DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is the second Office action on the merits of the claims.
All citations to the Manual of Patent Examining Procedure (MPEP) refer to Revision 01.2024, which was released in November 2024.
Status of the Claims
In the Reply filed 26 February 2026, Applicant amended claims 1, 2, 11, 14, 16, 17, 20-22, 25, 28, and 31. Additionally, Applicant cancelled claim 15 and added one new claim, i.e., claim 32. Claims 1-14 and 16-32 are pending and under consideration.
Status of the Rejections and Objections
The objection to claims 1-14 and 29-31 is withdrawn in view of Applicant’s amendment to claim 1 adding a hyphen between “oil-in” and “water.”
The rejection of claims 1-14 and 16-32 under 35 U.S.C. 112(a) is new and is necessitated by Applicant’s amendments to claims 1, 2, 21, and 32.
The rejection of the claims under 35 U.S.C. 112(b) has been modified in view of Applicant’s recent amendments.
The rejection of claims 7-14, 16-20, and 24-28 under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as unpatentable over Kraus (US 2013/0129786 A1) is withdrawn in view of Applicant’s narrowing amendment to claims 1, 2, and 21 requiring that the filtering “is performed while maintaining a transmembrane pressure of about 1 bar to about 3 bar.”
The rejection of claims 1-31 under 35 U.S.C. 103 as being unpatentable over Kraus (US 2013/0129786 A1) alone or in view of Lidgate (“Sterile filtration of a parenteral emulsion.” Pharmaceutical research 9.7 (1992): 860-863) is withdrawn in view of Applicant’s narrowing amendment to claims 1, 2, and 21 requiring that the filtering “is performed while maintaining a transmembrane pressure of about 1 bar to about 3 bar.”
The rejection of claims 1-14 and 16-32 under 35 U.S.C. 103 as being unpatentable over De Cupere (US 2015/0209278 A1) alone or in view of Kraus (US 2013/0129786 A1) is new and is necessitated by Applicant’s narrowing amendment to claims 1, 2, and 21. The examiner notes the De Cupere is newly cited.
Warning: Duplicate Claims
Applicant is advised again that should claim 1 be found allowable, claim 2 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. MPEP § 608.01(m).
Claim Rejections – 35 U.S.C. 112(a) – Written Description
The following is a quotation of 35 U.S.C. 112(a):
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.
Claims 1-14 and 16-32 are rejected under 35 U.S.C. 112(a) for failing to comply with the written description requirement.
Claims 1, 2, 21 and 32, as recently amended, now contain subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the invention, as now claimed.
Referring to the specification of the present application as originally filed 14 December 2022 (WO 2022/003560), Table 5 — which is located on page 35 and is reproduced below — supports a transmembrane pressure of 1 bar to 3 bar.
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However, Table 5 provides no support for the broadening adverb <about> recited in the italicized segments of the following limitation from claims 1, 2, and 21: “a transmembrane pressure of about 1 bar to about 3 bar.” Emphasis added.
No other relevant disclosure concerning the foregoing range of 1 to 3 bar is included in the specification.
Given that none of Applicant’s claims, as originally filed, compensates for the deficiency in the specification identified above, the present application does not reasonably convey to persons skilled in the art that the inventor, at the time the application was filed, had possession of the transmembrane pressure range of “about 1 bar to about 3 bar” now recited in claims 1, 2, and 21. Thus, each of those three claims recites new matter. 35 U.S.C. 132(a) (“No amendment shall introduce new matter into the disclosure of the invention.”); see also MPEP § 608.04. Accordingly, it is appropriate to reject claim 1, 2, 21, and all claims depending thereon under 35 U.S.C. 112(a).
In further regard to (new) claim 32, in addition to the broadening adverb <about>, the specification of the present application does not support the italicized segment of the following limitation: “wherein the transmembrane pressure is about 1 bar to about 3 bar throughout the membrane filter.” Consequently, claim 32 recites new matter. 35 U.S.C. 132(a) (quoted above); see also MPEP § 608.04. Accordingly, it is appropriate to reject claim 32 under 35 U.S.C. 112(a).
Claim Rejections - 35 U.S.C. 112(b)
The following is a quotation of 35 U.S.C. 112(b):
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.
Claims 11, 14, 17, 20, 25, 28, 31, and 32 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor regards as the invention.
