DETAILED ACTION
Status of Claims:
Claims 40-46 and 50-59 are pending.
Claims 40, 42-45, 51, 54, 58, and 59 are amended.
Claims 47-49 are canceled.
This Action is Made Final.
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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 6/30/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The applicant argues that Zhou does not teach a carbohydrate binding domain of Galanthus nivalis lectin, Triticum vulgaris lectin, Maackia amurensis lectin, or Musa paradisiaca lectin. The applicant is correct that Zhou does not disclose the claimed binding domains. This limitation is made obvious in view of Watters et al (USPN 10,435,457) which teaches a Galanthus nivalis lectin for binding carbohydrates (see col. 19 lines 16-25).
The double patenting rejections are now made in view of Watters.
The previous 112 rejections are withdrawn in view of the amendments.
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 40 and 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 of U.S. Patent No. 12,434,201 in view of Watters et al (USPN 10,435,457).
Regarding Claims 40 and 46:
The claims of the patent disclose separation media comprising: a support substrate (macroporous support); and a plurality of separation ligands for formula SL1 or SL2 (claim 1 of the patent discloses SL1 wherein Rp1 is equivalent to RpB with U1 as O, U2 as O and U3 as NH) (see claim 1), wherein Z is a separation group comprising an affinity group (protein A) (see claim 1), wherein the support substrate comprises a celluloses membrane (see claim 1) . Claim 40 only requires one of SL1 or SL2, therefore the claims of the patent do not need to disclose Sp is a spacer comprising a divalent organic group because the claims of the patent disclose SL1.
The claims do not teach the affinity group comprising teach a carbohydrate binding domain of Galanthus nivalis lectin, Triticum vulgaris lectin, Maackia amurensis lectin, or Musa paradisiaca lectin.
Watters teaches a Galanthus nivalis lectin for binding carbohydrates (see col. 19 lines 16-25).
The Patent and Jones are analogous inventions in the art of separation media. It would have been obvious to one skilled in the art before the effective filing date of the invention to replace the affinity group (protein A) of the patent with a carbohydrate binding domain, specifically Galanthus nivalis lectin, as disclosed by Watters, because it is the simple substitution of one known affinity group for another known affinity group, obviously resulting in the ability to bind carbohydrates to the media, with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Claims 40-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-39 of copending Application No. 18/383,468 in view of Watters et al (USPN 10,435,457).
Regarding Claim 40:
The claims of the copending application disclose separation media comprising: a support substrate (macroporous support); and a plurality of separation ligands for formula SL1 or SL2 (claim 29), wherein Z is a separation group comprising a carbohydrate binding domain (see claim 29), wherein the support substrate comprises a celluloses membrane (see claim 1) .
The claims do not teach the affinity group comprising teach a carbohydrate binding domain of Galanthus nivalis lectin, Triticum vulgaris lectin, Maackia amurensis lectin, or Musa paradisiaca lectin.
Watters teaches a Galanthus nivalis lectin for binding carbohydrates (see col. 19 lines 16-25).
The Copending application and Watters are analogous inventions in the art of separation media. It would have been obvious to one skilled in the art before the effective filing date of the invention to replace the affinity group of the copending application with a carbohydrate binding domain, specifically Galanthus nivalis lectin, as disclosed by Watters, because it is the simple substitution of one known affinity group for another known affinity group, obviously resulting in the ability to bind carbohydrates to the media, with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claims 41-46:
Claims 41-46 of the instant invention are disclosed by claims 30-39 of the copending application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 40-46 and 56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 17-20 of copending Application No. 18/925,985 in view of Watters et al (USPN 10,435,457).
Regarding Claim 40:
The claims of the copending application disclose the separation media comprising: a support substrate; and a plurality of separation ligands for formula SL1 or SL2 (see claim 1, which discloses identical SL1 and SL2 and identical structures of Rp1, Rp3 and Rp4), wherein: Z is a separation group comprising an affinity group.
