DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-6, 9-15, 17-20, and 22-34 are pending. Claims 7, 8, 16, 21, 35, and 36 are cancelled.
Status of Priority
The present application claims the benefits of priority to U.S. Provisional Application No. 63/428,690, filed on November 29, 2022.
Election/Restriction
Examiner previously required a restriction of the claimed inventions. The requirement filed on February 12, 2026 is now withdrawn and the prosecution will continue with a first non-final office action on the merits addressing all pending claims.
Specification - Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class.
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 4 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Examiner’s note on novelty and nonobviousness
The two closest prior art are the following:
Daum et al. (Daum) (WO2014144710A1; published September 18, 2014.) and
Chatterjee et al. (Chatterjee) (Chatterjee, A. et al. Discovery of thienoquinolone derivatives as selective and ATP non-competitive CDK5/p25 inhibitors by structure-based virtual screening. Bioorganic and Medicinal Chemistry 2014, 6409-6421.)
Instant invention is novel and nonobvious with respect to Daum as explained below:
Daum teaches compositions and methods for treating or inhibiting a bacterial infection involving at least one antibiotic and a compound that potentiates the antibiotic activity of the antibiotic (abstract). One of the antibiotic potentiators disclosed by Daum is the following compound:
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(compound of formula VI in Daum; see para. 0010). Note that this compound is the same as instant compound 22 (see pg. 36 of instant specification). However, this compound is NOT a compound of instant claim 1 (see proviso statement at the end of claim 1).
As stated above, the compound of formula VI in Daum is disclosed to be an antibiotic potentiator. Daum does not teach nor suggest the use of this compound (i.e., instant compound 22) for:
treating a disease or disorder modulated, at least in part, by MutSβ, in a subject in need thereof,
inhibiting the activity of MutSβ, or
treating a neurodegenerative or neurological disease or disorder.
Accordingly, the subject matter of the instant claim set is novel and nonobvious with respect to Daum.
Instant invention is novel and nonobvious with respect to Chatterjee as explained below:
Chatterjee teaches compounds that are CDK5/p25 inhibitors (abstract). One of the compounds disclosed by Chatterjee is as follows:
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(Figure 5, compound 12). Chatterjee further recognizes that selective inhibition of the CDK5/p25 complex is a potential therapeutic target in neurodegenerative diseases (abstract). Therefore, one of ordinary skill in the art would have found it obvious to use compound 12 of Chatterjee in a method for treating a neurodegenerative disease in a subject. Even though compound 12 of Chatterjee has the same core structure as the instant compounds, the substituents (i.e., -OMe and -NH(CH2)2OH) of compound 12 are not encompassed by instant formula I as recited in instant claim 31.
Chatterjee also does not teach nor suggest modifying the substituents to those that are encompassed by the instant claims such that the resulting compound would then be used to treat a neurodegenerative disease in a subject.
As stated above, compound 12 in Chatterjee is disclosed to be an inhibitor of CDK5/p25 (see Table 4 for CDK5/p25 inhibition by compound 12 in vitro). Chatterjee does not teach nor suggest the use of this compound for:
treating a disease or disorder modulated, at least in part, by MutSβ, in a subject in need thereof or
inhibiting the activity of MutSβ
Accordingly, the subject matter of the instant claim set is novel and nonobvious with respect to Chatterjee.
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.
