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 .
DETAILED ACTION
The office acknowledges Applicants filing of the claims on 5/21/2024. Claims 1-26 are pending and are examined based on the merits herein.
Application Priority
This application filed 05/21/2024 is a National Stage entry of PCT/CN2022/ 113807, International Filing Date, 08/22/2022, claims foreign priority to 202111069990.0, filed 09/13/2021.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 7/2/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents" of the University of California v. Eli Lilly & Co. the court stated:
"A written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula, [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of Califorrnia v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP states that for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP § 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP § 2163. Although the MPEP does not define what constitute a sufficient number of representative species, the courts have indicated what do not constitute a representative number of species to adequately describe a broad genus. In Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872, F.2d at 1012, 10 USPQ2d at 1618.
The Guidelines for Examination of Patent Applications Under 35 USC 112, "Written Description" Requirement (Federal Register, Vol. 66, No. 4, pg. ll05, column 3), in accordance with MPEP § 2163, specifically state that for each claim drawn to a genus the written description requirement may be satisfied through sufficient description of a representative number of species by a) actual reduction to practice; b) reduction to drawings or structural chemical formulas; c) disclosure of relevant, identifying characteristics (i.e. structure) by functional characteristics coupled with a known or disclosed correlation between function and structure. The analysis of whether the specification complies with the written description requirement calls for the examiner to compare the scope of the claim with the scope of the description to determine whether applicant has demonstrated possession of the claimed invention (Federal Register, Vol. 66, No. 4, p. ll05, 3rd column, 3rd paragraph). Below is such comparison.
Scope of claims: The scope is very broad in regards to the central nervous system disorders to be treated, to the additional pharmaceutical agents to be administered and to the subject types.
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Scope of disclosure and reduction to practice:
As per the specification,
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The CNS disorders include but not limited to neurotoxicity and/or neurotrauma, stroke, multiple sclerosis, spinal cord injury, epilepsy, a mental disorder, a sleep condition, a movement disorder, nausea and/or emesis, amyotrophic lateral sclerosis, Alzheimer's disease, Parkinson's disease, or drug addiction, wherein the neurotoxicity and/or neurotrauma includes: traumatic brain injury (TBI), stroke, epilepsy, multiple sclerosis, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis, or Alzheimer's disease, wherein the mental disorder includes depression, anxiety or anxiety- related conditions, a learning disability, or schizophrenia, the sleep condition includes: insomnia, narcolepsy, sleep apnea, restless legs syndrome (RLS), delayed sleep phase syndrome (DSPS), periodic limb movement disorder (PLMD), hypopnea syndrome, rapid eye movement behavior disorder (RBD), shift work sleep condition (SWSD), or sleep problems (e.g., parasomnias) such as nightmares, night terrors, sleep talking, head banging, snoring, or clenched jaw and/or grinding of teeth (bruxism1), the movement disorder includes Parkinson's disease, levodopa- induced dyskinesia, huntington’s disease, Gilles de laTourette's syndrome, tardive dyskinesia, or dystonia etc. (see claims). However the conditions as claimed (claims 1 and 14) are not limited to the above conditions. It includes infections, autoimmune disorders, CNS tumors etc.
The specification teach ‘“Anxiety” includes, but is not limited to anxiety and anxiety-related conditions, such as, for example, clinical anxiety, panic disorder, agoraphobia, generalized anxiety disorder, specific phobia, social phobia, obsessive-compulsive disorder, acute stress disorder, post-traumatic stress disorder, adjustment disorders with anxious features, anxiety disorder associated with depression, anxiety disorder due to general medical conditions, and substance-induced anxiety disorders, anxiety associated with drug addiction (e.g., withdrawal, dependence, reinstatement) and anxiety associated with nausea and/or emesis’ [00148].
In summary, the scope of the CNS conditions to be treated is very large. Further claims 13 and 26 recite the limitation of further administering an additional pharmaceutical agent.
Representative number of Examples:
The data provided is limited to the inhibitory effects of compounds (I), (II) and (III) of TYK2, JAK1, JAK3 and JAK3 (Table 1); inhibition of LPS induced neuronal cell death and inflammatory cytokine production; tests showing that compounds of formula II and III penetrate the blood brain barrier in rats and mice (examples 6-7). The instant specification teach that Myelin Oligodendrocyte Glycoprotein Induced Experimental Autoimmune Encephalomyelitis Model is one of the most common and widely used animal models for multiple sclerosis, which is a chronic inflammatory disease in the central nervous system that is characterized by axon demyelination and degeneration (See p 65, Example 8). The specification provide data for in vivo efficacy evaluation of Efficacy Evaluation in a Myelin Oligodendrocyte Glycoprotein Induced Experimental Autoimmune Encephalomyelitis.
Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, "the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved". See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
Central nervous system (CNS) disease is a broad category of conditions in which the brain does not function as it should, limiting health and the ability to function. The condition may be an inherited metabolic disorder; the result of damage from an infection, a degenerative condition, stroke, a brain tumor or other problem; or arise from unknown or multiple factors (See International Neuromodulation Society, 2023). Central nervous system disease is a type of nervous system disease that seriously affects the structure and function of the brain or spinal cord, and it seriously leads to functional deficits. CNS disorders include the conditions listed in the instant specification but also infections, autoimmune disorders, CNS tumors, structural disorders, seizures etc.
For example, infectious diseases of the CNS include a wide spectrum of infections caused by various pathogens affecting one or more of these components as well as the spaces between these components. Different components or compartments of the CNS are affected circumstantially; each of the disease entities will have different imaging pattern and characteristics according to their different transmission routes, locations and appearance, i.e. meningitis, brain abscess, septic emboli, spinal epidural empyema and osteomyelitis (OM). Despite the advances of modern medicine, accurate diagnoses of a specific disease entity of the CNS infections have proven to be very challenging as their clinical presentations are very general and nonspecific, such as fever, headaches, weakness, numbness or back pain (see Introduction, p 2227). Table 1 lists some of the common infectious diseases associated with CNS (Li, Quantitative Imaging in Medicine and Surgery, See pages 2253-2255, 2020).
There is a substantial variation within the genus of the CNS disorders to be treated. From the data provided in the specification or from the prior art one of ordinary skill in the art cannot predict that the compounds of formula I, II or III will treat all the claimed CNS conditions. A skilled artisan would not be able to extrapolate from the data provided to treating every CNS condition. A skilled artisan has to learn about the pathophysiology underlying any particular disorder before a rational approach to treatment can be attempted. The difficulties inherent in experimentation and enormous gulf exists between the discovery of widely diverse effects of a drug one skilled in the art cannot predict the outcome from the data provided or from the prior art teachings that the compounds of formula I, II or III will provide therapeutic benefits to all unrelated conditions, for e.g. Alzheimer’s and depression.
Applicants have failed to provide guidance or data or evidence as to how the skilled artisan would be able to extrapolate from the disclosure species to make and possibly use of the claimed invention. “A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F 3d at 923; Eli Lilly, 119 at 1568. Instead, the “disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.”
The specification provides insufficient written description to support the genus encompassed by the claim, Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521,222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.").
Thus, the specification fails to provide adequate written description for the use of the compounds or the composition of compounds of formula I, II and III in treating the CNS conditions as claimed and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the compounds and compositions of claim 1, including pharmaceutically acceptable salt, solvate, hydrate does not reasonably provide enablement for any prodrug as claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the
enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re
Wands, 8 USPQ2d1400 (Fed. Cir. 1988). Among these factors are: 1) nature of the invention; 2) scope or breadth of the claims; 3) relative level of skill possessed by one of
ordinary skill in the art; 4) state of, or the amount of knowledge in, the prior art; 5) level
or degree of predictability, or a lack thereof, in the art; 6) amount of guidance or
direction provided by the inventor; 7) presence or absence of working examples; and 8)
quantity of experimentation required to make and use the claimed invention based upon
the content of the supporting disclosure. While all of the factors have been considered,
only those required for a prima facie case are set forth below.
As stated in the MPEP 2164.01(a), “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’.” The court (In re Wands, 8 USPQ2d 1400 (1988)) established the following factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph:
(1)/(2) The nature of the invention & breadth of claims: The instant claims are to
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(3) The relative skill of those in the art:
The relative skill in the art is fairly high, with the typical practitioner having a medical degree and/or an advanced degree in the biochemical, chemistry or pharmaceutical-related arts.
