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 .
Election/Restrictions
Applicant’s election without traverse of Species #1 in the reply filed on 10/10/2025 is acknowledged.
Claims 11-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/10/2025.
Accordingly, the examiner will examine and search Species #1 and claims 1-10.
Claim Interpretation
The presently examined and searched claims, claims 1-10, contain at least one claim containing language directed to a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed. These types of recitations in device/apparatus and system claims do not always achieve what Applicant may be hoping for.
A recitation of intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. However, if a prior art structure is capable of performing the intended use as recited in the preamble, then it meets the claim. It is well established that a recitation with respect to the manner in which an apparatus is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963).
Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In re Ludtke, 441 F.2d 660, 169 USPQ 563 (CCPA 1971). In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, Applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon. In re Spada, 911 F.2d 705, 15 USPQ2d 1655 (Fed. Cir. 1990); In re King, 801 F.2d 1324, 1327, 231 USPQ 136, 138 (Fed. Cir. 1986); In re Ludtke, 441 F.2d at 664, 169 USPQ at 566 (CCPA 1971).
A recitation with respect to the manner in which an apparatus is intended to be employed does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitations of the claim. In re Pearson, 494 F.2d 1399, 181 USPQ 641 (CCPA 1974); In re Yanush, 477 F.2d 958, 177 USPQ 705 (CCPA 1973); In re Finsterwalder, 436 F.2d 1028, 168 USPQ 530 (CCPA 1971); In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967); In re Otto, 312 F.2d 937, 136 USPQ 458 (CCPA 1963); Ex parte Masham, 2 USPQ2d 1647 (BdPatApp & Inter 1987).
Claim Rejections - 35 USC § 112
112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 6 recites “the patient cornea element includes a circumferential step in the patient posterior cornea element surface, in particular in a peripheral region of the patient posterior cornea element surface.
The phrase “circumferential step” appears just three times in the present specification: A) twice in paragraph [0057], and B) once in claim 6. Paragraph [0057] recites “As will be explained in the following, such embodiments are particularly favorable for interlocking the cornea implant with respect to the patient cornea by way of complementary structures.”
It is very unclear what the circumferential step of claim 6 actually is. The written description appears to support the circumferential step is favorable for “interlocking (see [0057]) which begs the question: is the circumferential step: A) the circumferential surface with “zig-zag shapes” (see [0046] – which in turn leads to drawing objections (claimed structural features not shown in the drawings)), or B) the combination of the patient posterior lamellar cut with patient auxiliary side cut (see [0062] – which appears to lead to a duplicate claim objection (see present claim 3).
In order to provide an initial examination and search the examiner will interpret the circumferential step as being equivalent to the combination of the patient posterior lamellar cut with patient auxiliary side cut (see [0062]). This interpretation also avoids a drawing objection.
Also see the 112(b) rejection below.
112(b)
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.
Claim 6 is 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 6 recites the limitation "the patient posterior cornea element surface" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 depends directly from claim 1. Claim 1 does not recite “a patient posterior cornea element surface,” however, claim 5 does positively recite “a patient posterior cornea element surface” in lines 2-3.
The appropriate corrections are required.
The term “substantially” in claim 9 (line 3) is a relative term which renders the claim indefinite. The term “substantially” 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.
Accordingly, the examiner cannot determine the metes and bounds of invention as defined by present claim 9 and will not treat claim 9 further until a time when this error is corrected.
Claim Objections
Claim 6 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 3. (see above 112(a) rejection and initial interpretation by examiner) When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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, 5, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bischoff et al. (U.S. Patent Application Publication 2019/0159934).
