Prosecution Insights
Last updated: April 19, 2026
Application No. 18/562,917

COMPOSITION FOR TOPICAL TREATMENT OF MICROBIAL INFECTIONS

Non-Final OA §102§103§112§DP
Filed
Nov 21, 2023
Examiner
YOUNGBLOOD, WILLIAM JUSTIN
Art Unit
1629
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Hennepin Life Sciences LLC
OA Round
1 (Non-Final)
63%
Grant Probability
Moderate
1-2
OA Rounds
3y 7m
To Grant
99%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allow Rate
32 granted / 51 resolved
+2.7% vs TC avg
Strong +40% interview lift
Without
With
+39.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
35 currently pending
Career history
86
Total Applications
across all art units

Statute-Specific Performance

§101
2.8%
-37.2% vs TC avg
§103
29.2%
-10.8% vs TC avg
§102
24.7%
-15.3% vs TC avg
§112
25.2%
-14.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 51 resolved cases

Office Action

§102 §103 §112 §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 . Status of the Claims Claims 1-5 are pending in the instant application and subject to examination herein. Information Disclosure Statement The information disclosure statements (IDS) submitted on 11/21/2023 and 11/19/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. Claim Interpretation Claim 2 further limits the composition of claim 1, comprising “5-30% GML in a gel”, to further comprise “5-30% GML in a non-aqueous gel”, which can be understood by a person of ordinary skill in the art to represent either of the following: Claim 2 may represent a single non-aqueous gel comprising 5-30% GML and additional excipient(s) from the Markush group provided in claim 2; OR Claim 2 may indicate a second gel, separate from the gel disclosed in claim 1, given that claim 1 does not specify a “non-aqueous” gel and claim 2 does not recite that the “non-aqueous gel” is the gel recited in claim 1. Thus, claim 2 may represent a single composition comprising 2 gels, one of which is a non-aqueous gel, and each of which may comprise 5-30% GML, allowing the composition to include a total GML content of 10-60% GML. Claims 2-5 depend directly or indirectly from claim 1 and do not resolve the indefiniteness of claim 1 regarding the determination of GML % in a gel. Claim 3 depends from claim 2 and does not resolve the ambiguity of the determination of GML % in a non-aqueous gel. Claim Rejections - 35 USC § 112(b) The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 is drawn to a composition comprising 5-30% GML in a gel. Claim 2 similarly comprises 5-30% GML in a non-aqueous gel. Neither claim 1 nor claim 2 provides any definition of how the percentage GML is to be measured in the respective gel(s), and a person of ordinary skill in the art would not at once recognize whether the claim(s) intend for the GML % to be measured as a weight/weight % (w/w/) or a weight/volume % (w/v), or other consideration (for example, volume/volume or mole %). The instant disclosure does not provide a definition for how to measure/control the GML % in a gel, and does not contain a single exemplary gel formulation showing how to portion the GML content to achieve a specific % of GML in a gel so as to define the claimed invention. Table 1, on page 4 of the instant Specification, discloses the effects of GML gel treatment on the inhibition of microbial growth at varying %, but does not disclose the gel formulation or otherwise define the GML % on a w/w, w/v or other basis. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim 1 is anticipated by Zhang. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang (WO2016/169129A1)1. Claim 1 is drawn to a composition comprising 5-30% GML in a gel, wherein the GML (glycerol monolaurate) and gel comprise a biological active composition. Zhang discloses an antibacterial edible vegetable oil gel (paragraph [0001]) comprising an edible vegetable oil and glycerol laurate (paragraphs [0011]-[0013]), in which the “lauric monoglyceride” (i.e., glycerol monolaurate) is a gelling agent with bacteriostatic and bactericidal effects and the prepared gel has the characteristics of bacteriostasis (paragraph [0014]). Zhang further discloses exemplary compositions wherein the glycerol laurate is present in amounts of 10%, 20% and 30% by weight (paragraphs [0070]-[0072], including Table 1). Thus, claim 1 is anticipated by the disclosure of Zhang. Claim 1 is anticipated by Schlievert. Claim 1 