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 .
The Office Action is in response to the application filed December 13, 2023.
Claim Analysis
Summary of Claim 1:
A sealed ophthalmic product or kit, comprising:
a contact lens package comprising a sealed compartment comprising at least one sterile silicone hydrogel contact lens and a buffered packaging solution having a pH of about 4.5 to about 6.
Drawings
The drawings are objected to because the x-axis labels of Figures 1-12 are illegible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 3, 11, 13-16, 19-22, 26, 28, 31, 33, 35, 38 objected to because of the following informalities:
Claim 3 recites “And mixtures thereof” (emphasis added). Applicant is advised to rephrase to “and mixtures thereof” (emphasis added).
Claim 13 recites “the organic acid buffer is selected from maleic acid, its sodium or potassium salts and mixtures thereof”. Applicant is advised to rephrase to “the organic acid buffer is selected from maleic acid, the sodium or potassium salts of maleic acid, or mixtures thereof” as supported by the instant Specification [Page 8, Lines 5-9].
Claim 15 recites “the the packaging” (emphasis added). Applicant is advised to rephrase to “the packaging”.
Claim 19 recites “The product of embodiment 17”. Applicant is advised to rephrase “The product of embodiment 17” to “The product of claim 17”. For the purposes of examination, Claim 19 will be interpreted to read “The product of claim 17”.
Claim 26 recites “about 0.001to” (emphasis added). Applicant is advised to rephrase to “about 0.001 to” (emphasis added).
Claim 28 recites “claim 1further” (emphasis added). Applicant is advised to rephrase to “claim 1 further”.
Claim 31 recites “0.008 to about 0.075 wt%”. Applicant is advised to rephrase to “0.008 to about 0.075 wt% based on the total weight of the buffered packaging solution” as supported in the instant Specification [Page 19, Lines 9-15]. Similarly, Claim 38 recites “0.5 wt%” without specifying to what the amount is normalized.
Claims 11, 14-16, 20-22, 26, 33, and 35 recite “the packaging solution”. Applicant is advised to rephrase to “the buffered packaging solution”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5, 11-12, 14, 19-20, 26-27, 32, 35-37, and 40 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 5 recites the limitation "the silicone hydrogel". There is insufficient antecedent basis for this limitation in the claim. Similarly, Claim 35 recites “the silicone hydrogel” for there is insufficient antecedent basis in the claim. Thus, it is not clear what “the silicone hydrogel” recited in claims 5 and 35 are referring to, whether it is the silicone hydrogel contact lens recited in claim 1, on which they depend from, or something else/additional. For the purposes of examination, “the silicone hydrogel” of Claims 5 and 35 will be interpreted to read “the silicone hydrogel contact lens”.
Claim 12 recites “(such the sodium or potassium salts of the organic acids)”. However, there is insufficient antecedent basis for “the sodium or potassium salts of the organic acids” and it is unclear if the organic acids refer to the organic acid buffer or organic acid compounds. Furthermore, it is unclear whether the phrase “the sodium or potassium salts of the organic acids” enclosed in parentheses is required by the claim or not. As such, Claim 12 is rendered indefinite.
Similarly, Claim 14 recites the phrase “as sum of mono and di-basic salts” surrounded by parentheses and it is unclear whether the “as sum of mono and di-basic salts” is required by the claim or not. It is also not clear whether the content of organic acid is based on the sum of mono- and di-basic salt or the packaging solution. As such, Claim 14 is rendered indefinite
Claims 11, 14, 19-20, and 26-27 recite “the composition”. It is not clear what the composition recited in these cited claims referring to since “the composition” lacks proper antecedent basis. As such, these claims are rendered indefinite.
Claims 32 and 35 recite “the buffer”. It is not clear what “the buffer” recited in Claims 32 and 35 are referring to since there is a lack of proper antecedent basis for “the buffer”. As such, Claims 32 and 35 are rendered indefinite.
Claim 40 recites “the therapeutic agent”. It is not clear which particular therapeutic agents listed in claim 40 (e.g., atropine) refer to what therapeutic agent recited in claim 39, on which claim 40 depends from. Moreover, the therapeutic agent recited in claim 40 lacks antecedent basis since claim 39, on which claim 40 depends from, recite “at least one” therapeutic agent, and thus it is not clear what “the therapeutic agent” is referring to. As such, Claim 40 is rendered indefinite.
