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 . Claims 1-7, 10, 12-13, 16-18, 21-22, 29, 31-32, 42, and 48 are pending; claims 1-7, 10, 12-13, 16-18 and 42 are examined; claims 21-22, 29, 31-32, and 48 are currently withdrawn.
Election/Restrictions
Applicant’s election of Group I, claims 1-7, 10, 12-13, 16-18, 21-22, 29, 31-32, and 42, and species election of cyclic oligosaccharide in the reply filed on 09 December 2025, and dry powder in the telephonic response of 17 December 2025 are acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Upon further consideration, the species election requirement of a single sugar has been withdrawn.
Accordingly, claim 48 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, and claims 21-22, 29, and 31-32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Objections
Claim 2 is objected to because of the following informalities: “PHADand” in line 2 should be recited as --- PHAD, and ---. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-7, 10, 12-13, 16-18 and 42 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “monophosphoryl lipid A (MPLA) like” in claim 1 is a relative term which renders the claim indefinite. The term “like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Although the instant Specification discloses on p. 3, lines 5-6 that “MPLA-like compounds refers to any compound with the general structure shown in Figure 1,” said Fig. 1 does not show a general structure. Figure 1 shows a specific compound, namely glucopyranosyl lipid adjuvant (GLA). Although p. 3, lines 6-10 further describes what MPLA-like compounds can be, it is unclear if the Specification is actually limiting to the structure shown in Fig. 1, or if such description is illustrative only and not a definition. Clarification is requested.
Claims 4-7, 10, 12-13, 16-18 and 42 are rejected as they depend from claim 1.
Claims 2 and 3 contain the trademark/trade name PHADTM. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe glucopyranosyl lipid A and, accordingly, the identification/description is indefinite.
Claims 2-3 and 17 recite the limitation "the MPLA-like compound" in line 1 of claims 2-3, and line 2 of claim 17. There is insufficient antecedent basis for this limitation in the claims. Claim 1, from which each claim ultimately depends, recites one or more monophosphoryl lipid A (MPLA) like compounds. It is not clear if the MPLA-like compound of claims 2-3 and 17 refers to some or all of the one or more MPLA-like compounds of claim 1. To obviate this issue, it is suggested for the claims to recite --- the one or more MPLA-like compounds ---.
Claim 18 recites the limitation "the sugar" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claims. Claim 16, from which it depends, does not recite a sugar.
Claim Rejections - 35 USC § 103
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.
Claims 1-7, 12, 16-18 and 42 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, 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]).
As noted by page 4, lines 26-29 of the instant specification, "colloid" refers to any liquid or solid composition comprising multimolecular aggregate microstructures having diameters or lengths on the scale of 1 nm to 10 um. Such microstructures include liposomes and nanoparticles. Thus the nanoparticle of Van Haren meets the limitation of colloidal formulation as instantly claimed.
As noted by p. 10, lns. 8-11, 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 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]).
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]).
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.
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 and 42 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 feature are known in the art. As noted in the current rejections, the teachings of Van Haren render obvious claims 1-7, 12, 16-18 and 42. 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.
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®.
Conclusion
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612