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 response to communication filed on 04/27/2026.
Election/Restriction
Applicant elected, with traverse, 1) a method of improving visual performance in a patient comprising administering a daily dosage of phentolamine or a pharmaceutically acceptable salt thereof; and the species, 2) “an improvement in visual acuity”, in the reply filed on 04/27/2026.
Applicant identified claims 1-4, 8, 12 and new claims 48-58, read on the above elected species. The traversal is on the ground(s) that “search for publications relating to the elected species should reveal publications relating to the other species and, thus, would not impose a serious burden” .
Applicant’s argument is not persuasive because, as set forth in the election/restriction requirement mailed on 10/29/2025, a method of improving visual performance and method of reducing pupil diameter are directed to different subject matter with different intended treatment outcome of administrating phentolamine and are not obvious variants of each other based on the record. While reducing pupil size sharpens the image, it simultaneously reduces the amount of light reaching the retina, which can impair vision in low-light environments. Different search strategies and search queries would be needed for different method species with different treatment outcome. There is serious examination burden for different method species with different treatment outcome. As such, the requirement is still deemed proper and is therefore made FINAL.
Applicant identified claims 1-4, 8, 12 and new claims 48-58, read on the above elected species. Claims 13-20 and 59-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species there being no allowable generic or linking claim.
Status of Claims
Claims 1-4, 8, 12-20, and 48-61 are pending in the instant application.
Claims 13-20 and 59-61 are withdrawn.
Claims 1-4, 8, 12, and 48-58 are currently under examination.
Priority
This instant application 18/209,783, filed 06/14/2023, is a continuation of U.S. application No 17/229,061 (now U.S. patent No. 11717510), filed April 13, 2021, which is a continuation of U.S. Patent application serial number 15/714,475 (now U.S. Patent 11,000,509), filed September 25, 2017, which is a continuation of U.S. Patent Application serial number 14/754,965 (now U.S. Patent 9,789,088), filed June 30, 2015, which is a continuation of U.S. Patent Application serial number 14/169,342 (now U.S. Patent 9,089,560), filed January 31, 2014, which claims the benefit of and priority to United States Provisional Patent Application serial number 61/759,542, filed February 1, 2013.
Information Disclosure Statement
The information disclosure statements filed 11/30/2023 are in compliance with the provisions of 37 CFR 1.97. The copy of non-patent document are provided in parent application No 17/229,061. Accordingly, the relevant reference listed in IDS are being considered by the examiner.
Claim Interpretation
Independent claims recite “improving visual performance”, “minimizing eye redness”, “improved visual performance for at least twenty-four hours”, “improved visual acuity” , “improved contrast sensitivity”, etc. These recitation are construed as intended treatment outcome and/or intended results of the active method step of administering phentolamine mesylate in a therapeutically effective amount, which do not materially limit the claimed method since such limitations do not result in manipulative difference in method steps of the claims.
Please note biological/pharmaceutical activities are the properties of phentolamine and salt thereof. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). If the prior art teaches and suggests the same or similar method step as instantly claimed (i.e. administering phentolamine or salt thereof in a therapeutically effective amount to a subject in need thereof), the method of the prior art would have achieved the intended results as recited in instant claims and read on instant claimed methods.
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 1-4, 8, 12, and 48-58 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.
Claim 1 recites “a method of improving visual performance during low light conditions in a patient”. The term “improving visual performance” and “low light conditions” are vague and relative term which render the claim indefinite. Instant specification does not provide a standard for ascertaining the requisite degree of visual improvement. Claim 1 does not define what’s the target patient population. Instant spec (See [0026] only discloses “patient” refers to organisms to be treated by the methods of the present invention. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 2-4, 8, 12, and 48-58 are rejected due to dependency on claim 1.
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 (i.e., changing from AIA to pre-AIA ) 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 non-obviousness.
Claims 1-4, 8, 12, and 48-58 are rejected under 35 U.S.C. 103 as being unpatentable over Likitlersuang et al. (US20110178147A1 , Applicant’s IDS filed 11/30/2023, Cite # A77).
Likitlersuang discloses a method of improving quality of vision / controlling pupil dilation in a subject in need thereof in low ambient light, comprising administering to the eye of a subject, a therapeutically effective amount composition comprising 0.001% to about 1.0% by weight of an alpha-adrenergic receptor antagonist selected from phentolamine, phentolamine mesylate, or a phentolamine salt (See abstract, [0003]-[0006], [0015], [0018] Examples 1-4, claims 1-20). Likitlersuang teaches various concentration of phentolamine mesylate, 0.01% about 1.0% by w/v, 0.9-1.0% w/v., 1.1% w/v, etc. (See [0004], [0007]-[0009], Table 1-3). Likitlersuang discloses the subject is a human ( See [0014], Examples 1-4).
