DETAILED ACTION
Status of Claims
The amendment submitted February 13, 2026 has been entered.
Claims 1-19 are pending.
Claims 5-7, and 9-19 are withdrawn in the instant office action as explained below in the Election/Restriction section.
Claims 1-4 and 8 are under consideration in the instant office action as explained below in the Election/Restriction section
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 .
Election/Restrictions
Applicant's election with traverse of compound 36 as a species of Formula I, Acute flaccid myelitis as a species of a disease, disorder or symptom associated with a picornavirus and Picornavirus Enterovirus D68 (EV-D68) in the reply filed on February 13, 2026 is acknowledged.
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The elected species reads on claims 1-4 where X is N, Y is R5, R5 is hydrogen, R3 is methyl, A1 is aryl, L is NHCO, A2 is heteroaryl, and claim 8.
The traversal is on the ground(s) that Applicant disagrees the scope of Formula I would not present a serious search burden and that the restrictions will lead to duplicative searching and prosecution.
This is not found persuasive because as explained in the Requirement for Restriction/Election dated December 17, 2025, compounds of Formula I-II contain multiple classes of heterocyclic systems, and variations in sterics and electronics for substituents and ring substitutions patterns, which are each defined by a unique set of physical, chemical, and biological properties and require different preparation methods. It is well-known in the medicinal arts that small variations in sterics and electronics, and distinct chemical scaffolds can have significant effects on pharmacological properties.
The Examiner disagrees that the restrictions will lead to duplicative searching, with Applicant’s assertion that there is a limited number of variables, and also that Formula I contains a common structural scaffold. Such assertion is inaccurate from a chemistry perspective and assessing the limitations of claim 1.
By example only, considering the option with X is CR5 and Y is CR5R6 compared to X is N and Y is O creates the difference between searching for carbocyclic vs heterocyclic motifs. For just considering the options for X and Y for Formula I, the permutations would force searching of more than one type of heterocyclic family, each of which would be different and distinct classifications such as C07D 263/52 for benzoxazole, C07D 277/62 for benzothiazole, etc. This does not include the variations on the A1 ring, linker and A2 ring.
For the diseases, disorders and symptoms, the Examiner provided citations from Zell regarding the significant divergence in etiology, pathology, distinct and different patient populations and treatment plans. This is just for the context of the virus, and does not include the breadth of treating a disease vs a disorder vs a symptom.
Specifically, by example only, Zell comments that “Although the vast majority of picornavirus infections remain asymptomatic, many picornaviruses are important human and animal pathogens and cause diseases that affect the central nervous system, the respiratory and gastrointestinal tracts, heart, liver, pancreas, skin and eye. A stunning increase in the number of newly identified picornaviruses in the past decade has shown that picornaviruses are globally distributed and infect vertebrates of all classes. Moreover, picornaviruses exhibit a surprising diversity of both genome sequences and genome layouts, sometimes challenging the definition of taxonomic relevant criteria. At present, 35 genera comprising 80 species and more than 500 types are acknowledged. Fifteen species within five new and three existing genera have been proposed in 2017, but more than 50 picornaviruses still remain unassigned (Zell, Roland. "Picornaviridae—the ever-growing virus family." Archives of virology 163, no. 2 (2018): 299-317).”
Consequently, the requirement is still deemed proper and is therefore made FINAL.
Claims 5-7, and 9-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 13, 2025.
Claims 1-4 and 8 are under consideration and the subject of this Office Action.
Information Disclosure Statement
One information disclosure statements (IDS) submitted on October 3, 2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
Claim Objections
Claim 4 is objected to because of the following informalities: at claim 4, line 2 “wherein there 0, 1, 2, 3, or 4 N groups” should read as wherein there are 0, 1, 2, 3, or 4 N groups. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 8 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.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.01 (a).
Upon consideration of the factors discussed below, the examiner concludes that one skilled in the art could not practice the invention without being burdened with undue experimentation based on the information provided by the applicant.
A discussion of these factors they relate to the pending claims follows.
Breadth of Claims and Nature of the Invention
Claims 1-4 and 8 are directed to methods “of treating or preventing a disease or disorder, or a symptom associated with a picornavirus infection in a subject, the method comprising providing and administering a therapeutically effective amount of a compound of Formula I, and specifically “wherein the method is effective in treating, preventing, or ameliorating the disease or disorder associated with a picornavirus infection, or at least one symptom of the disease or disorder associated with a picornavirus infection.”
