Prosecution Insights
Last updated: October 02, 2026
Application No. 18/654,634

COMPOSITIONS AND RELATED METHODS

Non-Final OA §102§103§DP
Filed
May 03, 2024
Priority
May 04, 2023 — provisional 63/500,105
Examiner
BURGESS, JAMES DAVID
Art Unit
Tech Center
Assignee
Boston Scientific Corporation
OA Round
1 (Non-Final)
Grant Probability
Favorable
1-2
OA Rounds

Examiner Intelligence

Grants only 0% of cases
0%
Career Allowance Rate
0 granted / 0 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
Avg Prosecution
15 currently pending
Career history
1
Total Applications
across all art units
This examiner has no resolved cases yet (career too new); statute-level performance unavailable. The Grant Probability card shows Tech Center averages instead.

Office Action

§102 §103 §DP
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 § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 1, 2, 4, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Strauss (US 20160228140 on PTO-892). Strauss discloses a method for lifting a first layer of mucosal tissue during an endoscopic procedure as to remove lesions, the method including the delivery of a composition configured to undergo a phase transition from a liquid to solid where the solid may further comprise a gel, and the method includes use of an injection module (whole document, e.g., abstract). The injectable composition configured to undergo a phase transition can comprise a thermosensitive material comprising a biocompatible polymer such as pectin (para. 46), which exhibits shear thinning behavior (US 20180051099 A1, para 259), and in some embodiments pectin is present at 0.5 – 2% w/w (para.s 146 and 149). The composition can also comprise a phospholipid and use of a phosphate buffer, a pharmaceutically acceptable carrier fluid, and a gel, i.e., gelatin (para 144) at least partially dissolved (para. 19), yielding a solution or suspension carrier fluid, and present at 1% - 2% w/w in some embodiments (para.s 146 and 149) and crosslinking agents (para. 123) wherein the step of controllably inducing phase transition of the composition from a liquid to a solid involves incident electromagnetic radiation (para. 41), i.e., the composition is a photoactivatable material. Further embodiments may include carrier agents in water or saline as the solvent or suspension fluid (para. 138). 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. 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, 2, 4– 8, 13 - 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Strauss (US 20160228140 on PTO-892). Strauss is discussed above. Strauss also discloses that according to some embodiments the solid state composition may include pores where the pore size may be defined by the composition ingredients (para. 151). Strauss does not explicitly teach biocompatible materials in the composition that are present at 0.1% w/v to 20% w/v. It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to prepare the compositions containing buffer solubilized or suspended polymers, shear thinning gels, phospholipids, and photoactivatable materials, then to inject that composition into the submucosal layer such as under a lesion. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art teaches a method for lifting and removing mucosal lesions that involves injecting a composition that contains ingredients included in the compositions described by the instant claims and also, for some embodiments, the ingredients are present at concentrations that are within the range required by the instant claims (assuming a density of 1 g/ml). The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results. For example, the porosity of the solid state of the injected composition, after phase change, would likely be altered by optimization of ingredient amounts and this would affect the lifting force applied to the patch of tissue above the injected composition. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05. Claims 3, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Strauss as applied to claims 1, 2, 4– 8, 13 - 16 and 18 above, and further in view of Sun (ACS Appl. Mater. Interfaces, 2020 on PTO-892). Strauss is discussed above. Strauss does not disclose PEG-SG as an ingredient of the composition. Sun teaches PEG-SG as an ingredient of an injectable shear thinning adhesive that promotes wound sealing, closure and tissue regeneration (title and abstract) by adhering to tissue through PEG-SG ester functionalities and tissue protein amino functionalities (abstract and p. 9134, column 2, first para below Figure 1). It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the PEG-SG ingredient of Sun into the composition of Strauss. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art teaches the use of PEG-SG as an ingredient in an injectable wound healing composition that would promote wound healing after the excision of lifted mucosal tissue that can contain a lesion. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Strauss applied to claims 1, 2, 4 – 8, 13 - 16 and 18 above, and further in view of Allen (Advanced Drug Delivery Reviews, 2013 on PTO-892). Strauss is discussed above. Strauss does not explicitly teach phospholipid liposomes as a carrier that may be included in embodiments of the injectable composition. Allen teaches phospholipid liposomes as clinically established pharmaceutical carrying agents for delivery of cargo to human fluids and tissues including delivery of hydrophobic drugs, and anesthetics, antibiotics, and anti-inflammatory drugs, for example (abstract, whole document). It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the liposomes disclosed by Allen as carriers of drugs in the composition of Strauss. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art teaches phospholipid liposomes as an established platform with considerable clinical acceptance for drug delivery and thus liposomes would therefore be an acceptable agent to selected to carry/deliver specific active ingredients such as anesthetics that would numb the area being injected and excised. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Strauss as applied to claims 1, 2, 4 – 8, 13 – 16 and 18 above, and further in view of Longo (US11123460B2 on PTO-892). Strauss is discussed above. Strauss does not explicitly teach a composition consisting of an emulsion. Longo teaches the surprising discovery that an emulsion (para. 22) for mucosal dissection, including a polymer that exhibits inverse thermosensitive behavior with a critical gelation temperature of about 37º C, has an improved flowability compared to similar compositions formulated as simple aqueous solutions such that it flows through an injection needle without use of high pressure (claim1) at room temperature (para 22). It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the emulsion approach of Longo into the composition of Strauss that is configured to undergo a phase transition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art teaches an injectable emulsion containing an inverse thermosensitive polymer (i.e., polymer gels upon heating) that exhibits a phase change to a gel state upon injection. A required characteristic of the composition of Strauss is that it undergoes a phase transition to a solid/gel state once injected into the mucosal tissue and therefore one of ordinary skill in the art would recognize this attribute of Longo’s injectable emulsion. Claims 11, 12, 17, 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Strauss as applied to claims 1, 2, 4 – 8, 13 – 16 and 18 above, and further in view of Qi (Colloids and Surfaces B: Biointerfaces, 2021 on PTO-892). Strauss is discussed above. Strauss does not explicitly teach a biocompatible material formulated as a polymer microparticle suspension, for example a PEG microparticle suspension, where the polymer is crosslinked with trilysine and where the suspended particles carry/deliver other additives such as drugs and are present in the composition with a partially dissolved polymer ingredient. Qi teaches intact microparticles of PEG crosslinked through the primary amine functionalities of a modified trilysine (scheme 1), as an efficient and safe in vivo delivery platform for therapeutics (abstract) where the intact particles can enter cells (p. 7, section 3.5, second para). It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to select trilysine as disclosed by Qi as the crosslinker for the compositions disclosed by Strauss and/or to incorporate the trilysine crosslinked PEG microparticles of Qi into a compositions of Strauss. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art demonstrates the plurality of primary amine functional groups on trilysine as reaction sites in crosslinking a polymer in solution and Strauss teaches that a cross-linking agent can be present in the composition. Furthermore, the prior art teaches the application of polymer microparticles as an efficient and safe delivery platform that could be selected as a carrier that can be present in the compositions of Strauss. That is, the prior art motivates both the exploitation of trilysine primary amines as crosslinking reaction sites and the use of polymer microparticles to carry additional ingredients, such as in the solution/suspension of Strauss. 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. Claims 1, 2, 4, 5, 16, 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 of copending Application No. US 18650661 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 2, 4, 5, 16, 19 and 20 of the instant application are generic to all that is recited in claims 1 - 20 of US’661. That is, claims 1 - 20 of US’661 fall entirely within the scope of claims 1, 2, 4, 5, 16, 19 and 20 or, in other words, claims 1, 2, 4, 5, 16, 19 and 20 are anticipated by claims 1 – 20 of US’661. Claim 1 of US’661 recites an injectable composition containing a polymer formulated to form a gel to separate mucosal tissue layers. Claims 2 and 3 of US’661 recite PEG polymer amounts (0.125% w/v to about 3% w/v, claim 2, and 1% w/v to 2% about 2% w/v, claim 3) that are fully encompassed by the range (0.1% w/v to about 20% w/v) required by the instant application. Claims 4 - 11 of US’661 recite polymer constituents of the composition and use of saline solution in the injectable biocompatible material which read on the pharmaceutically acceptable fluid of the instant application. Claims 12 - 20 of US’661 recite injection of the composition into submucosal tissue of a patient providing a mucosal lifting force for at least 60 minutes, reading on the submucosal lifting of the instant application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1, 2, 4, 5 -7, 13 -16, 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 of copending Application No. US 18650661 in view of Strauss (US 20160228140 on PTO-892). US’661 is discussed above. US’661 does not claim removal of a portion of mucosal tissue from a subject or removal of a portion of mucosal tissue that contains a lesion as an application of an injectable shear-thinning composition containing a photoactivatable material. Strauss is discussed above. It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a photoactivatable material in a composition for lesion removal, as disclosed by Strauss, into the claimed injectable composition of US’661 where mucosal tissue separation is recited. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art disclosed by Strauss teaches an endoscopic procedure as an application of an injectable shear-thinning composition, that can contain a photoactivatable material to provide a means of initiating gel formation of the composition in mucosal tissue, for lifting mucosal tissue as claimed by US’661, and that allows removal of lifted lesions as taught be Strauss. The composition of US’661 is formulated to gel once injected into the mucosal tissue and triggering gel formation using a photoactivatable compound as taught be Strauss would have been obvious to the person of ordinary skill in the art. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1, 2, 4 - 6, 11, 12, and 16 - 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 of copending Application No. 18650661 in view of Strauss (US 20160228140 on PTO-892) and further in view of Qi (Colloids and Surfaces B: Biointerfaces, 2021 on PTO-892). US’661 is discussed above. US’661 does not claim a biocompatible material formulated as a polymer microparticle suspension, for example a PEG microparticle suspension, where the polymer is crosslinked with trilysine and where the suspended particles carry other additives such as drugs and are present in the composition with a partially dissolved polymer ingredient. Strauss is discussed above. Qi is discussed above. It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to select trilysine as disclosed by Qi as a crosslinker for the compositions disclosed by Strauss, and/or to incorporate the trilysine crosslinked PEG microparticles of Qi into a compositions of Strauss. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art demonstrates the plurality of primary amine functional groups on trilysine as reaction sites in crosslinking a polymer to form intact particles and US’661 claims a composition that forms a solid/gel to lift mucosal tissue, which could involve polymer crosslinking reactions as disclosed by Strauss. Furthermore, the prior art of Qi teaches the application of polymer microparticles as an efficient and safe therapeutic delivery platform that could be selected a carrier that can be included in the compositions of Strauss That is, the prior art motivates both the exploitation of trilysine primary amines as crosslinking reaction sites and the use of polymer microparticles to carry additional ingredients, such as in the compositions of Strauss. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1 - 5, 16, 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 of copending Application No. US’661 in view of Sun (ACS Appl. Mater. Interfaces, 2020 on PTO-892). US’661 is discussed above. US’661 does not claim PEG-SG as an ingredient of the injectable composition. Sun is discussed above. It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the PEG-SG ingredient of Sun into the composition of US’661. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art teaches the use of PEG-SG as an ingredient in an injectable composition that adheres to tissue which would contribute to a sustained mucosal lifting function recited by US’661. One or ordinary skill in the art would recognize the tissue adherence characteristic of the PEG-SG containing composition of Sun as an advantage in lifting mucosal tissue for a sustained period as claimed by US’661. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1, 2, 4, 5, 8, 9, 16, 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 –20 of copending Application No. US’661 in view of Allen (Advanced Drug Delivery Reviews, 2013 on PTO-892). US’661 is discussed above. US’661 does not claim phospholipid liposomes as a carrier that may be included in embodiments of the injectable composition. Allen is discussed above. It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the liposomes disclosed by Allen as a delivery platform for therapeutics in the composition of US’661. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art teaches phospholipid liposomes as an established platform with considerable clinical acceptance for drug delivery and thus liposomes would therefore be an acceptable agent to select to carry/deliver specific active ingredients such as antibiotics and anesthetics that would protect and numb the area being injected where mucosal tissue layers are separated as claimed by US’661. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1, 2, 4, 5, 10, 16, 19 and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 20 of copending Application No. 18650661 in view of Longo (US11123460B2 on PTO-892). US’661 is discussed above. US’661 does not claim a composition that is an emulsion which is injectable at a low pressure and that forms a gel in mucosal tissue. Longo is discussed above. It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the emulsion approach of Longo into the composition of US’611 that is configured to form a gel upon injection into the mucosa. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because the prior art teaches an injectable emulsion containing an inverse thermosensitive polymer (i.e., polymer gels upon heating) that exhibits a phase change to a gel state upon injection. A required characteristic of the composition of US’661 is that it forms a gel once injected into the mucosal tissue and therefore one of ordinary skill in the art would recognize this attribute of Longo’s injectable emulsion. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Nucleotide and/or Amino Acid Sequence Disclosures Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures 37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, 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 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted: 1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying: a. the name of the XML file b. the date of creation; and c. the size of the XML file in bytes; or 2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 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 statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying: a. the name of the XML file; b. the date of creation; and c. the size of the XML file in bytes. SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS: Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.831-1.834 because it does not contain a “Sequence Listing XML” as a separate part of the disclosure. A “Sequence Listing XML” is required because three amino acid sequences of four or more specifically defined residues are disclosed in the specification as submitted. Required response - Applicant must provide: • A “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2.; together with o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3); o A statement that the “Sequence Listing XML” includes no new matter as required by 37 CFR 1.835(a)(4) AND • A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of: o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version); o A copy of the amended specification without markings (clean version); and o A statement that the substitute specification contains no new matter. Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). Required response – Applicant must provide: A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, 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. Incorporation by reference paragraph- the incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is required for amendment. Applicant must: • 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. Required Statement for Amendment – there is a required statement of no new matter, in accordance with 37 CFR 1.835(a)(4) or 1.835(b)(5). Applicant must submit a statement that the “Sequence Listing XML,” identified by the date the “Sequence Listing XML” was filed, includes no new matter. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES DAVID BURGESS whose telephone number is (571)270-5640. The examiner can normally be reached Monday - Friday 8:30AM - 5:00PM. 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 Hartley can be reached at (571) 272-0616. 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. /JAMES D BURGESS/Examiner, Art Unit 1618 /Nissa M Westerberg/Primary Examiner, Art Unit 1618
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Prosecution Timeline

May 03, 2024
Application Filed
Sep 22, 2026
Non-Final Rejection mailed — §102, §103, §DP (current)

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1-2
Expected OA Rounds
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