Prosecution Insights
Last updated: April 19, 2026
Application No. 17/412,070

NON PEPTIDIC HETEROBIVALENT MOLECULES FOR TREATING INFLAMMATORY DISEASES

Final Rejection §112§DP
Filed
Aug 25, 2021
Examiner
SCHMITT, MICHAEL J
Art Unit
1629
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Glaxosmithkline Intellectual Property Development Limited
OA Round
2 (Final)
57%
Grant Probability
Moderate
3-4
OA Rounds
2y 10m
To Grant
79%
With Interview

Examiner Intelligence

Grants 57% of resolved cases
57%
Career Allow Rate
363 granted / 640 resolved
-3.3% vs TC avg
Strong +22% interview lift
Without
With
+22.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
34 currently pending
Career history
674
Total Applications
across all art units

Statute-Specific Performance

§101
4.0%
-36.0% vs TC avg
§103
36.7%
-3.3% vs TC avg
§102
16.6%
-23.4% vs TC avg
§112
18.8%
-21.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 640 resolved cases

Office Action

§112 §DP
DETAILED ACTION Claims 1-13 and 15-20 were pending. Claims 1, 2, 10, and 12 have been amended; claims 11, 15-17, and 19 have been canceled, and new claims 21-27 have been added. Claims 1-10, 12-13, 18, and 21-27 are pending; claims 7 and 9-10 stand withdrawn. Claims 1-6, 8, 12-13, 18, and 21-27 are the subject of the Office Action below. 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 . Priority The instant application, filed 8/25/2021 is a Continuation of 16478551, filed 7/17/2019, now abandoned. 16478551 is a National Stage entry of PCT/IB2018/050260, with an International Filing Date of January 16, 2018. PCT/IB2018/050260 claims Priority from Provisional Application 62/446,959, filed January 17, 2017. Claim Rejections - 35 USC § 112(b) (Maintained) The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-6, 8, 12-13, 18, and 21-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 is directed towards: PNG media_image1.png 272 622 media_image1.png Greyscale Applicant has only amened the nonce term “R” to a structure, though Applicant has not defined where or how the Q group is attached to R. A claim term is functional when it recites a feature "by what it does rather than by what it is" (e.g., as evidenced by its specific structure or specific ingredients). In re Swinehart, 439 F.2d 210, 212, 169 USPQ 226, 229 (CCPA 1971). There is nothing inherently wrong with defining some part of an invention in functional terms. Functional language does not, in and of itself, render a claim improper. Id. In fact, 35 U.S.C. 112(f) and pre-AIA 35 U.S.C. 112, sixth paragraph, expressly authorize a form of functional claiming (means- (or step-) plus- function claim limitations discussed in MPEP § 2181 et seq.). Functional language may also be employed to limit the claims without using the means-plus-function format. See, e.g., K-2 Corp. v. Salomon S.A., 191 F.3d 1356, 1363, 52 USPQ2d 1001, 1005 (Fed. Cir. 1999). Unlike means-plus-function claim language that applies only to purely functional limitations, Phillips v. AWH Corp., 415 F.3d 1303, 1311, 75 USPQ2d 1321, 1324 (Fed. Cir. 2005) (en banc) ("Means-plus-function claiming applies only to purely functional limitations that do not provide the structure that performs the recited function."), functional claiming often involves the recitation of some structure followed by its function. For example, in In re Schreiber, the claims were directed to a conical spout (the structure) that "allow[ed] several kernels of popped popcorn to pass through at the same time" (the function). In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997). As noted by the court in Schreiber, "[a] patent applicant is free to recite features of an apparatus either structurally or functionally." Id. In this case Applicant has not clearly used means for language, and Applicant has not used functional claiming wherein some structure is followed by its function. Applicant has simply states a function, therefore this claim is purely functional. Notwithstanding the permissible instances, the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs "when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty") (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938)); see also United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 234 (1942) (holding indefinite claims that recited substantially pure carbon black "in the form of commercially uniform, comparatively small, rounded smooth aggregates having a spongy or porous exterior"). When a claim limitation employs functional language, the examiner’s determination of whether the limitation is sufficiently definite will be highly dependent on context (e.g., the disclosure in the specification and the knowledge of a person of ordinary skill in the art). Halliburton Energy Servs., 514 F.3d at 1255, 85 USPQ2d at 1663. For example, a claim that included the term "fragile gel" was found to be indefinite because the definition of the term in the specification was functional, i.e., the fluid is defined by what it does rather than what it is ("ability of the fluid to transition quickly from gel to liquid, and the ability of the fluid to suspend drill cuttings at rest"), and it was ambiguous as to the requisite degree of the fragileness of the gel, the ability of the gel to suspend drill cuttings (i.e., gel strength), and/or some combination of the two. Halliburton Energy Servs., 514 F.3d at 1255-56, 85 USPQ2d at 1663. In another example, the claims directed to a tungsten filament for electric incandescent lamps were held invalid for including a limitation that recited "comparatively large grains of such size and contour as to prevent substantial sagging or offsetting during a normal or commercially useful life for such a lamp or other device." General Elec. Co., 304 U.S. at 370-71, 375. The Court observed that the prior art filaments also "consisted of comparatively large crystals" but they were "subject to offsetting" or shifting, and the Court further found that the phrase "of such size and contour as to prevent substantial sagging and offsetting during a normal or commercially useful life for a lamp or other device" did not adequately define