The claims do not teach the affinity group comprising teach a carbohydrate binding domain of Galanthus nivalis lectin, Triticum vulgaris lectin, Maackia amurensis lectin, or Musa paradisiaca lectin.
Watters teaches a Galanthus nivalis lectin for binding carbohydrates (see col. 19 lines 16-25).
The Copending application and Watters are analogous inventions in the art of separation media. It would have been obvious to one skilled in the art before the effective filing date of the invention to replace the affinity group of the copending application with a carbohydrate binding domain, specifically Galanthus nivalis lectin, as disclosed by Watters, because it is the simple substitution of one known affinity group for another known affinity group, obviously resulting in the ability to bind carbohydrates to the media, with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claims 41-46:
Claims 41-46 directly correspond to claims 2-5, 7 and 8 of the copending application.
Regarding Claim 56:
Claim 17 of the copending application, as modified buy Jones, directly corresponds to claims 56 of the instant invention
This is a provisional nonstatutory double patenting rejection.
Claims 57 and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 17-20 of copending Application No. 18/925,985 in view of Watters et al (USPN 10,435,457) and further in view of Willson et al (US 2021/0178290).
Regarding Claim 57:
The claims of the copending application, as modified by Jones, disclose the method of isolating a target molecule from an isolation solution, the isolation solution comprising: an isolation solvent; the method comprising: contacting the isolation solution with the separation media of claim 40 (see copending application claim 17).
The claims do not teach the target molecule comprising a lentiviral vector.
Willson teaches isolating (retaining) a target molecule comprising a lentiviral vector (see para. 0130-0131).
The claims of the copending application and Willson are analogous inventions in the art of isolating target molecules. It would have been obvious to one skilled in the art before the effective filing date of the invention to use the method of the claims of the copending application, as modified by Jones, to separate a lentiviral vector, as disclosed by Willson, because through routine experimentation one skilled in the art would have found appropriate molecules to separate with a known method. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
Regarding Claim 58:
Claim 58 of the instant invention directly correspond to claim 19 of the copending application.
This is a provisional nonstatutory double patenting rejection.
Claims 40-42, 44-46, and 56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11, 13 and 16 of copending Application No. 18/925,891 in view of Watters et al (USPN 10,435,457).
Regarding Claim 40:
The claims of the copending application disclose the separation media comprising: a support substrate; and a plurality of separation ligands for formula SL1 or SL2 (see claim 1, which discloses identical SL1 and SL2 and identical structures of Rp1, Rp3 and Rp4), wherein: Z is a separation group comprising an affinity group.
The claims do not teach the affinity group comprising teach a carbohydrate binding domain of Galanthus nivalis lectin, Triticum vulgaris lectin, Maackia amurensis lectin, or Musa paradisiaca lectin.
Watters teaches a Galanthus nivalis lectin for binding carbohydrates (see col. 19 lines 16-25).
The Copending application and Watters are analogous inventions in the art of separation media. It would have been obvious to one skilled in the art before the effective filing date of the invention to replace the affinity group of the copending application with a carbohydrate binding domain, specifically Galanthus nivalis lectin, as disclosed by Watters, because it is the simple substitution of one known affinity group for another known affinity group, obviously resulting in the ability to bind carbohydrates to the media, with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claims 41, 42 and 44-46:
Claims 41 and 42 directly correspond to claim 2 of the copending application. Claims 44-46 directly correspond to claims 3-5 of the copending application.
Regarding Claim 56:
Claims 11 of the copending application, as modified buy Jones, directly corresponds to claim 56 of the instant invention.
This is a provisional nonstatutory double patenting rejection.
Claim 57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 17 of copending Application No. 18/925,891 in view of Watters et al (USPN 10,435,457) and further in view of Willson et al (US 2021/0178290).
Regarding Claim 57:
The claims of the copending application, as modified by Jones, disclose the method of isolating a target molecule from an isolation solution, the isolation solution comprising: an isolation solvent; the method comprising: contacting the isolation solution with the separation media of claim 40 (see copending application claim 17).
