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 .
Information Disclosure Statement
The Information Disclosure Statement filed 10/16/2025 has been considered by the Examiner.
Response to Arguments
Applicant’s arguments, see page 5, filed 03/10/2026, with respect to Priority have been fully considered but they are not persuasive. The Applicant argues that (1) in view of the relevant date of the reference on which the Office Action relies for the pending anticipation rejections, it is unnecessary at this time to reach the question of whether claims 9-20 are “entitled to the benefit of the ‘086, ‘501, and ‘928 Provisionals” and (2) the ‘086, ‘501, and ‘928 provisional applications in any event provide adequate written description support and enablement for the pending claims. This is not found persuasive. The Examiner agrees that the priority does not affect the 35 U.S.C. 102 rejection over Vukelic, et al., but notes that the comment on Priority was made for the sake of completeness in the First Office Action. The Examiner doesn’t agree with Applicant’s point (2), and maintains that the ‘086, ‘501, and ‘928 Provisionals fail to provide adequate written description support or enablement for a method of altering the curvature of the cornea comprising initiating crosslinking within the extracellular matrix of the cornea to change the stiffness of the cornea. Please see the Priority section, re-pasted hereinbelow.
Applicant’s arguments, see page 6, filed 03/10/2026, with respect to claim objections have been fully considered and are persuasive. The claim objections have been obviated by amendments to the claims. The claim objections have been withdrawn.
Applicant’s arguments, see pages 6-7, filed 03/10/2026, with respect to 35 U.S.C. 112(b) rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) rejections have been obviated by amendments to the claims. The previously-held 35 U.S.C. 112(b) rejections have been withdrawn. A new 35 U.S.C. 112(b) rejection is necessitated as a result of the claim amendments. Please see 35 U.S.C. 112(b) rejection below.
Applicant’s arguments, see page 7, filed 03/10/2026, with respect to non-statutory double patenting rejections have been fully considered but they are not persuasive. The Applicant argues that the claims in the present application include features not present or suggested in the cited claims, and therefore the non-statutory double patenting rejections should be withdrawn. This is not found persuasive. The Examiner maintains that provisional non-statutory double patenting over co-pending App. 18/778,702 is proper, as instant claims 9-17 and 20 are not patentably distinct over claims 11-15 of the ‘702 Application. Please see non-statutory double patenting rejections hereinbelow.
Applicant’s arguments, see page 7, filed 03/10/2026, with respect to 35 U.S.C. 102 rejections have been fully considered but they are not persuasive. The Applicant argues that the Office does not meet its burden to identify disclosure in Vukelic that teaches every feature of claim 9 as those features are arranged in the claim. The Applicant therefore argues the 35 U.S.C. 102 rejections should be withdrawn without indicating the particular limitation in which the Office has not identified corresponding disclosure in Vukelic for. The Examiner maintains the 35 U.S.C. 102 rejections of claims 9-20 and respectfully contends that the 35 U.S.C. 102 rejections are proper. The Examiner notes that the 35 U.S.C. 102 rejections have been updated to reflect the claim amendments to claim 9. Despite the claim amendment, claims 9-20 continue to be rejected over Vukelic, et al. (US 2018/0221201). Please see 35 U.S.C. 102 rejections hereinbelow.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application No’s. 62/978086 (hereinafter ‘086 Provisional), 62/991501 (hereinafter ‘501 Provisional), and 63/044928 (hereinafter ‘928 Provisional), fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ‘086, ‘501, and ‘928 Provisionals fail to provide adequate support or enablement for a method of altering the curvature of the cornea comprising initiating crosslinking within the extracellular matrix of the cornea to change the stiffness of the cornea (see instant claim 9). Accordingly, claims 9-20 are not entitled to the benefit of the ‘086, ‘501, and ‘928 Provisionals. Claims 9-20 do have adequate support or enablement in PCT/US2021/018626, of which the instant application is a continuation of. Therefore, claims 9-20 of the instant application have an effective filing date of 02/18/2021.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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.
Claim 20 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 20 recites the limitation “a mechanical loading to the cornea” in lines 1-2, whereas a mechanically-loaded corneal tissue was already introduced in a claim that claim 20 depends from (claim 9). It is unclear whether the Applicant intended to claim the same or a different mechanical loading of the cornea. Consider changing to “the mechanical loading to the cornea”. The Examiner notes that additionally, it is unclear how this claim is further limiting. Please see 35 U.S.C. 112(d) rejection below.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 20 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. It is unclear how the limitation “further comprising applying a mechanical loading to the cornea” further limits the subject matter of the claim since claim 9 already recites “mechanically-loaded corneal tissue”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 9-17 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-15 of copending Application No. 18/778,702 (reference application – hereinafter ‘702 Application). Although the claims at issue are not identical, they are not patentably distinct from each other. References below are made to the claims filed 07/19/2024 in the ‘702 Application.
