DETAILED ACTION
Notice of AIA Status
The present application, filed on 11/11/22, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Under 37 C.F.R. 1.75 (f) “If there are several claims, they shall be numbered consecutively in Arabic numerals”. As a result, misnumbered claim 17 is hereby renumbered claim 13.
Claims 1-12 and claim 13 (misnumbered 17 in the 11/11/22 listing of claims) are pending.
Claims 1-12 and claim 13 (misnumbered 17 in the 11/11/22 listing of claims) are rejected.
Claims 1-12 and claim 13 (misnumbered 17 in the 11/11/22 listing of claims) are objected to.
Claim Objections
Claims 1-12 and claim 13 (misnumbered 17 in the 11/11/22 listing of claims) are objected to because of the following informalities:
Claim 1 recites “a corneal graft, comprising:”. For the sake of clarity, consider rephrasing to ‘a corneal graft, the device comprising:’.
Claim 5 recites “each of the LED”. For the sake of uniformity in terminology, consider rephrasing to ‘each light emitting diode of the one or more light emitting diodes’.
Claim 8 recites the bowl is at least one of molded, transparent, translucent, colored, or watertight”. For the sake of clarity, consider rephrasing to ‘the bowl is molded, transparent, translucent, colored, or watertight’ or to ‘the bowl is at least one of molded, transparent, translucent, colored and watertight’ or something similar.
Claim 11 recites “the illumination base”. For the sake of uniformity in terminology consider rephrasing to ‘the illuminated base’.
Claim 12 recites “the integral sterile drape is a rigid or semi rigid structure formed to conform to the shape of the illumination base”. For the sake of clarity, consider rephrasing to ‘the illuminated base has a shape and the integral sterile drape is a rigid structure or a semi rigid structure and is formed to conform to the shape”.
Claim 13 recites “wherein corneal graft holder”. For the sake of clarity, consider rephrasing to “wherein the corneal graft holder’.
Claims dependent on an objected claim are objected to because any claim in dependent form is construed to incorporate by reference all the limitations of the claim to which it refers.
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.
Claims 2, 5 and claim 13 (misnumbered 17 in the 11/11/22 listing of claims) are rejected under 35 U.S.C. 112(b) for being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 2 recites “the edges”. There isn’t sufficient antecedent basis for the limitation in the claim. Consider rephrasing to ‘edges’.
Claim 5 recites “the other LEDs”. There isn’t sufficient antecedent basis for the limitation in the claim. In addition, it isn’t clear whether the other LEDs correspond to the one or more light emitting diodes introduced in claim 4 or something else.
Claim 13 (misnumbered claim 17 in the 11/11/22 listing of claims) recites “a method comprising: providing a graft preparation device comprising an illuminated base and a corneal graft holder, wherein corneal graft holder is arranged to receive a donor cornea and the illuminated base is arranged to illuminate the donor cornea”. The metes and bounds of claim 13 (misnumbered 17 in the 11/11/22 listing of claims) are indefinite because the process doesn’t recite any active, positive steps delimiting how the method is practiced, here the “providing” encompasses mere possession of the device and isn’t an active, positive step delimiting how the method is practiced (see MPEP §2173.05(q), which recites “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) …. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986)”. In ex parte Erlich, even though using monoclonal antibodies inherently includes providing monoclonal antibodies to isolate and purify human fibroblast interferon, the mere possession of the monoclonal antibodies isn’t an active, positive step. Similarly, in the instant method claim 13 (misnumbered 17 in the 11/11/22 listing of claims) the mere possession of the graft preparation device isn’t an active, positive step and claim 13 (misnumbered 17 in the 11/11/22 listing of claims) is indefinite for falling to set forth any, active, positive steps involved in the process.
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 1-6 and claim 13 (misnumbered 17 in the 11/11/22 listing of claims) are rejected under 35 U.S.C. §102(a)(1) as being anticipated by Lipari (US20160183787).