Regarding claim 2-3 and night time conditions of instant claims 52-55, Likitlersuang discloses embodiments with improved vision at night wherein phentolamine mesylate is administered daily for 1 week (See Example 1). A skilled artisan would have known administering phentolamine mesylate at night (bedtime ) to minimize daytime adverse events (e.g. redness).
Regarding visual acuity of instant claim 4, Likitlersuang teaches embedment provides improved quality of vision in low ambient light without negative clinical effects in normal lighting conditions. The composition can be used to optimize pupil size to obtain enhanced vision acuity in low ambient light (See [0009] [0015], [0018]).
Regarding claims 48, Likitlersuang teaches the composition as a single or multi-dose dropper bottle or in a unit dose vial (See [0029]) and can be administered directly (i.e., via drops) or indirectly to an eye(See [0012]).
Regarding claim 49-51, Likitlersuang teaches the amount and frequency of administration can vary according to the need and underlying conditions, e.g. administered on a daily (i.e., 1, 2, 3, 4, or more times per day), bi- or tri-weekly, weekly, or on a monthly basis, or on an as-needed basis (for example in low ambient light situations), and can be administered for a finite period of time or indefinitely in order to treat a persistent or transient need (See [0006]).
Likitlersuang collectively teaches a method of improving vision/optimizing pupil size in dim light conditions, comprising administering an ophthalmic aqueous solution comprising phentolamine mesylate in a therapeutically effective amount to a human patient’s eye.
Likitlersuang is silent about “minimizing eye redness” and related limitation of CCLRU. Please note the recitation “minimizing eye redness”, “improving visual performance”, “improved visual performance for at least twenty-four hours”, “improved visual acuity” , “improved contrast sensitivity”, etc. are construed as intended treatment outcome and/or intended results of the active method step of administering phentolamine mesylate in a therapeutically effective amount, which do not materially limit the claimed method since such limitations do not result in manipulative difference in method steps of the claims. If the prior art teaches and suggests the same or similar method step as instantly claimed (i.e. administering phentolamine mesylate in a therapeutically effective amount to a subject in dim light ), the method of the prior art would have achieved the intended results as recited in instant claims and read on instant claimed methods. The burden of proof is shifted to the Applicant to show that the subject matter of the prior art does not possess the characteristic of improving visual performance, minimizing eye redness, etc. as instantly claimed.
It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instantly claimed invention to further explore/optimize method of improving vision/optimizing pupil size in dim light conditions with phentolamine mesylate, based on combined teachings of Likitlersuang and general knowledge of treating eye conditions/disease, and arrived instantly claimed invention with reasonable expectation of success. Before the effective filing date of instantly claimed invention, method of improving vision/optimizing pupil size in dim light conditions while minimizing redness with phentolamine was already known as taught by Likitlersuang. A skilled artisan in the art would also know the assessment of treatment outcome of visual performance and adverse event ( e.g. eye redness). The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to further explore/optimize phentolamine dosing regimen based on the general knowledge of treating eye condition/disease. Adjusting dosing regimen (time, frequency, period, etc.) based on treatment outcome/assessment is within the knowledge of a skilled artisan and routine experiment/ optimization of treatment for eye conditions.
One of ordinary skill in the art would have had reasonable expectation of success in producing instant claimed invention based on the combined teaching of prior art, together with exploration/optimization of dosing regimen based on general knowledge of eye treatment. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-4, 8, 12, and 48-58 are rejected under 35 U.S.C. 103 as being unpatentable over Horn (US 8979809 B2, hereafter “Horn’ 809”, Applicant’s IDS dated 11/30/2023, Cite # A51), in view of Likitlersuang et al. (US20110178147A1 , Applicant’s IDS filed 11/30/2023, Cite # A77) and Murphy (Eye, 2007, 21(5), pp. 633-638, Applicant’s IDS dated 11/30/2023, Cite # C136).
Horn’ 809 discloses a method for optimizing pupil size to improve vision in individuals in dim light while minimizing redness, comprising administering an ophthalmic aqueous solution comprising an alpha 1 antagonist (e.g. phentolamine) in a therapeutically effective amount to a human patient’s eye (See abstract, Col. 2, lines 1-44; Examples 1 and 2, Table 1 and 2; claims 1-21). Horn’ 809 teaches phentolamine at various amount/concentration, 0.01- 50 mg/cc, 3.3 mg/ml, 1% concentration or less, e.g. 0.35 % (See Col. 3, lines 31-36; Col. 7, lines 18-30; Col. 10, line 9; Example 1 and 2, claim 2). Horn’ 809 teaches embodiments at low concentration (1% or less) administered to a human patient’s eye prevent dilation of the eye in dim light to a level which is about twice the amount of dilation or less than occurs when the patient is present in bright light (See Col. 9, line 66-67; Col. 10, line 1-2, 10).
