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 .
DETAILED ACTION
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claims 1, 3-5, 7-14, 16-19, and 24, drawn to a glycopeptide and its composition.
Group II, claims 28, 30, and 36, drawn to a method of using the glycopeptide of Group I to treat a disease or inhibit P-selectin.
Species Election
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
Genus P: (glycopeptide sequence in claim 5)
Elect a single peptide SEQ ID NO listed in claim 5 (SEQ ID Nos: 2-12)
Genus L1: (Linker)
Elect a single and completely defined linker (L1) structure listed in claims 14 and 16-19
Genus D: (Disease, if Group II is elected)
A disease in claim 28
Allergy (claim 30)
Lung disease (claim 30)
Inhibiting P-selectin (claim 36)
Applicant is required, in reply to this action, to elect a single species from each Genus P, L1, and D to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: claims 1, 3-5, 7-14, 16-19, 24, 28, 30, and 36
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a PEG conjugated glycopeptide, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Cummings et al. (US 2016/0108092 A1) and Veronese (Biomaterials 22 (2001) 405-417). Cummings et al. teach the selectin inhibitor formula of SEQ ID NO: 1 (Y1X1Y2X2X3Y3 X4X5X6Z1 X7W1) [0009, claim 1] and definition of each variables [0011-0013]. Cummings et al. show the peptide sequences of SEQ ID NO; 2-12 [0082, claim 12] including the elected glycopeptide peptide species of SEQ ID NO: 12 [0083-0086]. Veronese teaches peptide and protein PEGylation (Title). Veronese teaches advantages of PEG conjugation comprising increase of the molecular size of the polypeptide to reduce its renal ultrafiltration, reducing the degradation by proteolytic enzymes and modifying biodistribution and solubility of the PEGylated peptide (p406, col 1, para1). Because the technical feature was taught by Cummings et al. in view of Veronese, this instant application lacks unity of invention without a technical feature.
During a telephone conversation with Mr. Will Czaplyski on 1/15/2026 (approved date of power of attorney), a provisional election was made without traverse to prosecute the invention of I, claims 1, 3-5, 7-14, 16-19, and 24. Affirmation of this election must be made by applicant in replying to this Office action. Claims 28, 30, and 36 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
PNG
media_image1.png
58
84
media_image1.png
Greyscale
In response to the species election requirement, applicant representative elected SEQ ID NO: 12 and the linker L1 structure as the first structure in claim 14 Thus, claims 16-19 are further withdrawn as directed a non-elected species.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Office Action of claim examination in the next page.
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 3-5, 7-14, 16-19, and 24 in the restriction by phone on 1/8/2026 is acknowledged. Claims 28, 30, and 36 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 by phone.
PNG
media_image1.png
58
84
media_image1.png
Greyscale
In response to the species election requirement, applicant representative elected SEQ ID NO: 12 and the linker L1 structure as the first structure in claim 14 Thus, claims 16-19 are further withdrawn as directed a non-elected species.
Claim Status
Claims 1, 3-5, 7-14, 16-19, 24, 28, 30, and 36 are pending.
Claims 2, 6, 15, 20-23, 25-27, 29, 31-35, and 37-41 are cancelled.
Claims 28, 30, and 36 are withdrawn as being directed to a non-elected method invention and claims 16-19 are further withdrawn as being directed to a non-elected species.
Claims 1, 3-5, 7-14 , and 24 have been examined.
Priority
This application is a 371 of PCT/US2022/012253 01/13/2022
PCT/US2022/012253 has PRO 63/137,354 01/14/2021
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/20/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 10, 12, and 14 are objected to because of the following informalities:
Claim 10 is objected to because the phrase “at least one instance of K, E, or D is substituted with -L1-PEG” should be revised to “at least one of K, E, or D is substituted with -L1-PEG” by deleting the word of “instance”.
Claim 12 is objected to because the phrase “between 20 and 3,500, inclusive” should be revised to “between 20 and 3,500” by deleting the comma “,” and the word of “inclusive”.
Claim 14 is objected to because the limitations of m and p should be revised to
“m is an integer between 0 and 20” and “p is an integer between 1 and 20”
Appropriate correction is required.
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.
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.
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.
1. Claims 1, 3-5, 7-9, 14, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Cummings et al. (US 2016/0108092 A1) in view of Veronese (Biomaterials 22 (2001) 405-417).
PNG
media_image2.png
404
744
media_image2.png
Greyscale
Claim 1 is drawn to a conjugate of PEG-(L1)-Y1X1Y2X2X3Y3 X4X5X6Z1 X7W1 (SEQ ID NO: 1).
