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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 24 September 2025 has been entered.
Drawings
The drawings were received on 23 September 2020. These drawings are acceptable.
Claim Interpretation
Attention is directed to MPEP 904.01 [R-08.2012].
The breadth of the claims in the application should always be carefully noted; that is, the examiner should be fully aware of what the claims do not call for, as well as what they do require. During patent examination, the claims are given the broadest reasonable interpretation consistent with the specification. See In re Morris, 127 F.3d 1048, 44 USPQ2d 1023 (Fed. Cir. 1997). See MPEP § 2111 - § 2116.01 for case law pertinent to claim analysis.
It is noted with particularity that narrowing limitations found in the specification cannot be inferred in the claims where the elements not set forth in the claims are linchpin of patentability. In re Philips Industries v. State Stove & Mfg. Co, Inc., 186 USPQ 458 (CA6 1975). While the claims are to be interpreted in light of the specification, it does not follow that limitations from the specification may be read into the claims. On the contrary, claims must be interpreted as broadly as their terms reasonably allow. See Ex parte Oetiker, 23 USPQ2d 1641 (BPAI, 1992). In added support of this position, attention is directed to MPEP 2111 [R-11.2013], where, citing In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550-51 (CCPA 1969), is stated:
The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.
Additionally, attention is directed to MPEP 2111.01 [R-01.2024], wherein is stated:
II. IT IS IMPROPER TO IMPORT CLAIM LIMITATIONS FROM THE SPECIFICATION
“Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004).
Attention is also directed to MPEP 2111.02 II [R-07.2022]. As stated herein:
II. PREAMBLE STATEMENTS RECITING PURPOSE OR INTENDED USE
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The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "'extraneous' limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation")… (Emphasis added)
Attention is directed to MPEP 2111 [R-10.2019]. As stated therein:
During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1). (Emphasis added).
Claim Rejections - 35 USC § 112, (b) / Second Paragraph
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.
Standard for Definiteness.
Attention is directed to MPEP 2171 [R-11.2013]:
Two separate requirements are set forth in 35 U.S.C. 112(b) and pre-AIA 35 U.S.C. 112, second paragraph, namely that:
(A) the claims must set forth the subject matter that the inventor or a joint inventor regards as the invention; and
(B) the claims must particularly point out and distinctly define the metes and bounds of the subject matter to be protected by the patent grant.
The first requirement is a subjective one because it is dependent on what the inventor or a joint inventor for a patent regards as his or her invention. Note that although pre-AIA 35 U.S.C. 112, second paragraph, uses the phrase "which applicant regards as his invention," pre-AIA 37 CFR 1.41(a) provides that a patent is applied for in the name or names of the actual inventor or inventors.
The second requirement is an objective one because it is not dependent on the views of the inventor or any particular individual, but is evaluated in the context of whether the claim is definite — i.e., whether the scope of the claim is clear to a hypothetical person possessing the ordinary level of skill in the pertinent art.
Attention is directed to MPEP 2173.02 I [R-07.2022]:
During prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. See, e.g., Johnson & Johnston Assoc. Inc. v. R.E. Serv. Co., 285 F.3d 1046, 1052, 62 USPQ2d 1225, 1228 (Fed. Cir. 2002) (en banc). As the Federal Circuit stated in Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008):
“We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.”
***
During examination, after applying the broadest reasonable interpretation to the claim, if the metes and bounds of the claimed invention are not clear, the claim is indefinite and should be rejected. Packard, 751 F.3d at 1310 (“[W]hen the USPTO has initially issued a well-grounded rejection that identifies ways in which language in a claim is ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention, and thereafter the applicant fails to provide a satisfactory response, the USPTO can properly reject the claim as failing to meet the statutory requirements of § 112(b).”); Zletz, 893 F.2d at 322, 13 USPQ2d at 1322.
Attention is also directed to MPEP 2173.02 III B, which states in part:
To comply with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, applicants are required to make the terms that are used to define the invention clear and precise, so that the metes and bounds of the subject matter that will be protected by the patent grant can be ascertained. See MPEP § 2173.05(a), subsection I. It is important that a person of ordinary skill in the art be able to interpret the metes and bounds of the claims so as to understand how to avoid infringement of the patent that ultimately issues from the application being examined. See MPEP § 2173.02, subsection II (citing Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470 (Fed. Cir. 1993)); see also Halliburton Energy Servs., 514 F.3d at 1249, 85 USPQ2d at 1658 (“Otherwise, competitors cannot avoid infringement, defeating the public notice function of patent claims.”). Examiners should bear in mind that “[a]n essential purpose of patent examination is to fashion claims that are precise, clear, correct, and unambiguous. Only in this way can uncertainties of claim scope be removed, as much as possible, during the administrative process.” Zletz, 893 F.2d at 322, 13 USPQ2d at 1322 [Fed. Cir. 1989]. (Emphasis added)
Attention is also directed to MPEP 2173.04 [R-10.2019], which states in part:
A broad claim is not indefinite merely because it encompasses a wide scope of subject matter provided the scope is clearly defined. But a claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear. For example, a genus claim that covers multiple species is broad, but is not indefinite because of its breadth, which is otherwise clear. But a genus claim that could be interpreted in such a way that it is not clear which species are covered would be indefinite (e.g., because there is more than one reasonable interpretation of what species are included in the claim). (Emphasis added)
Holding and Rationale
Claims 1-2, 4-5, 8-12, 15-17, 22, and 27-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “more” in claims 1 and 29 is a relative term which renders the claims indefinite. The term “more” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See lines 4, 6, 10, 13, 19, 24, 25, and 28 in claim 1; and line 2 in claim 29.
Claims 2, 4-5, 8-12, 15-17, 22, 27-30, which depend from claim 1, fail to overcome these issues and are similarly rejected.
Claim 28 is indefinite with respect to what constitutes the metes and bounds of “an inducible degron” and “Shield 1”.
Claim Rejections - 35 USC § 112, Written Description
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.
Standard for Written Description.
