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 .
DETAILED ACTION
This Non-Final Office Action is responsive to the communication received 8/11/2023.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 20-41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a judicial exception, an abstract idea (mental processes), without significantly more. Claims 21-41 depend directly or indirectly from claim 20.
The claim 20 limitations directed to an abstract idea (mental processes) are (iii) selecting the conditionally active antibody or antibody fragment from the mutant antibodies or antibody fragments which reversibly exhibits a decrease in activity in the first assay at the first pH of 6.0 compared to the same activity in a second assay at a second pH of 7.4; wherein the ratio of the activity at pH 6.0 to the same activity at pH 7.4 is at least about 1.3:1.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim recites additional elements that consist of well understood, routine, conventional activity already engaged in by the scientific community.
The claim 20 limitations directed to well understood, routine, conventional activity already engaged in by the scientific community are a method of preparing a conditionally active antibody or antibody fragment from a parent antibody, single chain antibody or antibody fragment, said method comprising steps of: (i) evolving a DNA encoding the parent antibody, single chain antibody or antibody fragment to increase the number of Aspartic acid residues, Glutamic acid residues or both of the parent antibody, single chain antibody or antibody fragment to create mutant DNAs; (ii) expressing the mutant DNAs to obtain mutant antibodies or antibody fragments. Short et al. (10/11/2012) US Patent Application Publication 2012/0258865 A1 cited in the 6/27/2023 IDS (hereinafter referred to as "Short") teaches a method of preparing a conditionally active antibody or antibody fragment from a parent antibody, single chain antibody or antibody fragment, said method comprising steps of: (i) evolving a DNA encoding the parent antibody, single chain antibody or antibody fragment to increase the number of Aspartic acid residues, Glutamic acid residues or both of the parent antibody, single chain antibody or antibody fragment to create mutant DNAs; (ii) expressing the mutant DNAs to obtain mutant antibodies or antibody fragments (see [0007] to [0012] and [0103] to [0252]).
This judicial exception is not integrated into a practical application because data gathering steps required to use the correlation do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 20-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Short et al. (10/11/2012) US Patent Application Publication 2012/0258865 A1 cited in the 6/27/2023 IDS (hereinafter referred to as "Short").
With regards to claims 20-41, Short teaches:
a) as in claims 20-41, a method of preparing a conditionally active antibody or antibody fragment from a parent antibody, single chain antibody or antibody fragment, said method comprising steps of: (i) evolving a DNA encoding the parent antibody, single chain antibody or antibody fragment to increase the number of Aspartic acid residues, Glutamic acid residues or both of the parent antibody, single chain antibody or antibody fragment to create mutant DNAs; (ii) expressing the mutant DNAs to obtain mutant antibodies or antibody fragments; and (iii) selecting the conditionally active antibody or antibody fragment from the mutant antibodies or antibody fragments which reversibly exhibits a decrease in activity in the first assay at the first pH of 6.0 compared to the same activity in a second assay at a second pH of 7.4; wherein the ratio of the activity at pH 6.0 to the same activity at pH 7.4 is at least about 1.3:1; wherein the evolving step employs site directed mutagenesis is oligonucleotide-mediated mutagenesis; wherein the evolving step comprises introducing one or more codons of acidic amino acids into the DNA encoding the parent antibody; wherein the evolving step comprises codon substitution; wherein the one or more codons are introduced into a region of the DNA encoding the parent antibody single chain antibody or antibody fragment that encodes an active site of the parent antibody; wherein the one or more codons are introduced into a region of the DNA encoding the parent antibody single chain antibody or antibody fragment that is outside of a region that encodes an active site of the parent antibody; wherein the evolving step comprises evolving the DNA to introduce one or more codons of acidic amino acid residues into a region of the DNA that encodes one or more complementarity determining regions of the parent antibody; wherein the first and second assays are performed in assay solutions comprising a protein found in blood; wherein the protein found in blood is albumin; wherein the first and second assays are performed in assay solutions in the absence of serum; wherein the first and second assays are performed in assay media including at least one species having a molecular weight of less than 900 a.m.u. and having a pKa up to 3 units away from the first pH of 7.4; wherein the first and second assays are performed in assay media including at least one species having a molecular weight of less than 900 a.m.u. and having a pKa between the second pH of 6.0 and the first pH of 7.4; wherein the first and second assays are performed in assay media including histidine; wherein the first and second assays are performed in assay media including hydrogen sulfide; wherein the activity is a binding activity to an antigen; wherein the selecting step further comprises selecting the conditionally active antibody or antibody fragment based on a property of affinity; wherein the expression step employs phage display or a eukaryotic cell production host; wherein the expression step is performed in the eukaryotic cell production host and the selected conditionally active antibody or antibody fragment is expressed in the same eukaryotic cell production host; wherein the ratio of the activity at pH 6.0 to the same activity at pH 7.4 is at least about 1.7:1; wherein the ratio of the activity at pH 6.0 to the same activity at pH 7.4 is at least about 3.0; wherein the ratio of the activity at pH 6.0 to the same activity at pH 7.4 is at least about 4.0; wherein the ratio of the activity at pH 6.0 to the same activity at pH 7.4 is at least about 8.0 (see [0007] to [0012] and [0103] to [0252]).
