DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment filed on 07/30/2026 has been entered. Claims 3-12 are cancelled. Claims 1, 2, and 13-18 are pending in this application. Claims 13-18 are withdrawn. Claims 1 and 2 are currently under examination.
Priority
This application is a 371 of PCT/US2022/042938 filed on 09/08/2022 and claims benefit of US PRO 63/243,099 filed on 09/11/2021.
Election/Restrictions
Applicant's election without traverse of Group I invention (claims 1 and 2) in the reply filed on 07/30/2026 is acknowledged. Claims 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Thus, claims 1 and 2 are currently under examination.
Specification/Claim Objections
Specification: The disclosure is objected to because of the following informalities: The chemical structures “
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” and “
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” for R3 and R4 of formula (I) is incorrect because the attachment site should be on the carbon also linking to COOH. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: In claim 1, the chemical structures “
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” and “
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” for R3 and R4 of formula (I) is incorrect because the attachment site should be on the carbon also linking to COOH. Appropriate correction is required.
Claim 2 is objected to because it includes reference characters which are not enclosed within parentheses. Reference characters corresponding to elements recited in the detailed description of the drawings and used in conjunction with the recitation of the same element or group of elements in the claims should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. See MPEP § 608.01(m). Applicant is advised to add parenthesis for the recitations “compound 1-1”, “compound 1-2”, “compound 1-3”, “compound 1-4”, and “compound 1-5”, beneath the corresponding chemical structures.
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 and 2 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 2 depends from claim 1.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: Claim 1 recites “R3 and R4 are independently…
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or
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”, which contradicts to the compounds in dependent claim 2, wherein the attachment site of R3 or R4 is on the carbon also linking to the COOH group. Thus, there is omission of structural relationship between the necessary structural connections.
Claim Rejections - 35 USC § 102/103
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.
(I) Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (PNAS 106, 43, p. 18137-18142, 2009, hereinafter referred to as Wang ‘2009).
With regard to structural limitation “a compound having a structure of formula (I),
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(= Neu5Ac-α2,3-Gal-ß1,4-Glc-ß-(CH2)5-NH2; or wherein R1 is H, or optionally substituted
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or
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, R2 is optionally substituted acetyl; and R3 and R4 are independently H” (claim 1):
[AltContent: rect]Wang ‘2009 disclosed glycan 2:
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, glycan 16:
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, and glycan 17:
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(page 18140, Fig. 3).
Thus, these teachings of Wang ‘2009 anticipate Applicant’s claim 1.
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.
(II) Claims 1 and 2 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 Vuskovic et al. (US 2014/0087957, Mar. 27, 2014, hereinafter referred to as Vuskovic ‘957).
[AltContent: rect]With regard to the structural limitations “a compound having a structure of formula (I),
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(= Neu5Ac-α2,3-Gal-ß1,4-Glc-ß-(CH2)5-NH2; or wherein R1 is H; R2 is optionally substituted acetyl; and R3 and R4 are independently H or optionally substituted
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; or compound 1-1:
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= Neu5Ac-α2,8-Neu5Ac-α2,3-Gal-ß1,4-Glc-ß-(CH2)5-NH2)” (claims 1 and 2):
Vuskovic ‘957 disclosed LC-9 glycan: Neu5Acα2-8Neu5Acα2-3Galß1-4Glcß-sp4 for diagnosing adenocarcinoma and Meso-1 glycan: Neu5Acα2-3Galß1-4Glcß-sp4 for diagnosing mesothelioma. A diagnosis of adenocarcinoma or mesothelioma by obtaining a test sample from a patient and detecting the presence of antiglycan autoantibodies against at least one of or a combination of the glycans (page 28/31, [0218, 0219]; page 29/31, [0230]). The glycans can have amino moieties provided by attached alkylamine groups. In some embodiments, the glycans have alkylamine moieties such as —OCH2CH2-NH2 (called Sp1) or —OCH2CH2CH2-NH2 (called Sp2 or Sp3) that have useful as linking moieties (the amine) and act as spacers or linkers (page 11/31, [0078]).
Thus, these teachings of Vuskovic ‘957 anticipate Applicant’s claims 1 and 2 because the Sp4 would be —OCH2CH2CH2CH2CH2-NH2 when Sp1 is —OCH2CH2-NH2 and Sp2 is —OCH2CH2CH2-NH2, described above. Or, in an alternative, skilled artisan would select spacer —OCH2CH2CH2CH2CH2-NH2 because Sp1, Sp2, Sp3, and Sp4 have been applied.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YIH-HORNG SHIAO whose telephone number is (571)272-7135. The examiner can normally be reached Mon-Thur, 08:30 am to 07:00 pm EST.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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