Claims 36-37 are rejected for being dependent on a rejected base claim 35.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 7, 10, 23-24, 32-34, and 41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zanini et al. (US 8507577 B2; cited in the IDS submitted on 02/04/2025; hereafter as “Zanini”).
Regarding Claims 1 and 41, Zanini teaches silicone hydrogel contact lenses that are packaged in vials containing buffered saline solution, capped, and sterilized [Examples 1-28; Abstract], corresponding to a sealed ophthalmic product comprising a contact lens package comprising a sealed compartment comprising a buffered packaging solution of Claims 1 and 41, wherein the sterile silicone hydrogel contact lens corresponds to the sterile silicone hydrogel contact lens of Claim 1, and which according to paragraph [0059] of applicants’ published application, i.e., US PG PUB 2024/01159938 corresponds to the sterile ocular insert of Claim 41. Zanini further teaches when the buffered saline solution has a protonated diluent with an amine group, the buffered saline solution has a pH between about 4 and about 7 [Claim 1; Column 15, Lines 23-25; Example 28], corresponding to the buffered packaging solution having a pH of about 4.5 to about 6 of Claims 1 and 41.
Regarding Claims 2-5, 7, 10, 23-24, and 32-34, Zanini further teaches:
2-hydroxy-3-methacryloxypropyloxypropyl-tris(trimethylsiloxy)silane [Column 6, Lines 1-5], corresponding to the hydrolysable silicone monomer of Claim 2; and thereby reading on the 2-hydroxy-3-methacryloxypropyloxypropyl-tris(trimethylsiloxy)silane of Claims 3-4;
Balafilcon [Column 17, Lines 33-35], thereby reading on the balafilcon of Claim 5;
borate buffered saline solution [Examples 1-27; Column 15, Lines 4-13], thereby reading on wherein the buffered packaging solution comprises a borate compound of Claim 7; and corresponding to the borate compound of Claim 10;
antibacterial agents [Column 15, Lines 7-16], which, according to the instant Specification, are therapeutic agents and unstable at neutral pH [Page 17, ¶ 2-3], corresponding to the therapeutic agent of Claims 23 and 32; corresponding to wherein the therapeutic agent is hydrolytically unstable at neutral pH of Claim 24;
other types of buffers, such as sodium bicarbonate solutions [Column 15, Lines 4-13], which are silent to borate, so for the purposes of examination will be interpreted to correspond to wherein the buffer is free from borate of Claim 32;
the buffer solution of Zanini optionally include but does not require preservatives [Column 15, Lines 7-16], thus Zanini’s embodiment without presence of preservative correspond to the claimed wherein the packaging solution is free from preservatives of Claim 33; and
packaged contact lenses were capped and sterilized at 120°C [Examples 1-27], corresponding to wherein the sealed ophthalmic product is heat sterilized of Claim 34.
In light of the above, the cited claims are rendered anticipated by Zanini.
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 6, 9, and 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Zanini et al. (US 8507577 B2; cited in the IDS submitted on 02/04/2025; hereafter as “Zanini”).
Zanini teaches the sealed compartment, sterile silicone hydrogel contact lens, buffered packaging solution, and pH of Claim 1 as set forth above and incorporated herein by reference.
Regarding Claims 6, 9, and 28-30, Zanini further teaches:
the buffered saline solution may have a pH between about 4 and about 7 [Claim 4; Column 15, Lines 23-25], thereby overlapping with wherein the pH is about 5 to about 6 of Claim 6;
borate buffered saline solution comprising 0.01-10% by weight additives such as sorbic acid [Examples 1-27; Column 15, Lines 4-13], thereby reading on a mixture of organic acid compounds and borate compounds of Claim 9;
ethylenediaminetetraacetic acid (EDTA) [Column 15, Lines7-16], which corresponds with the sequestering agent of Claim 28, thereby reading on the EDTA of Claim 29, and corresponding to the EDTA of Claim 30.
However, Zanini does not explicitly teach wherein the pH is about 5 to about 6 of Claim 6.
