Prosecution Insights
Last updated: August 16, 2026
Application No. 17/836,814

ORAL PRODUCTS WITH REDUCED IRRITATION

Final Rejection §103§112§DOUBLEPATENT
Filed
Jun 09, 2022
Priority
Dec 09, 2019 — CIP of 11/672,862 +1 more
Examiner
CHANDRAKUMAR, NIZAL S
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Nicoventures Trading Limited
OA Round
4 (Final)
73%
Grant Probability
Favorable
5-6
OA Rounds
0m
Est. Remaining
91%
With Interview

Examiner Intelligence

Grants 73% — above average
73%
Career Allowance Rate
1289 granted / 1774 resolved
+12.7% vs TC avg
Strong +18% interview lift
Without
With
+18.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 3m
Avg Prosecution
95 currently pending
Career history
1862
Total Applications
across all art units

Statute-Specific Performance

§101
2.2%
-37.8% vs TC avg
§103
29.1%
-10.9% vs TC avg
§102
11.1%
-28.9% vs TC avg
§112
36.7%
-3.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1774 resolved cases

Office Action

§103 §112 §DOUBLEPATENT
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 . Claims 1, 4-20 are pending. 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. Claims 1, 4-19 and method claim 20 are rejected under 35 U.S.C. 103 as being unpatentable over Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001, Chappell US8950408 and Gee US9027567. Chappell and Gee are new, added in view of amendments to claims. The rejection is maintained. Yes, amendments to claims are noted. Detailed Response is at the bottom of the following restatement of previously presented rejection, including the teachings of Chappell US8950408 and Gee. Bruun teach a pouch designed for administration of an active ingredient in the oral cavity; the pouch contains a matrix composition including a combination of nicotine and a water-soluble composition. Abstract. Claim 1, releasable PNG media_image1.png 23 418 media_image1.png Greyscale PNG media_image2.png 26 429 media_image2.png Greyscale PNG media_image3.png 59 429 media_image3.png Greyscale Claim 4, 7 in part, 8, non-sugar sweetener PNG media_image4.png 153 423 media_image4.png Greyscale Claim 5,6, 7 PNG media_image5.png 18 160 media_image5.png Greyscale xylitol Xylitol (as sugar alcohol) [0039] [0108] [0115] [0136] [0139] [0165] Table 1 (see below for more on how the above reads on ‘irritation’) PNG media_image6.png 101 413 media_image6.png Greyscale PNG media_image7.png 64 427 media_image7.png Greyscale Also according to Szel teaches xylitol has anti-irritant property. claims 7-8 sweetener PNG media_image4.png 153 423 media_image4.png Greyscale claims 9-12 flavor, double bond C=C, C=O [0113] [0114] [0117] PNG media_image8.png 200 430 media_image8.png Greyscale PNG media_image9.png 224 411 media_image9.png Greyscale The flavoring agent, taught as pepper mint in the above mentioned Bruun Table corresponds to the flavoring agent of dependent claims (including the structural limitations of ‘double bond’: Peppermint component, for example, ‘limonene’ of claim 12, see page 121 Table 19th flavor component as per Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. To visualize the double bonds of claim 10 see cartoons on page 127. Claims 13, 14, 15 particulate filler component (microcrystalline cellulose) PNG media_image10.png 193 431 media_image10.png Greyscale (see below for more on how the above reads on ‘filler’) PNG media_image11.png 39 430 media_image11.png Greyscale [0019]-[0022], [0073] , [0094], PNG media_image12.png 152 422 media_image12.png Greyscale Example 3.1, 3.4 PNG media_image13.png 133 421 media_image13.png Greyscale Claim 16 no more than 10% tobacco. T0obacco not excluded from the laundry list of active ingredients in the base claim 1; see Remarks filed 12/19/2025, page 1, last line. Further tobacco contains nicotine (about 5%). The relevant limitations pertaining to the instant claims 1, 4-20, for example the inherent property of the various ingredients, are PNG media_image14.png 38 604 media_image14.png Greyscale here in the obviousness analysis. What is good for applicant is good for examiner. Specification page 1, line 15-23: PNG media_image15.png 230 608 media_image15.png Greyscale taught in the applicant admitted to references in oral pouch products containing tobacco As set forth in the applicant admitted to references at page 1 Tobacco containing oral pouch products are well-known in the art as admitted to by the applicant at page 1 Claim 17 free flowing particulate form PNG media_image16.png 134 421 media_image16.png Greyscale The powder obtained (Example 3.6 of Bruun) is usable in different particle size and is ‘sieved’. Claim 18 salts, humectants [0086] [0095] [0138] [0142] [0150] [0147] [0156] [0157] PNG media_image10.png 193 431 media_image10.png Greyscale PNG media_image17.png 60 423 media_image17.png Greyscale PNG media_image18.png 156 419 media_image18.png Greyscale claim 19 mouth and throat, PNG media_image19.png 92 419 media_image19.png Greyscale Claim 20 method PNG media_image20.png 42 302 media_image20.png Greyscale PNG media_image21.png 56 298 media_image21.png Greyscale The nicotine patch (and its contents) taught by Bruun fall(s) under the scope of the base claim, in the stipulated free-flowing particulate form. More specifically, the active ingredient, the irritation reducing agent xylitol, the filler (microcrystalline cellulose), three critical elements of base claim 1 are present in