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
Newly submitted claim 31 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Newly submitted claim 31 is directed to a different species from previously pending claim 24. In particular, instant claim 24 indicates that the first bottom portion is contoured to hold the corneal tissue in place, while newly submitted claim 31 indicates that the first bottom portion is planar. The claims to the different species recite mutually exclusive characteristics of such species pertaining to the shape of the first bottom portion. The Examiner notes that Applicant’s Fig. 1 shows a planar first bottom portion 102a, but Applicant’s Par. [0020] explains that the first bottom portion 102a may be contoured or otherwise shaped, such as in the form of a depression that receives the lenticule. The Applicant therefore describes and has written description support for these two different configurations (i.e., two different species) of shapes of the first bottom portion. However, only the species directed to the contoured first bottom portion was previously presented (Claim 24).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 31 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added 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.
Response to Arguments
Applicant’s arguments, see page 9, filed 09/22/2025, with respect to drawing objections have been fully considered and are persuasive. The drawing objection has been obviated by an amendment to the specification. The objection to the drawings has been withdrawn.
Applicant’s arguments, see page 9, filed 09/22/2025, with respect to specification objections have been fully considered and are persuasive. The objections to the specification have been obviated by amendments to the specification. The objections to the specification have been withdrawn.
Applicant’s arguments, see pages 9-10, filed 09/22/2025, with respect to 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) has been obviated by an amendment to the claims. The 35 U.S.C. 112(b) rejection has been withdrawn.
Applicant’s arguments, see page 10, filed 09/22/2025, with respect to 35 U.S.C. 102 rejections have been fully considered but they are not persuasive. The Applicant argues that Otten fails to anticipate claim 15 at least because Otten fails to teach or suggest adhering corneal tissue to a first bottom portion of a well. The Applicant further argues that in the rejection to claim 25, the Office alleges that Otten teaches adhering corneal tissue to a bottom portion and proceeds to define “adhere”. The Applicant argues that a person of ordinary skill in the art would thus understand that “adhering” a corneal tissue to a first bottom portion requires more than simply placing the corneal tissue on the bottom portion. The Applicant argues that the portion of Otten cited by the Office merely states that “donor cornea 85 is placed in cage 63” (Col. 6, lines 37-47). The Applicant further argues that there is no additional teaching in Otten that a corneal tissue is “held fast” or “stuck” to a bottom portion, or indeed to any surface of a well. The Applicant argues that Otten therefore does not teach or suggest “adhering the corneal tissue to the first bottom portion” recited in claim 15.
This is not found persuasive. It is maintained that Otten does teach claim 15, as amended, and therefore does teach “adhering the corneal tissue to the first bottom portion”. In the Col. 6 (lines 37-47) teaching of Otten, Otten teaches that “In operation, donor cornea 85 is placed in cage 63, with a portion of the convex surface thereof in contact with bevels 83 and the perimeter received within notches 84”. The Examiner contends that this teaching in Otten communicates that the convex surface of the donor cornea 85 is in contact with bevels 83, and the perimeter of the donor cornea 85 is received within the notches 84. Please see Otten’s Figs. 3-4a. The bevels 83 form at least part of the first bottom portion defining a bottom of the well. Since Otten teaches that the convex surface of the corneal tissue 85 is in contact with the bevels, Otten does teach that the corneal tissue is adhered to the first bottom portion. Otten is not only stating that the donor cornea is placed in the cage, as the Applicant alleges. Instead, Otten teaches that the donor cornea is in contact with the bevels 83 which anticipates “adhering the corneal tissue to the first bottom portion”. To further support this interpretation, Otten explains that “As best illustrated in FIG. 4, the free ends of fingers 77 include, inter alia, an inwardly sloping bevel 83 and notch 84 for supporting a donor cornea, such as illustrated at 85” (Col. 6, lines 18-21). Therefore, the 35 U.S.C. 102 rejection of claim 15 over Otten is maintained. Please see 35 U.S.C. 102 and 103 rejections below.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 15, 18-19, 24-25, and 27-29 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Otten (U.S. Patent 6,540,358 – cited on IDS).
