DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
2. Claims 41-60 are presently pending. Applicant’s election of Group I (claims 41-50) in the reply filed on February 18, 2026 is acknowledged. Claims 51-60 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 February 18, 2026.
Information Disclosure Statement
3. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Objection to the Specification
4. The instant specification is objected to for the following reasons:
a. There are trademarks in this application that do not meet the requirements.
The use of the term (e.g., “Tween, Brij Pluronics, Triton-X” at pg. 16, line 16), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
b. The specification is also objected to for repeating the claims at pages 21-24. Claims must commence on a separate physical sheet or electronic page and should appear after the detailed description of the invention; therefore, inclusion of duplicative claims within the body of the specification is objected to. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
5. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Written Description
6. Claims 41-50 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 written description requirement. The claims contain 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.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention.”
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicants were in possession of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that:
"applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116.)
No Written Description for the Breath of the Claims (“Siglec ligand”):
The claims are directed to cis-binding Siglec agonists comprising “Siglec ligands.” The claims broadly encompass the genus “Siglec ligands,” and only more narrowly specify that the Siglec ligands may be immunosuppressive Siglec ligands, CD-33 related Siglec ligands, or Siglec-7/9 ligands in the dependent claims. The claimed Siglec agonists must possess specific functions, including binding Siglecs in cis and agonizing the Siglecs. However, there is no structure recited in the claims that would correlate with these functions. The specification only sets forth Siglec ligands S7L and S9L (see FIG 3A) specifically as potentially having the required functions, but these two species are not sufficiently representative of such a broad genus of Siglec agonists comprising “Siglec ligands” as instantly claimed.
The specification discloses biochemical properties of Siglec agonists comprising S7L and S9L Siglec ligands at FIGs. 3-4; and evaluations of in vitro activity Siglec agonists comprising S7L and S9L Siglec ligands at FIGs. 5-11. The specification does not disclose a Siglec agonist having any other Siglec ligand; only S7L and S9L Siglec ligands are disclosed. Furthermore, the specification indicates S7L and S9L, which are synthetic Siglec ligands known in the art, were specifically chosen due to their high selectivity and affinity for the respective Siglecs (see speciation at pg. 24, lines 23-25).
The claims recite functional language of the Siglec agonists comprising “Siglec ligands,” such as cis binding that results in Siglec agonism, however a definition by function does not suffice to define the genus because it is only an indication of what the Siglec agonist comprising Siglec ligands does, rather than what it is; therefore, it is only a definition of a useful result rather than a definition of what achieves that result. In addition, because the genus of Siglec agonists comprising Siglec ligands is highly variable (i.e., each different Siglec ligand would necessarily have a unique structure), the generic description of the substance is insufficient to describe the genus. Thus, the encompassed Siglec agonists comprising “Siglec ligands” have no correlation between their structure and function. To address this issue, a brief assessment of the state of the art of Siglec ligands is provided below, which shows that (i) the genus “Siglec ligands” is highly variable with respect to binding properties for Siglecs, and (ii) high affinity Siglec ligands are specifically required to overcome natural cis masking to effectuate a “cis-binding Siglec agonist” as required by the claims.
Hong et al. ("Modulation of siglec-7 signaling via in situ-created high-affinity cis-ligands." ACS Central Science 7.8 (2021): 1338-1346) is directed to tumor growth control with a cis high-affinity Siglec ligand. Hong et al. at synopsis. Hong et al. teaches that: “Siglec-7 on the NK cell surface is masked by cis ligands, such as Neu5Acα2–8Neu5Acα2–3 disialic acids displayed by the ganglioside GD3, which partially block its interactions with trans ligands found on target cells. The unmasking of Siglec-7 induces a strong suppression of NK-induced tumor cell killing due to the binding of Siglec-7 with its trans ligands. On the basis of this precedent, we thus hypothesized that functionalizing NK cells with a high-affinity ligand of Siglec-7 may induce even stronger cis interactions to boost the NK-associated cytotoxicity by preventing Siglec-7-trans ligand interactions.” Hong et al. at pg. 1342, left col. Therefore, Hong et al. teaches that specifically high-affinity cis ligands—not all cis ligands as encompassed by the claimed invention—are important to prevent trans Siglec interactions and maintain cis Siglec interactions.
