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 office action is a response to applicant’s communication submitted November 19, 2025, wherein claims 20-34 are canceled and new claims 35-54 are introduced. This application is a continuation of US application 16/341777, now US patent 11903958, filed April 12, 2019, which is a national stage application of PCT/AU2017/051102, filed October 12, 2017, which claims benefit of provisional application 62/407109, filed October 12, 2016.
Claims 35-54 are pending in this application.
Election/Restrictions
Applicant’s provisional election without traverse of group I, drawn to a chemical compound, filed November 19, 2025, is acknowledged.
Claims 44-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 35-43 are examined on the merits herein.
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 35-42 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.
Independent claim 35 directed to a chemical compound having a specific formula (I), containing variable groups including X1, Y1, X2, and Y2. These groups are defined as connecting or capping sugars, selected from various closed lists of monosaccharides, disaccharides, and oligosaccharides. None of the listed saccharides are sulfated and the saccharides represented by these variables are not described as being either necessarily or optionally substituted with any further groups. However, claim 35 then contains a later proviso requiring that “X1, X2, Y1, and Y2 comprise one or more sulfate groups;” which contradicts the seemingly closed definitions of these variables earlier in the claim. Furthermore while paragraph 63 of the specification describes that the glycoconjugates may be optionally modified and specifically names sulfation as a possible modification, this paragraph taken in its most reasonable interpretation provides written description of conjugates having sulfated sugars, but does not redefine “glucose,” “fructose,” “galactose,” and other specific sugars named in present claim 35 in such a way as to clearly include optional modifications such as sulfation, in the absence of specific claim language indicating that the variable group includes optional modification. Furthermore while p. 4 paragraph 13 of the specification describes a similar structure wherein the variable X and Y groups are specifically described as “optionally substituted,” this terminology is not reflected in the actual pending claims. Therefore present claim 35 contains conflicting claim limitations that make it unclear what the exact definitions of the groups X1, X2, Y1, and Y2 are, and whether further substitution of the base sugars listed in the claim is permitted.
Furthermore, the limitation “X1, X2, Y1, and Y2 comprise one or more sulfate groups;” is unclear as to whether it requires that each of X1, X2, Y1, and Y2 comprises one or more sulfate groups, or whether it merely requires that these four variables in total comprise one or more sulfate groups, allowing for embodiments wherein less than all of these groups are sulfated.
For these reasons claim 35 is indefinite. Dependent claims 36-42 depend from claim 35 and do not provide further clarity as to the definitions of X1, X2, Y1, and Y2. Therefore these dependent claims are also indefinite.
For the sake of the present office action, the indefinite limitations of claim 35 will be interpreted as follows: Each of X1, X2, Y1, and Y2 is an optionally substituted saccharide from the list provided in the claim, present in furanose, pyranose, or open configurations where applicable. Furthermore at least one of these variables must be substituted with at least one sulfate ester.
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.
Claims 35, 38-40 and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Megia-Fernandez et al. (Reference included with PTO-892)
Megia-Fernanzez et al. discloses a number of chemical compounds, including compound 4j on p. 1799 table 1. This compound is seen to anticipate an embodiment of formula (I) in present claim 35 wherein L is methylene, L1 is triazolyl, L2 is a bond, X1 is 5-sulfonated glucofuranose-6-yl, X2 is glucopyranose-1-yl, and both occurrences of n are zero, thereby anticipating the present claims.
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 35, 36, 38, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Kett et al. (PCT international publication WO2010/037179, Reference cited in PTO-1449) in view of Yao et al. (Reference cited in PTO-1449)
Independent claim 35 is directed to a conjugate having the structure X1-L1-(Y1-L3)n-L-(L4-Y2)n-L2-X2. L1-L4 are defied as various specific linking groups or direct bonds, and X1, X2, Y1, and Y2 are defined as various saccharides. Furthermore, as discussed under 35 USC 112(b) the claim contains a further proviso regarding the presence of a sulfate in X1, X2, Y1, and Y2. While this limitation renders the claim indefinite, as discussed in the rejection under 35 SUC 112(b) it is presently being interpreted as allowing X1, X2, Y1, and Y2 to be optionally substituted, and requiring that one or more of these sugars be substituted with a sulfate group.
Dependent claims 36-42 further specify the identities of the particular variable groups recited in structure (I) in claim 35.
