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 .
Notice of Priority
This applications claims priority for US Provisional Patent Application: 62/359,419 filed 07 July 2016.
DETAILED ACTION
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 13 November 2025 has been considered by the Examiner.
Claim Status
Claim(s) 1-20 are examined on the merits herein.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Rejections - 35 U.S.C. § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. § 112:
(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.
Method of treating a disease, health condition or disorder in a subject… comprising administering… a compound of Formula I
Claims 1-20 are rejected under 35 U.S.C. § 112(a) as failing to comply with the enablement requirement because the claims contain subject matter, particularly a method of treating a disease, health condition or disorder in a subject… comprising administering… a compound of Formula I, which was not described in the specification in such a way as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use (perform) 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 or joint 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:
Breadth of the claims - the breadth of the claims includes a method of treating a disease, health condition or disorder in a subject… comprising administering… a compound of Formula I, below:
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The breadth of the claims is quite vast, pertaining to a method of treating a panel of seemingly unrelated diseases beyond a mutual presence of sGC protein, such as, but not limited to, high blood pressure and decreased coronary blood flow… heart failure… ischemia-reperfusion associated with lung transplant, pulmonary transplant, cardiac transplant, venous graft failure… Duchenne muscular dystrophy… Alzheimer’s disease… Parkinson’s disease… Huntington’s disease… multiple sclerosis… sepsis… COPD… hepatitis… which under modern medical understandings lack mutual, more complex etiologies.
Nature of the invention - the nature of the invention is performance of a method of treating a disease, health condition or disorder in a subject… comprising administering… a compound of Formula I (above).
State of the prior art - Strebhardt et al (Strebhardt K et al, Paul Ehrlich’s magic bullet concept:100 years of progress, Nature Reviews Cancer, Volume 8, pgs. 473–480 (2008); henceforth Strebhardt) summarizes the well-known “magic bullet” principle in the art, wherein drugs are regarded as targeted medicines that go straight to their intended cell-structural targets (receptors) to efficaciously attack pathogens to treat disease yet remain harmless in healthy tissues [pg. 473; par. 4]. It is noted that no single drug has been discovered that is effective in treating the myriad of diseases, health conditions or disorders in a subject, including, but not limited to, high blood pressure and decreased coronary blood flow… heart failure… ischemia-reperfusion associated with lung transplant, pulmonary transplant, cardiac transplant, venous graft failure… Duchenne muscular dystrophy… Alzheimer’s disease… Parkinson’s disease… Huntington’s disease… multiple sclerosis… sepsis… COPD… hepatitis… Moreover, while it is noted that WO 2018/009596 of the priority chain illustrates the synthesis of compounds of Formula I, and/or methods of use thereof (Sheppeck, et al. WO 18/009596, 2018; henceforth Sheppeck) as prodrugs, an earlier filing of US 2016/0031903 (Nakai, et al. US 2016/0031903, 2016) illustrates the use of the parent alcohols of compounds of Formula as active sGC stimulators in methods of treating diseases. Furthermore, sGC stimulators are not known in the timely art to act directly on diseases like Huntington’s, Alzheimers, or Duchenne muscular dystrophy (i.e. diseases with complex etiologies), but rather to act on peripheral nitric oxide production networks (Gupta AD et al, Clin Pharmacol Ther. 2014 Nov 28;97(1):88–10) as treatment handles for diseases such pulmonary hypertension (PH). The mechanism of sGC stimulation is understood through the NO-sGC-cGMP pathway, briefly:
Gaseous NO is synthesized by nitric oxide synthases
sGC then adsorbs NO, using a heme-bearing prosthetic group.
