Prosecution Insights
Last updated: April 19, 2026
Application No. 17/782,976

EXOSOMES-BASED THERAPY FOR LIVER FIBROSIS AND OTHER DISEASES WITH FIBROSIS

Non-Final OA §103§112
Filed
Jun 06, 2022
Examiner
CHONG, KIMBERLY
Art Unit
1636
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
BOARD OF REGENTS OF THE UNIVERSITY OF TEXAS SYSTEM
OA Round
1 (Non-Final)
72%
Grant Probability
Favorable
1-2
OA Rounds
2y 7m
To Grant
85%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allow Rate
1066 granted / 1473 resolved
+12.4% vs TC avg
Moderate +12% lift
Without
With
+12.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
67 currently pending
Career history
1540
Total Applications
across all art units

Statute-Specific Performance

§101
3.9%
-36.1% vs TC avg
§103
26.8%
-13.2% vs TC avg
§102
20.6%
-19.4% vs TC avg
§112
29.5%
-10.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1473 resolved cases

Office Action

§103 §112
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 Election/Restrictions Applicant's election without traverse of Group II in the reply filed on 07/18/2025 is acknowledged. Status of the Application Claims 19 and 84-99 are pending. Claims 1-18 and 71 have been canceled and claims 19, 84-90 and 95-99 are currently under examination. Claims 91-95 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Information Disclosure Statement The submission of the Information Disclosure Statement s are compliance with 37 CFR 1.97. The information disclosure statement has been considered by the examiner and signed copies have been placed in the file. 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 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 set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 19, 86-90 and 95-9 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milara, Javier, et al. "The JAK2 pathway is activated in idiopathic pulmonary fibrosis." Respiratory research 19.1 (2018): 24 ), Chen et al. (US 20180200186) , Battaglia, Luigi, et al. ( "Lipid nanoparticles for intranasal administration: application to nose-to-brain delivery." Expert opinion on drug delivery 15.4 (2018): 369-378 ) , Swayze et al. (US Patent No. 8,816,056) and Oldham et al. ( "Comorbid conditions in idiopathic pulmonary fibrosis: recognition and management." Frontiers in medicine 4 (2017): 123 ). Regarding claim 19, Milara et al. teach Stat3 expression is increased and activated in the lungs of patients with Idiopathic Pulmonary Fibrosis (IPF) (page 3 results and Fig. 1). Milara et al. teach an inhibitor RNA that reduced expression of Stat3 and suggests Stat3 is a target for treatment of IPF (conclusion). Regarding claim s 86 and 87 , Chen et al. teach methods of using an siRNA in a lipid nanoparticle for treatment of lung disease such as IPF (see 0023, 0027, 0058). Chen et al. provides motivation to use an inhibitory oligonucleotide targeted to Stat3 for the treatment of IPF but does not specifically teach adding an anti-microbial or teach SEQ ID No. 5 . Regarding claims 98 and 99, Battaglia et al. teach using anti-microbial preservatives in lipid nanoparticles for certain routes delivery to a subject to prevent irritation and microbial growth in the tissue or cell (see page 371). It would have been obvious to one of ordinary skill in the art to include a n anti-microbial agent in the composition taught by Milara et al. for delivery to a subject. Regarding claims 87-90, 95, 96 and 97, Swayze et al. teach the use of a inhibitory RNA having the instantly claimed SEQ ID No 5 that targets Stat3 (see alignment below ) wherein the RNA can comprise modifications and is 18-30 nucleotides in length (col. 13) . Swayze et al. teach Stat3 is expressed in most cell types and is useful for treating hyperproliferative diseases such as lung cancer (see col. 2 ). Swayze et al. teach the siRNA can be formulated for delivery via parenterally, intravenously, intramuscularly or subcutaneous ly (see col. 38). Patent No. 8816056 APPLICANT: Eric E. Swayze SEQ ID NO 245 LENGTH: 16 TYPE: DNA ORGANISM: Artificial Sequence FEATURE: OTHER INFORMATION: Synthetic oligonucleotide Query Match 100.0%; Score 16; Length 16; Best Local Similarity 62.5%; Matches 10; Conservative 6; Mismatches 0; Indels 0; Gaps 0; Qy 1 CUAUUUGGAUGUCAGC 16 Db 1 CTATTTGGATGTCAGC 16 Oldham et al. teach there are many different comorbid conditions associated with IPF and states individuals with IPF have an increased risk of developing lung cancer wherein survival among those with IPF and comorbid lung cancer is poor (see page 2-3). It would have been obvious for one of ordinary skill in the art to try and use the inhibitory RNA sequence taught by Swayze et al. in methods of treating fibrosis such as IPF as taught by Milara et al. and Chen et al. Given the prior art sugges ts targeting Stat3 in methods to treat IPF and lung cancer is found to be associated with IPF with a poor outcome of survival of subjects and Swayze et al. teach an inhibitory RNA that efficiently reduced Stat3 mRNA levels by 97% (see Table 2 SEQ ID No. 245) that is useful in methods of treatment of diseases such as lung cancer , one of skill in the art would have had a good reason to use the inhibitory RNA taught by Swayze et al. Moreover, b ecause there was a known association between IPF and Stat3 expression and a known association between IPF and cancer and Swayze et al. identified an inhibitory RNA with a strong level of inhibition of expression of Stat3 , there is a predictable outcome of success at reducing Stat3 expression levels and treatment of fibrosis. There is an expectation of an advantage for using an inhibitory RNA to target Stat3 and thus a motivation to combine the prior art references for treatment of fibrosis ( see MPEP 2144). Conclusive proof of efficacy is not required to show a reasonable expectation of success and o bviousness does not require absolute predictability, but at least some degree of predictability is required (MPEP 2143.02). Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed. Claims 19, 84, 86, 87 and 89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milara, Javier, et al. ( "The JAK2 pathway is activated in idiopathic pulmonary fibrosis." Respiratory research 19.1 (2018): 24 ) and Das et al. ( "Exosome as a novel shuttle for delivery of therapeutics across biological barriers." Molecular pharmaceutics 16.1 (2018): 24-40 ). Regarding claim 19, Milara et al. teach Stat3 expression is increased and activated in the lungs of patients with Idiopathic Pulmonary Fibrosis (IPF) (page 3 results and Fig. 1). Milara et al. teach siRNA targeted to Stat3 that was capable of reducing expression (see page 3 and 6 cols. 1) and suggests Stat3 is a target for treatment of IPF (conclusion). Milara et al. do not teach using a lipid based nanoparticle such as a exosome with CD47 on the surface . Regarding claims 84, 86, 87 and 89, Das et al. teach the efficient use of exosomes for delivery of therapeutics across biological barriers for therapeutic treatment (see abstract). Das et al. teach methods for loading therapeutics such as inhibitory RNA into exosomes that had CD47 on the surface (see page 30 cols 1 and 2). Das et al. teach exosomes have better target specificity because they are less toxic (see page 32 first para) and are considered clinically safe and used in clinical trials (see page 33 second col.). It would have been obvious to one of ordinary skill in the art to try using an inhibitory RNA as taught in Milara et al. to knock down expression of Stat3 for the treatment of IPF. Further it would have been obvious to package the inhibitory RNA in an exome as taught by Das et al. because Das et al. teach advantages of such exosomes and have been proven safe as they have been used in clinical trials. There is an expectation of an advantage for using exosomes with a CD47 on the surface and thus a motivation to combine the prior art references for treatment of fibrosis using a nanoparticle comprising an inhibitory RNA targeted to Stat3 ( see MPEP 2144). Conclusive proof of efficacy is not required to show a reasonable expectation of success and o bviousness does not require absolute predictability, but at least some degree of predictability is required (MPEP 2143.02). Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed. Claims 19 and 85 -87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milara, Javier, et al. ( "The JAK2 pathway is activated in idiopathic pulmonary fibrosis." Respiratory research 19.1 (2018): 24 ), Chen et al. (US 20180200186 ) and von Andrian et al. (US 20100092425). Regarding claim 19, Milara et al. teach Stat3 expression is increased and activated in the lungs of patients with Idiopathic Pulmonary Fibrosis (IPF) (page 3 results and Fig. 1). Milara et al. teach siRNA targeted to Stat3 that was capable of reducing expression (see page 3 and 6 cols. 1) and suggests Stat3 is a target for treatment of IPF (conclusion). Milara et al. do not teach using a lipid based nanoparticle comprising a growth factor on the surface. Regarding claims 86 and 87, Chen et al. teach methods of using an siRNA in a lipid nanoparticle for treatment of lung disease such as IPF (see 0023, 0027, 0058). Chen et al. provides motivation to use an inhibitory oligonucleotide targeted to Stat3 for the treatment of IPF but does not specifically teach the nanoparticle has a growth factor on the surface. Regarding claim 85, v on Andrian et al. teach nanoparticles for delivery of RNA comprising targeting moieties that binds to an organ, cel l or tissue to enhance delivery of the composition to the desired cell, organ or tissue (0243). v on Andrian et al. t each the targeting moiety can be a cell surface receptor such as a growth factor (see 0244). It would have been obvious to one of ordinary skill in the art to try using an inhibitory RNA as taught in Milara et al. to knock down expression of Stat3 for the treatment of IPF. It would have been further obvious to one of ordinary skill in the art to make the lipid nanoparticle comprising an inhibitory RNA with a cell surface receptor, such as a growth factor , for efficient targeted delivery to the desired cell, tissue or organ. There is an expectation of an advantage for using a nanoparticle comprising an inhibitory RNA with a cell surface receptor, such as a growth factor and thus a motivation to combine the prior art references for treatment of fibrosis ( see MPEP 2144). Conclusive proof of efficacy is not required to show a reasonable expectation of success and o bviousness does not require absolute predictability, but at least some degree of predictability is required (MPEP 2143.02). Thus in the absence of evidence to the contrary, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed. Claim Rejections - 35 USC § 112 The following is a quotation 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 35 U.S.C. 112 (pre-AIA), first paragraph: 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. Written Description Claims 19, 84-90 and 95-99 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated: To fulfill the written description requirement, a 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." Lockwood v. American Airlines, Inc. , 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli , 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious" and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood , 107 F.3d at 1572, 41 USPQ2d at 