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 Office Action is in response to Applicant’s Arguments and Amendment filed, 07/02/2026, wherein the Amendment amended claims 1-5, cancelled claims 6-15, and added claims 16-25.
Claims 1-5 and 16-25 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant elected Group I, a pharmaceutical composition, in the reply filed on 09/18/2025.
Claims to all other inventions have been deleted. Thus, all pending claims are directed to Group I, the pharmaceutical composition.
As such, claims 1-5 and 16-25 are examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
35 U.S.C. § 112(b)
Applicant’s amendment to claims 2-4 and deletion of claims 6-9, is sufficient to overcome these rejections.
REJECTIONS-MODIFIED & NEW
Applicant’s amendment to the claims and addition of new claims has resulted in the below modified and new rejections.
Palczewski, Piercy, and Shibagaki continue to be relied upon as prior art references.
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.
(Modified) Claims 1-5, 16, 18-22 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0071285 to Palczewski (published 2018, PTO-892 of 01/05/2026) in view of Piercy (Pharmacology of pramipexole, a dopamine D3-preferring agonist useful in treating Parkinson’s disease, Clin. Neuropharmacol., published 1998, PTO-892 of 01/05/2026) and Shibagaki (Beneficial protective effect of pramipexole on light-induced retinal damage in mice, Experimental Eye Research, published 2015, PTO-892 of 01/05/2026).
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 claims 2 and 18-22, 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 claims 2 and 18-22, "[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.
Further regarding claim 5, Palczewski specifically teaches metoprolol tartrate as the salt form of metoprolol ([00-7], [0130], [0249]-Tables 5, 8, and 11), and Shibagaki teaches pramipexole dihydrochloride as the salt form of pramipexole (pg. 65, “2.2”).
Regarding claim 16, Palczewski teaches that its compounds are capable of forming salts and that such salts are within the scope of the claims. Palczewski further exemplifies specific salts and states, “Lists of salts are found in Remington’s Pharmaceutical Sciences” ([0077]-[0080]).
Regarding claim 25, Palczewski teaches its compositions as comprising pharmaceutically acceptable carriers ([0072]; ]0076]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0071285 to Palczewski (published 2018, PTO-892 of 01/05/2026) in view of Piercy (Pharmacology of pramipexole, a dopamine D3-preferring agonist useful in treating Parkinson’s disease, Clin. Neuropharmacol., published 1998, PTO-892 of 01/05/2026) and Shibagaki (Beneficial protective effect of pramipexole on light-induced retinal damage in mice, Experimental Eye Research, published 2015, PTO-892 of 01/05/2026), as applied to claims 1-5, 16, 18-22 and 25 above, and further in view of Pfizer (CARDURA XL, published 08/08/2016, PTO-892).
Palczewski, Piercy, and Shibagaki are applied as discussed above and incorporated herein.
Palczewski teaches that its compounds are capable of forming salts and that such salts are within the scope of the claims. Palczewski further exemplifies specific salts and states, “Lists of salts are found in Remington’s Pharmaceutical Sciences” ([0077]-[0080]).
Palczewski specifically teaches metoprolol tartrate as the salt form of metoprolol ([00-7], [0130], [0249]-Tables 5, 8, and 11).
Shibagaki teaches pramipexole dihydrochloride as the salt form of pramipexole (pg. 65, “2.2”).
The combination of Palczewski, Piercy, and Shibagaki differs from that of instant claim 17 in that it does not teach doxazosin mesylate.
Pfizer teaches doxazosin mesylate as a pharmaceutically acceptable salt form of doxazosin (pg. 1).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select mesylate as the salt form of doxazosin, to arrive at instant claim 18. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Palczewski teaches that its compounds, i.e., doxazosin can be in salt form, and
-Pfizer teaches doxazosin mesylate as a preferred salt form of doxazosin for pharmaceutical use.
As such, an ordinary skilled artisan would have been motivated to make such a selection, to predictably arrive at a pharmaceutically acceptable salt form of doxazosin for use in the combination of Palczewski, Shibagaki, and Piercy.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0071285 to Palczewski (published 2018, PTO-892 of 01/05/2026) in view of Piercy (Pharmacology of pramipexole, a dopamine D3-preferring agonist useful in treating Parkinson’s disease, Clin. Neuropharmacol., published 1998, PTO-892 of 01/05/2026) and Shibagaki (Beneficial protective effect of pramipexole on light-induced retinal damage in mice, Experimental Eye Research, published 2015, PTO-892 of 01/05/2026), as applied to claims 1-5, 16, 18-22 and 25 above, and further in view of Pfizer (CARDURA XL, published 08/08/2016, PTO-892), FDA Mirapex (published 2007, PTO-892), and FDA Lopressor (published 2008, PTO-892).
Palczewski, Piercy, and Shibagaki are applied as discussed above and incorporated herein.
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]).
The combination of Palczewski, Piercy, and Shibagaki differs from that of instant claims 23-24 in that it does not teach mg amounts.
