Prosecution Insights
Last updated: April 19, 2026
Application No. 17/054,115

COMPOSITIONS AND SYSTEMS FOR EX VIVO CELL MODULATION AND METHODS OF USE THEREOF

Final Rejection §102§112
Filed
Nov 09, 2020
Examiner
TIWARI, VYOMA SHUBHAM
Art Unit
1634
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Yale University
OA Round
2 (Final)
29%
Grant Probability
At Risk
3-4
OA Rounds
4y 1m
To Grant
75%
With Interview

Examiner Intelligence

Grants only 29% of cases
29%
Career Allow Rate
14 granted / 49 resolved
-31.4% vs TC avg
Strong +46% interview lift
Without
With
+46.3%
Interview Lift
resolved cases with interview
Typical timeline
4y 1m
Avg Prosecution
30 currently pending
Career history
79
Total Applications
across all art units

Statute-Specific Performance

§101
3.2%
-36.8% vs TC avg
§103
32.2%
-7.8% vs TC avg
§102
17.5%
-22.5% vs TC avg
§112
37.2%
-2.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 49 resolved cases

Office Action

§102 §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 . Status of Claims The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. This action is in response to the papers filed on 16 July, 2025. Claims 1 – 2, 4, 6 – 8, 10 – 17, 22 – 23, 25 – 28, 31 – 33, 44 and 45 are currently pending. Claims 1-2, 8, 10, 11 – 13, 15 – 16, and 25 have been amended and claims 44 and 45 have been newly added in the Applicant’s amendment filed 23 January 2025. Claims 20 and 35 have been canceled in the Applicant’s amendment filed 16 July, 2025. Applicant's election with traverse of Group I, 1 – 2, 4, 6 – 8, 10 – 17, 20, 22 – 23, and 25 - 28 drawn to a device, and the election of Species without traverse as follows: Species (A): A specific species election of the base support, wherein the base support is porous (instant claim 2); Species (B): A specific species selection of what the cell ligands comprise, wherein the ligands comprise one or more T cell ligands (instant claim 10); Species (C): A specific species selection of the antibodies that specifically bind CD28 (instant claim 14); Species (D): A specific species selection of growth factor or cytokine (instant claim 22), in the reply filed September 10, 2024 was previously acknowledged Claims 31 – 33 and 35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim. Claims 4, 13, 15 – 16, 23, and 25 – 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim. Please Note: claim 14 refers to back to withdrawn claim 13 and, therefore, claim 14 has not been examined on the merits. Claim 17 refers back to withdrawn claim 16, and therefore, claim 17 has not been examined on the merits. The restriction requirement is still deemed proper and is therefore made FINAL. The claims will be examined insofar as they read on the elected species. Therefore, claims 1 – 2, 6 – 8, 10 – 12, 22, 44, and 45 are under consideration to which the following grounds of rejection are applicable. Response to Applicants’ Arguments as they apply to species election requirement At page 7 of the remarks filed on 16 July 2025, Applicants essentially argue that: “Applicant submits that (a) claim 4 depends from claim 1, and is a more specific example, not mutually exclusive to the elected “porous base support,” and (b) claim 16 and 17 are generic and not part of a species election. Applicants’ arguments have been respectfully considered but have not been found persuasive. The examiner notes that claims 2 and 16 have been currently amended, however, the restriction was made final in the Office Action filed 16 January, 2025 Regarding (a), in the requirement for restriction filed 10 July, 2024, Applicant was required to do a species election of the base support between as recited in previously presented claim 2 or 4. In the response to restriction, filed 10 September, 2024 Applicant elected “porous base support”, which reads on claim 2. Thus, claim 4 was withdrawn. Regarding (b), in the requirement for restriction filed 10 July, 2024, Applicant was required to a species election of what the cell ligands comprise, electing one of the claims between 10, 13, 15 – 16, 23, 25, and 27. In the response to the restriction filed 10 September, 2024, Applicant elected “T cell ligands, which reads on claim 10. Thus, claims 13, 15 – 16, 23, 25, and 27 were withdrawn. Regarding claim 17, Claim 17 refers back to withdrawn claim 16, and therefore, claim 17 has not been examined on the merits. Thus, the claims 4, 16, and 17 remain withdrawn. Priority The present application filed November 9, 2020, is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2019/031494, filed May 9, 2019, which claims the benefit of Provisional Application, filed May 9, 2018. Therefore, the earliest priority date is May 9, 2018. Withdrawn Objections/Rejections Claim Rejection - 35 USC § 112(d) The rejection of claims 11 and 12 is withdrawn under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims have been amended to be further limiting the claim from which it depends. In view of the withdrawn rejection, Applicant’s arguments are moot. Claim Rejections - 35 USC § 102 The rejection of claims 1, 2, 6 – 8, 10 – 12, and 22 is withdrawn under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by Fahmy et al. (hereinafter referred to as “Fahmy”) (US2013216581 (A1), published August 22, 2013). Fahmy