DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 (i.e., changing from AIA to pre-AIA ) 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.
Nucleotide and/or Amino Acid Sequence Disclosures
The sequence listings in this application have been entered.
Claim Interpretation
Claim 27 is drawn to a method of reducing formation of aggregates of an anti-CD38 antibody in a composition, as of the first line of claim 27. Similarly, claim 39 recites a method of producing a storage stable anti-CD38 antibody product, as of the first line of claim 39. For the purposes of examination under prior art, the examiner will understand the above-indicated composition and product to be liquid. The examiner takes the position that this claim requirement does not exclude a composition that was previously lyophilized and reconstituted in aqueous solution. However, the claim would appear to exclude the case wherein the product and/or composition is lyophilized and not reconstituted. This is because a lyophilized product is solid, whereas the above-discussed composition or product appears to be liquid. The reason that the above-discussed composition appears to be liquid is at least because the second line of claim 27 and the second line of claim 39 recite a concentration of 55 to 75 mg/mL. This concentration measurement would have been appropriate for liquid compositions, but not for lyophilized solid compositions that are in the form of a powder and not measured by volume.
Examiner’s Comment Regarding Patent Prosecution Highway Program
Applicant filed a request to participate in the Patent Prosecution Highway (PPH) program on 19 March 2026, based upon the work product from an office of earlier examination, which in this case is the Japanese patent office and is Japanese application number 2024-221766. This request was granted as of the decision on 29 May 2026.
The examiner notes that one requirement of participation in the PPH program is that the claims in the instant application sufficiently correspond to the allowable/patentable claims in the office of earlier examination. See the petition decision mailed on 29 May 2026, relevant text reproduced below.
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However, in this case, there appears to be an indication that the claims in the office of earlier examination may not have been the same as the pending claims. In support of this position, the examiner notes the Office Action issued in corresponding Japanese Patent Application No. 2024-221766 dated November 4, 2025, 7 pages, which was submitted to the file record in the information disclosure statement (IDS) on 2 December 2025 along with an English translation thereof. In the English translation of the above-indicated document from the Japanese patent office on page 2/4, the translation states the following.
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This would appear to indicate that the claims examined by the Japanese patent office, which is the office of earlier examination, are drawn to a lyophilized formulation.
In contrast, the instant claims are drawn to a method of reducing formation of aggregates in a composition (as of claim 27) and producing a storage stable product (as of claim 39), wherein the composition and/or product is not lyophilized. This would appear to suggest that the claims examined by the Office of Earlier Examination relate a lyophilized composition or method related thereto, whereas the instantly claimed method is unrelated to a lyophilized composition. As such, this would appear to call into question whether the instant claims sufficiently correspond to the allowable/patentable claims in the Office of Earlier Examination application and therefore would appear to call into question whether participation in the Patent Prosecution Highway program is appropriate in this case.
Note Regarding Affidavits/Declarations from Parent Application
Affidavits or declarations, such as those submitted under 37 CFR 1.130, 1.131 and 1.132, filed during the prosecution of the prior application (in this case, application 17/298,156) do not automatically become a part of this application. Where it is desired to rely on an earlier-filed affidavit or declaration, the applicant should make the remarks of record in this application and include a copy of the original affidavit or declaration filed in the prior application.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/298,156, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, it is the examiner’s position that instant claims 38 and 49 do not appear to be adequately supported by the ‘156 parent application. The examiner presents the following arguments in support of this position.
Applicant appears to have tested storage at 4 weeks at 40°C at 75% relative humidity as of figure 6E, wherein the relevant portion of the figure is reproduced below.
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This would appear to indicate that upon storage at 40°C at 75% relative humidity (which is similar to the claimed 70% relative humidity), the monomer content is less than 90% rather than greater than 90%. As such, claims 38 and 49 do not appear to be adequately supported in the parent application.
Claim Rejections - 35 USC § 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 38 and 49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 38 and 49 recite that upon long term storage of the composition for 4 weeks at 40°C and 75% relative humidity, the monomer content is greater than 90%. This does not appear to be adequately supported by the original application as filed. This is because the original application as filed would appear to indicate that monomer content is less than 90% under these conditions. In support of this position, the examiner cites instant figure 6E, which is reproduced in part below with annotation by the examiner.
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This figure would appear to indicate that upon storage at 40°C at 75% relative humidity (which is similar to the claimed 70% relative humidity), the monomer content is less than 90% rather than greater than 90%. As such, claims 38 and 49 do not appear to be adequately supported in the manner required by 35 U.S.C. 112(a).