Rillahan et al. ("Click and pick: Identification of sialoside analogues for siglec‐based cell targeting." Angewandte Chemie International Edition 51.44 (2012): 11014-11018; cited in the specification at pg. 24, lines 23-25) is directed to the synthesis of high affinity / selective Siglec ligands. Rillahan et al. at para. 2. Rillahan et al. designed and tested 216 synthetic Siglec ligands and found that D24 (i.e., instant S9L) had the highest affinity and specificity for Siglec-9. See Rillahan et al. at FIG. 3, Supplemental Table 9. In fact, of the 216 tested Siglec agonists, only one other had at least 50% as much affinity for Siglec-9 as S9L (B24 has 62.6% affinity compared to D24 / S9L). See Rillahan et al. at Supplemental Table 9. Rillahan et al. therefore demonstrates it is very unpredictable how well a “Siglec ligand” will bind to a Siglec, and significant experimentation is required to determine Siglec ligands suitable for use with a Siglec agonist that binds Siglecs in cis and thereby agonizes the Siglecs.
Neither the art nor the specification provides a sufficient representative number of Siglec ligand species that bind to Siglecs with sufficient specificity and affinity to effectuate cis Siglec agonism to meet the written description requirement for instant claims directed to Siglec-7/9 ligands in general, let alone to meet the written description requirement for instant claims directed to Siglec agonists comprising the broad genus “Siglec ligand.”
It is therefore unknown how the genus of Siglec agonists comprising “Siglec ligands” would bind to Siglecs in cis and agonize the Siglecs. Applicant has not shown possession of a representative number of species that have the claimed function(s). The specification therefore provides insufficient written description to support the genus of Siglec agonists comprising “Siglec ligands” encompassed by the claims. Given all of the above, Applicant does not have written description for Siglec agonists comprising “Siglec ligands.”
The cited reference therefore demonstrate that Applicant is not in possession of: Siglec agonists comprising “Siglec ligands;” Applicant is in possession of: Siglec agonsists comprising S9L or S7L.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow person of ordinary skill in the art to recognize that he or she invented what is claimed’”. The courts have decided: the purpose of the "written description" requirement is broader than to merely explain how to "make and use"; the Applicant must convey with reasonable clarity to those skilled in the art, that as of the filing date sought, he or she was in possession of the invention. The invention is for purposes of the “written description” inquiry, whatever is now claimed. See Vas-Cath, Inc v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).
Furthermore, the written description provision of 35 USC §112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993). And Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Moreover, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has the Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that Applicant had possession of the claimed invention at the time the instant application was filed.
Enablement
7. Claims 41-50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for Siglec agonists comprising Siglec ligands S7L and S9L, does not reasonably provide enablement for Siglec agonists comprising the genus “Siglec ligand.” The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
It is noted that MPEP 2164.03 teaches that “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability of the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The amount of guidance or direction refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as how to make and use the invention in order to be enabling.”
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008). See also In re Cortright, 49 USPQ2d 1464, 1466 and Bristol-Myers Squibb Co. v. Rhone-Poulenc Rorer Inc., 49 USPQ2d 1370.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). The factors considered when determining if the disclosure satisfies the enablement requirement and whether any necessary experimentation is undue include, but are not limited to (In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)):
1) nature of the invention;
2) the breadth of the claims;
3) the state of the prior art;
4) the level of one of ordinary skill;
5) the level of predictability in the art;
6) the amount of direction or guidance provided by the inventor;
7) the existence of working examples; and
8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
When the above factors are weighed, it is the examiner’s position that one skilled in the art could not practice the invention without undue experimentation. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
(2) The breadth of the claims:
The claims are drawn to cis-binding Siglec agonists comprising “Siglec ligands” that bind to Siglecs in cis and agonize the Siglecs. The dependent claims further recite the “Siglec ligands” may be immunosuppressive Siglec ligands, CD-33 related Siglec ligands, or Siglec-7/9 ligands.