Nevertheless, one of ordinary skill in the art at the time the invention was made would have considered the invention to have been obvious because the pH range taught by Zanini (pH = 4-7) overlaps the instantly claimed pH range of 5-6. Thus, the subject matter as a whole would have been obvious to one having ordinary skill in the art at the time the invention was made, since it has been held that choosing the over lapping portion of the range taught in the prior art and the range claimed by the applicant, has been held to be a prima facie case of obviousness. See MPEP §2144.05.
Regarding Claims 9 and 28-31, Zanini do not mention the claimed sequestering agent (i.e., EDTA) of claims 28-31 and the particular organic acid compounds and borate compounds of Claim 9 with sufficient specificity constitute anticipation within the meaning of 35 USC 102. Zanini also do not specify the particular amount of the claimed sequestering agent. Nevertheless, Zanini do disclose employing borate buffered saline solution comprising additives and specific examples of such additives include sorbic acid and EDTA [Column 15, Lines 4-13], which correspond to the organic acid compound and borate of Claim 9, and sequestering agent of Claims 28-30, respectively. According to Zanini, any additives, such as the sorbic acid and EDTA, can be used to modify the contacting times and longer contacting times will provide greater leaching [Column 15, Lines 42-50]. Moreover, although Zanini exemplifies several additives, Zannini discloses that the other additives are equally suitable for the purposes of forming a contact lens buffered saline solution [Column 15, Lines 42-50].
Given that Zanini specifically discloses the claimed sorbic acid and EDTA as some of many additives suitable for forming a contact lens buffered saline solution with desirable properties, it would have been obvious to one of ordinary skill in the art to in the claimed specific sequestering agent, including EDTA, and particular organic acid compounds and borate compounds as the additives suggested by Zanini.
See also MPEP § 2141 [R-6], III (“obviousness can be established when there exists a finite number of predictable solutions with a reasonable expectation of success.”).
Additionally, Zanini discloses employing 0.01-10% by weight of additives such as ethylene diamine tetracetate (EDTA) [Column 15, Lines 4-13], which according to present claims 28-30 correspond to the claimed sequestering agent, i.e., EDTA, and thereby overlapping with wherein the sequestering agent is present in amount from about 0.008 to about 0.075 wt% of Claim 31. Thus, the subject matter as a whole would have been obvious to one having ordinary skill in the art at the time the invention was made, since it has been held that choosing the overlapping portion, of the range taught in the prior art and the range claimed by the applicant, has been held to be a prima facie case of obviousness. See MPEP § 2144.05.
Claims 8, 11, and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Zanini et al. (US 8507577 B2; cited in the IDS submitted on 02/04/2025; hereafter as “Zanini”) in view of Lum et al. (“Osmolality and buffering agents in soft contact lens packaging solutions”, Cont Lens Anterior Eye. 2004 Mar; 27(1):21-6; hereafter as “Lum”).
Zanini teaches the sealed compartment, sterile silicone hydrogel contact lens, buffered packaging solution, and pH of Claim 1 as set forth above and incorporated herein by reference.
Zanini further teaches:
borate buffered saline solution [Examples 1-27; Column 15, Lines 4-13], corresponding to the borate compound of Claim 11.
Regarding Claims 8, 11, 15-17, and 19, however, Zanini does not explicitly teach wherein the buffered packaging solution is a phosphate buffer system comprising one or more phosphate compound of Claim 8, wherein the composition comprises from about from about 0.2 wt% to less about 1.5 wt% of at least one borate compound, by weight of the packaging solution of Claim 11; wherein the phosphate buffer comprises from about 0.4 wt% to about 0.85 wt%, of at least one phosphate compound by weight of the packaging solution of Claim 15; the tonicity agent of Claim 16; wherein the tonicity adjusting agents are selected from ionic salts and non-ionic compounds of Claim 17; and wherein the ionic salts may be present in the composition in concentrations to provide an osmolality from the ionic salts alone of about 240 mOsm/kg to about 450 mOsm/kg of Claim 19.