Claim Rejections - 35 USC § 103 – Obviousness
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 27-34, 36-44 and 46-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Endell et al. (US 2015/0238603 A1) in view of Andya et al. (US 2006/0088523 A1).
Endell et al. (hereafter referred to as Endell) is drawn to an anti-CD38 antibody, as of Endell, title and abstract. Endell teaches the following sequence, as of page 10, claim 3 of the reference, which is reproduced below.
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This sequence appears to read on sequence IDs #7 and #8.
Endell does not teach the required excipients.
Andya et al. (hereafter referred to as Andya) is drawn to antibody formulations stabilized in histidine buffer, as of Andya, title and abstract. Andya teaches the following formulation, as of paragraph 0045, reproduced below.
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Andya teaches that this formulation results in physical and chemical stability, as of Andya, paragraph 0092. Andya teaches reducing aggregation as of paragraph 0046.
Andya does not teach the required antibody.
It would have been prima facie obvious for one of ordinary skill in the art to have used the buffer of Andya to have stored the antibody of Endell. Endell is drawn to the protein structure of a particular antibody but is silent as to the conditions under which the antibody is stored. Andya teaches a buffer which may be used for storage of antibodies. As such, the skilled artisan would have been motivated to have used the buffer of Andya to have predictably stored the antibody of Endell to have predictably stabilized the antibody of Endell with a reasonable expectation of success.
As to claim 27, the claim requires reducing the formation of aggregates. Andya teaches this as of at least paragraph 0045.
As to claim 27, the claim requires from 55 to 75 mg/mL of the antibody. Andya teaches 10 mg/mL to 250 mg/mL of antibody in paragraph 0045. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 27, part (a), Endell is understood to teach the required antibody, as of claim 3 of Endell.
As to claim 27 part (b), Andya teaches polysorbate 20 in paragraph 0045. This is a non-ionic surfactant.
As to claim 27 part (c), Andya teaches sucrose in paragraph 0045.
As to claim 27 part (d), Andya’s teaching of histidine-acetate buffer in paragraph 0045 reads on this claim requirement.
As to claim 28, Andya teaches polysorbate 20 in paragraph 0045.
As to claim 29, Andya teaches polysorbate 20 in a concentration of about 0.01% to 0.1% in paragraph 0045. This overlaps with the claimed amounts. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 30, Andya teaches polysorbate 20 in a concentration of about 0.01% to 0.1% in paragraph 0045. This reads on the requirement of 0.1% polysorbate 20.
As to claim 31, Andya teaches a pH of 5.5 to 6.5 in paragraph 0045.
As to claim 32, Andya teaches a pH of 5.5 to 6.5 in paragraph 0045. This overlaps with the claimed requirement of a pH of about 6. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 33, Andya teaches 60 mM to about 250 nM surose in paragraph 0045. This overlaps with claimed amounts of 150 mM to 350 mM sucrose.
As to claim 34, the amount of sucrose taught by paragraph 0045 of Andya is capped at about 250 mM. In view of the language “about” in Andya, this is understood to meet the requirements of 260 mM sucrose because the 250 mM sucrose of Andya is about 260 mM sucrose. Additionally, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05(I), second paragraph. Additionally, generally, differences in concentration between the claimed invention and prior art will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05(II)(A). In this case, no evidence of criticality appears to have been provided. Also, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of an antibody storage solution comprising polysorbate 20, sucrose, and histidine have been taught by Andya. As such, it would not have been inventive for the skilled artisan to have determined the optimum or workable range of sucrose via routine experimentation.
As to claim 36, this claim is rejected for essentially the same reason that claim 33 is rejected.
As to claims 37-38, claim 37 recites storage stability at 4 weeks at 25°C, and claim 38 recites storage stability at 4 weeks at 40°C. Andya teaches the following as of paragraph 0092, relevant portion of the paragraph reproduced below.
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This appears to indicate stability at 40°C for 4 weeks. As such, the skilled artisan would have had a reasonable expectation that the composition would have remained stable at both 25°C (as required by claim 37) and 40°C (as required by claim 38) for the recited time periods. The examiner notes that the skilled artisan would have expected greater instability at greater temperature; as such, the skilled artisan would have expected stability at 25°C in the case wherein stability at 40°C was achieved.
