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 .
Status of Claims
Claims 1-5, 7-9, 11-14, 17, 19, 21, and 39-42 are pending in this application. Claims 1-3 remain withdrawn, Claims 6 and 15-16 are cancelled and Claims 21, 4, 5, 7-9, 11-14, 17, 19, 39-42 have been examined on the merits.
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 21, 4, 5, 7-9, 11-14, 17, 19, 39-42 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.
Claim 21 recites the limitation “wherein the amyloid-reactive agent or detection dye is configured for uptake by amyloid in a first organ, and at least one of a blood pool and a second organ and calculation of an organ to blood ratio…”. It is unclear whether the dye or agent is being used for completing the additional steps of calculation, or what else may complete such steps. For purposes of examination, the limitation will be construed as the detection dye or amyloid-reactive agent being configured for the uptake and calculation of the steps. However, further clarification is required.
All remaining claims are rejected due to their dependency to independent claim 21.
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 21, 4-5, 7-9, 14, 17, 19, 39, and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Wall (WO2016032949A1, disclosed in Applicant’s IDS) in view of Antoni (“In Vivo Visualization of Amyloid Deposits in the Heart with 11C-PIB and PET”, 2013, The Journal of Nuclear Medicine, 54(2) 213-220).
Regarding Claim 21,
Wall teaches A kit for diagnosing a type of amyloid disease comprising an amyloid-reactive agent or detection dye, wherein the amyloid-reactive agent or detection dye is configured for uptake by amyloid in a first organ, and at least one of a blood pool and a second organ and calculation of an organ to blood ratio of the amyloid-reactive-agent or detection dye by dividing a measured uptake value of the amyloid-reactive agent or detection dye in an organ by a measured uptake value of the amyloid-reactive agent or detection dye in a blood pool, or calculation of a first organ to second organ ratio of the amyloid-reactive-agent or detection dye by dividing a measured uptake value of the amyloid-reactive agent or detection dye in the first organ by a measured uptake value of the amyloid-reactive agent or detection dye in the second organ; and instructions for use (Corresponding disclosure in at least [0093], where there are several amyloid reactive agents “ particular amyloid-reactive peptides and fusion peptides include one or more of the amino acid sequences set forth as SEQ ID NOS: l- 17, as shown in Table 2 (below)” and further in [0015], where there is a kit with instructions “ The kit also optionally includes instructions for using the kit, such as for administering the amyloid- reactive peptides, fusion peptides, and antibodies as described herein”).
Applicant is respectfully reminded that where a product merely serves as a support for printed matter, no functional relationship exists and such language is not given patentable weight. See MPEP 2111.05. In the present case, printed information e.g. that of "instructions for use" is met by disclosure of any type of printed information, regardless of the contents of that information.
Additionally, where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals (MPEP 2111.05).
Wall does not teach diagnosing a type of amyloid disease.
Antoni, in similar field of endeavor, teaches a similar concept (Diagnosis of amyloidosis) of diagnosing a type of amyloid disease (corresponding disclosure in at least [pg. 217, “Discussion”], where the type of amyloid disease is diagnosed “. The in vitro tissue analysis that was performed in the present study con firmed that there was specific binding of 11C-PIB in heart tissue with amyloid deposits. Amyloid deposits in the myo cardium of patients diagnosed with systemic amyloidosis of ALk,ALl, and transthyretin origin could be visualized with 11C-PIB, and patients could be identified by visual and semi quantitative assessment of 11C-PIB RI images”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated diagnosing a type of amyloid disease as taught by Antoni. One of the ordinary skill in the art would have been motivated to incorporate this because diagnosing the type of amyloid disease aids in the treatment as well for monitoring the disease.
Regarding Claim 4, Wall and Antoni teach the limitations of Claim 21, and Wall further teaches wherein the kit is for detecting or diagnosing systemic amyloidosis (corresponding disclosure in at least 00190, where detection of amyloidosis is completed with a red solution Detection of amyloid was achieved in consecutive tissue sections by staining with an alkaline Congo red solution”)
Regarding Claim 5, Wall and Antoni teach the limitations of Claim 21, and Wall further teaches wherein the kit is for diagnosing an amyloid disease selected from the group consisting of amyloid light chain amyloidosis (AL), transthyretin-associated amyloidosis (ATTR), and ALECT2 (corresponding disclosure in at least [0084], where the group that the peptides bind with consists of AL, ATTR, and ALECT2, which signifies the presence of one of the amyloids “For example, the amyloid-reactive peptides and fusion peptides may bind any one of AA, AL, AH, ATTR, AB2M, ALect2, Wild type TTR, AApoAI, AApoAII, AGel, ALys, ALect2, Afib, ACys, ACal, AMedin, AIA PP, APro, AIns, APrP, Αβ, or combinations thereof or other amyloids”).
