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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group III of claims 29-33 in the reply filed on 01/05/2026 is acknowledged.
Claims 1-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 filed on 01/05/2026.
Applicant's election with traverse of claim 31 in the reply filed on 01/05/2026 is acknowledged. The traversal is on the ground(s) that the Applicant believes that this requirement is presented as a typographical error. This is not found persuasive because the Examiner asked for three biomarkers to be elected for examination to proceed as noted in the restriction requirement of 10/08/2025. Consistent with this requirement, claims 32-33 are withdrawn because they read on more than three biomarkers.
The requirement is still deemed proper and is therefore made FINAL.
Thus, claims 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention of more than three biomarkers, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/05/2026.
Similarly, newly submitted claim 36 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention of more than three biomarkers, there being no allowable generic or linking claim.
Claims 34-35 are new claims, and the Applicant notes that no new matter is added.
Thus, claims 29-31 and 34-35 are under examination.
Priority
This application is a U.S. National Stage (371) application of PCT/SE2020/050984 filed on 10/15/2020 which claims priority to U.S. Provisional Application No. 62/923,336 filed on 10/18/2019. This application also claims priority to two foreign applications of SE2030164-4 filed on 05/15/2020 and SE1930339-5 filed on 10/18/2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/18/2022, 07/23/2025 and 01/05/2026 have been received. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner and all references are considered except where they were lined through.
Claim Interpretation
The functional limitations of the apparatus or device of claim 29 are examined so that the physical and chemical characteristics are not necessarily directed to the intended use of the apparatus. “Pancreatic cancer detection” is not a required part of the device, rather the device has a solid surface with antibodies that detect proteins that may increase or decrease in pancreatic cancer. The reasonable interpretation would be that the device has the minimum physical/chemical attributes to detect a protein with immobilized antibodies which is met by Reference Leelawat et al. (World J Gastroenterol 2010 October 7; 16(37): 4697-4703).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 29 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Leelawat et al. (World J Gastroenterol 2010 October 7; 16(37): 4697-4703).
Regarding claim 29, Leelawat teaches an ELISA device to detect MMP7 protein (Page 4698-4699, “The serum levels of MMP7 were measured using an enzyme-linked immunosorbent assay (ELISA) kit”).
Leelawat teaches an Elisa device kit which comprising a solid surface of 96-well plate (Page 4699, “Briefly, the diluted serum samples were added in duplicate to 96-well plates”).
Leelawat teaches an antibody bound to the solid surface that is configured to indicate selective binding between the antibody and a target protein of Matrix metalloproteinase 7 (MMP7) (Page 4699, “Briefly, the diluted serum samples were added in duplicate to 96-well plates coated with MMP7 antibody”).
Claims 29, 30 and 34 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Williams et al. (WO 2012/021795 A2).
Regarding claim 29, Williams teaches an ELISA device to detect MMP7 protein ([0150]; [0180]; page 101, Table 2, “Panels of 1 Biomarker”, “MMP7”).
Williams teaches kit which comprise a solid surface ([0262]).
Williams teaches an antibody bound to the solid surface that is configured to indicate selective binding between the antibody and a target protein ([0178]; [0262]).
Regarding claims 30 and 34, Williams teaches that the solid surface comprises antibodies configured to selectively bind two target proteins selected from the group of MPP7 and THBS2 ([0151] and [0262]; page 100, Table 1, “THBS2”, “MMP7”).
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 (PHOSITA) to which the claimed invention 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 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.
Claims 31 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (WO 2012/021795 A2) as applied to claim 29 above, and further in view of Arumugam et al. (Pancreas 2011;40: 815-822).
Regarding claim 31, Williams teaches that the solid surface comprises antibodies configured to selectively bind three target proteins ([0053]).
Regarding claim 35, Williams teaches the that the solid surface comprises antibodies configured to selectively bind Matrix metalloproteinase 7 and Thrombospondin 2 (([0151] and [0262]; page 100, Table 1, “THBS2”, “MMP7”)).
Regarding claims 31 and 35, Williams does not teach including a third antibody to Trefoil factor 1 as part of the panel.
Regarding claims 31 and 35, Arumugam teaches developing a solid surface of an ELISA that comprises antibodies configured to selectively bind Trefoil factor 1(TFF1) (Page 816, left column, third paragraph).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the Trefoil factor 1 biomarker of Arumugam with the biomarker panel of Williams of Matrix metalloproteinase 7 and Thrombospondin 2 for the detection and diagnosis of pancreatic cancer because Arumugam teaches that Trefoil factor 1 is highly increased in preneoplastic lesions and further noted that Trefoil factor 1 increased the aggressiveness of pancreatic cancer (Abstract, results; page 815, right column, third paragraph). Williams teaches using a microtiter plate such that each well in the plate is used to uniquely analyze one of multiple biomarkers to be detected in a biological sample ([0151]). A skilled artisan would have been motivated to combine the above biomarkers in one panel to increase the sensitivity and specificity of detection of pancreatic tumors. A PHOSITA would have had a reasonable expectation of success in combining the methods of Arumugam and Williams because both are methods directed to detecting biomarkers of pancreatic tumors by immunoassays.