Regarding claims 11, 14, 17, 20, 25 and 28 (as amended), the following trademark or tradename is recited therein: Span 85. 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. The trademark/tradename recited in the identified claims is used to identify or describe a nonionic surfactant and, consequently, causes confusion as to the scope of the claims. Therefore, claims 11, 14, 17, 20, 25, and 28 do not comply with the requirements of 35 U.S.C. 112(b). MPEP § 2173.05(u). Applicant is required to delete the trademark/tradename and, if desired, replace it with generic terminology describing the corresponding nonionic surfactant. The examiner suggests the following generic name: polysorbate 80.
In further regard to claims 25 and 28 (as amended), there is insufficient antecedent basis for the squalene, the polysorbate 80, and the Span 85. Because the mixing step in claim 21 results in formation of the oil-in-water emulsion, there must be a nexus between squalene (claim 25) and the oil introduced in that step. There must also be a nexus between (i) the polysorbate 80 and the Span 85 of claim 25 and (ii) the surfactant and/or the aqueous component of claim 21, as applicable. Stated another way, active (manipulative) steps must explain how the squalene, the polysorbate 80, and the Span 85 became constituents of the oil-in-water emulsion. In other words, active steps must define how those three excipients came to be present in the oil-in-water emulsion.
Regarding claim 31 (as amended), the oil-in-water emulsion and the antigen are admixed, as required by claim 29 and now acknowledged in claim 31. A kit generally requires the presence of two or more discrete components (other than packaging). Claim 31 is still confusing because it recites only one component, i.e., the admixture of the oil-in-water emulsion and the antigen. This ambiguity renders claim 31 indefinite. The examiner recommends cancelling this claim.
Regarding claim 32 (new), it unclear whether this claim even further limits claim 1. Doesn’t claim 1 already implicitly require that the transmembrane pressure is about 1 bar to about 3 bar throughout the membrane filter? How can the same filter have two different transmembrane pressures simultaneously? The specification of the present application provides no guidance on this matter. The examiner recommends cancelling this claim.
Claim Rejections - 35 U.S.C. 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-14 and 16-32 are rejected under 35 U.S.C. 103 as being unpatentable over De Cupere (US 2015/0209278 A1) alone or in view of Kraus (US 2013/0129786 A1).
De Cupere is directed to “improved processes for the production of submicron oil in water emulsions, in particular, filtration of submicron oil in water emulsions.” Para. [0001].
De Cupere discloses: “Oil in water emulsions, particularly submicron oil in water emulsions can be used as immunological adjuvants. Vaccine composition comprising said oil in water emulsions in combination with an antigen, such as an influenza antigens are administered parenterally and thus it is necessary for the oil in water emulsion to be sterile. The present inventors have demonstrated that in order to produce a sterile submicron oil in water emulsion is not sufficient to filter the emulsion through a single sterile grade filter. The inventors have shown that in order to provide a sterile oil in water emulsion it is necessary to prefilter the oil in water emulsion prior to filtration with a sterile grade filter.” Para. [0009]. “Accordingly,” De Cupere continues, “the present invention provides a process for the production of a submicron oil in water emulsion comprising the steps: a. preparing a submicron oil in water emulsion; b. pre-filtering the oil in water emulsion through sterile grade filter; c. filtering an oil in water emulsion filtered according to step b) through a sterile grade filter separate to that of step b).” (Emphasis added) Paras. [0010]-[0013].
De Cupere discloses: “By ‘sterile grade filter’ it is meant a filter that produces a sterile effluent after being challenged by microorganisms at a challenge level of greater than or equal to 1×107/cm2 of effective filtration area. Sterile grade filters are well known to the person skilled in the art of the invention and have a pore size of about 0.2 μm, and thus include filters with a pore size of about 0.22 μm.” Para. [0021].
De Cupere discloses: “In a particular embodiment of the invention, there is provided processes of the invention wherein the differential pressure of each filter is about 1 to about 1.5 bar, for example about 1 bar.” (Emphasis added) Paras. [0030]; see also Table at para. [0051] and claim 8. The foregoing range (about 1 to about 1.5 bar) and/or the foregoing exemplary point (about 1 bar) anticipates the corresponding “transmembrane pressure” range of “about 1 bar to about 3 bar” now recited in claims 1-2, 21, and 32 of the present application. MPEP § 2131.03(I) (a specific example in the prior art that is within a claimed range anticipates the range).
