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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/22/2023, 04/02/2024, 10/01/2024, 09/24/2025 was filed and is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
In Para [00141] examiner believes the chemical name of neutral red is misspelled, amniodimethylamniotoluamniozine hydrochloride.
For examination purposes amniodimethylamniotoluamniozine hydrochloride will be interpreted as 3-Amino-7-dimethylamino-2-methylphenazine hydrochloride.
Appropriate correction is required.
Claim Objections
Claim 16 is objected to because of the following informalities:
Claim 16 recites “amniodimethylamniotoluamniozine hydrochloride” examiner believes this to be a misspelling of the neutral red dye which is well known as 3-Amino-7-dimethylamino-2-methylphenazine hydrochloride.
For examination purposes “amniodimethylamniotoluamniozine hydrochloride” will be interpreted as 3-Amino-7-dimethylamino-2-methylphenazine hydrochloride.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 6, 10-12 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2022/0063182) in view of Solomon (US 2007/0068816) and Markle (US 8,738,107).
Regarding claim 1, Brown discloses a method of manufacturing an ophthalmic contact lens (see Fig 5A), comprising: a) preparing a first resin mixture including HEMA, PEGDA and a photoinitiator (see Fig 6A; Para [0184, 0204-0207]; a first mixture which may contain HEMA and EGDMA may be used as a first material); c) forming a first layer of the contact lens using an additive manufacturing apparatus by dispensing and curing the first resin mixture (see Fig 5B; Para [0187-0195, 0200]; a first portion forms a first layer which may contain a first mixture that is deposited and cured); and d) forming a second layer of the contact lens onto the first layer using the additive manufacturing apparatus by dispensing and curing the dispensed second resin mixture onto an outer surface of the first layer (see Fig 5B; Para [0187-0195, 0200]; a second portion forms a second layer which may contain a second mixture that is deposited and cured).
Brown does not disclose b) preparing a second resin mixture including HEMA, PEGDA, a photoinitiator, and a pH sensitive dye, wherein a ratio of HEMA to PEGDA is higher in the second resin mixture than the first resin mixture and a volume of photoinitiator in the second resin mixture is less than the is less than a volume of photoinitiator in the second resin mixture. Brown and Solomon are related because both disclose methods of manufacturing hydrogels.
Solomon discloses a method of manufacturing a hydrogel (see Fig 22) comprising: b) preparing a second resin mixture including HEMA, PEGDA, a photoinitiator , wherein a ratio of HEMA to PEGDA is higher in the second resin mixture than the first resin mixture and a volume of photoinitiator in the second resin mixture is less than the is less than a volume of photoinitiator in the second resin mixture (see Fig 22; Para [0269]; a first and second hydrogel composition may be of composed of a 10% and 40% HEMA and 90 and 60% EGDMA composition; a second mixture may have a higher percent of HEMA which in turn may contain less initiator as it is dependent on the number of double bonds of which EGDMA has more)
Brown in view of Solomon does not disclose wherein the second resin mixture includes a pH sensitive dye. Brown in view of Solomon and Markle are related because both disclose methods of manufacturing optical elements.
Markle discloses a method of manufacturing an optical element (Col 27, line 31-67) wherein the second resin mixture includes a pH sensitive dye (Col 27-line 43- Col 28-line 24).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon with wherein the second resin mixture includes a pH sensitive dye for the purpose of improving the capabilities of the optical element in order to detect pH levels of the patient. (Col 27-line 43- Col 28-line 24)
Regarding claim 6, Brown in view of Solomon and Markle discloses the method according to claim 1. Brown discloses further comprising: e) forming a third layer of the contact lens using the additive manufacturing apparatus by dispensing onto a central region of the first layer and curing the dispensed second resin mixture; and f) forming a fourth layer of the contact lens using the additive manufacturing apparatus by dispensing the first mixture such that the third layer and the first layer encapsulate the second layer and curing the dispensed first resin mixture (see Fig 5B; Para [0187-0192]; a third and fourth layers 524 and 526 may be dispensed encapsulating the second layer 522 on a top and bottom as seen in Fig 5B).
