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 .
Detailed Action
Claims 1, 3-17, 19-20, 34, and 65 are currently pending.
Specification
The specification is objected to because Table 2 recites “Triamcinolone (TA)” in the title thereof (Page 34). Para 29, however, recites “triamcinolone acetonide (TA)”. The contradiction creates ambiguity between what structure “TA” refers to. Although similar, triamcinolone
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and triamcinolone acetonide
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are in fact distinct structures. Applicant must correct or clarify or standardize the use of TA with respect to either compound because the TA is said to refer to the latter but is used in the specification to refer to the former structure as well.
Claim Interpretation
Claim 1 recites “triamcinolone”, but Claim 4 depending on Claim 1 states “the triamcinolone [
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] is triamcinolone acetonide [
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]”. These compounds are distinct but share a similar structure and use case. Further, the specification states “In some embodiments, the triamcinolone is triamcinolone acetonide” (Para 0007). Therefore, “triamcinolone” as stated in Claim 1 is interpreted to encompass both compounds triamcinolone and triamcinolone acetonide despite structural dissimilarities. No 112(d) issue is raised with respect to Claim 4 or claims dependent thereupon as a result.
Claim Objections
Claims 34 and 65 are objected to because of the following informalities:
Claims 34 and 65 recite “BCVA”. It is recommended applicant, at least in the first instance, amend “BCVA” to instead read “Best-Corrected Visual Acuity (BCVA)”.
Claim 65 recites “50 years old of age”. The phrase should be corrected to “50 years old” or “50 years of age”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1, 3-17, 19-20, 34, and 65 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 regards as the invention.
Claims 1, 34 (Line 4), and 65 recite “the eye”. There is insufficient antecedent basis for this limitation in the claim. No eye is described before the cited phrase in each of the three independent claims. Humans possess two eyes generally, and either eye may be subject to treatment in the subject in need thereof. Applicant is recommended to amend “the eye” to “an eye” in the appropriate claims. Claims 3-17, 19-20 are rejected by virtue of dependency.
Claims 1 and 65 (Line 4, first instance) recite “the human subject”. There is insufficient antecedent basis for this limitation in the claim. No “human subject” is described prior to the cited phrase in the independent claims. Applicant only describes “a subject” and it is unclear whether said subject is necessarily a “human subject” as written in the cited claims. Claims 3-17 and 19-20 are rejected by virtue of dependency.
Claim 17 reads “the method decreases retina thickness and/or macula thickness relative to a subject that did not receive the triamcinolone drug formulation”. It is unclear whether applicant is claiming 1) the total decrease, or change in thickness, is greater than that of an untreated subject or that 2) the absolute thickness of retina/macula of the treated patient is less than the untreated patient following treatment. At least two metes and bounds can be read from the claim as written, therefore the metes and bounds of the claim are not established and the claim is indefinite.
Claim 19 uses the phrase “the last dose”. The phrase lacks antecedent basis because no “last dose” is recited in Claims 1 or 16, upon which Claim 19 depends. Multiple doses are referenced in Claim 8, however.
Claim 20 uses the phrase “the first dose”. The phrase lacks antecedent basis because no “first dose” is recited in Claims 1 or 16, upon which Claim 20 depends. Multiple doses are referenced in Claim 8, however.
Claim 34 recites “the last dose”. No “last dose” is described or implied in the method of independent Claim 34. Therefore it is unclear what “last dose” refers to and the phrase lacks antecedent basis.
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.
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 1, 3-17, 19-20, and 34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by White (US20190269702, 7/29/2024 IDS).
White teaches “A method of treating macular edema associated with uveitis in a subject in need thereof, the method comprising non-surgically administering an effective amount of a first dose of a triamcinolone drug formulation to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment” (Claim 1). 4 mg is administered (Claim 2 and 33). The uveitis is noninfectious and of the pan, intermediate, or posterior variety (Claims 6-7). “[T]he method comprises administering two doses of the triamcinolone drug formulation to the SCS of the eye of the subject, wherein the two doses of the triamcinolone drug formulation are administered about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or 17 weeks apart” (Claim 3. See also Claim 34). The methods comprise achieving a durable clinical outcome by decreasing retina or macula thickness by “at least about 20 pm, at least about 40 pm, at least about 50 pm, at least about 100 pm, at least about 150 pm, or at least about 200 pm”, relative to a baseline measurement of the subject before injection, and “relative to a subject that did not receive” treatment (Claims 10-11, 14, and 28-29). The decrease lasts for 36 or 48 weeks following the last and first dose (Claims 10-11, 14, and 28-29). It is also taught that administration “increases a Best Corrected Visual Acuity (BCVA) of the subject relative to a baseline measurement prior to treatment of the subject with triamcinolone drug formulation” and relative to an untreated subject, wherein the increase “is a gain of about 5, about 6, about 7, about 8, about 9, about 10, about 12, about 14, about 15, or more letters” and lasts for at least 36 following the first or last dose or 48 weeks following the first dose (Claims 19-20, 22, 24, and 28-29).
