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 .
Response to Amendment
The Applicant's amendments and/or arguments filed 09/11/2026 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 09/11/2026, it is noted that claim 1 was amended. No new matter has been added.
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 not persuasive for following reasons:
1. “Consisting of” limitation
Applicants argue that “consisting of” excludes any ingredient not recited in claim 1 and that none of the references discloses the claimed closed composition.
The Examiner agrees that “consisting of” excludes additional composition ingredients that would materially affect the claimed composition. However, the obviousness rejection does not require a single reference to disclose every claimed component, nor does it require bodily incorporating every ingredient disclosed in a reference. The relevant question is whether the combined teachings would have suggested a composition having the claimed components, without the additional ingredients relied upon by Applicants.
The rejection relies on the references for their respective teachings regarding hypochlorous-acid ophthalmic compositions, PVP, and compatible ophthalmic excipients. The proposed combination does not require retaining every optional ingredient disclosed in the references. Accordingly, the rejection is not based on treating an extra ingredient as an impurity or disregarding the “consisting of” limitation.
2. Alleged additional ingredients
Applicants argue that Adkins ’415, Goldan, Baronian, Hanlim, Morikawa, Faraci, and Adkins ’511 either omit a claimed ingredient or disclose additional ingredients, and therefore cannot disclose the claimed composition under a “consisting of” construction.
This argument is directed primarily to anticipation, whereas the rejection is based on obviousness. The presence of optional or alternative ingredients in a reference does not preclude a conclusion of obviousness where the reference provides a reason to select the claimed subset of ingredients. A reference’s disclosure of a broader formulation or a list of alternatives does not establish that every disclosed embodiment must contain every listed ingredient.
Here, the cited references provide a finite set of compatible ophthalmic formulation components, including hypochlorous acid, PVP/povidone, glycerin, propylene glycol, polyethylene glycol, carboxymethyl cellulose, salts, buffers, and water. Selecting hypochlorous acid, PVP, one or more of the identified demulcents, and salts and/or buffers within the claimed pH range would have been a predictable formulation choice. The resulting composition would be evaluated as formulated and would not require inclusion of every optional ingredient disclosed in the references.
3. Adkins’415 and alleged absence of a demulcent or polymer
Applicants argue that Adkins ’415 is directed to an eyelid cleanser containing HLB 5–18 surfactants and does not disclose a demulcent or polymer-stabilization component.
The argument is not persuasive because Adkins ’415 is not relied upon alone for the PVP limitation. Goldan expressly teaches hypochlorous-acid compositions for ocular conditions, including dry-eye syndrome, formulated with pharmaceutically acceptable carriers such as povidone, carboxymethyl cellulose, and purified water; tonicity agents; buffers; and viscosity-building agents. Goldan further teaches ophthalmic administration as drops or an eyewash and discloses a pH range of about 4–7, which overlaps the claimed pH range.
Accordingly, Goldan provides the missing teaching and the reason to include PVP in a hypochlorous-acid ophthalmic composition. Baronian and Morikawa further confirm that PVP was a known ophthalmic excipient for treating or suppressing eye dryness.
In addition, the fact that Adkins ’415 identifies these components as moisturizers, osmolality or tonicity adjusters, surfactants, and/or viscosity-adjusting agents, rather than as “demulcents,” does not patentably distinguish the claim. Pharmaceutical excipients commonly perform multiple functions. For example, carboxymethyl cellulose is a polymer capable of providing a demulcent effect; and glycerin, propylene glycol, and polyethylene glycol are capable of providing moisturizing and lubricating effects associated with demulcents. Thus, the claimed functional designation does not impose a meaningful structural distinction over the disclosed materials.
Nor is the rejection overcome by asserting that Adkins ’415 addresses eyelid cleansing rather than dry-eye treatment. The relevant inquiry is whether the prior art teaches or suggests the claimed composition, not whether it identifies the same intended use or technical problem. Adkins ’415 provides guidance for selecting compatible excipients for a hypochlorous-acid ophthalmic composition, and such selection would have been a predictable formulation choice.
Accordingly, the different terminology and asserted difference in intended use do not distinguish the claimed composition. The rejection is maintained.
4. Alleged distinction between surfactants and demulcents
Applicants argue that Adkins ’415 uses surfactants to cleanse and foam, whereas the claimed invention uses PVP or another demulcent/polymer to stabilize hypochlorous acid and lubricate the ocular surface.
The asserted difference in functional terminology does not establish a patentable distinction. The obviousness inquiry is not limited to the principal purpose identified by a reference. The same ophthalmic excipients may provide multiple functions, including lubrication, moisturization, viscosity control, film formation, tonicity adjustment, and ocular-surface protection.
Moreover, the rejection relies on Goldan, Baronian, and Morikawa for the teaching or motivation to use PVP in a hypochlorous-acid ophthalmic composition. The fact that Adkins ’415 emphasizes cleansing does not negate Goldan’s express teaching of ophthalmic and dry-eye formulations containing PVP/povidone and related excipients.
Applicants have also not established that the alleged stability effect is critical to, or uniquely produced by, the claimed combination. The claim does not recite a measured stability property, a particular shelf life, a degradation rate, or a specific PVP concentration or molecular-weight limitation in claim 1. An unclaimed intended result cannot distinguish a composition otherwise suggested by the prior art.
Furthermore, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991) (discussed below).
5. Alleged need to delete surfactants from Adkins ’415
Applicants argue that the rejection requires impermissibly deleting surfactants from Adkins ’415 and that there is no motivation has been provided to omit them.
The rejection does not require modifying a complete Adkins ’415 formulation by removing a required ingredient. Adkins ’415 discloses formulation components and alternatives for hypochlorous-acid compositions; it does not require that every disclosed embodiment contain every disclosed optional ingredient. In any event, the combination is not limited to reproducing the specific cleanser formulation of Adkins ’415. A skilled artisan would have selected compatible components from the references to formulate an ophthalmic composition for the desired use.
The cases cited by Applicants, including *In re Gordon* and *In re Ratti*, are distinguishable. Those cases concern modifications that would defeat the reference’s operating principle or require removal of a component necessary for the disclosed device or process. Here, omission of a cleansing surfactant from a formulation intended for a different ophthalmic purpose would not defeat the general teaching of using hypochlorous acid in an ophthalmic composition. The proposed formulation would instead use PVP and other known ophthalmic excipients for lubrication, moisturization, viscosity control, or ocular-surface protection.
6. Alleged lack of motivation to combine
Applicants argue that the Examiner has not provided a sufficient rationale for combining the references.
The references address the same general field—aqueous ophthalmic compositions for ocular conditions—and disclose overlapping formulation components. Adkins ’415 and Goldan both teach hypochlorous-acid compositions for ocular or periocular use. Goldan specifically identifies PVP/povidone, salts, buffers, and ophthalmic carriers. Baronian and Morikawa demonstrate that PVP was a known dry-eye excipient, and the Leader reference demonstrates that polyethylene glycol 400 and propylene glycol were known components of dry-eye products.
The rationale for combining the teachings is therefore to obtain a hypochlorous-acid ophthalmic composition containing known, compatible excipients selected for their established functions, including lubrication, moisturization, viscosity control, tonicity adjustment, and pH control. Such a combination would have been predictable and within the level of ordinary skill.
Applicants request confirmation that each reference individually contains every ingredient recited in claim 1. Such a showing is not required for a rejection under 35 U.S.C. § 103. The references need not be considered in isolation, and no single reference is relied upon as disclosing the entire claimed combination.
In particular:
- Adkins ’415 teaches hypochlorous-acid ophthalmic or periocular compositions, aqueous vehicles, pH control, salts, buffers, and compatible excipients.
- Goldan teaches hypochlorous-acid compositions for ocular conditions, including dry eye, with povidone/PVP, carboxymethyl cellulose, purified water, tonicity agents, and buffers at an overlapping pH range.
- Baronian confirms that PVP/povidone was a known ophthalmic excipient for dry-eye formulations.
- Morikawa teaches PVP in ophthalmic compositions for suppressing eye dryness, including concentrations and molecular-weight ranges relevant to dependent claims.
- Hanlim supports the known use of polyethylene glycol 400 and propylene glycol in ophthalmic dry-eye formulations.
- Faraci provides evidence concerning the known surfactant properties of PEG 400 and does not establish a distinction from its other known ophthalmic formulation uses.
- Adkins ’511, to the extent relied upon, further supports the use of compatible ophthalmic excipients in hypochlorous-acid formulations.
The references are therefore relied upon for complementary teachings, not as though each individually disclosed the entire closed composition.
7. Alleged stability discovery
Applicants assert that the invention solves a stability problem because hypochlorous acid allegedly degrades in the presence of typical demulcents and that specific PVP grades maintain stability while lubricating the eye.
This assertion does not overcome the rejection. Claim 1 does not require a particular stability result or define the composition by a degradation rate, storage period, or comparative stability parameter. Nor does claim 1 require a particular PVP grade or molecular-weight range. The asserted stability advantage therefore does not impose a limitation distinguishing the claimed composition from the prior art.
To the extent claims 3 and 5 recite particular PVP concentrations, molecular weights, or grades, Morikawa expressly teaches PVP concentrations of about 0.0001–5.0% w/v, molecular weights of approximately 5,000–5,000,000, and grades including PVP K25, K30, and K90 for ophthalmic formulations. Applicants have not shown that the claimed selections produce an unexpected result across the full scope of those claims.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613
