Prosecution Insights
Last updated: July 17, 2026
Application No. 18/278,738

COATED MEDICAL DEVICE AND PRODUCTION METHOD THEREFOR

Final Rejection §103§112
Filed
Aug 24, 2023
Priority
Mar 02, 2021 — JP 2021-032266 +1 more
Examiner
HELM, CARALYNNE E
Art Unit
1615
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Toray Industries Inc.
OA Round
3 (Final)
29%
Grant Probability
At Risk
4-5
OA Rounds
1y 2m
Est. Remaining
78%
With Interview

Examiner Intelligence

Grants only 29% of cases
29%
Career Allowance Rate
228 granted / 792 resolved
-31.2% vs TC avg
Strong +50% interview lift
Without
With
+49.6%
Interview Lift
resolved cases with interview
Typical timeline
4y 1m
Avg Prosecution
49 currently pending
Career history
864
Total Applications
across all art units

Statute-Specific Performance

§101
0.3%
-39.7% vs TC avg
§103
66.4%
+26.4% vs TC avg
§102
3.3%
-36.7% vs TC avg
§112
11.4%
-28.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 792 resolved cases

Office Action

§103 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 8-10 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims recite a method of manufacturing a “coated device …comprising a mixed layer in which...at least a part of the hydrophilic polymer layer and the medical device are mixed.” The method houses the medical device in a container, brings the medical device into contact with a solution containing the hydrophilic polymer, and heats the container, wherein after the heating step the pH of the solution is 6.1 to 8. The only solvents disclosed in the solution are water and water soluble organic solvents, such as alcohols (see paragraph 54). The medical devices are not limited and include stents as well as contact lenses (see paragraph 16). Constituent materials for medical devices include metals, ceramics, and polymers (see US Patent No. 6,004,943 – previously cited - claim 3). While the applicant exemplifies the claimed process when employing some hydrogel polymer medical devices, they do not exemplify metal or ceramic medical devices. No guidance detailing the solvents to employ for medical devices with metal or ceramic surfaces is provided. It is not evident which solvent that dissolves the claimed polymer A would also yield a mixed layer with metal or ceramic composing a medical device surface, given the significant structural difference between polymer hydrogel and metals or ceramics. A heating step is also recited in the process. However, there are no particular heating regimen in water or alcohol that are detailed to permit the intermixing of the claimed polymer into the surface of a metal or ceramic. The method structure (method components and steps) necessary to yield the claimed product structure (intermixed polymer A in the claimed scope of medical device surfaces) is not adequate described. As a result, the artisan of ordinary skill would not have deemed the applicant to be in possession of the full scope of the invention as currently claimed at the time of filing. The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1 and 3-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites “a mixed layer in which the mixed layer, at least a part of the hydrophilic polymer layer, and the medical device are mixed, and wherein no covalent bond is present between the hydrophilic polymer layer and the medical device”. This recitation is circular, where the mixed layer is recited to be mixed with itself. The result is that the components of the mixed layer are not defined. For the sake of compact prosecution and the application of prior art, the recitation will be interpreted as a mixed layer in which at least part of the hydrophilic polymer layer and the medical device surface are mixed. Clarification is still required. Claims that are rejection but are not explicitly elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1, 3, and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Onishi et al. (EP 0693293) in view of Luthra et al. (previously cited). Onishi et al. teach a medical device with an applied hydrophilic coating composed of a water soluble or water swellable polymer that forms a lubricious hydrogel when wet (see abstract). Particular medical devices of interest include contact lenses as well as catheters (see page 9 lines 11-12 and 31). The polymer is envisioned to include a mixture of monomers selected from those that include glycidyl methacrylate as a reactive monomer and include acrylamides such as N,N-dimethylacrylamide and acrylic acid esters as water soluble monomers, where the polymer has reactive groups that crosslink with each other upon being heated (see page 5 lines 10- 30). The matrix composing the medical device is not limited and is envisioned as various materials that include polymers; however, it is preferably devoid of functional groups that are reactive with the reactive groups on the water soluble or water swellable polymer (see page 4 lines 54-page 5 line 2). Onishi et al. teach the coating polymer impregnating the medical device surface (mixed layer) while its intermolecular reaction occurs under heated conditions so as to form a tenacious coating layer on the device surface (see page 5 lines 36-46). They teach that the polymer and matrix may form an interpenetrating network (mixed layer) at the interface between the polymer medical device matrix and water soluble or water swellable polymer layer (see page 6 lines 2-24). An example pairs glycidyl methacrylate and N,N-dimethylacrylamide to compose the water soluble or water swellable polymer (see