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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 16, 2026 has been entered.
Status of the Claims
Claims 1-31 were originally filed May 25, 2021.
The preliminary amendment received May 25, 2021 amended claims 6-13, 17, 19, 21, and 24-31. Please note: claims 7-31 do not have status identifiers. Status identifiers for each claim should be provided for each claim after amendment.
The amendment to the claims received February 3, 2025 canceled claims 1-18, amended claims 19 and 21-28, and added new claims 32-40.
The amendment to the claims received August 18, 2015 amended claim 37 and added new claim 41.
The amendment to the claims received February 16, 2026 amended claims 19 and 41.
Claims 19-41 are currently pending.
Claims 19, 21-28, 32, and 41 are currently under consideration.
Election/Restrictions
Applicants elected Group II (claims 19-31) without traverse in the reply filed on May 24, 2024. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 1-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product, there being no allowable generic or linking claim.
Applicants elected, without traverse, SEQ ID NO: 1, method step a, NaCl at 1-200 mM, and a pH of 6-7.5 as the species in the reply filed on May 24, 2024 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note: applicants have conveniently elected a range (i.e. subgenus of NaCl concentration and pH) which is in direct contrast to what was discussed in the telephone conversation on March 6, 2024 (i.e. the examiner of record reiterated that a single, specific species must be elected). However, in order to advance prosecution, the species election has been accepted. It is respectfully noted that this does not preclude an additional species election requirement for any new and/or amended claims.
Claims 20, 29-31, and 36-40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 24, 2024.
Please note: applicants’ representative is traversing the species requirement in the August 18, 2025 response. Applicants previously elected a species for the composition comprising one or more peptides (i.e. SEQ ID NO: 1) without traverse in the response received May 24, 2024. Applicants may NOT now traverse an election that was made without traverse by original presentation. However, to clarify, applicants were provided the opportunity to elect a species of SEQ ID NOs: 1, 19, 20, 21, 22, 23, 33, 34, 35, and/or 36 (see claims 19 and 29; see the Restriction/Election Requirement mailed on February 2, 2024). Applicants’ representative chose to elect the species of SEQ ID NO: 1 by original presentation. This species does not read on SEQ ID NOs: 2-23 and 33-36.
Applicant’s election without traverse of protein and CHO cell proteins in the reply filed on August 18, 2025 is acknowledged.
Claims 33-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 18, 2025.
Priority
The present application is a 371 (National Stage) of PCT/US2019/063452 filed November 26, 2019 which claims the benefit of 62/784,104 filed December 21, 2018 and 62/771,272 filed November 26, 2018.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
New Rejections Necessitated by Amendment
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.
Claims 19, 21-28, 32, and 41 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. One of skill in the art would not be able to determine the scope of the presently claimed method. For example, it is unclear what the target biomolecules are. As presently claimed, the target biomolecules could include polypeptides, polynucleotides, small molecules, liquids, etc.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 41 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 41 depends on independent claim 19. Independent claim 19 requires the following reagents: (1) a mixture comprising one or more host cell proteins and one or more target biomolecules and (2) a composition comprising one or peptides wherein at least one peptide is SEQ ID NO: 1. Dependent claim 41 refers to a CHO host cell. However, the host cell is not one of the reagents utilized in the method of independent claim 19. Therefore, dependent claim 41 fails to further limit the reagents utilized in the method of independent claim 19 or the method step of independent claim 19. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
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.
Claim 41 is 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. One of skill in the art would not be able to determine the scope of the present claims. For example, the host cell is a CHO cell does not alter the scope of independent claim 19 since the cells are not part of the method. In addition, CHO cells do not alter the host cell proteins either because the host cell proteins could be naturally occurring CHO cell proteins, recombinant proteins that the CHO cells express, etc. Therefore, the scope is unclear.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) as being indefinite were considered but are not persuasive for the following reasons.
Applicants contend that paragraph 48 of the originally filed specification clarifies what a host cell protein is.
