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 .
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.
Claim(s) 1, 6, 8-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Casteels (US PG Pub 2021/0371457, also published as WO 2020/074483A1).
With respect to claim 1, Casteels teaches methods for purifying antibodies while obtaining high yields (abstract), a method for purifying a protein from solution comprising passing the solution through at least one membrane comprising cellulose acetate (0051-0057, 0132-0185, subjecting a composition to one or more filtering steps comprising passing the composition through a cellulose acetate membrane, substantially allowing the protein to pass through the membrane), the method using precipitation and washing to reduce contaminants where submicroscopic sized protein aggregates or particles are generated and the filtration removes particles (0057, 0077, a method of removing an aggregate of a protein from a composition comprising the protein, the aggregate of the protein and a liquid carrier), Casteels teaches antibody filtration and removal of aggregates with cellulose acetate membranes, the use of semi-permeable membranes comprising pores that will allow certain molecules or ions to pass through it while retaining other molecules (0052) and proteins retained on the membrane (0058-0062, to selectively adsorb at least some of the aggregate onto the membrane), additionally, examiner notes "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003); MPEP §2111.04). Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, the fact that the reference does not describe the recited effect in haec verba is of no significance because the reference meets the claim under the doctrine of inherency."
With respect to claim 6, the method of claim 1, is taught above. Casteels teaches antibodies (abstract, the protein comprises an antibody).
With respect to claim 8, the method of claim 1, is taught above. Casteels teaches a membrane with a surface area of 5100 cm2 ((0.51 m2), 0255, the cellulose acetate membrane has a size of about 0.015 m2 to about 0.6 m2).
With respect to claim 9, the method of claim 1, is taught above. Casteels teaches a pore size between 0.05-0.35 μm, such as 0.1-0.3 μm or between 0.15-0.25 μm, such as 0.2 μm (0020, 0055, the cellulose acetate membrane comprises pores having an average diameter of about 0.2 μm to about 0.8 μm).
With respect to claim 10, the method of claim 1, is taught above. Casteels teaches the protein in a buffer, the pH of the buffer is preferably 5 to about 7.5 (0014-0026, 0040, 0120-0121, the liquid in each filtering step independently has a pH of about 4.0 to about 8.0).
With respect to claim 11, the method of claim 1, is taught above. Casteels teaches the liquid carrier in each filtering step is independently an aqueous solution (0080-0085, 0141, 0146, 0149, 0155, 0221-0233).
With respect to claim 12, the method of claim 1, is taught above. Casteels teaches the protein in a buffer (0014-0026, 0040, 0120-0121, (the liquid carrier in each filtering step is independently a buffer solution).
With respect to claims 13 and 14, the method of claim 1, is taught above. Examiner notes "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003); MPEP §2111.04). Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, the fact that the reference does not describe the recited effect in haec verba is of no significance because the reference meets the claim under the doctrine of inherency."
Claim Rejections - 35 USC § 103
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.
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casteels (US PG Pub 2021/0371457, also published as WO 2020/074483A1).
With respect to claims 13 and 14, the method of claim 1, is taught above. Examiner notes "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003); MPEP §2111.04). Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, the fact that the reference does not describe the recited effect in haec verba is of no significance because the reference meets the claim under the doctrine of inherency."
Casteels teaches purity of at least about 90%, more preferably at least about 99%, comprising 10%-100% less impurities than the solution (0029-0030, 0061, 0116, 0151-0152, 0170-0172, each of the filtering steps independently reduces the aggregate content in the composition to not more than about 10%, relative to the total protein content of protein species in the composition. While Casteel does not explicitly teach each of the filtering steps independently reduces the aggregate content in the composition by about 0.02 mg/cm2 to about 0.15 mg/cm2, relative to the size of the cellulose acetate membrane, the value would appear to be dependent on a starting aggregate content. While Casteels does not explicitly teach each of the filtering steps independently reduces the aggregate content in the composition by about 0.02 mg/cm2 to about 0.15 mg/cm2, relative to the size of the cellulose acetate membrane, the value would appear to be dependent on a starting aggregate content. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the filtration process, depending on the starting concentration and dilution of protein to reduces the aggregate content in the composition by about 0.02 mg/cm2 to about 0.15 mg/cm2, relative to the size of the cellulose acetate membrane, to achieve a desired purity.