sGC-NO catalyzes the conversion guanosine triphosphate (GTP) into cyclic guanosine monophosphate (cGMP), a second messenger
Downstream targets of cGMP (i.e. cGMP-dependent protein kinases (PKGs), cGMP-gated cation channels, and phosphodiesterases) mediate physiology, such as vasodilation, inhibition of smooth muscle cell proliferation, prevention of fibrosis, and promote antithrombotic and anti-inflammatory effects
In the case of PH, a known disease treatable by sGC stimulation, dysregulation in the pathway is known to cause buildup of nitric oxides and reactive oxygen species that give way to pathogenesis (pg. 5; par. 03-04). Therefore, the prior art suggests that where diseases may intersect with cGMP-mediated physiology, they may potentially benefit from sGC stimulation, provided the mechanistic reason for pathogenesis be insufficient sGC activation/activity. sGC stimulation may have some involvement in diseases/disorders related to pulmonary hypertension, as claimed (i.e. hypertension), but certainly not in all of the various claimed diseases/disorders. Therefore, there wouldn’t be an expectation, based on the prior art, to treat the various claimed diseases like Huntington’s, Alzheimers, or Duchenne muscular dystrophy, by this method. In fact, for a disease like Alzheimer’s, it is known that clinical outcomes involving cGMP production networks are more dependent upon concurrently dysregulated networks (i.e. cAMP production networks) (Bollen E et al, Improved Long-Term Memory via Enhancing cGMP-PKG Signaling Requires cAMP-PKA Signaling, Neuropsychopharmacology (2014) 39, 2497–2505; henceforth Bollen) [pg. 2503; par. 2]. Additionally, there is some suggestion in the prior art for elevated levels sGC suppressing proliferation and survival of human breast cancer cells, where sGC levels were compromised and lower initially (Wen HC et al; Elevation of Soluble Guanylate Cyclase Suppresses Proliferation and Survival of Human Breast Cancer Cells, PLoS ONE, 2015 10(4)) [pg. 15/17; par. 1].
Level of one of ordinary skill in the art - the artisans performing the inventor’s or joint inventor’s method of treating a disease, health condition or disorder in a subject… comprising administering… a compound of Formula I, would be a collaborative team of synthetic chemists and/or health practitioners, possessing commensurate degree level and/or skill in the art, as well as several years of professional experience. Additionally, the skilled artisans would be well-aware of the use of both 1) synthetic phosphorylation reactions of alcohols and 2) the use phosphate compounds as prodrugs.
Level of predictability in the art – The art (i.e. Gupta) generally teaches the effectiveness of sGC stimulation in treating conditions like pulmonary hypertension. However, the FDA-approved indications for a known sGC stimulator, Adempas (Riociquant), are only for certain forms of PH (FDA Fact Sheet for Adempas, attached) and other indications were uncertain, and therefore unpredictable, at the time of filing. Similarly, it is well established that [T]he scope of enablement varies inversely with the degree of unpredictability of the factors involved, and physiological activity is generally considered to be an unpredictable factor {See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970)}.
Amount of direction provided by the inventor - the invention lacks direction with respect to making and/or using (performing) a method of treating a disease, health condition or disorder in a subject… comprising administering… a compound of Formula I.
Existence of working examples – The disclosure provides pharmacokinetic studies of claimed prodrugs (i.e. stability, metabolism) in rats [pgs. 79-80; [00280]-[00281]] and dogs [pg. 83; [00294]-[00295]], and provides in vitro data in HEK293 cell assay [pg. 73; [00251]-[00254]] to indicate cGMP production after application of Compound(s) I-1 and I-4. However, the disclosure does not provide working examples of the claimed prodrugs for treating the claimed diseases, and is insufficient to allow extrapolation of the limited examples (i.e. Rat PK, Dog PK, HEK GloSensor sGC activity) to enable performing the instantly recited method of treating a disease, health condition or disorder in a subject… comprising administering… a compound of Formula I, as there are no working examples of disease models being treated by the claimed compounds; disease models would include, but not be limited to, high blood pressure and decreased coronary blood flow… heart failure… ischemia-reperfusion associated with lung transplant, pulmonary transplant, cardiac transplant, venous graft failure… Duchenne muscular dystrophy… Alzheimer’s disease… Parkinson’s disease… Huntington’s disease… multiple sclerosis… sepsis… COPD… hepatitis… [Specification; pgs. 37-40]; however, the specification fails to set forth any convincing in vitro and/or in vivo assays corroborating the alleged activity in association with any of these mentioned diseases.
