DETAILED ACTION
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 .
Change of Examiner
Applicant is advised that the Examiner assigned to the prosecution of the instant application has changed.
Response to Amendment
The Applicant's amendments and/or arguments filed 07/25/2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 07/25/2025, it is noted that no claims have been amended or newly added. No new matter has been added.
Claim Objections
Claim 1 is objected to because of the following informalities: Appropriate correction is required. Claim 1 recites following abbreviation “PEG-400 and PEG-600to identify/describe Polyethylene Glycol 400 and Polyethylene Glycol 600, respectively. It is suggested to spell out PEG-400 and PEG-600.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5, 8, 12-14 and 16 are rejected under 35 U.S.C. 103 as being obvious over Adkins, JR. et al (US 20190336415) in view of Goldan et al. (US 88772570), and further in view of Baronian (WO 2009013019), Leader Lubricant Eye drops Product Information Printout (Hanlim Pharm. CO., LTD, 04/2010), Morikawa et al. (EP 4393510 A1) and/or Faraci et al. (WO 2018152334 A1).
The broadest claim 1 is related to an ophthalmic composition consisting of (a) hypochlorous acid, (b) polyvinylpyrrolidone and/or additional demulcents selected from group consisting of propylene glycol, glycerin, sodium carboxymethyl cellulose, PEG 400, PEG 600 and mixtures thereon in less than 1% w/w, (c) deionized or purified water and (d) inorganic and organic salts and/or buffers, wherein the pH of the composition is in the range of 3.5-6.5.
Adkins teaches or suggests an antimicrobial eyelid cleanser composition comprising (a) hypochlorous acid in 50-300 ppm, (b) one or more surfactant having a HLB value of 5 to 18, and (c) an aqueous vehicle wherein the aqueous vehicle comprising (i) one or more tonicity (e.g., chloride of sodium, potassium, calcium and magnesium) or viscosity adjusters (e.g., carboxymethyl cellulose, hydroxypropyl methylcellulose), (ii) one or more osmolality adjusters/moisturizers (e.g., glycerin, propylene glycol, polyethylene glycol and/or mixtures) wherein the one or more osmolarity adjusters are configured to adjust an osmolality of the composition from about 100 mOsm/kg to about 500 Osm/kg; and (iii) one or more pH adjusters/buffers (e.g., phosphate salts, citrate salts) for maintaining the pH of the composition at between about 4.5 to about 8.0 (entire documents; abstract; para. [0008]-[0012], [0014], [0028]-[0033] and claims 1-22) wherein the eyelid composition is applied to the eye in the form of spray, mist, foam or gel (para. [0035]-[0036]). Adkins also teaches or suggests a kit with applicator (para. [0016], claim 18) and the viscosity of the composition in 1-10 cps or greater than 10 cps (para. [0033]).
Even though Adkins discloses the use of carboxymethyl cellulose, glycerin, propylene glycol, polyethylene glycol and/or one or more surfactant having HLB value of 5 to 18 in formulating said composition, the reference is silent about i) use of polyvinylpyrrolidone or in combination with other ingredients selected from “propylene glycol, glycerin, sodium, carboxymethyl cellulose, PEG, PEG 600 and mixture thereof” in claim 1, ii) its specific concentration or molecular weight in the composition in claims 3, 5 and 12 and iii) the use of the claimed hypochlorous containing composition for the treatment of dry eye in claim 15.
Goldan teaches or suggests the use of a hypohalous acid such as HOCL in about 20 to about 1000 ppm for the treatment of ocular condition originating from an infection and/or inflammatory condition including dry or dry eye syndrome (entire documents; col. 4, line 9-col. 5, line 26; col. 7, lines 20-34; col. 10, lines 61-65; claims). Golden also teaches that the hypochlorous acid containing composition can be formulated with a pharmaceutically acceptable carrier (e.g., polyvinyl alcohol, povidone, hydroxypropyl methyl cellulose, carboxymethyl cellulose and purified water), tonicity agents (e.g., chloride of sodium, potassium, calcium, etc…) in an amount sufficient to cause the composition to have an acceptable osmolality in about 150 to 450 mOsm, buffers (e.g., sodium phosphate, sodium acetate, sodium citrate, etc…) to maintain a target pH within the rage of pH 4-7, surfactants, co-solvent and viscosity building agents to exhibit a viscosity of 1 to 400 cps (col. 6, lines 24-67). Goldan also teaches that the hypochlorous containing composition can be administered as drops to the eye or eye wash, and as a cleanser for the eyelids/or eyelid margins (col. 10, lines 34-38); the “hydrohalous acid solution may be generated by electrolysis of salt, such as saline, and may contain a mixture of oxidizing species such as predominantly hypochlorous acid (HOCL) and sodium hypochlorite” (col. 4, lines 37-40); and “Hypochlorous acid and hypochlorite are in equilibrium and the position of the equilibrium is determined solely by the pH…” (col. 4, lines 41-54).
Baronian is submitted as a supplemental reference to show that polyvinylpyrrolidone (PVP) or povidone) was a well-known excipient routinely used in ophthalmic formulations that is useful for the treatment of dry eye before the effective filling date of the invention was made (entire documents; page 4, line 16 through page 5, line 11). However, Baronian does not expressly disclose the concentration of PVP in such compositions, nor the molecular-weight parameters recited in claims 3 and 4.