Cummings et al. teach selectin inhibitors, compositions, and methods of using the compositions (Abstract). Cummings et al. teach the selectin inhibitor formula of SEQ ID NO: 1 (Y1X1Y2X2X3Y3 X4X5X6Z1 X7W1) [0009, claim 1] and definition of each variables [0011-0013]. Cummings et al. show the peptide sequences of SEQ ID NO; 2-12 [0082, claim 12] including the elected glycopeptide peptide species of SEQ ID NO: 12 [0083-0086].
Cummings et al. did not specify the glycopeptide further conjugating to PEG via a spacer.
PNG
media_image3.png
486
461
media_image3.png
Greyscale
Veronese teaches peptide and protein PEGylation (Title). Veronese teaches advantages of PEG conjugation comprising increase of the molecular size of the polypeptide to reduce its renal ultrafiltration, reducing the degradation by proteolytic enzymes and modifying biodistribution and solubility of the PEGylated peptide (p406, col 1, para1). Veronese teaches amino groups, namely the alpha amino or the epsilon amino of lysine, are the usual sites of PEG linking (p407, col 1, para 1). Veronese shows PEGylation of peptide can be formed by Alkylating PEGs(p407, Fig 2) or Acylating PEGs (p407, Fig 3 shown above).
Because Veronese teaches advantages of PEG conjugation comprising increase of the molecular size for a small polypeptide to reduce its renal ultrafiltration, reducing the degradation by proteolytic enzymes and modifying biodistribution and solubility of the PEGylated peptide (p406, col 1, para1), one of ordinary skill in the art would have found it obvious to beneficial conjugate PEG to Cummings’s small glycopeptide to reduce renal ultrafiltration of Cummings’s small glycopeptide, reduce its degradation by proteolytic enzymes and modifying biodistribution and solubility of the PEGylated small glycopeptide.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Cummings’s glycopeptide with Veronese’s PEG because (a) Cummings’s glycopeptides Seq ID Nos: 1-12 are short and small peptide and (b) Veronese teaches benefits of PEGylation comprising (i) increase of the molecular size for a small polypeptide to reduce its renal ultrafiltration, (ii) reducing the degradation by proteolytic enzymes and (iii) modifying biodistribution and solubility of the PEGylated peptide (p406, col 1, para1). The combination would have reasonable expectation of success because Veronese shows PEGylation of peptide can be formed by Alkylating PEGs(p407, Fig 2) or Acylating PEGs (p407, Fig 3).
With respect to claims 1, 3-5, and 9, Cummings et al. teach the selectin inhibitor formula of SEQ ID NO: 1 (Y1X1Y2X2X3Y3 X4X5X6Z1 X7W1) [0009, claim 1] with defined variables [0011-0013]. Cummings et al. further show the elected glycopeptide peptide species of SEQ ID NO: 12 [0083-0086].
With respect to claim 7, Cummings et al. teach saccharide structure as follows.
2-(acetylamino)-2-deoxy-galactose alpha 1 bonded to W1 [0073]
a first galactose beta 3 bonded to 2-(acetylamino)-2-deoxy-galactose [0074]
2-(acetylamino)-2-deoxy-glucose beta 6 bonded to 2-(acetylamino)-2-deoxy-galactose [0075]
fucose alpha 3 bonded to 2-(acetylamino)-2-deoxyglucose [0078]
a second galactose beta 4 bonded to 2-(acetylamino)-2-deoxy-glucose [0076], and
5-acetamido-3,5-dideoxy-glycero-galacto-2-nonulosonic acid is alpha 3 bonded to the second galactose [0077]
With respect to claim 8, Cummings et al. teach the polysaccharide is sialyl Lewis X or sialyl Lewis A [0047].
With respect to claims 10-11, Veronese teaches amino groups, namely the alpha amino or the epsilon amino of lysine, are the usual sites of PEG linking (p407, col 1, para 1). It is noted that the elected peptide species of SEQ ID NO: 12 has only a single N-terminal lysine residue comprising amine groups.
With respect to claim 14, Veronese shows PEGylation peptide comprising a linking moiety of C(O) moiety and m=0 in Fig. 3 (p407).
With respect to claim 24, Cummings et al. teach the composition comprising a glycopeptides and a pharmaceutically acceptable excipient [0101].
2. Claims 1, 3-5, 7-9, 13-14, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Cummings et al. in view of Veronese as applied to claims 1, 3-5, 7-9, 14, 24 and further in view of Roberts et al. (Advanced Drug Delivery Reviews 54 (2002) 459–476).