The claims do not teach the target molecule comprising a lentiviral vector.
Willson teaches isolating (retaining) a target molecule comprising a lentiviral vector (see para. 0130-0131).
The claims of the copending application and Willson are analogous inventions in the art of isolating target molecules. It would have been obvious to one skilled in the art before the effective filing date of the invention to use the method of the claims of the copending application, as modified by Jones, to separate a lentiviral vector, as disclosed by Willson, because through routine experimentation one skilled in the art would have found appropriate molecules to separate with a known method. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
This is a provisional nonstatutory double patenting rejection.
Claims 40-42, 44-46, and 56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35-38, 40, 42, and 50 of copending Application No. 18/383,453 in view of Watters et al (USPN 10,435,457).
Regarding Claim 40:
The claims of the copending application disclose the separation media comprising: a support substrate; and a plurality of separation ligands for formula SL1 or SL2 (see claim 35, which discloses identical SL1 and SL2 and identical structures of Rp1, Rp3 and Rp4), wherein: Z is a separation group comprising an affinity group.
The claims do not teach the affinity group comprising teach a carbohydrate binding domain of Galanthus nivalis lectin, Triticum vulgaris lectin, Maackia amurensis lectin, or Musa paradisiaca lectin.
Watters teaches a Galanthus nivalis lectin for binding carbohydrates (see col. 19 lines 16-25).
The Copending application and Watters are analogous inventions in the art of separation media. It would have been obvious to one skilled in the art before the effective filing date of the invention to replace the affinity group of the copending application with a carbohydrate binding domain, specifically Galanthus nivalis lectin, as disclosed by Watters, because it is the simple substitution of one known affinity group for another known affinity group, obviously resulting in the ability to bind carbohydrates to the media, with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claims 41-46 and 56:
Claims 41-46 and 56 respectively correspond to claims 36-40, 42, and 50.
This is a provisional nonstatutory double patenting rejection.
Claims 57 and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35, 51 and 52 of copending Application No. 18/383,453 in view of Watters et al (USPN 10,435,457) and further in view of Willson et al (US 2021/0178290).
Regarding Claim 57:
The claims of the copending application, as modified by Jones, disclose the method of isolating a target molecule from an isolation solution, the isolation solution comprising: an isolation solvent; the method comprising: contacting the isolation solution with the separation media of claim 40 (see copending application claim 51).
The claims do not teach the target molecule comprising a lentiviral vector.
Willson teaches isolating (retaining) a target molecule comprising a lentiviral vector (see para. 0130-0131).
The claims of the copending application and Willson are analogous inventions in the art of isolating target molecules. It would have been obvious to one skilled in the art before the effective filing date of the invention to use the method of the claims of the copending application, as modified by Jones, to separate a lentiviral vector, as disclosed by Willson, because through routine experimentation one skilled in the art would have found appropriate molecules to separate with a known method. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
Regarding Claim 58:
Claim 58 directly corresponds to claim 52 of the copending application.
This is a provisional nonstatutory double patenting rejection.
Claims 40, 41, 43-46, and 56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 7, and 17 of copending Application No. 18/925,848 in view of Watters et al (USPN 10,435,457).
Regarding Claim 40:
The claims of the copending application disclose the separation media comprising: a support substrate; and a plurality of separation ligands for formula SL1 or SL2 (see claim 1, which discloses identical SL1 and SL2 and identical structures of Rp1, Rp3 and Rp4), wherein: Z is a separation group comprising an affinity group.
The claims do not teach the affinity group comprising teach a carbohydrate binding domain of Galanthus nivalis lectin, Triticum vulgaris lectin, Maackia amurensis lectin, or Musa paradisiaca lectin.
Watters teaches a Galanthus nivalis lectin for binding carbohydrates (see col. 19 lines 16-25).
