DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: sterically hindered MM 104(sh) and endgroup 103(sh) [0124]. 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. 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
Claim 9 is objected to because of the following informalities: claim 9 states “the switchable UV absorber is selected from the group consisting of of azobenzene” in line 2. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-16 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 refers to “a shaped illumination” in line 5 that is unclear. Examiner is unsure whether this “shaped illumination” is synonymous with the “UV illumination” referenced in Applicant’s specification, or if another definition is to be understood, and further, what is meant by “shaped”. It is unclear whether the light adjustability of the lens is only activated by a certain “shaped” UV light, i.e., a certain angle of contact with the lens, or if the UV light itself allows for the shaping of the lens, or something else entirely. Further clarification is required. Claims 2-16 are rejected by dependency.
Claim 2 recites the limitation "the illumination" in line 4. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this “illumination” is the same as the “shaped illumination” of claim 1, or another illumination.
The term “low activity” in claims 7-8 is a relative term which renders the claim indefinite. The term “low activity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Further, there is nothing in the claim or Applicant’s specification that indicates where the boundary for “low activity” begins and ends.
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 1-5, 7, 9-10, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Goldshleger et al. (US 2021/0113328 A1), “Goldshleger”.
Regarding claim 1, Goldshleger teaches a Light Adjustable Lens (LAL) (Figs. 3A-F, MALAL 100), comprising: a polymer silicone network (Fig. 4, polymer host matrix 112 is silicone-based [0030]), infused with a mobile macromer (Fig. 4, photopolymerizable macromers 113), a non-switchable ultraviolet absorber (Fig. 4, UV absorber 116), and a photoinitiator (Fig. 4, photoinitiator 115); and a front protection layer (Fig. 3E, front protection layer 120), including a switchable ultraviolet absorber (Fig. 3A, modulable absorption compound 300); wherein the LAL is light adjustable by a shaped illumination activating the photoinitiator which induces a polymerization of the mobile macromer, thereby changing an optical power of the LAL (Fig. 5D, polymerization of macromers 113 causes swelling of the center of the LAL 110 and an increase in optical power [0037]); and the photoinitiator is switchable between a protected state and an activatable state (Fig. 4, photoinitiator 115 is activatable [0032] and in some cases prevented from being activated [0148]), but fails to explicitly teach the LAL is capable of accommodating an oxygen concentration in the range of 0.5 - 20 ppm. However, it has been established that "where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)." MPEP 2112.01(I). Therefore, the oxygen concentration in the range of 0.5 – 20 ppm is anticipated by the prior art.
Regarding claim 2, Goldshleger teaches wherein: the photoinitiator is switchable between the protected state and the activatable state by a light of a first wavelength (Fig. 4, photoinitiator 115 is activatable [0032] and in some cases prevented from being activated [0148]); and the illumination activating the photoinitiator has a second wavelength (photoinitiator 115 is substantially reduced at a wavelength suitable for activation of the photoinitiator 115 [0148]).
Regarding claim 3, Goldshleger teaches wherein: the photoinitator is less photoactivatable in the protected state than in the activatable state (Fig. 4, photoinitiator is prevented from being activated [0148]).
Regarding claim 4, Goldshleger teaches wherein: the photoinitator is minimally photoactivatable in the protected state (Fig. 4, photoinitiator is prevented from being activated [0148]).
Regarding claim 5, Goldshleger teaches wherein: the photoinitiator is capable of becoming an activated photoinitiator upon absorbing an UV photon (UV illumination is utilized as a modulating stimulus to activate the photoinitiator 115 [0032]); and the activated photoinitiator is capable of activating a mobile macromer by activating its endgroup (a modulating stimulus such as UV illumination activates the photoinitiator which induces photopolymerization of macromers 113 via their endgroups [0032]).
Regarding claim 7, Goldshleger teaches wherein: a reaction of the activated photoinitiator with oxygen creates a low activity photoinitiator derivative (photoinitiator 115 is identical to Applicant’s photoinitiator and inherently chemically reacts in a similar way because conditions within the lens are the same).
Regarding claim 9, Goldshleger teaches wherein: the switchable UV absorber is selected from the group consisting of of azobenzene, azo-aromatic compound, a diazene, an azo-pyrazole, a dienylethene, a fulgicide, an azulene, a spiropyran, an ethene-aromatic compound, a macromer of one of these compounds, a polymer of these compounds, a composition containing one of these compounds, a composition containing one of these compounds as side-chains, a composition containing one of these compounds as a backbone having a side-chain, a nanoparticulate bonded to one of these compounds, 4-methoxy azobenzene, indazole, allylated azobenzene with various spacer links, phenyl azopyrazoles, vinyl phenyl azo-pyrazole, and stilbene (modulable absorption compound 300 may be azobenzene [0056]).