page 6 lines 29-30). The instantly claimed monomer of formula I is not explicitly detailed. Luthra et al. teach a medical device, specifically a contact lens hydrogel device coated with a hydrophilic copolymer that is a hydrogel that also repels undesired deposits (see abstract and page 3 lines 1-33, page 4 lines 11-13, and example 17). The copolymer is made of monomers of instant formula I to repel deposits paired with acrylamide or methacrylamide monomers, where glycidyl methacrylate is also an envisioned monomer (see page 6 lines 9-19, page 8 lines 17-21, page 9 lines 4-19, example 15 and example 17). Here the monomer that fulfills instant formula I has a molecular weight of 350, 550, or 750 which corresponds to m as about 9, 14, or 19 (see example 17; as calculated by the examiner). Additionally, R1 is methyl, X is oxygen, and Y is methyl (C1 alkyl). Luthra et al. state that the mole percent of acrylamide with the compound of formula I ranges from 10% to 90% which corresponds to a mass ratio of amide monomer to formula I ranging from about 65:35 to 1:99 (as calculated by the examiner). Luthra et al. teach immersing the contact lens in a solution of the coating forming components, heating the mixture and incubating the warmed preparation for multiple hours (see example 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make a coated contact lens of Onishi et al. where a monomer of instant formula I, as taught by Luthra et al., is included to repel undesired deposits along with the glycidyl methacrylate and N,N-dimethylacrylamide in the water soluble or water swellable polymer. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The monomers envisioned in the coating polymers of Onishi et al. and Luthra et al. overlap in scope and yield hydrogel coatings, thus there would have been a reasonable expectation of success for the modification. Selecting a contact lens surface polymer material that is devoid of functional groups reactive with the glycidyl methacrylate would have been obvious because it is a preferred variety of medical device matrix according to Onishi et al. (see instant claim 1). The application of the relative proportions of the acrylamide and formula I polymer would follow and meet the instant claim limitations (see instant claim 1). It additionally would have been obvious to select a hydrogel polymer contact lens as taught by Luthra et al. because this variety was known to benefit from a hydrophilic surface coating. This modification is obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g. generic contact lens vs specific contact lens). None of the more specific options recited by claims 4-6 are required to be selected. Thus when the limitations of the parent claim are met otherwise, their limitations are met as well. Therefore claims 1, 3, and 5-7 are obvious over Onishi et al. in view of Luthra et al. Claims 1 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Onishi et al. in view of Luthra et al. as applied to claims 1, 3, and 5-7, further in view of Reich et al. (previously cited). Onishi et al. in view of Luthra et al. render obvious the limitations of instant claims 1, 3, and 5-7. A particular hydroxyethylmethacrylate lens is not detailed Reich et al. teach particular hydroxyethylmethacrylate based hydrogel contact lenses that were known and they include tetrafilcon, haflicon, and vilfilcon (see column 3 lines 16-34; instant claim 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select tetrafilcon, haflicon, or vilfilcon as particular hydroxyethylmethacrylate based hydrogel contact lenses to employ in the product of Onishi et al. in view of Luthra et al. This modification would have been obvious as the simple substitution of one known element for another in order to yield a predictable outcome (e.g., specific hydroxyethylmethacrylate contact lens vs. generic hydroxyethylmethacrylate contact lens). Instant claims 5-6 do not require that any of their recited components be present, but instead, they specify options from which a selection could be made. Therefore claims 1 and 3-7 are obvious Onishi et al. in view of Luthra et al. and Reich et al. Claims 1 and 3-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (previously cited) in view of Onishi et al., Neugebaur (Reactive and Functional Polymers 2008 68:535-543), and Luthra et al. as evidenced by Weinmüller et al. (Journal of Biomedical Materials Research 2006 77A:230–241). Zhao et al. teach the application of a polymer coating to an ionic contact lens via its packaging solution to improve comfort by increasing its water retention/hydrophilicity and/or reducing its surface friction (see abstract and paragraphs 5-6 and 55). The polymer is a phosphorylcholine containing polymer that is envisioned as a (meth)acrylate copolymer made from 2-methacryloyloxyethyl phosphorylcholine (see paragraphs 32-34). No covalent reactivity between the lens surface and the phosphorylcholine polymer is detailed or implied (see instant claim 1). Zhao et al. further teach a buffered aqueous packaging solution of the coating polymer with a pH of about 6 to about 8 in blister package in which the lens is placed, hermetically sealed, and heat sterilized (see paragraphs 10 and 31; see instant claims 9-10). They detail hydrating the lens in the packaging solution as well as the maintenance of the pH after heat sterilization (see paragraphs 45-46 and example 2; instant claim 8). The exemplified silicone hydrogel contact lens that is coated is composed of balafilcon A polymer and has a water uptake at