The claims are therefore broad and encompass Siglec agonists having any type of “Siglec ligand.”
(5) The predictability or unpredictability of the art:
The state of the art indicates it is very unpredictable how well members of the genus “Siglec ligand” will bind to Siglecs and thereby effectuate cis agonism of the Siglec.
Hong et al. ("Modulation of siglec-7 signaling via in situ-created high-affinity cis-ligands." ACS Central Science 7.8 (2021): 1338-1346) is directed to tumor growth control with a cis high-affinity Siglec ligand. Hong et al. at synopsis. Hong et al. teaches that: “Siglec-7 on the NK cell surface is masked by cis ligands, such as Neu5Acα2–8Neu5Acα2–3 disialic acids displayed by the ganglioside GD3, which partially block its interactions with trans ligands found on target cells. The unmasking of Siglec-7 induces a strong suppression of NK-induced tumor cell killing due to the binding of Siglec-7 with its trans ligands. On the basis of this precedent, we thus hypothesized that functionalizing NK cells with a high-affinity ligand of Siglec-7 may induce even stronger cis interactions to boost the NK-associated cytotoxicity by preventing Siglec-7-trans ligand interactions.” Hong et al. at pg. 1342, left col. Therefore, Hong et al. teaches that specifically high-affinity cis ligands—not all cis ligands as encompassed by the claimed invention—are important to prevent trans Siglec interactions and maintain cis Siglec interactions.
Rillahan et al. ("Click and pick: Identification of sialoside analogues for siglec‐based cell targeting." Angewandte Chemie International Edition 51.44 (2012): 11014-11018; cited in the specification at pg. 24, lines 23-25) is directed to the synthesis of high affinity / selective Siglec ligands. Rillahan et al. at para. 2. Rillahan et al. designed and tested 216 synthetic Siglec ligands and found that D24 (i.e., instant S9L) had the highest affinity and specificity for Siglec-9. See Rillahan et al. at FIG. 3, Supplemental Table 9. In fact, of the 216 tested Siglec agonists, only one other had at least 50% as much affinity for Siglec-9 as S9L (B24 has 62.6% affinity compared to D24 / S9L). See Rillahan et al. at Supplemental Table 9. Rillahan et al. therefore demonstrates it is very unpredictable how well a “Siglec ligand” will bind to a Siglec, and significant experimentation is required to determine Siglec ligands suitable for use with a Siglec agonist that binds Siglecs in cis and thereby agonizes the Siglecs.
The cited reference therefore demonstrates that effective agonism of a Siglec with members of the genus “Siglec ligand” in cis is highly unpredictable. Therefore, without actually performing the required experiments, it is unpredictable which members of the instantly claimed genus of Siglec agonists comprising “Siglec ligands” can bind to Siglecs in cis and agonize the Siglecs.
6) the amount of direction or guidance provided by the inventor:
The specification discloses biochemical properties of Siglec agonists comprising S7L and S9L Siglec ligands at FIGs. 3-4; and evaluations of the in vitro activity Siglec agonists comprising S7L and S9L Siglec ligands at FIGs. 5-11. The specification does not disclose a Siglec agonist having any other Siglec ligand; only S7L and S9L Siglec ligands are disclosed. Furthermore, the specification indicates S7L and S9L, which are synthetic Siglec ligands known in the art, were specifically chosen due to their high selectivity and affinity for the respective Siglecs (see speciation at pg. 24, lines 23-25).
The specification therefore only discloses Siglec agonists comprising optimized S7L and S9L Siglec ligands. Given the evidence above, one of skill in the art could not reasonably extrapolate the instant findings regarding Siglec agonists comprising S7L or S9L to Siglec agonists comprising genus “Siglec ligand,” without undue experimentation. It would also be undue experimentation to confirm which of the 100s of Siglec ligands encompassed by the claims could bind to Siglecs in cis and thereby agonize the Siglecs.
