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 .
Status of the Application
Claims 1-5 and 9-23 are pending in the application as of the response dated 12/08/2025. Claims 6-8 are cancelled. Claims 21-23 are newly added. Applicant’s election of a species of acute brain or nerve injury as stroke without traverse is acknowledged. Claims 1-5 and 9-23 are examined herein.
Priority
This application is a CON of 15/751,337 filed 02/08/2018 PAT 12042482, 15/751,337 is a 371 of PCT/US2016/046794 filed 08/12/2016 which claims priority to PRO 62/205,431 filed 08/14/2015.
The effective filing date of claims 1-5 and 9-23 is 08/14/2015 as the subject matter of the instant claims are supported by PRO 62/205,431.
Information Disclosure Statement
The information disclosure statement submitted on 06/18/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 14 is objected to because of the following informalities:
In claim 14, line 3, the limitation appearing at the end of the claim “for treating the brain or nerve injury” is redundant and may be removed.
Appropriate correction is required.
Drawings Objected To
The drawings are objected to because in Figure 4, the parameters of the bar graph are not very legible.
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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 10, 13, 15, 16-20 and 23 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 10, the claim recites “The method according to claim 9, wherein posiphen or the pharmaceutically acceptable salt of posiphen is administered intraocularly”. However, claim 9 is drawn to intravenous administration of posiphen or the pharmaceutically acceptable salt of posiphen. Intravenous administration and intraocular administration are distinct routes of administration. It is unclear how the same therapeutic agent can be administered by two different routes in the same method step. The metes and bounds of the claim are indefinite.
For the purpose of applying prior art, claim 10 has been interpreted to depend from claim 1.
Regarding claim 13, the claim recites “The method according to claim 12, wherein posiphen is administered intraocularly at a dose of 0.001 to 0.2 mg/kg body weight, or the pharmaceutically acceptable salt of posiphen is administered intraocularly at a dose that is equivalent to a posiphen dose of 0.001 to 0.2 mg/kg body weight”. However, claim 12 is drawn to intravenous administration of posiphen or the pharmaceutically acceptable salt of posiphen. Intravenous administration and intraocular administration are distinct routes of administration. It is unclear how the same therapeutic agent can be administered by two different routes in the same method step. The metes and bounds of the claim are indefinite.
For the purpose of applying prior art, claim 13 has been interpreted to depend from claim 1.
Regarding claim 15, the claim recites “consisting of administering an effective amount of posiphen, or a pharmaceutically acceptable salt of posiphen, to the subject in need thereof” and further recites the limitation “wherein the therapeutically effective amount is administered parenterally or orally”. The use of the transitional phrase “consisting of" excludes any element, step, or ingredient not specified in the claim (See MPEP 2111.03(II)). However, the oral and parenteral routes of administration call for different formulations with different excipients. The scope of the claim is unclear rendering the metes and bounds of the claim indefinite.
Additionally, there is insufficient antecedent basis for the limitation “the therapeutically effective amount” in claim 15.
For the purpose of applying prior art, claim 15 has been interpreted to read “comprising administering an effective amount of posiphen, or a pharmaceutically acceptable salt of posiphen, to the subject in need thereof wherein the effective amount is administered parenterally or orally”. The use of the transitional phrase “comprising” is supported by Para. [0006] and Para. [0022] of the instant specification.
Regarding claim 16, the claim recites “A method of treating acute brain or nerve injury in a subject consisting of administering … wherein posiphen, or the pharmaceutically acceptable salt of posiphen is administered before an episode of the acute brain or nerve injury”. The scope of the claim is indefinite because there is some ambiguity about the “subject” being treated. The preamble is drawn to “A method of treating acute brain or nerve injury in a subject”. However, the limitations drawn to “wherein posiphen, or the pharmaceutically acceptable salt of posiphen is administered before an episode of the acute brain or nerve injury” indicates that the subject has not yet had a brain or nerve injury. It is unclear as to whom the posiphen is being administered to. Thus, the metes and bounds of the claim are indefinite.
Claims 17-20 and 23 depend from claim 16 and are similarly rejected.
