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 .
Claims
The preliminary amendments to the claims have been entered. Claim 16 was cancelled and claims 17-22 have been newly added. Claims 1-15 and 17-22 are pending and are examined in this Office Action.
Objections and Rejections That Are Withdrawn
The objection to the drawings is withdrawn in light of Applicant’s submission of replacement drawings that have been accepted.
The objections to the specification for grammar errors and for the use of trademarks without a proper symbol are withdrawn in light of Applicant’s amendments to the specification. Hereafter the clean copy of the amended specification that was received on July 31, 2026, will be referred to for page numbers.
Most of the claim objections are withdrawn in light of Applicant’s amendments to the claims, however, some new objections were introduced by the amendments. The remaining objections are listed, below.
The rejections under 35 USC 112B for indefiniteness because of the terms “suitable”, “substantially”, “reduces”, “purity of monomer” are withdrawn in light of Applicant’s amendments to the claims. For claim 15, the claim recites specific purity minimums and this overcomes the recitation of “substantially”.
The indefiniteness rejection for Markush groups lack the conjunction “and” at the end of the list is withdrawn in light of Applicant’s amendments to the claims.
The rejections of claims 5, 11, and 12 for indefiniteness because of the word “preferably” are withdrawn in light of Applicant’s amendments to the claims.
The rejection of claim 13 for indefiniteness for lacking the wavelength for the peak being collected is withdrawn in light of Applicant’s amendments to the claims.
The rejection of claim 22 for indefiniteness for the recitation “increasing to elution buffer” is withdrawn in light of Applicant’s amendments to the claims.
The art rejections are all withdrawn in light of Applicant’s amendments to the claims and are edited to combine all three references relied upon into a new 103 rejection (see below).
Specification - Title
The title includes the words “An” and “improved”, and neither of these words are permitted in titles of patent applications (see MPEP 606).
The following title is suggested: - - PROCESS FOR PURIFICATION OF A FUSION PROTEIN - - .
Appropriate correction is required.
Applicant did not respond to this objection at all. A complete response to this Office Action must include an amendment to the title or some explanation as to why Applicant believes an exception is warranted.
Claim Objections
Claims 1, 12, and 22 are objected to because of the following informalities:
Claim 1 is missing an article in part c) between “as” and “second”.
Claim 1 recites the acronym “SE-HPLC” in part g) without first defining the acronym by its full terminology.
Claim 12 is missing an article between “in” and “linear” and between “increasing” and “proportion”.
Claim 22 is missing an article between “in” and “linear”.
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.
Indefiniteness
Claims 1-15 and 17-22 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim. Applicant’s arguments in the response received on July 31, 2026, were fully considered but were not found to be persuasive.
Claim 1 recites “high molecular weight (HMW) impurity”, and it is unclear how high a molecular weight needs to be to be considered “high”. The specification includes the following paragraph:
“The term used “high molecular weight” or “HMW” is product-related impurities that contribute to the size heterogeneity of fusion protein. The formation of HMW species within a therapeutic fusion protein drug product as a result of protein aggregation can potentially compromise both drug efficacy and safety (e.g., eliciting unwanted immunogenic response). HMW is considered critical quality attribute that are routinely monitored during drug development and as part of release testing of purified drug product during manufacturing. In certain embodiment the HMW relates to aggregates.” (Spec 9).
It is clear from this excerpt that HMW can include aggregates, but it is unclear if other high molecular weight impurities are also included by this term. It is unclear what the molecular weight cut-off would be between medium molecular weight and high molecular weight. This renders the claims indefinite.
“The term “about”, as used herein, is intended to refer to ranges of approximately 10-20% greater than or less than the referenced value. In certain circumstances, one of skill in the art will recognize that, due to the nature of the referenced value, the term “about” can mean more or less than a 10-20% deviation from that value.” (Spec 5).
This excerpt from the specification makes it completely unclear what the scope of “about” is. Given this lack of clarity, all claims that recite “about” are indefinite because the metes and bounds of these claims are not definitive.
Claims 5, 11, 12, 15, 21, and 22 recite “about”.
Claims 1-3 and 15 require a particular purity level “as measured by SE-HPLC”. It is unclear if the claims merely require that particular purity as a result, or if the claim is intended to include a method step that involves applying the last eluted fusion protein mixture to a Size Exclusion HPLC column (i.e. a “gel filtration” column). If Applicant intends to require the final step of the method as apply to and eluting from an SE-HPLC, than Applicant must amend the claim to clearly require that method step.
