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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/08/2026 has been entered. Claims 1-14, 19-22, 24-50 are pending in the application, the claim objection and 112(b) rejections of claims 1-17, and 19-23 previously set forth are withdrawn in view of the amendment.
Response to Arguments
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive.
Examiner notes the double patenting rejection with respect to US Patent 12,600,747 is the patent number of application 19/092,641 which appears to have the same inventive entities. See cover excerpt image below and attached patent.
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Examiner notes independent claims 1 and 33 require a composition of consisting essentially of omalizumab or a biosimilar of omalizumab, Examiner notes the transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps " and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." (see MPEP 2111.03). Omalizumab is a known compound in the recited purities, Schultz teaches monomer purities of 99.5% or more as discussed below, and see newly cited reference Duthe which teaches purities of 99.9% or more, and each of which provide known impurities including charge variants and HMW and LMW impurities, and the reduction thereof, absent clarification of unexpected results, the specific ratios of these known impurities would appear to be obvious of in view of the references below.
In response to applicant’s argument that Schultz is directed to solid units, not a purified drug substance and that the disclosure of acidic variants concerns the solid units not a drug substance, Shultz teaches a therapeutic agent, or drug substance.
In response to applicant’s argument that Schultz and the instant composition are different compositions evaluated at different manufacturing stages, Schultz teaches a therapeutic agent, protein or antibody (0146, abstract), the protein having (e.g. 98%, 99%, 99.5% or more) monomer (0115-0116), isolated, substantially pure antibodies (0078-0079, 0126-0128), lowering the amount of acidic species variants or process-related impurities (0252-0276), in embodiments preparing low acidic species variants of a protein by purification with affinity chromatography and anion exchange (AEX) (0282-0285) and the presence of HMW, examiner notes the instant claims include amounts of zero for each of the recited impurities.
In response to applicant’s argument that the references do not teach applicant’s specific flow-through purification strategy, examiner notes the claims are directed to a product, i.e., any composition having the claimed purities, even if the ratios are determined by a different method, as the claims are drawn to a composition comprising a biosimilar of omalizumab and a production related impurity (i.e., charge variants and high and low molecular weight species) and NOT a method of determining the purity of a biosimilar omalizumab product. Such that any biosimilar omalizumab composition that contains the claimed purities would qualify as prior art, regardless of the methods used to determine them.
In response to applicant’s argument that Schultz does not describe a structurally distant antibody with the recited specific variant distribution, HMW profile, or chromatographic behavior, examiner notes claim 1 requires omalizumab with ratios of acidic variants of 0.21 or less and/or HWM species of 0.0500 or less, including zero, Schultz teaches substantially pure monomer and reduction of acidic variants, charge variants may be the result of product preparation or storage and can be controlled based on production and storage, including adjusting culture media (0253-0279), and that the amount of acidic variants affect the biological and functional properties including efficacy of treatment or prevention of disorders (0266-0269), as Shultz teaches the amount of acidic variant can be modified, depending on production and storage conditions, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the amount of acidic variant in order to optimize efficacy and treatment depending on patient needs.
Additionally, see MPEP 2144.04 VII. Pure materials are novel vis-à-vis less pure or impure materials because there is a difference between pure and impure materials. Therefore, the issue is whether claims to a pure material are nonobvious over the prior art. In re Bergstrom, 427 F.2d 1394, 166 USPQ 256 (CCPA 1970). Purer forms of known products may be patentable, but the mere purity of a product, by itself, does not render the product nonobvious and in the case of product-by-process claims, if a first prior art process is improved to enhance the purity of the product produced by the process, and if the purified product has no structural or functional difference from the products produced by other prior art processes, then the improvement in the first process that improves the purity of the product does not give rise to patentability.
Claim interpretation
The examiner has interpreted the claims as follows:
Instant claim 1 recites, “A composition consisting essentially of a biosimilar of omalizumab and product related impurities selected from acidic variants (AV), and high molecular weight (HMW) species; wherein the composition is characterized by: (a) an average ratio of acidic variants to the main peak of the biosimilar omalizumab of less than 0.21; and (b) an average ratio of HMW species to the main peak of the biosimilar of omalizumab of below about 0.00500; wherein the biosimilar of omalizumab in the composition has purity of at least 99.5% as determined by Size Exclusion HPLC” In the instant case, the examiner is interpreting the claims to encompass any composition having the claimed purities, even if the ratios are determined by a different method, as the claims are drawn to a composition comprising a biosimilar of omalizumab and a production related impurity (i.e., acidic variants and high molecular weight species) and NOT a method of determining the purity of a biosimilar omalizumab product. Put simply, any biosimilar omalizumab composition that contains the claimed purities would qualify as prior art, regardless of the methods used to determine them. The rejections below reflect the examiner's interpretation. Please note that the dependent claims are also interpreted in the same manner.
