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 .
Election/Restrictions
Applicant’s election of Group 1 (compositions, claims 1, 4-6, and 8-15) in the reply filed on 20 March 2026 is 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)).
Claim Status
The amended claim set filed 20 March 2026 is acknowledged. Claims 1, 4-6, 8-15 are currently pending. Of those, claims 1, 6, 8-10, and 13-15 are currently amended, and no claims are new. Claims 2-3, 7, and 16-32 are cancelled. Claims 1, 4-6, and 8-15 will be examined on the merits herein.
Priority
The instant application claims priority to provisional application 63/553,366 (filed 14 Feb 2024). What follows is the examiner’s claim-by-claim analysis of effective filing date for the claims currently under examination. If the applicant disagrees with this examiner’s determination of effective filing date for any claim, the applicant may identify text within the prior applications that provides support the claimed language.
Regarding claims 8-10, the only concentrations listed in the provisional in mg/mL is the specific formulation in Table 2 (pg. 66). The one formulation does not provide support for the range of concentrations claimed because the one formulation is not a representative number of species within the range.
Regarding claims 11-15, the provisional does not support compositions comprising N-(5-(4-(4-((5-amino-7-(butylamino)-2H-pyrazolo[4,3- d]pyrimidin-2-yl)methyl)-3-methoxyphenyl)piperazin-1-yl)-5-oxopentyl)stearamide (Compound B-1). The molecule is not present in the provisional, note that Example 29B of the instant specification is absent from the provisional application.
Claims 1 and 4-6 are not supported because they are broader than the claims that contain unsupported subject matter, so they are not fully supported either. Therefore, all claims were searched using the effective filing date 16 May 2024.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 14 Oct 2024, 4 Dec 2024, and 20 March 2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action.
Warning About Claim Objections
Applicant is advised that should claim 11 be found allowable, claim 12 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. See MPEP § 608.01(m). The claims teach the same five components (S. pneumoniae serotypes conjugated to CRM197, and the four adjuvant ingredients of claim 11). The only difference is that parent claim 4 labels the four ingredients as having an adjuvant function, while claim 12 is silent on the function of the four ingredients. However, the ingredients will have the same adjuvant function whether or not it is explicitly disclosed. See MPEP 2112.01: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.” So, claims 11 and 12 encompass the same subject matter and are substantial duplicates.
Claim Rejections - 35 USC § 112(b)
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 6, and 8-15 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.
Claims 6 and 8-15 each contains the trademark/trade name SPAN™ 85. 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 Sorbitan Trioleate and, accordingly, the identification/description is indefinite.
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Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892).
Regarding claim 1, Abeygunawardan teaches “a multivalent immunogenic composition comprising up to 33 distinct polysaccharide protein conjugates, wherein each of the conjugates comprises a polysaccharide from a S. pneumoniae serotype conjugated to a carrier protein, and wherein the polysaccharide protein conjugates include polysaccharides of a group of S. pneumoniae serotypes selected from the group consisting of: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, 15C, 18C, 19A, 19F, 22F, 23B, 23F, 24F, 33F and 35B, further including one, two, three, four, five, six, seven, eight or nine additional S. pneumoniae serotypes selected from 7C, 9N, 16F, 21, 23A, 31, 34, 35F and 38” [0043]. Abeygunawardan further teaches “de-O-acetylated serotype 15B (DeOAc15B) pneumococcal polysaccharide is substantially equivalent to serotype 15C pneumococcal polysaccharide and has a substantially identical NMR spectra… Thus, in any of the embodiments of the multivalent immunogenic compositions herein, de-O-acetylated serotype 15B (DeOAc15B) can be used in place of serotype 15C.” [0179]. So, Abeygunawardan teaches a immunogenic composition comprising 23 serotypes from the claim, teaches that de-O-acetylated 15B can be used in place of serotype 15C to achieve a 24th serotype from the claim, and teaches that the remaining two serotypes (16F and 23A) may be included in the composition to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of the claimed list. Abeygunawardan also teaches that the preferred carrier protein for the polysaccharide protein conjugates is CRM197 [0001], and further clarifies that each polysaccharide can be conjugated to CRM197 [0192].
Regarding claims 4-5, Abeygunawardan teaches that the composition can further comprise an adjuvant [0195] and that the adjuvant can be APA [0206]. The examples also teach the use of the APA adjuvant with a very similar 24-valent immunogenic composition [0226, 0897, 0920].
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 4-6, and 8-10 are rejected under 35 U.S.C. 103 as being obvious over Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892) in view of Smith et al. (WO-2022169789-A1; hereafter Smith; PTO-892).
The teachings of Abeygunawardan were discussed above and teach all elements of claims 1 and 4-5. Additionally, Abeygunawardan teaches that the known adjuvants that can be used in the immunogenic composition include “oil-in-water emulsion formulations … such as, for example, (a) MF59 (International Patent Application Publication No. WO 90/14837), containing 5% Squalene, 0.5% Tween 80, and 0.5% Span 85 (optionally containing various amounts of MTP-PE) formulated into submicron particles using a microfluidizer” [0197].
Abeygunawardan does not teach the adjuvant comprises polysorbate-20, as in claim 6, and does not teach the concentrations of squalene, polysorbate-20 and SPAN-85 in claims 8-10.
Regarding claims 1 and 4-6, Smith teaches “compositions administered as a vaccine which include pneumococcal conjugates and a stable nanoemulsion (SNE) adjuvant formulation” (pg. 2 ln. 4-5). The “SNE [can] compris[e] sorbitan trioleate (SPAN-85), polysorbate-20 or polysorbate-80, squalene and an optional cationic lipid” (pg. 2 ln. 21-22). “Compared to the performance of 1) a non-adjuvanted pneumococcal conjugate composition; 2) an aluminum phosphate adjuvanted (APA) pneumococcal conjugate composition; or 3) an LNP adjuvanted pneumococcal conjugate composition; the described SNE adjuvant pneumococcal conjugate composition provided an equivalent or increased immunogenic response for the majority of pneumococcal serotypes tested” (pg. 3 ln. 10-14). Smith teaches that the composition can comprise “Streptococcus pneumoniae polysaccharide-carrier protein conjugates wherein the polysaccharides in the conjugates comprise one or more serotypes selected from any known serotype, including, but not limited to serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19A, 19F, 20, 20A, 20B, 22F, 23A, 23B, 23F, 24F, 33F, 35B, 35F, and 38.” (pg. 12 ln. 31 to pg. 13 ln. 3) and de-O-acetylated 15B (pg. 13 ln. 13). Smith teaches CRM197 can be used as the carrier protein (pg. 40 ln. 15-17).
