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 .
DETAILED ACTION
Election/Restrictions
2. Applicant’s election without traverse of claims 1 and 10-11 (Group I) in the reply filed on 17 February 2026 is acknowledged.
Claims 2-3, 5, 7-9, 13-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1 and 10-11 are pending in this application and are under consideration.
Claims 1 and 10-11 are examined on the merits.
Priority
3. Receipt is acknowledged of certified copies of papers required by 35 CFR 1.55.
Drawings
4. The drawings are objected to because the lines in Figure 6 are indiscernible. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
5. Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
6. Claims 1 and 10-11 are objected to because of the following informalities:
Regarding claim 1, the comma after “and” should be removed.
Regarding claim 10, the comma after “and/or” should be removed.
Regarding claim 11, the commas before “and” in (6) and (7) should be removed; the comma in (5) before “and” should be changed to a semicolon.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
7. 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.
8. Claim 11 is rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of the particle size, molar concentration ratios, pH, zero charge point, and absorption rate is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the different groups of (1)-(11) do not all share a “single structural similarity”, for example, particle size is unrelated to molar concentration ratios. Therefore, these alternatives are not all members of the same recognized physical or chemical class and do not share a singular similar structure feature.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 USC § 102
9. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
10. Claims 1 and 10-11 are rejected 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).
For the 35 USC 102(a)(1) rejection, applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
The applied reference has a common assignee and joint inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). In the event that applicants do provide a translation, Zhao is applied in this rejection under 35 U.S.C. 102(a)(2), which might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1 is drawn to an adjuvant comprising zinc aluminum risedronate with a zinc:risedronate molar concentration ratio of 1:1 to 16:1 and a zinc:aluminum molar concentration ratio of 1:1 to 50:1. Claim 10 further limits at least one of the two molar concentrations ratios to 2:1 to 16:1 for the zinc:risedronate or 5:1 to 50:1 for the zinc:aluminum. Claim 11 does not further limit the molar concentration ratios.
Regarding claims 1 and 10-11, Zhao teaches a zinc risedronate adjuvant with a zinc:risedronic acid molar concentration of (1-8):1 (Page 3, Last ¶), which may further comprise aluminum (Al) with a Zn:Al molar concentration ratio of 1:1 (Page 4, ¶ 3).
11. Claims 1 and 10-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Zhao2 (US Patent 12,419,951; priority to 30 May 2019).
The applied reference has a common assignee and joint inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1 is drawn to an adjuvant comprising zinc aluminum risedronate with a zinc:risedronate molar concentration ratio of 1:1 to 16:1 and a zinc:aluminum molar concentration ratio of 1:1 to 50:1. Claim 10 further limits at least one of the two molar concentrations ratios to 2:1 to 16:1 for the zinc:risedronate or 5:1 to 50:1 for the zinc:aluminum. Claim 11 does not further limit the molar concentration ratios.
Regarding claims 1 and 10-11, Zhao teaches a zinc risedronate adjuvant with a zinc:risedronic acid molar concentration of (1-8):1 (¶ [0010]), which may further comprise aluminum (Al) with a Zn:Al molar concentration ratio of 1:1 (¶ [0013]).
Claim Rejections - 35 USC § 103
11. 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.
12. 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.
13. Claims 1 and 10-11 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) in view of Shishido (US Patent 10,471,141; published 12 November 2019) (See IDS filed 08 June 2023).
The applied reference has a common assignee and joint inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claims 1 and 10-11, Zhao3 teaches a zinc zoledronate adjuvant with a zinc:zoledronate molar concentration of (1-8):1 (Page 4, ¶ 7), which may further comprise aluminum (Al) in a Zn:Al molar concentration of (0.2-1):1 (Page 4, ¶ 9). However, Zhao3 does not teach using risedronate.
Shishido teaches “The immunity induction promoter that is a bisphosphonate is preferably at least one selected from the group consisting of […] zoledronate, risedronate…” (¶ [0023]) in the context of vaccine compositions for induction of humoral immunity.
It would have been obvious to one of ordinary skill at the time of filing to take the zoledronate and replace it with risedronate, another bisphosphonate that is capable of inducing immunity. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
14. Claims 1 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Khajuria (Mater. Sci. Eng. C, 2016, 63: 78-87) in view of Shishido (Supra).
Regarding claims 1 and 10-11, Khajuria teaches a risedronate/zinc-hydroxyapatite based nanomedicine for osteoporosis at a ratio of 1:1 (Abstract, Table 1). It is noted that while Khajuria does not explicitly teach the composition as an adjuvant, it could have been used as one at the time of filing as the composition is substantially identical to that of the claimed invention. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an Applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. See In re Ludtke 441 F.2d 660, 169 USPQ 563 (CCPA 1971). Whether the rejection is based on “inherency” under USC 102, or “prima facie obviousness” under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. In re Best, Bolton, and Shaw, 195 USPQ 430, 433 (CCPA 1977) citing In re Brown, 59 CCPA 1036, 459 F.2d 531, 173 USPQ 685 (1972).
Khajuria does not teach that aluminum can be present in the adjuvant.
However, Shishido teaches “Examples of adjuvants or immunostimulants practically used for immunization by injections include aluminum salts (e.g., aluminum hydroxide, aluminum phosphate, and aluminum chloride)” (¶ [0004]).
Therefore, it would have been obvious to one of ordinary skill at the time of filing to take the composition disclosed by Khajuria that could be used as an adjuvant, and further including aluminum for its known properties of inducing an immune response as discussed in Shishido. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted).
Regarding the molar concentration ratios between the aluminum and zinc, and the zinc and risedronate, it would further be obvious with that the concentrations in a composition are clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient needed to achieve the desired results. The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." (Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." (In re Aller, 220 F.2d 454, 456, 105 USPQ 2).
Double Patenting
15. 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
16. Claims 1 and 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,419,951. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘951 discloses a vaccination method using a vaccine composition with a zinc risedronate adjuvant with a zinc:risedronic acid molar concentration ratio of (1-8):1. Claim 2 further limits that molar concentration ratio to 1:1, 4:1, or 8:1. The specification of ‘951 also discloses that the adjuvant may further comprise aluminum (Al) with a Zn:Al molar concentration ratio of 1:1 (¶ [0013]).
17. Claims 1 and 10-11 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 (Supra). Claim 1 of ‘250 discloses a vaccine composition using a vaccine composition with a zinc zoledronate adjuvant with a zinc:zoledronic acid molar concentration ratio of (1-8):1. Claim 2 further limits that molar concentration ratio to 1:1, 4:1, or 8:1. Claim 4 further adds aluminum to the adjuvant at a molar concentration ratio of zinc:aluminum of (0.02-1):1. ‘250 does not teach risedronate. However, Shishido teaches “The immunity induction promoter that is a bisphosphonate is preferably at least one selected from the group consisting of […] zoledronate, risedronate…” (¶ [0023]) in the context of vaccine compositions for induction of humoral immunity. It would have been obvious to one of ordinary skill at the time of filing to take the zoledronate and replace it with risedronate, another bisphosphonate that is capable of inducing immunity. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Conclusion
18. No claim is allowed. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached at (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTINA E. LY/Examiner, Art Unit 1671 /BENJAMIN P BLUMEL/Primary Examiner, Art Unit 1671