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 Group I (Claims 1, 3, 5-17, and 25) in the reply filed on August 27, 2025 is acknowledged.
Claims 18-22 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 August 27, 2025.
Response to Amendment
Claims 1, 3, 5-22 and 25 are pending in the application. Claims 18-22 are withdrawn. Claims 2, 4, 23, 24, and 26 have been cancelled. Claims 3, 5-17 and 25 have been amended. Claims 1, 3, 5-17 and 25 are rejected.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The information disclosure statements (IDS’s) submitted on August 11, 2022 and March 9, 2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Drawings
Figures 1A, 1B, and 1C should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because Figures 2-5 appear to be photographs and contain impermissible shading rendering the subject matter therein incomprehensible. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 25 objected to because of the following informalities:
Claim 25 recites: “The method according to claim 1 comprising:
- removing corneal epithelial cells from an eye of said subject without removing any corneal tissue or other ocular tissue located posterior to the corneal epithelial cell layer; and
- positioning a composition A composition composed of more than one layer, wherein each layer independently comprises a Bowman layer (BL), on the anterior surface of said corneal tissue located posterior to the corneal epithelial cell layer.” This is believed to be a typographical error.
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.
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 3, 5, 7, 10, 14, and 16 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.
Claim 3 currently recites:
“The method according to claim 1 comprising inducing a tissue remodeling response in the corneal stroma of the subject, wherein said corneal stroma comprises scar tissue associated with or resulting from the anterior corneal disorder, the method comprising:
- removing corneal epithelial cells from an eye of said subject without removing any corneal tissue or other ocular tissue located posterior to the corneal epithelial cell layer; and
- positioning an overlay composed of a Bowman layer (BL) or composed of more than one layer, wherein each layer is composed of a BL, on the anterior surface of said corneal tissue located posterior to the corneal epithelial cell layer.”
The limitations starting with “-removing…” and “-positioning…” are identical to the limitations found in claim 1. It is unclear whether the claim is intending to perform the same steps a second time or if the claim is referring back to the previously recited steps of claim 1. Additionally, it is unclear whether the limitations found between the two recitations of “comprising” are part of the preamble or part of the claim itself. For the purposes of examination, the steps of “-removing…” and “-positioning…” are deemed to be referring back to the same steps recited in claim 1 and the limitations between the two recitations of “comprising” are deemed to be part of the preamble. (See MPEP §2111.02)
Similarly, claim 25 recites the same “-removing..” limitation. It is likewise unclear whether the claim is intending to perform the same steps a second time or if the claim is referring back to the previously recited steps of claim 1. For the purposes of examination, the steps of “-removing…” and “-positioning…” are deemed to be referring back to the same steps recited in claim 1. Applicant is encouraged to amend the dependent claims to remove all previously recited limitations. (See MPEP §608.01(m) and (n))
Claim 3 recites the limitation "in the corneal stroma of the subject” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim since claim 1 does not recite “a corneal stroma”
Claim 5 recites “wherein said corneal tissue located posterior to the corneal epithelial cell layer comprises at least part of a BL and anterior corneal stromal tissue or, where the cornea” it is unclear what would be sufficient to meet this limitation since the recitation is merely the structural layers of the cornea in order found in nature.
Regarding claim 7, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “said overly has an average thickness of 7-600µm”, and the claim also recites “preferably 8-550 µm” and “more preferably 10-500µm” which are two separate narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claims 7, 14, and 16, the phrase "preferably" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "preferably"), thereby rendering the scope of the claim(s) unascertainable. See MPEP §2173.05(d). For the purposes of examination, the words following the term “preferably” are considered to be optional limitations and are not required to be taught by the prior art.
Claim 10 recites the limitation "wherein said one or more donor BLs” in line 2. There is insufficient antecedent basis for this limitation in the claim since claim 1 does not recite the BL is a donor BL. It appears applicant intended claim 10 to depend from claim 9 which recites “donor BLs”. Appropriate action is required.
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.
Claim(s) 1, 5-7, 9-14, 16, and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perez (US Pat. No 6,544,286).
Regarding claim 1, Perez teaches a method for the treatment or alleviation of an anterior corneal disorder (See Col. 3, lines19-20, note astigmatism and myopia are common and known corneal disorders) in a subject in need thereof, the method comprising:
- removing corneal epithelial cells from an eye of said subject without removing any corneal tissue or other ocular tissue located posterior to the corneal epithelial cell layer (See Col. 3, lines 35-37 and Col. 7, lines 55-64); and
- positioning an overlay (300) composed of1 a Bowman layer (BL)2 (See Col. 4, lines 61-65 and Col. 5, lines 53-64) on the anterior surface of said corneal tissue located posterior to the corneal epithelial cell layer (See Col. 4, lines 38-66 and Col. 7, lines 55-65).
Regarding claim 5, Perez teaches the method required by claim 1 as set forth above and further teaches wherein said corneal tissue located posterior to the corneal epithelial cell layer comprises at least part of a BL and anterior corneal stromal tissue or, where the cornea. (See Col. 4, lines 15-30). It is noted that in a normal eye, the Bowman layer is located posterior to the corneal epithelial cell layer and the stromal tissue is directly posterior thereto.