Regarding claims 8-10, Smith teaches a composition comprising “6 μg/mL -24 mg/mL SPAN-85, 6 μg/mL - 24 mg/mL PS-20 or PS-80 and 60 μg/mL - 240 mg/mL of squalene” (pg. 59 ln. 22-24). In one specific example, the composition used has “10 mg/mL of squalene; 1.0 mg/mL of PS-20; 1.0 mg/mL of SPAN-85” (pg. 74 Table 4). The specific example falls within the ranges for claims 8-10. See MPEP 2131.02: “"A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989)”.
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the Abeygunawardan immunogenic composition by using the nanoemulsion adjuvant of Smith, thereby arriving at the claimed invention, because Smith teaches that this adjuvant can be used in similar S. pneumoniae polysaccharide-carrier protein conjugate compositions to provide equivalent or increased immunogenic response for the majority of pneumococcal serotypes tested (Smith pg. 3 ln. 10-14). Therefore, the combination would be desirable because the adjuvant is similar or more effective than the adjuvants suggested in Abeygunawardan, potentially increasing the therapeutic efficacy. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” This modification could have been made with a reasonable expectation of success because Smith and Abeygunawardan both produce immunogenic compositions comprising an adjuvant and S. pneumoniae polysaccharide-carrier protein conjugate compositions, because Smith teaches that the adjuvant can be used with all serotypes disclosed in Abeygunawardan, and because the modification only requires mixing known ingredients so there is no technical barrier to making the product.
Alternately, one of ordinary skill in the art at the time of filing would also consider it prima facie obvious to modify the Smith immunogenic composition by choosing the serotypes disclosed in Abeygunawardan from the larger list of potential serotypes in Smith, because Abeygunawardan teaches that this combination of serotypes is in need of an immunogenic composition to treat pneumococcal disease at the time of filing. This modification could have been made with a reasonable expectation of success because Smith and Abeygunawardan both produce immunogenic compositions comprising an adjuvant and S. pneumoniae polysaccharide-carrier protein conjugate compositions, because Smith teaches that the adjuvant can be used with all serotypes disclosed in Abeygunawardan, and because the modification only requires mixing known ingredients so there is no technical barrier to making the product.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case all elements (i.e. the S. pneumoniae polysaccharide-CRM197 conjugates for each of the serotypes claimed, and the SNE adjuvant comprising SPAN-85, PS-20, and squalene) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1, 4-6, and 8-15 are rejected under 35 U.S.C. 103 as being obvious over Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892) in view of Ahl et al. (US-20240390471-A1, priority to 18 May 2023; hereafter Ahl; PTO-892). The applied reference (Ahl) has a common applicant 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.
The teachings of Abeygunawardan were discussed above and teach all elements of claims 1 and 4-5. Additionally, Abeygunawardan teaches that the known adjuvants that can be used in the immunogenic composition include “oil-in-water emulsion formulations … such as, for example, (a) MF59 (International Patent Application Publication No. WO 90/14837), containing 5% Squalene, 0.5% Tween 80, and 0.5% Span 85 (optionally containing various amounts of MTP-PE) formulated into submicron particles using a microfluidizer” [0197].
Abeygunawardan does not teach the adjuvant comprises polysorbate-20, as in claim 6 and 12, and does not teach the concentrations of squalene, polysorbate-20 and SPAN-85 in claims 8-10 and 13-15. Abeygunawardan also does not teach the adjuvant comprises N-(5-(4-(4-((5-amino-7-(butylamino)-2H-pyrazolo[4,3-d]pyrimidin-2- yl)methyl)-3-methoxyphenyl)piperazin-1-yl)-5-oxopentyl)stearamide (Compound B-1 as defined in the instant specification on pg. 74; the shorter name will be used in this action), as in claims 11-12, or the concentrations in claims 13-15.
Regarding claims 1 and 12, Ahl teaches pneumococcal conjugate vaccines where the antigens are S. pneumoniae polysaccharide-carrier protein conjugates, where the carrier protein is CRM197, and where multiple different formulations of S. pneumoniae serotype polysaccharides can be used [0007, 342].
Regarding claim 4-5, the compositions can have an APA adjuvant [0810].
Regarding claims 6 and 11-12, the compositions can further include SPAN-85, PS-80 or PS-20 and squalene as well as Compound B-1 [0811]. This compound name is defined as “N-(5-(4-(4-((5-amino-7-(butylamino)-2H-pyrazolo[4,3-d]pyrimidin-2-yl)methyl)-3-methoxyphenyl)piperazin-1-yl)-5-oxopentyl)stearamide (Compound B-1);” at [0726]. The specification gives a specific working example of the composition in Table 2, and Example 12 mixes the adjuvant with PCV24 (serotypes-1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, 15C, 18C, 19A, 19F, 22F, 23B, 23F, 24F, 33F and 35B each individually conjugated to CRM197), and found that “the vaccine formulations in [Infant Rhesus Monkeys] were deemed to be safe and well tolerated, and no vaccine-related adverse events were noted” and “PCV24 formulated with Compound B-1-SNE at all dose levels showed significantly higher antibody titers when compared to PCV24 without adjuvant” and “when compared to PCV24 formulated with APA for the majority of serotypes at post-dose 3” [1058, 1060].