With respect to claim 15, the method of claim 1, is taught above. Casteels teaches multiple steps of purification providing proteins substantially free of impurities including, for instance, contaminants, other proteins, host cells, product-related variants and/or chemicals, that could interfere with the use of that protein in such applications, or that at least would be undesirable for inclusion with the protein of interest (0116), and that the precipitation and removal of particles is used to further reduce contaminants in a step c., see MPEP 2144.04 II. A. omission of an element and its function is obvious if the function is not desired, additionally Casteel teaches the filtration technique physically and selectively removes particles and/or ions, absent clarification of the specific solution to be purified, the removal of the particles would be a function of the protein solution, such that Casteel’s method would be capable of being not for the removal of particulate matter or bioburden, depending on the solution. it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method not for the removal of particulate matter or bioburden, depending the specific protein and end use.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casteels (US PG Pub 2021/0371457, also published as WO 2020/074483A1), in view of Codd (US PG Pub 2025/0025582), or alternatively Codd in view of Casteels.
With respect to claims 1-4, the method of claim 1 is taught above. Casteels teaches methods for purifying antibodies while obtaining high yields (abstract), a method for purifying a protein from solution comprising passing the solution through at least one membrane comprising cellulose acetate (0051-0057, 0132-0185, subjecting a composition to one or more filtering steps comprising passing the composition through a cellulose acetate membrane, substantially allowing the protein to pass through the membrane), the method using precipitation and washing to reduce contaminants where submicroscopic sized protein aggregates or particles are generated and the filtration removes particles (0057, 0077, a method of removing an aggregate of a protein from a composition comprising the protein, the aggregate of the protein and a liquid carrier), Casteels teaches antibody filtration and removal of aggregates with cellulose acetate membranes, the use of semi-permeable membranes comprising pores that will allow certain molecules or ions to pass through it while retaining other molecules (0052) and proteins retained on the membrane (0058-0062, to selectively adsorb at least some of the aggregate onto the membrane), additionally, examiner notes "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003); MPEP §2111.04). Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, the fact that the reference does not describe the recited effect in haec verba is of no significance because the reference meets the claim under the doctrine of inherency." Casteels teaches antibodies (Abs) and fragments thereof are generally purified using a costly, multi-step, chromatography process, using a specific resin and buffer system at each chromatography step, and that the use of flow filtration minimizes cost and number of steps while maintaining purity (0001-0013). Casteels does not teach the protein comprises a conjugated chemical moiety, the conjugated chemical moiety comprises a chelating ligand, the chelating ligand is selected from desferrioxamine (DFO) and 1,4,7,10-tetraazacyclododecane-N,N',N",N"'tetraacetic acid (DOTA).
Codd teaches methods for the use and production compounds, complexes, pharmaceutical agents and compositions comprising chelating ligands and radionuclide complexes conjugated to an antibody (0001-0034), conjugates may possess multiple antibodies or antibody fragments, (0243-0249, protein and aggregates), in embodiments an antibody maybe conjugated with a chelating ligand (0243-0249), chelating ligands include DOTA and DFOB (0022-0022, 0145-0217). Codd teaches conjugated antibodies (0243-0247), that may be purified by any method known to one of ordinary skill in the art, including chromatography (0390). Codd teaches purification of compositions comprising proteins, but does not teach one or more filtering steps comprising passing through a cellulose acetate membrane.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply Casteels method of purification of antibodies to Codd’s conjugated antibodies, as according to Casteels the filtration method reduces cost, or alternatively to modify Casteel’s method to purify Codd’s conjugated protein, as Casteels and Codd each teach purification of proteins and compositions for pharmaceutical use, and the courts have held that combining prior art elements according to known methods to yield predictable results would have been obvious to a person of ordinary skill in the art before the filing date, see MPEP §2143.
With respect to claim 5, the method of claim 1, is taught above. Codd teaches targeting moieties (0116, 0243-0249, 371, 357), wherein the protein comprises a protein targeting agent.
With respect to claim 6, the method of claim 1, is taught above. Codd teaches antibodies as discussed above. Casteels teaches antibodies (abstract, the protein comprises an antibody).
With respect to claim 7, the method of claim 1, is taught above. Codd teaches girentuximab (0247, 0357, 0371, 439-0440).
With respect to claim 8, the method of claim 1, is taught above. Casteels teaches a membrane with a surface area of 5100 cm2 ((0.51 m2), 0255, the cellulose acetate membrane has a size of about 0.015 m2 to about 0.6 m2).
With respect to claim 9, the method of claim 1, is taught above. Casteels teaches a pore size between 0.05-0.35 μm, such as 0.1-0.3 μm or between 0.15-0.25 μm, such as 0.2 μm (0020, 0055, the cellulose acetate membrane comprises pores having an average diameter of about 0.2 μm to about 0.8 μm).
With respect to claim 10, the method of claim 1, is taught above. Casteels teaches the protein in a buffer, the pH of the buffer is preferably 5 to about 7.5 (0014-0026, 0040, 0120-0121, the liquid in each filtering step independently has a pH of about 4.0 to about 8.0).
With respect to claim 11, the method of claim 1, is taught above. Casteels teaches the liquid carrier in each filtering step is independently an aqueous solution (0080-0085, 0141, 0146, 0149, 0155, 0221-0233).
With respect to claim 12, the method of claim 1, is taught above. Casteels teaches the protein in a buffer (0014-0026, 0040, 0120-0121, (the liquid carrier in each filtering step is independently a buffer solution).
With respect to claims 13 and 14, the method of claim 1, is taught above. Examiner notes "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003); MPEP §2111.04). Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, the fact that the reference does not describe the recited effect in haec verba is of no significance because the reference meets the claim under the doctrine of inherency."
Casteels teaches purity of at least about 90%, more preferably at least about 99%, comprising 10%-100% less impurities than the solution (0029-0030, 0061, 0116, 0151-0152, 0170-0172, each of the filtering steps independently reduces the aggregate content in the composition to not more than about 10%, relative to the total protein content of protein species in the composition. While Casteels does not explicitly teach each of the filtering steps independently reduces the aggregate content in the composition by about 0.02 mg/cm2 to about 0.15 mg/cm2, relative to the size of the cellulose acetate membrane, the value would appear to be dependent on a starting aggregate content. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the filtration process, depending on the starting concentration and dilution of protein to reduces the aggregate content in the composition by about 0.02 mg/cm2 to about 0.15 mg/cm2, relative to the size of the cellulose acetate membrane, to achieve a desired purity.
With respect to claim 15, the method of claim 1, is taught above. Casteels teaches multiple steps of purification providing proteins substantially free of impurities including, for instance, contaminants, other proteins, host cells, product-related variants and/or chemicals, that could interfere with the use of that protein in such applications, or that at least would be undesirable for inclusion with the protein of interest (0116), and that the precipitation and removal of particles is used to further reduce contaminants in a step c., see MPEP 2144.04 II. A. omission of an element and its function is obvious if the function is not desired, additionally Casteel teaches the filtration technique physically and selectively removes particles and/or ions, absent clarification of the specific solution to be purified, the removal of the particles would be a function of the protein solution, such that Casteel’s method would be capable of being not for the removal of particulate matter or bioburden, depending on the solution. it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the method not for the removal of particulate matter or bioburden, depending the specific protein and end use.
With respect to claim 16, the method of claim 1, is taught above. Codd teaches formation of conjugates and conjugates may possess multiple antibodies or antibody fragments (0243-0249) the composition is obtained from a process for preparing a protein conjugate in which an undesired aggregate is formed, additionally, examiner notes "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. A “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003); MPEP §2111.04). Where a reference discloses the terms of the recited method steps, and such steps necessarily result in the desired and recited effect, the fact that the reference does not describe the recited effect in haec verba is of no significance because the reference meets the claim under the doctrine of inherency."
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rossin US 20220331458
Francis US 20220153779
Robillard US 20230121556
Weicszorek EP 3643322 A1
Chen US 10035817
Shima US 20160333073
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANNIE MCDERMOTT whose telephone number is (571)272-4479. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dieterle can be reached at 571 270-7872. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JEANNIE MCDERMOTT/Examiner, Art Unit 1776
/BRADLEY R SPIES/ Primary Examiner, Art Unit 1776
Prosecution Insights