Bruun page 6-8, working Examples. On page 8, Table 1, specific combination (see Patch No.102) of nicotine, xylitol, flavoring material and sweeteners are prepared. Components other than the active ingredient nicotine are taught by Bruun in explicit manner, though, not always with the recited property. For example, the agent/compound xylitol is taught (as sugar alcohol which in turn is listed with the cellulose (filler)) as humectants by Bruun. It is noted that compound and its properties are inseparable. Further, though not taught by Bruun as such, the anti-irritant property of xylitol is not unknown in the art . See Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, teaches that xylitol has anti-irritant property. Likewise, the flavoring agent, taught as pepper mint in the above mentioned Bruun Table corresponds to the flavoring agent of dependent claims (including the structural limitations of ‘double bond’: Peppermint component, for example, ‘limonene’ of claim 12, see page 121 Table 19th flavor component as per Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. To visualize the double bonds of claim 10 see cartoons on page 127. Similarly, as to the ‘free-flowing’ limitations: The powder obtained (Example 3.6 of Bruun) is usable in different particle size and is ‘sieved’. The position taken is that such ‘sieved’ material would provide the property of free-flow. As to ‘mouth and throat’ limitation: The position taken is that it is one of commonsense to expect an oral composition, once released, is likely to leak into the throat in view of the proximal nature of mouth and throat: PNG media_image22.png 38 151 media_image22.png Greyscale Various nicotine pouches are known to one of skill in the art. The global Nicotine Pouches market was valued at US$ 2.33 billion in 2020 and is expected to reach US$ 21.84 billion by the end of 2027, growing at a CAGR of 30.7% during 2021-2027. https://www.marketresearch.com/QYResearch-Group-v3531/Global-Nicotine-Pouches-Research-14261122/ With such motivation, one of skill in the art would make modifications to nicotine patches known in the prior art, to participate in the market. All the critical claimed elements of the claims are taught in the prior art of Bruun explicitly and or implicitly (by inherency) to make different forms of nicotine patches. Therefore with the teaching of the prior art one of skill in the art would have reasonable expectation of success in arriving at alternate versions of prior art composition As such there is nothing unobvious in the instant claim limitations, further because, data with regards to secondary considerations, or "objective indicia" of nonobviousness,, that is real-world facts—such as commercial success, long-felt need, failure of others, and industry praise—used to demonstrate that an invention was not obvious, could not be found in the disclosure for an oral composition comprising: an active ingredient that is releasable from the oral composition; a filler; and at least one irritation reducing agent effective to reduce irritation arising from the release of the active ingredient from the oral composition, wherein the active ingredient comprises one or more of: a vitamin selected from Vitamin A, Vitamin B1, Vitamin , Vitamin B3, Vitamin B5, Vitamin B7, Vitamin B9, Vitamin D, Vitamin E, Vitamin K; wherein the active ingredient, the filler component, and the at least one irritation reducing agent are combined as a mixture that is enclosed in a pouch to form a pouched product. Response to Applicants Remarks: Applicants arguments focus on the amendments limiting the active ingredients to vitamins. Applicant argues that in the presently claimed oral compositions, the active ingredient, the filler component and the irritation reducing agent are combined as a mixture that is enclosed in a pouch to form a pouched product. Emphasis by Applicant. See Remarks page 12 of 14. Applicants arguments are not persuasive. Active and inactive ingredients are known in the art. The inherent property of these ingredients are inseparable. How to combine these to make oral pouches are taught in the prior art. As per Examination guidance unappreciated property doctrine dictates that discovering a new, previously unappreciated property or scientific explanation for an old, existing composition does not make that composition patentably new. An inherently functioning property cannot support a patent, even if explicitly claimed by the applicant. According to MPEP § 2112 (Requirements of Rejection Based on Inherency), discovering that an old compound or prior art composition exhibits an unknown benefit or function does not render the composition patentable to the discoverer. This is because a composition that is old in the art does not suddenly become new simply because someone found a new use or function for it that was inherently present all along. The rejection is not under Claim Rejections - 35 USC § 103. Oral pouches with active ingredients are well-known in the art, two of these are Chappell US8950408 and Gee US9027567: Chappell US8950408: teaches Abstract PNG media_image23.png 62 730 media_image23.png Greyscale Chappell column 2: PNG media_image24.png 118 746 media_image24.png Greyscale Chappell Column 3: PNG media_image25.png 94 734 media_image25.png Greyscale PNG media_image26.png 82 724 media_image26.png Greyscale Gee US 9027567 teaches Abstract PNG media_image27.png 48 726 media_image27.png Greyscale Gee column 1: PNG media_image28.png 148 734 media_image28.png Greyscale Gee Column 6: PNG media_image29.png 116 726 media_image29.png Greyscale PNG media_image30.png 52 706 media_image30.png Greyscale Position taken with respect to other ingredients such as xylitol takes into consideration the inherent property of the excipients. Applicant is not responsive to reference to lack of any data for secondary consideration in the disclosure. See office action, starting at bottom of page 9 of previous action. 