Regarding claims 8-10 and 13-15, Ahl teaches vaccine compositions that comprise SPAN-85 at the range of “0.001 mg/mL to 100 mg/mL or 0.01 mg/mL to 50 mg/mL or 0.1 mg/mL to 10 mg/mL” [0169], PS-20 at the range of “0.001 mg/mL to 100 mg/mL or 0.01 mg/mL to 50 mg/mL or 0.1 mg/mL to 10 mg/mL” [0170], squalene at the range of “0.01 mg/mL to 100 mg/mL or 0.02 mg/mL to 20 mg/mL or 1 mg/mL to 20 mg/mL” [0171], and the compound at the range of “0.01 μg/mL to 1000 μg/mL or 0.1 μg/mL to 100 μg/mL or 80 μg/mL or 16 μg/mL or 4 μg/mL” [0168]. Ahl teaches an example composition in Example 12 that has 200 μg/mL Compound B-1 with SNE made of 8 mg/mL squalene, 2 mg/mL PS-20, and 2 mg/mL SPAN-85, or 10-fold dilutions down to 0.2 μg/mL Compound B-1 with SNE made of 0.008 mg/mL squalene, 0.002 mg/mL PS-20, and 0.002 mg/mL SPAN-85.
One of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the immunogenic composition of Abeygunawardan by using the adjuvant of Ahl, thereby arriving at the claimed invention, because Ahl teaches that this adjuvant is equally or more effective than the APA adjuvant taught in Abeygunawardan, while not causing adverse outcomes. Therefore the combination would be desirable because of the increased vaccine efficacy. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” This modification could be performed with a reasonable expectation of success because Ahl teaches that their adjuvant can be used in a pneumococcal vaccine very similar to the one of Abeygunawardan, Abeygunawardan teaches that their vaccine can be used with a similar nanoemulsion adjuvant, and because the modification only requires mixing previously known components using known methods, so there is no technical barrier to producing the composition.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case all elements (i.e. the S. pneumoniae polysaccharide-CRM197 conjugates of Abeygunawardan, the Compound B-1 SNE of Ahl) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1, 4-6, and 8-15 are rejected under 35 U.S.C. 103 as being obvious over Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892) in view of Ahl et al. (WO-2024238731-A1, priority to 18 May 2023; hereafter Ahl2; PTO-892). The applied reference (Ahl2) has a common applicant 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.
The Ahl reference above (US-20240390471-A1) is a 371 of Ahl2. Therefore, the teachings of this reference and the motivation to modify the vaccine of Abeygunawardan is the same as laid out above.
Claims 1, 4-6, and 8-15 are rejected under 35 U.S.C. 103 as being obvious over Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892) in view of Ahl et al. (WO-2024238735-A1, priority to 18 May 2023; hereafter Ahl3; PTO-892). The applied reference (Ahl3) has a common applicant 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 12, Ahl3 teaches pneumococcal conjugate vaccines where the antigens are S. pneumoniae polysaccharide-carrier protein conjugates, where the carrier protein is CRM197, and where multiple different formulations of S. pneumoniae serotype polysaccharides can be used [0534, Examples 12-14, 0567, 0570, 0573].
Regarding claim 4-5, the compositions can have an APA adjuvant [Examples 12-14, Tables 8-10].
Regarding claims 6 and 11-12, the compositions can include SPAN-85, PS-20 and squalene as well as Compound B-1 [0007, Examples 12-14, Tables 8-10]. This compound name is defined as “N-(5-(4-(4-((5-amino-7-(butylamino)-2H-pyrazolo[4,3-d]pyrimidin-2-yl)methyl)-3-methoxyphenyl)piperazin-1-yl)-5-oxopentyl)stearamide (Compound B-1);” at [0007]. Example 12 found that “the vaccine formulations in [Infant Rhesus Monkeys] were deemed to be safe and well tolerated, and no vaccine-related adverse events were noted” and “PCV24 formulated with Compound B-1-SNE at all dose levels showed significantly higher antibody titers when compared to PCV24 without adjuvant … [and] when compared to PCV24 formulated with APA for the majority of serotypes at post-dose 3” [0567-0568].
Regarding claims 8-10 and 13-15, Ahl teaches “a Compound B-1 SNE comprises 0.01 µg/mL to 1000 µg/mL Compound B-1, 0.001 mg/mL to 60 mg/mL SPAN-85, 0.001 mg/mL to 60 mg/mL PS-20 and 0.01 mg/mL to 200 mg/mL squalene. In further embodiments, a Compound B-1 SNE comprises 100 µg/mL or 80 µg/mL Compound B-1, 0.01 mg/mL to 10 mg/mL SPAN-85, 0.01 mg/mL to 10 mg/mL PS-20 and 0.03 mg/mL to 30 mg/mL squalene. In still further embodiments, a Compound B-1 SNE comprises 80 µg/mL or 16 µg/mL or 4 µg/mL or 0.5 µg/mL Compound B-1, 0.2 mg/mL to 10 mg/mL SPAN-85, 0.2 mg/mL to 10 mg/mL PS-20 and 0.5 mg/mL to 20 mg/mL squalene” [0091]. Ahl also teaches specific formulations in Examples 12-14 [Tables 8-10].
The teachings of Ahl3 are the same as the Ahl reference above (US-20240390471-A1). Therefore, the motivation to modify the vaccine of Abeygunawardan is the same as laid out above.
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, 4, 6, and 8-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-38 of copending Application No. 18/665,887 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 1 and 12, ‘887 claims 5, 10, 15, 20, and 28-29 teach an immunogenic composition comprising 26 Streptococcus pneumoniae polysaccharide-carrier protein conjugates, each comprising polysaccharide of a particular Streptococcus pneumoniae serotype conjugated to a carrier protein, wherein the Streptococcus pneumoniae serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B. ‘887 claims 32-34 teach that the carrier protein can be CRM197.
Regarding claims 4, 6, and 12, ‘887 claims 23 and 35 teach the composition can comprise SPAN-85, PS-20, and squalene.
Regarding claims 8-10, ‘887 claim 35 teaches the concentration of SPAN-85 is 0.01 mg/mL to 50 mg/mL, the concentration of PS-20 is 0.01 mg/mL to 50 mg/mL, and the concentration of squalene is 0.02 mg/mL to 20 mg/mL. See MPEP 2144.05: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” The disclosed ranges lie inside or overlap with the claimed ranges.
Regarding claims 11-12, ‘887 claims 1 (and dependent claims) teach the composition can further comprise N-(5-(4-(4-((5-amino-7-(butylamino)-2H-pyrazolo[4,3-d]pyrimidin-2-yl)methyl)-3-methoxyphenyl)piperazin-1-yl)-5-oxopentyl)stearamide, see for example claim 21-22, 24 that specifically disclose this species.