equilibrium of 36 wt% (see examples 1-2 and Weinmüller et al. page 231 second column last partial paragraph and table 1; instant claims 3-8). Acrylamide monomers and monomers that meet the limitations of instant formula I are not detailed. Onishi et al. teach a medical device with an applied hydrophilic coating composed of a water soluble or water swellable polymer that forms a lubricious hydrogel when wet (see abstract). Particular medical devices of interest include contact lenses as well as catheters (see page 9 lines 11-12 and 31). The polymer is envisioned to include a mixture of monomers such as acrylamides that include N,N-dimethylacrylamide and 2-methacryloyloxyethyl phosphorylcholine, as water soluble monomers (see page 5 lines 10- 30). The matrix composing the medical device is not limited and is envisioned as various materials that include polymers; however, it is preferably devoid of functional groups that are reactive with the reactive groups on the water soluble or water swellable polymer (see page 4 lines 54-page 5 line 2). Neugebaur teaches a copolymer of N,N-dimethylacrylamide (DMAA) and polyethylene glycol methyl ether methacrylate (PEGMA) as a double hydrophilic water soluble polymer envisioned as useful due to its biocompatibility (see abstract and page 536 first column last full paragraph). The polyethylene glycol methyl ether methacrylate meets the limitation of instant formula I where R1 is methyl, X is oxygen, Y is methyl (C1 alkyl), and m is 5 or 23 (see Scheme 1). The mass ratio of DMAA to PEGMA spans from 90:10 to 49:51 (see table 1; instant claim 1). Luthra et al. teach a medical device, specifically a contact lens hydrogel device coated with a hydrophilic copolymer that is a hydrogel that also repels undesired deposits (see abstract and page 3 lines 1-33, page 4 lines 11-13, and example 17). The copolymer is made of monomers of instant formula I to repel deposits paired with acrylamide or methacrylamide monomers where glycidyl methacrylate is also an envisioned monomer (see page 6 lines 9-19, page 8 lines 17-21, page 9 lines 4-19, example 15 and example 17). Here the monomer that fulfills instant formula I has a molecular weight of 350, 550, or 750 which corresponds to m as about 9, 14, or 19 (see example 17; as calculated by the examiner). Additionally, R1 is methyl, X is oxygen, and Y is methyl (C1 alkyl). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select N,N-dimethylacrylamide and polyethylene glycol methyl ether methacrylate as additional hydrophilic monomers to include in the phosphorylcholine based polymer applied in the method Zhao et al. This modification would have been obvious because both monomers were known to be useful in polymer coatings on contact lens as beneficial hydrophilic monomers based upon Onishi et al. and Luthra et al., where the phosphorylcholine monomer is contemplated in the polymer. In addition, the combination of DMAA and PEGMA in a copolymer was already known in light of Neugebaur and contemplated for their water solubility and biocompatibility. The ratio of DMAA and PEGMA taught by Neugebaur would therefore have been obvious to employ. This modification then renders obvious the active step limitations of instant claim 8. Application to the contact lens exemplified by Zhao et al. would follow. None of the more specific options recited by claims 4-6 are required to be selected. Thus when the limitations of the parent claim are met otherwise (e.g., balafilcon A silicone hydrogel contact lens), their limitations are met as well. Zhao et al. do not speak to the penetration of the coating polymer into the contact lens surface. However, the hydration of the lens in the packaging solution comprising a copolymer with DMAA and PEGMA and the water uptake of the lens would be expected to entrain at least some of the polymer along with the water into the lens and yield some mixing of the coating layer with the surface of the contact lens (see instant claim 1). Therefore claims 1 and 3-10 are obvious over Zhao et al. in view of Onishi et al., Neugebaur, and Luthra et al. as evidenced by Weinmüller et al. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented. Claims 1 and 3-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/871641 (reference application) in view of Fukuda et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a coated medical device where the coating is a hydrophilic copolymer of an amide containing monomer and a monomer of instant formula I. A mixed layer configuration between the coating layer and the medical device is recited by both sets of claims. The steps for making the claimed device are also the same and thus must yield the same product. The same medical devices and constituent materials are also recited by both sets of claims where hydrogel contact lenses are named. An acrylamide as the amide containing monomer is not detailed. Fukuda et al. teach a lubricious copolymer envisioned for contact lenses (see abstract and page 5 lines 1-10). The copolymer is envisioned to include a methylolacrylamide monomer and a hydrophilic monomer envisioned to include methoxy polyethylene glycol methacrylate (see page 4 lines 1-32). The methoxy polyethylene glycol methacrylate monomer meets the limitations of instant formula I where X is an oxygen atom, R1 and Y are methyl, and m is 9. They prepare various embodiments of the polymer, apply them to polymer surfaces, and test their lubricity (see page 35 lines 35-40). Polymer O in example 18, composed of methylolacrylamide monomer and methoxy