DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 62 is objected to because of the following informalities: includes chemical structures that is not in black. Claim 62 appears to include chemical structures that are drawn in gray-scale and not in black. Appropriate correction is required.
Claim 63 is objected to because of the following informalities: includes chemical structures that is not in black. Claim 63 appears to include chemical structures that are drawn in gray-scale and not in black. Appropriate correction is required.
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.
Claim 65 is 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 activation of orexin-2 receptor and for promoting wake states in a mice model, does not reasonably provide enablement for a method of treating any disease or disorder as broadly 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 use the invention commensurate in scope with these claims.
The claim 65 is drawn to a method of treating a disease or disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the compound of claim 46, or a pharmaceutically acceptable salt thereof. The instant specification fails to provide information that would allow a person of skill in the art to practice treating of any disease or disorder using compounds of claim 46, since the broad recitation of disease or disorder represents an innumerable number of pathologies with a variety of epidemiological causes and pathophysiological mechanisms.
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: 1) the quantity of experimentation necessary; 2) the amount of direction or guidance provided; 3) the presence or absence of working examples; 4) the nature of the invention; 5) the state of the prior art; 6) the relative skill of those in the art; 7) the predictability of the art; and 8) the breadth of the claims. All of the Wands factors have been considered and those most relevant to the cited claims are discussed below.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The breadth of the claims
Claim 65 is thus very broad insofar as it recites “disease or disorder.” Additionally, the claim is very broad since it fails to limit the disease or disorder to a particular pathway or mechanism of treatment. Thus the limitation of “disease or disorder,” includes any and all possible diseases and disorders. For example, disease and disorder includes inflammatory diseases or disorders, which further includes asthma, colitis, inflammatory bowel disease, which each disease representing a broad range of physiological responses or symptoms that are triggered by different pathways. Thus the inflammatory disease represents a very broad therapeutic target for treatment given the many pathways that are involved. Furthermore, cancer is a disease that is also within the scope of the broad limitation of disease or disorder. Cancer represents an extremely large class of disorders that have different causes, different physiological processes, and different treatment responses. Thus cancer, which is within the broad scope of disease or disorder, represent very broad therapeutic targets for treatment given the many pathways that are involved.
The amount of direction or guidance provided and the presence or absence of working examples
The disclosure does not provide representative examples which provide reasonable assurance to one skilled in the art that the instant method is effective in treating the full scope of diseases and disorders as claimed. In particular, the specification has provided guidance for biochemical analysis of orexin type 2 receptor agonist activity in an in vitro model. See page 222 paragraph 0759, page 223 paragraphs 0759 – 0760 Table B. Moreover, the specification has provided guidance for an in-vivo study for the promotion of wake states in B6.Cg-Tg( HCRT-MJD)1Stak/J (Atax) mouse model of NT1 through the oral administration of the instant compounds. See page 223 paragraph 0761, page 224 paragraph 0761 and Table C. The specification does not provide guidance for treatment of broadly claimed “disease or disorder,” with any of the compound of the instant claims.
The nature of the invention, state and predictability of the art, and relative skill level
The invention relates to a method of treating a disease or disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the compound of claim 46, or a pharmaceutically acceptable salt thereof. The relative skill of those in the art is high being that of an MD or PHD. That factor is outweighed; however, by the unpredictable nature of treating all diseases and disorders. As illustrative of the state of the art, the examiner cites the fact that while the prior art enables the use of certain small molecule biochemicals to target specific enzymes in specific pathways that lead to specific diseases and disorders, the basis of the instant invention relies on providing such alleviation through the administration of a generically broad small molecule biochemical as a broad treatment option for a broad variety of diseases and disorders.