Applicants’ arguments are not convincing since paragraph 48 of the originally filed specification is not a definition. Limitations from the specification should not be read into the claims. See MPEP § 2173.01.
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.
Claims 19, 21-28, 32, and 41 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. One of skill in the art would not be able to determine the scope of the presently claimed method. For example, there is a lack of a nexus between the preamble and the body of the claim. The present method requires a single step of “contacting”. It is unclear how “contacting” (i.e. body of the claim) removes “one or more host cell proteins from a mixture” (i.e. preamble). The present single step method would simply provide a mixture wherein the host cell proteins are bound to the peptide and target biomolecules.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112, second paragraph (indefinite), for claims 19, 21-28, 32, and 41 were considered but are not persuasive for the following reasons.
Applicants contend that the amendment negates the rejection. Applicant is also of the opinion that limitations from the specification should be read into the claim.
Applicants’ arguments are not convincing since the amendment does not negate the rejection. There is still a lack of a nexus between the preamble and method step a.
Limitations from the specification should not be read into the claims. See MPEP § 2173.01.
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.
Claims 19, 21-28, 32, and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Kumpalume et al. WO 2015/049651 published April 9, 2015; Vedantham et al. U.S. Patent Application Publication 2003/0166869 published September 4, 2003; and Ye et al. U.S. Patent Application Publication 2014/0288277 published September 25, 2014.
For present claims 19, 21-28, 32, and 41, Kumpalume et al. teach methods of purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) (i.e. removing one or more host cell proteins) via contacting the mixture with a peptide ligand which binds the polypeptide (i.e. affinity chromatography method) utilizing NaCl buffer at 137 mM or 150 mM and at pH of 5-7, 6.5-7.5, or 7.2-8.5 (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 21, 97, 98, 100, 105, 107-109, 112, 133, 115, 116, 162).
For present claims 19, 21-28, 32, and 41, Venantham et al. teach chromatography methods for purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) via contacting the mixture with a peptide ligand wherein a NaCl buffer is utilized at concentration of about 50-250 mM and a pH of at least about 5.5 or between about 6.0 and 8.6 (please refer to the entire specification particularly the abstract; paragraphs 7-16, 21-23, 26, 34, 41-43, 45, 47, 56, 58, 59, 63). Venantham et al. teach CHO cells as the host cell (please refer to the entire specification particularly paragraphs 9, 12, 16, 47; claims).
For present claims 19, 21-28, 32, and 41, Ye et al. teach methods of contacting antibodies and antigens wherein the Heavy Chain CDR3 is GSRYRYGSRGM (i.e. underlined and bold is present SEQ ID NO: 1) (please refer to the entire specification particularly Figures 5A, 5C). Ye et al. teach that mAb can be made in CHO cells (please refer to the entire specification particularly paragraph 88).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because a particular known technique (i.e. altering pH and salt concentration to optimize binding; utilizing CHO cells) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because the substitution of one known element (i.e. genus of peptide ligand) for another (i.e. species of peptide comprising GSRYRY) would have yielded predictable results (i.e. ability to bind another peptide particularly since GSRYRY is part of the CDR3 of an antibody) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Kumpalume et al.; Vedantham et al.; and Ye et al. for claims 19, 21-28, 32, and 41 were considered but are not persuasive for the following reasons.
Applicants contend that the present clams require that the peptide of SEQ ID NO: 1 has greater binding affinity for the host cell proteins than for the target biomolecules. Applicants contend that Kumpalume et al. teach small molecules utilized in affinity chromatography for purification of serum albumin. Applicants contend that Vedantham et al. teach separating a protein from one or more other proteins utilizing hydroxyapatite chromatography. Applicants contend that one of skill in the art would not anticipate that the heavy chain CDR3 alone (i.e. without CDR1 or CDR2 from the heavy or light chains and without the light chain CDR3) could bind a protein.
