Prosecution Insights
Last updated: April 19, 2026
Application No. 17/759,139

VACCINATION AGAINST ANTIGENS INDUCED IN PATHOGEN-INFECTED CELLS

Non-Final OA §103§112§DP
Filed
Jul 20, 2022
Examiner
PUTTLITZ, KARL J
Art Unit
1646
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
UNIVERSITY OF MIAMI
OA Round
2 (Non-Final)
69%
Grant Probability
Favorable
2-3
OA Rounds
2y 8m
To Grant
87%
With Interview

Examiner Intelligence

Grants 69% — above average
69%
Career Allow Rate
974 granted / 1409 resolved
+9.1% vs TC avg
Strong +18% interview lift
Without
With
+18.2%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
58 currently pending
Career history
1467
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
37.5%
-2.5% vs TC avg
§102
11.3%
-28.7% vs TC avg
§112
26.8%
-13.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1409 resolved cases

Office Action

§103 §112 §DP
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 . The rejection under section 112(a) is maintained: Claim Rejections - 35 USC § 112 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 1, 3-6, 8, 11-21 remain 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 rejected claims cover methods of using immune-modulating agents that direct a subject's existing immune response against cell-encoded antigens; wherein the immune-modulating agent inhibits and/or downregulates a mediator of antigen processing and induces antigen formation; and wherein the immune-modulating inhibits and/or downregulates one or more of a mediator of ERAAP, transporter associated with antigen processing (TAP). To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”). With regard to the recited genus of immune-modulating agents the following applies: Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010) states that “...a generic claim may define the boundaries of a vast genus of chemical compounds...the question may still remain whether the specification, including the original claim language, demonstrates that the applicant invented species sufficient to support a claim to a genus”. See page 1171. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, 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 claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See also Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species. Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) states that “it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it”. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or structural features common to the members of the genus, which features constitute a substantial portion of the genus, so that one of skill in the art can “visualize or recognize” the members of the genus (Emphasis added). Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)(“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(i), the court states, "An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention." Courts have stated that “[i]n claims involving [non-genetic] chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). (emphasis added). There is no such specificity here, nor could one skilled in the art identify particular immune-modulating agents encompassed by the claims. Specifically, Applicant fails to disclose any other immune-modulating agents, besides those covered by the formulas in the specification, and in relation to the above, these disclosed species or subgenre do not represent the substantial variety covered by the genus of immune-modulating agents. With regard to the functional definition of that directing a subject's existing immune response against cell-encoded antigens; or inhibiting and/or downregulating a mediator of antigen processing and induces antigen formation; inhibiting and/or downregulating one or more of a mediator of ERAAP, transporter associated with antigen processing (TAP); the specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed (see Vas-Cath at page 1116) because the specification contains almost no information by which a person of ordinary skill in the art would understand that the inventors possessed the all of the recited immune-modulating agents. At best, it simply indicates that one should test an inordinate number of compounds to see if the compounds can perform the required functions. In this connection, the specification contains no structural or specific functional characteristics of those compounds which perform the recited functions, besides those immune-modulating agents instantly disclosed, see In re ’318 Patent Infringement Litigation, 583 F.3d 1317, 1327 (Fed. Cir. 2009) (“[A]t the end of the day, the specification, even read in light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient.”). The Examiner acknowledges that a working example or exemplified embodiment is not necessarily a requirement for description. However, where a generic claim term is present in a claim, as in the present application, and defined only by functional characteristics, the specification must convey enough information, e.g., via sufficient representative examples, to indicate invention of species sufficient to constitute the genus. