DETAILED ACTION
Status of the Claims
Claims 104-123 are currently pending and are examined herein.
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/08/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 104-123 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 pre-AIA the applicant regards as the invention.
Claim 104 recites a composition comprising a cleavable linker, “wherein said cleavable linker is cleaved by a disease-associated protease”, which can reasonably be interpreted as reciting a product (a “composition”) and a process (“is cleaved”) in the same claim. As per MPEP § 2173.05(p), “[a] single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.” Accordingly, the metes and bounds of the claim are unascertainable. Claims 105-123 depend from claim 104 and are therefore similarly rejected.
In the interest of compact prosecution and for the application of prior art rejections, the claims will instead be interpreted herein as though the limitations of cleavage are limitations of intended use. That is, the composition will be interpreted as having a cleavable linker that can be cleaved in vivo, in vitro, and/or ex vivo.
Claim 110 recites that the disease-associated protease is selected from a group that contains tissue factor, however, it is noted that tissue factor does not appear to be a protease, but rather a membrane-bound cytokine receptor. Therefore, the metes and bounds of the claim are unascertainable.
As per MPEP 2173: It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art of the boundaries of protected subject matter. Therefore, claims that do not meet this standard must be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph as indefinite. Further, as per MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. As currently written, the metes and bounds of the rejected claims are unascertainable for the reasons set forth above, thus the above claim(s) and all dependent claims are rejected under 35 USC 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim Rejections – 35 U.S.C. 102
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Chait et al.
Claims 104-123 are rejected under 35 U.S.C. 102(b) as being anticipated by Chait et al. (U.S. 6,824,981 B2).
Regarding claims 104-106, Chait discloses a composition comprising a plurality of isotope-labeled molecules wherein each isotope-labeled molecule of said plurality of isotope-labeled molecules comprises a carrier (e.g., carriers as per col. 63-64, which associate a carrier, binding molecule(s) and reporter signals) and a mass tag (e.g., isobaric peptide mass tag as per Table 2 on col. 141-142) conjugated to said carrier via a cleavable linker (e.g., peptide mass tags of Table 2 end with arginine residues, which can be fused inline with proteins/peptide, as per col. 10+, thus creating a trypsin cleavage site), wherein said cleavable linker is cleaved by a disease-associated protease (e.g., trypsin).
Regarding claim 107, Chait discloses the above composition, wherein said isotope-labeled molecules are configured for use in mass spectrometry (MS) (e.g., as per col. 37).
Regarding claim 108, Chait discloses the above composition, wherein said isotope-labeled molecules are configured for use in liquid-chromatography mass spectrometry (LC-MS) (e.g., as per col. 37).
Regarding claim 109, Chait discloses the above composition, wherein said isotope-labeled molecules are configured for use in tandem mass spectrometry (MS/MS) (e.g., as per col. 37).
Regarding claims 111-114, Chait discloses the above composition, wherein each isotope-labeled molecules of said plurality of isotope-labeled molecules is the same (e.g., reporter signals and fusions thereof can be single as per col. 53) or wherein said plurality of isotope-labeled molecules comprises at least 20 different mass tag-conjugated cleavable linkers (e.g., reporter signals and fusions thereof can number several in a set, as per col. 53).
Regarding claims 115-117, Chait discloses the above composition, wherein said cleavage occurs in vivo, in vitro, or ex vivo (e.g., the composition of Chait comprises a peptide sequence which can be cleaved as detailed above).
Regarding claims 118-119, Chait discloses the above composition, wherein said carrier comprises a microparticle or a nanoparticle (e.g., carrier can be a nanoparticle or microparticle as per col. 63-64).
Regarding claims 120-121, Chait discloses the above composition, wherein said carrier further comprises a binding agent that is selected from a group consisting of an antibody, an antibody fragment, an aptamer, and an adnectin (e.g., binding molecule can be antibodies as per col. 48).
Regarding claim 122, Chait discloses the above composition, wherein said cleavable linker comprises a peptide (e.g., as per Table 2).
Regarding claim 123, Chait discloses the above composition, wherein each isotope-labeled molecule of said plurality of isotope-labeled molecules further comprises a reactive chemical moiety (e.g., “a reporter signal can be coupled to an analyte via reactive groups” asper col. 6).
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
U.S. 11,519,905 B2
Claims 104-105, 107-110, 115-121, and 123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 16-17 of U.S. Patent No. 11,519,905 B2 (the ‘905 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 104, the claims of the ‘905 patent disclose a composition comprising a plurality of isotope-labeled molecules wherein each isotope-labeled molecule of said plurality of isotope-labeled molecules comprises a carrier, and a mass tag conjugated to said carrier via a cleavable linker, wherein said cleavable linker is cleaved by a disease-associated protease (e.g., claim 1 of the ‘905 patent).
Regarding claim 105, the claims of the ‘905 patent disclose the above composition, wherein said mass tag comprises an isobaric mass tag (e.g., claim 5 of the ‘905 patent).
