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 amendment filed 26 January 2026 has been received and entered. Claims 25-54 have been amended and claims 1-24 and 55-98 have been canceled. Claims 25-54 are currently pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 26 January 2026 is acknowledged. Applicant’s election without traverse of the following species is also acknowledged:
(1) VEGF receptor fusion protein: Aflibercept.
(2) Treatment regimens: Treatment of DME patients with a regimen calling for an initial dose, 2-4 week secondary dosing intervals and 13-16 week tertiary dosing intervals.
(3) Pharmaceutical formulation: aqueous pharmaceutical formulation comprising 103-126 mg/ml aflibercept, 10 ± 1 mM histidine-based buffer, 5 ± 0.5% (w/v) sucrose, 0.02-0.04% (w/v) polysorbate 20, and 50 ± 5 mM L-arginine, pH 5.5-6.1.
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. (see specification beginning at page 66)
The information disclosure statements (IDS) submitted on 24 August 2023, 10 March 2025, 27 August 2025 and 26 January 2026 have been considered by the examiner.
Drawings
The drawings are objected to because they do not comply with 37 CFR 1.84. The drawings are not in black and white with solid black lines, which must be used for drawings (see 37 CFR 1.84(a)(1)). See screenshot below:
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The dotted nature of the lines is evident and the result is loss of clarity as well as a lack of solid black lines. Additionally, text (such as in claim 2) appears blurry due to the lack of solid black lines.
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.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title is not reflective of the claims which are directed to treatment of diabetic macular edema by administration of 8 mg doses of aflibercept.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it is not a concise statement of the invention as the invention is defined by the claims. The claims are limited to treatment of diabetic macular edema and the dose of aflibercept in the claims is limited to 8 mg. The abstract should reflect these elements as they are clearly components of the invention. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use various terms, which are trade names or marks used in commerce, have been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
EYLEA® is found throughout the disclosure, however, the generic terminology is not provided. While EYLEA® is properly denoted in [0005], it is not properly referenced elsewhere (see at least [0008], [000128], [000210], [000217], [000219], [000223], [000360], [000362], [000453] and [000454]). This list may not be complete and therefore, the specification should be reviewed carefully for compliance.
JETREA®, ILUVIEN® and OZURDEX® are found in [000266]. While they are properly capitalized and include their marks, generic terminology is not provided.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because of the following informalities:
The specification is replete with the abbreviation “HDq”. The first usage is found in [00019] but it is not defined. The “HDq” is used in conjunction with “12”, “16” and “20” which appear to refer to weeks and “q” in reference to dosing would mean every 12/16/20 weeks. It is noted that the definition of what the various regimens are appears on page 40 of the specification. However, the specification should indicate what the abbreviation means at its first usage as it is confusing otherwise. HD may refer to “high dose” however, “high dose” also appears to be limited to 8 mg so a limiting definition of what is intended is necessary to understand the meaning of the abbreviation.
All abbreviations should be defined at their first usage for the sake of clarity. ETDRS is found in [00024] but is not defined until [00044] and not fully defined until page 47 of the specification. Further, its use in the context of the disclosure is somewhat confusing (see for example [00024]; if (a) greater than 5 letters are lost in BCVA (ETDRS), relative to the BCVA observed at about 12 weeks after treatment initiation). This recitation does not make clear that “(ETDRS)” is probably used to mean “(according to ETDRS letter score)”.
The Brief Description of the Drawings is objected to because Figures 14A-14C and 25A-25B, 26A-26B are not properly identified. The Brief Description only refers to 14, 25 and 26 and fails to indicate the subparts. Correction is required.
Paragraph [000210] uses the abbreviation “TEAE”, which is not defined. This seems to be the first mention of this abbreviation. Likewise, the abbreviation “APTC” does not appear to be defined.
Paragraph [00036] of the specification refers to “A-KKKK”:
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This passage is confusing because there is no statement of what “A-KKKK” is intended to mean. There are a list of formulations in paragraph [000167] which begin with “A” and end with “KKKK”, but without clearly stating that the subject matter of [000167] is what is being referenced in [00036], the disclosure is confusing.