1966; Regents of the University of California v. Eli Lilly & Co. , 43 USPQ2d 1398. The fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc ., 935 F.2d at 1563-64, 19 USPQ2d at 1117. The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include: (1) Actual reduction to practice, (2) Disclosure of drawings or structural chemical formulas, (3) Sufficient relevant identifying characteristics (such as: i. Complete structure, ii. Partial Structure, iii. Physical and/or chemical properties, iv. Functional characteristics when coupled with a known or disclosed structure, and v. Correlation between function and structure), (4) Method of making the claimed invention, (5) Level of skill and knowledge in the art, and (6) Predictability in the art. Moreover, the written description requirement for a genus may be satisfied through sufficient description of a representative number of species 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 al and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed 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 claims are drawn to a genus of lipid-based nanoparticles contain ing an inhibitory RNA that hybridizes to Stat3, wherein the nanoparticle comprises CD47 or any growth factor on the surface, wherein the nanoparticle is an exosome or a liposome, wherein the inhibitory RNA is any RNA such as siRNA, shRNA, antisense, miRNA or a pre-miRNA and wherein the composition further comprises any anti-microbial agent with the function of reducing expression of Stat3 . The specification describes an exosome loaded with an siRNA or antisense targeting Stat3. The specification and claims do not indicate what distinguishing characteristics of this nanoparticle comprising an siRNA or an antisense that are concisely shared by the members of the broad genus of lipid-based nanoparticles as described above that would convey to one of skill in the art that this nanoparticle represent the entire genus . A review of the specification shows that it provides no description or guidance that would allow one of skill to distinguish the functional species of the recited structural genus from the non-functional members without empirical determination. The prior art of Das et al. (cited above) teach exosomes are from a vast variety of cells and their protein and lipid contents determine its functional aspects, which are cellular specific and further the surface markers on the exosomes may have a negative effects on the recipient cel and thus jeopardizing the therapeutic application (see page 26 last par to top of second col.). Wang et al. ( "RNA chemistry and therapeutics." Nature Reviews Drug Discovery 24.11 (2025): 828-851 ) gives the current state of RNA chemistry and therapeutics and lists many different types of inhibitory RNA such as small RNA , antisense, siRNA, miRNA, aptamers, translatable RNA, mRNA, circRNA, saRNA and CRISPR comprising guide RNA (see Box 2) each with different inhibitor functions (see page 831). Since the disclosure and the prior art fail to describe the common attributes and characteristics concisely identifying members of the proposed genus, and because the claimed genus is highly variant comprising a vast number of different exosomes, inhibitory RNA and microbial agents , one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus claimed. "A sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus" (AbbVie, 759 F.3d at 1297, reiterating Eli Lilly, 119 F.3d at 1568-69) ( emphasis added ). Further, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features.” Ex parte Kubin , 83 USPQ2d 1410, 1417 (Bd. Pat. App. & Int. 2007) citing University of Rochester , 358 F.3d at 927, 69 USPQ2d at 1895. Vas-Cath Inc. v. Mahurkar , 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention . The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed. ” (See page 1117.) 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). The MPEP further states that if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP 2163. The MPEP does state that for generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. MPEP 2163. If the genus has a substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. See MPEP 2163. Although the MPEP does not define what constitute a sufficient number of representative, the Courts have indicated what do not constitute a representative number species to adequately describe a broad generic. In Gosteli, the Court determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gosteli, 872 F.2d at 1012, 10 USPQ2d at 1618. Thus the specification and claims lack written description because it is clear that Applicant did not have possession of every nanoparticle, every type of exosome, every type of inhibitory RNA and microbial agents with the function of targeting Stat3 and reducing expression of the gene for treatment of fibrosis or conditions associated with fibrosis . The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder , 736 F.2d 1516, 1521,222 USPQ 369,372-372 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate."). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention . Enablement Clai ms 19, 84-90 and 95-99 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, because the specification, while being enabling for methods of targeting Stat3 and treating liver fibrosis , does not reasonably provide enablement for methods of treating any condition associated with fibrosis . The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. The following factors have been considered in the analysis of enablement: (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. The breadth of the claims and nature of the invention: The claims are drawn to methods of treating fibrosis or a condition associated with fibrosis comprising administering a composition comprising a nanoparticle and an inhibitory RNA that targets a Stat3 polynucleotide. The nature of the invention involves targeting Stat3 with an inhibitory RNA and treating a vast number of disease and conditions associated with fibrosis. Whether the specification would have been enabling as of the filing date involves consideration of the nature of the invention, the state of the prior art, and the level of skill in the art. The state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains. The relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the a pplication was filed. See MPEP § 2164.05(b). The state of the prior art provides evidence for the degree of predictability in the art and is related to the amount of direction or guidance needed in the specification as filed to meet the enablement requirement. The state of the prior art is also related to the need for working examples in the specification. The state of the prior art: The prior art of Oldham et al. ( "Comorbid conditions in idiopathic pulmonary fibrosis: recognition and management." Frontiers in medicine 4 (2017): 123 ) describes numerous different disease s and conditions associated with fibrosis such as emphysema, lung cancer, obstructive sleep apnea, coronary artery disease, pulmonary hypertension, pulmonary embolism, hernia, gastrointestinal issues and endocrine and metabolic disease such as diabetes (see pages 2-5). A review of the prior art does not provide a correlation between administration of an inhibitory RNA targeted to Stat3 and treatment for the vast number of conditions associated with fibrosis . The level of one of ordinary skill: While the level of one of ordinary skill practicing said invention would be high, the level of predictability is considered variable as evident in the prior art discussed above and is not considered to provide sufficient enablement to practice the claimed invention. Because the state of the prior art does not provide evidence of the degree of predictability that inhibiting the expression of Stat3 would provide treatment for the vast number of conditions associated with fibrosis , one of ordinary skill in the art would look for guidance or direction in the instant specification. The level of predictability in the art: “ The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. ” (MPEP 2164.03 ). The amount of direction provided by the inventor: The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004). In this case, little is known about the expression of Stat3 and a correlation with a vast number of conditions associated with fibrosis such that inhibition of Stat3 would provide treatment for these associated conditions. The existence of working examples: The working embodiment in the instant application describes using an siRNA or antisense targeted to Stat3 in hepatic stellate cells wherein expression patterns associated with liver fibrosis were improved. The working embodiments do not describe embodiments wherein inhibition of Stat3 provided treatment for the vast number of conditions associated with fibrosis. The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004). The instant invention suggests administration of a nanoparticle comprising an inhibitory RNA targeted to Stat3 to a subject to treat emphysema, lung cancer, obstructive sleep apnea, coronary artery disease, pulmonary hypertension, pulmonary embolism, hernia, gastrointestinal issues and endocrine and metabolic disease such as diabetes without an enabling disclosure or guidance in the prior art or instant disclosure . While the MPEP 2164.02 states the specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski, 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970), the lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art. The quantity of experimentation needed to make or use the invention based on the content of the disclosure : The prior art is undeveloped for the role Stat3 expression plays in the vast number of conditions associated with fibrosis . The specification does not provide sufficient guidance for the breadth of the claimed method and w ithout further guidance, one of skill in the art would have to practice a substantial amount of trial and error experimentation, an amount considered undue and not routine, to practice the instantly claimed invention. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Kimberly Chong at FILLIN "Phone number" \* MERGEFORMAT (571)272-3111 . The examiner can normally be reached Monday thru Friday between M-F 8:00am-4:30pm . If attempts to reach the examiner by telephone are unsuccessful please contact the SPE for 1636 Neil Hammell at 571-272-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application Information Retrieval system (PAIR) can now contact the USPTO’s Patent Electronic Business Center (Patent EBC) for assistance. Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197. When calling please have your application serial or patent number, the type of document you are having an image problem with, the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected. The USPTO’s Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The USPTO’s PAIR system provides Internet-based access to patent application status and history information. It also enables applicants to view the scanned images of their own application file folder(s) as well as general patent information available to the public. For more information about the PAIR system, see http://pair-direct.uspto.gov. For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199. /KIMBERLY CHONG/ Primary Examiner Art Unit 1636
Read full office action