Horn’ 809 explicitly teaches phentolamine administered to contract the pupil of the human
patient's eye in dim light in a single dose per day of use (See claims 3 and 7). Horn’ 809 teaches administration of a single drop daily (See Col. 7, line 29, 45-47) (which also reads on instant claim 48).
Regarding claim 3, Horn’ 809 teaches phentolamine is applied a single drop per day to render up to 20 to 24 hours of effect (See Col. 7, lines 28-35; Col. 12, lines 5-6; Table 1).
Regarding visual acuity of instant claim 4, Horn’ 809 teaches embedment obtain enhanced vision acuity in dim light by reducing the pupil diameter in dim light (See Col. 6, lines 28-30, 41-46).
Regarding night time conditions of instant claims 52-55, Horn’ 809 discloses effect of phentolamine (0.35% ) on night vision (See Table 2).
Horn’ 809 teaches administration of phentolamine eye drops in the morning and/or daytime (See Table 2). Horn’ 809 also teaches administered periodically on a daily basis (twice daily or as needed) and particularly administered in situations where the patient is subjected to dim light (See Col. 5, lines 44-47).
Horn’ 809 is silent about administration at or near the bedtime of the patient for at least five consecutive days, or more days as recited in instant claims 2 and 49-51. However, Horn’ 809 teaches effect of phentolamine on night vision and situations where the patient is subjected to dim light. It would have been prima facie obvious to a person of ordinary skill in the art to further explore administering phentolamine near bedtime since bedtime is a nighttime condition with dim light, A skilled artisan would be motivated to administering at night (bedtime ) to minimize daytime adverse events (e.g. redness). The adjustment/modification of dosing regimen (time, frequency, period, etc.) is within the general knowledge of a skilled artisan and construed as routine experiment/optimization of treatment for eye conditions.
Horn’ 809 is silent about phentolamine mesylate.
The collective teachings of Likitlersuang is elaborated in preceding 103 rejection and applied as before. Likitlersuang collectively teaches a method of improving vision/optimizing pupil size in dim light conditions, comprising administering an ophthalmic aqueous solution comprising phentolamine mesylate in a therapeutically effective amount to a human patient’s eye. A skilled artisan would have known to explore different salt form of phentolamine as alternative active ingredient and reasonably expect phentolamine mesylate exhibit similar activity in improving visual performance in dim light as taught by Likitlersuang. As stated in MPEP 2144.05, " It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."
Horn’ 809 collectively teaches a method of improving vision/optimizing pupil size in dim light conditions while minimizing redness, comprising administering an ophthalmic aqueous solution comprising phentolamine in a therapeutically effective amount to a human patient’s eye. Horn’ 809 teaches embodiments which reduces systemic absorption of the medication, vasodilation of the vessels and minimizes redness (See Col. Example 2; claims 1,3-5) .
Horn’ 809 is silent about CCLRU Redness Grading Scale.
Murphy 2007 teaches evaluation of eye redness using CCLRU Redness Grading Scale approximates an interval scale (See whole article). A skilled artisan would have known CCLRU Redness Grading Scale is standardized, widely-used assessment for eye redness. The evaluation of treatment outcome and adverse event (e.g. redness) is within the general knowledge of a skilled artisan and construed as routine experiment/optimization of eye treatment.
It would have been prima facie obvious to one of the ordinary skilled in the art before the effective filing date of instantly claimed invention to further explore/optimize the method of improving vision/optimizing pupil size in dim light conditions while minimizing redness with phentolamine, based on combined teachings of Horn’ 809, Likitlersuang and general knowledge of treating eye conditions/disease, and arrived instantly claimed invention with reasonable expectation of success. Before the effective filing date of instantly claimed invention, method of improving vision/optimizing pupil size in dim light conditions while minimizing redness with phentolamine and salt thereof was already known as taught by Horn’ 809 and Likitlersuang. Likitlersuang explicitly teaches phentolamine mesylate improving night vision/optimizing pupil size in dim light conditions. A skilled artisan in the art would also know the assessment of treatment outcome of visual performance ( (e.g. visual acuity, contrast sensitivity, etc.) and adverse event ( e.g. eye redness). The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to further explore/optimize phentolamine dosing regimen based on the general knowledge of treating eye condition/disease. Where 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.
