Prosecution Insights
Last updated: October 02, 2026
Application No. 19/068,745

ACTIVE VACCINATION FOR THE TREATMENT OF NGF-RELATED DISORDERS

Non-Final OA §103
Filed
Mar 03, 2025
Priority
Mar 04, 2024 — EU 24161057
Examiner
HAUK TEODORO, PRICILA NMN
Art Unit
Tech Center
Assignee
Boehringer Ingelheim International GmbH
OA Round
1 (Non-Final)
50%
Grant Probability
Moderate
1-2
OA Rounds
10m
Est. Remaining
50%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allowance Rate
3 granted / 6 resolved
-10.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
31 currently pending
Career history
30
Total Applications
across all art units

Statute-Specific Performance

§101
3.0%
-37.0% vs TC avg
§103
43.3%
+3.3% vs TC avg
§102
29.1%
-10.9% vs TC avg
§112
15.7%
-24.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 6 resolved cases

Office Action

§103
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 . DETAILED ACTION Claim Status Claims 1-29 are currently pending. Claims 1-27 have been amended. Claims 28-29 are new. Claims 1-29 will be examined on the merits. Priority Acknowledgement is made of applicant’s claim for foreign priority based on an application filed on March 4, 2024. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement (IDS) At the time of the instant Office action, no information disclosure statement (IDS) had been received. Claim Rejections - 35 USC § 103 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. Claims 1-22, 26, 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Bachmann et al. (US Pat. 10532107; hereafter Bachmann; PTO-892) in view of von Loga et al. (Published March 12, 2019; hereafter von Loga; PTO-892). Bachmann teaches “virus-like particles of plant virus Cucumber Mosaic Virus (CMV), and in particular to modified VLPs of CMV comprising Th cell epitopes, in particular universal Th cell epitopes. Furthermore, these modified VLPs serve as, preferably, vaccine platform, for generating immune responses, in particular antibody responses, against antigens linked to said modified VLPs. The presence of the Th cell epitopes, in particular universal Th cell epitopes, led to a further increase in the generated immune response”, which is pertinent to claims 1, 19. See for example, Abstract. Bachmann teaches “Th cell epitope is a PADRE sequence”, which is pertinent to claim 20. See for example, claim 6; SEQ ID NO: 5. Bachmann teaches “A modified virus-like particle (VLP) of cucumber mosaic virus (CMV), wherein said modified VLP of CMV comprises at least one modified CMV polypeptide, wherein said modified CMV polypeptide comprises (a) a CMV polypeptide, and (b) a T helper cell epitope, wherein said T helper cell epitope replaces an N-terminal region of said CMV polypeptide, wherein said N-terminal region of said CMV polypeptide corresponds to amino acids 2-12 of SEQ ID NO:1; and wherein said CMV polypeptide comprises (i) an amino acid sequence of a coat protein of CMV; or (ii) a mutated amino acid sequence, wherein the amino acid sequence to be mutated is an amino acid sequence of a coat protein of CMV, and wherein said mutated amino acid sequence and said coat protein of CMV show a sequence identity of at least 90%”, which is pertinent to claims 1, 17-19, 21. See for example, claim 1. Bachmann teaches SEQ ID NO: 1, which is pertinent to claims 17-18. See for example, claims 2, 10. The SEQ ID NO: 1 of Bachmann is 100% identical to SEQ ID NO: 39, which is pertinent to claims 17-18. See Figure below. PNG media_image1.png 865 803 media_image1.png Greyscale Bachmann teaches “antigen is a tumor antigen, a self-antigen, a polypeptide of a pathogen, an allergen or a hapten, which is pertinent to claim 2. See for example, claim 13. Bachmann teaches “the inventive VLPs serve as a carrier platform, in particular a vaccine platform, wherein antigens to which immune responses are desired to be generated are linked to the inventive VLPs. The introduced Th cell epitopes incorporated within the inventive modified VLPs of CMV further increased the immunogenicity of the VLPs and led to an increase of the overall immune responses generated by the inventive compositions, in particular to increased antibody responses”, which is pertinent to claims XX. See for example, column 4, lines 55-64. “Furthermore, the inventive compositions comprising the modified VLPs are used in a method of treating an inflammatory disease, preferably a chronic inflammatory disease in