The Copending application and Watters are analogous inventions in the art of separation media. It would have been obvious to one skilled in the art before the effective filing date of the invention to replace the affinity group of the copending application with a carbohydrate binding domain, specifically Galanthus nivalis lectin, as disclosed by Watters, because it is the simple substitution of one known affinity group for another known affinity group, obviously resulting in the ability to bind carbohydrates to the media, with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claims 41 and 43-46 and 56:
Claims 41, 43-46 and 56 respectively correspond to claims 2, 3, 4, 6, 7 and 17 of the copending application .
This is a provisional nonstatutory double patenting rejection.
Claims 57 and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18 and 19 of copending Application No. 18/925,848 in view of Watters et al (USPN 10,435,457) and further in view of Willson et al (US 2021/0178290).
Regarding Claim 57:
The claims of the copending application, as modified by Jones, disclose the method of isolating a target molecule from an isolation solution, the isolation solution comprising: an isolation solvent; the method comprising: contacting the isolation solution with the separation media of claim 40 (see copending application claims 1 as modified by Jones and claim 18).
The claims do not teach the target molecule comprising a lentiviral vector.
Willson teaches isolating (retaining) a target molecule comprising a lentiviral vector (see para. 0130-0131).
The claims of the copending application and Willson are analogous inventions in the art of isolating target molecules. It would have been obvious to one skilled in the art before the effective filing date of the invention to use the method of the claims of the copending application, as modified by Jones, to separate a lentiviral vector, as disclosed by Willson, because through routine experimentation one skilled in the art would have found appropriate molecules to separate with a known method. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
Regarding Claim 58:
Claim 58 directly corresponds to claim 19 of the copending application.
This is a provisional nonstatutory double patenting rejection.
Claims 40-46, and 56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-37, 39, 41 and 49 of copending Application No. 18/383,464 in view of Watters et al (USPN 10,435,457).
Regarding Claim 40:
The claims of the copending application disclose the separation media comprising: a support substrate; and a plurality of separation ligands for formula SL1 or SL2 (see claim 34, which discloses identical SL1 and SL2 and identical structures of Rp1, Rp3 and Rp4), wherein: Z is a separation group comprising an affinity group.
The claims do not teach the affinity group comprising teach a carbohydrate binding domain of Galanthus nivalis lectin, Triticum vulgaris lectin, Maackia amurensis lectin, or Musa paradisiaca lectin.
Watters teaches a Galanthus nivalis lectin for binding carbohydrates (see col. 19 lines 16-25).
The Copending application and Watters are analogous inventions in the art of separation media. It would have been obvious to one skilled in the art before the effective filing date of the invention to replace the affinity group of the copending application with a carbohydrate binding domain, specifically Galanthus nivalis lectin, as disclosed by Watters, because it is the simple substitution of one known affinity group for another known affinity group, obviously resulting in the ability to bind carbohydrates to the media, with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claims 41-46 and 56:
Claim 35 of the copending application corresponds to claims 41 and 42 of the instant invention. Claims 36, 37, 39, 41, and 49 respectively correspond to claims 43-46 and 56 of the instant invention.
This is a provisional nonstatutory double patenting rejection.
Claims 57 and 58 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35, 50 and 51 of copending Application No. 18/383,464 in view of Watters et al (USPN 10,435,457) and further in view of Willson et al (US 2021/0178290).
Regarding Claim 57:
The claims of the copending application, as modified by Jones, disclose the method of isolating a target molecule from an isolation solution, the isolation solution comprising: an isolation solvent; the method comprising: contacting the isolation solution with the separation media of claim 40 (see copending application claim 35 as modified by Jones and claim 50).
The claims do not teach the target molecule comprising a lentiviral vector.
Willson teaches isolating (retaining) a target molecule comprising a lentiviral vector (see para. 0130-0131).