Regarding claim 6, Perez teaches the method required by claim 1 as set forth above and further teaches wherein said overlay is positioned sutureless on said corneal tissue (See Col. 2, lines 62-63; Col. 3, lines 17-19; and Col. 7, lines 60-63).
Regarding claim 7, Perez teaches the method required by claim 1 as set forth above and further teaches said overlay has an average thickness of 7-600 µm, preferably 8-550 µm, more preferably 10-500µm3 and/or has an average diameter of 1-12 mm. (See Col. 5, lines 5-10 which state the thickness of the overlay is “preferably between 5-100µm” and the diameter is “between 10 and 15 mm” These disclosures anticipate the claimed ranges.)
Regarding claim 9, Perez teaches the method required by claim 1 as set forth above and further teaches said overlay consists of one donor BL. (See Col. 4, lines 61-65 and Col. 5, lines 53-64)
Regarding claim 10, Perez teaches the method required by claim 1 as set forth above and further teaches wherein said one or more donor BLs is or are selected from the group consisting of human or animal BL or BLs. (See Col. 2, lines 62-66; Col. 4, lines 61-68; and Col. 5, lines 50-62).
Regarding claim 11, Perez teaches the method required by claim 1 as set forth above and further teaches said treatment or alleviation comprises inducing a wound healing response at the interface between said overlay and the Bowman layer of the subject and/or a tissue remodeling response in the corneal stroma of the subject. (See Fig. 4B; Col. 7, lines 55-64 which states “The lens’ replaced epithelium and the host epithelium eventually grow to form a continuous, water-tight layer.” And the inventive overlay bonds to the recipient cornea without sutures or adhesives.)
Regarding claim 12, Perez teaches the method required by claim 1 as set forth above and further teaches said overlay or said BL is treated with a substance selected from the group consisting of dyes (See Col. 5, lines 45-47), adjuvants that facilitate visualization (See Col. 5, lines 45-47) and active components (See Col. 3, lines 25-27 and Col. 6, lines 10-45).
Regarding claim 13, Perez teaches the method required by claim 1 as set forth above and further teaches wherein said active component is selected from the group consisting of stromal growth factors, epithelial growth factors and any combination thereof. (See Col. 3, lines 25-27; Col. 6, lines 14-44; Col. 7, lines 50-54)
Regarding claim 144, Perez teaches the method required by claim 1 as set forth above and further teaches the cornea of said subject comprises at least part of a BL. Note Perez teaches only removing epithelial tissue from the host cornea, thus the Bowman’s layer will at least partially remain. (See Fig. 4A; Col. 3, lines 35-38; Col. 7, lines 55-63).
Regarding claim 16, Perez teaches the method required by claim 1 as set forth above and further teaches said overlay is stained, preferably with a vital dye, before said overlay is positioned on the anterior surface of said corneal tissue located posterior to the corneal epithelial cell layer. (See Col. 5, lines 45-50)
Regarding claim 17, Perez teaches the method required by claim 1 as set forth above and further teaches said wherein said anterior corneal disorder is selected from the group consisting of a corneal curvature disorder (See Col. 3, lines 19-21, note astigmatism and myopia are known corneal curvature disorders).
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 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perez (US Pat. No 6,544,286) as applied to claim 1 above and further in view of applicant cited Lie, et al. (“Isolated Bowman layer transplantation to manage persistent subepithelial haze after excimer laser surface ablation” Journal of Cataract Refract Surg 2010).
Regarding claim 3, Perez teaches the teaches the method required by claim 1 as set forth above including the steps of - removing corneal epithelial cells from an eye of said subject without removing any corneal tissue or other ocular tissue located posterior to the corneal epithelial cell layer (See Col. 3, lines 35-37 and Col. 7, lines 55-64); and
- positioning an overlay (300) composed of5 a Bowman layer (BL)6 (See Col. 4, lines 61-65 and Col. 5, lines 53-64) on the anterior surface of said corneal tissue located posterior to the corneal epithelial cell layer (See Col. 4, lines 38-66 and Col. 7, lines 55-65)
Perez teaches the method is performed to “correct astigmatism, myopia, aphakia, and presbyopia” but is silent as to performing the method on a patient whose corneal stroma comprises scar tissue so as to induce a tissue remodeling response.
Lie teaches an analogous method of treating a patient by implanting an isolated Bowman layer into the patient’s cornea so as to treat subepithelial scar tissue (See Page 1036, opening paragraph and page 1037 under subheading “Surgical Procedure”.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by Perez to incorporate the teachings of Lie and apply the method to treat a patient with scar tissue in the corneal stroma since to do so is merely applying a known technique (Perez’s Bowman onlay procedure) to improve a similar method (Lie’s treatment of scarred corneal tissue) in the same way. Both Lie and Perez teach methods of treating corneal tissue disorders and it would be obvious to one of ordinary skill in the art to apply Perez’s successful treatment method to patients with additional types of corneal disorders such as scarring.