an animal or human. Preferably, said inflammatory disease is selected from Rheumatoid arthritis (RA), MS, Psoriasis, asthma, Crohns, Colitis, COPD, diabetes, neurodermatitis (allergic dermatitis), again preferably wherein said inflammatory disease musculoskeletal (MS)”, which is pertinent to claims 3-8. See for example, column 34; lines 57-63. Bachmann teaches “A composition comprising: (a) a modified virus-like particle of claim 1, and wherein said modified virus-like particle comprises at least one first attachment site; and (b) at least one antigen, wherein said antigen comprises at least one second attachment site; wherein (a) and (b) are linked through said at least one first and said at least one second attachment site”, which is pertinent to claims 1, 15-16. See for example, claim 13. Bachmann teaches “canine”, “canine antigen” and “dogs”, which is pertinent to claims 1, 9-14. See for example column 35; lines 11-12.; Column 56-58. Bachmann teaches “a method of treating or preventing a disease, disorder or physiological condition in an animal said method comprising administering a modified VLP of the invention, a composition of the invention, a vaccine of the invention, or a pharmaceutical composition of the invention to said animal, wherein preferably said animal can be a human. In a further preferred embodiment said modified VLP, said composition, said vaccine, or said pharmaceutical composition is administered to said animal subcutaneously, intravenously, intradermally, intranasally, orally, intranodal or transdermally”, which is pertinent to claims 3, 14. See for example, column 41; lines 24-43. Bachmann teaches “Chemical interactions include covalent and non-covalent interactions. Typical examples for non-covalent interactions are ionic interactions, hydrophobic interactions or hydrogen bonds, whereas covalent interactions are based, by way of example, on covalent bonds such as ester, ether, phosphoester, carbon-phosphorus bonds, carbon-sulfur bonds such as thioether, or imide bonds. In certain preferred embodiments the first attachment site and the second attachment site are linked through at least one covalent bond, preferably through at least one non-peptide bond, and even more preferably through exclusively non-peptide bond(s). The term “linked” as used herein, however, shall not only refer to a direct linkage of the at least one first attachment site and the at least one second attachment site but also, alternatively and preferably, an indirect linkage of the at least one first attachment site and the at least one second attachment site through intermediate molecule(s), and hereby typically and preferably by using at least one, preferably one, heterobifunctional cross-linker. In other preferred embodiments the first attachment site and the second attachment site are linked through at least one covalent bond, preferably through at least one peptide bond, and even more preferably through exclusively peptide bond(s), which is pertinent to claims 15-16. See for example, column 18; lines 17-42. See for example, claims 13-14. Bachmann teaches “However, in particular for a second attachment site, which is not naturally occurring within the antigen, such a construct typically and preferably further comprises a “linker”. In another preferred embodiment the second attachment site is associated with the antigen through at least one covalent bond, preferably through at least one peptide bond. In a further embodiment, the second attachment site is naturally occurring within the antigen. In another further preferred embodiment, the second attachment site is artificially added to the antigen through a linker, wherein said linker comprises or alternatively consists of a cysteine. Preferably, the linker is fused to the antigen by a peptide bond, which is pertinent to claims 1, 15-16. See for example, column 18; lines 1-15. Bachmann teaches “a linker consisting exclusively of amino acid residues is a preferred embodiment of the invention. The amino acid residues of the linker are, preferably, composed of naturally occurring amino acids or unnatural amino acids known in the art, all-L or all-D or mixtures thereof. Further preferred embodiments of a linker in accordance with this invention are molecules comprising a sulfhydryl group or a cysteine residue and such molecules are, therefore, also encompassed within this invention. Further linkers useful for the present