Regarding claim 10, Brown discloses an ophthalmic contact lens, comprising (see Fig 5A), a clear first region formed of a first material HEMA, PEGDA and a photoinitiator (see Fig 6A; Para [0184, 0204-0207]; a first mixture which may contain HEMA, EGDMA, and a photo initiator may be used as a first material).
Brown does not disclose a dyed second region formed of second material containing HEMA, PEGDA, a photoinitiator, and a pH sensitive dye, wherein a ratio of HEMA to PEGDA is higher in the second resin mixture than the first resin mixture and a volume of photoinitiator in the second resin mixture is less than the is less than a volume of photoinitiator in the second resin mixture. Brown and Solomon are related because both disclose methods of manufacturing hydrogels.
Solomon discloses a method of manufacturing a hydrogel (see Fig 22) comprising: b) a dyed second region formed of second material containing HEMA, PEGDA, a photoinitiator, and a pH sensitive dye, wherein a ratio of HEMA to PEGDA is higher in the second resin mixture than the first resin mixture and a volume of photoinitiator in the second resin mixture is less than the is less than a volume of photoinitiator in the second resin mixture (see Fig 22; Para [0269]; a first and second hydrogel composition may be of composed of a 10% and 40% HEMA and 90 and 60% EGDMA composition; a second mixture may have a higher percent of HEMA which in turn may contain less initiator as it is dependent on the number of double bonds of which EGDMA has more)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown with a dyed second region formed of second material containing HEMA, PEGDA, a photoinitiator, wherein a ratio of HEMA to PEGDA is higher in the second resin mixture than the first resin mixture and a volume of photoinitiator in the second resin mixture is less than the is less than a volume of photoinitiator in the second resin mixture of Solomon for the purpose of improving water holding capabilities of lens (Para [0116])
Brown in view of Solomon does not disclose wherein the second resin mixture includes a pH sensitive dye. Brown in view of Solomon and Markle are related because both disclose methods of manufacturing optical elements.
Markle discloses a method of manufacturing an optical element (Col 27, line 31-67) wherein the second resin mixture includes a pH sensitive dye (Col 27-line 43- Col 28-line 24).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon with wherein the second resin mixture includes a pH sensitive dye for the purpose of improving the capabilities of the optical element in order to detect pH levels of the patient. (Col 27-line 43- Col 28-line 24)
Regarding claim 11, Brown in view of Solomon and Markle discloses the ophthalmic contact lens according to claim 10.
Brown further discloses wherein the second region is disposed on an outer surface of the first region, thereby exposing the second region to a tear film when the contact lens is worn (see Fig 5B; Para [0187-0195]; the second portion 522 is exposed on the rear side where a tear film would be).
Regarding claim 12, Brown in view of Solomon and Markle discloses the ophthalmic contact lens according to claim 10. Brown further discloses wherein the first region is formed in a disc shape (see Fig 5B; Para [0187-0195]; the central portion is a disk 520 as seen in Fig 5B).
Regarding claim 18, Brown in view of Solomon and Markle discloses the ophthalmic contact lens according to claim 10.
Brown further discloses further comprising: a central region formed of the second material and disposed on the first region, wherein the central region is encapsulated between the first region and a layer of the first material, thereby inhibiting contact of the central region with a tear film when the contact lens is worn. (see Fig 6B; Para [0205]; a central region at a second layer may be formed of a second material 624 and encapsulated between a first layer central region and rear layers to prevent contact)
Regarding claim 19, Brown in view of Solomon and Markle discloses the ophthalmic contact lens according to claim 18.
Brown further discloses wherein the second region is formed in an annular shape (see Fig 5B; Para [0187-0195]; the second portion 522 and third portion 524 form annular shape).
Regarding claim 20, Brown in view of Solomon and Markle discloses the ophthalmic contact lens according to claim 19.
Brown further discloses wherein the second region is formed closer to a periphery of the first region than the central region (see Fig 5B; Para [0187-0195]; the second portion 522 and third portion 524 form annular shape and is closer to a periphery than central region 520).