Kett et al. discloses an anionic conjugate of two or more glycosylated bacterial metabolites connected by a linking group. (p. 2 lines 10-19) Glycosylated bacterial metabolites can include acarbose. (p. 4 line 24, p. 10 top of page) A wide number of linking groups can be used to link the anionic bacterial metabolites including alkyl and alkylheteroaryl. (p. 21 lines 1-17) Anionic charge is imparted to the glycosylated metabolites by attachment of anionic groups including sulfate. (p. 40 lines 4-12) Specific sulfated acarbose conjugates are described that include sulfated saccharide groups falling within the scope of variables X1 and X2 in independent claim 35 and dependent claim 36. (p. 84 structure IE, p. 85 structures 1F-1I) Sulfated acarbose linked by triazole-containing linkers are also disclosed. (p. 101 structure 1AM1, p. 1-2 structure 1AN1) Kanamycin tetramers are also disclosed corresponding to embodiments wherein n=1. (p. 150 structure 226FF) Bacterial metabolites that can be included in these conjugates include 5’-O-alpha-D-glucopyranosyl, (p. 8 paragraph 25) which is considered to be an embodiment of “glucose” as recited in claim 35. Kett et al. does not specifically disclose conjugates wherein the linker has a structure as recited in the present claims.
Yao et al. discloses various linkers for conjugating glycosyl compounds. (p. 8182 fig. 1, p. 8183 scheme 3) These linkers include embodiments falling within the structures of L, L1, and L2 in the present claims, for example 8d, 85, and 86 in scheme 3. In particular, said structures correspond to embodiments wherein L1 and L2 are methoxymethylene triazole and L is a bond.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use one of the linkers described by Yao et al. to link the divalent conjugates described by Kett et al. One of ordinary skill in the art would have considered these linkers to be usable in the conjugates described by Kett et al. because Kett et al. generally describes conjugates using a wide variety of linkers, and furthermore discloses specific embodiments using triazole containing linkers. While Yao et al. discloses conjugates of C-glycoside compounds, one of ordinary skill in the art would have reasonably expected success in making similar conjugates using O0glycoside compounds as well.
Therefore the invention taken as a whole is prima facie obvious.
Claims 35, 36, 38, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Kett et al. (PCT international publication WO2010/037179, Reference cited in PTO-1449) in view of Andre et al. (Reference of record in PTO-892)
Independent claim 35 is directed to a conjugate having the structure X1-L1-(Y1-L3)n-L-(L4-Y2)n-L2-X2. L1-L4 are defied as various specific linking groups or direct bonds, and X1, X2, Y1, and Y2 are defined as various saccharides. Furthermore, as discussed under 35 USC 112(b) the claim contains a further proviso regarding the presence of a sulfate in X1, X2, Y1, and Y2. While this limitation renders the claim indefinite, as discussed in the rejection under 35 SUC 112(b) it is presently being interpreted as allowing X1, X2, Y1, and Y2 to be optionally substituted, and requiring that one or more of these sugars be substituted with a sulfate group.
Dependent claims 36-42 further specify the identities of the particular variable groups recited in structure (I) in claim 35.
Kett et al. discloses an anionic conjugate of two or more glycosylated bacterial metabolites connected by a linking group. (p. 2 lines 10-19) Glycosylated bacterial metabolites can include acarbose. (p. 4 line 24, p. 10 top of page) A wide number of linking groups can be used to link the anionic bacterial metabolites including alkyl and alkylheteroaryl. (p. 21 lines 1-17) Anionic charge is imparted to the glycosylated metabolites by attachment of anionic groups including sulfate. (p. 40 lines 4-12) Specific sulfated acarbose conjugates are described that include sulfated saccharide groups falling within the scope of variables X1 and X2 in independent claim 35 and dependent claim 36. (p. 84 structure IE, p. 85 structures 1F-1I) Sulfated acarbose linked by triazole-containing linkers are also disclosed. (p. 101 structure 1AM1, p. 1-2 structure 1AN1) Kanamycin tetramers are also disclosed corresponding to embodiments wherein n=1. (p. 150 structure 226FF) Bacterial metabolites that can be included in these conjugates include 5’-O-alpha-D-glucopyranosyl, (p. 8 paragraph 25) which is considered to be an embodiment of “glucose” as recited in claim 35. Kett et al. does not specifically disclose conjugates wherein the linker has a structure as recited in the present claims.