Scope of Enablement
Claims 1-6, 9-15, 17-20, and 22-34 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 compound of formula I:
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or a pharmaceutically acceptable salt, isotopically enriched analog, stereoisomer, or mixture of stereoisomers thereof, wherein:
R1 = H or C1-6 alkyl
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=
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,
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, or
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R1a = C1-3 alkyl
m = 0 or 1
R3 and R4 are each independently H or C1-3 alkyl
L = -NH-, -NHCH2-, -O-
R2 = C1-6 alkyl, halo, -O-C1-6alkyl, -NHC(O)C1-6alkyl, -S(O)2(C1-6alkyl), -S(O)2NH2, -C(O)NH2, or C3-6 cycloalkyl
wherein each C1-6 alkyl or C3-6 cycloalkyl is optionally substituted with 1 R10 wherein R10 = -COOH
R2a = C1-6 alkyl, halo, -O-(C1-6 alkyl), or -C(O)NH2
n = 0 or 1
and including the proviso statement as recited at the end of instant claim 1
a method for treating a disease or disorder modulated, at least in part, by MutSβ, in a subject in need thereof, the method comprising administering to the subject an effective amount of a compound of formula I:
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or a pharmaceutically acceptable salt, isotopically enriched analog, stereoisomer, or mixture of stereoisomers thereof, wherein the enabling variables are as recited above in point (1) and also the following:
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can be
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If X1 is O, then R1 is absent
R2 can be H; R2 cannot be -O-(C1-6 alkyl)
R2a cannot be -O-(C1-6 alkyl)
Does not include the proviso statement as recited in instant claim 1.
a method for inhibiting the activity of MutSβ, the method comprising administering to a subject in need thereof, an effective amount of a compound of Formula I:
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or a pharmaceutically acceptable salt, isotopically enriched analog, stereoisomer, or mixture of stereoisomers thereof, wherein the enabling variables are as recited above in point (2).
a method for treating a neurodegenerative or neurological disease or disorder, the method comprising administering to a subject in need thereof, an effective amount of a compound of formula I:
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or a pharmaceutically acceptable salt, isotopically enriched analog, stereoisomer, or mixture of stereoisomers thereof, wherein the enabling variables are as recited above in point (2) and wherein the neurodegenerative or neurological disease or disorder is any one of those listed in instant claim 33
does not reasonably provide enablement for elements that are outside the scope of the enabling elements listed above which includes a prodrug of the compound of formula I
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
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.”
In evaluating the enablement question, several factors are to be considered. According to In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988), these factors include:
1) The nature of the invention,
2) the state of the prior art,
3) the predictability or lack thereof in the art,
4) the amount of direction or guidance present,
5) the presence or absence of working examples,
6) the breadth of the claims, and
7) the quantity of experimentation needed to make and use the invention based on the content of the disclosure, and
8) the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
The nature of the invention
The nature of the invention claims a small molecule inhibitor of MutSβ protein that is represented by instant Formula I:
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, or a pharmaceutically acceptable salt, isotopically enriched analog, stereoisomer, or a mixture of stereoisomers thereof, methods of making and intermediates thereof, and methods of using thereof. The variables of instant formula 1 are defined in the instant specification.
State of the prior art
Van Oers et al. (Van Oers) (Van Oers, J. M. M et al. The MutSβ complex is a modulator of p53-driven tumorigenesis through its functions in both DNA double-strand break repair and mismatch repair. Oncogene 2014, 33, 3939-3946.)
Teaches that MutSβ is a complex comprising of the MSH2 and MSH3 proteins (abstract).
Teaches that the MutSβ complex is a modulator of p53-driven tumorigenesis (a recognized disease process; title and abstract).
Teaches that the loss of MSH3 (a component of MutSβ) leads to the development of a variety of tumors in mice (abstract, first sentence).
Therefore, one of ordinary skill in the art would not reasonably expect that inhibition of MutSβ would decrease tumor formation (i.e., treat the disease modulated by MutSβ) and, instead, would anticipate that such inhibition could drive tumor formation.
As discussed in the “Examiner’s note on novelty and nonobviousness” section above, the claimed invention is not disclosed in the prior art. Consequently, the art lacks established structure-activity relationships that would enable a person of ordinary skill in the art to predict which substituent combinations would impart MutSβ inhibitory activity, thereby increasing the degree of experimentation required.
Subramaniam et al. (Subramaniam) (Subramaniam, S. et al. Selective Neuronal Death in Neurodegenerative Diseases: The Ongoing Mystery. Yale Journal of Biology and Medicine 2019, 92, 695-705.)
Subramaniam briefly summarizes the mechanisms ascribed in Alzheimer’s disease (AD), Parkinson’s disease (PD), amyotrophic lateral sclerosis (ALS), and Huntington’s disease (HD).
“Loss of neurons in the cortical II layer of the entorhinal cortex is considered a major feature of Alzheimer disease” (pg. 695, last two lines).
