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 first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
The present application filed on or after March 16, 2013 is being examined under the first inventor to file provisions of the AIA because the priority or benefit application(s) filed before March 16, 2013 do not provide support for all of the claims in the present application. For example, claim(s) 12 and 14 are not supported by any such earlier application. The earliest document with polyvinylidene fluoride carbon black is the instant Applicant. Therefore, the priority date of claims 12 and 14 is 5/13/2024.
Please see 37 CFR 1.55(j), 1.78(a)(6) and 1.78(d)(6) for requirements regarding statements provided by applicants in patent applications that contain or contained at any time a claim to a claimed invention as defined in paragraph (A) above.
4. 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 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.
Status of the Claims
Claim(s) 1-14 is/are pending. Claim(s) 9 is/are withdrawn.
Allowable Subject Matter
Claims 12 and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-8 and 10-14, drawn to an apparatus for implantation in an eye, classified in A61F 2002/1696.
II. Claim 9, drawn to a method of implanting an apparatus for implantation in an eye, classified in A61F 2002/1696.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the product as claimed can be used in a materially different process of using that product, such as implanting the apparatus in front of a natural lens of the patient.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions require a different field of search (e.g. searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Patrick O’Riley on 7/31/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-8 and 11-14. Affirmation of this election must be made by applicant in replying to this Office action. Claim 9 is 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.
Product By Process
The Examiner recognizes claims 4, 6-7, and 13-14 as a "product-by-process" claim. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (see MPEP 2113).
As a product claim, Examiner has determined claims require the apparatus to comprise the following structural elements in addition to those in the claims from which they depend.
Claim 4: the apparatus having two zones with different refractive indices
Claim 6: the apparatus having three zones with different refractive indices
Claim 7: a nanostructured surface on the anterior surface
Claim 13: a darkened internal wall surrounding the central aperture made of a polymeric material
Claim 14: a polymeric lens body with a central area comprising a darkened area of PVFCB nanoparticles and a central circular hole within the darkened area
In the prior art rejection in this Office action, Examiner considers claims 7 and 13-14 to be met when a reference teaches these structural limitations.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims see Table I below rejected on the ground of nonstatutory double patenting as being unpatentable over claim see Table I below of U.S. Patent No. see Table I below. Although the claims at issue are not identical, they are not patentably distinct from each other because the following prior claims contain the limitations claimed by the current Application as indicated in the following table.
Table I
Current Application
Prior Patent
US 11,980,542
Prior Patent
US 11,596,513
1
1
1
2
2
2
3
3
3
4
4
4
5
5
5
6
6
6
7
7
7
8
8
9
10
12
--
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.
Claim 10 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.
The term "approximately" in claim 10 is a relative term which renders the claim indefinite. The term "approximately" 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. The disclosure provides no metric for determining the bounds of “approximately” (such as standard deviation or another metric). Therefore, this term is indefinite.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-8, 10-11, and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee, et al (Lee) (US 5,905,561) in view of Miller, et al (Miller) (US 5,245,367) and further in view of Christie, et al (Christie) (US 2011/0040376 A1).
Regarding Claim 1, Lee teaches an apparatus for implantation in an eye (e.g. column 3, lines 32-40, IOL), the apparatus comprising:
a lens body for providing vision correction for a patient (e.g. Figures 8-9, #10), said lens body having a central aperture (#20) and said lens body is configured as one of: a diffractive lens or a refractive lens (e.g. column 8, lines 6-24);
wherein said central aperture has a form of a circular hole extending fully through said lens body when said apparatus is implanted in the eye (e.g. Figures 8-9; abstract, #20 is an aperture, which is a hole that extends completely through the object it is in, here the lens body);
wherein said lens body is formed from a substantially transparent material (e.g. Figures 3 and 10; column 4, lines 23-64 and column 8, lines 34-67) and said central aperture includes a darkened perimeter (e.g. Figures 8-9, #18; Figures 3 and 10; column 4, lines 23-64 and column 8, lines 34-67); and
Lee discloses the invention substantially as claimed but fails to teach said darkened perimeter of said central aperture includes a darkened internal wall extending through said lens body from an anterior surface to a posterior surface of said lens body and at least one haptic extending from said lens body.
