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 .
DETAILED ACTION
Status of Application/Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-8 and 14-15), small molecule antagonist and vascular dementia in the reply filed on June 26, 2025 is acknowledged.
Claims 1-15 are pending in this application. Claims 9-13 are withdrawn without traverse (filed 06/26/2025) from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. In addition, claims 4 and 15 are withdrawn from further consideration because of non-elected species. Election was made without traverse in the reply filed on June 26, 2025.
Claims 1-3, 5-8 and 14 are under examination with respect to small molecule antagonist and vascular dementia in this office action.
Claim Objections
Claims 1, 3, 5-6 are objected to because of the following informalities: The recitation “LTA4H” is not a unique or common abbreviation in the art. Applicants are required to spell out “LTA4H” at the first usage. Appropriate correction is required.
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 1-3, 5-8 and 14 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 pre-AIA the applicant regards as the invention.
Claims 1-3, 5-8 and 14 are indefinite because:
i. The term "improving” in claim 1 is a relative term which renders the claim indefinite. The term "improving" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant fails to set forth the metes and bounds of what is encompassed within the definition of “improving”. Since the metes and bounds are unknown, a skilled artisan cannot envision what would be considered as “improving cognitive function” recited in the claim. Thus, the claim is indefinite.
ii. The term “LTA4H modulatory agent” recited in claim is indefinite because the term "modulatory agent" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Applicant fails to set forth the metes and bounds of what is encompassed within the definition of “modulatory agent”. An agent is either to enhance or inhibit LTA4H, and subsequently alleviate or treat a dementia disorder. It is unclear whether an agent that enhances or inhibits the activity of LTA4H is used for treating the claimed dementia disorder and thereby improving cognitive function. Since the metes and bounds are unknown, a skilled artisan cannot envision what agent would be considered as a “LTA4H modulatory agent” that can improve cognitive function” recited in the claim. Thus, the claim is indefinite.
iii. Claim 5 recites the limitation "the epoxide hydrolase…" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
iv. Claim 6 recites the limitation “the epoxide hydrolase activity and the aminopeptidase activity…” in lines 1-2 of claim 6. There is insufficient antecedent basis for this limitation in the claim.
v. The rest of claims are indefinite as depending from an indefinite claim.
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 1-3, 5-8 and 14 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
Claims 1-3, 5-8 and 14 are drawn to a method of improving cognitive function in a subject diagnosed with a dementia disorder, the method comprising administering a therapeutically effective amount of an LTA4H modulatory agent.
The claims encompass using a genus of LTA4H modulatory agent for improving cognitive function in a genus of dementia disorder. Claims 3, 5-6 encompass using a genus of small organic molecules antagonist to LTA4H including antagonists antagonizing epoxide hydrolase activity or both epoxide hydrolase and aminopeptidase activity of LTA4H for improving cognitive function in a genus of dementia disorder.
Applicant has not disclosed sufficient species for the broad genus of LTA4H modulatory agents, the broad genus of small organic molecules antagonist to LTA4H, the broad genus of antagonists antagonizing epoxide hydrolase activity or both epoxide hydrolase and amino peptidase activity of LTA4H and the broad genus of dementia disorder.
The specification only disclosed that i) treatment with the LTA4H dual inhibitor SC-57461A resulted in improvement in the radial Arm Water Maze test in aged mice (p. 116 and Figure 19D) and such an improvement correlates with reduction in mRNA levels of proinflammatory cytokines and astrocyte markers including IL-6, IL1b, TNFa, AQP4 and H2D1 (figures 21, 23-24) but not with treatment using pinostilbene hydrate (LTA4H hydrolase inhibitor) (p. 116). Based on Applicant’s own admission, using pinostilbene hydrate to inhibit LTA4H hydrolase alone or CP-105696 (i.e a LTB4 Receptor inhibitor) does not result in improvement of cognition in aged mice; and only using the LTA4H dual inhibitor, SC-574641A that inhibits both LTA4H epoxide hydrolase and aminopeptidase activity, can improve cognition in aged mice based on the Radial Arm Water Maze test as compared to control/vehicle (see p. 115-116; figures 19D, Figures 22, 23B-C, 23F, 24C).
