DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/20/2026 has been entered.
Status of Application
The response filed 07/20/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claims 1 have been amended.
Claim 17 has been cancelled.
Claims 1-15, 18-29 are pending.
Claims 1-15, 18-29 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All grounds not addressed in the action are withdrawn as a result of amendment.
Current Grounds of Rejection
Due to the amendment of the claims the new grounds of rejection are applied:
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 1-15, 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 sub Tenon 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 and can contain additional actives that work with the copper agents in additional crosslinking and reduce axial elongation (Page 11 line 17-25, 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 in composition forms like eyedrops and sustained delivery (topical administration with composition forms like eyedrops and sustained delivery have contact with the sclera, see instant claims 12-15) wherein the mechanism of activity of increasing the lysyl oxidase activity in the sclera which results in the increased scleral stiffness and axial elongation reduction of the eye 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 does not teach or suggest administration to the sclera and increasing sclera lysyl activity or increasing scleral stiffness or reducing axial elongation of the eye. Applicant also asserts that different mechanisms are taking place between the sclera and the cornea, and that administering the composition with incidental exposure is not the same as administering the composition to the sclera for the claimed method.
This is fully considered but not persuasive. Burr teaches treatment of myopia with the claimed copper-containing agents like copper perchlorate with the same claimed topical administration to the eye; wherein the same active is administered for the same myopic condition in the same mode of administration claimed wherein the same mechanism of action in the sclera with the same effects including scleral stiffness and axial elongation reduction would implicitly be present. It is noted that the instant independent claim does not have limitation on the mode of administration to the eye wherein any means with contact to the eye would apply.
The effects of administering the composition are implicit/intrinsic to the components of the composition and the mode of delivery. When the composition is delivered in the same manner as claimed, the effects of the composition would be the same such as increasing sclera lysyl activity and increasing scleral stiffness and reducing axial elongation of the eye, as they are a direct result of the structural components of the composition and the mode of administration which are met by the art whereby the resulting properties and effects would be met. As 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 discoverer.
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.
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 8-15 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 claims 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 claims 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, 18-29 are rejected.
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
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