Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is in response to the amendment filed on 11/28/2025. Currently claims 1-17 are pending.
Response to Arguments
Applicant’s arguments, see pgs. 7-9, filed 11/28/2025, with respect to the previous rejections of claims 10-18 under 35 USC 112(a) and 112(b) have been fully considered and are persuasive. The previous rejections of claims 10-18 under 35 USC 112(a) and 112(b) have been withdrawn.
While, applicant’s arguments are overall persuasive some further clarity needs to be provided with regard to the interpretation for the broadest reasonable interpretation in light of the specification of the negative limitation “a fixed 45 degree mirror, which does not rotate” in claim 10.
Applicant argues the following:
“One of skill in the art when reading the claims as a whole would readily understander the claim element "the laser delivery system including a fixed 45 degree mirror, which does not rotate." There is only one rational reading of this claim element in view of the Specification -- the laser system has a 45 degree mirror, it is fixed in the laser system, i.e., it does not move. Because it does not move, one of skill in the art would understand that it does not rotate. Rotation is a type of movement, and if the mirror is fixed and thus cannot move, it cannot rotate.” [see pg. 8 of applicant’s arguments received on 11/28/2025].
Among other embodiments of 45 degree mirrors discussed in the disclosure, a fixed 45 degree mirror on a gimbal mount is described in the disclosure [i.e. see Fig. 4 and para 59 of applicant’s disclosure received on 2/6/2023]. Thus, based on applicant’s arguments and applicant’s disclosure, the limitation of “a fixed 45 degree mirror, which does not rotate” in claim 10 appears to be attempting to exclude the gimbal mounted embodiment(s). Thus, the broadest reasonable interpretation in light of the specification and the one taken for this examination is the limitation “a fixed 45 degree mirror, which does not rotate” refers to the exclusion of fixed 45 degree mirrors that are mounted to gimbals or their functional equivalents. Under this interpretation, applicant’s arguments for the negative limitation “a fixed 45 degree mirror, which does not rotate” are persuasive and the 112 rejections are overcome.
Applicant's arguments filed 11/28/2025 with respect to the previous rejections of:
claim(s) 1-7 under 35 USC 103 as being unpatentable over Blumenkranz in view of Sedarevic
claim(s) 8-9 under 35 USC 103 as being unpatentable over Blumenkranz in view of Sedarevic in view of Kadziauskas
have been fully considered but they are not persuasive.
The crux of applicant’s is that the limitation “wherein the system is configured so that the laser beam propagates through the laser delivery system and into the eye
without a docking connection between the laser delivery system and the
means for holding the eye open” is not taught by Blumenkranz in view of Sedarevic. The crux appears to be a difference in how “no docking” is interpreted by the applicant and the examiner and the scope of what is required by the limitation “wherein the system is configured so that the laser beam propagates through the laser delivery system and into the eye without a docking connection between the laser delivery system and the means for holding the eye open”. Applicant appears to take the position that the prior art must disclose a laser delivery system not docked with the means for holding the eye opening while the eye is open. And that the previous and maintained position of elements being “spaced away” fails to meet two elements “not docking”, without providing any clarification on how “no docking” is being interpreted [see pgs. 9-10 of applicant’s arguments received on 11/28/2025].
