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 .
Drawings
The drawings were received on 29 July 2022. 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, 4, 6, 9, 12, 22, 23, 25, 28, 30, 31, 40-43, 52, 54, 56, 86, and 87 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 “complementary” in claim 1is a relative term which renders the claim indefinite. The term “complementary” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “region” in claim 1 is a relative term which renders the claim indefinite. The term “region” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 4, 6, 9, 12, 22, 23, 25, 28, 30, 31, 40-43, 52, 54, 86, and 87, which depend from claim 1, fail to overcome these issues and are similarly rejected.
Response to traversal
At pages 7-9 of the response of 27 October 2025, hereinafter the response, applicant’s representative traverses the rejection of claims under 35 USC 112(b).
At page 8 of the response said representative asserts:
Applicant submits that when the claims are read as a whole, a person of ordinary skill in the art would understand the meaning of the term "complementary," which is a common and well-understood term of art. The structural features of oligonucleotides, such as DNA and RNA, are well-known in the art and common to oligonucleotides regardless of origin, one commonality being simply the polynucleotide structure that allows for the specific and predictable hybridization of nucleotides to their complementary counterparts via canonical base pairing.
At page 9 of the response said representative asserts:
Applicant respectfully disagrees. Applicant submits that when the claims are read as a whole, a person of ordinary skill in the art would understand the metes and bounds of "region," which is a common and well-understood term of art referring to a portion of the sequence of a nucleic acid molecule. Each of "hybridization region," "region of interest," and "interrogatory region" are depicted in FIG. 1 or FIG. 2 of the application. Based on the foregoing, Applicant submits that one skilled in the art would understand the metes and bounds of each element and the indefiniteness rejection of claim 1 should be withdrawn.
These arguments have been fully considered and have not been found persuasive. 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
In view of the above analysis and in the absence of convincing evidence to the contrary, the rejections are maintained.
Claim Rejections - 35 USC § 112, Enablement
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 6, 9, 12, 22, 23, 25, 28, 30-31, 40-43, 52, 54, 56, 86, and 87 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.
As set forth in Cephalon Inc. v. Watson Pharmaceuticals Inc. 105 USPQ2d 1817, 1821 (CAFC, 2013):
To satisfy section 112 of the 1952 Patent Act, the specification must enable a person of ordinary skill in the art to make and use the invention. 35 U.S.C. § 112, ¶1. This requirement is met when at the time of filing the application one skilled in the art, having read the specification, could practice the invention without “undue experimentation.” In re Wands, 858 F.2d 731, 736-37 [8 USPQ2d 1400] (Fed. Cir. 1988). Whether undue experimentation is required “is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 940 [94 USPQ2d 1823] (Fed. Cir. 2010) (citing Wands, 858 F.2d at 737).
The following factors may be considered when determining if a disclosure requires undue experimentation:
(1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims.
Wands, 858 F.2d at 737 (“Wands factors”); Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362, 1372 [52 USPQ2d 1129] (Fed. Cir. 1999) (“The Wands factors, when applied from the proper temporal perspective … are a useful methodology for determining enablement….”). These factors while illustrative are not mandatory. Enzo Biochem, Inc., 188 F.3d at 1371. What is relevant depends on the facts, and although experimentation must not be undue, a reasonable amount of routine experimentation required to practice a claimed invention does not violate the enablement requirement. Id. The burden of proof here is on Watson to show that the Khankari patents are invalid for lack of enablement by clear and convincing evidence. See Auto. Tech. Int'l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 1281 [84 USPQ2d 1109] (Fed. Cir. 2007).
It is noted that claims drawn to an asserted pioneering invention are not entitled to a lesser showing of enablement. In support of this position, attention is directed to Plant Genetic Systems N. V. v. DeKalb Genetics Corp. 65 USPQ2d 1452 (Fed. Cir. 2003), which states at 1456:
Regarding PGS' extensive citation of statements from Hogan [In re Hogan, 559 F.2d 595, 604 [194 USPQ 527] (CCPA 1977)] such as that pioneering inventions “deserve broad claims to the broad concept,” id. at 606, we conclude that they are taken out of context and thus unconvincing. As the concurrence in Hogan pointed out, these statements are “extended dicta.” Id. at 610. We do not need to address all of the insightful comments made by the concurring judge; it is sufficient for the present case that we hold the district court did not err in not applying Hogan‘s dicta to its enablement analysis.
PGS also cites Hormone Research Foundation Inc. v. Genentech, Inc., 904 F.2d 1558, 1568 [15 USPQ2d 1039] (Fed. Cir. 1990), for its proposition that “a rigid application of the enablement requirement cannot be permitted to destroy the incentives in our patent system that encourage the early disclosure of pioneering inventions.” In Hormone Research, the enablement challenge focused on the lack of disclosure regarding how to make the compound as later produced with higher purity and potency. This court vacated a summary judgment of non-enablement because, inter alia, it was not clear from the record whether the technology of making the compound of higher purity and potency existed at the time the application was filed, and therefore, “[f]urther factual developments as to the state of the art at the date of the application … [were] required.” Id. at 1568-69.