invention are molecules comprising a C1-C6 alkyl-, a cycloalkyl such as a cyclopentyl or cyclohexyl, a cycloalkenyl, aryl or heteroaryl moiety. Moreover, linkers comprising preferably a C1-C6 alkyl-, cycloalkyl-(C5, C6), aryl- or heteroaryl-moiety and additional amino acid(s) can also be used as linkers for the present invention and shall be encompassed within the scope of the invention. Association of the linker with the antigen is preferably by way of at least one covalent bond, more preferably by way of at least one peptide bond”, which is pertinent to claim 18. See for example, column 18; lines 43-67; column 19; lines1-4. Bachmann teaches “linker is an amino acid linker, and wherein preferably said amino acid linker is selected from the group consisting of: (a) CGG; (b) N-terminal gamma 1-linker; (c) N-terminal gamma 3-linker; (d) Ig hinge regions; (e) N-terminal glycine linkers; (f) (G)kC(G)n with n=0-12 and k=0-5; (g) N-terminal glycine-serine linkers (h) (G)kC(G)m(S)l(GGGGS)n with n=0-3, k=0-5, m=0-10, 1=0-2; (i) GGC; (j) GGC-NH2; (k) C-terminal gamma 1-linker; (l) C-terminal gamma 3-linker; (m) C-terminal glycine linkers; (n) (G)nC(G)k with n=0-12 and k=0-5; (o) C-terminal glycine-serine linkers; and (p) (G)m(S)l(GGGGS)n(G)oC(G)k with n=0-3, k=0-5, m=0-10, 1=0-2, and o=0-8. In general, glycine residues will be inserted between bulky amino acids and the cysteine to be used as second attachment site, to avoid potential steric hindrance of the bulkier amino acid in the coupling reaction, which is pertinent to claim 22. See for example, column 31; Lines 59-67; column 32; lines 1-7. Bachmann does not explicitly teach NGF-related disorder is pain as claim 2. Bachmann does not explicitly teach nociceptive pain, inflammatory-related pain, postsurgical pain, pain associated with musculoskeletal diseases, pain associated with degenerative joint disease and/or osteoarthritis (OA)-associated pain as claim 3. Bachmann does not explicitly teach degenerative joint disease as claims 4-6. Bachmann does not explicitly teach refractory pain associated with degenerative joint disease as claim 7. Bachmann does not explicitly teach chronic, refractory pain associated with degenerative joint disease as claim 8. Von Loga teaches “Nerve growth factor (NGF) has emerged as a key driver of pain in osteoarthritis (OA) and antibodies to NGF are potent analgesics in human disease”, a novel vaccine strategy to generate anti-NGF antibodies for reversal of pain behaviour in a surgical model of OA, which is pertinent to claims 1-8, 26. See for example, XX. Von Loga teaches “Virus-like particles were derived from the cucumber mosaic virus (CuMV) and coupled to expressed recombinant NGF to create the vaccine”, which is pertinent to claims 1-8, 26. See for example, XX. Von Loga teaches immunization, vaccine, osteoarthritis, chronic pain, nerve growth factor, which is pertinent to claims 1-8, 26. See for example, XX. Von Loga teaches “Nerve growth factor (NGF) is a validated target for pain in human and mouse OA”, which is pertinent to claims 1-8, 26. See for example, XX. Von Loga teaches “Neutralising antibodies to NGF show therapeutic efficacy in Phase III clinical studies”, which is pertinent to claims 1-8, 26. See for example, XX. Von Loga teaches efficacy of an NGF vaccine that reversibly induces neutralising anti-NGF antibodies and suppresses pain behaviour in murine Osteoarthritis (OA), which is pertinent to claims 1-8, 26. See for example, XX. Von Loga teaches “a novel plant virus derived VLP based on the cucumber mosaic virus, that incorporates a tetanus toxoid epitope for T cell help (herein referred to as CuMVttl)”, which is pertinent to claims 1-8. See for example, XX. Von Loga teaches “Vaccines to self-antigens have been developed for other non-communicable diseases over the years. Early studies showed preclinical success but with limited clinical efficacy, which may have been due to poor immunogenicity of the vaccine platform, requiring the use of codelivery of adjuvant in preclinical models. Recent studies using refined vaccine platforms have demonstrated translatable efficacy from mouse to large animals including humans”. (…) This proof of concept study has significant translational potential; in the first instance within veterinary practice where activity measures are validated pain outcomes. Ultimately, this has the potential to reduce the burden of disease in humans”, which is