Regarding claims 13-15, ‘887 claim 35 teaches the concentration of compound is 0.1 µg/mL to 100 µg/mL, the concentration of SPAN-85 is 0.01 mg/mL to 50 mg/mL, the concentration of PS-20 or PS-80 is 0.01 mg/mL to 50 mg/mL, and the concentration of squalene is 0.02 mg/mL to 20 mg/mL. The concentration ranges are the same as, or narrower species within, the ranges disclosed for claims 13-14. See MPEP 2144.05: “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 233, 235 (CCPA 1955).” There is no evidence of record that the specific concentrations/ranges in instant claim 15 are critical, so it would require only routine experimentation to determine that the claimed ranges/ concentrations are workable when the broader range is disclosed in the ‘887 claims.
Claims 1, 4-6, and 8-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-27 of copending Application No. 19/484,065 in view of Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892). This is a provisional nonstatutory double patenting rejection.
‘065 claims 1 (and dependent claims) teach the compound N-(5-(4-(4-((5-amino-7-(butylamino)-2H-pyrazolo[4,3-d]pyrimidin-2-yl)methyl)-3-methoxyphenyl)piperazin-1-yl)-5-oxopentyl)stearamide, see for example claims 9-10, 13, 16, 19, 22, and 25 that specifically disclose this species. Claims 15, 17-18, 20-21, and 24 (and dependent claims) teach that the molecule can be used in a pharmaceutical/ immunogenic/ vaccine composition with at least one antigen, (iii) sorbitan trioleate (SPAN-85); (iv) polysorbate-20 (PS-20); (v) squalene; and (vi) a pharmaceutically acceptable carrier. Regarding the recitation of “adjuvant” function in instant claim 4, the ingredients will have the same adjuvant function whether or not it is explicitly disclosed. See MPEP 2112.01: “"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.”
The claims of ‘065 do not teach that the at least one antigen is “S. pneumoniae polysaccharide carrier protein conjugates, wherein each of the conjugates comprises a polysaccharide of a particular S. pneumoniae serotype conjugated to a carrier protein, wherein the S. pneumoniae serotypes consist of 1, 3,4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, and wherein the carrier protein is CRM197”, as in claim 1.
Regarding claim 1, Abeygunawardan teaches “a multivalent immunogenic composition comprising up to 33 distinct polysaccharide protein conjugates, wherein each of the conjugates comprises a polysaccharide from a S. pneumoniae serotype conjugated to a carrier protein, and wherein the polysaccharide protein conjugates include polysaccharides of a group of S. pneumoniae serotypes selected from the group consisting of: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, 15C, 18C, 19A, 19F, 22F, 23B, 23F, 24F, 33F and 35B, further including one, two, three, four, five, six, seven, eight or nine additional S. pneumoniae serotypes selected from 7C, 9N, 16F, 21, 23A, 31, 34, 35F and 38” [0043]. Abeygunawardan further teaches “de-O-acetylated serotype 15B (DeOAc15B) pneumococcal polysaccharide is substantially equivalent to serotype 15C pneumococcal polysaccharide and has a substantially identical NMR spectra… Thus, in any of the embodiments of the multivalent immunogenic compositions herein, de-O-acetylated serotype 15B (DeOAc15B) can be used in place of serotype 15C.” [0179]. So, Abeygunawardan teaches a immunogenic composition comprising 23 serotypes from the claim, teaches that de-O-acetylated 15B can be used in place of serotype 15C to achieve a 24th serotype from the claim, and teaches that the remaining two serotypes (16F and 23A) may be included in the composition to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of the claimed list. Abeygunawardan also teaches that the preferred carrier protein for the polysaccharide protein conjugates is CRM197 [0001], and further clarifies that each polysaccharide can be conjugated to CRM197 [0192].
Regarding claims 4-5, Abeygunawardan teaches that the composition can further comprise an adjuvant [0195] and that the adjuvant can be APA [0206]. The examples also teach the use of the APA adjuvant with a very similar 24-valent immunogenic composition [0226, 0897, 0920].
Regarding claims 6, 8-15, Abeygunawardan teaches that the known adjuvants that can be used in the immunogenic composition include “oil-in-water emulsion formulations … such as, for example, (a) MF59 (International Patent Application Publication No. WO 90/14837), containing 5% Squalene, 0.5% Tween 80, and 0.5% Span 85 (optionally containing various amounts of MTP-PE) formulated into submicron particles using a microfluidizer” [0197].
One of ordinary skill in the art at the time of filing would also consider it prima facie obvious to modify the immunogenic/ vaccine composition from the claims of ‘065 by choosing the serotypes disclosed in Abeygunawardan from the larger genus of potential antigens in the claims of ‘065, because Abeygunawardan teaches that this combination of serotypes is in need of an immunogenic composition to treat pneumococcal disease at the time of filing. This modification could have been made with a reasonable expectation of success because ‘065 and Abeygunawardan both produce vaccine compositions, Abeygunawardan teaches that similar adjuvants comprising oil-in-water emulsions can be used in the composition, and because the modification only requires mixing known ingredients so there is no technical barrier to making the product.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case all elements (i.e. the S. pneumoniae polysaccharide-CRM197 conjugates of Abeygunawardan, the Compound B-1 SNE of the claims of ‘065) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1, 4-6, and 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 11,491,216 in view of Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892), optionally further in view of Smith et al. (WO-2022169789-A1; hereafter Smith; PTO-892), optionally further in view of Ahl et al. (US-20240390471-A1, priority to 18 May 2023; hereafter Ahl; PTO-892).
Regarding claim 1, ‘216 claims 1 and 17 teaches a polysaccharide-carrier protein conjugate, wherein the polysaccharide has an S. pneumoniae serotype 23B polysaccharide and wherein the carrier protein is CRM197.
The claims of ‘216 do not teach combining this conjugate in a 26-valent immunogenic composition with S. pneumoniae polysaccharide carrier protein conjugates, wherein each of the conjugates comprises a polysaccharide of a particular S. pneumoniae serotype conjugated to a carrier protein, wherein the S. pneumoniae serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B and wherein the carrier protein is CRM197, as in claim 1. The claims of ‘216 do not teach the adjuvant and concentrations of claims 4-6 and 8-15.