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. Claims 1, 4-20 are rejected under 35 U.S.C. 103 as being unpatentable over Bruun1 WO2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001, Chappell US8950408 and Gee US9027567. Chappell and Gee are new, added in view of amendments to claims. The rejection is maintained. Yes, amendments to claims are noted. Detailed Response is at the bottom of the following restatement of previously presented rejection, including the teachings of Chappell US8950408 and Gee. Bruun1 teaches a pouch designed for administration of an active ingredient in the oral cavity is disclosed, the pouch containing an amount of one or more cannabinoids. Abstract. Bruun1 teaches that the cannabinoid pouch contains, cellulose and xylitol. Bruun1 composition comprises at least one of carbohydrates, sugars, sugar alcohol, maltodextrin, sucralose, modified food starches, cornstarch, microcrystalline cellulose, THC distillate, MCT oil, baking soda, natural flavoring, botanical terpenes, vanilla extract, and salt. In some embodiments, the cannabinoid composition or cannabinoid infused wafer fragments composition do not comprise of microcrystalline cellulose. As used herein the term "humectant" is understood as a moistening agent used to attract moisture or water in the form of saliva. Humectants may typically include suitably hygroscopic compositions. In some cases, humectants may also be described as moistening agents, due to their role in attraction of moisture. Examples of humectants include cellulose, such as microcrystalline cellulose and other cellulose types disclosed herein, sugar alcohols, such as those disclosed herein, alginate, cellulose, such as microcrystalline cellulose, pectin, xanthan gum, etc. Applicant is encouraged to use word search technique known to one of skill in the art by pressing Ctrl + F (or Cmd + F on Mac) to quickly find, search, or highlight specific words, phrases to claim limitations in Bruun1. The technique was used to locate these limitations in Bruun, which teaches nicotine replacement for cannabinoid in the Bruun1 pouch, as shown below: Claim 1, releasable PNG media_image1.png 23 418 media_image1.png Greyscale PNG media_image2.png 26 429 media_image2.png Greyscale PNG media_image3.png 59 429 media_image3.png Greyscale Claim 4, 7 in part, 8, non-sugar sweetener PNG media_image4.png 153 423 media_image4.png Greyscale Claim 5,6, 7 PNG media_image5.png 18 160 media_image5.png Greyscale xylitol Xylitol (as sugar alcohol) [0039] [0108] [0115] [0136] [0139] [0165] Table 1 (see below for more on how the above reads on ‘irritation’) PNG media_image6.png 101 413 media_image6.png Greyscale PNG media_image7.png 64 427 media_image7.png Greyscale Also according to Szel teaches xylitol has anti-irritant property. claims 7-8 sweetener PNG media_image4.png 153 423 media_image4.png Greyscale claims 9-12 flavor, double bond C=C, C=O [0113] [0114] [0117] PNG media_image8.png 200 430 media_image8.png Greyscale PNG media_image9.png 224 411 media_image9.png Greyscale The flavoring agent, taught as pepper mint in the above mentioned Bruun Table corresponds to the flavoring agent of dependent claims (including the structural limitations of ‘double bond’: Peppermint component, for example, ‘limonene’ of claim 12, see page 121 Table 19th flavor component as per Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001. To visualize the double bonds of claim 10 see cartoons on page 127. Claims 13, 14, 15 particulate filler component (microcrystalline cellulose) PNG media_image10.png 193 431 media_image10.png Greyscale (see below for more on how the above reads on ‘filler’) PNG media_image11.png 39 430 media_image11.png Greyscale [0019]-[0022], [0073] , [0094], PNG media_image12.png 152 422 media_image12.png Greyscale Example 3.1, 3.4 PNG media_image13.png 133 421 media_image13.png Greyscale Claim 16 no more than 10% tobacco. T0obacco not excluded from the laundry list of active ingredients in the base claim 1; see Remarks filed 12/19/2025, page 1, last line. Further tobacco contains nicotine (about 5%). The relevant limitations pertaining to the instant claims 1, 4-20, for example the inherent property of the various ingredients, are PNG media_image14.png 38 604 media_image14.png Greyscale here in the obviousness analysis. What is good for applicant is good for examiner. Specification page 1, line 15-23: PNG media_image15.png 230 608 media_image15.png Greyscale taught in the applicant admitted to references in oral pouch products containing tobacco As set forth in the applicant admitted to references at page 1 Tobacco containing oral pouch products are well-known in the art as admitted to by the applicant at page 1 Claim 17 free flowing particulate form PNG media_image16.png 134 421 media_image16.png Greyscale The powder obtained (Example 3.6 of Bruun) is usable in different particle size and is ‘sieved’. Claim 18 salts, humectants [0086] [0095] [0138] [0142] [0150] [0147] [0156] [0157] PNG media_image10.png 193 431 media_image10.png Greyscale PNG media_image17.png 60 423 media_image17.png Greyscale PNG media_image18.png 156 419 media_image18.png Greyscale claim 19 mouth and throat, PNG media_image19.png 92 419 media_image19.png Greyscale Claim 20 method PNG media_image20.png 42 302 media_image20.png Greyscale PNG media_image21.png 56 298 media_image21.png Greyscale All the claimed limitations are known in the prior art of Bruun1 and Bruun. Since the claimed elements were known in the prior art, one of skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions to arrive at the instantly claimed composition. Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. Suggestion: See MPEP 1204 Notice of Appeal [R-01.2024] PNG media_image31.png 1080 1150 media_image31.png Greyscale PNG media_image32.png 676 1108 media_image32.png Greyscale https://cannadips.com/?srsltid=AfmBOoq2En5mt9eK_BFfVthF2Msd6Wcf1hKy8iOHw5_2UdkPo3RMsDTW PNG media_image33.png 150 470 media_image33.png Greyscale Response to Applicants Remarks: Applicants arguments focus on the amendments limiting the active ingredients to vitamins. Applicant argues that in the presently claimed oral compositions, the active ingredient, the filler component and the irritation reducing agent are combined as a mixture that is enclosed in a pouch to form a pouched product. Emphasis by Applicant. See Remarks page 12 of 14. Applicants arguments are not persuasive. Active and inactive ingredients are known in the art. The inherent property of these ingredients are inseparable. How to combine these to make oral pouches are taught in the prior art. As per Examination guidance unappreciated property doctrine dictates that discovering a new, previously unappreciated property or scientific explanation for an old, existing composition does not make that composition patentably new. An inherently functioning property cannot support a patent, even if explicitly claimed by the applicant. According to MPEP § 2112 (Requirements of Rejection Based on Inherency), discovering that an old compound or prior art composition exhibits an unknown benefit or function does not render the composition patentable to the discoverer. This is because a composition that is old in the art does not suddenly become new simply because someone found a new use or function for it that was inherently present all along. The rejection is not under Claim Rejections - 35 USC § 103. Oral pouches with active ingredients are well-known in the art, two of these are Chappell US8950408 and Gee US9027567: Chappell US8950408: teaches Abstract PNG media_image23.png 62 730 media_image23.png Greyscale Chappell column 2: PNG media_image24.png 118 746 media_image24.png Greyscale Chappell Column 3: PNG media_image25.png 94 734 media_image25.png Greyscale PNG media_image26.png 82 724 media_image26.png Greyscale Gee US 9027567 teaches Abstract PNG media_image27.png 48 726 media_image27.png Greyscale Gee column 1: PNG media_image28.png 148 734 media_image28.png Greyscale Gee Column 6: PNG media_image29.png 116 726 media_image29.png Greyscale PNG media_image30.png 52 706 media_image30.png Greyscale Position taken with respect to other ingredients such as xylitol takes into consideration the inherent property of the excipients. Applicant is not responsive to reference to lack of any data for secondary consideration in the disclosure. See office action, starting at bottom of page 9 of previous action. Claim Rejections - 35 USC § 112 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, 4-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The metes and bounds of the base claims 1 and 20 and dependent claims is unclear. For example, with respect to the limitation for active ingredients, that is PNG media_image34.png 14 236 media_image34.png Greyscale in addition to specific compounds (active ingredients), the term comprising in the claims renders the scope of the claims with respect to the active ingredient unclear. As per Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) "comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts. In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held. "The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended." For example consider claim 16: PNG media_image35.png 76 588 media_image35.png Greyscale Reference to less than PNG media_image36.png 76 590 media_image36.png Greyscale could be present in the PNG media_image34.png 14 236 media_image34.png Greyscale implies active ingredients more that positively recited as PNG media_image37.png 52 614 media_image37.png Greyscale Suggestion: See MPEP 1204 Notice of Appeal [R-01.2024] 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, 4-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US patents 12642292, 12635723, 12564552, 12520867, 12496276,12491250,12439952,12439949,12342847,12274779,12213510,12178905,12138342,12064424,11793230 and 11617744, further in view of Bruun1 WO2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001, Chappell US8950408 and Gee US9027567. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims as highlighted below contain overlapping subject matter. The active ingredients and inactive ingredients have species-genus relationship. The discussion under Claim Rejections - 35 USC § 103 in its entirety is incorporated by reference in the obviousness analysis. US 12642292: PNG media_image38.png 112 752 media_image38.png Greyscale PNG media_image39.png 68 756 media_image39.png Greyscale US 12635723: PNG media_image40.png 246 772 media_image40.png Greyscale PNG media_image41.png 124 756 media_image41.png Greyscale PNG media_image42.png 112 752 media_image42.png Greyscale US 12564552 PNG media_image43.png 164 762 media_image43.png Greyscale US 12520867: PNG media_image44.png 176 746 media_image44.png Greyscale US 12496276: PNG media_image45.png 86 738 media_image45.png Greyscale PNG media_image46.png 50 752 media_image46.png Greyscale PNG media_image47.png 22 748 media_image47.png Greyscale US 12491250: PNG media_image48.png 128 754 media_image48.png Greyscale US 12439952: PNG media_image49.png 68 734 media_image49.png Greyscale PNG media_image50.png 50 732 media_image50.png Greyscale PNG media_image51.png 40 708 media_image51.png Greyscale US 12439949: PNG media_image52.png 46 746 media_image52.png Greyscale PNG media_image53.png 48 722 media_image53.png Greyscale US 12342847: PNG media_image54.png 194 734 media_image54.png Greyscale US 12274779: PNG media_image55.png 98 752 media_image55.png Greyscale PNG media_image56.png 50 720 media_image56.png Greyscale PNG media_image57.png 32 682 media_image57.png Greyscale US 12213510: PNG media_image58.png 180 740 media_image58.png Greyscale US 12178905: PNG media_image59.png 32 726 media_image59.png Greyscale PNG media_image60.png 50 736 media_image60.png Greyscale US 12138342: PNG media_image61.png 212 760 media_image61.png Greyscale US 12064424: PNG media_image62.png 82 752 media_image62.png Greyscale US 11793230: PNG media_image63.png 30 698 media_image63.png Greyscale US 11617744: PNG media_image64.png 118 744 media_image64.png Greyscale Also note that reliance on specification of a potentially conflicting patent or application is generally prohibited. However limited exceptions do exist. Exceptions to the General Prohibition of Using the Disclosure of a Potentially Conflicting Patent or Application include Dictionary for claim terminology, Portions of the disclosure which provide support for the claims in the potentially conflicting patent or application. The MPEP refers to two exceptions to the general prohibition of using the disclosure of a potentially conflicting patent or application in an ODP-Obviousness analysis. The two exceptions are: 1. The disclosure can be used as a dictionary for claim terminology; and 2. “[T]hose portions of the specification which provide support for the patent claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the patent” (MPEP § 804). The MPEP further notes: The court in Vogel recognized “that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim,” but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent which provides support for the patent claim. According to the court, one must first “determine how much of the patent disclosure pertains to the invention claimed in the patent” because only “[t]his portion of the specification supports the patent claims and may be considered.” The court pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103 since only the disclosure of the invention claimed in the patent may be examined.”) Claims 1, 4-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25, 27-40 of copending Application No. 18143391 (reference application) further in view of Bruun1 WO2018233782 and Bruun, US 20190255035 (equivalent to WO 2018233795 12/27/2018), Szel, The Journal of European Academy of Dermatology and Venereology, Volume 29, Issue12, December 2015, 2333-2341, Günter, Takeoka et al.; Aroma Active Compounds in Foods, ACS Symposium Series; American Chemical Society: Washington, DC, 2001, Chappell US8950408 and Gee US9027567. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims as highlighted below contain overlapping subject matter. The active ingredients and inactive ingredients have species-genus relationship. The discussion under Claim Rejections - 35 USC § 103 in its entirety is incorporated by reference in the obviousness analysis. Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Note: Appeal Brief filed 07/20/2026 after Notice of panel decision from pre-appeal brief filed 06/18/2026 is found in the file wrapper of 18143391. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804 Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330. Suggestion: See MPEP 1204 Notice of Appeal [R-01.2024] Copending Applications Applicant is encouraged to check for additional copending applications and issued patents for overlapping subject matter in the claims and file terminal disclaimers. As set forth by the court (not by this Examiner) in Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972): [W]e think that it is unfair to the busy examiner, no matter how diligent and well informed he may be, to assume that he retains details of every pending file in his mind when he is reviewing a particular application. THIS ACTION IS MADE FINAL. 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 NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at (571) 272-0913. 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. /NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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Prosecution Timeline

