Prosecution Insights
Last updated: April 19, 2026
Application No. 18/324,056

METHODS AND COMPOSITIONS FOR TREATMENT OF THYROID EYE DISEASE

Non-Final OA §102§112§DP
Filed
May 25, 2023
Examiner
LUNDE, GRACE HENRY
Art Unit
1641
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Horizon Therapeutics Ireland Dac
OA Round
1 (Non-Final)
75%
Grant Probability
Favorable
1-2
OA Rounds
3y 7m
To Grant
99%
With Interview

Examiner Intelligence

Grants 75% — above average
75%
Career Allow Rate
12 granted / 16 resolved
+15.0% vs TC avg
Strong +44% interview lift
Without
With
+44.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
30 currently pending
Career history
46
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
27.2%
-12.8% vs TC avg
§102
15.9%
-24.1% vs TC avg
§112
28.6%
-11.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 16 resolved cases

Office Action

§102 §112 §DP
DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. The claim listing filed February 3, 2026 is pending. Claims 1-2 33 and 237 are canceled. Claims 238-252 are new. Claims 234-236 and 238-252 are pending . Election/Restrictions Applicant’s election of the species of anti-IGF1R antibodies as the IGF1R antagonist and teprotumumab as the anti-IGF1R antibody in the reply filed on February 3, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). It is noted that the originally presented claims (claims 234-236) are drawn to method of treating thyroid eye disease in an individual with pre-existing hyperglycemia, prediabetes or diabetes and newly added claims 245-252 are drawn to a method of monitoring an individual with pre-existing hyperglycemia, prediabetes or diabetes being treated for thyroid eye disease with an antagonist of IGF 1R signaling. The methods of treating thyroid eye disease in an individual with pre-existing hyperglycemia, prediabetes or diabetes (234-236 and 238-244, Invention I) and monitoring an individual with pre-existing hyperglycemia, prediabetes or diabetes being treated for thyroid eye disease with an antagonist of IGF 1R signaling (245-252, Invention II) are unrelated methods. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the method of treating thyroid eye disease in an individual with pre-existing hyperglycemia, prediabetes or diabetes and the method of monitoring an individual with pre-existing hyperglycemia, prediabetes or diabetes being treated for thyroid eye disease with an antagonist of IGF 1R signaling are patentably distinct as they involve different ingredients, method steps, and end points. Thus, each invention is patentably distinct. Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: (a) the inventions have acquired a separate status in the art in view of their different classification; (b) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or (c) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries) . Given that the originally presented claims, for which a species election requirement was sent on 11/03/2025, were drawn to Invention I, the method of treating thyroid eye disease in an individual with pre-existing hyperglycemia, prediabetes or diabetes, the Examiner is treating that as the Applicant’s election of Invention I. It is noted that if the newly added claims 245-252, which are drawn to a method of monitoring an individual with pre-existing hyperglycemia, prediabetes or diabetes being treated for thyroid eye disease with an antagonist of IGF 1R signaling (invention II), were originally presented in the claim listing filed on 10/06/2023, the Examiner would have required restriction between Inventions I and II. As such, claims 238 and 245-252 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions. Claims 234-236 and 239-244 are currently under consideration. Claim Rejections - 35 USC § 112 Indefinite language 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 244 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. Claim 244 recites “or combinations thereof” in line 5. However, claim 244 is dependent on claim 243 which recites “treating the individual with an anti-diabetic drug” in lines 1 and 2. The recitation of “ an anti-diabetic drug” implies a single anti-diabetic drug is being delivered to the patient, not more than one. However, claim 244 recitation of “or combinations thereof” implies that more than one anti-diabetic is being delivered to the patient. Therefore, the limitation in claim 244 lack antecedent basis. Amending claim 244 to delete the phrase “or combinations thereof” would obviate this part of the rejection. 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 234-236, 243, and 244 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 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. T he instant claims are drawn to a method of treating thyroid eye disease in an individual with pre- existing hyperglycemia, prediabetes or diabetes, the method comprising: a) selecting the individual for treatment with an antagonist of IGF1R signaling if the individual exhibits an HbA1c measurement below 6.5% or a fasting blood glucose measurement below 126 mg/dL after an overnight fast by a first test for blood glucose control, wherein the antagonist of IGF1R signaling is an antibody that binds IGF1R ; b) administering a first dose of the antagonist of IGF1R signaling to the individual; and c) obtaining the results of a second