Claims 2 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2022/0063182) in view of Solomon (US 2007/0068816) and Markle (US 8,738,107) as applied to claim 1 above, and further in view of Lin (US 2023/0285599)
Regarding claim 2, Brown in view of Solomon and Markle disclose the method according to claim 1. Brown in view of Solomon and Markle do not disclose wherein the photoinitiator is TPO. Brown in view of Solomon and Markle and Lin are related because both disclose methods of manufacturing contact lenses.
Lin discloses a method of manufacturing a contact lens (see Fig 1) wherein the photoinitiator is TPO (see Fig 1; Para [0009]; contact lens may use TPO as initiator)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with wherein the photoinitiator is TPO of Lin for the purpose of allowing proper polymerization of components (see Para [0006-0009])
Regarding claim 13, Brown in view of Solomon and Markle disclose the method according to claim 10. Brown in view of Solomon and Markle do not disclose wherein the photoinitiator is TPO. Brown in view of Solomon and Markle and Lin are related because both disclose methods of manufacturing contact lenses.
Lin discloses a method of manufacturing a contact lens (see Fig 1) wherein the photoinitiator is TPO (see Fig 1; Para [0009]; contact lens may use TPO as initiator)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with wherein the photoinitiator is TPO of Lin for the purpose of allowing proper polymerization of components (see Para [0006-0009])
Claims 3, 4, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2022/0063182) in view of Solomon (US 2007/0068816) and Markle (US 8,738,107) as applied to claim 1 above, and further in view of Slep (US 2017/0368742).
Regarding claim 3, Brown in view of Solomon and Markle discloses the method according to claim 1. Solomon further discloses wherein the first resin mixture contains HEMA and PEGDA in a ratio of about 1:1 (Para [0030-0035]; a composition may be made of 50% to 50% PEGDA or a 1:1 ratio). Brown in view of Solomon and Markle does not disclose wherein the first resin mixture contains about 5% TPO by volume
Brown in view of Solomon and Markle and Slep are related because both disclose methods of manufacturing lenses.
Slep discloses a method of manufacturing a lens (Para [0007]) wherein the first resin mixture contains about 5% TPO by volume (see Para [0012]; lens may use TPO as initiator in a value range from 1-10 wt % calculated to .893%- 8.93% in terms of volume using TPO density of 1.12 g/ml)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with wherein the first resin mixture contains about 5% TPO by volume of Slep for the purpose of allowing proper polymerization of components (see Para [0012-0016])
Regarding claim 4, Brown in view of Solomon, Markle, and Slep discloses the method according to claim 3. Solomon discloses wherein the second resin mixture contains HEMA and PEGDA in a ratio of about 10:1 (Para [0315]; HEMA to PEGDA ratio may be 10:1 as shown in example; 60% HEMA to 6% PEGDA)
Brown in view of Solomon and Markle does not disclose wherein the first resin mixture contains about 1% TPO by volume. Brown in view of Solomon and Markle and Slep are related because both disclose methods of manufacturing contact lenses.
Slep discloses a method of manufacturing a contact lens (Para [0007]) wherein the first resin mixture contains about 1% TPO by volume (see Para [0012]; lens may use TPO as initiator in a value range from 1-10 wt % calculated to .893%- 8.93% in terms of volume using TPO density of 1.12 g/ml)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with wherein the first resin mixture contains about 1% TPO by volume is TPO of Slep for the purpose of allowing proper polymerization of components (see Para [0012-0016])
Regarding claim 14, Brown in view of Solomon and Markle discloses the ophthalmic contact lens according to claim 10. Solomon further discloses wherein the first region contains HEMA and PEGDA in a ratio of about 1:1 (Para [0030-0035]; a composition may be made of 50% to 50% PEGDA or a 1:1 ratio).
Brown in view of Solomon and Markle does not disclose wherein the first resin mixture contains about 5% TPO by volume.
Brown in view of Solomon and Markle and Slep are related because both disclose manufacturing lenses.