does not specifically exemplify that the polymer layer is absorbed on a surface of a base support (amended claim 1). In view of the withdrawn rejection, Applicant’s arguments are moot. Maintained Objections/Rejections Claim Rejection - 35 USC § 112(b) The rejection of claims 1, 2, 6 – 8, 10 – 12, 22, and 44 - 45 is maintained under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 is indefinite for the recitation of “a layer of one or more polymers and/or co-polymers absorbed on a surface of the base support” in lines 3 – 4. The as-filed Specification teaches that “the polymer is in the form of a layer adsorbed onto or otherwise coated onto at least one surface of the base support” (Paragraph [0021]). It is unclear whether the polymer layer is adsorbed or absorbed onto the surface of the base support. Thus, the metes and bounds of the claim cannot be determined. Claim 1 is indefinite for recitation of “graphene, metallic nanoparticles, metallic microparticles, or carbon nanotubes having bound to or present on the surface thereof, one or more ligands” in line 7 – 8. It is unclear whether the ligands are on the surface of the scaffold, or the graphene etc. is on the surface of the scaffold. Thus, the metes and bounds of the claim cannot be determined. Claims 1 is indefinite because of its recitation in line 5 of the term “and/or” While this may be a convenient means for Applicant, such legalese renders the claims indefinite because the claimed one or more active agents cannot simultaneously be each of the structurally different agents recited: encapsulated within, surrounded by, and dispersed therein. To put it another way, the active agents cannot be both encapsulated and non-encapsulated. Appropriate correction is required. Claims 1 and 7 are indefinite for the recitation of “and/or” such as recited in claim 1, lines 2 and 5. It is unclear what the metes and bounds of the term “and/or”, could interpreted in claim 1 and 11. Specifically, it is unclear whether the layer comprises polymer and co-polymers, or just one instead of the others, as described by “or,” implying that the property types are in the alternative. Claims 2, 6, 8, 10 – 12, 22, and 44 - 45 are indefinite insofar as it ultimately depends from claim 1. New Objections/Rejections Claim Rejections - 35 USC § 112(a) - Written Description The following is a quotation of the first paragraph of 35 U.S.C. 112, first paragraph: (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1, 2, 6 – 8, 10 – 12, 22 , 44 and 45 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. This is a new rejection necessitated by the response filed 16 July, 2025. Claims 1 – 2, 6 – 8, 10 – 12, 22, 44, and 45 encompass a device comprising a base support, a polymer layer, and the scaffolds, wherein the polymer layer is absorbed on the surface of the base support, and there are a plurality of scaffolds embedded in the polymer layer, wherein the scaffolds comprise graphene, metallic nanoparticles, or carbon nanotubes bounds to or present on the surface of cell ligands. Overall, what these statements indicate is that the Applicant must provide adequate description of such core structure and function related to that method such that the Artisan could determine the desired effect. Hence, the analysis below demonstrates that Applicant has not determined the core structure and function for full scope of the claimed method. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail such that the Artisan can reasonably conclude that the inventors had possession of the claimed invention. Such possession may be demonstrated by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and/or formulae that fully set forth the claimed invention. Possession may be shown by an actual reduction to practice, showing that the invention was "ready for patenting", or by describing distinguishing identifying characteristics sufficient to show that Applicant was in possession of the claimed invention (January 5, 2001 Fed. Reg., Vol. 66, No. 4, pp. 1099-11). MPEP § 2163.II.A.3.(b) states, “when filing an amendment an applicant should show support in the original disclosure for new or amended claims” and “[i]f the originally filed disclosure does not provide support for each claim limitation, or if an element which applicant describes as essential or critical is not claimed, a new or amended claim must be rejected under 35 U.S.C. 112, para. 1, as lacking adequate written description”. Moreover, MPEP 2163 states: [A] biomolecule sequence described only by a functional characteristic, without any known or disclosed characteristic, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence. 