Additionally, regarding claim 17, the claim depends from claim 16, and recites “wherein posiphen, or a pharmaceutically acceptable salt of posiphen, is administered parenterally or orally”. Claim 16 recites the transitional phrase “consisting of administering an effective amount of posiphen, …" which excludes any element, step, or ingredient not specified in the claim (See MPEP 2111.03(II)). However, the oral and parenteral routes of administration call for different formulations with different excipients. The scope of the claim is unclear rendering the metes and bounds of the claim indefinite.
Similarly, the scope claims 18 and 20 are indefinite since they depend from claim 16 and are drawn to specific dosages of the “orally or intravenously administered (that require different excipients)” posiphen or a pharmaceutically acceptable salt of posiphen.
For the purpose of applying prior art, claim 16 has been interpreted to read “A method of preventing acute brain or nerve injury in a subject comprising administering an effective amount of posiphen, … wherein posiphen, or the pharmaceutically acceptable salt of posiphen is administered before an episode of the acute brain or nerve injury”. The use of the transitional phrase “comprising” is supported by Para. [0006] and Para. [0022] of the instant specification.
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.
Claims 1-2, 4-5 and 9-23 are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Ieni et al. (WO 2004/034963 A2, 29 April 2004, hereinafter Ieni, in the IDS), Maccecchini (US 2012/0225922 A1, 06 September 2012, in the IDS), Klein (Phenserine, 26 June 2007, in the IDS) and Lee et al. (Circulating beta amyloid protein is elevated in patients with acute ischemic stroke, 31 January 2005, hereinafter Lee).
Regarding instant claims 1-2, 5, 14-17, 19 and 21-23, Ieni teaches methods for treating and/or preventing disorders, such as anoxic brain injury (acute brain injury), strokes (the instantly elected species of acute brain injury), encephalitis by administering to a patient in need thereof a therapeutically effective amount of at least one cholinesterase inhibitor (Abstract; Pg. 1, Lns. 7-10; Pg. 1, Lns. 20-27). Ieni teaches the cholinesterase inhibitor is preferably an acetylcholinesterase inhibitor, such as phenserine (Pg. 12, Lns. 14-17). Ieni teaches the cholinesterase inhibitors can be administered in the form of a pharmaceutically acceptable salt, including salts of an organic acid (Pg. 21, Lns. 11-20). Ieni teaches the dosage regimen for treating and preventing the diseases described herein can be selected in accordance with a variety of factors, including the age, weight, sex, and medical condition of the patient, the route of administration, pharmacological considerations such as the activity, efficacy, pharmacokinetic and toxicology profiles of the drugs, etc. (Pg. 22, Lns. 9-14).
Ieni do not explicitly teach administering the (+)enantiomer of phenserine, i.e., posiphen, as instantly claimed.
Maccecchini teaches a method of preventing or treating neurotoxicity in a subject in need thereof, comprising administering to a subject (3aR)-13a,8-trimethyl 1.2.3,3a,8.8a-hexahydropyrrolo2,3-bindol-5-yl phenylcarbamate or a salt thereof (Abstract; Paras. [0022]-[0023]; Claim 19; Claim 20). Maccecchini teaches (3aR)-13a,8-trimethyl 1.2.3,3a,8.8a-hexahydropyrrolo2,3-bindol-5-yl phenylcarbamate to be posiphen or Compound (1) (Fig. 18). Maccecchini teaches posiphen optimally matches acetylcholinesterase (AChE) inhibitory activity with APP/Aβ lowering action (Para. [0016]). Maccecchini teaches the administration of posiphen (Compound (1)) caused reduction in Aβ40 levels in vivo (Para. [0042]; Fig. 15). Maccecchini teaches the AChE inhibition observed for posiphen was found to reside on the N'-desmethyl metabolite of posiphen and has a slow onset acetylcholinesterase inhibitory action (Para. [0017]). Maccecchini teaches posiphen to have an excellent toxicology profile and a much better safety profile than traditional AChE inhibitors in animals (Para. [0017]). Maccecchini teaches the compound may be administered as frequently as several times daily, or it may be administered less frequently, such as once a day, once a week, etc. (Para. [0125]). Maccecchini teaches the frequency of the dose will be readily apparent to the skilled artisan and will depend upon any number of factors, such as, but not limited to, the type and severity of the disease being treated, the type and age of the animal, etc. (Para. [0125]).