8) the quantity of experimentation needed to make or use the invention:
It would be undue experimentation to make or use the invention encompassed by the breadth of the claims because 100s of Siglec agonists comprising “Siglec ligands” would need to be made and evaluated for functionality; Applicant has only made and evaluated two Siglec agonists comprising optimized Siglec ligands (i.e., S7L and S9L) that Rillahan et al. shows are not representative of the genus “Siglec ligand.”
In conclusion, the claimed invention does not provide enablement for Siglec agonists comprising genus “Siglec ligand;” the claimed invention provides enablement for Siglec agonist comprising S7L or S9L. Thus, for the reasons outlined above, the specification is not considered to be enabling for one skilled in the art to make and use the claimed invention as the amount of experimentation required is undue, due to the broad scope of the claims, the lack of guidance and working examples provided in the specification. Therefore, the specification is not representative of the instant claims and the specification is not fully enabled for the instant claims. In view of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention.
Claim Rejections - 35 USC § 102
9. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 41-46 and 48-50 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Paulson (I) et al. (US20190151444A1, published May 23, 2019).
Claim 41 is drawn to a cis-binding Siglec agonist comprising: a scaffold bearing Siglec ligands; and a membrane-tethering domain.
Claim 42 is drawn to the Siglec agonist of claim 41, wherein the scaffold bearing Siglec ligands comprises a polymer scaffold.
Claim 43 is drawn to the Siglec agonist of claim 42, wherein the scaffold bearing Siglec ligands comprises a glycopolypeptide scaffold.
Claim 44 is drawn to the Siglec agonist of claim 41, wherein the scaffold comprises from 2 to 50 Siglec ligands.
Claim 45 is drawn to the Siglec agonist of claim 41, wherein the Siglec ligands comprise immunosuppressive Siglec ligands.
Claim 46 is drawn to the Siglec agonist of claim 45, wherein the Siglec ligands comprise ligands for one or more CD33-related Siglecs.
Claim 48 is drawn to the Siglec agonist of claim 46, wherein the Siglec ligands comprise Siglec-7 ligands.
Claim 49 is drawn to the Siglec agonist of claim 41, wherein the membrane-tethering domain comprises a lipid membrane-tethering domain.
Claim 50 is drawn to a pharmaceutical composition comprising: the Siglec agonist of claim 41; and a pharmaceutically acceptable carrier.
Claim Interpretation: The term “membrane-tethering domain” is being interpreted in view of the instant specification, which broadly defines membrane-tethering domains to include: “membrane-tethering domains also include moieties adapted to stably bind to the cell membrane, including any constituents thereof (e.g., membrane-associated proteins, such as transmembrane proteins).” Specification at pg. 12, lines 29-31. Therefore, “membrane-binding domains” include moieties that stably bind to membrane-associated proteins (e.g., a Siglec ligand stably binding to a membrane-associated Siglec).
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Paulson (I) et al. at FIG. 5A (above) discloses a liposome carrier (i.e., a “scaffold”) bearing five CD33-L Siglec agonist ligands binding to three membrane-associated CD33 Siglecs in cis. The binding of the CD33-L Siglec agonist ligands to the membrane-associated CD33 Siglecs constitutes a “membrane-tethering domain” because the Siglec agonist ligands of Paulson (I) et al. are high affinity and therefore stably bind the membrane-associated Siglecs, falling within the instant specification’s definition of a membrane-tethering domain (Paulson (I) et al. at title; claims 41, 44, and 46).