Regarding the particular formulation, White teaches Examples 1-3 (Starting Page 24) with particular formulations of specific forms and amounts in Table 2 of Page 24. Formulation A comprises triamcinolone in the form of triamcinolone acetonide in an amount of 40mg/mL wherein the particle size is D50 of 2um (less than 3um), 0.02% (w/v) polysorbate 80, and 0.5% (w/v) carboxymethylcellulose sodium.
Regarding the two doses, the first dose was administered at day 0 and week 12 (Para 206-207). Also described as an embodiment which is “highly effective, to a highly statistically significant degree compared to control treated patients” is administration of 4mg as follows: “at least two dosing sessions spaced about 90 days apart” (Para 224). Further, 90 days is 12.8 weeks (90days/7days per week), which falls in the range established by applicant by the limitation “about 12 weeks”. Applicant states in Para 46 of the instant specification that "about" and "approximately" generally mean plus or minus 10% of the value stated. 12 weeks +/- 10% of said value is 10.8 to 13.2 weeks, which encompasses 90 days or 12.8 weeks.
Regarding the subjects, inclusion criteria for the patients to be treated in the above examples includes a visual acuity score of greater than 5 or less than 70 letters (Para 212).
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 65 is rejected under 35 U.S.C. 103 as being unpatentable over White (US20190269702, 7/29/2024 IDS).
White teaches “A method of treating macular edema associated with uveitis in a subject in need thereof, the method comprising non-surgically administering an effective amount of a first dose of a triamcinolone drug formulation to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment” (Claim 1). 4 mg is administered (Claim 2 and 33). The uveitis is noninfectious and of the pan, intermediate, or posterior variety (Claims 6-7). “[T]he method comprises administering two doses of the triamcinolone drug formulation to the SCS of the eye of the subject, wherein the two doses of the triamcinolone drug formulation are administered about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or 17 weeks apart” (Claim 3. See also Claim 34). The methods comprise achieving a durable clinical outcome by decreasing retina or macula thickness by “at least about 20 pm, at least about 40 pm, at least about 50 pm, at least about 100 pm, at least about 150 pm, or at least about 200 pm”, relative to a baseline measurement of the subject before injection, and “relative to a subject that did not receive” treatment (Claims 10-11, 14, and 28-29). The decrease lasts for 36 or 48 weeks following the last and first dose (Claims 10-11, 14, and 28-29). It is also taught that administration “increases a Best Corrected Visual Acuity (BCVA) of the subject relative to a baseline measurement prior to treatment of the subject with triamcinolone drug formulation” and relative to an untreated subject, wherein the increase “is a gain of about 5, about 6, about 7, about 8, about 9, about 10, about 12, about 14, about 15, or more letters” and lasts for at least 36 following the first or last dose or 48 weeks following the first dose (Claims 19-20, 22, 24, and 28-29).
Regarding the particular formulation, White teaches Examples 1-3 (Starting Page 24) with particular formulations of specific forms and amounts in Table 2 of Page 24. Formulation A comprises triamcinolone in the form of triamcinolone acetonide in an amount of 40mg/mL wherein the particle size is D50 of 2um (less than 3um), 0.02% (w/v) polysorbate 80, and 0.5% (w/v) carboxymethylcellulose sodium.
Regarding the two doses, the first dose was administered at day 0 and week 12 (Para 206-207). Also described as an embodiment which is “highly effective, to a highly statistically significant degree compared to control treated patients” is administration of 4mg as follows: “at least two dosing sessions spaced about 90 days apart” (Para 224). Further, 90 days is 12.8 weeks (90days/7days per week), which falls in the range established by applicant by the limitation “about 12 weeks”. Applicant states in Para 46 of the instant specification that "about" and "approximately" generally mean plus or minus 10% of the value stated. 12 weeks +/- 10% of said value is 10.8 to 13.2 weeks, which encompasses 90 days or 12.8 weeks.