(4) The state of the prior art :
The instant specification in page 8 describes, that the term "prodrug" refers to an agent, which is converted into the active polymer (the active parent drug) in vivo. Prodrugs are typically useful for facilitating the administration of the parent drug. An example, without limitation, of a prodrug would be a compound of the present invention, having one or more carboxylic acid moieties, which is administered as an ester (the "prodrug"). Such a prodrug is hydrolyzed in vivo, to thereby provide the free compound (the parent drug). The selected ester may affect both the solubility characteristics and the hydrolysis rate of the prodrug. It is noted that a prodrug is a compound that, following administration to a subject, is metabolized to pharmacologically active form of the administered compound’.
"Prodrug compound" means a derivative that is converted into a biologically active compound under physiological conditions in the living body, e.g. by oxidation, reduction, hydrolysis or the like, each of which is carried out enzymatically, or without enzyme involvement.
The state of the prodrug art is summarized by Wolff (Burger's Medicinal Chemistry and Drug Discovery, 5th Edition, Vol. I" Principles and Practice, pp. 975-977, 1995). The table on the left side of page 976 outlines the research program to be undertaken to find a prodrug. The second paragraph in section 10 and the paragraph spanning pages 976-977 indicate the low expectation of success. In that paragraph the difficulties of extrapolating between species are further developed. Since, the prodrug concept is a pharmacokinetic issue, the lack of any standard pharmacokinetic protocol discussed in the last sentence of this paragraph is particularly relevant. Banker (Modern Pharmaceutics, Third Edition and Expanded, pp. 451 and 596 (1996)) in the first sentence, third paragraph on page 596 states that “extensive development must be undertaken” to find a prodrug. A prodrug as defined by Bundgaard (Design of Prodrugs, 1985, Chapter 1) “is an inactive species, and therefore, once its job is completed, intact prodrug represents unavailable drug” (see page 1). Thus, an important requirement of prodrugs is that they be pharmacologically inactive.
(5) The predictability or unpredictability of the art: A prodrug as defined by Bundgaard “prodrug is an inactive species, and therefore, once its job is completed, intact prodrug represents unavailable drug” (see page 1, Design of Prodrugs, 1985, chapter 1). Thus, an important requirement of prodrugs is that they be pharmacologically inactive.
The scope of the term 'prodrugs' is quite broad. A state of the art reference, Silverman (Prodrugs and Drug Delivery Systems, The Organic Chemistry of Drug Design and Drug Action, pp. 352-399, 1992) teaches many strategies for making prodrugs. Among them are polymer-bound prodrugs (pages 369-374), acyclic prodrugs which form heterocyclic compounds in vivo (page 360), conjugates consisting of two or more drug molecules which are cleaved into active drug molecules (page 377), amine precursors which are converted to amines in vivo (page 358), and drugs bound to a carrier via a linker (page 374). In a clinical trial setting, it would require undue experimentation to determine whether a particular compound meets the criteria of a 'prodrug'.
The description of the synthesis and structures of compounds of claim 1 as in the instant case does not constitute a description of all prodrugs that might be metabolized to yield the claimed compounds in vivo. From the data in the specification, it is not possible to extrapolate information of how to make and use all the prodrugs claimed in the method of treatment.
(6) The amount of direction or guidance presented: The instant specification defines prodrug in [0098].
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However no direction or guidance of making or using the same in the method(s) is provided.
The amount of guidance or direction to enable an invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. MPEP 2164.03 (quoting In re Fisher, 427 F.2d 833, 839, 166 USPQ 18 24 (CCPA 1970). The specification does not disclose an example of a prodrug within the scope of the claims and the corresponding active compound.
(5) The presence or absence of working examples: Applicants provide support for the compounds of formula I, II and III. There is no data or evidence that any prodrug of claim 1 was synthesized and/or used in the instant method(s).
(8) The quantity of experimentation necessary: In the instant case, the application neither teaches how to make the claimed prodrugs nor discloses an example of a prodrug within the scope of the claims and the corresponding active compound. Therefore, the application clearly fails to provide a representative number of species of the widely divergent subject matter encompassed by the claimed prodrugs. Applicant's specification provides no guidance/working examples in making the prodrugs of the compounds of claim 1 and claim 14. Guidance to making and using of the prodrugs requires more than a mere statement that it is part of the invention; what is required is a description of the prodrug itself.
In a clinical trial setting, it would require undue experimentation to determine whether a particular compound meets the criteria of a 'prodrug'. It would require undue experimentation to make all the prodrugs of general formula I and use it in a method of treatment as claimed. It is not sufficient to define an invention solely by its principal property (i.e., it is a prodrug of the disclosed compound). In addition, naming a type of material generically known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material. Due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activity. One skilled in the art would need to determine whether any of these compounds would be toxic, have the necessary bioavailability to specific condition(s) to be treated. Therefore, it would require undue, unpredictable experimentation to practice the claimed invention. MPEP 2164.01 (a) states, "A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)."