The claims of the copending application and Willson are analogous inventions in the art of isolating target molecules. It would have been obvious to one skilled in the art before the effective filing date of the invention to use the method of the claims of the copending application, as modified by Jones, to separate a lentiviral vector, as disclosed by Willson, because through routine experimentation one skilled in the art would have found appropriate molecules to separate with a known method. Applying a known technique to a known device (method or product) ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
Regarding Claim 58:
Claim 58 directly corresponds to claim 51 of the copending application.
This is a provisional nonstatutory double patenting rejection.
Claims 40 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of copending Application No. 19/323,197 in view of Watters et al (USPN 10,435,457).
Regarding Claims 40 and 46:
The claims of the patent disclose separation media comprising: a support substrate (macroporous support); and a plurality of separation ligands for formula SL1 or SL2 (claim 21 of the patent discloses SL1 wherein Rp1 is equivalent to RpB with U1 as O, U2 as O and U3 as NH) (see claim 1), wherein Z is a separation group comprising an affinity group (protein A) (see claim 21), wherein the support substrate comprises a celluloses membrane (see claim 1) . Claim 40 only requires one of SL1 or SL2, therefore the claims of the patent do not need to disclose Sp is a spacer comprising a divalent organic group because the claims of the patent disclose SL1.
The claims do not teach the affinity group comprising teach a carbohydrate binding domain of Galanthus nivalis lectin, Triticum vulgaris lectin, Maackia amurensis lectin, or Musa paradisiaca lectin.
Watters teaches a Galanthus nivalis lectin for binding carbohydrates (see col. 19 lines 16-25).
The Copending application and Watters are analogous inventions in the art of separation media. It would have been obvious to one skilled in the art before the effective filing date of the invention to replace the affinity group of the copending application with a carbohydrate binding domain, specifically Galanthus nivalis lectin, as disclosed by Watters, because it is the simple substitution of one known affinity group for another known affinity group, obviously resulting in the ability to bind carbohydrates to the media, with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
This is a provisional nonstatutory double patenting rejection.
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 55 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.
Regarding Claim 55:
The claim refers to “the…carbohydrate binding ligand”. There is insufficient antecedent basis for this limitation within the claim. Claim 40 has been amended to remove the carbohydrate binding ligand from the claim.
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) 40, 43-46 and 50-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al (US 2020/0188859) in view of Watters et al (USPN 10,435,457).
Regarding Claim 40:
Zhou teaches the separation media comprising: a support structure (cellulose membrane) (see para. 0011); and a plurality of separation ligands for formula SL1 or SL2 (see Fig. 4, Figure 4 shows a separation ligand equivalent to SL2, wherein Rp3 and Rp4 are each RpE (U5 of RP3 is O and U5 of Rp4 is NH), and Sp is the carbonyl group); wherein Z is a separation group comprising an affinity group, the affinity group comprising a carbohydrate binding domain (see para. 0122, 0090).
Zhou does not teach that the carbohydrate binding domain is Galanthus nivalis lectin, Triticum vulgaris lectin, Maackia amurensis lectin, or Musa paradisiaca lectin.
Watters teaches an affinity group comprising Galanthus nivalis lectin for binding carbohydrates (see col. 19 lines 16-25).
Zhou and Watters are analogous inventions in the art of separation media. It would have been obvious to one skilled in the art before the effective filing date of the invention to replace the affinity group of Zhou with the Galanthus nivalis lectin of Watters because it is the simple substitution of one known affinity group for another, obviously resulting in the ability to bind carbohydrates, with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claim 43:
Zhou, as modified, teaches the separation media of claim 40, wherein Sp comprises —C(O)— (carbonyl) (see Zhou fig. 4).
Regarding Claim 44:
Zhou, as modified, teaches the separation media of claim 40, wherein Rp3 and Rp4 comprises RpE (see Zhou Fig. 4, claim mapping of claim 40 above).
Regarding Claim 45:
Zhou, as modified, teaches the separation media of claim 40, wherein SL2 comprises
PNG
media_image1.png
95
193
media_image1.png
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(see Zhou fig. 4, para. 0122 which teaches Pro A replaced with Con A).