Regarding the subjects, inclusion criteria for the patients to be treated in the above examples includes a visual acuity score of greater than 5 or less than 70 letters (Para 212).
White does not teach the claimed patient population of 50+ years of age.
White does teach “Uveitis…can affect both eyes and is often initially diagnosed in individuals 20 to 50 years” (Para 3). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05 (I). The age 50 years is common to both populations.
One of skill in the art seeking to treat a patient of 50 years old, an age which is taught to be susceptible to uveitis, the condition with which macular edema is associated in the instant claim, would find it obvious to treat the macular edema associated with said condition in said patient because the patient age of 50 is taught by White to be a relevant patient group with respect to the methods described above before the effective filing date of the instant invention. One would expect success in treating a 50-year-old patient because White identifies such a patient as potentially having the condition to be treated and does not disavow or preclude the age group from treatment by the above White methods.
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.
PROVISIONAL:
1. Claims 1, 3-14, 16, 19-20, and 34 are provisionally rejected on the grounds of anticipatory-type nonstatutory double patenting as being unpatentable over Claims 55-80 and 84-86 of copending Application No. 17478112 (hereinafter referred to as Clearside).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating macular edema associated with noninfectious intermediate, posterior, and panuveitis in a human via non-surgical (30-gauge needle; see instant specification, Para 1018) SCS administration of 4mg triamcinolone acetonide formulated as 40mg/mL, D50 of 3um or less, with 0.02% (w/v) polysorbate 80 and 0.5% (w/v) carboxymethylcellulose sodium in two separate doses administered 12 weeks apart to achieve decreased CST (macular/retina) thickness by at least about 100um compared to a baseline measurement and increased visual acuity scores by 15 letters compared to a baseline measurement for at least 48 weeks.
Clearside does not teach lasting reduction for 48 weeks with respect to the first or second dose, particularly. However, 48 weeks from day 0 or week 12 satisfies both claim limitations “at least 48 weeks following the first dose” and “at least 36 weeks following the last dose” (week 0 + 48 weeks = 48 weeks; 12 weeks between a first and second dose + 36 weeks following = 48 weeks).
Clearside teaches 12 weeks between doses which is 84 days, which is encompassed by applicant’s range of “about 90 days” of instant Claim 11. Applicant states in Para 46 of the instant specification that "about" and "approximately" generally mean plus or minus 10% of the value stated. 90 +/- 10% is 81-99days, encompassing the 84 days equal to 12 weeks.
This is a provisional nonstatutory double patenting rejection.
2. Claims 1, 3-17, 19-20, 34, and 65 are provisionally rejected on the grounds of obviousness-type nonstatutory double patenting as being unpatentable over Claims 55-80 and 84-86 of copending Application No. 17478112 (hereinafter referred to as Clearside) in view of White (US20190269702, 7/29/2024 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating macular edema associated with noninfectious intermediate, posterior, and panuveitis in a human via non-surgical (30-gauge needle; see instant specification, Para 1018) SCS administration of 4mg triamcinolone acetonide formulated as 40mg/mL, D50 of 3um or less, with 0.02% (w/v) polysorbate 80 and 0.5% (w/v) carboxymethylcellulose sodium in two separate doses administered 12 weeks apart to achieve decreased CST (macular/retina) thickness by at least about 100um compared to a baseline measurement and increased visual acuity scores by 15 letters compared to a baseline measurement for at least 48 weeks.
Clearside does not teach lasting reduction for 48 weeks with respect to the first or second dose, particularly. However, 48 weeks from day 0 or week 12 satisfies both claim limitations “at least 48 weeks following the first dose” and “at least 36 weeks following the last dose” (week 0 + 48 weeks = 48 weeks; 12 weeks between a first and second dose + 36 weeks following = 48 weeks).
Clearside teaches 12 weeks between doses which is 84 days, which is encompassed by applicant’s range of “about 90 days” of instant Claim 11. Applicant states in Para 46 of the instant specification that "about" and "approximately" generally mean plus or minus 10% of the value stated. 90 +/- 10% is 81-99days, encompassing the 84 days equal to 12 weeks.
