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
Claims 1-4 and 9-32 are pending in the present application file.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 03/21/2024 and 07/29/2025 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
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. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
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.
The abstract of the disclosure is objected to because the use of. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Improper Markush Grouping Rejection
Claims 1-4 and 9-32 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of Formula I is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The core structure of the presently claimed genus is
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which is not sufficient to convey the claimed utility as GHSRla-agonist compounds useful for the treatment of imbalance in brain dopamine homeostasis until the identity of all the isomers of a compound of formula (I) of claim 1 are known.
The common meaning of the general term isomer is (taken from Merriam-Webster):
One of two or more compounds, radicals, or ions that contain the same number of atoms of the same elements but differ in structural arrangement and properties.
The following are examples of compounds that are constitutional isomers of a compound of present claim 4 containing the same number of atoms of the same elements (C24H25ClN2O6) but differing in the structural arrangement and properties, which are embraced by present claim 4:
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These varying functional groups are not recognized to belong to the same physical or chemical class or to the same art-recognized class. For example, in the US classification system classifies compounds containing two phenyl rings and an amide linkage in class 562, whereas compounds containing anthraquinones are classified in class 552 and compounds containing morpholine are classified in class 544. Heteroaryl groups which contain indole and phenyl connected by carbonyl are classified in class 548.
To overcome this rejection, Applicant may delete the optional formation of “isomers” from claim 1 or set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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 1-4 and 9-32 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 a compound having the formula of present claim 1 or possible chiral variants thereof or a pharmaceutically acceptable salt of any of the foregoing, does not reasonably provide enablement for the full scope of “isomers” of a compound having the formula of present claim 1. 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.
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) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
(a) Breadth of the claims - The breadth of the claim includes all of the thousands of compounds having the formula of present claim 1 as well as all isomers thereof. The common meaning of the general term isomer is (Merriam-Webster):
One of two or more compounds, radicals, or ions that contain the same number of atoms of the same elements but differ in structural arrangement and properties.
Accordingly, the scope of “isomers” as a general term would encompass not only stereoisomers such as diastereomers, enantiomers, geometric isomers, etc., but compounds that have the same molecular formula, i.e. same number of carbon atoms, hydrogen atoms, etc., in any configuration. This would include compounds that bear little structural resemblance to a compound falling within the explicit definitions of the formula of claim 1.
(b) Nature of the invention - The nature of the invention is drawn to compounds and their isomers for use as agonists of GHSRla for the treatment of Parkinson's disease, attention deficit hyperactivity disorder, Tourette syndrome, schizophrenia, bipolar disorder, Alzheimer's Disease, addiction, eating disorder, or any combination thereof in a subject.
(c) State of the prior art – It is well established that stereoisomers are reasonably expected to have similar properties to a racemate or a geometric isomer since these compounds have the same functional groups and atom connectivity while differing only slightly in spatial orientation. Constitution isomers are drawn to compounds that have the same molecular formula but differ in atom connectivity. It is well established that constitutional isomers can have wildly different properties since it is the structure of a compound that controls its properties and not its atom count.
(d) Level of one of ordinary skill in the art - The artisans synthesizing applicant’s compounds and isomers would be a collaborative team of synthetic chemists and/or medicinal chemists, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
(e) Level of predictability in the art - Synthetic organic chemistry is quite unpredictable (In re Marzocchi and Horton 169 USPQ at 367 ¶ 3). The following excerpt is taken from Dörwald (Dörwald, F. Zaragoza. Side Reactions in Organic Synthesis: A Guide to Successful Synthesis Design, Weinheim: WILEY-VCH Verlag GmbH & Co. KGaA, 2005, Preface):
Most non-chemists would probably be horrified if they were to learn how many attempted syntheses fail, and how inefficient research chemists are. The ratio of successful to unsuccessful chemical experiments in a normal research laboratory is far below unity, and synthetic research chemists, in the same way as most scientists, spend most of their time working out what went wrong, and why.
