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
Priority and Status of the Claims
1. This application is a CON of 17138604 12/30/2020 ABN, which is a CON of 16/351,225 03/12/2019 PAT 10940146, which is a CON of 14/783,983 10/12/2015 PAT 10272079, which is a 371 of PCT/ US2014/033603 04/10/2014, which has PRO 61/888,879 10/09/2013, and PRO 61/811,613 04/12/2013.
2. Claims 1, 6-8 and 12-18 are pending in the application.
Claim Rejections - 35 USC § 112
3. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1, 6-8 and 12-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112,
first paragraph (pre- AIA ), because the specification does not reasonably provide
enablement of the instant “compound” without limitation (i.e., no chemical formula). The
specification does not enable any person skilled in the art to which it pertains, or with
which it is most nearly connected, to make the invention commensurate in scope with
these claims.
ln In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or Iack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is a method of use using “a compound” without limitation (i.e., no chemical formula), see claim 1.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Carreras et al. US 10,940,146, it discloses a compound
Of formula (X), see column 423.
The amount of direction or guidance present and the presence or absence
of working examples
The only direction or guidance present in the instant specification is the description of a number of “compound” with various formulae on pages 58-65 of the specification. There is no data present in the instant specification for the “compound” without limitation (i.e., no chemical formula).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “compound” are without limitation (i.e., no chemical formula).
The quantity or experimentation needed and the Ievel of skill in the art
While the level of the skill in the chemical arts is high, it would require
undue experimentation of one of ordinary skill in the art to resolve any “compound” without limitation. There is no guidance or working examples present for constitutional any “compound” without limitation for the instant invention. Incorporation of the limitation of ““compound” supported by specification (i.e., claims 17 and 18) into claim 1 would overcome this rejection.
4. 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.
Claim 6 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 6 recites the limitation “Table E3 or Table E4” without a chemical name is ambiguous and indefinite. It is unclear what the scope of the limitation “Table E3 or Table E4” is. Claims must stand alone to define invention, and incorporation into claims by express reference to specification is not permitted, are properly rejected under 35 U.S.C. 112 (b), see Ex parte Fressola, No. 93-0828. Incorporation of the limitation “Table E3 or Table E4” with a chemical name or structure into claim 6 respectively would obviate the rejection.
Double Patenting
5. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claim 1 is rejected under the judicially created doctrine of obviousness- type double patenting as being unpatentable independently over claim 1 of Bell et al. US 10,385,024, over claim 1 of Carreras et al. US 10,940,146, over claim 1 of Carreras et al. US 10272,079, Carreras et al. US 10,543,207, and Dragoli et al. US 11,242,337 respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a method for inhibiting phosphate uptake in the gastrointestinal tract of a patient in need of phosphate lowering, comprising enterally administering to the patient a substantially systemically non-bioavailable compound that binds to NHE3 and is substantially active in the gastrointestinal tract to inhibit transport of phosphate ions (Pi) therein upon administration to the patient in need thereof, see claim 1.
Bell et al. ‘024 claims a compound
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427
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, see column 145. Bell et al. ‘024 compound is able to bind NHE3 and is used for treating gastrointestinal tract disorder.
Carreras et al. ‘146 claims a method for inhibiting phosphate uptake in the gastrointestinal tract of a patient in need of phosphate lowering, comprising enterally administering to the patient an effective amount of a compound having the structure of Formula (X):
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74
266
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, see column 423.
Carreras et al. ‘079 claims a method for inhibiting phosphate uptake in the gastrointestinal tract of a patient in need of phosphate lowering, comprising enterally administering to the patient an effective amount of the compound:
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264
376
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, see column 460.
Carreras et al. ‘207 claims a method for treating a disorder selected from the group consisting of heart failure, chronic kidney disease, end-stage renal disease, liver disease, gastrointestinal tract disorder, hypertension, edema, and peroxisome proliferator-activated receptor (PPAR) gamma agonist-induced fluid retention, the method comprising administering to a mammal in need thereof a pharmaceutically effective amount of a compound having the formula (X):
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74
266
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, see column 490.
Dragoli et al. ‘337 claim a compound of formula (I), which is used for treating
gastrointestinal tract disorder, see columns 485-501.
The difference between instant claims and Bell et al. ‘024 and Carreras et al. ’146, ‘079, and ‘207 and Dragoli et al. ‘337 is the instant claims are embraced within the scope of compound of Bell et al. ‘024 and Carreras et al. ’146, ‘079, and ‘207 and Dragoli et al. ‘337. It is noted that instant claim is silent on the scope of compound (i.e., no chemical formula).
One having ordinary skill in the art would find the claims 1 prima facie obvious because one would be motivated to employ the compound and methods of use of Bell et al. ‘024 and Carreras et al. ’146, ‘079, and ‘207 and Dragoli et al. ‘337 to obtain instant invention.
The motivation to make the claimed methods of use derived from the known compounds and methods of use of Bell et al. ‘024 and Carreras et al. ’146, ‘079, and ‘207 and Dragoli et al. ‘337 would possess similar activity to that which is claimed in the reference.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
June 15, 2026
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