As aforementioned, compounds of Formula I are incredibly broad and contain multiple classes of heterocyclic and carbocylic systems, and variations in sterics and electronics for substituents and ring substitutions patterns, which are each defined by a unique set of physical, chemical, and biological properties. It is well-known in the medicinal arts that small variations in sterics and electronics, and distinct chemical scaffolds can have significant effects on pharmacological properties, including drug delivery, metabolism, activity, etc.
Consequently, it is reasonable to conclude the claims are broad with respect to pharmacological agent.
On page 72, paragraph [0156], Application defines “As used herein, the term "administering" or "providing" means the actual physical introduction of a composition into or onto (as appropriate) a subject, a host or cell. Any and all methods of introducing the composition into the subject, host or cell are contemplated according to the invention; the method is not dependent on any particular means of introduction and is not to be so construed. Means of introduction are well-known to those skilled in the art, and also are exemplified herein. It also means giving, administering, selling, distributing, transferring (for profit or not), manufacturing, compounding, or dispensing.”
On page 73, paragraph [0159], Application defines “As used herein, the terms "treat," "treating," and "treatment" include inhibiting the pathological condition, disorder, or disease, e.g., arresting or reducing the development of the pathological condition, disorder, or disease or its clinical symptoms; or relieving the pathological condition, disorder, or disease, e.g., causing regression of the pathological condition, disorder, or disease or its clinical symptoms. These terms also encompass therapy and cure. Treatment means any way the symptoms of a pathological condition, disorder, or disease are ameliorated or otherwise beneficially altered. Preferably, the subject in need of such treatment is a mammal, preferably a human.”
Consequently, it is reasonable to conclude the claims are broad with respect to the goal of treating, preventing and ameliorating.
On page 74, paragraph [0162], Application defines “[0162] The term "subject" or "patient" is used herein to refer to an animal, such as a mammal, including a primate (such as a human, a non-human primate, e.g., a monkey, and a chimpanzee), a non-primate (such as a cow, a pig, a camel, a llama, a horse, a goat, a rabbit, a sheep, a hamster, a guinea pig, a cat, a dog, a rat, a mouse, and a whale), a bird (e.g., a duck or a goose), and a shark. In an embodiment, the subject is a human, such as a human being treated or assessed for a disease, disorder or condition, a human at risk for a disease, disorder or condition, a human having a disease, disorder or condition, and/or human being treated for a disease, disorder or condition as described herein. In some embodiments, the subject does not suffer from an ongoing autoimmune disease. In one embodiment, the subject is about 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 years of age. In another embodiment, the subject is about 5-10, 10-15, 15-20, 20-25, 25- 30, 30-35, 35-40, 40-45, 45-50, 50-55, 55-60, 60-65, 65-70, 70-75, 75-80, 80-85, 85-90, 90-95, 95-100 years of age. Values and ranges intermediate to the above recited ranges are also intended to be part of this invention. In addition, ranges of values using a combination of any of the above-recited values as upper and/or lower limits are intended to be included.”
Consequently, it is reasonable to conclude the claims are broad with respect to subject, species, and patient population, including pediatric patients.
On page 1, paragraph [003], Applicant describes “Picornaviruses make up the family Picornaviridae, which is in the order Picornavirales and realm Riboviria. Of note, the Picornavirales order constitutes a group of positive-strand RNA viruses that are characterized by a set of highly conserved genes, including nonstructural protein 2C, which is an ATPase. Picronaviruses comprise a major group of viruses and include several important pathogens of humans and animals, and include the notable genera Enterovirus, which includes Rhinovirus and Poliovirus), Aphthovirus, Cardiovirus, and Hepatovirus A. Enteroviruses (EVs) comprise a major group of viruses within the family of picornaviruses. EVs are small, non-enveloped, single stranded positive sense RNA viruses forming a genus within the Picornaviridae family. Seven out of fifteen species of enteroviruses are human pathogens that cause a myriad diseases of the skin, respiratory, circulatory and nervous systems. Enterovirus A71 (EV-A71) is one of the common causative agents of hand-foot-and-mouth disease. Although predominantly a disease in children, this can also affect adults and pose a serious threat to immunocompromised people. In a relatively small number of infections, EV-A71 can lead to more serious complications such as meningitis, encephalitis and acute flaccid myelitis and in the Asia-Pacific region, EV-A71 outbreaks have had an overall mortality rate of 0.5 to 19 %. The related EV-D68 is responsible for acute flaccid myelitis outbreaks in multiple countries, including the USA, where there have been 682 confirmed cases since 2014. Poliovirus causes paralytic poliomyclitis and although almost eradicated, it still poses a threat due to the reversion of vaccine-derived poliovirus to pathogenic virus shed by people immunized with these vaccines. There are no Federal Drug Administration (FDA) approved drugs available against these viruses and there is an unmet clinical need for broad-spectrum anti-viral agents that show activity against enteroviruses. Such broad-acting drugs would relieve the need to identify the specific virus and facilitate treatment for acute infections that have a relatively small therapeutic window.”