Regarding claim 15, Otten teaches a method for processing corneal tissue (Abstract – method for determining if a cornea has been modified (i.e., processing corneal tissue); Col. 2, lines 55-57; Col. 3, lines 15-33), comprising:
(Figs. 3-4A, # 63 – cage, 85 – donor cornea, i.e. corneal tissue) receiving a corneal tissue (Col. 6, lines 37-47 – donor cornea 85 is placed in cage 63);
(Figs. 3-4A, # 61 – body portion, 63 – cage, 67 – bottom surface, 69 – upper skirt portion, 74 – cavity, i.e. well, 75 – conical shaped skirt, 77 – fingers, 79 – ring portion of skirt, 85 – donor cornea – body portion 61, bottom surface 67, upper skirt portion 69, conical shaped skirt 75, ring portion of skirt 79, fingers 77, and cage 63 all make up a first wall) placing the corneal tissue in a well defined by a first wall (Col. 6, lines 7-36), wherein (Figs. 3-4A, # 77 – fingers, i.e., free ends are at least part of first bottom portion, 83 – bevel, i.e. at least part of first bottom portion – please see annotated Fig. 4 below) the first wall includes a first bottom portion that defines a bottom of the well (Col. 6, lines 7-47 – the free ends of fingers 77 include, inter alia, an inwardly sloping bevel 83 and notch 84 for supporting a donor cornea 85. In operation, donor cornea 85 is placed in cage 63, with a portion of the convex surface thereof in contact with bevels 83 and the perimeter received within notches 84.);
(Figs. 3-4A, # 83 – bevels, i.e., at least part of first bottom portion, 85 – donor cornea, i.e. corneal tissue) adhering the corneal tissue to the first bottom portion (Col. 6, lines 37-47 – donor cornea 85 is placed in cage 63, with a portion of the convex surface thereof in contact with bevels 83 and the perimeter received within notches 84. In this position, donor cornea is substantially centered about axis 81; It is noted that this explains that a portion of the convex surface of the donor cornea is in contact (i.e., adhered to) with bevels 83 (i.e., part of first bottom portion));
(Figs. 3-4A, # 74 – well) filling the well with a fluid medium to keep the corneal tissue hydrated in the well (Col. 3, lines 46-47 – cornea is immersed in a suitable storage fluid; Col. 6, line 41 – cavity 74 is then filled with a suitable storage fluid); and
(Figs. 3-4A, # 65 – cap, i.e. second wall) sealing the corneal tissue and the fluid medium in the well by positioning a second wall over the first wall and coupling the second wall to the first wall (Col. 6, lines 7-36 – cap portion 65 includes a skirt portion 93, a shoulder 95 which seats against o-ring seal 73 of body portion 61 (i.e., part of first wall), a top portion 96, and an inner skirt portion 97 having a circumferential lip 99; Col. 6, lines 41-42 – Cavity 74 is then filled with suitable storage fluid and capped by screwing on cap 65), (Figs. 3-4A, # 97 – inner skirt portion, 99 – circumferential lip, 101 – plano lens – inner skirt portion 97, circumferential lip 99, and plano lens 101 form a recess of the second wall 65) the second wall including a recess configured to extend into the well to define a chamber between the first wall and the second wall, the chamber configured to hold the corneal tissue when the well is sealed (Col. 6, lines 7-47 – see Fig. 4A, where the optical cornea container 151 is in the closed position).
PNG
media_image1.png
648
546
media_image1.png
Greyscale
Annotated Fig. 4
Therefore, claim 15 is unpatentable over Otten.
Regarding claim 18, Otten teaches the method of claim 15, further comprising measuring the corneal tissue while the corneal tissue is in the well (Col. 1, lines 9-11 – determine whether or not a cornea has been altered, i.e. measuring; Col. 3, lines 15-33; Col. 4, line 65-Col. 5, line 20 – wavefront sensing, i.e. measuring).
Therefore, claim 18 is unpatentable over Otten.
Regarding claim 19, Otten teaches the method of claim 18, wherein (Fig. 1, # 11 – apparatus, i.e. OCT system, 13 – source of collimated coherent light, 21 – detector) the corneal tissue is measured with an optical coherence tomography (OCT) system, the OCT system being positioned to direct incident light to the corneal tissue in the well and to receive optical scattering from the corneal tissue in response to the incident light, the optical scattering indicating a measurement of the corneal tissue (Col. 4, line 65-Col. 5, line 20; Col. 7, lines 13-15 – container 15 is placed in instrument 11 and in optical beam path 25).