Slep discloses manufacturing a contact lens (Para [0007]) wherein the first resin mixture contains about 5% TPO by volume (see Para [0012]; lens may use TPO as initiator in a value range from 1-10 wt % calculated to .893%- 8.93% in terms of volume using TPO density of 1.12 g/ml).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with wherein the first resin mixture contains about 5% TPO by volume is TPO of Slep for the purpose of allowing proper polymerization of components (see Para [0012-0016])
Regarding claim 15, Brown in view of Solomon, Markle, and Slep discloses the ophthalmic contact lens according to claim 10.
Solomon discloses wherein the second region contains HEMA and PEGDA in a ratio of about 10:1 (Para [0315]; HEMA to PEGDA ratio may be 10:1 as shown in example; 60% HEMA to 6% PEGDA)
Brown in view of Solomon and Markle does not disclose wherein the second resin mixture contains about 1% TPO by volume. Brown in view of Solomon and Markle and Slep are related because both disclose manufacturing lenses.
Slep discloses manufacturing a lens (Para [0007]) wherein the second resin mixture contains about 1% TPO by volume (see Para [0012]; lens may use TPO as initiator in a value range from 1-10 wt % calculated to .893%- 8.93% in terms of volume using TPO density of 1.12 g/ml)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with wherein the second resin mixture contains about 1% TPO by volume is TPO of Slep for the purpose of allowing proper polymerization of components (see Para [0012-0016])
Claims 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2022/0063182) in view of Solomon (US 2007/0068816) and Markle (US 8,738,107) as applied to claim 1 and 10 above, and further in view of Kim (KR 2017/0033553).
Regarding claim 5, Brown in view of Solomon and Markle discloses the method according to claim 1. Brown in view of Solomon and Markle does not disclose wherein the pH sensitive dye contains neutral red dye and deionized water in a ratio of about 4:1. Brown in view of Solomon and Markle and Kim are related because both disclose methods using ph sensitive dyes.
Kim discloses a method of using ph sensitive dyes (Pg 52, Para [0001]) wherein the pH sensitive dye contains neutral red dye and deionized water in a ratio of about 4:1 (Pg 52, Para [0001]; pH sensitive dye, neutral red, is combined with distilled water at a ratio of 4:1).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with wherein the pH sensitive dye contains neutral red dye and deionized water in a ratio of about 4:1 of Kim for the purpose of properly preparing dyes for effective use with polymer materials (Pg 52, Para [0001]).
Regarding claim 17, Brown in view of Solomon and Markle discloses the ophthalmic contact lens according to claim 10. Brown in view of Solomon and Markle does not disclose wherein the pH sensitive dye contains neutral red dye and deionized water in a ratio of about 4:1. Brown in view of Solomon and Markle and Kim are related because both disclose devices using ph sensitive dyes.
Kim discloses a device using a ph sensitive dye (Pg 52, Para [0001]) wherein the pH sensitive dye contains neutral red dye and deionized water in a ratio of about 4:1 (Pg 52, Para [0001]; pH sensitive dye, neutral red, is combined with distilled water at a ratio of 4:1).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with wherein the pH sensitive dye contains neutral red dye and deionized water in a ratio of about 4:1 of Kim for the purpose of properly preparing dyes for effective use with polymer materials (Pg 52, Para [0001])
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2022/0063182) in view of Solomon (US 2007/0068816) and Markle (US 8,738,107) as applied to claim 6 above, and further in view of Biasini (US 12,552,717).
Regarding claim 7, Brown in view of Solomon and Markle discloses the method according to claim 6. Brown in view of Solomon and Markle does not disclose comprising: pausing the additive manufacturing apparatus, cleaning the first layer, and replacing the first resin mixture with the second resin mixture between steps c) and d); and pausing the additive manufacturing apparatus, cleaning the second layer, and replacing the second resin mixture with the first resin mixture between steps e) and f). Brown in view of Solomon and Markle and Biasini are related because both disclose methods to manufacture contact lenes using additive manufacturing.