The claims are not limited to agents and method set forth above but also using a genus of structurally and functionally undefined LTA4H modulatory agent, a genus of small organic molecule antagonists to LTA4H including a genus of LTA4H antagonists antagonizing epoxide hydrolase function of LTA4H or both epoxide hydrolase function aminopeptidase activity of LTA4H. However, the specification provides no specific common structural and functional relationship between the LTA4H modulatory agents/antagonists that can improve cognitive function in a subject diagnosed with a dementia disorder.
In making a determination of whether the application complies with the written description requirement of 35 U.S.C. 112, first paragraph, it is necessary to understand what Applicant is in possession of and what Applicant is claiming.
M.P.E.P. § 2163 instructs:
An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. . . .
An applicant may show possession of an invention by disclosure of drawings or structural chemical formulas that are sufficiently detailed to show that applicant was in possession of the claimed invention as a whole. . . .
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, 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.”
This standard has not been met in this case. From the specification, it is clear that Applicant is in possession of using a structurally and functionally defined LTA4H dual inhibitor/antagonist that specifically effects both epoxide hydrolase function aminopeptidase activity in the claimed method. However, Applicant is not in possession of using other structurally and functionally undefined “LTA4H modulatory agents”, structurally and functionally undefined small organic molecule antagonist to LTA4H or structurally and functionally undefined antagonists to LTA4H antagonizing epoxide hydrolase activity of LTA4H or both epoxide hydrolase activity and aminopeptidase activity of LTA4H recited in claims 3 and 5-6.
The specification discusses that TA4H contributes to the development of cognitive disorders, such as Alzheimer’s disease, etc., based upon the conversion of leukotriene A4 to leukotriene B4, which leads to neuroinflammation (on p. 2-5 of the specification). Antagonists of LTA4H are then proposed to be useful to treat neuroinflammation, cognition and to improve motor function. The limitation “LTA4H modulatory agent” recited in instant claim 1 also encompasses LTA4H “modulatory agent” that alternatively increases neuroinflammation. However, any LTA4H “modulatory agent” that alternatively increases neuroinflammation does not appear to be useful for treating these neurodegenerative diseases, yet are encompassed by claim 1. The specification describes various compounds that may modulate LTA4H function, or act as LTA4H antagonists (p. 16-81 of the specification). However, there is no correlation between structure and either inhibitory or activating function/activity recited within the claims nor adequately described within the specification. The specification provides no specific common structural and functional relationship between the LTA4H modulatory agent that antagonizing/inhibiting LTA4H or agonizing/activating LTA4H. The specification also provides no specific common structural and functional relationship between antagonists to LTA4H antagonizing epoxide hydrolase activity of LTA4H or both epoxide hydrolase activity and aminopeptidase activity of LTA4H recited in claims 3 and 5-6 and the LTA4H dual inhibitor, SC-574641A that used in Examples to improve cognition based on the Radial Arm Water Maze test in Aged mice as compared to a control vehicle. There is no common structure between the generic “LTA4H modulatory agents” recited in claim 1, or even specific compounds that antagonize the epoxide hydrolase activity or aminopeptidase activity of LTA4H recited in claims 5-6 to demonstrate possession of the “LTA4H modulatory agents” or LTA4H antagonists encompassed for use by the current claims. Thus, a skilled artisan cannot envision what critical chemical structure is correlated with the functionality of making a LTA4H antagonist that specifically effects either epoxide hydrolase function or aminopeptidase activity, or both for making a “modulatory agent” in general, as currently claimed and thus can be used in the claimed method of improving cognitive function in a subject diagnosed with a dementia disorder. Thus, no adequate written description is provided in the instant specification as to what structurally constitutes the genus of “LTA4H antagonists” or “LTA4H modulatory agents” required to be used in the currently claimed method, because merely listing putative “antagonists”, which possess no common structure, does not reasonably show a representative number of species to demonstrate possession of the claimed genus of antagonist compounds required to practice the instantly claimed method.