Claim 13 is drawn to the PEG terminates in one or more hydroxy or alkoxy end groups.
Cummings et al. in view of Veronese teach a PEGylated glycopeptide composition as applied to claims 1, 3-5, 7-9, 14, and 24.
Cummings et al. in view of Veronese did not specify the PEG terminates in one or more hydroxy or alkoxy end groups.
Similarly, Roberts et al. teach that PEG conjugation increases the apparent size of the polypeptide, thus reducing the renal filtration and altering biodistribution as well as prevents recognition and degradation by proteolytic enzymes well known in the art (Abstract). Roberts et al. teach the most common reactive groups involved in coupling PEG to a peptide are the alpha or epsilon amino groups of lysine for PEGylation well-known in the art (p462, col 2, 3.1.1. PEG chemistry for amine conjugation) shown in Fig. 1 (p463), consistent with Veronese’s teaching above. Roberts et al. teach most common form poly(ethylene glycol), PEG, is a linear or branched polyether terminated with hydroxyl groups and most useful for polypeptide modification is monomethoxy PEG, mPEG, as CH3O-(CH2CH2O)n-CH2CH2-OH (p460, col 2, 2. Properties of PEG).
Because Roberts et al. teach most common form poly(ethylene glycol), PEG, is a linear or branched polyether terminated with hydroxyl groups and most useful for polypeptide modification is monomethoxy PEG, mPEG, one of ordinary skill in the art would have found it obvious to use PEG terminates in either hydroxy or alkoxy (preferred) as taught by Roberts et al.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Cummings et al. in view of Veronese with Roberts’s PEG for PEGylation because (a) Cummings et al. in view of Veronese teach PEGylation of a small glycopeptide at lysine residue and (b) Roberts et al. teach PEG can terminates in either hydroxy or alkoxy but most useful for polypeptide modification is monomethoxy PEG, mPEG, (p460, col 2, 2. Properties of PEG). The combination would have reasonable expectation of success because both reference Veronese and Roberts et al. teach peptide PEGylation.
3. Claims 1, 3-5, 7-9, 12, 14, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Cummings et al. in view of Veronese as applied to claims 1, 3-5, 7-9, 14, 24 and further in view of O’Connor et al. (Molecules. 2014, 19, 17559-17577).
Claim 12 is drawn to the number of conjugated PEG monomer between 20 and 3,500.
Cummings et al. in view of Veronese teach a PEGylated glycopeptide composition as applied to claims 1, 3-5, 7-9, 14, and 24.
Cummings et al. in view of Veronese did not specify a number of conjugated PEG monomers between 20 and 3,500.
O’Connor et al. teach “Poly(Ethylene Glycol)-Based Backbones with High Peptide Loading Capacities” (Title). O’Connor et al. teach functionalised linear poly(ethylene glycol)s are utilised for peptide conjugation, to increase their potential loading capacities (Abstract). O’Connor et al. teach the repeating units of synthetic polymer (e.g., PEG) for peptide conjugate is a result effective variable depending on the peptide sequence and suggest be repeating unit of PEG can be optimized between 20 to 50 (p17560, last para to p17561, para 1), reading on claim 12.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Cummings et al. in view of Veronese with O’Connor’s teach repeating units pf PEG for peptide conjugation because (a) Cummings et al. in view of Veronese teach PEGylation of a small glycopeptide at lysine residue and (b) O’Connor et al. teach functionalised linear poly(ethylene glycol)s are utilised for peptide conjugation, to increase their potential loading capacities (Abstract). O’Connor et al. teach the repeating units of synthetic polymer (e.g., PEG) for peptide conjugate is a result effective variable depending on the peptide sequence and suggest be repeating unit of PEG can be optimized between 20 to 50 (p17560, last para to p17561, para 1). The combination would have reasonable expectation of success because both Veronese and O’Connor et al. teach peptide PEGylation.
Additional reference:
The additional reference Cummings et al. (US 7,189,828 B2 cited in IDS). The refence is also relevant to the instant claims and can be further used a prior art to demonstrate common knowledge for PEGylation of a glycopeptide including (i) Pegylation also reduces the potential antigenicity of the GSP molecule. Pegylation can also enhance the solubility of GSPs thereby improving their therapeutic effect. PEGs used may be linear or branched-chain (col 20, line 11-15), (ii) The PEG can be linked to any N-terminal amino acid of the GSP, and/or can be linked to an amino acid residue downstream of the N-terminal amino acid (col 20, 44-47), and (iii) The PEG moiety attached to the protein as a result effective variable may range in molecular weight from about 200 to 20,000 MW (col 20, line 59-63), consistent with the cited prior art teachings.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-5, 7-9, 14, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12, and 14 of U.S. Patent No. 10,253,071 B2 (the ‘071 patent, cited in IDS) in view of Cummings et al. (US 2016/0108092 A1) in view of Veronese (Biomaterials 22 (2001) 405-417).