As to claim 1, Lipari teaches a device (apparatus 1 in [0028]) that facilitates preparation of a corneal graft (the device of Lipari is capable of facilitating preparation of a corneal graft, the device), comprising:
an illuminated base (illumination device 3 in [0028]); and
a corneal graft holder (observation seat 12 in [0029]) that can be selectively coupled to the illuminated base to illuminate a portion of a donor cornea to facilitate preparation of the corneal graft (the corneal graft holder of Lipari is capable of being selectively coupled to the illuminated base to illuminate a portion of a donor cornea to facilitate preparation of the corneal graft).
As to claim 2, Lipari teaches the device of claim 1, wherein the illuminated base (illumination device 3) is arranged to illuminate the corneal graft to highlight the edges of the corneal graft and a Descemet's membrane (the illuminated base of Lipari is capable of illuminating the corneal graft to highlight the edges of the corneal graft and a Descemet's membrane).
As to claim 3, Lipari teaches the device of claim 1, wherein the illuminated base (illumination device 3) illuminates the corneal graft from around and below the corneal graft (the illuminated base of Lipari is capable of illuminating the corneal graft from around and below the corneal graft).
As to claim 4, Lipari teaches the device of claim 1, wherein the illuminated base (illumination device 3) comprises one or more light emitting diodes (LEDs) (see [0031], which recites “the illumination device 3 comprises an annular light source 13 … the light source 13 is of the LED type”).
As to claim 5, Lipari teaches the device of claim 4, wherein each of the LEDs can be selectively illuminated independently of the other LEDs (the one or more light emitting diode of Lipari is capable of being selectively illuminated independently of the other LEDs) (see [0032], which recites “the light source 13 is of the LED type and is driven by the control unit 8 through a regulation signal SR”).
As to claim 6, Lipari teaches the device of claim 4, wherein the illuminated base (illumination device 3) comprises a plurality of LEDs are arranged in a circular shape (see Fig. 3).
As to claim 13 (misnumbered 17 in the 11/11/22 listing of claims), Lipari teaches a method comprising:
providing a graft preparation device (apparatus 1 in [0028]) comprising an illuminated base (illumination device 3) and a corneal graft holder (observation seat 12 in [0029]), wherein corneal graft holder (observation seat 12) is arranged to receive a donor cornea (see claim 1, which recites “the cornea is in an observation seat”) and the illuminated base is arranged to illuminate the donor cornea (see claim 1, which recites “a lighting device configured to direct a first luminous radiation (F1), polarized in an adjustable polarization direction (D1), to a cornea”).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Lipari (US20160183787) in view of Lin (US20050010243).
As to claim 7, Lipari teaches the device of claim 1.
Lipari doesn’t teach a supporting member arranged adjacent to a bowl.
In the analogous art of providing surgical apparatus, Lin teaches a supporting member (support block 4 in [0020]) arranged adjacent to a bowl (removable base plate 6) (see Figs. 1 and 5) (see [0020], which recites “support block 4 has a bore sized and shaped to receive removable base plate 6 and handle 8. See FIG. 2A. Once removable base plate 6 and support block 4 are combined, a support block filler 12 is inserted into the bore, so that removable base plate 6 and support block 4 form a smooth and continuous concave surface … see FIG. 2B. The curvature of the concave surface formed between removable base plate 6 and support block 4 is adapted to approximate that of the anterior surface of donor corneal tissue 34”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Lipari by incorporating the supporting member as disclosed by Lin with a reasonable expectation of success for the benefit of effectively supporting donor corneal tissue (see [0020] of Lin) which is desirable in the field of corneal graft preparation.
As to claim 8, Lipari in view of Lin teaches the device of claim 7, wherein the bowl (removable base plate 6 of Lin) is at least one of molded, transparent, translucent, colored, or watertight (see [0021] of Lin, which recites “removable base plate 6 is transparent”).
Claim 9 rejected under 35 U.S.C. 103 as being unpatentable over Lipari (US20160183787) in view of Tan (WO2011040888).
As to claim 9, Lipari teaches the device of claim 1.
Lipari doesn’t teach an illuminated corneal Descemet's Membrane Endothelial Keratoplasty (DMEK) trephination device.