Nevertheless, Lum teaches the osmolality of different commercially available contact lens packaging solutions [Table 1], wherein:
phosphate buffer solution comprising 0.017 M Na2HPO4 and 0.0038 M NaH2PO4 [Section 2.3. Solutions], which is equivalent to 0.3 wt. % phosphate1, corresponding to the phosphate buffer solution comprising one or more phosphate compound of Claim 8; which for the purpose of examination will be interpreted to be substantially close to the lower claimed range of about 0.4 wt. % to about 0.85 wt. % of at least one phosphate compound of Claim 15;
isotonic saline comprising sodium chloride [Section 2.3. Solutions], corresponding to the tonicity agent of Claim 16; and thereby reading on wherein the tonicity adjusting agent is an ionic salt of Claim 17;
borate buffer solution comprising 0.1 M H3BO3 [Section 2.3. Solutions], which is equivalent to 0.6 wt. % borate2, which is encompassed by about 0.2 wt% to less than about 1.5 wt% of at least one borate compound of Claim 11;
the phosphate osmolality is 270-302 mOsmol/kg [Table 1], corresponding to wherein the ionic salts may be present in the composition in concentrations to provide an osmolality from the ionic salts alone of about 240 mOsm/kg to about 450 mOsm/kg of Claim 19.
Lum offers the motivation that phosphate buffer solution and borate buffer solution are utilized in commercially available soft contact lens solutions [Section 2.3. Solutions].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the buffer solutions of Lum with the buffered packaging solution of Zanini, for the purposes of using the same for commercially available contact lens solutions.
Regarding Claim 15, however, Lum does not explicitly teach about 0.4 wt. % to about 0.85 wt. % of at least one phosphate compound of Claim 15.
Nevertheless, Lum teaches 0.3 wt. % of phosphate compounds in the phosphate buffer solution [Section 2.3. Solutions]. The amount of 0.3 wt. % as taught by Zanini is substantially close to the lower range of 0.4 wt. % as required by the instant claims. One of ordinary skill would have expected compositions that are in such close proportions to those in prior art to be prima facie obvious and to have the same properties. Titanium Metals Corp., 227 USPQ 773 (CA FC 1985). See MPEP 2144.05. Therefore, it would have been obvious to one of ordinary skill in the art to expect the amount of 0.3 wt. % of phosphate compounds as taught by Zanini would result in the same properties as the claimed range of 0.4 wt. % thereby rendering the claimed range obvious.
Regarding Claims 18, and 20-22, Zanini also teaches diluents such as dipropylene glycol [Column 3, Lines 56-64], and hydrophilic components such as polyethylene glycol [Column 9, Lines 17-43], which Page 10, ¶ 1 of the instant Specification discloses are non-ionic tonicity agents, which corresponds with the non-ionic tonicity agents of Claims 18, 20, the propylene glycol of Claim 21, and polyethylene glycol of Claim 22.
However, Zanini does not explicitly teach wherein the composition has an osmolality of about 240 to about 600m Osm/kg of Claim 20, propylene glycol in amounts between about 0.5 to about 3 wt%, based upon the packaging solution of Claim 21, wherein the non-ionic compound comprises polyethylene glycol in amounts between 0.5 to about 3 wt%, based upon the packaging solution of Claim 22.
Nevertheless, Lum teaches the osmolality of different contact lens packaging solutions with osmolality ranges of 270-302 mOsmol/kg [Table 1], which overlaps with an osmolality of about 240 mOsm/kg to about 600 mOsm/kg of Claim 20.
Lum offers the motivation that the contact lens packaging solutions are commercially available [Section 2.3. Solutions].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the osmolality of Lum with the buffered packaging solution of Zanini, with the motivation to produce a contact lens rewetting eye drop solution using commercially available products.
Furthermore, Zanini teaches diluents, such as dipropylene glycol, are useful to solubilize components in the reactive mixture [Column 3, Lines 36-45], and hydrophilic compounds like polyethyelene glycol, can modify the water content in the contact lenses [Column 9, Lines 17-43]. Therefore, the amount of the dipropylene glycol and polyethylene glycol can be optimized to reach the desired solubility and water content, respectively, via a routine optimization. Discovering an optimum value of a result effective variable involves only routine skill in the art. See MPEP 2144.05. Thus, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to adjust the amount of dipropylene glycol and polyethylene glycol for the intended application via a routine optimization, thereby obtaining the present invention.
