DETAILED ACTION
This office action supersedes the office action mailed out on April 28, 2026.
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 .
Election/Restrictions
Applicant’s election without traverse of the following species:
Parkinson's disease as the species of neurodegenerative condition;
L-dopa as the species of additional medicament; and
a patient population wherein the motor symptom that develops is slowed movement (bradykinesia) as the elected species of patient
in the reply filed on March 19, 2026 is acknowledged.
Claims 4, 11, 46, 48 and 50-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 19, 2026.
Please note applicant indicated claim 48 read on the elected species in the reply; However, said claim is drawn to a species non-elected (dopamine agonist), which also depends on claim 4 that does not read on the elected species; Therefore, the Examiner has determined said claim is drawn to a non-elected species.
Expansion of Election of Species Requirement
A reasonable and comprehensive search of the elected species conducted by the Examiner
discover a prior art by Nicoletti et al. that anticipates the claimed invention, wherein the prior art teaches impaired balance on a rotating cylinder as the motor symptom. In light of this discovery, the search is expanded to the subject matter of the motor symptom to include impaired balance in addition to the elected species (slowed movement [bradykinesia]), such that it does not encompass the full scope of the claims.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on March 19, 2026, wherein claims 1-12 and 46-53 are unchanged; and claim 13-34 are cancelled.
Claims 1-12 and 46-53 are pending.
Claims 4, 11, 46, 48 and 50-51 are withdrawn.
Claims 1-3, 5-10, 12, 47, 49 and 52-53 are under examination in accordance with the elected species along with the expanded species sets forth in the Expansion of Election of Species Requirement section above.
Priority
The instant application 18/511,027 filed on November 16, 2023 is a continuation of PCT/US2022/027294 filed on May 2, 2022, which claims priority to, and the benefits of U.S. Provisional Application No. 63/189,880 filed on May 18, 2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/189,880, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In this case, the prior-filed application fails to describe the following features:
the Parkinson's disease is parkinsonisms, idiopathic Parkinson disease, a parkinsonian syndrome, or vascular parkinsonism;
wherein the method further comprises administering at least one additional medicament to the patient; wherein the at least one additional medicament comprises at least one dopamine precursor; wherein the at least one additional medicament is administered at a delay time after a first administration of the composition; wherein the at least one dopamine precursor is selected from the group consisting of carbidopa, levodopa, DUOPA, INBRIJA, RYTARY, SINEMET, SINEMET CR, and STALEVO; wherein at least one motor symptom and/or at least one motor complication develops when at least one additional medicament has been excreted or metabolized to a sub-therapeutic concentration; wherein at least one motor symptom and/or at least one motor complication develops when the L-Dopa has been excreted or metabolized to a sub-therapeutic concentration;
wherein the at least one additional medicament is administered at a delay time after a first administration of the composition; wherein the delay time is equal to or greater than 2 years;
wherein at least one motor symptom and/or at least one motor complication develops in the patient; wherein the at least one motor symptom and/or the at least one motor complication develops at a time equal to or greater than 2 years after at least one additional medicament is administered; wherein the at least one motor symptom is selected from tremor and/or shaking in the extremities, slowed movement (bradykinesia), muscle stiffness, rigidity, immobility (freezing), muscle cramps, impaired posture, and/or balance, falls, dizziness, loss of automatic movements such as blinking or smiling, changes in speech and/or writing, motor fluctuations, dystonia, and any combination of the foregoing.
Therefore, to the extent that claims 1-3, 5-10, 12, 47, 49, 52-53 includes one of the features noted above, the claims are not entitled to the benefits of U.S. Provisional Application No. 63/189,880, and will receive an effective filing date of May 2, 2022, which is a filing date of PCT/US2022/027294.
Drawings
The drawings are objected to because the following matters:
Fig 4: vehicle and amantadine are each labeled as a circle, in which amantadine has a white hole inside; However, the circles illustrated in the dot graph are too small to tell whether it is supposed to have a white hole or not, for example (see box and arrow):
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is this upper circle a vehicle group or amantadine?
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Fig. 1: the figure includes the characters “*&”, “*&@”, “*&#”, “*&#$” that are not mentioned in the description.
Fig. 2: the figure includes the characters “*&” that is not mentioned in the description.