“Degeneration of the substantia nigra pars reticulata (SNr), the region that produces neurotransmitters such as dopamine, is the primary cause of PD” (pg. 696, right col., section “Neuronal vulnerability in Parkinson Disease (PD)”, 1st sentence).
“Motor neurons in the spinal cord and brain stem are the primary neuronal targets that are degenerated in ALS” (pg. 698, section “Neuronal vulnerability in amyotrophic lateral sclerosis (ALS), 1st sentence).
HD “is caused by a CAG expansion mutation in the huntingtin (HTT) gene that produces glutamine (poly-Q) expanded proteins (mHTT)” (pg. 698, right col., section “Neuronal vulnerability in Huntington Disease”, 2nd sentence).
“Proteins such as… mismatch repair protein MutSβ are implicated in CAG expansion” (pg. 699, left col., middle of 2nd paragraph).
Accordingly, a person of ordinary skill in the art would reasonably expect that inhibition of MutSβ may have relevance in diseases driven by repeat expansion mechanisms, such as HD. However, a POSITA would not be motivated to apply MutSβ inhibition to other neurological diseases, including AD, PD, or ALS, which are understood to arise from distinct pathological mechanisms that mainly do not involve trinucleotide repeat expansion or MutSβ activity.
The level of the skill in the art
The level of ordinary skill in the art is relatively high. A person of ordinary skill would typically have formal training in medicinal chemistry and organic synthesis and would be familiar with standard methods for evaluating therapeutic efficacy of compounds.
The presence or absence of working examples
In the instant case, the specification only provides in vitro assay data evaluating inhibition of MutSβ by the disclosed compounds.
The breadth of the claims
The claims are broad insofar as they include claims that:
recite a compound of formula 1 wherein the compound can possess a structurally diverse range of chemical groups,
are directed to a method for treating every disease or disorder modulated, at least in part, by MutSβ, or
are directed to a method for treating every neurodegenerative or neurological disease or disorder which includes neurodegenerative or neurological disease that are not known to involve MutSβ activity within the disease pathology (as discussed above in “2. State of the prior art”).
The amount of direction or guidance present and the quantity of experimentation needed to make and use the invention based on the content of the disclosure
The instant specification provides limited direction and guidance with respect to both the claimed compounds and their claimed therapeutic uses. The disclosure only provides results from in vitro biochemical assays evaluating inhibition of MutSβ (as discussed above) and does not provide meaningful guidance as to how such inhibition translates into therapeutic efficacy across all diseases or disorders modulated, at least in part, by MutSβ.
With respect to the claims directed to compounds of Formula I, the instant specification does not establish any structure-activity relationship that would enable a person of ordinary skill in the art to predict which combinations of substituents will result in compounds possessing MutSβ inhibitory activity. As discussed above in the state of the prior art, the claimed compounds are not disclosed in the art, and there is no established framework that correlates structural features with MutSβ inhibition. Accordingly, a person of ordinary skill in the art would be required to synthesize and screen a large number of structurally diverse compounds to identify those that exhibit the claimed activity, which constitutes undue experimentation.
With respect to the claims directed to methods of treatment, the specification is limited to in vitro assay data demonstrating inhibition of MutSβ and does not provide evidence establishing a relationship between such inhibition and therapeutic efficacy across all diseases or disorders modulated, at least in part, by MutSβ. As discussed above in the state of the prior art, Van Oers teaches that the MutSβ complex (comprising MSH2 and MSH3) modulates p53-driven tumorigenesis and the loss of MSH3 has been shown to result in the development of a variety of tumors in vivo. Accordingly, a person of ordinary skill in the art would not reasonably expect that inhibition of MutSβ would decrease tumor formation (i.e., treat a disease or disorder modulated, at least in part, by MutSβ), but rather would anticipate that such inhibition could further promote tumorigenesis (i.e., MutSβ inhibition would not treat but worsen the disease or disorder).