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-4, 8, 14-17, 21 are rejected under 35 U.S.C. 103 as being unpatentable over Liang (IDS: WO 2020244348 A1, see English translation) in view of Fang (CN 111704617 A, English Translation attached).
Liang teach 2-[(2R,5S)-5-[2-methylfuro[3,2-b]imidazo[4,5-d]pyridin-1-yl]tetrahydropyran-2-yl]acetonitrile as a selective Jak1/TYK2 kinase inhibitor
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(See Abstract, claims). Liang teach pharmaceutical composition of the compound for use (see p 2, para 2, English translation).
Liang do not teach the use of the compound in the treatment of CNS disorders as claimed.
Fang teach JAK1/TYK2, TYK2/JAK1 inhibitor(s) can be used for treatment of multiple sclerosis (MS) (See p 2, Contents of the invention, English translation).
A person skilled in the art before the effective filing date of the invention would have found it obvious to use the compound of Liang (which is formula II of the instant claims) for treating a CNS disorder such as multiple sclerosis. A person skilled in the art would have been motivated to arrive at treating MS in a subject with a compound that is a TYK2/JAK1 inhibitor (e.g. compound of formula II) with a reasonable expectation of success and to provide therapeutic benefits. As to the composition of the agents in claim 14, it is noted that Thus claims 1, 3, 4, 14, 16, 17 would have been obvious over the combined prior art teachings. As to claims 2, 15 the compound being a TYK2/JAK1 kinase inhibitor is the property of the agent and further administration of the compound or its composition will result in the same effects of inhibiting TYK2/JAK1. As to claims 8, 21 multiple sclerosis is one of the CNS disorders claimed for treatment. Hence it is modulated by TYK2/JAK1.
Claims 13, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Liang (IDS: WO 2020244348 A1, see English translation) in view of Fang (CN 111704617 A, English Translation attached) and further in view of Hauser et al. (The American J of Medicine, 2020, p 1380-1390).
Liang and Fang as discussed above. The rejections above are incorporated herein.
The prior art do not teach additional pharmaceutical agent in the method.
Hauser review is to the treatment of multiple sclerosis. The reference teaches in Table 3 of approved therapies for MS treatment, for e.g. Siponimod (p 1386).
From Hauser a skilled artisan before the effective filing date of the invention would have found it obvious to use an agent such as Siponimod or any other agent in Hauser in combination with the compound or composition of Liang to treat MS. It is well known in the art to combine two agent useful to treat the same disorder, herein MS to derive synergistic or additive therapeutic benefits. A person skilled in the art would have been motivated to derive additional therapeutic benefits in the combination therapy by using additional therapeutic agent. Thus claims 13, 26 would have been obvious over the prior art teachings.
Claim Rejections - 35 USC § 112
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 5, 6, 18-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5 and 18 recite a limitation of ‘anxiety or anxiety-related conditions’. The specification teach ‘“Anxiety” includes, but is not limited to anxiety and anxiety-related conditions, such as, for example, clinical anxiety, panic disorder, agoraphobia, generalized anxiety disorder, specific phobia, social phobia, obsessive-compulsive disorder, acute stress disorder, post-traumatic stress disorder, adjustment disorders with anxious features, anxiety disorder associated with depression, anxiety disorder due to general medical conditions, and substance-induced anxiety disorders, anxiety associated with drug addiction (e.g., withdrawal, dependence, reinstatement) and anxiety associated with nausea and/or emesis’ [00148]. If anxiety-related conditions is anxiety, then it is not clear why both anxiety and the sub genus is claimed. In other words according to the specification anxiety includes anxiety-related conditions.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Appropriate correction is required.
Claims 6 and 19 recite a limitation of ‘such as’ (line 4), that is unclear by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989); Exparte Steigewald, 131 USPQ 74 (Bd. App. 1961); Exparte Hall, 883 USPQ 38 (Bd. App. 1948); and Exparte Hasche, 86 USPQ 481 (Bd. App. 1949). MPEP 2173.05(d). Clarification is required.
Claims 6 and 19 recite a limitation of e.g. (line 4), the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/ Primary Examiner, Art Unit 1627
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