Klein teaches both enantiomers of phenserine reduce APP expression in cell culture and amyloid peptides in vivo in Alzheimer’s disease model (Abstract; Pg. 1094, first column, continued paragraph). Klein teaches the poor acetylcholinesterase (AChE) activity of (+)-phenserine (posiphen) may actually be an advantage for therapeutic purposes because (+)-phenserine largely lacks procholinergic (especially parasympathomimetic) effects and is tolerated in much higher doses than (−)-phenserine (Pg. 1092, first column, second full paragraph). Klein teaches (−)-phenserine exhibits adverse peripheral side effects at moderate doses (> 10 mg) and some centrally mediated adverse cholinergic responses (e.g., tremor) (Pg. 1093, second column, second full paragraph). Klein teaches the combination of the enantiomers of phenserine may be a promising aspect owing to its dual-action involving cholinesterase inhibitory (ChEI) and non- cholinesterase inhibitory (non-ChEI) activities (Pg. 1094, first column, last paragraph – second column, continued paragraph).
Lee teaches circulating Aβ1–40 was markedly elevated in patients with ischemic stroke, as compared to non-ischemic controls (Pg. 1376, fourth full paragraph). Lee teaches elevated circulating Aβ in ischemic stroke patients may be derived from the brain as a consequence of ischemic insults, since the level of serum Aβ was significantly correlated with the degree of brain damage, judged clinically and radiologically (Pg. 1376, last paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the combined teachings of Ieni, Maccecchini, Klein and Lee to have modified the method of Ieni to include posiphen OR substitute the active agent with posiphen, to arrive at the instant method of treating and/or preventing acute brain or nerve injury in a subject, say stroke, comprising administering an effective amount of posiphen, or a pharmaceutically acceptable salt of posiphen, to the subject in need thereof, with a reasonable expectation of success in treating such a condition. Ieni teaches methods for treating and/or preventing disorders, such as anoxic brain injury, strokes (the instantly elected species of acute brain injury), encephalitis by administering to a patient in need thereof a therapeutically effective amount of at least one cholinesterase inhibitor or a pharmaceutically acceptable salt thereof. Ieni teaches the cholinesterase inhibitor is preferably an acetylcholinesterase inhibitor, such as phenserine. Maccecchini teaches a method of preventing or treating neurotoxicity in a subject in need thereof, comprising administering to a subject (3aR)-13a,8-trimethyl 1.2.3,3a,8.8a-hexahydropyrrolo2,3-bindol-5-yl phenylcarbamate, i.e., posiphen or a salt thereof. Maccecchini teaches posiphen optimally matches AChE inhibitory activity with APP/Aβ lowering action. Maccecchini teaches posiphen to have an excellent toxicology profile and a much better safety profile than traditional AChE inhibitors in animals. Maccecchini teaches the administration of posiphen (Compound (1)) caused reduction in Aβ40 levels in vivo. Klein teaches both enantiomers of phenserine reduce APP expression in cell culture and amyloid peptides in vivo. Klein teaches the poor acetylcholinesterase (AChE) activity of (+)-phenserine (posiphen) may actually be an advantage for therapeutic purposes because (+)-phenserine largely lacks procholinergic (especially parasympathomimetic) effects and is tolerated in much higher doses than (−)-phenserine. Klein teaches (−)-phenserine exhibits inherent adverse peripheral and some centrally mediated side effects at moderate doses. Klein indicates the combination of the enantiomers of phenserine may be a promising aspect owing to its dual-action involving cholinesterase inhibitory (ChEI) and non- cholinesterase inhibitory (non-ChEI) activities. Lee teaches circulating Aβ1–40 was markedly elevated in patients with ischemic stroke, as compared to non-ischemic controls.
