DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-36 have been canceled.
Claims 37-46 are pending and under examination.
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 37-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11846634. Although the claims at issue are not identical, they are not patentably distinct from each other because 634’ patent also recites a method of mass spectrometric imaging of mass-tag comprising providing compounds having mass-tag linked to a photocleavable linker attached to a probe, said probe bound to a surface, then by illuminating said mass-tag with light so as to photocleave at least a portion of the mass-tag from said surface, wherein said photocleavable mass-tags have a terminal amine group followed by applying a matrix-assisted laser desorption ionizing mass spectrometry imaging on said surface. 634’ also recites that the probe can be of antibodies, proteins or nucleic acids.
Claims 42-43, 46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11906527. Although the claims at issue are not identical, they are not patentably distinct from each other because 527’ patent also recites a method of mass spectrometric imaging of mass-tag comprising providing compounds (detailed chemical structure shown in claim 1) having mass-tag linked to a photocleavable linker attached to an antibody probe, then by illuminating said mass-tag with light so as to photocleave at least a portion of the mass-tag from said surface followed by illuminating light for mass spectrometry imaging. The method places a tissue samples on a slide provides motivation for one ordinary skilled person in the art to have the mass-photocleavable tag conjugated probes immobilized on a microscope in order to identify and localize the target antigen(s0 recognized by the antibody probe on the tissue. Note, claim 45 is rejected on the ground of nonstatutory double patenting as being unpatentable over 527’ patent in view of Chen (US 20020146743) because using isotope-amino acid for mass tag analysis provide better specificity and sensitivity (see below prior art rejection).
Claims 42-43, 45-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 12078639. Although the claims at issue are not identical, they are not patentably distinct from each other because 639’ patent also recites a method of mass spectrometric imaging of mass-tag comprising providing compounds (detailed chemical structure shown in claim 1) having mass-tag linked to a photocleavable linker attached to an antibody probe then by illuminating said mass-tag with light so as to photocleave at least a portion of the mass-tag from said surface followed by applying light illuminating for mass spectrometry imaging. Note, claim 45 is rejected on the ground of nonstatutory double patenting as being unpatentable over 639’ patent in view of Chen (US 20020146743) because using isotope-amino acid for mass tag analysis provide better specificity and sensitivity (see below prior art rejection).
Claims 42-43, 45-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 12181481. Although the claims at issue are not identical, they are not patentably distinct from each other because 481’ patent also recites a method of mass spectrometric imaging of mass-tag comprising providing compounds (detailed chemical structure shown in claim 1) having mass-tag linked to a photocleavable linker attached to an antibody or nucleic acid probe then by illuminating said mass-tag with light so as to photocleave at least a portion of the mass-tag followed by illuminating light for mass spectrometry imaging on said surface. The method places a tissue samples on a slide (claims 6-11) provides motivation for one ordinary skilled person in the art to have the mass-photocleavable tag conjugated probes immobilized on a microscope in order to identify and localize the target antigen(s0 recognized by the antibody probe on the tissue. Note, claim 45 is rejected on the ground of nonstatutory double patenting as being unpatentable over 481’ patent in view of Chen (US 20020146743) because using isotope-amino acid for mass tag analysis provide better specificity and sensitivity (see below prior art rejection).
Claims 42-43, 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of US patent No. 11940447 because 447’ patent also recites using mass spectrometry imaging method having nucleic probes (DNA or RNA) conjugated with a photocleavable mass-tag compounds (chemical structure as shown in claim 1)attached to a surface followed by illuminating of UV light source and then detecting imaging from mass-tag spectrometry.
Claims 42-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 12-13, 15-20 of copending Application No. 17399434 because 434’ application also recites using mass spectrometry imaging method having carbohydrate-binding protein probes conjugated with a photocleavable mass-tag compounds (chemical structure as shown in claim 1) attached to a surface followed by illuminating of UV light source and then detecting imaging from mass-tag spectrometry. This is a provisional nonstatutory double patenting rejection. The method places a tissue samples on a slide (claim 6) provides motivation for one ordinary skilled person in the art to have the mass-photocleavable tag conjugated probes immobilized on a microscope in order to identify and localize the target antigen(s) recognized by the antibody probe on the tissue.
Claims 42-43, 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-43 of copending Application No. 18495089 because 089’ application also recites using mass spectrometry imaging method having antibody probes conjugated with a photocleavable mass-tag compounds (chemical structure as shown in claim 1)attached to a surface followed by illuminating of light source and then detecting imaging from mass-tag spectrometry. The method places a tissue samples on a slide (claim 35) provides motivation for one ordinary skilled person in the art to have the mass-photocleavable tag conjugated probes immobilized on a microscope in order to identify and localize the target antigen(s) recognized by the antibody probe on the tissue. This is a provisional nonstatutory double patenting rejection.
Claims 42 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 36-38 of copending Application No. 18678276 because 276’ application also recites using mass spectrometry imaging method having nucleic acid probes conjugated with a photocleavable mass-tag compounds (chemical structure as shown in claim 1)attached to a surface followed by illuminating of light source and then detecting imaging from mass-tag spectrometry. This is a provisional nonstatutory double patenting rejection.