Additionally, the claims encompass a method for treating a broad range of neurodegenerative or neurological disease or disorders including Alzheimer’s disease, Parkinson’s disease, and Amyotrophic lateral sclerosis, which are understood in the prior art (i.e., Subramaniam as discussed above) to arise from pathological mechanisms distinct from MutSβ-mediated processes. The specification does not provide any guidance as to how inhibition of MutSβ would be relevant to, or effective in treating, such diseases. Therefore, a person of ordinary skill in the art would be required to engage in extensive and unpredictable experimentation to determine whether any of the claimed MutSβ inhibitors would be effective for all the diseases or disorders encompassed by the instant claims that include those that currently are known to not be modulated by MutSβ.
Taken together, the lack of structural guidance, the absence of demonstrated correlation between in vitro and therapeutic effect across all diseases or disorders encompassed by the instant claims, and the breadth of the claimed subject matter would require a person of ordinary skill in the art undue experimentation to make and use the full scope of the claimed invention. Accordingly, the claims are not enabled.
With regard to a “prodrug” of a compound of Formula I:
The quantity of experimentation needed to make or use the invention must be considered to determine if undue experimentation is present. With regard to quantity of experimentation needed, (note Wolff et. al., "Burger's Medicinal Chemistry and Drug Discovery," 5th Ed. Part 1, pp. 975-977 (1995) provided with this action), which emphasizes the many experimental factors for consideration for a successful prodrug as well as the difficulty in extrapolating data from one species to another. See p.975-977. “Extensive development must be undertaken to find the correct chemical modification for a specific drug. Additionally, once a prodrug is formed, it is a new drug entity and therefore requires extensive and costly studies to determine safety and efficacy.” Banker, et. al., (1996), Modern Pharmaceutics, p.596, section “B. Prodrugs”, last paragraph. In view of all these factors undue experimentation would be required to practice the invention.
The scope of prodrugs is not adequately enabled or defined. Applicants provide no guidance as how the compounds are made more active in vivo. The choice of a prodrug will vary from drug to drug. Therefore, more than minimal routine experimentation would be required to determine which ester will be suitable for the instant invention. The application does not provide any guidance for one skilled in the art on how the prodrug is converted to active compounds, by what mechanisms and at what site the prodrug will be activated, what in vivo enzymes are likely involved in cleaving the protected group, etc.
Applicants provide no reasonable assurance that any and all known prodrugs will have the ability to regenerate in vivo to the instant compounds by one or more biological processes. It is not the norm that one can predict with any degree of accuracy a particular prodrug form of an active compound will be more soluble, more easily handled in formulations or more bioavailable without actual testing in vivo. Pursuant to In re Wands, 8 USPQ2d 1400, factors such as direction or guidance are not seen in the specification.
Many functional groups (e.g., hydroxy, amino groups) present in drugs are capable at least in theory to being derivatized but determining what is a prodrug and what is not requires knowledge of an intended effect (i.e. modification of an undesirable property in the parent drug- poor solubility, poor bioavailability, poor shelf-life) which is never identified by the specification.
Written Description
Claims 1-6, 9-15, 17-20, and 22-34 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.
According to MPEP § 2163:
“Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’ See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014).
In the instant case, claim 1 is directed to a compound of Formula I:
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or a pharmaceutically acceptable salt, isotopically enriched analog, stereoisomer, mixture of stereoisomers, or prodrug thereof (wherein the variables are defined in instant claim 1) and claims 2-6, 9-15, 17-20, and 22-28 are dependent on claim 1. According to the instant specification (para. 0002), these compounds are small molecule MutSβ modulators.
Instant formula I encompasses compounds that can possess a structurally diverse range of chemical groups. However, the specification only provides data on the MutSβ inhibitory activity of working examples that are confined to a narrower subgenus and are not prodrugs. For example, there are no working examples of compounds of Formula I wherein R3 is not H or Me and R4 is not H. Since R3 and R4 are directly bonded to the core structure, a person of ordinary skill in the art would understand that variation at these positions may alter the electronic properties of the core and, consequently, affect MutSβ inhibitory activity. The specification does not provide representative examples or data for such variations. Furthermore, as discussed in the “Examiner’s note on novelty and nonobviousness” section, the prior art does not provide guidance or predictability regarding the effect of such substituent modifications. Accordingly, the specification fails to demonstrate possession of the full scope of compounds encompassed by Formula I as recited in instant claim 1 and 30.