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 967 2 (Fed. Cir. 2002). The written description requirement “requires a description of an invention, not an indication of a result that one might achieve if one made that invention.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997); see also Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1350 (Fed. Cir. 2013) (“A patent...‘is not a reward for the search, but compensation for its successful conclusion.’ ... For that reason, the written description requirement prohibits a patentee from ‘leaving it to the ... industry to complete an unfinished invention.’” (citations omitted)). Accordingly, the specification lacks adequate written description for the recited immune-modulating agents. Applicant fails to disclose the number and variety of oligonucleotides that inhibits and/or downregulates one or more of a mediator of ERAAP, transporter associated with antigen processing (TAP) or invariant chain (ii) which represent the substantial variety covered by the genus of immune-modulating agents. Moreover, the specification leaves it to those of ordinary skill to conceive of an inordinate number of oligonucleotides and test the oligonucleotides to see if they can perform the required functions. In this connection, the specification contains no generic structural characteristics of those oligonucleotides which can perform the recited function of inhibiting and/or downregulating one or more of a mediator of ERAAP, transporter associated with antigen processing (TAP) or invariant chain (ii). Claim 1 has been amended to include limitations of claim 11, namely, targeting pathogen-infected cells. These embodiments are now rejected under section 103, below, since the references contemplate pathogen-infected cells. The rejection is non-final. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. Claims 1, 3-6, 8, 11-21 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018227116, previously cited (WO 116) in view of WO 9825645, previously cited (WO 645). WO 116 demonstrates the concept of administering an effective amount of an immune-modulating agent to a subject to direct a subject's existing immune response to a neoantigen against a cell, where the immune-modulating agent inhibits and/or downregulates a mediator of antigen processing and induces neoantigen formation; and the subject has an existing immune response against the induced neoantigen. Immune-modulating agents are taught: PNG media_image1.png 106 660 media_image1.png Greyscale PNG media_image2.png 56 702 media_image2.png Greyscale PNG media_image3.png 200 666 media_image3.png Greyscale PNG media_image4.png 286 700 media_image4.png Greyscale See pages 6+. Lipid carriers are taught, see pages 12+. WO 116 explicitly teaches that the methods are analogous to treating viral infections: PNG media_image5.png 210 674 media_image5.png Greyscale See page 6. Nonetheless, WO 645 discloses a method of treating an pathogenic infection in a subject need thereof (a method for treatment of virus infections; page 13, lines 20-21), comprising administering an effective amount of an immune-modulating agent to pathogen-infected cells in the subject to direct a subject's existing immune response against cell-encoded antigens that are induced in a pathogen-infected cell (administering an effective amount of TAP-inhibitors (immune-modulating agent) to the body of an infected individual (pathogen-infected cells) to stimulate an immune response against antigens associated with impaired TAP-function, where the immune response is CD8+ T-cells in a subject (existing immune response); page 6, lines 18-24; page 7, lines 20-28; page 13, lines 12-21; page 14, lines 1-3), wherein: the immune-modulating agent inhibits and/or downregulates a mediator of antigen processing and induces antigen formation (where the inhibitor of TAP (mediator of antigen processing) induces antigen formation; page 6, lines 18-24; page 7, lines 20-28); and the subject has an existing immune response against the induced antigen (eliciting an immune response in a subject against the antigens associated with impaired TAP, where the immune response is CD8+ T-cells in a subject (existing immune response); page 6, lines 18-24; page 7, lines 20-28). See pages 9+: PNG media_image6.png 650 510 media_image6.png Greyscale WO 645 further discloses wherein the pathogen is bacterial, viral antigen, or parasitic (a method for treatment of virus infections by stimulating a response to antigens; page 6, lines 18-24). WO 645 further discloses wherein the pathogen is viral (a method for treatment of virus infections by stimulating a response to antigens; page 6, lines 18-24). WO 645 discloses a method of treating a viral infection in a subject need thereof (a method for treatment of virus infections; page 13, lines 20-21), comprising administering an effective amount of an immune-modulating agent to viral-infected cells in the subject to direct a subject's existing immune response against