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
Claims 1-20 are pending and under examination.
Claim Objections
Claims 1-6, 8, 9, 11-16, 18, and 19 are objected to because of the following informalities: the claims contain ungrammatical, redundant and convoluted sentences.
Claim 1 may be amended to recite: A method of reducing or eliminating a hyaluronic acid-induced blockage in one or more blood vessels supplying blood to an eye of
In claims 2-5, the recitation of: “hyaluronidase is in a concentration of” should be amended to recite: “hyaluronidase at a concentration of”.
Claim 6 may be amended to recite: The method according to claim 1, wherein the composition is administered at
Claim 8 may be amended to recite: The method according to claim 7, wherein the multiple doses and
Claim 9 may be amended to recite: The method according to claim 7, wherein the multiple doses of each other.
Claim 11 may be amended to recite: A method of reducing or inhibiting a vascular occlusion in an eye of an individual in need thereof,
wherein the vascular occlusion is caused by a hyaluronic acid-induced blockage in one or more blood vessels supplying blood to an eye,
and wherein administration of the hyaluronidase reduces or eliminates the hyaluronic acid-induced blockage
In claims 12-15, the recitation of: “hyaluronidase is in a concentration of” should be amended to recite: “hyaluronidase at a concentration of”.
Claim 16 may be amended to recite: The method according to claim 11, wherein the composition is administered at
Claim 18 may be amended to recite: The method according to claim 17, wherein the multiple doses and
Claim 19 may be amended to recite: The method according to claim 17, wherein the multiple doses are of each other.
Appropriate correction is required.
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 6 and 16 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.
Claims 6 and 16 recite about 50 µL to about 250 µL in volume. The term “about” is a term of approximation which renders the claim indefinite. The range that is encompassed by the term “about” is not defined by the claim, and the specification does not provide the upper and lower limits of the range encompassed by the term “about”. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is therefore unclear what volume is within approximation as required by the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 10-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al., (Effectiveness of Retrobulbar Hyaluronidase Injection in an Iatrogenic Blindness Rabbit Model Using Hyaluronic Acid Filler Injection. Plast Reconstr Surg. 2019 Jul;144(1):137-143; cited in the IDS filed 03/07/2025) in view of Prausnitz et al., (US2018/0028357A1; cited in the IDS filed 03/07/2025).
Regarding claim 1, Lee teaches a method of treating hyaluronic-induced retinal artery occlusion (p. 138, col. 1, Retinal Artery Inclusion Model), i.e., hyaluronic acid-induced blood vessel blockage, in rabbits comprising administering 1,500 IU/mL of hyaluronidase, and in a subsequent study, 2 ml of 3000 IU hyaluronidase was injected into the retrobulbar area (p. 138, col. 2, Retrobulbar Hyaluronidase Injection). Although the concentration of Lee differs from that of the instant claim, MPEP§ 2144.05 II states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.")”. The selection of specific hyaluronidase concentrations would have been a matter of routine optimization on the part of the artisan of ordinary skill, said artisan recognizing that hyaluronidase concentration would affect the level of hyaluronic acid degradation.
Lee does not teach that the hyaluronidase was administered to a suprachoroidal space of the eye.
However, Prausnitz teaches methods for targeted administration of a drug to a patient’s eye, comprising inserting a hollow microneedle into the sclera of the eye into the suprachoroidal space of the eye (Abstract). In one embodiment, the fluid drug formulation further includes an agent effective to degrade collagen or GAG fibers in the sclera, which may enhance penetration/release of the drug into the ocular tissues. This agent may be, for example, an enzyme, such a hyaluronidase [0086].
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify Lee’s method by replacing the site of administering hyaluronidase from retrobulbar in the eye of a rabbit to the suprachoroidal space of the eye of a patient, as taught by Prausnitz. One of ordinary skill would have been motivated to do so because Prausnitz teaches that an enzyme, such as hyaluronidase, may be administered in combination with a drug formulation (para. [0086]. One of ordinary skill in the art would have had a reasonable expectation of success because Lee and Prausnitz are in the same field of endeavor of ocular drug (hyaluronidase) delivery.