Regarding Claim 7, Wall and Antoni teach the limitations of Claim 21, and
Wall further teaches wherein the amyloid- reactive agent is an amyloid-reactive peptide that is detectably labeled (corresponding disclosure in at least [0093], where there are several amyloid reactive peptides “, particular amyloid-reactive peptides and fusion peptides include one or more of the amino acid sequences set forth as SEQ ID NOS: l- 17, as shown in Table 2 (below)” further in [0099], where it’s specified the reactive agent SEQ ID NO:18 is p66 “an amyloid-reactive fusion peptide including the 11-1F4 antibody 12-mer epitope fused to the p5+14 peptide has the following amino acid sequence (SEQ ID NO: 18 or "p66")” and further in [0182], where P66 is labeled “ the binding of p66 and p5+14 to synthetic and naturally-occurring amyloid, peptides p66 or p5+14 were radiolabeled with iodine-125”).
Regarding Claim 8, Wall and Antoni teach the limitations of Claim 21, and
Wall further teaches wherein the amyloid- reactive peptide comprises an amino acid sequence set forth in SEQ ID NO: 1, SEQ ID NO: 2, SEQ ID NO: 13, SEQ ID NO: 14, SEQ ID NO: 18, or SEQ ID NO: 19 (corresponding disclosure in at least [0093], where there are several amyloid reactive peptides, which include the listed sequences “, particular amyloid-reactive peptides and fusion peptides include one or more of the amino acid sequences set forth as SEQ ID NOS: l- 17, as shown in Table 2 (below)”).
Regarding Claim 9, Wall and Antoni teach the limitations of Claim 21, and
Wall further teaches wherein the amyloid- reactive agent reacts with A3 fibrils or synthetic fibrils composed of light chains or fragments thereof (corresponding disclosure in at least [00180], where the reactive agents (p66) react (bind) to the synthetic fibrils “We found that when p66 was added to fibrils coated to the microplate well the reactivity of the 11-1F4 mAb was enhanced, particularly to the Wil fibrils, but also to the Wil fibrils (FIG. 1 1). Effect of BSA-blocking on p66 binding to synthetic fibrils”).
Regarding Claim 14, Wall and Antoni teach the limitations of Claim 21, and
Wall further teaches wherein the amyloid- reactive agent is radiolabeled (corresponding disclosure in at least [0182], where P66 is labeled “ the binding of p66 and p5+14 to synthetic and naturally-occurring amyloid, peptides p66 or p5+14 were radiolabeled with iodine-125”).
Regarding Claim 39, Wall and Antoni teach the limitations of Claim 8, and
Wall further teaches wherein the amyloid- reactive peptide comprises the amino acid sequence set forth in SEQ ID NO:13 (corresponding disclosure in at least [0093] and Table 2, where the amyloid reactive peptide comprises SEQ ID NO:13 “In certain example embodiments, particular amyloid-reactive peptides and fusion peptides include one or more of the amino acid sequences set forth as SEQ ID NOS: l- 17, as shown in Table 2… SEQ ID NO: 13 “).
Regarding Claim 41, Wall and Antoni teach the limitations of Claim 21, and
Wall further teaches wherein the instructions for use for diagnosing the type of amyloid disease include instructions to: administer an amyloid-reactive agent or detection dye to an individual and measure an organ distribution pattern of the amyloid-reactive agent or detection dye in one or more organs of the individual, wherein the organ distribution pattern of the amyloid-reactive agent or detection dye indicates the type of amyloid disease (corresponding disclosure in at least [0015], where there is a kit with instructions “ The kit also optionally includes instructions for using the kit, such as for administering the amyloid- reactive peptides, fusion peptides, and antibodies as described herein”).
Applicant is respectfully reminded that where a product merely serves as a support for printed matter, no functional relationship exists and such language is not given patentable weight. See MPEP 2111.05. In the present case, printed information e.g. that of "instructions for use" is met by disclosure of any type of printed information, regardless of the contents of that information. Anything contained within the instructions is being considered as printed matter and therefore is not being considered.