There is insufficient disclosure to reasonably conclude that the method of treating a disease, health condition or disorder in a subject… comprising administering… a compound of Formula I, as recited, would contribute to treatment of any diseases, health conditions or disorders in a subject, including, but not limited to, high blood pressure and decreased coronary blood flow… heart failure… ischemia-reperfusion associated with lung transplant, pulmonary transplant, cardiac transplant, venous graft failure… Duchenne muscular dystrophy… Alzheimer’s disease… Parkinson’s disease… Huntington’s disease… multiple sclerosis… sepsis… COPD… hepatitis…. Furthermore, the combination of the instant specification and Sheppeck (priority filing), lacks adequate credible evidence to support the assertion that a method of treating a disease, health condition or disorder in a subject… comprising administering… a compound of Formula I, as recited, would contribute to the prophylaxis of any diseases, health conditions or disorders in a subject, including, but not limited to, high blood pressure and decreased coronary blood flow… heart failure… ischemia-reperfusion associated with lung transplant, pulmonary transplant, cardiac transplant, venous graft failure… Duchenne muscular dystrophy… Alzheimer’s disease… Parkinson’s disease… Huntington’s disease… multiple sclerosis… sepsis… COPD… hepatitis…, since the inventor or joint inventor has neither provided convincing data for any patient population, nor indicated any art recognized correlation between the disclosed data and the breadth of the claims.
Quantity of experimentation needed to make and/or use (perform) the invention based on the content of the disclosure - It is unclear, based on the guidance provided by the specification, whether a compound of Formula I, such as Compound I-4 [pg. 18; Table 1], below:
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possesses utility as a therapeutic agent, useful in a method of treating a disease, health condition or disorder in a subject… comprising administering… a compound of Formula I, as would a compound with structural dissimilarity, such as Compound I-1 [pg. 17; Table 1], below:
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or Compound I-3 [pg. 17; Table 1], below:
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given that their mode of function, at least in part, is due to the action of endogenous phosphatases [pg. 74-75; [00257]] with presumably altered kinetics due to the structural differences of these substrates. Thus, one of ordinary skill in the art at the time of the Instant filing, would have an unreasonable expectation for undue experimentation to 1) validate the limited in vitro data through clinical disease models; and 2) validating each molecule claimed in the Markush grouping (Claim 1) of Formula (I) as enabled for treating diseases claimed further in the methods.
Therefore, the Specification, at the time of filing, would not have taught one skilled in the art how to make and/or use (perform) the full scope of the claimed invention without undue experimentation. {See In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}. The skilled artisan, while
Additionally, 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.
Claim(s) 2-6 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.
MPEP 2173.05(a)(I) states:
The meaning of every term used in a claim should be apparent from the prior art or from the specification and drawings at the time the application is filed. Claim language may not be "ambiguous, vague, incoherent, opaque, or otherwise unclear in describing and defining the claimed invention." In re Packard, 751 F.3d 1307, 1311, 110 USPQ2d 1785, 1787 (Fed. Cir. 2014). Applicants need not confine themselves to the terminology used in the prior art, but are required to make clear and precise the terms that are used to define the invention whereby the metes and bounds of the claimed invention can be ascertained. During patent examination, the pending claims must be given the broadest reasonable interpretation consistent with the specification. In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997); In re Prater, 415 F.2d 1393, 162 USPQ 541 (CCPA 1969). See also MPEP § 2111 - § 2111.01. When the specification states the meaning that a term in the claim is intended to have, the claim is examined using that meaning, in order to achieve a complete exploration of the applicant’s invention and its relation to the prior art. In re Zletz, 893 F.2d 319, 13 USPQ2d 1320 (Fed. Cir. 1989).
In regards to Claim 2, the phrase “more specific forms of HF” renders the metes and bounds of the claim as unclear. The terminology “more specific” is relative, and it is unclear how much specificity should be applied to the HF before the bounds of “more specific” are reached. For example, to what degree must a form of HF be “more specific” until it becomes the “most specific”. Additionally, “more specific” should be understood relative to a baseline HF, and that baseline is not clearly defined in the specification. A laundry list of potential forms of HF are provided [00182], however, it is unclear which terminological gaps are to be filled between the “non-specific” forms of HF and the outlined forms of HF (i.e. acute decompensated HF, HF with valvular defects, etc.). It is also observed that there is colon (i.e. “:”) following “more specific forms of HF”. It is unclear whether this grammatical choice for the claim language is meant to provide a closed list of “more specific forms” as a limitation, or whether they are to be treated as suggested examples without strict claim boundaries.
The use of exemplary claim language is also noted to contribute to the lack of clarity set forth by the claim language. For example, Claim 2 cites, below:
“ocular diseases or disorders such as glaucoma, retinopathy and diabetic retinopathy.”