Please note the recitation “improving visual performance”, “minimizing eye redness”, “improved visual performance for at least twenty-four hours”, “improved visual acuity” , “improved contrast sensitivity”, etc. are construed as intended treatment outcome and/or intended results of the active method step of administering phentolamine mesylate in a therapeutically effective amount, which do not materially limit the claimed method since such limitations do not result in manipulative difference in method steps of the claims. If the prior art teaches and suggests the same or similar method step as instantly claimed (i.e. administering phentolamine in a therapeutically effective amount to a subject in dim light ), the method of the prior art would have achieved the intended results as recited in instant claims and read on instant claimed methods. The burden of proof is shifted to the Applicant to show that the subject matter of the prior art does not possess the characteristic of improving visual performance, minimizing eye redness, etc. as instantly claimed.
One of ordinary skill in the art would have had reasonable expectation of success in producing instant claimed invention based on the combined teaching of prior art, together with exploration/optimization of dosing regimen based on general knowledge of eye treatment. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 8, 12, and 48-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. patent No. 9089560 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims are drawn to a method of improving visual performance in a patient while minimizing eye redness during the patient's waking hours, comprising administering to an eye of a patient once per day at or near the bedtime of the patient for at least five consecutive days a daily dosage of phentolamine or a pharmaceutically acceptable salt thereof sufficient to provide improved visual performance for at least twenty hours, wherein the patient experiences an increase in eye redness of no more than two grades measured using the CCLRU Redness Grading Scale during the patient's waking hours compared to the patient's level of eye redness without receiving said dosage.
Reference claim 26-28 recited about 0.25% (w/v) to about 1% or 2% (w/v) of phentolamine mesylate. ;
Reference claim 4 and 7 recite improvement in visual acuity which read on instant claim 4.
Reference claim 8-11 teaches improved contrast sensitivity which reads on instant claim 8 .
The difference between instant claims and reference claims are dosing period as recited in instant claims 49-51 and nighttime vision of instant claims 52-55.
It would have been prima facie obvious to one of the ordinary skilled in the art to further explore/optimize the method of improving vision with phentolamine mesylate taught by reference claims based on general knowledge of treating eye conditions/disease. Adjusting dosing regimen (time, frequency, period, etc.) based on assessment of treatment outcome/ adverse event are within the knowledge of a skilled artisan and construed as routine experiment/ optimization of eye treatment. Where 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.
Instant application is continuation of reference patent and no 35 USC 121 shield exists. See MPEP 804.01.
Claims 1-4, 8, 12, and 48-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. patent No. 9789088 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims are drawn to a method of improving visual performance in a patient while minimizing eye redness during the patient's waking hours, comprising administering to an eye of a patient once per day within 1 hour of the patient's bedtime for at least five consecutive days a daily dosage of phentolamine or a pharmaceutically acceptable salt thereof sufficient to provide improved visual performance for at least twenty hours, wherein the patient experiences an increase in eye redness of no more than two grades measured using the CCLRU Redness Grading Scale during the patient's waking hours compared to the patient's level of eye redness without receiving said dosage; wherein the daily dosage is an ophthalmic solution comprising water, a polyol, and phentolamine or a pharmaceutically acceptable salt thereof
Reference claim 11, 14 and 15 recite about 0.5-1 % (w/v) phentolamine mesylate.
Reference claim 8 recites improvement in visual acuity which read on instant claim 4.
Reference claim 2 recites improved contrast sensitivity which reads on instant claim 8 .
Reference claims 3-6 also recite limitation of reducing pupil diameter.
The difference between instant claims and reference claims are dosing period as recited in instant claims 49-51 and nighttime vision of instant claims 52-55.
It would have been prima facie obvious to one of the ordinary skilled in the art to further explore/optimize the method of improving vision with phentolamine mesylate taught by reference claims based on general knowledge of treating eye conditions/disease. Adjusting dosing regimen (time, frequency, period, etc.) based on assessment of treatment outcome/ adverse event are within the knowledge of a skilled artisan and construed as routine experiment/ optimization of eye treatment. Where 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.
Instant application is continuation of reference patent and no 35 USC 121 shield exists. See MPEP 804.01.
Claims 1-4, 8, 12, and 48-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. patent No. 11,000,509 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims are drawn to a method of improving visual performance in a patient while minimizing eye redness during the patient's waking hours, comprising administering to an eye of a patient once per day at or near the bedtime of the patient for at least five consecutive days a daily dosage of phentolamine or a pharmaceutically acceptable salt thereof sufficient to provide improved visual performance for at least twenty hours, wherein the patient experiences an increase in eye redness of no more than two grades measured using the CCLRU Redness Grading Scale during the patient's waking hours compared to the patient's level of eye redness without receiving said dosage; wherein the daily dosage is an aqueous ophthalmic solution comprising from about 0.5% (w/v) to about 2% (w/v) of phentolamine or a pharmaceutically acceptable salt thereof that is administered to the eye in the form of an eye drop, and the patient is a human.