Attention is directed to MPEP 2163.02 Standard for Determining Compliance With the Written Description Requirement [R-07-2022]:
An objective standard for determining compliance with the written description requirement is, "does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an 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, and that the invention, in that context, is whatever is now claimed. (Emphasis added)
Attention is also set directed to MPEP 2161.01 I [R-07-2022], wherein is stated:
For instance, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed. Ariad, 598 F.3d at 1349-50, 94 USPQ2d at 1171 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention’s boundaries.") (citing Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1405-06); Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002) (holding that generic claim language appearing in ipsis verbis in the original specification did not satisfy the written description requirement because it failed to support the scope of the genus claimed); Fiers v. Revel, 984 F.2d 1164, 1170, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993) (rejecting the argument that "only similar language in the specification or original claims is necessary to satisfy the written description requirement").
As set forth in Fiers v. Revel 25 USPQ2d 1601, 1604-5 (CAFC, January 1993):
We thus determined that, irrespective of the complexity or simplicity of the method of isolation employed, conception of a DNA, like conception of any chemical substance, requires a definition of that substance other than by its functional utility.
Fiers' attempt to distinguish Amgen therefore is incorrect. We also reject Fiers' argument that the existence of a workable method for preparing a DNA establishes conception of that material. (Emphasis added)
Conception of a substance claimed per se without reference to a process requires conception of its structure, name, formula, or definitive chemical or physical properties...
The difficulty that would arise if we were to hold that a conception occurs when one has only an idea of a compound, defining it by its hoped-for function, is that would-be inventors would file patent applications before they had made their inventions and before they could describe them. That is not consistent with the statute or the policy behind the statute, which is to promote disclosure of inventions.
As set forth in the en banc decision in Ariad Pharmaceuticals Inc. v. Eli Lilly and Company, 94 USPQ2d 1161 (Fed. Cir. 2010) at 1171:
We held that a sufficient description of a genus instead 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. Id. at 1568-69. We explained that an 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. at 1568 (quoting Fiers v. Revel, 984 F.2d 1164, 1171 [25 USPQ2d 1601] (Fed. Cir. 1993)). We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. See Enzo, 323 F.3d at 964 (quoting 66 Fed. Reg. 1099 (Jan. 5, 2001)). But 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 genus and showing that one has invented a genus and not just a species.
***
In Fiers, we rejected the argument that “only similar language in the specification or original claim is necessary to satisfy the written description requirement.” 984 F.2d at 1170 (emphasis added). Rather, we held that original claim language to “a DNA coding for interferon activity” failed to provide an adequate written description as it amounted to no more than a “wish” or “plan” for obtaining the claimed DNA rather than a description of the DNA itself. Id. at 1170-71. That Fiers applied § 112, first paragraph, during an interference is irrelevant for, as we stated above, the statute contains no basis for ignoring the description requirement outside of this context. And again in Enzo we held that generic claim language appearing in ipsis verbis in the original specification does not satisfy the written description requirement if it fails to support the scope of the genus claimed. 323 F.3d at 968. We concluded that “[a] claim does not become more descriptive by its repetition, or its longevity.” Id. at 969.
***
The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function—a problem that is particularly acute in the biological arts.
Attention is also directed to MPEP 2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, “Written Description” Requirement [R-01-2024], at part II ii):
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 inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).") (Emphasis added)
Attention is also directed to the decision of University of California v. Eli Lilly and Co. (CA FC, July 1997) 43 USPQ2d 1398 wherein is stated:
In claims involving chemical materials, generic formulas usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate written description of the claimed genus. In claims to genetic material, however, a generic statement such as “vertebrate insulin cDNA” or “mammalian cDNA,” without more, is not an adequate written description of the genus because it does not distinguish the claimed genus from others, except by function. It does not specifically define any of the genes that fall within its definition. It does not define any structural features commonly possessed by members of the genus that distinguish them from others. One skilled in the art therefore cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus. A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). It is only a definition of a useful result rather than a definition of what it achieves as a result. Many such genes may achieve that result. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 222 USPQ 369, 372-373 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”). Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.
Thus, as we have previously held, a cDNA is not defined or described by the mere name cDNA,” even if accompanied by the name of the protein that it encodes, but requires a kind of specificity usually achieved by means of the recitation of the sequence of nucleotides that make up the cDNA. See Fiers, 984 F.2d at 1171, 25 USPQ2d at 1606.
Holding and Rationale
Claims 1-2, 4-5, 8-12, 15-17, 22, and 27-30 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 1, 2, 4, 5, 12, 15, 16, 22 and 29 are deemed to be representative and, for convenience, are reproduced below.
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As evidenced above, the claimed method requires the use of guide sequences that range from 15 to 80 nucleotides in length. As seen in claim 2, one is required to use “a set of probes… wherein each probe in the set of probes comprises an RNA or a DNA nucleic acid sequence; and wherein each probe in the set selectively binds to a corresponding target sequence in a target site among the plurality of target sites”. As seen in claim 15, “the barcode sequence comprises a nucleotide sequence having a length between 400 nucleic acids and 2,000 nucleic acids.”