Regarding claims 2-5, Lee teaches a hyaluronidase concentration of 1,500 IU/mL (p. 138, col. 2, Retrobulbar Hyaluronidase Injection). Lee does not teach the hyaluronidase concentrations of the instant claims, however, as stated, generally concentrations and temperature will not affect patentability as it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding claim 6, Lee teaches administration of the hyaluronidase composition at a volume of 2 mL (p. 138, col. 2, Retrobulbar Hyaluronidase Injection). Although the volume of Lee is different than that of the instant claim, it is not inventive to discover the optimum or workable ranges by routine experimentation, as stated.
Regarding claim 10, Lee teaches that the hyaluronidase was administered with saline (p. 138, col. 2, Retrobulbar Hyaluronidase Injection), which is considered an agent.
Regarding claim 11, Lee teaches a method of treating hyaluronic-induced retinal artery occlusion (p. 138, col. 1, Retinal Artery Inclusion Model), i.e., vascular occlusion, in rabbits comprising administering 1,500 IU/mL of hyaluronidase (p. 138, col. 2, Retrobulbar Hyaluronidase Injection). Although the concentration of Lee differs from that of the instant claim, MPEP§ 2144.05 II states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.")”. The selection of specific hyaluronidase concentrations would have been a matter of routine optimization on the part of the artisan of ordinary skill, said artisan recognizing that hyaluronidase concentration would affect the level of hyaluronic acid degradation.
Lee does not teach that the hyaluronidase was administered to a suprachoroidal space of the eye.
However, Prausnitz teaches methods for targeted administration of a drug to a patient’s eye, comprising inserting a hollow microneedle into the sclera of the eye into the suprachoroidal space of the eye (Abstract). In one embodiment, the fluid drug formulation further includes an agent effective to degrade collagen or GAG fibers in the sclera, which may enhance penetration/release of the drug into the ocular tissues. This agent may be, for example, an enzyme, such a hyaluronidase [0086].
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify Lee’s method by replacing the site of administering hyaluronidase from retrobulbar in the eye of a rabbit with the suprachoroidal space of the eye of a patient, as taught by Prausnitz. One of ordinary skill would have been motivated to do so because Prausnitz teaches that an enzyme, such as hyaluronidase, may be administered in combination with a drug formulation (para. [0086]. One of ordinary skill in the art would have had a reasonable expectation of success because Lee and Prausnitz are in the same field of endeavor of ocular drug delivery.
Regarding claims 12-15 and 17, Lee teaches administration of a single dose of hyaluronidase at a concentration of 1,500 IU/mL (p. 138, col. 2, Retrobulbar Hyaluronidase Injection). Lee does not teach the hyaluronidase concentrations of the instant claims, however, as stated, generally concentrations and temperature will not affect patentability as it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding claim 16, Lee teaches administration of the hyaluronidase composition at a volume of 2 mL (p. 138, col. 2, Retrobulbar Hyaluronidase Injection). Although the volume of Lee is different than that of the instant claim, it is not inventive to discover the optimum or workable ranges by routine experimentation.’
Regarding claim 20, Lee teaches that the hyaluronidase was administered with saline (p. 138, col. 2, Retrobulbar Hyaluronidase Injection), which is considered an agent.
Claims 7-9, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al., (Effectiveness of Retrobulbar Hyaluronidase Injection in an Iatrogenic Blindness Rabbit Model Using Hyaluronic Acid Filler Injection. Plast Reconstr Surg. 2019 Jul;144(1):137-143) and Prausnitz et al., (US2018/0028357A1) as applied to claims 1 and 11 above, and further in view of DeLorenzi., (New High Dose Pulsed Hyaluronidase Protocol for Hyaluronic Acid Filler Vascular Adverse Events. Aesthet Surg J. 2017 Jul 1;37(7):814-825; cited in the IDS filed 03/07/2025).
See discussion of Lee and Prausnitz above, which is incorporated into this rejection as well.
Regarding claims 7, 8, and 18, DeLorenzi teaches a method of reducing hyaluronic-acid vascular obstruction comprising administering three to four treatments of hyaluronidase to ischemic, i.e., obstructed, area (Abstract; p. 825, col 1., para. 1).