Applicant themselves admits to date there are no antiviral drugs available against these viruses and illustrates the wide diversity of viral infections, diseases, disorders and symptoms encompassed by the scope of instant invention.
As explained above by Zell, “…picornaviruses exhibit a surprising diversity of both genome sequences and genome layouts, sometimes challenging the definition of taxonomic relevant criteria. At present, 35 genera comprising 80 species and more than 500 types are acknowledged. Fifteen species within five new and three existing genera have been proposed in 2017, but more than 50 picornaviruses still remain unassigned (Zell, Roland. "Picornaviridae—the ever-growing virus family." Archives of virology 163, no. 2 (2018): 299-317).”
Zell further explains that “It is likely that the number of picornavirus structures will substantially increase in the near future and improve our knowledge of virus capsids, interaction of viruses with certain antivirals or their receptors, or RNA penetration. Tools have to be established to isolate and propagate in cell culture those viruses which are known only from their sequences. Presently, there is a frustrating disparity in our capabilities of virus isolation and genome sequencing. Without viruses at hand, biochemical and other molecular analyses are hampered.”
Consequently, picornaviruses are a broad heterogenous class of viruses, many of which are unknown and unassigned, and in fact are presently challenged by technological limitations. It is therefore unreasonable to conclude one could cure or provide treatment for viruses that are unknown and challenging to classify,
Additionally, it is well-known in the art of virology that viruses are not homogenous entities and are incredibly diverse with respect to genetic makeup, structure, replication mechanism, host interactions, and other factors.
Jones et al. explains that “Viral heterogeneity poses a difficult challenge for medicine. Adequate medical interventions are still lacking for many viral infections, particularly the ones discussed in this Review (Jones, Jennifer E., Valerie Le Sage, and Seema S. Lakdawala. "Viral and host heterogeneity and their effects on the viral life cycle." Nature Reviews Microbiology 19, no. 4 (2021): 272-282).”
Jones further explains “Current technologies make it easier than ever before to screen thousands of compounds for efficacy against viral infection and rapidly identify potential new therapeutic candidates. Nevertheless, these results should be interpreted with caution. A given virus may exhibit extraordinary diversity in genomic content and particle morphology, so candidate therapeutics must be pan-protective against a heterogeneous viral population.”
Consequently, it is reasonable to conclude the claims are broad with respect to disease, disorder or symptom associated with picornavirus.
In summary, it is reasonable to conclude that the claims are broad with respect to compound of Formula 1, goal of treating, preventing and ameliorating, disease, disorder and symptom, virus and subject.
The state of the prior art
The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed. See MPEP § 2164.05(b). See Pac. Biosciences of Cal., Inc. v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir. 2021).
The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification. See MPEP § 2164.05 (a).
Applicant’s invention is directed towards methods for preventing or treating a disease, disorder or symptom associated with a picornavirus.
There is no known antiviral present in the art capable of treating and preventing all picornaviruses in all species, including humans. In fact, many viruses do not have treatment or prevention options.
Lee explains that “Enteroviruses, a diverse genus within the Picornaviridae family, are responsible for a wide range of human infections, including hand, foot, and mouth disease, respiratory disease, aseptic meningitis, encephalitis, myocarditis, and acute flaccid paralysis. Despite their substantial global health burden and the frequent emergence of outbreaks, no specific antiviral therapies are currently approved for clinical use against non-polio enteroviruses (Lee, M.F., Tham, S.K. and Poh, C.L., 2025. Antiviral strategies targeting enteroviruses: current advances and future directions. Viruses, 17(9), p.1178).”
