Prosecution Insights
Last updated: April 19, 2026
Application No. 17/782,501

ENHANCING BLOOD-BRAIN BARRIER DRUG TRANSPORT BY TARGETING ENDOGENOUS REGULATORS

Non-Final OA §112
Filed
Jun 03, 2022
Examiner
WANG, CHANG YU
Art Unit
1675
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
The United States Department of Veterans Affairs
OA Round
1 (Non-Final)
34%
Grant Probability
At Risk
1-2
OA Rounds
4y 1m
To Grant
86%
With Interview

Examiner Intelligence

Grants only 34% of cases
34%
Career Allow Rate
287 granted / 850 resolved
-26.2% vs TC avg
Strong +52% interview lift
Without
With
+52.5%
Interview Lift
resolved cases with interview
Typical timeline
4y 1m
Avg Prosecution
93 currently pending
Career history
943
Total Applications
across all art units

Statute-Specific Performance

§101
4.2%
-35.8% vs TC avg
§103
26.5%
-13.5% vs TC avg
§102
18.8%
-21.2% vs TC avg
§112
32.5%
-7.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 850 resolved cases

Office Action

§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 Status of Application/Election/Restrictions Applicant’s election without traverse of Group III (claims 12-19) and with traverse of protein for species of therapeutic agent and neurodegenerative disease for species of disease, which are not applicable for claims 12-19 in the reply filed on June 30, 2025 is acknowledged. Claims 1-20 are pending. Claims 1-11 and 20 are withdrawn without traverse (filed 06/30/2025) from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 30, 2025. Claims 12-19 are under examination in this office action. Information Disclosure Statement The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Claim Rejections - 35 USC § 112 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 12-19 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 pre-AIA the applicant regards as the invention. Claims 12-19 are indefinite because: i. It is unclear whether the limitation “a biomolecule” and “the biomolecule” recited in step (f) of claim 12 and the limitation “labeling biomolecules” recited in step (a) of claim 12 refer to the same biomolecule. Thus, the claim is indefinite. ii. The recitation “regulates blood brain barrier permeability” recited in claim 12 is indefinite because it is unclear how biomolecule regulates BBB permeability and whether increased plasma uptake can increase BBB permeability or decrease BBB permeability or whether decreased plasma uptake can increase BBB permeability or decrease BBB permeability, which renders the claim indefinite. iii. Claims 12-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements/steps, such omission amounting to a gap between the elements/steps. See MPEP § 2172.01. The omitted elements/steps are: i) how to detectably label unknown biomolecules of blood plasma isolated from a first animal; ii) unknown labeled biomolecules; iii) how and what to measure and determine plasma uptake in each of the isolated brain endothelial cells using flow cytometry to produce a population of sorted brain endothelial cells because the labeled biomolecules are undefined and unknown; iv) how and what to detect and determine whether expression of genes correlates with plasma uptake in each of the sorted brain endothelial cells because there is no cooperative relationship among unknown labeled biomolecules, plasma uptake by brain endothelial cells and undefined expression of unknown genes; and v) what and how to determine and select a biomolecule encoded by a gene whose expression correlates with increased or decreased plasma uptake in a brain endothelial cell, and whether the increased or decreased plasma uptake in a brain endothelial cell increases or decreases BBB permeability in the subject, or how to regulate BBB permeability in the subject. There is no cooperative structural and functional relationship among labeled biomolecules, plasma uptake by a brain endothelial cell, how gene expression correlates with increased or decreased plasma uptake in a brain endothelial cell, and how to determine and select a biomolecule encoded by a gene correlating with increased or decreased plasma uptake and how the biomolecule regulates blood-brain barrier permeability in the subject. The metes and bounds of “labeled biomolecules”, “plasma uptake by a brain endothelial cell”, “gene expression correlating with increased or decreased plasma uptake” and “how to select biomolecules regulating BBB permeability” cannot be determined. Thus, a skilled artisan cannot envision what is encompassed within the scope of the claims. iv. The rest of claims are indefinite as depending from an indefinite claim. 