Clearside does not teach the durable outcomes as compared to “a subject that did not receive” treatment, patient visual acuity score, or a particular age group.
White teaches the same methods with the same formulation “of treating macular edema associated with uveitis in a subject in need thereof, the method comprising non-surgically administering an effective amount of a first dose of a triamcinolone drug formulation to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment” (Claim 1). 4 mg is administered (Claim 2 and 33). The uveitis is noninfectious and of the pan, intermediate, or posterior variety (Claims 6-7). Regarding the particular formulation, White teaches Examples 1-3 with particular formulations with specific forms in amounts in Table 2 of 24. Formulation A comprises triamcinolone in the form of triamcinolone acetonide in an amount of 40mg/mL wherein the particle size is D50 of 2um (less than 3um), 0.02% (w/v) polysorbate 80, and 0.5% (w/v) carboxymethylcellulose sodium. “[T]he method comprises administering two doses of the triamcinolone drug formulation to the SCS of the eye of the subject, wherein the two doses of the triamcinolone drug formulation are administered about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or 17 weeks apart” (Claim 3. See also Claim 34). The methods comprise achieving a durable clinical outcome by decreasing retina or macula thickness by “at least about 20 pm, at least about 40 pm, at least about 50 pm, at least about 100 pm, at least about 150 pm, or at least about 200 pm”, relative to a baseline measurement of the subject before injection, and “relative to a subject that did not receive” treatment (Claims 10-11, 14, and 28-29). The decrease lasts for 36 or 48 weeks (Claims 10-11, 14, and 28-29). It is also taught that administration “increases a Best Corrected Visual Acuity (BCVA) of the subject relative to a baseline measurement prior to treatment of the subject with triamcinolone drug formulation” and relative to an untreated subject, wherein the increase “is a gain of about 5, about 6, about 7, about 8, about 9, about 10, about 12, about 14, about 15, or more letters” and lasts for at least 36 following the first or last dose or 48 weeks following the first dose (Claims 19-20, 22, 24, and 28-29). Regarding the subjects, inclusion criteria for the patients to be treated in the above examples includes a visual acuity score of greater than 5 or less than 70 letters (Para 212).
White does teach “Uveitis, which can affect both eyes and is often initially diagnosed in individuals 20 to 50 years” (Para 3). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05 (I). The age 50 years is common to both populations.
One of skill in the art seeking to treat a patients of white, including those of 50 years old, an age which is taught to be susceptible to uveitis, the condition with which macular edema is associated in the instant claim, would find it obvious to treat the macular edema associated with said condition in said patient because the patient age of 50 is taught by White to be a relevant patient group with respect to the methods described above. One would expect success in treating a 50-year-old patient with the Clearside/White methods because White identifies such a patient as potentially having the condition to be treated and does not disavow or preclude the age group from treatment by the above methods taught by both White and Clearside.
Since both applications teach methods of treating macular edema with uveitis with the same nonsurgical means and formulations of triamcinolone acetonide, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Clearside.
This is a provisional nonstatutory double patenting rejection.
3. Claims 1, 3-17, 19-20, 34, and 65 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 74-93 of copending Application No. 19301455 (hereinafter referred to as Clearside) in view of White (US20190269702, 7/29/2024 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating macular edema associated with uveitis via non-surgical (30-gauge needle; see instant specification, Para 1018) SCS administration of triamcinolone acetonide formulated as 40mg/mL, D50 of 3um or less, with polysorbate 80 and carboxymethylcellulose sodium.
Regarding the kits of copending Claims 92-93, In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context with respect to the examined methods. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). See MPEP 804 (II) (B) (1).
Clearside does not teach a particular variety of uveitis, a human subject, % amounts of excipients, 4mg API, two separate doses, patient age, or durable outcomes related to visual acuity scores and macula/retina thickness.
