DETAILED ACTION
Notice of 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 .
Status of Application
Claims 80-99 are pending and subject to examination on the merits.
Priority
The instant application is a CON of US 18/178,917 (now US Patent 12195521) which is a DIV of US 17/110,766 (now US Patent 11634475) which is a CON of US 16/514,591 (now US patent 10889631) which is a DIV of US 15/528,387 (now US patent 10400028) which is a 371 of PCT/US15/61852 filed 20 November 2015 and which claims benefit of US Provisional application 62/082,304 filed 20 November 2014.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03 February 2025 has been considered by the examiner. See initialed and signed PTO/SB08.
Specification
Sequence Compliance #1
The sequence listing, filed in computer readable form (.xml) on 14 November 2024, has been received and entered. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.831(b). However, this application fails to fully comply with the requirements of 37 C.F.R. 1.831-1.839.
The following Figures/parts of the specification contain sequences that contain four or more specifically defined amino acids or ten or more specifically defined nucleotides without any corresponding SEQ ID NO: and/or no reference to any SEQ ID NO: in the Brief Description of the Drawings.
Figure 20 shows four different Bait sequences without any reference to sequence identifiers in the Figure itself or in the Brief Description of the Drawings.
* If the noted sequences are in the sequence listing as filed, Applicants must amend the specification to identify the sequences appropriately by SEQ ID NO:. If the noted sequences are not in the sequence listing as filed, Applicants must provide (1) an updated copy of the sequence listing containing the requisite sequences in computer readable form (.xml), (2) an amendment directing its entry into the specification, (3) a statement that no new matter has been added and (4) an amendment to the specification to identify the identified sequences by SEQ ID NO:, which can be in the Brief Description of the Drawings section of the specification (For Figures only) and (5) an updated incorporation by reference statement with the new date of creation, sequence file name and size. – See also MPEP 2422.
Sequence Compliance (ST.26) - #2
The specification is objected to for lack of sequence compliance. It is noted, under the new rules for WIPO Standards for ST.26 sequences, any sequence having less than four specifically defined amino acids or less than 10 specifically defined nucleotides should not be referred to with a sequence identifier, e.g. those that are “skipped” sequences in the sequence listing noted only as “000”. Thus, all instances/reference to the following sequence identifiers should be removed from the specification, leaving only the sequences themselves: SEQ ID NO: 82 and SEQ ID NO: 83.
This would require removing all references to SEQ ID NO: 82 and replacing with “X1X2X3X4X5X6X7X8 wherein: X1 is an amino acid selected from the group consisting of glycine (G), praline (P) and glutamic acid (E), X2 is any natural amino acid, X3 is any natural amino acid, X4 is glycine (G) or glutamic acid (E), X5 is an amino acid selected from the group consisting of glycine (G), valine (V), leucine (L), serine (S), alanine (A), phenylalanine (F) and threonine (T), X6 is any natural amino acid, X7 is any natural amino acid, and X8 is glycine (G)”.
Similarly, it will require removing all reference to SEQ ID NO: 83 and replacing with: “EXEO4XG, wherein X is any natural amino acid and O4 is selected from the group consisting of glycine (G), valine (V), glutamic acid (E), alanine (A), threonine (T), serine (S), glutamine (Q), proline (P), asparagine (N) and aspartate (D)”.
Claim Objections
Claims 81, 97 and 99 are objected to for lack of sequence compliance. It is noted, under the rules for WIPO Standards for ST.26 sequences, any sequence having less than four specifically defined amino acids or less than 10 specifically defined nucleotides should not be referred to with a sequence identifier. Thus, all instances/reference to “SEQ ID NO: 82” in the claims should be removed, while keeping the sequence as defined in the claims.
Claim Rejections - 35 USC § 112(b)
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 83 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 pre-AIA the applicant regards as the invention.
Claim 83 recites the limitation "wherein the host cell….” in reference to claim 80. There is insufficient antecedent basis for this limitation in the claim because claim 80 does not recite or refer to a host cell; rather, claim 82 does.
Claims 81, 97 and 99 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.