Miller teaches a lens having a central pinhole aperture surrounded by an annular darkened perimeter extending through the lens body from an anterior surface to a posterior surface of the lens body (e.g. Figures 1A, 3, #18).
Miller and Lee are concerned with the same field of endeavor as the claimed invention, namely lens bodies having pinhole apertures surrounded by darkened regions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lee such that the darkened perimeter of said central aperture includes a darkened internal wall extending through said lens body from an anterior surface to a posterior surface of said lens body as taught by Miller in order to more tightly control and reduce blurring at the pinhole (e.g. Miller, column 4, lines 8-30).
The combination of Lee and Miller discloses the invention substantially as claimed but fails to teach at least one haptic extending from said lens body.
Christie teaches a lens body having a darkened region that is an IOL having haptics extending from the lens body (e.g. Figure 25A, shown extending from the left; full set of haptics seen in Figure 4A, #s 404).
Christie and the combination of Lee and Miller are concerned with the same field of endeavor as the claimed invention, namely lens bodies having central apertures and darkened regions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Lee and Miller such that there is at least one haptic extending from the lens body of the IOL as taught by Christie to prevent the lens body from moving or rotating when implanted within the eye (e.g. Christie, [(0151)].
Regarding Claim 2, the lens body has a first index of refraction (all materials inherently have an index of refraction, which is a physical property of the material) and is formed from at least one material configured to have a second index of refraction when subjected to a laser (the material is fully capable of being modified by a laser, such as a laser used to make a small hole through the material for movement of aqueous humor or to reduce the weight of the lens; the location at and immediately adjacent the opening would have a second, different index of refraction; the Examiner notes the claim does not require the second index of refraction differ from the first — in this case, when laser light hits the lens there is a second index of refraction even when no change to the material happens, it is second because it is after laser treatment).
Regarding Claim 3, the combination of Lee, Miller, and Christie discloses the invention substantially as claimed but fails to teach said lens body includes a UV-absorbent peripheral portion.
Christie teaches a lens body having a UV-absorbent peripheral portion (e.g. [0194], [0202]).
Christie and the combination of Lee, Miller, and Christie supra are concerned with the same field of endeavor as the claimed invention, namely lens bodies having central apertures and darkened regions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Lee, Miller, and Christie supra such that the lens body having a UV-absorbent peripheral portion as taught by Christie in order to provide resistance to degradation by UV-radiation (e.g. Christie, [0194]).
Regarding Claim 4, said lens body further comprises:
a first femtosecond laser modified index of refraction zone having a first index of refraction and being proximate to, and surrounding, said central aperture; and
a second femtosecond laser modified index of refraction zone having a second index of refraction being different than said first index of refraction located at a peripheral portion of said lens body, inside an outer border of said lens body
(as claimed these are product-by-process limitations; the claim does not specify how the lasers are used or what modifications are made nor features of the final product present due to either process; therefore, for example, heating of the lens during processing meets this language; the index of refraction of the darkened portion of the lens differs from that at the lens’ periphery),
for providing an expanded panoramic image to a peripheral retina of a user of said apparatus (as broadly claimed, there is no relationship here, i.e. what the image is expanded relative to; therefore, as the prior art device has a transparent outer annular periphery (e.g. Lee, #17), the image is expanded relative to a device ending at the masked region #18).
Regarding Claim 6, said lens body further comprises:
a first femtosecond laser modified index of refraction zone having a first index of refraction and covering 20% of the total surface area of said anterior surface of said lens body configured for near focus;
a second femtosecond laser modified index of refraction zone having a second index of refraction being different than said first index of refraction and covering 40% of the total surface area of said anterior surface of said lens body configured for intermediate focus; and
a third femtosecond laser modified index of refraction zone having a third index of refraction being different than said first index of refraction and said second index of refraction, and
said third femtosecond laser modified index of refraction zone covering 40% of the total surface area of said anterior surface of said lens body configured for far focus.