Regarding claims 9, 17, and 20 of the instant application, claim 11 of the ‘702 application discloses:
A method of altering a curvature of a cornea (Claim 11, line 1 – steepening a curvature, i.e. altering a curvature) comprising:
controlling a light source to apply light energy pulses to mechanically-loaded corneal tissue, wherein the light energy pulses are below an optical breakdown threshold for the cornea (Claim 11, lines 2-3 – flattening, i.e., applying a mechanical load, 4-5, and 9-10); ionizing water molecules within the treated corneal tissue to generate reactive oxygen species (Claim 11, lines 10-11); and initiating crosslinking within extracellular matrix of the cornea to change a stiffness of the cornea (Claim 11, lines 5 and 11 – corneal stroma is a collagen-rich extracellular matrix).
The method of claim 9, wherein controlling the light source comprising applying the light energy pulses in one or more layers to the tissue (Claim 11, lines 4-5).
The method of claim 9, further comprising applying a mechanical loading to the cornea (Claim 11, lines 2-3 – flattening, i.e., applying a mechanical load).
Claim 11 of the ‘702 Application anticipates instant claims 9, 17, and 20. Therefore, the instant claims 9, 17, and 20 are not patentable over claim 11 of the ‘702 Application.
Regarding claims 10-11 of the instant application, claim 12 of the ‘702 application discloses:
The method of claim 9, wherein the light source is a laser (Claim 12, line 1).
The method of claim 10, wherein the laser is a femtosecond laser (Claim 12, line 1).
Claim 12 of the ‘702 Application anticipates instant claims 10-11. Therefore, the instant claims 10-11 are not patentable over claim 12 of the ‘702 Application.
Regarding claims 12-13 of the instant application, claim 13 of the ‘702 application discloses:
The method of claim 9, wherein the light energy pulses have an average power output between about 10 mW and about 100 mW (Claim 13, lines 1-2).
The method of claim 12, wherein the light energy pulses have an average power output of about 60 mW (Claim 13, lines 1-2).
Claim 13 of the ‘702 Application anticipates instant claims 12-13. Therefore, the instant claims 12-13 are not patentable over claim 13 of the ‘702 Application.
Regarding claims 14-15 of the instant application, claim 14 of the ‘702 application discloses:
The method of claim 9, wherein the light energy pulses have a pulse energy between about 0.9 nJ and about 1.5 nJ (Claim 14, lines 1-2).
The method of claim 9, wherein the light energy pulses have a pulse energy of about 1.2 nJ (Claim 14, lines 1-2).
Claim 14 of the ‘702 Application anticipates instant claims 14-15. Therefore, the instant claims 14-15 are not patentable over claim 14 of the ‘702 Application.
Regarding claim 16 of the instant application, claim 15 of the ‘702 application discloses:
The method of claim 9, wherein the light energy pulses have a wavelength of about 1060 nm (Claim 15, lines 1-2).
Claim 15 of the ‘702 Application anticipates instant claim 16. Therefore, the instant claim 16 is not patentable over claim 15 of the ‘702 Application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 9-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Vukelic, et al. (U.S. PGPub No. 2018/0221201 – cited on IDS).
Regarding claim 9, Vukelic teaches a method of altering a curvature of a cornea (Par. [0007] – defects such as keratoconus can be corrected by strengthening the cornea; the corneal curvature is modified to correct vision problems; Par. [0010]; Par. [0043] – the focused laser light provides strengthening of the corneal collagen and modification of the corneal curvature), comprising:
(Fig. 5A, # 503-505) controlling a light source to apply light energy pulses to mechanically-loaded corneal tissue, wherein the light energy pulses are below an optical breakdown threshold for the cornea (Par. [0050] – various parameters of the laser can be manipulated to control the safety and efficiency of the cross-linking of collagen. For example, the laser beam, as defined by its wavelength, temporal pulse width, and pulse energy, as well as the numerical aperture of the scanning objective and the scanning speed should be high enough to induce ionization of water molecules in the cornea, but below optical breakdown level; Par. [0064]; Par. [0081] – placement of the coverslip also ensured the flatness of the top surface of the cornea (flattening via coverslip evidences mechanical loading); Par. [0084] – inflation test using a loading regimen consisting of a series of linear load/unload cycles; Par. [0087]); ionizing water molecules within the treated corneal tissue to generate reactive oxygen species (Par. [0002] – collagen based tissues such as corneal stroma; Par. [0003]; Par. [0005]; Par. [0044]; Par. [0050-0051] – ionization of water molecules in the cornea, wherein the ionization causes the formation of reactive oxygen products); and initiating crosslinking within extracellular matrix of the cornea to change a stiffness of the cornea (Par. [0006] – the target tissue can be the corneal stroma, which is a collagen-rich extracellular matrix; Par. [0007]; Par. [0088] – stiffening of the laser treated part of the cornea, which can be attributed to creation of cross-links that increase the structural stability of the stroma; Par. [0111]).