Again, PGS relies on dicta from Hormone Research but ignores the holding of the case. In both Hogan and Hormone Research, which relied on Hogan, compounds having better qualities did not seem to be in existence on the date when the patent applications were filed, but the claims (albeit with a narrower scope) might be nevertheless enabled in view of the state of the art then existing. In the present case, PGS does not allege that monocots or stably transformed monocot cells were not in existence in 1987 or that the cell claims were enabled in 1987 under the standard enablement analysis. Instead, PGS attempts to use the dicta from Hogan and Hormone Research to expand the coverage of claims, yet create a new, lower standard of enablement.
We conclude that the law does not support PGS' assertion that the ′236 patent is entitled to both a broad scope of coverage and a lower standard of enablement. The extended dicta PGS cites cannot be used to alter the holdings of these precedents. PGS' reliance on Hogan and related cases is misplaced. (Emphasis added)
The nature of the invention; The breadth of the claims; and The state of the prior art
Claims 1 and 56 are the only independent claims pending.
Claims 1, 56, 86 and 87 are deemed to be representative and, for convenience, are reproduced below
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Applicant, at page 11, paragraph [0031], provides the following definition for target nucleic acid. As disclosed therein:
[0031] In any of the preceding embodiments, the target nucleic acid can be a viral DNA, bacterial DNA, or cellular DNA or RNA molecule or a product thereof in the biological sample. In any of the preceding embodiments, the target nucleic acid can be genomic DNA, mitochondrial DNA, mRNA or cDNA. (Emphasis added)
Applicant, at page 28, paragraph [0083], asserts:
[0083] A sample disclosed herein can be or derived from any biological sample… In addition to the subjects described above, a biological sample can be obtained from a prokaryote such as a bacterium, an archaea, a virus, or a viroid. A biological sample can also be obtained from non-mammalian organisms ( e.g., a plant, an insect, an arachnid, a nematode, a fungus, or an amphibian). A biological sample can also be obtained from a eukaryote, such as a tissue sample, a patient derived organoid (PDQ) or patient derived xenograft (PDX). (Emphasis added)
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]
“Insect”, (Wikipedia.com; accessed 09/10/2020) teaches:
Insects are the most diverse group of animals; they include more than a million described species and represent more than half of all known living organisms. The total number of extant species is estimated at between six and ten million; potentially over 90% of the animal life forms on Earth are insects.
“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 10 June 2024) 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)
Attention is directed to “Eukaryotic Genome Complexity” (Pray, Nature Education, 1(1):36, 2008, pages 1-4.). As seen therein, a table of estimated protein encoding genes in different genomes is provided.
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As evidenced by both claim 1 and claim 56, the claimed method is based on the concept that hybridization of a probe to a complementary strand, applicant’s “blocking strand” will prohibit/block the probe from hybridizing to the target. The aspect of a probe being hybridized to a complementary strand is recognized in the art as not necessarily blocking the probe from also hybridizing to the target. In support of this position attention is directed to US 2007/0065865 A1 (Carlton et al.), which teaches at paragraph [0016]:
[0016] "Hybridization-based assay" means any assay that relies on the formation of a stable duplex or triplex between a probe and a target nucleotide sequence for detecting or measuring such a sequence. In one aspect, probes of such assays anneal to (or form duplexes with) regions of target sequences in the range of from 8 to 100 nucleotides; or in other aspects, they anneal to target sequences in the range of from 8 to 40 nucleotides, or more usually, in the range of from 8 to 20 nucleotides. A "probe" in reference to a hybridization-based assay mean a polynucleotide that has a sequence that is capable of forming a stable hybrid (or triplex) with its complement in a target nucleic acid and that is capable of being detected, either directly or indirectly. (Emphasis added)
Attention is also directed to US 2017/0232109 A1 (Mirkin et al.), which teaches the following at paragraph [0111].
In some aspects, hybridization of the polynucleotide that is part of the core-shell nanoparticle can form a triplex structure with a double-stranded target polynucleotide. In another aspect, a triplex structure can be formed by hybridization of a double-stranded polynucleotide that is part of a core-shell nanoparticle to a single-stranded target polynucleotide.
