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 .
Priority
This Application is a 371 of PCT/US2022/025912, filed Apr. 22, 2022 and claims priority benefit of U.S. Provisional Application no. 63178578, filed Apr. 23, 2021.
Claim Status – Response to Restriction/ Election Requirement
Claims 1, 3-5, 7, 9, 29-31, 33, 34, 84, 117, 133, 144, 156, and 169-171 are currently pending.
Applicant’s election of Group II in the reply filed on April 13, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). The Applicant traversed on the grounds that a search for Group I and Group II would not create an undue burden on the office because both groups require administering an alpha-adrenergic antagonist for the treatment of an ocular condition. The requirement, however, was based on Unity of Invention for this 371 application and that unity was broken because alpha-adrenergic antagonists are known for the treatment of ocular conditions and therefore there was no special technical feature linking the groups of the invention. The Applicant does not distinctly and specifically point out the errors in the requirement for unity of invention, and therefore, the election is treated as an election without traverse.
The Applicant’s election, with traverse, of phentolamine mesylate and angle-closure glaucoma is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 84, 117, 133, 144, 156, 169, 170 and 172 read on the elected invention and are currently active and subject to examination.
Claims 1, 3-5, 7, 9, 29-31, 33, and 34 are withdrawn.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Rejections – 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
“(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.”
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
“Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.”
Claim 144 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 144 is directed towards the method of claim 84, wherein the patient experiences at least a 10% reduction in intraocular pressure in the eye due to the method. Claim 144 does not further limit the method of claim 84 because it merely recites a result to be achieved by the method. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 84, 144, 156, 169, 170, 171 and 172 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kostyuchenkov (Farmakologiya i Toksikologiya (Moscow), Volume 33, Issue 5, p. 569-72, 1970) (Machine translated with Google Translate) in view of Halasa et al. (Arch. Ophthalmol, Vol. 90, Sept. 1973, p. 177-179).
Claim 84 is directed towards a method selected from:
(a) treating acute angle-closure glaucoma in a patient, comprising administering to an eye of a patient in need thereof a dosage of an alpha-adrenergic antagonist selected from phentolamine or a pharmaceutically acceptable salt thereof in an amount effective to treat the acute angle-closure glaucoma;
(b) preventing angle-closure glaucoma in a patient, comprising administering to an eye of a patient in need thereof a dosage of an alpha-adrenergic antagonist selected from phentolamine or a pharmaceutically acceptable salt thereof in an amount effective to prevent angle-closure glaucoma; or
(c) treating or preventing a narrow angle attack in a patient, comprising administering to an eye of a patient in need thereof a dosage of an alpha-adrenergic antagonist selected from phentolamine or a pharmaceutically acceptable salt thereof in an amount effective to treat or prevent the narrow angle attack.
Kostyuchenkov teaches a method of treating glaucoma (reducing intraocular pressure) in a patient, comprising administering to a patient in need thereof a therapeutic dosage of phentolamine:
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Kostyuchenkov, p. 571 (machine translated with google translate).
Kostyuchenkov teaches that phentolamine can be administered to the eye of rabbits in order to decrease the intraocular pressure:
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Id.
Kostyuchenkov teaches that phentolamine can be administered to rabbits to prevent a reactive increase in intraocular pressure from subconjunctival injection of sodium chloride:
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Id.
Kostyuchenkov teaches that phentolamine blocks alpha-adrenergic receptors (id., p. 572).
While Kostyuchenkov teaches phentolamine for the treatment of glaucoma patients with varying degrees of glaucoma and intraocular pressure compensation, Kostyuchenkov does not specifically teach phentolamine for treating or preventing angle-closure glaucoma or treating or preventing narrow angle attack. One of ordinary skill in the art, however, would have a reasonable expectation of success to administer phentolamine to the eye of a patient in need of prevention or treatment of angle-closure glaucoma or narrow angle attack because it is commonly known in the art that similar alpha-adrenergic antagonists are effective for the treatment of angle-closure glaucoma and narrow angle attack.