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. In analyzing whether the written description requirement is met for the claimed method, it is first determined whether the examples describe a device comprising a base support, a polymer layer, and the scaffolds, wherein the polymer layer is absorbed on the surface of the base support, and there is a plurality of scaffolds embedded in the polymer layer, wherein the scaffolds comprise graphene, metallic nanoparticles, or carbon nanotubes bounds to or present on the surface of cell ligands. There is no structure/function correlation for all the claimed devices. In the instant case, Applicant does not disclose any relevant examples that teach the device, comprising all 3 components (the base support, the polymer layer, wherein the polymers are absorbed on a surface of the base support, and the scaffolds are embedded in the polymer layer with the contemplated use of activating T cells via T cell receptor activators (new claim 44) or antigen-specific T cell activator (new claim 45)i. However, the Examiner acknowledges that Applicant teaches an illustration showing the materials, structure, and preparation of an exemplary bioreactor cartridge (Paragraph [0027]). In this figure, a base support formed of a polypropylene layer supports the adsorption of PLGA (a biodegradable polymer) and IL-2 (an active agent), wherein the liquid polymer is poured onto a surface of the base support and allowed to coat the surface and form a polymer layer (Paragraph 0027]). Then, carbon nanotube bundles functionalized with a linker, in this case neutravidin, can be added to the semi-dry polymer sheet, and thus embedded in the layer formed therefrom (Paragraph [0027]). The Examiner notes that this is just an exemplary bioreactor cartridge, but the as-Filed Specification does not any examples comprising all of these components. The Examiner also acknowledges FIG. 7 and Example 1 of the as-Filed Specification, which is an illustration of an assay designed to test the difference in configurational design of the substrate and T cell activation, microparticles, nanoparticles, soluble multivalent stimuli (tetrameric antibodies) and scaffold (the invention) are used as presentation stimulatory and co-stimulatory ligands are used as T cell activation (Paragraph [0033]). However, the scaffold refers to the base support without carbon nanotubes (CNTs)(Paragraph [0345]). Thus, this example also does not teach all 3 components of the claimed device - the base support, the polymer layer, and the scaffold, wherein the polymers are absorbed on a surface of the base support, and the scaffolds are embedded in the polymer layer. The other examples and figures in the as-Filed Specification teach properties for optimizing the scaffold or T cell activation, such as scaffold pore size (example 2), scaffold antibody density (example 3), the impact scaffold-released IL-2 on T cell activation (example 4), and the laminar flow of T cell activation (example 5). These examples do not teach the device comprising all 3 components of the instantly recited claims. Before the effective filing date of the claimed invention, it was known in the art that that nanocarriers formulated with polymers, specifically PLGA, is advantageous because of properties such as controlled and sustained release, low cytotoxicity, long-standing biomedical applications, biocompatibility with tissues and cells, prolonged residence time and targeted delivery, as evidenced by Sharma et al. (Sharma S. et al. PLGA-based nanoparticles: A new paradigm in biomedical applications, TrAC Trends in Analytical Chemistry, Volume 80, pg 30-40. 2016). (Abstract). Sharma et al. teaches that the degradation of the PLGA polymer leads to the formation of acids that limit the drugs therapeutic efficacy, and there is relatively poor drug loading, leading to higher cost of product and difficulty in scaling up the use of PLGA nanoparticles (pg. 39, left column, Section 14: 14. Drawbacks of using PLGA nanoparticle-based DDSs). It was also known in the art that CNTs intrinsically have poor stability, and that that the microstructure and CNTs dispersion into PP (polypropylene) matrix is very crucial in order a high performance material to be achieved, as evidenced by Bikiaris. (Bikiaris D. Microstructure and Properties of Polypropylene/Carbon Nanotube Nanocomposites. Materials (Basel). 2010 Apr 21;3(4):2884–946. doi: 10.3390/ma3042884. PMCID: PMC5445858.) (pg. 2887, last paragraph). Bikiaris teaches that the carbon nanotubes have a small tendency to be separated and dispersed homogenously into PP matrix at low CNTs concentration (pg. 2890, second paragraph). Additionally, it was known in the art that PLGA nanoparticles loaded with magnetite and IL-2 are bound to the antigen presenting CNTs surface, as evidenced by Fahmy et al. (US2013216581 (A1), published August 22, 2013) (Paragraph [0021]). Fahmy et al. also teaches that (the CNPs) can be coated with surfactants, such as polypropylene glycol butyl ether Paragraph [0191]. Thus, Fahmy teaches that the polypropylene is used to coat only the CNPs, and not the polymer layer. Thus, these references indicate that there is a lot of unpredictability in the art pertaining to the use of polypropylene and PLGA in regards to CNTs (carbon nanotubes), specifically regarding the poor drug loading and high cost of usage of the PLGA, the importance of the concentration of the CNTs in the polypropylene matrix, and the use of the polypropylene as a surfactant to coat only the CNTs, and the not the PGLA polymer layer. There is no structure/function correlation for all the claimed devices. In the instant case, Applicant does not disclose any relevant examples that teach the device, comprising all 3 components (the base support, the polymer layer, wherein the polymers are absorbed on a surface of the base support, and