US 2017/0073748 A1 (Lizardi et al.), at paragraph [0116], teaches:
In some forms, the hybridization probes are designed to induce duplex invasion or triplex invasion of the target nucleic acid. Therefore, although not preferred, hybridization probes can include two or more target sequences that are partially overlapping, or non-overlapping on the target nucleic acid fragment. In some forms, hybridization probes that are capable of inducing triplex invasion of the target nucleic acid are designed to induce triplex invasion of the target nucleic acid. (Emphasis added)
In view of the above teachings in the prior art, it stands to reason that the probe, even when hybridized to a “blocking sequence” and is thusly a duplex structure, can and will form a triplex structure with the target and that one does not necessarily have to displace a blocking strand prior to the probe hybridizing to the target.
The 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 art suggests that there are millions of species of viruses and fungi that are yet to be identified and characterized. Assuming, arguendo, that one were to identify a new virus or fungus every day, 365 days a year, and to also determine in the same day the nucleotide sequence of the genome of said organism, and additionally, identify probes and primers that would be useful in the identification of a target sequence found in said new organism wherein said target sequence has utility under 35 USC 101, it would take approximately 2739 years to sequence even 1 million viruses or fungi. Clearly, such an effort to enable the full scope of that claimed would constitute undue experimentation. In support of this position attention is directed to Cephalon, 1823:
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). Likewise, we have held that the amount of experimentation would be undue where: (1) the specification lacks guidance by teaching away from the subject matter that was eventually claimed; and (2) there is evidence of the patentee's own failures to make and use the later claimed invention at the time of the application. See, e.g., AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244 [68 USPQ2d 1280] (Fed. Cir. 2003)
Alternatively, even if the claimed method was limited to the detection of known organisms, the selection of probes and primers would also constitute undue experimentation. In support of this position, it is noted that if one were to utilize a probe or primer that was but 20 nucleotides long, and to then substitute each of the positions with the four common dNTPs, there are some 420, or 1.099 x 1012 different sequences to screen/evaluate. In support of the position that to screen such a number of candidate molecules would constitute undue experimentation, attention is directed to Wyeth v. Abbott Laboratories 107 USPQ2d 1273, 1276 (Fed. Cir. June 2013):
The remaining question is whether having to synthesize and screen each of at least tens of thousands of candidate compounds constitutes undue experimentation. We hold that it does. Undue experimentation is a matter of degree. Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1253 [70 USPQ2d 1321] (Fed. Cir. 2004) (internal quotation omitted). Even “a considerable amount of experimentation is permissible,” as 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). Yet, routine experimentation is “not without bounds.” Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330, 1339 [105 USPQ2d 1817] (Fed. Cir. 2013). (Emphasis added)
Our cases have described limits on permissible experimentation in the context of enablement. For example, in ALZA Corp. v. Andrx Pharmaceuticals, LLC, we affirmed a judgment of nonenablement where the specification provided “only a starting point, a direction for further research.” 603 F.3d 935, 941 [94 USPQ2d 1823] (Fed. Cir. 2010) (internal quotation omitted). We concluded that one of ordinary skill “would have been required to engage in an iterative, trial-and-error process to practice the claimed invention even with the help of the … specification.” Id. at 943. In Cephalon, although we ultimately reversed a finding of nonenablement, we noted that the defendant had not established that required experimentation “would be excessive, e.g., that it would involve testing for an unreasonable length of time.” 707 F.3d at 1339 (citing White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] (Fed. Cir. 1983)). Finally, in In re Vaeck, we affirmed the PTO's nonenablement rejection of claims reciting heterologous gene expression in as many as 150 genera of cyanobacteria. 947 F.2d 488, 495-96 [20 USPQ2d 1438] (Fed. Cir. 1991). The specification disclosed only nine genera, despite cyanobacteria being a “diverse and relatively poorly understood group of microorganisms,” with unpredictable heterologous gene expression. Id. at 496. (Emphasis added)
Here, the specification similarly discloses only a starting point for further iterative research in an unpredictable and poorly understood field. Synthesizing candidate compounds derived from sirolimus could, itself, require a complicated and lengthy series of experiments in synthetic organic chemistry. Even putting the challenges of synthesis aside, one of ordinary skill would need to assay each of at least tens of thousands of candidates. Wyeth's expert conceded that it would take technicians weeks to complete each of these assays. The specification offers no guidance or predictions about particular substitutions that might preserve the immunosuppressive and antirestenotic effects observed in sirolimus. The resulting need to engage in a systematic screening process for each of the many rapamycin candidate compounds is excessive experimentation. We thus hold that there is no genuine dispute that practicing the full scope of the claims, measured at the filing date, required undue experimentation. (Emphasis added)
The amount of direction or guidance presented,
The amount of guidance provided is limited, generally prophetic, and not commensurate with the scope of the claims.
The presence or absence of working examples
The disclosure has been found to comprise 2 examples, and they are:
“Example 1: Use of a Metastable Stem-Loop Padlock Probe to Increase Specificity and Stringency When Detecting a Region of Interest in a Target mRNA Molecule”, page 124; and
“Example 2: Use of a Padlock Probe and Separate Blocking Strand to Increase Specificity and Stringency When Detecting a Region of Interest in a Target mRNA Molecule”, page 127.