Applicants’ arguments are not convincing since the teachings of Kumpalume et al.; Vedantham et al.; and Ye et al. render the method of the instant claims prima facie obvious.
It is respectfully noted that the presently claimed “target biomolecule” is not limited to a polypeptide, but can encompass any “biomolecule”.
Kumpalume et al.; Vedantham et al.; and Ye et al. all teach at least a single “contacting” method step.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, one of skill in the art would readily ascertain that antibodies most typically bind peptide antigens and that the same CDR3 could be screened for binding to peptide antigens. Antibodies are well-understood, conventional, and routine in the prior art for screening assays. In addition, utilizing CDR3 alone (i.e. peptide) is well-understood, conventional, and routine in the prior art for screening assays. References will be provided upon request. It is well-known in the prior art that CDR3 is the hypervariable region of antibodies which bind antigen. One of skill in the art would know this.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 19, 24-26, and 32 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-12, 15, 16, 26, 27, 29, and 34-36 of copending Application No. 18/701,164 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented. Both the presently claimed method and the method as claimed in copending Application No. 18/701,164 (reference application) are drawn to methods of purifying a target biologic from a mixture comprising host cell proteins via contacting the mixture with present SEQ ID NOs: 1-18 (i.e. SEQ ID NOs: 6-23).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of statutory double patenting as being unpatentable over copending Application No. 18/701,164 (reference application) for claims 19, 24-26, and 32 were considered but are not persuasive for the following reasons.
Applicants contend that copending Application No. 18/701,164 (reference application) only claims compositions.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 18/701,164 (reference application) claims the same method as the instant claims (see claim 36 of copending Application No. 18/701,164). In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
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 19, 21-28, 32, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 15, 16, 26, 27, 29, and 34-36 of copending Application No. 18/701,164 in view of Vedantham et al. U.S. Patent Application Publication 2003/0166869 published September 4, 2003.
Copending Application No. 18/701,164 (reference application) claims a method of purifying a target biologic from a mixture comprising host cell proteins via contacting the mixture with present SEQ ID NOs: 1-18 (i.e. SEQ ID NOs: 6-23).
Venantham et al. teach chromatography methods for purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) via contacting the mixture with a peptide ligand wherein a NaCl buffer is utilized at concentration of about 50-250 mM and a pH of at least about 5.5 or between about 6.0 and 8.6 (please refer to the entire specification particularly the abstract; paragraphs 7-16, 21-23, 26, 34, 41-43, 45, 47, 56, 58, 59, 63). Venantham et al. teach CHO cells as the host cell (please refer to the entire specification particularly paragraphs 9, 12, 16, 47; claims).
The claims would have been obvious because a particular known technique (i.e. altering pH and salt concentration to optimize binding; utilizing CHO cells as host cells) was recognized as part of the ordinary capabilities of one skilled in the art. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
This is a provisional nonstatutory double patenting rejection.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 18/701,164 in view of Vedantham et al. for claims 19, 21-28, 32, and 41 were considered but are not persuasive for the following reasons.
Applicants contend that all the claims of copending Application No. 18/701,164 are drawn to compositions and present SEQ ID NO: 1 is not taught.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 18/701,164 in view of Vedantham et al. renders obvious the method of the instant claims. Applicants are respectfully directed to claim 36 (i.e. method claim) and SEQ ID NO: 6 (i.e. GSRYRY – present SEQ ID NO: 1) of claim 34. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
New Rejections
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 19, 21-28, 32, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of copending Application No. 19/483,663 in view of Kumpalume et al. WO 2015/049651 published April 9, 2015; Vedantham et al. U.S. Patent Application Publication 2003/0166869 published September 4, 2003; and Ye et al. U.S. Patent Application Publication 2014/0288277 published September 25, 2014.
Copending Application No. 19/483,663 claims a method of purifying AAV from a biological fluid comprising contacting a peptide ligand with a biological fluid and AAV.
