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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-2, 5-6, 9, and 12-19) in the reply filed on 12 September 2025 is acknowledged. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 September 2025.
Claim Status
The amended claim set filed on 12 September 2025 is acknowledged. Claims 1-2, 5-6, 9, and 12-20 are currently pending. There are no new claims and claim 20 is withdrawn. Claims 3-4, 7-8, 10-11, and 21-22 are cancelled. Claims 1-2, 5-6, 9, and 12-19 will be examined on the merits herein.
Priority
The instant application is a 371 of PCT/CN2019/118479 (filed 14 November 2019) and claims priority to foreign applications CN201910777479.2, CN201910777473.5, CN201910777595.4, CN201921369450.2, CN201910777606.9 (all filed 22 August 2019). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, because no certified translations of the foreign priority documents have been filed, the priority claim has not been perfected. Therefore, for the purpose of searching the prior art, the effective filing date of claims 1-2, 5-6, 9, and 12-19 is 14 November 2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 February 2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: Scientific names (e.g., Pseudomonas aeruginosa, Klebsiella pneumoniae, Acinetobacter baumannii, etc.) should be italicized. Appropriate correction is required.
Claim Objections
Claims 1, 9, 12-15, and 17 are objected to because of the following informalities:
“Pseudomonas aeruginosa” should be italicized, and in claim 9, the phrase “injection take places” is grammatically incorrect. Appropriate correction is required.
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 1-2, 5-6, 9, and 12-19 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 1-2, 5-6, 9, and 12-19 are drawn to a “use” of a Pseudomonas aeruginosa vaccine. The claim is indefinite because one of ordinary skill in the art would not be able to determine whether the claim should be drawn to a product with an intended use or a method of using a product. As these interpretations have different claim scopes (a product remains capable of an intended use even when not actively being used in that way), one of ordinary skill in the art would not be able to determine the scope required by the claim; therefore, the claim is indefinite. Additionally, the claim is indefinite because it merely recites a use 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).
Regarding claim 2, the terms “primary respiratory disease” and “secondary respiratory disease” are not defined in the specification and do not appear to have a clear meaning in the prior art. Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term is indefinite because the specification and the art at the time of filing does not clearly define the term; thus one of ordinary skill in the art would not be able to determine the scope of claim.
Regarding claim 10, the claim recites “immunization procedures of the Pseudomonas aeruginosa vaccine comprise: injection take places (i) 0, 3rd, and 7th days, and (ii) 0, 2nd and 4th weeks.” As written, it is unclear how many injections occur on the recited days or weeks and if/how (i) and (ii) are meant to be combined (i.e., is the immunization procedure a single or some number of injections on days 0, 3, and 7 of the 0, 2nd, and 4th weeks or on days 0, 3, and 7 and one or more additional injections in the 0, 2nd, and 4th weeks?). Additionally, it is not clear what reference point is used to determine when day “0” is.
Regarding claims 13-14, the values recited in the claims (e.g., 1 x 1011/injection) lack a unit identifying what is being measured in the injection (i.e., cells, CFU, g, etc.). In the interest of compact prosecution, the claim has been interpreted to refer to CFU/injection, because this is the unit used in the experiments described in the instant specification (para. 119-124).
Regarding claim 14, the claim recites “the content of whole-cell Pseudomonas aeruginosa in the Pseudomonas aeruginosa vaccine comprises: 1 x 104/injection, 1 x 105/injection, 1 x 106/injection, 1 x 107/injection, 1 x 108/injection, 1 x 109/injection, and 1 x 1011/injection.” The claim is indefinite because neither the claims nor specification explain how the P. aeruginosa content in the vaccine can simultaneously comprise 1 x 104/injection and 1 x 105/injection and 1 x 106/injection, etc. In the interest of compact prosecution, the limitation has been interpreted to recite a list of alternative concentrations.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 18-19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claims 18-19, claim 18 (upon which claim 19 depends) recites “the medicament can also contain”. The term “can” indicates that the limitation is not required by the claim. MPEP 2111.04(I) states: “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.” The claims only recite an optional limitation and thus does not limit the subject matter of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2, 5-6, 9, and 12-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are drawn to a “Use of a Pseudomonas aeruginosa vaccine in the manufacture of a medicament for the prevention and treatment of respiratory system disease”, which does not fall within any of the statutory categories of eligible subject matter. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). See also the other case law cited in MPEP 2173.05(q).
Therefore, claims 1-2, 5-6, 9, and 12-19 do not qualify as eligible subject matter. See MPEP 2106.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Li et al. (2016, Sci. Rep.) teaches a vaccine comprising inactivated Pseudomonas aeruginosa (P. aeruginosa) cells that have been inactivated by x-ray irradiation (Abstract and pg. 2, para. 1-2). Li et al. also teaches that the inactivated P. aeruginosa vaccine comprises 1 x 108 or 1 x 109 CFU/injection (pg. 10, para. 2) and may be administered subcutaneously (pg. 2, para. 2).
Zhang et al. (2018, Vaccine) teaches a vaccine against P. aeruginosa infection in the lungs comprising P. aeruginosa outer membrane vesicles (OMVs) and aluminum phosphate adjuvant (Abstract).
Conclusion
No claim is allowed.
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/BAILEY M MORGAN/Examiner, Art Unit 1645
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674