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 .
Claim Status
Claims 1-18 are pending.
Claim 18 is withdrawn.
Claims 1-17 are under examination. Applicant’s amendment has necessitated new grounds of rejection. Accordingly, this Action is FINAL.
Withdrawn rejections
Applicant's amendments and arguments filed 7/11/25 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 1-17 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph. Applicant has amended the claims. Claims 8 and 17 were rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant has amended the claims.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Jean-Sébastien Garrigue et al (US20150025020A1, publication date: 01/22/2015) (Hereinafter Garrigue) in view of Greef, R. (Atlas of External Diseases of the Eye For Physicians and Students 1909, Rebman Company, NY; 8 pages).
Applicant claims:
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Regarding claim 15, Garrigue teaches “use of boric acid” (claim 16) which is taught to be “useful for eye care or for the treatment of eye diseases or eye conditions” including ocular inflammation, uveitis, cancerous growth, neovessel growth originating from the cornea, retinal edema, macular edema, diabetic retinopathy, retinopathy of prematurity, degenerative diseases of the retina (macular degeneration, retinal dystrophies (para 76), which are interpreted to be ischemia related vascular disorders. Garrigue also teaches administration to a patient (para 42). (See instant specification [0031].)
Regarding claim 16, Garrigue teaches the composition to also comprise “VEGF inhibitors” (claim 12).
Regarding claim 15, Garrigue teaches a preservative effective amount of boric acid, which is an amount ranging from 0.005% to 0.075% in weight of the total weight for boric acid (Abstract; claim 1).
Regarding claims 15 and 17, Greef teaches that it has been known since at least 1909 that a therapeutic amount of boric acid is 2-4% is “very helpful” for the treatment of iritis eye condition, which is a form of uveitis (Page 118; last page of 8).
It would have been obvious to one of ordinary skill in the art at the time of instant application to have modified the embodiments of Garrigue with a therapeutic amount of 2-4% boric acid, as suggested by Greef, and achieve the instant invention. While Garrigue teaches a preservative amount of boric acid for treating conditions including uveitis, it is known in the art through the teachings of Greef to apply a therapeutic amount of 2-4% boric acid to be “very helpful” in treating the condition such as iritis, which is a form of uveitis. That amount is readily extrapolated to the Garrigue teachings of treating ischemia related vascular disorders in its broader disclosures. Thus, a person of ordinary skill in the art would be motivated to treat patients with ischemia related vascular disorders with a “very helpful” therapeutic amount of 2-4% boric acid with a reasonable expectation of success.
Response to Arguments:
Applicant’s arguments filed 7/11/2025 have been carefully considered but are not persuasive.
Applicant asserts that Garrigue employs only a preservative amount of boric acid and not a therapeutic amount. However, the ordinary artisan knows that a therapeutic amount of boric acid is 2-4% as taught by Greef and would modify Garrigue with that amount with a reasonable expectation of not only maintaining a preservative function but also providing a therapeutic effect.
Applicant argues that the Examiner’s interpretation of general eye diseases or eye conditions as ischemia is erroneous and merely conclusory. On the contrary, the specification only mentions ischemia once [0004] and leaves it to the Examiner to figure out what vascular disorders are related to ischemia. In the instant case, at least diabetic retinopathy, macular degeneration and retinopathy of prematurity are related to ischemic diseases1. Where the Examiner’s position is supported by evidence, Applicant’s arguments are without merit and groundless.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Jean-Sébastien Garrigue et al (US20150025020A1, publication date: 01/22/2015) (Hereinafter Garrigue), Greef, R. (Atlas of External Diseases of the Eye For Physicians and Students 1909, Rebman Company, NY; 8 pages), Hitoshi Maegawa (US20090082455A1, publication date: 03/26/2009) (Hereinafter Maegawa), Josef Pesso (US20070003605A1, publication date: 01/04/2007) (Hereinafter Pesso), and Okada Atsushi (JP2914708B2, publication date: 07/05/1999) (Hereinafter Atsushi). It is noted that Google English Translation of Atsushi is being utilized to address the instant claim limitations below.
