DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 12-14 and 29-31, drawn to a method for performing laser eye surgery, classified in A61F 2009/00889.
II. Claim 32, drawn to a liquid interface, classified in A61F 9/009.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus can be used in a method that does not include coupling an eye having a penetration through the cornea, such as non-invasive laser therapy that does not produce incisions and applies therapy through an intact cornea.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions have acquired a separate status in the art in view of their different classification as set forth above;
--the inventions have acquired a separate status in the art due to their recognized divergent subject matter drawn to a generic liquid interface and specific surgical procedures not required by the generic interface device; and/or
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries) due to the specific method steps not required by the liquid interface device.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Sanjesh Sharma on 2/12/2026 a provisional election was made without traverse to prosecute the invention of group I, claims 12-14 and 29-31. Affirmation of this election must be made by applicant in replying to this Office action. Claim 32 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
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 12-14 and 29-31 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.
In regards to claim 12, “coupling an eye having a penetration through the cornea” is vague because it is unclear whether this method step requires coupling the laser system to an eye with a pre-existing penetration through the cornea (i.e., the cornea having a penetration before the eye is coupled to the laser surgery system), or whether the claim merely requires coupling the eye having a penetration to a laser surgery system at any point during the procedure (i.e., forming the penetration while the liquid interface is still coupling the eye to the laser system). In other words, it is unclear whether “coupling” requires “initiating coupling” or also includes “maintaining coupling.” For prior art purposes, the examiner is considering the claim to include either scope, but clarification is respectfully requested.
The remaining claims are rejected by virtue of their dependency.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 12 and 13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Van Saarloos (US 2003/0158543, hereinafter “Van Saarloos”).
In regards to claim 12, Van Saarloos discloses a method for performing laser eye surgery on an eye having a cornea (abstract), the method comprising:
coupling an eye having a penetration through the cornea (Fig. 1. par. 0030; the examiner is considering the creation of the corneal flap to constitute a “penetration through the cornea” in a direction transverse to the optical axis because at least a portion of the cornea is completely penetrated to allow the lifting off of the flap) to a laser surgery system by using a liquid interface disposed between the cornea and the laser surgery system (Fig. 4, pars. 0031 and 0032, element 32); and
forming one or more incisions in the eye by using the laser surgery system to transmit light through the liquid interface (par. 0030, ablating beam).
In regards to claim 13, the method further comprises forming the penetration through the cornea (par. 0030).
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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 12, 13 and 29-31 are rejected under pre-AIA 35 U.S.C. 102 as anticipated by Gooding et al. (US 2012/0078241, hereinafter “Gooding”) or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Gooding in view of Kurtz et al. (US 2010/0324543, hereinafter “Kurtz”).
In regards to claim 12, Gooding discloses a method for performing laser eye surgery on an eye having a cornea (par. 0014), the method comprising:
coupling an eye having a cornea to a laser surgery system by using a liquid interface disposed between the cornea and the laser surgery system (Figs. 5A-5C, par. 0033, element 172); and
forming one or more incisions in the eye by using the laser surgery system to transmit light through the liquid interface (par. 0033, “a broad range of interventional laser cutting, including but not limited to corneal incisions”).
Gooding discloses making plural incisions/perforations of the cornea (par. 0033, “a broad range of interventional laser cutting, including but not limited to corneal incisions such as limbal relaxation cuts, etc.”) while the liquid interface is coupled to the eye. Accordingly, the second and additional incisions are performed on an eye having a penetration through the cornea (the “penetration” being the first incision). Alternatively and additionally, Kurtz in the same field of endeavor of laser eye surgery teaches coupling an eye having a penetration through the cornea (Fig. 6A, element 665, “corneal incision”) to a laser surgery system and forming one more incisions in the eye (Fig. 6A, element 655, “capsular incision”) to provide the predictable results of avoiding creating an opening in the eye in a single integrated process, instead of requiring numerous steps carried out by different devices, and high skill from the surgeon (par. 0105) that increases the optical and/or refractive predictability and functioning of the eye after the intervention (par. 0106).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Gooding by coupling an eye having a penetration through the cornea to a laser surgery system and forming one more incisions in the eye to provide the predictable results of avoiding creating an opening in the eye in a single integrated process, instead of requiring numerous steps carried out by different devices, and high skill from the surgeon that increases the optical and/or refractive predictability and functioning of the eye after the intervention.
In regards to claim 13, Kurtz teaches that the method further comprises forming the penetration through the cornea (Fig. 6A, element 665) to provide the same predictable results as set forth above.
In regards to claim 29, Kurtz teaches that the one or more incisions in the eye include an anterior capsulotomy, a posterior capsulotomy, or one or more lens fragmentation incisions (Fig. 6A, element 655, anterior capsulotomy) to provide the same predictable results as set forth above.
In regards to claim 30, the coupling of the eye to the laser surgery system by using the liquid interface includes: coupling a liquid containment member of the liquid interface to a sclera of the eye away from a limbus of the eye via suction (Fig. 5C, par. 0029, “vacuum suction subsystem and flange may be incorporated into the system and used to stabilize the interfacing between the focusing lens (66), pertinent housing thereof, and the eye (68)”); and providing a liquid in a reservoir formed by a combination of the eye and the liquid containment member (Fig. 5C, element 172), wherein the liquid is exposed to a surrounding ambient pressure (par. 0033, “liquid layer (172) is open to the external environment (i.e., to the atmospheric pressure configuration of the patient examination or operating room)”).
In regards to claim 31, the liquid interface further includes a disposable lens that is offset from the eye, and wherein the liquid is disposed between the disposable lens and the cornea of the eye and the liquid is in contact with both a posterior surface of the disposable lens and an anterior surface of the cornea of the eye (Fig. 5C, element 92, par. 0033; the lens is dimensioned such that it can be thrown away/disposable).
Allowable Subject Matter
Claim 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Reynard (US 2002/0123744) is another example of providing eye incisions in an eye having a cornea with a perforation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL W KAHELIN whose telephone number is (571)272-8688. The examiner can normally be reached M-F, 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792