One of ordinary skill in the art at the time the invention was made would have considered the invention to have been obvious because the osmolarity range (270-302 mOsmol/kg) as taught by Lum overlaps the claimed range (240 mOsm/kg to about 600 mOsm/kg) and is therefore considered to establish a prima facie case of obviousness. It would have been obvious to one of ordinary skill in the art to select any portion of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art reference, MPEP section 2144.05.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zanini et al. (US 8507577 B2; cited in the IDS submitted on 02/04/2025; hereafter as “Zanini”) in view of Hyugaji et al. (WO 2015/119256A1; English translation incorporated herein; hereafter as “Hyugaji”).
Zanini teaches the sealed compartment, sterile silicone hydrogel contact lens, buffered packaging solution, and pH of Claim 1 as set forth above and incorporated herein by reference.
Claims 12-13 are dependent on Claim 9 which is unpatentable over Zanini as disclosed above. More specifically, Zanini teaches borate buffered saline solution comprising weight additives such as sorbic acid [Examples 1-27; Column 15, Lines 4-13], thereby reading on a mixture of organic acid compounds and borate compounds of Claim 9. However, Zanini do not mention the particular organic acid compounds and borate compounds of Claim 9 with sufficient specificity constitute anticipation within the meaning of 35 USC 102. Nevertheless, Zanini do disclose any additives, such as the sorbic acid, can be used to modify the contacting times and longer contacting times will provide greater leaching [Column 15, Lines 42-50]. Therefore, it would have been obvious to one of ordinary skill in the art to in the claimed specific organic acid compounds and borate compounds as the additives suggested by Zanini.
However, Zanini does not teach the particular organic acid buffers of Claims 12-13.
Nevertheless, Hyugaji teaches contact lens solutions [Abstract], comprising:
buffering agents such as maleic acid [Page 41, ¶ 1], thereby reading on wherein the organic acid buffer is maleic acid of Claims 12-13.
Hyugaji offers the motivation that the contact lens solution has excellent lipid cleaning power and exhibits high hydrophilicity performance, and when coated on lenses, it exhibits excellent lipid adhesion prevention and lubrication effects [Page 4, ¶ 5].
Thus, it would have been obvious to one of ordinary skill in the art to employ the claimed particular organic acid buffers including maleic acid taught by Hyugaji in the contact lens solution of Zanini for the purposes of obtaining excellent lipid cleaning power and high hydrophilicity performance, and when coated on lenses, it exhibits excellent lipid adhesion prevention and lubrication effects.
Regarding Claim 14, which is dependent on claim 12, Zanini further teaches borate buffered saline solution comprising 0.01-10% by weight additives such as sorbic acid [Examples 1-27; Column 15, Lines 4-13], thereby overlapping with an organic acid content in the range of about 0.10% to about 0.4%, by weight of the packaging solution of Claim 14.
However, Zanini does not explicitly teach an organic acid content in the range of about 0.10% to about 0.4 %, by weight of the packaging solution of Claim 14.
Nevertheless, one of ordinary skill in the art at the time the invention was made would have considered the invention to have been obvious because the range taught by Zanini for the sorbic acid content of Claim 14 (0.01-10 wt. %) overlaps the instantly claimed ranges (about 0.10 wt. % to about 0.4 wt. % of Claim 14) and is therefore considered to establish a prima facie case of obviousness. It would have been obvious to one of ordinary skill in the art to select any portion of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art reference, MPEP section 2144.05.
Claims 25-27 and 35-37 are rejected under 35 U.S.C. 103 as being unpatentable over Zanini et al. (US 8507577 B2; cited in the IDS submitted on 02/04/2025; hereafter as “Zanini”) in view of Cheng et al. (CN 103576337 B; English translation incorporated herein; hereafter as “Cheng”).
Zanini teaches the sealed compartment, sterile silicone hydrogel contact lens, buffered packaging solution, and pH of Claim 1 as set forth above and incorporated herein by reference.
Zanini teaches medicinal agents [Column 12, Lines 33-37], which correspond to the therapeutic agent of Claims 25.
However, Zanini does not explicitly teach the wherein the therapeutic agent comprises at least one atropine compound selected from atropine, atropine sulfate, and mixtures thereof of Claim 25; wherein the composition comprises about 0.001 to about 0.05 wt% atropine compound based upon the total weight of the packaging solution of Claim 26; and wherein said composition is free of borate compounds of Claim 27.
