Office Action 3: Notice of Allowance (2024-10-09)

CLAIMS:
Listing of Claims:

This listing of claims will replace all prior versions, and listings, of claims in the application.

1\. (Canceled)

2\. (Previously Presented) A polynucleotide encoding a light chain of an antibody, or antigen-binding fragment thereof, that immunospecifically binds to platelet factor 4 (PF4), wherein the light chain or antigen-binding fragment thereof comprises a light chain CDR and framework region comprising the amino acid sequence of SEQ ID NO: 4.

3\. (Previously Presented) The polynucleotide of claim 2, wherein the light chain or antigen- binding fragment thereof comprises the amino acid sequence of SEQ ID NO: 6.

4\. (Previously Presented) The polynucleotide of claim 2, wherein the light chain or antigen- binding fragment thereof comprises a light chain variable region comprising the amino acid sequence of SEQ ID NO: 5.

5\. (Previously Presented) An expression vector comprising the polynucleotide of claim 2.

6\. (Previously Presented) An expression vector comprising the polynucleotide of claim 3.

7\. (Previously Presented) An expression vector comprising the polynucleotide of claim 4.

8\. (Previously Presented) A host cell comprising the expression vector of claim 7.

9\. (Previously Presented) The host cell of claim 8, wherein the host cell is a eukaryotic cell,a yeast cell, a plant cell or a bacterium.

10\. (Previously Presented) The host cell of claim 9, wherein the eukaryotic cell is a 293T cell or a Chinese Hamster Ovary (CHO) cell.

11\. (Previously Presented) A polynucleotide encoding a heavy chain of an antibody, or antigen-binding fragment thereof, that immunospecifically binds to platelet factor 4 (PF4), wherein the heavy chain or antigen-binding fragment thereof comprises a heavy chain CDR and framework region comprising the amino acid sequence of SEQ ID NO:10.

12\. (Previously Presented) The polynucleotide of claim 11, wherein the heavy chain or antigen-binding fragment thereof comprises the amino acid sequence of SEQ ID NO: 12.

13\. (Previously Presented) The polynucleotide of claim 11, wherein the heavy chain or antigen-binding fragment thereof comprises a heavy chain variable region comprising the amino acid sequence of SEQ ID NO: 11.

14\. (Previously Presented) An expression vector comprising the polynucleotide of claim 11.

15\. (Previously Presented) An expression vector comprising the polynucleotide of claim 12.

16\. (Previously Presented) An expression vector comprising the polynucleotide of claim 13.

17\. (Previously Presented) A host cell comprising the expression vector of claim 16.

18\. (Previously Presented) The host cell of claim 17, wherein the host cell is a eukaryotic cell, a yeast cell, a plant cell or a bacterium.

19\. (Previously Presented) The host cell of claim 18, wherein the eukaryotic cell is a 293T cell or a Chinese Hamster ovary (CHO) cell.

20\. (Currently Amended) A combination of polynucleotides comprising:a polynucleotide encoding a light chain of an antibody, or antigen-binding fragment thereof, that immunospecifically binds to platelet factor 4 (PF4), wherein the

light chain or antigen-binding fragment thereof comprises a light chain CDR and framework region comprising the amino acid sequence of SEQ ID NO: 4 and a polynucleotide encoding a heavy chain of an antibody, or antigen-binding fragment thereof, that immunospecifically binds to PF4, wherein the heavy chain or antigen-binding fragment thereof comprises a heavy chain CDR and framework region comprising the amino acid sequence of SEQ ID NO: 10.

21\. (Currently Amended) The combination of polynucleotides of The combination of polynucleotides of wherein the polynucleotide encoding the light chain or antigen-binding fragment thereof encodes the amino acid sequence of SEQ ID NO: 6 and the polynucleotide encoding the heavy chain or antigen-binding fragment thereof encodes he amino acid sequence of SEQ ID NO: 12.

22\. (Currently Amended) The combination of polynucleotides of The combination of polynucleotides of wherein the polynucleotide encoding the light chain or antigen-binding fragment thereof encodes a variable domain comprising the amino acid sequence of SEQ ID NO: 5 and the polynucleotide encoding the heavy chain or antigen-binding fragment thereof encodes a variable domain comprising the amino acid sequence of SEQ ID NO: 11.

