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 .
Claim Status
The amended claim set filed on 27 April 2023 is acknowledged. Claims 1-12 are currently pending. Of those, claims 3-7 and 10-12 are amended. There are no new claims and no claims are withdrawn. Claims 1-12 will be examined on the merits herein.
Priority
The instant application is a 371 of PCT/IB2021/060097 (filed 1 November 2021) which claims benefit of U.S. Provisional Application 63/109,423 (filed 4 November 2020). Therefore, the effective filing date of instant claims 1-12 is 4 November 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 20 July 2023, 26 March 2024, and 27 March 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, each information disclosure statement is being considered by the examiner.
Claim Objections
Claim 8 is objected to because of the following informalities: in line 6, “serotypes 15A” should read “serotype 15A”. Appropriate correction is required.
Claim Interpretation
With respect to the clause, “wherein said compositions are for concurrent, concomitant or sequential administration”, recited in claims 1-2, according to MPEP 2111.04: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” In the instant case, the “wherein” clause recited in claims 1-2 does not limit the structure of the recited compositions because neither the claims nor the specification identify a structural component of any of the immunogenic compositions that allows them to be administered concurrently, concomitantly, or sequentially with another immunogenic composition; therefore, the clause is interpreted as reciting an intended use for the claimed compositions and any reference teaching the structure of the claimed composition is assumed to be capable of the recited intended use, unless the reference specifically teaches away from the recited use.
Claim 12 recites, “A kit comprising the set of immunogenic compositions of claim 1 and an information leaflet.” The only difference in the scope of claims 1 and 12 is the limitation “an information leaflet”. The recited information leaflet is considered printed matter, which, in the instant case, does not have a functional relationship with the recited immunogenic compositions. MPEP 2111.05(I)(B) states: “…where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864.” Therefore, the element of “an information leaflet” is not given patentable weight. See MPEP 2111.05.
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 8-11 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.
Claim 8 recites the limitation, “for use in a method of complementing a pneumococcal conjugate vaccine which comprises a glycoconjugate from S. pneumoniae serotype 15B but which does not comprise glycoconjugates from S. pneumoniae serotypes 15A.” This limitation suggests a method is claimed, particularly because dependent claims 9-11 refer to a “use of claim 8”, but the other limitations of claim 8 and dependent claims 9-11 recite limitations to the structure of a product. The claim is indefinite because it is unclear whether the claim is intended to be drawn to a product or a method. Furthermore, the claim is indefinite because it merely recites a use of the claimed product without any active, positive steps describing how the use is actually practiced. See MPEP 2173.05(q) and Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). In the interest of compact prosecution and for the purposes of searching the prior art, claim 8 has been interpreted to recite an immunogenic composition having the intended use of “complementing a pneumococcal conjugate vaccine which comprises a glycoconjugate from S. pneumoniae serotype 15B but which does not comprise glycoconjugates from S. pneumoniae serotypes 15A”, and any reference teaching the structure of the claimed product is assumed to be capable of the recited intended use, unless the reference specifically teaches away from the recited use. Clarification is requested.
Claim Rejections - 35 USC § 102
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)(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 8-11 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Anderson et al. (WO 2020/208502 A1; effectively filed 10 April 2019; cited in IDS; herein “Anderson”).
Regarding claims 8-11, Anderson teaches immunogenic compositions comprising glycoconjugates from two different S. pneumoniae serotypes (i.e., a 2-valent composition), including 15A and 16F, 15A and 17F, 15A and 20, 15A and 23A, 15A and 23B, 15A and 31, 15A and 34, 15A and 35B, 15A and 35F, or 15A and 38 (pg. 248, lines 13-15 and 21-22).
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson et al. (published 5 Sept. 2019, Vaccine; herein “Thompson”) in view of Anderson (WO 2020/208502 A1; effectively filed 10 April 2019; cited in IDS).
Regarding claims 1-2 and 12, Thompson teaches PCV20, a vaccine (i.e., immunogenic composition) comprising a glycoconjugate from S. pneumoniae serotype 15B (section 2.2.).