Therefore, claim 19 is unpatentable over Otten.
Regarding claim 24, Otten teaches the method of claim 15, further comprising (Figs. 3-4A, # 63 – cage, 83 – bevel, i.e. contoured part of first bottom portion, 85 – donor cornea) holding the corneal tissue in place by the first bottom portion, and wherein the first bottom portion is contoured to hold the corneal tissue in place (Col. 6, lines 37-47 – donor cornea 85 is placed in cage 63, with a portion of the convex surface thereof in contact with bevels 83 (i.e., contoured part of first bottom portion) and the perimeter received by notches 84; The convex surface and the perimeter refer to the convex surface and perimeter of the donor cornea 85. The convex surface of the donor cornea is in contact with bevels 83 (i.e., contoured part of first bottom portion) to hold the corneal tissue in place).
Therefore, claim 24 is unpatentable over Otten.
Regarding claim 25, Otten teaches the method of claim 24, wherein (Figs. 3-4A, # 63 – cage, 83 – bevel, i.e. contoured part of first bottom portion, 85 – donor cornea) holding, by the first bottom portion, the corneal tissue in place comprises adhering the corneal tissue to the first bottom portion (Col. 6, lines 37-47 – donor cornea 85 is placed in cage 63, with a portion of the convex surface thereof in contact with bevels 83 and the perimeter received within notches 84. In this position, donor cornea is substantially centered about axis 81; It is noted that this explains that a portion of the convex surface of the donor cornea is in contact (i.e., adhered to) with bevels 83 (i.e., part of first bottom portion) in order to hold the corneal tissue in place).
Therefore, claim 25 is unpatentable over Otten.
Regarding claim 27, Otten teaches the method of claim 24, wherein (Figs. 3-4A, # 99 – lip, 101 – plano/plano lens, 103 – bottom parallel surface of plano/plano lens 101 – lip 99, plano/plano lens 101, and bottom parallel surface 103 together form a second bottom portion that defines a bottom of the recess) the second wall includes a second bottom portion that defines a bottom of the recess (Col. 6, lines 7-47 – secured to lip 99 is a second plano/plano lens 101 having plano parallel surface 103), wherein the corneal tissue is positioned between the first bottom portion and the second bottom portion when the second wall seals the well (Col. 6, lines 7-47 – the corneal tissue 85 is positioned between the first bottom portion of the cage 63 and the combined surface of the lip 99, the plano/plano lens 101, and the bottom parallel surface 103 (i.e., second bottom portion)).
Therefore, claim 27 is unpatentable over Otten.
Regarding claim 28, Otten teaches the method of claim 27, wherein (Figs. 3-4A, # 99 – lip, i.e. contoured portion of the second bottom portion) the second bottom portion is contoured to hold the corneal tissue in place (Col. 6, lines 7-36).
Therefore, claim 28 is unpatentable over Otten.
Regarding claim 29, Otten teaches the method of claim 15, wherein (Figs. 3-4A, # 69 – upper skirt portion of first wall, i.e. first top portion) the first wall includes a first top portion that defines a first periphery at a top of the well, (Figs. 3-4A, # 65, 93, and 97 – skirt portion 93 and inner skirt portion of cap portion 65, i.e. second top portion) the second wall includes a second top portion that defines a second periphery at a top of the recess, and the second wall seals the well when the second top portion is coupled to the first top portion (Col. 6, lines 7-37 – Cap portion 65 includes a skirt portion 93 which seats against o-ring seal 73 of upper skirt portion 69 of first wall).
Therefore, claim 29 is unpatentable over Otten.
Claim Rejections - 35 USC § 103
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.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Otten (U.S. Patent 6,540,358 – cited on IDS) in view of Gain, et al. (U.S. PGPub No. 2016/0029618).
Regarding claim 16, Otten teaches the method of claim 15, as indicated hereinabove. Otten does not explicitly teach the limitation of instant claim 16, that is wherein the method is further comprising shaping the corneal tissue with a laser while the corneal tissue is in the well.
