DETAILED ACTION
Status of Application
The response filed 12/29/2025 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1 have been amended.
Claim 16 has been cancelled.
Claims 1-15, 17-29 are pending.
Claims 1-15, 17-29 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All grounds not addressed in the action are withdrawn as a result of amendment.
New grounds of rejection are set forth in the current office action as a result of amendment.
New Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
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.
Claim 17 is 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.
The claim recites that the composition that is administered to the eye is delivered by air-gun delivery or ballistic air delivery wherein the terms “air-gun” and “ballistic air delivery” are unclear. it is unclear how is a traditional air gun is meant to be deliver an active to the eye as they are known to cause ocular trauma as seen by Sharif et al., it is also unclear if the term air gun was mean to be a different delivery system like a jet injector (needleless microdevice) that could use compressed air which is generally referred as a jet gun or pneumatic injection. For purposes of examination either view may apply. The term “ballistic air delivery” is also unclear as a search does not produce a ocular drug delivery system that is a “ballistic air delivery system” wherein it is unclear what it is directed to. It cannot be further treated on its merits.
Response to Arguments:
Applicant's arguments are centered on the assertion that the terms “air-gun” and “ballistic air delivery” are simply broad that refer to any delivery method to the eye that uses air to project an active to the eye such as a jet injector pointed by the Examiner.
This is fully considered but not persuasive.
The term isn’t merely broad as asserted by Applicant, they are unclear and indefinite. As established above, the term “ballistic air delivery” is indefinite as it is not clear which it is and a search does not produce an ocular drug delivery system that is a “ballistic air delivery system” wherein it is unclear what it is directed to and could not further treated on its merits.
It remain unclear how is a traditional air gun is meant to be deliver an active to the eye as they are known to cause ocular trauma as seen by Sharif et al., wherein it is indefinite and Applicant’s assertion that the phase embraces a jet injector as pointed by the Examiner is not perusiave as addressed by the rejection, the Examiner points that it is unclear if the term was meant to be a different delivery system like a jet injector (needleless microdevice) that could use compressed air which is generally referred as a jet gun or pneumatic injection - which means it is subject to interpretation and one cannot ascertain the metes and bounds of the claim which is the basis of indefiniteness.
Accordingly, the rejection stands.
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.
Claims 1-16, 18-29 are rejected under 35 U.S.C. 103 as being unpatentable over Burr et al. (WO 2019/136358).
Rejection:
Burr et al. teaches treating myopia and myopic progression (progressive myopia, i.e. Example 6) with the administration to the eye with a composition comprising a pharmaceutical carrier and copper-containing agent such as copper perchlorate (abstract, claim 1 and 8)
The copper-containing agent can be from about 0.00001wt% to about 15%wt. (claim 6), including about 0.001-about 0.01% (falling within instant claim 3 and 5, 0.01mg/ml-1mg/ml=0.001-0.1%) and about 0.005-5% (Page 10 line 25 and 30-31).
The formulation can be solutions, suspension, emulsions, gels, hydrogels, formulations for subconjunctival injection , sub Tenon injections, depots, sustained delivery matrixes, sustained release compositions for various sites like the subTenon and cul-de-sac of the eye, ophthalmic drops (eyedrop), contact lenses (claims 2-4, Page 12-13, Page 18 line 9-16)
Excipients include solubilizing agents, tonicity agent, pH adjuster, thickener/gelling agent, preservatives, polymer, combinations thereof. Tonicity is from about 200-about 600milliosmoles/L (mOsm/L), pH can be from about 5.5-about 8.5 and about 5.8-about 7.8 and about 6.5-7.8 (claims 9-11 and page 13-14). the formulation does not require a second active ingredient. The method is to a patient in thereof (i.e. anyone in need of treatment at any age, Page 8 1st paragraph) and can include school age child, adolescent, and young adult such as about 3 years to about 25 years old (claim 20, Page 7 line 31-Page 8 line 2, Page18 1st paragraph, includes at least ages of about 25 i.e. 25, 27, etc.).