polyethylene glycol methacrylate, provides excellent lubricity (see page 35 and table 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select methylolacrylamide as the amide monomer to pair with formula I because Fukuda et al. exemplify their utility together in a hydrophilic and lubricious coating for a medical device envisioned as a contact lens. In addition, it also would have been obvious to make the mixed layer version of the product of the copending claims via the method steps of the copending claims with the recited medical devices because the claims suggest to do so. Therefore claims 1 and 3-10 are unpatentable over claims 1-10 of copending Application No. 18/871641 in view of Fukuda et al. Claims 1 and 3-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, and 8-10 of copending Application No. 18/278677 (reference application) in view of Fukuda et al. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a coated medical device where the coating is a hydrophilic copolymer of an amide containing monomer and a monomer of instant formula I. A mixed layer configuration is recited by both sets of claims. Several of the same medical devices and constituent materials are also recited by both sets of claims where contact lenses are named. An acrylamide as the amide containing monomer is not detailed. Fukuda et al. teach a lubricious copolymer envisioned for contact lenses (see abstract and page 5 lines 1-10). The copolymer is envisioned to include a methylolacrylamide monomer and a hydrophilic monomer envisioned to include methoxy polyethylene glycol methacrylate (see page 4 lines 1-32). The methoxy polyethylene glycol methacrylate monomer meets the limitations of instant formula I where X is an oxygen atom, R1 and Y are methyl, and m is 9. They prepare various embodiments of the polymer, apply them to polymer surfaces, and test their lubricity (see page 35 lines 35-40). Polymer O in example 18, composed of methylolacrylamide monomer and methoxy polyethylene glycol methacrylate, provides excellent lubricity (see page 35 and table 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select methylolacrylamide as the amide monomer to pair with formula I because Fukuda et al. exemplify their utility together in a hydrophilic and lubricious coating for a medical device envisioned as a contact lens. In addition, it also would have been obvious to make the mixed layer version of the product of the copending claims with the recited medical devices and via the recited method steps, because the claims suggest to do so. Therefore claims 1 and 3-10 are unpatentable over claims 1-2, 5-6, and 8-10 of copending Application No. 18/278677 in view of Fukuda et al. Response to Arguments Applicant's arguments filed March 26, 2026 have been fully considered. In light of the amendment to the claims, the previous grounds of objection and rejection under 35 USC 103 are hereby withdrawn. New grounds of rejection are detailed to address the new claim limitations. The applicant’s argument regarding the rejection under 35 USC 112 are not persuasive. The applicant states that the amendment to the claims addresses the issues raised under 35 USC 112. As noted in the modified rejection, claims 8-10 still lack adequate description such that their embraced scope was clearly possessed by the applicant at the time of filing. A device comprising a material is not the same as the surface of the device being composed of the material. Given the requires mixing between the medical device the coating layer, the location of the constituent material in the device is important. Further, it is not clear which steps the applicant contemplated such that disclosed solvents would permit dissolution of the claimed polymer and mixing between the device surface and the polymer for the recited materials, such as polystyrene. The acknowledgement of the double patenting rejections is noted. It is also noted that 37 CFR 1.111 states that “[t]he reply by the applicant or patent owner must be reduced to a writing which distinctly and specifically points out the supposed errors in the examiner’s action and must reply to every ground of objection and rejection in the prior Office action. The reply must present arguments pointing out the specific distinctions believed to render the claims, including any newly presented claims, patentable over any applied references. If the reply is with respect to an application, a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated.” Double patenting rejections are not objections or requirements of form that may be held in abeyance and warrant a substantive reply. Conclusion No claim is allowed. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5. 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, Robert Wax can be reached at (571) 272-0623. 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. /CARALYNNE E HELM/Examiner, Art Unit 1615 /MELISSA S MERCIER/Primary Examiner, Art Unit 1615
Read full office action

Prosecution Timeline

Aug 24, 2023
Application Filed
Aug 08, 2025
Non-Final Rejection mailed — §103, §112
Oct 03, 2025
Response Filed
Jan 22, 2026
Non-Final Rejection mailed — §103, §112
Mar 26, 2026
Response Filed
Jun 16, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

4-5
Expected OA Rounds
29%
Grant Probability
78%
With Interview (+49.6%)
4y 1m (~1y 2m remaining)
Median Time to Grant
High
PTA Risk
Based on 792 resolved cases by this examiner. Grant probability derived from career allowance rate.

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