Regarding claims 9 and 19, DeLorenzi teaches the administration of hyaluronidase every hour to 90 minutes (p. 824, col. 2, para. 3). Although this time period between hyaluronidase administration differs from that of the instant claim, selection of specific dosage times would have been a routine matter of optimization on the part of the artisan of ordinary skill, said artisan recognizing that time between hyaluronidase administration would affect rate of hyaluronic acid degradation.
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to further modify the method of administering hyaluronidase to the suprachoroidal space of the eye, as taught by Lee as modified by Prausnitz, by administering at repeated intervals, as taught by DeLorenzi. One of ordinary skill in the art would have been motivated to do so because DeLorenzi teaches that repeated hyaluronidase administration is based on the hypothesis that flooding occluded blood vessels with a sufficient concentration of hyaluronidase allows for the hyaluronic acid to dissolve to the point where the products of hydrolysis can pass through capillary beds (Abstract). One of ordinary skill in the art would have had a reasonable expectation of success because Lee, Prausnitz, and DeLorenzi are in the same field of endeavor of reducing hyaluronic-acid vascular obstruction using hyaluronidase administration methods.
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, 6, 11-14, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-6, 8, 11, 12, 14-16, and 18 of U.S. Patent No. 11,878,051. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the conflicting claims.
Claims 1, 2, 4-6, 8, 11, 12, 14-16, and 18 of ‘051 recite:
1. A method of reducing or eliminating a hyaluronic acid-induced blockage in one or more blood vessels supplying blood to an eye in an individual in need thereof, the method comprising administering at most 500 µL of a composition comprising a therapeutically effective amount of hyaluronidase of at least 6,000 IU/mL to a suprachoroidal space of the eye of the individual, wherein administration of the hyaluronidase reduces or eliminates a hyaluronic acid-induced blockage in one or more blood vessels supplying blood to an eye in at most 30 minutes.
2. The method according to claim 1, wherein the therapeutically effective amount of hyaluronidase is in a concentration of at least 8,000 IU/mL.
4. The method according to claim 1, wherein the therapeutically effective amount of hyaluronidase is in a concentration of at least 10,000 IU/mL.
5. The method according to claim 1, wherein the therapeutically effective amount of hyaluronidase is in a concentration of at least 15,000 IU/mL.
6. The method according to claim 1, wherein the therapeutically effective amount of hyaluronidase is in a concentration of at least 20,000 IU/mL.
8. The method according to claim 1, wherein the composition is administered in a volume of about 50 μL to about 250 μL.
11. A method of reducing or inhibiting a vascular occlusion in an eye of an individual in need thereof, the method comprising administering at most 400 μL of a composition comprising a therapeutically effective amount of hyaluronidase of at least 6,000 IU/mL to a suprachoroidal space of the eye of the individual, wherein administration of the hyaluronidase reduces or eliminates a hyaluronic acid-induced blockage in one or more blood vessels supplying blood to an eye in at most 30 minutes, thereby reducing or inhibiting the vascular occlusion in the eye.
12. The method according to claim 11, wherein the therapeutically effective amount of hyaluronidase is in a concentration of at least 8,000 IU/mL.
14. The method according to claim 11, wherein the therapeutically effective amount of hyaluronidase is in a concentration of at least 10,000 IU/mL.
15. The method according to claim 11, wherein the therapeutically effective amount of hyaluronidase is in a concentration of at least 15,000 IU/mL.
16. The method according to claim 11, wherein the therapeutically effective amount of hyaluronidase is in a concentration of at least 20,000 IU/mL.
18. The method according to claim 11, wherein the composition is administered in a volume of about 50 μL to about 250 μL.
Instant claim 1 is unpatentable over claims 1 and 2 of ‘051 because all claims require a method of reducing or eliminating a hyaluronic acid-induced blockage in one or more blood vessels supplying blood to an eye of an individual in need thereof, comprising administering a therapeutically effective amount of hyaluronidase of at least 8,000 IU/mL to a suprachoroidal space of the eye.
Instant claim 2 is unpatentable over claim 4 of ‘051 because both claims require a hyaluronidase concentration of at least 10,000 IU/mL.
Instant claim 3 is unpatentable over claim 5 of ‘051 because both claims require a hyaluronidase concentration of at least 15,000 IU/mL.
Instant claim 4 is unpatentable over claim 6 of ‘051 because both claims require a hyaluronidase concentration of at least 20,000 IU/mL.
