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.
Status of the Claims
Claim(s) 33-42 is/are pending. Claim(s) 1-32 and 43-45 is/are canceled.
Response to Arguments
Applicant’s arguments, filed 12/23/2025, with respect to the claim objections have been fully considered and are persuasive. The claim objections of claim 42 has/have been withdrawn due to the Applicant’s amendments.
Applicant’s arguments, filed 12/23/2025, with respect to the 35 USC 112(b) rejections have been fully considered and are persuasive, except that at #26 in the 10/1/2025 Office action. The 35 USC 112(b) rejections of claims 35, 37, and 42, except that at #26 in the 10/1/2025 Office action, has/have been withdrawn due to the Applicant’s amendments.
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Applicant argues the amended claim language of claim 33 is not taught by Baccala. The Examiner notes Applicant made no additional arguments regarding these limitations beyond they are not taught even though both limitations were previously in claims 38 and 39.
Each limitation is taught as described below in the prior art rejection section.
Claim Interpretation - 35 USC § 112, 6th paragraph
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
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.
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: see Table I below in claim see Table I below.
Table I: Language Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure in the Specification
34
Element
Clamping
The clip functions as a clamping element, page 7, line 2
37
Element
Rotatable operating
None provided
40
Element
Pressing
#308, page 12, line 27; Figure 6A
41
Element
Pinch
Formed by two handles, page 9, line 5
#508, page 13, line 32; Figure 8A
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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: see Table II below in claim see Table II below.
Table II: Language Not Invoking 112(f)
Claim(s)
Placeholder
Functional Language
Corresponding Structure in the Claim
33
Mechanism
Folding
Folding and fixing clip
33
Mechanism
Positioning
Guide
38
Mechanism
Folding
Folding and fixing clip
39
Mechanism
Positioning
Guide
40
Mechanism
Positioning
Spring element
40
Element
Spring
Spring
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 35, 37, and 40-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 33 has been amended to require the “folding mechanism” be “a folding and fixing clip”.
Claim 35 requires the “folding mechanism” to comprise “a curved tip”.
Claim 41 requires the “folding mechanism” to comprise “a pinch element”.
These three different “folding mechanisms” are disclosed as separate embodiments and thus those in claims 35 and 41 are not disclosed together with that in claim 33.
The following are disclosures of the “folding mechanism”.
Page 6, lines 32-33 disclose the “folding and fixing clip” as an embodiment
Page 9, lines 1-2 disclose the “pinch element” as an embodiment
Page 6, line 16 discloses the “curved tip” as an embodiment
Thus, as disclosed each “folding mechanism” is a separate species/embodiment and the combination of embodiments in dependent claims 35 and 41 are new matter.
Claim 33 has been amended to require the “positioning mechanism” be “a guide”.
Claim 37 requires the “positioning mechanism” be “a rotatable operating element”.
Claim 40 requires the “positioning mechanism” be a “pressing element”/”spring element”.
These three different “positioning mechanisms” are disclosed as separate embodiments and thus those in claims 37 and 40 are not disclosed together with that in claim 33.
The following are disclosures of the “positioning mechanism”
Page 7, line 25 disclose the “guide” as an embodiment
Page 6, lines 25-26 disclose the “rotatable operating element” as an embodiment
Page 8, lines 13-14 disclose the “pressing element” as an embodiment and page 8, line 18 discloses the pressing element embodiment is “further provided” with the “spring element”.
Thus, as disclosed each “positioning mechanism” is a separate species/embodiment and the combination of embodiments in dependent claims 37 and 40 are new matter.
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 37 recites “a rotatable operating element”, which invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function.
Here, Applicant’s specification recites “rotatable operating element” twice and neither instance includes the structure associated with this term.
“In an advantageous embodiment the positioning mechanism is further provided with a rotatable operating element for retracting and/or extending the spatula.” (page 6, lines 25-26)
“Providing a rotatable operating element provides a practical instrument for the user whereby the spatula can be extended with optimal control for the user, and can here be passed through an incision if desired. A rotating movement of the operating element is here converted into a translating movement of the spatula using a transmission. This can be performed in usual manner, preferably in the interior of the insertion instrument.” (page 6, lines 27-31)
Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 38-39 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. All of the limitations in each of claims 38 and 39 has been amended into claim 33. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 33-42 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baccala, et al (Baccala) (US 4,785,810 A1).