The specification contains several Tables. However, some of the Tables have font which is too small to read and which does not appear to comply with 37 CFR 1.52(b)(2)(ii). See screenshot below from Table 1-2 as exemplary:
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The screenshot has been magnified to show the degradation of the quality of the text.
Several of the Tables do not have solid black lines and some of the text does not appear to be in black ink (appears gray which does not provide sufficient contrast between the text and the paper/background which degrades the clarity of the Tables).
Appropriate correction is required.
Claim Objections
Claim 41 is objected to because of the following informalities: claim 41 capitalizes the conditions listed in lines 3-6. These are not conditions which should be capitalized nor are the terms at the beginning of a sentence. Appropriate correction is required.
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.
Claim(s) 25-54 are is/are rejected under 35 U.S.C. 103 as being unpatentable over US PGPub 2019/0343918 A1 (Graham et al.) in view of WO 2012/097019 (Yancopoulos).
Graham et al. is directed to high concentration formulations of a VEGF receptor fusion protein, aflibercept. Graham et al. state at [0005] that “[h]igher concentration antibody formulations allow for shorter injection times, smaller injection volumes, lower frequency of antibody administration” and that high “concentration VEGF receptor fusion protein containing formulations could allow for shorter ocular injection times, smaller injection volumes, fewer possible injections per administration cycle” (see [0006]).
Graham et al. teach pharmaceutical formulations of aflibercept wherein a single dose is in less than about 100µl (less than about 50, about 50, about 57, about 60, about 70 or about 75µl (see [0010]) (see instant claims 35-36, 42, 47-54). Graham et al. specifically exemplify a concentration of 114.3 mg/ml VEGF receptor fusion protein (e.g., aflibercept) (see [0242]: Formulation GGGG: 114.3 mg/ml VEGF receptor fusion protein (e.g., aflibercept) (e.g., 103- 126 mg/ml), 10 mM histidine-based buffer (e.g., +1 mM), 5% (w/v) sucrose (e.g., +0.5%), 0.03% (w/v) polysorbate 20 (e.g., 0.02-0.04%), and 50 mM L-arginine monohydrochloride (e.g., +5 mM), with a pH of 5.8 (e.g., 5.6-6.0 or 5.5-6.1)). This concentration is the same as instant claim 37, 42, 47-54 and the formulation is the same as instant claims 38-40 [see 0242]. With regard to the formulations administered in claims 43-46, Graham et al. teach histidine-based buffers, phosphate-based buffers, addition of trehalose and addition of sucrose and trehalose (see [0013- 0014] and formulations A-KKKK beginning at [0156]).
Graham et al. teach that the high concentration VEGF receptor fusion protein formulations can be used to treat angiogenic eye disorders which include diabetic macular edema (DME) (see [0036]). Graham et al. teach a method of treating diabetic macular edema by intraocularly injecting at least about 2 mg (e.g., 4 mg, 6 mg or 8 mg) of VEGF receptor fusion protein (e.g., aflibercept) into the eye of a subject in need thereof. Graham et al. further teach administering a therapeutically effective amount of VEGF receptor fusion protein (e.g., aflibercept)(e.g., about 4, 6, or 8.0, 8.1, 8.4 or 8.5 mg) “in a pharmaceutical formulation according to the present invention, intraocularly” (see [0278] and claim 33), including into both eyes. Graham et al. continues that the formulation is administered every 2-24 weeks (see [0278]).
Graham et al. does not teach the specific dosing regimen of an initial dose, followed by one or more secondary doses, followed by one or more tertiary doses wherein the secondary dose is administered about 2 to 4 weeks after the immediately preceding dose and wherein the tertiary dose is administered about 13-16 weeks after the immediately preceding dose. Graham et al. also does not teach that the subject being treated in the claimed method does not have one or more of ocular infection, periocular infection, active intraocular inflammation and/or hypersensitivity to aflibercept or any component of the aqueous formulation being administered in the claimed method.