In response these arguments do not appear commensurate with the scope of the claims. Applicant’s disclosure doesn’t seem to provide a special definition in the disclosure for what is meant by docking. However, in describing docking between different elements in particular when describing docking between the eye and a laser device docking seems to be a direct physical attachment as can be seen in Fig. 21-22 of applicant’s disclosure. Therefore, it would seem the interpretation that docking is a direct physical attachment between two elements is at the very least supported under the broadest reasonable interpretation (even in light of applicant’s specification). The examiner previously took and maintains the position that no docking indicates no direct physical attachment between two elements. This is why the previous rejection and maintained current rejection discusses elements being “spaced away” (i.e. as it clearly demonstrates no direct physical attachment). And since this is an apparatus claim where the claim limitations are to what the device is structurally and not how it is used [see MPEP 2114], the limitation “wherein the system is configured so that the laser beam propagates through the laser delivery system and into the eye without a docking connection between the laser delivery system and the means for holding the eye open” simply requires a structure capable propagating the laser beam into the eye while the laser delivery system and the means for holding the eye open are not directly physically attached. Actually, performing the action is intended use and not the structure. Since Blumenkranz is merely being modified to include the use of a speculum (i.e. a means for holding the eye open), Sedarevic doesn’t actively disclose directly attaching the speculum to laser delivery system in its disclosure, and Blumenkranz is directed to include embodiments that include no physical attachment connection to the eye with the entire laser delivery system as indicated by the Blumenkranz’s device being “spaced away from the eye”, it follows that under the four corners of the teachings of Blumenkranz for these same embodiments, the laser delivery system will also be spaced away (i.e. no direct physical attachment) from elements directly connected to the eye (i.e. the speculum) when modified by Sedarevic. For these reasons, applicant’s arguments are NOT persuasive and the rejections to claims 1-9 has been maintained. However, if applicant could clarify the claims to better define what they mean by “without a docking connection”, so that broadest reasonable interpretation is restricted to a narrower interpretation than that taken for this and previous examinations, applicant could potentially overcome the current rejection.
Applicant’s arguments, see pgs. 11-12, filed 11/28/2025, with respect to the previous rejections of:
claim(s) 10-15 and 18 under 35 USC 103 as being unpatentable over Kaschke
claim(s) 16-17 under 35 USC 103 as being unpatentable over Kaschke in view of Kadziauskas
have been fully considered and are persuasive. These previous 103 rejections of claims 10-18 have 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.
In this case these limitation(s) is/are:
“a means for holding the eye open” recited in claim 1.
The best support comes from para 85 of applicant’s specification received on
2/6/2023. Para 85 states:
“The speculum 203 is holding the eye open and in the same time pushes the contact lens towards the eye through a contact of the speculum wire 202 or blade with the sloped surface 224. The amount of down force can be adjusted by the amount of speculum opening and by the design angle of the slope 224. This contact lens creates stable eye fixation and minimizes laser beam aberrations for laser access of the entire eye.”
Also, best support can be found in Fig. 23 which describes a patient interface (element 229) and Fig. 17 (element 402) which describes a suction ring that both are understood to hold the eye open as well.
Based on the specification and figures “a means for holding an eye open” is interpreted as a speculum, a suction ring, a patient interface and their structural equivalents.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Blumenkranz et al (US 20060195076) hereafter known as Blumenkranz in view of Sedarevic et al (US 20090099557 first cited in previous final rejection mailed on 8/13/2024 as pertinent prior art) hereafter known as Sedarevic.
Independent claim:
Regarding Claim 1:
Blumenkranz discloses:
A system for eye surgery [see Fig. 13 and abstract… “System and method for making incisions in eye tissue at different depths”], comprising
a femtosecond laser system [see Fig. 13 is the system and para 54… “Threshold radiant exposure, .PHI., for dielectric breakdown for 100 fs is about .PHI.=2J/cm.sup.2; for 1 ps it is .PHI.=2.5 J/cm.sup.2. Using the above pulse durations, and a focal spot diameter d=15 .mu.m, the threshold pulse energies will be E.sub.th=.PHI.*.pi.d.sup.2/4=3.5 and 4.4 .mu.J for 100 fs and 1 ps pulses, respectively.” The laser applies laser energy in the femtosecond range domain (i.e. a femtosecond laser)] to cut a tissue structure of an eye with a laser beam [see abstract… “System and method for making incisions in eye tissue at different depths”];
the laser system comprising at least a laser delivery system [see Fig. 13 and elements: “DM1”, “M1”, “L1”, “G1”, “G2”, “L2”, “M2” which define the delivery system] and
a laser engine [see Fig 13 element “LS” and para 75… “a laser source LS” A laser source is at least a laser engine],
wherein the system is configured so that the laser beam propagates through the laser delivery system and into the eye [see Fig. 13 and para 75… “the light beam B” which shows the laser beam B propagating as claimed] without a docking connection between the laser delivery system and the means for holding the eye open [see Fig. 13 and para 45… “An optional ophthalmic lens 18 can be used to focus the optical beam 11 into the patient's eye 1” As shown the elements of the laser delivery system are spaced and separated from the eye by an ophthalmic lens with the absent of any structure (i.e. no contact between the laser delivery system and a means for holding the eye open), indicating no docking connection between the laser delivery system or a means for holding the eye open.]