Regarding Claim 42, Wall and Antoni teach the limitations of Claim 21, and
Wall further teaches wherein the instructions for use for diagnosing the type of amyloid disease include instructions to: receive organ distribution pattern data for an amyloid-reactive-agent or detection dye for an individual; and calculate the first organ to second organ for two or more organs, wherein the first organ to the second organ ratio is used to diagnose the type of amyloid disease in the individual (corresponding disclosure in at least [0015], where there is a kit with instructions “ The kit also optionally includes instructions for using the kit, such as for administering the amyloid- reactive peptides, fusion peptides, and antibodies as described herein”).
Applicant is respectfully reminded that where a product merely serves as a support for printed matter, no functional relationship exists and such language is not given patentable weight. See MPEP 2111.05. In the present case, printed information e.g. that of "instructions for use" is met by disclosure of any type of printed information, regardless of the contents of that information. Anything contained within the instructions is being considered as printed matter and therefore is not being considered.
Regarding Claim 17, Wall and Antoni teach the limitations of Claim 21 and further teaches wherein the first organ to second organ ratio is selected from the group consisting of a liver to heart ratio, a heart to liver ratio, a spleen to heart ratio, a heart to spleen ratio, a spleen to liver ratio, a liver to spleen ratio, a spleen to kidney ratio, a kidney to spleen ratio, a kidney to heart ratio, a heart to kidney ratio, a liver to kidney ratio, and a kidney to liver ratio (corresponding disclosure in at least [0015], where there is a kit with instructions “ The kit also optionally includes instructions for using the kit, such as for administering the amyloid- reactive peptides, fusion peptides, and antibodies as described herein”).
Applicant is respectfully reminded that where a product merely serves as a support for printed matter, no functional relationship exists and such language is not given patentable weight. See MPEP 2111.05. In the present case, printed information e.g. that of "instructions for use" is met by disclosure of any type of printed information, regardless of the contents of that information. Anything contained within the instructions is being considered as printed matter and therefore is not being considered.
Regarding Claim 19, Wall and Antoni teach the limitations of Claim 17, and Wall further teaches wherein: (i) if the first organ to second organ ratio is the heart to spleen ratio and the heart to spleen ratio is above 1.4, the individual is diagnosed with ATTR amyloidosis; or (ii) if the first organ to second organ ratio is the heart to kidney ratio and the heart to kidney ratio is above 1.62, the individual is diagnosed with ATTR amyloidosis (corresponding disclosure in at least [0015], where there is a kit with instructions “ The kit also optionally includes instructions for using the kit, such as for administering the amyloid- reactive peptides, fusion peptides, and antibodies as described herein”).
Applicant is respectfully reminded that where a product merely serves as a support for printed matter, no functional relationship exists and such language is not given patentable weight. See MPEP 2111.05. In the present case, printed information e.g. that of "instructions for use" is met by disclosure of any type of printed information, regardless of the contents of that information. Anything contained within the instructions is being considered as printed matter and therefore is not being considered.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Wall (WO2016032949A1, disclosed in Applicant’s IDS) and Antoni (“In Vivo Visualization of Amyloid Deposits in the Heart with 11C-PIB and PET”, 2013, The Journal of Nuclear Medicine, 54(2) 213-220) as applied in Claim 21 and in view of Moussaoui (WO2017153922A2).
Regarding Claim 11, Wall and Antoni teaches the limitations of Claim 21 but does not teach wherein the amyloid- reactive agent is selected from the group consisting of florbetapir, florbetaben and flutemetamol.
Moussaoui, in a similar field of endeavor, teaches a similar concept (disease diagnosis) of wherein the amyloid- reactive agent is selected from the group consisting of florbetapir, florbetaben and flutemetamol (corresponding disclosure in at least [0106], where florbetapir or flumetamol is used “using one of the existing radiotracers monitoring brain metabolism such as' 8F-fluofodeoxyglucose or radiotracers of brain amyloidosis such as ' 8F-florbetapir and 18F- flutemetamol)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of florbetapir or flumetamol as taught by Moussaoui. One of the ordinary skill in the art would have been motivated to incorporate this because they are commonly used diagnostic agents in imaging scans for estimating amyloid plaque.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wall (WO2016032949A1, disclosed in Applicant’s IDS) and Antoni (“In Vivo Visualization of Amyloid Deposits in the Heart with 11C-PIB and PET”, 2013, The Journal of Nuclear Medicine, 54(2) 213-220) as applied in Claim 21 and in view of Mathis (“Development of Positron Emission Tomography β-Amyloid Plaque Imaging Agents”, 2012, Semin Nucl Med.,42(6): 423-432).
