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 .
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.
Election/Restrictions
Applicant’s election of Group II, Clams 17-40 in the reply filed on 11/05/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 17-40 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.
Regarding Claim 17, the limitation “said lenticule” in line 5 lacks proper antecedent basis, and should read as “lenticule graft.” Similarly, the limitation “the same” in line 8 should read as “said lenticule graft”.
Regarding Claim 37, it is unclear whether or not the claim is supposed to be dependent from claim 1 or claim 17, as claim 37 was elected under the second group in the response to the restriction requirement, and claim 1 is in the first non-elected group. For purposes of expedited prosecution, the Examiner is interpreting this to be dependent on claim 17. The Examiner suggests either removing the dependency of claim 1, or changing the dependency to claim 17.
Claims 18-40 are rejected as well, as they are dependent on claim 17. Any referral in these respective claims to the “lenticule” in the dependent claims should be changed to the “lenticule graft”.
Claim Rejections - 35 USC § 102
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 17-18, 23, 29-30, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20060241751 A1 (hereafter –Marmo--).
Regarding Claim 17, Marmo discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see paragraph [0063]), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0088]); wherein said method comprising steps of a. providing at least one portion of said lenticule to comprise or to be coated by at least one selected from a group consisting of collagen (see paragraphs [0074] and [0088]); collagen solution, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see paragraph [0074]); and, b. processing the same by a method selected from 3D printing, laser ablating, molding, and any combinations thereof (see paragraph [0088]).
Regarding Claim 18, Marmo discloses the method of claim 17, additionally comprising step of providing at least one portion of said lenticule to comprise or to be coated by at least one selected from a group consisting Keratocytes and/or stem cells and any combination thereof (see paragraphs [0018], [0064] and [0085]).
Regarding Claim 23, Marmo discloses the method of claim 17, characterized by step of molding of said collagen solution (see paragraph [0088]).
Regarding Claim 29, Marmo discloses the method of claim 17, wherein said molding is provided by designated tool, having the predefined geometry and surface roughness (see paragraph [0088]).
Regarding Claim 30, Marmo discloses the method of claim 29, wherein said tool is made of a material selected from a group consisting of composite material, glass, PP, PE, PET, PDMS, PTFE, FEP, and any combination thereof (see paragraph [0088] denoting that the mold could be made of ceramics, which is composite material).
Regarding Claim 34, Marmo discloses the method of claim 17, comprising step ablating said lenticule by laser to shape and size (see paragraph [0088] denoting that the lends may be shaped through ablation).
Claims 17-20, 22, 24-25, 31, 34-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200337830 A1 (hereafter –Peyman--).
Regarding Claim 17, Peyman discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see paragraphs [0127] and Abstract), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0110] and Abstract); wherein said method comprising steps of a. providing at least one portion of said lenticule to comprise or to be coated by at least one selected from a group consisting of collagen, collagen solution, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see paragraphs [0150], [0153], and [0154]); and, b. processing the same by a method selected from 3D printing, laser ablating, molding, and any combinations thereof (see Abstract and paragraph [0111-0114]).
Regarding Claim 18, Peyman discloses the method of claim 17, additionally comprising step of providing at least one portion of said lenticule to comprise or to be coated by at least one selected from a group consisting Keratocytes and/or stem cells and any combination thereof (see paragraphs [0110]).
Regarding Claim 19, Peyman discloses the method of claim 17, characterized by step of 3D printing and/or molding a collagen solution (see Abstract), and crosslinking the same to form a transparent hydrogel (see paragraph [0110], [0152], and [0157]).
Regarding Claim 20, Peyman discloses the method of claim 17, characterized by step of concentrating collagen solution to a predefined value in the range of about 1 to about 15% w/w (see paragraphs [0203] and [0204]).
Regarding Claim 22, Peyman discloses the method of claim 17, characterized by step of 3D printing the collagen solution to a predefined shape (see Abstract, see also paragraphs [0109], [0157], and [0191]).
Regarding Claim 24, Peyman discloses the method of claim 19, wherein said crosslinking is provided by admixing photo initiator to said collagen solution and applying light on it (see paragraph [0022], [0106]).
Regarding Claim 25, Peyman discloses the method of claim 19, wherein said crosslinking is provided by admixing EDC and/or NHS molecules to said collagen solution (see paragraph [0107]).
Regarding Claim 31, Peyman discloses the method of claim 17, wherein said solution is provided to form hydrogel with an optical refractive index which is similar to the native corneal stroma (see paragraph [0174]), thereby configured to avoid light scattering and/or reflections (see paragraph [0151]).
Regarding Claim 34, Peyman discloses the method of claim 17, comprising step ablating said lenticule by laser to shape and size (see paragraph [0125] denoting that the lends may be shaped through ablation).
Regarding Claim 35, Peyman discloses the method of claim 34, comprising scanning said lenticule by an OCT (see paragraph [0204]), simultaneously to said step of ablating, hence forming a closed-loop feedback mechanism (see paragraph [0221]).
Regarding Claim 36, Peyman discloses the method of claim 34, wherein said laser system comprises excimer and/or a femtosecond laser (see paragraphs [0125] and [0146]).
Regarding Claim 37, Peyman discloses a method of grafting an intrastromal corneal lenticule graft, comprising a step of using a laser system, including an Excimer Laser and/or a femtosecond laser (see paragraph [0025]).
Regarding Claim 38, Peyman discloses the method of claim 37, comprising a step of shaping said intrastromal lenticule, by means of laser within patient's cornea, after grafting the same (see paragraph [0125]).
Regarding Claim 39, Peyman discloses the method of claim 37, comprising step of optimizing depth and position within the cornea, which was optimized based on OCT scans and mechanical properties measurement of the cornea (see paragraph [0221]).
