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 .
Status of the Claims
Claims 1-11, 16-17, and 20-28 are currently pending and are the subject of this Office Action and are under consideration. This is the first Office Action on the merits of the claims.
IDS
The references cited on the information disclosure statement(s) were considered and have been made of record.
Priority
The effective filing date of the claims is deemed the filing date of the provisional application (i.e., 63/342,264), namely May 16, 2022.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-9, 20, 21, 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brantly1.
Brantly teaches the use of AAT-Fc fusion protein (INBRX-101 used in the provided examples; SEQ ID NO:1) for treating AAT deficiency when administered at dose of administered at dose of 10, 40, 80 or 120 mg/kg via IV infusion (i.e., starting dose and consecutive dose every 3 weeks; ATT levels is determined). AAT deficiency is a genetic disorder causing low serum levels of AAT, leading to uncontrolled serine protease activity.
Thus, Brantly anticipates the subject matter of instant claims 1-9, 20, 21, 23.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-11, 16-17, and 20-28 are rejected under 35 U.S.C. 103 as being unpatentable over Brantly (supra) in view of Iorio2, EMA3, and Indalao4.
The teachings of Brantly are discussed above and are incorporated herein.
Regarding claim 11, Brantly teaches determining AAT expression in patients being administered the AAT-Fc fusion protein5, rendering obvious the steps set forth in instant claim 11.
The prior art of Brantly differs from the instantly claimed invention as follows: Brantly does not expressly teach the formulations, infusion delivery periods, serum AAT level, and infection characteristics set forth in the claims.
Regarding claim 16, Iorio discloses a fusion protein pharmaceutical composition characterized by a pH of 5.7-6.1 and comprising 45-55 mg/mL fusion protein, 5-15 mM buffer system, 90-110 mM ionic tonicifier; 40-60 mM disaccharide, 40-60 mM amino acid component, 0.3-0.7 mg/mL non-ionic surfactant, and optionally 2-8 mM antioxidant (see Iorio, e.g., at claim 15.e.). Iorio further discloses: wherein the fusion protein is at a concentration of about 100 mg/ml system (see Iorio, e.g., at para.[0094] to [0095]); wherein the buffer system is a Tris buffer system, more specifically 5-20mM Tris buffer system (see Iorio, e.g., at para.[0094] to [0095]); wherein the disaccharide sugar component comprises one or more of trehalose and sucrose, and more specifically, 150-170mM trehalose and 50-300mM sucrose (see Iorio, e.g., at para. [00116] to [00124]); wherein the amino acid component is proline, and more specifically, 90-110mM proline (see Iorio, e.g., at para. [00135], [00142]); wherein the antioxidant is methionine, and more specifically, 2-20mM methionine (see Iorio, e.g., at para. [00172], [00142]); wherein the surfactant is a poloxamer, more specifically, 0.01-2% poloxamer (see Iorio, e.g., at para. [00108] to [00115]); using sodium hydroxide to adjust the pH poloxamer (see Iorio, e.g., at para. [00108] to [00235]); wherein the pH is 4-8 (see Iorio, e.g., at para. [0066]); wherein the ionic strength is about 5-200mM (see Iorio, e.g., at para. [00153]; reads on “about 5 mg/ml… about 4.3 mM” in instant claim 16).
Regarding claim 17, 24-25, and 28, EMA teaches the antibody formulation comprising 24 mg/ml antibody, 51 mM sodium phosphate, 60 mg/ml α,α-trehalose dihydrate, and 0.04% polysorbate 20, diluted in 0.9 % sodium chloride solution prior to administration (see EMA, e.g., at p. 3; reads on “about 5 mg/ml… polysorbate 20” in instant claims 17 and 28). EMA further suggests that the antibody infusions should be delivered over a period of 30 to 90 minutes (see EMA, e.g., at p. 22-23; reads on instant claims 24-25).
Regarding claim 22 and 26-27, Indalao teaches AAT in humans normally circulates in plasma at levels between 20 to 48 mM and interstitial fluid at levels between 10 to 40 mM (See Indalao, e.g., at the introduction; reads on instant claims 26-27), and that AAT deficiency predisposes patients to viral and bacterial infections (See Indalao, e.g., at p.52; reads on instant claim 22).
Obviousness Analysis:
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have arrived at the presently claimed invention in view of the prior art because it amounts to no more than:
combining the prior art elements of the cited references according to known methods to yield predictable results (e.g., formulating the fusion protein of Brantly with the known protein infusion formulations and administration periods, as taught by Iorio and EMA) (see MPEP 2143(I)(A),(G); render claims 16-17, 24-25, and 28 obvious); and
some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention (e.g., specifically treating patients that have a viral or bacterial infection and patients with less than normal serum AAT levels, as the prior art of Indalao teaches the normal levels of AAT in the body and that AAT deficiency predisposes patients to viral and bacterial infections) (e.g., formulating the fusion protein of Brantly with the known protein infusion formulations and administration periods, as taught by Iorio and EMA) (see MPEP 2143(I)(A),(G); renders claims 22 and 26-27 obvious).
Furthermore, doses, dosage regimens, as well as monitoring and adjusting for effective therapeutic regimens are result effective variables6, and are well known by medical practitioners, and thus can be easily developed by those skilled in the art through routine optimization (see MPEP § 2144.05(II); render claims 10-11 obvious).
Additionally, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Thus, a skilled artisan could predictably and reasonably produce the methods and compositions of the present invention, as the prior art references cited above provides support and motivation for doing so, as discussed above.
Accordingly, claims 1-11, 16-17, and 20-28 are rejected.
Conclusion
Claims 1-11, 16-17, and 20-28 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEA S O'BRIEN whose telephone number is (703)756-4793. The examiner can normally be reached Monday - Thursday 9:00 AM to 6:00 PM PT.
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/LEA S O'BRIEN/Examiner, Art Unit 1646
/MARK HALVORSON/Primary Examiner, Art Unit 1646
1 lnhibrx Inc.: "lnhibrx to Present INBRX-101 Data at ATS 2022 Annual Meeting", 5 April 2022 (2022-04-05), XP93075442, Retrieved from the Internet: URL:https://www.prnewswire.com/news-releases/inhibrx-to-presentinbrx-101-data-at-ats-2022-annual-meeting-301518363.html [retrieved on 2023-08-22]; cited on the IDS
2 EP3838260A1; published June 23, 2021
3 European Medicines Agency. 2005. Avastin: EPAR - Scientific Discussion. (EMA/2005). Retrieved from https://www.ema.europa.eu/en/documents/scientific-discussion/avastin-epar-scientific-discussion_en.pdf
4 Indalao, İrene L., et al. “The Utilization of Alpha-1 Anti-Trypsin (A1AT) in Infectious Disease Monitoring and Treatment”. Journal of Microbiology and Infectious Diseases, vol. 09, no. 01, Mar. 2019, pp. 51-58, doi:10.5799/jmid.537178.
5 See Brantly, e.g., at p. 3–“serum antigenic and PK and AAT levels were assessed”.
6 It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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