Kumpalume et al. teach methods of purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) (i.e. removing one or more host cell proteins) via contacting the mixture with a peptide ligand which binds the polypeptide (i.e. affinity chromatography method) utilizing NaCl buffer at 137 mM or 150 mM and at pH of 5-7, 6.5-7.5, or 7.2-8.5 (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 21, 97, 98, 100, 105, 107-109, 112, 133, 115, 116, 162).
Venantham et al. teach chromatography methods for purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) via contacting the mixture with a peptide ligand wherein a NaCl buffer is utilized at concentration of about 50-250 mM and a pH of at least about 5.5 or between about 6.0 and 8.6 (please refer to the entire specification particularly the abstract; paragraphs 7-16, 21-23, 26, 34, 41-43, 45, 47, 56, 58, 59, 63). Venantham et al. teach CHO cells as the host cell (please refer to the entire specification particularly paragraphs 9, 12, 16, 47; claims).
Ye et al. teach methods of contacting antibodies and antigens wherein the Heavy Chain CDR3 is GSRYRYGSRGM (i.e. underlined and bold is present SEQ ID NO: 1) (please refer to the entire specification particularly Figures 5A, 5C). Ye et al. teach that mAb can be made in CHO cells (please refer to the entire specification particularly paragraph 88).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because a particular known technique (i.e. altering pH and salt concentration to optimize binding; utilizing CHO cells) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because the substitution of one known element (i.e. genus of peptide ligand) for another (i.e. species of peptide comprising GSRYRY) would have yielded predictable results (i.e. ability to bind another peptide particularly since GSRYRY is part of the CDR3 of an antibody) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 19, 21-28, 32, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 7, 8, 10, 12, 15-17, 19, 24, 26-30, 35, 44, and 45 of copending Application No. 19/348,346 in view of Kumpalume et al. WO 2015/049651 published April 9, 2015; Vedantham et al. U.S. Patent Application Publication 2003/0166869 published September 4, 2003; and Ye et al. U.S. Patent Application Publication 2014/0288277 published September 25, 2014.
Copending Application No. 19/348,346 claims a method of purifying lentivirus from a sample comprising contacting a peptide with a sample and lentivirus.
Kumpalume et al. teach methods of purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) (i.e. removing one or more host cell proteins) via contacting the mixture with a peptide ligand which binds the polypeptide (i.e. affinity chromatography method) utilizing NaCl buffer at 137 mM or 150 mM and at pH of 5-7, 6.5-7.5, or 7.2-8.5 (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 21, 97, 98, 100, 105, 107-109, 112, 133, 115, 116, 162).
Venantham et al. teach chromatography methods for purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) via contacting the mixture with a peptide ligand wherein a NaCl buffer is utilized at concentration of about 50-250 mM and a pH of at least about 5.5 or between about 6.0 and 8.6 (please refer to the entire specification particularly the abstract; paragraphs 7-16, 21-23, 26, 34, 41-43, 45, 47, 56, 58, 59, 63). Venantham et al. teach CHO cells as the host cell (please refer to the entire specification particularly paragraphs 9, 12, 16, 47; claims).
Ye et al. teach methods of contacting antibodies and antigens wherein the Heavy Chain CDR3 is GSRYRYGSRGM (i.e. underlined and bold is present SEQ ID NO: 1) (please refer to the entire specification particularly Figures 5A, 5C). Ye et al. teach that mAb can be made in CHO cells (please refer to the entire specification particularly paragraph 88).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because a particular known technique (i.e. altering pH and salt concentration to optimize binding; utilizing CHO cells) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because the substitution of one known element (i.e. genus of peptide ligand) for another (i.e. species of peptide comprising GSRYRY) would have yielded predictable results (i.e. ability to bind another peptide particularly since GSRYRY is part of the CDR3 of an antibody) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 19, 21-28, 32, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of copending Application No. 19/154,929 in view of Kumpalume et al. WO 2015/049651 published April 9, 2015; Vedantham et al. U.S. Patent Application Publication 2003/0166869 published September 4, 2003; and Ye et al. U.S. Patent Application Publication 2014/0288277 published September 25, 2014.