It would have been obvious for a PHOSITA to test for the levels of Trefoil factor 1 in a patient with the biomarkers of Williams to predict the aggressiveness of the pancreatic tumors in patients.
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.
Claim 29-31 and 34-35 and provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 7-10 of copending Application No. 18/556,559 (reference application). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 29 pertaining to a pancreatic cancer detection device, comprising a solid surface comprising an antibody bound to the solid surface, the solid surface configured to indicate selective binding between the antibody and a target protein; and wherein the antibody is configured to selectively bind to the target protein selected from the group consisting of Claudin 18 (CLDN18), Galectin 4 (LGALS4), Matrix metalloproteinase 7 (MMP7), Mucin 2 (MUC2), Mucin 4 (MUC4), Olfactomedin 4 (OLFM4), Regenerating islet-derived protein 1-alpha (REG1A), Regenerating islet-derived
protein 1-beta (REG1B), Serine protease inhibitor Kazal-type 1 (SPINK1), Syncollin (SYCN), Trefoil factor 1 (TFF1), Carcinoembryonic antigen (CEA), Lymphatic vessel endothelial hyaluronan receptor 1 (LYVE1), Tenascin C (TNC), Thrombospondin 2 (THBS2) and Carbohydrate antigen 19-9, ‘559 teaches a pancreatic cancer detection device, comprising a solid surface comprising a plurality of antibodies bound to the solid surface, the solid surface configured to indicate selective binding between each antibody and a corresponding target protein; and wherein the antibodies are configured to selectively bind to two of the target proteins selected from the group consisting of MMP7, CA 19-9, THBS2, MUC2, REG1B, TNC, and TFF1 (See claim 1 of ‘559).
Regarding claim 30 pertaining to that the solid surface comprises antibodies configured to selectively bind two target proteins selected from the group of Claudin 18 (CLDN18), Galectin 4 (LGALS4), Matrix metalloproteinase 7 (MMP7), Mucin 2 (MUC2), Mucin 4 (MUC4), Olfactomedin 4 (OLFM4), Regenerating islet-derived protein 1-alpha (REG1A), Regenerating islet-derived
protein 1-beta (REG1B), Serine protease inhibitor Kazal-type 1 (SPINK1), Syncollin (SYCN), Trefoil factor 1 (TFF1), Carcinoembryonic antigen (CEA), Lymphatic vessel endothelial hyaluronan receptor 1 (LYVE1), Tenascin C (TNC), Thrombospondin 2 (THBS2) and Carbohydrate antigen 19-9, ‘559 teaches the solid surface configured to indicate selective binding between each antibody and a corresponding target protein; and wherein the antibodies are configured to selectively bind to two of the target proteins selected from the group consisting of MMP7, CA 19-9, THBS2, MUC2, REG1B, TNC, and TFF1 (See claim 1 of ‘559).
Regarding claim 31 pertaining to that the solid surface comprises antibodies configured to selectively bind three target proteins selected from the group of Claudin 18 (CLDN18), Galectin 4 (LGALS4), Matrix metalloproteinase 7 (MMP7), Mucin 2 (MUC2), Mucin 4 (MUC4), Olfactomedin 4 (OLFM4), Regenerating islet-derived protein 1-alpha (REG1A), Regenerating islet-derived protein 1-beta (REG1B), Serine protease inhibitor Kazal-type 1 (SPINK1), Syncollin (SYCN), Trefoil factor 1 (TFF1), Carcinoembryonic antigen (CEA), Lymphatic vessel endothelial hyaluronan receptor 1 (LYVE1), Tenascin C (TNC), Thrombospondin 2 (THBS2) and Carbohydrate antigen 19-9, ‘559 teaches that the solid surface comprises antibodies configured to selectively bind three target proteins selected from the group of MMP7, CA 19-9, THBS2, MUC2, REG1B, TNC, and TFF1 (See claim 2 of ‘559).
Regarding claim 34 pertaining to that the solid surface comprises antibodies configured to selectively bind Matrix metalloproteinase 7 and Thrombospondin 2, ‘559 teaches that the solid surface comprises antibodies configured to selectively bind Matrix metalloproteinase 7 and Thrombospondin 2 (See claims 7-10 of ‘559).
Regarding claim 35 pertaining to that the solid surface comprises antibodies configured to selectively bind Matrix metalloproteinase 7, Trefoil factor 1 and Thrombospondin 2, ‘559 teaches that the solid surface comprises antibodies configured to selectively bind Matrix metalloproteinase 7, Trefoil factor 1 and Thrombospondin 2 (See claims 7-10 of ‘559).
Conclusion
No claims are allowed.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678