Claim(s) 8 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perez (US Pat. No 6,544,286).
Regarding claim 8, Perez teaches the method required by claim 1 as set forth above but does not explicitly teach wherein at least 80% of corneal epithelial cells covering the part of the anterior surface of the corneal tissue that will be covered by the overlay is removed from the eye of said subject.
Perez does teach “de-epithelialization” of the anterior surface of the recipient cornea (See Fig. 4A; Col. 3, lines 35-38; Col. 7, lines 55-63). Perez also teaches wherein preparing the anterior of the cornea comprises “removing a substantial portion of any epithelial cells present upon the anterior surface” (See claims 85 and 86).
As disclosed, the percentage of epithelial cells removed is disclosed to be a result effective variable which assists with healing. Further it appears one of ordinary skill in the art would have a reasonable expectation of success in modifying Perez to remove at least 80% of the epithelial cells of the anterior surface of treated corneal tissue, as it only involves adjusting the dimension of a component already disclosed to be adjustable. Furthermore, Perez explicitly teaches “de-epithelialization” of the anterior surface of the recipient cornea. Therefore, 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 percentage of epithelial cells removed as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
Regarding claim 25, Perez teaches the method required by claim 1 as set forth above and further teaches - removing corneal epithelial cells from an eye of said subject without removing any corneal tissue or other ocular tissue located posterior to the corneal epithelial cell layer (See Col. 3, lines 35-37 and Col. 7, lines 55-64); and
- positioning a composition (overlay) (300) composed of7 a Bowman layer (BL)8 (See Col. 4, lines 61-65 and Col. 5, lines 53-64) on the anterior surface of said corneal tissue located posterior to the corneal epithelial cell layer (See Col. 4, lines 38-66 and Col. 7, lines 55-65).
Perez does not explicitly teach the composition is composed of more than one layer where each layer independently comprises a Bowman layer.
It would have been obvious to one of ordinary skill in the art before the effective filing date to have the composition (overlay) be composed of more than one layer where each layer independently comprises a Bowman layer since to do so would be a mere duplication of a working part of the device. The mere duplication of essential working parts involves only routine skill in the art. Additionally, the court has held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See also MPEP §2144.04(VI)(B). Additionally, neither the claim, nor the originally filed specification give any reason for or criticality to the parameter of the composition (overlay) having more than one layer. The specification as filed suggests single and multiple layered onlays are interchangeable and would work equally well. (See paragraphs [0070], [0097], [0100], [0129]).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perez (US Pat. No 6,544,286) as applied to claim 1 above and further in view of de Juan, Jr. (US PG Pub 2014/0155800).
Regarding claim 15, Perez teaches the method required by claim 1 as set forth above but does not explicitly teach wherein said method further comprises positioning a soft bandage lens onto the eye.
De Juan teaches bandage contact lenses are thin, soft contact lenses commonly used to improve patient comfort and to promote epithelial healing of an injury to the eye following ocular surgeries. (See paragraph [0185]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to incorporate the teachings of de Juan into the method as taught by Perez such that the method includes positioning a soft bandage lens onto the eye since soft bandage lenses are widely known and used in the art to improve patient comfort and promote healing after eye surgeries.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm .
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 call the examiner at the number listed above. Applicant may 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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.S.H/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
1 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, “composed of” is defined by Merriam-Webster as “to form by putting together” as in “a committee composed of three representatives” and “to form the substance of” as in “composed of many ingredients”. Thus, “an overlay composed of a Bowman Layer (BL)” is sufficiently broad to encompass the arrangement as taught by Perez.
2 Note the limitation “or composed of more than one layer, wherein each layer is composed of a BL” is optional and not required to be taught in the prior art. See MPEP §2143.03 and §2111.04
3 As noted above in the 112 section, the narrow limitations following “preferably” are being interpreted as optional.
4 As noted above in the 35 U.S.C. 112 rejection, the limitation “preferably wherein said part comprises at least 10% of an intact Bowman’s layer” is being interpreted as optional. It is further noted that routine optimization of result effective variables is considered to be within the level of ordinary skill in the art. “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955). See also MPEP §2144.05
5 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, “composed of” is defined by Merriam-Webster as “to form by putting together” as in “a committee composed of three representatives” and “to form the substance of” as in “composed of many ingredients”. Thus, “an overlay composed of a Bowman Layer (BL)” is sufficiently broad to encompass the arrangement as taught by Perez.
6 Note the limitation “or composed of more than one layer, wherein each layer is composed of a BL” is optional and not required to be taught in the prior art. See MPEP §2143.03 and §2111.04
7 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. In the instant case, “composed of” is defined by Merriam-Webster as “to form by putting together” as in “a committee composed of three representatives” and “to form the substance of” as in “composed of many ingredients”. Thus, “an overlay composed of a Bowman Layer (BL)” is sufficiently broad to encompass the arrangement as taught by Perez.
8 Note the limitation “or composed of more than one layer, wherein each layer is composed of a BL” is optional and not required to be taught in the prior art. See MPEP §2143.03 and §2111.04