pertinent to claims 9-14, 26. Bachmann and von Loga do not explicitly teach the composition is administered to said canine in at least two doses wherein the time interval between the first and the second dose is at least 7 days as claim 10. Bachmann and von Loga do not explicitly teach the composition is administered to said canine in at least two doses, wherein time interval between the first and the second dose is between 7 and 21 days as claim 11. Bachmann and von Loga do not explicitly teach the composition is administered to said canine in at least three doses, wherein time interval between the first and second dose is between one to three weeks, the time interval between the second and third dose is between two to six months, and the time interval between any further dose to the previous dose is between three to six months as claim 12. Bachmann and von Loga do not explicitly teach the composition is administered to said canine in an amount of 50 to 300 pg/dose as claim 13. Bachmann and von Loga do not explicitly teach the composition is administered to said canine subcutaneously, intramuscularly or transdermal as claim 14. Bachmann and von Loga do not explicitly teach acute OA associated pain as claim 28. Bachmann and von Loga do not explicitly teach chronic OA associated pain as claim 29. Even though, Bachmann and von Loga are silent regarding to examples of administration/regimen of doses for canine “dogs” subject as claims 10-14, and also are specifically silent for the use of the method of treating specifically acute/chronic Osteoarthritis (OA) in canines as claims 28-29, it would have been obvious to one of ordinary skill in the art to combine the teachings of Bachmann and von Loga, thereby arriving at the invention of claims 1-22, 26, 28-29. Because, Bachmann teaches a vaccine platform, for generating immune responses, in particular antibody responses, against antigens linked to said modified VLPs, and in particular universal Th cell epitopes to a further increase in the generated immune response, which was successfully used to immunize canines against a dog allergen and von Loga also teaches the use of the same vaccine platform taught by Bachmann to generate antibodies against the self-antigen NFG using a murine model for Osteoarthritis, as a proof of concept that the virus-like vaccine can be used for delivering others antigens to promote immune response. Both Bachmann and von Loga teach that the virus-like vaccine platform can be used for delivering antigens, and treating inflammatory diseases, which includes joint inflammatory diseases. The vaccine platform has been shown to be translatable and successfully administered to canines and mice. One of skill in the art would know that the doses, administration of doses and regimen are based on the subject and their general health conditions, it would have been obvious to substitute these known equivalents; see MPEP 2144.06. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination. Reasonable expectation of success would be expected because Bachmann specifically suggests using the virus-like vaccine platform for delivering antigens, and for treating inflammatory diseases in animals, including canine and does not specify any antigen that should not be used or any animal that should not be treated. Von Loga teaches the successful combination of the virus-like vaccine platform for delivering NFG antigens in OA murine model. Therefore, claims 1-22, 26, 28-29 would have been prima facie obvious, absent evidence to the contrary. Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Bachmann et al. (US Pat. 10532107; hereafter Bachmann; PTO-892) and in view of von Loga et al. (Published March 12, 2019; hereafter von Loga; PTO-892) as claims 1-22, 26, 28-29 above and in further view of Ji et al. (Published April 17, 2023; hereafter von Loga; PTO-892) as evidenced by Zeltins et al. (US 20220073946 A1; hereafter Zeltins; PTO-892). Bachmann von Loga teach the limitations of claims 1-22, 26, 28-29 in view of von Loga as fully discussed above and incorporated herein. However, neither Bachmann nor von Loga teach the stretch of consecutive negative amino acids consists solely of glutamic acids as claim 23. Neither Bachmann nor von Loga teach polypeptide comprising the stretch of consecutive negative amino acids consists of SEQ ID NO:49, SEQ ID NO:50 or SEQ ID NO:51 as claim 24. Neither Bachmann nor von Loga teach CMV VLP