Yancopoulos teaches the treatment of angiogenic eye diseases by sequentially administering multiple doses of a VEGF antagonist to a patient overtime (see [0005]). Yancopoulos teaches that the method can be used to treat any angiogenic eye disorder, including diabetic macular edema (see [0006]) and according to the method disclosed, following an initial dose, each secondary dose of VEGF antagonist is administered 2 to 4 weeks after the immediately preceding dose, and each tertiary dose is administered at least 8 weeks after the immediately preceding dose (see also Figure 1). Yancopoulos teaches that one advantage of such a dosing regimen is that, for most of the course of treatment (i.e., the tertiary doses), it allows for less frequent dosing compared to prior administration regimens for angiogenic eye disorders which require monthly administrations throughout the entire course of treatment (see [0005]). While Yancopoulos exemplifies administration of the tertiary dose at a frequency of every 8 weeks, Yancopoulos teaches that the tertiary dose is administered at least 8 (e.g., 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14, 14.5 or more) weeks after the immediately preceding dose (see [0017]). Yancopoulos also teaches that the frequency of administration may be adjusted by a physician depending on the needs of the individual patient following clinical examination (see [0020]). The VEGF antagonist which is exemplified by Yancopoulos is commonly known as aflibercept (see [0023]; referred to as VEGFT which is short for VEGF Trap). The method of Yancopoulos administers a dose of VEGF antagonist which is about 0.05 mg to about 5 mg (see [0030]) and exemplifies various doses including 0.5, 2 and 4 mg (see at least Example 2). Yancopoulos also teaches the exclusion of patients from the disclosed method who have active intraocular inflammation in either eye, active ocular or periocular invention in either eye (see page 12, bottom of page, #’s 18-20) as well as “30. History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications” (see page 13, middle of page).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat a subject suffering from diabetic macular edema (DME) with the compositions of Graham et al. because Graham et al. teach that high concentration formulations of a VEGF receptor fusion protein, aflibercept, allow for shorter ocular injection times, smaller injection volumes, and fewer possible injections per administration cycle when treating angiogenic eye conditions, including DME. Graham et al. teach the administration of 8 mg of aflibercept for treating DME as well as administration in a volume of less than 100 µl, including in a volume of about 70 µl. Graham et al. additionally teach various aqueous pharmaceutical formulations for administration which are identical to those recited in the instant claims. Graham et al. further teach administering a therapeutically effective amount of VEGF receptor fusion protein (e.g., aflibercept), in a pharmaceutical formulation according to the present invention, intraocularly, including into both eyes and that the formulation is administered every 2-24 weeks. While Graham et al. does not teach the dosing regimen of the instant claims, it would have been prima facie obvious to one of ordinary skill in the art before the filing date of the instant claims to adopt the dosing regimen taught by Yancopoulos because Yancopoulos teaches the advantages of the disclosed dosing regimen for treating the same conditions (angiogenic eye disease, including DME) with the same therapeutic compound (aflibercept). Additionally, it would have been obvious to one of ordinary skill in the art to exclude subjects from the treatment of Graham et al. who have ocular or periocular infection or inflammation or might have an adverse reaction to the treatment because Yancopoulos teaches that such subjects should not be treated. One would have been motivated to adopt the dosing regimen of Yancopoulos when practicing the method of Graham et al. because Yancopoulos teach that such a dosing regimen allows for less frequent dosing compared to other prior dosing regimens for other therapeutics used for treating angiogenic eye disease. One of ordinary skill in the art would have readily appreciated the advantage because reducing the number of intraocular injections for a therapeutic effect would not only reduce the number of visits for treatment, but would also reduce the amount of discomfort a given patient would need to endure. One of ordinary skill in the art would have had a reasonable expectation of success in applying the dosing regimen of Yancopoulos to the method of Graham et al. because the same therapeutic compound is being administered for treating the same condition. While Yancopoulos does not specifically recite the particular combination of secondary doses/tertiary doses and number of weeks (i.e. 2 secondary doses every 4 weeks followed by one or more tertiary doses every 15 weeks) specifically enumerated in the instant claims, the disclosure of Yancopoulos clearly encompasses the various combinations recited in the instant claims. Additionally, it would have been well within the skill of the artisan at the time of the instant invention to explore various interval timings and arrive at applicant’s claimed invention with a reasonable expectation of success. In addition, dosage amounts or concentrations of drugs and length of administrations etc., are result effective variables, because a skilled person in the art determines these variables through a routine experimentation and which is common practice in the art, absent evidence to the contrary. Generally, differences in concentrations of components of a formulation (or drug or tuning length of interval) will not support the patentability of subject matter encompassed by the prior art. Such formulations are results-effective variables which can be optimized. In In re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980), it was held that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Further, in In re Aller, 220 F. 2d454, 456, 105 USPQ 233,235 (CCPA 1955) the courts maintained that: "Where the general condition of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As formulating optimal compositions for medicaments is routine in the art of pharmacology, the claims are considered to be prima facie obvious.