The predictability or unpredictability of the art
As noted in In re Fisher 166 USPQ 18 (CCPA, 1970):
In cases involving predictable factors, such as that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.
Attention is also directed to Wyeth v. Abbott Laboratories 107 USPQ2d 1273 (Fed. Cir. June 2013):
The remaining question is whether having to synthesize and screen each of at least tens of thousands of candidate compounds constitutes undue experimentation. We hold that it does. Undue experimentation is a matter of degree. Chiron Corp. v. Genentech, Inc., 363 F.3d 1247, 1253 [70 USPQ2d 1321] (Fed. Cir. 2004) (internal quotation omitted). Even “a considerable amount of experimentation is permissible,” as 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). Yet, routine experimentation is “not without bounds.” Cephalon, Inc. v. Watson Pharm., Inc., 707 F.3d 1330, 1339 [105 USPQ2d 1817] (Fed. Cir. 2013).
Our cases have described limits on permissible experimentation in the context of enablement. For example, in ALZA Corp. v. Andrx Pharmaceuticals, LLC, we affirmed a judgment of nonenablement where the specification provided “only a starting point, a direction for further research.” 603 F.3d 935, 941 [94 USPQ2d 1823] (Fed. Cir. 2010) (internal quotation omitted). We concluded that one of ordinary skill “would have been required to engage in an iterative, trial-and-error process to practice the claimed invention even with the help of the … specification.” Id. at 943. In Cephalon, although we ultimately reversed a finding of nonenablement, we noted that the defendant had not established that required experimentation “would be excessive, e.g., that it would involve testing for an unreasonable length of time.” 707 F.3d at 1339 (citing White Consol. Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788, 791 [218 USPQ 961] (Fed. Cir. 1983)). Finally, in In re Vaeck, we affirmed the PTO's nonenablement rejection of claims reciting heterologous gene expression in as many as 150 genera of cyanobacteria. 947 F.2d 488, 495-96 [20 USPQ2d 1438] (Fed. Cir. 1991). The specification disclosed only nine genera, despite cyanobacteria being a “diverse and relatively poorly understood group of microorganisms,” with unpredictable heterologous gene expression. Id. at 496.
Here, the specification similarly discloses only a starting point for further iterative research in an unpredictable and poorly understood field. Synthesizing candidate compounds derived from sirolimus could, itself, require a complicated and lengthy series of experiments in synthetic organic chemistry. Even putting the challenges of synthesis aside, one of ordinary skill would need to assay each of at least tens of thousands of candidates. Wyeth's expert conceded that it would take technicians weeks to complete each of these assays. The specification offers no guidance or predictions about particular substitutions that might preserve the immunosuppressive and antirestenotic effects observed in sirolimus. The resulting need to engage in a systematic screening process for each of the many rapamycin candidate compounds is excessive experimentation. We thus hold that there is no genuine dispute that practicing the full scope of the claims, measured at the filing date, required 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.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 1, 4, 6, 9, 12, 22, 23, 25, 28, 30-31, 40-43, 52, 54, 56, 86, and 87 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 traversal
At pages 9-20 of the response said representative traverses the rejection of claims under 35 USC 112 for not satisfying the enablement requirement.
At page 10 of the response said representative asserts:
Applicant submits that one of ordinary skilled in the art would be able to design a probe and blocking strand given the sequence of the interrogatory region such that displacement would proceed as required in the claim.
At page 12 of the response said representative asserts:
Applicant respectfully traverses the enablement rejection with respect to the claims currently under consideration. Applicant respectfully submits that the method claimed is fully enabled by the disclosure of the originally filed application. "The test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation." United States V. Telectronics, Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988). As discussed below in more detail, Applicant respectfully submits that, at the time of filing the instant application, one of ordinary skill in the art reading the application would have been able to practice the claimed method without undue experimentation.
*****
The quantity of experimentation necessary. Applicant respectfully submits that the quantity of experimentation necessary to perform the claimed method, if any, is minimal, and the Examiner has significantly overstated the quantity of experimentation necessary.
Applicant’s representative, at page 15 of the response, asserts:
The Examiner further alleges that the selection of probes and primers would also constitute undue experimentation and notes that "if one were to utilize a probe or primer that was but 20 nucleotides long, and to then substitute each of the positions with the four common dNTPs, there are some 4²⁰, or 1.099 X 10¹² different sequences to screen/evaluate." Page 17 of the Office Action. Here, the Examiner does not consider the high degree of predictability of the canonical binding of nucleic acids. One of ordinary skill in the art, working from a target nucleic acid sequence and understanding that, e.g., thymine hybridizes with adenine and cytosine hybridizes with guanine, could readily design a probe as recited in the pending claims with sufficient confidence that it will hybridize to the target nucleic acid. The predictable nature of nucleic acid hybridization would not require one of ordinary skill in the art to screen and evaluate all possible nucleic acid sequences as alleged by the Examiner. That which one skilled in the art could do in minutes using a pencil and paper, or seconds using a computer program, cannot be considered any significant quantity of experimentation.
