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) 1, 9, and 17 are not supported by any such earlier application. The anterior and posterior members’ optical powers being substantially unchanged is first disclosed 61/881,870 filed 9/24/2023.
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.
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) 1-20 is/are pending. Claim(s) 17-20 is/are withdrawn.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-16, drawn to an AIOL, classified in A61F2/1635.
II. Claims 17-20, drawn to a method of changing an optical power of an AIOL, classified in A61F2/1635.
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 a method of delivering the AIOL to the eye.
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 Benjamin Cashdollar on 2/23/2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-16. Affirmation of this election must be made by applicant in replying to this Office action. Claims 17-20 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.
Information Disclosure Statement
The information disclosure statements filed 6/7/2025 and 11/15/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the lined through citations were not provided in the instant Application or its parent Applications. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
All non-lined through citations were considered.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
Claim 1, line 9 recites “of one or more”, which should be “of the one or more”.
Claim 1, line 9 recites “the shape or volume”, which should be “the shape or the volume”.
Claim 1, line 11 recites “the posterior and anterior”, which should be “the posterior and the anterior”.
Claim 4, line 3 recites “the inner and outer”, which should be “the inner and the outer”.
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 9-12 and 15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, and 7 of U.S. Patent No. 11,540,916. 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 11,540,916
9
1
10
3
11
1, 5
12
1, 5
15
7
16
1
Claims 9-11 and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 5 of U.S. Patent No. 10,709,549. 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 10,709,549
9-11, 14-16
5
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 7 and 9-16 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 7, line 5 recites “a radial force”. It is unclear if this is the radial force introduced in claim 1 or a different radial force. For purposes of examination the Examiner considers this language to be “the radial force”.
Claim 7, line 6 recites “the optical power of the fluid lens portion”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the Examiner notes this language is being interpreted as “an optical power of the fluid lens portion”. The Examiner notes the optical power introduced in claim 1 is that of the fluid-filled chamber, rather than of the fluid lens portion.
Claim 9, line 12 recites “an eye”. It is unclear if this if this feature is the same or different than the eye introduced earlier in claim 9. For purposes of examination the Examiner considers this language to be “the eye”.
Claim 10, line 3 recites “an eye”. It is unclear if this if this feature is the same or different than the eye(s) introduced earlier in claim 9. For purposes of examination the Examiner considers this language to be “the eye”.
Claim 10, line 3 recites “the eye”. It is unclear which instance of “an eye” is being referred back to. The Examiner notes that if the issues with the multiple instances of “an eye” are addressed as noted supra, then this rejection becomes moot. Claim 15, line 4 and claim 16, line 4 each also recite “the eye” and are rejected for the same reason as claim 10.
Claim 11, line 4 recites “an eye”. It is unclear if this if this feature is the same or different than the eye(s) introduced earlier in claim 9. For purposes of examination the Examiner considers this language to be “the eye”.
Claim 11, line 4 recites “a patient”. It is unclear if this is the same of different than the patient introduced in claim 9. For purposes of examination the Examiner considers this language to be “the patient”.
Claim 11, line 6 recites “an eye”. It is unclear if this if this feature is the same or different than the eye(s) introduced earlier in claim 9. For purposes of examination the Examiner considers this language to be “the eye”.
Claim 11, line 6 recites “the patient”. It is unclear which instance of “a patient” is being referred back to. The Examiner notes that if the issue with multiple instances of “a patient” is addressed as noted supra, then this rejection becomes moot.
Claim(s) 12-14 are rejected as dependent from a rejected claim.
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.
Functional language and intended use language is presented in italicized font.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Esch, et al (Esch) (US 2006/0100701).
Regarding Claim 1, Esch teaches an accommodating intraocular lens (e.g. abstract), comprising:
an optical structure (e.g. annotated Figure 6B(1) below) comprising a posterior member (#92), an anterior member (#85), and a fluid-filled chamber therebetween (#97) providing an optical power (e.g. [0069]); and
a haptic structure coupled to the optical structure (e.g. annotated Figure 6B(1), radially outward of the optical structure),
wherein one or more of a shape or volume of the fluid-filled chamber is configured to change in response to a radial force exerted on the haptic structure (e.g. [0069]),
wherein the posterior member is displaced when the radial force is exerted on the haptic structure (e.g. [0069]), and
wherein the change of one or more of the shape or volume of the fluid-filled chamber changes the optical power of the fluid-filled chamber while leaving optical powers provided by the posterior and anterior members substantially unchanged (e.g. [0069], the change in fluid changes the shape and thickness of the fluid in the chamber by pushing the anterior and posterior members apart, thus the fluid’s power changes and the power of the anterior and posterior members remains substantially unchanged).
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Annotated Figure 6B(1), Esch
Regarding Claim 2, one or both of the posterior member and the anterior member provide substantially no optical power (e.g. Figure 6B, the lens shown is substantially flat; [0051] teaches flatter (more planar) lenses have less power; thus, a substantially flat lens has “substantially” no optical power).
Regarding Claim 3, the fluid-filled chamber includes an inner portion and an outer portion (e.g. annotated Figure 6B(2) below), and wherein the radial force exerted on the haptic structure is configured to displace fluid from the outer portion toward the inner portion (e.g. [0069]-[0070]).
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Annotated Figure 6B(2), Esch
Regarding Claim 4, one or both of the posterior member and the anterior member define one or more openings that fluidly couple the inner and outer portions of the fluid-filled chamber (e.g. annotated Figure 6B(3) below).
