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 the Application
Applicant’s cancellation of claims 1-9 in the reply filed on 3/26/2026 is acknowledged.
Applicant’s addition of new claims 10-17 in the reply filed on 3/26/2026 is acknowledged.
Applicant’s claim that cancelled claims 1-5 and 7 correspond to new claims 10-15 and that cancelled claims 8-9 correspond to new claims 16-17 in the reply filed on 3/26/2026 is acknowledged.
Applicant’s election without traverse of Group II (new claims 10-15) in the reply filed on 3/26/2026 is acknowledged.
Claims 16-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I (new claims 16-17), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/26/2026.
Claims 10-17 are under examination.
Information Disclosure Statement
The information disclosure statement filed 08/28/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Drawings
The drawings are objected to because of the following reasons:
T
Figure 15 contains improper labeling of circle sectors. The circles have lines, while the legend has dots.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification - Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
In the instant case, the document designated as abstract just has the caption, “FIG. 1”.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 10 is objected to because of the following informalities: the phrase "administering to the subject of delivering" is . Appropriate correction is required.
Claim 10 are objected to because of the following informalities: improper antecedent basis in the phrase "the imaging agent". Appropriate correction is required.
Claim Interpretation
Within claim 10, the phrase “administering to the subject of delivery an anti-TREM3 antigen…” (emphasis added) is interpreted as “administering to the subject, an anti-TREM3 antigen…”.
Claims 11-15 are interpreted for the purposes of examination to refer to claim 10 rather than the cancelled claim 1.
Claim Rejections - 35 USC § 112(a) – Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification and drawings do not mention "TREM3", "anti-TREM3", or "anti-TREM3 antigen" .
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11-15 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 11-15 depend on claim 1 which has been canceled. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over James et al. (US 2018/0353628 A1) and Ford et al. (Ford, J. W.; McVicar, D. W. TREM and TREM-like Receptors in Inflammation and Disease, 2009, 21, 1, 38-46).
James et al. (hereafter referred to as James) is drawn to a method for detecting immune diseases in a subject (title, abstract, introduction, claim 1) using imaging techniques (para [0002], lines 1-2; para [0057], lines 3-5), administering to a range of subjects (para [0035]), using an anti-TREM1 antigen binding molecule conjugated to an imaging or diagnostic substance (para [0005], lines 5-6; para [0005], col 2, lines 2-8; claims 1, 5-8, 11, and 13).
As to claim 10, James teaches a method for detecting immune dysfunction in a subject (title, abstract, introduction, claim 1) by administering to the subject (para [0005], lines 3-4; para [0006], lines 2-5; Figures 1-11; claim 1; claim 11) an anti-TREM1 antigen binding molecule conjugated to one or more imaging or diagnostic substances (para [0005], lines 5-6; para [0005], col 2, lines 2-8; para [0053], lines 1-9; para [0054]; para [0055], lines 1-4; lines 1-3; para [0066], lines 1-10; claims 1, 5-8, 11, and 13), and detection of the imaging agent in an organ of the subject is an indication of immune dysfunction in the organ (para [0006], lines 9-12).
James does not teach anti-TREM3 antigen binding molecule conjugated to one or more imaging or diagnostic substances.
Ford et al. (hereafter referred to as Ford) is drawn to TREM-like receptors in inflammation and disease (title; abstract; pg 2, para 4, lines 1-19; pg 4, para 3, lines 1-3; pg 5, para 3, lines 18-21) and to various types of TREM (TREM-1, TREM-2, TREM-3) as alternatives that physically associate with immunoreceptors (pg 5, para 2, lines 1-5).
Ford teaches TREM3 as an alternative to TREM1 (pg 5, para 2, lines 1-5).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another and the results of the substation would have been predictable. See MPEP 2143(I)(B).
As to claim 11, James teaches that the subject is in need of diagnosis (para [0006], lines 1-3; para [0035], lines 10-11; para [0053], lines 5-7; para [0058], lines 1-4; para [0065], lines 6-8).
As to claim 12, James teaches detection of the imaging agent in the brain of the subject (para [0005], line 13; para [0017], lines 1-3; Fig 6; para [0022], lines 1-5; Fig 11; para [0066]; para [0092], lines 1-9; claim 2) and that detection identifies the location of an inflammation associated with a disease or condition (para [0005], lines 7-9) comprising one or more of multiple sclerosis, Alzheimer’s disease, Huntingdon’s disease, Parkinson’s disease, epilepsy, stroke, brain tumor, brain trauma, infections, and other CNS, peripheral inflammatory diseases or related biological conditions (para [0005], lines 10-17; para [0058]; para [0066]; claim 2).
As to claim 13, James teaches the subject is human (para [0002], lines 8-11; para [0035], lines 1-2; para [0041], lines 5-7).
As to claim 14, James teaches the administration is IV, subcutaneous, intraperitoneal, intravitreal, or intrathecal administration (para [0033]) and intramuscular (para [0074], line 8).
As to claim 15, James teaches diagnostic substance which comprises one or more of PET and PET/MRI (para [0057]) and radiolabels and radioisotopes (para [0062]; para [0063], lines 10-14; para [0048], col 2, lines 8-14; para [0060], lines 1-8; claims 1; claim 5; claim 9; claim 15).
Nonstatutory 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.
Issued Patent No. 11,213,598
Claims 10-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 13, and 21 of U.S. Patent No. 11,213,598 in view of James and Ford.
Instant claim 10 is drawn to a method for detecting immune dysfunction in a subject, comprising administering to the subject of delivering an anti-TREM3 antigen binding molecule conjugated to one or more imaging or diagnostic substance(s), wherein detection of the imaging agent in an organ of the subject is an indication of immune dysfunction in the organ.
Conflicting claims 1 and 9 are drawn to a method of imaging inflamed tissue in a subject using a labeled probe which is made of TREM-1 antibody and radiolabel where detection of the signal corresponds to the disease.
However, the claims of issued patent no. 11,213,598 do not teach TREM-3. As noted in the current rejections above, the combined teachings of James and Ford render obvious claim 1 in the instant application.
Instant claim 11 is drawn to a subject in need of diagnosis.
Conflicting claims 1 and 9 teach that the subject can have a neurological disease.
Instant claim 12 is drawn to a detection of the imaging agent in the brain of the subject identifies the location of an inflammation associated with a disease or condition comprising one or more of multiple sclerosis, Alzheimer's disease, Huntington's disease, Parkinson's disease, epilepsy, brain tumor, stroke, amyotrophic lateral sclerosis, spinal cord and/or brain trauma, a disease or condition which would benefit from enzyme replacement therapy ("ERT"), a neurological disease, chronic inflammatory conditions, acute inflammatory conditions, autoimmume disease, or infection.
Conflicting claims 1 and 9 teach imaging a portion of the subject and one or more of multiple sclerosis, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, stroke, traumatic brain injury, and epilepsy.
Instant claim 13 teaches the subject is human.
Conflicting claim 1 teaches a subject.
However, the claims of Issued Patent No. 11,213,598 does not teach the subject is a human. As noted in the current rejections above, the combined teachings of James and Ford render obvious claim 13 in the instant application.
Instant claim 14 is drawn to methods of administration.
Conflicting claim 1 teaches administration to a subject.
However, the claims of Issued patent No. 11,213,598 does not teach the method of administration. As noted in the current rejections above, the combined teachings of James and Ford render obvious claim 14 in the instant application.
Instant claim 15 is drawn to the diagnostic substance comprising one or more PET and/or MRI probe(s), radiolabel(s), or isotope(s).
Conflicting claims 1 and 9 teach PET and radiolabels.
However, the claims of issued patent no. 11,213,598 does not explicitly teach MRI nor radioisotopes. As noted in the current rejections above, the combined teachings of James and Ford render obvious claim 15 in the instant application.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evan M Lewoczko whose telephone number is (571)272-9830. The examiner can normally be reached Monday-Friday 9-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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