André et al. discloses synthetic glycoconjugates including a bivalent conjugate having a linker falling within the scope of L, L1, and L2 in present claims 35 and 38-40. (p. 4355 scheme 1 compound 5) In particular this linker corresponds to an embodiment wherein L1 and L2 are methylene triazole ethylene, and L is ethylene glycol.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use one of the linkers described by André et al. to link the divalent conjugates described by Kett et al. One of ordinary skill in the art would have considered these linkers to be usable in the conjugates described by Kett et al. because Kett et al. generally describes conjugates using a wide variety of linkers, and furthermore discloses specific embodiments using triazole containing linkers. As a result, one of ordinary skill in the art would have looked to any existing linkers comprising triazole groups for use in the generic structure recited by Kett et al., and expected success in making Kett’s conjugates using these linkers.
Therefore the invention taken as a whole is prima facie obvious.
Claims 35, 36, 38, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Kett et al. (PCT international publication WO2010/037179, Reference cited in PTO-1449) in view of Alix et al. (Reference of record in PTO-892)
Independent claim 35 is directed to a conjugate having the structure X1-L1-(Y1-L3)n-L-(L4-Y2)n-L2-X2. L1-L4 are defied as various specific linking groups or direct bonds, and X1, X2, Y1, and Y2 are defined as various saccharides. Furthermore, as discussed under 35 USC 112(b) the claim contains a further proviso regarding the presence of a sulfate in X1, X2, Y1, and Y2. While this limitation renders the claim indefinite, as discussed in the rejection under 35 SUC 112(b) it is presently being interpreted as allowing X1, X2, Y1, and Y2 to be optionally substituted, and requiring that one or more of these sugars be substituted with a sulfate group.
Dependent claims 36-42 further specify the identities of the particular variable groups recited in structure (I) in claim 35.
Kett et al. discloses an anionic conjugate of two or more glycosylated bacterial metabolites connected by a linking group. (p. 2 lines 10-19) Glycosylated bacterial metabolites can include acarbose. (p. 4 line 24, p. 10 top of page) A wide number of linking groups can be used to link the anionic bacterial metabolites including alkyl and alkylheteroaryl. (p. 21 lines 1-17) Anionic charge is imparted to the glycosylated metabolites by attachment of anionic groups including sulfate. (p. 40 lines 4-12) Specific sulfated acarbose conjugates are described that include sulfated saccharide groups falling within the scope of variables X1 and X2 in independent claim 35 and dependent claim 36. (p. 84 structure IE, p. 85 structures 1F-1I) Sulfated acarbose linked by triazole-containing linkers are also disclosed. (p. 101 structure 1AM1, p. 1-2 structure 1AN1) Kanamycin tetramers are also disclosed corresponding to embodiments wherein n=1. (p. 150 structure 226FF) Bacterial metabolites that can be included in these conjugates include 5’-O-alpha-D-glucopyranosyl, (p. 8 paragraph 25) which is considered to be an embodiment of “glucose” as recited in claim 35. Kett et al. does not specifically disclose conjugates wherein the linker has a structure as recited in the present claims.
Alix et al. discloses synthetic glycoconjugates including a bivalent conjugate having a linker falling within the scope of L, L1, and L2 in the present claims, that is the same as the one used in the fifth compound recited in present claim 27. (p. 8925 table 4 compounds 3-4) In particular this linker corresponds to an embodiment wherein L1 and L2 are methylene triazole ethylene, and L is a bond.
It would have been obvious to one of ordinary skill in the art at the time of the invention to use one of the linkers described by Alix et al. to link the divalent conjugates described by Kett et al. One of ordinary skill in the art would have considered these linkers to be usable in the conjugates described by Kett et al. because Kett et al. generally describes conjugates using a wide variety of linkers, and furthermore discloses specific embodiments using triazole containing linkers. As a result, one of ordinary skill in the art would have looked to any existing linkers comprising triazole groups for use in the generic structure recited by Kett et al., and expected success in making Kett’s conjugates using these linkers.
Therefore the invention taken as a whole is prima facie obvious.
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 35-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11903958. (Cited in PTO-892, herein referred to as
‘958) Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘958 recites five chemical structures that fall within the scope of present claims 35-43, anticipating said claims.
Claims 35-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 16 of copending Application No. 19/498415 (reference application, unpublished, cited in PTO-892, herein referred to as ‘415). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 16 of ‘415 recite structures falling within the present claims, and in particular which are the same as structures appearing in present claim 43, for example structures (IX) or (XII) in claim 16 of ‘415.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 35-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of copending Application No. 19/498419 (reference application, unpublished, cited in PTO-892, herein referred to as ‘419). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 13 of ‘419 recite structures falling within the present claims, and in particular which are the same as structures appearing in present claim 43, for example structure (VI) in claim 13 of ‘419.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed in this action.
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 1/9/2026