DETAILED ACTION
Status of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-8 are pending and are included in the prosecution.
Response to Arguments
The remarks filed 5/28/2026 have been fully considered and are persuasive in overcoming the prior art rejections, in particular the arguments on page 6 of the remarks which reiterate that, “Tolerability, the central driver of the claimed formulation design, is particularly non-linear and difficult to predict. As the specification demonstrates, counterintuitive trade-offs exist between output rate, particle size, buffer type, co-solvent identity, and osmolality in ways that cannot be predicted from first principles or from a broad reference such as Surber. The correct combination of parameters was identified only through extensive experimental optimization. Table 30 of the specification as filed demonstrates this directly. The results therein indicate that slower device outputs (less than or about 0.5 mL/minute) improve tolerability (even with a larger particle size) over smaller particles of greater output (more than or about 0.7 mL/min). This counter-intuitive output/tolerability trade-off can only be overcome by a specific combination of liquid formulation characteristics that were determined empirically and not predicted from the prior art: 1. the pH range between 5 and 6 is generally better than neutral pH;
2. sodium chloride is more well tolerated than magnesium chloride, which tends to
carry a stronger metallic flavor; and 3. citrate buffer (and associated pH range) is more well tolerated than phosphate buffer. The vast majority of combinations within Surber's expansive disclosure would not yield the tolerability and clinical performance profile required by the instant claims. A POSITA, presented with Surber's broad parameter space (including disclosure of magnesium chloride, phosphate buffer, and neutral pH as among the acceptable choices) would not have had any principled basis for converging on the specific combination recited in claim 1”. Therefor the prior art rejections over the Surber reference have been withdrawn.
Upon receipt and approval of the terminal disclaimers over each of the patents below, the application will be in condition for allowance.
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 §§ 706.02(l)(1) -
706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,023,342 B2.
The instant claims and the claims of the ‘342 Patent both require pirfenidone; sodium citrate; sodium chloride; and wherein the pH of the solution is about 5 to about 6.
The instant claims differ from the claims of the ‘342 Patent because instant claim 1 requires pirfenidone at concentrations of from about 4.0 mg/ml to about 16.0 mg/ml.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made the claimed composition because 4.0 mg/ml to about 16.0 mg/ml and 3.0 mg/mL to about 20 mg/mL are overlapping ranges of pirfenidone.
This is a nonstatutory double patenting rejection.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,028,966 B2.
The instant claims and the claims of the ‘966 Patent both require pirfenidone; sodium citrate; sodium chloride; and wherein the pH of the solution is about 5 to about 6.
The instant claims differ from the claims of the ‘966 Patent because instant claim 1 requires pirfenidone at a concentration from about 4.0 mg/ml to about 16.0 mg/ml.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made the claimed composition because 4.0 mg/ml to about 16.0 mg/ml and 0.1 mg/mL to about 20 mg/mL are overlapping ranges of pirfenidone.
This is a nonstatutory double patenting rejection.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,610,536 B2.
The instant claims and the claims of the ‘536 Patent both require pirfenidone; sodium citrate; sodium chloride; and wherein the pH of the solution is about 5 to about 6.
The instant claims differ from the claims of the ‘536 Patent because instant claim 1 requires pirfenidone at a concentration from about 4.0 mg/ml to about 16.0 mg/ml.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made the claimed composition because 4.0 mg/ml to about 16.0 mg/ml and 0.1 mg/mL to about 20 mg/mL are overlapping ranges of pirfenidone.
This is a nonstatutory double patenting rejection.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,071,741B2.
The instant claims and the claims of the ‘741 Patent both require pirfenidone; sodium citrate; sodium chloride; and wherein the pH of the solution is about 5 to about 6.
The instant claims differ from the claims of the ‘741 Patent because instant claim 1 requires pirfenidone at a concentration from about 4.0 mg/ml to about 16.0 mg/ml.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made the claimed composition because 3.0 mg/ml to about 16.0 mg/ml and 0.1 mg/mL to about 20 mg/mL are overlapping ranges of pirfenidone.
This is a nonstatutory double patenting rejection.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,770,443 B2.
The instant claims and the claims of the ‘443 Patent both require pirfenidone; sodium citrate; sodium chloride; and wherein the pH of the solution is about 5 to about 6.
The instant claims differ from the claims of the ‘443 Patent because instant claim 1 requires pirfenidone at a concentration from about 4.0 mg/ml to about 16.0 mg/ml.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have made the claimed composition because 4.0 mg/ml to about 16.0 mg/ml and 0.1 mg/mL to about 20 mg/mL are overlapping ranges of pirfenidone.
This is a nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00 am-5:00 pm.
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/QUANGLONG N TRUONG/Examiner, Art Unit 1615
Prosecution Insights