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 .
DETAILED ACTION
The amended claim set filed 9/29/2023 is acknowledged.
Claims 1-10 will be examined on the merits herein.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, support for the claimed invention cannot be determined because the foreign priority documents provided are not in English. Applicant cannot rely upon the certified copy of the foreign priority application to overcome any prior art rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216. Failure to provide a certified translation may result in no benefit being accorded for the non-English application. Accordingly, the filing date of the PCT application of 03/16/2022 will be used for the purpose of applying prior art.
Specification Objections
The disclosure is objected to because it contains embedded hyperlinks on page 3 of the specification and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The disclosure is objected to because it uses a foreign language on p.7, the disclosure must be in English; see in particular the brief description of Figure 13.
The following is a quotation of 37 CFR § 1.52(b):
(b) The application (specification, including the claims, drawings, and the inventor’s oath or declaration) or reexamination or supplemental examination proceeding, any amendments to the application or reexamination proceeding, or any corrections to the application, or reexamination or supplemental examination proceeding.
(1) The application or proceeding and any amendments or corrections to the application (including any translation submitted pursuant to paragraph (d) of this section) or proceeding, except as provided for in § 1.69 and paragraph (d) of this section, must:
(i) Comply with the requirements of paragraph (a) of this section; and
(ii) Be in the English language or be accompanied by a translation of the application and a translation of any corrections or amendments into the English language together with a statement that the translation is accurate.
Claim Objections
The following claims are objected to because of the following informalities, appropriate action is required.
Claim 7 recites “a method of treatment a subject” which is improper English, and there is no comma after uveitis and cytokine release syndrome.
Claim 8 recites “mg/kg of weigh” which should be “mg/kg of weight”.
Claim 9 recites “at least weekly administered and at least one dose and until use limiting toxicity occurs as maintenance weekly administered.” At least one dose here is redundant over the previous limitation of 1 to 6 doses. The examiner suggests rewriting this claim to be clearer and using commas.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3 and 6-10 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 1, 2, 6, 7, and 10 are drawn to Markush groups selected from an open list of alternatives as defined by the applicant using the term “comprising”. This is indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. See MPEP 2173.05(h). Changing comprising to consisting can overcome this rejection. Claims 3 and 8 depend on claims 1 and 7 respectively and do not resolve this ambiguity.
Claim 9 drawn to administration 1 to 6 doses at least weekly, is indefinite because if it is only 1 dose, there is no other dose to be administered the next week.
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)(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 1-3, 5 and 6 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Islam et al (2015).
Islam teaches a vaccine used in EAE (experimental autoimmune encephalomyelitis) which is an animal model for multiple sclerosis (p.2) an inflammatory disease. Islam teaches a fusion protein of GMCSF (Granulocyte macrophage colony stimulating factor) and MOG (myelin oligodendrocyte glycoprotein) which is a mammalian protein and, in this context, can be inherently considered a carrier protein. The vaccine is administered in an experiment with CFA which is Complete Freund’s Adjuvant the composition of which is detailed on p.5.
In fig. 3A of Islam, administration of a composition comprising GMCSF-MOG and CFA represented by black filled squares is demonstrated to reduce the mean clinical score of EAE in C57BL/6 mice.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Islam in view of Me Therapeutics (WO 2018145206 A1, from IDS 9/29/2023) in further view of Aliper et al. (2014). The teachings of Islam are laid out in full in the 102 rejections above and anticipate claims 1-3, 5 and 6. Islam teaches a vaccine comprising GMCSF.
Islam does not teach a vaccine comprising GCSF (granulocyte colony stimulating factor) as in instant claim 4 or for use in the diseases listed in claim 7. However, it is known in the art that GCSF and GMCSF are similar as they both are cytokines that regulate maturation of progenitor cells in the bone marrow see Aliper p.737-738, in addition the role of the aforementioned cytokines can promote tumors in a variety of ways see Aliper Table 1. As such it would have been obvious to a person having ordinary skill in the art to look at GCSF as well for cancer treatments because GCSF was listed as cancer promoting in more types of cancers in Aliper Table 1, in addition a person having ordinary skill in the art may wish to target specific cancers.
Me Therapeutics teaches GCSF plays an important role in both cancer and chronic inflammatory diseases par.3, and an antibody to GCSF in claim 1. Me therapeutics also teaches a composition comprising the antibody in claim 21 and a method of using the composition to treat cancer in claim 25. It would have been obvious to a person having ordinary skill in the art to combine the teachings of Me Therapeutics to extend the teachings of Islam from one inflammatory disease to other inflammatory diseases such as cancer, by swapping out the GMCSF to the related GCSF. In addition, it would have been obvious to use other methods of generating antibodies to GSCF, including using it in a conjugated or fusion protein in a vaccine, because once a vaccine is administered the subject’s own body may continue to produce antibodies over a longer period of time without need for a higher frequence administration regiment and increased costs of administration of a purified antibody.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Islam in view of Me Therapeutics in further view of Casimiro (EP 1829893 A1, from IDS 9/29/2023). The teachings of Islam and Me Therapeutics are laid out in full in the 103 rejections above and render claim 7 obvious. However, neither Islam nor Me Therapeutics teach the dosage of instant claim 8.
Claim 8 is drawn to administration of 0.01 – 10 mg/Kg of the vaccine composition. Casimiro teaches a vaccine having related components, it is a conjugate of a cytokine, interleukin 2 par.17, for treatment of cancer. A person having ordinary skill in the art would have been motivated to combine the teaching of Islam and Me Therapeutics with dosage that has been previously been shown to work in a related composition and disease. Casimiro used mice of approximately 19 grams par.30 and administered an immunization dose of 10 micrograms par.31 resulting in a dose of 0.55 mg/Kg.
Claim 9 depends on claim 8 which is rejected above. Claim 9 is drawn to 1 to 6 doses is disclosed by Islam as a single dose administration in Fig. 3A description.
Claim 10 depends on claim 9 which is rejected above. Claim 10 of the instant application is drawn to methods of administration including subcutaneous, Islam teaches subcutaneous administration on p.5.
Conclusion
No claims are allowed.
Inquiry Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUDOLPH E. SLOUP Jr. IV Ph.D. whose telephone number is (571)272-7899. The examiner can normally be reached Monday to Friday, 9am to 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E. Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUDOLPH E. SLOUP Jr. IV Ph.D./
Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645