Prosecution Insights
Last updated: July 26, 2026
Application No. 17/995,869

Biological Indicator with Test Microorganisms Enveloped by Wax Composition

Final Rejection §112
Filed
Oct 10, 2022
Priority
Apr 22, 2020 — provisional 63/013,782 +1 more
Examiner
GOUGH, TIFFANY MAUREEN
Art Unit
1651
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
3M Company
OA Round
2 (Final)
31%
Grant Probability
At Risk
3-4
OA Rounds
9m
Est. Remaining
79%
With Interview

Examiner Intelligence

Grants only 31% of cases
31%
Career Allowance Rate
161 granted / 515 resolved
-28.7% vs TC avg
Strong +48% interview lift
Without
With
+47.7%
Interview Lift
resolved cases with interview
Typical timeline
4y 6m
Avg Prosecution
35 currently pending
Career history
556
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
65.0%
+25.0% vs TC avg
§102
5.7%
-34.3% vs TC avg
§112
4.1%
-35.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 515 resolved cases

Office Action

§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 . Applicant’s response filed 1/22/2026 has been received and entered into the case. Claims 1-20 are pending. Claims 18-20 are withdrawn. Claims 1-17 have been considered on the merits herein. All arguments and amendments have been considered. 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 1-17 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. Claim 1 recites “the wax composition comprises a long-chain linear or branched alkyl or alkenyl alcohol having greater than 22 carbon atoms; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a short chain alkyl or aryl group having 1 to 6 carbon atoms; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a long chain alkyl or alkenyl group having 8 to 36 carbon atoms; wherein the alkyl or alkenyl alcohol is not linked through an amide bond to a linear or branched long chain alkyl or alkenyl amine or acid having 8 to 36 carbon atoms, wherein the wax composition has a melting point between 78-120°C”. The specification exemplifies only UNILIN™ 350, 425, 550 and 700 as the wax composition. UNILIN™ 350, 425, 550 and 700 are long chain linear primary alcohols and the UNILIN™ alcohols are products available with average carbon chain lengths up to C50. The specification does not provide adequate written description of the claimed genus of wax compositions comprising a long-chain linear or branched alkyl or alkenyl alcohol having greater than 22 carbon atoms which have a melting point between 78-120°C, other than the UNILIN™ products, which are limited to linear long-chain alcohols having up to C50, and falling within applicants claimed melting points. The specification does not adequately describe, for example, any branched alkyl or alkenyl alcohols having greater than 22 carbons atoms and having the claimed melting point, and any wax composition as claimed having greater than C50 and which has a melting point between 78-120°C. Additionally, branched alcohols generally have lower melting points due to disruption of crystal packing. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the genus of wax compositions according to claim 1. The guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, § 1 "Written Description" Requirement make clear that if a claimed genus does not show actual reduction to practice for a representative number of species, then the Requirement may be alternatively met by reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the Applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Fri. January 5, 2001, see especially page 1106 column 3). The specification does not provide adequate written description of the claimed invention. The legal standard for sufficiency of a patent's (or a specification's) written description is whether that description "reasonably conveys to the artisan that the inventor had possession at that time of the. . .claimed subject matter", Vas-Cath, Inc. V. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991). In the instant case, the specification does not convey to the artisan that the Applicant had possession at the time of invention of the claimed invention, i.e. the genus of wax compositions having long chain alcohols of either C8-C36 or greater than C22 according to claim 1. The Federal Circuit addressed the application of the written description requirement to DNA-related inventions in University of California v. Eli Lilly and Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997). The court stated that “[a] written description of an invention involving a chemical genus, like a description of a chemical species, requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials.” Id. At 1567, 43 USPQ2d at 1405. The court concluded that “naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material.” Id. The Federal Circuit clarified that a molecule can be adequately described without disclosing its complete structure. See Enzo