Despite the many pitfalls lurking in organic synthesis, most organic chemistry textbooks and research articles do give the impression that organic reactions just proceed smoothly and that the total synthesis of complex natural products, for instance, is maybe a labor-intensive but otherwise undemanding task. In fact, most syntheses of structurally complex natural products are the result of several years of hard work by a team of chemists, with almost every step requiring careful optimization. The final synthesis usually looks quite different from that originally planned, because of unexpected difficulties encountered in the initially chosen synthetic sequence. Only the seasoned practitioner who has experienced for himself the many failures and frustrations which the development (sometimes even the repetition) of a synthesis usually implies will be able to appraise such work.
Chemists tend not to publish negative results, because these are, as opposed to positive results, never definite (and far too copious).
(f) Amount of direction provided by the inventor and Existence of working examples – The application provides direction for the preparation of a compound having the formula of present claim 1 and for chiral variants thereof; however, the application is negligent with respect to making any of the other possible constitutional isomers of a compound having the formula of present claim 1. Applicant has provided sufficient guidance to make and use of a compound having the formula of present claim 1 and chiral variants thereof; however, the disclosure is insufficient to allow extrapolation of the limited examples to enable the scope of the tens of thousands of constitutional isomers thereof.
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims. Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula.” See MPEP § 608.01(p).
(h) Quantity of experimentation needed to make or use the invention based on the content of the disclosure – Based on the lack of guidance in the instant specification, a person having ordinary skill in the art would be faced with undue experimentation in making and using the full scope of the instant claim. A person having ordinary skill in the art, in seeking to make constitutional isomers for use as GHSRla-agonist compounds of even one species instantly disclosed, would be faced with hundreds of possible constitutional isomers. In order to test the properties of these isomers, a person having ordinary skill in the art would need to develop synthetic approaches to these compounds, which can be quite unpredictable as discussed in section (e). Since Applicant only provides guidance as to the particular structural attributes of the formula (I) that lead to agonists of GHSRla, a person having ordinary skill in the art would be faced with undue experimentation in attempting to synthesize the millions of structurally dissimilar constitutional isomers instantly claimed in order to find additional agonists of GHSRla.
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)}.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that applicant is insufficiently enabled for making and using all isomers of a compound having the formula of present claim 1 is clearly justified. It is suggested that Applicant amend the instant claims to replace “isomers” with “stereoisomers”.
Claims 17-29 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 a method for treating a subject), does not reasonably provide enablement a method for treating a subject. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
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) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
(a) Breadth of the claims - The breadth of the instant claims comprise the treatment of any disease comprising a compound of instant claim 1 or a composition of instant claim 16.
(b) Nature of the invention - The nature of the invention of instant claims 17-29 is a method for treating a subject having a health condition, comprising administering to the subject having a health condition, the compound according to claim 1 or the pharmaceutical composition according to claim 16. Applicant provides in para. 118 where any of the claimed compounds may be used for preventing, alleviating and/or treating pathological disruptions of brain dopamine (DA) homeostasis. Applicant discloses the following definition for “treating”:
As used herein, the term "treating" refers to the application or administration of a composition including one or more active agents to a subject, who is in need of the treatment, for example, having a target disease or disorder, a symptom of the disease/disorder, or a predisposition toward the disease/disorder, with the purpose to cure, heal, alleviate, relieve, alter, remedy, ameliorate, improve, or affect the disorder, the symptom of the disease, or the predisposition toward the disease or disorder.
See para. 121 of the instant specification.
(c) State of the prior art and Level of predictability in the art – The prior art discloses where agonists of GHSRla are useful for treatment of cancer cachexia, aging related cognitive decline, obesity and diabetes.