Paulson (I) et al. further discloses that the Siglec agonist may comprise polymer or glycopolypeptide scaffolds (see e.g., Paulson (I) et al. at para. [0151]-[0152] describing Siglec ligands displayed/linked on carriers, and that the carriers can be polyamino-based; and at para. [0163] describing Siglec ligands as glycans; glycans (e.g., Siglec ligands) displayed/linked to a polyamino/polypeptide scaffold renders a glycopolypeptide scaffold (claims 42-43)); that the Siglec ligands may effectuate immunosuppression (see e.g., Paulson (I) et al. at para. [0163] (claim 45)); that the Siglec ligands may be Siglec-7 ligands (see e.g., Paulson (I) et al. at claim 15 (claim 48)); that the membrane-tethering domain comprises a lipid membrane tethering domain (see e.g., Paulson (I) et al. at para. [0049]; the third sugar of the Siglec ligand may comprise lipid or pegylated lipid to insert into a liposome scaffold (claim 49)); and that the Siglec agonist may be comprised in a pharmaceutical composition with pharmaceutically acceptable carrier (see e.g., Paulson (I) et al. at para. [0174] (claim 50). Accordingly, Paulson (I) et al. anticipates claims 41-46 and 48-50.
Claims 41-48 and 50 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Paulson (II) et al. (US20090238837A1, published September 24, 2009).
Claim 41 is drawn to a cis-binding Siglec agonist comprising: a scaffold bearing Siglec ligands; and a membrane-tethering domain.
Claim 42 is drawn to the Siglec agonist of claim 41, wherein the scaffold bearing Siglec ligands comprises a polymer scaffold.
Claim 43 is drawn to the Siglec agonist of claim 42, wherein the scaffold bearing Siglec ligands comprises a glycopolypeptide scaffold.
Claim 44 is drawn to the Siglec agonist of claim 41, wherein the scaffold comprises from 2 to 50 Siglec ligands.
Claim 45 is drawn to the Siglec agonist of claim 41, wherein the Siglec ligands comprise immunosuppressive Siglec ligands.
Claim 46 is drawn to the Siglec agonist of claim 45, wherein the Siglec ligands comprise ligands for one or more CD33-related Siglecs.
Claim 47 is drawn to the Siglec agonist of claim 46, wherein the Siglec ligands comprise Siglec-9 ligands.
Claim 48 is drawn to the Siglec agonist of claim 46, wherein the Siglec ligands comprise Siglec-7 ligands.
Claim 50 is drawn to a pharmaceutical composition comprising: the Siglec agonist of claim 41; and a pharmaceutically acceptable carrier.
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Paulson (II) et al. at FIG. 7B (above) discloses a decavalent antibody carrier (i.e., a “scaffold”) bearing twelve CD22 Siglec agonist ligands binding to two membrane-associated CD22 Siglecs in cis. The binding of the CD22 Siglec agonist ligands to the CD22 Siglecs constitutes a “membrane-tethering domain” because the Siglec agonist ligands of Paulson (II) et al. are high affinity and therefore stably bind the membrane-associated Siglecs, falling within the instant specification’s definition of a membrane-tethering domain (Paulson (II) et al. at title; claims 41 and 44).
Paulson (II) et al. further discloses that the Siglec agonist may comprise polymer or glycopolypeptide scaffolds (see e.g., Paulson (II) et al. at claim 11 (claims 42-43)); that the Siglec ligand can be for any of Siglecs 1-11 (see e.g., Paulson (II) et al. at para. [0077]; and specifically naming Siglecs 7 and 9 at para. [0106] (claims 45-48)); and that the Siglec agonist may be comprised in a pharmaceutical composition with pharmaceutically acceptable carrier (see e.g., Paulson (II) et al. at para. [0156] (claim 50). Accordingly, Paulson (II) et al. anticipates claims 41-48 and 50.
Conclusion
10. No claim is allowed.
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON R SCHWECHTER whose telephone number is (571)272-1270. The examiner can normally be reached M-Th 7-5 EST.
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/BRANDON R SCHWECHTER/
Examiner, Art Unit 1674
/VANESSA L. FORD/ Supervisory Patent Examiner, Art Unit 1674
Prosecution Insights