Regarding claim 10, Goldshleger teaches wherein: the front protection layer includes a non-switchable ultraviolet absorber (front protection layer 120 includes modulable absorption compound 300 to block photoinitiation by absorbing the UV component of the incident light [0148]).
Regarding claim 13, Goldshleger teaches wherein: the mobile macromer is sterically hindered (polymerizable moiety may include a methacrylic functional group [0109] (i.e., example of sterically hindered functional group per Applicant’s specification [0124])).
Regarding claim 14, Goldshleger teaches wherein: the photoinitiator is switchable between a protected state and an activatable state (Fig. 4, photoinitiator 115 is activatable [0032] and in some cases prevented from being activated [0148]).
Regarding claim 15, Goldshleger teaches wherein: chemical compositions, concentrations and reaction rates of the silicone network, the mobile macromer, the switchable and non-switchable ultraviolet absorber and the photoinitiator are such that, wherein t(activate) is in a range of 3- seconds - 100 seconds (the spatially varying profile can be power-adjusting over the entire time of the illumination [0044]), but fails to explicitly teach a slope of a time dependent power adjustment curve increases by a factor of two or more. However, because the lens composition of Goldshleger is essentially identical to Applicant’s, it inherently chemically reacts in a similar way, and at a similar rate, because conditions within the lens are the same.
Regarding claim 16, Goldshleger teaches wherein: the photoinitiator is anchored to the polymer silicone network (Fig. 4, photoinitiator 115 can be a functional group at the end of photopolymerizable macromers 113 [0031]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Goldshleger et al. (US 2021/0113328 A1), “Goldshleger” in view of Grubbs et al. (US Pat. No. 9119710 B2), “Grubbs”.
Regarding claim 6, Goldshleger fails to teach the limitations of claim 6. Grubbs teaches an optical element wherein: the activated endgroup of the mobile macromer is capable of forming a bond with a second mobile macromer, activating an endgroup of the second mobile macromer in the process (polymerization refers to a reaction wherein the macromer reacts to form at least one covalent or physical bond with a like component (col. 3, par. 5)). Grubbs discloses that the macromer is preferably a type of polysiloxanes so as to produce a flexible and foldable IOL (col. 6, par. 3). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the polymer silicone network taught by Goldshleger with the macromer and its endgroup taught by Grubbs in order to provide a materially flexible IOL that is more adaptable to the eye.
Claims 8 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Goldshleger et al. (US 2021/0113328 A1), “Goldshleger” in view of Brand et al. (US 2005/0209359 A1), “Brand”.
Regarding claim 8, Goldshleger teaches wherein: a reaction of the activated mobile macromer with oxygen creates a low activity compound (macromer 113 is identical to Applicant’s macromer and inherently chemically reacts in a similar way because conditions within the lens are the same), but fails to teach the LAL includes a radical scavenger that is capable of reacting with the low activity compound to turn it into a deactivated compound.
Brand teaches radiation-curable coating compositions wherein the LAL includes a radical scavenger that is capable of reacting with the low activity compound to turn it into a deactivated compound (an antioxidant is used to compensate the inhibition caused by oxygen in the curing process [0033]). Brand discloses that the antioxidants used in the curing process are ones which stabilize properties such as storability, weatherability, and UV stability in polymer coatings [0035]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the polymer silicone network taught by Goldshleger with the antioxidant taught by Brand in order to increase the LAL’s UV stability and long term storability.
Regarding claim 11, Goldshleger fails to teach the limitations of claim 11. Brand teaches radiation-curable coating compositions comprising: a radical scavenger or an anti-oxidant (an antioxidant is used to compensate the inhibition caused by oxygen in the curing process [0033]). Brand discloses that the antioxidants used in the curing process are ones which stabilize properties such as storability, weatherability, and UV stability in polymer coatings [0035]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the polymer silicone network taught by Goldshleger with the antioxidant taught by Brand in order to increase the LAL’s UV stability and long term storability.
Regarding claim 12, Goldshleger teaches wherein: the mobile macromer is monofunctional (modulable absorption compound 300 further includes a functional group which may be an acrylate [0109] (i.e., monofunctional)).
Double Patenting
Claims 1, 10-13, and 16 of this application are patentably indistinct from claims 1 and 12 of Application No. 18/678723, claims 1 and 13 of Application No. 18/678235, claims 1 and claims 15 of Application No. 18/378181, claims 1 and 15 from Application No. 18/678146, and claims 1 and 14 of Application No. 18/678297. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1 and 16 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 12 of copending Application No. 18/678723 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1 and 12 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 13 of copending Application No. 18/678235 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1 and 11 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 15 of copending Application No. 18/678181 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1 and 10 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 15 of copending Application No. 18/678146 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Claims 1 and 13 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1 and 14 of copending Application No. 18/678297 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2016/0339657 A1, US 6450642 B1.
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/G.G.R./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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