The claims refer to SEQ ID NO: 82. While the claims and specification defines this sequence, is it is noted that the same sequence in the sequence listing is defined as “000” in the sequence listing, which is a skipped sequences because it does not meet the standards for the minimum sequence length for entry into the sequence listing under the WIPO Standards for ST.26 sequences. Thus, it is not apparent which sequence “SEQ ID NO: 82” is referring, the one as listed in the claim or the “000” sequence of the sequence listing.
Claim Rejections - 35 USC § 102
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 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 95 is rejected under 35 U.S.C. 102(a)(1) AND 102(a)(2) as being anticipated by Hanna et al. (WO 2013/126587 – cited on IDS. Said reference has an effectively filed date of 21 February 2012 and a publication date of 29 August 2013, which falls outside of the one-year grace period).
The applied reference of Hanna et al. has three common inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The applied reference of Hanna et al. also constitutes prior art under 35 U.S.C. 102(a)(1) based upon its earlier publication date.
It should be noted, said reference was published outside the one-year grace period for the instant application. In addition, Applicants should be aware that under AIA rules, there is no rule of “by others”; e.g. under 35 U.S.C. 102(a)(1) it is entirely permissible to have the exact same inventive entities for an applied reference. Applicants are referred to M.P.E.P. 2152.02(f).
It should be noted, the disqualification of prior art under 35 U.S.C. 102(a)(2) by the 35 U.S.C. 102(b)(2)(C) exception does not disqualify said prior art with regard to 35 U.S.C. 102(a)(1).
Claim 95 is drawn to: A method of making a recombinant polynucleotide construct comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide, the method comprising:
(a) providing a vector containing a recombinant polynucleotide comprising a sequence with at least 80% sequence identity to SEQ ID NO 2; (b) digesting the vector with a restriction enzyme to form a linear vector; (c) ligating an end of a polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to an end of the linear vector; and (d) ligating the other end of the polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to the other end of the linear vector, thereby forming the recombinant polynucleotide construct comprising a sequence encoding the A2M polypeptide.
Regarding claim 95, Hanna et al. teaches a method of making an A2M polypeptide comprising expressing a polynucleotide encoding an A2M polypeptide and compositions thereof having a non-natural bait region, taught as SEQ ID NO: 47, which has 79.4% sequence identity with instant SEQ ID NO: 20 – See Supplemental Content, 20260903_094729_us-18-947-045-20.rag file, Result #5. Also see Hanna et al. at claims 147-170, and paragraphs 0085-0086; 0172-0178, 199-219. Regarding the polynucleotide encoding said A2M polypeptide having a non-natural bait region selected from SEQ ID NO: 5-66 (inclusive of the noted SEQ ID NO: 47 above), they further teach the vector sequence of SEQ ID NO: 2 which has 100% sequence identity to instant SEQ ID NO: 2 and which encodes an A2M having a non-natural bait region of 79.4% sequence identity to SEQ ID NO: 20 as noted above (See Supplemental Content, 20260903_094320_us-18-947-045-2.rng file, Result #1; and See Claim 190; paragraph 0199). Specifically in paragraph 0031 it is recited:
[031] In one aspect, provided herein is a method for making a variant A2M polynucleotide comprising: (a) providing a vector containing a variant A2M polynucleotide comprising a sequence of SEQ ID NO 2; (b) digesting the vector containing a variant A2M polynucleotide with restriction endonucleases to form a linear vector; (c) ligating one end of the one or more polynucleotides encoding one or more of the non-natural bait regions of SEQ ID NOs 5-66 to one end of the linear vector; and (d) ligating the other end of the one or more polynucleotides encoding one or more of the non-natural bait regions of SEQ ID NOs 5-66 to the other end of the linear vector, thereby forming a vector containing a variant A2M polynucleotide comprising the non-natural bait regions of SEQ ID NOs 5-66.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 80-99 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,400,028. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap in scope to such an extent to be obvious variations of one another.