comprises the amino acid sequence of SEQ ID NO:10, SEQ ID NO:11 or SEQ ID NO:12 as claim 25. Ji teaches the evolution of unstructured polypeptides, starting from natural polypeptides to engineered polypeptides, and that hat unstructured polypeptides have been successfully applied to numerous drugs, including peptides, proteins, antibody fragments, and nanocarriers, for half-life extension. Innovative applications of unstructured peptides as releasable masks, multimolecular adaptors and intracellular delivery carriers, which is pertinent to claims 23-25. Ji teaches “a class of engineered polypeptides consisting of poly-amino acid. One example is polyglutamate, a polyanionic peptide that has been successfully conjugated to the anti-tumor drug paclitaxel. Polyglutamate paclitaxel, also known as Opaxio, has recently finished phase III clinical trials for the treatment of ovarian cancer, and was shown to improve the solubility and plasma half-life of paclitaxel with enhanced tumor targeting through enhanced permeability and retention (EPR) effects. Besides, given the simplest structure and flexible conformation of glycine, the simplest genetically encoded PEG mimic, polyglycine, also known as homo-amino-acid polymer (HAP), emerged. At present, the most developed HAP is (Gly4Ser)n. By fusing with (Gly4Ser)40, the half-life of Trastuzumab Fab was extended by about 3 times”, which is pertinent to claims 23-24. See for example, Table 1; Figure 7A. SEQ ID NO:10, SEQ ID NO:11 or SEQ ID NO:12 have been searched. The SEQ ID NO: 10 is 98.7% identical to SEQ ID NO: 8 of Zeltins, which is pertinent to claim 25. In addition, it is noted that the stretch of consecutive negative amino acids consists of SEQ ID NO:50 is within the SEQ ID NO: 10. The SEQ ID NO: 8 of Zeltins lacks only 3 glutamate residues of SEQ ID NO:50, which is pertinent to claims 24-25. See Figure below. PNG media_image2.png 778 872 media_image2.png Greyscale It would have been obvious to one of ordinary skill in the art to modify the teachings of Ji and Zeltins, thereby arriving at the invention of claims 23-25, because since the virus-like vaccine platform for delivering antigens, and for treating inflammatory diseases in animals, including canine was taught by Bachmann and Von Loga has shown the successful combination of the virus-like vaccine platform for delivering NFG antigens in OA murine model. It would be very desirable and beneficial to improve the solubility and plasma half-life and enhanced permeability and retention (EPR) effects of the SEQ ID NO:8 of Zeltins by adding glutamate residues as taught by Ji, because one of skill in the art would know the need for adapting the sequence by altering the ratios of Glutamates (E)/Glycine (G)/Serine (S) amino acid residues, depending on antigen fused to the virus-like vaccine as already known in the art and taught by Ji . See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination. Therefore, claims 23-25 would have been prima facie obvious, absent evidence to the contrary; see MPEP 2144.06. Claim 27 are rejected under 35 U.S.C. 103 as being unpatentable over Bachmann et al. (US Pat. 10532107; hereafter Bachmann; PTO-892) in view of von Loga et al. (Published March 12, 2019; hereafter von Loga; PTO-892) as claims 1-22, 26, 28-29 and further view of Barbeito et al. (WO 2023139542 A1; hereafter Barbeito; PTO-892). Bachmann von Loga teach the limitations of claims 1-22, 26, 28-29 in view of von Loga as fully discussed above and incorporated herein. Neither Bachmann nor von Loga teach wherein NGF antigen comprise an amino acid sequence selected from any of SEQ ID NO:30, SEQ ID NO:31, SEQ ID NO:33 and SEQ ID NO:55, or an amino acid sequence having a sequence identity of at least 90%; with any of SEQ ID NO:30, SEQ ID NO:31, SEQ ID NO:33 and SEQ ID NO:55 as claim 27. Barbeito teaches “a recombinant fusion protein used to treat pain such as osteoarthritis-associated pain. The fusion protein comprises at least one immunogenic fragment derived from a nerve growth factor (NGF) (see BNM82662-BNM82669), and at least one immunogenic fragment derived from substance P (SP) or calcitonin gene-related peptide (CGRP), where the recombinant fusion protein elicits the production of neutralizing antibodies. The invention further discloses: (1) a recombinant vector comprising at least a nucleic acid encoding the recombinant fusion protein; (2) a method for producing the recombinant