DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claim(s) 1-20 is/are pending. Claim(s) 10-20 is/are withdrawn.
Priority
Claim(s) 1-20 is/are pending. Claim(s) 10-20 is/are withdrawn.
The earliest disclosure of (1) the data describing the normalized radial distance and (2) the first and second regions is in the PCT/JP2012/004953 document. Therefore, the earliest priority date for claims 2-6 is that of this PCT document, which is 8/3/2012.
The remaining claims 1 and 7-9 are supported by the provisional document, 61/515,311, having a date of 8/4/2011.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-9, drawn to an IOL, classified in A61F 2/1637.
II. Claims 10-20, drawn to a method of adding a higher order aberration to an eye, classified in A61F 2/1637.
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 being used in a method including implanting a second lens having the HOA since none is required by the claimed lens or a method where the HOA is achieved by a combination of the optical device and a laser treatment of the cornea.
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 Laura Smalley on 1/30/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-9. Affirmation of this election must be made by applicant in replying to this Office action. Claims 10-20 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 Objections
Claims 4-8 are objected to because of the following informalities:
Claims 4-5 each recites “wherein HOA-NRD profile”, which should be “wherein the HOA-NRD profile”.
Claim 6 recites “the first and second”, which should be “the first and the second”.
Claim 7 recites “of spherical aberration, trefoil or coma”, which should be “of a spherical aberration, a trefoil or a coma”.
Claim 8 recites “is spherical aberration”, which should be “is a spherical aberration”.
Appropriate correction is required.
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 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 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.
Current Application
Prior Patent
US 9,901,441
Prior Patent
US 10,702,376
Prior Patent
US 11,744,698
1
1, 9
1
1
2
9
5
7
3
9
7
9
4
10
8
10
5
11
9
11
6
12
10-11
12-13
7
5
1
1
8
6
1
1
9
7
3
6
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 2-6 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 2, line 5 recites the limitation "the longitudinal HOA". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a longitudinal HOA”.
Claim 5, line 2 recites the limitation "the substantial majority". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “a substantial majority”.
Claim(s) 3-4 and 6 are rejected as dependent from a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-8 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Portney (US 2010/0234943 A1).
Regarding Claim 1, Portney teaches an intraocular lens, comprising:
a monofocal lens body that defines a focal length and is configured to add more higher order aberration (HOA) to an eye than a spherical IOL with the same focal length (e.g. Figures 3-4, 7, abstract, [0025], [0053]).
Regarding Claim 2, the lens body defines an optical center, an outer edge (the lens body inherently has these elements), a first region that extends from the optical center to a radius between the outer edge and the optical center (e.g. annotated Figure 7(1) below), and a second region located radially outward of the first region (e.g. annotated Figure 7(1) below); and
the second region is configured to reduce the longitudinal HOA that would otherwise occur in low light conditions within an optical system defined by the lens body and the eye (e.g. Portney, [0029]).
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Annotated Figure 7(1), Portney
Regarding Claim 3, the lens body is configured to create, within the optical system, a higher order aberration to normalized radial distance ratio (HOA-NRD ratio) profile that increases in slope as NRD increases within at least a portion of the first region (e.g. Portney, annotated Figure 7(2) below, labels 1-4) and does not increase in slope as NRD increases within at least a portion of the second region (e.g. Portney, annotated Figure 7(3) below, label 4 to A to B to C, the slope decreases).
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904
784
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Annotated Figure 7(2), Portney
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904
784
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Annotated Figure 7(3), Portney
Regarding Claim 4, the HOA-NRD profile increases in slope as NRD increases within the entire first region (e.g. Portney, annotated Figure 7(2) above).
Regarding Claim 5, the HOA-NRD profile decreases in slope as NRD increases within at least the substantial majority of the second region (e.g. Portney, annotated Figure 7(3) above, second region option 1).
Regarding Claim 6, the first and second regions are separated by an HOA-NRD profile inflection point (e.g. Portney, Figure 7, annotated Figures 7(1)-7(3) above).
Regarding Claim 7, the HOA is selected from the group consisting of spherical aberration, trefoil and coma (e.g. Portney, Figure 7, [0053], spherical).
Regarding Claim 8, the HOA is spherical aberration (e.g. Portney, Figure 7, [0053]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim(s) 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Portney (US 2010/0234943 A1) in view of Hong, et al (Hong) (US 2007/0282438 A1).
Regarding Claim 9, Portney discloses the invention substantially as claimed but fails to teach the lens body comprises a 20 D monofocal aspheric lens body that adds 0.4 micrometer of spherical aberration to the eye at 6 mm entrance pupil and adds 0.1 micrometer of spherical aberration to the eye at 4 mm entrance pupil.
Hong teaches a monofocal lens body comprising a 20 D monofocal aspheric lens body (e.g. [0027]) that adds 0.4 pm of spherical aberration to the eye at 6 mm entrance pupil and adds 0.1 pm of spherical aberration to the eye at 4 mm entrance pupil (e.g. [0030]).
Hong and Portney are concerned with the same field of endeavor, namely aspheric lenses with additional spherical aberrations.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify Portney to have the base power and deviations as taught by Hong as it is a simple substitution of one known element for another to obtain predictable results (MPEP 2143) of base vision correction and of reducing/eliminating radially symmetric aberrations (e.g. Hong, [0030]).
Relevant Prior Art
US 2010/0315589 A1 to Portney teaches a lens having longitudinal spherical aberration corrections (e.g. abstract, Figure 7).
US 2009/0270984 A1 to Sanger, et al teaches an IOL including corrections by adding spherical aberrations (e.g. Figure 3, [0023]).
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, THOMAS BARRETT can be reached at (571)272-4746. 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 2/4/2026