The growth hormone secretagogue receptor (GHS-R) is a component of the ghrelin signaling pathway and is involved in mediating the pleiotropic effects of ghrelin. Two isoforms have been identified, but only GHS-R1a binds with acyl ghrelin and transduces its message. However, the inactive variant of GHS-R, GHS-R1b, appears to play a critical role in modulating the activity of GHS-R1a by forming heterodimeric complexes which attenuates trafficking of the active variant to the cell surface. The molecular mechanisms of signal transduction are complex and are specific of the tissues where GHS-R1a is expressed. The potent induction of GH secretion and the stimulation of appetite are the most intensively studied functions of GHS-R1a. However, the tissue distribution of GHS-R1a extends beyond the pituitary and the hypothalamus, and reflects the different biological functions of the ghrelin/GHS-R system. GHS-R1a is also expressed in other brain areas, in the pancreas, adipose tissue, immune cells and cardiovascular system, and modulates learning and memory, glucose and lipid metabolism, inflammatory response and cardiac performance. The pleiotropic effects of the ghrelin/GHS-R system suggest their exploitation to prevent and treat a number of clinical conditions. Among many other syndromes and diseases, cancer cachexia, aging related cognitive decline, obesity and diabetes may significantly benefit from the use of GHS-R1a agonists or antagonists.
See Laviano (Laviano, Alessandro, et al. "The growth hormone secretagogue receptor (Ghs-R)." Current pharmaceutical design 18.31 (2012): 4749-4754.), abstract.
Over the years, several GHS-R1a agonists have been reported and developed for the treatment of disorders related to the dysregulation of the functions mediated by GHS-R1a. Some of them, such as ibutamoren, MK-0677 (Figure 5), capromorelin (CP-424391, 5), anamorelin (ONO-7643, 6), and ulimorelin (TZP-101, 7) (Figure 7), have reached advanced clinical trials for gastrointestinal diseases, cancer cachexia, and sarcopenia (see section 4). See Giorgioni (Giorgioni, Gianfabio, et al. "Advances in the development of nonpeptide small molecules targeting ghrelin receptor." Journal of Medicinal Chemistry 65.4 (2022): 3098-3118.), section 3.1 on pages 3101-3105.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute.
The present claimed invention is highly unpredictable as discussed below:
Accumulating evidence, suggests that GHS-R1a may not be the only responsible for all these effects. As an example, GHS-R1a-deficient mice are similar to wild type animals in growth and diet-induced obesity, whereas ghrelin and the non-acylated form of ghrelin, which does not bind GHS-R1a,share the same biological actions on the heart, adipose tissue, pancreas, cancer cells and brain. These results suggests the existence of a still unknown, functionally active binding site for this family of molecules, whose identification is still evasive.
See Laviano page 4750, left col., second para.
Hence, in the absence of a showing of correlation between all the diseases claimed as capable of treatment and prevention by the administration of the compounds of the claims, one of skill in the art is unable to fully predict possible results from the administration of the compound of the present claims due to the unpredictability.
(d) Level of one of ordinary skill in the art - The artisans synthesizing applicant’s compounds and isomers would be a collaborative team of synthetic chemists and/or medicinal chemists, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience.
(e) Amount of direction provided by the inventor and Existence of working examples –
The only direction or guidance present in the present disclosure is the definitions of treating and alleviating a target disease/disorder located on page 40 and listing and definitions of diseases/disorders that arise from disruptions of brain dopamine homeostasis from page 47 to page 49. Applicant provides wherein alleviating the disease does not necessarily require curative results. See para 122 of the instant specification. The exemplary diseases or disorders which arise from disruptions of brain dopamine homeostasis include Parkinson's disease, attention deficit hyperactivity disorder, Tourette syndrome, schizophrenia, bipolar disorder, Alzheimer's Disease, eating disorders, and addiction (e.g., food/alcohol/drug).
Additionally, molecular docking, in vitro and in vivo evaluation of the present compound N8279 for GHSRla agonist activity and selectivity is found in Examples 1 and 69-74 on pages 88-98. Data, in vitro or in vivo, for the treatment of diseases or disorders which arise from disruptions of brain dopamine homeostasis, or any health condition generally, is lacking for the instant disclosure.