fusion protein; (3) an immunogenic composition comprising the recombinant fusion protein; (4) an immunogenic composition produced by the method; (5) a method for treating or preventing pain in a mammal comprising administering the immunogenic composition; (6) a vaccine for treating or preventing OA-associated pain in dogs comprising the NGF-SP recombinant fusion protein or NGF-CGRP recombinant fusion protein; and (7) a method for treating or preventing osteoarthritis (OA)-associated pain in dogs. The recombinant fusion protein is easy to administer and easy to produce in economical manner. The recombinant fusion protein or immunogenic composition is useful for treating pain in a subject and treating and preventing nociceptive, inflammatory-related pain, OA-associated pain, preferably chronic and refractory OA-related pain in a mammal, where the pain is associated with OA, neurogenic inflammation, neuropathies, rheumatoid arthritis, post-surgery or cancer. The present sequence is a fusion comprising dog NGF fused with substance P via linker and His tag, useful for treating pain in a subject”, which is pertinent to claim 27. Barbeito teaches SEQ ID NO: 26. SEQ ID NO: 55 is 100% identical to SEQ ID NO: 26 of Barbeito, which is pertinent to claim 27. See for example, Claim 4; SEQ ID NO 26; 75pp. See Figure below. PNG media_image3.png 303 884 media_image3.png Greyscale It would have been obvious to one of ordinary skill in the art to combine the teachings of Bachmann and von Loga, thereby arriving at the invention of claim 27. Because, Bachmann teaches a vaccine platform, for generating immune responses, in particular antibody responses, against antigens linked to said modified VLPs, and in particular universal Th cell epitopes to a further increase in the generated immune response, which was successfully used to immunize canines against a dog allergen and von Loga also teaches the use of the same vaccine platform taught by Bachmann to generate antibodies against the self-antigen NFG using a murine model for Osteoarthritis, as a proof of concept that the virus-like vaccine can be used for delivering others antigens to promote immune response. Both Bachmann and von Loga teach that the virus-like vaccine platform can be used for delivering antigens, and treating inflammatory diseases, which includes joint inflammatory diseases. Thus, it would be an advantage and beneficial to one of skill in the art to substitute the dog allergen of Bachmann or the NFG sequence of von Loga by the canine NFG sequence of Barbeito (SEQ ID NO: 26) to treat OA in canines, it would have been obvious to substitute these known equivalents; see MPEP 2144.06. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination. Reasonable expectation of success would be expected because Bachmann specifically suggests using the virus-like vaccine platform for delivering antigens, and for treating inflammatory diseases in animals, including canine and does not specify any antigen that should not be used or any animal that should not be treated. Therefore, the invention as a whole would have been prima facie obvious, absent to the contrary. It would have been obvious to substitute these known equivalents; see MPEP 2144.06. Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements were known in the art (Cucumber virus, engineered linkers and variations, fusions, virus-like vaccine platform; NFG sequences; method of treating inflammatory disease, such as OA in animals by using the virus-like vaccine platform adapted to a specific antigen). In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary. Conclusion No claims are allowable. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PRICILA HAUK TEODORO whose telephone number is (571)272-2784. The examiner can normally be reached M-F 6:15AM-3:00PM. 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, Heather Calamita can be reached at (571) 272-2876. 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. /PRICILA NMN HAUK TEODORO/Examiner, Art Unit 1645 /HEATHER CALAMITA/Supervisory Patent Examiner, Art Unit 1684
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Prosecution Timeline

Mar 03, 2025
Application Filed
Aug 12, 2026
Non-Final Rejection mailed — §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
50%
Grant Probability
50%
With Interview (+0.0%)
2y 5m (~10m remaining)
Median Time to Grant
Low
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