Regarding claim 1, and 5, Bischoff et al. disclose an eye surgical laser apparatus comprising:
a) a treatment laser device (“laser device 4,” see abstract, [0060] and figures 1 and 5) for implementing cornea cuts;
b) a computerized treatment control device (“controller 11,” see abstract, [0061], [0064], [0069], [0073] and figures 1, and 5) in operative coupling with the treatment laser device, the treatment control device configured to control the treatment laser device to implement a number of patient cornea cuts, the patient cornea cuts forming, in combination, a patient cornea cut pattern with a geometry of the patient cornea element being defined by the patient cornea cut pattern, the number of patient cornea cuts including:
a patient anterior lamellar cut (“anterior flap cut surface 22,” see [0071] and figure 4), the patient anterior lamellar cut extending in the patient cornea at a patient anterior lamellar cut distance from a patient posterior cornea surface of the patient cornea, the patient anterior lamellar cut defining a patient anterior cornea element surface,
a patient side cut (“circumferential side cut 25”, [0071] and figure 4), the patient side cut extending in the patient cornea from a circumferential edge of the patient anterior lamellar cut towards the patient posterior cornea surface in a circumferentially closed manner, the patient side cut defining, at least in part, a circumferential patient cornea element surface (it should be noted the circumferential side cut 25 defines a circumferential surface that defines “corneal volume 21 is removed” along with 1) “anterior flap cut surface 22” shown above, and 2) “posterior lenticule cut surface 23,” see [0071]-[0072] and figure 4),
a patient access cut (“opening incision 24,” see [0071] and figure 4), the patient access cut extending in the patient cornea from the patient side cut to a peripheral region of the patient anterior cornea surface, the patient access cut forming an access passage in the patient cornea,
the patient cornea cut pattern further defining a patient cornea interlocking structure (“corneal volume 21” which is removable, see [0071]-[0072] and figure 1).
Additionally, Bischoff et al. disclose the patient cornea interlocking structure is defined, at least in part, by a patient posterior cornea element surface (“posterior lenticule cut surface 23,” see [0071] and figure 4).
It should be noted the recitation “the patient cornea interlocking structure being configured to interlock the patient cornea with a cornea implant after replacing the patient cornea element by the cornea implant” is a recitation of 1) intended use, 2) functional limitation, or 3) language directed to the manner in which an apparatus is intended to be employed.
Regarding claim 7, Bischoff et al. disclose the claimed invention including patient
access cut meets the patient anterior cornea surface in an acute angle. As seen in the reproduced and annotated figure 4 of Bischoff et al. the initial portion of the patient
access cut (initial length of line 24 in figure 4 below) meets the patient anterior cornea surface (“cut surfaces 22”) in an acute angle (i.e., greater than zero and less than 90º).
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248
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[AltContent: textbox (Axis defining direction of the patient anterior cornea surface )]
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.
Claims 2, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Bischoff et al. (U.S. Patent Application Publication 2019/0159934) as applied to claim 1 above, and further in view of Peyman (U.S. Patent Application Publication 2021/0113375).
Regarding claims 2, and 10, Bischoff et al. shows the invention above
but fails to recite:
1) the treatment control device is configured to control the treatment laser device to implement the patient anterior lamellar cut subsequent to the patient side cut and the patient access cut subsequent to the patient anterior lamellar cut, and
2) the treatment control device is configured to implement the patient cornea cuts that define the geometry of the patient cornea element in sequence one after the other.
Like Bischoff et al., Peyman discloses a laser system and method of laser cutting a volume of the cornea (e.g., lenticle) for cornea transplant/implant and teach:
“three (3) sequential cuts may be made in the stromal portion of the cornea 212 of the eye 210 using a femtosecond laser in order to form the pocket. First, a lower circular cut or incision centered about the visual axis (i.e., a lower incision with the patient in a supine position) is made using the femtosecond laser. Then, a second vertical cut is made above the lower incision using the femtosecond laser to form the side(s) of a circular cutout portion. Finally, a third square or circular cut (i.e., an upper incision) is made above the vertical cut using the femtosecond laser. In the illustrative embodiment, the lower incision is parallel to the upper incision, and the vertical cut extends between lower incision and the upper incision,”
see [[0273].
Peyman teaches this use a sequential surface cutting method in order to provide the implant/transplant method with a known and workable sequence of cutting the 1) bottom (posterior) surface, 2) side surface, and 3) top (anterior) surface for cornea transplant/implant procedures methods.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Bischoff et al., as taught by Peyman, to use a sequential surface cutting method in order to provide the implant/transplant method with a known and workable sequence of cutting the 1) bottom (posterior) surface, 2) side surface, and 3) top (anterior) surface for cornea transplant/implant procedures.
Claims 3, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Bischoff et al. (U.S. Patent Application Publication 2019/0159934) as applied to claim 1 above, and further in view of Klopotek (U.S. Patent Application Publication 2020/0146812).
