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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 09/29/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
The application is examined in view of elected A-68930 as specific compound without traverse. Claims 1,3-7, 9-13 and 17-24 read on the elected species and are under examination.
Claims 1,3-7, 9-13 and 17-24 are pending and under examination.
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 of this title, 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1,3-7, 9-13 and 17-24 are rejected under 35 U.S.C. 103 as being unpatentable over Cincotta (US20090143390) as evidenced by Lederer et al. (“Dopamine Regulates Phosphate Uptake by Opossum Kidney Cells Through Multiple Counter-Regulatory Receptors”, J Am Soc Nephrol 9: 975-985, 1998) and Friedman (“Consequences and management of hyperphosphatemia in patients with renal insufficiency”, Kidney International, Vol. 67, Supplement 95 (2005), pp. Sl-S7).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Cincotta teaches stable pharmaceutical compositions for parenteral administration comprising dopamine agonists and peripheral acting agents useful for treatment of metabolic disorders or key elements thereof (abstract). The dosage forms are particularly suited for treatment of metabolic disorders and/or key elements of these disorders including renal disease including renal insufficiency ([0028-0029]). Routes of parenteral administration include, without limitation, buccal, sublingual, subcutaneous, nasal, oral, otic, ocular, rectal, vaginal, or upper respiratory mucosa, or through the skin or lungs. Accordingly, the dosage forms include, without limitation, injection, oral, otic, ophthalmic, or nasal sprays or drops, sublingual and/or buccal sprays, drops, tablets, solutions, colloidal suspensions, and/or ointments, hard capsule and soft capsules, tablets, coated tablets, or sachets, lozenge, films, chewing gum, chewable tablet, liquid gargle, skin patch, ointment, lotion, or cream, a respiratory inhaler, aerosols, or rectal or vaginal suppository ([0095]). Renal disease including renal failure and renal insufficiency ([0136]). Administration of D1 and D2 agonists typically lead to improvement of at least one condition or indices indicative of a metabolic disorder such as renal dysfunction and/or insufficiency ([0181]). A stable parenteral dosage form comprising at least one dopamine agonist including D1 agonist is selected from the group consisting of dopamine, apomorphine, fenoldapam, SKF38393, SKF 75670, SKF 82957, SKF 81297, SKF 82958, SKF 82598, A77636, A68930, and benzazepine analogs and a pharmaceutically acceptable excipient for treating renal disease including renal insufficiency (claims 1, 6, 11, 14 and 16).
Lederer et al. teaches dopamine receptor D1 agonist such as SKF-38393 inhibit phosphate uptake (abstract; page 976; page 980, Fig. 5).
Friedman teaches Progressive renal insufficiency leads to hyperphosphatemia, hypocalcemia, and secondary hyperparathyroidism. In patients with end-stage renal disease (ESRD), kidney failure results in decreased secretion and increased retention of phosphate. This causes hyperphosphatemia, a condition that results in the development of secondary hyperparathyroidism and renal osteodystrophy (page S1, left column).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Cincotta is that Cincotta do not expressly teach all claimed limitations in one embodiment.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the instant invention.
Cincotta teaches a method of treating renal disease such as renal insufficiency and renal failure by administration of a composition comprising dopamine receptor D1 agonist SKF38393 or A68930, Cincotta is silent about inhibiting phosphate uptake in the gastrointestinal tract in claim 1 as well as functional properties in claims 3-7, 9-13, 17-24, which are regarded as inherent results from prior art process.
Regarding “patient in need of phosphate lowering”, according to applicant’s claim 20, the patient in need thereof has ESRD; since Cincotta teaches patient of renal failure encompassing ESRD as one known renal failure, further evidence from Friedman that patient of renal failure and insufficiency has higher level of phosphate, the patient of renal failure and insufficiency in prior art is the patient in need of phosphate lowering.
In summary, although the reference is silent about all the functional properties instantly claimed, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure because Cincotta teaches a method of treating renal disease such as renal insufficiency and renal failure by administration of a composition comprising dopamine receptor D1 agonist SKF38393 or A68930, as evidenced from Lederer et al. teaching dopamine receptor D1 agonist such as SKF-38393 inhibit phosphate uptake, the administration of a composition comprising dopamine receptor D1 agonist SKF38393 or A68930 would result in inhibiting phosphate uptake. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, Cincotta teaches, either expressly or inherently implied, each and every limitation of the instant claims. It remains the Examiner's position that the instantly claimed method is obvious.