Regarding Claim 46:
Zhou, as modified, teaches the separation media of claim 40, wherein the support substrate comprises a polyolefin membrane, a polyethersulfone membrane, a poly(tetrafluoroethylene) membrane, a nylon membrane, a fiberglass membrane, a hydrogel membrane, a hydrogel monolith, a polyvinyl alcohol membrane, a cellulose membrane structure (cellulose membrane) (see Zhou para. 0011), a cellulose ester membrane, a cellulose acetate membrane, a regenerated cellulose membrane, a cellulosic nanofiber membrane, a cellulosic monolith, a filter paper, or any combination thereof.
Regarding Claim 50:
Zhou, as modified, teaches the separation media of claim 40, wherein the separation media is configured for isolating a target molecule comprising a carbohydrate from an isolation solution comprising a solvent and the target molecule, the target molecule comprising a viral vector (purifying viral vectors) (see Zhou para. 0001). Zhou does not explicitly teach the separation media is configures for isolating a target molecule from an isolation solution comprising a solvent. However, the media of Zhou would inherently be configured as claimed because it is the same structure as claimed as disclosed in the specification. Specifically Zhou discloses the same support substrate (cellulose membrane), the same structures for SL2, and the same affinity group (Concanavalin A). As the stricture is the same the media is inherently configured for the same separation.
Regarding Claims 51-54:
Zhou, as modified, teaches the separation media of claim 50, wherein the viral vector comprises a surface protein comprising a carbohydrate, the viral vector is a lentiviral vector, the carbohydrate is a glycan, and the surface protein is a vesicular stomatitis virus glycoprotein, an envelope glycoprotein GP120, or both, and the carbohydrate binding domain or carbohydrate binding ligand is capable of recognizing and binding to a monosaccharaide or a glycosylation pattern of the vesicular stomatitis virus glycoprotein, the envelope glycoprotein GP120, or both. Zhou does not explicitly teach these limitations, however the media of Zhou would inherently be configured as claimed because it is the same structure as claimed as disclosed in the specification. Specifically Zhou discloses the same support substrate (cellulose membrane), the same structures for SL2, and the same affinity group (Galanthus nivalis). As the structure is the same the media is inherently configured for the same separation. The substance that is being isolated is not a required part of the claim, as the claim is directed to the separation media, not a method of separation.
Regarding Claim 55:
Zhou teaches the separation media of claim 40, wherein the carbohydrate binding or carbohydrate binding ligand is capable of recognizing and binding to αMan, αGlc, or both (Galanthus nivalis is capable of recognizing and binding to αMan) (see Applicants instant specification pg. 31 Table 5).
Regarding Claim 56:
Zhou, as modified, teaches the separation device comprising a housing (column) and the separation media of claim 40 disposed within the housing (see Zhou para. 0117, 0118).
Claim(s) 41 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Zhou et al (US 2020/0188859) and Watters et al (USPN 10,435,457) as applied to claim 40 above, and further in view of Goffe et al (USPN 5,683,916).
Regarding Claim 41:
Zhou, as modified, teaches the separation media of claim 40, wherein the plurality of separation ligands are of formula SL2 (see Zhou fig. 4, and claim for claim 40 mapping above).
Zhou does not teach Sp is an alkanediyl or alkenediyl comprising one or more catenated functional groups.
Goffe teaches a separation media comprising a linker moiety (spacer Sp), wherein Sp is an alkanediyl or alkenediyl comprising one or more catenated functional groups (ethylene glycol diglycidy ether) (see col. 22 lines 64- col. 23 line 5).