As taught by the state of the art of DiSabato et. al. ((2016), Neuroinflammation: the devil is in the details, J. Neurochem., 139, 136 – 153), neuroinflammation is defined as an inflammatory response within the brain or spinal cord. See page 136 column 1 paragraph 1. DiSabato et. al. teach that neuroinflammation, is mediated by the production of cytokines, chemokines, reactive oxygen species, and secondary messengers. See page 136 column 1 paragraph 1. Furthermore, DiSabato et. al. teach that the degree of neuroinflammation depends on the context, duration, and course of the primary stimulus or insult since there are positive aspects of neuroinflammation that is beneficial to the host. See page 136 column 1 paragraph 1 and Fig. 1. Thus DiSabato et. al. suggests that the treatment of neuroinflammation, a disease or disorder within the scope of claim 65, is unpredictable and nuanced since it would depend on the context for which the neuroinflammation occurs.
Furthermore, as taught by the state of the art of Zugazagoitia et. al. ((2016), Current Challenges in Cancer Treatment, Clinical Therapeutics, 38, 1551 – 1566), predictive genomic abnormalities are uncommon, diverse in nature, and distributed across many tumor types. See page 1557 column 1 paragraph 3. Furthermore, Zugazagoitia et. al. teach that several lines of evidence indicate that tumor initiation and progression could rely on a relatively minor population of self-renewing cancer stem cells. See page 1559 column 2 paragraph 2. Moreover, Zugazagoitia et. al. teach that tumor progression is accelerated by the progressive genomic instability inherent in cancer cells or exogenous carcinogens (eg, sunburn and smoking), which increase the generation of new mutations, probably exceeding Darwinian selection. See page 1559 column 2 paragraph 2. Thus Zugazagoitia et. al. suggest the unpredictability of trying to use single compound to treat all cancers, a disease or disorder within the scope of claim 65, as recited.
Moreover, small molecule biochemical are known in the art to have a number of adverse side effects that are dependent on the additional chemical structures attached the core structure. Thus, a method of treating a disease or disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the compound of claim 46, or a pharmaceutically acceptable salt thereof would result in different or unpredictable physiological responses when administered to treat all diseases or disorders. Therefore, one of ordinary skill in the art would recognize the need for different methods of administration to compensate for the different and unpredictable physiological responses.
Furthermore, there is no way to predict based on the state of the prior art or the teachings in the specification whether or not the claimed compound would be effective for treating all diseases or disorders are broadly recited.
The quantity of experimentation necessary
While the treatment of a specific disease or disorder theoretically possible, as a practical matter it is not possible to treat all disease or disorders through the administration of a specific small molecule. And thus, it is nearly impossible to treat any disease or disorder, with the method as claimed.
The amount of experimentation needed to determine how to any disease or disorder suing a compound of claim 46 would be enormous. The types of studies that would be necessary to establish the treatment would include study the individual situations and specific contexts in which a specific disease or disorder is occurring, metabolomics studies to identify key pathways involved in the progression of the specific disease or disorder, extensive structural activity relationship studies to identify design therapeutical scaffolds that are capable of crossing the blood brain barrier and effectively targeting identified enzymes of interest.
Considering the diversity of conditions related within the scope of disease and disorder, the complexity of the underlying mechanisms, and the high unpredictability in the art, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in scope with the instant claim. Since the specification does not demonstrate treatment of all diseases or disorders using a compound of claim 46, the examiner maintains that the instant claim is not enabled for the full scope of claim 65 in light of the entire disclosure.
Accordingly, claim 65 does not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 62 and 63 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.
Claim 62 recites, the compound of claim 46, wherein the compound of Formula (III) is selected from: a group of compounds that includes the following compounds:
PNG
media_image1.png
240
206
media_image1.png
Greyscale
and
PNG
media_image2.png
226
198
media_image2.png
Greyscale
. These structures fail to further limit independent claim 46, because they include the structural limitation where X is an -O-. However, as recited in claim 46 X can only be -N(C1-C6 alkyl)-, -N(C1-C6 haloalkyl)-, or -C1-C6 alkyl-. Thus claim 62 includes a limitation that expands what X can be; and fails to further limit claim 46. 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.