Therefore, one of ordinary skill in the art would have been motivated to include posiphen or a salt thereof, that effectively reduces the circulating levels of Aβ in a subject, as taught by the combined teachings of Maccecchini, Klein and Lee, in the method of Ieni to treat a subject who has experienced a stroke (the recitation of the transitional phrase “comprising” in claim 1 allows for administering additional unrecited elements, such as phenserine), to arrive at the method of the instant claims. The motivation being to provide an exemplary method of treating and/or preventing acute brain or nerve injury in a subject with a dual-action cholinesterase inhibitory (ChEI) and non- cholinesterase inhibitory (non-ChEI) activities, thereby effecting an improvement of cholinergic transmission, reduction of amyloid peptide formation and potentially anti-inflammatory and/or neurotrophic actions (Klein, Pg. 1094, second column, continued paragraph).
Alternatively, one of ordinary skill in the art would have been motivated to substitute the active agent of Ieni with posiphen or a salt thereof, that effectively reduces the circulating levels of Aβ in a subject, as taught by the combined teachings of Ieni, Maccecchini, Klein and Lee, to arrive at the method of the instant claims. The motivation being to provide an exemplary method of treating and/or preventing acute brain or nerve injury in a subject, with a much better safety profile, thereby reducing the risk of severe side effects (Maccecchini, Para. [0017]; Klein, Pg. 1093, second column, second full paragraph; Klein, Pg. 1092, first column, second full paragraph; Pg. 1093, first column, first paragraph; Pg. 1093, second column, last paragraph).
As stated in MPEP 2144.06 (II), “An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)”. In the instant case, both phenserine and posiphen, are taught to reduce APP expression in mouse models of AD, and are considered equivalents in the prior art.
Further, regarding the limitations of instant claim 14 drawn to “wherein posiphen or the pharmaceutically acceptable salt of posiphen is administered after an episode of the acute brain or nerve injury has occurred for treating acute brain or nerve injury” and claim 15 drawn to “wherein posiphen or the pharmaceutically acceptable salt of posiphen is administered after an episode of the acute brain or nerve injury”, the combined teachings of Ieni, Maccecchini, Klein and Lee render obvious the method of treating acute brain or nerve injury in a subject, say stroke, comprising administering an effective amount of posiphen, or a pharmaceutically acceptable salt of posiphen, to the subject in need thereof. The use of the phrase “a subject in need thereof” implicitly indicates the method step being carried out in a subject who has experienced acute brain or nerve injury, i.e., after an episode of acute brain or nerve injury. Therefore, the claim limitations of instant claims 14-15 have been met by the combined teachings of Ieni, Maccecchini, Klein and Lee.
Furthermore, regarding the limitations of instant claim 16 drawn to “wherein posiphen or the pharmaceutically acceptable salt of posiphen is administered before an episode of the acute brain or nerve injury”, see claim interpretation for claim 16 under the 35 U.S.C. 112(b) rejection above, where the claim has been treated as being drawn to the prevention aspect. The combined teachings of Ieni, Maccecchini, Klein and Lee render obvious the method of preventing acute brain or nerve injury in a subject, say stroke, consisting of administering an effective amount of posiphen, or a pharmaceutically acceptable salt of posiphen, to the subject in need thereof. Therefore, the claim limitations of instant claim 16 has been met by the combined teachings of Ieni, Maccecchini, Klein and Lee.
According to MPEP 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed treatment regimen of posiphen or a pharmaceutically acceptable salt thereof (as in instant claim 19). This is well within the skill of a person of ordinary skill in the pharmaceutical arts.
Regarding instant claims 4 and 9-10, the combined teachings of Ieni, Maccecchini, Klein and Lee render the method of instant claim 1 prima facie obvious. Ieni teaches the cholinesterase inhibitors can be administered orally, topically, parenterally, wherein parenteral routes include subcutaneous, intravenous, intramuscular administration (Pg. 23, Lns. 3-7). Maccecchini teaches suitable routes of administration to include oral, … parenteral, sublingual, … transmucosal (e.g., sublingual, lingual, (trans)buccal), … subcutaneous, intramuscular, … intravenous, … and topical administration (Para. [0133]). Maccecchini teaches parenteral administration to include the intraocular route (Para. [0146]). Therefore, the limitations of claims 4 and 9-10 with regard to routes of administration are rendered prima facie obvious.