test for blood glucose control from the individual being treated with the antagonist of IGF1R signaling . All of the examples disclosed by the Applicant for treating thyroid eye disease are prophetic and only use teprotumumab, an anti-IGF1R antibody (e.g. see Examples 2-5 on pages 137-141). Teprotumumab comprises the instantly claimed CDR (claim 239) , VH and VL (claim 240) , and HC and LC (claim 241) amino acid sequences. The Applicant has also disclosed the an anti-IGF1R antibodies: ganitumab, figitumumab, cixutumumab, dalotuzumab, robatumumab, AVE1642, or istiratumab (e.g. see claims 238 and 248). When given the broadest reasonable interpretation in light of specification, the anti-IGF1R antibodies of the instant invention are defined broadly to be any antibody that binds to and antagonizes IGF1R. It is noted that the broadest claim (claim 234 ) does not indicate any specific structure for the genus of anti-IGF1R antibodies. Dependent claims 235, 236, 243, and 244 also does not indicate any specific structure for the genus of anti-IGF1R antibodies. Only claims 239-242 recite sufficient structure for the claimed anti-IGF1R antibody . The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, January 5, 2001, see especially page 1106 column 3). In The Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412) 19 F. 3d 1559, the court held that disclosure of a single member of a genus (rat insulin) did not provide adequate written support for the claimed genus (all mammalian insulins). In this same case, the court also noted: “A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). It is only a definition of a useful result rather than a definition of what achieves that result. Many such genes may achieve that result. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”). Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” A rtisans are well aware that knowledge of a given antigen (for instance IGF1R ) provides no information concerning the sequence/structure of antibodies that bind the given antigen. For example, Edwards et al. (J. Mol. Biol., 2003, 334:103-118) teach that over 1,000 different antibodies to a single protein can be generated, all with different sequences spanning almost the entire heavy and light chain germline repertoire (42/49 functional heavy chain germlines and 33 of 70 V-lambda and V-kappa light chain germlines, and with extensive diversity in the HCDR3 region sequences (that are generated by VDJ germline segment recombination) as well, see entire document). As such, it does not seem possible to predict the sequence/structure of an antibody that binds a given antigen, as there does not appear to be any common or core structure present within all antibodies that gives rise to the function of antigen binding. Further, given data, such as that of Edwards et al., indicating the diversity of sequences in a population of antibodies that bind to a given antigen, no number of species appears to reasonably representative of the breadth of the genus of antibodies that bind the given antigen. It should be pointed out that it is well established in the art that the formation of an intact antigen-binding site requires the association of the complete heavy and light chain variable regions of a given antibody, each of which consists of three different complementarity determining regions, CDR1, 2 and 3, which provide the majority of the contact residues for the binding of the antibody to its target epitope. The amino acid sequences and conformations of each of the heavy and light chain CDRs are critical in maintaining the antigen binding specificity and affinity which is characteristic of the parent immunoglobulin (Janeway Jr et al., Immunology, 3rd Edition, 1997 Garland Publishing Inc., pages 3:1-3:11.see entire selection). Thus, based upon the prior art, skilled artisans would reasonably understand that it is the structure of the CDRs within an antibody which gives rise to the functional property of antigen binding, the epitope to which said CDRs bind is an inherent property which appears to necessarily be present due to conservation of critical structural elements, namely the CDR sequences themselves. This applies to the instant invention which is drawn to a genus of anti-IGF1R antibodies. As noted above, the Applicant has disclosed eight anti-IGF1R antibodies (teprotumumab, ganitumab, figitumumab, cixutumumab, dalotuzumab, robatumumab, AVE1642, or istiratumab). Such a disclosure does not serve to provide sufficient written description of the claimed genus of anti-IGF1R antibodies . The disclosure does not identify any specific structural features or combination of features which give rise to the function of IGF1R binding and antagonism. Additionally, there does not appear to be any reasonable shared structure present in the genus of recited fusion proteins which gives rise to their functional activity. Ultimately, identifying a fusion protein simply on the basis of binding to and antagonizing IGF1R rather than by identifying the sequence/structure, namely the CDRs , of the anti-IGF1R antibodies in question is generally insufficient to provide written description. The claims are drawn to a broad genus of anti-IGF1R antibodies which are functionally defined by their ability to bind to and antagonize IGF1R without reciting a corresponding structure expected to