Regarding claims 3, and 6, Bischoff et al. shows the invention above,
fail to recite:
#1 - the patient side cut does not extend to the patient posterior cornea surface, the patient cornea cut pattern further including a patient posterior lamellar cut, the patient posterior lamellar cut extending circumferentially in the patient cornea from a posterior edge of the patient side cut inwards with respect to the patient cornea, in particular with a constant distance to the patient anterior lamellar cut and a patient auxiliary side cut, the patient auxiliary side cut extending from an inner edge of the patient posterior lamellar cut to the patient posterior cornea surface,
#2 - the patient cornea element includes a circumferential step in the patient posterior cornea element surface, in particular in a peripheral region of the patient posterior cornea element surface (which is just a rewording of #1 above as noted in the 112 rejections and claim objections above).
Like Bischoff et al., Klopotek discloses a laser system and method of laser cutting a volume of the cornea (e.g., lenticle) for cornea transplant/implant and teach using alternate/equivalent configurations of cutting lenticular volumes one having recited structures of claim 3 (and claim 6) in order to provide known and workable alternate/equivalent “complementary” lenticular volumes for cornea implant/transplant procedures (see [0161] and figure 8B).
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Bischoff et al., as taught by Klopotek, to use alternate/equivalent configurations of cutting lenticular volumes one having recited structures of claim 3 (and claim 6) in order to provide known and workable alternate/equivalent “complementary” lenticular volumes for cornea implant/transplant procedures.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bischoff et al. (U.S. Patent Application Publication 2019/0159934) in view of Klopotek (U.S. Patent Application Publication 2020/0146812) as applied to claim 3 above, and further in view of Peyman (U.S. Patent Application Publication 2021/0113375) in view of Official Notice.
Regarding claim 4, Bischoff et al. in view of Klopotek show the invention above
but fail to recite the treatment control device is configured to control the treatment laser device to implement the patient posterior lamellar cut subsequent to the patient auxiliary side cut and prior to the patient side cut.
Like both Bischoff et al. and Klopotek, Peyman discloses a laser system and method of laser cutting a volume of the cornea (e.g., lenticle) for cornea transplant/implant and teach:
“three (3) sequential cuts may be made in the stromal portion of the cornea 212 of the eye 210 using a femtosecond laser in order to form the pocket. First, a lower circular cut or incision centered about the visual axis (i.e., a lower incision with the patient in a supine position) is made using the femtosecond laser. Then, a second vertical cut is made above the lower incision using the femtosecond laser to form the side(s) of a circular cutout portion. Finally, a third square or circular cut (i.e., an upper incision) is made above the vertical cut using the femtosecond laser. In the illustrative embodiment, the lower incision is parallel to the upper incision, and the vertical cut extends between lower incision and the upper incision,”
see [[0273].
Peyman teaches this use a sequential surface cutting method in order to provide the implant/transplant method with a known and workable sequence of cutting the 1) bottom (posterior) surface, 2) side surface, and 3) top (anterior) surface for cornea transplant/implant procedures methods.
Even though Peyman does not mention the patient auxiliary side cut, the examiner takes Official Notice of the recited order since it would be obvious to continue Peyman’s bottom-up sequence regarding the order of the cutting surfaces.
If applicant does not traverse the examiner’s assertion of official notice or applicant’s traverse is not adequate, the examiner should clearly indicate in the next Office action that the common knowledge or well-known in the art statement is taken to be admitted prior art because applicant either failed to traverse the examiner’s assertion of official notice or that the traverse was inadequate. If the traverse was inadequate, the examiner should include an explanation as to why it was inadequate,” see MPEP 2144.03C.
Therefore, at the time of the of invention it would have been obvious to one of ordinary skill in the art to modify the invention of Bischoff et al., as taught by Peyman, to use a sequential surface cutting method in order to provide the implant/transplant method with a known and workable sequence of cutting the 1) bottom (posterior) surface, 2) side surface, and 3) top (anterior) surface for cornea transplant/implant procedures, and still further taken Official Notice, to implement the patient posterior lamellar cut subsequent to the patient auxiliary side cut and prior to the patient side cut to continue Peyman’s bottom up sequence.
Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 8 distinguishes over all the prior art the examiner reviewed (if rewritten in independent form including all of the limitations of the base claim and any intervening claims). One of the most relevant prior art references, Voorhees et al. (U.S. Patent Application Publication 2022/0054316) , has multiple opposing cuts/slits (arcuate incisions 405, see figure 4B), but these slits are shallow and it is silent as to any physical connection to a side cut surface which is important.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON F ROANE whose telephone number is (571)272-4771. The examiner can normally be reached generally Mon-Fri 8am-9pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON F ROANE/Primary Examiner, Art Unit 3792