White teaches “A method of treating macular edema associated with uveitis in a subject in need thereof, the method comprising non-surgically administering an effective amount of a first dose of a triamcinolone drug formulation to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment” (Claim 1). 4 mg is administered (Claim 2 and 33). The uveitis is noninfectious and of the pan, intermediate, or posterior variety (Claims 6-7). “[T]he method comprises administering two doses of the triamcinolone drug formulation to the SCS of the eye of the subject, wherein the two doses of the triamcinolone drug formulation are administered about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or 17 weeks apart” (Claim 3. See also Claim 34). The methods comprise achieving a durable clinical outcome by decreasing retina or macula thickness by “at least about 20 pm, at least about 40 pm, at least about 50 pm, at least about 100 pm, at least about 150 pm, or at least about 200 pm”, relative to a baseline measurement of the subject before injection, and “relative to a subject that did not receive” treatment (Claims 10-11, 14, and 28-29). The decrease lasts for 36 or 48 weeks (Claims 10-11, 14, and 28-29). It is also taught that administration “increases a Best Corrected Visual Acuity (BCVA) of the subject relative to a baseline measurement prior to treatment of the subject with triamcinolone drug formulation” and relative to an untreated subject, wherein the increase “is a gain of about 5, about 6, about 7, about 8, about 9, about 10, about 12, about 14, about 15, or more letters” and lasts for at least 36 following the first or last dose or 48 weeks following the first dose (Claims 19-20, 22, 24, and 28-29).
Regarding the particular formulation, White teaches Examples 1-3 with particular formulations with specific forms in amounts in Table 2 of 24. Formulation A comprises triamcinolone in the form of triamcinolone acetonide in an amount of 40mg/mL wherein the particle size is D50 of 2um (less than 3um), 0.02% (w/v) polysorbate 80, and 0.5% (w/v) carboxymethylcellulose sodium.
Regarding the two doses, the first dose was administered at day 0 and week 12 (Para 206-207). Also described as an embodiment which is “highly effective, to a highly statistically significant degree compared to control treated patients” is administration as follows: “at least two dosing sessions spaced about 90 days apart” (Page 224). Further, 90 days is 12.8 weeks (90days/7days per week), which falls in the range established by applicant by the limitation “about 12 weeks”. Applicant states in Para 46 of the instant specification that "about" and "approximately" generally mean plus or minus 10% of the value stated. 12 weeks +/- 10% of said value is 10.8 to 13.2 weeks, which encompasses 90 days or 12.8 weeks.
Regarding the subjects, inclusion criteria for the patients to be treated in the above examples includes a visual acuity score of greater than 5 or less than 70 letters (Para 212).
One of skill in the art seeking to treat the same or more narrow conditions as described in White would find it obvious to use the more narrow methods and particular regimens described therein by applying the conditions to the more general methods of Clearside because one would be motivated to achieve the “durable outcomes” as compared to baseline measurements and such conditions are described as “highly effective, to a highly statistically significant degree compared to control treated patients” by White. One would expect success in practicing the narrower scope of the methods because the White conditions are effective and encompassed by the bounds of the methods taught in Clearside.
White further teaches “Uveitis, which can affect both eyes and is often initially diagnosed in individuals 20 to 50 years” (Para 3). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05 (I). The age 50 years is common to both populations.
One of skill in the art seeking to treat a patient of 50 years old, an age which is taught to be susceptible to uveitis, the condition with which macular edema is associated in the instant claim, would find it obvious to treat the macular edema associated with said condition in said patient because the patient age of 50 is taught by White to be a relevant patient group with respect to the methods described above in Clearside and White. One would expect success in treating a 50-year-old patient because White identifies such a patient as potentially having the condition to be treated and does not disavow or preclude the age group from treatment by the above methods.
Since both applications teach methods of treating macular edema with uveitis with nonsurgical means and formulations of triamcinolone acetonide, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Clearside.
This is a provisional nonstatutory double patenting rejection.
NONPROVISIONAL:
1. Claims 1, 3-17, 19-20, 34, and 65 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1 and 3-12 of U.S. Patent No. 9931330 (hereinafter referred to as Clearside) in view of White (US20190269702, 7/29/2024 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating macular edema via nonsurgical SCS administration of triamcinolone acetonide.
Clearside does not teach a macular edema associated with uveitis, particular patient and administration conditions claimed in the examined claims, or durable outcomes related to visual acuity scores and macula/retina thickness.