Show 2 earlier events
Aug 11, 2025
Response Filed
Aug 27, 2025
Final Rejection mailed — §103, §112, §DOUBLEPATENT
Dec 19, 2025
Response after Non-Final Action
Dec 19, 2025
Notice of Allowance
Jan 29, 2026
Response after Non-Final Action
Mar 25, 2026
Non-Final Rejection mailed — §103, §112, §DOUBLEPATENT
Jun 25, 2026
Response Filed
Jul 24, 2026
Final Rejection mailed — §103, §112, §DOUBLEPATENT (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12698292
TOXIN MOLECULE SUITABLE FOR ANTIBODY-DRUG CONJUGATE
3y 0m to grant Granted Aug 04, 2026
Patent 12698263
PROCESS FOR PREPARING 3-AMINO-1-BUTANOL AND RELATED COMPOUNDS
2y 9m to grant Granted Aug 04, 2026
Patent 12693297
COUMARIN-BASED CROSSLINKING REAGENTS
5y 4m to grant Granted Jul 28, 2026
Patent 12685738
INOTODIOL AS AGONIST OF LIVER X RECEPTORS, AND USE THEREOF
3y 5m to grant Granted Jul 21, 2026
Patent 12678466
Method to Improve Therapeutic Properties of Stem Cells
3y 0m to grant Granted Jul 14, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

5-6
Expected OA Rounds
73%
Grant Probability
91%
With Interview (+18.3%)
2y 3m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 1774 resolved cases by this examiner. Grant probability derived from career allowance rate.

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