Applicant claims, for example:
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Regarding claim 1, Garrigue teaches “use of boric acid” (claim 16) which is taught to be “useful for eye care or for the treatment of eye diseases or eye conditions” including ocular inflammation, uvetis, cancerous growth, neovessel growth originating from the cornea, retinal edema, macular edema, diabetic retinopathy, retinopathy of prematurity, degenerative diseases of the retina (macular degeneration, retinal dystrophies (para 76) which are interpreted to be medical conditions having pathological vascular proliferation as an underlying cause. Garrigue also teaches administration to a patient (para 42). In addition to boric acid, Garrigue also teaches “sodium chloride” (para 72).
Regarding claim 13, Garrigue teaches the composition to also comprise “VEGF inhibitors” (claim 12).
Regarding claims 2-4, 6 and 13, Garrigue teaches as discussed above.
Regarding claim 5, Garrigue’s teaching of “glaucoma” is interpreted to meet the instantly claimed “central retinal vein occlusion” since glaucoma patients can have central retinal vein occlusion.
Regarding claim 8, Garrigue teaches a preservative amount of boric acid ranging from 0.005% to 0.075% in weight of the total weight” (Abstract; claim 1).
Regarding claim 9, Garrigue teaches treatment as “eye drops” (para 123).
Regarding claim 13, Garrigue teaches the composition to also comprise “VEGF inhibitors” (claim 12).
Regarding claim 1, Garrigue does not teach “potassium chloride”, “aluminum sulfate”, and “chamomile extract.”
Regarding claim 7, Garrigue does not teach “atherosclerotic vascular disorders in whole body vasculature.”
Regarding claim 1 and 8, Garrigue does not teach a therapeutic amount of boric acid of 0.5-6% by weight.
Regarding claim 10, Garrigue does not teach “administered as an oral formulation, the oral formulation selected from a group consisting of tablet, capsule, suspension, and syrup.”
Regarding claim 11, Garrigue does not teach “administered as a parenteral formulation, the parenteral formulation selected from a group consisting of intravenous injection, intramuscular injection, and subcutaneous injection.”
Regarding claim 12, Garrigue does not teach “administered as a topical spray or a topical patch for the medical conditions of atherosclerotic disorders and vasculitis.”
Regarding claim 1, Maegawa teaches “An agent for prevention, treatment and/or inhibition of symptom progression of an ophthalmic disease” (claim 1) comprising “potassium chloride” (para 29). It is noted that Megawa also teaches “boric acid” (para 38) and “sodium chloride” (para 29).
Regarding claim 1, Pesso teaches “Use of an eyelid and eyelid surroundings sterilized cleansing composition comprising cleansing ingredients in the preparation of a non-discoloring sterilized cleansing pad for hygiene maintenance of said eyelid and eyelid surroundings in a human subject in need thereof, said cleansing composition being essentially hypoallergenic, and standing dermatologic and ophthalmologic requirements” (claim 19) wherein said composition comprises sodium chloride and chamomile. Pesso also teaches an eyelid cleansing pad (claim 1) comprising “sodium chloride” (claim 3), and “chamomile” (claim 3). Pesso also teaches “said pad is suitable, according to ophthalmologic requirements, for suppressing subjective irritation (stinging, burning, itching, dryness) . . . neovascularization or opacities in a human subject.” (claim 7).
Regarding claim 1, Atsushi teaches an “eye pack agent” (title) comprising “potassium alum” (claim 4) as a gelling agent. Potassium alum is synonymous with aluminum sulfate.