Gain is directed to analogous art and teaches a medical device intended for the long-term storage of a cornea, or for ex vivo experimentation on a human or animal cornea (Title, Abstract). Gain expresses that a problem in the art is that none of the previous art devices allows for flattening of the cornea to allow laser cutting of the corneal tissue or facilitating the observation of endothelial cells on a flat surface (Par. [0010]). Gain teaches (Fig. 1, # 4 and 5) that the two transparent faces of the endothelial lid and the epithelial lid allow for an obstacle-free passage of light through the cornea without having to open the bioreactor (Par. [0036]). Gain teaches that the light could be a laser beam for analysis (e.g., optical coherence tomography imaging), cell therapy, or tissue therapy (the laser cutting the cornea) (Par. [0036] and Par. [0063]).
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 implemented Gain’s teaching of using a container for holding a corneal tissue for laser cutting treatment (i.e., tissue therapy) of the cornea into Otten’s method for processing corneal tissue, because doing so would be an example of using a known technique to improve similar methods in the same way. One of ordinary skill in the art would recognize that Otten teaches a method of conducting wavefront analysis of a corneal tissue by directing and sensing light reflected by the corneal tissue, and so one of ordinary skill in the art would find it obvious that Otten’s method could be improved to be used for laser cutting, which is a known technique as evidenced by Gain. One of ordinary skill in the art would have been motivated to implement such a capability in Otten’s method in order to eliminate the need to extract corneal tissue from long-term storage devices to specific supports for laser cutting (see Par. [0010] of Gain).
Therefore, claim 16 is unpatentable over Otten and Gain, et al.
Claims 17, 26, 30, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Otten (U.S. Patent 6,540,358 – cited on IDS) in view of Ruzza, et al. (U.S. PGPub No. 2013/0130222).
Regarding claim 17, Otten teaches the method of claim 15, as indicated hereinabove. Otten does not explicitly teach the limitation of instant claim 17, that is wherein the method is further comprising sterilizing the corneal tissue while the corneal tissue is in the well.
Ruzza, directed to analogous art, teaches a device and a kit for the shipment and the preservation of corneal lenticules ready for use in a lamellar keratoplasty surgery (Abstract). Ruzza teaches (Figs. 1-2, # 1, 2, 10) that the device comprises a first open portion 2, apt to receive and contain the lenticule, and a fenestrated lid 10, apt to close said first portion 2 (Par. [0048-0049]). Ruzza teaches that the sterilizable solution for the preservation of biological material contained in the kit is, e.g., a solution used for the preservation of cell tissues, for instance solutions for in-culture maintaining of cells of human origin (Par. [0067]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the suitable storage fluid used in Otten for positioning the corneal tissue in (see Col. 3, lines 45-48 of Otten) would be a sterilizing fluid for sterilizing the corneal tissue, as is evidenced in Ruzza.
Therefore, claim 17 is unpatentable over Otten and Ruzza, et al.
Regarding claim 26, Otten teaches the method of claim 24, as indicated hereinabove. Otten also teaches the limitation of instant claim 26, that is wherein (Figs. 3-4A, # 63 – cage, which includes contoured first bottom portion, 85 – donor cornea) the first bottom portion is configured to allow the corneal tissue to be situated along the first bottom portion without folding or rolling (Col. 6, lines 37-47 – donor cornea 85 is placed in cage 63, with a portion of convex surface thereof in contact with bevels 83 and the perimeter received within notches 84 – donor cornea is not shown to be folding or rolling). Otten does not explicitly teach the limitation of instant claim 26, that is wherein the corneal tissue has a diameter of up to approximately 10 millimeters.
Ruzza, directed to analogous art, teaches a device and a kit for the shipment and the preservation of corneal lenticules ready for use in a lamellar keratoplasty surgery (Abstract). Ruzza teaches that the desired diameter of the lenticules is around 8-9 mm (Par. [0036] and [0038]). Ruzza teaches (Figs. 1-2, # 1, 2, 10) that the device comprises a first open portion 2, apt to receive and contain the lenticule, and a fenestrated lid 10, apt to close said first portion 2 (Par. [0048-0049]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the diameter of the corneal tissue to be processed would be known to be up to 10 mm, as is evidenced by Ruzza’s analogous method/device for storage/transportation of corneal tissue. It is also noted that Otten teaches a maximum collimated beam size of a 12 mm diameter for wavefront sensing (see Col. 7, lines 33-41 of Otten), and would also therefore find it obvious that the corneal tissue would have a diameter of about 10 mm. One of ordinary skill in the art would find it obvious that the maximum collimated beam size would be larger than the corneal tissue in order to distribute the light across the entire corneal tissue, including edges, which would therefore make the corneal tissue’s diameter around 10 mm.