Regarding instant claims 11-13, 18 and 20, the combined teachings of Ieni, Maccecchini, Klein and Lee render the method of instant claim 1 prima facie obvious. Ieni teaches the cholinesterase inhibitors can be administered to treat or prevent the diseases in doses of about 0.01 milligrams to about 300 milligrams per day (Pg. 22, Lns. 21-30). Maccecchini teaches typical dosages administered in the methods to an animal, preferably a human, range in an amount from 0.5µg to about 50 mg per kilogram of body weight of the animal (Para. [0106]; Para. [0103]). Maccecchini teaches the precise dosage administered will vary depending upon any number of factors, including but not limited to, the type of animal and type of disease state being treated, the age of the animal and the route of administration (Paras. [0106]-[0107]).
According to MPEP 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount of posiphen or a pharmaceutically acceptable salt thereof for the preferred route of administration, in the absence of any criticality of the recited amounts.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Ieni et al. (WO 2004/034963 A2, 29 April 2004, hereinafter Ieni, in the IDS), Maccecchini (US 2012/0225922 A1, 06 September 2012, in the IDS), Klein (Phenserine, 26 June 2007, in the IDS) and Lee et al. (Circulating beta amyloid protein is elevated in patients with acute ischemic stroke, 31 January 2005, hereinafter Lee) as applied to claims 1-2, 4-5 and 9-23 above, and further in view of Lahiri et al. (The Experimental Alzheimer’s Disease Drug Posiphen [(+)-Phenserine] Lowers Amyloid-β Peptide Levels in Cell Culture and Mice, 2007, hereinafter Lahiri, in the IDS).
The teachings of Ieni, Maccecchini, Klein and Lee are set forth in the obviousness rejection above and incorporated herein by reference.
Regarding instant claim 3, the combined teachings of Ieni, Maccecchini, Klein and Lee render the method of instant claim 1 prima facie obvious. Ieni do not teach wherein the pharmaceutically acceptable salt of posiphen is posiphen tartrate.
Maccecchini teaches the term "salt” embraces addition salts of free acids, with appropriate salts of organic acids to include tartaric acid (Para. [0087]; Para. [0097]).
Lahiri teaches posiphen administration lowered levels of both APP and Aβ in a dose-dependent manner (Abstract; Pg. 387, second column, second full paragraph). Lahiri teaches Aβ40 levels were significantly lowered by posiphen compared with controls in mouse models of AD (Pg. 391, second column, second full paragraph; Pg. 395, first column, first full paragraph). Lahiri exemplifies posiphen tartrate as the compound used in all experiments (Pg. 387, second column, third full paragraph).
Therefore, one of ordinary skill in the art would have been motivated to use posiphen tartrate as the salt of choice in the method of treating and/or preventing acute brain or nerve injury in a subject, in view of the teachings of Ieni, Lee, Maccecchini, Klein and Lahiri, to arrive at the method of the instant claims with a reasonable expectation of success. The motivation being to effectively lower β-secretase as well as APP, thereby addressing the increase in production of Aβ-40 that follows acute brain injury (Pg, 395, second column, continued paragraph).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-6 of U.S. Patent No. 12,042,482 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are drawn to a method of preventing acute brain or nerve injury in a subject (see claim interpretation in 35 U.S.C. 112(b) rejection above), consisting of administering an effective amount of posiphen, or a pharmaceutically acceptable salt of posiphen, to the subject in need thereof, wherein the therapeutically effective amount is administered parenterally or orally, wherein posiphen or the pharmaceutically acceptable salt of posiphen is administered before an episode of the acute brain or nerve injury.