Further, although Figure 19 describes use of the radical arm water maze as a model system to assess cognition, this model system more accurately may be considered an appropriate model system for assessing spatial memory loss in Alzheimer’s disease, and not any other dementia disorder not involving spatial memory loss (see p. 1-4, Cantone, Intl. J. Mol. Sci. 2023; 24:13027. Doi.org/10.3390/ijms241713027). The specification provides no well-established correlation between the model system of the radical arm water maze test in aged mice and other dementia disorders. The specification provides no well-established correlation between improvement of cognition based on the radical arm water maze behavior test in aged mice treated with a LTA4H dual inhibitor, SC-574641A, and other dementia disorders treated a LTA4H dual inhibitor, SC-574641A. The specification also provides no well-established correlation between improvement of cognition based on the radical arm water maze behavior test in aged mice treated with a LTA4H dual inhibitor, SC-574641A, and other dementia disorders treated other structurally and functionally undefined “LTA4H antagonists” or “LTA4H modulatory agents”.
There is no universal treatment for dementia disorders is currently accepted within the art. For example, not all patients with Alzheimer’s disease also have Parkinson’s disease or ALS or MS, etc.. Accordingly, a model system for one type of neurodegenerative disease state (e.g., as shown in Figure 19), is not reasonably representative of possessing a treatment method for treating cognition, in general.
In the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of use of the claimed genus of “LTA4H modulatory agents”, “LTA4H antagonists”, ““LTA4H antagonists antagonizing epoxide hydrolase activity of LTA4H” ““LTA4H antagonists antagonizing both epoxide hydrolase activity and aminopeptidase activity of LTA4H” required to practice the currently claimed method, because one skilled in the art cannot envision structurally any functional generic chemical structure that would structurally define/characterize the genus of LTA4H modulatory agents or LTA4H antagonists required to be used by current claims. Furthermore, the prior art does not provide compensatory structural or correlative teachings sufficient to enable one of skill to identify what other LTA4H modulatory agents or LTA4H antagonists might be. Since the common characteristics/features of other LTA4H modulatory agents or LTA4H antagonists are unknown, a skilled artisan cannot envision the functional correlations of the genus with the claimed invention. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the genus of LTA4H modulatory agents or LTA4H antagonists and the genus of dementia disorders.
Based on MPEP § 2161.01 and §2163, “to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116”.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of LTA4H modulatory agents or LTA4H antagonists and the genus of dementia disorders, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483.
Therefore, the claimed method has not met the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision (see page 1115).
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-3, 5-8 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Isakson et al (US5700816, as in IDS) as evidenced by Kalaria et al. (Biochem. Biophys. Acta, 2016; 1862:915-925).
Claims 1-3, 5-8 and 14 are drawn to a method of improving cognitive function in a subject diagnosed with a dementia disorder including vascular dementia, the method comprising administering a therapeutically effective amount of an LTA4H modulatory agent.
Isakson et al. (US5700816) teach a method of treating Alzheimer’s disease (AD) (i.e. which is, a dementia disorder and a CNS age-related cognitive impairment human disease), dementia (i.e., which is CNS cognitive impairment disorders; col 3; as it relates to claims | & 2) and CNS damage resulting from stroke, ischemia and trauma (i.e which leading to vascular dementia) with “LTA4H hydrolase inhibitors” (see col. 4, lines 19-33; col. 6, line 13-col. 16, line 29; col. 16, lines 30-34; col. examples 1-2; & col. 41-50, claims 2-4, 8, 12 & 15), which meets the limitations recited in instant claims 1-3, 5-8 and 14 because AD is a dementia disorder and a CNS age-related cognitive impairment human disease, dementia is CNS cognitive impairment disorders as recited in claims 1-2, and CNS damage caused by stroke, ischemia and trauma which results in cognitive impairment or vascular dementia as evidenced by Kalaria et al. (see p. 915 abstract; Kalaria et al. Biochem. Biophys. Acta, 2016; 1862:915-925); and the “LTA4H hydrolase inhibitors” disclosed by Isakson is a LTA4H modulatory agent for treating AD/dementia/stroke/ischemia leading to vascular dementia, and these “LTA4H hydrolase inhibitors”/small organic compounds reasonably antagonize both the epoxide hydrolase (i.e., as it relates specifically to claims 5 & 6) and aminopeptidase activities of LTA4H given the structure of Isakson’s compounds inhibiting inflammation, the limitations of claims 5 & 6 are reasonably anticipated; absent evidence to the contrary. Thus, claims 1-3, 5-8 and 14 are anticipated by Isakson et al (US5700816) as evidenced by Kalaria et al..
