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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/28/2026 has been entered.
Claims 1 and 7 are pending. Claim 1 is independent. Claims 2-6, 8-11 are cancelled.
Claim Interpretation
Claim 1 copied herein:
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recites both “consists essentially of” language to a buffer solution comprising (EDTA.2NA, CaCl2, KCl, NaCl, and Na2HPO4). Examiner’s interpretation of the scope of claim 1 is that BRI is to comprising since the buffer must comprise the 5 reagents (EDTA.2NA, CaCl2, KCl, NaCl, and Na2HPO4) however, other buffer reagents are not excluded as the claim language specifically recites “…the buffer solution comprises…”.
Response to Amendment
The rejection of claims 1 and 7 under 35 U.S.C. 103 as being unpatentable over de Rijk (US 9,499,419 B2) in view of Kiyobayashi (JP4863589B2) is maintained.
Response to Arguments
Applicant's arguments filed 4/28/2026 have been fully considered but they are not persuasive.
Applicant’s urge on page 3 of 7 of the Remarks 4/28/2026 that the amendment to claim 1 specifies the exact components of the buffer solution (EDTA.2NA, CaCl2, KCl, NaCl, and Na2HPO4). Contrary to Applicant’s arguments, BRI of the scope of claim 1 is to ‘comprising’ since the buffer must comprise (EDTA.2NA, CaCl2, KCl, NaCl, and Na2HPO4) however, other buffer reagents are not excluded as the claim 1 presented for examination specifically recites “…the buffer solution comprises…”. Thus the Argument 3 that the claim 1 recites a specific buffer system that creates a critical ionic microenvironment for structural stability (see Remarks 4/28/2026 page 5 of 7) is not on point with the scope of the claim language presented for examination.
Applicants further urge in Argument 1 on page 4 of 7 that de Rijk does not teach the claimed 1:1 ratio of alginic acid to carrageenan thickener and one of ordinary skill could not have predicted synergistic effect of a sudden non-linear drop in protein adsorption highlighting the efficacy at the claimed ratio.
In response, Applicant’s arguments are not pertinent to the BRI of claim 1. One of ordinary skill reading de Rijk is guided by col.3,ln.35-45 copied herein:
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de Rijk et al. specifically guide one of ordinary skill that the use of the contact lens cleaner removes protein deposits on contact lenses including both hard and soft contacts (see col.60,ln.5). de Rijk guides one of ordinary skill to a contact lens cleaning solution having pH of about 7 (col.40 ln.5) copied herein:
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and the combination of sodium alginate and carrageenan gum sodium alginate (col.35,ln38-39) copied herein:
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further suggesting a ratio of 1:1 (col.9,ln.44) copied herein:
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. Thus, De Rijk et al. disclosure of sodium alginate and carrageenan gum sodium alginate with guidance to include the mixtures of salts in a 1:1 ratio. De Rijk et al. teach an amount of 0.1 to 2 wt % (col.32,ln.35-40) thus, guiding one of ordinary skill to add the claimed alginic acid and carrageenan to a buffer solution and arrive at a similar solution that removes protein deposits on hard and soft contacts.
Applicants continue to urge their declaration showing that de Rijk et al. concentration at 15 mg/ml is insoluble and thus the claimed 1:1 ratio of alginic acid to carrageenan is unexpectedly superior. In response, Applicant’s showing is not commensurate in scope of the claim language, as the claims presented for examination having material limitation to consists essentially of alginic acid, carrageenan, and buffer solution comprising (EDTA.2NA, CaCl2, KCl, NaCl, and Na2HPO4) which claim language requires the buffer must comprise each of the 5 reagents (EDTA.2NA, CaCl2, KCl, NaCl, and Na2HPO4) however, other buffer reagents are not excluded as the claim language specifically recites “…the buffer solution comprises…”
Furthermore, de Rijk et al. teach their contact lens solution removes protein deposits from hard and soft contact lenses and de Rijk et al. is properly combined with Kiyobayashi teaching it is commonly known to optimize the alginic acid and carrageenan as taught by de Rijk in varying amounts of about 0.001 to 10% with respect to the whole preparation based on the type of ocular mucosa application. Accordingly, the claim amendments are addressed below.
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 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over de Rijk (US 9,499,419 B2) in view of Kiyobayashi (JP4863589B2) Google Patents Translation attached.
With respect to claim 1, de Rijk et al. teach a liquid formulation multipurpose solution comprising a polysaccharide composition for cleaning, disinfecting and storing hard contact lenses and/or soft contact lenses (col.60,ln.1-5) comprising a buffer solution having a pH of about 7( col.40,ln.5) encompassing the claim 1 pH of 6.5 to 7.5. de Rijk et al. teach the buffer solution comprising (EDTA.2NA (see col.40,ln.37 and example 1, col.45,ln.37), CaCl2 (see col.9,ln.52), KCl (see col.9,ln.53), NaCl (see col.9,ln51), and Na2HPO4(see col.65,ln.15).
de Rijk et al. teach the claim 1 combination for reducing protein adsorption the polysaccharide composition consisting of alginic acid and carrageenan by teaching car rageenan gum sodium alginate in col.35,ln38-39. Col.32,ln.35-40 and 55-56 teach 0.1-5% thickeners including the claimed alginic acid and carrageenan. It is the Examiner’s position that de Rijk guide one of ordinary skill to the claimed 1:1 ratio of the alginic acid to carrageenan and to a concentration of 1 ~ 10 mg/ml because it teaches both the claimed alginic acid and carrageenan thickeners typically in an amount of from about 0.01% to about 10% by weight in general. See col.14,ln.40. One of ordinary skill is motivated to include equivalent amounts of carrageenan and alginic acid as such as taught by the prior art. de Rijk et al. specifically guide one of ordinary skill that the use of the contact lens cleaner removes protein deposits on contact lenses including both hard and soft contacts (see col.60,ln.5). de Rijk guides one of ordinary skill to a contact lens cleaning solution having pH of about 7 (col.40 ln.5) copied herein:
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and the combination of sodium alginate and carrageenan gum sodium alginate (col.35,ln38-39) copied herein:
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further suggesting a ratio of 1:1 (col.9,ln.44) copied herein:
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. Thus, De Rijk et al. disclosure of sodium alginate and carrageenan gum sodium alginate with guidance to include the mixtures of salts in a 1:1 ratio and teach in an amount of 0.1 to 2 wt % (col.32,ln.35-40) thus, guiding one of ordinary skill to add the claimed alginic acid and carrageenan to a buffer solution and arrive at a similar solution that removes protein deposits on hard and soft contacts. .
de Rijk does not explicitly teach 0.225 to 0.9g of alginic acid with 0.225 to 0.9 g carrageenan as required by claim 1.
In the analogous contact lens solution art, Kiyobayashi (JP4863589B2) Google Patents Translation attached, teaches on page 11, that it is commonly known to optimize the alginic acid and carrageenan, as taught by de Rijk, in varying amounts of about 0.001 to 10% with respect to the whole preparation based on the type of ocular mucosa application being prepared. See [0029-0031] on page 11 of the (JP4863589B2) Google Patents Translation copied herein:
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Kiyobayashi guides one of ordinary skill to include the the alginic acid and carrageenan can be included in a range of 0.0001-10% which range is also encompassed by de Rijk. Kiyobayashi teaches in [0031] that the alginic acid and carrageenan are in varied concentrations for decongestant, anti-inflammatory, anesthetic properties. Examiner notes that de Rijk teach the same range of 0.0001-10% effectively removes protein in contact lenses. Thus, optimizing the same ingredients within the broadly claimed concentration is well within the skill of one of ordinary skill in the art to achieve the beneficial properties of the ophthalmic solution.
de Rijk and Kiyobayashi are both considered to be analogous to the claimed invention because they are in the same field of aqueous compositions for cleaning hard or soft contact lenses. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the claimed 0.225 to 0.9 g alginic acid with 0.225 to 0.9g carrageenan as claimed because de Rijk teach about 0.01% to about 10% inclusion of alginic acid and carrageenan individually in a buffer solution is effective for removing protein, disinfecting, and storing hard/soft contact lenses in general and Kiyobayashi (JP4863589B2) teaches that it is commonly known to optimize the alginic acid and carrageenan as taught by de Rijk in varying amounts of about 0.001 to 10% with respect to the whole preparation based on the type of ocular mucosa application.
One of ordinary skill is motivated to combine the teachings of de Rijk with that of Kiyobayashi since both are in the same field of contact lens solutions and Kiyobayashi teaches in [0031] that alginic acid and carrageenan are included in various concentrations for decongestant, anti-inflammatory, anesthetic properties and de Rijk teach the same amounts ie 0.01% to about 10%, as taught by Kiyobayashi, of the same alginic acid and carrageenan, is effective to remove protein in contact lenses. Further it is the Examiner’s position that the claimed 0.225 to 0.9g alginic acid with 0.225 to 0.9g carrageenan is encompassed by both de Rijk and Kiyobayashi teaching the similar percentages of about 0.001 to 10% of the same alginic acid and carrageenan with respect to the whole preparation of the contact lens solution.
With respect to claim 7, col.60,ln.5 of de Rijk et al. teach the contact lens solution removes protein deposits on both hard and soft lenses.
Claims 1 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over de Matsunaga et al. (EP 2439579B1) in view of Kiyobayashi (JP4863589B2) Google Patents Translation attached.