In the analogous art of providing surgical apparatus, Tan (WO2011040888) teaches an illuminated corneal Descemet's Membrane Endothelial Keratoplasty (DMEK) trephination device (femtosecond laser-assisted … DMEK in page 14)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Lipari by incorporating the illuminated corneal Descemet's Membrane Endothelial Keratoplasty (DMEK) trephination device as disclosed by Tan with a reasonable expectation of success for the benefit of effectively preserving graft geometry which is desirable in the field of corneal graft preparation.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Lipari (US20160183787) in view of Busin (US20110166650).
As to claim 10, Lipari teaches the device of claim 1.
Lipari doesn’t teach that the corneal graft holder is a pre-sterilized disposable structure.
In the analogous art of providing surgical apparatus, Busin (US20110166650) teaches a pre-sterilized disposable corneal graft holder structure (see claim 19, which recites “spatula (1) for a “DMEK” surgery”) (see also claim 20, which recites “the spatula (1) according to claim 19, made of a disposable material”) (see also claim 21, which recites “spatula (1) according to claim 19, made of sterilizable material suitable for surgery”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Lipari by replacing the corneal graft holder with the pre-sterilized disposable corneal graft holder structure as disclosed by Busin such that the corneal graft holder is a pre-sterilized disposable structure with a reasonable expectation of success for the benefit of effectively preventing cross contamination which is desirable in the field of corneal graft preparation.
Claims 11-12 is rejected under 35 U.S.C. 103 as being unpatentable over Lipari (US20160183787) in view of Busin (US20110166650) as applied to claim 10 further in view of Chua (US20150002937).
As to claim 11, Lipari in view of Busin teaches the device of claim 10.
Lipari in view of Busin doesn’t teach that the corneal graft holder incorporates an integral sterile drape that covers the illumination base.
In the analogous art of providing surgical apparatus, Chua (US20150002937) teaches an integral sterile drape (drape body 23 in [0024]) that covers a illumination base (surgical microscope 22 in [0024]) (see also [0006], which recites “the disposable surgical drape is typically manufactured and packaged under sterile conditions so that, when unpackaged and placed on a microscope, the drape creates a sterile field around the microscope and its components”) (see also [0016], which recites “drape assemblies of the present invention may be used on surgical microscopes and various other optical devices, such as medical imaging equipment (e.g., surgical cameras), operating room light fixtures”)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Lipari in view of Busin by incorporating the integral sterile drape as disclosed by Chua such that the corneal graft holder incorporates an integral sterile drape that covers the illumination base with a reasonable expectation of success for the benefit of effectively preventing contamination which is desirable in the field of corneal graft preparation.
As to claim 12, Lipari in view of Busin in view of Chua teaches the device of claim 11, wherein the integral sterile drape is a rigid or semi rigid structure formed to conform to the shape of the illumination base (see [0024], which recites “The size and shape of the drape body 23 is sufficient to cover at least a portion, but preferably all of the surgical microscope 22. The geometry and dimensions of the drape 20 may be varied depending upon factors such as the size and design of the microscope 22 and other practical considerations. It is generally desirable that the drape 20 be provided with the appropriate extensions and necessary openings that cover and/or allow access to the various microscope oculars. The drape 20 may also include optional strips of cloth or plastic (not shown), which allow the drape body 23 to be tightened and secured to the microscope 22. For instance, plastic straps may be adhered or otherwise fixed at one end to an outer-side surface of the drape body 23, and provided with adhesive on the opposite end such that the user can wrap the straps around loose drape material, then secure the loose drape material to the microscope 22”).
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tran (US 20180106704) teaches corneal tissue sample assemblies (see [0054], which recites “it was found that both specular microscopy and slit-lamp examination were possible with prestained preloaded tissues. For prestained grafts, all external surfaces of the scroll can be evaluated by rotating the chamber during slit-lamp evaluations. However, it can be difficult to visualize the endothelium that is on the interior of a tightly scrolled prestained graft as the scroll is less transparent due to staining. In these instances, visualization can be aided by retro-illumination of the scrolled graft by shining a light source (e.g., a pen light) through the graft towards the observer”).
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797