“cognitive disturbances such as those occurring in mild cognitive impairment, age-related learning and memory disturbances… etc.”
The use of parentheticals is also noted to contribute to the lack of clarity set forth by the claim language. For example, Claim 2 cites, below:
“acute phases of an existing chronic HF (worsening HF)”
“Raynaud's syndrome or phenomenon (primary and secondary)”
“prophylaxis and control of consequences of cerebral infarction (apoplexia cerebri)”
“micro and macrovascular damage (vasculitis)”
“electrolyte disturbances (herkalemia, hyponatremia)”
Additionally, Claim 3 cites, below:
“heart muscle inflammation (myocarditis)”
Additionally, Claim 4 cites, below:
“diabetic ulcers; diabetic foot ulcers)”
In regards to exemplary claim language and parenthetical examples, MPEP 2173.05(d) states:
“Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.”
In cases such as those above, the metes and bounds are unclear for potential narrower limitation set forth in the examples and parentheticals; the Examiner is uncertain whether the exemplary and parenthetical terms are merely suggested examples to support a limitation, or whether they are to be treated as limitations in and of themselves.
In a similar light, the repetition of limitations within a single claim is also noted to contribute to the lack of clarity set forth by the claim language. For example, Claim 2 cites:
“heart failure/cardiorenal syndrome; portal hypertension; endothelial dysfunction or injury;”
“myocardial insufficiency; endothelial dysfunction; stroke;”
“gestational hypertension; pre-eclampsia; portal hypertension; myocardial infarction;”
“infarction; myocardial infarction; heart attack;”
“heart failure, HFPEF, HFREF”
“heart failure/cardiorenal syndrome”
“neuropathic pain neuropathic pain associated with MS”
The metes and bounds of the claimed limitation are unclear, as to whether the repeated limitations (i.e. endothelia dysfunction, myocardial infarction, heart failure, neuropathic pain) should be treated as context-dependent limitations or as suggested examples; in the latter case, it would be unclear which context is the limitation and which is the suggested example.
The use of subjective terminology is also noted to contribute to the lack of clarity set forth by the claim language.
For example, Claim 2 cites, below:
“worsening HF”
“increased acute and chronic coronary blood pressure;”
“increased levels of fibrinogen and low density DLD”
“increased concentration of plasminogen activator inhibitor I (PA-I)”
“diseases characterized by abnormally increased blood concentrations of urea, nitrogen, potassium and/or creatinine”
“diseases characterized by increased microalbuminuria, diseases characterized by macroalbuminuria”
“disorders related to high blood pressure and decreased coronary blood flow”
“decreased high-density lipoprotein cholesterol (HDL-cholesterol)”
“improving perception, capacity for concentration, capacity for learning or memory performance after cognitive disturbances”
Additionally, Claim 6 cites, below:
“neurologic disorders associated with decreased nitric oxide production”
With the terminology being subjective, or relative, it is necessary to define the scope of increased and/or decreased, for example. In context to this assertion, MPEP 2173.05(b)(IV) states:
When a subjective term is used in the claim, the examiner should determine whether the specification supplies some objective standard for measuring the scope of the term. Some objective standard must be provided in order to allow the public to determine the scope of the claim. A claim term that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005))
The specification does not cite objective standards or definitions for determining the scope of worsening, increased, improving, and/or decreased in any of the mentioned contexts; these terms are relative to a baseline, and that baseline is not provided. Provided the lack of ranges for what would constitute a disease treatable by the Instant methods, the metes and bounds for the claimed limitations are uncertain.
Additionally, the metes and bounds of various named parameters are unclear. For example, Claim 2 cites in context to “improving… ”, below:
“perception”
“capacity for concentration”
“capacity for learning or memory performance”
“general disturbances of concentration”
Additionally, Claim 2 cites, below:
“use of luxury foods”
The metes and bounds for “perception”, “capacity”, and “general” are unclear, as the mentioned are highly subjective experiences that vary between individuals. Also, the Specification provides no direction as to interpreting the boundaries for these terms. Similarly, it is unclear what is meant by “luxury foods” and uses thereof.