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 12-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as based on a disclosure which is not enabling. The elements and steps “Labeled biomolecules of blood plasma isolated from a first animal; How and what to measure and determine plasma uptake in each of the isolated brain endothelial cells using flow cytometry to produce a population of sorted brain endothelial cells; how and what to detect and determine whether expression of genes correlates with plasma uptake in each of the sorted brain endothelial cells; and what and how to determine and select a biomolecule encoded by a gene whose expression correlates with increased or decreased plasma uptake in a brain endothelial cell” critical or essential to the practice of the invention, but not included in the claim(s) are not enabled by the disclosure. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). Applicant cannot use unknown and undefined labeled biomolecules to measure unknown plasma uptake using undefined flow cytometry to sort and isolate undefined brain endothelial cells, and then detect and determine undefined expression of genes that correlate with undefined plasma uptake, and then select a undefined biomolecule based on undefined expression of genes correlating undefined plasma uptake to determine whether the undefined biomolecule regulate BBB permeability. Applicant cannot use an unknown molecule to determine and select another unknown molecule. Claims 12-19 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is ‘undue’. These factors include, but are not limited to: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988)”. See MPEP § 2164.01. Claims 12-19 are drawn to a method for identifying a biomolecule that regulates blood-brain barrier permeability in a mammal, which method comprises: (a) detectably labeling biomolecules of blood plasma isolated from a first mammal; (b) introducing the isolated blood plasma comprising the labeled biomolecules into a second mammal; (c) isolating brain endothelial cells from the second mammal that form the blood- brain barrier; (d) measuring plasma uptake in each of the isolated brain endothelial cells using flow cytometry to produce a population of sorted brain endothelial cells; (e) detecting expression of genes that correlate with plasma uptake in each of the sorted brain endothelial cells; and (f) selecting a biomolecule encoded by a gene whose expression correlates with increased or decreased plasma uptake in a brain endothelial cell, whereby the biomolecule regulates blood-brain barrier permeability in the subject. The claims encompass using structurally and functionally undefined labeled biomolecules of blood plasma isolated from a first mammal, using undefined flow cytometry parameters to measure plasma uptake and isolate a population of undefined sorted brain endothelial cells, using undefined expression of genes to correlate with plasma uptake in each of the undefined sorted brain endothelial cells and using undefined expression of genes to correlate undefined plasma uptake to select and determine a biomolecule without knowing how the biomolecule regulate the BBB in the subject. The instant invention is based on findings that: i) labeling the mouse plasma with the small but bright far-red Atto 647N fluorophore used in super-resolution imaging; ii) administering labeled plasma to young healthy mice; iii) visualizing labeled plasma protein transcytosis, with both diffuse and punctate signal on the parenchymal side of the CD31+ endothelium and accumulated in the choroid plexus, subarachnoid space, and perivascular space and visualizing labeled plasma uptake in multiple cell types including neurons and microglia across brain regions in young healthy mice; iv) recording plasma uptake by endothelial cells via flow cytometry and index sorting for deep, single-cell RNA sequencing (scRNA-seq, average 1.5 million reads per cell); v) linking transcriptomic data and plasma uptake for every cell to enable and generate an unbiased and high-throughput correlation between each gene's expression and degree of plasma uptake; vi) processing 745 brain endothelial cells from healthy adult mice four hours after administration of fluorescently-labeled plasma to ensure measurement of transcytosis; vii) across the 745 brain endothelial cells and 19,899 genes sequenced, using transferrin receptor (Tfrc) and CD98hc (Slc3a2) as validating controls to generate correlates and anticorrelates; and identifying both correlates and anticorrelates localized to the cell surface (see figure 9c, table 1), and that expression of Tfrc was mutually exclusive with that of anticorrelates like Alpl; viii) Comparison between young and aged mice revealed an increase in immunoglobulin G (IgG) uptake and a decrease in transport of IgG- and albumin-depleted plasma with age; and transcriptomic analysis suggested a decline in ligand-specific, receptor-mediated transcytosis and an increase in non-specific caveolar uptake; ix) intravenous administration of a selective ALPL inhibitor upregulated both TFRC and ferroprtin expression on the aged BBB (Example 6, figures 23-24). Applicant extrapolates the above findings to the claimed method for