Attention is directed to paragraph [0079] of the disclosure and the definition of “genetic scratchpad” provided therein. As stated therein:
[0079] As used herein, the term "genetic scratchpad" refers to a polynucleotide
sequence within a prokaryotic or eukaryotic cell. In some embodiments, the genetic scratchpad can be synthesized in vitro and then put into the cell. In some embodiments, the genetic scratchpad refers to a defined location within the natural genomic sequence of the cell. In some embodiments, the genetic scratchpad can refer to a defined location within the natural genomic sequence of the cell that has been modified. Within the polynucleotide sequence of a genetic scratchpad, there are multiple target sites. In some embodiments, each target site comprises a guide sequence that can be recognized by a unique guide molecule. (Emphasis added)
As evidenced above, the aspect of one evaluating “one or more genetic scratchpads” has been construed as encompassing one or more chromosomes in a cell. In further support of this interpretation attention is directed to paragraph [00190] of the disclosure wherein applicant asserts:
The embodiments here are provided by way of example and should not in any way limit the scope of the invention. (Emphasis added)
Attention is directed to paragraph [00192] of the disclosure wherein applicant asserts:
[00192] In some embodiments, the system disclosed herein can also be implemented in
organisms, including but not limited to, for example, mice, zebrafish, and flies. (Emphasis added)
Attention is also directed to page 37, paragraph [00205], wherein applicant asserts:
[00205] As disclosed herein, the current system and method can be applied to analyze
cell development/differentiation by monitoring cellular functions and/or processes that include but are not limited to: PI3K/AKT Signaling, ERK/MAPK Signaling, Glucocorticoid Receptor Signaling, Axonal Guidance Signaling, Ephrin Receptor Signaling, Actin Cytoskeleton Signaling, Huntington's Disease Signaling, Apoptosis Signaling, B Cell Receptor Signaling, Leukocyte Extravasation Signaling, Integrin Signaling, Acute Phase Response Signaling, PTEN Signaling, p53 Signaling, Aryl Hydrocarbon Receptor Signaling, Xenobiotic Metabolism Signaling, SAPK/JNK Signaling, PPAr/RXR Signaling, NF-KB Signaling, Neuregulin Signaling, Wnt & Beta catenin Signaling, Insulin Receptor Signaling, IL-6 Signaling, hepatic Cholestasis, IGF-1 Signaling, NRF2-mediated Oxidative Stress Response, Hepatic, Fibrosis/Hepatic Stellate Cell Activation, PP AR Signaling, Fe Epsilon RI Signaling, G-Protein Coupled Receptor Signaling, Inositol Phosphate Metabolism, PDGF Signaling, VEGF Signaling, Natural Killer Cell Signaling, T Cell Receptor Signaling, FGF Signaling, GM-CSF Signaling,
Chemokine Signaling, IL-2 Signaling and many more. (Emphasis added)
Applicant, at page 40, paragraph [00220], asserts:
[00220] Having described the invention in detail, it will be apparent that
modifications, variations, and equivalent embodiments are possible without departing from the scope of the invention defined in the appended claims. Furthermore, it should be appreciated that all examples in the present disclosure are provided as non-limiting examples. (Emphasis added)
A review of the disclosure fails to find where applicant has disclosed or incorporated by reference, the nucleotide sequence found in any organism, much less the nucleotide sequence of any chromosome as found in any cell of any organism, much less the nucleotide sequence of any virus. Likewise, the disclosure has not been found to disclose the nucleotide sequence of any “guide sequence” that ranges from 15 to 80 nucleotides in length (claims 4 and 5) or barcode sequence that can range from 50 to 2,000 nucleic acids in length (claims 15 and 16) or any “inducible guide RNA (gRNA) promoter [that] initiates expression of two or more gRNAs” (claim 29). Such sequences are deemed to constitute essential material.1
Applicant’s non-disclosure of any sequences that are essential to the claimed method has not been found to reasonably suggest that applicant was in possession of the full genus of sequences encompassed and required by the claimed methods, and thusly, fails to satisfy the written description requirement.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 1-2, 4-5, 8-12, 15-17, 22, and 27-30 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.
Response to argument
At pages 20-28 of the response of 24 September 2025, hereinafter the response, applicant’s representative traverses the rejection of claims under 35 USC (a) for not satisfying the written description requirement.
Acknowledgement is made of applicant’s referral to a series of Board decisions. It is noted that decisions of the Board does not control or overturn decisions of the Fed. Cir, or CAFC. It is further noted that the response does not identify any aspect of the rejections that run counter to guidance and legal precedence set forth in the MPEP. Attention is again directed to MPEP 2163 Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112(a) or Pre-AIA 35 U.S.C. 112, first paragraph, “Written Description” Requirement [R-01-2024], at part II ii):
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 inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ( "[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).") (Emphasis added)
It is noted that the claimed method is not limited to those cells of organisms where the nucleic acid sequences were known. It is noted, for example, that the last human chromosome to be sequenced, the Y chromosome, was not completely sequenced until 2023, which is some 6 years post applicant’s filing date, and some 9 years post applicant’s effective priority date. See Rhie et al., “The complete sequence of a human Y chromosome”, Nature, Vol. 621, 14 September 2023.
Attention is directed to MPEP 2111 [R-10.2019]. As stated therein:
During patent examination, the pending claims must be "given their broadest reasonable interpretation consistent with the specification." The Federal Circuit’s en banc decision in Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) expressly recognized that the USPTO employs the "broadest reasonable interpretation" standard:
The Patent and Trademark Office ("PTO") determines the scope of claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction "in light of the specification as it would be interpreted by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364[, 70 USPQ2d 1827, 1830] (Fed. Cir. 2004). Indeed, the rules of the PTO require that application claims must "conform to the invention as set forth in the remainder of the specification and the terms and phrases used in the claims must find clear support or antecedent basis in the description so that the meaning of the terms in the claims may be ascertainable by reference to the description." 37 CFR 1.75(d)(1). (Emphasis added).
