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 73 and 75 are objected to because of the following informalities:
In claim 73, the first instance of the acronym “OCDR” (line 2) should be spelled out.
In claim 75, the term “vis-à-vis” (line 4) should be changed to an appropriate English equivalent.
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 73-95 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
Antecedent Basis
Claim 76 recites the limitation "the detection of focusing on a target structure" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claims 77, 78, 94 recite the limitation "ZS" in line 2. There is insufficient antecedent basis for this limitation in the claims.
Claim 77 recites the limitation "the spatial variation of a periodically moving target laser beam" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 84, 85 recite the limitation "the contact glass KG" in lines 1-2. There is insufficient antecedent basis for this limitation in the claims.
Claim 85 recites the limitation "RS" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 85 recites the limitation "the scattering or polarization" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 90 recites the limitation "the contact glass" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claims 90, 91 recite the limitation "the function f" in lines 5, 4-5, respectively. There is insufficient antecedent basis for this limitation in the claims.
Indefinite Language
Regarding claim 92, the phrase "by preference" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 73-75, 79-80, 83, 89-91, the phrases “using” and “used” render the claims indefinite because the claims merely recite a use without any active, positive steps delimiting how this use is practiced. See MPEP 2173.05(q).
Regarding claim 95, the phrase “enabling” renders the claim indefinite because the claim merely recites a use without any active, positive steps delimiting how this use is practiced. See MPEP 2173.05(q).
Relative Term/Term of Degree
The term “any selectable values of a change in distance” in claims 73-75 is a relative term which renders the claims indefinite. The term “any selectable values of a change in distance” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what the functional and/or optimal range of device operation is. For example, assuming the device is not operable at any possible distance (e.g., several hundred meters away from the subject’s eye), what values of distance are appropriate/deemed to be selectable?
The term “approximately” in claims 73-75 is a relative term which renders the claims indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how accurate the calculation of the assumable focus position is.
The term “predominantly” in claim 87 is a relative term which renders the claim indefinite. The term “predominantly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how much of the treatment laser beam is transmitted.
The term “vicinity” in claim 94 is a relative term which renders the claim indefinite. The term “vicinity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how close the target structure needs to be to a structure to be worked on.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 80, 83, 92-93 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The claims are directed to selecting/using eye structures as target or reference structures, including a lens, capsular bag, retinal surface, and cornea, which reads on a human organism. The Examiner recommends changing the claim language to recite: “wherein the target structures include…”, followed by all relevant structures, to overcome the 35 USC 101 rejection.
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention 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 35 U.S.C. 103 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.
Claims 73-83, 88-89, 91-95 are rejected under 35 U.S.C. 103 as being unpatentable over Hacker et al. (US Pre-Grant Publication 2024/0139033), hereinafter ‘Hacker’.
Regarding claim 73, Hacker teaches a method to recalibrate a focus of an ophthalmological system for intraocular laser treatment (abstract, central control/operating unit is configured to focus the laser system), the ophthalmological system also comprising:
an OCDR system (OCDR system 2, Fig. 1) and a control unit (central control and operating unit 6, Fig. 1) in addition to a treatment laser unit (laser system 3, Fig. 1), an imaging unit (visual display unit 5, Fig. 1) and an optical system that performs focusing and beam superposition (focusing unit 14, Fig. 1), the method comprising:
focusing a target laser beam (laser focus 12, Fig. 1) of the system for ophthalmological laser treatment on at least one target structure ZS1 (located floater 11, Fig. 1) in an eye to be treated by adjusting a distance A of the ophthalmological system for laser treatment from the eye being treated until focusing of the target laser beam of the laser treatment system on the target structure ZS1 is detected ([0041], iterative reduction in the axial distance between relative focal position and relative floater position) (Fig. 2b, floater reflection 20 and laser focus are aligned);
determining a distance A1 from a position of a chosen reference structure PRS (posterior lens side 18 and retina 19, Figs. 2a, 2b), and a position of a target structure PZS1 (floater reflection 20, Figs. 2a, 2b) in an OCDR signal profile, in each case in relation to a reference plane RE ([0103-0104]), and
wherein, for any selectable values of a change in distance ΔA of the laser treatment system from the eye, a respective assumable focus position PF (position at Fig. 2b where 12 and 20 are aligned) of the laser beam of the laser treatment system in the OCDR signal profile is estimated approximately using the parameters A1 and PZS1 ([0088]).
Hacker teaches that calibrating a focal position can be achieved by detecting relative focus position-dependent OCDR signal increases of eye structures including the cornea, lens, capsular bag, vitreous humor scattering or retinal structures ([0088]). It is the Examiner’s position/interpretation of the recited claim feature that any changes in the distance of the system from the eye (A), as claimed in the instant application, is accounted for in Hacker’s detection of “position-dependent signals”.
Regarding claim 74, Hacker does not explicitly teach the calculation of focus positions for any change in distance of the system from the eye. However, it is the Examiner’s position/interpretation of the recited claim feature that any change in the distance between the system/eye would be equal to the change in the focus position. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have created a function that shifts the focus position based on a change in distance between the system and eye. This is a direct mathematical relationship that is well-understood by one of ordinary skill in the art.
