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 .
Election/Restrictions
Applicant’s election without traverse of patient inclusion criteria of possible or probable MSA of the Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C); sustained reduction in BP of ≥ 20 mmHg (systolic) or ≥ 10 mmHg (diastolic) within 3 minutes of standing as part of orthostatic standing test or being tilted up ≥60°C from a supine position as determined by a tilt table test; a score ≤4 on UMSARS Part IV at Visit 1 (screening) and a score of at least a 4 on the OHSA item 1 at visit 2 (Day 1); and required outcomes of the claimed administration method of supine plasma norepinephrine level greater than about 500 pg/mL after about 8 weeks of treatment (claim 18) in the reply filed on March 4, 2026 is acknowledged.
Due to the election in the alternative or “Parkinsonian subtype (MSA-P) or cerebellar subtype (MSA-C)” in the response filed March 4, 2026, Applicants were called to elect just one of these subtypes. In the telephone exchange with Nathan Lee on April 15, 2026, a further election of MSA-P was made.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to because color drawings are present and there is no granted petition to accept color drawings. 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.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 112 – Indefiniteness
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 30 is 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. The step(s) that are required by this claim is not clear. It would appear that some assessment or re-assessment of the subject is required given the conditional statement “if the subject is responsive to ampreloxetine or a pharmaceutically acceptable salt thereof” but such a step is not positively recited. The time frame of administration in claim 29, from which claim 30 depends, is at least 8 weeks so if the (re)assessment is carried out, it is not clear if this is done after 8 weeks of administration or at an earlier or later time frame. If this conditional statement is met, then the claim recites “further administering the pharmaceutical composition to the subject”. But the subject has already been receiving the pharmaceutical composition comprising ampreloxetine so the method can not further comprise such a step as it is already being done. Do Applicants mean that administration of the pharmaceutical composition is continued after the (re)assessment for longer periods of time than 8 weeks if the subject is deemed to be responsive? Please clarify.
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.
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.
Claim(s) 1 – 4, 11 – 16, 18, 26 – 31, 33 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Hegde (US 10,238,642).
Hegde discloses methods for treating neurogenic orthostatic hypotension (nOH) with 4-[2-(2,4,6-trifluorophenoxymethyl)phenyl]piperidine (ampreloxetine) or a pharmaceutically acceptable salt thereof (whole document, e.g., abstract). The salt form can be the hydrochloride salt (col 4, ln 61 – 62). nOH is a form of OH involving the nervous system, such as OH caused by a peripheral or central neurological disorder including Parkinson’s disease (col 1, ln 42 – 47). One objective of nOH treatment is to increase levels of norepinephrine such as by administering an agent that generates norepinephrine (col 1, ln 61 – col 2, ln 15) or by administering compounds that are inhibitors the norepinephrine transporter that re-uptakes norepinephrine (col 2, ln 16 – 37). Ampreloxetine is known as a serotonin and norepinephrine reuptake inhibitor (col 2, ln 62 onward). The compound can be administered to treat nOH and symptoms thereof in a patient by administering ampreloxetine or a pharmaceutically acceptable salt thereof to a subject that results in an increase in seated systolic blood pressure, increase in standing time and/or decrease in dizziness of lightheadedness experienced by the patient (col 3, ln 33 – 64). The ampreloxetine is typically administered in a pharmaceutical composition or formulation (col 7, ln 59 – 62) that typically contains a therapeutically effective amount of the ampreloxetine (col 8, ln 6 – 8). Unit dosages of 1, 3 5, and 10 mg are disclosed (col 8, ln 28). Any conventional or suitable pharmaceutically acceptable carrier may be used with carrier selection depending on factors including that mode of administration, dosage amount and frequency of dosing (col 8, ln 29 – 35). Representative examples of pharmaceutically acceptable carriers include lactose and microcrystalline cellulose (col 8, ln 46 – 50) and solid dosage forms for oral administration can comprise fillers or extenders such as microcrystalline cellulose or lactose and lubricants such as magnesium stearate (col 9, ln 11 – 32). In the clinical study of Example 16 (beginning at col 29, ln 5), a maximum dose of 10 mg was administered to subjects as part of a daily, single, escalating dose regimen (col 29, ln 14 – 20) Subjects were diagnosed with symptomatic OH due to pure autonomic failure, multiple system atrophy or Parkinson’s disease and had to demonstrate certain changes in blood pressure (BP) upon standing; impaired autonomic reflexes during the Valsalva maneuver; dizziness, light-headedness or fainting when standing and absence of other causes of autonomic neuropathy (col 29, ln 29 – 43). Efficacy was evaluated with once daily administration carried out 20 weeks in patients that were confirmed to be responsive in initial Part A of the study (col 29, ln 24 – 28).