Fig. 3: the figure includes the characters “**” that is not mentioned in the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The disclosure includes reference: “U.S. Patent Number 8,252,947” that is not subsequently cited in an Information Disclosure Statement (IDS).
The use of the terms: “APOKYN”, “KYNMOBI”, “MIRAPEX”, “NEUPRO”, “PARLODEL”, “REQUIP”, “COMTAN”, “DUOPA”, “INBRIJA”, “RYTARY”, “SINEMET”, “SINEMET CR”, and “STALEVO” which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore, the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Interpretation
The claimed term “treat”, when reasonably construed in light of special definition recites in paragraph [0034] of the instant specification shown below:
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, is taken to include preventing the disease or symptoms.
The claimed term “patient”, when reasonably construed in light of the special definition provides in paragraph [0032] of the instant specification shown below:
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, is taken to include any mammals, including human and non-human mammals, and any non-human primate.
Claim Objections
Claims 2-3, 5-10, 12, 47, 49 and 52-53 are objected to because of the following informalities:
Regarding claim 7, the recitation of “the composition” is not being consistent with the term “pharmaceutical composition” set forth in claim 1; therefore, for the sake of clarity, the recitation should read –the pharmaceutical composition—, so it is clear that the composition recites therein is referring back to the pharmaceutical composition set forth in claim 1.
Regarding claim 47, the term “parkinsonisms” contains a letter “s” that appears to be a typographical error, said term should read – parkinsonism--.
Regarding claims 2-3, 5-10, 12, 47, 49 and 52-53, the term “Claim” recites in the sentence contains an uppercase “C”. Since only the first letter of the first word in sentence needs be capitalized, said term should read –claim--.
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.
Claims 1-3, 5-10, 12, 47, 49 and 52-53 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Instant claim 1 recites “[a] method to treat a neurodegenerative condition, the method comprising administering to a patient in need thereof an effective amount of a pharmaceutical composition comprising 17α-ethynylandrost-5-ene-3β,7β,17β-triol and at least one pharmaceutically acceptable excipient”. It is noted that the claimed term, when reasonably construed in light of the special definition provides in paragraph [0034] of the instant specification shown below:
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, is taken to include inhibiting or relieving the disease symptoms, preventing the disease or symptom thereof, partial or complete stabilizing or curing the disease and/or adverse effect attribute to the disease. The specification fails to sufficiently describe a representative number of species of “effective amount” in the method to reflect the claimed genus.
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
According to MPEP 2163 I, “[t]o satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116”. Additionally, according to MPEP II-A-3-a-ii, “[t]he written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406”; “[a] ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).”; and “’[a] patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.’ In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
In the instant case, the claims encompass a broad genus of any “effective amount” of the claimed pharmaceutical composition. The only factor presents in the specification is the definition of “effective amount” in paragraph [0033]:
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, such that it can be any effective amount for inhibiting, relieving, preventing, partial or complete stabilizing, and curing the neurodegenerative condition. In other words, Applicant does not describe a representative number of species of “effective amount”, aside from broad recitation that any effective amount of the claimed pharmaceutical composition can be used.
Therefore, in view of the foregoing, it is not apparent that applicant was actually in possession of the full scope of effective amount of the claimed pharmaceutical composition, based on the limited disclosure provided.
Claims 1-3, 5-10, 12, 47, 49 and 52-53 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 treating parkinsonism to the extent that treating does not include preventing and curing, does not reasonably provide enablement for treating the entire scope neurodegenerative condition to the extent that treating includes preventing and curing. 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.
Attention is directed to 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 nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and, (8) the quantity of experimentation necessary. All of the Wands factors have been considered and discussed below:
(1, 5) The breadth of the claims and the Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
Instant claim 1 recites “[a] method to treat a neurodegenerative condition, the method comprising administering to a patient in need thereof an effective amount of a pharmaceutical composition comprising 17α-ethynylandrost-5-ene-3β,7β,17β-triol and at least one pharmaceutically acceptable excipient”.
The claimed term “treat”, when reasonably construed in light of the special definition provides in paragraph [0034] of the instant specification shown below:
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, is taken to include inhibiting or relieving the disease symptoms, completely or partially preventing the disease or symptom thereof, partial or complete stabilizing or curing the disease and/or adverse effect attribute to the disease.