For example, Halasa teaches that thymoxamine, a similar alpha-adrenergic antagonist, can be applied topically to the eye to treat angle-closure glaucoma/ narrow angle attack and decrease intraocular pressure in the eyes of patients with angle-closure glaucoma and narrow angle attack:
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Halasa, p. 177;
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Id., col. 1, p. 178;
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Id., col. 2-3, p. 178; col. 1, p. 179;
“Our results indicate that 0.5% thymoxamine was successful in breaking the attack of angle-closure glaucoma in cases 1 to 4” (Id., p. 179, col. 2).
Therefore, claim 84 was prima facie obvious at the time of filing.
Claim 144 is directed towards the method of claim 84, wherein the patient experiences at least a 10% reduction in intraocular pressure due to the method.
One of ordinary skill in the art would have a reasonable expectation of success to decrease the intraocular pressure of the patient by at least 10% because it is commonly known in the art that alpha-adrenergic antagonists can decrease intraocular pressure by at least 10%.
For example, Kostyuchenkov teaches that administration of phentolamine can decrease intraocular pressure by at least 10%:
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Fig. 1. Effect of phentolamine on normal ophthalmotonus.
1 - introduction of phentolamine reg os in a dose of 10 mg/kg;
2- intravenously at a dose of 5 mg/kg;
3- intravenously at a dose of 10 mg/kg;
4- subconjunctivally 0.5 ml 0.1% solvent
The abscissa axis shows time (in hours); the ordinate axis shows the change in intraocular pressure (in %).
Kostyuchenkov, Fig. 1, p. 570 (machine translated with google translate);
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Fig. 2. Effect of phentolamine on pathologically increased ophthalmotonus.
1 - administration of 0.5 ml of 10% NaCl solution under the conjunctiva;
2 - administration of phentolamine at a dose of 10 mg/kg;
3 - intravenously at a dose of 5 mg/kg,
4- intravenously at a dose of 10 mg/kg.
The abscissa axis shows time (in minutes); the ordinate axis shows the change in intraocular pressure (in %).
Kostyuchenkov, Fig. 2, p. 571 (machine translated with google translate);
For example, in Case 1 of Halasa, thymoxamine decreased intraocular pressure from 35 mmHg to 9 mmHg OD (74% decrease) and from 25 mmHg to 19 mmHg OS (24% decrease) (Halasa, col. 1, p. 178) and in Case 2, thymoxamine decreased intraocular pressure from 40 mmHg to 16 mmHg OD (60% decrease) and from 22 mmHg to 18 mmHg OS (18% decrease) (Id., col. 2).
Therefore, claim 144 was prima facie obvious at the time of filing.
Claim 156 is directed towards the method of claim 84, wherein the patient’s eye has an intraocular pressure greater than about 25 mmHg before the method is performed.
While Kostyuchenkov does not teach the intraocular pressure in the patients before the method is performed, one of ordinary skill in the art would have a reasonable expectation of success to perform the method on patients with an intraocular pressure greater than 25 mmHg because it is commonly known in the art that patients with angle-closure glaucoma with intraocular pressures greater than 25 mmHg can be treated with alpha-adrenergic antagonists.
For example, in Case 1 of Halasa, thymoxamine decreased intraocular pressure from 35 mmHg to 9 mmHg OD (74% decrease) and from 25 mmHg to 19 mmHg OS (24% decrease) (Halasa, col. 1, p. 178) and in Case 2, thymoxamine decreased intraocular pressure from 40 mmHg to 16 mmHg OD (60% decrease) and from 22 mmHg to 18 mmHg OS (18% decrease) (Id., col. 2).
Therefore, claim 156 was prima facie obvious at the time of filing.
Claim 169 is directed towards the method of claim 84, wherein the patient’s eye has a narrow angle. While Kostyuchenkov does not teach that the patient’s eye has a narrow angle, one of ordinary skill in the art would have a reasonable expectation of success to treat a patient with narrow angle because it is commonly known in the art that patients with narrow angle can be treated with alpha-adrenergic antagonists.
For example, Halasa teaches that thymoxamine can be used to treat patients with both narrow angles and closed angles (e.g. Halasa, case 1, p. 178).
Therefore, claim 169 was prima facie obvious at the time of filing.