White teaches “A method of treating macular edema associated with uveitis in a subject in need thereof, the method comprising non-surgically administering an effective amount of a first dose of a triamcinolone drug formulation to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment” (Claim 1). 4 mg is administered (Claim 2 and 33). The uveitis is noninfectious and of the pan, intermediate, or posterior variety (Claims 6-7). “[T]he method comprises administering two doses of the triamcinolone drug formulation to the SCS of the eye of the subject, wherein the two doses of the triamcinolone drug formulation are administered about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or 17 weeks apart” (Claim 3. See also Claim 34). The methods comprise achieving a durable clinical outcome by decreasing retina or macula thickness by “at least about 20 pm, at least about 40 pm, at least about 50 pm, at least about 100 pm, at least about 150 pm, or at least about 200 pm”, relative to a baseline measurement of the subject before injection, and “relative to a subject that did not receive” treatment (Claims 10-11, 14, and 28-29). The decrease lasts for 36 or 48 weeks (Claims 10-11, 14, and 28-29). It is also taught that administration “increases a Best Corrected Visual Acuity (BCVA) of the subject relative to a baseline measurement prior to treatment of the subject with triamcinolone drug formulation” and relative to an untreated subject, wherein the increase “is a gain of about 5, about 6, about 7, about 8, about 9, about 10, about 12, about 14, about 15, or more letters” and lasts for at least 36 following the first or last dose or 48 weeks following the first dose (Claims 19-20, 22, 24, and 28-29).
Regarding the particular formulation, White teaches Examples 1-3 with particular formulations with specific forms in amounts in Table 2 of 24. Formulation A comprises triamcinolone in the form of triamcinolone acetonide in an amount of 40mg/mL wherein the particle size is D50 of 2um (less than 3um), 0.02% (w/v) polysorbate 80, and 0.5% (w/v) carboxymethylcellulose sodium.
Regarding the two doses, the first dose was administered at day 0 and week 12 (Para 206-207). Also described as an embodiment which is “highly effective, to a highly statistically significant degree compared to control treated patients” is administration as follows: “at least two dosing sessions spaced about 90 days apart” (Page 224). Further, 90 days is 12.8 weeks (90days/7days per week), which falls in the range established by applicant by the limitation “about 12 weeks”. Applicant states in Para 46 of the instant specification that "about" and "approximately" generally mean plus or minus 10% of the value stated. 12 weeks +/- 10% of said value is 10.8 to 13.2 weeks, which encompasses 90 days or 12.8 weeks.
Regarding the subjects, inclusion criteria for the patients to be treated in the above examples includes a visual acuity score of greater than 5 or less than 70 letters (Para 212).
One of skill in the art seeking to treat the same or more narrow conditions as described in White would find it obvious to use the more narrow methods and particular regimens described therein by applying the specific conditions to the more general methods of Clearside because one would be motivated to achieve the “durable outcomes” as compared to baseline measurements and such specific conditions are described as “highly effective, to a highly statistically significant degree compared to control treated patients” by White. One would expect success in practicing the narrower scope of the methods because the White conditions are effective and they are encompassed by the bounds of the methods taught in Clearside.
White further teach “Uveitis, which can affect both eyes and is often initially diagnosed in individuals 20 to 50 years” (Para 3). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05 (I). The age 50 years is common to both populations.
One of skill in the art seeking to treat a patient of 50 years old, an age which is taught to be susceptible to uveitis, the condition with which macular edema is associated in the instant claim, would find it obvious to treat the macular edema associated with said condition in said patient because the patient age of 50 is taught by White to be a relevant patient group with respect to the methods described above in Clearside and White. One would expect success in treating a 50-year-old patient because White identifies such a patient as potentially having the condition to be treated and does not disavow or preclude the age group from treatment by the above methods.
Since both claim sets teach treating macular edema with SCS administration and formulations of triamcinolone acetonide, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Clearside.
2. Claims 1, 3-17, 19-20, 34, and 65 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-17 of U.S. Patent No. 9636332 (hereinafter referred to as Clearside) in view of White (US20190269702, 7/29/2024 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating posterior uveitis via nonsurgical SCS administration of triamcinolone acetonide with microparticles of D50 of 2um or less.
Clearside does not teach a macular edema associated with uveitis, particular patient and administration conditions claimed in the examined claims, or durable outcomes related to visual acuity scores and macula/retina thickness.
