DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The art unit and the examiner of your application in the PTO has changed. To aid in correlating any papers for this application, all further correspondence regarding this application should be directed to Yunsoo Kim, Art Unit 1641, Technology Center 1600.
3. Claims 1-3, 5, 6, 8, 9, 11, 12, 14, 15, 17, 19, 21-25, 27-29, 31, 33, 36-40, 42 and 45 are pending upon entry of amendment filed on 12/22/23.
Applicant’s election of group I, claims 1-3, 5, 6, 8, 9, 11, 12, 14, 15, 17, 19, 21-25, 27-29, 31, 33, 36-37 and 45 without traverse in the reply filed on 2/27/26 has been acknowledged.
Accordingly, claims 38-40 and 42 are withdrawn from further consideration by the examiner, 37 CFR 1.142 (b) as being drawn to a nonelected invention.
Claim 1-3, 5, 6, 8, 9, 11, 12, 14, 15, 17, 19, 21-25, 27-29, 31, 33, 36-37 and 45 are under consideration in the instant application.
4. Applicant’s IDS filed on 12/22/23 and 2/27/26 have been acknowledged.
5. The oath filed on 2/27/26 has been acknowledged.
6. 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.
7. Claims 2-3, 5, 6, 8, 9, 11, 12, 14, 15, 17, 19, 25, 28 and 29 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” in claims 3, 6, 9, 11, 12, 15, 17, 19 and 25 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). The phrase following the term is interpreted as not a part of claims.
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 5 for example recites the broad recitation of buffer of “about 1mM to about 50mM” with about “10-20mM” which is the narrower statement of the range/limitation. Note claims 8, 11, 14, 17, 19, and 29 recite broader and narrow ranges in the same claims.
8. 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.
9. 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.
10. Claims 1-3, 5, 6, 8, 9, 11, 12, 14, 15, 17, 19, 23-25, 28-29, 31, 33, 36-37 and 45 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat 10,729,767 (IDS reference) in view of U.S.Pub 2007/0053900.
The ‘767 patent teaches anti-C1s antibody formulations comprising the claimed antibody set forth in the SEQ ID NO:7-8 (note SEQ ID NO:14, 22 and claims 1-6) at 50-200mg/ml and a pharmaceutically acceptable carrier or excipients. Further, the pharmaceutical excipients include histidine buffer at about 1-50mM, sucrose as a tonicity agent at 5-350mM, and polysorbate at 0.01-0.1% at pH 7 (note col. 22-24). Given that the molecular weight of sucrose is 342.3g/mole, 100mM of sucrose is about 3% and meets the claimed limitation. In addition, the ‘767 patent allows addition of amino acid and antioxidant (col22). As the term “optionally” is interpreted that the phrase following is optional, claims 11-12 are included in this rejection and the antibody being IgG4 is taught in col.4.
Further, the claimed SEQ ID NO:7-8 comprises CDRs set forth in SEQ ID NO:1-6, it meets the claimed limitation of claim 1 and thus claims 28-29 are included in this rejection. The CDR1 would be expected to have less isomerization rate.
Moreover, the ‘767 patent teaches the lyophilization and reconstitution of lyophilized powder (col. 22) and containers and kits comprising the antibody formulation (note col. 28). The ‘767 patent further teaches the container is syringe and a needle.
The disclosure of the ‘767 patent differs from the instant claimed invention in that it does not teach the use of arginine as in claims 1-3 of the instant application.
The ‘900 publication teaches addition of arginine at about 150mM for highly concentrated antibody of 100-260mg/ml of antibody in the presence of histidine and polysorbate at pH 5.5-7.0 (claims) to improve stability and term “stable” is defined to retain physical, chemical and biological activity after 2 years at 30oC (p.7). The stable formulation may retain less than 5% of aggregates.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize about 150mM of arginine as taught by the ‘900 publication into the antibody formulation taught by the ‘767 patent.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of arginine would improve stability and control viscosity for high antibody formulation.
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.
11. Claims 1 and 21-22 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pat 10,729,767 (IDS reference) and U.S.Pub 2007/0053900 as applied to claim 1 above, and further in view of U.S. Pub. 2005/0276823.
The teachings of the ‘767 patent and ‘900 publication have been discussed, supra.
The disclosure of the references differs from the instant claimed invention in that it does not teach the use of DTPA at 1-50um as in claims 21-22 of the instant application.
The ‘823 publication allows addition of 1-50um of DTPA in the presence of histidine buffer (claims 1-20) to reduce oxidative degradation of antibody and reduces non-reducible covalent protein aggregates (p.2-3).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize DTPA at 1-50um into the antibody formulation taught by the ‘767 patent and ‘900 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because known concentration and DTPA that reduces or prevents oxidative degradation of protein taught by the ‘823 publication.
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.
12. Claims 1 and 27 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub 2020/0048332 (IDS reference) in view of U.S.Pub 2007/0053900.
The ‘332 publication teaches C1s antibody formulation comprising the claimed SEQ ID NO:9-10 (note p. 21, SEQ ID NO:29-30).
The disclosure of the ‘332 publication differs from the instant claimed invention in that it does not teach the use of arginine as in claim 1 of the instant application.
The teachings of the ‘900 publication have been discussed, supra.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize about 150mM of arginine as taught by the ‘900 publication into the antibody formulation taught by the ‘332 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the utilization of arginine would improve stability and control viscosity for high antibody formulation.
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. No claims are allowable.
14. 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.
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.
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
June 23, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
Prosecution Insights