Copending Application No. 19/154,929 claims a method of purifying AAV from a biological fluid comprising contacting a peptide ligand with a biological fluid and AAV.
Kumpalume et al. teach methods of purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) (i.e. removing one or more host cell proteins) via contacting the mixture with a peptide ligand which binds the polypeptide (i.e. affinity chromatography method) utilizing NaCl buffer at 137 mM or 150 mM and at pH of 5-7, 6.5-7.5, or 7.2-8.5 (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 21, 97, 98, 100, 105, 107-109, 112, 133, 115, 116, 162).
Venantham et al. teach chromatography methods for purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) via contacting the mixture with a peptide ligand wherein a NaCl buffer is utilized at concentration of about 50-250 mM and a pH of at least about 5.5 or between about 6.0 and 8.6 (please refer to the entire specification particularly the abstract; paragraphs 7-16, 21-23, 26, 34, 41-43, 45, 47, 56, 58, 59, 63). Venantham et al. teach CHO cells as the host cell (please refer to the entire specification particularly paragraphs 9, 12, 16, 47; claims).
Ye et al. teach methods of contacting antibodies and antigens wherein the Heavy Chain CDR3 is GSRYRYGSRGM (i.e. underlined and bold is present SEQ ID NO: 1) (please refer to the entire specification particularly Figures 5A, 5C). Ye et al. teach that mAb can be made in CHO cells (please refer to the entire specification particularly paragraph 88).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because a particular known technique (i.e. altering pH and salt concentration to optimize binding; utilizing CHO cells) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because the substitution of one known element (i.e. genus of peptide ligand) for another (i.e. species of peptide comprising GSRYRY) would have yielded predictable results (i.e. ability to bind another peptide particularly since GSRYRY is part of the CDR3 of an antibody) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 19, 21-28, 32, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of copending Application No. 19/152,281 in view of Kumpalume et al. WO 2015/049651 published April 9, 2015; Vedantham et al. U.S. Patent Application Publication 2003/0166869 published September 4, 2003; and Ye et al. U.S. Patent Application Publication 2014/0288277 published September 25, 2014.
Copending Application No. 19/152,281 claims a method of purifying a biologic from a biological fluid comprising contacting a peptide ligand with a biological fluid and a biologic.
Kumpalume et al. teach methods of purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) (i.e. removing one or more host cell proteins) via contacting the mixture with a peptide ligand which binds the polypeptide (i.e. affinity chromatography method) utilizing NaCl buffer at 137 mM or 150 mM and at pH of 5-7, 6.5-7.5, or 7.2-8.5 (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 21, 97, 98, 100, 105, 107-109, 112, 133, 115, 116, 162).
Venantham et al. teach chromatography methods for purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) via contacting the mixture with a peptide ligand wherein a NaCl buffer is utilized at concentration of about 50-250 mM and a pH of at least about 5.5 or between about 6.0 and 8.6 (please refer to the entire specification particularly the abstract; paragraphs 7-16, 21-23, 26, 34, 41-43, 45, 47, 56, 58, 59, 63). Venantham et al. teach CHO cells as the host cell (please refer to the entire specification particularly paragraphs 9, 12, 16, 47; claims).
