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
This application is a national stage application of PCT/JP2021/041323, filed November 10, 2021, which claims benefit of foreign application JP2020-188350, field November 11, 2020. Claims 1-7 and 9-24 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted May 9, 2023, is acknowledged wherein claims 1-7 and 9-15 are amended, claim 8 is canceled, and new claims 16-24 are introduced.
Claim Rejections - 35 USC § 112
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 2-3 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. Base claim 1, from which these claims depend, defines a variable Z as a halogen atom or a group OR1, wherein R1 is a hydrogen atom or a glycoside structure (II) or (III). However, dependent claims 2 and 3 both directly define Z as one of these two glycoside structures without the intervening oxygen atom that is required by the definition of Z as OR1 in claim 1. Therefore these claims fail to include all of the limitations of the base claim. 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.
Claims 18 and 21 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. These claims depend from base claims 16 and 19, both of which describe a method comprising administering a compound according to claim 1 and an antigen. However, dependent claims 18 and 21 both include as their sole additional limitation that the compound of claim 1 and the antigen are administered either in combination at the same time or at different times. Since any method of combined administration will be either at the same or at different times, this limitations encompasses all possible embodiments of the base claim. Therefore these claims fail to further limit the base claim. 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 § 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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al. (PCT internation al publication WO2006/016997, Reference included with PTO-892).
Independent claim 1 is directed to a compound having formula (I) which is an aminoalkyl glucosaminidine phosphate, containing a group at position Z which can be a halogen. Said compounds are disclosed by Johnson et al. (See compound 26B at the top of p. 14, specifically wherein R1 is carboxyl.
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.
Claims 1, 6, 7, 10, 11, 13-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (PCT internation al publication WO2006/016997, Reference included with PTO-892)
Independent claim 1 is directed to a compound having formula (I) which is an aminoalkyl glucosaminidine phosphate. Dependent claims 6 and 7 further claim pharmaceutical composition comprising this molecule. Dependent claims 10, 11, 13-16, and 18 claim methods of treating disease or producing immunostimulatory effects comprising administering these compounds to a subject.
Johnson et al. discloses an aminoalkyl glucosamidine-4-phosphate compound having a generic structure (I) which overlaps with the structure recited in claim 1. (p. 3 paragraph 6, p. 4 paragraph 9) These compounds are specifically described as being structural derivatives produced by varying chemical functionalities of a parent AGP. As discussed previously, the embodiment wherein Z is fluoro is anticipated by Johnson et al. Regarding the remaining scope of the claimed formula (I), Johnson et al. furthermore describes structure 18b (top of p. 55) which falls within the exclusionary proviso recited in claim 1. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify said compound described by inserting a methylene linker between the carboxyl and the alkylene corresponding to the variable n in presently claimed formula (I). One of ordinary skill in the art would have seen the generic structure (I) on p. 4 of Johnson et al. as suggesting such a modification, in particularly by the variable p, which can be selected as 1 rather than 0. Modifying the structure further in this manner would be in keeping with the process of modifying the parent AGP structure as described by Johnson et al.
Regarding claims 6, 7, 14, and 15 Johnson et al. describes administering the disclosed compounds to an animal such as human, with or without an antigen to elicit an immune response. (p. 17 paragraphs 41-42) Regarding claim 13, AGP compounds are described as exerting their immunostimulant activity from activating toll-like receptors including TLR4. (p. 1 paragraph 2 – p. 2 paragraph 4) Regarding claims 16 and 18, Johnson et al. describes these compounds as being used as vaccines in combination with various antigens, (p. 38 paragraph 106, p. 39 paragraph 10, p. 40 paragraph 111) as well as being used to treat cancer. (p. 49 paragraph 143)
For these reasons the invention taken as a whole is prima facie obvious.
Claims 9, 12, 17, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. as applied to claims 1, 6, 7, 10, 11, 13-16, and 18 above, and further in view of Rosewich et al. (Reference included with PTO-892)
The disclosure of Johnson et al. is discussed above. Johnson et al. does not specifically disclose a method wherein the antigen is a pollen allergen such a birch or timothy pollen. However, Rosewich discloses a study of immunotherapy sing monophosphoryl lipid A (MPL) as an adjuvant. (p. 257 left column second and third paragraphs) The allergens are selected from birch and timothy pollen. (pp. 258-259, “Materials and Methods”) This treatment induced tolerance to the allergens. (p. 261 left column last paragraph – right column first paragraph)
It would have been obvious to one of ordinary skill in the art at the time of the invention to administer the AGP compounds described by Johnson et al. as part of an allergy immunotherapy, for example in combination with birch or timothy pollen. One of ordinary skill in the art would have been motivated to do so because Johnson et al. describes the disclosed AGP compounds as being developed as improved analogs to MPL, thereby suggesting their use in place of MPL in therapeutic protocols such as those described by Rosewich et al.
For these reasons the invention taken as a whole is prima facie obvious.
Claims 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. as applied to claims 1, 6, 7, 10, 11, 13-16, and 18 above, and further in view of Kocourkova et al. (Reference included with PTO-892)
The disclosure of Johnson et al. is discussed above. Johnson et al. does not specifically disclose a method wherein the antigen is a viral antigen as described in claims 19-21.
Kocourkova et al. discloses that vaccines containing inactivated or attenuated pathogens typically contain additional adjuvants that improve the immune response to the antigen. (p. 455 left column third and fourth paragraphs) Such adjuvants include toll like receptor agonists such as monophosphoryl lipid A. (p. 455 right column second paragraph, p. 459 right column second paragraph) Pathogens targeted by live attenuated or inactivated vaccines include for example influenza virus. (p. 454 table 2)
It would have been obvious to one of ordinary skill in the art at the time of the invention to include an AGP adjuvant as described by Johnson et al. as the adjuvant in a viral vaccine, for example a live attenuated or inactivated influenza virus. One of ordinary skill in the art would have found this to be obvious in view of the disclosure of Kocourkova et al., which they would interpret as indicating that MPL adjuvants, of which the AGP adjuvants described by Johnson et al. are an improved derivative, can be used in viral vaccines of this type.
For these reasons the invention taken as a whole is prima facie obvious.
Conclusion
Claims 1-3, 6, 7, and 9-24 are rejected. Claims 4 and 5 are seen to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREA OLSON/Primary Examiner, Art Unit 1693 1/7/2026