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 .
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-10, 19 and 20, drawn to a bilateral heterogeneous polymer-based artificial intraocular lens, classified in A61K 9/0051.
II. Claims 11-18, drawn to a process for preparing the bilateral heterogenous polymer-based artificial intramolecular lens, classified in A61K 31/00.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the transparent cellulose solution can be made by dissolving the cellulose in an ionic liquid or by breaking down the cellulose fibers into nanocellulose (instead of repeating freeze/thaw cycles).
During a telephone conversation with Mr. Justin I. King (attorney for applicant) on August 20, 2026, a provisional election was made without traverse to prosecute the invention of Group I, claims 1-10, 19 and 20. Affirmation of this election must be made by applicant in replying to this Office action. Claims 11-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 1-10, 19 and 20 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 recites “wherein the dopamine is modified on a first surface of the cellulose hydrogel.” The claim language is unclear as to whether it is the cellulose hydrogel or dopamine that is being modified. Don’t applicant mean to say “wherein the cellulose hydrogel is modified with the dopamine on a first surface of the cellulose hydrogel”? Appropriate correction and clarification are required.
Claim 4 is 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 4 recites “wherein the zwitterion is modified on the second surface to form a hydration layer.” The claim language is unclear as to whether it is the cellulose hydrogel or zwitterion that is being modified. Don’t applicant mean to say “wherein the zwitterion modifying the second surface of the cellulose hydrogel forms a hydration layer”? Appropriate correction and clarification are required.
Claims 6-8 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.
In claim 6, applicant recite that the second surface of located on “an intermediate area” of the cellulose hydrogel. It is unclear what applicant mean by “an intermediate area” of the cellulose hydrogel (present specification does not define the term, and “intermediate” is a relative term).
For the purpose of examining the claim on the merit, the Examiner assumed (based on Fig.1) that by the “intermediate area”, applicant is referring to the area on the anterior surface of the intraocular lens (cellulose hydrogel) that is located in between the two haptic/ peripheral areas located on both ends of the intraocular lens.
Appropriate correction and/or clarification is required.
Claims 19-20 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 19 recites that the method comprises “using” the artificial intraocular lens of claim 1 to a subject in need thereof, without stating how the lens are used, thus making the scope of the claim indefinite. Instant rejection can be overcome by changing claim 19 to state --- A method for achieving antifouling, anti-cell migration, anti-inflammation, and anti-posterior capsule opacification properties, comprising implanting the bilateral heterogeneous polymer-based artificial intraocular lens according to claim 1 to the eye(s) of a subject in need thereof. ---.
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.
Claim(s) 1-10, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al (“Zwitterionic modified and freeze-thaw reinforced foldable hydrogel as intraocular lens for posterior capsule opacification prevention”, Biomaterials, vol.309 (2024) 122593, pg.1-14).
Yang teaches (see abstract) a foldable and antifouling sharp-edged intraocular lens (IOL) implant based on naturally-derived cellulose hydrogel and teaches that such IOL implant was synthesized in order to address the issue of posterior capsule opacification (PCO). Yang teaches (abstract) that the hydrogel is zwitterionic modified and that such zwitterionic-modified hydrogel exhibits uveal and capsular biocompatibility synchronously with no signs of inflammatory and prevents PCO formation. Yang further teaches (abstract) that dopamine is grafted onto both the haptic and the periphery of the posterior surface of the hydrogel to ensure the adhesion of the hydrogel to the posterior capsule and impede the migration of lens epithelial cells (LECs) without compromising transparency. Yang also teaches (abstract) that the mechanical strength and transparency of the hydrogel is enhanced via repeated freeze-thaw (FT) cycles: Yang teaches (see paragraph under section 3.3. on pg.7) that the cellulose hydrogel built with three FT cycles demonstrated the highest transparency (>90%) and teaches (see last paragraph on the right-hand column of pg.5) that the cellulose hydrogel subjected to seven FT cycles exhibited the highest CD (degree of crystallinity) value. Yang teaches (abstract) that its hydrogel featuring heterogeneous surface design (i.e., the hydrogel being heterogeneously designed with zwitterionic modification and dopamine modification – see first paragraph under section 3.1 on pg.5) displays great potential to eradicate PCO and attain post-operative efficacy after cataract surgery. Yang teaches (see the paragraph above “2. Materials/method” in the right-hand column of pg.2) that the anterior surface (instant second surface of the cellulose hydrogel) of the cellulose hydrogel is modified with zwitterions like SBMA or MPC whereas dopamine is grafted on the haptic and periphery of optic of the intraocular lens (i.e., haptic and the periphery of the posterior surface of the cellulose hydrogel – instant first surface of the cellulose hydrogel). Yang further teaches (in the same paragraph) that the zwitterions on the anterior surface of the cellulose hydrogel bind water molecules via electrostatic interactions and construct dense hydration layer to avoid impurities contamination.
Thus, Yang teaches instant claims 1-4, 9, 10, 19 and 20.
With respect to instant claim 5, Yang teaches (see first two paragraphs under section 2.2 on pg.2) that its cellulose hydrogel is crosslinked using ECH (epichlorohydrin). Thus, Yang teaches instant claim 5.
With respect to instant claims 6-8, as already discussed above, Yang teaches that dopamine is grafted on the haptic and periphery of optic of the intraocular lens (i.e., haptic and the periphery of the posterior surface of the cellulose hydrogel) whereas the cellulose hydrogel is zwitterionic-modified on the anterior surface. From Yang’s Fig.1, it is shown that the location (on the anterior surface of the intraocular lens) where the zwitterionic modification takes place (as indicated by the purple colored curved line) is in-between the two haptic/peripheral areas (as indicated by green colored ovals and green colored curved lines) located on both ends of the intraocular lens. Thus, Yang teaches instant second surface (where the zwitterionic modification takes place) of claim 6 which is located on an “intermediate area” of the cellulose hydrogel and teaches instant first surface (where the dopamine modification takes place) of claim 7 which is located on a surrounding area of the cellulose hydrogel (i.e., haptic and periphery of the intraocular lens as claimed in claim 8). Thus, Yang teaches instant claims 6-8.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SIN J. LEE whose telephone number is (571)272-1333. The examiner can normally be reached on M-F 9 am-5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached on 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov . Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice .
/SIN J LEE/
Primary Examiner, Art Unit 1613
August 22, 2026
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