The claimed term “patient”, when reasonably construed in light of the special definition provides in paragraph [0032] of the instant specification shown below:
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, is taken to include any mammals, including human and non-human mammals, and any non-human primate. The claimed term “Parkinson’s disease” is reasonably construed in light of instant claim 47 shown below:
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, such that it includes parkinsonism, idiopathic Parkinson disease, a parkinsonian syndrome and vascular parkinsonism.
The claimed term “neurodegenerative condition” is reasonably construed its broadest reasonable interpretation to include any neurodegenerative condition known to those skilled in the art, including Alzheimer's disease and Parkinson's disease.
Thus, the breadth of the claims covers administering any effective amount of each and every pharmaceutical composition comprising 17α-ethynylandrost-5-ene-3β,7β,17β-triol and at least one of any pharmaceutically acceptable excipient to any patient for treating each and every neurodegenerative condition, such that the term “treating” includes inhibiting, relieving, completely or partially preventing, partial or complete stabilizing, and curing of said condition.
(2, 3, 4) The state of the prior art, the level of skill in the art, and the predictability or lack
thereof in the art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the
art would have known, at the time the application was filed, about the subject matter to which the
claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art
refers to the skill of those in the art in relation to the subject matter to which the claimed invention
pertains at the time the application was filed.”
As discussed above, the instantly claimed invention pertains to a method of treating each and every neurodegenerative condition, such that the term “treating” includes inhibiting, relieving, completely or partially preventing, partial or complete stabilizing, and curing of said condition.
At the time the application was filed, one skilled in the art would have known 17α-ethynyl-androst-5-ene-3β,7β,17β-triol is a synthetic androstenetriol in Phase II clinical development for the treatment of inflammatory disease according to Nicoletti et al. (Parkinson's disease, 2012. Vol. 2012: 969418)(see e.g., abstract). One skilled would have also known in the 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) model of Parkinson’s disease, the mice received 40 mg/kg gavage BID of 17α-ethynyl-androst-5-ene-3β,7β,17β-triol in an aqueous microsuspension (including carboxymethyl cellulose sodium salt) successfully decrease the loss of motor coordination induced by MPTP, decrease the expression of inflammatory mediators in the brains of MPTP-treated mice, and attenuate the loss of TH-positive neurons and decreased neuron damage, according to Nicoletti et al. (Parkinson's disease, 2012. Vol. 2012: 969418)(see e.g., p. 3, left column, line 8-11; abstract; p. 4, right column, “5. Discussion”, 1st paragraph). One skilled would have also known that the MPTP model of Parkinson disease is a model that uses MPTP to induce Parkinsonism according to Schneider et al. (Parkinson's Disease, academic Press, 2008. abstract.).
According to Carnegie Mellon University (“A cure for Alzheimer’s is taking longer than expected; here’s why” [Online]. Published on January 20, 2022), age is the most significant factor in whether a person shows symptoms of Alzheimer’s, and although diagnostic information to confirm the disease is improving, there are still no cures or treatments to slow down or stop the progression of the disease (see e.g., 2nd paragraph). Therefore, the cited reference demonstrates the relative skill of those in the art for treating or curing Alzheimer’s disease would have been low.
One skilled in the art would have also known that there’s no cure for Parkinson’s disease, including familial (genetic) Parkinson’s disease; and there’s no way to prevent it in many cases, because the exact reason Parkinson’s disease develops still isn’t fully understood, according to Cleveland Clinic (“Parkinson’s Disease” [Online]. Published on February 17, 2026) (see e.g., “What Is Parkinson’s Disease?”; “Types of Parkinson’s”; “Causes of Parkinson’s disease”). Therefore, the cited reference demonstrates the relative skill of those in the art for preventing and curing the entire scope of Parkinson’s disease would have been low.
While the pharmaceutical composition comprising 17α-ethynyl-androst-5-ene-3β,7β,17β-triol and carboxymethyl cellulose sodium salt administered at a dose of 40 mg/kg to a mice in the MPTP model of Parkinson’s disease may play a role in relieving parkinsonism-induced by MPTP, it is uncertain whether administering any effective amount of any pharmaceutical composition comprising 17α-ethynyl-androst-5-ene-3β,7β,17β-triol and at least one of any pharmaceutically acceptable excipient
can successfully treat the entire scope of neurodegenerative condition, to the extent that the term “treat” includes inhibiting, relieving, completely or partially preventing, partial or complete stabilizing, and curing of said condition.