Claim 63 recites, the compound of claim 46, wherein the compound of Formula (III) is selected from: a group of compounds that includes the following compounds:
PNG
media_image1.png
240
206
media_image1.png
Greyscale
and
PNG
media_image2.png
226
198
media_image2.png
Greyscale
. These structures fail to further limit independent claim 46, because they include the structural limitation where X is an -O-. However, as recited in claim 46 X can only be -N(C1-C6 alkyl)-, -N(C1-C6 haloalkyl)-, or -C1-C6 alkyl-. Thus claim 63 includes a limitation that expands what X can be; and fails to further limit claim 46. 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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 46, 50 – 52, 54, 56 – 60, and 64 – 65 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by International Publication Number WO 2022051583 A1 to Lefker et. al. (Lefker’853; cited on the IDS ).
The applied reference has a common applicants and joint inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claims 46, 50 – 52, 54, 56 – 60, and 64 – 65, Lefker’583 teach compounds for the modulation of orexin receptor activity in the brain, including activation of the orexin-2 receptor, with improved therapeutic potential. See page 2 paragraph 0006. Moreover, Lefker’583 teach compounds with improved physicochemical, pharmacological and pharmaceutical properties to existing compounds are desirable. See page 2 paragraph 0006. Additionally, Lefker’583 teach that pharmaceutical compositions comprising compounds of the disclosure can be used in treatment of disorders in which the orexin-2 receptor is implicated such as narcolepsy. See page 7 paragraph 0024. In particular, Lefker’583 teach compounds of Formula (I’)
PNG
media_image3.png
220
260
media_image3.png
Greyscale
. See page 3 paragraph 0007. Specifically, Lefker’583 teach compound no. A1-2 of structure
PNG
media_image4.png
146
224
media_image4.png
Greyscale
. See page 69 Table A1 row 2. See claim 46 limitation for a compound of formula (III) where X = -N(CH3)- ; L = -CH2-CH2-; Y = -O-; n = 2; Z = -NH-; R1 = -CH3; Ar1 = phenyl; and T = phenyl. See claim 50 limitation for a compound where R1 = -CH3. See claim 53 limitation for a compound where L = -CH2-CH2-. See claim 55 limitation for a compound where n = 2. See claim 56 limitation for a compound where Ar1 = phenyl. See claim 57 limitation for a compound where T = phenyl. See claim 59 limitation for a compound where the compound is of Formula (II-a) where n1 = 0. See claim 60 limitation for a compound where the compound is of Formula (IIIA) where n1 = 0 and n2 = 0.
Moreover, Lefker’583 teach compound no. A1-21 and A1-22 of structures
PNG
media_image5.png
292
389
media_image5.png
Greyscale
. See page 72 Table A1 rows 4 and 5. See claim 46 limitation for a compound of formula (III) where X = -CH2CH2CH2- ; L = absent; Y = -O-; n = 1; Z = -NH-; R1 = -CH2CH3; Ar1 = phenyl; and T = phenyl. See claim 51 limitation for a compound where X = -CH2-CH2-CH2-.See claim 52 limitation for a compound where L = absent. See claim 54 limitation for a compound where n = 1. See claim 58 limitation for a compound where the compound is Formula (I-a) and/or (I-b).
Furthermore, Lefker’583 teach compound no. A1-80 of structure
PNG
media_image6.png
200
422
media_image6.png
Greyscale
. See page 83 Table A1 row 4. See claim 46 limitation for a compound of formula (III) where X = -CH2CH2- ; L = absent; Y = -O-; n = 2; Z = -NH-; R1 = -CH2F; Ar1 = phenyl; and T = phenyl. See claim 49 limitation for a compound where R1 = -CH2F. See claim 52 limitation for a compound where L = absent. See claim 54 limitation for a compound where n = 1. See claim 58 limitation for a compound where the compound is Formula (I-a) and/or (I-b).
Additionally, Lefker’583 teach compound no. A1-84 of structure
PNG
media_image7.png
204
426
media_image7.png
Greyscale
. See page 84 Table A1 row 4. See claim 46 limitation for a compound of formula (III) where X = -CH2CH2- ; L = absent; Y = -O-; n = 2; Z = -NH-; R1 = cyclopropyl; Ar1 = phenyl; and T = phenyl. See claim 52 limitation for a compound where L = absent. Likewise, Lefker’583 teach that in order to measure the compounds orexin type 2 receptor agonist activity the compounds, which include compound species A1-2, A1-21, A1-22, A1-80, and A1-84, were first dissolved in DMSO before being diluted with the assay buffer 2 which was (20 mM HEPES, Hank's balanced salt solution, 0. 1 % bovine serum albumin). See page 320 paragraph 1206. See claim 64 limitation for a pharmaceutical composition comprising a compound of claim 46 and a pharmaceutically acceptable excipient.