cell-encoded antigens that are induced in the viral-infected cells (administering an effective amount of TAP-inhibitors to the body of an infected individual (pathogen-infected cells) to stimulate an immune response against antigens associated with impaired TAP-function, where the immune response is CD8+ T-cells in a subject (existing immune response); page 6, lines 18-24; page 7, lines 20-28; page 13, lines 12-21; page 14, lines 1-3), wherein: the immune-modulating agent comprises an oligonucleotide molecule and inhibits and/or downregulates one or more of a mediator of ERAAP, transporter associated with antigen processing "TAP", and invariant chain "Ii" (where the inhibitor of TAP induces antigen formation, where the TAP inhibitor is an antisense oligonucleotide; page 6, lines 18-24; page 7, lines 20-28; page 8, lines 16-20, 24-29) and the subject has an existing immune response against the induced antigen (eliciting an immune response in a subject against the antigens associated with impaired TAP, where the immune response is COB+ T-cells in a subject (existing immune response); page 6, lines 18-24; page 7, lines 20-28. In this way, those of ordinary skill could have applied the disclosed immune-modulating agents in the manner required and in a predictable fashion for the purposes treating pathogenic infections. As outlined above, WO 116 demonstrates the concept of administering an effective amount of an immune-modulating agent to a subject to direct a subject's existing immune response to a neoantigen against a cell, where the immune-modulating agent inhibits and/or downregulates a mediator of antigen processing. WO 645 is added for the proposition that treating pathogenic diseases is applicable to this process of inhibiting and/or down regulating a mediator of antigen processing. Specifically, WO 645 teaches that the particular known technique of downregulating a mediator of antigen processing in pathological infections was recognized as part of the ordinary capabilities of one skilled in the art. In this manner, those of ordinary skill would have recognized that applying the known technique with immune-modulating agents would have yielded predictable results. Accordingly, using immune-modulating agents for the purposes of treating pathogenic infections would have been prima facie obvious. Those of ordinary skill would appreciate that the above methods can be optimized to the specific viruses set forth in the claims (e.g., CMV, ESB, HSV, HIV, SIV) or that combination therapies can asl be tailored to specific infections. Any observed pharmacological effect, such as directing a subject's existing immune response against cell-encoded antigens; or inhibiting and/or downregulating a mediator of antigen processing and induces antigen formation; inhibiting and/or downregulating one or more of a mediator of ERAAP, transporter associated with antigen processing (TAP) are invariable aspects of the immune-modulating agents of the applied references, see MPEP 2112.01 (“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”). The double patenting rejections remain outstanding: 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 1, 3-6, 8, 11-21 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Application No. 18/906621 in view of in view of WO 9825645 (WO 645). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims the concept of administering an effective amount of an immune-modulating agent to a subject to direct a subject's existing immune response to a neoantigen against a cell, where the immune-modulating agent inhibits and/or downregulates a mediator of antigen processing and induces neoantigen formation; and the subject has an existing immune response against the induced neoantigen. WO 645 discloses a method of treating an pathogenic infection in a subject need thereof (a method for treatment of virus infections; page 13, lines 20-21), comprising administering an effective amount of an immune-modulating agent to pathogen-infected cells in the subject to direct a subject's existing immune response against cell-encoded antigens that are induced in a pathogen-infected cell (administering an effective amount of TAP-inhibitors (immune-modulating agent) to the body of an infected individual (pathogen-infected cells) to stimulate an immune response against antigens associated with impaired TAP-function, where the immune response is CD8+ T-cells in a subject (existing immune response); page 6, lines 18-24; page 7, lines 20-28; page 13, lines 12-21; page 14, lines 1-3), wherein: the immune-modulating agent inhibits and/or downregulates a mediator of antigen processing and induces antigen formation (where the inhibitor of TAP (mediator of antigen processing) induces antigen formation; page 6, lines 18-24; page 7, lines 20-28); and the subject has an existing immune response against the induced antigen (eliciting an immune response in a subject against the antigens associated with impaired TAP, where the immune response is CD8+ T-cells in a subject (existing immune response); page 