protein will function in a given manner. Therefore, the state of the art supports that even the skilled artisan requires guidance on the critical structures of the amino acid sequences per se and thereby does not provide adequate written description support for which structural features of any given polypeptide would predictably retain their functional activities.
Adequate written description requires more than a mere statement that is part of the invention. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chungai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class. The specification provided only the bovine sequence.
The University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a patent specification must describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines Inc. 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (1997); In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an Applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2dat1966.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, ‘does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed’”. The courts have decided: the purpose of the “written description" requirement is broader than to merely explain how to "make and use"; the Applicant must convey with reasonable clarity to those skilled in the art, that as of the filing date sought, he or she was in possession of the invention. The invention is for purposes of the “written description” inquiry, whatever is now claimed. See Vas-Cath, Inc v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).
Furthermore, the written description provision of 35 USC §112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993). And Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
Claim Status
No claims are allowed.
Conclusion
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/SANDRA CARTER/Examiner, Art Unit 1674
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