Further regarding claim 1, the transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." (see MPEP 2111.03).
Priority
Acknowledgment is made of applicant's claim for foreign priority based on applications filed in IN on 05/01/2020. It is noted, however, that applicant has not filed a certified copy of application IN 2020/21018452 as required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 25-47, and 48-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 25-28 recite purities of 99.6, 99.7, 99.8, 99.9, these limitations do not appear to have support in the instant specification.
Claims 34, 35, 36, 38, 40, 42, 44 recite limitations with respect to the amount of acidic variants, these limitations do not appear to have support in the instant specification.
Claims 33, 46, 47, 49 recites purity of more than 83%, 83.5, 85.5, this does not appear to have support in the instant specification.
Claim 50 recites the low-molecular weights aggregates (LMWs) are present in an amount of 0.4%, 0.3%, 0.2%, and 0.1 % determined by SE- HPLC, this limitation does not appear to have support in the instant specification.
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.
Claims 29-50 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.
Claims 29-32 each recite the limitation the high molecular weight aggregate (HMWs), there is insufficient antecedent basis for this limitation, for the purposes of examination this is interpreted as high molecular weight species.
Examiner notes claims 34-50 are dependent on claim 32, not independent claim 33, and that claims 46-49 depend on claim 32, which depends from claim 1, requiring purity of 99.5%, the recited purities of claims 46-49 of 83.5, 84, 85, and 85.5 are not further limiting, for the purposes of examination these claims will be interpreted as depending from independent claim 33.
Claim 50 depends from claim 32, the limitation of the low-molecular weights aggregates (LMWs) are present in an amount of 0.4%, 0.3%, 0.2%, and 0.1 % determined by SE- HPLC, lacks antecedent basis, and do not appear to have support in the instant specification.
Claims 32-45 recite limitations with respect to the amount of acidic variants, these limitations do not appear to have support in the instant specification.
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.
Claims 1-23 of this application is patentably indistinct from claims 1-15 US Patent 12,600,747, (granted patent for application 19/092641), in view of the rejections below.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application requires a substantially the same composition comprising acidic variants, the relationship between the recited ratio and percents are discussed in the rejections below.
Claims 1-23 of this application is patentably indistinct from claim 30, 38-41, 45, 45, 48, 50-54 of Application No. 17/922,729. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 38-41, 45, 45, 48, 50-54 of copending Application No. 17/922,729 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application requires a substantially pure composition of omalizumab: Instant claims 1-4 : Reference claim 31, 38, 50-52, acidic variants Instant claims 1, 4-8 : Reference claim 31, 53, 54 high molecular weight; Instant claims 13, 14 : Reference claim 48 monomer purity, in view of the rejections below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-23 of this application is patentably indistinct from claim 37 of Application No. 17/922,734. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 37of copending Application No. 17/922,734 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application requires a substantially pure composition omalizumab comprising acidic variants and HMW, in view of the rejections below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-23 of this application is patentably indistinct from claim 1-11 of Application No. 19230884. Pursuant to 37 CFR 1.78(f), when two or more applications filed by the same applicant or assignee contain patentably indistinct claims, elimination of such claims from all but one application may be required in the absence of good and sufficient reason for their retention during pendency in more than one application. Applicant is required to either cancel the patentably indistinct claims from all but one application or maintain a clear line of demarcation between the applications. See MPEP § 822.
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over from claim 1-11 of Application No. 19230884.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application requires a substantially pure composition omalizumab comprising acidic variants and HMW, in view of the rejections below.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim(s) 1-14, 19-22, 24-28, 33-50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz (US PG Pub 2016/0228371), in view of Wong (US PG Pub 2022/0203347).