(f) Quantity of experimentation needed to make or use the invention based on the content of the disclosure – Based on the lack of guidance in the instant specification, a person having ordinary skill in the art would be faced with undue experimentation in making and using the full scope of the instant claim. One of skill in the art would need to perform experimentation to determine which diseases can be treated or prevented by the present compounds.
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)}.
The determination that undue experimentation would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. (In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404). These factual considerations are discussed comprehensively in MPEP § 2164.08 (scope or breadth of the claims), § 2164.05(a) (nature of the invention and state of the prior art), § 2164.05(b) (level of one of ordinary skill), § 2164.03 (level of predictability in the art and amount of direction provided by the inventor), § 2164.02 (the existence of working examples) and § 2164.06 (quantity of experimentation needed to make or use the invention based on the content of the disclosure).
Based on a preponderance of the evidence presented herein, the conclusion that applicant is insufficiently enabled for using the method of treating a subject having any possible health condition comprising administering to the subject having a health condition, the compound according to claim 1 or the pharmaceutical composition according to claim 16. It is suggested that Applicant amend the instant claim 17 to recite “A method for treating a subject having an imbalance in brain dopamine homeostasis”, cancel claim 18, and update the dependencies of claims 19-30 accordingly.
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 9-15 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.
Claim 9 recites a compound of claim 1 wherein the compound comprises agonistic activity toward growth hormone secretagogue receptor la (GHSRla).
When claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008). See MPEP 2173.05(g).
Without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. See Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc).
As such, it is indefinite which alternatives, or combination of alternatives, of the compound of claim 1 are required to meet the limitation of the claim 9.
The term “bias”, “biased” and “compete” in claims 9-15 is a relative term which renders the claim indefinite. The terms are not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As the relative terms are not defined, the scope of bias towards GSHR1a or a subunit thereof, or agonistic activity, required to meet limitations of the claims are indefinite.
Claim Rejections - 35 USC § 112
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.
Claims 9-15, 17-30 and 32 are 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.
Instant claims 9-15 recite further limitations of a compound of claim 1 dependent on agonist activity or biased selectivity for the compound of claim 1 towards GHSR1a and particular subunits of GHSR1a.
The additional limitations of instant claims 9-15 are interpreted as intended uses or results for the compound of claim 1. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
Regarding an intended use limitation, MPEP 2111.02(II) notes:
“If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020)”.
In this situation, the limitation does not affect the structure of the compound of formula (I). If the prior art structure is capable of performing the intended use, then it meets the claim. Claims reciting the intended result for a compound of claim 1, do not impart a further limitation of the genus of compounds of claim 1.
Claim 17 is directed to a method for treating a subject having a health condition comprising administration of the compound according to claim 1 or the pharmaceutical composition according to claim 16. The pharmaceutical composition of claim 16 comprises the compound according to claim 1, and therefore claim 17 does not further limit claim 16 and incorporates the different features of compound and composition within the present method claim.
Claims 18-24, which are dependent upon instant claim 17, are similarly rejected.
Applicant can amend claim 17 to depend on the pharmaceutical composition of claim 16 to overcome this aspect of this rejection.
Instant claim 24 is also rejected as a multiple dependent claim, further dependent upon another multiple dependent claim – claim 17.
Claims 25-30, which are dependent upon instant claim 24, are similarly rejected.
Applicant can amend claims 24-30 to depend on the pharmaceutical composition of claim 16 to overcome this aspect of this rejection.
Claim 32, recites the kit according to claim 31, wherein the kit is of use to treat a health condition in a subject having or suspected of having an imbalance in brain dopamine homeostasis. The manner in which the kit of instant claim 31 are to be used to treat a health condition in a subject having or suspected of having an imbalance in brain dopamine homeostasis, therefore one cannot be sure how the use is further limiting.
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
Claims 1-4 and 9-32 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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