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 Claims
1. This application is a DIV of 17722244 04/15/2022 PAT 12128037, which is a DIV of 16/766,660 05/22/2020, PAT 11304936, which is a 371 of PCT/EP2018/082330 11/23/2018, which claims benefit the foreign application: EUROPEAN PATENT OFFICE (EPO) 17203275.7 with a filing date 11/23/2017.
2. Claims 1-7 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 2-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
It is well recognized in the art that process of preparing composition will produce the thermodynamically stable form of crystals, thus, the instant crystalline, after mixing, grinding, compressing would be transformed into a thermodynamically stable form(s), see Brittain’s publication, pages 348-361.
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 pharmaceutical composition comprising a crystalline form of the compound of Form A piperazine sulfasalazine or Form B of diethylamine sulfasalazine, see claims 2-5.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is that a similar pharmaceutical composition comprising
similar compound, see columns 30-31of Mensonides-Harsema et al. US 12,274,706.
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 general description of the instant composition on page 5-7. There is no data present in the instant specification for the instant composition, wherein the Form A piperazine sulfasalazine or Form B of diethylamine sulfasalazine, still exists after the process of preparation, i.e., mixing, grinding, and compressing. Applicants do not provide evidence that the instant form would not convert into another crystalline forms after mixing, grinding and compression.
The breadth of the claims
The instant breadth of the rejected claims lack enablement requirement,
specifically, the instant composition comprises the crystalline form after processes of preparing pharmaceutical compositions.
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 solid pharmaceutical compositions, wherein the crystalline Form A piperazine sulfasalazine or Form B of diethylamine sulfasalazine, still exists after the processes of pharmaceutical preparation. There is no data present in the instant specification for the instant solid compositions, wherein the Form A piperazine sulfasalazine or Form B of diethylamine sulfasalazine, still exists after the process of preparation, i.e., mixing, grinding, and compressing. Therefore, the claims Iack enablement for the composition comprising the crystalline form.
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 provides for the use of the compound, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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).
Claims 1-7 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1, 5, 7 and 11 of Mensonides-Harsema et al. US 12,274,706, and over claims 11-15 and 24 of Mensonides-Harsema et al. US 11,690,857, respectively. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicant claim a Form A piperazine sulfasalazine or Form B of diethylamine sulfasalazine and their compositions, and their methods of use for treating disease including inflammation, arthritis or osteoarthritis, see claims 1-7.
Mensonides-Harsema et al. ‘706 claims a compound/composition comprising sulfasalazine and its organic amine salt selected from piperazine and diethylamine, and methods od use for treating inflammation, arthritis or osteoarthritis, see claims 1, 5, 7 and 11 in columns 31-33.
Mensonides-Harsema et al. ‘857 claims a compound/composition comprising sulfasalazine and its organic amine salt selected from piperazine and diethylamine, and methods od use for treating inflammation, arthritis or osteoarthritis, see claims 11-15 and 24 in columns 31-33.
The difference between instant claims and Mensonides-Harsema et al. ‘706 and ‘857 is that ensonides-Harsema et al. ‘706 and ‘857 are silent on the instant crystalline forms.
One having ordinary skill in the art would find the claims 1-7 prima facie obvious because one would be motivated to employ the compounds/compositions and methods of use of Mensonides-Harsema et al. ‘706 and ‘857 to obtain instant invention. However, the instant crystalline Form A piperazine sulfasalazine or Form B of diethylamine sulfasalazine would convert into a free form under administration in a patient. Thus they would be no distinct from Mensonides-Harsema et al. ‘706 and ‘857.
The motivation to make the claimed compound/composition and methods of use derived from the known methods of use of Mensonides-Harsema et al. ‘706 and ‘857 would possess similar activity to that which is claimed in the reference.
Claim Objections
6. Claim 6, line 2, is objected to as having a typographic error: deletion of the
symbol “/” after the term “medicament for” would obviate the objection.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
July 13, 2026
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