White teaches “A method of treating macular edema associated with uveitis in a subject in need thereof, the method comprising non-surgically administering an effective amount of a first dose of a triamcinolone drug formulation to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment” (Claim 1). 4 mg is administered (Claim 2 and 33). The uveitis is noninfectious and of the pan, intermediate, or posterior variety (Claims 6-7). “[T]he method comprises administering two doses of the triamcinolone drug formulation to the SCS of the eye of the subject, wherein the two doses of the triamcinolone drug formulation are administered about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or 17 weeks apart” (Claim 3. See also Claim 34). The methods comprise achieving a durable clinical outcome by decreasing retina or macula thickness by “at least about 20 pm, at least about 40 pm, at least about 50 pm, at least about 100 pm, at least about 150 pm, or at least about 200 pm”, relative to a baseline measurement of the subject before injection, and “relative to a subject that did not receive” treatment (Claims 10-11, 14, and 28-29). The decrease lasts for 36 or 48 weeks (Claims 10-11, 14, and 28-29). It is also taught that administration “increases a Best Corrected Visual Acuity (BCVA) of the subject relative to a baseline measurement prior to treatment of the subject with triamcinolone drug formulation” and relative to an untreated subject, wherein the increase “is a gain of about 5, about 6, about 7, about 8, about 9, about 10, about 12, about 14, about 15, or more letters” and lasts for at least 36 following the first or last dose or 48 weeks following the first dose (Claims 19-20, 22, 24, and 28-29).
Regarding the particular formulation, White teaches Examples 1-3 with particular formulations with specific forms in amounts in Table 2 of 24. Formulation A comprises triamcinolone in the form of triamcinolone acetonide in an amount of 40mg/mL wherein the particle size is D50 of 2um (less than 3um), 0.02% (w/v) polysorbate 80, and 0.5% (w/v) carboxymethylcellulose sodium.
Regarding the two doses, the first dose was administered at day 0 and week 12 (Para 206-207). Also described as an embodiment which is “highly effective, to a highly statistically significant degree compared to control treated patients” is administration as follows: “at least two dosing sessions spaced about 90 days apart” (Page 224). Further, 90 days is 12.8 weeks (90days/7days per week), which falls in the range established by applicant by the limitation “about 12 weeks”. Applicant states in Para 46 of the instant specification that "about" and "approximately" generally mean plus or minus 10% of the value stated. 12 weeks +/- 10% of said value is 10.8 to 13.2 weeks, which encompasses 90 days or 12.8 weeks.
Regarding the subjects, inclusion criteria for the patients to be treated in the above examples includes a visual acuity score of greater than 5 or less than 70 letters (Para 212).
One of skill in the art seeking to treat uveitis or macular edema which is a condition known to be associated therewith as taught in White would find it obvious to use the more narrow methods and particular regimens described therein by applying the specific conditions to the more general methods of Clearside because one would be motivated to achieve the “durable outcomes” as compared to baseline measurements in treating macular edema as claimed and such specific treatment conditions are described as “highly effective, to a highly statistically significant degree compared to control treated patients” by White. One would expect success in practicing the narrower scope of the methods directed to macular edema associated with the particular forms of uveitis, especially posterior uveitis specifically taught in Clearside, because the White conditions are effective and they are encompassed by the bounds of the broader methods taught in Clearside.
White further teach “Uveitis, which can affect both eyes and is often initially diagnosed in individuals 20 to 50 years” (Para 3). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05 (I). The age 50 years is common to both populations.
One of skill in the art seeking to treat a patient of 50 years old, an age which is taught to be susceptible to uveitis, the condition with which macular edema is associated in the instant claim, would find it obvious to treat the macular edema associated with said condition in said patient because the patient age of 50 is taught by White to be a relevant patient group with respect to the methods described above in Clearside and White. One would expect success in treating a 50-year-old patient because White identifies such a patient as potentially having the condition to be treated and does not disavow or preclude the age group from treatment by the above methods.
Since both claim sets teach treating uveitis with SCS administration and formulations of triamcinolone acetonide, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Clearside.
3. Claims 1, 3-17, 19-20, 34, and 65 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-17, 20, and 23-26 of U.S. Patent No. 12419833 (hereinafter referred to as Clearside) in view of White (US20190269702, 7/29/2024 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating macular edema via SCS administration of triamcinolone acetonide formulated as 40mg/mL, D50 of 3um or less, with 0.5% w/v of carboxy methylcellulose sodium, 0.02% w/v of polysorbate 80.