Morikawa is submitted as a supplemental reference to show that polyvinylpyrrolidone (PVP) has been used successfully in ophthalmic compositions for suppressing eye dryness at concentrations of 0.0001–5.0% w/v based on the total composition (entire document; paras. [00014]–[0017], [0089]). Morikawa also discloses the use of PVP across a broad range of molecular weights (approximately 5,000 to 5,000,000), identifies preferred subranges, and specifically names grades such as PVP K25, K30, and K90 for ophthalmic formulations. These disclosures show that the use of PVP and the cited molecular-weight ranges/grades in ophthalmic compositions were well known before the effective filling date of the invention was made.
The Leader Lubricant Eye Drops product information printout (Hanlim Pharm. Co., Ltd., Apr. 2010) is submitted as a supplemental reference to show that polyethylene glycol 400 and propylene glycol are known components of ophthalmic solutions used in the treatment of dry eye.
The Faraci reference is submitted as extrinsic evidence that PEG‑400 is a well‑known surfactant with an HLB value between 10 and 15 (see Faraci, p. 13, line 12 through p. 15, line 10).
With respect to selecting a combination of polyvinylpyrrolidone (PVP) with one or more of propylene glycol, glycerin, sodium carboxymethylcellulose, PEG 400, PEG 600, or mixtures thereof, the cited references establish that the components recited in limitation (b)—including PVP, propylene glycol, glycerin, carboxymethylcellulose, and PEG 400 (having an HLB value between 10 and 15)—are well-known excipients in ophthalmic or eyelid-cleanser formulations, ultimately for the treatment of dry eye. A person of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed composition by combining such known elements for their established purposes. As the Supreme Court explained, when a patent “simply arranges old elements with each performing the same function it had been known to perform” and the result “yields no more than one would expect from such an arrangement,” the combination is obvious. KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1740 (2007) (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976)). When the question is whether a combination of prior-art elements is obvious, the inquiry is whether the improvement is more than the predictable use of prior-art elements according to their established functions. Id. The obviousness analysis under 35 U.S.C. § 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim,” because a factfinder may consider the inferences and creative steps that a person of ordinary skill would employ. Id. at 1741–42. Consistent with this reasoning, it would have been obvious to select and combine various disclosed ingredients from the prior art to arrive at the claimed compositions, which would be expected to yield no more than predictable results. Accordingly, on this record, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date, absent evidence to the contrary.
With respect to the specific amount of the specific concentration amount of PVP or molecular weight, as discussed above, Morikawa teaches or suggests the PVP in concentration of 0.0001 to 5 w/v% based on a total of the composition (para. [00014]-[0017] and the PVP having molecular weight of “approximately 5000 to 5,000,000, preferably 10,000 to 3,000,000 and more preferably 10,0000 TO 1,000,000….preferably polyvinyl pyrrolidone K25, polyvinylpyrrolidone K30 and polyvinylpyrrolidone K90
which overlaps with the instantly claimed range. Therefore, the reference makes obvious the claimed
ranges. That being said and in lieu of objective evidence of unexpected results, the amount can be
viewed as a variable that achieves the recognized result of successfully making the oral film
composition. The optimum or workable range of the concentration can be accordingly characterized as
routine optimization and experimentation (see MPEP 2144.05 (IDB). "[Discovery of an optimum value of
a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617
F.2d 272.
With respect to the specific pH range, the specific concentration range of the hypochlorous acid, the specific osmolarity range and the specific viscosity range recited in claim 1-2 and 12-13, the cited prior art clearly shows that it overlaps with the instantly claimed range. The optimum or workable range of the concentration can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (IDB). "[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272.
With respect to “dry eye” in preamble of claim 1 and its dependent claims, it is noted that a preamble is not automatically limiting or entitled to patentable weight. During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference. In the instant application, when reading the preamble in the context of the entire claim, the recitation of “dry eye” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Even assuming arguendo that “dry eye” in the preamble gives “life, meaning and vitality” to the claims, the Examiner determines that such property necessarily flows from the prior art. As discussed above, Goldan teaches the use of HOCL in treating condition characterized by infection and/or inflammation such as dry eye. Therefore, it makes obvious the claimed invention.
With respect to the asserted demulcent function of polyvinylpyrrolidone (PVP) and of propylene glycol, glycerin, sodium carboxymethylcellulose, PEG 400, and PEG 600, the prior art does not expressly identify these materials as demulcents. Rather, the cited references describe them as lubricants, moisturizers, osmolarity adjusters, and/or viscosity-building agents. In the pharmaceutical arts, however, excipients frequently serve multiple roles. Accordingly, claims reciting a “demulcent” must be distinguished from the prior art on the basis of structure and inherent capability, not merely by the label of a function; the pertinent inquiry is whether the prior art materials are capable of performing the claimed demulcent function. On this record, the examiner determines that the cited polymers/agents are capable of functioning as demulcents, and the functional designation alone does not patentably distinguish the claims.
Claim 15 is rejected under 35 U.S.C. 103 as being obvious over the modified teaching of Adkins above as applied to claims 1-3, 5, 8, 12-14 and 16, further in view of Adkins JR. et al. (US2017/0281511).
Even though Goldan teaches that the hypochlorous containing composition can be administered as drops to the eye or eye wash, the modified teaching of Adkins does not expressly teach that the applicator can be designed as an integrated dropper device, a bottle with an auxiliary dropper device or a spray dispenser in claim 15.
Adkins’511 discloses the eyelid composition in aqueous solution wherein the composition is delivered with applicator (a spray dispenser) (Figure 1; claims).
One having ordinary skill in the would have been motivated to incorporate teaching of Adkins’511 into the modified teaching of Adkins with a reasonable expectation of success to deliver the formulation with applicator, as a spray dispenser or dropper bottle. Generally changes in shape and/or size/proportion is considered obvious task for the skilled artisan in absent evidence to the contrary. In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.)
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3, 5, 8 and 12-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613