Zhou and Goffe are analogous inventions in the art of separation media. It would have been obvious to one skilled in the art before the effective filing date of the invention to replace the carbonyl spacer of Zhou with the alkanediyl or alkenediyl comprising one or more catenated functional groups spacer of Goffe because it is the simple substitution of one known spacer group with another known spacer group, obviously resulting in the ability to bind with other ligands (see Goffe col. 22 lines 54-67) with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Regarding Claim 42:
Zhou, as modified, teaches the separation media of claim 40, wherein the alkanediyl or alkenediyl comprises a backbone chain of length C1 to C18 (C2, ethylene glycol diglycidy ether) (see Goffe col. 22 lines 64- col. 23 line 5).
Claim(s) 57 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Zhou et al (US 2020/0188859) and Watters et al (USPN 10,435,457) as applied to claim 40 above, and further in view of Willson et al (US 2021/0178290).
Regarding Claim 57:
Zhou, as modified, teaches the method of isolating a target molecule comprising contacting the isolation solution with the separation media of claim 40 (contacting hIgG with the column containing the membranes) (see Zhou para. 0117, claim mapping for claim 40 above).
Zhou does not teach the isolation solution comprising: an isolation solvent; and the target molecule comprising a lentiviral vector. Zhou further teaches that the target molecules can be viral vectors (see para. 0110).
Willson teaches a method of isolating a target molecule comprising a viral vector from an isolation solution, the isolation solution comprising: an isolation solvent (feed containing LVs, material other than the LV is the solvent); and the target molecule comprising a lentiviral vector (see para. 0130-0131).
Zhou and Willson are analogous inventions in the art of isolating target compounds. It would have been obvious to one skilled in the art before the effective filing date of the invention to use the method of Zhou to separate lentiviral vectors from an isolation solvent, as disclosed by Willson lentiviral vectors are a desirable product to isolate (see Willson para. 0130) and Zhou teaches that the separation media of claim40 can be used to separate viral vectors (see Zhou para. 0110). Further one skilled in the art, through routine experimentation, would have found it obvious to use a known method to separate a known compound. The use of a known technique to improve similar devices (methods or products) in the same way is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, C.).
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Zhou et al (US 2020/0188859), Watters et al (USPN 10,435,457) and of Willson et al (US 2021/0178290) as applied to claim 57 above, and further in view Thompson et al (WO 2013/190453).
Regarding Claim 58:
Zhou, as modified, teaches the method of claim 58.
Zhou does not teach the method further comprises washing the separation media with a washing solution.
Thompson teaches a method of isolating a target molecule (target complexes), wherein the method further comprises washing the separation media with a washing solution (washed) (see para. 00211).
Zhou and Thompson are analogous inventions in the art of isolating target molecules. It would have been obvious to one skilled in the art before the effective filing date of the invention to add the washing step of Thompson to the method of Zhou (as modified) because it is the simple addition of a known processing step to a known separation method obviously resulting in the removal of un-bound substances from the column (see Thompson para. 00211), with an expectation of success. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over by Zhou et al (US 2020/0188859), Watters et al (USPN 10,435,457), Willson et al (US 2021/0178290), and Thompson et al (WO 2013/190453) as applied to claim 57 above, and further in view of Schmidt et al (US 2021/0032297).
Regarding Claim 59:
Zhou, as modified, teaches the method of claim 58.
Zhou does not teach wherein the method further comprises eluting the target molecule from the separation media with an elution solution comprising an elution solvent and an affinity group competitive molecule.
Schmidt teaches a method of isolating a target molecule wherein the method further comprises eluting the target molecule (competitive elution) (see para. 0106) from the separation media with an elution solution comprising an elution solvent and an affinity group competitive molecule (adding a competitor) (see para. 0106).
Zhou, as modified, and Schmidt are analogous inventions in the art of isolating target molecules. It would have been obvious to one skilled in the art before the effective filing date of the invention to add the step of eluting with an elution solution comprising an elution solvent and an affinity group competitive molecule, as disclosed by Schmidt, to the method of Zhou, because it is the simple addition of a known method step to a known process, obviously resulting in the removal of the target molecule from the column, with an expectation of success. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CLAIRE A NORRIS/Primary Examiner, Art Unit 1779 7/26/2026
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