Lee further explains that “Despite increasing recognition of EVs as significant human pathogens, particularly EV-D68, which has been associated with outbreaks of acute flaccid myelitis (AFM), there are still no approved antiviral therapies. While several compounds such as Rupintrivir, Enviroxime, and Pleconaril have shown efficacy against EV-D68 in vitro, they have not progressed to clinical application [272]. The lack of approved treatments is partly due to the rarity and unpredictable nature of EV-D68, causing severe infections, making it difficult to conduct well-planned randomized controlled trials. The sporadic and geographically dispersed pattern of outbreaks further complicated efforts to systematically evaluate potential therapies.”
Consequently, Lee illustrates the lack of approved antiviral therapies and specific challenges of unpredictability associated with EV-D68.
Lee further explains that “A key limitation in the past was the absence of reliable animal models for studying EV-D68 pathogenesis and therapeutic responses…. These challenges are not limited to EV-D68. Other clinically relevant EVs, such as EV-A71 and CV-B3, also face comparable hurdles in the development of effective therapeutics. One major obstacle is the inconsistent manifestation of disease in animal models. For example, EV-A71 infection in neonatal mice often fails to replicate hallmark features of severe human disease, such as brainstem encephalitis, neurogenic pulmonary edema, or limb paralysis [275]. Similarly, CV-B3-induced myocarditis in mice is highly strain- and age-dependent, with common outcomes like pancreatitis that are not typically seen in human patients, thereby reducing the translational value of these models. Reproducing the full clinical spectrum—including acute neurological or cardiac complications—remained a significant challenge. Although the use of neonatal animals, genetically modified mice, or virus-adapted strains has improved model sensitivity and enabled the study of specific disease mechanisms, these approaches still fall short in recapitulating the complex pathophysiology observed in humans. Moreover, many models only represent the acute phase of infection, lacking the capacity to study long-term complications or chronic sequelae.”
Consequently, Lee illustrates the challenges in developing reliable animal models, and limitations in translation from in vitro to in vivo including assess long-term complications. It is therefore not viable to conclude an antiviral such as instant invention would be effective in curing the broad range of diseases in all subjects as claimed based on the current state of the art and challenges presently faced.
Lee explains “In conclusion, while important advances have been made in modeling EV infections and identifying candidate antivirals, numerous challenges persist. These include the infrequent occurrence of severe disease outcomes across various EV serotypes, the need for validated and standardized animal models that could reflect diverse disease manifestations, and the difficulty of translating promising in vitro results into clinical success.”
Lee explains “EVs represent a significant public health burden due to their wide range of clinical manifestations, from mild febrile illness to severe neurological and cardiac complications. Despite substantial research efforts, there are still no approved antiviral therapies targeting EV infections. This therapeutic gap is largely driven by challenges such as high viral mutation rates, limited broad-spectrum efficacy, and poor translation from in vitro studies to effective in vivo outcomes.”
Therefore, it is not reasonable to conclude that the broad genus of compounds of Formula I would be predicted to generally treat and prevent all picornaviruses, diseases, disorders and symptoms associated with a picornavirus in all subjects as claimed based on the broad definition of “treating”,“preventing,” and “ameliorating.”
Therefore, it is reasonable to conclude that the current state of the art is highly unpredictable, indicating that more details, working examples and guidance would be required to practice the invention as disclosed for the full scope of invention.
(D) The level of one of ordinary skill
The person of ordinary skill in the art is a hypothetical person who is presumed to have known the relevant art at the relevant time. Factors that may be considered in determining the level of ordinary skill in the art may include: (A) "type of problems encountered in the art;" (B) "prior art solutions to those problems;" (C) "rapidity with which innovations are made;" (D) "sophistication of the technology; and" (E) "educational level of active workers in the field. In a given case, every factor may not be present, and one or more factors may predominate." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121 (Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955, 962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983). See MPEP § 2141.03 (I)
The invention described pertains to medicine and pharmacology. One of ordinary skill would be a person with training in medicine, veterinary medicine, virology, pharmacology, biochemistry or a related technical discipline.
(E) The level of predictability in the art
The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling.
The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required. A single embodiment may provide broad enablement in cases involving predictable factors, such as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ 122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA 1971). However, in applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. See MPEP § 2164.03.