Regarding claim 1, Abeygunawardan teaches “a multivalent immunogenic composition comprising up to 33 distinct polysaccharide protein conjugates, wherein each of the conjugates comprises a polysaccharide from a S. pneumoniae serotype conjugated to a carrier protein, and wherein the polysaccharide protein conjugates include polysaccharides of a group of S. pneumoniae serotypes selected from the group consisting of: 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, 15C, 18C, 19A, 19F, 22F, 23B, 23F, 24F, 33F and 35B, further including one, two, three, four, five, six, seven, eight or nine additional S. pneumoniae serotypes selected from 7C, 9N, 16F, 21, 23A, 31, 34, 35F and 38” [0043]. Abeygunawardan further teaches “de-O-acetylated serotype 15B (DeOAc15B) pneumococcal polysaccharide is substantially equivalent to serotype 15C pneumococcal polysaccharide and has a substantially identical NMR spectra… Thus, in any of the embodiments of the multivalent immunogenic compositions herein, de-O-acetylated serotype 15B (DeOAc15B) can be used in place of serotype 15C.” [0179]. So, Abeygunawardan teaches a immunogenic composition comprising 23 serotypes from the claim, teaches that de-O-acetylated 15B can be used in place of serotype 15C to achieve a 24th serotype from the claim, and teaches that the remaining two serotypes (16F and 23A) may be included in the composition to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of the claimed list. Abeygunawardan also teaches that the preferred carrier protein for the polysaccharide protein conjugates is CRM197 [0001], and further clarifies that each polysaccharide can be conjugated to CRM197 [0192].
Regarding claims 4-5, Abeygunawardan teaches that the composition can further comprise an adjuvant [0195] and that the adjuvant can be APA [0206]. The examples also teach the use of the APA adjuvant with a very similar 24-valent immunogenic composition [0226, 0897, 0920]. Abeygunawardan teaches that the known adjuvants that can be used in the immunogenic composition include “oil-in-water emulsion formulations … such as, for example, (a) MF59 (International Patent Application Publication No. WO 90/14837), containing 5% Squalene, 0.5% Tween 80, and 0.5% Span 85 (optionally containing various amounts of MTP-PE) formulated into submicron particles using a microfluidizer” [0197].
One of ordinary skill in the art at the time of filing would also consider it prima facie obvious to modify the ‘216 glycoconjugate by using it in the vaccine disclosed in Abeygunawardan, thereby arriving at the invention of claims 1 and 4-5, because Abeygunawardan teaches that this combination of serotypes is in need of an immunogenic composition to treat pneumococcal disease at the time of filing. This modification could have been made with a reasonable expectation of success because Abeygunawardan teaches how to use the same 23B-CRM197 conjugate and because the modification only requires mixing known ingredients so there is no technical barrier to making the product. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case all elements (i.e. the S. pneumoniae polysaccharide-CRM197 conjugates for each of the serotypes claimed) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the invention of claims 1 and 4-5 is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Regarding claims 1 and 4-6, Smith teaches “compositions administered as a vaccine which include pneumococcal conjugates and a stable nanoemulsion (SNE) adjuvant formulation” (pg. 2 ln. 4-5). The “SNE [can] compris[e] sorbitan trioleate (SPAN-85), polysorbate-20 or polysorbate-80, squalene and an optional cationic lipid” (pg. 2 ln. 21-22). “Compared to the performance of 1) a non-adjuvanted pneumococcal conjugate composition; 2) an aluminum phosphate adjuvanted (APA) pneumococcal conjugate composition; or 3) an LNP adjuvanted pneumococcal conjugate composition; the described SNE adjuvant pneumococcal conjugate composition provided an equivalent or increased immunogenic response for the majority of pneumococcal serotypes tested” (pg. 3 ln. 10-14). Smith teaches that the composition can comprise “Streptococcus pneumoniae polysaccharide-carrier protein conjugates wherein the polysaccharides in the conjugates comprise one or more serotypes selected from any known serotype, including, but not limited to serotypes 1, 2, 3, 4, 5, 6A, 6B, 6C, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19A, 19F, 20, 20A, 20B, 22F, 23A, 23B, 23F, 24F, 33F, 35B, 35F, and 38.” (pg. 12 ln. 31 to pg. 13 ln. 3) and de-O-acetylated 15B (pg. 13 ln. 13). Smith teaches CRM197 can be used as the carrier protein (pg. 40 ln. 15-17).
Regarding claims 8-10, Smith teaches a composition comprising “6 μg/mL -24 mg/mL SPAN-85, 6 μg/mL - 24 mg/mL PS-20 or PS-80 and 60 μg/mL - 240 mg/mL of squalene” (pg. 59 ln. 22-24). In one specific example, the composition used has “10 mg/mL of squalene; 1.0 mg/mL of PS-20; 1.0 mg/mL of SPAN-85” (pg. 74 Table 4). The specific example falls within the ranges for claims 8-10. See MPEP 2131.02: “"A generic claim cannot be allowed to an applicant if the prior art discloses a species falling within the claimed genus." The species in that case will anticipate the genus. In re Slayter, 276 F.2d 408, 411, 125 USPQ 345, 347 (CCPA 1960); In re Gosteli, 872 F.2d 1008, 10 USPQ2d 1614 (Fed. Cir. 1989)”.
Additionally, one of ordinary skill in the art at the time of filing would consider it prima facie obvious to improve the ‘216 and Abeygunawardan immunogenic composition by using the nanoemulsion adjuvant of Smith, thereby arriving at the invention of claims 1, 4-6, and 8-10, because Smith teaches that this adjuvant can be used in similar S. pneumoniae polysaccharide-carrier protein conjugate compositions to provide equivalent or increased immunogenic response for the majority of pneumococcal serotypes tested (Smith pg. 3 ln. 10-14). Therefore, the combination would be desirable because the adjuvant is similar or more effective than the adjuvants suggested in Abeygunawardan, potentially increasing the therapeutic efficacy. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” This modification could have been made with a reasonable expectation of success because Smith and Abeygunawardan both produce immunogenic compositions comprising an adjuvant and S. pneumoniae polysaccharide-carrier protein conjugate compositions, because Smith teaches that the adjuvant can be used with all serotypes disclosed in Abeygunawardan and ‘216, and because the modification only requires mixing known ingredients so there is no technical barrier to making the product. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case all elements (i.e. the S. pneumoniae polysaccharide-CRM197 conjugates for each of the serotypes claimed, and the SNE adjuvant comprising SPAN-85, PS-20, and squalene) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the invention of claims 1, 4-6, and 8-10 is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Regarding claims 1 and 12, Ahl teaches pneumococcal conjugate vaccines where the antigens are S. pneumoniae polysaccharide-carrier protein conjugates, where the carrier protein is CRM197, and where multiple different formulations of S. pneumoniae serotype polysaccharides can be used [0007, 342].
