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 1-4, 8, 13-17, 30, 39, 44-47 and 137-140 are pending upon entry of amendment filed on 4/28/26.
3. Applicant’s IDS filed on 4/28/26 has been acknowledged.
4. IN light of Applicant’s amendment to the claims filed on 4/28/26, the provisional double patenting rejection (see sections 12-13 of the office action mailed on 1/6/26) has been withdrawn.
5. The following rejections remain.
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 39 and 138 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.
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, claims 39 and 138 recites the lower recitation the temperature between 5oC for at least 7 months, 25oC for at least 1 months, and the claims also recites 2-8oC for at least 2 years or two weeks at 15-30oC which is the higher statement of the range/limitation.
Applicant’s response filed on 4/28/26 has been fully considered but they were not persuasive.
Applicant has asserted that the currently amended claims obviate the rejection.
Unlike Applicant’s assertion, the claims remain reciting higher and low temperatures in the same claims. Applicant is advised to recite the temperature and storage length in the separate 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 1-4, 8, 13-17, 39, 44-47 and 138-140 are rejected under 35 U.S.C. 103(a) as being unpatentable over AU2018/207367 (IDS reference, of record) in view of WO2015/057622 (of record) for the reasons set forth in the office action mailed on 1/6/26.
The ‘367 publication teaches stable liquid pharmaceutical compositions comprising antibody at 50-150mg/ml antibody, about 10mM of acetate buffer, 250mM of glycine and about 0.1% of surfactant at pH about 5.5 (note claims 15-17). In addition, the ‘367 publication teaches surfactant includes polysorbate 20 at 0.02% ([0064-0065]), addition of about 5% of sorbitol ([0068-0070]). Given that the stability of formulation includes conditions of 40oC for 6 weeks (p. 15-16) that is more contingent than claimed 15-30oC for 2 weeks, claims 39 and 138 are included in this rejection.
Moreover, the ‘367 publication teaches having main peak of greater than 95% of IgG by NR-CE-SDS (p. 15-18) and having monomer content of greater than 80% recited by claims 13-17, also readable upon less than 20% of dimers and claim 140 are included in this rejection. As the antibody is expressed as IgG and it meets the limitation of “immunoglobulins” of claim 1 and claim 44 of the instant application.
The disclosure of the ‘367 publication differs from the instant claimed invention in that it does not teach the use of disialylation of immunoglobulins at Fc region by NeuAc-a 2, 6, Gal terminal as in claims 1, 8, 44 and 139 of the instant application.
The ‘622 publication teaches pharmaceutical compositions comprising immunoglobulin with disialylation of immunoglobulins at least of 90% at NeuAc-a 2, 6, Gal terminal linkage (p. 2-5) improves biological activities and purity during the purification process (p.20-25).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize disialylation of immunoglobulin taught by the ‘622 publication enhances purification method and biological activity.
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 disialylation of immunoglobulin improves purity during purification and biological activity.
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 4/28/26 has been fully considered but they were not persuasive.
Applicant has asserted that there is no motivation to combine the references and the ‘367 publication is not an analogous art. Further Applicant has asserted that the combination of the references fails result in the claimed invention.
Applicant’s assertion relies on the ‘367 publication is formulation of monoclonal antibody while the claimed invention is immunoglobulin from pooled polyvalent human immunoglobulins and there is no reasonable expectation of success in combining the references.
Unlike Applicant’s assertion, although the ‘367 publication relates formulation of monoclonal antibody, the monoclonal antibody and immunoglobulin share structural similarity having two heavy and light chain polypeptides. The sialylation is taught by the ‘622 publication. The IVIG as well as FC or IgG antibodies may also be sialylated (note p. 11, 14-15) and antibody encompasses pooled polyvalent immunoglobulins and monoclonal antibody (p. 7, 11). The IVIG also be formulated with sodium acetate buffer, sorbitol and polysorbate (p. 23). The enriched sialylated polyvalent immunoglobulins pooled from plasma of at least 1000 human donors (p. 6-7) reads on the currently amended limitation of “hypersialylated pooled polyvalent human immunoglobulin” and the formulation used generally in monoclonal antibody may be applicable to polyvalent immunoglobulins as currently amended. The combination of the references results in claimed invention and there is reasonable expectation of combining the references. Obviousness dose not require absolute predictability; however, at least some degree of predictability is required. See MPEP 2143.02
11. Claims 1-4, 8, 13-17, 39, 44-47 and 138-140 are rejected under 35 U.S.C. 103(a) as being unpatentable over WO2015/057622 (of record) in view of AU2018/207367 (IDS reference, of record) for the reasons set forth in the office action mailed on 1/6/26.