The instant claims are in their broadest are drawn to A composition comprising a recombinant polynucleotide comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide comprising a non-natural bait region, wherein the non-natural bait region of the A2M polypeptide comprises an amino acid sequence with at least 80% sequence identity to SEQ ID NO: 20 (claim 80); and A method of making a recombinant polynucleotide construct comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide, the method comprising: (a) providing a vector containing a recombinant polynucleotide comprising a sequence with at least 80% sequence identity to SEQ ID NO 2; (b) digesting the vector with a restriction enzyme to form a linear vector; (c) ligating an end of a polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to an end of the linear vector; and (d) ligating the other end of the polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to the other end of the linear vector, thereby forming the recombinant polynucleotide construct comprising a sequence encoding the A2M polypeptide (claim 95); and A composition comprising a recombinant polynucleotide comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide comprising a non-natural bait region, wherein the non-natural bait region of the A2M polypeptide comprises an amino acid sequence with at least 70% sequence identity to SEQ ID NO: 2; wherein the non-natural bait region comprises an amino acid sequence comprising SEQ ID NO: 82: X1X2X3X4X5X6X7X8
wherein: X1 is an amino acid selected from the group consisting of glycine (G), proline (P) and glutamic acid (E), X2 is any natural amino acid, X3 is any natural amino acid, X4 is glycine (G) or glutamic acid (E), X5 is an amino acid selected from the group consisting of glycine (G), valine (V), leucine (L), serine (S), alanine (A), phenylalanine (F) and threonine (T), X6 is any natural amino acid, X7 is any natural amino acid, and
X8 is glycine (G); wherein the non-natural bait region further comprises an amino acid sequence comprising EXE-Θ4XG, wherein each X is any natural amino acid and Θ4 is an amino acid selected from the group consisting of glycine (G), valine (V), glutamic acid (E), alanine (A), threonine (T), serine (S), glutamine (Q), proline (P), asparagine (N) and aspartic acid (D); and wherein the non-natural bait region does not comprise SEQ ID NO: 104, SEQ ID NO: 105, SEQ ID NO: 106, SEQ ID NO: 109, SEQ ID NO: 111, SEQ ID NO: 112, SEQ ID NO: 114, SEQ ID NO: 120, SEQ ID NO: 121, SEQ ID NO: 122, or SEQ ID NO: 123.
The claims to the ‘028 patent in their broadest are drawn to a composition comprising a an A2M polypeptide comprising a non-natural bait which comprises at least 80% sequence identity to SEQ ID NO: 20. Dependent claims recite said non-natural bait region comprises SEQ ID NO: 20 or those having 85%, 90%, 95% or more identity thereto.
Thus, the claims in their broadest, differ in the composition claims of the ‘028 patent are encoding and/or made by the instant method claims. However, given no restriction requirement was filed between the patented product claims and the instant methods of making claims, they would be obvious variations of one another – See MPEP 804.
Claims 80-99 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,889,631. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap in scope to such an extent to be obvious variations of one another.
The instant claims are in their broadest are drawn to A composition comprising a recombinant polynucleotide comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide comprising a non-natural bait region, wherein the non-natural bait region of the A2M polypeptide comprises an amino acid sequence with at least 80% sequence identity to SEQ ID NO: 20 (claim 80); and A method of making a recombinant polynucleotide construct comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide, the method comprising: (a) providing a vector containing a recombinant polynucleotide comprising a sequence with at least 80% sequence identity to SEQ ID NO 2; (b) digesting the vector with a restriction enzyme to form a linear vector; (c) ligating an end of a polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to an end of the linear vector; and (d) ligating the other end of the polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to the other end of the linear vector, thereby forming the recombinant polynucleotide construct comprising a sequence encoding the A2M polypeptide (claim 95); and A composition comprising a recombinant polynucleotide comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide comprising a non-natural bait region, wherein the non-natural bait region of the A2M polypeptide comprises an amino acid sequence with at least 70% sequence identity to SEQ ID NO: 2; wherein the non-natural bait region comprises an amino acid sequence comprising SEQ ID NO: 82: X1X2X3X4X5X6X7X8
wherein: X1 is an amino acid selected from the group consisting of glycine (G), proline (P) and glutamic acid (E), X2 is any natural amino acid, X3 is any natural amino acid, X4 is glycine (G) or glutamic acid (E), X5 is an amino acid selected from the group consisting of glycine (G), valine (V), leucine (L), serine (S), alanine (A), phenylalanine (F) and threonine (T), X6 is any natural amino acid, X7 is any natural amino acid, and
X8 is glycine (G); wherein the non-natural bait region further comprises an amino acid sequence comprising EXE-Θ4XG, wherein each X is any natural amino acid and Θ4 is an amino acid selected from the group consisting of glycine (G), valine (V), glutamic acid (E), alanine (A), threonine (T), serine (S), glutamine (Q), proline (P), asparagine (N) and aspartic acid (D); and wherein the non-natural bait region does not comprise SEQ ID NO: 104, SEQ ID NO: 105, SEQ ID NO: 106, SEQ ID NO: 109, SEQ ID NO: 111, SEQ ID NO: 112, SEQ ID NO: 114, SEQ ID NO: 120, SEQ ID NO: 121, SEQ ID NO: 122, or SEQ ID NO: 123.