Claims 42 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33-48 of copending Application No. 18946328 because 328’ application also recites using mass spectrometry imaging method having nucleic acid or antibody probes conjugated with a photocleavable mass-tag compounds followed by illuminating of light source and then detecting imaging from mass-tag spectrometry. This is a provisional nonstatutory double patenting rejection.
Claims 42-43 and 45-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 19216026 because 026’ application also recites using mass spectrometry imaging method having nucleic acid probes or antibody probes (claims 10 and 25) conjugated with a photocleavable mass-tag compounds followed by illuminating of UV light source and then detecting imaging from mass-tag spectrometry. This is a provisional nonstatutory double patenting rejection.
Claims 42-43, 45-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of copending Application No. 19369929 because 929’ application also recites using mass spectrometry imaging method having antibody probes conjugated with a photocleavable mass-tag (claim 22) compounds followed by illuminating of UV light source and then detecting imaging from mass-tag spectrometry. This is a provisional nonstatutory double patenting rejection.
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.
Claim 46 is 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.
As to claim 46, the term “said probe” lacks antecedent basis since no “probe” is in claim 42. Examiner would consider a probe is attached to the photocleavable mass tag.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim 42-43 and 46 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thiery (Proteomics 2008 Vol. 8, page 3725-3734) in view of Chaurand (US 20080113875).
The current invention directs to a method of mass spectrometric imaging of mass-tag. The method comprise (a) providing a mass-tag comprising a photocleavable linker; (b) illuminating said mass-tag wit light so as to photocleave a portion of said mass tag, and (c ) performing mass spectrometry imaging on the photocleaved mass-tag. As to the above 35USC 112(b) rejection, the “said probe” in dependent claim 46 is considered part of the mass-tag. Thus claim 42 (a) reads “providing mass-tags comprising a linker, at least a portion of said linker being photocleavable, wherein said linker attached to a probe”.
Thiery teaches a method of TArgeted multiplex MS IMaging (TAMSIM) for tissue detection (see Title and Abstract). Under section “2.4 Immunohistochemistry with Photocleavable Tags”, Thiery teaches conjugating photocleavable mass-tag with antibody, and the mass is released by laser followed by scanning MS images for the mass-tag (see Abstract; page 3276, left column, 4th paragraph). Thiery uses photocleavable mass tag (see Materials and Methods, page 3726, right column). However Thiery does not teach using photocleavable linker linked the mass tag.
Chaurand teaches using photocleavable linker linked with mass tag followed by mass spectrometry detection (see Figure 1).
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The different diamond shapes are different mass tags linked to antibody by photocleavable linker. The mass tags are released by laser light (hv) and each mass tag can be identified by mass spectrometry.
Chaurand teaches a variety of mass tags for different uses, including polymer, positive or negative functional groups, or amino acid peptide (section 0010, 0045). Chaurand teaches that using peptide tag has advantages of easy to synthesize and have enough structural diversity so that the individual members of a probe library could each have a unique peptide-based MS tag (section 0045).
Therefore, it would have been prima facie obvious to one ordinary skilled person in the art before the filing date of the invention to motivate Thiery to use photocleavable linker-mass tag probe as taught by Chaurand for detection target molecules in a sample for taking the advantages of more diverse varieties of amino acid mass tags (compared to the only three photocleavable mass tags, i.e. EI 307, EI 308 and JC14-110; see Thiery “Tag Synthesis”, page 3726 right column). Moreover, the peptide-mass is easy to synthesize and cost less.
As to claim 46, the probe can be an antibody (see above Figure 1 of Chaurand, and “Materials and Methods” of Thiery).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim 45 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thiery in view of Chaurand as applied to claim 42-43 and 46 above, and further in view of Chen (US 20020146743).
Thiery and Chaurand references have been discussed above, but no explicit teaching in using isotope-labeled amino acid for mass tag is mentioned.
Chen teaches using isotope-labeled amino acid for mass tag in mass spectrometry analysis. Such modification would provide advantages in increasing data search specificity, efficiency and accuracy for peptide sequencing and protein identification (section 0014).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made, such as Thiery to adapt method of using isotope-labeled amino acid as taught by Chen to optimize data search specificity, efficiency and accuracy for peptide sequencing and protein identification.
Claims 37-41 and 44 are free of prior art because no prior art teaches or fairly suggests a method of mass spectrometry imaging using mass-tags linked to a photocleavable linker attached to a probe bound to a surface (claim 44 on a microscope) and the performing mass spectrometric imaging on the released mass tag is on said surface. The above combined prior arts Thiery and Chaurand do not teach or suggest having a probe bound to a surface. Rather Thiery teaches directly binding the mass-tag conjugated antibody to the target tissue where antibody is not linked to a surface. Moreover, Thiery does not teach performing mass spectrometric imaging of the released mass tag is on said surface. Rather Thiery performing mass spectrometry imaging on the tissue.
Conclusion
No claim is allowed.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/Primary Examiner, Art Unit 1678