Explicit administration of 10 mg of ampreloxetine or a pharmaceutical acceptable salt thereof to a patient diagnosed with MSA and nOH is not disclosed.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat symptomatic patients with MSA and nOH with a daily 10 mg dosage of ampreloxetine or a salt such as the HCl salt for time periods such as 8 weeks or longer. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Hegde discloses ampreloxetine for the treatment of such patients with a daily dosing regimen with dosages such as 10 mg. As the patients are diagnosed with these conditions, they are experiencing symptoms of nOH in the absence of treatment. Factors such as the dose and length of treatment can be routinely optimized by one of ordinary skill in the art based on their knowledge, guidance in the prior art such as Hegde as to suitable dosages and the response of the patient. One of ordinary skill in the art, upon observation of a therapeutic effect by showing improvement in at least one symptom would continue the dosing regimen to at least maintain the observed improvement or for possible additional therapeutic effect with continued administration of the ampreloxetine. There is no evidence of record as to the criticality of the claimed dosage regimen in a particular patient population.
Hegde does not disclose improvements in at least one of Orthostatic Hypotension Symptom Assessment (OHSA) composite score, Orthostatic Hypotension Daily Activities Scale (OHDAS) item 1 score (standing for a short time), and OHDAS item 3 score (walking for a short time) as required by claim 1; a measurable reduction at least one of (i) the subject's OHSA composite score, (ii) Orthostatic Hypotension Questionnaire (OHQ) composite score, (iii) Orthostatic Hypotension Daily Activity Scale (OHDAS) composite score, or (iv) OHDAS item 1 (standing short time) as required claim 14 or increase in supine norepinephrine levels recited in claim 18. All of these claim limitations reflect the therapeutic effect of ampreloxetine administration to a subject as required by each of the independent claims with nOH and MSA. As the same drug is given to the same patient population, the same effects on these assessment criteria reflecting improvement in the underlying condition will necessarily occur even if not explicitly assessed or reported by the applied prior art.
Claim(s) 4, 7 – 10, 14 – 16, 18, 23 – 28, 32 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Hegde as applied to claims 1 – 4, 11 – 16, 18, 26 – 31, 33 and 34 above, and further in view of Pavy-Le Traon et al. (J Neurol Neurosurg Psychiatry, 2015) and/or Kaufmann et al. (Clin Auton Res, 2012).
Hegde is discussed above.
Specific inclusion criteria based on the BP changes in tests, the Unified Multiple System Atrophy Rating Scale (UMSARS) Part IV scale, OHSA item 1, the OSHA composite score is not disclosed.
Pavy-Le Traon et al. discloses the evaluation of the severity of disease in a large number patients with possible or probable MSA (p 1, col 2, ¶ 4) using UMSARS at the same visit as BP measurements (p 2, col 1, ¶ 5). UMSARS is a validated, MSA-specific scale that assess various aspects including global disability (UMSARS IV). Higher scores indicate greater disease severity (p 2, col 1, ¶ 5). Supine hypertension is a hallmark of cardiovascular autonomic failure that is frequently associated with OH and severity of this was also assessed (p 2, col 1, ¶ 6).