the scaffolds are embedded in the polymer layer with the contemplated use of activating T cells via T cell receptor activators (new claim 44) or antigen-specific T cell activator (new claim 45). These claims are termed "reach through claims" and rejection is proper on the grounds that the applicants do not possess device, comprising all 3 claimed components. Therefore, the specification does not contain a written description of the invention, and a 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 can make and use the same, nor does it set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. This limited information is not deemed sufficient to reasonably convey to one skilled in the art that Applicant is in possession of the device comprising a base support, polymer layer, and scaffold, as recited in the instant claims. Claim Rejection - 35 USC § 112(a) Scope of Enablement The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1, 2, 6 – 8, 10 – 12, 22 , 44 and 45 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. Claims 1, 2, 6 – 8, 10 – 12, 22 , 44 and 45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the Specification does not reasonably provide enablement for a device comprising a base support, a polymer layer, and the scaffolds, wherein the polymer layer is absorbed on the surface of the base support, and there is a plurality of scaffolds embedded in the polymer layer. This is a new rejection necessitated by the response filed 16 July, 2025. The Specification does not enable any person skill in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The claims, when given the broadest possible interpretation, encompasses a device comprising a base support, a polymer layer, and the scaffolds, wherein the polymer layer is absorbed on the surface of the base support, and there are a plurality of scaffolds embedded in the polymer layer, wherein the scaffolds comprise graphene, metallic nanoparticles, or carbon nanotubes bounds to or present on the surface of cell ligands. The Specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The test of enablement is whether one skilled in the art could make and use the claimed invention from the disclosures in the patent coupled with information known in the art without undue experimentation (United States v. Telectronics, Inc., 8 USPQ2d 1217 (Fed. Cir. 1988)). Whether undue experimentation is required is not based on a single factor but is rather a conclusion reached by weighing many factors (See Ex parte Forman, 230 USPQ 546 (Bd. Pat. App. & Inter, 1986) and In re Wands, 8USPQ2d 1400 (Fed. Cir. 1988); these factors include the following: Nature of invention. The invention encompasses a device comprising a base support, a polymer layer, and the scaffolds, wherein the polymer layer is absorbed on the surface of the base support, and there are a plurality of scaffolds embedded in the polymer layer, wherein the scaffolds comprise graphene, metallic nanoparticles, or carbon nanotubes bounds to or present on the surface of cell ligands. Scope of the invention. The invention encompasses a device comprising a base support, a polymer layer, and the scaffolds for activating T cells via T cell receptor activators. Number of working examples and guidance. Applicant does not disclose any relevant examples that teach the device, comprising all 3 components (the base support, the polymer layer, wherein the polymers are absorbed on a surface of the base support, and the scaffolds are embedded in the polymer layer with the contemplated use of activating T cells via T cell receptor activators (new claim 44) or antigen-specific T cell activator (new claim 45). However, the Examiner acknowledges that Applicant teaches an illustration showing the materials, structure, and preparation of an exemplary bioreactor cartridge (Paragraph [0027]). In this figure, a base support formed of a polypropylene layer supports the adsorption of PLGA (a biodegradable polymer) and IL-2 (an active agent), wherein the liquid polymer is poured onto a surface of the base support and allowed to coat the surface and form a polymer layer (Paragraph 0027]). Then, carbon nanotube bundles functionalized with a linker, in this case neutravidin, can be added to the semi-dry polymer sheet, and thus embedded in the layer formed therefrom (Paragraph [0027]). The Examiner notes that this is just an exemplary bioreactor cartridge, but the as-Filed Specification does not any examples comprising all of these components. The Examiner also acknowledges FIG. 7 and Example 1 of the as-Filed Specification, which is an illustration of an assay designed to test the difference in configurational design of the substrate and T cell activation, microparticles, nanoparticles, soluble multivalent stimuli (tetrameric antibodies) and scaffold (the invention) are used as presentation stimulatory and co-stimulatory ligands are used as T cell activation (Paragraph [0033]). However, the scaffold refers to the base support without carbon nanotubes (CNTs)(Paragraph [0345]). Thus, this example also does not teach all 3 components of the claimed device - the base support, the polymer layer, wherein the polymers are absorbed on a surface of the base support, and the scaffolds are embedded in the polymer layer.The other