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 .
DETAILED ACTION
This action is responsive to the Response to Election/Restriction filed 09/18/2025.
Claims 1-15 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant’s election without traverse of Group I, a pharmaceutical composition, in the reply filed on 09/18/2025, is acknowledged.
Claims 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-9 are examined on the merits herein.
Claim Rejections - 35 USC § 112(b)
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 2-4 and 6-9 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.
-In claims 2-4, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention or merely exemplary. See MPEP § 2173.05(d).
In view of compact prosecution, for the purpose of applying prior art, the limitations following “preferably” are interpreted as exemplary and as not further limiting the claims.
-Claims 6-9 recite the limitation "the chronic kidney disease" in lines 1-2. There is insufficient antecedent basis for these limitations in the claims.
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 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 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0071285 to Palczewski (published 2018, PTO-892) in view of Piercy (Pharmacology of pramipexole, a dopamine D3-preferring agonist useful in treating Parkinson’s disease, Clin. Neuropharmacol., published 1998, PTO-892) and Shibagaki (Beneficial protective effect of pramipexole on light-induced retinal damage in mice, Experimental Eye Research, published 2015, PTO-892).
Palczewski teaches a method of treating an ocular disorder, or a geographic atrophy, such as Stargardt disease, macular degeneration, retinitis pigmentosa, or diabetic retinopathy, comprising administering bromocriptine, metoprolol, and doxazosin, to a subject (pg. 52, claims 1-6, 10-15).
Palczewski teaches administering to the subject a therapeutically effective amount of the agents alone or in combination and teaches that the exact formulation, route of administration, and dosage is chosen by the individual physician ([0144]). Palczewski explicitly teaches administering a combination of bromocriptine, metoprolol, and doxazosin ([0044]-[0045]; [0056]; [0249]; [0284]).
Palczewski teaches pharmaceutical compositions using its described agents, for use in modes of administration ([0150]).
Regarding claim 1, while Palczewski teaches a composition comprising bromocriptine, doxazosin, and metoprolol, it differs from that of instant claim 1 in that it does not teach pramipexole.
Palczewski teaches bromocriptine as a Dopamine receptor D2 agonist that targets the GPCRs (pg. 40, Table 9).
Piercey teaches pramipexole as a dopamine agonist that has high selectivity for interacting with dopamine D2 subfamily receptors, wherein pramipexole provides neuroprotective effects through depression of dopamine metabolism, antioxidant effects, and stimulation of trophic activity (abstract).
Shibagaki teaches pramipexole as a potent dopamine D2/D3 agonist that is effective for the treatment of macular degeneration (abstract; pg. 65, Col. 1; pg. 71).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective fling date of the instantly claimed invention, to substitute the bromocriptine of Palczewski with pramipexole, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
- Palczewski teaches bromocriptine as a D2 dopamine agonist,
-Piercey and Shibagaki teach pramipexole as a dopamine agonist with high selectivity for the dopamine D2 receptor,
- Palczewski teaches its compositions for the treatment of macular degeneration,
-Shibagaki teaches pramipexole for the treatment of macular degeneration, and
-substituting equivalents known for the same purpose is prima facie obvious, see MPEP 2144.06.
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a pharmaceutical composition comprising a D2 dopamine agonist effective for the treatment of macular degeneration.
Alternatively, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective fling date of the instantly claimed invention, to add pramipexole to the composition of Palczewski, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
- Palczewski teaches bromocriptine as a D2 dopamine agonist,
-Piercey and Shibagaki teach pramipexole as a dopamine agonist with high selectivity for the dopamine D2 receptor,
- Palczewski teaches its compositions for the treatment of macular degeneration,
-Shibagaki teaches pramipexole for the treatment of macular degeneration, and
-"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). MPEP 2144.06
As such, an ordinary skilled artisan would have been motivated to make such an addition, to predictably arrive at a more potent/therapeutically effective pharmaceutical combination for the treatment of macular degeneration.
