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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on September 9, 2025 has been entered.
Applicants' arguments, filed September 9, 2025, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Comments and Notes
Applicants cite Glycobiology 2009 Jun;19(6):568-75 on p 9 of the remarks filed September 9, 2025 but do not provide a copy and this reference was not previously cited on an IDS. The Examiner was able to find a complete copy of this reference which is provided with this action so that the complete contents of this reference are now of record.
Claim Interpretation
Claim 1 has been amended to recite that the composition “binds exclusively to CD206”. CD206 is another name for the mannose receptor and the claims also require the presence of at least one mannose residue in a non-dextran glycan backbone. No definition of “exclusively” is given in the specification but relevant definitions of “exclusive” are definitions 3, 4 and 8 on page 1 of the definition of “exclusive” from dictionay.com (accessed November 12, 2025) of “limited to the object or objects designated”, “shutting out all others from a part or share” and “single or sole” respectively. This renders the broadest reasonable interpretation of the phrase “binds exclusively to CD206” to require that the carrier molecule with a non-dextran glycan backbone, one or more mannose residues and a detectable moiety are limited to those that solely bind to CD206 and do not bind even weakly to any natural or synthetic material such as receptors, enzymes, nucleic acids such as an aptamer as that would result in a composition that does not meet the required function of binding exclusively to CD206.
Claim Rejections - 35 USC § 112 – Enablement
Claims 1, 3, 7,8, 10 and 12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The disclosure and claims of the application have been compared per the factors indicated in the decision In re Wands, 8 USPQ2nd 1400 (Fed. Cir. 1988) as to undue experimentation
The factors include:
1. The nature of the invention;
2. The breadth of the claims;
3. The predictability or unpredictability of the art;
4. The amount of direction or guidance presented;
5. The presence or absence of working examples
6. The quantity of experimentation necessary;
7. The state of the prior art; and
8. The relative skill of those skilled in the art.
Each relevant factor is addressed below on the basis of comparison of the disclosure, the claims and the state of the art in the assessment of undue experimentation.
The nature of the invention; the breadth of the claims:
The interpretation of the phrase “exclusively binds to CD206” is set forth above. The carrier with a glycan backbone cannot have a dextran as the backbone and must include at least one mannose residue but is other not particularly specified. Other sugar molecules in the non-dextran glycan backbone such as fructose or galactose are not specifically excluded but the non-dextran glycan backbone must meet the functional limitation of binding exclusively to CD206. A detectable moiety is attached to the carrier molecule. The construct is then administered to a subject and the detectable moiety detected in at least one lymph node of the subject.
The predictability or unpredictability of the art; the amount of direction or guidance presented; the presence or absence of working examples; the quantity of experimentation necessary; the state of the prior art; the relative skill of those skilled in the art:
The relative skill of those skill in the art is relatively high, such as research chemist developing imaging constructs for pharmaceutical use.
The specific structures shown as the beginning of the specification as filed are for tilmanocept and contains a dextran backbone and therefore do not fall within the scope of the instant claims. Backbones with a plurality of monosaccharide residues are generally described with varying numbers of such residues (¶ [0017] – [0053]) although no specific carriers were prepared and therefore no information about CD206 binding specificity of any specific linkers is present. To achieve exclusive binding to CD206/mannose receptor, no other sugar molecule that has a lectin known for binding that sugar can be present in the carrier as then the construct would be capable of binding to CD206 due to the required mannose residue but would also bind to the lectin for the other sugar residue(s) and result in a composition that does not bind exclusively to CD206. Those substrates could also bind to other substrates but lectins are known class of proteins that bind carbohydrates. The existence of lectins and other materials that bind non-mannose sugars could lead one of skill in art to contemplate a carrier backbone with only mannose residues given that CD206 is also known as the mannose receptor. However, Applicant cites Hollmig et al. (Glycobiology, 2009) and a copy of that reference accompanies this action. Page 571, col 1, ¶ 4 of Hollmig et al. states that dectin-2 recognizes mannan related carbohydrates in a Ca2+ dependent manner but with low affinity. But even that low affinity binding means that mannan-related carbohydrates do not bind exclusively to CD206 as required by the instant claims and hence does not meet the functional limitation.
Based on the state of the art, even non-dextran glycan backbones comprised solely of mannose residues do not meet the required function of exclusively binding to CD206. Potentially sugar residues such as mannose could be modified in some way, and while derivatives such as mannan derivatives are contemplated in the application as originally filed (e.g., ¶ [0055] of the PGPub of the instant application), no guidance as to modifications that will preserve the ability to bind to CD206 while excluding binding to any other substrate is given. Undue experimentation would be required to not only generate sugar derivatives without any guidance as the modification to be made but then to screen those generated carrier backbones and demonstrate a lack of binding to all substrates other than CD206. The undue experimentation required to identify suitable carrier backbones that meet the required functional limitation of the claim means that the claims are not enabled.
Claim Rejections - 35 USC § 112 – Written Description
Claims 1, 3, 7,8, 10 and 12 are under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
A generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define boundaries of a claimed genus. In such a case, the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. But the specification must demonstrate that the applicant has made a generic invention the achieves the claimed results and do so by showing that that the applicant has invented species sufficient to support a claim to a functionally-defined genus.
Claim 1, from which all other claims depend, has been amended to further limit by function the structure of the carrier molecule with detectable label present in the claimed composition that now must exclusively bind to CD206/mannose receptor. Required structural elements are at least one mannose reside and a glycan backbone that is not dextran. The scope of the exclusively binding limitation in claim 1 has been discussed above and will not be reiterated here. Hollmig et al. demonstrates that even the presence of multiple mannose residues does not result in a material that binds exclusively to CD206 as mannan (a homopolymer of mannose) also binds to dectin-2. While possible elements for the carrier such as various sugar residues are disclosed in the application as originally filed, there is no structure-function even postulated as to modifications or materials that could be prepared that would retain the ability to bind to CD206 while excluding binding to another possible substrate. Possible glycans could be generated, but without any guidance as to a structure function relationship, what those possible glycan backbones could be cannot be determined. With the lack of examples in the specification of carriers that meet the functional limitation, possession of non-dextran glycan backbones containing at least one mannose residue that binds exclusively to CD206/mannose receptor at the time of filing has not been demonstrated and therefore the written description requirement has not been satisfied.
The dependent claims fall therewith.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
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/Nissa M Westerberg/Primary Examiner, Art Unit 1618