With respect to claims 1, 22, and 24, Schultz teaches formulations of stable compositions of a therapeutic agent (particularly a therapeutic protein such as an antibody, DVD-Ig protein, or peptide, therapeutic agent a drug substance) and a stabilizer, referred to as solid units (abstract, 0001-0013), examples of antibodies include omalizumab or a biosimilar (0302), the protein having (e.g. 98%, 99%, 99.5% or more) monomer (0115-0116), in embodiments solid units comprising less than about 15% acidic species of the antibody and isolated, substantially pure antibodies (0078-0079, 0126-0128), acidic species can be detected by various methods, such as, for example, WCX-10 HPLC (a weak cation exchange chromatography) (0254, 0611), lowering the amount of acidic species variants or process-related impurities (0252-0276), in embodiments preparing low acidic species variants of a protein by purification with affinity chromatography and anion exchange (AEX) (0282-0285), compositions comprising stable therapeutic agents, and stability of the therapeutic agent is determined by a result of 90%, 95%, 98% or more monomer therapeutic agent (0030), the protein is considered stable if there is a low percentage of aggregates protein, or a high level (e.g. 98%, 99%, 99.5% or more) monomer (0115-0116), size exclusion chromatography (SEC) may be used to determine fragment and monomer (aggregation) content for protein, such as antibodies (0171, 0611, by SE-HPLC), SEC results indicating 99.5% or more monomer antibody, monomer percentages may be described in terms of percent aggregate, including less than 1% aggregate (0172-0173), low process related impurities refer to about 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, or less of process-related impurities, in embodiments a low process-related impurity composition is free of process-related impurities or is substantially free of process-related impurities (0255), less than 0.5% impurities, and quantitation was based on the relative area percentage of detected peaks, including acidic peaks (0614, Table 20), and HWM (Table 34). Shultz taught percentage appear to provide the recited an average ratio of acidic variants to the main peak of the antibody of about 0.21 or less), providing the recited composition.
Further, as Schultz teaches omalizumab and the limitations of the process of claim 22 of production by recovery from cell culture (0256, 0272-0280, 0311-0312) and purification with affinity chromatography (0275-0285). Because the prior art has disclosed all structural limitations of the claimed product except for the specific claimed ratios of peaks, which the Examiner cannot determine whether the prior art inherently possesses, a case of prima facie obviousness has been established. The burden of proof shifts to the Applicant to show that the prior art reference does not teach or suggest the claimed properties (In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980)). Examiner notes the limitations with respect to how the purity of the composition is determined do not differentiate over the prior art, “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP 2113, in the interest of compact prosecution.
As noted above, the transitional phrase “consisting essentially of” limits the scope of a claim to the specified materials or steps "and those that do not materially affect the basic and novel characteristic(s)" of the claimed invention. In re Herz, 537 F.2d 549, 551-52, 190 USPQ 461, 463 (CCPA 1976). For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." (see MPEP 2111.03).
Alternatively, Schultz teaches purification with anion exchange (0282-0285) and monomer percentages may be described in terms of percent aggregate, including less than 1% aggregate (0172-0173), and acidic variants may be the result of product preparation or storage and can be controlled based on production and storage, including adjusting culture media (0253-0279), and that the amount of acidic variants affect the biological and functional properties including efficacy of treatment or prevention of disorders (0266-0269), as Shultz teaches the amount of acidic variant can be modified, depending on production and storage conditions, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the amount of acidic variant in order to optimize efficacy and treatment depending on patient needs.
Additionally, Wong teaches a similar process including purification of antibodies including omalizumab (0019, 0070, 0233-0235, 0544), contaminants removed include variants (0083, 0211, 0238) and HMW, aggregated polypeptide can be high molecular weight (HMW) protein, the amount of aggregated protein may be reduced by a number of ranges of 5% to about 99% (0216), analyzed by SEC (0564-0565), and methods of measuring are known in the art (0216, HMW is less than 0.5%), analyzed by SE-HPLC (0188-0189, 0565), examiner notes “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP 2113, in the interest of compact prosecution, Wong teaches purification of impurities using protein A followed by anion exchange chromatography (009-0015, 0036-0045, 0115 0123, 0165-0179, 0496, 0530-0545), and aggregated polypeptide can be high molecular weight (HMW) protein (0216).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that Shultz taught antibody with monomer percentages described in terms of percent aggregate and HMW would include as a function of the preparation process and according to Wong aggregated polypeptide can be high molecular weight (HMW) protein, and as the use of anion exchange is known to reduce HWM impurities as shown by Wong, 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 claims 2-7, as noted above, Shultz teaches high levels (e.g. 98%, 99%, 99.5% or more) monomer (0115-0116), low process related impurities refer to about 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, or less of process-related impurities, the average ratio of acidic variants is 0.20, 0.18, 0.16, 0.14, 0.12, 0.10 or less. Schultz teaches omalizumab and the limitations of the process of claim 22 of production by recovery from cell culture (0256, 0272-0280, 0311-0312) and purification with affinity chromatography (0275-0285). Because the prior art has disclosed all structural limitations of the claimed product except for the specific claimed ratios of peaks, which the Examiner cannot determine whether the prior art inherently possesses, a case of prima facie obviousness has been established. The burden of proof shifts to the Applicant to show that the prior art reference does not teach or suggest the claimed inherent properties (In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980)).