Applicant’s representative, at page 16 of the response, asserts:
The amount of direction or guidance presented. Applicant respectfully submits that the application has provided significant guidance to one skilled in the art to make and use the claimed invention. The disclosure of the instant application teaches one how to perform the steps of the instant claims, including identifying a target nucleic acid and designing the claimed probes and blocking strands. See, e.g., paragraphs [0185]-[0196] in the section titled "Target sequences"; paragraphs [0219]-[0220]; and the Examples. Furthermore, schematics of the claimed probes are provided. See, e.g., FIGS. 1-4. The new combination of claimed steps is readily performed by one of ordinary skill in the art reading the instant application by applying well-known molecular biology techniques. Thus, Applicant respectfully submits that the direction and guidance presented in the originally filed application supports Wands factors corroborating a finding that no undue experimentation is required to practice the full scope of the claimed method.
Applicant’s representative, at page 18 of the response, asserts:
The predictability or unpredictability of the art. Applicant respectfully submits that, while there is a generally accepted understanding that molecular biology as a whole is an unpredictable art, there is a high level of predictability in designing probes that bind to target nucleic acids. The general principles of nucleic acid design and nucleic acid hybridization based on pairing of complementary bases (e.g., canonical Watson-Crick binding), as well as nucleic acid manipulation and detection, were well developed at the time of filing the instant application and are appreciated to be highly predictable. The well-developed nature of the art, including methods used to perform the claimed method (e.g., hybridization, ligation, and detection), the advanced state of the prior art, the high degree of skill of an ordinary artisan (e.g., Ph.D. or equivalent level of research experience), and the high level of predictability (such as based on the high degree of predictability of the binding of nucleic acids) make it clear that one of ordinary skill in the art can readily practice the full scope of the pending claims based on the disclosure of the originally filed application without undue experimentation. (Emphasis in the original)
Applicant’s representative, at page 19 of the response, asserts:
The breadth of the claims. The claimed method is for detecting a region of interest in a target nucleic acid" (emphasis added"). That is, the scope of the claim is limited to those target nucleic acids that are bound by the probe. It is well known that nucleic acids follow the same basic hybridization rules, regardless of the origin of sample or species from which the target nucleic acid is obtained. Thus, regardless of the range of samples and target nucleic acids that may be practiced with the claimed methods, the ability of nucleic acids to hybridize with one another is not at issue. The Examiner construes the term "target nucleic acid" as "be any mRNA or cDNA molecule found in or derived from any form of "biological sample" from any eukaryotic or prokaryotic source." Page 26 of the Office Action. But this consideration is not relevant to whether the claims at issue are enabled. (Emphasis in the original)
The above arguments have been considered and have not been found persuasive towards the withdrawal of the rejection. Agreement is reached in that the state of the art is one where the nucleotide sequence of an organism can be determined, and once armed with this information, one of skill in the art could determine the nucleotide sequence of probes that would bind to sequences within the genome of the organism.
As evidenced above, it is thought that there are between 10 million and 1 billion bacteria. If one could isolate and sequence a different bacteria in just 1 day, and did this 365 days a year, it would take on the order of 2,739 years to sequence just 1 million bacteria.
Such effort clearly constitutes undue experimentation.
Applicant, at page 60, paragraph [0191], asserts:
[0191] In some embodiments, any of the hybridization regions and/or regions of interest
contained in the target nucleic acid are between or between about 5 and 40 nucleotides in length. In some embodiments, the target hybridization regions and/or regions of interest are between or between about 5 and 15 nucleotides in length. In some embodiments, the target hybridization regions and/or regions of interest are between or between about 15 and 20 nucleotides in length. In some embodiments, the target hybridization regions and/or regions of interest are between or between about 20 and 25 nucleotides in length. In some embodiments, the target hybridization regions and/or regions of interest are between or between about 25 and 30 nucleotides in length. In some embodiments, the target hybridization regions and/or regions of interest are between or between about 30 and 35 nucleotides in length. In some embodiments, the target hybridization regions and/or regions of interest are between or between about 25 and 30 nucleotides in length. In some embodiments, the target hybridization regions and/or regions of interest are between or between about 35 and 40 nucleotides in length. (Emphasis added)
If one were to use a probe that comprises 5 nucleotides, there are some 45,or 1,024 different sequences. If one were to use probes that are 40 nucleotides in length, there would be 440, or 1.2089 x 1024 different sequences to evaluate/screen. These sequences, be it a target or probes, are deemed to constitute essential material.1 At page 122, paragraph [0354] of the disclosure, applicant asserts:
SNPs for use in the present invention and their respective alleles may be derived from
any number of sources, such as public databases (U.C. Santa Cruz Human Genome Browser Gateway (genome.ucsc.edu/cgi-bin/hgGateway) or the NCBI dbSNP website (www.ncbi.nlm.nih gov/SNP/)… (Emphasis added)
As evidenced by 37 CFR 1.57(d), one cannot rely upon public databases for any purpose, including its being a source for nonessential material. So while applicant has provided two hyperlinks to public databases, such cannot be relied upon for satisfying the enablement and written description requirements of 35 USC 112(a).
