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 .
Response to Amendment
Applicant’s response filed 21 June 2025 has been received and entered. Claims 4, 7, 8, 10-12, 14 and 16 have been amended, claims 1-3, 5-6, 13, 15, 17-18 and 20-43 have been canceled and claims 44-46 have been added. Claims 4, 7-12, 14, 16, 19 and 44-46 are currently pending.
The text of those sections of Title, 35, U.S. Code not included in this action can be found in a prior Office action.
Any objection or rejection of record which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
Applicant’s arguments filed 21 June 2025 have been fully considered but are not deemed to be persuasive.
Drawings
The drawings (received 21 June 2025) are objected to because they do not meet the requirements of 37 CFR 1.84(a)(1) which requires the use of India ink, or its equivalent that secures solid black lines. Additionally, 37 CFR 1.84(l) requires that all drawings must be made by a process which will give them satisfactory reproduction characteristics and that every “line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined”.
Below is a sample screenshot from the most recent submission (taken from the file and not the scanned documents). As can be seen, text is still faint in Figure 1. This may be the result of conversion of figures prepared with color into a black/white environment.
PNG
media_image1.png
144
267
media_image1.png
Greyscale
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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.
Response to Arguments
Applicant has filed replacement drawing sheets and asserts that the drawings to which the Office action objects are not the same quality as the drawings that Applicant filed on July 6, 2022. Applicant requests that the Office preserve the original quality of the drawings that are submitted herewith.
The Examiner has no control over such matters. A review of drawings that issued in the most recent parent application (16/363,886; U.S. Pat. No. 11,209,444) shows that Figures 1 and 11-13 do not reproduce with solid black lines even though the “file” version appears adequate (except for Figure 1 which still has a figure legend which is clearly not compliant). The lines in Figures 11-13 may not be of sufficient thickness and possibly this may be causing the issue (see 37 CFR 1.84 (l); “[t]he weight of all lines and letters must be heavy enough to permit adequate reproduction”).
Claim Objections
Claim 9 is objected to because of the following informalities: claim 9 recites “wherein the risk score comprises an odds ratio, a relative risk, an overall risk over a period of time”. It is suggested that the word “or” be inserted after “a relative risk” for clarity. Appropriate correction is required.
Improper Markush
Claims 7 and 44-46 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of VEGFR-2 inhibitor and VEGFR-3 inhibitor is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the inhibitors inhibit different targets which would necessarily require structures which are not common to each inhibitor (i.e. an antibody which inhibits a target binds to a particular antigenic region on the target which is distinct to that target and results in a structurally distinct antibody).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Response to Arguments
Applicant argues at page 13 of the response that the Office has not cited the proper criteria for evaluating a Markush element in a method claim and assert that common/shared use is sufficient. Applicant also argues that the previously presented claims recited alternatives but were not written in Markush format. Applicant lastly asserts that the rejection has been rendered moot by amendment or claim cancellation.
Applicant’s arguments have been fully considered, but are not found persuasive. Markush claims are addressed in MPEP 2117. A “Markush” claim recites a list of alternatively useable members. There is no requirement that Markush language be used nor is there any requirement that the list be of a particular length, only that there is a listing of specified alternatives. With regard to Applicant’s assertion regarding “proper criteria for evaluating a Markush element in a method claim”, no such distinction could be found in MPEP 2117 for a Markush element recited in a product claim versus a method claim. MPEP 2117 clearly states that a “Markush grouping is proper if the members of a group share a single structural similarity and a common use”. The claims recite that the VEGF-C inhibitor is a VEGFR-2 inhibitor or a VEGFR-3 inhibitor. Clearly, the inhibitors do not share a common structural feature which provides for a common function as they inhibit different VEGF receptors
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 14 is 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 14(c) has been amended to recite “administering, to the eye of a subject diagnosed with, or identified as having elevated risk for, a disease or condition selected from a maculopathy and pathogenic ocular neovascularization and identified as having elevated VEGF-C in the biological sample”. However, it is not clear that the subject who has been diagnosed in step (c) is the same subject from whom a VEGF-C measurement was obtained in step (a). Additionally, step (b) recites “determining from the VEGF-C measurement that VEGF-C is elevated in the mammalian subject” which seems to be a predetermination that all of the measured VEGF-C will be elevated (note the use of “that” in the claim rather than “if”. Lastly, it is not clear if the measuring and determining of VEGF-C in the biological sample is meant to be used in diagnosis or in identification of elevated risk for disease because step (c) does not appear to link step (b) to step (c) in any meaningful way. If step (b) is not intended to be informative for diagnosis or assessing risk, the claim could recite the specific patient population in the preamble, which would make clear that the measurement/determinination of VEGF-C in the sample is not intended for this purpose. As the claim is currently written, it is not clear if the mammalian subject must be diagnosed/identified as at risk apart from the VEGF-C determination or if the VEGF-C determination is meant to be part of the diagnosis/risk identification.