(6, 7, 8) The amount of guidance given, the presence of working example and the quantitation
of experimentation required:
In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the claimed invention. In the absence of working examples, the quantity of experimentation necessary to carry out the entire scope of claimed invention is high. One of the relative skill in the art could not reasonably predict which neurodegenerative condition encompassed by the claims could be inhibit, relieve, completely or partially prevent, partial or complete stabilize, and cure by administering any effective amount of each and every pharmaceutical composition comprising 17α-ethynylandrost-5-ene-3β,7β,17β-triol and at least one of any pharmaceutically acceptable excipient, based on the limited disclosure. Therefore, it would require an undue experimentation as it is highly unpredictable that the administration of any effective amount of the claimed pharmaceutical composition to any patient would, in fact, be usable across the full scope of “treating” each and every neurodegenerative condition, to the extent that the term “treat” includes inhibiting, relieving, completely or partially preventing, partial or complete stabilizing, and curing of said condition.
Accordingly, the method of “treating” (includes inhibiting, relieving, completely or partially preventing, partial or complete stabilizing, and curing of said condition) the full scope of neurogenerative condition is not enabled by the instant specification. To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure.
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 7, 10 and 49 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.
Regarding claim 7, the recitation of “after a first administration of the composition” renders the claim indefinite, because said recitation can be interpreted in various way. For instance, said recitation can be interpreted such that the “first administration” referring back to the previous administration step set forth in claim 1 (“administering to a patient in need thereof an effective amount of a pharmaceutical composition comprising 17α-ethynylandrost-5-ene-3β,7β,17β-triol and at least one pharmaceutically acceptable excipient”); or it can be interpreted such that the “first administration” is another step in addition to the administration set forth in claim 1, and that gives a total of two administration. Given that the metes and bounds of the claim lacks clarity, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In order to advance prosecution, the Examiner is examining the claim to the extent that the “first administration” is referring back to the administration step set forth in claim 1(“administering to a patient in need thereof an effective amount of a pharmaceutical composition comprising 17α-ethynylandrost-5-ene-3β,7β,17β-triol and at least one pharmaceutically acceptable excipient”).
Regarding claim 10,
the phrase "such as" in the recitation of: “such as blinking or smiling” in line 4 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d);
the phrase “bradykinesia” and the phrase “freezing” are recited in the parenthesis that renders the claim indefinite, because it is unclear whether the limitation(s) recites in the parenthesis are part of the claimed invention.
Regarding claim 49, the contains the trademark/trade names: “DUOPA”, “INBRIJA”, “RYTARY”, “SINEMET”, “SINEMET CR”, and “STALEVO”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe carbidopa and/or levodopa and, accordingly, the identification/description is indefinite.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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 1-3, 5-6, 9-10, 12, 47, 49 and 52-53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nicoletti et al. (Parkinson's disease, 2012. Vol. 2012: 969418), as evidenced by Schneider et al. (Parkinson's Disease, academic Press, 2008. abstract.)
Nicoletti et al. teaches in a 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) murine model of Parkinson’s disease (PD), a four-day treatment schedule was initiated one hour after the last MPTP: group 3 received vehicle gavage twice daily (BID), and group 4 received 17α-ethynyl-androst-5-ene-3β,7β,17β-triol (HE3286) 40 mg/kg gavage BID (see e.g., p. 3, left column, line 8-11; abstract). Nicoletti et al. further teaches HE3286 was formulated for oral gavage as an aqueous microsuspension in 1 mg/mL carboxymethyl cellulose sodium salt, 9 mg/mL NaCl, 20 mg/mL polysorbate-80, and 0.5 mg/mL phenol (see e.g., p. 2, right column, line 7-11). Nicoletti et al. further teaches HE3286 readily permeated the blood-brain barrier (BBB), and that oral administration of HE3286 decreased the loss of motor coordination induced by MPTP, and decreased the expression of inflammatory mediators in the brains of MPTP-treated mice; Importantly, HE3286 attenuated the loss of TH-positive neurons and decreased neuron damage (see e.g., p. 4, right column, “5. Discussion”, 1st paragraph). Nicoletti et al. further teaches the effect of HE3286 on MPTP induce motor coordination impairment was evaluated by measuring the ability of animals to balance on a rotating cylinder (rotarod test) (see e.g., p. 4, “4.2 Effect of HE3286 Treatment MPTP-Induced Motor Impairment”). Nicoletti et al. further teaches MPTP treatment reduce the mean latency to fall from a baseline of 180.0 ± 0.0 sec to 59.2 ± 27.3 and 58.2 ± 27.5 sec in the absence of any treatment or vehicle treatment, respectively; and treatment with HE3286 after MPTP induction significantly increase the mean latency to fall to 90.9 ± 18.4 sec (see e.g., p. 4, “4.2 Effect of HE3286 Treatment MPTP-Induced Motor Impairment”). Nicoletti et al. further teaches in the subsequent experiments, L-DOPA (i.p.) in combination with HE3286 (40mg/kg gavage) were administered for 4 days beginning 1 hour prior to MPTP, and the mean latency for said combination was 84.0 ± 12.5 sec, similar to HE3286 initiated after MPTP induction (see e.g., Figure 2; p.4, left column, last paragraph). Nicoletti et al. further teaches the mice receive four intraperitoneal injections of 20 mg/kg MPTP two hours apart (see e.g., Col. 3, line 4-5 and 19-21).