As noted above, applicant asserts repeatedly that the claimed methods are not limited to the embodiments described. In support of this interpretation attention is again directed to paragraph [00190] of the disclosure wherein applicant asserts:
The embodiments here are provided by way of example and should not in any way limit the scope of the invention. (Emphasis added)
Attention is directed to paragraph [00192] of the disclosure wherein applicant asserts:
[00192] In some embodiments, the system disclosed herein can also be implemented in
organisms, including but not limited to, for example, mice, zebrafish, and flies. (Emphasis added)
Attention is also directed to page 37, paragraph [00205], wherein applicant asserts:
[00205] As disclosed herein, the current system and method can be applied to analyze
cell development/differentiation by monitoring cellular functions and/or processes that include but are not limited to: PI3K/AKT Signaling, ERK/MAPK Signaling, Glucocorticoid Receptor Signaling, Axonal Guidance Signaling, Ephrin Receptor Signaling, Actin Cytoskeleton Signaling, Huntington's Disease Signaling, Apoptosis Signaling, B Cell Receptor Signaling, Leukocyte Extravasation Signaling, Integrin Signaling, Acute Phase Response Signaling, PTEN Signaling, p53 Signaling, Aryl Hydrocarbon Receptor Signaling, Xenobiotic Metabolism Signaling, SAPK/JNK Signaling, PPAr/RXR Signaling, NF-KB Signaling, Neuregulin Signaling, Wnt & Beta catenin Signaling, Insulin Receptor Signaling, IL-6 Signaling, hepatic Cholestasis, IGF-1 Signaling, NRF2-mediated Oxidative Stress Response, Hepatic, Fibrosis/Hepatic Stellate Cell Activation, PP AR Signaling, Fe Epsilon RI Signaling, G-Protein Coupled Receptor Signaling, Inositol Phosphate Metabolism, PDGF Signaling, VEGF Signaling, Natural Killer Cell Signaling, T Cell Receptor Signaling, FGF Signaling, GM-CSF Signaling,
Chemokine Signaling, IL-2 Signaling and many more. (Emphasis added)
Applicant, at page 40, paragraph [00220], asserts:
[00220] Having described the invention in detail, it will be apparent that
modifications, variations, and equivalent embodiments are possible without departing from the scope of the invention defined in the appended claims. Furthermore, it should be appreciated that all examples in the present disclosure are provided as non-limiting examples. (Emphasis added)
Acknowledgement is made of the fact that the claims are to a method and not to a product. However, it is well settled that in order to satisfy the written description for a method, one must also disclose the molecules required to perform the method. In support of this position attention is directed to University of Rochester v. G.D. Searle & Co. 68 USPQ2D 1424 (W.D.N.Y. 2003) at 1433 (affirmed; University of Rochester v. G.D. Searle & Co. 69 USPQ2d 1886 (Fed. Cir. 2004)):
Plaintiff also argues that the requirements for written descriptions of claims to chemical compounds are irrelevant to this case because the '850 patent does not claim a compound, but a method of treatment by targeting PGHS-2 activity over PGHS-1 activity. Virtually any compound claim could be transformed into a method claim, however, simply by means of wording the claim in terms of a method of using the compound. With respect to the issue before the Court, then, this is little more than a semantic distinction without a difference. The claimed method depends upon finding a compound that selectively inhibits PGHS-2 activity. Without such a compound, it is impossible to practice the claimed method of treatment. It means little to “invent” a method if one does not have possession of a substance that is essential to practicing that method. Without that substance, the claimed invention is more theoretical than real; it is, as defendants argue, akin to “inventing” a cure for cancer by utilizing a substance that attacks and destroys cancer cells while leaving healthy cells alone. Without possession of such a substance, such a “cure” is illusory, and there is no meaningful possession of the method. (Emphasis added)
***
What the inventors did not do, however, is succeed in taking the last, critical step of actually isolating such a compound, or at least of developing a process through which one skilled in the art would be directly led to such a compound. Absent that step, their discoveries, valuable though they might have been, did not blossom into a full-fledged, complete invention. Scientific discoveries, and theories based on those discoveries, frequently lay the groundwork for later inventions, but that does not make the discoverer the inventor as well.
Attention is also directed to the decision in Ariad Pharmaceuticals Inc. v. Eli Lilly & Co.
(Fed. Cir. 2010) 94 USPQ2d 1161, 1175, which teaches:
In accordance with Rochester, the ?516 patent must adequately describe the claimed methods for reducing NF-?B activity, including adequate description of the molecules that Ariad admits are necessary to perform the methods. (Emphasis added)
As evidenced above, applicant has asserted in a repeated manner that the claimed method is not limited to cells and target sequences that are were known as of the effective filing date. Given such assertion, and the fact that the subject application does not comprise a Sequence Listing where any sequence of any nucleic acid, be it DNA or RNA, of any length and function, known or new, has been disclosed, applicant has not been found to satisfy the written description requirement. In view of the above analysis and in the absence of convincing evidence to the contrary, claims 1-2, 4-5, 8-12, 15-17, 22, and 27-30 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.
Claim Rejections - 35 USC § 112 - 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.
Standard for Enablement
As set forth in the unanimous U.S. Supreme Court decision in Amgen Inc., et al. v. Sanofi et al. 598 U.S. ___ (2023):
Our decisions in Morse, Incandescent Lamp, and Holland Furniture reinforce the simple
statutory command. If a patent claims an entire class of processes, machines,
manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405, 419 (1908) (“[T]he claims measure the invention.”). (Emphasis added)
***
To be fair, Amgen does not dispute this much. It freely admits that it seeks to claim for
itself an entire universe of antibodies. Still, it says, its broad claims are enabled because scientists can make and use every undisclosed but functional antibody if they simply follow the company’s “roadmap” or its proposal for “conservative substitution.” We cannot agree. These two approaches amount to little more than two research assignments… Whether methods like a “roadmap” or “conservative substitution” might suffice to enable other claims in other patents—perhaps because, as this Court suggested in Incandescent Lamp, the inventor identifies a quality common to every functional embodiment, supra, at 13—they do not here. They leave a scientist about where Sawyer and Man left Edison: forced to engage in “painstaking experimentation” to see what works. 159 U. S., at 475. That is not enablement. More nearly, it is “a hunting license.” Brenner v. Manson, 383 U. S. 519, 536 (1966). (Emphasis added)
Holding and Rationale
Claims 1-2, 4-5, 8-12, 15-17, 22, and 27-30 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1, 2, 4, 5, 12, 15, 16, 22 and 29 are deemed to be representative and, for convenience, are reproduced below.
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As evidenced above, the claimed method requires the use of guide sequences that range from 15 to 80 nucleotides in length. As seen in claim 2, one is required to use “a set of probes… wherein each probe in the set of probes comprises an RNA or a DNA nucleic acid sequence; and wherein each probe in the set selectively binds to a corresponding target sequence in a target site among the plurality of target sites”. As seen in claim 15, “the barcode sequence comprises a nucleotide sequence having a length between 400 nucleic acids and 2,000 nucleic acids.”