Claim 11 is indefinite for the lack of antecedent basis for “the fusion protein mixture” because the parent claim has four different fusion protein mixtures and it is unclear which one is being referred to.
Claims 21 and 22 each include the term “preferably”, and this renders each of these claims indefinite because it is unclear if the limitations following “preferably” are required by the claims or if it is just optional.
Applicant argues that “HMW” is defined in the application as species resulting from protein aggregation (Resp 10). This is not persuasive, however, because the Examiner included the excerpt of this paragraph, above, and it is clear that the very first “definition” for HMW is: “The term used “high molecular weight” or “HMW” is product-related impurities that contribute to the size heterogeneity of fusion protein.” This is followed by: “The formation of HMW species within a therapeutic fusion protein drug product as a result of protein aggregation can potentially compromise both drug efficacy and safety (e.g., eliciting unwanted immunogenic response). HMW is considered critical quality attribute that are routinely monitored during drug development and as part of release testing of purified drug product during manufacturing. In certain embodiment the HMW relates to aggregates.” This shows that “HMW” relates to aggregates only in “certain embodiment” rather than “HMW” being defined by protein aggregation.
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.
Obvious Over Ramakrishnan, Sutter, and Protein Purification Handbook
Claim(s) 1-15 and 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021) in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Applicant’s arguments in the response received on July 31, 2026, as they apply to the amended claims and to this new rejection, have been considered but were not found to be persuasive.
Ramakrishnan teaches (and claims) a method of purifying an Fc-fusion protein from a composition comprising the fusion protein and one or more contaminants, the method comprising chromatography steps in the order of:
affinity chromatography
hydrophobic interaction chromatography
mixed mode chromatography, and
anion-exchange chromatography
(Ramakrishnan 11, claim 1). Ramakrishnan teaches the fusion protein being expressed in Chinese Hamster Ovary cells (which are mammalian cells) (Id. 6-7). Ramakrishnan teaches applying the fusion protein to a protein-A chromatography column (an affinity column) followed by eluting it. Ramakrishnan teaches subjecting the eluate to hydrophobic interaction chromatography (Id. 7-8) which necessarily involved applying the collected fusion protein to a hydrophobic interaction chromatography column and eluting it. Ramakrishnan teaches subjecting the eluate from the hydrophobic interaction chromatography column to a mixed-mode chromatography followed by anion exchange chromatography which involved loading the collected fusion protein to an anion exchange chromatography support and eluting it (Id. 8-10). The resulting product had only 0.5% HMW impurities (Id. 10, Table 8). The resulting product has 0% non-covalent dimer (Id.). This addresses all limitations in instant claim 15 because 0.5% is less than “about” 0.3%, and all limitations in claims 1, 3, 9, and 17 except for “less than 0.5% HMW impurities” that was added to claim 1.
With regard to claim 5, Ramakrishnan teach that their buffers for hydrophobic interaction chromatography were at pH 7.8 and 7.5 (Id. 8, Table 3). This compares to the elution buffer utilized in the working example in the instant application where the buffer utilized was 10mM TrisAc, pH 8.0 (Spec 26, Table 2). Ramakrishnan utilized a buffer made of 20 mM Tris + 0.5 M Ammonium sulphate (Ramakrishnan 8, Table 3). Ramakrishnan is silent with regard to the conductivity of their buffer, however, this is an inherent property of any given buffer, and their buffer is similar enough to the buffer utilized in the instant working example, that it would have inherently had conductivity in the range of “about” 40 mS/cm to “about” 70 mS/cm. Furthermore, the use of the word “about” does not set clear boundaries for the required conductivity.
With regard to claims 8 and 19, Ramakrishnan utilized Capto® Butyl for their hydrophobic interaction chromatography column (Id. 7).
With regard to claims 10 and 20, Ramakrishan utilized DEAE Sepharose 4FF for their anion exchange chromatography (Id. 9) which is a Sepharose fast flow.
With regard to claims 11 and 21, Ramakrishnan teaches the use of a buffer with a pH of 7.5 +/- 0.3 (Id.)