In the instant case, Nicoletti et al. clearly teaches administering 40 mg/kg of 17α-ethynyl-androst-5-ene-3β,7β,17β-triol to a mice in the MPTP model of Parkinson’s disease can successfully improve motor function, and the 17α-ethynyl-androst-5-ene-3β,7β,17β-triol is formulated as a pharmaceutical composition (aqueous microsuspension) comprising carboxymethyl cellulose sodium salt. Please note the carboxymethyl cellulose sodium salt taught by Nicoletti et al. is a pharmaceutically acceptable excipient.
Regarding the limitation of “wherein at least one motor symptom and/or at least one motor complication develops in the patient” in claim 9, the limitation of “wherein the at least one motor
symptom is selected from…impaired posture and/or balance…” in claim 10, Nicoletti et al. clearly teaches MPTP injection in mice, a murine model of Parkinson’s disease, induce motor coordination impairment, resulting in a reduced mean latency to fall on the rotarod test (test the ability of mice to balance on a rotating cylinder) compared to baseline; and treatment with HE3286 after MPTP induction significantly increase the mean latency to fall. In other words, the mice in the MPTP murine model of Parkinson’s disease is a mice that develops impaired balance as one of the motor symptoms after MPTP treatment.
Regarding the limitation of “the Parkinson's disease is parkinsonisms…” in claim 47, Nicoletti et al. clearly teaches 17α-ethynyl-androst-5-ene-3β,7β,17β-triol for treating a mice in the MPTP model of Parkinson’s disease. Please note said Parkinson model is a model that uses MPTP to induce Parkinsonism (see e.g., abstract). In other words, the fact that Nicoletti et al. teaches the mice in MPTP model of Parkinson’s disease, parkinsonism will necessarily present in said mice.
Regarding the limitation of “the method further comprises administering at least one additional medicament to the patient” in claim 3, the limitation of “wherein the at least one additional
medicament comprises at least one dopamine precursor” in claim 5, the limitation of “wherein the at least one additional medicament comprises L-dopa” in claim 6, the limitation of “wherein the at least one dopamine precursor is selected from the group consisting of… levodopa” in claim 49, Nicoletti et al. clearly teaches in the subsequent experiments, L-3,4-dihydroxyphenylalanine (L-DOPA) is administered in combination with HE3286 (40mg/kg gavage) to a mice for 4 days. In other words, Nicoletti et al. clearly teaches the administration of L-DOPA and 40mg/kg of 17α-ethynyl-androst-5-ene-3β,7β,17β-triol formulated in a pharmaceutical composition (aqueous microsuspension) comprising carboxymethyl cellulose sodium salt to the same patient in need. Please note L-3,4-dihydroxyphenylalanine (L-DOPA) is also referred to as “levodopa” in the instant specification.