As evidenced above, the aspect of one evaluating “one or more genetic scratchpads” has been construed as encompassing one or more chromosomes in a cell.
Attention is directed to paragraph [0079] of the disclosure and the definition of “genetic scratchpad” provided therein. As stated therein:
[0079] As used herein, the term "genetic scratchpad" refers to a polynucleotide
sequence within a prokaryotic or eukaryotic cell. In some embodiments, the genetic scratchpad can be synthesized in vitro and then put into the cell. In some embodiments, the genetic scratchpad refers to a defined location within the natural genomic sequence of the cell. In some embodiments, the genetic scratchpad can refer to a defined location within the natural genomic sequence of the cell that has been modified. Within the polynucleotide sequence of a genetic scratchpad, there are multiple target sites. In some embodiments, each target site comprises a guide sequence that can be recognized by a unique guide molecule. (Emphasis added)
As evidenced above, the aspect of one evaluating “one or more genetic scratchpads” has been construed as encompassing one or more chromosomes in a cell. In further support of this interpretation attention is directed to paragraph [00190] of the disclosure wherein applicant asserts:
The embodiments here are provided by way of example and should not in any way limit the scope of the invention. (Emphasis added)
Attention is directed to paragraph [00192] of the disclosure wherein applicant asserts:
[00192] In some embodiments, the system disclosed herein can also be implemented in
organisms, including but not limited to, for example, mice, zebrafish, and flies. (Emphasis added)
Attention is also directed to page 37, paragraph [00205], wherein applicant asserts:
[00205] As disclosed herein, the current system and method can be applied to analyze
cell development/differentiation by monitoring cellular functions and/or processes that include but are not limited to: PI3K/AKT Signaling, ERK/MAPK Signaling, Glucocorticoid Receptor Signaling, Axonal Guidance Signaling, Ephrin Receptor Signaling, Actin Cytoskeleton Signaling, Huntington's Disease Signaling, Apoptosis Signaling, B Cell Receptor Signaling, Leukocyte Extravasation Signaling, Integrin Signaling, Acute Phase Response Signaling, PTEN Signaling, p53 Signaling, Aryl Hydrocarbon Receptor Signaling, Xenobiotic Metabolism Signaling, SAPK/JNK Signaling, PPAr/RXR Signaling, NF-KB Signaling, Neuregulin Signaling, Wnt & Beta catenin Signaling, Insulin Receptor Signaling, IL-6 Signaling, hepatic Cholestasis, IGF-1 Signaling, NRF2-mediated Oxidative Stress Response, Hepatic, Fibrosis/Hepatic Stellate Cell Activation, PP AR Signaling, Fe Epsilon RI Signaling, G-Protein Coupled Receptor Signaling, Inositol Phosphate Metabolism, PDGF Signaling, VEGF Signaling, Natural Killer Cell Signaling, T Cell Receptor Signaling, FGF Signaling, GM-CSF Signaling,
Chemokine Signaling, IL-2 Signaling and many more. (Emphasis added)
Applicant, at page 40, paragraph [00220], asserts:
[00220] Having described the invention in detail, it will be apparent that
modifications, variations, and equivalent embodiments are possible without departing from the scope of the invention defined in the appended claims. Furthermore, it should be appreciated that all examples in the present disclosure are provided as non-limiting examples. (Emphasis added)
A review of the disclosure fails to find where applicant has disclosed or incorporated by reference, the nucleotide sequence found in any organism, much less the nucleotide sequence of any chromosome as found in any cell of any organism, much less the nucleotide sequence of any virus. Likewise, the disclosure has not been found to disclose the nucleotide sequence of any “guide sequence” (claims 4 and 5), of any length.
Attention is directed to paragraph [00109] of the disclosure. As asserted to therein:
[00109] In alterative embodiments, a genetic scratchpad is located in defined regions
within the natural genome of a cell. Because the sequence information of the genome of many organisms, including humans, is known, a genetic scratchpad can be defined based on the sequence information of selected genetic regions of interest in a genome. (Emphasis added)
As noted above, applicant has asserted that the nucleotide sequence of the human genome was known as of their effective priority date- 11 February 2014. This assertion has not been found persuasive for the nucleotide sequence of the human Y chromosome was not known until 2023, which is some 9 years post filing. In support of this position attention is directed to Rhie et al., “The complete sequence of a human Y chromosome”, Nature, vol. 621, 14 September 2023. As stated therein:
The human Y chromosome has been notoriously difficult to sequence and assemble
because of its complex repeat structure that includes long palindromes, tandem
repeats and segmental duplications. As a result, more than half of the Y chromosome
is missing from the GRCh38 reference sequence and it remains the last human
chromosome to be finished.
As presently worded, the claimed method has been construed as encompassing the analysis of the “genetic scratchpads” (chromosomes) in cells of virtually any organism where one is to evaluate the scratchpads for “molecular events” which, as seen in claim 13, mutations “selected from the group consisting of an insertion mutation, a deletion mutation, a point mutation, multiple point mutations and combinations thereof.”
Attention is directed to the following publications which teach of the enormity of the genera of virus, plants, insects, bacteria, mammals, and species encompassed by the subfamily Murinae as the detection of any and all genes from all members of the various genera are encompassed by the instant claims.
“Viruses” (Wikipedia.com, accessed 08 September 2023), teaches:
An enormous variety of genomic structures can be seen among viral species; as a group, they contain more structural genomic diversity than plants, animals, archaea, or bacteria. There are millions of different types of viruses, although fewer than 7,000 types have been described in detail. (Emphasis added)
“How many species of bacteria are there” (wisegeek.com; accessed 21 January 2014) teaches:
Currently, estimates of the total number of species of bacteria range from about 10 million to a billion, but these estimates are tentative, and may be off by many orders of magnitude. By comparison, there are probably between 10 and 30 million species of animals, the vast majority of them insects. The number of scientifically recognized species of animals is about 1,250,000. There are almost 300,000 recognized species of plants.