Nevertheless, Cheng teaches a silicone hydrogel contact lens for controlling the development of myopia [Claims 1-14], corresponding to:
control of myopia with 0.001% to about 0.50% by weight atropine in the solution [Claims 4-5, 7-8; ¶ 0036], thereby reading on the atropine of Claims 25, and corresponding to wherein the composition comprises about 0.001 to about 0.05 wt% atropine compound based upon the total weight of the packaging solution of Claim 26.
The contact lens buffered saline solution of Cheng does not require borate which, for the purposes of examination, will be interpreted to read on wherein the composition is free of borate compounds of Claim 27.
Cheng offers the motivation that daily instillation of atropine drops showed an effect of slowing the progression of myopia [¶ 0072].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the atropine of Cheng with the buffered packaging solution of Zanini, with the motivation to slow the progression of myopia, thereby arriving at the claimed invention.
Regarding Claims 35-37, Zanini further teaches:
2-hydroxy-3-methacryloxypropyloxypropyl-tris(trimethylsiloxy)silane [Column 6, Lines 1-5], corresponding to the hydrolysable silicone monomer unit of Claim 35; and
medicinal agents [Column 12, Lines 33-37], corresponding to the therapeutic agent of Claim 35.
However, Zanini does not explicitly teach and the phosphate buffer of Claim 35; wherein the therapeutic agent comprises atropine or an ophthalmically compatible salt thereof of Claim 36; and wherein the silicone hydrogel contact lens is a myopia control contact lens of Claim 37.
Nevertheless, Cheng teaches:
phosphate buffer solution [¶ 0056, 0067], corresponding to the wherein the buffer is a phosphate buffer of Claim 35;
a silicone hydrogel contact lens for controlling the development of myopia [Claims 1-14], corresponding to wherein the silicone hydrogel contact lens is a myopia control contact lens of Claim 37; and
control of myopia with 0.001% to about 0.50% by weight atropine in the solution [Claims 4-5, 7-8; ¶ 0036], thereby reading on the atropine of Claim 36.
Cheng offers the motivation that the phosphate buffer solution can be used to store contact lenses and daily instillation of atropine drops showed an effect of slowing the progression of myopia [¶ 0067, 0072].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the phosphate buffer solution and atropine of Cheng with the buffered packaging solution of Zanini, with the motivation to store contact lenses and to slow the progression of myopia, thereby arriving at the claimed invention.
Claims 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Zanini et al. (US 8507577 B2; cited in the IDS submitted on 02/04/2025; hereafter as “Zanini”) in view of Lum et al. (“Osmolality and buffering agents in soft contact lens packaging solutions”, Cont Lens Anterior Eye. 2004 Mar; 27(1):21-6; hereafter as “Lum”) and Liu et al. (US 2010/0086514 A1; hereafter as “Liu”).
Regarding Claims 38 and 39, Zanini teaches silicone hydrogel contact lenses that are packaged in vials containing buffered saline solution, capped, and sterilized [Examples 1-28; Abstract], corresponding to a sealed ophthalmic product comprising a contact lens package comprising a sealed compartment comprising a buffered packaging solution of Claim 38, wherein the sterile silicone hydrogel contact lens corresponds to the sterile silicone hydrogel contact lens of Claim 38. Zanini further teaches when the buffered saline solution has a protonated diluent with an amine group, the buffered saline solution has a pH between about 4 and about 7 [Claim 1; Column 15, Lines 23-25; Example 28], which overlaps with the buffered packaging solution having a pH of about 4.5 to about 6 of Claim 38. Zanini also teaches diluents such as dipropylene glycol [Column 3, Lines 56-64], which is a propylene glycol, which Page 10, ¶ 1 of the instant Specification discloses is a non-ionic tonicity agent, which corresponds with the non-ionic tonicity agent of Claim 38. Moreover, Zanini teaches antibacterial agents compounds [Column 15, Lines 7-16], thereby reading on the antibiotics of Claim 39.
However, Zanini does not teach the buffered packaging solution having a pH of about 4.5 to about 6 of Claim 38, the non-ionic compound tonicity agent of Claim 38, and wherein the composition has an osmolality of about 240 to about 600 mOsm/kg of Claim 38; and the non-ionic tonicity agent in an amount between about 0.5 wt% and amounts that increase the osmolality of the packaging solution by up to about 280 mOsm/kg of Claim 38.