Regarding claims 3-6, Thompson teaches that PCV20 further comprises glycoconjugates from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 18C, 19A, 19F, 22F, 23F, and 33F (i.e. a 20-valent composition) individually conjugated to CRM197 (section 2.2.). Thompson also teaches the importance of expanding vaccine serotype coverage as new serotypes (e.g., 8, 10A, 11A, 12F, 15B, 22F, and 33F) increasingly contribute to pneumococcal disease (Abstract).
However, Thompson does not teach a second immunogenic composition comprising either glycoconjugates from S. pneumoniae serotypes 15A and 15C, as in claim 1, or a glycoconjugate from S. pneumoniae serotype 15A, but not serotype 15C, as in claim 2, or a second immunogenic composition comprising 7-25 different serotypes of S. pneumoniae, as in claim 7.
Regarding claims 1-2 and 12, Anderson teaches immunogenic compositions comprising glycoconjugates from one or more different Streptococcus pneumoniae (S. pneumoniae) serotypes, such as 15A, 15B, and/or 15C (pg. 248, lines 8-11). Anderson also teaches that the immunogenic compositions may be used in combination with a second immunogenic composition (pg. 252, line 33 – pg. 253, line 6). Anderson teaches that increasing resistance to antibiotics underlines the need for effective pneumococcal vaccines with broad protection and the growing prevalence of new serotypes causing disease emphasizes the need for expanding vaccine coverage (pg. 2, lines 11-29).
Regarding claims 2 and 8-11, Anderson teaches immunogenic compositions comprising glycoconjugates from S. pneumoniae serotype 15A, but not comprising a glycoconjugate from S. pneumoniae serotype 15C, including 2-valent compositions comprising conjugates of serotypes 15A and 16F, 15A and 17F, 15A and 20, 15A and 23A, 15A and 23B, 15A and 31, 15A and 34, 15A and 35B, 15A and 35F, or 15A and 38 (pg. 248, lines 13-15 and 21-22). Anderson also teaches that the immunogenic compositions may be used in combination with a second immunogenic composition (pg. 252, line 33 – pg. 253, line 6).
Regarding claim 7, Anderson teaches that the immunogenic compositions may comprise 7, 8, 9, 10, 11, 12, 13, 14, 15, or 16 different serotypes of S. pneumoniae (pg. 247, line 35 – pg. 248, line 6).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to combine the PCV20 vaccine taught by Thompson with the immunogenic composition comprising glycoconjugates from S. pneumoniae serotypes 15A and 15C taught by Anderson, thereby arriving at the invention of claims 1, 3-7, and 12 or the immunogenic composition comprising a glycoconjugate from S. pneumoniae serotype 15A, but not 15C taught by Anderson, thereby arriving at the invention of claim 2. The person of ordinary skill in the art would have been motivated to make the modification because the PCV20 vaccine taught by Thompson contains conjugates of serotypes that are not in the compositions taught by Anderson (i.e., 8, 10A, 11A, 12F, and 23F), and the compositions of Anderson contain conjugates of serotypes that are not in Thompson’s PCV20 vaccine (i.e., 15A and 15C, and 16F, 17F, 20, 23A, 23B, 31, 34, 35B, 35F, or 38). Both Thompson and Anderson teach the importance of expanding serotype coverage of vaccines in order to prevent disease caused by new serotypes not covered by previous vaccines, while continuing to protect against serotypes that are covered by previous vaccines. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because Anderson teaches that their immunogenic compositions may be used in combination with immunogenic compositions comprising S. pneumoniae serotypes other than 15A, 15B, or 15C. Therefore, the combination leads to expected results because each element performs the same function as is does individually. The compositions of Thompson and Anderson are both made for the purpose of preventing disease caused by S. pneumoniae. From MPEP 2144.06(I): "'It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art.' In re Kerkhoven, 626 F.2d 846,850,205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)...."
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., an immunogenic composition comprising a glycoconjugate from S. pneumoniae serotype 15B, an immunogenic composition comprising glycoconjugates from S. pneumoniae serotypes 15A and 15C, an immunogenic composition comprising a glycoconjugate from S. pneumoniae serotype 15A, but not 15C, glycoconjugates from S. pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and CRM197) were known in the art. In addition, combining these elements yields a 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.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645