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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group I (claims 1-18 and 22-26) in the reply filed on 07/28/2025 is acknowledged.
Claims 19-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/28/2025.
The invention of Group I further includes claims directed to the following patentably Species:
Species A₁ (directed to a method of implanting lamellar corneal graph onto an eye, wherein the lamellar corneal graft is in the form of an autologous corneal graft, and wherein the cut portion of the cornea that is removed from the eye of the patient forms the autologous corneal graft).
Species A₂ (directed to a method of implanting lamellar corneal graph onto an eye, wherein the lamellar corneal graft is in the form of homologous corneal graft, and wherein a donor corneal portion that is removed from an eye bank cornea forms the homologous corneal graft).
Species B₁ (directed to a method of implanting lamellar corneal graph onto an eye, wherein the lamellar corneal graft implantation is performed on a human patient, and the lamellar corneal graft implanted into the human patient is formed from a human cornea.
Species B2 (directed to a method of implanting lamellar corneal graph onto an eye, wherein the lamellar corneal graft implantation is performed on an animal, and the lamellar corneal graft implanted into the animal is formed from an animal cornea.
Species C1 (directed to a method of implanting lamellar corneal graph onto an eye, wherein the lamellar corneal graft implantation is performed on an animal, and the lamellar corneal graft implanted into the animal is formed from a human cornea.
Species C2 (directed to a method of implanting lamellar corneal graph onto an eye, wherein the lamellar corneal graft implantation is performed on a human patient, and the lamellar corneal graft implanted into the human patient is formed from an animal cornea.
Species D1 (directed to a method of implanting lamellar corneal graph onto an eye, wherein the lamellar corneal graft implantation is performed on a human patient, the lamellar corneal graft is decellularized and crosslinked, and the lamellar corneal graft implanted into the human patient is formed from an animal cornea.
Species D2 (directed to a method of implanting lamellar corneal graph onto an eye, wherein the lamellar corneal graft implantation is performed on an animal, the lamellar corneal graft is decellularized and crosslinked, and the lamellar corneal graft implanted into the animal is formed from a human cornea.
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.
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 use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: chemical means to prevent in claim 11.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,396,889 (hereinafter “US Patent 889”). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to analogous methods of lamellar corneal graft implantations.
Regarding claim 1 of the instant application, claim 1 of the US Patent 889 is directed to a method of lamellar corneal graft implantation, said method comprising the steps of:
forming a corneal flap or one or more intrastromal incisions/cuts in a cornea of an eye of a patient (forming one or more intrastromal incisions/cuts in a cornea of an eye of a patient);
pivoting the corneal flap or removing a cut portion of the cornea defined by the one or more intrastromal incisions from the eye of the patient (removing a cut portion of the cornea defined by the one or more intrastromal incisions/cuts from the eye of the patient so as to form a pocket in the cornea, the pocket being bounded on all sides by corneal tissue of the cornea); forming one or more corneal access incisions in the cornea of the eye of the patient, the pocket being accessible through the one or more corneal access incisions in the cornea;
applying laser energy to a lamellar corneal graft using an excimer laser or a femtosecond laser so as to modify the refractive power of the lamellar corneal graft, the lamellar corneal graft being in the form of an autologous corneal graft, a homologous corneal graft, or an exogenous corneal graft (applying laser energy to a lamellar corneal graft using an excimer laser so as to modify the refractive power of the lamellar corneal graft, the lamellar corneal graft being in the form of a autologous corneal graft or a homologous corneal graft); and;
implanting the lamellar corneal graft into the eye of the patient under the corneal flap or in a location previously occupied by the cut portion of the cornea so as to correct the refractive power of the eye of the patient (implanting the lamellar corneal graft into the pocket in the cornea of the eye of the patient in a location previously occupied by the cut portion of the cornea so as to correct the refractive power of the eye of the patient).
Regarding claim 2 of the instant application, claim 3 of the US Patent 889 teaches (The method according to claim 1, wherein the lamellar corneal graft is in the form of an autologous corneal graft, and wherein the cut portion of the cornea that is removed from the eye of the patient forms the autologous corneal graft).
Regarding claim 3 of the instant application, claim 4 of the US Patent 889 teaches (The method according to claim 1, wherein the lamellar corneal graft is in the form of an homologous corneal graft, and wherein a donor corneal portion that is removed from an eye bank cornea forms the homologous corneal graft).