6, lines 18-24; page 7, lines 20-28). See pages 9+: PNG media_image6.png 650 510 media_image6.png Greyscale WO 645 further discloses wherein the pathogen is bacterial, viral antigen, or parasitic (a method for treatment of virus infections by stimulating a response to antigens; page 6, lines 18-24). WO 645 further discloses wherein the pathogen is viral (a method for treatment of virus infections by stimulating a response to antigens; page 6, lines 18-24). WO 645 discloses a method of treating a viral infection in a subject need thereof (a method for treatment of virus infections; page 13, lines 20-21), comprising administering an effective amount of an immune-modulating agent to viral-infected cells in the subject to direct a subject's existing immune response against cell-encoded antigens that are induced in the viral-infected cells (administering an effective amount of TAP-inhibitors to the body of an infected individual (pathogen-infected cells) to stimulate an immune response against antigens associated with impaired TAP-function, where the immune response is CD8+ T-cells in a subject (existing immune response); page 6, lines 18-24; page 7, lines 20-28; page 13, lines 12-21; page 14, lines 1-3), wherein: the immune-modulating agent comprises an oligonucleotide molecule and inhibits and/or downregulates one or more of a mediator of ERAAP, transporter associated with antigen processing "TAP", and invariant chain "Ii" (where the inhibitor of TAP induces antigen formation, where the TAP inhibitor is an antisense oligonucleotide; page 6, lines 18-24; page 7, lines 20-28; page 8, lines 16-20, 24-29) and the subject has an existing immune response against the induced antigen (eliciting an immune response in a subject against the antigens associated with impaired TAP, where the immune response is COB+ T-cells in a subject (existing immune response); page 6, lines 18-24; page 7, lines 20-28. In this way, those of ordinary skill could have applied the disclosed immune-modulating agents in the manner required and in a predictable fashion for the purposes treating pathogenic infections. As outlined above, the conflicting claims recite administering an effective amount of an immune-modulating agent to a subject to direct a subject's existing immune response to a neoantigen against a cell, where the immune-modulating agent inhibits and/or downregulates a mediator of antigen processing. WO 645 is added for the proposition that treating pathogenic diseases is applicable to this process of inhibiting and/or down regulating a mediator of antigen processing. Specifically, WO 645 teaches that the particular known technique of downregulating a mediator of antigen processing in pathological infections was recognized as part of the ordinary capabilities of one skilled in the art. In this manner, those of ordinary skill would have recognized that applying the known technique with immune-modulating agents would have yielded predictable results. Accordingly, using immune-modulating agents for the purposes of treating pathogenic infections would have been prima facie obvious. Those of ordinary skill would appreciate that the above methods can be optimized to the specific viruses set forth in the claims (e.g., CMV, ESB, HSV, HIV, SIV) or that combination therapies can asl be tailored to specific infections. Any observed pharmacological effect, such as directing a subject's existing immune response against cell-encoded antigens; or inhibiting and/or downregulating a mediator of antigen processing and induces antigen formation; inhibiting and/or downregulating one or more of a mediator of ERAAP, transporter associated with antigen processing (TAP) are invariable aspects of the immune-modulating agents of the applied references, see MPEP 2112.01 (“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.”). The rejection under section 112(b) is withdrawn in view of Applicant’s amendments. The following is a new ground of rejection under this section: 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, 3-6, 8, 11-21 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. The term “the targeting agent” in claim 1 lacks antecedent basis. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m. If attempts to reach the examiner by telephone are unsuccessful, the examiner's acting supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. 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 http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646
Read full office action

Prosecution Timeline

Jul 20, 2022
Application Filed
May 08, 2025
Non-Final Rejection — §103, §112, §DP
Oct 14, 2025
Response Filed
Mar 04, 2026
Non-Final Rejection — §103, §112, §DP (current)

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Prosecution Projections

2-3
Expected OA Rounds
69%
Grant Probability
87%
With Interview (+18.2%)
2y 8m
Median Time to Grant
Moderate
PTA Risk
Based on 1409 resolved cases by this examiner. Grant probability derived from career allow rate.

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