DETAILED ACTION
Applicant’s arguments, filed 11 May 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 . Claims 1-7, 10, 12-13, 16-18, 21-22, 29, 31-32, 42, 48, 64-65 are pending; claims 1-7, 10, 12-13, 16-18, 42, and 64-65 are examined; claims 21-22, 29, 31-32, and 48 are currently withdrawn.
Claim Interpretation
Applicant defines the term “monophosphoryl lipid A (MPLA) like” compounds in the Remarks dated 11 May 2026 as a compound with the general structure of Fig. 1, wherein OH or NH2 positions of the molecule can carry 4-9 acyl groups and wherein acyl chains are between 8 to 20 carbon atoms long.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-7, 12, 16-18, 42, and 64-65 are rejected under 35 U.S.C. 103 as being unpatentable over Van Haren et al. (US 2017/0224811 A1, 08/10/2017) (hereinafter Van Haren).
Van Haren discloses a composition comprising at least one TLR4 agonist and at least one Dectin-1 agonist, wherein the at least one TLR4 agonist is monophosphoryl lipid A (MPLA) or glucopyranosyl lipid A (GLA) (abs), formulated as a nanoparticle, such as a liposome ([0206]). Dectin-1 agonist(s) include beta-glucan ([0165]).
As noted by p. 10, lns. 8-11 of the instant Specification, phosphorylated hexaacyl disaccharide (PHADTM) is also known as glucopyranosyl lipid A, or GLA. Thus the GLA of Van Haren meets the limitation of the one or more MPLA-like compound of instant claims 1-3.
Regarding claim 1 reciting the transitional phrase “consisting of”, as noted by p.6, lines 5-19, p. 18, lines 7-8, and p. 24, lines 6-11 of the instant Specification, beta-glucans are secondary immunostimulatory agents or polysaccharide suitable as a pharmaceutically acceptable excipient. Thus the beta-glucan of Van Haren, as a suitable Dectin-1 agonist, meets the limitation of a pharmaceutically acceptable excipient and transitional phrase of “consisting of” as instantly claimed.
Regarding claim 4 and 6-7, Van Haren further discloses wherein the composition further comprises pharmaceutical excipients including sugars such as glucose and maltose ([0235]).
Regarding claim 5, Van Haren further discloses wherein the composition further comprises other ingredients including monosaccharides, disaccharides, and other carbohydrates including dextrins ([0232]).
Regarding claim 12, Van Haren further discloses wherein the composition includes trehalose-6,6’-dimycolate ([0059]). As noted by p. 15, lines 9-11, trehalose further modified by an addition of surface modifiers is exemplary of polysaccharide carriers. Thus the trehalose-6,6’-dimycolate of Van Haren meets the claimed limitation of a trehalose as instantly claimed.
Regarding claim 16, Van Haren further discloses wherein the composition may take on the form of powders ([0122]).
Regarding claim 17, Van Haren further discloses wherein the at least one TLR4 agonist is in the range of about 0.1 to about 5% of the mass of the fraction ([0067]). Accordingly the claimed amount (i.e. between 0.5% and 10% by weight) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art. See MPEP § 2144.05(A).
Regarding claim 18, Van Haren does not explicitly disclose an amount of the other ingredients such as dextrins. However, since these are other ingredients in addition to the at least one TLR4 agonist, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amounts of sugar (i.e. between 80% and 99.5%) through routine experimentation based on the general guidance of the amounts of the at least one TLR4 agonist desired. "[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." See MPEP § 2144.05(II)(A).
Regarding claim 42, Van Haren further discloses wherein the composition may further comprise pharmaceutical excipients including preservatives ([0235]).
Regarding claim 64, Van Haren further discloses wherein the composition may also comprise pharmaceutical excipients including chitosan ([0235]). As noted by p. 20, lines 25-27 of the instant Specification, chitosan is a mucoadhesive agent.
Regarding claim 65, Van Haren further discloses wherein the composition may also comprise pharmaceutically acceptable carriers including lecithin ([0231]). As noted by p. 18, lines 26-29 of the instant Specification, lecithin is a phospholipid.
Response to Arguments
Applicant mainly asserts that claim 1 as amended recites a pharmaceutical composition consisting of one or more MPLA like compounds and a pharmaceutically acceptable excipient. Since Van Haren’s composition also comprises at least one Dectin-1 agonist, Van Haren neither teaches nor suggests the subject matter of amended claim 1.