Reference claim 22 explicitly recites 1 % (w/v) phentolamine mesylate.
Reference claim 3 explicitly teaches improved visual acuity which reads on instant claim 4 .
The difference between instant claims and reference claims are the limitation “improving visual performance during the low light conditions”, dosing period as recited in instant claims 49-51 and “nighttime conditions” as recited in claims 52-55.
Please note the recitation “ improving visual performance during the low light conditions”, e.g. nighttime conditions, etc. are construed as intended treatment outcome and/or intended results of the active method step of administering phentolamine mesylate in a therapeutically effective amount, which do not materially limit the claimed method since such limitations do not result in manipulative difference in method steps of the claims. Adjusting dosing regimen (time, frequency, period, etc.) based on treatment outcome/assessment is within the knowledge of a skilled artisan and construed as routine experiment/ optimization of treatment for eye conditions.
It would have been prima facie obvious to one of the ordinary skilled in the art to further explore/optimize the method of improving vision with phentolamine taught by reference claims based on general knowledge of treating eye conditions/disease. Where 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.
The instant application is a continuation of reference patent, thus no 35 USC 121 shield exists. See MPEP 804.01.
Claims 1-4, 8, 12, and 48-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. patent No.11717510 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims are drawn to a method for improving visual performance during low-light conditions, comprising daily ophthalmic administration of an aqueous ophthalmic solution comprising about 1% (w/v) phentolamine mesylate to an eye of a patient at or near the bedtime of the patient, to thereby improve visual performance under low-light conditions, wherein the method is characterized by:
the patient experiences an increase in eye redness of no more than one grade measured using the CCLRU Redness Grading Scale during the patient's waking hours compared to the patient's level of eye redness without receiving said aqueous ophthalmic solution;
the aqueous ophthalmic solution is administered to the eye of the patient in an amount sufficient to provide improved visual performance for at least twenty-four hours;
the aqueous ophthalmic solution is administered as an eye drop to the eye of the patient;
within 8 hours after administration of phentolamine mesylate to the patient's eye, the amount of eye redness returns to the baseline amount of eye redness present in the patient's eye prior to said administration of phentolamine mesylate; and the patient is a human.
Reference claim 2 recites nighttime conditions which reads on instant claims 52-55.
Reference claim 3 wherein the improvement in visual performance is an improvement in visual acuity, which reads on instant claim 4.
The difference between instant claims and reference claims are dosing period as recited in instant claims 49-51.
It would have been prima facie obvious to one of the ordinary skilled in the art to further explore/optimize the method of improving vision with phentolamine taught by reference claims based on general knowledge of treating eye conditions/disease. Adjusting dosing regimen (time, frequency, period, etc.) based on treatment outcome/assessment is within the knowledge of a skilled artisan and construed as routine experiment/ optimization of treatment for eye conditions. Where 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.
The instant application is a continuation of reference patent and no 35 USC 121 shield exists. See MPEP 804.01.
Claim 1-4, 8, 12, and 48-58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 -14 of U.S. patent No. 12016841 B2. Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claims are drawn to a method of treating presbyopia in a patient according to a monotherapy treatment regimen, comprising administering to an eye of a patient in need thereof a dosage of a single therapeutic agent, wherein the single therapeutic agent is phentolamine mesylate, the dosage is administered as an eye drop, the dosage of the single therapeutic agent is one eye drop of a 1% (w/w) phentolamine mesylate solution, and the method results in an improvement in near-vision visual acuity characterized by at least a two-line improvement in the patient's vision measured using a vision chart.
Reference claim 5-6 recite improvement in near-vision visual acuity which read on instant claim 4. Reference claim 7-8 recite CCLRU Redness Grading Scale which reads on instant claims 56-58. Reference claims 9-10 also recite limitation of reducing pupil diameter.
The scope of reference claims reciting specific eye disease/condition is narrower than instant claims. Adjusting dosing regimen (time, frequency, period, etc.) based on assessment of treatment outcome/ adverse event are within the knowledge of a skilled artisan and construed as routine experiment/ optimization of eye treatment. Where 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.
The instant application shares at least one common inventor/applicant with the reference patent. Further, instant application is not related to the reference patent and thus no 35 USC 121 shield exists. See MPEP 804.01.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached on (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LIYUAN MOU/ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628
Prosecution Insights