The teachings of the ‘622 publication and ‘367 publication have been discussed, supra.
The disclosure of the ‘622 publication differs from the instant claimed invention in that it does not teach the use of 10mM acetate buffer, 250mM glycine and 0.02% polysorbate as in claims 1 and 44 of the instant application.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize stabilizing formulation comprising acetate buffer, glycine and polysorbate as in the ‘367 publication stability of the antibody at various temperature ranges.
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 formulation comprising acetate, glycine and polysorbate improve stability of antibody.
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 4/28/26 has been fully considered but they were not persuasive.
Applicant has asserted that there is no motivation to combine the references and the ‘367 publication is not an analogous art. Further Applicant has asserted that the combination of the references fails result in the claimed invention.
Applicant’s assertion relies on the ‘367 publication is formulation of monoclonal antibody while the claimed invention is immunoglobulin from pooled polyvalent human immunoglobulins and there is no reasonable expectation of success in combining the references.
In light of the discussion above in section 10 of this office action, the rejection is maintained.
12. Claim(s) 30 and 137 is/are rejected under 35 U.S.C. 103 as being unpatentable over AU2018/207367 (IDS reference) in view of WO2015/057622 as applied to claims 1 and 44 above, and further in view of Kiese et al (Journal of Pharm Sci, vo. 97, p. 4347-4366, 2008, IDS reference).
The teachings of the ‘367 and ‘622 publication have been discussed, supra.
The disclosure of the ‘622 publication or ‘367 publication differs from the instant claimed invention in that it does not teach having less than 1000 particles with a diameter 10-100um after agitation at 1000RPM for 8 hours at 2-8oC as in claims 30 and 137 of the instant application.
Kiese et al. teach agitation stress at 5oC upto 168 hours at 1000 RPM in the presence polysorbate reduces subvisible particles at 2-25um (Fig 3 p. 4347-4353) and mechanical stress through agitation or shaking result in formation of protein aggregates.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to induce aggregates by agitation as taught by the Kiese et al into the antibody formulation taught by the ‘367 and ‘622 publications.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the agitation induces aggregation in protein formulation and the monitoring of the agitation profile may reduce the aggregation formation in the antibody formulation to improve stability.
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 4/28/26 has been fully considered but they were not persuasive.
Applicant has asserted that there is no motivation to combine the references and the ‘367 publication is not an analogous art. Further Applicant has asserted that the combination of the references fails result in the claimed invention.
Applicant’s assertion relies on the ‘367 publication is formulation of monoclonal antibody while the claimed invention is immunoglobulin from pooled polyvalent human immunoglobulins and there is no reasonable expectation of success in combining the references.
In light of the discussion above in section 10 of this office action, the rejection is maintained.
13. The following new ground of rejection is necessitated by Applicant’s amendment filed on 4/28/26.
14. 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.
15. Claims 1-4, 8, 13-17, 30, 39, 44-47 and 137-140 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
The specification or the original claims as filed does not provide a written description the phrases “hypersialylated pooled polyvalent human immunoglobulins”. Applicants assert that no new matter has been added. However, the instant application shows “pooled polyvalent immunoglobulins” at most in p.14. No support is found where the “hypersialylated” is from.
The currently amended range is not supported by the original claims or instant specification.
The instant claims now recite a limitation which was not clearly disclosed in the specification as filed, and now changes the scope of instant disclosure as filed.
Such limitations recited in the present claims, which did not appear in the specification as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C.112.
16. 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.
17. Claims 1-4, 8, 13-17, 30, 39, 44-47 and 137-140 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 6-11, 13, 16-18, 21-24, 27, 29, 32, 33 and 35-37 of U.S. Application No.17/602,156 (US20220211849) in view of AU2018/207367 (IDS reference, of record)
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘156 application recites a liquid pharmaceutical composition comprising immunoglobulins disialylated by NeuAc-a 2, 6-Gal terminal linkage, 10mM acetate, 0.02% polysorbate 20 and 250mM glycine or 5% sorbitol at pH 4-7. The claims further recite the stable formulation exhibit less than 1000 particles with diameter between 10-100um after agitation at 1000RPM for 8 hours at 2-8oC.
The claims of the ‘156 application differs from the instant claimed invention in that it does not teach the use of 10mM acetate buffer, 250mM glycine and 0.02% polysorbate as in claims 1 and 44 of the instant application.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to utilize stabilizing formulation comprising acetate buffer, glycine and polysorbate as in the ‘367 publication stability of the antibody at various temperature ranges.
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 formulation comprising acetate, glycine and polysorbate improve stability of antibody.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
18. No claims are allowable.
19. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
20. 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 16, 2026
/YUNSOO KIM/Primary Examiner, Art Unit 1641
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