With regard to claims 12 and 22, Ramakrishnan is silent with regard to the conductivity of their buffer, however, this is an inherent property of any given buffer, and their buffer (Id.) is similar enough to the buffer utilized in the instant working example (Spec 27-28, Table 4), that it would have inherently had conductivity in the range of 40 mS/cm to 90 mS/cm.
With regard to claim 14, Ramakrishnan teach an Fc-fusion protein with the Fc portion of an IgG1 fused to CTLA4 (Ramakrishnan 1, 3 and claims 9-10). Note: “abadacept” utilizes IgG1.
Ramakrishnan does not teach a method resulting in less than 0.5% HMW impurities (as required by instant claim 1 after being amended in response received on July 31, 2026).
Ramakrishnan does not teach a method resulting in less than 0.1% pre-peak impurities (as required by instant amended claim 2).
Ramakrishnan does not teach the use of bind-elute mode for hydrophobic chromatography (as required by instant claim 4).
Ramakrishnan does not teach the use of a buffer containing Tris acetate, sodium citrate, acetate, or sodium chloride for hydrophobic chromatography (as required by instant claims 6, 7, and 18).
Ramakrishnan is silent with regard to the specific absorbance units at the beginning and end of their peak collection and about the wavelength utilized and does not teach wavelength 280 nm (as required by instant amended claim 13).
Sutter teaches a method for purifying antibodies that utilizes “mixed mode” chromatography using Capto Adhere® (8, Example 2) which includes hydrophobic interaction as one of the modes. Sutter utilizes a buffer with sodium chloride and started collecting the antibody fraction when absorbance reaches 12.5 mAU at wavelength 280 nm (Id. 8). Sutter is silent with regard to when the collection ended for this particular reduction to practice, however, in Example 4, Sutter stops collecting antibody fraction when absorbance decreases under 100 mAU (Id. 9, Example 4). Sutter teaches a level of purity showing 0.2% HMW impurities have the second mixed-mode step (Id. Example 2).
The Protein Purification Handbook teaches the use of hydrophobic interaction chromatography (HIC) as an intermediate step in a purification scheme (Protein Purification Handbook, 77). The Protein Purification Handbook teaches that HIC often utilizes a high ionic strength solution such that the samples bind as they are loaded onto a column, and this is followed by differential elution using decreasing salt concentration (Id.). This is a bind-elute mode.
At the time the instant application was filed, it would have been obvious and within the scope of one of ordinary skill in the art to modify the protocol taught by Ramakrishnan to utilize the Capto Adhere® column taught by Sutter and to utilize the sodium chloride containing buffer taught by Sutter. One would have been motivated to combine these teachings because they are each directed to methods for purifying antibodies. This is the substitution of a known equivalent with predictable results. In the absence of any showing of criticality or superior performance, this substitutions would have been an obvious variation of what was known in the art at the time of filing.
With regard to the specified absorbances at the beginning of peak collection and end of peak collection, this is a standard part of process optimization. As shown by Sutter’s disclosed mAU readings for their peak collection, the recited ranges of absorbances are not unusual. In the absence of any showing of criticality or superior performance, these particular absorbances for the beginning and end of peak collection would have been an obvious variation of what was known in the art at the time of filing.
At the time the instant application was filed, it would have been an obvious variation of the purification method taught by Ramakrishnan to utilize a bind-elute mode for the HIC step because the Protein Purification Handbook teaches that the bind-elute mode is often used for HIC. This is a substitution of a known equivalent for the HIC step, and it would have produced a predictable result. A fair reading of the Protein Purification Handbook demonstrates that the method of the instant claims is, in fact, an obvious combination of known options leading to predictable results. Nothing in the claims is specific enough to amount to an optimized process for a particular fusion protein that yielded superior results.
Applicant argues that Ramakrishnan fails to disclose a method wherein the eluted fusion protein comprises less than 0.5% HMW impurities as measured by SE-HPLC (Resp. 12). The Examiner agrees and has amended the claim to convert it to a 103 which relies upon Sutter and the Protein Purification Handbook in addition to Ramakrishnan. Sutter teaches HMW impurities less than 0.5%. It is unclear if the claimed methods require an active method step of using SE-HPLC to determine the level of HMW impurities (see indefiniteness rejection, above), but if the claims do require such a method step, size exclusion (i.e. gel filtration “GF”) is taught in the Protein Purification Handbook, and is a standard and routine practice in the art.