While argument has been presented that one would know how to find a single probe sequence, and that such would constitute full enablement, it is noted that the claims are not limited to any specific sequence. Rather, the claimed method encompasses any sequence in any form of nucleic acid found in virtually any and all manner of life forms. In support of this position attention is directed to page 11, paragraph [0031], which provides the following definition for target nucleic acid. As disclosed therein:
[0031] In any of the preceding embodiments, the target nucleic acid can be a viral DNA, bacterial DNA, or cellular DNA or RNA molecule or a product thereof in the biological sample. In any of the preceding embodiments, the target nucleic acid can be genomic DNA, mitochondrial DNA, mRNA or cDNA. (Emphasis added)
Applicant, at page 28, paragraph [0083], asserts:
[0083] A sample disclosed herein can be or derived from any biological sample… In addition to the subjects described above, a biological sample can be obtained from a prokaryote such as a bacterium, an archaea, a virus, or a viroid. A biological sample can also be obtained from non-mammalian organisms ( e.g., a plant, an insect, an arachnid, a nematode, a fungus, or an amphibian). A biological sample can also be obtained from a eukaryote, such as a tissue sample, a patient derived organoid (PDQ) or patient derived xenograft (PDX). (Emphasis added)
It is well settled that an applicant must enable the full scope of that which is claimed. In support of this position attention is directed to 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)
While argument has been presented that one of skill in the art would know how to find/determine the sequences of target nucleic acids, there are limits to the amount of time permitted to perform the research and development such that the full scope of the claimed invention is achieved. In support of this position attention is directed to Cephalon, 1823:
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). Likewise, we have held that the amount of experimentation would be undue where: (1) the specification lacks guidance by teaching away from the subject matter that was eventually claimed; and (2) there is evidence of the patentee's own failures to make and use the later claimed invention at the time of the application. See, e.g., AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244 [68 USPQ2d 1280] (Fed. Cir. 2003)
To the degree that the “target nucleic acid” can be that found in humans, it is noted that the nucleotide sequence of the human Y chromosome was not determined and published until September 2023 (“The complete sequence of a human Y chromosome”, Nature, vol. 621, 14 September 2023, which is 1 year and 2 months after applicant’s priority date. Given such, applicant’s arguments that they had enabled the full scope of the claimed invention has not been found persuasive.
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 1, 4, 6, 9, 12, 22, 23, 25, 28, 30-31, 40-43, 52, 54, 56, 86, and 87 remain 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.
Claim Rejections - 35 USC § 101 (Utility) & 112 (Enablement)
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 6, 9, 12, 22, 23, 25, 28, 30, 31, 40-48, 52-54, 56, 86, and 87 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific, substantial, and credible asserted utility or a well-established utility.