Prosecution Timeline

Jun 06, 2022
Application Filed
Jul 18, 2025
Response Filed
Oct 20, 2025
Response after Non-Final Action
Dec 12, 2025
Non-Final Rejection — §103, §112
Jan 15, 2026
Applicant Interview (Telephonic)
Jan 21, 2026
Examiner Interview Summary

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12595481
METHODS AND COMPOSITIONS FOR NEUROPROTECTION
2y 5m to grant Granted Apr 07, 2026
Patent 12590307
TRANSLATION ENHANCING NUCLEIC ACID COMPOUNDS: ASO COUPLED TRANSLATION – UPREGULATION 1 (ACT-UP1) AND USES THEREOF
2y 5m to grant Granted Mar 31, 2026
Patent 12571052
Immunomodulatory RNA
2y 5m to grant Granted Mar 10, 2026
Patent 12559750
Methods and Compositions for Treatment of Polycystic Kidney Disease
2y 5m to grant Granted Feb 24, 2026
Patent 12539309
COMPOSITIONS COMPRISING CIRCULAR POLYRIBONUCLEOTIDES AND USES THEREOF
2y 5m to grant Granted Feb 03, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

1-2
Expected OA Rounds
72%
Grant Probability
85%
With Interview (+12.5%)
2y 7m
Median Time to Grant
Low
PTA Risk
Based on 1473 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month