However, Blumenkranz fails to disclose “a means for holding the eye open” as recited by claim 1.
Sedarevic discloses in the analogous art of ophthalmic surgery [see abstract… “Disclosed herein are methods and compositions for use in surgical procedures for refractive ablation of the cornea to achieve vision correction with a minimum of undesirable side effects and for a broad range of optical conditions such myopia, hyperopia, presbyopia and astigmatism.”] that use of a speculum (i.e. a means for holding an eye open) is a well known way to provide a physician access unhindered access to patient’s eye for surgery [see para 57… “Typically, a mechanical aid such as a speculum is utilized to allow the treating physician unhindered access to the patient's eye.”]
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify Blumenkranz by including “a means for holding the eye open” similarly to that of Sedarevic on the eye similarly spaced away from the laser delivery as the eye (i.e. thereby reciting “a means for holding the eye open”) because this would reduce hindrances thereby improving access to the patient’s eye for ophthalmic surgeries.
Regarding claim 2, the abstract of Blumenkranz [see “System and method for making incisions in eye tissue at different depths”], discloses the device is capable of making incisions on different tissues on the eye. At the very least Blumenkranz discloses a capability to form incisions on the different tissues claimed. Thus, Blumenkranz in view of Sedarevic is at least capable of reciting performing cuts as claimed.
Regarding claim 3, see Fig. 13 element OL and para 76 [see “An optional ophthalmic lens OL may be used to help focus the light. Ophthalmic lens OL may be a contact lens and further serve to dampen any motion of eye EYE, allowing for more stable treatment.”] discloses an ophthalmic lens which is a patient interface affixed to the eye and as shown in Fig. 13 the patient interface has no physical connection to the laser delivery system as claimed.
Regarding claims 4, Fig. 13 of Blumenkranz and para 80 of Blumenkranz [see “a confocal microscope CM”] disclose a confocal microscope system (i.e. a surgical microscope system) and that most of the elements laser delivery system are placed below this microscope system. Additionally, based on para 77 of Blumenkranz [see “Mirror M2 could be a dichroic element that the user looks through in order to visualize the target directly or using a camera, or may be made as small as possible to provide an opportunity for the user to view around it, perhaps with a binocular microscope.”] the microscope system is integrated such than there is no blocking of visualization with other elements of the laser system indicating that the microscope is mounted such that it “allows viewing of the eye through the surgical microscope while the laser beam is simultaneously delivered into the eye through the laser delivery system” as recited by claim 4.
Regarding claim 5, see para 76 of Blumenkranz [“In the configuration shown, lens L2 ideally is moved along with the scanner G1 & G2 to maintain telecentricity. With that in mind, one may move the entire optical assembly to adjust the depth along the z-axis.”] and Fig. 13 of Blumenkranz. These sections disclose the entire optical system (understood to refer to elements of the laser system) as being moved between different positions to adjust for a target. A position where the laser system is in focus with the target is interpreted as an engaged position and a position where the laser system is not in focus with the target is a disengaged position. Since the microscope is always positioned over the elements of the laser system and aligned with the eye as shown in Fig. 13, Blumenkranz in view of Sedarevic is understood to recite “wherein the laser delivery system can be moved between an engaged and a disengaged position under the surgical microscope while the surgical microscope stays aligned over the eye”.
Regarding claim 6, see labelled figure 13 of Blumenkranz below rejection to this claim which shows the articulating arm with a proximal articulating end and a distal articulating end as claimed. Also as shown that figure element B is the laser beam that propagates as claimed.
