Prosecution Insights
Last updated: August 15, 2026
Application No. 18/354,345

COMPOSITIONS AND METHODS FOR FILTERING MICROORGANISMS FROM A FLUID

Final Rejection §103§DP
Filed
Jul 18, 2023
Priority
Sep 19, 2022 — provisional 63/376,203
Examiner
SONG, JIANFENG
Art Unit
1613
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Food And Drug Administration
OA Round
2 (Final)
56%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
89%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allowance Rate
482 granted / 858 resolved
-3.8% vs TC avg
Strong +33% interview lift
Without
With
+33.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 7m
Avg Prosecution
65 currently pending
Career history
929
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
48.4%
+8.4% vs TC avg
§102
10.2%
-29.8% vs TC avg
§112
17.8%
-22.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 858 resolved cases

Office Action

§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 . Withdrawn Rejections: Applicant's amendments and arguments filed on 07/05/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application. The application is examined in view of Nylon 11 as specific filament and acid methylene blue as specific dye. Claims 1, 6-10 and 26 read on the elected species and are under examination. Claims 1, 6-26 are pending and claims 1, 6-10 and 26 are under examination. 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Claims 1, 6-10 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US12516471) in view of Adams (US3233019). Determination of the scope and content of the prior art (MPEP 2141.01) Anderson et al. teaches methods of continuously imparting a desired characteristic, optionally color, to a linear polymeric substrate with reliability and reproducibility. According to some aspects, a method of continuously bonding an active agent to or into a polymeric substrate may include contacting an active agent solution with a polymeric substrate. Contacting the active agent solution with the polymeric substrate may occur at a treatment temperature and for a treatment time (abstract). Any substrate type or shape of polymeric substrate is suitable for use such as hollow, tubular, linear, solid, or multilayer substrates. While the examples as provided herein and description thereof may be directed to linear substrates, such is presented for illustrative and descriptive purposes alone. The disclosure is equally applicable to any substrate shape that includes a polymeric surface material, sometimes referred to herein as "polymeric substrates," such as but not limited to hose or other hollow tubing, solid substrates, multicomponent or multilayer substrates, coated wire, sheeting or films optionally of an elongated nature, among other items recognized in the art. Optionally, a substrate is a linear polymeric substrate. The disclosure is equally applicable to any linear substrate that includes a polymeric surface material, sometimes referred to herein as "linear polymeric substrates," but is not limited to hose or other hollow tubing, solid linear substrates, multicomponent or multilayer linear substrates, sheeting or films of an elongated nature, among other items recognized in the art (column 7, line 40-67). In some aspects, an active agent is suitable to impart color or a change in color to the linear substrate. In some aspects, the active agent is a dye. The dye used to form a colored linear polymer according to particular aspects is optionally an acid dye (Column 7, line 26-31). A substrate optionally includes or is an outer layer that includes one or more polyamide polymeric materials. Exemplary illustrative examples of a polymeric material include polyamides. In particular aspects, the polymeric material is a polyamide known as nylon. In some particular aspects, the polymeric material is or includes a polyamide. Optionally, a polymer is a homopolymer, a copolymer or a reinforced polymer as long as the polymer includes one or more polyamides. Illustrative examples of a polyamide include nylon 6 nylon 66, nylon 6/6-6, nylon 6/9, nylon 6/10, nylon 6/12, nylon 11, nylon 12, among others, or any combination thereof (column 8, line 20-33). The systems and methods described herein may be used to impart color or other desired physical or chemical characteristic into a linear polymeric substrate by a process that may include bonding an active agent to or into a linear substrate at a treatment temperature. In some aspects, the treatment time is sufficient to enable the active agent(s) to infuse into the surface or penetrate the surface of the linear polymeric material to a depth of less than 1 millimeter. In some aspects, the treatment time is sufficient to enable the active agents to infuse to the surface or penetrate the surface of the linear polymeric material to a depth of less than 200 microns. Accordingly, in some aspects, the active agents penetrate the surface of the linear polymeric material from 1 micron to 1 millimeter, from 5 microns to 500 microns, from 10 microns to 250 microns, or from 20 microns to 200 microns. In other aspects, the active agents bind to the surface of the linear polymeric substrate, optionally through covalent bonding, hydrogen bonding, ionic bonding, by van der Walls interactions, or combinations thereof (column 11, line 48-67). Adams teaches a process by which synthetic fibers and fila ents and films can be more deeply and effectively dyed by a wide variety of dyestuffs, including those which are not substantive or possessing of any affinity for the poly meric structure itself or which lack diffusibility (column 2, line 1-10). The fibers include nylon (column 9, line 1-30; claim 1 and 6). In one example, the dye is methylene blue (column 9, line 35-40). Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) The difference between the instant application and Anderson et al. is that Anderson et al. do not expressly teach methylene blue. This deficiency in Anderson et al. is cured by the teachings of Adams. Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143) It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Anderson et al., as suggested by Adams, and produce the instant invention. One of ordinary skill in the art would have been motivated to use methylene blue as dye for Nylon 11 in the composition of Anderson et al. because methylene blue is a suitable dye for nylon fiber. MPEP 2144.07. Under guidance from Anderson et al. teaching dye and Adams teaching methylene blue for dyeing nylon fiber, it is obvious for one of ordinary skill in the art to use methylene blue as dye for Nylon 11 in the composition of Anderson et al. and produce instant claimed invention with reasonable expectation of success. Regarding claims 1 and 6, Prior art teaches Nylon 11 treated with methylene blue to impart color or other desired physical or chemical characteristic into a linear polymeric substrate Nylon 11 so Nylon 11 is functionalized with methylene blue Regarding the limitation of filament, it is the examiner’s position that linear polymeric substrate read on filament. In arguendo that linear polymeric substrate does not read on filament, since Anderson et al. teaches any form of nylon fiber recognized in the art, under guidance from Adams that nylon filament is a fiber suitable for dyeing, it is obvious to have dyed nylon 11 filament. Regarding claims 7-10, this is regarded as inherency of prior art composition. MPEP 2112.01 II, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. MPEP 2112 I, "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). Regarding claim 26, “an instruction material” is not limiting. Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004). "Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability….[T]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate." ); In re Miller, 418 F.2d 1392, 1396 (CCPA 1969). MPEP 2112.01. III. In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary. Response to Argument; Applicants argue that there is no teaching for the amended claim. In response to this argument: this is not persuasive. The modified 103 rejection teaches each limitation of applicant’s amended claim, and the 103 rejection is still proper. MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it. 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, 6-10 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13, 17 and 20 of copending Application No. 18953424 (reference application) in view of Adams (US3233019). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches dye bound to nylon-6, in view of Adams teaching methylene blue as dye for nylon filament, claims 7-10 are regarded as inherency and instruction material in claim 26 is not limiting, it is obvious to produce applicant’s claimed invention. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1, 6-10 and 26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13, 16, 18-20 of copending Application No.18406908 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches dye (methylene blue) bound to nylon (encompassing Nylon 11 as known nylon) filament, claims 7-10 are regarded as inherency and instruction material in claim 26 is not limiting, it is obvious to produce applicant’s claimed invention. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. 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 JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5. 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, Brian-Yong Kwon can be reached at (571)272-0581. 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. /JIANFENG SONG/Primary Examiner, Art Unit 1613
Read full office action

Prosecution Timeline

Jul 18, 2023
Application Filed
Apr 06, 2026
Non-Final Rejection mailed — §103, §DP
Jul 05, 2026
Response Filed
Jul 23, 2026
Final Rejection mailed — §103, §DP (current)

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Prosecution Projections

3-4
Expected OA Rounds
56%
Grant Probability
89%
With Interview (+33.1%)
2y 7m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 858 resolved cases by this examiner. Grant probability derived from career allowance rate.

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