23\. (Currently Amended) The \[\[An\]\] combination of polynucleotides of claim 20, wherein a first expression vector comprises the polynucleotide encoding the light chain or antigen-binding fragment thereof and a second expression vector comprises the polynucleotide encoding the heavy chain or antigen-binding fragment thereof .

24\. (Previously Presented) A host cell comprising the expression vector of claim 23.

OFFICE ACTION:
EXAMINER'S AMENDMENT
An examiner’s amendment to the record appears below. Should the changes and/or additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR 1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the payment of the issue fee.
Authorization for this examiner’s amendment was given in an interview with Dr. Elizabeth A. Browning on 27 September 2024.
The application has been amended as follows:
Claims 20-24 have been cancelled.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
Claims 20-24 as originally filed on 6/24/2024 constituted new matter for reasons of record.  The amendments proposed in the 9/17/2024 after final response did not have basis and did not overcome the new matter rejection for these claims.  Applicant elected to cancel these claims.
The terminal disclaimer filed on 9/23/2024 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,524,999 has been reviewed and is accepted.  The terminal disclaimer has been recorded.  The double patenting rejection of record has been withdrawn.
The prior art of record does not disclose or suggest polynucleotides encoding the light chain and heavy chain anti-platelet factor 4 (PF4) antibodies or antigen binding fragments recited in the claims. The prior art of record does not disclose or suggest expression vectors or host cell containing them. SEQ ID NO: 4 is 74 amino acids and contains the light chain CDRs of SEQ ID NOS: 1, 2, and 3 and the second and third framework regions. SEQ ID NO: 4 is contained within SEQ ID NOS: 5 and 6. SEQ ID NO: 10 is 83 amino acids and contains the heavy chain CDRs of SEQ ID NOS: 7, 8, and 9 and the second and third framework regions. SEQ ID NO: 10 is contained within SEQ ID NOS: 11 and 12. See at least Table 2.
Claims 1 and 20-24 have been cancelled.  Claims 2-19 are allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion

APPLICANT REBUTTAL: REMARKS
Claims 2-24 are pending. Claims 20-23 are amended herein. Support for these
amendments is found throughout the specification and claims as originally filed. No new subject matter has been added.
Applicant submits that the reply is consistent and compliant with the Patent Office's
After Final Consideration Pilot Program and the goals of the compact prosecution. Form SB 434 is submitted with this reply.
Claim Rejections - Double Patenting
I.
Claims 2-4, 11-13, and 20-22 stand rejected for non-statutory double patenting as
allegedly being unpatentable over claims 1-5 and 10-12 of U.S. Patent No. 11,524,9991. Applicant respectfully disagrees.
Although Applicant does not concede the correctness of the non-statutory double
patenting rejections, a terminal disclaimer with respect to U.S. Patent No. 11,524,999 is being filed concurrently with this reply.
Accordingly, Applicant respectfully requests that the non-statutory double patenting rejections be reconsidered and withdrawn.
II.    Claims 5-10, 14-19, 23, and 24 stand rejected for non-statutory double patenting as allegedly being unpatentable over claims 1-5 and 10-12 of U.S. Patent No. 11,524,999 in view of U.S. Patent No. 4,816,5672.
Although Applicant does not concede the correctness of the non-statutory double
patenting rejections, a terminal disclaimer with respect to U.S. Patent No. 11,524,999 is being filed concurrently with this reply.
1 Office Action, at 4.
2 Office Action, at 5.
Accordingly, Applicant respectfully requests that the non-statutory double patenting rejections be reconsidered and withdrawn.
Claim Rejections - 35 U.S.C. § 112
I.
Claims 20-24 stand rejected under 35 U.S.C. § 112(a) as allegedly failing to comply with
In particular, the Office Action contends the specificationdoes not appear to disclose a composition of two discrete polynucleotides as recited in claim 20 and dependent claims 21-22. Applicant respectfully disagrees with the rejection. Solely to advance prosecution, however, and without conceding the correctness of the rejections, claim 20 is amended to replace "composition" with "combination of polynucleotide." To the extent that the rejections are maintained in view of the amendments, Applicant traverses the rejections.
Paragraph [0090] of the instant specification states that "[t]he heavy chain and light chain sequences were synthesized and cloned into pSectag vectors using the QuickChange® mutagenesis kit" and that "[d]ifferent combinations of heavy chain and light chain plasmids were then co-transfected into 293T cells or expi-CHO cells for expression." (Application at [0090]; emphasis added). In other words, to express the antibodies, a combination of polynucleotides (one encoding a light chain or antigen-binding fragment thereof and one encoding a heavy chain or antigen-binding fragment thereof) were used. As such, the instant specification provides support for claim 20 and the claims that depend therefrom. Applicant respectfully requests reconsideration and withdrawal of the rejections to claims 20-22 under 35 U.S.C. § 112(a).
II.    Claims 21-24 stand rejected under 35 U.S.C. § 112(b) as being indefinite4. The preamble of claims 21-23 are amended to align with claim 20, and claim 24 is amended to depend from claim 20. Accordingly, Applicant respectfully requests reconsideration and withdrawal of the rejections.
3 Office Action, at 6.
4 Office Action, at 6.
CONCLUSION


