Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/5/2025 has been entered.
Response to Amendment
This office action is in response to the amendment filed on 9/5/2025. Currently claims 32-36 are pending.
Response to Arguments
Applicant’s arguments, see pg. 5, filed 9/5/2025, with respect to previous objection of claim 32 have been fully considered and are persuasive. The previous objection of claim 32 has been withdrawn.
Applicant's arguments, see pgs. 5-8 filed 9/5/2025 with respect to the previous rejection of claims 32-36 under 35 USC 112 have been fully considered but they are not persuasive.
The crux of applicant’s arguments with respect to the previous rejection of claims 32-36 under 35 USC 112(b) has to do with the means plus function limitation of “a) a means for determining an axis of astigmatism of an eye having a cataractous lens”. Applicant seems to argue that the previous 112(b) rejection for indefiniteness is improper because the rejection is requiring that the specification contain express limitations on the structures that can perform the claimed function which is more specific that what is required that being one of ordinary skill in the art recognize the corresponding structure in the Specification for performing the claimed function. Applicant further argues the disclosure clearly identifies an astigmatism measuring system and provides examples including a corneal topographer, Keratometer, and a Placido ring. Thus, as best understood applicant is arguing one of ordinary skill in the art to understand “a means for determining an axis of astigmatism of an eye having a cataractous lens” to refer to an astigmatic measuring system with specific examples including but not limited to a corneal topographer, Keratometer, and a Placido ring. Thus, applicant’s arguments allege the limitation “a) a means for determining an axis of astigmatism of an eye having a cataractous lens” to not be indefinite
As applicant argues:
“The Office Action does not address or consider how one of skill in the art would understand the claim terms in view of the Specification.
Moreover, the examiner has the burned of establishing a prima facie case of
unpatentability on the basis of indefiniteness. ln re Packard, 751 F.3d 1307, 1312
(Fed. Cir. 2014) ("The same approach [i.e., prima fade case for obviousness] to
making the examination process work is an appropriate one for addressing the
question of indefiniteness.") "The examiner's focus during examination of claims
for compliance with the requirement for definiteness of 35 U.S.C. 112(b) or pre-AIA
35 U.S.C. 112, second paragraph, is whether the claim meets the threshold
requirements of clarity and precision set forth in the statute, not whether more
suitable language or modes of expression are available." § MPEP § 2173.02 II. The
indefiniteness determination is based upon how one of skill in the art would
understand the claims based upon the claims as a whole in view of the
specifications. The Office Action has not met this burden of establishing a prima
facie case of indefiniteness.
Further, the Office Action does not apply the correct legal standard in evaluating the means-plus-function claim elements. The Office Action appears to require that the Specification contain express limitations on the structures that can perform the claimed function. This is not the law. There is no requirement under§ 112 to limit the structures disclosed in the Specification, or to exclude or otherwise limit how one of skill in the art would understand the teachings of the Specification. To the contrary, the law only requires that one of ordinary skill in the art recognize the corresponding structure in the Specification for performing the claimed function.
The limitation need not connote a single, specific structure; rather, it
may describe a class of structures. See, e.g., Personalized Media Commc'ns~ LLC v. lnt'J Trade Comm'n, 161 F.3d 696,705 (Fed. Cir.199B) ("Even though the term 'detector' does not specifically evoke a particular structure, it does convey to one knowledgeable in the art a variety of structures known as 'detectors."');
Apple Inc. v. Motorola, Inc., 757 F.3d 1286, 1300 (Fed. Cir. 2014)
In order to determine whether the specification adequately links a structure that corresponds to the claimed function, we must look at the disclosure from the perspective of a person of ordinary skill in the art. "Under 35 U.S.C. § 112 ,r 2 and ,r 6, a means-plus function clause is indefinite if a person of ordinary skill in the art would be unable to recognize the structure in the specification and associate it with the corresponding function in the claim." AllVoice Computing PLCv. Nuance Commc'ns, Inc., 504 F.3d 1236, 1241 (Fed. Cir. 2007).
SPEX Techs., Inc. v. W Dig. Corp., 859 F. App'x 557,562 (Fed. Cir. 2021)
Regarding the "means for determining an axis of astigmatism of an eye," the Specification provides a clear road map to the skilled person to identify the corresponding structures. The Specification provides that "[t]he present inventions relates to a system for performing an astigmatism measurement." (¶ 2 ( emphasis added)) The Specification goes on to teach "measuring the patient's
axis of astigmatism by an integrated astigmatism axis measuring system built
into the laser." (¶ 10 ( emphasis added)) The Specification also identifies the devices
that one of skill in the art would understand to be this "astigmatism axis measuring
system." For example, the skilled persons would understand that, inter alia, a
corneal topographer Cir 3), a keratometer (¶ 3), ¶ 13 ("keratometer to measure ...
axis of astigmatism"), ¶ 14 ("keratometer ... determines an astigmatism axis"), ¶ 25
("a measuring and treatment system ... includes a keratometer"), and a Placido ring
(¶ 7) are structures to measure an axis of astigmatism.”
[see pg. 6-8 of applicant’s arguments received on 9/5/2025].
In response, these arguments are not persuasive. First, MPEP 2181 states the following regarding interpretation of means plus function limitation:
“Therefore, the broadest reasonable interpretation of a claim limitation that invokes 35 U.S.C. 112(f) is the structure, material or act described in the specification as performing the entire claimed function and equivalents to the disclosed structure, material or act. As a result, section 112(f) limitations will, in some cases, be afforded a more narrow interpretation than a limitation that is not crafted in "means plus function" format.