Standard for Utility
Attention is directed to the decision in In re Langer (CCPA, 1974) 183 USPQ 288, at 297:
As a matter of Patent Office practice, a specification which contains a disclosure of utility which corresponds in scope to the subject matter sought to be patented must be taken as sufficient to satisfy the utility requirement of § 101 for the entire claimed subject matter unless there is reason for one skilled in the art to question the objective truth of the statement of utility or its scope. Assuming that sufficient reason to question the statement of utility and its scope does exist, a rejection for lack of utility under § 101 will be proper on that basis; such a rejection can be overcome by suitable proofs indicating that the statement of utility and its scope as found in the specification are true. Cf. In re Marzocchi, 58 CCPA 1069, 1073, 439 F.2d 220, 223, 169 USPQ 367, 369 (1971) (involving the enablement requirement of 35 U.S.C. 112, first paragraph). (Emphasis added)
Attention is also directed to MPEP 2107.02 I [R-07.2022], which states in part:
The claimed invention is the focus of the assessment of whether an applicant has satisfied the utility requirement. Each claim (i.e., each “invention”), therefore, must be evaluated on its own merits for compliance with all statutory requirements… Only where it can be established that other species clearly encompassed by the claim do not have utility should a rejection be imposed on the generic claim. In such cases, the applicant should be encouraged to amend the generic claim so as to exclude the species that lack utility. (Emphasis added)
Attention is also directed to MPEP 2106 II [R-10.2019], which states in part:
A claim whose BRI covers both statutory and non-statutory embodiments embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step (Step 1: NO) and should be rejected under 35 U.S.C. 101, for at least this reason. (Emphasis added)
Attention is also directed to MPEP 2107.01 I [R-07.2022], which states in part:
Specific Utility
A "specific utility" is specific to the subject matter claimed and can "provide a well-defined and particular benefit to the public." In re Fisher, 421 F.3d 1365, 1371, 76 USPQ2d 1225, 1230 (Fed. Cir. 2005). This contrasts with a general utility that would be applicable to the broad class of the invention. Office personnel should distinguish between situations where an applicant has disclosed a specific use for or application of the invention and situations where the applicant merely indicates that the invention may prove useful without identifying with specificity why it is considered useful. For example, indicating that a compound may be useful in treating unspecified disorders, or that the compound has "useful biological" properties, would not be sufficient to define a specific utility for the compound. See, e.g., In re Kirk, 376 F.2d 936, 153 USPQ 48 (CCPA 1967); In re Joly, 376 F.2d 906, 153 USPQ 45 (CCPA 1967). Similarly, a claim to a polynucleotide whose use is disclosed simply as a "gene probe" or "chromosome marker" would not be considered to be specific in the absence of a disclosure of a specific DNA target. See In re Fisher, 421 F.3d at 1374, 76 USPQ2d at 1232 ("Any EST [expressed sequence tag] transcribed from any gene in the maize genome has the potential to perform any one of the alleged uses…. Nothing about [applicant’s] seven alleged uses set the five claimed ESTs apart from the more than 32,000 ESTs disclosed in the [ ] application or indeed from any EST derived from any organism. Accordingly, we conclude that [applicant] has only disclosed general uses for its claimed ESTs, not specific ones that satisfy § 101."). A general statement of diagnostic utility, such as diagnosing an unspecified disease, would ordinarily be insufficient absent a disclosure of what condition can be diagnosed. Contrast the situation where an applicant discloses a specific biological activity and reasonably correlates that activity to a disease condition. Assertions falling within the latter category are sufficient to identify a specific utility for the invention. Assertions that fall in the former category are insufficient to define a specific utility for the invention, especially if the assertion takes the form of a general statement that makes it clear that a "useful" invention may arise from what has been disclosed by the applicant. Knapp v. Anderson, 477 F.2d 588, 177 USPQ 688 (CCPA 1973).
B. Substantial Utility
"[A]n application must show that an invention is useful to the public as disclosed in its current form, not that it may prove useful at some future date after further research. Simply put, to satisfy the ‘substantial’ utility requirement, an asserted use must show that the claimed invention has a significant and presently available benefit to the public." Fisher, 421 F.3d at 1371, 76 USPQ2d at 1230. The claims at issue in Fisher were directed to expressed sequence tags (ESTs), which are short nucleotide sequences that can be used to discover what genes and downstream proteins are expressed in a cell. The court held that "the claimed ESTs can be used only to gain further information about the underlying genes and the proteins encoded for by those genes. The claimed ESTs themselves are not an end of [the inventor’s] research effort, but only tools to be used along the way in the search for a practical utility…. [Applicant] does not identify the function for the underlying protein-encoding genes. Absent such identification, we hold that the claimed ESTs have not been researched and understood to the point of providing an immediate, well-defined, real world benefit to the public meriting the grant of a patent." Id. at 1376, 76 USPQ2d at 1233-34). Thus a "substantial utility" defines a "real world" use. Utilities that require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use are not substantial utilities. For example, both a therapeutic method of treating a known or newly discovered disease and an assay method for identifying compounds that themselves have a "substantial utility" define a "real world" context of use. An assay that measures the presence of a material which has a stated correlation to a predisposition to the onset of a particular disease condition would also define a "real world" context of use in identifying potential candidates for preventive measures or further monitoring. On the other hand, the following are examples of situations that require or constitute carrying out further research to identify or reasonably confirm a "real world" context of use and, therefore, do not define "substantial utilities":
(A) Basic research such as studying the properties of the claimed product itself or the mechanisms in which the material is involved;
(B) A method of treating an unspecified disease or condition;
(C) A method of assaying for or identifying a material that itself has no specific and/or substantial utility;
(D) A method of making a material that itself has no specific, substantial, and credible utility; and
(E) A claim to an intermediate product for use in making a final product that has no specific, substantial and credible utility.