See Tyco Healthcare Group LP V. Mutual Pharmaceutical Co., 642 F.3d 1370 (Fed. Cir. 2011) ("the court observed that the parties did not dispute that 'physicians always seek to prescribe the lowest effective dose of any medication"). "[t]he test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art." See In re Keller, 642 F.2d 413, 425 (CCPA 1981).
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 25-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 17-20, 28-33 and 36 of U.S. Patent No. 11,103,552 in view of WO 2012/097019 (Yancopoulos). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of ‘552 in view of Yancopoulos.
‘552 is directed to a method of treating an angiogenic eye disorder in a subject in need thereof (claim 17) wherein the angiogenic eye disorder is diabetic macular edema (claim 36) by administering an aqueous pharmaceutical formulation comprising aflibercept (claim 1), wherein about 8 mg is administered (claims 18, 29 and 33) and wherein the formulation of ‘552 is of the same scope as that of the instant claims. ‘552 does not claim a particular dosing regimen as recited in the instant claims but does claim administration wherein the fusion protein is administered every 8-24 weeks. However, the dosing regimen of the instant claims would have been obvious over the claims of ‘552 in view of Yancopoulos for the reasons provided above in the 103 rejection. Therefore, the instant claims are not patentably distinct from those of ‘552 in view of Yancopoulos.
Claims 25-37, 41, 42, 46-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 16-17, 27, 29, 31, 33, 35 and 37 of U.S. Patent No. 12,168,036 in view of WO 2012/097019 (Yancopoulos). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious over the claims of ‘036 in view of Yancopoulos.
‘036 is directed to a method of treating an angiogenic eye disorder in a subject in need thereof (claim 1) wherein the angiogenic eye disorder is diabetic macular edema (claim 16, 29, 33 and 37) by administering an aqueous pharmaceutical formulation comprising aflibercept (claim 12), wherein about 8 mg is administered (claims 1). ‘036 does not claim a particular dosing regimen as recited in the instant claims. However, the dosing regimen of the instant claims would have been obvious over the claims of ‘036 in view of Yancopoulos for the reasons provided above in the 103 rejection. Therefore, the instant claims are not patentably distinct from those of ‘036 in view of Yancopoulos.