“Fungi,” (Wikipedia.com; accessed 08 September 2023), teaches:
As of 2020, around 148,000 species of fungi have been described by taxonomists,[6] but the global biodiversity of the fungus kingdom is not fully understood.[48] A 2017 estimate suggests there may be between 2.2 and 3.8 million species.[5]
“Plant,” (Wikipedia.com; accessed 08 September 2023) teaches:
There are about 380,000 known species of plants, of which the majority, some 260,000, produce seeds.
“Mammal,” (Wikipedia.com; accessed 08 September 2023) teaches:
According to Mammal Species of the World, which is updated through periodic editions, 5,416 species were identified in 2006. These were grouped into 1,229 genera, 153 families and 29 orders.[5]
“Murinae,” (Wikipedia.com, accessed 08 September 2023) teaches:
The Old World rats and mice, part of the subfamily Murinae in the family Muridae, comprise at least 519 species. Members of this subfamily are called murines. In terms of species richness, this subfamily is larger than all mammal families except the Cricetidae and Muridae, and is larger than all mammal orders except the bats and the remainder of the rodents.
“Fish,” (Wikipedia.com, accessed 08 September 2023) teaches:
Fish are abundant in most bodies of water. They can be found in nearly all aquatic environments, from high mountain streams (e.g., char and gudgeon) to the abyssal and even hadal depths of the deepest oceans (e.g., cush-eels and snailfish), although no species has yet been documented in the deepest 25% of the ocean.[4] At 34,300 described species, fish exhibit greater species diversity than any other group of vertebrates.[5]
“Archaea,” Wikipedia.com (accessed 08 September 2023), teaches:
The classification of archaea into species is also controversial. Ernst Mayr defined a species as a group of interbreeding organisms which are reproductively isolated, but this is of no help since archaea only reproduce asexually.[37]
Archaea show high levels of horizontal gene transfer between lineages. Some researchers suggest that individuals can be grouped into species-like populations given highly similar genomes and infrequent gene transfer to/from cells with less-related genomes, as in the genus Ferroplasma.[38] On the other hand, studies in Halorubrum found significant genetic transfer to/from less-related populations, limiting the criterion's applicability. Some researchers question whether such species designations have practical meaning.[40]
Current knowledge on genetic diversity is fragmentary, so the total number of species cannot be estimated with any accuracy.[22] (Emphasis added)
“Algae,” Wikipedia.com (accessed 03-04-2016) teaches:
The most recent estimate suggests 72,500 algal species worldwide.
“Protozoa,” Wikipedia.com (accessed 05-11-2016), teaches:
The classification of protozoa has been and remains a problematic area of taxonomy. Where they are available, DNA sequences are used as the basis for classification; however, for the majority of described protozoa, such material is not available. (Emphasis added)
It is further noted that “routine experimentation is ‘not without bounds.’” Wyeth v. Abbott Laboratories 107 USPQ2d 1273, 1275, 1276 (Fed. Cir. June 2013), citing Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330, 1339 [105 USPQ2d 1817] (Fed. Cir. 2013), and that what constitutes "undue experimentation" can be evaluated from the perspective of the amount of time required to enable the full scope of the invention. In support of this position, attention is directed to Cephalon at 1823, citing White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 218 USPQ 961 (Fed. Cir. 1983), that work that would require 18 months to 2 years so to enable the full scope of an invention, even if routine, would constitute undue experimentation. As stated therein:
Permissible experimentation is, nevertheless, not without bounds. This court has held that experimentation was unreasonable, for example, where it was found that eighteen months to two years’ work was required to practice the patented invention. See, e.g., White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] Fed. Cir.1983). (Emphasis added)
As disclosed in “How many species of bacteria are there?” (WiseGeek.com, accessed 21 January 2014) it is estimated that there are between 10 million and a billion different species of bacteria. As stated therein:
Currently, estimates of the total number of species range from about 10 million to a billion, but these estimates are tentative, and may be off by many orders of magnitude. By comparison, there are probably between 10 and 30 million species of animals, the vast majority of them insects. The number of scientifically recognized species of animals is about 1,250,000. There are almost 300,000 recognized species of plants.
The nucleotide sequence for the genome of any given species of bacteria, much less any and all other organisms, is highly unpredictable.
In order to enable the full scope of the invention, one would have to perform the step of “characterizing, at one or more time points during the time period, a status of molecular changes at each time point for the plurality of target sites in each genetic scratchpad in cells in the cell population” (claim 1), wherein the “genetic scratchpad” is any chromosome in any organism. Such information is neither provided by the disclosure nor the art of record.
As evidenced above, it is estimated that there are many tens of millions of different species of bacteria. “List of sequenced bacterial genomes” (Wikipedia.com; accessed 24 January 2014) teaches that less than 300 different species of bacteria have had their genomes sequenced, which comprises species found in some 8 genera of cyanobacterium.
The lack of guidance and quantity of experimentation necessary
The quantity of experimentation necessary is great, on the order of many man-years, and then with little if any reasonable expectation of successfully enabling the full scope of the claims. In support of this position, it is noted that the claimed method requires the pairing of probes/primers with template. In order to select the appropriate probe/primers, which are deemed to be essential, one must have knowledge of the nucleotide sequence of the template. Neither the as-filed specification nor the state of the art provides such guidance so that one skilled in the art, without any undue experimentation, could reasonably generate such a probe system contemplated by the intended breadth of the claimed method. Absent knowledge of the nucleotide sequence of the template, selection of the correct primer is highly unpredictable.
Time required to enable a portion of the claims’ scope.
If one were to use a probe/primer that is but 20 nucleotides long, and substituting each position with the four traditional nucleotides, there are some 420 or 1.099 x 1012 or 1,099,000,000,000 different potential probes from which to select. If one could somehow produce and screen 100 million (100,000,000) 20mer oligonucleotides a week, and to do so for 52 weeks a year, it would take over 211 years to screen for useful primers of this one size for one target. Such a tremendous effort constitutes undue experimentation.
