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. Claims 1, 31, 37-45, 47, 50, 57 and 58 are pending upon entry of amendment filed on 3/12/26.
Claims 1, 31, 37-45, 47, 50, 57 and 58 are under consideration in the instant application.
3. Applicant’s IDS filed on 3/12/26 has been acknowledged.
4. The following rejection remains.
5. 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.
6. 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.
7. Claims 1, 31, 37-45, 47, 50, 57 and 58 are rejected under 35 U.S.C. 103(a) as being unpatentable over U.S. Pub. 2016/0319022 (IDS reference, of record) in view of U.S. Pat. 7,767,429 (IDS reference, of record) for the reasons set forth in the office action mailed on 12/12/25.
The claimed invention as recited in claims 1 and 56 relates a liquid pharmaceutical formulation comprising 100-150g/l atezolizumab (monoclonal PD-L1 antibody), about 15-25 mM of histidine-acetate buffer, about 200-280mM of sucrose, about 0.04-0.08 % (w/v) polysorbate, about 5-15mM of methionine, and a hyaluronidase enzyme wherein the formulation is at about pH 5.6-6.0 and the kit comprising the antibody formulation thereof.
The ‘022 publication teaches PD-L1 antibody formulation comprising the instantly disclosed SEQ ID NO:1-6 as heavy and light chain CDRs at about 125mg/ml, histidine acetate buffer at 15-25mM, 240mM of sucrose and about 0.06% (w/v) of polysorbate at pH about 5.5-6.3 (claims 1-41, [0291-296]). Further, the ‘022 publication teaches that the formulation comprises methionine as well as hyaluronidase ([0297]). The hyaluronidase includes rHuPH20 ([297]). Note the antibody is not subject to the prior lyophilization (claim 17).
Given that the ‘022 publication teaches the buffer concentration of 5-25mM, the amino acid methionine act as a buffer having multiple pKa’s as noted by the histidine-acetate buffer, the concentration of buffer is applicable to methionine and meets the limitation of claims 1 and 12 of the instant application.
As evidenced by the specification in p.31-37, the humanized PD-L1 antibody set forth in SEQ ID NO:1-6 is deemed atezolizumab and meets the claimed limitation. Note 125mg/ml concentration of antibody is equivalent of 125g/L and meets the claimed invention.
In addition, the ‘022 publication teaches that the formulation is sterile, stable at 2-8oC for at least 12 or 24months (claim 29), having at least 80 % of biological activity after storage (claim 30), and being intravenous and/or subcutaneous administration ([301]), being stored in 15cc syringes, in kit as well as in 316L stainless steel or Hastelloy ([0032], [309]). Claim 57 is included in this rejection as the mg amount is equivalent of molar concentration as set forth in claim 56.
The disclosure of the ‘022 publication differs from the instant claimed invention in that it does not teach the use of 2000U/ml of hyaluronidase as in claim 1 of the instant application.
The ‘429 patent teaches the use hyaluronidase at 1-5000U/ml in improvement of stability and availability and facilitation of systemic delivery of therapeutic molecules (col. 3-8, claims)
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize the known concentration of hyaluronidase as in the ‘429 patent into the PD-L1 antibody formulation taught by the ‘022 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the therapeutically approved concentration of hyaluronidase improve and stabilize availability, stability and systemic delivery of therapeutic molecules.
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.
Applicant’s response filed on 3/12/26 has been fully considered but they were not persuasive.
Applicant has asserted that the currently amended claims require “subcutaneous” administration and the combination of the references fails teach the specific combination of the excipients required by the claimed invention.
In addition, the currently amended claims have exhibited unexpected property as being stable compared to other pharmaceutically acceptable excipients.
However, the subcutaneous administration has been suggested by both ‘029 patent and ‘022 publication as in col.58 and [298-301], respectively. Further, it is not inventive to discover optimum or workable range by routine experimentation where the general conditions of claim are disclosed in the prior art. See MPEP2144.05. As discussed, previously by the ‘022 and the ‘029 patent, the general conditions are taught.
In addition, the unexpected property of the stable formulation is not persuasive. Note ‘022 publication defines and discusses the stability to maintain at least 80oC of activity 2-8oC for 24 months (p.2, [0030]). As such, the unexpected characteristics of the property of the excipient combination taught by the ‘022 publication is known and seems expected property of the claimed formulation. The combination of the references is deemed obvious and the rejection is maintained.
8. No claims are allowable.
9. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. 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 ExaminerTechnology Center 1600
April 13, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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