DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to filed provisions of the AIA .
2. Claims 1, 2, 4-7, 11-13, 15-19, 21-23, 26, 30, 34, 36, 38, 39 and 52 are pending upon entry of amendment filed on 8/3/26.
Applicant’s election of group I, claims 1, 4-7, 11-13, 15-19, 21-23, 26, 30, 34, 36, 38, 39 and 52 without traverse in the reply filed on 8/3/26 has been acknowledged.
Accordingly, claim 2 is withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claim 1, 4-7, 11-13, 15-19, 21-23, 26, 30, 34, 36, 38, 39 and 52 are under consideration in the instant application.
3. Applicant’s IDS filed 9/8/23, 11/27/23 and 3/7/24 have been acknowledged.
4. The oath filed on 9/8/23 has been acknowledged.
5. 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.
6. Claims 6, 7, 13, 15, 19, 21-23, 26, 30, 34, 36 and 39 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.
The use of the term “optionally” or phrase “such as” or “e.g.” in claims 7, 13, 15, 19, 23, 26, 34, 36 and 39 render the claims indefinite because it is unclear whether the limitations following such terms or phrases are part of the claimed invention. See MPEP 2173.05 (h).
Claims 15 and 30 recite improper Markush groups. Claims should recite “selected from the group consisting of A, B, C and D”. Appropriate correction is required.
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 7 recites the broad recitation of the concentration “about 100mM to about 500mM” and the claim also recites “about 150mM to about 400mM” which is the narrower statement of the range/limitation.
7. 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.
8. 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.
9. Claim(s) 1, 4-7, 11-13, 15-19, 21-23, 26, 30, 34, 36, 38, 39 and 52 is/are rejected under 35 U.S.C. 102(a)(1) or (a)(2) as being anticipated by U.S. Pub. 2013/00209465 (IDS reference).
The ‘465 publication teaches pharmaceutical compositions comprising an antibody at 100mg/ml, EDTA at 15mM and 250mM of 1,2 propandiol (Examples 1-3) at pH 5.
The antibody includes human, monoclonal, fragments and therapeutic antibodies as well as adalimumab ([0026-0030]), trehalose of 200mM (examples 1-3), in the presence of various surfactants (Examples 3-4) and benzylalkonium chloride ([0041-0043]). The administration method includes injections ([0043]). Therefore, the reference teachings anticipate the claimed invention.
10. 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 of this title, 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.
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.
11. Claim(s) 1, 4-7, 11-13, 15-19, 21-23, 26, 30, 34, 36, 38, 39 and 52 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2013/00209465 (IDS reference).
The teachings of the ‘717 publication have been discussed, supra.
Given that the reference teaches the various excipients at difference concentrations, Tables 1-12 further disclose 150mM sodium chloride, sodium lactate 100mM, as well as poloxamer ([0042]) and preservatives, it is prima facie obvious to combine excipients each of which is taught by the prior art to be useful for the same purpose in order to form compositions that is to be used for the same purpose as taught by the prior art. In re Kerkhoven 205 USPQ 1069, CCPA 1980, See MPEP 2144.06.
Therefore, claimed invention as a hole was prima facie obvious to one of ordinary skilled in the art at the time the invention was made, as evidenced by reference, especially in the absence to the contrary.
12. Claims 1, 4-7, 11-13, 15-19, 21-23, 26, 30, 34, 36, 38, 39 and 52 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2013/00209465 (IDS reference) in view of U.S.Pub 2008/0112953 (IDS reference).
The teachings of the ‘465 publication have been discussed, supra.
The disclosure of the ‘465 publication differs from the instant claimed invention in that it does not teach the use of acetate buffer and sucrose and/or concentrations of preservatives as in claims 29 and 38 of the instant application.
The ‘953 publication teaches the use acetic acid (1-100mM), 2.6 % glycerol, 0.004% polysorbate as well as upto 10% sucrose (Example 1, embodiments, claims 1-68) in antibody formulations to reduce aggregates and extend stability (p. 13-16).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize known excipient concentrations and combinations that are suitable for antibody as in ‘953 publications into the antibody compositions taught by the ‘465 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because addition of sucrose, acetate buffer, poloxamer/polysorbate are known to reduce aggregates thus improves stability of antibody formulation upon storage.
From the teachings of references, it would have been obvious to one of ordinary skill in art to combine the teachings of the references and there would have been a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of the ordinary in the art at the time of invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
13. 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.
14. Claims 1, 4-7, 11-13, 15-19, 21-23, 26, 30, 34, 36, 38, 39 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Pat. 11,534,402.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘402 patent recite a pharmaceutical composition comprising antibody, acetate buffer, EDTA, glycerol, arginine and amino acids.
15. Claims 1, 4-7, 11-13, 15-19, 21-23, 26, 30, 34, 36, 38, 39 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Pat. 11,534,403.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘403 patent recite a pharmaceutical composition comprising antibody, acetate buffer, glycerol, arginine and methionine.
16. Claims 1, 4-7, 11-13, 15-19, 21-23, 26, 30, 34, 36, 38, 39 and 52 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Pat. 11,608,357.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘357 patent recite a pharmaceutical composition comprising antibody, acetate buffer, glycerol, arginine and methionine.
18. No claims are allowable.
19. 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 on Mon-Fri 8:30-5. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 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
August 19, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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