As to claim 39, this is an independent claim reciting producing a storage stable anti-CD38 antibody product. This claim recites filling a syringe or vial with a composition, wherein the composition appears to be the same as that in the method of claim 27. Andya teaches a syringe or vial in paragraphs 0052, 0382, 0395, 0399 and elsewhere in the reference. Otherwise, claim 39 is rejected for essentially the same reason that claim 27 is rejected.
As to claim 40, Andya teaches polysorbate 20 in paragraph 0045.
As to claim 41, Andya teaches polysorbate 20 in a concentration of about 0.01% to 0.1% in paragraph 0045. This overlaps with the claimed amounts. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
As to claim 42, Andya teaches polysorbate 20 in a concentration of about 0.01% to 0.1% in paragraph 0045. This reads on the requirement of 0.1% polysorbate 20.
As to claim 43, Andya teaches 60 mM to about 250 nM surose in paragraph 0045. This overlaps with claimed amounts of 150 mM to 350 mM sucrose.
As to claim 44, this claim is rejected for essentially the same reason that claim 34 is rejected.
As to claim 46, Andya teaches a pH of 5.5 to 6.5 in paragraph 0045.
As to claim 47, this claim is rejected for essentially the same reason that claim 43 is rejected.
As to claims 48-49, these claims are rejected for essentially the same reason that claims 37-38 are rejected.
Claim(s) 35, 37-38, 45 and 48-49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Endell et al. (US 2015/0238603 A1) in view of Andya et al. (US 2006/0088523 A1), the combination further in view of Whitaker et al. (Journal of Pharmaceutical Sciences, Vol. 106, 2017, pages 3230-3241 and 6 pages of supplemental information).
Endell teaches a particular anti-CD38 antibody with a particular sequence. Andya teaches a particular formulation for storing antibodies. See the rejection above over Endell in view of Andya. Andya teaches histidine, sucrose, and polysorbate 20 in paragraph 0045.
Andya is silent as to the concentration of histidine.
Whitaker et al. (hereafter referred to as Whitaker) is drawn to a formulation for stabilizing a monoclonal antibody, as of Whitaker, page 3230, title and abstract. Whitaker appears to teach the following compositions as the most optimized for this purpose, as of Whitaker, page 3240, right column, relevant text reproduced below.
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Whitaker differs from the claimed invention because Whitaker does not teach the required antibody. Also, Whitaker appears to teach a higher concentration of antibody than recited by the instant claims. This is at least because Whitaker teaches greater than 150 mg/mL antibody as of page 3232, right column, bottom paragraph whereas the instant claims require 55 to 75 mg/mL antibody.
It would have been prima facie obvious for one of ordinary skill in the art to have modified the concentrations of polysorbate 20, sucrose, and histidine, as taught by Andya, in the manner taught by Whitaker. Andya is drawn to a formulation for storing an antibody comprising polysorbate 20, sucrose, and histidine. Whiatker also teaches these ingredients for storing an antibody and teaches an optimized formulation at which these ingredients can be present and result in a stable antibody. As such, the skilled artisan would have been motivated to have modified the composition of Andya in the manner taught by Whiatker in order to have predictably stabilized an antibody with a reasonable expectation of success.
As to claim 35, the claim requires 5 mM to 15 mM histidine buffer. Andya teaches histidine buffer in paragraph 0045, but appears to be silent regarding its concentration. Whiataker teaches 10 mM histidine, which is within the claimed range. As such, the skilled artisan would have been motivated to have optimized the formulation of Andya to have had the histidine concentration taught by Whitaker for predictable stabilization of an antibody with a reasonable expectation of success.
As to claim 37, Whitaker teaches over 90% monomer at 1 month of storage at 25°C, as of Whitaker, pages 3237, relevant text reproduced below.
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As such, there would have been a reasonable expectation that over 90% monomer would have been achievable at 1 month of storage.
As to claim 38, Whitaker teaches the following regarding storage at 40°C, as of Whitaker, page 3237, relevant text reproduced below with annotation by the examiner pointing out 90% monomer and 1 month of storage.
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As such, the above-reproduced data indicates 90+% monomer at 1 month of storage at 40°C.
As to claim 45, this claim is rejected for essentially the same reason that claim 35 is rejected.
As to claim 48, this claim is rejected for essentially the same reason that claim 37 is rejected.
As to claim 49, this claim is rejected for essentially the same reason that claim 38 is rejected.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights