DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments and Amendments
2. Claims 1-16, 18 and 19 are pending.
Claims 1-4, 6-9 and 13 have been amended.
Claims 1-16, 18 and 19 are examined on the merits.
3. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Withdrawn Grounds of Rejection
Claim Rejections - 35 USC § 112
4. The rejection over claims 1-16, 18 and 19 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of the amendment to claims 1-4, 6-9 and 13 to include the recitation, “antibody-binding fragment thereof”, see Remarks (page 5, Rejections…segment) and Amendments to the Claims submitted June 12, 2025.
Double Patenting
5. The nonstatutory double patenting rejection over claims 1-3, 8-16, 18 and 19 as being unpatentable over claims 1-9 of U.S. Patent No. 11,073,521 B2 (issued July 27, 2021) is withdrawn in light of Applicant’s arguments presented in the Remarks submitted June 12, 2025, page 8.
Maintained Grounds of Rejection
Claim Rejections - 35 USC § 102
6. 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.
7. 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.
8. The rejection of claim(s) 1-3, 8, 9, 11, 15, 18 and 19 under 35 U.S.C. 102(a)(1) as being anticipated by Kominami et al., US 2009/0203039 A1 (published August 13, 2009/ IDS reference #1 submitted September 27, 2023) is maintained.
Initially, Applicant argues “…Kominami…fails to teach step d. of claim 1, separating the antibody-bound PMN-MDSC from PMN that are not bound to the antibody.”, see Remarks submitted June 12, 2025, page 5, last paragraph.
Applicant argues the prior art, “Kominami…refers to monoclonal antibodies that are capable of binding soluble LOX-1 and the use of same as a diagnostic method for acute coronary syndrome.”, see Remarks, page 6, 1st paragraph.
Applicant further argues, “Kominami, does not teach or suggest any anti-LOX-1 antibodies that bind the LOX-1 present in the membrane of any cell, including PMNs or PMN-MDSCs.”, see page 6, 2nd paragraph of the Remarks.
These arguments have been previously cited in former Remarks, see Rejection…segment spanning pages 5 and 6. Applicant concludes arguments stating the teachings of their specification and contrasts them to what Kominami discloses.
Applicant’s arguments and points of view have been carefully considered, but fail to persuade.
Kominami discloses “, the LOX-1 or a part thereof is fractured at a location adjoining the membrane of the extracellular domain, and is shown to exist as a soluble molecule (soluble LOX-1) in the blood.”, see page 8, section 0113. Hence, the skilled artisan would recognize the same antibody that binds the soluble LOX-1 is able to recognize and bind membrane bound LOX-1. Also see page 1, section 0016; page 2, section 0022 and entire (I) Monoclonal Antibodies segment.
As stated in previous Actions, Applicant’s independent claim 1 does not read on any particular disease or disorder, hence the diagnostic method disclosed in Kominami reads on the claimed invention. Kominami discloses each step cited in claim 1, including newly added step d., as Kominami discloses immunochemical assay systems such as enzyme-linked immunosorbent assay (ELISA) and radio immunoassay (RIA), see page 3, section 0047; page 4, section 0069; page 6, section 0098; page 7, sections 0101-0103 and 0109; page 13, sections 0172 and 0173; Working Example 5 spanning pages 14-16; and Brief Description of Drawings on page 16, sections 0204, 0206 and 0207. Wash steps are repeated within these particular assays, thereby removing unbound materials and separating bound and unbound components.
And while the Kominami reference does not explicitly cite PMNs and PMN-MDSCs that is of no consequence given a biological fluid including whole blood innately contains these types of cells. Yan et al. (OncoImmunology 3 (7): e950163-1 to e950163-8, August 1, 2014) clearly informs one in the art that PMNs are present in the blood of all individuals as they “…are the most abundant immune cells in the body…” and “the main effectors of the innate immune system”, see page e950163-1, abstract and 1st sentence of the Introduction; page e950163-2, column 1, 1st full paragraph and Results, 1st paragraph; PMN…section bridging pages e950163-2 and e950163-3; and Discussion on page e950163-4.
Moreover, Montero et al. (J. Immunother. 35(2): 107-115, February-March 2012), Cassetta et al., (Cancer Immunology, Immunotherapy 68: 687-697, 2019) and Pawelec et al. (Frontiers in Immunology 10 (1099): 1-10, May 2019), all make clear PMN-MDSCs are present in healthy controls, albeit less than those detected in cancer patients, see Montero, page 110, paragraph bridging both the columns; page 111, 1st full paragraphs in column 1 and column 2; see Pawelec, page 4, paragraph bridging columns 1 and 2 and the middle of MDSCs in Aging section; see Cassetta, Human neutrophils…section on page 689 and page 692, 1st column, 1st complete paragraph.
Accordingly, the rejection is maintained.
Kominami discloses immunochemical methods of ascertaining the distribution, presence and concentration of soluble lectin-like oxidized LDL receptor-1 (LOX-1) expression and LOX-1+ in serum, tissues samples and a range of biological fluids with antibodies that specifically recognize human soluble LOX-1, see page 2, sections 0039, 0042 and 0043; page 3, section 0045; page 6, sections 0096-0099; section 0110 spanning pages 7 and 8; page 8, 0111; and page 14, section 0185. The PMN-MDSCs bound by LOX-1 specific antibodies are substantially free of PMN.
It is within the Examiner’s purview, tissues taught by Kominami include tumor tissue. All disclosed samples comprise polymorphonuclear myeloid derived suppressor cells (PMN-MDSCs) and polymorphonuclear neutrophils (PMNs).
The assays include detectable labels and LOX-1 specific antibodies tethered to solid holding bodies, see page 7, sections 0100-0111. The antibodies include monoclonal and polyclonal antibodies that specifically recognize LOX-1 protein, see page 3, sections 0045, 0046 and 0055; page 4, sections 0056 and 0057; page 7, sections 102, 103, 109 and 110; page 8, section 0111; page 15, section 0199 and 0200; and page 16, section 0202. The antibodies are “…used in a marked material state marked by any marked agent useable…” such as “enzymes widely known in the industry (for example alkaline phosphatase (ALP, peroxidase (HRP), etc.), radioactive isotopes (for example, 125I, 3H, 14C, etc.), fluorescent compounds (for example, flouricene isothionate (FITC), tetra methyl rhodamine iso-thio cyanate (RITC), etc.), luminescent chemical compounds, as well as bioluminescent chemical compounds, etc., have been widely presented as binding marker agents for monoclonal antibodies.”, see page 7, sections 0101-0103.
Kominami also discloses an assay utilizing two different antibodies, including a LOX-1 specific antibody, wherein there is a washing step, see Working Example 2 beginning on page 9. Immunonochemical assays, ELISA, enzyme immunoassay (EIA), enzyme immunometric assay (EIA), RIA, all require washing and separation steps thereby removing free unbound antibody and/or antigen, see page 3, section 0047; page 4, section 0069; page 6, section 0098; page 7, sections 0101-0103 and 0109; page 13, sections 0172 and 0173; Working Example 5 spanning pages 14-16; and Brief Description of Drawings on page 16, sections 0204, 0206 and 0207.
Claim Rejections - 35 USC § 103
9. 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.
10. 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.
11. The rejection over claims 1-16, 18 and 19 under 35 U.S.C. 103 as being unpatentable over Kominami et al., US 2009/0203039 A1 (published August 13, 2009/ IDS reference #1 submitted September 27, 2023), and further in view of Vetsika et al. Journal of Immunology Research 12 pages, published 11 November 2014/ IDS reference #65 submitted September 27, 2023) and Pillay et al. (Cell. Mol. Life Sci. 70: 3813-3827, published online February 20, 2013/ IDS reference #11 submitted September 27, 2023) is maintained.
Applicant continues to argue primary reference, Kominami is deficient as asserted in the pending 102 rejection. Applicant further argue secondary references, Vetsika and Pillay do not make up for the alleged misgivings of the primary reference, see Remarks submitted June 12, 2025, Rejections under 35 U.S.C. 103 beginning on page 6. Applicant also argues the references do not “…teach…LOX-1 antibodies can be used to separate PMN-MDSCs and PMN in blood and tumor tissues.”, see Remarks, page 7, 1st paragraph (para.).
Applicants’ assertions and arguments have been carefully considered, but fail to persuade.
For the reasons set forth in the pending 102 rejection, this instant rejection does not fall, see pages 3-7 herein. Accordingly, the instant rejection is maintained as primary reference, Kominami does not fall and the combination of references teach the claimed invention.
Kominami teaches immunochemical methods of ascertaining the distribution, presence and concentration of soluble lectin-like oxidized LDL receptor-1 (LOX-1) expression and LOX-1+ in serum, tissues samples and a range of biological fluids with antibodies that specifically recognize human soluble LOX-1, see page 2, sections 0039, 0042 and 0043; page 3, section 0045; page 6, sections 0096-0099; section 0110 spanning pages 7 and 8; page 8, 0111; and page 14, section 0185. The PMN-MDSCs bound by LOX-1 specific antibodies are substantially free of PMN.
Kominami teaches each step cited in claim 1, including step d., as Kominami discloses immunochemical assay systems such as enzyme-linked immunosorbent assay (ELISA) and radio immunoassay (RIA), see page 3, section 0047; page 4, section 0069; page 6, section 0098; page 7, sections 0101-0103 and 0109; page 13, sections 0172 and 0173; Working Example 5 spanning pages 14-16; and Brief Description of Drawings on page 16, sections 0204, 0206 and 0207. Wash steps are repeated within these particular assays, thereby removing unbound materials and separating bound and unbound components.
It is within the Examiner’s purview, tissues taught by Kominami include tumor tissue. All taught samples comprise polymorphonuclear myeloid derived suppressor cells (PMN-MDSCs) and polymorphonuclear neutrophils (PMNs).
The assays include detectable labels and LOX-1 specific antibodies tethered to solid holding bodies, see page 7, sections 0100-0111. The antibodies include monoclonal and polyclonal antibodies that specifically recognize LOX-1 protein, see page 3, sections 0045, 0046 and 0055; page 4, sections 0056 and 0057; page 7, sections 102, 103, 109 and 110; page 8, section 0111; page 15, section 0199 and 0200; and page 16, section 0202. The antibodies are “…used in a marked material state marked by any marked agent useable…” such as “enzymes widely known in the industry (for example alkaline phosphatase (ALP, peroxidase (HRP), etc.), radioactive isotopes (for example, 125I, 3H, 14C, etc.), fluorescent compounds (for example, flouricene isothionate (FITC), tetra methyl rhodamine iso-thio cyanate (RITC), etc.), luminescent chemical compounds, as well as bioluminescent chemical compounds, etc., have been widely presented as binding marker agents for monoclonal antibodies.”, see page 7, sections 0101-0103.
Kominami also teaches an assay utilizing two different antibodies, including a LOX-1 specific antibody, wherein there is a washing step, see Working Example 2 beginning on page 9. Immunonochemical assays, ELISA, enzyme immunoassay (EIA), enzyme immunometric assay (EIA), RIA, all require washing and separation steps thereby removing free unbound antibody and/or antigen, see page 3, section 0047; page 4, section 0069; page 6, section 0098; page 7, sections 0101-0103 and 0109; page 13, sections 0172 and 0173; Working Example 5 spanning pages 14-16; and Brief Description of Drawings on page 16, sections 0204, 0206 and 0207.
Kominami does not teach the claimed method, wherein whole blood, red blood cells are destroyed and lysed, neutrophil ligands that identify PMNs are implemented and separation techniques by size exclusion are utilized.
Vetsika teaches phenotypic analysis of myeloid derived suppressor cell subpopulations and immunophenotypic analysis of peripheral blood in order to classify the subsets and/or subpopulation based on expression of particular markers, see section 2.2 bridging pages 2 and 3. The method assays biological samples from lung cancer patients, see page 2, sections 2.1 and 2.2. “Blood samples [including whole blood] underwent red blood cell lysis using red blood cell (RBC) lysing buffer”, see page 2, section 2.2. Fluorescence-active cell sorting (FACS) analysis was performed and cells were stained for expression of surface markers, including neutrophil biomarkers, see page 3, 1st column, 1st full paragraph. Neutrophil biomarkers include CD14-, CD11b+, CD15+, HLA-DR- and CD33+, see entire Vetsika document. Antibodies that bind these biomarkers are taught in column 1 on page 3.
Moreover, Pillay teaches assaying and characterizing a population of cells including neutrophils based on the expression of markers including CD66b, see page 3815, Identification…section. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of all the references to identify, characterize, isolate, separate and quantify different cell types, including LOX-1+ and LOX-1 expressing cells based on morphological differences using LOX-1 specific antibodies with the immunophenotypic analysis set forth in Kominami, Vetsika and Pillay, see all references, particularly section 2.2 of Vetsika; and sections 0096-0111 spanning pages 6-8. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings Kominami with the secondary references to wash unbound cells in the sample from the substrate to separate, collect and enumerate PMN-MCSCs utilizing the taught ligands specific to particular cell types. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in these references that one of ordinary skill in the art can obtain a group of cells from a sample in order to assay a population of cells to determine differences in cell types that may be essential to the diagnosis of a condition, potential therapeutic treatment and the probable prognosis, see all references in their entirety.
12. The rejection of claims 1-6, 8-16, 18 and 19 under 35 U.S.C. 103 as being unpatentable over Kominami et al., US 2009/0203039 A1 (published August 13, 2009/ IDS reference #1 submitted September 27, 2023), and further in view of Condamine et al. (Journal of Clinical Investigation 124(6): 2626-2639, June 2014/ IDS reference #20 submitted September 27, 2023) is maintained.
Applicant continues to argue primary reference, Kominami is deficient as asserted in the pending 102 rejection. Applicant further argue secondary reference, Condamine does not make up for the alleged misgivings of the primary reference, see Remarks submitted June 12, 2025, page 7, 3rd paragraph (para.). Applicant also argues the references do not “…teach…LOX-1 antibodies of Kominami… can be used to separate PMN-MDSCs and PMN in blood and tumor tissues.”, see Remarks, page 7, 3rd para.
Applicants’ assertions and arguments have been carefully considered, but fail to persuade.
For the reasons set forth in the pending 102 rejection, this instant rejection does not fall, see pages 3-7 herein. Accordingly, the instant rejection is maintained as primary reference, Kominami does not fall and the combination of references teach the claimed invention.
Kominami teaches immunochemical methods of ascertaining the distribution, presence and concentration of soluble lectin-like oxidized LDL receptor-1 (LOX-1) expression and LOX-1+ in serum, tissues samples and a range of biological fluids with antibodies that specifically recognize human soluble LOX-1, see page 2, sections 0039, 0042 and 0043; page 3, section 0045; page 6, sections 0096-0099; section 0110 spanning pages 7 and 8; page 8, 0111; and page 14, section 0185. The PMN-MDSCs bound by LOX-1 specific antibodies are substantially free of PMN.
Kominami teaches each step cited in claim 1, including added step d., as Kominami discloses immunochemical assay systems such as enzyme-linked immunosorbent assay (ELISA) and radio immunoassay (RIA), see page 3, section 0047; page 4, section 0069; page 6, section 0098; page 7, sections 0101-0103 and 0109; page 13, sections 0172 and 0173; Working Example 5 spanning pages 14-16; and Brief Description of Drawings on page 16, sections 0204, 0206 and 0207. Wash steps are repeated within these particular assays, thereby removing unbound materials and separating bound and unbound components.
It is within the Examiner’s purview, tissues taught by Kominami include tumor tissue. All taught samples comprise polymorphonuclear myeloid derived suppressor cells (PMN-MDSCs) and polymorphonuclear neutrophils (PMNs).
The assays include detectable labels and LOX-1 specific antibodies tethered to solid holding bodies, see page 7, sections 0100-0111. The antibodies include monoclonal and polyclonal antibodies that specifically recognize LOX-1 protein, see page 3, sections 0045, 0046 and 0055; page 4, sections 0056 and 0057; page 7, sections 102, 103, 109 and 110; page 8, section 0111; page 15, section 0199 and 0200; and page 16, section 0202. The antibodies are “…used in a marked material state marked by any marked agent useable…” such as “enzymes widely known in the industry (for example alkaline phosphatase (ALP, peroxidase (HRP), etc.), radioactive isotopes (for example, 125I, 3H, 14C, etc.), fluorescent compounds (for example, flouricene isothionate (FITC), tetra methyl rhodamine iso-thio cyanate (RITC), etc.), luminescent chemical compounds, as well as bioluminescent chemical compounds, etc., have been widely presented as binding marker agents for monoclonal antibodies.”, see page 7, sections 0101-0103.