Regarding claim 4 of the instant application, claim 5 of the US Patent 889 teaches (The method according to claim 4, wherein, prior to implantation of the homologous corneal graft or after implantation of the homologous corneal graft, the method further comprises the steps of: treating the homologous corneal graft with a solution of riboflavin or benzalkonium chloride (BAK) for making the homologous corneal graft acellular, and for killing any bacteria, viruses, or parasites prior to implantation; and irradiating the homologous corneal graft so as to cross-link the homologous corneal graft, thereby killing keratocytes and decellularizing the homologous corneal graft and preventing graft rejection without affecting the transparency of the homologous corneal graft.
Regarding claim 5 of the instant application, claim 13 of the US Patent 889 teaches (The method according to claim 1, wherein the lamellar corneal graft implantation is performed on a human patient, and the lamellar corneal graft implanted into the human patient is formed from a human cornea).
Regarding claim 6 of the instant application, claim 14 of the US Patent 889 teaches (The method according to claim 1, wherein the lamellar corneal graft implantation is performed on an animal, and the lamellar corneal graft implanted into the animal is formed from an animal cornea).
Regarding claim 7 of the application, claim 16 of the Patent 889 teaches (The method according to claim 1, wherein the lamellar corneal graft implantation is performed on an animal, and the lamellar corneal graft implanted into the animal is formed from a human cornea).
Regarding claim 8 of the application, claim 17 of the Patent teaches (The method according to claim 1, wherein the lamellar corneal graft implantation is performed on a human patient, the lamellar corneal graft is decellularized and crosslinked, and the lamellar corneal graft implanted into the human patient is formed from an animal cornea).
Regarding claim 9 of the application, claim 18 of the patent teaches (The method according to claim 1, wherein the lamellar corneal graft implantation is performed on a human patient, the lamellar corneal graft is decellularized and crosslinked, and the lamellar corneal graft implanted into the human patient is formed from an animal cornea).
Regarding claim 10 of the application, claim 19 of the patent teaches (The method according to claim 1, wherein the lamellar corneal graft implantation is performed on an animal, the lamellar corneal graft is decellularized and crosslinked, and the lamellar corneal graft implanted into the animal is formed from a human cornea).
Regarding claim 11 of the application, claim 20 of the patent teaches (The method according to claim 19, wherein the lamellar corneal graft is decellularized using chemical means, the chemical means for destroying the cellular elements in the lamellar corneal graft are selected from the group consisting of cthanol, glycerol, acids, alkalis, peracetic acid, ammonium hydroxide ionic detergents, sodium dodecyl sulfate, sodium deoxycholate non-ionic detergents, zwitterionic detergents, Triton X-100, benzalkonium chloride, Igepal, genipin, and combinations thereof).
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over White, U.S. Patent Nol. 5,269,812, in view of Schuele et al., U.S. Patent No. 9,833,358 (hereinafter “Schuele”).
Regarding claims 1, White discloses a method of lamellar corneal graft implantation, the method comprising: one or more intrastromal incisions/cuts in a cornea of an eye of a patient (abstract, Fig. 4, col. 1, lines 51-56); removing a cut portion of the cornea defined by the one or more intrastromal incisions from the eye of the patient (Fig. 3, col. 2, lines 52-54, Col. 4, lines 14-21, and col. 12 lines 65 through col. 13 line 6); and implanting the lamellar corneal graft into the eye of the patient in a location previously occupied by the cut portion of the cornea to correct the refractive power of the eye of the patient, wherein the lamellar corneal graft is in the from homologous corneal graft (col. 1, lines 64-69 and col. 2 line 66 though col. 3).
White does not teach a step of applying laser energy to the corneal graft using an excimer or femtosecond laser (col. 2 lines 35to modify the refractive power of the graft as claimed. Schuele discloses a system and method for making physical modification to target ocular tissue, including corneal transplant teaches a method of applying laser light to create one or more physical modification on the corneal tissue (col. 4 lines 14-27 and col. 7, lines 5-9 ). He further teaches that ArF excimer lasers are routinely used for corneal modification (col. 8 lines 34-35). Therefore, it would have been obvious the time applicant’s invention to one having an ordinary skill in the art to use an excimer laser to modify the size and/or the shape of the corneal graft to precisely place the corneal transplant into the formed intrastromal cut as presently claimed.
Allowable Subject Matter
Claims 12-18and 22-26 are allowed. The following is a statement of reasons for the indication of allowable subject matter: the prior art of record, alone or in combination, does not disclose, imply or anticipate a control system for a laser surgery device, the system comprising the combination of the method steps and features recited in claims 12, 13, 17, 18, and 22 in its entirety, or provide a properly motivated combination to make obvious the presently claimed invention.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AHMED M FARAH whose telephone number is (571)272-4765. The examiner can normally be reached Mon - Fri. 9:30AM -10:30 PM.
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/AHMED M FARAH/Primary Examiner, Art Unit 3792