Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to amendments
Applicant’s claim amendments dated 12/2/25 amend claims 12-13, 15, and 20. Claims 12-23 are pending.
The claim amendments overcome the previous rejections under 35 USC 112(a) and (b).
Claim Interpretation
The “living hinge” of claim20 is interpreted as a “thin flexible hinge made from the same material as the two rigid pieces it connects.” (https://en.wiktionary.org/wiki/living_hinge, accessed 2/20/26).
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “positioning element configured to maintain the cartridge at a predetermined position relative to the port” in claim 12. This is interpreted as a structural element [such as element 68 in Figs. 3A-B of Applicant’s Specification] which is sized and shaped to interact with a part of the cartridge only in specific position(s).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
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 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) 12-14, 17-19, 23 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Tourrette et al. [US 20050125000 A1, hereinafter “Tourrette”].
Re. claim 12, Tourrette discloses: a system for delivering an intraocular lens [see Title, Abstract], comprising:
a cartridge [cassette 20] configured to house the intraocular lens [Fig. 1], the cartridge comprising: a first channel [33], an optic receiving area [30 and 31], a leading haptic receiving area [Annotated Fig. 1], and a trailing haptic receiving area extending laterally away from an axis passing through the first channel and the optic receiving area [Annotated Fig. 1]; and
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a delivery device [injector 40, Figs. 3-6], comprising: a port [housing 53] adapted to receive the cartridge [Figs. 3-6, Par. 0069], a second channel [bore 52] configured to be aligned with the first channel when the cartridge is received at the port of the delivery device [Fig. 4], and an actuator [piston 60] configured to advance the intraocular lens through the cartridge [Pars. 0070-0071; Fig. 5], and
a positioning element [groove 58, Fig. 4, equivalent to the claimed positioning element because it performs substantially the same function in substantially the same manner] configured to maintain the cartridge at a predetermined position relative to the port [“on the exterior of the lid 22, on the entry side, there is a second rib 28 with an oblique front end that cooperates with a complementary groove 58 communicating with the housing 53 in the tubular body, firstly to guide the cassette on insertion into the housing 53 of the tubular body and secondly to constitute polarizing means to prevent incorrect orientation of the cassette in the housing of the tubular body,” Par. 0052].
Re. claim 13, Tourrette discloses: the positioning element [58] is disposed on a lateral side of the delivery device [Fig. 4] to maintain the cartridege at the predetermined position relative to the port and to facilitate alignment of the first channel with the second channel when the cartridge is inserted into the port of the delivery device [Note that “to maintain..” and “to facilitate…” is the intended use of the positioning element, and not given further patentable weight, though this element would aid in this positioning].
Re. claim 14, Tourrette discloses: the intraocular lens is advanced through the cartridge and into a nozzle [70] of the delivery device [Note that this relates to the intended use of the system, and is not given further patentable weight, though Tourrette’s device does perform this function; see e.g. Figs. 5, 8].
Re. claim 17, Tourrette discloses: the leading haptic receiving area is distal to the optic receiving area [see Annotated Fig. 1 above. The distal end is region 35].
Re. claim 18, Tourrette discloses: the cartridge has an open configuration [Fig. 1] and a closed configuration [Fig. 2], and wherein the cartridge is coupled to the delivery device in the closed configuration [Par. 0030, Fig. 3].
Re. claim 19, Tourrette discloses: part of the delivery device is proximal to the cartridge when the cartridge is coupled to the delivery device and another part of the delivery device is distal to the cartridge [Annotated Fig. 4 excerpt below].
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Re. claim 23, Tourrette discloses: the leading haptic receiving area comprises a tapered portion [Annotated Fig. 1 below. The sidewall, and thus the depth, are tapered].
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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, 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 negated by the manner in which the invention was made.
Claims 15-16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tourrette in view of Kobayashi et al. [US 20080071286 A1, hereinafter “Kobayashi 286,” cited on Applicant’s IDS].
Re. claim 15, Tourrette discloses the actuator [60] is retractable and advanceable [Par. 0069 and Figs. 3 vs. 5]. Tourrette teaches the cartridge comprises a fluid [aqueous/saline solution, Par. 0061]; but it is unclear whether or not the actuator [60] advances this fluid, or any other fluid, through the cartridge. However, Kobayashi 286 teaches, in a system for delivering an intraocular lens, the actuator [16-1 and 16-2, together, Fig. 6B] is configured to advance a fluid through the “cartridge” [Par. 0125], and the actuator is retractable [Par. 0124] and advanceable [Par. 00125] and is configured to advance a fluid through the cartridge when advanced in a distal direction [Par. 0125] It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Tourrette by configuring the actuator to advance fluid through the cartridge, as taught by Kobayashi, in order to provide lubrication so that the lens is smoothly moved [Kobayashi 286, Pars. 0005-0006].
Re. claim 16, Tourrette discloses the first and second channel being in physical communication, meaning that if fluid passes through the first channel at least some of it will enter the second channel. Kobayashi, as used to modify Tourette above, further teaches the channel through which the plunger moves being in communication with the “cartridge.” The combined Tourrette-Kobayashi as modified with respect to claim 15 above thus reasonably teaches the first channel and the second channel are in fluid communication.
Claims 20-22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tourrette in view of Pynson et al. [US 20060142781 A1, hereinafter “Pynson” cited on Applicant’s IDS].
Re. claim 20, Tourrette discloses: the cartridge comprises a first portion and a second portion connected by a hinge [Annotated Fig. 1 below], but fails to disclose the hinge being a living hinge.
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However, Pynson teaches a cartridge for an IOL having a first and second portion connected by a living hinge [Par. 0046]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Tourette by replacing the hinge with a living hinge as taught by Pynson because this amounts to a simple substitution of one hinge type known in the art for another with predictable results.
Re. claim 21, Tourrette discloses: The system of claim 20, wherein the leading haptic receiving area is disposed in the first portion [see Annotated Fig. 1 with respect to claim 20 above].
Re. claim 22, Tourrette discloses: The system of claim 20, wherein the trailing haptic receiving area is disposed in the first portion [see Annotated Fig. 1 with respect to claim 20 above].
Response to Arguments
Applicant's arguments filed 12/2/25 have been fully considered but they are not persuasive. Regarding the argument that Tourrette fails to disclose a positioning element, the examiner respectfully disagrees, with the element recited as set forth above.
Regarding the argument that Kobayashi fails to teach an actuator which advances a fluid through the cartridge when advanced, the examiner agrees that the previously cited Kobayashi fails to teach this feature, but has introduced Kobayashi 286 to teach this.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN MCGRATH whose telephone number is (571)270-0674. The examiner can normally be reached M-F 9 am to 5 pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACKIE HO can be reached at (571) 272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771