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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/25/2024 has been considered by the examiner.
Specification
The abstract of the disclosure is objected to because the abstract contains more than 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 11, recites “mobile toric intraocular lens”. The examiner requests the term “mobile” be removed.
Appropriate correction is required.
Claim Interpretation
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 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 limitations are: orientation means for arrangement of the toric intraocular lens in claims 6- 8;
device for carrying out optical coherence tomography, in claim 11;
device for carrying out device for carrying out reflection illuminations 11.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is 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 these limitations 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 being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-11 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation ascertaining at least one axis of an astigmatism to be corrected of a cornea of a human eye, and the claim also recites, in particular the axis of the incidence plane of the strongest light refraction and/or the axis of the incidence plane of the weakest light refraction which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the sake of prosecution, the examiner interprets the limitation to mean ascertaining any axis of an astigmatism to be corrected of a cornea of a human eye.
Claim 1 recites the limitation "the incidence plane of the strongest light refraction" in line 6. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution, the examiner interprets the limitation to mean an incidence plane is present.
Claim 1 recites the limitation "the incidence plane of the weakest light refraction" in line 6. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution, the examiner interprets the limitation to mean an incidence plane is present.
Claim 3 recites the limitation "the instantaneous and correct position" in lines 3 and 4. There is insufficient antecedent basis for this limitation in the claim. For the sake of prosecution, the limitation is understood to mean the target axis is the axis running through the center point.
Claim 9 recites the limitation “the position and dimension of the cuts or incisions” in line 1. There is insufficient antecedent basis for this limitation in the claim. For the sake of compact prosecution, the limitation “the position and dimension of the cuts or incisions” is understood by the examiner to mean markings on the intraocular lens.
Regarding claims 6-8, the limitation “orientation means” in claims 6-8 is a relative limitation which renders the claim indefinite. The limitation "orientation means” is not defined by the claim and the specification does not provide any details as to what is the “orientation means”. Page 11, line 14 “The orientation means could therefore have at least one line and/or angle graduation” and Fig. 3 element 20 shows the orientation means. However, the specification does not explain what device is the orientation means and Fig.3 shows a line. For the sake of compact prosecution, the limitation “orientation means” is understood by the examiner to mean is a control unit for arrangement of the intraocular lens.
Regarding claim 11, the limitation “device for carrying out reflection illuminations.” in claim 11 is a relative limitation which renders the claim indefinite. The limitation " device for carrying out reflection illuminations” is not defined by the claim and the specification does not provide any details as to what is the “device”. For the sake of compact prosecution, the limitation “device for carrying out reflection illuminations” is understood by the examiner to mean a reflector.
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 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.
Claims 1, 2 and 5-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Madjlessi (DE Patent Number 102013105738 A1).
Madjlessi, teaches as in claim 1, a method for monitoring and/or evaluating the correct positioning of a toric intraocular lens (7) during an operation (¶0001 “refractive surgery”) on the human eye (¶0002 “Cataracts of the human eye are nowadays regularly treated by the insertion of intraocular lenses”), by which the toric intraocular lens (7) is to be fitted into the human eye (Fig. 4) and brought into its intended final location1 (¶0031 “specific axis is provided as alignment information and the control device 5 determines and generates from this information both the resulting axis and the marking contours 6 corresponding to the resulting axis with regard to their position”), comprising the following steps: ascertaining at least one axis (12a) of an astigmatism to be corrected of a cornea (¶0034 “alignment information comprises a reference axis 12 a, b through the center point 13 of the lens 3 and an axis position angle 14 of an astigmatism of the eye 4. The axial position angle 14 astigmatism of the eye 4 is calculated from the position of the two main sections of the eye 4 with maximum and minimum corneal radius”) of a human eye (4), representing the target axis (15) for the privileged axis (12b, ¶0035 “reference axis 12 a, b is therefore specified, which either corresponds to a geometrically or intramuscularly known axis or is marked on the eye 4 itself for example by the mechanical color marking mechanism”) of the toric intraocular lens (7) relative to the ascertained axis (14) of the astigmatism in an electronic display device (19a) of an apparatus (19 “visualization device”), so that the toric intraocular lens (7) can be arranged in the correct position and brought into its intended final location with the aid of the representation ( ¶0028 “ the control device 5 is configured to control the laser emitter 1 for generating marking contours 6 on the capsule 2 based on alignment information, wherein the marking contours 6 enable an angular adjustment of a toric intraocular lens 7 inserted into the eye 4” ¶0044 “the corresponding alignment information thus previously determined can then be transmitted to the control device 5. It is therefore preferred that the control device 5 is configured to receive the alignment information in electronic form”).