The formulation can be administered daily, once/day, 2x/day, 3x/day, 4x/day or more, or once every 2-5 day, once a week, etc. (page 15-17). The sustained release devices can release the copper active from about 2 days to about 6 months (claim 3) The treatment period can depend on a number of factors such as severity of the condition and age of the subject. The subject can receive treatment for a period of about 6 months to chronic treatment like 5 years or other suitable period until a desired outcome is achieved (claim 58, Page 18 line 1-8). The eyedrop formulation can be given in a drop wise manner at a drop volume of about 5µl to about 100 µl (each drop/time, claim 35), Burr et al. demonstrates the effectiveness with copper actives like CuSO4 pentahydrate (see full document specifically areas cited)
While Burr et al. does not expressly exemplify the method with copper perchlorate, Burr et al. does teach and claim method of treatment with specific copper actives including copper perchlorate wherein it is prima facie obvious before the effective filing date of the claimed invention to exemplify the express claimed teachings of Burr et al with a reasonable expectation of success. Burr et al. expressly teaches treating myopia with the topical administration of these copper agents like copper perchlorate wherein the mechanism of activity of increasing the lysyl oxidase activity in the sclera is implicitly present as it is a direct result of the same active being topically administered in the same way for the same myopic condition that is met by the art, wherein the mechanism of action naturally flows from the teaching of the prior art. The discovery of a previously unappreciated property of the prior art or of a scientific explanation of the prior art’s functioning, does not render the old composition patentably new to the discover.
Burr et al. does not teach the exact claimed values for the amount of copper active in the dependent claims (instant claims 4, 6-7), but they are embraced by the larger teaching and overlapped by the specific taught range wherein even a slight overlap in range establishes a prima facie case of obviousness wherein optimization to attain the desired therapeutic profile would arrive at the overlapping values with a reasonable expectation of success absent evidence of criticality for the claimed values.
Response to Arguments:
Applicant's arguments are centered on the assertion that Burr teaches the compistion comprising the copper-containing agent such as copper perchlorate for treating myopia and that it increases corneal lysyl oxidase activity in the eye of the subject but that Burr does not teach or suggest increasing sclera lysyl activity or admisntration to the sclera and asserts that different mechanisms are taking place between the sclera and the cornea. This is fully considered but not persusive. Burr teaches treatment of myopia with copper-containing agents like copper perchlorate with topical administration to the eye wherein the same active is administered for the same myopic condition in the same mode of adminstreation wherein the same mechanism of action in the sclera and the cornea would implicitly be present. It is noted that contrary to Applicant’s assertion, Burr does not teach admisntration to the sclera as it teaches periocular injections (subconjunctival and sub-Tenon injections) and scleral lens delivery which are means for transscleral drug delivery, and this assertion is also not commensurate in scope with the instant claims.
The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). It is noted that “[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). As an inherent or implicit feature need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized its disclosure at the time of invention, but only that the subject matter is in fact present in the prior art reference.
Accordingly, the rejection stands.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Burr et al. (WO 2019/136358) as applied to claim 1-16, 18-29 above, in view of Lerner (U.S. Pat. Pub. 2014/0039456).
Rejection:
The teachings of Burr et al. are addressed above.
Burr et al. does not expressly teach injection by jet/pneumatic injection (the 112 rejection is addressed above), but does teach ocular injection of the formulation.
Lerner teaches that injection devices for intraocular delivery are known and include actuation mechanisms like pneumatic mechanisms that use compressed air (pneumatic injection, abstract, [9, 311]).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize pneumatic injection as suggested by Lerner and produce the claimed invention; as it is prima facie obvious utilize known means of ocular injection with a reasonable expectation of success.
Response to Arguments:
Applicant's arguments are those of Burr which are addressed above.
Accordingly, the rejection stands.