The claims of the reference ‘482 patent are drawn to a method of treating an acute brain or acute nerve injury in a human subject, consisting of administering an effective amount of posiphen, or a pharmaceutically acceptable salt of posiphen intravenously, intramuscularly, subcutaneously, intraperitoneally, topically, orally, sublingually or buccally, to a human subject prior to the human subject experiencing the acute brain or acute nerve injury in order to reduce nerve cell death, wherein the posiphen or pharmaceutically acceptable salt thereof is administered within about 3 days before an episode of the acute brain or nerve injury and is thereafter administered for at least 7 days, and wherein posiphen or a pharmaceutically acceptable salt of posiphen is administered once, twice, three times or four times within the first day, second day or third day before the episode of the acute brain or acute nerve injury occurs, wherein the acute brain or acute nerve injury is traumatic brain injury.
Both sets of claims are drawn to a method of preventing an acute brain or acute nerve injury in a subject, consisting of administering an effective amount of posiphen, or a pharmaceutically acceptable salt of posiphen to a subject prior to the subject experiencing the acute brain or acute nerve injury.
Claims 1 and 4-6 of the reference ‘482 patent anticipates the oral/intravenous route of administration of instant claims 17-18 and 20, the oral and intravenous dosages as in instant claims 18 and 20 and the dosage schedule as in instant claim 19.
Therefore, instant claims 16-20 and claims 1 and 4-6 of the ‘482 patent are not patentably distinct.
This is a nonstatutory double patenting rejection.
Claims 1-5 and 9-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 10-11, 14-15 and 19-20 of U.S. Patent No. 12,144,798 B2 in view of Johnson et al. (Traumatic brain injury and amyloid-β pathology: a link to Alzheimer’s disease?, May 2010, hereinafter Johnson).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a method of treating a condition by administering posiphen, or a pharmaceutically acceptable salt thereof.
The instant claims are drawn to a method of treating acute brain or nerve injury in a subject comprising administering an effective amount of posiphen or a pharmaceutically acceptable salt of posiphen, to the subject in need thereof.
The claims of the reference ‘798 patent are drawn to a method of ameliorating Alzheimer's Disease in human patient consisting of administering a pharmaceutical composition consisting of posiphen or a pharmaceutically acceptable salt thereof.
The claims of the reference ‘798 patent do not teach treating acute brain or nerve injury in a subject.
Johnson teaches an association between traumatic brain injury (TBI) (a type of acute brain injury) and Alzheimer’s disease (AD) later in life (Abstract). Johnson teaches amyloid-β (Aβ) plaques - one of the hallmarks of AD - to be found in patients within hours following a TBI (Abstract). Johnson teaches the plaques found in TBI patients are strikingly similar to those observed in the early stages of AD (Pg. 361, third column, first full paragraph; Figure 1). Johnson teaches drug discoveries in the field of AD, such as BACE and γ-secretase inhibitors, may have potentially important roles in the management of both acute and chronic TBI (Pg. 367, second column, last paragraph). Claim 19 of the reference ‘798 patent teaches posiphen as an inhibitor of APP synthesis.
In view of the teachings of the reference ‘798 patent and Johnson, one of ordinary skill in the art would have been motivated to utilize posiphen, or a pharmaceutically acceptable salt of posiphen in a method of treating acute brain or nerve injury in a subject, with a reasonable expectation of success.
The claims of the reference ‘798 patent anticipates the oral and parenteral routes of administration of posiphen or a pharmaceutically acceptable salt of posiphen. The reference ‘798 patent teaches oral dosages of about 1 mg to about 30 mg/day and intravenous dosages of about 0.1 mg to about 25 mg/day of posiphen or a pharmaceutically acceptable salt of posiphen.
According to MPEP 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the instantly claimed oral and intravenous dosages of posiphen or a pharmaceutically acceptable salt of posiphen, based on the type and severity of the disease being treated, the type and age of the subject, etc.
The instant claims 1-5 and 9-15 are rendered obvious by claims 1-3, 10-11, 14-15 and 19-20 of the ‘798 patent in view of Johnson.
Therefore, the instant claims and claims of the ‘798 patent are not patentably distinct.
This is a nonstatutory double patenting rejection.
Conclusion
Claims 1-5 and 9-23 are rejected.
Claim 14 is objected to.
No claims are allowed.
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/PADMAJA S RAO/Examiner, Art Unit 1627