identifying a biomolecule that regulates BBB permeability in a mammal comprising recited steps (a)-(f). However, the claims are not limited to the method set forth above but also encompass using undefined labeled biomolecules, measuring undefined plasma uptake in undefined brain endothelial cells using undefined flow cytometry, detecting undefined expression to correlate the plasma uptake and selecting a biomolecule based on undefined expression gene to correlate increased or decreased plasma uptake to determine undefined regulation of the BBB. The specification fails to provide sufficient guidance to enable a skilled artisan to practice the claimed invention without undue experimentation because the specification provides no well-established structural and functional relationship or correlation between the claimed steps and the steps used in Examples 1-6 of the specification (p.45-64). The structural and functional relationship or correlation between the step of labeling mouse plasma with the Atto 647N fluorophore and other labeling methods of labeling plasma proteins for visualizing plasma uptake is unknown. The specification does not teach whether other labeling methods or other undefined labeled biomolecules in plasma can affect the activity of plasma uptake by brain endothelial cells or have the same activity as mouse plasma with the Atto 647N fluorophore without affecting plasma uptake by brain endothelial cells shown in Examples of the specification. The specification provides no well-established structural and functional correlation between the claimed steps (d)-(f) and the steps of “recording plasma uptake by endothelial cells via flow cytometry and index sorting for deep, single-cell RNA sequencing (scRNA-seq, average 1.5 million reads per cell) and linking transcriptomic data and plasma uptake for every cell enabled an unbiased and high-throughput correlation between each gene's expression and degree of plasma uptake”; “processing 745 brain endothelial cells were processed from healthy adult mice four hours after administration of fluorescently-labeled plasma to ensure measurement of transcytosis”; “using transferrin receptor (Tfrc) and CD98hc (Slc3a2) as validating controls and identifying expression of Tfrc that is mutually exclusive with that of anticorrelates, Alpl”; and “administering an ALPL inhibitor to validate the upregulation of TFRC and ferroprtin expression on the aged BBB” shown in Examples of the specification. The specification fails to teach that any parameters or conditions or undefined controls as recited in instant claims can be used for determining, selecting and identifying a biomolecule that regulates or enhances or decreases the BBB permeability based on undefined expression of genes because there is high sequencing depth variation and measurement errors in scRNA-sequencing data as taught by Su et al. (Nat Commun. 2023 Aug 10; doi.org/10.1038/s41467-023-40503-7). Bases on Applicant’s own admission, it requires “processing 745 brain endothelial cells from healthy adult mice four hours after administration of fluorescently-labeled plasma to ensure measurement of transcytosis”; and “the vast majority of the 19,899 sequenced genes showed no effect,…. Certain genes, like transferrin receptor (Tfrc) and CD98hc (Slc3a2), served as validating controls; and as expected, genes that correlated with enhanced plasma uptake (“Correlates”) were enriched in the vesicle-mediated transport pathway……” to generate correlates and anticorrelates (p. 48-49 of the instant specification), and “expression of Tfrc was mutually exclusive with that of anticorrelates like Alpl” (p. 55 of the instant specification), and the correlation was validated by the results of “the top upregulated gene after ALPL inhibitor was the transferrin receptor” (p. 60); and “administration of an ALPL inhibitor upregulated TFRC and ferroprtin expression on the aged BBB” (p. 63 of the instant specification). However, the claimed method does not contain such steps for validate the specific correlation as mentioned above. Therefore, in view of the breadth of the claims, the lack of guidance in the specification, the unpredictability of inventions, the limited working examples, and the current status of the art, undue experimentation would be required by one of skill in the art to perform in order to practice the claimed invention as it pertains to a method for identifying a biomolecule that regulates BBB permeability in a mammal. Claim Rejections - 35 USC § 112 Claims 12-19 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. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. Claims 12-19 encompass using a genus of undefined labeling methods, a genus of structurally and functionally undefined labeled biomolecules of blood plasma isolated from a first mammal, using a genus of undefined flow cytometry parameters to measure plasma uptake and isolate a population of undefined sorted brain endothelial cells, detecting a genus of undefined expression of genes to correlate with undefined plasma uptake in each of the undefined sorted brain endothelial cells and using undefined expression of genes to correlate undefined plasma uptake to select and determine a biomolecule without knowing how the biomolecule regulate the BBB in the subject. Applicant has not disclosed sufficient species for the broad genus of labeling methods, biomolecules of blood plasma, flow cytometry parameter to measure plasma uptake and detecting undefined expression to identify a biomolecule that regulates BBB permeability without a defined manner. In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is in possession of and what Applicant is claiming. M.P.E.P. § 2163 instructs: An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. . . . An applicant may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. . . . An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.” This standard has not been met in this case. The specification only describes i) labeling the mouse plasma with the small but bright far-red Atto 647N fluorophore used in super-resolution imaging; ii) administering labeled plasma to young healthy mice; iii) visualizing labeled plasma protein transcytosis, with both diffuse and punctate signal on the parenchymal side of the CD31+ endothelium and accumulated in the choroid plexus, subarachnoid space, and perivascular space and visualizing labeled plasma uptake in multiple cell types including neurons and microglia across brain regions in young healthy mice; iv) recording plasma uptake by endothelial cells via flow cytometry and index sorting for deep, single-cell RNA sequencing (scRNA-seq, average 1.5 million reads per cell); v) linking transcriptomic data and plasma uptake for every cell to enable and generate an unbiased and high-throughput correlation between each gene's expression and degree of plasma uptake; vi) processing 745 brain endothelial cells from healthy adult mice four hours after administration of fluorescently-labeled plasma to ensure measurement of transcytosis; vii) across the 745 brain endothelial cells and 19,899 genes sequenced, using transferrin receptor (Tfrc) and CD98hc (Slc3a2) as validating controls to generate correlates and anticorrelates; and identifying both correlates and anticorrelates localized to the cell surface (see figure 9c, table 1), and that expression of Tfrc was mutually exclusive with that of anticorrelates like Alpl; viii) Comparison between young and aged mice revealed an increase in immunoglobulin G (IgG) uptake and a decrease in transport of IgG- and albumin-depleted plasma with age; and transcriptomic analysis suggested a decline in ligand-specific, receptor-mediated transcytosis and an increase in non-specific caveolar uptake; ix) intravenous administration of a selective ALPL inhibitor upregulated both TFRC and ferroprtin expression on the aged BBB (Example 6, figures 23-24). The claims are not limited to the agents, steps and method set forth above but also encompass using structurally and functionally undefined labeling methods, labeled biomolecules of blood plasma, flow cytometry parameter to measure plasma uptake and detecting undefined expression to identify a biomolecule that regulates BBB permeability without a defined manner. However, Applicant is not in possession of the claimed method comprising the recited steps (a)-(f) because there is no well-established structural and functional relationship or correlation between the agents, steps and method shown in Examples and the steps recited in instant claims. The specification fails to teach what other labeling methods or labeled biomolecules can be used for plasma uptake by brain endothelial cells without affecting plasma uptake like mouse plasma with the Atto 647N fluorophore uptake by brain endothelial cells. The specification fails to teach whether any flow cytometry parameters, any expression of genes, steps or conditions or undefined controls for correlation or anti-correlation as recited in instant claims can be used for determining, selecting and identifying a biomolecule that regulates or enhances or decreases the BBB permeability based on undefined expression of genes. There is no well-established structural and functional relationship or correlation between the recited steps to the function of the steps used in Examples 1-6. Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what other labeling methods or labeled biomolecules, other flow cytometry parameters, any expression of genes or conditions or undefined controls might be. Since the common characteristics/features of other labeling methods, other labeled biomolecule of blood plasma, flow cytometry parameters, other expression of genes or conditions, steps or undefined controls for correlation and anti-correlation are unknown, a skilled artisan cannot contemplate the functional correlations of the genus with the claimed invention. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of labeling methods, labeled biomolecule of blood plasma, flow cytometry parameters, undefined expression of genes or conditions, steps or undefined controls for correlation and anti-correlation that can be used in the claimed method. Based on MPEP § 2161.01 and §2163, “to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116”. Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of labeling methods, labeled biomolecule of blood plasma, flow cytometry parameters, undefined expression of genes or conditions, steps or undefined controls for correlation and anti-correlation that can be used in the claimed method, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. Therefore, the claimed method has not met the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115). Applicant is directed to the Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement. See MPEP § 2161.01 and 2163. Conclusion NO CLAIM IS ALLOWED. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Han et al. (Nat. Commun. 2017; doi:10.1038/s41467-017-01503-6) teach cell permeable organic fluorescent probes for live cell imaging (p. 1). Zeragngue (US7452680) teaches a method for screening compounds and/or chemical moieties for their ability to be actively transported across the blood brain barrier (BBB), comprising: (a) providing a cell expressing the MCT1 transporter; (b) contacting the cell with an agent, conjugate or conjugate moiety in vitro; and (c) determining whether the agent, conjugate or conjugate moiety passes through the plasma membrane via the MCT1 transporter, passage through the plasma membrane via the MCT1 transporter indicating the agent, conjugate or conjugate moiety has capacity to be transported through the blood brain barrier; wherein: if step (b) comprises contacting the cell with the agent, the agent is a neuropharmaceutical agent or an imaging component; if step (b) comprises contacting the cell with the conjugate, the conjugate comprises an agent that is a neuropharmaceutical agent or an imaging component; or if step (b) comprises contacting the cell with the conjugate moiety, the method further comprises linking the conjugate moiety to an agent that is a neuropharmaceutical agent or an imaging component, and provided if the agent is a cytotoxic agent or an imaging component, the method further comprises: (i) administering the agent, conjugate, or conjugate moiety to a peripheral tissue of an animal and measuring the amount of agent, conjugate, or conjugate moiety that passes through the blood brain barrier into the brain of the animal; or (ii) contacting the agent to one side of a polarized monolayer of brain microvessel endothelial cells; and determining whether the agent is transported across the polarized monolayer, wherein if the agent is transported across the polarized monolayer it has the capacity to be transported through the blood brain barrier (see col.2, lines 26-53; col. 3-5; col. 12,line 18-col.20, line 46; col.56-58, claims 1-17). Webster et al. (US10184008, issued Jan 22, 2019, priority Dec 19, 2014) teach a method of screening for blood brain barrier (BBB) transporter molecules including humanized FC5-scFv variants was via a fluorometric microvolume assay technology assay (FMAT) (see col. 18-28; col. 39-41, Example 3) Kadakkuzha et al. (Front Cell Neurosci.. 2015; Mar 6; 9:63. Doi:10.3389/fncel.2015.00063) teach identifying 2759 long non-coding RNAs (IncRNAs)) and 17859 mRNAs in the hippocampus and 2561 lncRNs and 17464 mRNAs expressed in pre-frontal cortex by analyzing RNASeq datasets. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANG-YU WANG whose telephone number is (571)272-4521. The examiner can normally be reached on Monday-Thursday, 7:00am-5:00pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Chang-Yu Wang October 21, 2025 /CHANG-YU WANG/Primary Examiner, Art Unit 1675
Read full office action

Prosecution Timeline

Jun 03, 2022
Application Filed
Oct 21, 2025
Non-Final Rejection — §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12599670
METHODS OF PROMOTING NERVOUS SYSTEM REGENERATION
2y 5m to grant Granted Apr 14, 2026
Patent 12589118
USE OF CEREBROLYSIN
2y 5m to grant Granted Mar 31, 2026
Patent 12576130
DOMINANT NEGATIVE SARM1 MOLECULES AS A THERAPEUTIC STRATEGY FOR NEURODEGENERATIVE DISEASES OR DISORDERS
2y 5m to grant Granted Mar 17, 2026
Patent 12559549
ANTIBODY BINDING TO SUPER-REPRESSOR IkB (srIkB) OR ANTIGEN BINDING FRAGMENT THEREOF
2y 5m to grant Granted Feb 24, 2026
Patent 12545725
ANTI-PACAP ANTIBODIES, NUCLEIC ACIDS AND METHODS OF MAKING THEREOF
2y 5m to grant Granted Feb 10, 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
34%
Grant Probability
86%
With Interview (+52.5%)
4y 1m
Median Time to Grant
Low
PTA Risk
Based on 850 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