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Regarding claim 7, Fig. 13 element Am and para 77 of Blumenkranz [see “The optional aiming beam AIM” Please note AM is understood to be a typo of AIM] disclose an aiming beam that is at least a guidance system as claimed.
Claims 8-9 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Blumenkranz in view of Sedarevic as applied to claim 1 above, and further in view of Kadziauskas et al (US 20060200068) hereafter known as Kadziauskas.
Blumenkranz in view of Sedarevic discloses the invention substantially as claimed including all the limitations of claim 1 as outlined above. Additionally, Blumenkranz in view of Sedarevic discloses that use of the laser device often includes additional treatment using phacoemulsification [see para 69 of Blumenkranz … “the laser patterning may be used to pre-fragment or segment the nucleus for later conventional ultrasonic phacoemulsification. In this case however, the conventional phacoemulsification would be less than a typical phacoemulsification performed in the absence of the inventive segmenting techniques because the lens has been segmented.”]
However, Blumenkranz in view of Sedarevic fails to actually disclose any time of integration with a phacoemulsification system. Thus, Blumenkranz in view of Sedarevic fails to disclose “wherein the laser engine is integrated as a sub-module into a common housing with at least a portion of a phacoemulsification system” as recited by claim 8 or “wherein the femtosecond laser system is controlled by a phacoemulsification system” as recited by claim 9.
Kadziauskas discloses using an console [see element 36 of Kadziauskas] integrated with a laser system [see element 14] that includes both a laser [element 18] and a phacoemulsification system [see element 40] to allow for simultaneous sequential operation of both laser ablation and emulsification so that a targeted area can be preconditioned for softer lens tissue thereby improving the effect of the operating laser [see para 14 of Kadziauskas.. “A control console is provided and interconnected with both first and second handpieces for controlling irrigation and aspiration rates and enabling simultaneous sequential operation of the laser emitting probe and the vibrated needle. In this manner, particularly hard or lens portions, that are resistant to emulsification, may be preconditioned for emulsification by laser radiation. The softening of lens tissue by laser is well known].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Blumenkranz in view of Sedarevic to include a phacoemulsification system and to integrate this system’s control with the laser system control similarly to that disclosed by Kadziauskas (i.e. thereby reciting “wherein the femtosecond laser is controlled by a phacoemulsification system” as recited by claim 9) to allow for simultaneous sequential operation of ablation and emulsification thereby improving the effect of the operating laser in surgery.
It would have been obvious to one having ordinary skill in the art at the time the invention was invented to modify Blumenkranz in view of Sedarevic in view of Kadziauskas to include both the femtosecond laser and a phacoemulsification system housed in a common housing (i.e. thereby reciting “wherein the laser engine is integrated as a sub-module into a common housing with at least a portion of a phacoemulsification system” as recited by claim 8) because absent unexpected results such a modification is a mere integration of parts and the courts have ruled that such a modification would be a matter of obvious engineering choice [In re Larson. 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965)].
Allowable Subject Matter
Claims 10-17 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Claim 10 is the broadest allowable independent claim. Claim 10 recites a system for eye surgery. The closest prior art is Kaschke as outlined in the previous non-final rejection mailed on 5/28/2025. However, Kaschke fails to disclose a “fixed 45 degree mirror, which does not rotate” as claimed. Furthermore, as applicant successfully argues [see pgs. 10-12 of applicant’s arguments received on 11/28/2025] it would not have been obvious to modify Kaschke to include this feature and nothing in the prior art when viewed with Kaschke would obviate this deficiency. It is important to note that the missing limitation alone does not define the invention over the prior art, as fixed 45 degree mirrors, which do not rotate are known in the field of laser ophthalmology surgery. Rather, the allowability of claim 10 lies in the combination of the missing limitation with all the other limitations of claim 10 together. Therefore, the combination of claimed limitations of claim 10 is neither anticipated, nor obviated in view of the prior art.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792