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 4, 7-12, 14, 16, 19 and 44-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 10,274,503. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are encompassed by the claims of ‘503.
Claim 4 of the instant application is directed to a method with no recited intended purpose. The steps of claim 4 include measuring VEGF-C which is included in all of the claims of ‘503. Claim 4 then recites “using the VEGF-C measurement” in a variety of ways, which of which are encompassed by the claims of ‘503 because the VEGF-C measurement is a consideration for determining treatment (claim 1) or monitoring or adjusting dosage (claim 2). While ‘503 does not explicitly claim calculating risk scores, such claims are mathematical determinations which are routinely performed in the art with regard to determining risk for various diseases/condition. Furthermore, ‘503 clearly encompasses determining risk as claim 2 requires administration based on the subject being identified as having elevated risk and claim 27 encompasses determining risk in step (c). ‘503 also does not claim communicating risk to a third party or generating a communication, however, in health care, it is routine for a physician to explain a diagnosis to a third party as well as for communications to be generated for a patient’s file or for the purposes of reporting to an insurance company, etc. The claims of ‘503 administer a specific VEGF-C inhibitor, however, administration of a specific VEGF-C inhibitor anticipates the generic VEGF-C inhibitor being administered in the instant claims. Therefore, the instant claims are obvious over the claims of ‘503.
Claims 4, 7-12, 14, 16, 19 and 44-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 11,209,444. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are encompassed by the claims of ‘444.
Claim 4 of the instant application is directed to a method with no recited intended purpose. The steps of claim 4 include measuring VEGF-C which is included in all of the claims of ‘444. Claim 4 then recites “using the VEGF-C measurement” in a variety of ways, which of which are encompassed by the claims of ‘444 because the VEGF-C measurement is a consideration for determining treatment (claim 1) or monitoring or adjusting dosage (claim 12). While ‘444 does not explicitly claim calculating risk scores, such claims are mathematical determinations which are routinely performed in the art with regard to determining risk for various diseases/condition and risk is recited in claims 12 and 27 of ‘444. ‘444 also does not claim communicating risk to a third party or generating a communication, however, in health care, it is routine for a physician to explain a diagnosis to a third party as well as for communications to be generated for a patient’s file or for the purposes of reporting to an insurance company, etc. The claims of ‘444 administer a specific VEGF-C inhibitor, however, administration of a specific VEGF-C inhibitor anticipates the generic VEGF-C inhibitor being administered in the instant claims. Therefore, the instant claims are obvious over the claims of ‘444.
Response to Arguments
Applicant argues that claims have been amended “rendering moot the original bases [sic] for the rejection”. Applicant’s arguments have been fully considered but are not found persuasive. The amendments which were added to the instant claims do not add any limitation which are not already found in ‘503 and ’444 or made obvious by the claims of ‘503 and ’444.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 6am-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 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, Gary Nickol can be reached on 571-272-0835. 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.
/Christine J Saoud/Primary Examiner, Art Unit 1645