Kaufmann et al. discloses the validation of the orthostatic hypotension questionnaire (OHQ) with two components – the Orthostatic Hypotension Symptom Assessment (OHSA) to measure the presence and severity of symptoms and the Orthostatic Hypotension Daily Activity Scale (OHDAS) to measure the impact of orthostatic symptoms on daily activities (whole document, e.g., abstract and p 80, col 1, ¶ 4). Orthostatic hypotension is defined operationally as a fall in systolic blood pressure of at least 20 mmHg and/or a fall in diastolic blood pressure of at least 10 mmHg within 3 min of standing (p 80, col 1, ¶ 3). There is no comprehensive validated symptom assessment questionnaire or validated disease specific activity questionnaire for orthostatic hypotension, arguably the most disabling symptom of autonomic failure and one that produces a diverse array of symptoms (p 87, col 1, ¶¶ 3 and 4). The OSHA part has 6 questions related to symptom severity and the OHDAS part has 4 questions assessing the impact of nOH symptoms on daily activities (p 81, col 1, ¶ 1 and Table 1). The composite OHQ score is calculated by averaging the OSHA and OHDAS scores (p 81, col 1, ¶ 2). The OHQ focuses on the full range of relevant symptoms, with assessments specific to the most prominent impairments of standing or walking for short or long periods of time and can accurately measure symptoms and the impact of nOH in a valid and reliable way (p 88, col 2, ¶ 2). This is of particular importance for an outcome measure used to assess the impact of treatment inventions and can detect change over time (p 88, col 2, ¶ 2).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate validated rubrics for assessing nOH generally and symptom severity such as those that greatly impact daily life such as standing or walking for short or long periods of time including UMSARS, OHQ, OHSA and/or OHDAS to confirm a diagnosis of MSA initially and also to evaluate the impact of treatments such as the ampreloxetine administration disclosed by Hegde. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pavy-Le Traon et al. and Kaufmann et al. discloses scales and systems for use with patients suspected of having or having nOH such as those being treated in Hegde. Higher scores indicate greater severity and one of ordinary skill in the art can use these validated systems for diagnosis that required treated with a therapeutic agent such as ampreloxetine and then to re-assess as treatment continues to determine the impact of treatment. There is no evidence of record as to the criticality of the diagnostic criteria for the patients being treated with ampreloxetine.
Claim(s) 1 – 5, 7 – 16, 18, 19, 23 – 35 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Hegde and optionally Pavy-Le Traon et al. and Kaufmann et al. as applied to claims 1 – 4, 7 – 16, 18, 23 – 34 and 37 above, and further in view of Fanciulli et al. (Mov Disorders, 2019).
Hegde, Pavy-Le Traon et al. and Kaufmann et al. are discussed above.
That the subject has MSA subtype P is not specifically disclosed.
Fanciulli et al. discloses that distinguishing the Parkinson variant of MSA (MSA-P) from Parkinson’s disease (PD) is often difficult at disease outset so a retrospective study of patients with MSA-P or PD that has undergone tilt table testing at early disease (p 440, col 1, ¶¶ 1 and 4). Orthostatic hypotension was one of four features from early disease associated with a final diagnosis of MSA-P (¶ bridging p 440 and 441). Patients at high risk for MSA may benefit from referral to specialized movement disorder centers and ultimately recruitment in ongoing neuroprotective studies (p 441, col 2, ¶ 4).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer ampreloxetine to subject with what could be PD or MSA with orthostatic hypotension in early disease as this is associated with MSA type-P and such patients could benefit from neuroprotective treatments. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Hegde discloses that patients with MSA or PD fall within the scope of patients to be treated and there is difficulty in distinguishing between them and patients MSA type-P could benefit from the ampreloxetine treatment disclosed by Hegde although OH in early disease is associated with high MSA-risk, suggesting that such patients could benefit from the ampreloxetine treatment disclosed by Hegde.
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 – 4, 7 – 12, 14 - 16, 18, 23 – 27, 29 - 34 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 24 of U.S. Patent No. 10,238,642 optionally in view of Pavy-Le Traon et al. (J Neurol Neurosurg Psychiatry, 2015) and/or Kaufmann et al. (Clin Auton Res, 2012).
The claims of US’642 recite a method for treating nOH and the symptoms thereof in a human patient with multiple system atrophy, pure autonomic failure or Parkinson’s disease by administering the compound of formula I in claim 1, which is ampreloxetine, or a pharmaceutically salt thereof. The salt can be the hydrochloride salt (claim 6). A pharmaceutically acceptable carrier and the compound can also be administered (claim 13). Claimed dosages includes about 1 mg/day to about 10 mg/day (claim 12).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat symptomatic patients with MSA and nOH with a daily 10 mg dosage of ampreloxetine or a salt such as the HCl salt for time periods such as 8 weeks or longer. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because US’642 ampreloxetine for the treatment of such patients with a daily dosing regimen with dosages such as 10 mg. As the patients are diagnosed with these conditions, they are experiencing symptoms of nOH in the absence of treatment. Factors such as the dose and length of treatment can be routinely optimized by one of ordinary skill in the art based on their knowledge, guidance in the prior art such as Hegde as to suitable dosages and the response of the patient. One of ordinary skill in the art, upon observation of a therapeutic effect by showing improvement in at least one symptom would continue the dosing regimen to at least maintain the observed improvement or for possible additional therapeutic effect with continued administration of the ampreloxetine. There is no evidence of record as to the criticality of the claimed dosage regimen in a particular patient population.
