DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Preliminary Amendment filed on November 12, 2024, have been received and entered.
Claim Disposition
3. Claims 1-35 were cancelled. Claims 36-79 have been added and are pending. Claims 36-79 are under examination.
Information Disclosure Statement
4. The Information Disclosure Statements filed on July 31, 2026 and August 22, 2024, have been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Specification Objection
5. The specification is objected to for the following informalities:
The specification is objected to because of missing periods (.) on page 24.
Appropriate correction is required.
Claim objection
6. Claims 51-65 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 51 is amended to delete the phrase, “in particular”. The dependent claims hereto are also included.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
7. Claims 51-65 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 51 and the dependent claims hereto are indefinite for the recitation of ‘in particular’ because it is similar to ‘preferably’ which has ambiguity in scope; it leaves the ordinary skilled worker guessing whether the features following the word are mandatory limits of the invention or just optional suggestions. Claims must point out and distinctly claim the invention, not state preferences or particular options.
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.
8. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
9. Claims 36-76 is/are rejected under 35 U.S.C. 103 as being unpatentable over CSL BEHRING GMBH (WO 2016/131958, 2016, of record in the application) taken with ABBOTT LAB (WO2009/073569, of record in the application) and WO2014145519.
The claimed invention is directed to a kit with a C1-esterase-inhibitor preparation containing histidine and not citrate or phosphate. The WO 2016/131958 document discloses kits comprising the pharmaceutical formulation of the invention as a lyophilized powder and a respective volume of a suitable liquid for reconstitution. Yet another aspect of the invention refers to kits comprising the pharmaceutical formulation of the invention and at least one syringe and/or one needle. The primary reference also relates to a need for a C1-INH formulation that has a proven long term storage stability by being less prone to denaturation and degradation, does not cause serious drug-related adverse events. In addition, the reference proposes also two amino acids of which there I glycine and either arginine or histidine; and proposes also sodium chloride. However, the WO 2016/131958 reference has citrate and phosphate.
The technical effect conferred by this difference is provided and identical to WO 2016/131958 teaching because the reference provides stable compositions for long term storage. Further, the reference teach that the technical effect resides in the fact that the generation of C1-Inh fragments is minimized and the C1-Inh monomers have a low tendency to form polymers (see page 4, lines 24-27 of the application), the filed experimental data do not support this effect. Further, the experimental data provide also comparative examples. Table 1 provides values 99,17 to 99.47 and table 2 (comparative formulations) values from 99,09 to 99,37 . The values do not differ significantly. Tables 3 and 4 and tables 5 and 6 show significant differences. The description is silent about the differences, in particular in the absence of an indication to error bar(s).
The primary reference discloses that their invention relates to stable pharmaceutical formulations comprising (a) C1-INH at a concentration of about 400 IU/mL — 2,000 IU/mL; and (b) sodium citrate having a calculated osmolarity of 20-120 mom/L or sodium di- 30 hydrogen phosphate / di-sodium hydrogen phosphate having a calculated osmolarity of 60-120 mOsm/L; and (c) one or more physiologically acceptable salt(s), other than the substances in (b), having a calculated osmolarity of 150-600 mOsm/L; or one or more amino acid(s) selected from glycine and/or one or more basic and/or 35 one or more acidic L-amino acid(s) or a salt/salts thereof having a calculated osmolarity of 50-500 mOsm/L…( see pages 1-4). On page 6 a pH of about 6.7-7.5. Therefore, starting from the primary reference the skilled person would have made routine experimentations during which the ordinary worker would delete or replace conventional ingredients. An ordinary skilled worker could consult the secondary reference by ABBOTT LAB which advises the ordinary skilled worker to use a combination of two amino acids with sodium chloride in order to stabilize C1-esterase inhibitor compositions. ABBOTT Lab teach liquid formulations (see pages 1-10 and entire document). Regarding the language of ‘does not comprise citrate or phosphate, the WO 2014145519 teach no citrate in compositions, kits and methods for the treatment and/or prevention of disorders associated with C1 esterase inhibitor deficiency (see abstract and detailed description), rendering the claimed invention as obvious.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to arrive at the claimed invention as a whole because of the combined teaching of the references. One of ordinary skill in the art would be able to modify the primary reference and combine with the teaching of the secondary reference to arrive at the claimed invention. Motivation exists to combine the teaching of the references because they are analogous art. Moreover, the Supreme Court pointed out in KSA, “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art.” KSA, 127 S. Ct. at 17471. The Court thus reasoned that the analysis under 35 U.S.C. 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the “inferences and creative steps that a person of ordinary skill in the art would employ.” /d. at 1747. The Court further advised that “[a] person of ordinary skill is...a person of ordinary creativity, not an automation.” /d. at 1742. Therefore, the claimed invention was obvious to make and use at the time the invention was made and was prima facie obvious.
Conclusion
10. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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