The claims also broadly recite a method for treating any disease or disorder modulated, at least in part, by MutSβ, as well as a method for treating any neurodegenerative or neurological disease or disorder through administration of the claimed compounds. However, the specification does not provide sufficient description to support such breadth.
Van Oers teaches that MutSβ (which comprises MSH2 and MSH3 proteins) modulates p53-driven tumorigenesis and the loss of MSH3 has been shown to result in the development of a variety of tumors in vivo (see “2. State of the prior art” of the “Scope of enablement” section above for details). Thus, given the prior art, a POSITA would expect that inhibition of MutSβ can be associated with furthering a disease or disorder progression (i.e., tumorigenesis) rather than treating a disease or disorder modulated by MutSβ. Therefore, in view of the prior art, the specification fails to demonstrate possession of the full scope of a method for treating all diseases or disorders modulated, at least in part, by MutSβ, as the biological role of MutSβ is complex and context-dependent.
Furthermore, the claimed methods encompass neurodegenerative diseases such as Alzheimer’s disease, Parkinson’s disease, and Amyotrophic lateral sclerosis, which are understood to arise from pathological mechanisms distinct from MutSβ-mediated processes (see teachings of Subramaniam as discussed in “2. State of the prior art” of the “Scope of enablement” section above for details). Although MutSβ has been implicated in repeat expansion in Huntington’s disease, the specification does not demonstrate possession of methods for treating neurodegenerative diseases that are not driven by such mechanisms. The disclosure lacks representative examples, mechanistic rationale, or data supporting treatment of these broader disease classes.
Accordingly, the specification fails to provide a representative number of species or sufficient identifying characteristics to support the full scope of the claimed genus of treatment methods. The disclosure therefore does not reasonably convey possession of methods for treating all diseases or disorders modulated, at least in part, by MutSβ, nor of methods for treating all neurodegenerative or neurological diseases recited in 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 1-6, 9-15, 17-20, and 22-34 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 1, 4, 9, 11, 13, 14, 23, and 27-32 recite “or prodrug thereof”. The term “prodrug” renders claims 1, 4, 9, 11, 13, 14, 23, and 27-32 indefinite as a prodrug does not have a defined structure known in the art. For example, one would not be apprised of the pharmacologically inactive form of the claimed compound from the simple recitation of “prodrug” as the compound itself has multiple sites to which a prodrug moiety could bind. Moreover, one could not ascertain as to which prodrug moieties are within the scope of the claim, resulting in millions of combinations of prodrug moieties associated with the claimed compound at different locations on its structure. One could not possibly envisage all the possibilities of a prodrug of any compound of the instant invention.
Claims 2, 3, 5, 6, 10, 12, 15, 17-20, 22, and 24-26 (which are dependent on claim 1); and claims 33 and 34 (which are dependent on claim 31) are also rendered indefinite for further requiring and/or reciting the limitation “or prodrug thereof” of claim 1 and claim 31.
Claim 32 recites “The method of claim 29, wherein the compound… is selected from Table 1.” There is a lack of antecedent basis for the limitations, “Table 1” as claim 29 (in which claim 32 is dependent on) does not disclose a Table 1.
Further, according to MPEP 2173.05(s):
“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).”
In the instant case, Table 1 from the instant specification only includes 48 compounds. Therefore, instead of having claim 32 refer to Table 1 of the instant specification, it would be clearer if Applicant pastes the compounds of Table 1 into claim 32 instead.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 32 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 32 is directed to “The method of claim 29, wherein the compound… is selected from Table 1” wherein the table is provided in the instant specification. Table 1 includes the following compounds:
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. In instant compound 30, R2a = OMe and in instant compound 40, R2 = OMe. However, according to claim 29, the compound of Formula I cannot have R2 or R2a be OMe. Therefore, claim 32 is not further limiting the subject matter of the claim upon which it depends and, instead, broadens the scope of claim 29.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY H. MURRAY can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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