Consequently, technologies involving physiological activity as opposed to mechanical or electrical inventions are generally regarded as being unpredictable sciences.
As aforementioned, there are numerous viruses that diverge based on viral and genomic structures, populations susceptible to infection, disease severity, seasonality of circulation, transmissibility, modes of transmission, and treatment options, including picornaviruses.
There is to date no general pharmacological agent known to treat and prevent all picornaviruses known in addition to picornaviruses that are unknown or challenging to diagnose.
Additionally, picornaviruses face unique challenges in unpredictability associated with the viruses, in having reliable animal models and in translating from in vitro to in vivo, including monitoring long-term effects and chronic conditions.
Based on these cumulative factors, it is reasonable to conclude that predictability in the art is extremely low.
Consequently, the applicant would need to provide more details, working examples and guidance in order for the claimed invention to be enabling based on the scope and nature of the claimed invention.
The existence of working examples
The applicants’ working examples are directed towards:
In silico screen to identify potential 2C inhibitors using partial crystal structure of enterovirus A71 (EV-A71) 2C (page 39, paragraph [0069]).
In vitro studies of two compounds showing in vitro 2C ATPase inhibition and EV-A71 inhibition (page 40, paragraph [0070]).
Antiviral activity of six active compounds against EV-A71 (page 45, Table 6).
Cell-based assay against EV-A71 in Vero cells (page 45, paragraph [0074]).
Analogs inhibiting virus-induced cellular cytopathic effect (Table 8, page 49).
Test of antiviral activity of compound 36 (only active against EV-71 and EV-68)(page 56, Table 14).
Applicant has failed to provide working examples and key details encompassing the diverse range of viruses and subjects claimed, including providing working examples representative for the diversity of viruses, patient populations, and goal of virus treatment, prevention and curing.
On this basis and the prior discussion, the working examples are both not commensurate with the scope of protection sought and are not enabling. One ordinarily skilled in the art would be unable to simply translate the evidence provided by the applicant without undue experimentation across the full scope of the instant invention.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
As aforementioned, the quantity of experimentation depends on the prior art, the predictability of the art, and the direction provided by the inventor, which are factors that were already discussed.
In order for one ordinarily skilled in the art to practice the invention as disclosed, some attributes one would require, but are not limited to:
Studies supporting that the diverse genus of compounds is active and effective against the broad range of diseases, disorders and symptoms associated with picornavirus.
Translation of in vitro into in vivo studies, and long-term studies demonstrating the compounds can cure and prevent the diseases, disorders and symptoms as claimed.
Data supporting translation across the broad range of subjects (i.e: humans, mammals, infants, elderly) particularly related to dosing, treatment regimen, and long-term and chronic affects.
Consequently, the examiner concludes that one ordinarily skilled in the art would require undue experimentation in order to practice invention based on the details provided and scope of invention defined in Claims 1-4 and 8.
Therefore, Claims 1-4 and 8 are rejected for lacking enablement commensurate with the scope of the claims.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 and 8 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.
There are numerous instances in claims 1-2 where a limitation is followed by an example in parentheses such as “(such as a monocyclic aryl or bicyclic aryl).”
For instance, claim 1 at lines 10-11, recites “A₁ and A₂ are each independently an aryl (such as a monocyclic aryl or bicyclic aryl), a heteroaryl (such as a monoheteroaryl or bicyclic heteroaryl), an aryloxy (such as phenoxy).”
The phrases "such as” and use of parentheses render the claims indefinite because it is unclear whether the limitations following the phrase and in the parentheses are part of the claimed invention. The examiner has only provided selected instances; however, requests Applicant to assist in correcting all instances accordingly.
As per MPEP § 2173.05(d), “description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim.”
Claims 3-4 are likewise rejected for failing to remedy the ambiguities.
Claim 8 recites the claim limitation “wherein the compound is selected from compounds 1-50,” which incorporates a reference to the specification.
“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).” See MPEP § 2173.05(s).
Therefore, Claims 1-4 and 8 are rejected as being indefinite.
Conclusion
Claims 1-4 and 8 are under consideration and are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN L. LADD whose telephone number is (703)756-5313. The examiner can normally be reached M-Th, 7:00 am to 5:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H. Alstrum-Acevedo can be reached at 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.L.L./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
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