DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. This Office Action is in response to the amendment filed 07 July 2026, wherein claims 1 and 10-11 were amended and claims 18-22 were newly added.
Claims 4 and 6 are cancelled.
Claims 2-3, 5, 7-9, 12-17 are withdrawn.
Claims 1, 10-11, and 18-22 are under consideration.
Priority
3. Receipt is acknowledged of certified copies of papers required by 35 CFR 1.55. A certified English translation of foreign application CN202011278492.2 was filed on 07 July 2026. Claims 1, 10-11, and 18-22 are supported by the foreign priority document and thus the U.S. effective filing date of these claims is 16 November 2020.
Objections Withdrawn
Drawings
4. The objection to the drawings for the lines in Figure 6 being indiscernible is withdrawn in view of Applicant’s amendments.
Claim Objections
5. The objections to claims 1 and 10-11 for informalities is withdrawn in view of Applicant’s amendments.
Rejections Withdrawn
Claim Rejections - 35 USC § 112
7. The rejection of claim 11 on the basis that it contains an improper Markush grouping of alternatives is withdrawn in view of Applicant’s amendments.
Claim Rejections - 35 USC § 102
9. Applicant’s arguments, see page 17-18, filed 07 July 2026, with respect to rejection of claims 1 and 10-11 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhao (WO/2020/238394; published 03 December 2020, priority to 30 May 2019) (See PTO-892 mailed 07 April 2026) have been fully considered and are persuasive. The 35 U.S.C. 102(a)(1) and 102(a)(2) rejections of claims 1 and 10-11 have been withdrawn.
11. Applicant’s arguments, see page 18, filed 07 July 2026, with respect to rejection of claims 1 and 10-11 under 35 U.S.C. 102(a)(2) as being anticipated by Zhao2 (US Patent 12,419,951; priority to 30 May 2019) (See PTO-892 mailed 07 April 2026) have been fully considered and are persuasive. The 35 U.S.C. 102(a)(2) rejection of claims 1 and 10-11 has been withdrawn.
Claim Rejections - 35 USC § 103
12. Applicant’s arguments, see page 21-22, filed 07 July 2026, with respect to rejection of claims 1 and 10-11 under 35 U.S.C. 103 as being unpatentable over Khajuria (Mater. Sci. Eng. C, 2016, 63: 78-87) (See PTO-892 mailed 07 April 2026) in view of Shishido (US Patent 10,471,141; published 12 November 2019) (See IDS filed 08 June 2023) have been fully considered and are persuasive. The 35 U.S.C. 103 rejection of claims 1 and 10-11 has been withdrawn.
Rejections Maintained
13. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 103
14. Claims 1, 10-11, and 18-22 remain/are rejected under 35 U.S.C. 103 as being obvious over Zhao3 (WO/2020/207472; published 15 October 2020, priority to 11 April 2019) (See PTO-892 mailed 07 April 2026) in view of Shishido (US Patent 10,471,141; published 12 November 2019) (See IDS filed 08 June 2023).
Applicant’s Arguments: Applicant argues that the cited combination of references fail to teach or suggest each and every claim limitation of claim 1, and that a prima facie case of obviousness can only been made if one of ordinary skill would have been motivated or had rational to modify the teachings of the references and have a reasonable expectation of success. Applicant argues that Zhao3 does not teach an adjuvant comprising risedronate while Shishido does not teach an adjuvant that contains both a bisphosphonate and zinc-aluminum. Applicant further argues that Shishido does not suggest that a risedronate-zinc-aluminum adjuvant is equivalent or superior to that of a zoledronate-zinc-aluminum adjuvant and that a person of ordinary skill in the art would have no basis to consider the risedronate and zoledronate interchangeable without impermissible hindsight. Applicant states that Zhao3 teaches away from using aluminum in an adjuvant as they demonstrate that antibody titers to zinc/aluminum/zoledronate was significantly lower than that induced by zinc/zoledronate. Finally, Applicant states that the zinc:aluminum molar concentration ratios are different between Zhao3 and the claimed invention.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive.
Applicant argues that the cited combination of references fail to teach or suggest each and every claim limitation of claim 1. Examiner respectfully disagrees, each claim limitation was met in the rejection in section 13 of the Non-Final Office Action mailed 07 April 2026. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding Applicant’s argument of impermissible hindsight, such reconstruction was done without the aid of the Instant Specification. “[a]ny judgement on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper.” In re McLaughlin 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).
Applicant’s argument that Shishido does not teach that a risedronate-zinc-aluminum adjuvant is equivalent or superior to that of a zoledronate-zinc-aluminum adjuvant is irrelevant. The combination of references just needs to be predictably functional with a reasonable expectation of immunogenicity. Such reasonable expectation is given as both Zhao3 and Shishido teach an adjuvant, and Shishido makes it obvious to substitute one bisphosphonate for another. Regarding Zhao3 teaching away from using aluminum in the adjuvant, Zhao3 does not teach away from using aluminum as they show that aluminum does work to some extent (some sort of immune response) when compared to a control. To teach away, the reference must show that it does not work at all. Applicant is reminded that preferred embodiments are not the only teaching of a reference. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.”In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also > Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); < Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. “The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.”).
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Finally, regarding the zinc:aluminum molar concentration ratios, the claims require 1:1 to 50:1 and Zhao3 teaches a zing:aluminum ratio of 0.02:1 to 1:1. The 1:1 ratios will overlap and thus is obvious here.
Regarding new claims 18-22, since Zhao3 in view of Shishido makes every aspect of claim 1 obvious, as discussed supra, claims 18-22 must be obvious as well as they are physical attributes of the adjuvant of claim 1.
Double Patenting
15. Claims 1, 10-11, and 18-22 remain/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,419,951.
Applicant’s Arguments: Applicant states that they have submitted a terminal disclaimer over the ‘951 patent.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive.
The terminal disclaimer was denied due to Applicant’s name being incomplete on the form. The name(s) must be listed in its entirety as it is on the ADS. Applicant is recommended to resubmit the terminal disclaimer form. No additional fee is required with the resubmission.
16. Claims 1, 10-11, and 18-22 remain/are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 4 of U.S. Patent No. 12,472,250 in view of Shishido (US Patent 10,471,141; published 12 November 2019) (See IDS filed 08 June 2023).
Applicant’s Arguments: Applicant states that the ‘250 patent is a national phase entry of Zhao3 and thus is nonobvious for at least the same reasons discussed above.
Examiner’s Response to Traversal: Applicant’s arguments have been carefully considered but are not found persuasive. For the same reasons as discussed supra, ‘250/Zhao3 in view of Shishido renders the Instant Claims obvious.
Conclusion
17. No claim is allowed. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm EST.
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/KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