Claims 25-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-54 of copending Application No. 18/121,499 (reference application) in view of WO 2012/097019 (Yancopoulos). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to treatment of angiogenic eye disease with the exact same therapeutic agent and formulations with the exact same dosing regimen. The difference between the claims of the instant application and the claims of ‘499 is that the instant claims are directed to treating diabetic macular edema (DME) while the claims of ‘499 are directed to treating neovascular age-related macular degeneration (nAMD). While the conditions which are being treated are distinct, the instant claims directed to treating DME would have been obvious over the claims of ‘499 because the prior art of Yancopoulos teaches that angiogenic eye diseases in general and including both DME and nAMD can be treated by administration of a VEGF antagonist (e.g. aflibercept) (see [0001] of Yancopoulos). Therefore, the instantly claimed method of treating DME would have been obvious over the claims of ‘499 directed to treating nAMD because the method of ‘499 is applicable to any and all angiogenic eye diseases as taught by Yancopoulos. Therefore, the instant claims are not patentably distinct from those of ‘499.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 25-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 7, 11-12, 18-25, 28-35, 37-40 of copending Application No. 18/021,802 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of the instant claims are anticipated by the claims of ‘802. The claims of the instant application and those of ‘802 administer the same compositions for the same purpose, treatment of angiogenic eye disorders. While the instant claims are limited to diabetic macular edema (DME), the claims of ‘802 necessarily include treatment of DME (see claims 12 and 31 of ‘802). The claims of ‘802 recite that particular therapeutic outcomes are to be achieved by the method of treatment which are not recited in the instant claims, however, because the same compounds/compositions are being administered to the same patient population, these outcomes would also be realized by the subjects of the instant claims. The claims of ‘802 recite that the tertiary dose is administered about 4, 8 or 12 weeks after the immediately preceding dose while the instant claims recite this interval as being about 13-16 weeks (+/- 5 days). However, the recited ranges overlap at the upper end of ‘802 and the lower end of the instant range. Addtionally, the instant claimed interval for the tertiary administration of 13-16 weeks would have been obvious in view of the claims of ‘802 because it would have been well within the skill of the artisan at the time of the instant invention to explore various interval timings and arrive at the claimed range with a reasonable expectation of success. In addition, dosage amounts or concentrations of drugs and length of administrations etc., are result effective variables, because a skilled person in the art determines these variables through a routine experimentation and which is common practice in the art, absent evidence to the contrary. One of ordinary skill in the art would have been motivated to extend the interval of the tertiary administration because intraocular injections are uncomfortable and require in person visits to the physician who is administering the treatment and increasing the interval would be advantageous for this reason. Therefore, the instant claims are not patentably distinct from those of ‘802.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 25-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 8, 13, 20-27, 33, 35, 38, 40-42, 45, 47, 49, 50, 52-67, 74-77, 79-83 of copending Application No. 18/751,087 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. Both sets of claims are generally directed to methods of treating angiogenic eye disorders including diabetic macular edema, the method comprising administering a high dose (including 8 mg) of a VEGF receptor fusion protein such as aflibercept at repeated intervals. The main difference between the claim sets is a difference in dosing frequency. The instant claim set recites a single initial dose, followed by one or more secondary doses about 2-4 weeks after the immediately preceding dose, followed by one or more tertiary doses about 13-16 weeks after the immediately preceding dose. The copending claims recite a different range of dosing frequencies, but include, a single initial dose followed by one or more
secondary doses about 2, 3, or 4 weeks after the immediately preceding dose, followed by one or more tertiary doses at about 16-24 weeks after the immediately preceding dose. Since the copending clams specifically recite an alternative that is also recited in the alternative in the instant claims, the copending claims fairly suggest the instant claims, at least regarding those alternatives. The claim sets also differ in that ‘087 recites effects achieved by the administrations. However, since the copending claims fairly suggest administering the same active agent to treat the same diseases, it can be assumed that the effects of the administrations would have been inherent to the method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 25-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 62-66, 69, 73, 77 and 81 of copending Application No. 18/367,444 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. Both sets of claims are generally directed to methods of treating angiogenic eye disorders including diabetic macular edema, the method comprising administering about 8 mg of a VEGF receptor fusion protein (aflibercept). ‘444 does not claim a particular dosing regimen as recited in the instant claims. However, the dosing regimen of the instant claims would have been obvious over the claims of ‘444 in view of Yancopoulos for the reasons provided above in the 103 rejection. Therefore, the instant claims are not patentably distinct from those of ‘444 in view of Yancopoulos.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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, 8am-4pm.
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/Christine J Saoud/Primary Examiner, Art Unit 1645
Prosecution Insights