Claim 170 is directed towards the method of claim 84, wherein the method is for treating acute angle-closure glaucoma in a patient, comprising administering to an eye of a patient in need thereof a dosage of an alpha-adrenergic antagonist selected from phentolamine or a pharmaceutically acceptable salt thereof in an amount effective to treat the acute angle-closure glaucoma.
As shown in the rejection of claim 84, Kostyuchenkov teaches a method of treating glaucoma in a patient, comprising administering to a patient in need thereof a therapeutic dosage of phentolamine, an alpha-adrenergic antagonist, and that phentolamine can be administered to the eye of a subject to reduce intraocular pressure.
While Kostyuchenkov does not specifically teach treating acute-angle closure glaucoma, one of ordinary skill in the art would have a reasonable expectation of success to treat acute-angle closure glaucoma with an alpha-adrenergic antagonist such as phentolamine because it is commonly known in the art that similar alpha-adrenergic antagonists can treat acute-angle closure glaucoma.
For example, see the teachings of Halasa shown in the rejection of claim 84.
Therefore, claim 170 was prima facie obvious at the time of filing.
Claim 171 is directed towards the method of claim 84, wherein the method is for preventing angle-closure glaucoma in a patient, comprising administering to an eye of a patient in need thereof a dosage of an alpha-adrenergic antagonist selected from phentolamine or a pharmaceutically acceptable salt thereof in an amount effective to prevent angle-closure glaucoma.
As shown in the rejection of claim 84, Kostyuchenkov teaches a method of treating glaucoma in a patient, comprising administering to a patient in need thereof a therapeutic dosage of phentolamine and that phentolamine can prevent a reactive increase in intraocular pressure from subconjunctival injection of sodium chloride in an animal model of glaucoma.
While Kostyuchenkov does not specifically teach administering phentolamine to prevent angle-closure glaucoma, one of ordinary skill in the art would have a reasonable expectation to prevent angle-closure glaucoma by administering an alpha-adrenergic antagonist because it is commonly known in the art that similar alpha-adrenergic antagonists can reverse an attack of angle-closure glaucoma and reduce intraocular pressure in patients with narrow angles.
For example, as shown in the rejection of claim 84, Halasa teaches that thymoxamine is effective to reverse an attack of angle-closure glaucoma and reduce intraocular pressure in patients with narrow angles.
Therefore, claim 171 was prima facie obvious at the time of filing.
Claim 172 is directed towards the method of claim 84, wherein the method is for treating or preventing a narrow angle attack in a patient, comprising administering to an eye of a patient in need thereof a dosage of an alpha-adrenergic antagonist selected from phentolamine or a pharmaceutically acceptable salt thereof in an amount effective to treat or prevent the narrow angle attack.
As shown in the rejection of claim 84, Kostyuchenkov teaches a method of treating glaucoma in a patient, comprising administering to a patient in need thereof a therapeutic dosage of phentolamine and that phentolamine can prevent a reactive increase in intraocular pressure from subconjunctival injection of sodium chloride in an animal model of glaucoma.
While Kostyuchenkov does not specifically teach administering phentolamine treat or prevent a narrow angle attack, one of ordinary skill in the art would have a reasonable expectation to treat or prevent a narrow angle attack by administering an alpha-adrenergic antagonist because it is commonly known in the art that similar alpha-adrenergic antagonists can treat or prevent a narrow angle attack.
For example, as shown in the rejection of claim 84, Halasa teaches that thymoxamine is effective to reverse an attack of angle-closure glaucoma and reduce intraocular pressure in patients with narrow angles.
Therefore, claim 172 was prima facie obvious at the time of filing.
Claim(s) 84, 117, 133, 144, 156, 169, 170 and 172 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kostyuchenkov (Farmakologiya i Toksikologiya (Moscow), Volume 33, Issue 5, p. 569-72, 1970) (Machine translated with Google Translate) in view of Halasa et al. (Arch. Ophthalmol, Vol. 90, Sept. 1973, p. 177-179), as applied to claims 84, 144, 156, 169, 170, 171 and 172 above, and further in view of Meyer (US 9,089,560 B2, Published July 28, 2015).
The rejection of claims 84, 144, 156, 169, 170, 171 and 172 above as unpatentable over Kostyuchenkov in view of Halasa is incorporated herein by reference.