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Annotated Figure 6B(3), Esch
Regarding Claim 5, when the accommodating intraocular lens is implanted within an eye of a patient, at least a portion of the haptic structure is positioned anterior to the fluid-filled chamber (e.g. annotated Figure 6B(1) above).
Regarding Claim 6, the fluid-filled chamber contains a fluid (e.g. [0069]), and wherein the fluid includes saline, a non-ionic solution, and/or silicone oil (e.g. [0058], silicone oil).
Regarding Claim 7, the fluid-filled chamber includes a haptic reservoir portion (e.g. annotated Figure 6B(2) above, “outer portion”) and a fluid lens portion (e.g. annotated Figure 6B(2) above, “inner portion”) providing the optical power (e.g. [0069]) and positioned radially inward from the haptic reservoir portion (e.g. annotated Figure 6B(2) above), and a volume of fluid within the fluid lens portion increases in response to a radial force exerted on the haptic reservoir portion to change the optical power of the fluid lens portion (e.g. [0069]-[0070]).
Regarding Claim 8, the haptic structure includes at least two outwardly-extended portions and a recessed relief portion between the two outwardly-extended portions (e.g. annotated Figure 6(B)(4) below).
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Annotated Figure 6B(4), Esch
Regarding Claim 9, Esch teaches an accommodating intraocular lens (discussed supra for claim 1), comprising:
a base lens component defining a fluid-filled interior of the accommodating intraocular lens (discussed supra for claim 1, optical structure of claim 1), wherein the base lens component includes—
an inner portion providing a first optical power and defining an optical chamber portion of the fluid-filled interior (discussed supra for claim 3), and
an outer portion positioned radially outward of the optical chamber portion and defining a haptic chamber portion of the fluid-filled interior (discussed supra for claims 1 and 3; here the outer portion is that in annotated Figure 6B(2) above and the elements radially outward of the optical portion of claim 1),
wherein a volume of fluid within the optical chamber portion of the base lens component provides a second optical power (discussed supra for claim 7), and
wherein, when the accommodating intraocular lens is implanted in an eye of a patient, the haptic chamber portion of the base lens component is configured to receive a compressive force from an eye of the patient and (i) deform at least part of the inner portion of the base lens component without substantially changing the first optical power of the inner portion (discussed supra for claim 1) and (ii) increase the volume of fluid within the optical chamber portion to increase the second optical power (discussed supra for claim 7).
Regarding Claim 10, the outer portion of the base lens component includes a haptic (discussed supra for claim 9) configured to receive the compressive force from an eye of the patient when the base lens component is implanted in the eye (e.g. [0069]-[0070]).
Regarding Claim 11, the outer portion of the base lens component defines an outermost perimeter of the accommodating intraocular lens (discussed supra for claim 9 and e.g. Figure 6B), and when the accommodating intraocular lens is implanted in an eye of a patient, one or more regions of the outermost perimeter are configured to receive the compressive force from an eye of the patient (discussed supra for claim 10).
Regarding Claim 12, the compressive force displaces the fluid within the fluid-filled interior from the haptic chamber portion toward the optical chamber portion (e.g. [0069]-[0070]).
Regarding Claim 13, the first optical power is substantially zero (discussed supra for claim 2).
Regarding Claim 14, the base lens component includes an anterior component and a posterior component coupled to the anterior component to define the fluid-filled interior (discussed supra for claim 1), wherein one or both of the anterior component and the posterior component provide substantially no optical power (discussed supra for claim 2).
Regarding Claim 15, the base lens component includes an anterior component and a posterior component coupled to the anterior component to define the fluid-filled interior (e.g. annotated Figure 6B(5) below), and wherein the compressive force from the eye deforms one or both of the anterior component and the posterior component to increase a distance between the anterior component and the posterior component (e.g. [0069]-[0070]).
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Annotated Figure 6B(5), Esch
Regarding Claim 16, the base lens component includes an anterior component and a posterior component coupled to the anterior component to define the fluid-filled interior (discussed supra for claim 15), and wherein the compressive force from the eye deforms one or both of the anterior component and the posterior component to increase a volume of the optical chamber portion to increase the volume of fluid within the optical chamber portion (discussed supra for claim 15).
Relevant Prior Art
US 2014/0180403 A1 to Silvestrini, et al teaches an accommodating IOL having anterior and posterior portions and a fluid-filled chamber therebetween and a radially outer haptic portion that receives forces from eye muscles, when implanted (e.g. abstract, Figures 3-4C, 7-8).
US 2007/0118216 A1 to Pynson teaches an accommodating IOL having anterior and posterior portions and a fluid-filled chamber therebetween and a radially outer haptic portion that receives forces from the eye muscles, when implanted (e.g. abstract, Figures 3A-4D).
US 2006/0241752 A1 to Israel teaches an accommodating IOL having anterior and posterior portions and a chamber therebetween and a radially outer haptic portion that receives forces from the eye muscles, when implanted (e.g. abstract, Figures 4A-E).
US 4,888,012 to Horn, et al teaches an accommodating IOL having anterior and posterior portions and a fluid-filled chamber therebetween and a radially outer haptic portion that receives forces from the eye muscles, when implanted (e.g. abstract, Figure 6).
US 4,709,996 to Michelson teaches an accommodating IOL having anterior and posterior portions and a fluid-filled chamber therebetween (e.g. abstract, Figures 1-2).
US 4,253,199 to Banko teaches an accommodating IOL having anterior and posterior portions and a fluid-filled chamber therebetween and a radially outer haptic portion that receives forces from the eye muscles, when implanted (e.g. abstract, Figures 5, 7).
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 2/24/2026