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Schlievert (US PG Pub 2018/0092835 A1)2. The limitations of claim 1 are discussed in the rejection above and hereby incorporated into the instant rejection. Schlievert discloses compositions for topical treatment of infections that comprise glycerol monolaurate that are administered topically to treat viral, fungal or bacterial infections (Abstract). Schlievert further disclose “Example 10: Decolonization Studies” in which a study was undertaken to assess the ability of GML (5% w/v), formulated in a non-aqueous gel, to decolonize the respiratory tract in humans, and to decolonize contaminated surgical incision sites in experimental rabbits (paragraph [0158]). Three human subjects underwent swabs of the anterior nares in order to assess whether GML was capable of decolonizing the respiratory tract. Swabs were dipped in phosphate-buffered saline (PBS), which has previously been shown to result in the uptake of 0.1 ml of PBS, and then used to swab anterior nares of each subject. The swabs were rotated around each nare up to the nasal bone 3 times. Colony-forming units of microbes from swabs were determined by plate counts on blood agar and mannitol salt agar. The anterior nares were then treated in the same way with swabs that had been dipped one time in GML gel. The anterior nares of each participant were swabbed at designated time periods for up to 24 hours, and swabs were cultured for S. aureus and coagulase-negative staphylococci (paragraph [0159]). In a final study , S . aureus strain MN8 (1x1010 CFU) was used to coat surgical incision sites of three rabbits per group. The surgical incision sites were 4 cm subcutaneous incisions that had been closed with 4 silk sutures (Ethicon, Cornelia, Ga.). After closing, GML 5% w/v non-aqueous gel was swabbed onto the incision sites of three animals, and PBS was swabbed onto the incision sites of control animals. Enough GML gel was swabbed to provide a uniform coating of the surface. After 24 hours, the rabbits were examined for inflammation (as determined by redness in the incision sites) and total CFU/mL that could be obtained by swabbing the incision sites with PBS-saturated swabs (paragraph [0165]). Schlievert concludes the discussion of “Example 10” with the statement that “collectively, the data presented in this study showed that a 5% GML non-aqueous gel could be used effectively to reduce colonization of the nasal and oral cavities of humans and rabbit surgical incision sites by potential pathogens (paragraph [0167]). Thus, claim 1 is anticipated by the disclosure of Schlievert. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1 and 4-5 are unpatentable over Schlievert. Claims 1 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Schlievert (US PG Pub 2018/0092835 A1)3. The limitations of claim 1 and the disclosure of Schlievert are discussed in the rejection above and hereby incorporated into the instant rejection. Claim 4 further limits claim 1 to wherein the composition further comprises agents that enhance antimicrobial activities. Claim 5 further limits claim 4 to wherein the composition further comprises ethylenediaminetetraacetic acid (EDTA) or has a pH below 7.0. Schlievert discloses that the composition(s) of the invention disclosed therein can include one or more “accelerants”, including such examples as an organic acid, a chelator, an anti-bacterial agent, an anti-fungal agent, an anti-viral agent, or a combination thereof, and EDTA, a well-known chelator, is provided as a specific example (paragraph [0016]). Schlievert further defines an accelerant as a compound, substance, liquid, powder, or mixture that, when added to the composition, has the effect of enhancing or contributing to the antimicrobial properties of the composition, and provides EDTA and tenofovir as specific examples (paragraph [0060]). Schlievert shows in “Example 3: Synergistic Effects of GML and EDTA on the Growth of E. coli” that GML’s antibacterial effects are enhanced by including EDTA in a formulation together with GML in a study of the inhibition of growth of cultured E. coli in well plates. GML alone did not exhibit any bactericidal activity against E. coli, whereas EDTA alone inhibited the growth of E. coli to some extent and the combination of 100 mg/mL GML with EDTA showed increased anti-bacterial activity, in a dose-dependent fashion (paragraphs [0134]-[0137]). Schlievert further discloses “Example 6: Solubility of Tenofovir in GML Gels” in which non-aqueous gels comprising propylene glycol, polyethylene glycol and hydroxypropylcellulose were adjusted to a pH from 4.0-4.5 and the anti-HIV drug tenofovir was added to the gels at a concentration of 10 mg/mL and shown to be soluble with the pH range off 4.4-4.5 (paragraph [0146]). Schlievert does not disclose that the gel prepared in Example 6 also comprised GML within a range of 5-30%, or further comprised EDTA and/or tenofovir; however, a person of ordinary skill in the art would have a reasonable expectation of success in making and using a non-aqueous gel that includes 5% GML, and also comprises tenofovir in the pH 4.4-4.5 range and/or EDTA, for the following reasons: Schlievert’s Example 6 title specifically refers to the gels prepared therein as “GML Gels” and because Schlievert separately discloses the preparation and use of a non-aqueous gel containing 5% GML on human and rabbit subjects in the “Example 10” discussed in the rejection above; Schlievert discloses that such compositions can include “accelerants” that work synergistically with GML, for example EDTA and tenfovir; Schlievert shows that EDTA exhibits a synergistic anti-bacterial effect with GML; Schlievert shows that the anti-viral tenofovir is soluble in a non-aqueous “GML Gel” at pH 4.4-4.5; A person of ordinary skill in the art would at once envisage that the different optional “accelerants” and GML % concentration(s) in a non-aqueous gel could be used in combination with each other. Applicant’s invention is unpatentable over the disclosure of Schlievert, because a person of ordinary skill in the art, at the effective time of filing, would have a reasonable expectation of success in making and using a non-aqueous gel the comprises 5% GML and further comprises agents that enhance the anti-microbial activity of the GML gel, because Schlievert discloses how to make and use a non-aqueous gel containing 5% GML as an anti-microbial topical treatment, and further discloses that some substances, such as EDTA or tenofovir, can work synergistically with GML, and that tenofovir is soluble in such a gel at pH 4.4-4.5. Thus, the invention was prima facie obvious at the time of filing. Claims 1-5 are unpatentable over Schlievert in view of Chang, Rowe and Aboofazeli. Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Schlievert (US PG Pub 2018/0092835 A1) in view of Chang (Chang, et al.; The AAPS Journal, v15, pp.41-52; 2013), Rowe (Rowe, et al.; Handbook of Pharmaceutical Excipients, Pharmaceutical Press, London, 2009) and Aboofazeli (Aboofazeli, et al.; Drug Delivery, v9, pp239-247; 2002). The limitations of claims 1 and 4-5 and the disclosures of Schlievert are discussed in the rejections above and hereby incorporated into the instant rejection. Claim 2 further limits claim 1 to wherein the claimed gel is a non-aqueous gel requiring 10-11 specific excipients including the following: Claim 2 further limits claim 1 to wherein the claimed gel is a non-aqueous gel requiring 10-11 specific excipients including the following: propylene glycol, ethyl alcohol, diethylene glycol monoethyl ether, polysorbate 20, polysorbate 80, polyoxyl 35 castor oil, octyl dodecanol, dimethyl isosorbide, polyethylene glycol 400; and hydroxypropyl cellulose, hydroxyethyl cellulose, or a combination thereof. Schlievert’s “Example 6” discussed above discloses a non-aqueous gel comprising propylene glycol, polyethylene glycol 400, and hydroxypropyl cellulose. Schlievert further discloses formulations wherein non-aqueous gels comprising propylene glycol, polyethylene glycol 400, and a “cellulose derivative” are further combined with water or saline solution, and/or a lipid such as a vegetable oil or Vaseline (paragraph [0094] and Table 1). Schlievert discloses that petroleum jelly (i.e., the Vaseline cited in Table 1) and/or vegetable oil serve the purpose of “topical carrier” (paragraph [0008]). Schlievert also discloses that the “cellulose derivative” can be hydroxypropyl cellulose, or hydroxyethyl cellulose (paragraph [0061]) and further discloses multiple embodiments wherein the GML-containing formulation can comprise a combination of two cellulose derivatives, wherein the two cellulose derivatives are hydroxypropyl cellulose and hydroxyethyl cellulose (paragraphs [0081] and [0084]). Schlievert discloses that compositions of the invention disclosed therein can