Regarding claim 107, the claims of the ‘905 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in mass spectrometry (MS) (e.g., claim 5 of the ‘905 patent).
Regarding claim 108, the claims of the ‘905 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in liquid-chromatography mass spectrometry (LC-MS) (e.g., claim 5 of the ‘905 patent).
Regarding claim 109, the claims of the ‘905 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in tandem mass spectrometry (MS/MS) (e.g., claim 5 of the ‘905 patent).
Regarding claim 110, the claims of the ‘905 patent disclose the above composition, wherein said disease-associated protease is selected from the group consisting of MMP2, MMP7, MMP9, MMP12, MMP14, tissue factor, factor Xa, cathepsin, and thrombin (e.g., claim 4 of the ‘905 patent).
Regarding claims 115-117, the claims of the ‘905 patent disclose the above composition, wherein said cleavage occurs in vivo, in vitro, or ex vivo (e.g., claim 1 of the ‘905 patent).
Regarding claims 118-119, the claims of the ‘905 patent disclose the above composition, wherein said carrier comprises a microparticle or a nanoparticle (e.g., claim 16 of the ‘905 patent).
Regarding claims 120-121, the claims of the ‘905 patent disclose the above composition, wherein said carrier further comprises a binding agent that is selected from a group consisting of an antibody, an antibody fragment, an aptamer, and an adnectin (e.g., claim 16 of the ‘905 patent).
Regarding claim 123, the claims of the ‘905 patent disclose the above composition, wherein each isotope-labeled molecule of said plurality of isotope-labeled molecules further comprises a reactive chemical moiety (e.g., claim 1 of the ‘905 patent).
U.S. 10,006,916 B2
Claims 104-109, 111-117, and 122-123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,006,916 B2 (the ‘916 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 104, The claims of the ‘916 patent disclose a composition comprising a plurality of isotope-labeled molecules wherein each isotope-labeled molecule of said plurality of isotope-labeled molecules comprises a carrier, and a mass tag conjugated to said carrier via a cleavable linker, wherein said cleavable linker is cleaved by a disease-associated protease (e.g., iCOREs as per claim 1 of the ‘916 patent).
Regarding claim 105, The claims of the ‘916 patent disclose the above composition, wherein said mass tag comprises an isobaric mass tag (e.g., as per claim 3 of the ‘916 patent).
Regarding claim 106, The claims of the ‘916 patent disclose the above composition, wherein said mass tag comprises a peptide mass tag (e.g., as per claim 4 of the ‘916 patent).
Regarding claim 107, The claims of the ‘916 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in mass spectrometry (MS) (e.g., as per claim 9 of the ‘916 patent).
Regarding claim 108, The claims of the ‘916 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in liquid-chromatography mass spectrometry (LC-MS) (e.g., as per claim 9 of the ‘916 patent).
Regarding claim 109, The claims of the ‘916 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in tandem mass spectrometry (MS/MS) (e.g., as per claim 9 of the ‘916 patent).
Regarding claim 111, The claims of the ‘916 patent disclose the above composition, wherein each isotope-labeled molecules of said plurality of isotope-labeled molecules is the same (e.g., as per claim 6 of the ‘916 patent).
Regarding claims 112-114, The claims of the ‘916 patent disclose the above composition, wherein said plurality of isotope-labeled molecules comprises at least 20 different mass tag-conjugated cleavable linkers (e.g., as per claim 18 of the ‘916 patent).
Regarding claims 115-117, The claims of the ‘916 patent disclose the above composition, wherein said cleavage occurs in vivo, in vitro, or ex vivo (e.g., as per claim 1 of the ‘916 patent).
Regarding claim 122, The claims of the ‘916 patent disclose the above composition, wherein said cleavable linker comprises a peptide (e.g., as per claim 13 of the ‘916 patent).
Regarding claim 123, The claims of the ‘916 patent disclose the above composition, wherein each isotope-labeled molecule of said plurality of isotope-labeled molecules further comprises a reactive chemical moiety (e.g., as per claim 1 of the ‘916 patent).
U.S. 11,549,947 B2
Claims 104-109, 111-117, and 122-123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-15 of U.S. Patent No. 11,549,947 B2 (the ‘947 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 104, The claims of the ‘947 patent disclose a composition comprising a plurality of isotope-labeled molecules wherein each isotope-labeled molecule of said plurality of isotope-labeled molecules comprises a carrier, and a mass tag conjugated to said carrier via a cleavable linker, wherein said cleavable linker is cleaved by a disease-associated protease (e.g., iCOREs as per claim 5 of the ‘947 patent).
Regarding claim 105, The claims of the ‘947 patent disclose the above composition, wherein said mass tag comprises an isobaric mass tag (e.g., iCOREs as per claim 5 of the ‘947 patent).