the structural characteristics of the grains (e.g., the size and contour) to distinguish the claimed invention from the prior art. Id. at 370. Similarly, a claim was held invalid because it recited "substantially pure carbon black in the form of commercially uniform, comparatively small, rounded smooth aggregates having a spongy or porous exterior." United Carbon Co., 317 U.S. at 234. In the latter example, the Court observed various problems with the limitation: "commercially uniform" meant only the degree of uniformity buyers desired; "comparatively small" did not add anything because no standard for comparison was given; and "spongy" and "porous" are synonyms that the Court found unhelpful in distinguishing the claimed invention from the prior art. Id. at 233. In this case, the Heterobivalent Molecule lacks any structure. To overcome the rejection Applicant has amended the claims to recite the “structure” of P-Q-R, wherein: P represents a CCR binding moiety Q is a chemical linker and R is cotinine. The rejection is maintained as the structure P-Q-R still lacks structure and are not using “means for” language. Therefore the metes and bounds of these terms are still indefinite as the claim lacks a defined structure to the hyphen in the structure, as it is indefinite as to how the groups are connected together. Applicant could overcome the rejection simply by adding the structures from the specification to the claim. Response to Arguments: Applicant argues the amendments obviate the rejection, this is not the case as outlined above. Claim Rejections - 35 USC § 112(b) (Maintained) The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-6, 8, 12-13, 18, and 21-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 limitation “moiety binding to a CCR receptor” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because Applicant did not use “means for” language. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may: (a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function; (b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function; (c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or (d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function. Response to Arguments: Applicant argues the amendments obviate the rejection, this is not the case as outlined above. Claim Rejections - 35 USC § 112 (Maintained) The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-6, 8, 12-13, 18, and 21-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 limitation “moiety binding to endogenous or exogenous antibodies” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because Applicant did not use “means for” language. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may: (a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function; (b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function; (c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or (d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function. Response to Arguments: Applicant argues the amendments obviate the rejection, this is not the case as outlined above. Claim Rejections - 35 USC § 112(a) Claims 1-6, 8, 12-13, 18, and 21-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the following claim limitations all suffer from the same flaw: “a Heterobivalent Molecule (HBM)” defined as “P-Q-R” is a purely functional recitation with no limitation of structure; “P represents a CCR binding moiety” is a purely functional recitation with no limitation of structure; and “Q represents a linker” is a purely functional recitation with no limitation of structure. Applicant appears to be using a “means for” type claiming without the recitation of “means”..... Applicant's claim reads as a "means for binding CCR receptor and an endogenous or exogenous antibody while inducing destruction of CCR-positive cells in a human.” An omnibus claim. When a claim uses the term “means” to describe a limitation, a presumption inheres that the inventor used the term to invoke § 112, ¶ 6. Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1375 (Fed. Cir. 2003). “This presumption can be rebutted when the claim, in addition to the functional language, recites structure sufficient to perform the claimed function in its entirety.” Id. As the court set forth in LG Electronics: " '[A] claim term that does not use 'means' will trigger the rebuttable presumption that § 112 ¶ 6 does not apply.' " Lighting World, Inc. v. Birchwood Lighting, Inc., 382 F.3d 1354, 1358 (Fed. Cir. 2004) (quoting CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1369 (Fed. Cir. 2002)). This presumption can be rebutted "by showing that the claim element recite[s] a function without reciting sufficient structure for performing that function." Watts v. XL Sys., 232 F.3d 877, 880 (Fed. Cir. 2000) (citing Rodime PLC v. Seagate Tech., Inc., 174 F.3d 1294, 1302 (Fed. Cir. 1999)). However, the presumption "is a strong one that is not readily overcome." Lighting World, Inc., 382 F.3d at 1358. LG Electronics, Inc. v. Bizcom Electronics, Inc., 453 F.3d 1364, 1372 (Fed. Cir. 2006). Because the Applicant did not use “means” to recite the limitations in claims the presumption is that the Applicant did not intend to invoke interpretation under § 112, sixth paragraph. Applicant is reminded that 35 U.S.C. § 112, sixth paragraph, when enacted, was a statutory response to the Supreme Court’s decision in Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946). This general prohibition against the use of “purely functional claim language” (and the more specific Halliburton rule) has not been completely eliminated. Rather, “purely functional claim language” is now permissible but only under the conditions of 35 U.S.C. § 112, sixth paragraph, i.e., if its scope is limited to the corresponding structure, material, or act disclosed in the specification and equivalents thereof. In the absence of such limited construction, the concerns expressed by the Court in Halliburton are still applicable to prohibit the use of “purely functional” claim language. Hence, any claim that includes purely functional claim language, and which is not subject to the