With respect to claim 1, Matsunaga et al. page 9, [0050] teach a buffer solution for contact lenses [including both hard and soft lenses [0002] comprising a mixture of alginic acid with a buffer similar to the claim 1 buffer.
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The solution in [0050] does not exemplify a carrageenan or the calcium chloride. Examiner notes that [0015] teaches a mixture of alginates with carrageenan and the [0050] guides one of ordinary skill to the alginate A+ B mixture having 1:1 ratio. Also [0031] teaches calcium chloride along with the exemplified KCl and NaCl in [0050]. It is the Examiner’s position that one of ordinary skill is guided by [0031] to include the CaCl as claimed because the same is taught by Matsunaga et al. Further it is the position of the Examiner that one of ordinary skill is guided to a 1:1 ratio of thickener as that is exemplified by Matsunaga et al. and further Matsunaga et al. suggest the claimed carrageenan with the alginate in [0015]. One of ordinary skill is motivated to modify the exemplary disclosure of Matsunaga et al.[0050] with the claimed CaCl because that is taught in [0031]. And one of ordinary skill would modify the solution with carrageenan as it is taught by Matsunaga et al. as an option to include in a buffer solution having 1:1 ratio of alginate A+B. See [0050 with 0015].
Matsunaga et al. do not specifically teach the claim 1 pH of the buffer is 6.5-7.5. Also Matsunaga et al. do not explicitly teach 0.225 to 0.9g of alginic acid with 0.225 to 0.9 g carrageenan as required by claim 1.
In the analogous contact lens solution art, Kiyobayashi (JP4863589B2) Google Patents Translation attached, teaches in [0045] that it is commonly known that ophthalmic solutions will have a pH of 4.0 to 7 in order to reduce irritation.
On page 11, that it is commonly known to optimize the alginic acid and carrageenan, as taught by Matsunaga et al. in varying amounts of about 0.001 to 10% with respect to the whole preparation based on the type of ocular mucosa application being prepared. See [0029-0031] on page 11 of the (JP4863589B2) Google Patents Translation, Kiyobayashi guides one of ordinary skill to include the alginic acid and carrageenan can be included in a range of 0.0001-10% which range is also encompassed by Matsunaga et al. See table 1 buffer solution composition (weight portions). Kiyobayashi teaches in [0031] that the alginic acid and carrageenan are in varied concentrations for decongestant, anti-inflammatory, anesthetic properties. Examiner notes that Matsunaga et al. page 12 teach the same range of 0.01-1% effectively anticontaminates contact lenses. Thus, optimizing the same ingredients within the broadly claimed concentration is well within the skill of one of ordinary skill in the art to achieve the beneficial properties of the ophthalmic solution.
Matsunaga and Kiyobayashi are both considered to be analogous to the claimed invention because they are in the same field of aqueous buffer solutions for hard or soft contact lenses.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the claimed 6.5-7.5 pH of the buffer as required by claim 1 because Matsunaga et al. [0050] and [0031] disclose a buffer comprising the claimed reagents in general and Kiyobayashi establish that the claimed pH would not cause irritation. Further, one of ordinary skill would reasonably expect the same reagents in the similar solution to result in the same pH.
Also, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the claimed 0.225 to 0.9 g alginic acid with 0.225 to 0.9g carrageenan because Matsunaga et al. [0050], [0015] and page 12 suggest about 0.01% to about 1% inclusion of alginic acid and carrageenan in a buffer solution is effective for anticontamination of hard/soft contact lenses in general and Kiyobayashi (JP4863589B2) teaches that it is commonly known to optimize the alginic acid and carrageenan as taught by Matsunaga et al. in a range of 0.0001-10% with respect to the whole preparation based on the type of ocular mucosa application.
One of ordinary skill is motivated to combine the teachings of Matsunaga et al. with that of Kiyobayashi since both are in the same field of contact lens solutions and Kiyobayashi teaches in [0031] that alginic acid and carrageenan are included in various concentrations for decongestant, anti-inflammatory, anesthetic properties and Matsunaga et al. teach the same amounts ie 0.01% to about 1%, as taught by Kiyobayashi, of the same alginic acid and carrageenan, is effective to remove protein in contact lenses. Further it is the Examiner’s position that the claimed 0.225 to 0.9g alginic acid with 0.225 to 0.9g carrageenan is encompassed by both Matsunaga et al. and Kiyobayashi teaching the similar percentages of about 0.01 to 1% of the same alginic acid and carrageenan with respect to the whole preparation of the contact lens solution.
Conclusion
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/PREETI KUMAR/Examiner, Art Unit 1761
/ANGELA C BROWN-PETTIGREW/Supervisory Patent Examiner, Art Unit 1761
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