Lee teaches the lens is multi-powered (e.g. column 8, lines 6-24; column 6, lines 31-39, near, far, and intermediate distances).
The combination of Lee, Miller, and Christie discloses the invention substantially as claimed but fails to teach the claimed percentages of zone coverage.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Lee, Miller, and Christie such that the percentages of zone coverages are as claimed as such a modification would have been an obvious matter of design choice involving a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art and it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04 IV).
The combination of Lee, Miller, and Christie teaches: differing indices of refraction in each zone as each zone focuses on a different field of depth.
Regarding Claim 7, the combination of Lee, Miller, and Christie supra discloses the invention substantially as claimed but fails to teach said lens body further comprises a sprayed coating of a nanoparticle composition on said anterior surface to produce a nanostructured surface.
Christie teaches a lens body comprising a nanoparticle composition as claimed (e.g. [0183]).
Christie and the combination of Lee, Miller, and Christie supra are concerned with the same field of endeavor as the claimed invention, namely lens bodies having central apertures and darkened regions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Lee, Miller, and Christie supra such that lens body comprising a nanostructured surface as taught by Christie in order to provide the ability to respond to different light environments (e.g. Christie, [0183]).
Regarding Claim 8, said lens body is in a form of a posterior chamber lens or a collamer lens configured to be implanted in front of an existing primary intraocular lens of the eye and behind an iris of the eye (the lens of claim 1 is fully capable of being implanted in the claimed position);
wherein the at least one haptic extending from said lens body comprises a plurality of haptics (e.g. Christie, Figure 4A) configured to reach to a ciliary body of the eye so as to stabilize the posterior chamber lens or the collamer lens (e.g. Christie, [0150]); and
wherein the posterior chamber lens or the collamer lens is configured to correct a refractive power of the eye and extend a focal point of the existing intraocular lens from a far point to a near point continuously, while simultaneously correcting a refractive error of the eye (e.g. Lee, column 8, lines 6-24).
Regarding Claim 10, the combination of Lee, Miller, and Christie teaches the aperture is a pinhole aperture and is 0.6 mm to 1.0 mm (e.g. Lee, column 6, line 40 to column 7, line 7), but fails to teach the diameter is between approximately 1 millimeter and approximately 2 millimeters.
Lee, Miller, and Christie are concerned with the same field of endeavor as the claimed invention, namely lens bodies having central apertures.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Lee, Miller, and Christie such that the diameter is between approximately 1 millimeter and approximately 2 millimeters since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05).
Regarding Claim 11, said lens body with said central aperture is formed from a polymeric material (e.g. Lee, column 7, line 62 to column 8, line 5).
Regarding Claim 13, said lens body with said darkened internal wall surrounding said central aperture is molded or 3-D printed from said polymeric material (e.g. Lee, column 7, line 62 to column 8, line 5, the claim only requires the material of the lens body).
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee, et al (Lee) (US 5,905,561) in view of Miller, et al (Miller) (US 5,245,367) and further in view of Christie, et al (Christie) (US 2011/0040376 A1) as discussed supra and further in view of Currie, et al (Currie) (US 2014/0277437) .
Regarding Claim 5, the combination of Lee, Miller, and Christie discloses the invention substantially as claimed but fails to teach the device of claim 1 in combination with an IOL and arranged such that said apparatus overlies and is anterior of said IOL when implanted in the eye.
Currie teaches the use of a mask (lens body with a darkened region) with a separate IOL (e.g. [0517], on the IOL).
Currie and the combination of Lee, Miller, and Christie are concerned with the same field of endeavor as the claimed invention, namely IOLs having darkened regions (masks).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Lee, Miller, and Christie such that the device is applied to an IOL as taught by Currie in order to effect the optical properties of an IOL (e.g. Currie, [0516]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH EDWARDS can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 8/21/2026
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