Therefore, claim 26 is unpatentable over Otten and Ruzza, et al.
Regarding claim 30, Otten teaches the method of claim 1, as indicated hereinabove. Otten does not explicitly teach the limitation of instant claim 30, that is wherein the corneal tissue comprises a lenticule.
Ruzza, directed to analogous art, teaches a device and a kit for the shipment and the preservation of corneal lenticules ready for use in a lamellar keratoplasty surgery (Abstract). Ruzza teaches wherein the corneal tissue comprises a lenticule (Abstract – shipping and prearranging lenticules; Par. [0001]; Par. [0002] – more conservative treatment to corneal transplant is posterior lamellar keratoplasty where the posterior part of the diseased cornea is replaced with a thin lenticule formed by a healthy endothelium, its Descemet’s membrane and a thin layer of stroma which makes the preparation firmer and therefore easier to handle. The recipient cornea preserves the epithelium and the stroma (the healthy anterior part) preventing gaps in its general architecture. Thus, the chances of complications (infections, graft rejection) are reduced.)
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 implemented Ruzza’s feature of the corneal tissue comprising a lenticule into Otten’s method for processing corneal tissue because it can be desirable to prepare for a lamellar keratoplasty (using lenticules) instead of a full corneal transplant, as evidenced by Ruzza. For instance, Ruzza explains that a more conservative treatment to a corneal transplant is posterior lamellar keratoplasty, where the posterior part of the diseased cornea is replaced with a thin lenticule formed by a healthy endothelium, its Descemet’s membrane and a thin layer of stroma (Par. [0002]). One of ordinary skill in the art would desire processing lenticules because doing so would make the preparation firmer and easier to handle, along with lowering the risk of complications such as infections and graft rejections (Par. [0002] of Ruzza).
Therefore, claim 30 is unpatentable over Otten and Ruzza, et al.
Regarding claim 33, Otten teaches the method of claim 1, as indicated hereinabove. Otten does not explicitly teach the limitation of instant claim 33, that is wherein the first bottom portion is formed from glass.
Ruzza, directed to analogous art, teaches a device and a kit for the shipment and the preservation of corneal lenticules ready for use in a lamellar keratoplasty surgery (Abstract). Ruzza teaches wherein the first bottom portion is formed of glass (Par. [0047] – the device is therefore disposable and consisting in any one sterilizable material so as to be suitably sterilized before use; Par. [0062] – Suitable containers are, e.g., containers made of glass, plastics, or any other sterilizable material, provided they are of dimensions such as to be able to contain the device; Ruzza evidences that glass is considered a sterilizable material, and therefore may be used for the device 1 for the preservation and the shipment of an isolated corneal lenticule (see also Par. [0009] of Ruzza)).
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 implemented Ruzza’s teaching that the device is formed of a sterilizable material (e.g., glass, as evidenced by Ruzza) into Otten’s first bottom portion that adheres to the corneal tissue, because doing so would be an example of using a known technique to improve similar methods in the same way. One of ordinary skill in the art would recognize that using sterilizable materials (such as glass) would be desirable for improving sanitation in processing corneal tissue and to reduce risks of infections (see Par. [0002] of Ruzza).
Therefore, claim 33 is unpatentable over Otten and Ruzza, et al.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Otten (U.S. Patent 6,540,358 – cited on IDS) in view of Jay, et al. (NPL – “Characterization of Tissue-Engineered Posterior Corneas Using Second- and Third-Harmonic Generation Microscopy – please see attached).
Regarding claim 20, Otten teaches the method of claim 18, as indicated hereinabove. Otten does not explicitly teach the limitation of instant claim 20, that is wherein the corneal tissue is measured with a second-harmonic generation (SHG) or third-harmonic generation (THG) microscopy system, the SHG or THG microscopy system including:
a light source positioned to direct incident light to the corneal tissue; and
a detector positioned to receive a respective 2nd or 3rd harmonic light respectively from the corneal tissue in response to the incident light, the respective 2nd or 3rd harmonic light indicating a measurement of the corneal tissue,
wherein the light source and the detector are positioned on opposite sides of the first wall and the first wall is transmissive to allow the detector to receive the respective 2nd or 3rd harmonic light.