Instant claim 6 is unpatentable over claim 8 of ‘051 because both claims require a volume of 50-250 µL.
Instant claim 11 is unpatentable over claims 11 and 12 of ‘051 because all claims require a method of reducing or eliminating a hyaluronic acid-induced blockage in one or more blood vessels supplying blood to an eye of an individual in need thereof, comprising administering a therapeutically effective amount of hyaluronidase of at least 8,000 IU/mL to a suprachoroidal space of the eye.
Instant claim 12 is unpatentable over claim 14 of ‘051 because both claims require a hyaluronidase concentration of at least 10,000 IU/mL.
Instant claim 13 is unpatentable over claim 15 of ‘051 because both claims require a hyaluronidase concentration of at least 15,000 IU/mL.
Instant claim 14 is unpatentable over claim 16 of ‘051 because both claims require a hyaluronidase concentration of at least 20,000 IU/mL.
Instant claim 16 is unpatentable over claim 18 of ‘051 because both claims require a volume of 50-250 µL.
Claims 5, 7, 15, and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 11, and 17 of U.S. Patent No. 11,878,051. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the conflicting claims.
Claim 7 of ‘051 recites: The method according to claim 1, wherein the composition is administered as a single dose or in multiple doses.
Claim 17 of ‘051 The method according to claim 11, wherein the composition is administered as a single dose or in multiple doses.
Instant claim 5 is unpatentable over claim 1 of ‘051 because the instant hyaluronidase concentrations are at least 6,000 IU/mL as recited in claim 1 of ‘051. Therefore, it would have been obvious to one of ordinary skill in the art to select a hyaluronidase concentration of 8,000-20,000 IU/mL.
Instant claim 7 is unpatentable over claims 1 and 7 of ‘051 because all claims require that the composition may be administered in multiple doses. The instant concentration of hyaluronidase falls within the concentration range recited in the claims of ‘051. Therefore, it would have been obvious to one of ordinary skill in the art to select a hyaluronidase concentration of 8,000 IU/mL.
Instant claim 15 is unpatentable over claim 11 of ‘051 because the instant hyaluronidase concentrations are at least 6,000 IU/mL as recited in claim 11 of ‘0511. Therefore, it would have been obvious to one of ordinary skill in the art to select a hyaluronidase concentration of 8,000-20,000 IU/mL.
Instant claim 17 is unpatentable over claims 11 and 17 of ‘051 because all claims require that the composition may be administered in multiple doses. The instant concentration of hyaluronidase falls within the concentration range recited in the claims of ‘051. Therefore, it would have been obvious to one of ordinary skill in the art to select a hyaluronidase concentration of 8,000 IU/mL.
Claims 1-7, 10-17, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 10, 11-17, and 20 of U.S. Patent No. 11,890,331. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the conflicting claims.
Claims 1-7, 10-17, and 20 of ‘331 recite:
A method of reducing or eliminating a hyaluronic acid-induced blockage in one or more blood vessels supplying blood to an eye in an individual in need thereof, the method comprising administering at most 500 µL of a composition comprising a therapeutically effective amount of hyaluronidase of at least 2,000 IU/mL to a suprachoroidal space of the eye of the individual, wherein administration of the hyaluronidase reduces or eliminates a hyaluronic acid-induced blockage in one or more blood vessels supplying blood to an eye in at most 30 minutes, thereby restoring or maintaining normal retinal blood flow.
The method according to claim 1, wherein the therapeutically effective amount of the hyaluronidase is in a concentration of at least 4,000 IU/mL.
The method according to claim 1, wherein the therapeutically effective amount of the hyaluronidase is in a concentration of about 2,500 IU/mL to about 10,000 IU/mL.
The method according to claim 1, wherein the therapeutically effective amount of the hyaluronidase is in a concentration of at least 10,000 IU/mL.
The method according to claim 1, wherein the therapeutically effective amount of the hyaluronidase is in a concentration of at least 20,000 IU/mL.
The method according to claim 1, wherein the composition is administered as a single dose or in multiple doses.
The method according to claim 1, wherein the composition is administered in a volume of about 50 µL to about 250 µL.
The method according to claim 1, wherein the composition further comprises a supplementary active compound, an agent, a drug, a local anesthetic, or a hormone.