In regards to Claim 5, the phrase “some forms of adhesive capsulitis” renders the metes and bounds of the claim as unclear, as no direction is provided for the limitation of “some”; from the claim language, it is unclear as to which forms of adhesive capsulitis are treatable by the method, and which are not. Additionally, Claim 5 cites several semicolon-delimited, ambiguous conditions for which the metes and bounds are unclear, namely below:
“fibrotic topical or skin disorders or conditions;”
“diseases of the bones;”
“other hearing diseases or disorders;”
In regards to Claim 6, the phrase “certain types of cancers” renders the metes and bounds of the claim as unclear. The terminology “certain types” is too broad, as there may be even multiple types of a given cancer (i.e. Hodgkin’s/non-Hodgkin’s lymphoma), with specific, non-overlapping treatment modalities. The bounds of “certain types” are not clearly defined in the specification, and it is therefore unclear which types of cancers are treatable by the method, and which are not. A compound’s ability to treat a disease can be known and defined, and the specific metes and bounds pertaining to “certain types of cancers” be similarly defined and set. As those metes and bounds are not directly stated, it is unclear exactly what they are.
Therefore, Claim(s) 1-20 are rejected 35 U.S.C. 112(a), with Claim(s) 2-6 further rejected under 35 U.S.C. 112(b).
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.
Claim(s) 1 and 7-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over reference claim(s) 1-15 of U.S. Patent No. US 10,927,136 B2 (henceforth ‘136).
Claim 1 is found to be patentably indistinct from Reference Claim 1 of ‘136, as the reference claim details the same compound of Formula (I) with the analogous substituent limitations.
Claim 7 is found to be patentably indistinct from Reference Claim 2 of ‘136, as the reference claim details analogous limitations to R1 and R2.
Claim 8 is found to be patentably indistinct from Reference Claim 3 of ‘136, as the reference claim details analogous limitations for R3.
Claim 9 is found to be patentably indistinct from Reference Claim 4 of ‘136, as the reference claim details the analogous limitation to R3.
Claim 10 is found to be patentably indistinct from Reference Claim 5 of ‘136, as the reference claim details the analogous limitation to X.
Claim 11 is found to be patentably indistinct from Reference Claim 6 of ‘136, as the reference claim details analogous limitations for X.
Claim 12 is found to be patentably indistinct from Reference Claim 7 of ‘136, as the reference claim details the analogous limitation to X.
Claim 13 is found to be patentably indistinct from Reference Claim 8 of ‘136, as the reference claim details the analogous limitation to m.
Claim 14 is found to be patentably indistinct from Reference Claim 9 of ‘136, as the reference claim details the analogous limitation to m.
Claim 15 is found to be patentably indistinct from Reference Claim 10 of ‘136, as the reference claim details analogous limitations for n.
Claim 16 is found to be patentably indistinct from Reference Claim 11 of ‘136, as the reference claim details analogous limitation for JB.
Claim 17 is found to be patentably indistinct from Reference Claim 12 of ‘136, as the reference claim details the identical compound of Formula (V).
Claim 18 is found to be patentably indistinct from Reference Claim 13 of ‘136, as the reference claim details the identical compound of Formula (VI).
Claim 19 is found to be patentably indistinct from Reference Claim 14 of ‘136, as the reference claim details the identical claimed compound.
Claim 20 is found to be patentably indistinct from Reference Claim 15 of ‘136, as the reference claim details the identical claimed compound.
It is noted that the reference claims cover compounds while the Instant claims cover methods of treatment utilizing identical compounds. However, the Instant claims are found to be patentably indistinct from the reference claims because the limitations of the method are drawn to the compounds themselves, with limitations found to be nearly identical between the two documents. Furthermore, the “method of treating a disease, health condition or disorder in a subject in need thereof, wherein the disease, health condition or disorder is one that would benefit from sGC” of Instant Claim 1 is taught by ‘136 in the Summary of the Invention [Col. 2; lines 52-59]:
“In another embodiment, the invention relates to a method of treating a disease, health condition or disorder in a subject in need thereof, comprising administering, alone or in combination therapy, a therapeutically effective amount of a compound of Formula I, or a pharmaceutically acceptable composition thereof to the subject; wherein the disease or disorder is one that would benefit from sGC stimulation or from an increase in the concentration of NO and/or cGMP”
Therefore, Claim(s) 1 and 7-20 are rejected on the ground of nonstatutory double patenting.
Conclusion
No claims are allowed in this action.
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/STANLEY BRAM/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