Applicant argues that Sutter uses the particular buffer with mixed-mode chromatography rather than with hydrophobic chromatography (Resp 13). The Examiner disagrees because mixed mode includes hydrophic interaction, that is part of the mix. There is nothing in the current claim language to exclude mixed mode.
The Protein Purification Handbook gives example purification protocols that utilize different types of columns and different buffers (i.e. Handbook p. 13 Table 1, p., 22 Figure 5, p. 28 Figure 8, p. 31 Figure 9, p. 34 Figure 10, p. 36 Figure 11, p. 39, Figure 12, p. 44 Figure 14, p. 45 Figure 15, p. 46 Figure 16, p. 48 Figure 19, p. 49 Figure 20, p. 50 Figure 21, p. 51 Figure 22, p. 55, p. 59 Table 7, p. 62 Table 9, p. 75). Sodium chloride (NaCl) appears in multiple examples and Tables as does Tris-HCl and NaAc (sodium acetate). The Examiner takes official notice that Tris acetate, Sodium citrate, Acetate, and Sodium chloride are all well known components of chromatography buffers and are routinely used in the art. The Protein Purification Handbook specifically teaches that the buffer chosen will depend on the chosen separation principle which depends on the particular protein properties (Handbook p. 18 Table 3 and p. 94). Claims 6, 7, and 11 do not require any particular protein, therefore, the claimed fusion protein is generic. In the absence of any showing of criticality or unexpected results, any of the known buffer choices are obvious variations of the methods taught by Ramakrishnan, Sutter, and the Protein Purification Handbook.
Applicant argues that the reliance on Sutter for teaching the absorbance threshold of 12.5 mAU/mm at 280 nm is misplaced because it is in the context of mixed-mode chromatography rather than HIC and the separation mechanisms and collection criteria for mixed-mode cannot be directly applied to HIC (Resp 13). This is not persuasive, however, because the absorbance at 280 nm is merely a well-known protein detection and quantification method and has nothing to do with the separation or collection methods.
Applicant argues that the GE Handbook does not suggest modifying a specific process, such as the teachings of Ramakrishnan, specifically, switching from flow-through to bind-elute mode and therefore fails to remedy the deficiencies of Ramakrishnan (Resp 13). This is not persuasive, however, because there does not need to be a specific teaching or motivation in the prior art for obviousness if the differences are well-known alternatives that yield predictable results. The Handbook provides extensive guidance as to what would be expected from a particular type of column for proteins with particular properties. Given that the instant claims are directed to a method for purification any fusion protein (generic), one of ordinary skill would analyze the properties of the particular protein and choose accordingly. None of the claimed limitations are surprising or unknown, instead they are a combination of known techniques that would have been obvious to combine if the particular desired fusion protein had the appropriate properties.
Double Patenting
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Applicant has requested that all of these provisional nonstatutory double patenting rejections be held in abeyance (Resp 14). This is not allowed. A proper response to a nonstatutory double patenting, either provisional or non-provisional, is to provide a terminal disclaimer or to point out where the claims in conflict have a particular limitation that distinguishes over the claims under examination and explain why this distinguishing feature is non-obvious. Applicant is required to do one of those two options in the next response or it will be treated as non-responsive.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-17, 19, 20, 23, 27-31, and 34 of copending Application No. 17/922,734 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘734 claims are directed to a process for purifying an antibody or fusion protein that utilizes many of the same method steps. Some elements of the ‘734 claims are significantly more narrow compared with the instant claims, however, these would be species that fall within the generic recitations of the instant claims. All claim elements required by the instant claims that are not claimed in the ‘734 claims can be found in Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-18, and 22-24 of copending Application No. 17/922,742 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘742 claims are directed to a process for purifying an antibody or fusion protein that utilizes many of the same method steps. Some elements of the ‘742 claims are significantly more narrow compared with the instant claims, however, these would be species that fall within the generic recitations of the instant claims. All claim elements required by the instant claims that are not claimed in the ‘742 claims can be found in Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 11-18 of copending Application No. 17/934,950 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘950 claims are directed to a process for purifying an Fc antibody that utilizes many of the same method steps. Some elements of the ‘7950 claims are significantly more narrow compared with the instant claims, however, these would be species that fall within the generic recitations of the instant claims. All claim elements required by the instant claims that are not claimed in the ‘950 claims can be found in Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 10-19, 22-30, 32, 33, and 35 of copending Application No. 18/657,920 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘920 claims are directed to a process for purifying an Fc antibody that utilizes many of the same method steps. Some elements of the ‘920 claims are significantly more