correlate with this ability as supported by Applicant’s disclosure. Thus, there is insufficient written description for the breadth of anti-IGF1R antibodies as currently claimed, which are distinct and diverse and do not share a common structure that contributes to a common ability to bind to and antagonize IGF1R . Therefore, in view of the breadth of the claims and the limited disclosure, artisans would reasonably conclude that applicant was not in possession of the full breadth of anti-IGF1R antibodies encompassed by the claims at the time the instant application was filed. Amending claim 234 to recite the CDR, VH and VL, or HC and LC amino acid sequences of claims 239-241, respectively, or that the anti-IGF1R antibodies are teprotumumab, ganitumab, figitumumab, cixutumumab, dalotuzumab, robatumumab, AVE1642, or istiratumab would obviate this part of the rejection. Claim Rejections - 35 USC § 102 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 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. Claims 234-236 and 239-244 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. 2017 (N Engl J Med. 376:1748-1761, an IDS reference filed 11/13/2023, see supplementary appendix attached). Independent claim 234 is drawn to a method of treating thyroid eye disease in an individual with pre- existing hyperglycemia, prediabetes or diabetes, the method comprising: a) selecting the individual for treatment with an antagonist of IGF1R signaling if the individual exhibits an HbA1c measurement below 6.5% or a fasting blood glucose measurement below 126 mg/dL after an overnight fast by a first test for blood glucose control, wherein the antagonist of IGF1R signaling is an antibody that binds IGF1R; b) administering a first dose of the antagonist of IGF1R signaling to the individual; and c) obtaining the results of a second test for blood glucose control from the individual being treated with the antagonist of IGF1R signaling. Dependent claim 235 limits the method to that further comprising interrupting treatment of the individual with the antagonist of IGF1R signaling if the individual exhibits an HbA1c measurement of 6.5% or above or a fasting blood glucose measurement of 126 mg/dL or above after an overnight fast by the results of the second test for blood glucose control. Dependent claim 236 limits the method to that further comprising administering a second dose of the antagonist of IGF1R signaling to the individual if the individual exhibits an HbA1c measurement of6.5%o or above or a fasting blood glucose measurement of 126 mg/dL or above after an overnight fast by the results of the second test for blood glucose control, wherein the second dose is lower than the first dose. Dependent claims 239-242 limit the anti-IGF1R antibody that that comprising the CDRs, VH and VL, or HC and LC amino acid sequences of teprotumumab (claims 239-241, respectively) or to teprotumumab itself (claim 242). Dependent claim 243 limits the method to that further comprising treating the individual with an anti- diabetic drug if the individual exhibits an HbA1c measurement of 6.5% or above or a fasting blood glucose measurement of 126 mg/dL or above after an overnight fast by the results of the second test for blood glucose control. Dependent claim 244 limits anti-diabetic drug of claim 243 to insulin, metformin, pioglitazone, rosiglitazone, acarbose, miglitol, bromocriptine, alogliptin, linagliptin, saxagliptin, sitagliptin, dulaglutide, exenatide, liraglutide, lixisenatide, semaglutide, tirzepatide, nateglinide, repaglinide, canagliflozin, dapagliflozin, empagliflozin, ertugliflozin, glimepiride, gliclazide, glipizide, or combinations thereof. Regarding claim 234, Smith et al. teach a method of treating thyroid eye disease (thyroid-associated ophthalmopathy) in an individual with pre-existing diabetes with teprotumumab (e.g. see Abstract ; page 1757, paragraph spanning left and right columns ; and Table S 4 , see patients with asterisk ). Smith et al. also teach patients with pre-existing diabetes that participated in their study and received teprotumumab who had an HbA1c measurement below 6.5% (e.g. see Table S 4 , patients 021 -0001, 023-0001, and 022-0002 ). Smith et al. also teach that blood glucose control was monitored through subsequent tests over the course of the study (e.g. see page 1757, paragraph spanning left and right columns; and Table S4, weeks 12, 24, 36, and 72). Regarding claim 235, Smith et al. also teach a patient whose treatment with teprotumumab was interrupted (early termination for 015-0001) after the results of the second test for blood glucose control s how ed an HbA1 c measurement over 6.5% (e.g. see patient 015-0001 in Table S4). Regarding claim 236, Smith et al. also teach a patient who was administered a second dose of teprotumumab after the results of the second test for blood glucose control showed an HbA1c measurement over 6.5% (e.g. see patient 003-0009 in Table S4). Regarding claims 239-241, by definition, teprotumumab inherently comprises the instantly claimed CDR, VH and VL, and LC and LC amino acid sequences. Regarding claims 243 and 244, Smith et al. also teach a patient who was administered metformin and glimepiride after the results of the second test for blood glucose control showed an HbA1c measurement over 6.5% (e.g. see figure caption for patient 003-0009 