Regarding claim 75, Hacker does not explicitly teach using multiple target structures to determine a function that can determine a focus position for any distance between the system and eye. However, it is the Examiner’s position/interpretation of the recited claim feature that any change in the distance between the system/eye would be equal to the change in the focus position. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have created a function that shifts the focus position based on a change in distance between the system and eye. This is a direct mathematical relationship that is well-understood by one of ordinary skill in the art.
Regarding claim 76, Hacker teaches the method of claim 73, further comprising:
implementing the detection of focusing on a target structure by visual or automated establishment of one or more of the following states:
1) maximized backscatter of the target laser from the target structure,
2) minimized diameter of the target laser beam light distribution on the target structure,
3) characteristic state or characteristic change in the OCDR signal of the target structure ([0088], vitreous humor scattering, OCDR signal has maximum when focused on structure).
Regarding claim 77, Hacker teaches the method of claim 73, further comprising:
focusing target lasers on the target structure ZS by virtue of the spatial variation of a periodically moving target laser beam being minimized ([0100], laser focused is moved along A-scan until a floater is detected, then a pulse is triggered).
Regarding claim 78, Hacker teaches the method of claim 73, further comprising:
implementing the focusing of at least one target laser on the target structure ZS by maximizing backscatter from at least one target beam laser focus via confocal detection ([0088], vitreous humor scattering, OCDR signal has maximum when focused on structure).
Regarding claim 79, Hacker teaches the method of claim 77, further comprising:
using a continuous wave laser beam with the same or similar focal position as the laser beam of the laser treatment system as target laser ([0032], laser and measuring beam have the same or virtually the same wavelength/focus).
Regarding claim 80, Hacker teaches the method of claim 73, further comprising:
using a lens back side, a capsular bag back side, a retinal surface or other structures in the eye as target structures ZS ([0088]).
Regarding claims 81 and 82, Hacker teaches the method of claim 76 and 77, respectively, further comprising:
creating a target structure ZS in the eye by a pulse or a modulation of a laser beam of the laser treatment system, said target structure being a modification in the vitreous humor or any other eye structure, which brings about a signal change in the OCDR, or a modified backscatter or a phase or speckle grain modification in the OCDR signal ([0102]).
Regarding claim 83, Hacker teaches the method of claim 73, further comprising:
using a front or a back side of a contact glass KG present, a technical structure situated in the contact glass, or eye structures including a front or a back side of cornea, a front or a back side of lens or a front or a back side of capsular bag or a retinal surface serve as reference structure RS ([0129], Fig. 4, contact glass 24).
Regarding claim 88, Hacker teaches the method of claim 73, further comprising:
wherein identification of the positions of the target structures and of the reference structure is implemented by determining the maximum value or the centroid value or a threshold value of an OCDR signal in the OCDR signal profile ([0088], detecting focus-dependent signal increases since OCDR has maximum when focused on structure).
Regarding claims 89 and 91, Hacker teaches the method of claim 75 and 73, respectively, but does not specifically teach the calculation of focus positions for any change in distance of the system from the eye. However, it is the Examiner’s position/interpretation of the recited claim feature that any change in the distance between the system/eye would be equal to the change in the focus position. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have created a function that shifts the focus position based on a change in distance between the system and eye. This is a direct mathematical relationship that is well-understood by one of ordinary skill in the art.
Regarding claim 91, the Examiner notes that Hacker discloses determining the anterior and posterior lens sides [0086], which is equivalent to determining the thickness of the lens.
Regarding claim 92, Hacker teaches the method of claim 75, further comprising:
wherein the target structures ZSi, ..., ZSN each contain at least one structure in front and back vitreous humor regions, with by preference the front or back side of the cornea and the retinal surface are selected ([0034], cornea and retina, [0042], floaters are detected in vitreous humor, [0058], vitreoretinal interface).
Regarding claim 93, Hacker teaches the method of claim 75, further comprising:
also choosing target structures ZSn located in desired exclusion zones ([0103], exclusion zone boundaries, Fig. 3) for treatment of laser vitreolysis ([0042], controlling a laser for vitreolysis), selected from a group including at least the lens back side (posterior lens side 18, Fig. 3) and the retinal surface (retina 19, Fig. 3).
Regarding claim 94, Hacker teaches the method of claim 93, further comprising:
creating the target structure ZS by a laser beam of the treatment system for laser vitreolysis in a vicinity of a structure to be worked on ([0111], z-tracking of structures of the eye close to the located floater).
Regarding claim 95, Hacker teaches the method of claim 86, further comprising ensuring the presence of sufficient pupil dilation for treatment [0117]. Hacker does not specifically teach that the pupil diameter is greater than 4mm in an anterior region, greater than 5mm in a central region, and greater than 6mm in a posterior region. It would have been a design choice at the time of invention for the surgeon to adjust the dilation of the eye in order to optimize treatment results, because the surgeon would naturally need to clearly view the target to optimize the surgery outcome.
Conclusion
Claims 84-87 and 90 are free of the prior art of record, but remain rejected under 112(b) in addition to depending on rejected independent claims.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gooding et al. (US Pre-Grant Publication 2019/0175409) teaches an ophthalmic system with an imaging device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
June 11, 2026
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