comprise alcohols (paragraph [0088]) but does not specifically disclose the incorporation of ethyl alcohol or octyl dodecanol. Schlievert also does not disclose any embodiment that includes diethylene glycol monoethyl ether, polysorbate 20, polysorbate 80, polyoxyl 35 castor oil, octyl dodecanol or dimethyl isosorbide. However, a person of ordinary skill in the art would have a reasonable expectation of success in making a nonaqueous gel according to the invention of Schlievert with the additional excipients of polysorbates 20 and 80, polyoxyl 35 castor oil, diethylene glycol monoethyl ether, ethanol, dimethyl isosorbide and octyl dodecanol, because these excipients were known in the art to be useful in the formulation of topical pharmaceutical formulations, per the teachings of Chang, Rowe and Aboofazeli. Chang reviews the considerations involved in developing a topical pharmaceutical composition for generic formulations of known drugs. Chang teaches an extensive list of exemplary excipients for particular roles, as shown in the table below, wherein agents included among instant claims 2-3, and the roles they may perform (at left) have been highlighted by the Examiner. These include polyethylene glycol, polysorbate 20 and 80, diethylene glycol monoethyl ether, propylene glycol, hydroxypropyl cellulose and ethanol. PNG media_image1.png 596 806 media_image1.png Greyscale Rowe teaches the physicochemical properties and most common uses for an exhaustive list of pharmaceutical excipients, aiding a person of ordinary skill in the art in evaluating the compatibility of excipients with each other and the drug agent of choice. For example, Rowe teaches that polyoxyl 35 castor oil, more fully known as polyoxyethylene castor oil, is mainly used as an emulsifying and solubilizing agent (page 542), which, as Chang teaches, are important properties for topical formulations. Rowe also teaches that octyl dodecanol is widely used in cosmetics and topical pharmaceutical formulations, and is an emulsifying and opacifying agent (page 465). Aboofazeli teaches a study in the transdermal delivery of nicardipine by studying the skin permeation of nicardipine through hairless guinea pig skin upon topical administration of the drug in neat solvent suspensions, mixed solvent suspensions and lecithin based organogels containing various excipients and permeation enhancers including propylene glycol, ethanol, Transcutol (i.e., dimethylene glycol monoethyl ether) and dimethyl isosorbide that are listed in instant claim 2 (page 242, Table 1 shows a list of the evaluated excipients). In a comparison of permeation of nicardipine by suspensions of the drug in each of four solvents (polyethylene glycol 300, propylene glycol, dimethyl isosorbide and Transcutol), Aboofazeli teaches that dimethyl isosorbide far exceeded the other solvents in permeation of the drug (page 242, including Figure 1), and that a mixed solvent system of propylene glycol, oleic acid and dimethyl isosorbide showed the highest solubility of nicardipine (page 242, Table 1), and shows that a lecithin organogel comprising dimethyl isosorbide along with propylene glycol and oleic acid showed significantly greater skin permeation of nicardipine compared to the corresponding gel lacking the dimethyl isosorbide (page 243, Table 3). Thus, Aboofazeli shows that dimethyl isosorbide is an effective permeation enhancer, which according to Chang is an important property of an excipient for a topical formulation. Applicant’s invention is unpatentable over the disclosure of Schlievert in view of the teachings of Chang, Rowe and Aboofazeli, because a person of ordinary skill in the art, at the effective time of filing, would have a reasonable expectation of success in modifying the gel formulation disclosed by Schlievert to include hydroxyethyl cellulose, because Schlievert teaches that the composition can include a combination of hydroxyethyl cellulose and hydroxypropyl cellulose, and by including additional excipients of polysorbates 20 and 80, polyoxyl 35 castor oil, diethylene glycol monoethyl ether, ethanol, dimethyl isosorbide and octyl dodecanol, because these additional excipients are identified by Chang, Rowe and Aboofazeli as being useful in topical pharmaceutical formulations. Thus, the invention was prima facie obvious at the time of filing. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. The limitations of claims 1 and 4-5 are discussed in the rejections above and hereby incorporated into the instant rejections below. Claims 1 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 9,724,295 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 15 of U.S. Patent No. 9,724,295 B2 claims a composition comprising up to 5% glycerol monolaurate (GML) and a non-aqueous gel having a pH of about 4.0-6.0. While the instant claims include a range of GML content that reaches a higher maximum (30%), the instant disclosure does not indicate any criticality of higher % in the instantly claimed invention. While claim 15 of of U.S. Patent No. 9,724,295 B2 does not disclose a “biological active composition”, a person of ordinary skill in the art would at once recognize that the composition does comprise a biological active composition because the composition comprises GML, which U.S. Patent No. 9,724,295 B2 identifies as a biologically active compound: “Glycerol monolaurate (GML) is a naturally occurring glycerol-based compound that has previously been shown to have anti-microbial, anti-viral, and anti-inflammatory properties” (Col. 1, lines 28-31). Claims 1 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11,786,454 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 11,786,454 B2 claims a method of treating or preventing a gram-positive bacterial skin infection, a gram-positive bacterial infection of a wound or a gram-positive bacterial infection of surgical incision site in a subject in need thereof, the method comprising topically administering a composition comprising GML and a non-aqueous gel having a pH from about 4.0 to about 4.5, and claim 4 of U.S. Patent No. 11,786,454 B2 further limits claim 1 to wherein the GML comprises about 0.001% to 10% of the composition. While the instant claims include a range of GML content that reaches a higher maximum (30%), the instant disclosure does not indicate any criticality of higher % in the instantly claimed invention. While claims 1 and 4 of U.S. Patent No. 11,786,454 B2 do not disclose a “biological active composition”, a person of ordinary skill in the art would at once recognize that the composition does comprise a biological active composition because the composition comprises GML, which U.S. Patent No. 11,786,454 B2 identifies as a biologically active compound: “Glycerol monolaurate (GML) is a naturally occurring glycerol-based compound that has previously been shown to have anti-microbial, anti-viral, and anti-inflammatory properties” (Col. 1, lines 31-34). Claims 1 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 9 of U.S. Patent No. 12,194,140 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of U.S. Patent No. 12,194,140 B2 claims a composition comprising GML and a non-aqueous gel having a pH of about 4-5.5, and claim 9 of U.S. Patent No. 12,194,140 B2 further limits claim 1 to wherein the GML comprises about 0.001% to 10% of the composition. While the instant claims include a range of GML content that reaches a higher maximum (30%), the instant disclosure does not indicate any criticality of higher % in the instantly claimed invention. While claims 1 and 9 of U.S. Patent No. 12,194,140 B2 do not disclose a “biological active composition”, a person of ordinary skill in the art would at once recognize that the composition does comprise a biological active composition because the composition comprises GML, which U.S. Patent No. 12,194,140 B2 identifies as a biologically active compound: “Glycerol monolaurate (GML) is a naturally occurring glycerol-based compound that has previously been shown to have anti-microbial, anti-viral, and anti-inflammatory properties” (Col. 1, lines 33-36). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice. /W.J.Y./Examiner, Art Unit 1629 /JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629 1 Cited in Applicant’s Information Disclosure Statement dated 11/21/2023. 2 Cited in Applicant’s Information Disclosure Statement dated 11/21/2023. 3 Cited in Applicant’s Information Disclosure Statement dated 11/21/2023.
Read full office action

Prosecution Timeline

Nov 21, 2023
Application Filed
Feb 20, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
63%
Grant Probability
99%
With Interview (+39.6%)
3y 7m
Median Time to Grant
Low
PTA Risk
Based on 51 resolved cases by this examiner. Grant probability derived from career allow rate.

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