in Table S4). Regarding the limitation of claim 236 which recites “wherein the second dose is lower than the first dose” in line 5, determination of the optimal intervals of treatment and the dosage regimen of a known drug was well within the purview of one of ordinary skill in the art at the time the invention was made and lends no patentable import to the claimed invention. The duration of treatment, the effective dosages, and like factors are well within the knowledge and expertise of the medical practitioner. A skilled artisan would have readily determined that the second dose of teprotumumab should be lower than the first dose if the first dose induced hyperglycemia, which is a known adverse event attributed to the administration of teprotumumab (e.g. see page 1757, paragraph spanning left and right columns). Optimal intervals and dosages are an art-recognized, result-effective variable which would have been routinely determined and optimized in the pharmaceutical art. Further, if there are any differences between the Applicant’s claimed method and that suggested by the teachings of the prior art, the differences would be appear minor in nature. Although the prior art do not teach that the second dose is lower than the first dose if the patient is hyperglycemic, it would be conventional and within the skill of the art to identify the optimal dosages of treatment. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A. As such, claims 234-236 and 239-244 are anticipated by Smith et al . 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 234-236 and 239-244 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 23 of co-pending U.S. Application No. 18/978,929 (the ‘ 929 Application) in view of Smith et al. 2017 (N Engl J Med. 376:1748-1761, an IDS reference filed 11/13/2023, see supplementary appendix attached). The instant claims are drawn to a method of treating thyroid eye disease in an individual with pre- existing hyperglycemia, prediabetes or diabetes, the method comprising: a) selecting the individual for treatment with an antagonist of IGF1R signaling if the individual exhibits an HbA1c measurement below 6.5% or a fasting blood glucose measurement below 126 mg/dL after an overnight fast by a first test for blood glucose control, wherein the antagonist of IGF1R signaling is an antibody that binds IGF1R; b) administering a first dose of the antagonist of IGF1R signaling to the individual; and c) obtaining the results of a second test for blood glucose control from the individual being treated with the antagonist of IGF1R signaling. The claims on the ‘929 Application are drawn to method of treating thyroid eye disease in a patient in need thereof comprising administering one of 10 insulin-like growth factor-1 receptor (IGF-1R) antagonist antibodies to the patient. It is noted that the anti-IGF1R antibodies of the ‘929 Application are species encompassed by the genus of anti-IGF1R antibodies of instant claims 234-236 , 243, and 244. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29, USPQ2d 2010 (Fed. Cir. 1993). Nonetheless, t he claims in the ‘929 Application differ from the instant invention by failing to recite (1) only an antibody comprising the CDRs, VH and VL, or HC and LC of teprotumumab, specifically only antibody (b) of claim 1 of the ‘929 Application ; (2) that the patient has pre-existing hyperglycemia, prediabetes, or diabetes and exhibits an HbA1c measurement below 6.5% or a fasting blood glucose measurement below 126 mg/dL after an overnight fast; and (3) that first and second blood glucose control tests were done. The teachings of Smith et al. are outlined in the 102 rejection above. It would be obvious to one of ordinary skill in the art to have modify the claims in the ‘929 Application to incorporate the teachings of Smith et al. to specifically select an antibody comprising the CDRs, VH and VL, or HC and LC of teprotumumab; and to include that the patient has pre-existing hyperglycemia, prediabetes, or diabetes and exhibits an HbA1c measurement below 6.5% or a fasting blood glucose measurement below 126 mg/dL after an overnight fast; and that first and second blood glucose control tests were done. This is because Smith et al. teaches the treatment of thyroid eye disease (thyroid-associated ophthalmopathy) in an individual with pre-existing diabetes with teprotumumab. Given that thyroid eye disease has already been treated with teprotumumab in an individual with pre-existing diabetes exhibiting an HbA1c measurement below 6.5% which was monitored by first and second blood glucose control tests throughout treatment (Smith et al.) ; it would be obvious to a skilled artisan to specifically select an antibody comprising the CDRs, VH and VL, or HC and LC of teprotumumab (i.e. antibody (b) of claim 1 of the ‘929 Application ) for specifically treating an individual with pre-existing diabetes exhibiting an HbA1c measurement below 6.5% which is monitored by first and second blood glucose control tests throughout treatment with a reasonable expectation of success. Therefore, the claims in the ‘ 929 Application would render the instant claims obvious. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 234-236 and 239-244 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims in the following co-pending Applications in view of Smith et al. 2017 (N Engl J Med. 376:1748-1761, an IDS reference filed 11/13/2023, see supplementary appendix attached) for similar reasons to the ‘929 Application . The instant claims are drawn to a method of treating thyroid eye disease in an individual with pre- existing hyperglycemia, prediabetes or diabetes, the method comprising: a) selecting the individual for treatment with an antagonist of IGF1R signaling if the individual exhibits an HbA1c measurement below 6.5% or a fasting blood glucose measurement below 126 mg/dL after an overnight fast by a first test for blood glucose control, wherein the antagonist of IGF1R signaling is an antibody that binds IGF1R; b) administering a first dose of the antagonist of IGF1R signaling to the individual; and c) obtaining the results of a second test for blood glucose control from the individual being treated with the antagonist of IGF1R signaling. Claims 101-120 of Application No. 18/548,484 are drawn to an anti-IGF1R antibody; a polynucleotide; an expression vector; a pharmaceutical composition; a method of treating thyroid eye disease (TED) in a subject with TED; a method of reducing proptosis in a subject with TED; a method of reducing a clinical activity score (CAS) in a subject with TED; and a method of treating or reducing the severity of diplopia in a subject with TED. Claims 1-27, 29-33, and 38 of Application No. 19/373,528 are drawn to method of treating thyroid eye disease in a patient in need thereof comprising administering an anti-IGF1R antibody comprising the CDRs of teprotumumab. Claims 1, 2, 40-42, 92, 93, and 95-106 of Application No. 17/654,318 methods of reducing proptosis in a subject with moderate-to- severe inactive/chronic thyroid eye disease (TED) comprising administering an anti-IGF1R antibody or specifically teprotumumab. It is noted that the anti-IGF1R antibodies of the co-pending Application s are species encompassed by the genus of anti-IGF1R antibodies of instant claims 234-236, 243, and 244. It has been held that a generic invention is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29, USPQ2d 2010 (Fed. Cir. 1993). Nonetheless, the claims in the above co-pending Applications differ from the instant invention by failing to recite that the patient has pre-existing hyperglycemia, prediabetes, or diabetes and exhibits an HbA1c measurement below 6.5% or a fasting blood glucose measurement below 126 mg/dL after an overnight fast and that first and second blood glucose control tests were done. The claims in the ‘484 Application also differ from the instant invention by failing to recite an antibody comprising the CDRs, VH and VL, or HC and LC of teprotumumab. The teachings of Smith et al. are outlined in the 102 rejection above. It would be obvious to one of ordinary skill in the art to have modify the claims in the co-pending Applications to incorporate the teachings of Smith et al. to include that the patient has pre-existing hyperglycemia, prediabetes, or diabetes and exhibits an HbA1c measurement below 6.5% or a fasting blood glucose measurement below 126 mg/dL after an overnight fast; that first and second blood glucose control tests were done; and for the ‘484 Application, that the antibody comprises the CDRs, VH and VL, or HC and LC of teprotumumab. This is because Smith et al. teaches the treatment of thyroid eye disease (thyroid-associated ophthalmopathy) in an individual with pre-existing diabetes with teprotumumab. Given that thyroid eye disease has already been treated with teprotumumab in an individual with pre-existing diabetes exhibiting an HbA1c measurement below 6.5% which was monitored by first and second blood glucose control tests throughout treatment (Smith et al.); it would be obvious to a skilled artisan to treat a patient that has pre-existing hyperglycemia, prediabetes, or diabetes and exhibits an HbA1c measurement below 6.5% or a fasting blood glucose measurement below 126 mg/dL after an overnight fast which is monitored by first and second blood glucose control tests throughout treatment; and for the ‘484 Application, that the antibody comprises the CDRs, VH and VL, or HC and LC of teprotumumab with a reasonable expectation of success. Therefore, the claims in the co-pending Applications would render the instant claims obvious. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Enter examiner's name" \* MERGEFORMAT Grace H. Lunde whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-1851 . The examiner can normally be reached FILLIN "Work schedule?" \* MERGEFORMAT Monday - Thursday 6:00 a.m. - 3:00 p.m. (EST) . 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, FILLIN "SPE Name?" \* MERGEFORMAT Misook Yu can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-0839 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /GRACE H LUNDE/ Examiner, Art Unit 1641 /MISOOK YU/ Supervisory Patent Examiner, Art Unit 1641
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Prosecution Timeline

May 25, 2023
Application Filed
Mar 24, 2026
Non-Final Rejection — §102, §112, §DP (current)

Precedent Cases

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
75%
Grant Probability
99%
With Interview (+44.4%)
3y 7m
Median Time to Grant
Low
PTA Risk
Based on 16 resolved cases by this examiner. Grant probability derived from career allow rate.

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