Thus, Short anticipates the present claims.
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 20-41 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-21 of U.S. Patent Number 11279924.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claim 20 is drawn to a method of preparing a conditionally active antibody or antibody fragment from a parent antibody, single chain antibody or antibody fragment, said method comprising steps of: (i) evolving a DNA encoding the parent antibody, single chain antibody or antibody fragment to increase the number of Aspartic acid residues, Glutamic acid residues or both of the parent antibody, single chain antibody or antibody fragment to create mutant DNAs; (ii) expressing the mutant DNAs to obtain mutant antibodies or antibody fragments; and (iii) selecting the conditionally active antibody or antibody fragment from the mutant antibodies or antibody fragments which reversibly exhibits a decrease in activity in the first assay at the first pH of 6.0 compared to the same activity in a second assay at a second pH of 7.4; wherein the ratio of the activity at pH 6.0 to the same activity at pH 7.4 is at least about 1.3:1 and claim 1 in U.S. Patent Number 11279924 is drawn to a method of preparing a conditionally active antibody or antibody fragment from a parent antibody, single chain antibody or antibody fragment, said method comprising steps of: i. evolving a DNA encoding the parent antibody, single chain antibody or antibody fragment to increase the net charge of the parent antibody, single chain antibody or antibody fragment using one or more techniques selected from increasing a total number of codons of charged amino acid residues in the DNA, decreasing a total number of codons of uncharged amino acid residues in the DNA and a combination thereof, to create mutant DNAs; ii. expressing the mutant DNAs to obtain mutant antibodies or antibody fragments; and iii. selecting the conditionally active antibody or antibody fragment from the mutant antibodies or antibody fragments which is reversibly inactivated in a first assay at a first value of a condition and exhibits a decrease in activity in the first assay at the first value of the condition compared to the same activity in a second assay at a second value of the same condition, and the charged amino acid residues are selected from Aspartic acid, Glutamic acid, Arginine, Lysine, and Histidine.
Therefore, the present claims are obvious in view of the claims of U.S. Patent Number 11279924.
Claims 20-41 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-19 of U.S. Patent Number 11773509.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the present claim 20 is drawn to a method of preparing a conditionally active antibody or antibody fragment from a parent antibody, single chain antibody or antibody fragment, said method comprising steps of: (i) evolving a DNA encoding the parent antibody, single chain antibody or antibody fragment to increase the number of Aspartic acid residues, Glutamic acid residues or both of the parent antibody, single chain antibody or antibody fragment to create mutant DNAs; (ii) expressing the mutant DNAs to obtain mutant antibodies or antibody fragments; and (iii) selecting the conditionally active antibody or antibody fragment from the mutant antibodies or antibody fragments which reversibly exhibits a decrease in activity in the first assay at the first pH of 6.0 compared to the same activity in a second assay at a second pH of 7.4; wherein the ratio of the activity at pH 6.0 to the same activity at pH 7.4 is at least about 1.3:1 and claim 1 in U.S. Patent Number 11773509 is drawn to a method of preparing a conditionally active antibody or antibody fragment from a parent antibody, single chain antibody or antibody fragment, said method comprising steps of: (i) evolving a DNA encoding the parent antibody, single chain antibody or antibody fragment to increase the number of acidic amino acid residues of the parent antibody, single chain antibody or antibody fragment to create mutant DNAs; (ii) expressing the mutant DNAs to obtain mutant antibodies or antibody fragments; and (iii) selecting the conditionally active antibody or antibody fragment from the mutant antibodies or antibody fragments which is reversibly inactivated in a first assay at a first pH of 7.4 and exhibits a decrease in activity in the first assay at the first pH of 7.4 compared to the same activity in a second assay at a second pH of 6.0.
Therefore, the present claims are obvious in view of the claims of U.S. Patent Number 11773509.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Christian Boesen whose telephone number is 571-270-1321. The Examiner can normally be reached on Monday-Friday 9:00 AM to 5:00 PM.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Heather Calamita can be reached at 571-272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice .
/CHRISTIAN C BOESEN/Primary Examiner, Art Unit 1684
Prosecution Insights