Regarding claim 4-5, the compositions can have an APA adjuvant [0810].
Regarding claims 6 and 11-12, the compositions can further include SPAN-85, PS-80 or PS-20 and squalene as well as Compound B-1 [0811]. This compound name is defined as “N-(5-(4-(4-((5-amino-7-(butylamino)-2H-pyrazolo[4,3-d]pyrimidin-2-yl)methyl)-3-methoxyphenyl)piperazin-1-yl)-5-oxopentyl)stearamide (Compound B-1);” at [0726]. The specification gives a specific working example of the composition in Table 2, and Example 12 mixes the adjuvant with PCV24 (serotypes-1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, 15C, 18C, 19A, 19F, 22F, 23B, 23F, 24F, 33F and 35B each individually conjugated to CRM197), and found that “the vaccine formulations in [Infant Rhesus Monkeys] were deemed to be safe and well tolerated, and no vaccine-related adverse events were noted” and “PCV24 formulated with Compound B-1-SNE at all dose levels showed significantly higher antibody titers when compared to PCV24 without adjuvant” and “when compared to PCV24 formulated with APA for the majority of serotypes at post-dose 3” [1058, 1060].
Regarding claims 8-10 and 13-15, Ahl teaches vaccine compositions that comprise SPAN-85 at the range of “0.001 mg/mL to 100 mg/mL or 0.01 mg/mL to 50 mg/mL or 0.1 mg/mL to 10 mg/mL” [0169], PS-20 at the range of “0.001 mg/mL to 100 mg/mL or 0.01 mg/mL to 50 mg/mL or 0.1 mg/mL to 10 mg/mL” [0170], squalene at the range of “0.01 mg/mL to 100 mg/mL or 0.02 mg/mL to 20 mg/mL or 1 mg/mL to 20 mg/mL” [0171], and the compound at the range of “0.01 μg/mL to 1000 μg/mL or 0.1 μg/mL to 100 μg/mL or 80 μg/mL or 16 μg/mL or 4 μg/mL” [0168]. Ahl teaches an example composition in Example 12 that has 200 μg/mL Compound B-1 with SNE made of 8 mg/mL squalene, 2 mg/mL PS-20, and 2 mg/mL SPAN-85, or 10-fold dilutions down to 0.2 μg/mL Compound B-1 with SNE made of 0.008 mg/mL squalene, 0.002 mg/mL PS-20, and 0.002 mg/mL SPAN-85.
As an alternative to the modification taught by Smith, one of ordinary skill in the art at the time of filing would consider it prima facie obvious to modify the immunogenic composition of Abeygunawardan and ‘216 by using the adjuvant of Ahl, thereby arriving at the invention of claims 1, 4-6, and 8-15, because Ahl teaches that this adjuvant is equally or more effective than the APA adjuvant taught in Abeygunawardan, while not causing adverse outcomes. Therefore the combination would be desirable because of the increased vaccine efficacy. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.” This modification could be performed with a reasonable expectation of success because Ahl teaches that their adjuvant can be used in a pneumococcal vaccine very similar to the one of Abeygunawardan and ‘216, Abeygunawardan teaches that their vaccine can be used with a similar nanoemulsion adjuvant, and because the modification only requires mixing previously known components using known methods, so there is no technical barrier to producing the composition. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case all elements (i.e. the S. pneumoniae polysaccharide-CRM197 conjugates of Abeygunawardan and ‘216, the Compound B-1 SNE of Ahl) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the invention of claims 1, 4-6, and 8-15 is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 1, 4-6, and 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 26-28, 31, 33 and 36 of U.S. Patent No. 11,524,076 in view of Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892), optionally further in view of Smith et al. (WO-2022169789-A1; hereafter Smith; PTO-892), optionally further in view of Ahl et al. (US-20240390471-A1, priority to 18 May 2023; hereafter Ahl; PTO-892).
Regarding claim 1, ‘076 claims 21 and 33 teach an immunogenic composition comprising one or more polysaccharide-carrier protein conjugates, wherein each of the conjugates comprises a polysaccharide of a particular S. pneumoniae serotype conjugated to CRM197, and wherein the S. pneumoniae serotypes are selected from the group consisting of: 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7B, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 17F, 18C, 19A, 19F, 20, 21, 22A, 22F, 23A, 23B, 23F, 24F, 27, 28A, 31, 33F, 34, 35A, 35B, 35F, and 38.
Regarding claim 4-5, ‘076 claims 26-28, 31, and 36 teach that the composition can further comprise an aluminum phosphate adjuvant.
The claims of ‘076 do not teach choosing the with S. pneumoniae polysaccharides to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, as in claim 1. The claims of ‘076 do not teach the adjuvant and concentrations of claims 6 and 8-15. The teachings of Abeygunawardan, Smith, and Ahl were laid out above for the rejection of ‘216. One of ordinary skill in the art would have considered it prima facie obvious to use the polysaccharides/compositions of ‘076 in the vaccine disclosed in Abeygunawardan, and to use the adjuvants of Smith and/or Ahl for the same reasoning laid out above for the rejection of ‘216.
Claims 1, 4-6, and 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 7-9 of U.S. Patent No. 11,759,510 in view of Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892), optionally further in view of Smith et al. (WO-2022169789-A1; hereafter Smith; PTO-892), optionally further in view of Ahl et al. (US-20240390471-A1, priority to 18 May 2023; hereafter Ahl; PTO-892).
Regarding claim 1, ‘510 claim 2 teaches an immunogenic composition comprising one or more polysaccharide-carrier protein conjugates, wherein each of the conjugates comprises a polysaccharide of a particular S. pneumoniae serotype conjugated to CRM197, and wherein the S. pneumoniae serotypes are selected from the group consisting of: 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7B, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 17F, 18C, 19A, 19F, 20, 21, 22A, 22F, 23A, 23B, 23F, 24F, 27, 28A, 31, 33F, 34, 35A, 35B, 35F, and 38.