Therefore, claim 9 is unpatentable over Vukelic, et al.
Regarding claim 10, Vukelic teaches the method of claim 9, wherein the light source is a laser (Abstract – femtosecond laser; Par. [0003-0004]; Par. [0008]).
Therefore, claim 10 is unpatentable over Vukelic, et al.
Regarding claim 11, Vukelic teaches the method of claim 10, wherein the laser is a femtosecond laser (Abstract – femtosecond laser; Par. [0003-0004]; Par. [0008]).
Therefore, claim 11 is unpatentable over Vukelic, et al.
Regarding claim 12, Vukelic teaches the method of claim 9, wherein the light energy pulses have an average power output between about 10 mW and about 100 mW (Par. [0008] – average power from about 10 to about 100 mW; Par. [0011]).
Therefore, claim 12 is unpatentable over Vukelic, et al.
Regarding claim 13, Vukelic teaches the method of claim 12, wherein the light energy pulses have an average power output of about 60 mW (Par. [0082]; Par. [0093]; Par. [0114]).
Therefore, claim 13 is unpatentable over Vukelic, et al.
Regarding claim 14, Vukelic teaches the method of claim 9, wherein the light energy pulses have a pulse energy between about 0.9 nJ and about 1.5 nJ (Par. [0008]; Par. [0101]).
Therefore, claim 14 is unpatentable over Vukelic, et al.
Regarding claim 15, Vukelic teaches the method of claim 9, wherein the light energy pulses have a pulse energy of about 1.2 nJ (Par. [0008]; Par. [0101]).
Therefore, claim 15 is unpatentable over Vukelic, et al.
Regarding claim 16, Vukelic teaches the method of claim 9, wherein the light energy pulses have a wavelength of about 1060 nm (Par. [0011] – the femtosecond laser can irradiate light in the wavelength range from about 600 nm to about 1100 nm; Par. [0076]; Par. [0082] – 1059.2 nm wavelength; Par. [0093]; Par. [0114] – output wavelength centered around 1060 nm).
Therefore, claim 16 is unpatentable over Vukelic, et al.
Regarding claim 17, Vukelic teaches the method of claim 9, wherein controlling the light source comprises applying the light energy pulses in one or more layers to the corneal tissue (Par. [0009] – the laser can be scanned in multiple layers of the cornea; Par. [0063] – laser beam can scan the cornea in multiple layers; Par. [0065]; Par. [0067] – the corneal tissue can be treated in multiple layers to cover the volume of damaged stroma and/or infectious elements).
Therefore, claim 17 is unpatentable over Vukelic, et al.
Regarding claim 18, The method of claim 17, wherein two of the one or more layers are spaced about 50 microns apart (Par. [0082] – the laser beam was focused in the interior of cornea, creating planar zigzag patterns with 50 μm pitch. Multiple planes parallel to the corneal surface were treated with 150 μm distance between two consecutive planes; Par. [0115] – multiple treatment layers parallel to the superficial surface were applied with 50 μm distance between two consecutive planes).
Therefore, claim 18 is unpatentable over Vukelic, et al.
Regarding claim 19, Vukelic teaches the method of claim 17, wherein controlling the light source comprises applying the light energy pulses in two to five layers to the corneal tissue (Par. [0063] – first pattern and second pattern of exposure to provide multiple layers of exposure; Par. [0115-0116] – example of five laser treated layers).
Therefore, claim 19 is unpatentable over Vukelic, et al.
Regarding claim 20, Vukelic teaches the method of claim 9, further comprising applying a mechanical loading to the cornea (Par. [0081] – placement of the coverslip also ensured the flatness of the top surface of the cornea (flattening via coverslip evidences mechanical loading); Par. [0084] – inflation test using a loading regimen consisting of a series of linear load/unload cycles; Par. [0087]).
Therefore, claim 20 is unpatentable over Vukelic, et al.
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/Primary Examiner, Art Unit 3796
Prosecution Insights