In order to determine the appropriate probes/primers for the millions of organisms encompassed by the claimed method, one would need to determine the nucleotide sequence of the various target sequences. “How many species of bacteria are there?” teaches that it would take “a few months” to determine the nucleotide sequence of any given bacteria. As stated therein:
Today, given that sequencing a bacterial genome costs half a million US dollars and takes a few months, this is infeasible. (Emphasis added)
Assuming, arguendo, that one needed to sequence but only 200 bacteria, and it took on average just 3 months to sequence one strain of one species of bacteria, it would take some 600 months, or 50 years to sequence just 1 strain from each of 200 different species of bacteria. Such effort is deemed to constitute undue experimentation.
Alternatively, if one were to determine the nucleotide sequence of the genome of an organism every day, 365 days a year, and to also identify in the same day probes/primers that would be useful in the identification of target sequence(s) found in said organism wherein said target sequence(s) has/have utility under 35 USC 101, it would take approximately 2739 years to sequence even 1 million bacteria, viruses or fungi. Clearly, such an effort to enable the full scope of that claimed would constitute undue experimentation.
As presently worded, the claimed method fairly encompasses the many species of cyanobacterium encompassed by the 150 genera of cyanobacterium at issue in Vaeck. “List of sequenced bacterial genomes” (Wikipedia.com; accessed 24 January 2014) teaches that the genomic sequence of less than 300 species of bacteria has been determined, and that these include some 17 strains of cyanobacterium, which are limited to but 8 genera. By comparison, in Vaeck, 9 genera of cyanobacterium had been disclosed, yet it was held that to enable the full scope of the invention which was limited to the 150 genera of cyanobacterium, it would require undue experimentation.
Attention is also directed to MPEP 2164.06(b) and In re Vaeck, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991).
Where, as here, a claimed genus represents a diverse and relatively poorly understood group of microorganisms, the required level of disclosure will be greater than, for example, the disclosure of an invention involving a “predictable” factor such as a mechanical or electrical element. See Fisher, 427 F.2d at 839, 166 USPQ at 24.
Attention is also directed to the decision in Promega Corp. v. Life Techs. Corp. 113 USPQ2d 1181, 1187, 1189 (Fed. Cir. 2014):
The enablement requirement ensures that “the public knowledge is enriched by the patent specification to a degree at least commensurate with the scope of the claims.” Nat'l Recovery Techs., Inc. v. Magnetic Separation Sys., Inc., 166 F.3d 1190, 1195-96 [49 USPQ2d 1671] (Fed. Cir. 1999). The scope of the claims must be “less than or equal to the scope of enablement.” Id. at 1196.
[1] Here, we disagree with Promega's characterization that unrecited STR loci combinations in the “open loci set” limitation of the asserted claims are merely “unrecited elements”; under the undisputed claim construction, they are part of the claim scope.
***
While the claims of the
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patents are not directed to a genus of compounds as in Wyeth, the claims at issue here similarly cover potentially thousands of undisclosed embodiments in an unpredictable field. And similar to Wyeth, the specification of the
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patents provides only a starting point—specific STR loci combinations that successfully co-amplify—with no disclosure that would have allowed a skilled artisan, absent laborious testing, to add new loci to these recited STR loci combinations that would still successfully co-amplify. Undue experimentation is a matter of degree, and even “a considerable amount of experimentation is permissible,” so long as it is “merely routine” or the specification “provides a reasonable amount of guidance” regarding the direction of experimentation. Johns Hopkins Univ. v. CellPro, Inc., 152 F.3d 1342, 1360-61 [47 USPQ2d 1705] (Fed. Cir. 1998) (internal quotation omitted). But permissible routine experimentation “is not without bounds.” Wyeth, 720 F.3d at 1386 (citation omitted). As the extensive evidence here demonstrates, undue experimentation would have been required in order to enable the full scope of coverage sought by
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— the successful co-amplification of potentially thousands of unrecited STR loci combinations. (Emphasis added)
In view of such legal precedence, the aspect of having to work for many tens of years just to provide the starting materials for minute fraction of the scope of the claimed invention is deemed to constitute both an unreasonable length of time and undue experimentation.
In view of the breadth of scope clamed, the limited guidance provided, the unpredictable nature of the art to which the claimed invention is directed, and in the absence of convincing evidence to the contrary, the claims are deemed to be non-enabled by the disclosure. Accordingly, claims 1-2, 4-5, 8-12, 15-17, 22, and 27-30 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 enablement requirement.
Response to argument
At pages 9-17 of the response applicant’s representative traverses the rejection of claims under 35 USC 112(a) for not satisfying the enablement requirement.
At page 15 of the response said representative asserts:
It is not necessary to identify all the nucleic acids (scratchpads, promoters expressing gRNAs, gRNAs, and oligonucleotide probes) to enable the claimed method for establishing the lineage information among cells in a cell population, given the extensive existing knowledge of nucleic acids.
Nucleic acids were extremely well-known and characterized at the time of the claimed invention, and “[t]he specification need not disclose what is well known in the art.” Lindemann Maschinenfabrik GMBH, 730 F.2d at 1463; see also MPEP 2164.01. The level of skill in the art of genetic research was also quite high. In short, the structure, chemistry, biology, function, and information content of nucleic acids had been extensively studied and described as of the time of the claimed invention, and sophisticated methods of analysis were common. Indeed, commercial products for the analysis of nucleic acid sequences in a sample had been widely available for over a decade. See Appendix A, Figure 1. A person of skill in the art would have had or would have been able to get — either from the literature or from well-known sequencing tools and methods — nucleic acid sequences of interest for a particular line of research. Id.
Insofar as the Office further contends that probes for the nucleic acids are not enabled, the state of the art and level of skill belie any such position. See Final Office Action at paragraph 79.