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 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 of U.S. Patent No. 11524032.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to the same method with the same copper perchlorate wherein the claims are obvious.
Response to Arguments:
Applicant asks that the rejection be held in abeyance, there is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7 of U.S. Patent No. 11524032 as applied to claims 1-2 above, in view of Beringer (Types of Ophthalmic Dosage Forms, Drug Administration, Ophthalmic Preparation Characteristics).
The teachings of the patented claim are addressed above.
The patented claim does not recite the types of ophthalmic forms and excipients.
Beringer addresses that known ophthalmic forms include solutions (eyedrops, topically), gels, suspensions, inserts intraocular injections like subconjunctival (Types of Ophthalmic Dosage Forms, Drug Administration); excipient used in formulations include buffers and should be formulated ideally to 7.4 which is the equivalent to tear fluid (Buffer and pH), and additives like tonicity agents like sodium chloride to isotonic levels like 290mOsm (Tonicity).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize known ophthalmic forms and excipients as suggested by Remington and produce the claimed invention; as it is prima facie obvious to formulate ophthalmic compositions with their known components and forms with a reasonable expectation of success.
Response to Arguments:
Applicant asks that the rejection be held in abeyance, there is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12544400 (previously presented copending Application No. 18/080466).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claim is directed to a composition for use for the same method with the same copper perchlorate wherein the claims are obvious.
Response to Arguments:
Applicant asks that the rejection be held in abeyance, there is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 8-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 7 of U.S. Patent No. 12544400 (previously presented copending Application No. 18/080466).as applied to claims 1-2 above, in view of Beringer (Types of Ophthalmic Dosage Forms, Drug Administration, Ophthalmic Preparation Characteristics).
The teachings of the patented claim are addressed above.
The patented claim does not recited the types of ophthalmic forms and excipients.
Beringer addresses that known ophthalmic forms include solutions (eyedrops, topically), gels, suspensions, inserts intraocular injections like subconjunctival (Types of Ophthalmic Dosage Forms, Drug Administration); excipient used in formulations include buffers and should be formulated ideally to 7.4 which is the equivalent to tear fluid (Buffer and pH), and additives like tonicity agents like sodium chloride to isotonic levels like 290mOsm (Tonicity).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize known ophthalmic forms and excipients as suggested by Remington and produce the claimed invention; as it is prima facie obvious to formulate ophthalmic compositions with their known components and forms with a reasonable expectation of success.
Response to Arguments:
Applicant asks that the rejection be held in abeyance, there is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14, 36 of copending Application No. 17/626469 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims are directed to the same method with the same copper perchlorate wherein the claims are obvious. The copending claims directed to a composition is for use for the same method with the same copper perchlorate wherein the claims are obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant asks that the rejection be held in abeyance, there is no terminal disclaimer.
Accordingly, the rejection stands.
Claims 8-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14, 36 of copending Application No. 17/626469 (reference application).as applied to claims 1-2 above, in view of Beringer (Types of Ophthalmic Dosage Forms, Drug Administration, Ophthalmic Preparation Characteristics).
The teachings of the copending claim are addressed above.
The copending claim does not recited the types of ophthalmic forms and excipients.
Beringer addresses that known ophthalmic forms include solutions (eyedrops, topically), gels, suspensions, inserts intraocular injections like subconjunctival (Types of Ophthalmic Dosage Forms, Drug Administration); excipient used in formulations include buffers and should be formulated ideally to 7.4 which is the equivalent to tear fluid (Buffer and pH), and additives like tonicity agents like sodium chloride to isotonic levels like 290mOsm (Tonicity).
Wherein it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize known ophthalmic forms and excipients as suggested by Remington and produce the claimed invention; as it is prima facie obvious to formulate ophthalmic compositions with their known components and forms with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant asks that the rejection be held in abeyance, there is no terminal disclaimer.
Accordingly, the rejection stands.
Conclusion
Claims 1-15, 17-29 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613