Regarding Claim 40, Peyman discloses the method of claim 37, wherein said of grafting said lenticule is provided before or after a corneal crosslinking (see paragraph [0110], [0152], and [0157]).
Claims 17 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 7476398 B1 (hereafter –Doillon--).
Regarding Claim 17, Doillon discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see Abstract, see also claim 1), configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see column 5, lines 14-18, see also column 5, lines 30-40, see also ); wherein said method comprising steps of a. providing at least one portion of said lenticule to comprise or to be coated by at least one selected from a group consisting of collagen, collagen solution, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see column 5, lines 41-59) and, b. processing the same by a method selected from 3D printing, laser ablating, molding, and any combinations thereof (see column 4, lines 12-15, see also column 7, lines 50-53, see also column 9, lines 22-31).
Regarding Claim 32, Doillon discloses the method of claim 17, wherein at least one of the following is held true: a. said solution is configured to form a hydrogel characterized by elastic modulus ranging between about 50kPA to about 13MPa (see column 3, lines 33-40). [b. said solution is configured to form a hydrogel characterized with permeability to glucose, oxygen and proteins which is at least about 50% of the permeability of native corneal stroma tissue; c. said solution is configured to form a hydrogel which at least partially blocks UV light.]
Claims 17, 19, 26, and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200046884 A1 (hereafter –Griffith--).
Regarding Claim 17, Griffith discloses a method for the production of an intrastromal corneal lenticule graft for either or both Keratoconus treatment and vision-correction (see paragraphs [0021] and [0091]) configured to mimic native corneal stroma tissue by means of its optical properties, mechanical properties, permeability and interaction with corneal stromal cells (see paragraph [0075], [0218], and [0256]); wherein said method comprising steps of a. providing at least one portion of said lenticule to comprise or to be coated by at least one selected from a group consisting of collagen (see paragraph [0081]); collagen solution, collagen methacrylate, recombinant mammal collagen, mammal-sourced collagen and any combination thereof (see paragraph [0081]); and, b. processing the same by a method selected from 3D printing, laser ablating, molding, and any combinations thereof (see paragraph [0027]).
Regarding Claim 19, Griffith discloses the method of claim 17, characterized by step of 3D printing and/or molding a collagen solution (see Abstract), and crosslinking the same to form a transparent hydrogel (see paragraphs [0173], [0164], [0180], and [0113]).
Regarding Claim 26, Griffith discloses the method of claim 19, wherein said crosslinking is provided in a controlled temperature and humidity (see paragraphs [0173], [0164], [0180], and [0113]).
Regarding Claim 28, Griffith discloses the method of claim 19 wherein said crosslinking is provided in a controlled gas mixture environment, other than air (see paragraphs [0173], [0164], [0180], and [0113]).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 21 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200337830 A1 (hereafter –Peyman--), as applied to claim 17 above, in view of US 5067961 A (hereafter --Kelman--).
Regarding Claim 21, Peyman discloses the method of claim 17.
Peyman fails to disclose characterized by step of centrifuging collagen solution.
Kelman discloses a corneal implant and method of preparing said implant (see Abstract). Kelman teaches characterized by step of centrifuging collagen solution (see column 2, lines 36-45).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Peyman to further include centrifuging collagen solution, as by doing so would enable recovering the fibrous fractions of the collagen to form the implant (see column 2, lines 36-45).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over US 20200337830 A1 (hereafter –Peyman--), as applied to claim 18 above, in view of US 20220409362 A1 (hereafter --Peyman #2--).
Regarding Claim 27, Peyman discloses the method of claim 18.
Peyman fails to disclose additionally comprising step of lyophilizing said intrastromal corneal lenticule graft prior to said step of crosslinking said corneal lenticule graft.
Peyman #2 discloses a corneal implant and method of preparing said implant (see Abstract). Peyman #2 teaches additionally comprising step of lyophilizing said intrastromal corneal lenticule graft prior to said step of crosslinking said corneal lenticule graft (see paragraph [0841]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Peyman to further additionally comprising step of lyophilizing said intrastromal corneal lenticule graft prior to said step of crosslinking said corneal lenticule graft, as by doing so would promote the process of killing the corneal keratocytes around the inlay, and preventing an immune response to the inlay while increasing the mechanical resistance of the cornea and eliminating all potential pathogens in the inlay (see paragraph [0841]).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over US 20190307551 A1 (hereafter –Peyman--), as applied to claim 17 above, in view of US 20190307551 A1 (hereafter --Peyman #3--).
Regarding Claim 33, Peyman discloses the method of claim 17.
Peyman fails to disclose additionally comprising step of marking said transparent crosslinked hydrogel for the correct orientation by one or more members of a group consisting of a laser engraver, mechanical press, pigmented ink, or a combination thereof.
Peyman #2 discloses a corneal implant and method of preparing said implant (see Abstract). Peyman #2 teaches additionally comprising step of marking said transparent crosslinked hydrogel for the correct orientation by one or more members of a group consisting of a laser engraver, mechanical press, pigmented ink, or a combination thereof (see paragraph [0568]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the method of Peyman to further additionally comprising step of marking said transparent crosslinked hydrogel for the correct orientation by one or more members of a group consisting of a laser engraver, mechanical press, pigmented ink, or a combination thereof, as by doing so would promote ease of implantation (see paragraph [0568]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20110208300 A1: This reference discloses a crosslinked corneal implant.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PARIS MARIE BLASS whose telephone number is (703)756-5375. The examiner can normally be reached Monday - Thursday 9 a.m. - 7 p.m. ET.
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, 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.
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.
/PARIS MARIE BLASS/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774