Ye et al. teach methods of contacting antibodies and antigens wherein the Heavy Chain CDR3 is GSRYRYGSRGM (i.e. underlined and bold is present SEQ ID NO: 1) (please refer to the entire specification particularly Figures 5A, 5C). Ye et al. teach that mAb can be made in CHO cells (please refer to the entire specification particularly paragraph 88).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because a particular known technique (i.e. altering pH and salt concentration to optimize binding; utilizing CHO cells) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because the substitution of one known element (i.e. genus of peptide ligand) for another (i.e. species of peptide comprising GSRYRY) would have yielded predictable results (i.e. ability to bind another peptide particularly since GSRYRY is part of the CDR3 of an antibody) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 19, 21-28, 32, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6, 10, 11, 14, 16-19, 22, 23, 25, 31-34, and 37 of copending Application No. 19/118,176 in view of Kumpalume et al. WO 2015/049651 published April 9, 2015; Vedantham et al. U.S. Patent Application Publication 2003/0166869 published September 4, 2003; and Ye et al. U.S. Patent Application Publication 2014/0288277 published September 25, 2014.
Copending Application No. 19/118,176 claims a method of purifying a target biologic from a fluid comprising contacting a peptide ligand with a fluid and a target biologic.
Kumpalume et al. teach methods of purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) (i.e. removing one or more host cell proteins) via contacting the mixture with a peptide ligand which binds the polypeptide (i.e. affinity chromatography method) utilizing NaCl buffer at 137 mM or 150 mM and at pH of 5-7, 6.5-7.5, or 7.2-8.5 (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 21, 97, 98, 100, 105, 107-109, 112, 133, 115, 116, 162).
Venantham et al. teach chromatography methods for purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) via contacting the mixture with a peptide ligand wherein a NaCl buffer is utilized at concentration of about 50-250 mM and a pH of at least about 5.5 or between about 6.0 and 8.6 (please refer to the entire specification particularly the abstract; paragraphs 7-16, 21-23, 26, 34, 41-43, 45, 47, 56, 58, 59, 63). Venantham et al. teach CHO cells as the host cell (please refer to the entire specification particularly paragraphs 9, 12, 16, 47; claims).
Ye et al. teach methods of contacting antibodies and antigens wherein the Heavy Chain CDR3 is GSRYRYGSRGM (i.e. underlined and bold is present SEQ ID NO: 1) (please refer to the entire specification particularly Figures 5A, 5C). Ye et al. teach that mAb can be made in CHO cells (please refer to the entire specification particularly paragraph 88).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because a particular known technique (i.e. altering pH and salt concentration to optimize binding; utilizing CHO cells) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because the substitution of one known element (i.e. genus of peptide ligand) for another (i.e. species of peptide comprising GSRYRY) would have yielded predictable results (i.e. ability to bind another peptide particularly since GSRYRY is part of the CDR3 of an antibody) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 19, 21-28, 32, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7, 8, 10-13, 15, 22-25, 28, 30, 32, and 35 of copending Application No. 18/890,315 in view of Kumpalume et al. WO 2015/049651 published April 9, 2015; Vedantham et al. U.S. Patent Application Publication 2003/0166869 published September 4, 2003; and Ye et al. U.S. Patent Application Publication 2014/0288277 published September 25, 2014.
Copending Application No. 18/890,315 claims a method of purifying a target biologic from a sample comprising contacting a ligand with a sample and a target biologic.
Kumpalume et al. teach methods of purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) (i.e. removing one or more host cell proteins) via contacting the mixture with a peptide ligand which binds the polypeptide (i.e. affinity chromatography method) utilizing NaCl buffer at 137 mM or 150 mM and at pH of 5-7, 6.5-7.5, or 7.2-8.5 (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 21, 97, 98, 100, 105, 107-109, 112, 133, 115, 116, 162).
Venantham et al. teach chromatography methods for purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) via contacting the mixture with a peptide ligand wherein a NaCl buffer is utilized at concentration of about 50-250 mM and a pH of at least about 5.5 or between about 6.0 and 8.6 (please refer to the entire specification particularly the abstract; paragraphs 7-16, 21-23, 26, 34, 41-43, 45, 47, 56, 58, 59, 63). Venantham et al. teach CHO cells as the host cell (please refer to the entire specification particularly paragraphs 9, 12, 16, 47; claims).