Regarding Claim 12, Wall and Antoni teaches the limitations of Claim 21, but does not teach wherein the detection dye is ThT.
Wall, in a similar field of endeavor teaches a similar concept (amyloid detection) of wherein the detection dye is ThT (corresponding disclosure in at least [pg. 3, “Evaluation of Thioflavin-T-Analogs], where thioflavin (THT) is used for detection “. Thioflavin-T is a well-characterized relatively small molecule, and has only 1 positive charge. We therefore chose to synthesize neutral derivatives of thioflavin-T”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated thioflavin as the detection dye as taught by Mathis. One of the ordinary skill in the art would have been motivated to incorporate this because THT is a highly attractive detection dye for amyloid-binding due to their size and only having 1 positive charge ([pg. 3, “Evaluation of Thioflavin-T-Analogs] of Mathis).
Claim 13, 40 is rejected under 35 U.S.C. 103 as being unpatentable over Wall (WO2016032949A1, disclosed in Applicant’s IDS) and Antoni (“In Vivo Visualization of Amyloid Deposits in the Heart with 11C-PIB and PET”, 2013, The Journal of Nuclear Medicine, 54(2) 213-220) as applied in Claim 21 and in view of Wall (“Preclinical Validation of the Heparin-Reactive Peptide p5+14 as a Molecular Imaging Agent for Visceral Amyloidosis”, 2015, Molecules, 20, 7657-7682, disclosed in Applicant’s IDS).
Regarding Claim 13, Wall and Antoni teaches the limitations of Claim 21 but does not teach wherein the organ distribution pattern is measured using PET/CT images.
Wall, in a similar field of endeavor, teaches a similar concept (amyloid disease) of wherein the organ distribution pattern is measured using PET/CT images (corresponding disclosure in at least [pg. 7660, 2.1 Structural Characteristics…”], where PET/CT (SPECT) imaging is used for imaging, which shows the organs and patterns of distribution “the 45-amino acid sequence of peptide p5+14 (Table 1) contains 12 lysine residues and a tyrosine residue at position 4, which is a site for facile radioiodination of the peptide, to allow for SPECT and PET molecular imaging studies”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of PET/CT images to measure organ distribution patterns as taught by Wall. One of the ordinary skill in the art would have been motivated to incorporate this because the imaging modalities show the organs and the distribution of the radiolabeled portions and how they distribute in the body.
Regarding Claim 40, Wall and Antoni teaches the limitations of Claim 8 and Wall further teaches the amyloid- reactive peptide which comprises the amino acid sequence set forth in SEQ ID NO:13 (corresponding disclosure in at least [0093] and Table 2, where the amyloid reactive peptide comprises SEQ ID NO:13 “In certain example embodiments, particular amyloid-reactive peptides and fusion peptides include one or more of the amino acid sequences set forth as SEQ ID NOS: l- 17, as shown in Table 2… SEQ ID NO: 13 “)., but does not teach labeling with a 124I radioisotope.
Wall, in a similar field of endeavor, teaches a similar concept (imaging in amyloid-dense regions) of labeling with a 124I radioisotope (corresponding disclosure in at least [pg. 7666, “2.3 Pharmacokinetic Analysis…”], where 124I radioisotope was used “Due to the limited temporal resolution of these data the pharmacokinetics (PK) of 124I-labeled peptide were followed over the initial 2 h pi by using dynamic PET imaging.”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of labeling with a 124I radioisotope as taught by Wall. One of the ordinary skill in the art would have been motivated to incorporate this because 124I radioisotope is a commonly used imaging agent for PET scans.
Response to Arguments
Applicant's arguments filed 08/13/26 regarding the Claim Objections have been fully considered and the objections are withdrawn in light of the objections.
Applicant's arguments filed 08/13/26 regarding the 35 U.S.C. 112b rejections have been fully considered and the previous rejections are withdrawn in light of the objections. However, the 35 U.S.C. 112b rejection still remains in light of the amendments (see rejection above).
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.E.K./Examiner, Art Unit 3797
/SHAHDEEP MOHAMMED/Primary Examiner, Art Unit 3797