Regarding claim 4-5, ‘510 claims 7-9 teach that the composition can further comprise an aluminum phosphate adjuvant.
The claims of ‘510 do not teach choosing the with S. pneumoniae polysaccharides to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, as in claim 1. The claims of ‘510 do not teach the adjuvant and concentrations of claims 6 and 8-15. The teachings of Abeygunawardan, Smith, and Ahl were laid out above for the rejection of ‘216. One of ordinary skill in the art would have considered it prima facie obvious to use the polysaccharides/compositions of ‘510 in the vaccine disclosed in Abeygunawardan, and to use the adjuvants of Smith and/or Ahl for the same reasoning laid out above for the rejection of ‘216.
Claims 1, 4-6, and 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 7-9, and 21 of U.S. Patent No. 11,759,511 in view of Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892), optionally further in view of Smith et al. (WO-2022169789-A1; hereafter Smith; PTO-892), optionally further in view of Ahl et al. (US-20240390471-A1, priority to 18 May 2023; hereafter Ahl; PTO-892).
Regarding claim 1, ‘511 claim 2 teaches an immunogenic composition comprising one or more polysaccharide-carrier protein conjugates, wherein each of the conjugates comprises a polysaccharide of a particular S. pneumoniae serotype conjugated to CRM197, and wherein the S. pneumoniae serotypes are selected from the group consisting of: 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7B, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 17F, 18C, 19A, 19F, 20, 21, 22A, 22F, 23A, 23B, 23F, 24F, 27, 28A, 31, 33F, 34, 35A, 35B, 35F, and 38.
Regarding claim 4-5, ‘511 claims 7-9 and 21 teach that the composition can further comprise an aluminum phosphate adjuvant.
The claims of ‘511 do not teach choosing the with S. pneumoniae polysaccharides to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, as in claim 1. The claims of ‘511 do not teach the adjuvant and concentrations of claims 6 and 8-15. The teachings of Abeygunawardan, Smith, and Ahl were laid out above for the rejection of ‘216. One of ordinary skill in the art would have considered it prima facie obvious to use the polysaccharides/compositions of ‘511 in the vaccine disclosed in Abeygunawardan, and to use the adjuvants of Smith and/or Ahl for the same reasoning laid out above for the rejection of ‘216.
Claims 1, 4-6, and 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 7-9 of U.S. Patent No. 11,759,523 in view of Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892), optionally further in view of Smith et al. (WO-2022169789-A1; hereafter Smith; PTO-892), optionally further in view of Ahl et al. (US-20240390471-A1, priority to 18 May 2023; hereafter Ahl; PTO-892).
Regarding claim 1, ‘523 claim 2 teaches an immunogenic composition comprising one or more polysaccharide-carrier protein conjugates, wherein each of the conjugates comprises a polysaccharide of a particular S. pneumoniae serotype conjugated to CRM197, and wherein the S. pneumoniae serotypes are selected from the group consisting of: 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7B, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 17F, 18C, 19A, 19F, 20, 21, 22A, 22F, 23A, 23B, 23F, 24F, 27, 28A, 31, 33F, 34, 35A, 35B, 35F, and 38.
Regarding claim 4-5, ‘523 claims 7-9 teach that the composition can further comprise an aluminum phosphate adjuvant.
The claims of ‘523 do not teach choosing the with S. pneumoniae polysaccharides to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, as in claim 1. The claims of ‘523 do not teach the adjuvant and concentrations of claims 6 and 8-15. The teachings of Abeygunawardan, Smith, and Ahl were laid out above for the rejection of ‘216. One of ordinary skill in the art would have considered it prima facie obvious to use the polysaccharides/compositions of ‘523 in the vaccine disclosed in Abeygunawardan, and to use the adjuvants of Smith and/or Ahl for the same reasoning laid out above for the rejection of ‘216.
Claims 1, 4-6, and 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 7-9, and 21 of U.S. Patent No. 11,964,023 in view of Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892), optionally further in view of Smith et al. (WO-2022169789-A1; hereafter Smith; PTO-892), optionally further in view of Ahl et al. (US-20240390471-A1, priority to 18 May 2023; hereafter Ahl; PTO-892).
Regarding claim 1, ‘023 claim 2 teaches an immunogenic composition comprising one or more polysaccharide-carrier protein conjugates, wherein each of the conjugates comprises a polysaccharide of a particular S. pneumoniae serotype conjugated to CRM197, and wherein the S. pneumoniae serotypes are selected from the group consisting of: 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7B, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 17F, 18C, 19A, 19F, 20, 21, 22A, 22F, 23A, 23B, 23F, 24F, 27, 28A, 31, 33F, 34, 35A, 35B, 35F, and 38.
Regarding claim 4-5, ‘023 claims 7-9 and 21 teach that the composition can further comprise an aluminum phosphate adjuvant.
The claims of ‘023 do not teach choosing the with S. pneumoniae polysaccharides to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, as in claim 1. The claims of ‘023 do not teach the adjuvant and concentrations of claims 6 and 8-15. The teachings of Abeygunawardan, Smith, and Ahl were laid out above for the rejection of ‘216. One of ordinary skill in the art would have considered it prima facie obvious to use the polysaccharides/compositions of ‘023 in the vaccine disclosed in Abeygunawardan, and to use the adjuvants of Smith and/or Ahl for the same reasoning laid out above for the rejection of ‘216.
Claims 1, 4-6, and 8-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 12,280,107 in view of Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892), optionally further in view of Smith et al. (WO-2022169789-A1; hereafter Smith; PTO-892), optionally further in view of Ahl et al. (US-20240390471-A1, priority to 18 May 2023; hereafter Ahl; PTO-892).
Regarding claim 1, ‘107 claims 1-2 teaches an immunogenic composition comprising one or more polysaccharide-carrier protein conjugates, wherein each of the conjugates comprises a polysaccharide of a particular S. pneumoniae serotype conjugated to CRM197, and wherein the formulation comprises S. pneumoniae serotypes 6A, 6B, 7F, 19A, 19F and 23F.