The claims to the ‘631 patent in their broadest are drawn to methods of treating an inflammatory disease by administering a pharmaceutical composition comprising an A2M polypeptide which comprises a non-natural bait region having at least 80% identity to SEQ ID NO: 20, and which also comprises a pharmaceutically acceptable carrier.
Thus, the claims differ in the claims to the ‘631 are drawn to methods of treating inflammatory diseases with the products made by instant methods and encoded by the instant polynucleotides. This, nonetheless constitutes obvious variations of one another, especially given no restriction requirement was made between the two sets of methods.
Claim 95 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,940,189. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap in scope to such an extent to be obvious variations of one another.
The instant claims are in their broadest are drawn to a method of making a recombinant polynucleotide construct comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide, the method comprising: (a) providing a vector containing a recombinant polynucleotide comprising a sequence with at least 80% sequence identity to SEQ ID NO 2; (b) digesting the vector with a restriction enzyme to form a linear vector; (c) ligating an end of a polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to an end of the linear vector; and (d) ligating the other end of the polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to the other end of the linear vector, thereby forming the recombinant polynucleotide construct comprising a sequence encoding the A2M polypeptide (claim 95).
The claims to the ‘189 patent in their broadest are drawn to a composition comprising a recombinant alpha-2-macroglobulin (A2M) polypeptide comprising a non-natural bait region, wherein: (a) the non-natural bait region comprises:
(i) a sequence with 100% sequence identity to at least 24 contiguous amino acid residues of SEQ ID NO: 47, and (ii) two or more protease recognition sequences;
(b) the non-natural bait region replaces the bait region of a wild-type A2M polypeptide with a sequence according to SEQ ID NO: 3; and (c) the non-natural bait region has at least 70% identity to the entirety of SEQ ID NO: 47.
It is noted, SEQ ID NO: 47 and instant SEQ ID NO: 20 share 79.8% sequence identity to one another and have 100% identity to one another over 26 amino acids – See Supplemental Content, 20260903_094729_us-18-947-045-20.rai file, Result 5; Duplicates thereof.
Thus, the claims in their broadest differ in the composition claims of the ‘917 patent are made by the instant method claim. However, given no restriction requirement was filed between the patented product claims and the instant methods of making claims, they would be obvious variations of one another – See MPEP 804.
Claims 80-99 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,634,475. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap in scope to such an extent to be obvious variations of one another.