Nevertheless, Lum teaches the osmolality of different contact lens packaging solutions with osmolality ranges of 270-302 mOsmol/kg [Table 1], which overlaps with an osmolality of about 240 mOsm/kg to about 600 mOsm/kg of Claim 38.
Lum offers the motivation that the contact lens packaging solutions are commercially available [Section 2.3. Solutions].
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the osmolality of Lum with the buffered packaging solution of Zanini, with the motivation to produce a contact lens rewetting eye drop solution using commercially available products.
One of ordinary skill in the art at the time the invention was made would have considered the invention to have been obvious because the osmolality range (270-302 mOsmol/kg) as taught by Lum overlaps the claimed ranges (an osmolality of about 240 mOsm/kg to about 600 mOsm/kg of Claim 38) and the pH range taught by Zanini (pH of about 4 to about 7) overlaps the instantly claimed pH range of about 4.5 to about 6 and is therefore considered to establish a prima facie case of obviousness. It would have been obvious to one of ordinary skill in the art to select any portion of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art reference, MPEP 2144.05.
Furthermore, Zanini teaches diluents, such as dipropylene glycol, are useful to solubilize components in the reactive mixture [Column 3, Lines 36-45]. Therefore, the amount of the dipropylene glycol can be optimized to reach the desired solubility via a routine optimization. The case law has held that discovering an optimum value of a result effective variable involves only routine skill in the art. See MPEP 2144.05. Thus, it would have been obvious to one having ordinary skill in the art at the time of the invention was made to adjust the amount of dipropylene glycol for the intended application via a routine optimization, thereby obtaining the present invention.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Zanini et al. (US 8507577 B2; cited in the IDS submitted on 02/04/2025; hereafter as “Zanini”) in view of Lum et al. (“Osmolality and buffering agents in soft contact lens packaging solutions”, Cont Lens Anterior Eye. 2004 Mar; 27(1):21-6; hereafter as “Lum”) and Liu et al. (US 2010/0086514 A1; hereafter as “Liu”) as applied to claims 38 and 39 above and in further view of Cheng et al. (CN 103576337 B; English translation incorporated herein; hereafter as “Cheng”).
The disclosures with respect to Zanini, Lum and Liu mentioned supra are incorporated here by reference.
However, Zanini does not explicitly teach wherein the therapeutic agent is selected from atropine, atropine sulfate, brimonidine, brimonidine tartrate, lifitigrast, perfluorohexyloxtane, ketotifen, ketotifen fumarate, olopatadine, alcaftadine, azelastine, cetirizine, latanoprost, bimatoprost, pilocarpine, prednisolone, prednisolone acetate and dexamethasone of Claim 40.
Nevertheless, Cheng teaches a silicone hydrogel contact lens for controlling the development of myopia [Claims 1-14], comprising atropine in the solution [Claims 4-5, 7-8; ¶ 0036], thereby reading on the atropine of Claims 40.
Cheng offers the motivation that daily instillation of atropine drops showed an effect of slowing the progression of myopia [¶ 0072].
Zanini, Lum, Liu, and Cheng are considered to be analogous art as the claimed invention, as all are in the same field of soft silicone hydrogel contact lenses and storage solutions for contact lenses.
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the atropine of Cheng with the buffered packaging solution of Zanini, Lum, and Liu with the motivation to slow the progression of myopia, thereby arriving at the claimed invention.
Conclusion
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/DORIS LING/Examiner, Art Unit 1764
/HANNAH J PAK/Primary Examiner, Art Unit 1764
1 Na2HPO4 MW = 141
g
m
o
l
, amt. Na2HPO4 =
141
g
m
o
l
*
0.017
M
=
2.4
g
L
; NaH2PO4 MW = 120
g
m
o
l
, amt. Na2HPO4 =
120
g
m
o
l
*
0.0038
M
=
0.46
g
L
;
2.4
g
L
+
0.46
g
L
=
2.9
g
L
=
0.3
w
t
.
%
2 H2BO3 MW = 60
g
m
o
l
, amt. H2BO =
60
g
m
o
l
*
0.1
M
=
6
g
L
=
0.6
w
t
.
%
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