Ye et al. teach methods of contacting antibodies and antigens wherein the Heavy Chain CDR3 is GSRYRYGSRGM (i.e. underlined and bold is present SEQ ID NO: 1) (please refer to the entire specification particularly Figures 5A, 5C). Ye et al. teach that mAb can be made in CHO cells (please refer to the entire specification particularly paragraph 88).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because a particular known technique (i.e. altering pH and salt concentration to optimize binding; utilizing CHO cells) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because the substitution of one known element (i.e. genus of peptide ligand) for another (i.e. species of peptide comprising GSRYRY) would have yielded predictable results (i.e. ability to bind another peptide particularly since GSRYRY is part of the CDR3 of an antibody) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 19, 21-28, 32, and 41 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-11, 13, 14, 16, 17, 19, 26-28, 31, and 35 of copending Application No. 18/890,289 in view of Kumpalume et al. WO 2015/049651 published April 9, 2015; Vedantham et al. U.S. Patent Application Publication 2003/0166869 published September 4, 2003; and Ye et al. U.S. Patent Application Publication 2014/0288277 published September 25, 2014.
Copending Application No. 18/890,289 claims a method of purifying a target biologic from a sample comprising contacting a ligand with a sample and a target biologic.
Kumpalume et al. teach methods of purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) (i.e. removing one or more host cell proteins) via contacting the mixture with a peptide ligand which binds the polypeptide (i.e. affinity chromatography method) utilizing NaCl buffer at 137 mM or 150 mM and at pH of 5-7, 6.5-7.5, or 7.2-8.5 (please refer to the entire specification particularly the abstract; paragraphs 3, 4, 21, 97, 98, 100, 105, 107-109, 112, 133, 115, 116, 162).
Venantham et al. teach chromatography methods for purifying polypeptide(s) from a mixture comprising host cell proteins (HCP) and the polypeptide(s) via contacting the mixture with a peptide ligand wherein a NaCl buffer is utilized at concentration of about 50-250 mM and a pH of at least about 5.5 or between about 6.0 and 8.6 (please refer to the entire specification particularly the abstract; paragraphs 7-16, 21-23, 26, 34, 41-43, 45, 47, 56, 58, 59, 63). Venantham et al. teach CHO cells as the host cell (please refer to the entire specification particularly paragraphs 9, 12, 16, 47; claims).
Ye et al. teach methods of contacting antibodies and antigens wherein the Heavy Chain CDR3 is GSRYRYGSRGM (i.e. underlined and bold is present SEQ ID NO: 1) (please refer to the entire specification particularly Figures 5A, 5C). Ye et al. teach that mAb can be made in CHO cells (please refer to the entire specification particularly paragraph 88).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.). See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.") and In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
The claims would have been obvious because a particular known technique (i.e. altering pH and salt concentration to optimize binding; utilizing CHO cells) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because the substitution of one known element (i.e. genus of peptide ligand) for another (i.e. species of peptide comprising GSRYRY) would have yielded predictable results (i.e. ability to bind another peptide particularly since GSRYRY is part of the CDR3 of an antibody) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication 2016/0024147
JP 11-507919 (translation)
WO 97/00270
WO 2003/004628 (with translation)
CA 2 447 818
U.S. Patent 7,408,030
Lundstrom et al., 2014, Sensitive methods for evaluation of antibodies for host cell protein analysis and screening of impurities in a vaccine process, Vaccine, 32: 2911-2915.
Arfi et al., 2016, Polyclonal antibodies for specific detection of tobacco host cell proteins can be efficiently generated following RuBisCO depletion and the removal of endotoxins, Biotechnol. J., 11: 507-518.
Jin et al., 2010, Profiling of Host Cell Proteins by Two-Dimensional Difference Gel Electrophoresis (2D-DIGE): Implications for Downstream Process Development, Biotechnology and Bioengineering, 105(2): 306-316.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658