Prosecution Insights
Last updated: July 17, 2026
Application No. 18/257,215

HILIC UPLC-MS Method For Separating and Analyzing Intact Adeno-Associated Virus Capsid Proteins

Non-Final OA §103§112
Filed
Jun 13, 2023
Priority
Dec 15, 2020 — provisional 63/125,689 +1 more
Examiner
LY, KRISTINA ELISABETH
Art Unit
1671
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Pfizer Inc.
OA Round
1 (Non-Final)
50%
Grant Probability
Moderate
1-2
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allowance Rate
2 granted / 4 resolved
-10.0% vs TC avg
Strong +100% interview lift
Without
With
+100.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
46 currently pending
Career history
34
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
54.0%
+14.0% vs TC avg
§102
3.2%
-36.8% vs TC avg
§112
27.0%
-13.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 4 resolved cases

Office Action

§103 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status 1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Election/Restrictions 2. Applicant’s election without traverse of the species of AAV9 and VP1 in the reply filed on 03 February 2026 is acknowledged. Claims 16-21 and 33-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 1-5, 9-15, 22-24, and 26-32 are under consideration. Information Disclosure Statement 3. The information disclosure statements (IDS) submitted on 13 June 2023 and 07 September 2023 was filed on or after the mailing date of the Instant Application on 13 June 2023. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. 4. 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. Nucleotide and/or Amino Acid Sequence Disclosures 5. REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES Items 1) and 2) provide general guidance related to requirements for sequence disclosures. 37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted: In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying: the name of the ASCII text file; ii) the date of creation; and iii) the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying: the name of the ASCII text file; the date of creation; and the size of the ASCII text file in bytes; In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended). When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical. If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical. Specific deficiencies and the required response to this Office Action are as follows: 6. Specific deficiency - This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 - 1.825. The sequence disclosures are located [00018], [00099], [000203], [000251], and [000258]. See also claims 5 and 24. Required response – Applicant must provide: A "Sequence Listing" part of the disclosure, as described above in item 1); as well as An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application in accordance with 1.825(b)(2); A statement that the "Sequence Listing" includes no new matter in accordance with 1.825(b)(5); and A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(b)(4). If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of: A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); A copy of the amended specification without markings (clean version); and A statement that the substitute specification contains no new matter; If the "Sequence Listing" part of the disclosure is submitted according to item 1) b), c), or d) above, Applicant must also provide: A replacement CRF in accordance with 1.825(b)(6); and Statement according to item 2) a) or b) above. Specification 7. The use of the term “Luxturna” and “ZOLGENSMA” in ¶ [0003], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks. Note that these are merely examples and all improper uses of trademarks in the specification should be identified by Applicant and properly addressed. 8. The disclosure is objected to because of the following informalities: the working examples indicate that the starting water concentration in the mobile phase is “wt. %” but the claims recite “volume percent”. Appropriate correction is required. Claim Objections 9. Claims 1, 13-14, 22, and 30-31 are objected to because of the following informalities: Regarding claim 1, the comma after “0.14 mL/min” should be replaced with a semicolon and a semicolon should also be added before “and the HILIC column temperature”. Regarding claims 1 and 22, part a) should read “AAV or rAAV particle” instead of “AAV particle”. Regarding claims 13 and 30, “serotype of the AAV capsid” should be reworded to “the AAV capsid serotype” for consistency with the wording in claim 5. Regarding claim 14, add “the” before “heterogeneity”. Regarding claim 22, the comma after “0.14 mL/min” should be deleted. In addition, “wherein the starting water concentration in the mobile phase is” is repeated and “step c)” in c) appears to be a typo. Regarding claim 31, the “or” before “truncated” should be removed. Appropriate correction is required. Claim Rejections - 35 USC § 112(b) 10. 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. 11. Claims 1-5, 9-15, 22-24, and 26-32 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. The term “about” in claims 1 and 22 are a relative term which renders the claim indefinite. The term “about” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While the specification does address this term in ¶ [000170], it does not make the term definite. Claims 2-5 and 9-15, which depend on claim 1, are similarly rejected. Claims 23-24 and 26-32, which depend on claim 22, are similarly rejected. Regarding claims 4 and 23, it is unclear what “neat” means. It could be interpreted as a sample not in solvent which could be a powder or solid sample, or a liquid sample not further diluted. Examiner is interpreting this term to mean a liquid sample that is not further diluted. See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) ("[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite."). Claims 26-27, which depend on claim 23, are similarly rejected. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 5 and 24 recite the broad recitation “RHM4-1” which could be a variant or mutation thereof, and the claims also recite “SEQ ID NO: 5” which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claims 9-14, which depend on claim 5, are similarly rejected. Claims 26-31, which depend on claim 24, are similarly rejected. Claims 13-14 recite the limitation "masses". There is insufficient antecedent basis for this limitation in the claim. This term is recited in claim 2, but claims 13-14 do not depend on claim 2. Claim Rejections – Improper Markush 12. Claims 11 and 29 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117. The Markush grouping of VP1, VP2, VP3, and any PTMs therefore are improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: there are no PTMs shared by all embodiments and there is no base amino acid sequence to establish a shared structure. VP1, VP2, and VP3 are different sequences. To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. Claims 12-15 and 26-31, which depend on claims 11 and 29, respectively, are similarly rejected. Claim Rejections - 35 USC § 112(d) 13. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. 14. Claims 9 and 27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, 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. Claims 1 and 22 require a AAV or rAAV particle, which would need to be intact in order to be a particle. Therefore, claims 9 and 27 are simply stating an inherent condition. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form so long as no duplicates are made, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 103 15. 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. 16. 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. 17. Claims 1-2 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 20200131533 A1; Published 30 April 2020, filed 24 October 2019) (See IDS filed 13 June 2023). Regarding claims 1-2 and 22, Wang teaches “the method comprises: (a) subjecting the viral particle to HILIC to separate protein components of the viral particle capsid; (b) determining the masses of protein components of the protein capsid; and (c) comparing the determined masses of the protein components of the viral particle capsid with theoretical masses, wherein a deviation of one or more of the masses of protein components of the viral particle capsid from the theoretical masses is indicative of the capsid heterogeneity.” (¶ [0007]), shown to be used with AAV9 in with the conditions in Table 1, including an amide column (¶ [0129]). In regards to determining the masses of the protein, mass spectrometry can be used (¶ [0087]). Wang further teaches that the mobile phase can include water, TFA, and acetonitrile, wherein there can be two mobile buffer whose ratios are changed in order to make a concentration gradient (¶ [0106]), the temperature of the column can range from 50-70°C (¶ [0107]), the flow rate of the mobile phase can be between about 0 to about 100 mL/min (¶ [0108]), and that AAV9 would be injected into a HILIC column (¶ [0128]). The claimed flow rate of 0.14 mL/min falls within the taught range. Wang does not teach the exact concentrations of the mobile phase or the temperature of the column. Wang does contemplate a range of column temperatures, indicating that it would be a result-effective variable. When temperatures are lower, the mobile phase will move through the column slower, allowing for better separation between proteins of similar size in the eluent. In regards to the water concentration within the mobile phase, increasing the water concentration during the run will cause the least polar compounds to elute off of the column first, then the more polar compounds as the water concentration increases. This would result in better separation of molecule species. The amount of TFA in the mobile phase would also be an optimized variable as the pH of the mobile phase will control the ionization of the sample particles. The more ionized the particle, the more hydrophilic it is, and thus would be more strongly retained by the column. Therefore, it would have been obvious to one of ordinary skill before the time of filing to take the method of Wang and further optimize the column temperature, water concentration and increase rate, and TFA concentration. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art. With respect to the temperatures of claim 1 also, it is noted that body temperature, about 37C, is within the range and it is this temperature that the virus functions naturally and so capsid proteins are stable at said temperature. Thus, it would be expected to function as a column temperature here to arrive at expected results, producing purified proteins of the capsid. In summary, Wang makes obvious a method of separating AAV9 particles by loading them onto a HILIC column and eluting the column with the mobile phase comprising water, acetonitrile, and TFA, determining the mass of the eluted proteins via mass spectrometry, and comparing them to their theoretical mass. The concentrations of the mobile phase and the temperature of the column are routinely optimized variables. 18. Claims 3-5, 9-11, 13-15, 23-24, and 26-32 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (supra) as applied to claims 1-2 and 22 above, in view of Agilent (01 May 2018, Hydrophilic Interaction Chromatography Method Development and Troubleshooting). Regarding claims 3-4 and 23, Wang teaches the limitations claims 1 and 22, respectively, as discussed supra. All discussions thereon incorporated here. Wang does not teach a direct injection of a neat sample. However, Agilent teaches a comparison of HILIC with a direct injection of a sample vs. a dilute sample (page 8): PNG media_image1.png 381 721 media_image1.png Greyscale Therefore, it would be obvious to one of ordinary skill to do a direct injection of an undiluted sample as it is shown to work with HILIC. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02). Regarding claims 5, 9, 24, and 26, Wang and Agilent teach the limitations of claims 3 and 23, all discussions thereon incorporated here. Wang teaches using serotype AAV9 and loading the particle into the HILIC, as discussed supra. Regarding claims 10 and 28, Wang and Agilent teach the limitations of claims 5 and 24, respectively, all discussions thereon incorporated here. Wang further teaches: “the method comprises: (a) subjecting a sample of viral particles to hydrophilic interaction liquid chromatography (HILIC) to separate the protein components of the viral capsid of the viral particles; (b) determining the masses of protein components of the viral capsid to identify the protein components separated by HILIC; and (c) determining the relative abundance of the protein components of the viral capsid from the HILIC separation, thereby determining the stoichiometry of protein components of a viral capsid of a viral particle.” (¶ [0006]). This is just an alternative last step to the method made obvious in claims 1-2. It would have been obvious to one of ordinary skill to take the method of claim 1-2 and further substitute the last step to determine relative abundance rather than measuring and comparing masses. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). Regarding claims 11, 13-15, and 29-32, Wang and Agilent teach the limitations of claims 10 and 28, all discussions thereon incorporated here. Wang further teaches: “In certain embodiments the method includes determining the masses of protein components of the viral capsid to identify the protein components separated by HILIC, for example, using mass spectrometry techniques, such as those described herein. In embodiments, the method includes calculating the relative abundance of the protein components of the viral capsid from the HILIC separation to determine the stoichiometry of protein components of a viral capsid of a viral particle, for example using ultraviolet (UV) detection of the protein components of the viral capsid as they are eluted from the HILIC column. […] In certain embodiments, the method is used to determine the serotype of a viral particle. For example, the masses of VP1, VP2 and VP3 of each AAV serotype are unique and can be used to identify or differentiate AAV capsid serotypes. In addition, the separated capsid proteins can be subjected to downstream analysis, such as a determination of protein sequence and post-translational modifications of the capsid proteins, for example with accurate mass measurement at the intact protein level.” (¶ [0087]) and “Aspects of this disclosure are directed a method of determining the heterogeneity of protein components in a capsid of a viral particle. […] In embodiments, heterogeneity is due to one or more of mixed serotypes, variant capsids, capsid amino acid substitutions, truncated capsids, or modified capsids. In some embodiments, the determination of the stoichiometry of protein components of a viral capsid of a viral particle and the determination of the heterogeneity of protein components in a capsid of a viral particle are done on the same sample, for example is a single test.” (¶ [0088]). In summary, Wang teaches that the methods of claims 1-2 and 22 can be used to determine both serotype and heterogeneity of the AAV particles, by looking at VP1 and its PTMs. Regarding claim 27, Wang and Agilent teach the limitations of claim 26, all discussions thereon incorporated here. Wang further teaches the AAV particle having a transgene (¶ [0030], Fig. 1): PNG media_image2.png 350 773 media_image2.png Greyscale This would result in the capsid encapsulating a nucleic acid sequence. 19. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (supra) and Agilent (supra) as applied to claims 1-5, 9-11, 13-15, 23-24, and 26-32 above, and further in view of Liu (21 July 2020, J. Pharm. Biomed. Analysis, 189: 113481) (See IDS filed 13 June 2023). Regarding claim 12, Wang and Agilent teach the limitations of claim 11, all discussions thereon incorporated here. Neither teach the specific PTMs of VP1. However, Liu teaches “Moreover, HILIC-based separation was shown to be particularly sensitive in detecting capsid protein variants resulting from different post-translational modifications (PTMs) (e.g. phosphorylation and oxidation) and protein backbone clippings, making it ideally suited for capsid heterogeneity characterization.” (Abstract). Therefore, it would have been obvious to one of ordinary skill to take the method made obvious by Wang and Agilent, which already looked at PTMs and further look for the specific PTMs discussed by Liu. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.). A rationale to support a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02). Conclusion 20. No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINA E LY whose telephone number is (571)272-5169. The examiner can normally be reached Monday - Thursday, 8:00 am - 5:00 pm 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, Michael Allen can be reached at (571) 270-3497. 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. /KRISTINA E. LY/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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Prosecution Timeline

Jun 13, 2023
Application Filed
Jun 01, 2026
Non-Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
50%
Grant Probability
99%
With Interview (+100.0%)
3y 0m (~0m remaining)
Median Time to Grant
Low
PTA Risk
Based on 4 resolved cases by this examiner. Grant probability derived from career allowance rate.

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