A method of reducing or inhibiting a vascular occlusion in an eye of an individual in need thereof, the method comprising administering at most 400 μL of a composition comprising a therapeutically effective amount of hyaluronidase at least 3,000 IU/mL to a suprachoroidal space of the eye of the individual, wherein administration of the hyaluronidase reduces or eliminates a hyaluronic acid-induced blockage in one or more blood vessels supplying blood to an eye in at most 30 minutes, thereby restoring or maintaining normal retinal blood flow.
The method according to claim 11, wherein the therapeutically effective amount of the hyaluronidase is in a concentration of at least 5,000 IU/mL.
The method according to claim 11, wherein the therapeutically effective amount of the hyaluronidase is in a concentration of about 3,000 IU/mL to about 10,000 IU/mL.
The method according to claim 11, wherein the therapeutically effective amount of the hyaluronidase is in a concentration of at least 10,000 IU/mL.
The method according to claim 11, wherein the therapeutically effective amount of the hyaluronidase is in a concentration of at least 20,000 IU/mL.
The method according to claim 11, wherein the composition is administered as a single dose or in multiple doses.
The method according to claim 11, wherein the composition is administered in a volume of about 50 μL to about 250 μL.
The method according to claim 11, wherein the composition further comprises a supplementary active compound, an agent, a drug, a local anesthetic, or a hormone.
Instant claim 1 is unpatentable over claims 1-3 of ‘331 because all claims require administering hyaluronidase to a suprachoroidal space of the eye of the individual, wherein administration of the hyaluronidase reduces or eliminates a hyaluronic acid-induced blockage in one or more blood vessels supplying blood to an eye. The instant concentration of hyaluronidase falls within the concentration range recited in the claims of ‘331. Therefore, it would have been obvious to one of ordinary skill in the art to select a hyaluronidase concentration of 8,000 IU/mL.
Instant claims 2-4 are unpatentable over claims 4 and 5 of ‘331 because all claims require a hyaluronidase concentration of 10,000 IU/mL to 20,000 IU/mL.
Instant claim 5 is unpatentable over claim 1 of ‘331 because the instant hyaluronidase concentrations are at least 2,000 IU/mL as recited in claim 1 of ‘331. Therefore, it would have been obvious to one of ordinary skill in the art to select a hyaluronidase concentration of 8,000-20,000 IU/mL.
Instant claim 6 is unpatentable over claim 7 of ‘331 because both claims require a volume of about 50-250 µL.
Instant claim 7 is unpatentable over claims 3 and 6 of ‘331 because all claims require administering the composition in multiple doses and the instant hyaluronidase concentration falls within the concentration range recited in claim 3 of ‘331.
Instant claim 10 is unpatentable over claim 10 of ‘331 because all claims require that the composition may be administered with a supplementary active compound, an agent, a drug, or a hormone.
Instant claim 11 is unpatentable over claims 11-13 of ‘331 because all claims require a method of reducing or inhibiting vascular occlusion in an eye of an individual in need thereof comprising administering a composition comprising hyaluronidase. The instant hyaluronidase concentration falls within the range recited in the claims of ‘331. Therefore, it would have been obvious to one of ordinary skill in the art to select a hyaluronidase concentration of 8,000 IU/mL.
Instant claims 12-14 are unpatentable over claims 14 and 15 because all claims require a hyaluronidase concentration of 10,000-20,000 IU/mL.
Instant claim 15 is unpatentable over claims 11 of ‘331 because the instant hyaluronidase concentrations are at least 2,000 IU/mL as recited in claim 11 of ‘331. Therefore, it would have been obvious to one of ordinary skill in the art to select a hyaluronidase concentration of 8,000-20,000 IU/mL.
Instant claim 16 is unpatentable over claim 17 of ‘331 because both claims require a volume of about 50-250 µL.
Instant claim 17 is unpatentable over claims 13 and 16 of ‘331 because all claims require administering the composition in multiple doses and the instant hyaluronidase concentration falls within the concentration range recited in claim 13 of ‘331.
Instant claim 20 is unpatentable over claim 10 of ‘331 because all claims require that the composition may be administered with a supplementary active compound, an agent, a drug, or a hormone.
Conclusion
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657
/JENNIFER K MICHENER/Group Director, TC 1600