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 .
Claim Objections
Claims 25 and 42 are objected to because of the following informalities: in lines 1-2 both claims establish that the method is one of “for selecting an intraocular lens”; however, the claims require that the lens be implanted into the eye in the terminal step of claim 25 and at least applied instead of merely selected in claim 42. Therefore, the preamble is objectionable as it does not match the scope of the claims. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: in line 16 the claim recites “implanation” which should be drafted as –implantation---. Appropriate correction is required.
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 25-27, 33, 36-40, and 42-50 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.
Claims 25 and 42 both recite the limitation "the intraocular lens selection" in lines 15 and 16 respectively. There is insufficient antecedent basis for this limitation in the claim. For compact prosecution purposes the examiner notes that the preamble limitation that the method is “for selecting an intraocular lens” is acknowledged but does not provide antecedence for “the intraocular lens selection” because there is not step of selecting a lens in the body of the claim. Claims 26-27, 33, 36-40, and 43-50 are each similarly affected, at least by virtue of dependency.
Claim 42 recites the limitation “applying the intraocular lens selection to an eye surgery”; however, it is prima facie unclear what scope this sets forth as there is no clear action performed by the step. Claims 43-50 are each similarly affected, at least by virtue of dependency.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
As an initial matter, it may compact prosecution to clearly iterate that claim 25 and its dependents are not rejected under this title, because claim 25 requires a treatment step. Specifically, claim 25 iterates “applying the intraocular lens … to implantation in the eye” which requires (at least in scope) the action/step of ‘implanting the intraocular lens in the eye’ as best understood. Therefore claims 25-27 and 33-40 are patent eligible.
With that established, Claims 42-50 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims are directed to a process/method and therefore fall into one of the four statutory categories. In particular Claim 42 recite steps which are directed towards an abstract idea (i.e. specifically a mental process) including: “identifying a location of a reference frontal plane”, “determining at least two different parameters in relation to the reference frontal plane”, and “identifying at least one characteristic of the intraocular lens to be implanted into the eye based on the at least two different parameters”. In more detail, the examiner notes that as per MPEP 2106.04(a) the steps such as of identifying clearly falls into the enumerated grouping “3)” cited therein. Then see also MPEP 2106.04(a)(2)(III) which further iterates:
“The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978) (same).
Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. A discussion of concepts performed in the human mind, as well as concepts that cannot practically be performed in the human mind and thus are not "mental processes", is provided below with respect to point A.”
Having established why the above cited states constitute an abstract idea, the examiner turns to the remaining step of the claims to determine whether or not the claims recite additional elements that amount to significantly more than the judicial exception.
In this instance the examiner notes that the only other steps of claim 42 are the steps of “receiving a plurality of points of a landmark” and “applying the intraocular lens … to an eye surgery”. The former of these steps is not material to the eligibility analysis as it is a data gathering step and thus pre-solution as addressed below. That is, when referring to the guidance provided by MPEP 2106.04(d) the examiner notes that extra-solution activities such as data gathering and displaying/outputting have been recognized by the courts to fail to integrate judicial exceptions into practical applications. Then see also MPEP 2106.05(g) which describes what is considerable to be insignificant extra-solution activity and which iterates both:
“Another consideration when determining whether a claim integrates the judicial exception into a practical application in Step 2A Prong Two or recites significantly more in Step 2B is whether the additional elements add more than insignificant extra-solution activity to the judicial exception. The term "extra-solution activity" can be understood as activities incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Extra-solution activity includes both pre-solution and post-solution activity. An example of pre-solution activity is a step of gathering data for use in a claimed process, e.g., a step of obtaining information”
And “(3) Whether the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering)… Below are examples of activities that the courts have found to be insignificant extra-solution activity: • Mere Data Gathering: … vi. Determining the level of a biomarker in blood, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis)… • Insignificant application: … ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.”
That is data gathering including specifically, e.g. ultrasound imaging for using in further analysis, has been held by the courts as insignificant pre-solution activity and outputting data has been held by the courts to be insignificant post-solution activity and these court findings are codified in the guidance provided by the MPEP which require the examiner to hold these steps to be insignificant and extra-solution and therefore cannot cause the claim to be more than an abstract idea in this analysis.