Regarding Claim 33, Baccala teaches an insertion instrument for inserting a lens into an eye (e.g. column 1, lines 6-12; Figure 2, the lens the instrument is shown being used with is foldable, has a circular periphery and haptics; the instrument would also be usable with an IOL having a form-locking element that is foldable, has a circular periphery, and haptics), the instrument comprising:
a spatula configured to receive a lens (e.g. Figure 2, #16);
a folding mechanism (e.g. annotated Figure 2(1) below, where the folding and fixing clip is #s 70/72 and #14) configured to fold the lens (e.g. column 3, lines 30-38); and
a positioning mechanism (e.g. column 4, line 59 to column 5, line 15, handle means with actuation arms and locking means; Figure 1, arms #s 62, 64 and #s 38, 46, 50; locking means # 54) configured to move the spatula for the purpose of inserting the lens (e.g. column 6, lines 3-24; unlocking of the spatula allows for delivery; further, as broadly claimed, the tool can be rotated in space while holding the handle in order to properly align the instrument with the eye for delivery);
wherein the folding mechanism comprises a folding and fixing clip (discussed supra) to fix the lens on the spatula (e.g. Figure 2; column 3, lines 30-38); and
wherein the positioning mechanism comprises a guide (discussed supra) which is configured for movement thereover of the folding and fixing clip during insertion of the lens (e.g. Figure 2, #72 moves over the edge of #s 38, 46 when the pivot brings #s 70/72 together).
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547
395
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Annotated Figure 2(1), Baccala
Regarding Claim 34, the spatula is provided with a clamping element configured to hold the lens in a folded state (see 35 USC 112(f) claim interpretation section above – the clamping element is the folding and fixing clip; e.g. Figure 2, where the folding and fixing clip is discussed supra with claim 33).
Regarding Claim 37, the positioning mechanism is arranged and configured as a rotatable operating element (e.g. positioning mechanism as discussed supra for claim 33; at least around #50) for retracting and/or extending the spatula (discussed supra for the positioning mechanism in claim 33).
Regarding Claim 38, the folding mechanism comprises a folding and fixing clip (discussed supra for claim 33).
Regarding Claim 39, the positioning mechanism comprises a guide (discussed supra for claim 33) which is configured for movement thereover of the folding and fixing clip during insertion of the lens (discussed supra for claim 33).
Regarding Claim 40, the positioning mechanism is provided with a pressing element (e.g. column 4, line 59 to column 5, line 15, actuation arms) for retraction and/or extension of the spatula (as broadly claimed, the movement of the instrument to and from the eye while the arms are held is sufficient to meet this functional requirement), wherein the positioning mechanism further comprises a spring element (e.g. Figure 1, #52; column 4, lines 34-58).
Regarding Claim 41, there is a screening functioning as spatula (this feature is not required due to the “or” that follows) and/or
wherein the folding mechanism is provided with a pinch element (e.g. Figure 2, #14, see 35 USC 112(f) claim interpretation section above; here the handles are the two extension of the L-shape of #14) and
further comprising an operating lever (e.g. Figure 1, #s 40, 48) for retracting and/or extending the spatula (as broadly claimed, the movement of the instrument to and from the eye while the arms are held is sufficient to meet this functional requirement), wherein the operating lever is provided with fixing points (e.g. Figure 1, where #s 40, 48 meet at #52).
Regarding Claim 35, the folding mechanism includes a curved tip (e.g. Figure 2, #14 is curved).
Regarding Claim 36, the tip is provided with a marking for positioning the tip during insertion of the lens (e.g. Figure 2, the location where the width of #14 increases serves as a making, which is a visual feature that is easily recognizable).
Regarding Claim 42, the insertion instrument is provided with an intraocular lens (e.g. Figure 2, #24) to provide an assembly of the insertion instrument and the intraocular lens (e.g. Figure 2).
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 LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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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 3/17/2026