The above cited arguments have been considered and have not been found persuasive. While an applicant may not need to disclose each and every possible sequence in order to satisfy the enablement requirement, applicant, in the present application, has not been found to disclose any sequence, much less those sequences that have a specific and substantial utility. More to the point, the subject application does not comprise a Sequence Listing wherein it would disclose any sequence.
As presently worded, the claimed method fairly encompasses the many species of cyanobacterium encompassed by the 150 genera of cyanobacterium at issue in Vaeck. “List of sequenced bacterial genomes” (Wikipedia.com; accessed 24 January 2014) teaches that the genomic sequence of less than 300 species of bacteria has been determined, and that these include some 17 strains of cyanobacterium, which are limited to but 8 genera. By comparison, in Vaeck, 9 genera of cyanobacterium had been disclosed, yet it was held that to enable the full scope of the invention which was limited to the 150 genera of cyanobacterium, it would require undue experimentation.
It is noted that the claimed method is not limited to those cells of organisms where the nucleic acid sequences were known. It is noted, for example, that the last human chromosome to be sequenced, the Y chromosome, was not completely sequenced until 2023, which is some 6 years post applicant’s filing date, and some 9 years post applicant’s effective priority date. See Rhie et al., “The complete sequence of a human Y chromosome”, Nature, Vol. 621, 14 September 2023.
By way of analogy, the claimed method fairly encompasses the determination of lineage information of the cells that produce the genus of antibodies at issue in Amgen. As set forth in the unanimous U.S. Supreme Court decision in Amgen Inc., et al. v. Sanofi et al. 598 U.S. ___ (2023):
Our decisions in Morse, Incandescent Lamp, and Holland Furniture reinforce the simple
statutory command. If a patent claims an entire class of processes, machines,
manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405, 419 (1908) (“[T]he claims measure the invention.”). (Emphasis added)
***
To be fair, Amgen does not dispute this much. It freely admits that it seeks to claim for
itself an entire universe of antibodies. Still, it says, its broad claims are enabled because
scientists can make and use every undisclosed but functional antibody if they simply
follow the company’s “roadmap” or its proposal for “conservative substitution.”
We cannot agree. These two approaches amount to little more than two research
assignments… Whether methods like a “roadmap” or “conservative substitution” might
suffice to enable other claims in other patents—perhaps because, as this Court suggested
in Incandescent Lamp, the inventor identifies a quality common to every functional
embodiment, supra, at 13—they do not here. They leave a scientist about where Sawyer
and Man left Edison: forced to engage in “painstaking experimentation” to see what
works. 159 U. S., at 475. That is not enablement. More nearly, it is “a hunting license.”
Brenner v. Manson, 383 U. S. 519, 536 (1966).
While argument has been presented that nucleic acids are well known, no evidence has been presented showing that the nucleotide sequence encoding each member of the genus of antibodies produced in the genus of antibody-producing organisms, was known in the art as of the effective filing date (February 11, 2014). Likewise, no evidence has been presented that the complete nucleotide sequence of the human Y chromosome was known as of the effective priority date. To the contrary, evidence has been made of record showing that such a sequence was not known for years subsequent to applicant’s filing of the instant application.
Attention is directed to MPEP 2145 I [R-01.2024].
An argument by the applicant is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection. See MPEP § 2129 and § 2144.03 for a discussion of admissions as prior art.
Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) ("An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness."). See MPEP § 716.01(c) for examples of applicant statements which are not evidence and which must be supported by an appropriate affidavit or declaration.
A review of the response fails to find where any affidavit or declaration has been provided.
It is further noted that no showing has been made that the full scope of bacterial, plant, viral, insect, mammal, and fish chromosomal sequences could be determined within a time span that would not constitute undue experimentation.
In view of the above analysis and in the absence of convincing evidence to the contrary, the rejection is maintained.
As noted above, argument has been presented that means exist for the sequencing of he genome of various organisms. While the method of sequencing nucleic acids may be known in the art, no evidence has been presented showing that the full scope of the claimed invention could be enabled in a time span that would not constitute undue experimentation- that the full scope of the claimed invention could be achieved in less than 18 to 24 months. In support of this position, attention is directed to Cephalon at 1823, citing White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 218 USPQ 961 (Fed. Cir. 1983), that work that would require 18 months to 2 years so to enable the full scope of an invention, even if routine, would constitute undue experimentation. As stated therein:
Permissible experimentation is, nevertheless, not without bounds. This court has held that experimentation was unreasonable, for example, where it was found that eighteen months to two years’ work was required to practice the patented invention. See, e.g., White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] Fed. Cir.1983). (Emphasis added)
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 1-2, 4-5, 8-12, 15-17, 22, and 27-30 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 enablement requirement.
Conclusion
Objections and/or rejections which appeared in the prior Office action and which have not been repeated hereinabove have been withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradley L. Sisson whose telephone number is (571)272-0751. The examiner can normally be reached Monday to Thursday, from 6:30 AM to 5 PM..
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/Bradley L. Sisson/Primary Examiner, Art Unit 1682
1 Attention is directed to 37 CFR 1.57(d), which sates in part:
(d) "Essential material" may be incorporated by reference, but only by way of an incorporation by reference to a U.S. patent or U.S. patent application publication, which patent or patent application publication does not itself incorporate such essential material by reference. "Essential material" is material that is necessary to:
(1) Provide a written description of the claimed 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 set forth the best mode contemplated by the inventor of carrying out the invention as required by 35 U.S.C. 112(a);
(2) Describe the claimed invention in terms that particularly point out and distinctly claim the invention as required by 35 U.S.C. 112(b); or
(3) Describe the structure, material, or acts that correspond to a claimed means or step for performing a specified function as required by 35 U.S.C. 112(f). (Emphasis added)
(e) Other material ("Nonessential material") may be incorporated by reference to U.S. patents, U.S. patent application publications, foreign patents, foreign published applications, prior and concurrently filed commonly owned U.S. applications, or non-patent publications. An incorporation by reference by hyperlink or other form of browser executable code is not permitted.