Biasini discloses a method of manufacturing contact lenses (Col 5, line 23 - line 35) comprising: pausing the additive manufacturing apparatus, cleaning the first layer, and replacing the first resin mixture with the second resin mixture between steps c) and d); and pausing the additive manufacturing apparatus, cleaning the second layer, and replacing the second resin mixture with the first resin mixture between steps e) and f) (Col 5, line 23 - line 35; cleansing is preformed to remove unwanted resin mixture before application of a second mixture layer and after application of a pause to cure resin; curing and polymerization steps accomplished layer by layer).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with comprising: pausing the additive manufacturing apparatus, cleaning the first layer, and replacing the first resin mixture with the second resin mixture between steps c) and d); and pausing the additive manufacturing apparatus, cleaning the second layer, and replacing the second resin mixture with the first resin mixture between steps e) and f) of Biasini for the purpose of reducing the amount of unreacted polymer in order to improve the accuracy of the print (Col 5, line 23 - line 35).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2022/0063182) in view of Solomon (US 2007/0068816) and Markle (US 8,738,107) as applied to claim 1 above, and further in view of Tanaka (US 4,157,892).
Regarding claim 8, Brown in view of Solomon and Markle discloses the method according to claim 6. Brown in view of Solomon and Markle does not disclose wherein the second resin mixture is immersed in a solution with a suitable pH to obtain a desired color of the third layer as it is printed onto the first layer. Brown in view of Solomon and Markle and Tanaka are related because both disclose methods of manufacturing contact lenses.
Tanaka discloses a method of manufacturing a contact lens (Col 7, lines 25 - 34) wherein the second resin mixture is immersed in a solution with a suitable pH to obtain a desired color of the third layer as it is printed onto the first layer (Col 3, lines 46 - 66).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with wherein the second resin mixture is immersed in a solution with a suitable pH to obtain a desired color of the third layer as it is printed onto the first layer of Tanaka for the purpose of providing a specified colored resin with no migration of the coloring agent (Col 1, lines 55 - 59).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2022/0063182) in view of Solomon (US 2007/0068816) and Markle (US 8,738,107) as applied to claim 1 above, and further in view of Lund (US 2022/0356363).
Regarding claim 9, Brown in view of Solomon and Markle discloses the method according to claim 1. Brown in view of Solomon and Markle does not disclose wherein a curing time of the first and second layers is between 20 and 45 seconds. Brown in view of Solomon and Markle and Lund are related because both disclose methods using additive manufacturing.
Lund discloses a method of curing resin using additive manufacturing (Para [0060]) wherein a curing time of the first and second layers is between 20 and 45 seconds (Para [0060]; a layer of deposited resin is configured to cure in 30 seconds)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with wherein a curing time of the first and second layers is between 20 and 45 seconds of Lund for the purpose of increasing the printing rate while adequately curing the resin polymer (Para [0101])
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Brown (US 2022/0063182) in view of Solomon (US 2007/0068816) and Markle (US 8,738,107) as applied to claim 1 and 10 above, and further in view of Keshishian (US 8,979,260).
Regarding claim 16, Brown in view of Solomon and Markle discloses the ophthalmic contact lens according to claim 10. Brown in view of Solomon and Markle does not disclose wherein the pH sensitive dye is 3-Amino-7-dimethylamino-2-methylphenazine hydrochloride. Brown in view of Solomon and Markle and Keshishian are related because both disclose contact lenses.
Keshishian discloses contact lenses (see Fig 1; Col 3, lines 19-26) wherein the pH sensitive dye is 3-Amino-7-dimethylamino-2-methylphenazine hydrochloride (see Fig 1; Col 3, lines 27-40; pH indicator may include neutral red).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify Brown in view of Solomon and Markle with wherein the pH sensitive dye is 3-Amino-7-dimethylamino-2-methylphenazine hydrochloride of Keshishian for the purpose of providing visual indication of ph changes (Col 3, lines 27-40).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Thayumanavan (US 2011/0200675) discloses a hydrogel material which may be used to make contact lenses to contain HEMA and EGDA.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GABRIEL ANDRES SANZ whose telephone number is (571)272-3844. The examiner can normally be reached Monday-Friday 8:30 am -5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pinping Sun can be reached at (571) 270-1284. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.A.S./Examiner, Art Unit 2872
/WILLIAM R ALEXANDER/Primary Examiner, Art Unit 2872
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