Regarding claim 2, Palczewski teaches that treatment methods include administering to the subject a therapeutically effective amount of the agents alone or in combination, and that determination of a therapeutically effective amount is within the capability of those skilled in the art. The exact formulation, route of administration and dosage can be chosen by the individual physician in view of the subject’s condition ([0144]; [0147]-[0149]).
Further regarding claim 2, "[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," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences. It has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
As such, an ordinary skilled artisan would have been motivated to modify the amounts of doxazosin, pramipexole, and metoprolol, to predictably arrive at the most therapeutically effective composition for the treatment of ocular disorders, such as macular degeneration, with the least amount of side effects.
Regarding claims 3-4, Palczewski teaches oral administration ([0145]).
Regarding claim 5, the combination of Palczewski, Piercey and Shibagaki, teaches a composition comprising doxazosin, pramipexole, and metoprolol. Claim 5 depends from claim 1 and further limits the “pharmaceutically acceptable salt” of pramipexole, metoprolol, and/or doxazosin. However, claim 5 does not limit the pramipexole, metoprolol, and/or doxazosin to a salt form. As such, claim 5 is interpreted as if the doxazosin, pramipexole, and metoprolol are in salt forms, then the salts are those recited in lines 2-5 of claim 5. Since the combination of Palczewski, Piercey and Shibagaki, does not teach salt forms, the limitations of claim 5 are met.
Claim 6-9 are directed toward the intended use of the instantly claimed composition. Applicant is reminded that if the prior art composition is capable of performing the intended use, then it meets the limitations of the claim; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim (MPEP 2112.01 and 2111.02). Since the combined composition of Palczewski, Piercey and Shibagaki is capable of performing the instantly claimed intended uses, the limitations of these claims are met.
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/apply/applying-online/eterminal-disclaimer.
Claims 1-9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/562,008 (claim set dated 07/03/2024, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘008 claims a method of treating, preventing, or improving ischemic stroke, and other diseases, in a subject, by administering a therapeutically effective amount of doxazosin, pramipexole, and metoprolol (claim 1).
While’008 does not explicitly state administering a therapeutically effective amount of the doxazosin, pramipexole, and metoprolol, in a composition, an ordinary skilled artisan would have been motivated to select a composition to administer the three active agents to predictably arrive at a simple means of administering the active agents with greater patient adherence, to treat the claimed diseases, since administering a single formulation or tablet, is less complicated and quicker than administering three individual formulations. Moreover, pg. 17 of ‘008 teaches its invention in the form of a single pharmaceutical composition.
Regarding claim 2, "[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," MPEP 2144.05(II).
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences. It has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 3-4, ‘008 defines “administration” as “an act of delivering, or causing delivery of, a compound or pharmaceutical component/composition to the body of a subject by a method described herein or known in the art. Administering a compound or pharmaceutical component/composition includes prescribing the compound or pharmaceutical component/composition to be delivered to a subject’s body. Exemplary forms of administration include oral dosage forms, such as tablets, capsules, syrups, suspensions, injectable dosage forms (pgs. 26-27).
Regarding claim 5, ‘008, teaches a composition comprising doxazosin, pramipexole, and metoprolol. Claim 5 depends from claim 1 and further limits the “pharmaceutically acceptable salt” of pramipexole, metoprolol, and/or doxazosin. However, claim 5 does not limit the pramipexole, metoprolol, and/or doxazosin to a salt form. As such, claim 5 is interpreted as if the doxazosin, pramipexole, and metoprolol are in salt forms, then the salts are those recited in lines 2-5 of claim 5. Since ‘008, does not teach salt forms, the limitations of claim 5 are met.
Claim 6-9 are directed toward the intended use of the instantly claimed composition. Applicant is reminded that if the prior art composition is capable of performing the intended use, then it meets the limitations of the claim; the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim (MPEP 2112.01 and 2111.02). Since the composition of ‘008 is capable of performing the instantly claimed intended uses, the limitations of these claims are met.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622