Regarding the limitation of “wherein the at least one motor symptom and/or the at least one motor complication develops at a time equal to or greater than 2 years after at least one additional medicament is administered” in claim 12, the limitation of “wherein at least one motor symptom and/or at least one motor complication develops when at least one additional medicament has been excreted or metabolized to a sub-therapeutic concentration” in claim 52, and “wherein at least one motor symptom and/or at least one motor complication develops when the L-Dopa has been excreted or metabolized to a sub-therapeutic concentration” in claim 53, these limitations appears to be the intended result or outcome of the method steps positively recited. However, by practicing the method of Nicoletti et al. set forth above (administering L-DOPA in combination with 4 of 17α-ethynyl-androst-5-ene-3β,7β,17β-triol in aqueous microsuspension to a mice for 4 days beginning 1 hour prior to MPTP), the features of “at least one motor symptom and/or at least one motor complication develops when at least one additional medicament has been excreted or metabolized to a sub-therapeutic concentration” and “at least one motor symptom and/or at least one motor complication develops when the L-Dopa has been excreted or metabolized to a sub-therapeutic concentration” will necessarily be present since the same additional medicament (L-DOPA) is being administered in the same combination (L-DOPA + 17α-ethynyl-androst-5-ene-3β,7β,17β-triol) to the same patient in need (a mice before MPTP-induction in the murine model of Parkinson’s disease). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. MPEP 2112 I states: “[t]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)”.
Therefore, the claimed invention is being anticipated by Nicoletti et al. et al.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-6, 9-10, 12, 47, 49 and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Nicoletti et al. (Parkinson's disease, 2012. Vol. 2012: 969418).
To the extent that the at least one motor symptom is the elected slowed movement (bradykinesia), then the following 35 U.S.C. 103 rejection applies.
The teachings of Nicoletti et al. are set forth above and applied as before.
Nicoletti et al. does not teaches the elected slowed movement (bradykinesia) as claimed in claim 10; However, Nicoletti et al. further teaches Parkinson’s disease is a neurodegenerative disorder characterized by a progressive degeneration of dopaminergic (DAergic) neurons in the substantia nigra pars compacta (SNpc) and decreased levels of dopamine in the putamen of the dorsolateral striatum; the loss of dopamine in the striatum manifests clinically as motor disabilities that include bradykinesia, resting tremor, and muscular rigidity (see e.g., p. 1, left column, line 1-7).
Regarding to the limitation of “wherein the at least one motor symptom is selected from… slowed movement (bradykinesia)” in claim 10, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to include a patient with a motor symptom of bradykinesia in the method of Nicoletti et al. set forth above. One would have been motivated to do so, because Nicoletti et al. teaches bradykinesia is a clinical symptoms of Parkinson’s disease results from the loss of dopamine in the striatum. One would have reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by including the patient that develops a clinical symptom of Parkinson’s disease, in this case, slowed movement (bradykinesia), the clinical symptom associated with said disease would also be treated by targeting the cause (Parkinson’s disease).
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claims 1-3, 5-10, 12, 47, 49 and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Nicoletti et al. (Parkinson's disease, 2012. Vol. 2012: 969418), in view of Philippens et al. (“Anti-Parkinson and anti-L-Dopa induced dyskinesia efficacy of HE3286 in a MPTP non-human primate model” [Online]. The Michael J. Fox Foundation for Parkinson's Research. Published online on June 2014) and Stochhi et al. (Transl Neurodegener, 2015. Vol. 4: 4).
The teachings of Nicoletti et al. are set forth above and applied as before.
Nicoletti et al. does not teach the at least one additional medicament is administered at a delay time after a first administration of the composition as claimed in claim 7. Nicoletti et al. does not teach the delay time is equal to or greater than 2 years as claimed in claim 8; However, Nicoletti et al. teaches prolonged treatment of Parkinson’s disease with L-DOPA usually results in a dyskinesia that can be more disabling than the disease itself (see e.g., p. 1, left column, line 10 to right column, line 1); Nicoletti et al. further teaches HE3286 is an ERK regulator, but not a classical inhibitor, may possess a useful therapeutic index for the treatment of neuroinflammatory disease; and ERK hyperactivation also has a pivotal role in other neuroinflammatory conditions, and importantly in the context of this study, L-DOPA, induced dyskinesia (see e.g., p. 6, right column, line 29-38).