The instant claims are in their broadest are drawn to A composition comprising a recombinant polynucleotide comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide comprising a non-natural bait region, wherein the non-natural bait region of the A2M polypeptide comprises an amino acid sequence with at least 80% sequence identity to SEQ ID NO: 20 (claim 80); and A method of making a recombinant polynucleotide construct comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide, the method comprising: (a) providing a vector containing a recombinant polynucleotide comprising a sequence with at least 80% sequence identity to SEQ ID NO 2; (b) digesting the vector with a restriction enzyme to form a linear vector; (c) ligating an end of a polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to an end of the linear vector; and (d) ligating the other end of the polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to the other end of the linear vector, thereby forming the recombinant polynucleotide construct comprising a sequence encoding the A2M polypeptide (claim 95); and A composition comprising a recombinant polynucleotide comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide comprising a non-natural bait region, wherein the non-natural bait region of the A2M polypeptide comprises an amino acid sequence with at least 70% sequence identity to SEQ ID NO: 2; wherein the non-natural bait region comprises an amino acid sequence comprising SEQ ID NO: 82: X1X2X3X4X5X6X7X8
wherein: X1 is an amino acid selected from the group consisting of glycine (G), proline (P) and glutamic acid (E), X2 is any natural amino acid, X3 is any natural amino acid, X4 is glycine (G) or glutamic acid (E), X5 is an amino acid selected from the group consisting of glycine (G), valine (V), leucine (L), serine (S), alanine (A), phenylalanine (F) and threonine (T), X6 is any natural amino acid, X7 is any natural amino acid, and
X8 is glycine (G); wherein the non-natural bait region further comprises an amino acid sequence comprising EXE-Θ4XG, wherein each X is any natural amino acid and Θ4 is an amino acid selected from the group consisting of glycine (G), valine (V), glutamic acid (E), alanine (A), threonine (T), serine (S), glutamine (Q), proline (P), asparagine (N) and aspartic acid (D); and wherein the non-natural bait region does not comprise SEQ ID NO: 104, SEQ ID NO: 105, SEQ ID NO: 106, SEQ ID NO: 109, SEQ ID NO: 111, SEQ ID NO: 112, SEQ ID NO: 114, SEQ ID NO: 120, SEQ ID NO: 121, SEQ ID NO: 122, or SEQ ID NO: 123.
The claims to the ‘475 patent in their broadest are drawn to A pharmaceutical composition comprising: (a) a therapeutically effective amount of a recombinant alpha-2-macroglobulin (A2M) polypeptide comprising a non-natural bait region, wherein the non-natural bait region comprises a sequence comprising SEQ ID NO: 82: X1X2X3X4X5X6X7X8 wherein:
X1 is an amino acid selected from the group consisting of glycine (G), proline (P) and glutamic acid (E), X2 is any natural amino acid, X3 is any natural amino acid,
X4 is glycine (G) or glutamic acid (E), X5 is an amino acid selected from the group consisting of glycine (G), valine (V), leucine (L), serine (S), alanine (A), phenylalanine (F) and threonine (T), X6 is any natural amino acid, X7 is any natural amino acid, and
X8 is glycine (G); and (b) a pharmaceutically acceptable carrier, wherein the non-natural bait region further comprises a sequence comprising EXEΘ4XG (SEQ ID NO: 83), wherein each X is any natural amino acid and Θ4 is an amino acid selected from the group consisting of glycine (G), valine (V), glutamic acid (E), alanine (A), threonine (T), serine (S), glutamine (Q), proline (P), asparagine (N) and aspartic acid (D);
wherein the non-natural bait region comprises a sequence with at least 70% sequence identity to SEQ ID NO: 20; and wherein the non-natural bait region does not comprise SEQ ID NO: 104, SEQ ID NO: 105, SEQ ID NO: 106, SEQ ID NO: 109, SEQ ID NO: 111, SEQ ID NO: 112, SEQ ID NO: 114, SEQ ID NO: 120, SEQ ID NO: 121, SEQ ID NO: 122 or SEQ ID NO: 123
Thus, the claims differ in that the instant polynucleotides and methods of using the polynucleotides are used to make or encode the exact same recombinant alpha-2-macroglobulin (A2M) polypeptide comprising a non-natural bait region. Nonetheless, these would be considered obvious variations of one another.
Claims 80-99 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,195,521. Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap in scope to such an extent to be obvious variations of one another.