US’642 does not claim improvements in at least one of Orthostatic Hypotension Symptom Assessment (OHSA) composite score, Orthostatic Hypotension Daily Activities Scale (OHDAS) item 1 score (standing for a short time), and OHDAS item 3 score (walking for a short time) as required by claim 1; a measurable reduction at least one of (i) the subject's OHSA composite score, (ii) Orthostatic Hypotension Questionnaire (OHQ) composite score, (iii) Orthostatic Hypotension Daily Activity Scale (OHDAS) composite score, or (iv) OHDAS item 1 (standing short time) as required claim 14 or increase in supine norepinephrine levels recited in claim 18. All of these claim limitations reflect the therapeutic effect of ampreloxetine administration to a subject as required by each of the independent claims with nOH and MSA. As the same drug is given to the same patient population, the same effects on these assessment criteria reflecting improvement in the underlying condition will necessarily occur even if not explicitly assessed or reported by the applied prior art.
Specific inclusion criteria based on the BP changes in tests, the Unified Multiple System Atrophy Rating Scale (UMSARS) Part IV scale, OHSA item 1, the OSHA composite score is not disclosed.
Pavy-Le Traon et al. and Kaufmann et al. are discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate validated rubrics for assessing nOH generally and symptom severity such as those that greatly impact daily life such as standing or walking for short or long periods of time including UMSARS, OHQ, OHSA and/or OHDAS to confirm a diagnosis of MSA initially and also to evaluate the impact of treatments such as the ampreloxetine administration claimed by US’642. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because Pavy-Le Traon et al. and Kaufmann et al. discloses scales and systems for use with patients suspected of having or having nOH such as those being treated in US’642. Higher scores indicate greater severity and one of ordinary skill in the art can use these validated systems for diagnosis that required treated with a therapeutic agent such as ampreloxetine and then to re-assess as treatment continues to determine the impact of treatment. There is no evidence of record as to the criticality of the diagnostic criteria for the patients being treated with ampreloxetine.
Claims 1 – 4, 7 – 16, 18, 23 – 34 and 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 24 of U.S. Patent No. 10,238,642 optionally in view of Pavy-Le Traon et al. (J Neurol Neurosurg Psychiatry, 2015) and/or Kaufmann et al. (Clin Auton Res, 2012) further in view of Hegde (US 2018/0055831; Hegde-831).
The claims of US’642, Pavy-Le Traon et al. and Kaufmann et al. are discussed above.
While a pharmaceutically acceptable carrier for the ampreloxetine is claimed in US’642, specific ingredients for the pharmaceutically acceptable carrier are not claimed.
Hegde discloses when intended for oral administration as solid dosage form, the composition may also comprise fillers or extenders such as microcrystalline cellulose or lactose and lubricants such as magnesium stearate (¶ [0057]).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use ingredients such as microcrystalline cellulose, lactose and/or magnesium stearate as part of the pharmaceutically acceptable carrier to prepare an oral solid dosage form comprising ampreloxetine to a subject as claimed in US’642. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because based on the knowledge of one of ordinary skill in the art and the disclosure of Hegde, various excipients including microcrystalline cellulose, lactose and magnesium stearate are well-known excipients in the art for the formation of dosage forms for oral administration.
Claims 1 – 5, 7 – 12, 14 - 16, 18, 19, 23 – 27, 29 - 35 and 37 are are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 24 of U.S. Patent No. 10,238,642 optionally in view in of Pavy-Le Traon et al. (J Neurol Neurosurg Psychiatry, 2015) and/or Kaufmann et al. (Clin Auton Res, 2012) further in view of Fanciulli et al. (Mov Disorders, 2019).
The claims of US’642, Pavy-Le Traon et al. and Kaufmann et al. are discussed above.
That the subject has MSA subtype P is not specifically disclosed.
Fanciulli et al. is discussed above.
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to administer ampreloxetine to subject with what could be PD or MSA with orthostatic hypotension in early disease as this is associated with MSA type-P and such patients could benefit from neuroprotective treatments. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because US’642 claimed treatment of patients with MSA or PD and there is difficulty in distinguishing between them and patients MSA type-P could benefit from the ampreloxetine treatment disclosed by Hegde although OH in early disease is associated with high MSA-risk, suggesting that such patients could benefit from the ampreloxetine treatment disclosed by Hegde.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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, Michael Hartley can be reached at 571-272-0616. 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.
/Nissa M Westerberg/Primary Examiner, Art Unit 1618