De Cupere discloses: “In a further embodiment, there is provided processes of the invention wherein filtration is performed at a temperature of between about 15° C. and about 30° C., about 16° C. and about 29° C., about 17° C. and about 28° C., about 16° C. and about 27° C., about 16° C. and about 28° C. or 22° C.±4° C.” (Emphasis added) Paras. [0031]; see also claim 9.
Paragraph [0031] of De Cupere does not anticipate the corresponding temperature range of “less than or equal to 10°C” recited in Applicant’s claims 1, 2, and 21. MPEP § 2131.03(III) (“prior art which teaches a value or range that is very close to, but does not overlap or touch, the claimed range does not anticipate the claimed range”). Nevertheless, it is important to recognize that the temperature of “about 15° C” encompasses 13.5° C. De Cupere at para. [0042] (“The term ‘about’ in relation to a numerical value x means x±5% or 10%.”). The latter (13.5° C) is close enough to Applicant’s claimed temperature range to establish prima facie obvious. MPEP § 2144.05(I) (“Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.”). Therefore, claims 1, 2, 4, 7-8, 12-13, 16, 18-19, and 32 are prima facie obvious.
Regarding claims 3 and 5, it is axiomatic that emulsion sterilization via a sterile-grade filter having a pore size of 0.2 or 0.22 μm reduces bioburden and particle size.
Regarding claim 6, the lowest filtration temperature disclosed in De Cupere is 13.5° C, as established above. Applicant is alerted that “[g]enerally, 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.” MPEP § 2144.05(II)(A) (emphasis added). Applicant must show that the claimed range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range. MPEP § 2144.05(II)(A), citing In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990). “‘To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.’” MPEP § 716.02(d)(II), citing In re Hill, 284 F.2d 955 (CCPA 1960).
Regarding claims 9 and 10, Applicant is referred to paragraphs [0036]-[0038] and claims 13-17 of De Cupere.
Regarding claims 11, 14, 17 and 20, Applicant is referred to claim 17 of De Cupere, which discloses that “the submicron oil in water emulsion comprises squalene, polyoxyethylene sorbitan monooleate (TWEEN 80) and sorbitan trioleate (SPAN 85).” The examiner notes TWEEN 80 is also known as polysorbate 80, as evidenced by paragraphs [0036]-[0038] of De Cupere. A person having ordinary skill in the art would have readily recognized that those excipients are the primary constituents of the vaccine adjuvant MF59, which is discussed in paragraph [0002] of De Cupere. The optional reference (Kraus) teaches that MF59 comprises about 5% squalene, about 0.5% polysorbate 80, and about 0.5% sorbitan trioleate. Para. [0118].
Regarding claims 21-24 and 26-27, De Cupere discloses: “Submicron oil in water emulsions can be produced by methods known to the person skilled on the art such as, but not limited to, high pressure homogenisation, for example using a microfluidiser.” (Emphasis added) Para. [0020]. Applicant is additionally referred to paragraphs [0043]-[0045] and [0009] of De Cupere.
Regarding claims 25 and 28, Applicant is referred above to the §103 rejection of claims 11, 14, 17 and 20.
Regarding claims 29-31, paragraph [0009] of De Cupere discloses, in relevant part: “Vaccine composition comprising said oil in water emulsions in combination with an antigen, such as an influenza antigens are administered parenterally.” On the basis of the foregoing disclosure, a person having ordinary skill in the art would have readily inferred that the O/W emulsion and the antigen are mixed together and, thereafter, the resulting mixture (a vaccine) is packaged in a single-dose or multi-dose vial to facilitate administration by injection. MPEP § 2144.01 (“‘[I]n considering the disclosure of a reference, it is proper to take into account not only specific teachings of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom.’”), quoting In re Preda, 401 F.2d 825, 826 (CCPA 1968). In the alternative, paragraphs [0125]-[0126] of the optional reference (Kraus) compensate for any deficiency in De Cupere.
Conclusion
Claims 1-14 and 16-32 are rejected.
No claim is allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER ANTHOPOLOS whose telephone number is 571-270-5989. The examiner can normally be reached on Monday – Friday (9:00 am – 5:00 pm). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany P. Barham, can be reached on Monday – Friday (9:00 am – 5:00 pm) at 571-272-6175. The fax number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.A./
23 May 2026
/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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