Regarding claim 24, as evidenced by applicant’s specification that the compound is systemically non-bioavailable upon enteral administration to the patient (page 5, line 23-24). Since Cincotta teaches oral dosage form such as oral tablet or solution, which is considered as enteral dosage, A-68930 is expected to be systemically non-bioavailable upon enteral administration to the patient according to the same rational for the above discussion for functional properties.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue that Cincotta does not teach inhibiting phosphate uptake and Lenderer does not teach inhibiting phosphate uptake. All related arguments are incorporate herein by reference.
In response to this argument: this is not persuasive. As discussed in the above 103 rejection, although the reference is silent about all the functional properties instantly claimed, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure because Cincotta teaches a method of treating renal disease such as renal insufficiency and renal failure by administration of a composition comprising dopamine receptor D1 agonist SKF38393 or A68930, as evidenced from Lederer et al. teaching dopamine receptor D1 agonist such as SKF-38393 inhibit phosphate uptake (see abstract and Fig. 5), the administration of a composition comprising dopamine receptor D1 agonist SKF38393 or A68930 would result in inhibiting phosphate uptake. See Bristol-Myers Squibb Company v. Ben Venue Laboratories, 58 USPQ2d 1508 (CAFC 2001). “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991). See M.P.E.P. 2145. On this record, it is reasonable to conclude that the same patient is being administered the same active agent by the same mode of administration in the same amount in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, Cincotta teaches, either expressly or inherently implied, each and every limitation of the instant claims. It remains the Examiner's position that the instantly claimed method is obvious. MPEP 2112 V, ONCE A REFERENCE TEACHING PRODUCT APPEARING TO BE SUBSTANTIALLY IDENTICAL IS MADE THE BASIS OF A REJECTION, AND THE EXAMINER PRESENTS EVIDENCE OR REASONING TO SHOW INHERENCY, THE BURDEN OF PRODUCTION SHIFTS TO THE APPLICANT, "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims. In re Fitzgerald, 619 F.2d 67, 70, 205 USPQ 594, 596 (CCPA 1980) (citing Best, 562 F.2d at 1255). Since applicants failed to prove prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
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 1,3-7, 9-13 and 17-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11813304 in view of Cincotta (US20090143390) and Lederer et al. (“Dopamine Regulates Phosphate Uptake by Opossum Kidney Cells Through Multiple Counter-Regulatory Receptors”, J Am Soc Nephrol 9: 975-985, 1998). The reference patent teaches a method for inhibiting phosphate uptake in the gastrointestinal tract of a patient in need of phosphate lowering, comprising administering to the patient a guanylate cyclase C receptor (GC-C) agonist compound, but silent about dopamine receptor D1 agonist SKF38393 or A68930, and one of ordinary skill in the art would have been motivated to replace dopamine receptor D1 agonist SKF38393 or A68930 for guanylate cyclase C receptor (GC-C) agonist compound to inhibit phosphate uptake because this is simple substitution of one known phosphate uptake inhibiting compound for another to obtain predictable results. Under guidance from Cincotta teaching dopamine receptor D1 agonist SKF38393 or A68930 for treating renal failure and insufficiency; Lederer et al. teaching dopamine receptor D1 agonist such as SKF-38393 inhibit phosphate uptake; it is obvious for one of ordinary skill in the art to replace dopamine receptor D1 agonist SKF38393 or A68930 for guanylate cyclase C receptor (GC-C) agonist compound and produce instant claimed invention with reasonable expectation of success.
Claims 1,3-7, 9-13 and 17-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of copending Application No. 17986739 in view of Cincotta (US20090143390). The reference application teaches a method for lowering serum phosphate by administering a compound of dopamine D1 agonist (claim 4) but silent about lowering phosphate uptake in the gastrointestinal tract of a patient and dopamine receptor D1 agonist SKF38393 or A68930, under guidance from Cincotta teaching dopamine receptor D1 agonist SKF38393 or A68930 for treating renal failure and insufficiency, it is obvious for one of ordinary skill in the art to use dopamine receptor D1 agonist SKF38393 or A68930 for lowering serum phosphate, which would also result in inhibiting phosphate uptake in in the gastrointestinal tract of a patient because the same patient is being administered the same active agent by the same mode of administration in both the instant claims and the prior art reference. The fact that Applicant may have discovered yet another beneficial effect from the method set forth in the prior art does not mean that they are entitled to receive a patent on that method. Thus, the reference application in view of Cincotta teaches, either expressly or inherently implied, each and every limitation of the instant claims.
This is a provisional nonstatutory double patenting rejection.
Response to Argument:
Applicants argue the same as in 103 rejection.
In response to this argument: this is not persuasive. For the same rational in the response to argument for the 103 rejection, the double patenting rejections are still popper.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong Kwon can be reached at (571)272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANFENG SONG/Primary Examiner, Art Unit 1613