Biochem, Inc. V. Gen-Probe Inc., 296 F.3d 1316, 63 USPQ2d 1609 (Fed. Cir. 2002). The Enzo court adopted the standard that the written description requirement can be met by “show[ing] that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. “Id. At 1324, 63 USPQ2d at 1613 (emphasis omitted, bracketed material in original). However, without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“definition by function … does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”). Thus, the specification does not provide an adequate written description of the genus of wax composition comprises a long-chain linear or branched alkyl or alkenyl alcohol having greater than 22 carbon atoms; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a short chain alkyl or aryl group having 1 to 6 carbon atoms; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a long chain alkyl or alkenyl group having 8 to 36 carbon atoms; wherein the alkyl or alkenyl alcohol is not linked through an amide bond to a linear or branched long chain alkyl or alkenyl amine or acid having 8 to 36 carbon atoms, wherein the wax composition has a melting point between 78-120°C according to claim 1 that is required to practice the claimed invention. Applicants have not described the genus of wax compositions comprising a long-chain greater than C22 linear or branched alkyl or alkenyl alcohol sufficiently to show they had possession of the claimed genus. Since the disclosure fails to provide sufficient relevant identifying characteristics, and because the genus is highly variant, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed. Response to Arguments Applicant's arguments filed 1/22/2026 have been fully considered but they are not persuasive. While the 112(a) rejection is pending, it has been amended to address applicants’ amendments to claims 1 and 13. With regards to the previous 112(a) rejection, applicants assert that they disclose various examples further identifying specific wax compositions and provide physical property data, specifically the specification discloses UNILIN™ 350, 425, 550 and 700 alcohols, and having melting points within the claimed range, thus identifying physical and functional properties of the compositions. As addressed above in the 112(a) rejection pending herein, applicants amended claims are drawn to a wax composition comprising a long-chain linear or branched alkyl or alkenyl alcohol having greater than 22 carbon atoms; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a short chain alkyl or aryl group having 1 to 6 carbon atoms; wherein the alkyl or alkenyl alcohol is not linked through an ester bond or an ether bond to a long chain alkyl or alkenyl group having 8 to 36 carbon atoms; wherein the alkyl or alkenyl alcohol is not linked through an amide bond to a linear or branched long chain alkyl or alkenyl amine or acid having 8 to 36 carbon atoms, wherein the wax composition has a melting point between 78-120°C; however, the specification only teaches UNILIN™ 350, 425, 550 and 700 wax alcohols, which are linear alcohols having up to 50 carbon atoms. The claims encompass wax compositions comprising a long-chain linear or branched alkyl or alkenyl alcohol having greater than 22 carbon atoms with no upper limit of carbon atoms and having the claimed melting point. The specification fails to provide adequate description of any branched alkyl or alkenyl alcohol having greater than 22 carbon atoms, and any claimed wax alcohols other than the UNILIN™ 350, 425, 550 and 700 wax alcohols (which are linear alcohols having up to 50 carbon atoms) which would have the claimed structural and functional characteristics. The claims encompass wax compositions having no upper limit of carbon atoms, which include linear and branched alcohols and having a claimed melting point range, for which adequate written description of the claimed genus of wax compositions is not provided. Conclusion The claims are free of the art. 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 TIFFANY MAUREEN GOUGH whose telephone number is (571)272-0697. The examiner can normally be reached M-Thu 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, Melenie Gordon can be reached at 571-272-8037. 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. /TIFFANY M GOUGH/ Examiner, Art Unit 1651 /MELENIE L GORDON/ Supervisory Patent Examiner, Art Unit 1651
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Prosecution Timeline

Oct 10, 2022
Application Filed
Nov 14, 2025
Non-Final Rejection mailed — §112
Jan 22, 2026
Response Filed
May 26, 2026
Final Rejection mailed — §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
31%
Grant Probability
79%
With Interview (+47.7%)
4y 6m (~9m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 515 resolved cases by this examiner. Grant probability derived from career allowance rate.

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