Regarding claim 106, The claims of the ‘947 patent disclose the above composition, wherein said mass tag comprises a peptide mass tag (e.g., as per claim 7 of the ‘947 patent).
Regarding claim 107, The claims of the ‘947 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in mass spectrometry (MS) (e.g., as per claim 5 of the ‘947 patent).
Regarding claim 108, The claims of the ‘947 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in liquid-chromatography mass spectrometry (LC-MS) (e.g., as per claim 5 of the ‘947 patent).
Regarding claim 109, The claims of the ‘947 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in tandem mass spectrometry (MS/MS) (e.g., as per claim 5 of the ‘947 patent).
Regarding claim 111, The claims of the ‘947 patent disclose the above composition, wherein each isotope-labeled molecules of said plurality of isotope-labeled molecules is the same (e.g., as per claim 5 of the ‘947 patent).
Regarding claims 112-114, The claims of the ‘947 patent disclose the above composition, wherein said plurality of isotope-labeled molecules comprises at least 20 different mass tag-conjugated cleavable linkers (e.g., as per claim 15 of the ‘947 patent).
Regarding claims 115-117, The claims of the ‘947 patent disclose the above composition, wherein said cleavage occurs in vivo, in vitro, or ex vivo (e.g., as per claim 5 of the ‘947 patent).
Regarding claim 122, The claims of the ‘947 patent disclose the above composition, wherein said cleavable linker comprises a peptide (e.g., as per claim 5 of the ‘947 patent).
Regarding claim 123, The claims of the ‘947 patent disclose the above composition, wherein each isotope-labeled molecule of said plurality of isotope-labeled molecules further comprises a reactive chemical moiety (e.g., as per claim 5 of the ‘947 patent).
U.S. 12,320,801 B2
Claims 104-123 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,320,801 B2 (the ‘801 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 104, the claims of the ‘801 patent disclose a composition comprising a plurality of isotope-labeled molecules wherein each isotope-labeled molecule of said plurality of isotope-labeled molecules comprises a carrier, and a mass tag conjugated to said carrier via a cleavable linker, wherein said cleavable linker is cleaved by a disease-associated protease (e.g., as per claims 1 and 6 of the ‘801 patent).
Regarding claim 105, the claims of the ‘801 patent disclose the above composition, wherein said mass tag comprises an isobaric mass tag (e.g., iCOREs as per claim 8 of the ‘801 patent).
Regarding claim 106, the claims of the ‘801 patent disclose the above composition, wherein said mass tag comprises a peptide mass tag (e.g., as per claim 6 of the ‘801 patent).
Regarding claim 107, the claims of the ‘801 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in mass spectrometry (MS) (e.g., as per claim 1 of the ‘801 patent).
Regarding claim 108, the claims of the ‘801 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in liquid-chromatography mass spectrometry (LC-MS) (e.g., as per claim 1 of the ‘801 patent).
Regarding claim 109, the claims of the ‘801 patent disclose the above composition, wherein said isotope-labeled molecules are configured for use in tandem mass spectrometry (MS/MS) (e.g., as per claim 1 of the ‘801 patent).
Regarding claim 110, the claims of the ‘801 patent disclose the above composition, wherein said disease-associated protease is selected from the group consisting of MMP2, MMP7, MMP9, MMP12, MMP14, tissue factor, factor Xa, cathepsin, and thrombin (e.g., as per claim 7 of the ‘801 patent).
Regarding claim 111, the claims of the ‘801 patent disclose the above composition, wherein each isotope-labeled molecules of said plurality of isotope-labeled molecules is the same (e.g., as per claim 1 of the ‘801 patent).
Regarding claims 112-114, the claims of the ‘801 patent disclose the above composition, wherein said plurality of isotope-labeled molecules comprises at least 20 different mass tag-conjugated cleavable linkers (e.g., as per claim 15 of the ‘801 patent).
Regarding claims 115-117, the claims of the ‘801 patent disclose the above composition, wherein said cleavage occurs in vivo, in vitro, or ex vivo (e.g., as per claim 1 of the ‘801 patent).
Regarding claims 118-119, the claims of the ‘801 patent disclose the above composition, wherein said carrier comprises a microparticle or a nanoparticle (e.g., as per claim 5 of the ‘801 patent).
Regarding claims 120-121, the claims of the ‘801 patent disclose the above composition, wherein said carrier further comprises a binding agent that is selected from a group consisting of an antibody, an antibody fragment, an aptamer, and an adnectin (e.g., as per claim 6 of the ‘801 patent).
Regarding claim 122, the claims of the ‘801 patent disclose the above composition, wherein said cleavable linker comprises a peptide (e.g., as per claim 6 of the ‘801 patent).
Regarding claim 123, the claims of the ‘801 patent disclose the above composition, wherein each isotope-labeled molecule of said plurality of isotope-labeled molecules further comprises a reactive chemical moiety (e.g., as per claim 1 of the ‘801 patent).
Conclusion
No claims are allowed.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684