DETAILED ACTION
1. The present application is being examined under pre-AIA first to invent provisions.
2. Claims 2-13 and 15-17 are pending upon entry of amendment filed on 11/7/23.
The application contains 3 independent claims and the claimed invention relates stable antibody formulation comprising about 25-250mg/ml antibody, a buffer at pH 5-7 in the presence of non-ionic surfactant and lyoprotectant.
3. Applicant’s IDS filed on 11/7/23 has been acknowledged. The copies of non-patent literature and foreign patent literatures are submitted in US 13/510,929.
4. Applicant’s claim for foreign priority under 35. U.S.C. 119(a)-(d) is acknowledged.
The priority document is in the U.S application number 13/510,929.
5. The oath filed on 11/7/23 has been considered.
6. The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
7. 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.
8. Claims 2-13 and 15-17 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 pre-AIA the applicant regards as the invention.
Claim 2 recites “fragment thereof”. The antibody fragment is indeed an antigen binding fragment of the antibody. Any random fragment that reads on “fragment” may not bind antigen to be functional as an antibody. IT should read “antigen binding fragment”.
Claims 3, 5, 6, 10 and 12 recite improper Markush groups. The claims should recite “is selected from the group consisting A, B and C”. Appropriate correction is required.
The use of the term “optionally” in claims 6 and 13 renders the claim indefinite because it is unclear whether the limitations following such terms or phrases are part of the claimed invention. See MPEP 2173.05 (h).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949). In the present instance, claim 13 recites the broad recitation of the antibody about 25mg/ml or 50mg/ml to about 250mg/ml of antibody.
9. The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
10. Claim(s) 2-13 and 15-17 are rejected under pre-AIA 35 U.S.C. 102 (b) as being anticipated by U.S. Pat. 6,267,958 (IDS reference).
The ‘958 patent teaches antibody formulation comprising 25mg/ml of antibody, 5mM of histidine, 85mM of sucrose or trehalose and 0.01% polysorbate at pH 6 (Table 10, claims 1-47). Further, the ‘958 patent teaches use of sterile water or bacteriostatic water for reconstituting the lyophilized formulation up to 150mg/ml of antibody (claims 24-47) and addition of glycine and mannitol as bulking agent (note claim 28). In addition, the ‘958 patent teaches the lyophilization results in lyophilized cake (claim 27).
Given that the claimed invention uses lyoprotectant and/or cryoprotectant being sucrose, trehalose, and or mannitol, it meets the limitations of claimed invention. The reference teachings anticipate the claimed invention.
11. Claim(s) 2-13 and 15-17 are rejected under pre-AIA 35 U.S.C. 102 (b) as being anticipated by U.S. Pub. 2004/0197324 (IDS reference).
The ‘324 publication teaches antibody formulations comprising about 100-260mg/ml of antibody, histidine, trehalose at 150mM and about 0.02% polysorbate (claims 1-27, table). Further, the ‘324 publication teaches addition of glycine and/or mannitol as bulking agent and polysorbate is polysorbate 20 or 80 ([202, 216-217]).
The ‘324 publication teaches antibody formulation is lyophilized resulting in cake or powder ([208]) and may be reconstituted in sterile water or bacteriostatic water ([207-209]). The reference teachings anticipate the claimed invention.
12. 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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
13. Claims 2-13 and 15-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 162-191 of U.S. Application No. 18/256,748 (U.S.Pub 2024/0084018).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘748 application recites a pharmaceutical composition comprising species of antibody fragment (e.g. fusion construct) in the presence of buffer, sucrose, trehalose, and/or mannitol in the presence of polysorbate at pH 5-7.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
14. No claims are allowable.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
December 9, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641