Regarding claim 7, Maegawa teaches treating “arteriosclerotic retinopathy” (para 22) which is a condition where damage to the retina occurs due to arteriosclerosis (hardening of the arteries) and hypertension, evidencing treatment of “atherosclerotic vascular disorders in whole body vasculature.” It is also noted that Maegawa also teaches “retinal vascular occlusion,” “diabetic retinopathy, central retinal artery occlusion, central retinal vein occlusion,” “age-related macular degeneration (age-related maculopathy)”, “diabetic retinopathy,” “retinopathy of prematurity.” (para 22-23).
Regarding claims 10-11, Maegawa teaches “either systemic administration or topical administration. For example, the systemic administration includes that via an oral route (oral administration), a parenteral route (parenteral administration) such as intravenous administration and the like. The topical administration includes, for example, ocular instillation and the like” (para 25). For oral administration, Maegawa teaches “tablet, “capsule” (para 31) and as parenteral administration, Maegawa teaches “injection such as intravenous administration” (para 29).
Regarding claim 12, Pesso’s teaching of eyelid pad (discussed above) is interpreted as a topical patch. Regarding instantly claimed “atherosclerotic disorders,” Maegawa teaches as discussed above. Regarding instantly claimed “vasculitis,” this is interpreted as inflammation of vessels which is taught by Garrigue (ocular inflammation) (para 76) and Maegawa diseases listed in para 22 are interpreted to have vasculitis as a result.
It would have been obvious to one of ordinary skill in the art at the time of instant application to have combined the teachings of Garrigue, Greef, Pesso, Atsushi and Maegawa. All five references are directed to eye treatments. A person of ordinary skill in the art would achieve the instant invention by merely combining prior art elements according to known methods to yield predictable results. Aluminum sulfate is known as a gelling agent (per Atshushi) and would be incorporated if a gel is to be achieved. Pesso evidences chamomile and sodium chloride are used in eye formulations. Maegawa evidences potassium chloride, sodium chloride and boric acid are used in eye formulations. Absent evidence of unexpected results, there is a prima facie case of obviousness over the instant claims.
Response to Arguments:
Applicant’s arguments filed 7/11/2025 have been carefully considered but are not persuasive.
On page 9 of remarks, Applicant asserts that the boric acid is now in a therapeutic amount. The Examiner has addressed this limitation above.
On pages 9-10, Applicant discusses the secondary references. However, the Examiner is relying upon those references as detailed in the rejection and not as characterized by Applicant. Applicant asserts: “The Applicant emphasizes that most inventions arise from a combination of old elements and each element may often be found in the prior art . ... However, mere identification in the prior art of each element is insufficient to defeat the patentability of the combined subject matter as a whole ....” In the present case, all the components were known by the ordinary artisan for the same purpose. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.” In re Susi, 58 CCPA 1074, 1079--80, 440 F.2d 442,445 (1971); In re Crockett, 47 CCPA 1018, 1020-21, 279 F.2d 274, 276-77 (1960). As explained in Crockett, the idea of combining them flows logically from their having been individually taught in the prior art. (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)). (See MPEP 2144.06(I)). Also: "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). In the present case, the combination of components yields predictable results. While the specification teaches that chamomile extract increases cell membrane permeability and enhances the efficacy of boric acid in the formulation by two or threefold [0023], there is no objective evidence to substantiate that statement. Consequently, Applicant is just mixing up known components with predictable results. That is not inventive without more. There must be ingenuity over and above mechanical skill of mixing components. Especially when the specification teaches that boric acid is the active ingredient and the other ingredients are generally inert and just excipients or carriers [0022]. No hindsight was used by the Examiner to arrive at the finding of obviousness.
With regard to claim 7, Applicant argues that the retinal disorders are not directly related to pathological vascular proliferation. However, as discussed above, Maegawa teaches treating “arteriosclerotic retinopathy” and the eye is part of the whole body thus rendering obvious atherosclerotic vascular disorders in the whole body vasculature for treatment.
On page 12 of remarks, Applicant’s concerns about the amount of boric acid have been addressed by the Examiner in the rejection.