examples and figures in the as-Filed Specification teach properties for optimizing the scaffold or T cell activation, such as scaffold pore size (example 2), scaffold antibody density (example 3), the impact scaffold-released IL-2 on T cell activation (example 4), and the laminar flow of T cell activation (example 5). These examples do not teach the device comprising all 3 components of the instantly recited claims. State of the art. Although the use of scaffolds is highly developed, the device comprising base support, the polymer layer, and scaffold, wherein the polymers are absorbed on a surface of the base support, and the scaffolds are embedded in the polymer layer is not highly developed. The art must therefore be considered to be poorly developed. Unpredictability of the art. Before the effective filing date of the claimed invention, it was known in the art that that nanocarriers formulated with polymers, specifically PLGA, is advantageous because of properties such as controlled and sustained release, low cytotoxicity, long-standing biomedical applications, biocompatibility with tissues and cells, prolonged residence time and targeted delivery, as evidenced by Sharma et al. (Sharma S. et al. PLGA-based nanoparticles: A new paradigm in biomedical applications, TrAC Trends in Analytical Chemistry, Volume 80, pg 30-40. 2016). (Abstract). Sharma et al. teaches that the degradation of the PLGA polymer leads to the formation of acids that limit the drugs therapeutic efficacy, and there is relatively poor drug loading, leading to higher cost of product and difficulty in scaling up the use of PLGA nanoparticles (pg. 39, left column, Section 14: 14. Drawbacks of using PLGA nanoparticle-based DDSs). It was also known in the art that CNTs intrinsically have poor stability, and that that the microstructure and CNTs dispersion into PP (polypropylene) matrix is very crucial in order a high performance material to be achieved, as evidenced by Bikiaris. (Bikiaris D. Microstructure and Properties of Polypropylene/Carbon Nanotube Nanocomposites. Materials (Basel). 2010 Apr 21;3(4):2884–946. doi: 10.3390/ma3042884. PMCID: PMC5445858.) (pg. 2887, last paragraph). Bikiaris teaches that the carbon nanotubes have a small tendency to be separated and dispersed homogenously into PP matrix at low CNTs concentration (pg. 2890, second paragraph). Additionally, it was known in the art that PLGA nanoparticles loaded with magnetite and IL-2 are bound to the antigen presenting CNTs surface, as evidenced by Fahmy et al. (US2013216581 (A1), published August 22, 2013) (Paragraph [0021]). Fahmy et al. also teaches that (the CNPs) can be coated with surfactants, such as polypropylene glycol butyl ether Paragraph [0191]. Thus, Fahmy teaches that the polypropylene is used to coat only the CNPs, and not the polymer layer. Amount of Experimentation Required. Given the unpredictability of the art, the poorly developed state of the art with regard to the use polypropylene and PLGA in regards to CNTs (carbon nanotubes), specifically regarding the poor drug loading and high cost of use of the PLGA, the importance of concentration of the CNTs in the polypropylene-scaffold matrix, and the use of use of the polypropylene as a surfactant to coat only the CNTs, and the not the PGLA polymer layer, the skilled artisan would have to conduct undue, and unpreidcatable experimentation to practice the claimed invention using all 3 components of the claimed device. The instant invention, as claimed, falls under the “germ of an idea” concept defined by the CAFC. The court has stated that “patent protection is granted in return for an enabling disclosure, not for vague intimations of general ideas that may or may be workable”. The court continues to say that “tossing out the mere germ of an idea does not constitute an enabling disclosure” and that “the specification, not knowledge in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement”. (See Genentech inc v. Novo Nordisk A/S 42 USPQ2d 1001, at 1005). The claimed device constitute such a “germ of an idea”. Conclusion Claims 1 – 2, 6 – 8, 10 – 12, 22, 44, and 45 remain rejected. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYOMA SHUBHAM TIWARI whose telephone number is (571)272-2954. The examiner can normally be reached M-F 8:30 - 5:30 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, Maria Leavitt can be reached on (571) 272-1085. 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. /VYOMA SHUBHAM TIWARI/Examiner, Art Unit 1634 /MARIA G LEAVITT/ Supervisory Patent Examiner, Art Unit 1634
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Prosecution Timeline

Nov 09, 2020
Application Filed
Jan 10, 2025
Non-Final Rejection — §102, §112
Jul 16, 2025
Response Filed
Sep 29, 2025
Final Rejection — §102, §112
Apr 01, 2026
Request for Continued Examination
Apr 03, 2026
Response after Non-Final Action
Apr 03, 2026
Examiner Interview Summary

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Prosecution Projections

3-4
Expected OA Rounds
29%
Grant Probability
75%
With Interview (+46.3%)
4y 1m
Median Time to Grant
Moderate
PTA Risk
Based on 49 resolved cases by this examiner. Grant probability derived from career allow rate.

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