Regarding claim 4-5, ‘107 claims 1-2 teach that the composition can further comprise an aluminum salt.
The claims of ‘107 do not teach choosing the with S. pneumoniae polysaccharides to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, as in claim 1. The claims of ‘107 do not teach the adjuvant and concentrations of claims 4-6 and 8-15. The teachings of Abeygunawardan, Smith, and Ahl were laid out above for the rejection of ‘216. One of ordinary skill in the art would have considered it prima facie obvious to use the polysaccharides/compositions of ‘023 in the vaccine disclosed in Abeygunawardan, and to use the adjuvants of Smith and/or Ahl for the same reasoning laid out above for the rejection of ‘216.
Claims 1, 4-6, and 8-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29, 31-32, and 36-37 of copending Application No. 18/263,277 in view of Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892), optionally further in view of Smith et al. (WO-2022169789-A1; hereafter Smith; PTO-892), optionally further in view of Ahl et al. (US-20240390471-A1, priority to 18 May 2023; hereafter Ahl; PTO-892). This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, ‘277 claims 29 (and dependent claims) teach a composition comprising at least one S. pneumoniae polysaccharide conjugated to a carrier protein. ‘277 claim 31 teaches the polysaccharide is CRM197. ‘277 claim 32 teaches that the S. pneumoniae serotypes are selected from the group 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, de-O-acetylated-15B, 15C, 16F, 17F, 18C, 19A, 19F, 20A, 22F, 23A, 23B, 23F, 24F, 31, 33F and 35B.
The claims of ‘076 do not teach choosing the with S. pneumoniae polysaccharides to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, as in claim 1. The claims of ‘076 do not teach the adjuvant and concentrations of claims 4-6 and 8-15. The teachings of Abeygunawardan, Smith, and Ahl were laid out above for the rejection of ‘216. One of ordinary skill in the art would have considered it prima facie obvious to use the polysaccharides/compositions of ‘076 in the vaccine disclosed in Abeygunawardan, and to use the adjuvants of Smith and/or Ahl for the same reasoning laid out above for the rejection of ‘216.
Claims 1, 4, 6, and 8-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-60 of copending Application No. 18/263,289 in view of Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892), optionally further in view of Ahl et al. (US-20240390471-A1, priority to 18 May 2023; hereafter Ahl; PTO-892). This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, ‘289 claims 23 (and dependent claims), 29 (and dependent claims), 32 (and dependent claims), 39 (and dependent claims), 48 (and dependent claims), 51 (and dependent claims), 54 (and dependent claims) teach a composition comprising at least one S. pneumoniae polysaccharide. ‘289 claim 24, 29, 32, 40, 48, 51, 54 teaches the polysaccharide is conjugated to a carrier protein, and ‘289 claim 25, 29, 32, 41, 48, 51, 54 teaches the polysaccharide is CRM197. ‘289 claim 26, 32, 45, 48, 51, 54 teaches that the at least one S. pneumoniae serotypes are selected from groups that include 1, 3, 4, 5, 6A, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, de-O-acetylated-15B, 15C, 16F, 17F, 18C, 19A, 19F, 20A, 22F, 23A, 23B, 23F, 24F, 31, 33F and 35B.
Regarding claims 4 and 6, ‘289 claim 23, 29, 32, 39, 48, 51, 54 teaches that the composition comprises SPAN-85, PS-20, and squalene.
Regarding claims 8-10, ‘289 claims 27-28, 30-31, 33, 36, 46-47, 49-50, 52-53, 55, 58 teach the SPAN-85 concentration is 6 pg/mL - 2.4 mg/mL, the PS-20 concentration is 6 pg/mL - 2.4 mg/mL, and the squalene concentration is 60 pg/mL - 24 mg/mL. See MPEP 2144.05: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).” The disclosed ranges overlap with the claimed ranges.
The claims of ‘289 do not teach choosing the with S. pneumoniae polysaccharides to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, as in claim 1. The claims of ‘076 do not teach the adjuvant and concentrations of claims 11-15. The teachings of Abeygunawardan and Ahl were laid out above for the rejection of ‘216. One of ordinary skill in the art would have considered it prima facie obvious to use the polysaccharides/compositions of ‘076 in the vaccine disclosed in Abeygunawardan, and to use the adjuvants of Ahl for the same reasoning laid out above for the rejection of ‘216.
Claims 1, 4-6, and 8-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of copending Application No. 19/293,773 in view of Abeygunawardan et al. (US-20200197503-A1; hereafter Abeygunawardan; PTO-892), optionally further in view of Smith et al. (WO-2022169789-A1; hereafter Smith; PTO-892), optionally further in view of Ahl et al. (US-20240390471-A1, priority to 18 May 2023; hereafter Ahl; PTO-892). This is a provisional nonstatutory double patenting rejection.
Regarding claim 1, ‘076 claims 1 (and dependent claims) teach an immunogenic composition comprising S. pneumoniae capsular polysaccharides. ‘076 claims 10-12 teach the S. pneumoniae serotypes comprise 3, 6B, 14, and 23F.
Regarding claim 4-5, ‘076 claim 1 teaches an adjuvant. ‘076 claim 8 teaches an aluminum adjuvant, and ‘076 claim 9 teaches aluminum phosphate.
Regarding claim 6, ‘076 claim 18 teaches the composition can comprise PS20.
The claims of ‘076 do not teach choosing the with S. pneumoniae polysaccharides to result in a 26-valent immunogenic composition wherein the S. pneumoniae serotypes consist of 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, de-O-acetylated 15B, 16F, 18C, 19A, 19F, 22F, 23A, 23B, 23F, 24F, 33F and 35B, as in claim 1. The claims of ‘076 do not teach the adjuvant and concentrations of claims 6 and 8-15. The teachings of Abeygunawardan, Smith, and Ahl were laid out above for the rejection of ‘216. One of ordinary skill in the art would have considered it prima facie obvious to use the polysaccharides/compositions of ‘076 in the vaccine disclosed in Abeygunawardan, and to use the adjuvants of Smith and/or Ahl for the same reasoning laid out above for the rejection of ‘216.
Conclusion
No claims are allowed.
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/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/SAMIRA J JEAN-LOUIS/Supervisory Patent Examiner, Art Unit 1642
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