With respect to claims 8-14, as noted above, Shultz teaches high levels (e.g. 98%, 99%, 99.5% or more) monomer (0115-0116), low process related impurities refer to about 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, or less of process-related impurities, HWM of 1.7-3.3% with monomer of 96.7-99.9%, Table 34, as discussed above, Schultz teaches omalizumab and the limitations of the process of claim 22 of production by recovery from cell culture (0256, 0272-0280, 0311-0312) and purification with affinity chromatography (0275-0285). Because the prior art has disclosed all structural limitations of the claimed product except for the specific claimed ratios of peaks, which the Examiner cannot determine whether the prior art inherently possesses, a case of prima facie obviousness has been established. The burden of proof shifts to the Applicant to show that the prior art reference does not teach or suggest the claimed properties (In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980)).
With respect to claim 19, Shultz teaches the composition as discussed above, and that the ability to make reproducibly consistent products (0356) the composition is reproducible.
With respect to claims 20 and 21, Schultz teaches the composition and purity as discussed above, and the invention provides for reproducible product that is easier to manufacture (0013), examiner notes the limitations with respect to how the purity of the composition is determined do not differentiate over the prior art, “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP 2113, in the interest of compact prosecution.
With respect to claim 22, Schultz teaches the composition and purity as discussed above, and the invention provides for reproducible product that is easier to manufacture (0013), examiner notes the limitations with respect to how the purity of the composition is determined do not differentiate over the prior art, “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP 2113, in the interest of compact prosecution, Shultz teaches culturing cells and purification with affinity chromatography (0271-0278).
With respect to claims 25-28, the composition of claim 1, is taught above. Schultz teaches a high level (e.g. 98%, 99%, 99.5% or more) monomer (0115-0116) as discussed above, and 99.9% monomer (table 34), 99.6, 99.7, 99.8, 99.9%.
With respect to claim 33-50, the limitations of claim 1 are discussed above, Shultz teaches high levels (e.g. 98%, 99%, 99.5% or more) monomer (0115-0116), low process related impurities of about 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, or less of process-related impurities, as discussed above, LMW (Table 34) and basic charge variants (0252-0285). Shultz teaches acidic variants may be the result of product preparation or storage and can be controlled based on production and storage, including adjusting culture media (0253-0279), and that the amount of acidic variants affect the biological and functional properties including efficacy of treatment or prevention of disorders (0266-0269), while Shultz does not explicitly teach the acidic variant is present in the range of amount of about 9.8% or less, to about 5.0% or less, as Shultz teaches the amount of acidic variant can be modified, depending on production and storage conditions, such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention optimize the amount of acidic variant in order to optimize efficacy and treatment depending on patient needs.
Claim(s) 22-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schultz (US PG Pub 2016/0228371), in view of Wong (US PG Pub 2022/0203347), in view of Duthe (US PG Pub 2021/00096342).
With respect to claims 22-32, the composition of claim 1, is taught above. As noted above, Shultz teaches high levels (e.g. 98%, 99%, 99.5% or more) monomer (0115-0116), low process related impurities of about 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, or less of process-related impurities, and HWM impurities. Shultz does not explicitly teach 0.4% or less, 0.3% or less, 0.2% or less, 0.1% or less HWM, however, such purities are known in the art as shown by Duthe, Duthe teaches antibody purification of monoclonal antibodies (mAbs) (0001-0004) including omalizumab (0117), and highly pure protein that can for instance exhibit a purity of at least 70%, 75%, 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99%, 99.2%, 99.5%, or 99.9%, and concentrations of HMW species of less than 0.6%, less than 0.5%, less than 0.4%, less than 0.3%, less than 0.2% or less than 0.1% (0212).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fraunhofer (US PG Pub 2009/0291062)
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/JEANNIE MCDERMOTT/Examiner, Art Unit 1776
/BRADLEY R SPIES/ Primary Examiner, Art Unit 1776
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