Office personnel must be careful not to interpret the phrase "immediate benefit to the public" or similar formulations in other cases to mean that products or services based on the claimed invention must be "currently available" to the public in order to satisfy the utility requirement. See, e.g., Brenner v. Manson, 383 U.S. 519, 534-35, 148 USPQ 689, 695 (1966). Rather, any reasonable use that an applicant has identified for the invention that can be viewed as providing a public benefit should be accepted as sufficient, at least with regard to defining a "substantial" utility.
Rationale.
For convenience, claims 1 and 56, the only independent claims pending, are reproduced below.
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As is evidenced above, claims 1, 4, 6, 9, 12, 22, 23, 25, 28, 30, 31, 40-43, 52, 54, 86, and 87 are drawn to “a method for detecting a region of interest in a target nucleic acid”.
Claim 56 is drawn to “a method for analyzing a biological sample comprising a plurality of target RNA molecules comprising a single nucleotide of interest”.
Applicant, at page 11, paragraph [0031], provides the following definition for target nucleic acid. As disclosed therein:
[0031] In any of the preceding embodiments, the target nucleic acid can be a viral DNA, bacterial DNA, or cellular DNA or RNA molecule or a product thereof in the biological sample. In any of the preceding embodiments, the target nucleic acid can be genomic DNA, mitochondrial DNA, mRNA or cDNA. (Emphasis added)
Applicant, at page 28, paragraph [0083], asserts:
[0083] A sample disclosed herein can be or derived from any biological sample… In addition to the subjects described above, a biological sample can be obtained from a prokaryote such as a bacterium, an archaea, a virus, or a viroid. A biological sample can also be obtained from non-mammalian organisms ( e.g., a plant, an insect, an arachnid, a nematode, a fungus, or an amphibian). A biological sample can also be obtained from a eukaryote, such as a tissue sample, a patient derived organoid (PDQ) or patient derived xenograft (PDX). (Emphasis added)
As evidenced above, the target nucleic acid can be any mRNA or cDNA molecule found in or derived from any form of “biological sample” from any eukaryotic or prokaryotic source. Such breadth of scope has been construed as encompassing the expressed sequence tags or ESTs at issue in Fisher, and which were held to lack a specific and substantial utility.
The claims do not require that the nucleic acid to ultimately be detected even be known at the time of filing, much less require that it be useful under 35 USC 101. Brenner, Comr. Pats. v. Manson, 148 USPQ 689 (U.S. 1966). The case at hand is deemed to be analogous to that set forth in MPEP 2107.01 I B (C), supra, which teaches that “[a] method of assaying for or identifying a material that itself has no specific and/or substantial utility” is not considered to have a substantial utility.
For "specific utility", the invention must have a utility specific to the subject matter claimed in contrast with a general utility that would be applicable to the broad class of the invention. According to 35 U.S.C. 101, a specific utility is not a list of potential applications for which the broad class of the invention would also have utility.
While nucleic acids, which satisfy the utility requirements of 35 USC 101, were known at the time of filing, such narrowing limitations have not been read into the claims. See MPEP 2111.01 and Superguide.
Applicant is urged to consider amending the claims such that the claims are drawn to those nucleic acids that unquestionably do have utility under 35 USC 101 and which are adequately supported by the original disclosure.
Claims 1, 4, 6, 9, 12, 22, 23, 25, 28, 30, 31, 40-43, 52, 54, 56, 86, and 87 are also 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. Specifically, since the claimed invention is not supported by either a specific, substantial, and credible asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
Response to traversal
At pages 20-23 of the response applicant’s representative traverses the rejection of claims under 35 USC 101 for encompassing embodiments that lack a specific and substantial utility, and for not satisfying the enablement requirements of 35 USC 112(a). As seen at page 21 of the response attention is directed to passages of the specification. These arguments have been considered and have not been found persuasive. As noted above, the claimed method has been construed to encompass the detection of both a) sequences that do have utility under 35 USC 101, and b) sequences that do not have utility under 35 USC 101. In the later case, sequences such a mRNA and cDNA which do not have a known function were specifically identified.
While attention has been directed to Board decisions, attention is again directed to MPEP 2106 II [R-10.2019], which states in part:
A claim whose BRI covers both statutory and non-statutory embodiments embraces subject matter that is not eligible for patent protection and therefore is directed to non-statutory subject matter. Such claims fail the first step (Step 1: NO) and should be rejected under 35 U.S.C. 101, for at least this reason. (Emphasis added)
In view of the above analysis and in the absence of convincing evidence to the contrary, claims 1, 4, 6, 9, 12, 22, 23, 25, 28, 30, 31, 40-48, 52-54, 56, 86, and 87 remain rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific, substantial, and credible asserted utility or a well-established utility. Claims 1, 4, 6, 9, 12, 22, 23, 25, 28, 30, 31, 40-43, 52, 54, 56, 86, and 87 also remain 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.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.