narrow compared with the instant claims, however, these would be species that fall within the generic recitations of the instant claims. All claim elements required by the instant claims that are not claimed in the ‘920 claims can be found in Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 21-25, 27, and 29-39 of copending Application No. 18/620,255 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘255 claims are directed to a process for purifying a CTLA4-Ig fusion protein that utilizes many of the same method steps. Some elements of the ‘255 claims are significantly more narrow compared with the instant claims, however, these would be species that fall within the generic recitations of the instant claims. All claim elements required by the instant claims that are not claimed in the ‘255 claims can be found in Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 50, 52, and 64-70 of copending Application No. 18/620,441 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘441 claims are directed to a pharmaceutical composition comprising a CTLA4-IgG1 fusion protein comprising similar levels of purity compared with the instant method claims: NOTE: the instant claims include a product claim in addition to the method claims. The instant methods for producing a CTLA4-IgG1 fusion protein would have been obvious over the ‘441 claims in view of the prior art because one would have been motivated to find a good method for making the product claimed in the ‘441 application, and such a method can be found in the combination of Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 7, 8, 11, 12, 14, 17-25, 27, 28, 31, 48, 53, and 55 of copending Application No. 18/620,649 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘649 claims are directed to a process for purifying a CTLA4-Ig fusion protein that utilizes many of the same method steps. Some elements of the ‘649 claims are significantly more narrow compared with the instant claims, however, these would be species that fall within the generic recitations of the instant claims. All claim elements required by the instant claims that are not claimed in the ‘649 claims can be found in Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11-15, 17, and 22-24 of copending Application No. 18/972,007 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘007 claims are directed to a process for purifying an antibody that utilizes many of the same method steps. Some elements of the ‘007 claims are significantly more narrow compared with the instant claims, however, these would be species that fall within the generic recitations of the instant claims. All claim elements required by the instant claims that are not claimed in the ‘007 claims can be found in Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of copending Application No. 19/230,884 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘884 claims are directed to a composition comprising an antibody and a process for purifying an antibody that utilizes many of the same method steps. Some elements of the ‘884 claims are significantly more narrow compared with the instant claims, however, these would be species that fall within the generic recitations of the instant claims. All claim elements required by the instant claims that are not claimed in the ‘884 claims can be found in Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 12-15 of copending Application No. 19/230,889 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘889 claims are directed to a process for purifying an antibody that utilizes many of the same method steps. Some elements of the ‘889 claims are significantly more narrow compared with the instant claims, however, these would be species that fall within the generic recitations of the instant claims. All claim elements required by the instant claims that are not claimed in the ‘889 claims can be found in Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 11, 12, 14-18, 20, 22, and 23 of copending Application No. 18/629,465 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘465 claims are directed to a process for purifying a CTLA4-IgG1 fusion protein that utilizes many of the same method steps. Some elements of the ‘465 claims are significantly more narrow compared with the instant claims, however, these would be species that fall within the generic recitations of the instant claims. All claim elements required by the instant claims that are not claimed in the ‘465 claims can be found in Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 and 17-22 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/699,511 (reference application), in view of Ramakrishnan et al. (WO 2021/181417 A1; published on Sept. 16, 2021), further in view of Sutter et al (US Pre-Grant publication US 2021/0130396 A1; published on May 6, 2021), and further in view of Protein Purification Handbook ((2007) GE Healthcare, pp. 1-96). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘511 claims are directed to a process for purifying a protein mixture, including a mixture comprising a CTLA4-IgG1 fusion protein (claim 19) that utilizes many of the same method steps. Some elements of the ‘511 claims are significantly more narrow compared with the instant claims, however, these would be species that fall within the generic recitations of the instant claims. All claim elements required by the instant claims that are not claimed in the ‘511 claims can be found in Ramakrishnan, Sutter, and Protein Purification Handbook (see art rejections, above).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Summary
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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CATHY KINGDON
Primary Examiner
Art Unit 1663
/CATHY KINGDON/Primary Examiner, Art Unit 1663
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