On pages 13-14, Applicant argues that Maegawa only teaches boric acid as an ophthalmic agent without further explanation. However, no further explanation is required and Maegawa is relied upon by the Examiner as characterized in the rejection.
On page 14, Applicant asserts that the Examiner’s position on claim 12 is erroneous and merely conclusory. However, Pesso and Maegawa are relied upon by the Examiner as characterized in the rejection. Applicant has failed to demonstrate that the references are non-analogous art.
Respectfully, none of Applicant’s arguments are persuasive.
Claim 14 in addition to claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Jean-Sébastien Garrigue et al (US20150025020A1, publication date: 01/22/2015) (Hereinafter Garrigue), Greef, R. (Atlas of External Diseases of the Eye For Physicians and Students 1909, Rebman Company, NY; 8 pages), Hitoshi Maegawa (US20090082455A1, publication date: 03/26/2009) (Hereinafter Maegawa), Josef Pesso (US20070003605A1, publication date: 01/04/2007) (Hereinafter Pesso), Okada Atsushi (JP2914708B2, publication date: 07/05/1999) (Hereinafter Atsushi), and Elizabeth Enlow et al (US10160765B2, publication date: 12/25/2018) (Hereinafter Enlow).
Regarding claim 1, Garrigue, Greef, Pesso, Atsushi and Maegawa teach as discussed above.
Regarding claim 14, while Garrigue teaches VEGF inhibitors “as discussed above,” Garrigue does not teach the species Bevacizumab or Aflibercept.
Regarding claim 14, Enlow teaches treatment of ocular disease such as “retinopathy, age-related macular degeneration, corneal neovascularization, diabetic macular edema, or retinal vein occlusion” (claim 6) and cancer (claim 7) by inhibiting VGEF (claim 1) using “bevacizumab” (column 35 line 24) and/or “aflibercept” (column 37 line 14).
It would have been obvious to one of ordinary skill in the art at the time of instant application to have combined the teachings of Garrigue, Greef, Pesso, Atsushi, Maegawa and Enlow. All references are directed to eye treatments. A person of ordinary skill in the art would achieve the instant invention by merely combining prior art elements according to known methods to yield predictable results. Aluminum sulfate is known as a gelling agent (per Atshushi) and would be incorporated if a gel is to be achieved. Pesso evidences chamomile and sodium chloride are used in eye formulations. Maegawa evidences potassium chloride, sodium chloride and boric acid are used in eye formulations. Enlow merely teaches the species for VGEF inhibitors. Absent evidence of unexpected results, there is a prima facie case of obviousness over the instant claims.
Response to Arguments:
Applicant asserts that claim 14 depends upon claim 1. The Examiner has reconsidered the rejection and it is maintained for the reasons provided above.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Datta (WO02094256) teaches a medicament(s) for topical and/or systemic applications in tissues with ischaemic conditions, the artisan can use a composition comprising 1-10% of a combination of boric acid and chamomile extract (Page 8, line 27 through page 9, line 17).
Braswell et al. (WO9832435) teaches liquid eye drops comprising zinc sulfate, boric acid and potassium (Abstract; claim 7) where the boric acid can be present from 1-10% (Page 5, lines 35-36). Isotonic vehicles such as sodium chloride are taught (Page 7, lines 5-7).
Abelson et al. ([online] retrieved on 5/22/26 from: https://www.reviewofophthalmology.com/article/all-you-need-to-make-an-artificial-tear; 2003; 5 pages) teaches the use of astringents such as zinc sulfate in ophthalmic compositions with the purpose of relieving the burning, itching and discomfort due to airborne irritants. Such drops can offer temporary relief of mild, nonspecific ocular discomfort. (Page 2 of 5).
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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
1 See Rivera et al. Ischemic Retinopathies: Oxidative Stress and Inflammation. Hindawi Oxidative Medicine and Cellular Longevity Volume 2017, Article ID 3940241, 16 pages.
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