This is important to keep in mind as this means plus limitation may be interpreted narrower based on what is disclosed in the specification than if applicant was to simply recite the structure in the claim.
Based on applicant’s arguments, the specification provides that the function is done by the class of astigmatism axis measuring systems with the examples of these systems as keratometers, Placido rings and corneal topographer. Examiner agrees that keratometers, Placido rings and corneal topographers have a definite structure known to one of ordinary skill. Also, since the specification clearly links keratometers and Placido rings (i.e. structures) with the function of measuring the axis of astigmatism, the specification is not devoid of structure to perform the function of astigmatism measurement. This is why the means plus function is NOT rejected under 35 USC 112(a). The issue with the arguments is that “astigmatism axis measuring system” is not a definite class of structures. MPEP 2181 actively identifies system as a generic placeholder [see “The following is a list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f): "mechanism for," "module for," "device for," "unit for," "component for," "element for," "member for," "apparatus for," "machine for," or "system for." Welker Bearing Co., v. PHD, Inc., 550 F.3d 1090, 1096, 89 USPQ2d 1289, 1293-94 (Fed. Cir. 2008); Mass. Inst. of Tech. v. Abacus Software, 462 F.3d 1344, 1354, 80 USPQ2d 1225, 1228 (Fed. Cir. 2006); Personalized Media, 161 F.3d at 704, 48 USPQ2d at 1886–87; Mas-Hamilton Group v. LaGard, Inc., 156 F.3d 1206, 1214-1215, 48 USPQ2d 1010, 1017 (Fed. Cir. 1998).”]. Even being modified by “astigmatism axis measuring” there is no definitive structure. So, the question that is raising indefiniteness based on the provided arguments and the specification is: are Keratometers and Placido rings the only classes of structures being claimed by the means plus function limitation of “means for determining an axis of astigmatism of an eye having a cataractous lens”? This question is especially relevant as applicant also appeared to argue that corneal topographers are an example in the disclosure of an astigmatism axis measuring system. While the specification does disclose “corneal topographer” as measuring astigmatism used in systems for correcting astigmatism, it is only mentioned when addressing the background and in discussion of other systems (see para 3 of applicant’s specification) and nothing is mentioned in the disclosure of this structure being used in combination with the other features recited in claim 32. In other words, the disclosure never recites this structure in any of applicant’s own embodiments or with a femtosecond laser (i.e. how “a means for providing a femtosecond laser beam for performing a capsulotomy comprising a tag aligned with the axis of astigmatism” is interpreted as outlined in the rejection below) so it is not clear how one of ordinary skill would interpret “a) a means for determining an axis of astigmatism of an eye having a cataractous lens” (hereafter also referred to as “limitation a”) to include corneal topographers when this structure is only mentioned in discussion of other systems (not the applicant’s own system). This discrepancy on what the scope of structures the disclosure provides support for demonstrates the crux of the current 112(b) rejection as outlined below. For example, the examiner takes the position that the specification clearly identifies keratometers and Placido rings as outlined in the 112(b) rejection below, but applicant appears to take the position that additional structures beyond those clearly linked and identified groups of structures are being claimed. Instead, applicant appears to argue that any of astigmatism measuring system known to one of ordinary skill (even those mentioned in regard to other prior art, but not necessarily explicitly linked to the function in applicant’s own embodiments) are structures being recited by “limitation a”. This lack of ability to agree on the metes and boundaries of what specific structures or groups of structures are being claimed based on the specification as support for means plus limitation of “a) a means for determining an axis of astigmatism of an eye having a cataractous lens” renders claim 32 still indefinite. Thus, 32-36 are still rejected under 35 USC 112(b) as being indefinite.
Applicant’s arguments, see pgs. 8-12, filed 9/5/2025, with respect to previous rejections of claims 32-36 under 35 USC 103 as being unpatentable over Kurtz in view of Bor have been fully considered and are persuasive. The previous rejection of claims 32-36 under 35 USC 103 has been withdrawn.
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 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:
“a) a means for determining an axis of astigmatism of an eye having a cataractous lens” recited in claim 1
This means plus function limitation appears to raise a 112(b) rejection, please see 112 rejection section below for information as to how this limitation has been interpreted for this examination.
“b) a means for providing a femtosecond laser beam for performing a capsulotomy comprising a tag aligned with the axis of astigmatism” recited in claim 1
Based on the cited sections in applicant’s arguments received on 10/28/2024 of Fig. 1 element 104 and para 37 of applicant’s specification received on 7/14/2021, this is understood to be a femtosecond laser.
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 § 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 32-36 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 limitation “a means for determining an axis of astigmatism of an eye having a cataractous lens” in claim 32 invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. While, the application clearly provides specific structural examples of keratometers disclosed in para 25 and Placido rings in paras 7 and 38 of applicant’s specification received on 7/14/2021, it is never specified if “a means for determining an axis of astigmatism of an eye having a cataractous lens” is limited to these structures only. Thus, it is not definitively clear what the metes and boundaries are for the structures and their equivalents being claimed with this means plus function limitation. Thus, in this situation, while applicant’s disclosure is not devoid of any structure, since no clear boundary on the structures being claimed provided in the disclosure, the boundaries for the structures being claimed and their equivalents is unclear. For this examination, any structural element that is capable to determine an axis of astigmatism of an eye is interpreted as reciting this limitation.
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.
Additionally, claims 33-36 are rejected under 35 USC 112(b) as well based on dependency to claim 32.
Examiner Note
The prior art does not demonstrate the features as claimed in claims 32-36. However, as demonstrated above, these claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AlA), 2nd paragraph, set forth in this Office action.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792