Pfizer teaches that 4mg and 8mg amounts of doxazosin are known in the pharmaceutical art (pg. 1).
FDA Mirapex teaches that 0.125, 0.25, 0.5, 1, and 1.5 mg dosage amounts of pramipexole are known in the pharmaceutical art (pg. 1).
FDA Lopressor teaches that 50 and 100mg dosage amounts of metoprolol are known in the pharmaceutical art.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the dosage amounts taught by Pfizer, FDA Mirapex, and FDA Lopressor, as the amounts of doxazosin, pramipexole, and metoprolol in the combination of Palczewski, Piercy, and Shibagaki, to arrive at instant claims 23-24. One of ordinary skill in the art would have been motivated to make such selections, with a reasonable expectation of success, because:
-Palczewski teaches that determination of a therapeutically effective amount is within the capability of those skilled in the art and that the dosage can be chosen by the individual physician in view of the subject’s condition,
- Pfizer teaches that 4mg and 8mg amounts of doxazosin are known in the pharmaceutical,
-FDA Mirapex teaches that 0.125, 0.25, 0.5, 1, and 1.5 mg dosage amounts of pramipexole are known in the pharmaceutical art,
-FDA Lopressor teaches that 50 and 100mg dosage amounts of metoprolol are known in the pharmaceutical art, and
- "[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.
Response to Arguments
On pg. 6, Remarks, Applicant argues that a) a person of ordinary skill would not be motivated to replace bromocriptine with pramipexole because they are both D2/D3 dopamine agonists, and that such an allegation is unduly broad and is not supported by any evidence, and b) the fact that Palczewski mentions numerous possible combinations and dopamine agonists but without mentioning pramipexole shows that a person of ordinary skill in the art has no motivation to use pramipexole in the combinations described in Palczewski.
These arguments have been fully considered, but are not found persuasive. As discussed in the rejection:
-Palczewski specifically teaches a composition comprising bromocriptine, metoprolol, and doxazosin, for the treatment of diseases, such as macular degeneration,
-Palczewski teaches bromocriptine as a D2 dopamine agonist,
-Piercy teaches pramipexole as a D2 dopamine agonist, and
-Shibagaki teaches pramipexole as a potent D2/D3 agonist effective for the treatment of macular degeneration.
As such, and ordinary skilled artisan would have been motivated to add pramipexole to the composition comprising bromocriptine, metoprolol, and doxazosin, or to substitute the bromocriptine for pramipexole, to arrive at instant claim 1, to predictably arrive at a functionally similar D2 dopamine agonist that is effective in treating macular degeneration.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
On pgs. 6-7, Remarks, regarding MPEP 2144.06, Applicant argues that the examiner has not cited any evidence showing that bromocriptine and pramipexole were recognized as equivalent in Palczewski’s combination and points to the distinct structures of pramipexole and bromocriptine and further argues that it is well known in the pharmaceutical field that even a small change in structure can result in very different pharmaceutical activities.
These arguments have been fully considered, but are not found persuasive. As discussed above:
-Palczewski specifically teaches a composition comprising bromocriptine, metoprolol, and doxazosin, for the treatment of diseases, such as macular degeneration,
-Palczewski teaches bromocriptine as a D2 dopamine agonist,
-Piercy teaches pramipexole as a D2 dopamine agonist,
-Shibagaki teaches pramipexole as a potent D2/D3 agonist effective for the treatment of macular degeneration.
Thus, it is known in the art that bromocriptine and pramipexole are D2 dopamine agonists that are known in the art to treat macular degeneration. Therefore, as discussed in the above rejection, substituting equivalents (pharmaceutically effective D2 dopamine agonists) known for the same purpose (treating macular degeneration) is prima facie obvious, see MPEP 2144.06.
And while the examiner acknowledges that pramipexole and bromocriptine have distinct structures, they are both known in the art as pharmaceutically effective D2 dopamine agonists. And further, while the examiner acknowledges that small changes in structure can result in very different pharmaceutical activities, Applicant has provided no evidence that the D2 dopamine agonist activity of bromocriptine is “very different” from that of pramipexole. Applicant is respectfully reminded that the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965), see MPEP 716.01(c).
As such, Applicant’s arguments are not persuasive to overcome the rejections.
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 1-5, 16, and 18-25 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 or a salt thereof, pramipexole or a salt thereof, and metoprolol or a salt thereof (claim 1).
Regarding claim 1 and 25, 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 comprising a carrier 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 claims 2 and 18-24, "[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).
In view of ‘008’s definition of administration, an ordinary skilled artisan would reasonably expect that the methods of ‘008 can be administered orally.
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.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant argues that because the instant application has an earlier effective US filing date compared to the ‘008 application, the provisional nonstatutory double patenting rejection should be withdrawn.
This argument has been fully considered, but is not found persuasive since the Double Patenting rejection is not the only rejection remaining in the instant application. See MPEP 804(I)(b)(i).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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