Jay teaches that second- and third-harmonic generation imaging are well known to provide high-contract, high spatial resolution images engineered corneal tissue, by taking advantage of the endogenous contrast agents of the tissue itself (Abstract). Jay demonstrates that second- and third-harmonic imaging can non-invasively provide important information regarding the quality and the integrity of posterior corneal substitutes (Abstract). Jay explains that SHG and THG microscopy are two techniques of nonlinear optical microscopy that allow imaging of thick, un-fixed, and unstained living tissues (Page 2). Jay teaches that the combination of SHG and THG imaging proved to be an efficient tool for the noninvasive imaging of tissue-engineered posterior corneas (Conclusion).
It is noted that Otten does teach (Fig. 1, # 11) an apparatus for determining whether an in vitro cornea has been modified (either surgically or otherwise) (Col. 4, lines 65-67). Otten teaches (Fig. 1, # 11, 13, 15, 17, 19, 21) that the apparatus includes a source of collimated coherent light 13, a cornea container 15, a distorted diffraction grating 17, a high quality imaging lens (or lens set) 19, and a detector 21 (either film or electronic) having a detector plane 23 (Col. 4, line 65-Col. 5, line 4).
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 implemented well-known second- and third-harmonic generation imaging, as evidenced by Jay, into Otten’s method as doing so would be an example of applying a known technique to a known method ready for improvement to yield predictable results. Otten already teaches the ability for wavefront sensing by teaching an apparatus including a light source and a detector (see Fig. 1 and Col. 4, line 65-Col. 5, line 4 of Otten), and therefore one of ordinary skill in the art would have been motivated to apply well-known techniques of SHG and THG for imaging/processing corneal tissue.
Therefore, claim 20 is unpatentable over Otten and Jay, et al.
Regarding claim 21, Otten, in view of Jay, renders obvious the method of claim 20, as indicated hereinabove. Otten also teaches the limitation of instant claim 21, that is wherein (Figs. 3-4A, # 99 – lip, 101 – plano/plano lens, 103 – bottom parallel surface of plano/plano lens 101 – lip 99, plano/plano lens 101, and bottom parallel surface 103 together form a second bottom portion that defines a bottom of the recess) the second wall includes a second bottom portion that defines a bottom of the recess (Col. 6, lines 7-47 – secured to lip 99 is a second plano/plano lens 101 having plano parallel surface 103), wherein the corneal tissue is positioned between the first bottom portion and the second bottom portion when the second wall seals the well (Col. 6, lines 7-47 – the corneal tissue 85 is positioned between the first bottom portion of the cage 63 and the combined surface of the lip 99, the plano/plano lens 101, and the bottom parallel surface 103 (i.e., second bottom portion)).
Therefore, claim 21 is unpatentable over Otten and Jay, et al.
Claims 23 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Otten (U.S. Patent 6,540,358 – cited on IDS) and Jay, et al. (NPL – “Characterization of Tissue-Engineered Posterior Corneas Using Second- and Third-Harmonic Generation Microscopy – please see attached), further in view of Ruzza, et al. (U.S. PGPub No. 2013/0130222).
Regarding claim 23, Otten, in view of Jay, renders obvious the method of claim 21, as indicated hereinabove. Otten does not explicitly teach the limitation of instant claim 23, that is wherein a distance between the first bottom portion and the second bottom portion allows the corneal tissue with a thickness between approximately 10 µm and approximately 50 µm to be received.
