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 .
Election/Restrictions
Applicant’s election without traverse of claims 9-11 in the reply filed on 12/05/2025 is acknowledged.
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/05/2025.
Priority
This application is a 371 of PCT/PL2021/000085 (11/25/2021) which claims priority to PLP.436077 (11/25/2020) as reflected in the filing receipt issued on 09/28/2023.
The certified copy of the foreign priority document is not in English. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 08/25/2023 and 04/11/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to for the following reasons:
37 CFR 1.84 states “Character of lines, numbers and letters. All drawings must be made by a process that will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined.”
In the current case, the text in Figure 8 is illegible, as it is blurry and it is difficult to read the graph axes and the sample labels and understand the information on the graphs. Additionally, some of the text in Figure 8 is not in English.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al., US 2006/0211032 A1, as evidenced by NCBI Reference Sequence: NP_002930.2 ribonuclease inhibitor.
Regarding claim 9, Huang teaches a solution, or liquid formulation, comprising an RNase inhibitor protein in a buffer (Huang p. 4 para. 54). The buffer may be Promega Buffer B, which contains 6 mM Tris-HCl buffer at pH 7.5; and 50 mM of a monovalent salt, NaCl (Huang pp. 4-5 para. 54). This buffer does not contain glycerol.
The protein having an amino acid sequence according to instant SEQ ID NO: 1 is the wild type human placental RNase inhibitor protein (see NCBI ref.; instant specification p. 1 para. 1 and p. 3 para. 1). Huang teaches that the RNase inhibitor may be human placental RNase inhibitor (Huang p. 5 para. 56). As the human placental RNase inhibitor has a sequence according to SEQ ID NO: 1, it is expected that the RNase inhibitor of Huang has this same sequence. Thus, Huang teaches a liquid formulation comprising:
a protein having an amino acid sequence according to SEQ ID NO: 1;
a buffer of pH 7.0 to 8.2 in a concentration between 5 mM and 50 mM; and
a monovalent salt in a concentration between 5 mM and 100 mM; and
no glycerol.
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.
The factual inquiries 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.
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.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al., US 2006/0211032 A1, in view of Bretscher et al., Journal of Biological Chemistry; 275(14):9893-6, as evidenced by NCBI Reference Sequence: NP_002930.2 ribonuclease inhibitor.
Huang teaches an embodiment comprising the RNase inhibitor protein of SEQ ID NO: 1, a buffer, a monovalent salt, and no glycerol, which anticipates claim 9 as discussed above. This embodiment does not contain HEPES (claim 10) or potassium chloride (claim 11).
However, regarding claims 10-11, Huang teaches another embodiment comprising human placental RNase inhibitor protein with SEQ ID NO: 1 (see NCBI ref) in Promega Storage buffer, which contains 20 mM of HEPES-KOH buffer (HEPES adjusted with potassium hydroxide) at pH 7.6; and 50 mM of a monovalent salt, potassium chloride (KCl) (Huang pp. 4-5 para. 54). This embodiment contains glycerol. However, it would have been obvious to remove glycerol from this solution given the teachings of Bretscher.
Bretscher teaches a glycerol-free solution comprising an RNase inhibitor protein of undisclosed origin; 20 mM HEPES-HCl buffer at pH 7.6; and 50 mM of a monovalent salt, KCl (Bretscher p. 9894 “Preparation of Ribonuclease Inhibitor”). Bretscher teaches that the glycerol was removed because glycerol is a viscogen, which may lessen the accuracy of volumes delivered by pipette (Bretscher p. 9894 “Preparation of Ribonuclease Inhibitor”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date, to remove glycerol from the formulation taught by Huang comprising HEPES-KOH and KCl, thus resulting in a formulation comprising the protein according to SEQ ID NO: 1, HEPES-KOH (claim 10), potassium chloride (claim 11); and no glycerol. The solutions taught by Huang and Bretscher both comprise an RNase inhibitor protein and the same type of buffer and monovalent salt. It would have been obvious that the composition of Huang could be modified to remove the glycerol as taught by Bretscher for a similar formulation.
A skilled artisan would have been motivated, with a reasonable expectation of success, to remove glycerol from the formulation comprising RI, HEPES-KOH, and KCl taught by Huang, because Bretscher teaches that removal of glycerol from a similar RI solution has the benefit of improved pipetting accuracy, which is useful when using the formulation to perform assays that require pipetting small volumes. A skilled artisan could expect success in making this modification to the formulation of Huang given the teachings of Bretscher that glycerol can be successfully and beneficially removed from a similar RNase inhibitor liquid formulation.
Conclusion
Claims 9-11 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY F EIX whose telephone number is (571)270-0808. The examiner can normally be reached M-F 8am-5pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY F EIX/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653