Regarding the compositions of copending claims, In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context with respect to the examined methods. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). See MPEP 804 (II) (B) (1).
Clearside does not teach a macular edema associated with uveitis, a human subject, non-surgical means, 4mg API, two separate doses, patient age, or durable outcomes related to visual acuity scores and macula/retina thickness.
White teaches “A method of treating macular edema associated with uveitis in a subject in need thereof, the method comprising non-surgically administering an effective amount of a first dose of a triamcinolone drug formulation to the suprachoroidal space (SCS) of the eye of the human subject in need of treatment” (Claim 1). 4 mg is administered (Claim 2 and 33). The uveitis is noninfectious and of the pan, intermediate, or posterior variety (Claims 6-7). “[T]he method comprises administering two doses of the triamcinolone drug formulation to the SCS of the eye of the subject, wherein the two doses of the triamcinolone drug formulation are administered about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, or 17 weeks apart” (Claim 3. See also Claim 34). The methods comprise achieving a durable clinical outcome by decreasing retina or macula thickness by “at least about 20 pm, at least about 40 pm, at least about 50 pm, at least about 100 pm, at least about 150 pm, or at least about 200 pm”, relative to a baseline measurement of the subject before injection, and “relative to a subject that did not receive” treatment (Claims 10-11, 14, and 28-29). The decrease lasts for 36 or 48 weeks (Claims 10-11, 14, and 28-29). It is also taught that administration “increases a Best Corrected Visual Acuity (BCVA) of the subject relative to a baseline measurement prior to treatment of the subject with triamcinolone drug formulation” and relative to an untreated subject, wherein the increase “is a gain of about 5, about 6, about 7, about 8, about 9, about 10, about 12, about 14, about 15, or more letters” and lasts for at least 36 following the first or last dose or 48 weeks following the first dose (Claims 19-20, 22, 24, and 28-29).
Regarding the particular formulation, White teaches Examples 1-3 with particular formulations with specific forms in amounts in Table 2 of 24. Formulation A comprises triamcinolone in the form of triamcinolone acetonide in an amount of 40mg/mL wherein the particle size is D50 of 2um (less than 3um), 0.02% (w/v) polysorbate 80, and 0.5% (w/v) carboxymethylcellulose sodium.
Regarding the two doses, the first dose was administered at day 0 and week 12 (Para 206-207). Also described as an embodiment which is “highly effective, to a highly statistically significant degree compared to control treated patients” is administration as follows: “at least two dosing sessions spaced about 90 days apart” (Page 224). Further, 90 days is 12.8 weeks (90days/7days per week), which falls in the range established by applicant by the limitation “about 12 weeks”. Applicant states in Para 46 of the instant specification that "about" and "approximately" generally mean plus or minus 10% of the value stated. 12 weeks +/- 10% of said value is 10.8 to 13.2 weeks, which encompasses 90 days or 12.8 weeks.
Regarding the subjects, inclusion criteria for the patients to be treated in the above examples includes a visual acuity score of greater than 5 or less than 70 letters (Para 212).
One of skill in the art seeking to treat the same or more narrow conditions as described in White would find it obvious to use the more narrow methods and particular regimens described therein by applying the conditions to the more general methods of Clearside because one would be motivated to achieve the “durable outcomes” as compared to baseline measurements and such specific conditions are described as “highly effective, to a highly statistically significant degree compared to control treated patients” by White. One would expect success in practicing the narrower scope of the methods because the White conditions are effective and encompassed by the bounds of the methods taught in Clearside.
White further teach “Uveitis, which can affect both eyes and is often initially diagnosed in individuals 20 to 50 years” (Para 3). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP 2144.05 (I). The age 50 years is common to both populations.
One of skill in the art seeking to treat a patient of 50 years old, an age which is taught to be susceptible to uveitis, the condition with which macular edema is associated in the instant claim, would find it obvious to treat the macular edema associated with said condition in said patient because the patient age of 50 is taught by White to be a relevant patient group with respect to the methods described above in Clearside and White. One would expect success in treating a 50-year-old patient because White identifies such a patient as potentially having the condition to be treated and does not disavow or preclude the age group from treatment by the above methods.
Since both claim sets teach treating macular edema with SCS administration and formulations of triamcinolone acetonide, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Clearside.
Conclusion
No claim is allowable.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
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