Thus prior art species A1-2, A1-21, A1-22, A1-80, A1-84 as taught above anticipates examined claims 46, 50 – 52, 54, 56 – 60, and 64 – 65.
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.
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2022051583 A1 to Lefker et. al. (Lefker’853; cited on the IDS).
The teachings of Lefker’853 as they relate to claim 46, from which claim 65 depends, are given previously in this office action and are fully incorporated here.
Now while Lefker’853 fails to exemplify the use of compounds of the disclosure in method of treating; Lefker’853 does teach that pharmaceutical compositions comprising compounds of the disclosure can be used in treatment of disorders in which the orexin-2 receptor is implicated such as narcolepsy. See page 7 paragraph 0024. Moreover, Lefker’583 teach that in order to measure the compounds orexin type 2 receptor agonist activity the compounds, which include compound species A1-2, A1-21, A1-22, A1-80, and A1-84, were first dissolved in DMSO before being diluted with the assay buffer 2 which was (20 mM HEPES, Hank's balanced salt solution, 0. 1 % bovine serum albumin). See page 320 paragraph 1206.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the examined application to use the compounds of Lefker’853 in methods of treating a disease or disorder in which the orexin-2 receptor is implicated such as narcolepsy. One of ordinary skill in the art would have been motivated to make the modification to expand the treatment options for diseases are disorders in which the orexin-2 receptor is implicated. One of ordinary skill in the art would have had a reasonable expectation of success because the compounds of Lefker’853 had orexin type 2 receptor agonist activity.
Claims 47 – 48, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2022051583 A1 to Lefker et. al. (Lefker’853; cited on the IDS) as applied to claims 46, 50 – 52, 54, 56 – 60, and 64 – 65 above, and further in view of Meanwell ((2011), Synopsis of Some Recent Tactical Application of Bioisosteres in Drug Design, J. Med. Chem., 54, 2529 – 2591).
The teachings of Lefker’853 as they relate to claim 46, from which claims 47 – 48, and 61 depend, are given previously in this office action and are fully incorporated here.
However, Lefker’853 fails to teach a compound of Formula (III) where R1 = C3 cycloalkyl substituted with a fluoro. See claims 47 – 48, and 61 limitations.
Nevertheless, Meanwell teach that in the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates. See page 2529 column 1 paragraph 1. Additionally, Meanwell teach that bioisosteres are typically less than exact structural mimetics and are often more alike in biological rather than physical properties. See page 2529 column 1 paragraph 1. Moreover, Meanwell teach that F, and H are classical monovalent bioisosteres. See page 2530 column 1 Table 1. Thus Meanwell suggest the ability to substitute F for H with a reasonable expectation that compounds with either F or H would have similar biological properties.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the instant application to modify compound species A1-84 of Lefker’853 in view of Meanwell, that is to substitute the one of the H atom of the cyclopropyl ring for a F atom. One of ordinary skill in the art would be motivated to make this modification and have a reasonable expectation of success because both F and H are classical monovalent bioisosteres and would be reasonable expected to at least have the same biological properties.
Claims 62 and 63 are rejected under 35 U.S.C. 103 as being unpatentable over International Publication Number WO 2022051583 A1 to Lefker et. al. (Lefker’853; cited on the IDS) and as applied to claims 46, 50 – 52, 54, 56 – 60, and 64 – 65 above, Meanwell ((2011), Synopsis of Some Recent Tactical Application of Bioisosteres in Drug Design, J. Med. Chem., 54, 2529 – 2591).
The teachings of Lefker’853 as they relate to claim 46, from which claims 62 and 63 depend, are given previously in this office action and are fully incorporated here.
However, Lefker’853 fails to teach a compound of the structure
PNG
media_image8.png
234
222
media_image8.png
Greyscale
.See claims 62 – 63 limitation.