limited construction under 35 U.S.C. § 112, sixth paragraph, fails to meet the requirements of 35 U.S.C. § 112, first paragraph, according to reasoning in Halliburton and thus is unpatentable. While the particular claim language involved in the Supreme Court's Halliburton decision uses the word “means,” the issue was claiming in a purely functional manner, a practice condemned by pre-existing case law, and not any particular problem associated uniquely with the word “means” as distinguished from other purely functional words and phrases. With regard to pre-existing case law around the time of the Supreme Court's Halliburton decision, see In re Fuetterer, 319 F.2d 259, 263 (CCPA 1963), wherein the Court of Customs and Patent Appeals explained: In the Fullam case [In re Fullam, 161 F.2d 247 (CCPA 1947)], this court stated that some claims were properly rejected as “functional in claiming merely the desired result well known to and sought after by workers skilled in the art.” Claims directed merely to a “desired result” have long been considered objectionable primarily because they cover any means which anyone may ever discover of producing the result. See, e.g., O'Reilly v. Morse, 15 How. 62; Heidbrink v. McKesson, 290 F. 665. When an applicant has not given notice to the public that his or her purely functional claim element is to be limited by the application of 35 U.S.C. § 112, sixth paragraph, a first USPTO concern is that the claim is indefinite under 35 U.S.C. § 112, second paragraph. A second USPTO concern is that such unlimited purely functional claiming may reasonably be construed to encompass any and all structures for performing the recited function, including those which are not what the applicant invented. Thus, it is doubly critical that the USPTO be in possession of such public notice when making a determination to grant a patent. That is, when the limitation encompasses any and all structures or acts for performing a recited function, including those which were not what the applicant had invented, the disclosure fails to provide a scope of enablement commensurate with the scope of the claim and the claim would violate the prohibition of Halliburton. The Supreme Court’s Halliburton case remains viable for claims having purely functional claim language which is unlimited either by (1) the application of 35 U.S.C. § 112, sixth paragraph, or (2) the additional recitation of structure. In the present case, the limitations discussed above all violate the rule set forth in Halliburton, because the claims are not limited by the application of 35 U.S.C. § 112, sixth paragraph, and they do not contain any additional recitation of structure. As such, these claims are unpatentable under 35 U.S.C. § 112, first paragraph, for lack of an enabling disclosure commensurate with the scope of the claims. Without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). See also Datamize LLC v. Plumtree Software Inc., 75 USPQ2d 1801 (Fed. Cir. 2005) where a claim directed to a software based system for creating a customized computer interface screen recited that the screen be "aesthetically pleasing," which is an intended result and does not provide a clear cut indication of scope because it imposed no structural limits on the screen. Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 USPQ2d at 1167. For instance, a single means claim covering every conceivable means for achieving the stated result was held to be invalid under 35 U.S.C. 112, first paragraph because the court recognized that the specification, which disclosed only those means known to the inventor, was not commensurate in scope with the claim. Hyatt, 708 F.2d at 714-715, 218 USPQ at 197. For more information regarding the written description requirement and enablement requirement under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, see MPEP §§ 2161-2164.08(c). Examiners should keep in mind that whether or not the functional limitation complies with 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, is a different issue from whether the limitation is properly supported under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, or is distinguished over the prior art. Response to Arguments: Applicant argues the amendments obviate the rejection, this is not the case as outlined above. 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. Application No. 18/813,364 Claims 1-6, 8, 12-13, 18, and 21-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 78 of copending Application No. 18/813,364 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to destroying cells expressing CCR2 with a cotinine-linker-binder drug conjugate (HBM). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Application No. 18/682,193 Claims 1-6, 8, 12-13, 18, and 21-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 28-29 of copending Application No. 18/682,193 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to destroying cells expressing CCR2 with a cotinine-linker-binder drug conjugate (HBM). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. US Patent No. 12,521,393 Claims 1-6, 8, 12-13, 18, and 21-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-27 of U.S. Patent No. 12,521,393. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘393 patent is directed to a method of using a HBM to target cells expressing CCR2 and treating disease. Conclusion No claims allowed. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached on M-F 8-6 MidDay Flex. 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, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MICHAEL J SCHMITT/Examiner, Art Unit 1629 /JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
Read full office action

Prosecution Timeline

Aug 25, 2021
Application Filed
May 14, 2025
Non-Final Rejection — §112, §DP
Nov 14, 2025
Response Filed
Mar 15, 2026
Final Rejection — §112, §DP (current)

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Prosecution Projections

3-4
Expected OA Rounds
57%
Grant Probability
79%
With Interview (+22.2%)
2y 10m
Median Time to Grant
Moderate
PTA Risk
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