CITED REFERENCE SUMMARIES: Ref US11524999: Claims:
1. An isolated antibody, or antigen-binding fragment thereof, that immunospecifically binds to platelet factor 4 (PF4), the antibody or antigen-binding fragment thereof comprising a light chain CDR and framework region comprising SEQ ID NO: 4 and a heavy chain CDR and framework region comprising SEQ ID NO: 10.
2. The isolated antibody, or antigen-binding fragment thereof, of claim 1, wherein the isolated antibody or antigen-binding fragment thereof has a light chain variable domain comprising the amino acid sequence of SEQ ID NO: 5 and a heavy chain variable domain comprising the amino acid sequence of SEQ ID NO: 11.
3. The isolated antibody, or antigen-binding fragment thereof, of claim 2, wherein the light chain variable domain has the amino acid sequence of SEQ ID NO: 5 and the heavy chain variable domain has the amino acid sequence of SEQ ID NO: 11.
4. The isolated antibody, or antigen-binding fragment thereof, of claim 1, wherein the isolated antibody or antigen-binding fragment thereof has a light chain comprising the amino acid sequence of SEQ ID NO: 6 and a heavy chain comprising the amino acid sequence of SEQ ID NO: 12.
5. The isolated antibody, or antigen-binding fragment thereof, of claim 4, wherein the light chain has the amino acid sequence of SEQ ID NO: 6 and the heavy chain has the amino acid sequence of SEQ ID NO: 12.
6. The isolated antibody, or antigen-binding fragment thereof, of claim 1, wherein the antibody isotype is IgG.
7. The isolated antibody, or antigen-binding fragment thereof, of claim 1, wherein the antigen-binding fragment is a Fv, Fab, Fab', Fab'-SH or F(ab')2.
8. The isolated antibody, or antigen-binding fragment thereof, of claim 1, wherein the antibody is a single chain antibody, a diabody, or a multispecific antibody formed from more than one antigen-binding fragment.
9. A pharmaceutical composition comprising the isolated antibody or the antigen-binding fragment of claim 1 and a pharmaceutically acceptable carrier.
10. A recombinant cell comprising:
(a) a vector comprising a nucleic acid molecule encoding a heavy chain CDR and framework region comprising SEQ ID NO: 10;
(b) a vector comprising a nucleic acid molecule encoding a light chain CDR and framework region comprising SEQ ID NO: 4; or
(c) the vectors of both (a) and (b).
11. A recombinant cell comprising:
(a) a vector comprising a nucleic acid molecule encoding a heavy chain comprising SEQ ID NO: 12;
(b) a vector comprising a nucleic acid molecule encoding a light chain comprising SEQ ID NO: 6; or
(c) the vectors of both (a) and (b).
12. The recombinant cell of claim 11, wherein the recombinant cell is a eukaryotic cell, a yeast cell, a plant cell or a bacterium.
13. The recombinant cell of claim 12, wherein the eukaryotic cell is a 293T cell or a Chinese Hamster Ovary (CHO) cell.
14. A method of reducing thrombosis in a subject having heparin-induced thrombocytopenia (HIT), the method comprising administering to the subject a therapeutically effective amount of the isolated antibody or antigen-binding fragment thereof of claim 1, thereby reducing thrombosis.
15. The method of claim 14, wherein the isolated antibody or antigen-binding fragment thereof is administered with heparin.
16. The method of claim 15, wherein the heparin is heparin fragment, low-molecular-weight heparin or unfractionated heparin.
17. The method of claim 14, wherein the isolated antibody or antigen-binding fragment thereof is administered with a heparin mimic.
18. The method of claim 17, wherein the heparin mimic is fondaparinux.