Nevertheless, Lefker’583 teach compound no. A1-2 of structure
PNG
media_image4.png
146
224
media_image4.png
Greyscale
. See page 69 Table A1 row 2. Two of the only difference between prior art compound A1-2 of structure
PNG
media_image4.png
146
224
media_image4.png
Greyscale
and the examined compound of structure
PNG
media_image8.png
234
222
media_image8.png
Greyscale
is the ring size of the heterocycle and the F atom on the sulfonyl group. In regards to the ring size given that the ring increase only by a -CH2- group the two ring structures are structural homologs. Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09(II).
However, Lefker’853 fails to teach a compound of the structure
PNG
media_image8.png
234
222
media_image8.png
Greyscale
where there is a F atom on the alkyl group attached to the sulfonyl group. See claims 62 – 63 limitation.
Nevertheless, Meanwell teach that in the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates. See page 2529 column 1 paragraph 1. Additionally, Meanwell teach that bioisosteres are typically less than exact structural mimetics and are often more alike in biological rather than physical properties. See page 2529 column 1 paragraph 1. Moreover, Meanwell teach that F, and H are classical monovalent bioisosteres. See page 2530 column 1 Table 1. Thus Meanwell suggest the ability to substitute F for H with a reasonable expectation that compounds with either F or H would have similar biological properties.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the instant application to modify compound species A1-2 of Lefker’853 that is to decrease the ring size from a six membered heterocycle to a five membered heterocycle in view of Meanwell, that is to substitute the one of the H atom of the methyl group for a F atom. One of ordinary skill in the art would be motivated to make this modification and have a reasonable expectation of success because both F and H are classical monovalent bioisosteres and would be reasonable expected to at least have the same biological properties.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 46 – 65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 of copending Application No. 19/177396 to Ott et. al. (reference application; Ott’396) in view of Meanwell ((2011), Synopsis of Some Recent Tactical Application of Bioisosteres in Drug Design, J. Med. Chem., 54, 2529 – 2591).
Ott’396 recite a compound of Formula (III’)
PNG
media_image9.png
264
294
media_image9.png
Greyscale
where R1, Ra, Rb, n, Ar1, T, Y, and X are defined. See reference claim 1. Furthermore, Ott’396 recite compound species that differ from the examined application with the inclusion of alkyl groups or halogens on the 5 membered N containing heterocyclic ring. See reference claims 2 – 18. Moreover, Ott’396 recite a pharmaceutical composition comprising the compound of (reference) claim 1, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient. See reference claim 19. See examine claim 64. Additionally, Ott’396 recite a method of treating a disease or disorder in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of the compound of (reference) claim 1, or a pharmaceutically acceptable salt thereof. See examined claim 65.
However, copending application Ott’396 fails to recite compounds of formula (III)
PNG
media_image10.png
284
330
media_image10.png
Greyscale
where (reference) Ra = Rb = H. See examined claim 46.
Nevertheless, Meanwell teach that in the contemporary practice of medicinal chemistry, the development and application of bioisosteres have been adopted as a fundamental tactical approach useful to address a number of aspects associated with the design and development of drug candidates. See page 2529 column 1 paragraph 1. Additionally, Meanwell teach that bioisosteres are typically less than exact structural mimetics and are often more alike in biological rather than physical properties. See page 2529 column 1 paragraph 1. Moreover, Meanwell teach that F, CH3, and H are classical monovalent bioisosteres. See page 2530 column 1 Table 1. Thus Meanwell suggest the ability to substitute H for either F, or CH3 with a reasonable expectation that compounds with either F, CH3, or H would have similar biological properties.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling date of the instant application to modify the compounds of copending Ott’396 in view of Meanwell, that is to replace the CH3 group or F atom on the 5 membered N containing heterocyclic ring with H atom. One of ordinary skill in the art would be motivated to make this modification and have a reasonable expectation of success because the CH3 group, F atom, and H atom are classical monovalent bioisosteres and would be reasonable expected to at least have the same biological properties.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 46 – 65 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
Prosecution Insights