The Examiner does not find Applicant’s assertion to be persuasive. As discussed above in the rejection, Van Haren discloses wherein Dectin-1 agonist includes beta-glucan. As noted by p.6, lines 5-19, p. 18, lines 7-8, and p. 24, lines 6-11 of the instant Specification, beta-glucans are secondary immunostimulatory agents or polysaccharide suitable as a pharmaceutically acceptable excipient. Thus the beta-glucan of Van Haren, as a suitable Dectin-1 agonist, meets the limitation of a pharmaceutically acceptable excipient and transitional phrase of “consisting of” as instantly claimed. As such, Applicant’s assertion is unpersuasive.
Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Van Haren et al. (US 2017/0224811 A1, 08/10/2017) (hereinafter Van Haren) in view of Yoshino et al. (JP-H0597695 A, 04/20/1993) (hereinafter Yoshino).
The disclosure of Van Haren has been discussed in detail above, and differs from the instant claims insofar as not explicitly disclosing wherein the dextrins include a cyclodextrin.
However, Yoshino discloses a macrophage activating composition comprising a macrophage activating factor and a cyclodextrin (abs) such as β-cyclodextrin (clm. 1). The macrophage activating factor includes lipid-A (clm. 2).
Accordingly, it would have been obvious to one of ordinary skill in the art to have included β-cyclodextrin in the composition of Van Haren since it is a known and effective dextrin suitable for compositions comprising immune compounds as taught by Yoshino.
Response to Arguments
Applicant does not present specific arguments with regard to Van Haren and Yoshino.
Since the Examiner has discussed Van Haren above, this rejection is maintained.
Double Patenting
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.
Claims 1-7, 10, 12-13, 16-18, 42, and 64-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 8-12, 17, 19, 21, 25, 28, 31, 33-34, 39, 42, 46, and 52-53 of copending Application No. 18/562,696 (reference application) in view of Van Haren et al. (US 2017/0224811 A1, 08/10/2017) (hereinafter Van Haren) and Yoshino et al. (JP-H0597695 A, 04/20/1993) (hereinafter Yoshino).
Regarding claims 1-5, 7, 10, 12-13, 16-18 and 42, although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite a colloidal formulation of a MPLA compound and the sugars of the pending claims, and thus read on the pending claims.
In regard to claim 6, the copending claims differ from the pending claims insofar as not explicitly teaching all the features of the claimed invention, such as instantly claimed monosaccharide.
However, these features are known in the art. As noted in the current rejections, the teachings of Van Haren render obvious claims 1-7, 12, 16-18, 42, and 64-65. Furthermore, the combined teachings of Van Haren and Yoshino render obvious claims 10 and 13.
Therefore, as claims 1-2, 8-12, 17, 19, 21, 25, 28, 31, 33-34, 39, 42, 46, and 52-53 of copending Application No. 18/562,696, Van Haren, and Yoshino all disclose compositions comprising lipid A or related compounds, it would have been prima facie obvious to one of ordinary skill in the art to have modified the copending application and to include the teachings of Van Haren and Yoshino as discussed in the rejections above, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. "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." See MPEP 2144.06(I).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant requests the present double-patenting rejection be held in abeyance until indication of otherwise allowable subject matter.
Since the Applicant has not addressed these rejections yet, the rejections are maintained.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bredehorst et al. (US 2016/0271257 A1, 09/22/2016, IDS reference), directed to pharmaceutical compositions comprising monophosphoryl lipid A.
Kensil et al. (US 2005/0191310 A1, 09/01/2005), directed to compositions comprising QS-21 and beta-cyclodextrins.
Reed et al. (US 2010/0310602 A1, 12/09/2010), directed to GLA compounds in vaccine compositions.
Irvine et al. (US 2020/0085756 A1, 03/19/2020), directed to particles comprising an adjuvant.
Lederhofer et al. (“Development of a Virosomal RSV Vaccine Containing 3D-PHAD® Adjuvant: Formulation, Composition, and Long-Term Stability,” 07/2018), drawn to a formulation comprising a synthetic monophosphoryl lipid A compound, 3D-PHAD®.
Sherwood et al. (US 2020/0085850 A1, 03/19/2020), directed to administering an effective amount of a phosphorylated hexaacyl disaccharide.
Conclusion
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 LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
Prosecution Insights