Claims 1-3 the ‘071 patent disclosed the instant peptide formula of SEQ ID NO: 1.
Claim 4 of the ‘071 patent disclosed polysaccharide is sialyl Lewis X or sialyl Lewis A.
Claims 5-9 of the ‘071 patent disclosed the polysaccharide structures
Claim 12 of the ‘071 patent disclosed the instant glycopeptide sequences of SEQ ID Nos: 2-12.
Claim 14 of the ‘071 patent disclosed a pharmaceutical composition comprising a glycopeptide of claim 1 and a pharmaceutically acceptable excipient.
Claims 1-9, 12, and 14 the ‘071 patent did not disclose PEGylation of the glycopeptide.
The relevancy of Cummings et al. in view of Veronese as applied to claims 1, 3-5, 7-9, 14, and 24 described above not repeated here.
Because Cummings et al. in view of Veronese teach benefits of PEGylation for small peptide, one of ordinary skill in the art would have found it obvious to perform PEGylation of the small glycopeptides taught by claims 1-9, 12, and 14 the ‘071 patent.
Thus, claims 1-9, 12, and 14 the ‘071 patent in view of Cummings et al. in view of Veronese are obvious to the instant claims 1, 3-5, 7-9, 14, and 24.
Claims 1, 3-5, 7-9, 14, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 12, and 14 of U.S. Patent No. 12,162,960 B2 (the ‘960 patent) in view of Cummings et al. (US 2016/0108092 A1) in view of Veronese (Biomaterials 22 (2001) 405-417).
Claim 1 of the ‘960 patent disclosed a glycopeptide composition comprising SEQ ID Nos: 4 or 8-12.
Claim 2 of the ‘960 patent disclosed polysaccharide is sialyl Lewis X or sialyl Lewis A.
Claims 3-7 of the ‘960 patent disclosed polysaccharide structures on the glycopeptide.
Claim 11 of the ‘960 patent disclosed the elected glycopeptide sequence of Seq ID NO: 12.
Claims 1-7 and 11 the ‘960 patent did not disclose PEGylation of the glycopeptide.
The relevancy of Cummings et al. in view of Veronese as applied to claims 1, 3-5, 7-9, 14, and 24 described above not repeated here.
Because Cummings et al. in view of Veronese teach benefits of PEGylation for small peptide, one of ordinary skill in the art would have found it obvious to perform PEGylation of the small glycopeptides taught by claims 1-7 and 11 the ‘960 patent.
Thus, claims 1-7 and 11 the ‘960 patent in view of Cummings et al. and Veronese are obvious to the instant claims 1, 3-5, 7-9, 14, and 24.
Claims 1, 3-5, 7-9, 14, and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 16 of copending Application No. 18/693,494 (the ‘494 application, 3/19/2024) in view of Cummings et al. (US 2016/0108092 A1) and Veronese (Biomaterials 22 (2001) 405-417).
Claims 1 and 16 of the ‘494 application disclosed the instant glycopeptide of SEQ ID Nos: 2-12.
Claim 2 of the ‘494 application disclosed the polysaccharide structure of the glycopeptide.
Claims 1-2 and 16 the ‘494 application did not disclose PEGylation of the glycopeptide.
The relevancy of Cummings et al. in view of Veronese as applied to claims 1, 3-5, 7-9, 14, and 24 described above not repeated here.
Because Cummings et al. in view of Veronese teach benefits of PEGylation for small peptide, one of ordinary skill in the art would have found it obvious to perform PEGylation of the small glycopeptides taught by claims 1-2 and 16 the ‘494 application.
Thus, claims 1-2 and 16 the ‘494 application in view of Cummings et al. and Veronese are obvious to the instant claims 1, 3-5, 7-9, 14, and 24.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIA-HAI LEE whose telephone number is (571)270-1691. The examiner can normally be reached Mon-Fri from 9:00 AM to 6:00 PM.
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, Melissa Fisher can be reached at 571-270-7430. 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.
/J.L/Examiner, Art Unit 1658
15-January-2026
/LI N KOMATSU/ Primary Examiner, Art Unit 1658