Madjlessi, teaches as in claim 2, ascertaining at least one axis (12a) of an astigmatism to be corrected of a cornea of a human eye (4).
Madjlessi, teaches as in claim 5, no preoperatively prepared reference image or registering image, in which the target axis (15) is displayed relative to an axis (7) of the astigmatism, is used (no preoperatively image or registered image discussed with the target axis displayed to the axis of astigmatism).
Madjlessi, teaches as in claim 6, control unit (5) for arrangement of the toric intraocular lens (7).
Madjlessi, teaches as in claim 7, that the privileged axis (12b) of the toric intraocular lens (7) is displayed by means of the display device (19a) by at least a control unit (5) that rearranges the toric intraocular lens (7), the position of the privileged axis (12b) of the toric intraocular lens (7) being established by the recognition of markings (6; 0031 “specific axis is provided as alignment information and the control device 5 determines and generates from this information both the resulting axis and the marking contours 6 corresponding to the resulting axis with regard to their position”) on the toric intraocular lens (7).
Madjlessi, teaches as in claim 8, characterized in that the privileged axis (12) of the toric intraocular lens (7) is displayed by means of the display device (19a) by at least control unit (5), the position of the privileged axis (12b) of the toric intraocular lens (7) being established by the recognition of markings (6) on the toric intraocular lens (7).
Madjlessi, teaches as in claim 9, markings (6) on the intraocular lens (7).
Madjlessi, teaches as in claim 10, an electronic display device (19a) for displaying the target axis (15) for a privileged axis (12b) of a toric intraocular lens (7), wherein the apparatus (21) further comprises a control unit (18a), and wherein the control unit (18a) is manually controllable2 in order to visualize the location of the target axis (15) on the display device (See Fig. 4).
Madjlessi, teaches as in claim 11, characterized by its being configured as an operation microscope (19), the operation microscope comprising a camera (17).
Allowable Subject Matter
Claims 3 and 4 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The prior art fails to simultaneously teach all the limitations of claim 3 which includes the display of the target axis is updated according to predeterminable time intervals during a predeterminable period of time, so that the instantaneous and correct location of the target axis is constantly displayed, in particular during an operation on the human eye.
Regarding claim 4 has dependency upon allowable claim 3.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zaldivar (US Patent Publication Number 2013/0018276 A1) teaches a method for evaluating the correct positioning of a toric intraocular lens.
Buckland (US Patent Publication Number 2018/0035884 A1) teaches a method for evaluating the correct positioning of a toric intraocular lens.
Snook (US Patent Number 5,512,965 A) teaches a method for evaluating the correct positioning of a toric intraocular lens.
Sayegh (US Patent Publication Number 2016/0302915 A1) teaches a method for evaluating the correct positioning of a toric intraocular lens.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOURNEY F SUMLAR whose telephone number is (571)270-0656. The examiner can normally be reached M-F 8-4pm.
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, Ricky Mack can be reached at 571-272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
JOURNEY F. SUMLAR
Examiner
Art Unit 2872
12 December 2025
/RICKY L MACK/Supervisory Patent Examiner, Art Unit 2872
1 Aligning the contours to the resulting axis is interpreted by the examiner to mean the IOL is brought into its intended final location
2 Figure 1 shows a manual control lever
Prosecution Insights