Claim 117 is directed towards the method of claim 84, wherein the alpha-adrenergic antagonist is phentolamine mesylate.
As shown in the rejection of claim 84, Kostyuchenkov teaches phentolamine, an alpha adrenergic antagonist for the treatment of glaucoma and Halasa teaches alpha-adrenergic antagonists for the treatment of angle-closure glaucoma. As shown in the rejection of claim 84, Halasa teaches that alpha-adrenergic antagonists are effective to treat angle-closure glaucoma because they block the action of the dilator muscle to break the pupillary block.
While Kostyuchenkov does not teach that the phentolamine is phentolamine mesylate, one of ordinary skill in the art would have a reasonable expectation of success to apply phentolamine mesylate to angle-closure glaucoma because ocular formulations of phentolamine mesylate are commonly known in the art.
For example, Meyer teaches eye drops comprising phentolamine mesylate for reducing pupillary diameter, similar to the thymoxamine eye drops of Halasa:
Example 1
A clinical study was performed in which phentolamine mesylate was administered to eyes of patients suffering from severe night vision difficulty. Experimental procedures and results are described below.
Part I—Experimental Procedures
Sixty patients with normal day vision (i.e., 20/40 or better) but which suffer from severe night vision difficulty were enrolled in the study. During the first period of the study, patients were randomized into three groups. The groups received either placebo, 0.5% (w/v) phentolamine mesylate, or 1.0% (w/v) phentolamine mesylate once daily for 15 days. The patients were observed on days 1, 4, 8, and 15 prior to administering the ophthalmic solution of phentolamine mesylate and then observed again two hours after the ophthalmic solution of phentolamine mesylate was administered. During the second period of the study, all sixty patients were instructed to administer an ophthalmic solution of phentolamine mesylate (1% (w/v)) as needed, but no more than once daily to each eye. The ophthalmic solution of phentolamine mesylate contained: 1% (w/v) phentolamine mesylate, 4% (w/v) mannitol, 3 mM sodium acetate, and water. The placebo was a solution containing 4% (w/v) mannitol, 3 mM sodium acetate, and water.
Meyer, Specification, col. 25;
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Id., Fig. 9; “FIG. 9 shows the reduction in pupil diameter relative to baseline when measured two hours after that day's administration of phentolamine mesylate” (Id., Specification, col. 26).
Therefore, claim 117 was prima facie obvious at the time of filing.
Claim 133 is directed towards the method of claim 84, wherein the dosage of alpha-adrenergic antagonist contains from about 0.3 mg to about 0.7 mg of phentolamine mesylate.
As shown in the rejection of claim 144, Kostyuchenkov teaches to administer 0.5 mL of a 0.1% (1 mg/mL) solution of phentolamine subconjunctivally in a rabbit model of glaucoma, which is 0.5 mg, falling within the claimed range.
While Kostyuchenkov does not teach the amount of phentolamine mesylate, one of ordinary skill in the art would have a reasonable expectation of success to administer from about 0.3 mg to about 0.7 mg of phentolamine mesylate because similar dosages of phentolamine mesylate are commonly known in the art.
For example, Meyer teaches that “the daily dosage is about one eye drop per eye of an ophthalmic solution comprising from about 0.5% (w/v) to about 1.0% (w/v) phentolamine mesylate.” (Meyer, Specification, col. 10, lines 53-55) and “A standard eye drop typically contains from about 0.03 mL to about 0.05 mL of solution.” (id., col. 11, lines 4-5). This corresponds to a dosage of from about 0.15 mg (5 mg/mL* 0.03 mL) to about 0.5 mg (1 mg/mL* 0.05 mL) of phentolamine mesylate, overlapping with the claimed range. In the case where claimed ranges overlap the ranges disclosed by the prior art, a prima facie case of obviousness exists (MPEP § 2144.05).
Therefore, claim 133 was prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Nonstatutory 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 84, 117, 133, 144, 156, 169, 170 and 172 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,161,629 B2 (hereinafter “the ‘629 patent”). While the claims at issue are not identical, they are not patentably distinct because both the instant application and the claims of the ‘629 patent are directed towards treating closed-angle glaucoma comprising administering phentolamine mesylate to the eye of a patient in need thereof.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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