Kominami also teaches an assay utilizing two different antibodies, including a LOX-1 specific antibody, wherein there is a washing step, see Working Example 2 beginning on page 9. Immunonochemical assays, ELISA, enzyme immunoassay (EIA), enzyme immunometric assay (EIA), RIA, all require washing and separation steps thereby removing free unbound antibody and/or antigen, see page 3, section 0047; page 4, section 0069; page 6, section 0098; page 7, sections 0101-0103 and 0109; page 13, sections 0172 and 0173; Working Example 5 spanning pages 14-16; and Brief Description of Drawings on page 16, sections 0204, 0206 and 0207.
Kominami does not teach the claimed method, wherein whole blood, red blood cells are destroyed and lysed, neutrophil ligands that identify PMNs are implemented and separation techniques by size exclusion are utilized.
Condamine teaches analyzing whole blood from patients with non-small cell lung cancer (NSCLC) and tumor tissue from head and neck cancer (HNC) and subjected to a ficoll density gradient in order to separate and evaluate polymorphonuclear neutrophils-myeloid derived suppressor cells (PMN-MDSCs) and neutrophils, see page 2367, Human samples section. The PMN-MDSC were isolated on a gradient and exposed to beads labeled with a specific antibody and the red blood cells from these samples, see page 2637, Cell…section; and Western…section. Using flow cytometry monoclonal antibodies (mAbs) specific for surface markers cells expressing the particular antibody was analyzed using flow cytometry, see page 2637, Flow…section. Moreover, Western blotting which uses a solid substrate was conducted utilizing specific antibodies and labeled secondary antibodies, see Western…section on page 2637. Monoclonal antibodies specific for neutrophils include CD15, see page 2637, Flow…section.
“[R]ed blood cells were removed using ammonium chloride lysis buffer, … were isolated subsequently using magnetic beads …”, see page 2637, Cell isolation…section. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of all the references to identify, characterize, isolate, separate and quantify different cell types, including LOX-1+ and LOX-1 expressing cells based on morphological differences using LOX-1 specific antibodies with the immunophenotypic analysis set forth in Condamine and Kominami, see all references, particularly page 2637 of Condamine; and sections 0096-0111 spanning pages 6-8 of Kominami. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings Kominami with the secondary reference to wash unbound cells in the sample from the substrate to separate, collect and enumerate PMN-MCSCs utilizing the taught ligands specific to particular cell types. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success by teachings in these references that one of ordinary skill in the art can obtain a group of cells from a sample in order to target a particular expression marker to determine subpopulations and/or subsets within the said group, see both references and in particular Condamine. Differences in cell types may be essential to the diagnosis of a condition, potential therapeutic treatment and the probable prognosis, see all references in their entirety.
Double Patenting
13. 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.
14. The nonstatutory double patenting provisional rejection over claims 1-16, 18 and 19 as being unpatentable over claims 29, 30, 33, 35 and 37-39 of copending Application No. 17/634,968 (filed February 12, 2022) is maintained.
“Applicant respectfully disagrees with the Examiner. However, Applicant respectfully requests that the Office hold the double patenting rejections in abeyance until the claim(s) are otherwise in condition for allowance.”, see Remarks submitted June 12, 2025, page 7, last paragraph.
Applicant’s request has been considered, but not persuasive. At this point in prosecution, the claims are not allowable. Hence, the rejection is maintained.
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims read on obtaining a biological sample and identifying LOX-1+ with a ligand, as well as identifying neutrophil biomarker, CD15 or CD66b with requisite ligands. The method steps of both sets of claims result in distinguishing polymorphonuclear neutrophils (PMNs) from polymorphonuclear myeloid derived suppressor cells (PMN-MDSCs).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
15. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
16. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ALANA HARRIS DENT whose telephone number is (571)272-0831. The Examiner works a flexible schedule, however she can generally be reached 8AM-8PM, Monday through Friday.
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, Julie Wu can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALANA HARRIS DENT
Primary Examiner
Art Unit 1643
26 June 2025
/Alana Harris Dent/ Primary Examiner, Art Unit 1643
Prosecution Insights