Ruzza, directed to analogous art, teaches a device and a kit for the shipment and the preservation of corneal lenticules ready for use in a lamellar keratoplasty surgery (Abstract). Ruzza teaches that the desired diameter of the lenticules is around 8-9 mm (Par. [0036] and [0038]). Ruzza also teaches a physiological thickness of the cornea as 0.15 mm (150 µm) or 0.5 mm (500 µm) (Par. [0038] and [0042]). Ruzza teaches (Figs. 1-2, # 1, 2, 10) that the device comprises a first open portion 2, apt to receive and contain the lenticule, and a fenestrated lid 10, apt to close said first portion 2 (Par. [0048-0049]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that Otten’s device would allow for a corneal tissue with a thickness between approximately 10 µm and approximately 50 µm to be received, as Ruzza evidences that corneal tissues are known to have a thicknesses of 150 µm and 500 µm. Otten does not clarify a thickness of corneal tissue, but would necessarily be large enough to receive a corneal tissue with a thickness between 10 µm and 50 µm if corneal tissues were known to have even larger thicknesses, as evidenced by Ruzza.
Therefore, claim 23 is unpatentable over Otten, Jay, et al., and Ruzza, et al.
Regarding claim 32, Otten, in view of Jay, renders obvious the method of claim 21, as indicated hereinabove. Otten does not explicitly teach the limitation of instant claim 32, that is wherein the corneal tissue comprises a lenticule. While Otten doesn’t explicitly teach that the corneal tissue comprises a lenticule, Otten does teach wherein (Figs. 3-4A, # 77 – fingers, i.e., free ends are at least part of first bottom portion, 83 – bevel, i.e. at least part of first bottom portion; Figs. 3-4A, # 99 – lip, 101 – plano/plano lens, 103 – bottom parallel surface of plano/plano lens 101 – lip 99, plano/plano lens 101, and bottom parallel surface 103 together form a second bottom portion that defines a bottom of the recess) a distance between the first bottom portion and the second bottom portion is configured to hold a lenticule in place (Col. 6, lines 7-47 – the corneal tissue 85 is positioned between the first bottom portion of the cage 63 and the combined surface of the lip 99, the plano/plano lens 101, and the bottom parallel surface 103 (i.e., second bottom portion); therefore, a distance between the first bottom portion and the second bottom portion is configured to hold a lenticule in place (a lenticule is a smaller piece of a full cornea tissue, so the distance is necessarily large enough to hold a lenticule in place)).
Ruzza, directed to analogous art, teaches a device and a kit for the shipment and the preservation of corneal lenticules ready for use in a lamellar keratoplasty surgery (Abstract). Ruzza teaches wherein the corneal tissue comprises a lenticule (Abstract – shipping and prearranging lenticules; Par. [0001]; Par. [0002] – more conservative treatment to corneal transplant is posterior lamellar keratoplasty where the posterior part of the diseased cornea is replaced with a thin lenticule formed by a healthy endothelium, its Descemet’s membrane and a thin layer of stroma which makes the preparation firmer and therefore easier to handle. The recipient cornea preserves the epithelium and the stroma (the healthy anterior part) preventing gaps in its general architecture. Thus, the chances of complications (infections, graft rejection) are reduced.)
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 implemented Ruzza’s feature of the corneal tissue comprising a lenticule into Otten’s method for processing corneal tissue because it can be desirable to prepare for a lamellar keratoplasty (using lenticules) instead of a full corneal transplant, as evidenced by Ruzza. For instance, Ruzza explains that a more conservative treatment to a corneal transplant is posterior lamellar keratoplasty, where the posterior part of the diseased cornea is replaced with a thin lenticule formed by a healthy endothelium, its Descemet’s membrane and a thin layer of stroma (Par. [0002]). One of ordinary skill in the art would desire processing lenticules because doing so would make the preparation firmer and easier to handle, along with lowering the risk of complications such as infections and graft rejections (Par. [0002] of Ruzza).
Therefore, claim 32 is unpatentable over Otten, Jay, et al., and Ruzza, et al.
Allowable Subject Matter
Claim 22 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.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record (namely Otten and Ruzza, et al.) does not disclose or fairly suggest either singly or in combination the claimed invention of dependent claim 22 when taken as a whole, comprising, in addition to the other recited claim elements, wherein a distance between the first bottom portion and the second bottom portion for receiving the corneal tissue is approximately 100 µm. No other prior art reference could be found that teaches or renders obvious the limitations of instant claim 22.
Therefore, in view of the prior art and its deficiencies, the claimed invention as a whole is rendered novel and non-obvious, and thus, is allowable as claimed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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, Jennifer McDonald can be reached at (571) 270-3061. 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 T. HOLTZCLAW/Examiner, Art Unit 3796