Regarding the latter of these steps, the examine notes that merely iterating that an otherwise abstract idea should be applied, without positively setting forth specific steps to enact the application, is also not enough to render the claims eligible as explained in the MPEP at 2106.04(d)(I) which states in salient part:
“The courts have also identified limitations that did not integrate a judicial exception into a practical application:
• Merely reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f);”
Additionally, MPEP 2106.05(f), as cited therein, also expounds upon this idea. As such while using the term “apply it” or the like is not a firm bar on whether a step can render a claim patent eligible (see note on claim 25 above, wherein the claim is being interpreted as applying the lens to a specific step/action of implantation); merely using “apply it” language without any clear and specific step (e.g. with the goal or generality of some unspecified surgical procedure that does not clearly set forth the actual actions that would result in treatment) is not on its own enough to render the claim patent eligible.
Having established that claim 42 is ineligible for a patent under this title, the examiner turns to dependent claims 43-50 and further notes the following:
With regards to claims 43-44 the claims merely limit what the characteristic is and therefore do not add any new steps or factors which would require additional consideration.
With regards to claims 45, and 47 the claims merely limit what the parameter is and therefore do not add any new steps or factors which would require additional consideration.
With regards to claims 46, and 48-49 the claims merely limit what the landmarks are and therefore do not add any new steps or factors which would require additional consideration.
With regards to claim 50 the claim merely establishes which imaging devices can be used as the base source of the image data. This is not only not a step that could have any impact on the claim but is also strictly pre-solution as addressed above and therefore does not require additional consideration.
Therefore and for the foregoing reasons the examiner concludes that claims 42-50 are directed towards a judicial exception, specifically a mental process, without significantly more and are therefore not eligible subject matter under 35 U.S.C. 101.
Allowable Subject Matter
Claim 25 and its dependents would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, and objections set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
In this instance the claims are not rejectable over the prior art and appear to be both novel and unobvious. More specifically the applicant has correctly identified that the major Intra-Ocular Lens (IOL) selection algorithms use data which does not overlap with any of the claimed parameters (e.g. see applicant’s specification at [0027]). However, many academics have attempted to come up with better methods to select IOLs selectors and better predictors of IOL surgical outcomes which leads the closest prior art to be Marchini (of record) who describes multiple measures which are taken with regards to a reference plane/reference line within the eye, some of which overlap with the claims. However, none of Marchini’s proposed measurements use the same reference plane/reference line to determine two different parameters that would read on the claimed set of the parameter options. Likewise, no other art has yet used a single reference plane/reference line to determine two of the applicant’s claimed parameter options. When considering what is obvious based on the prior art the examiner must also acquiesce that there is no reasonable way to obviate the claims except by hindsight as none of the publications which the examiner has searched ascribes particular merit to combinations of the parameters claimed by the applicant or would otherwise speak to a need to combine the claimed parameters in an IOL selection algorithm. Therefore, while the claims are not currently patentable due to other grounds of rejection, the examiner notes that the claims are both novel and unobvious over the prior art.
Response to Arguments
Applicant’s arguments, see page 8, filed 11/12/2025, with respect to the 101 rejection of claim 25-27, 33, and 36-40 has been fully considered and is persuasive. The associated rejection of the previous office action has been withdrawn.
Applicant's arguments filed 11/12/2025 with respect to the 101 rejection of claim 42-50 have been fully considered but they are not persuasive as follows:
Regarding claim 42, the applicant argues that the newly amended claim language is patent eligible. The examiner notes that the amended claim iterates the step of “applying the intraocular lens selection to an eye surgery”. In one sense, the eye surgery may well (arguendo) include a treatment, but the claim does not actually set forth what sort of step(s) will occur to enact such treatment. Rather, instead of iterating a treatment step, the claims generally recite “apply it” and propose that some surgery shall occur without any specific identifiable treatment step/act being identified in or required by the claim. As such, the claim fails to render the claim patent eligible as set forth in the newly amended 101 rejection iterated above. In particular, for the reasons set forth in MPEP at 2106.04(d)(I) and 2106.05(f). Therefore, the applicants’ arguments against the 101 rejection are not found convincing for claim 42.
The applicant additionally addresses that the remaining claims are patentable by virtue of dependency, but for the foregoing reasons this argument is not convincing for claims 43-50 which depend from clam 42.
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 Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL S KELLOGG/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798