The instant claims are in their broadest are drawn to A composition comprising a recombinant polynucleotide comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide comprising a non-natural bait region, wherein the non-natural bait region of the A2M polypeptide comprises an amino acid sequence with at least 80% sequence identity to SEQ ID NO: 20 (claim 80); and A method of making a recombinant polynucleotide construct comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide, the method comprising: (a) providing a vector containing a recombinant polynucleotide comprising a sequence with at least 80% sequence identity to SEQ ID NO 2; (b) digesting the vector with a restriction enzyme to form a linear vector; (c) ligating an end of a polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to an end of the linear vector; and (d) ligating the other end of the polynucleotide comprising a sequence that encodes for a non-natural bait sequence with at least 70% sequence identity to SEQ ID NO: 20, to the other end of the linear vector, thereby forming the recombinant polynucleotide construct comprising a sequence encoding the A2M polypeptide (claim 95); and A composition comprising a recombinant polynucleotide comprising a sequence encoding an alpha-2-macroglobulin (A2M) polypeptide comprising a non-natural bait region, wherein the non-natural bait region of the A2M polypeptide comprises an amino acid sequence with at least 70% sequence identity to SEQ ID NO: 2; wherein the non-natural bait region comprises an amino acid sequence comprising SEQ ID NO: 82: X1X2X3X4X5X6X7X8
wherein: X1 is an amino acid selected from the group consisting of glycine (G), proline (P) and glutamic acid (E), X2 is any natural amino acid, X3 is any natural amino acid, X4 is glycine (G) or glutamic acid (E), X5 is an amino acid selected from the group consisting of glycine (G), valine (V), leucine (L), serine (S), alanine (A), phenylalanine (F) and threonine (T), X6 is any natural amino acid, X7 is any natural amino acid, and
X8 is glycine (G); wherein the non-natural bait region further comprises an amino acid sequence comprising EXE-Θ4XG, wherein each X is any natural amino acid and Θ4 is an amino acid selected from the group consisting of glycine (G), valine (V), glutamic acid (E), alanine (A), threonine (T), serine (S), glutamine (Q), proline (P), asparagine (N) and aspartic acid (D); and wherein the non-natural bait region does not comprise SEQ ID NO: 104, SEQ ID NO: 105, SEQ ID NO: 106, SEQ ID NO: 109, SEQ ID NO: 111, SEQ ID NO: 112, SEQ ID NO: 114, SEQ ID NO: 120, SEQ ID NO: 121, SEQ ID NO: 122, or SEQ ID NO: 123.
The claims to the ‘521 patent in their broadest are drawn to a method of producing a recombinant alpha-2-macroglobulin (A2M) polypeptide comprising expressing a recombinant A2M polypeptide encoded by a sequence of a polynucleotide, wherein the recombinant A2M polypeptide comprises a non-natural bait region, wherein the non-natural bait region comprises a sequence with at least 80% sequence identity to SEQ ID NO: 20, dependent claim 11 recites the non-natural bait region comprises an amino acid sequence comprising SEQ ID NO: 82: X1X2X3X4X5X6X7X8
wherein: X1 is an amino acid selected from the group consisting of glycine (G), proline (P) and glutamic acid (E), X2 is any natural amino acid, X3 is any natural amino acid, X4 is glycine (G) or glutamic acid (E), X5 is an amino acid selected from the group consisting of glycine (G), valine (V), leucine (L), serine (S), alanine (A), phenylalanine (F) and threonine (T), X6 is any natural amino acid, X7 is any natural amino acid, and
X8 is glycine (G); wherein the non-natural bait region further comprises an amino acid sequence comprising EXE-Θ4XG, wherein each X is any natural amino acid and Θ4 is an amino acid selected from the group consisting of glycine (G), valine (V), glutamic acid (E), alanine (A), threonine (T), serine (S), glutamine (Q), proline (P), asparagine (N) and aspartic acid (D) (claim 11 and/or claim 20 is a combined claimed of claims 1 and 11 and is independent). Dependent claim 2 recites the polynucleotide comprises a sequence with at least 80% sequence identity to SEQ ID NO: 2. It is noted, SEQ ID NO: 2 in the instant application and that of the ‘512 patent have 100% sequence identity to one another (See Supplemental Content, 20260903_094320_us-18-947-045-2.rni, Result #1, Duplicates).
Thus, the claims of the ‘512 patent are drawn to methods to make the same products using the same polynucleotides and thus, the claims of the ‘512 patent would anticipate the instant claims.
Conclusion
No claim is allowed.
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 03 September 2026
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