Philippens et al. teaches HE3286 as a stand-alone Parkinson’s disease (PD) therapy may improve motor coordination and/or decrease levodopa-induced dyskinesia, or it may enhance the efficacy of levodopa; and HE3286 could be an alternative to levodopa for patients who have developed levodopa-induced dyskinesia or desire or need to postpone initiation of levodopa therapy (see e.g., p. 4, “Relevance to Diagnosis/Treatment of Parkinson’s Disease”). Philippens et al. further teaches HE3286 targets a molecular pathway that causes the loss of muscle coordination in Parkinson’s patients and the loss of muscle control caused by long-term levodopa therapy (levodopa-induced dyskinesia or LID) (see e.g., p. 1, “Objective/Rationale”; and p. 3, “Project Description”, last paragraph).
Stochhi et al. teaches until now, the recommendation that drug treatment should be delayed until the symptoms of Parkinson’s disease significantly limited the patient’s motor functions has become established in teaching and part of many guidelines (see e.g., p. 1, right column, last paragraph). Stochhi et al. further teaches the rationale for this was to protect the patients from unnecessary side effects, particularly the motor complications associated with levodopa (see e.g., p. 1, right column, last two line to p. 2, left column, line3).
Regarding the limitation of “wherein the at least one additional medicament is administered at a delay time after a first administration of the composition” in claim 7, the difference between the method of Nicoletti et al. and the claimed method is that the prior art initiated the administration of L-DOPA and 17α-ethynyl-androst-5-ene-3β,7β,17β-triol (40mg/kg) in combination and is silent regarding the order of administration. The instant situation is amenable to the type of analysis set forth in Ex parte Rubin , 128 USPQ 440 (Bd. App. 1959) and also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946), where the court found that the selection of any order of performing process steps is prima facia obvious in the absence of new or unexpected results. As such, applying the same logic to the instant process claims, one of ordinary skill in the art would have a reasonable expectation that by administering L-DOPA after 17α-ethynyl-androst-5-ene-3β,7β,17β-triol to the patient in the method of Nicoletti et al. set forth above would successfully treat the Parkinson’s disease; and by separating the administration of L-DOPA and 17α-ethynyl-androst-5-ene-3β,7β,17β-triol, it renders obvious the “time delay”. In the alternative, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the method of Nicoletti et al. by selectively choose to administer the L-DOPA at a time delay after the administration of 7α-ethynyl-androst-5-ene-3β,7β,17β-triol. One would have been motivated to do so, because Philippens et al. teaches long-term levodopa therapy causes loss of muscle control known as levodopa-induced dyskinesia, and HE3286, which is 17α-ethynyl-androst-5-ene-3β,7β,17β-triol taught by Nicoletti et al., is a stand-alone Parkinson’s disease therapy that can be an alternative to levodopa for patients who desire or need to postpone initiation of levodopa therapy; and Stochhi et al. teaches the rational for delaying drug treatment in Parkinson’s disease is to protect the patients from unnecessary side effects, particularly the motor complications associated with levodopa. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by administering the L-DOPA at a delay time after the administration of 17α-ethynyl-androst-5-ene-3β,7β,17β-triol can successfully protect the patients from unnecessary motor complications associated with levodopa.
Regarding the limitation of “wherein the delay time is equal to or greater than 2 years” in claim 8, it would have been prima facie obvious to one of ordinary skill in the art the time the application was filed to optimize the time delay for initiating the L-DOPA in the method of Nicoletti et al., Philippens et al., and Stochhi et al. set forth above through routine experimentation. One would have been motivated to do so, because Philippens et al. teaches delaying drug treatment is desirable to protect patients from unnecessary motor complications associated with levodopa, and is recommend to delay until the symptoms of Parkinson’s disease significantly limited the patient’s motor functions. One would have a reasonable expectation of success to arrive at the claimed invention through routine experimentation, because optimizing time delay for initiating L-DOPA therapy is known to protect the patients from unnecessary the motor complications associated with L-DOPA until the symptoms of Parkinson’s disease significantly limited the patient’s motor functions. Thus, the claimed range represents optimization of known results-effective variable, which would have been obvious. See In re Aller, 220 F.2d 454 (CCPA 1955).
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
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 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-7, 10-17, 19 and 21 of copending Application No. 19/055,380 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application is drawn to a method to treat, reduce or ameliorate of a neurodegenerative condition or disease in a subject in need thereof, the method comprising: administering to the subject a therapeutically effective amount of a composition comprising 17α-ethynyl-androst-5-ene-3β,7β,17β-triol and at least one pharmaceutically acceptable excipient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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