Double Patenting
9. 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 1-8 and 14-15 are ejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No.11426399 or claims 1-13 U.S. Patent No. 11957671 as evidenced by Salloway et al. (J. Geriatr. Psychiatry Neurol., 1998; 11:71-77). Although the claims at issue are not identical, they are not patentably distinct from each other because the method recited in the claims of US11426399 (the ‘399 patent) or US11957671 (the ‘671 patent) anticipate instant claims.
Claims 1-17 of the ‘399 patent claim a method of improving cognitive function in a subject diagnosed with an age-related cognitive impairment caused by neuroinflammation, comprising administering a small molecule inhibiting LTA4H aminopeptidase and epoxide hydrolase activity, wherein the cognitive impairment includes cognitive impairment is caused by a neuroinflammatory disease including Alzheimer’s disease, mild cognitive impairment, Parkinson’s disease, parkinsonism, Frontotemporal dementia, dementia, dementia with Lewy bodies
Claims 1-13 of the ‘671 patent claim a method of improving cognitive function in a subject diagnosed with an age-related cognitive disease, comprising administering a compound of formula (I), which is a class of benodioxane inhibitors that inhibit LTA4H aminopeptidase and epoxide hydrolase activity; and wherein the age-related cognitive disease includes CADASIL (claim 12), which is a genetic form of vascular dementia as evidenced by Salloway et al. (see p. 71, abstract; p. 71, 2nd col. 3rd paragraph; Salloway et al. J. Geriatr. Psychiatry Neurol., 1998; 11:71-77); and the limitation “age-related cognitive disease” includes Alzheimer’s disease, mild cognitive impairment, vascular dementia, Parkinson’s disease, parkinsonism, Frontotemporal dementia, dementia, dementia with Lewy bodies. Therefore, claims 1-8 and 14-15 of the instant Application are not patentably distinct from claims 1-17 of the ‘399 patent or claims 1-13 of the ‘671 patent because claims 1-8 and 14-15 of the instant Application are anticipated by claims 1-17 of the ‘399 patent or claims 1-13 of the ‘671 patent.
10. Claims 1-8 and 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No.18585939 as evidenced by Salloway et al. (J. Geriatr. Psychiatry Neurol., 1998; 11:71-77). Although the claims at issue are not identical, they are not patentably distinct from each other because the method recited in claims 1-20 of Application No.18585939 (the ‘939 Application) anticipate instant claims.
Claims 1-20 of the ‘939 Application claim a method of improving cognitive function in a subject diagnosed with an age-related cognitive disease, comprising administering to the subject a compound of formula (I) or a pharmaceutically acceptable salt thereof, which is a class of Beno dioxane inhibitors that inhibit LTA4H aminopeptidase and epoxide hydrolase activity, and wherein the age-related cognitive disease includes CADASIL (claim 12), which is a genetic form of vascular dementia as evidenced by Salloway et al. (see p. 71, abstract; p. 71, 2nd col. 3rd paragraph; Salloway et al. J. Geriatr. Psychiatry Neurol., 1998; 11:71-77), and the limitation “age-related cognitive disease” includes Alzheimer’s disease, mild cognitive impairment, vascular dementia, Parkinson’s disease, parkinsonism, Frontotemporal dementia, dementia, dementia with Lewy bodies. Therefore, claims 1-8 and 14-15 of the instant Application are not patentably distinct from claims 1-17 of the ‘399 patent or claims 1-13 of the ‘671 patent because claims 1-8 and 14-15 of the instant Application are anticipated by claims 1-17 of the ‘399 patent or claims 1-13 of the ‘671 patent.
This is a provisional nonstatutory double patenting rejection.
Conclusion
11. NO CLAIM IS ALLOWED.
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Chang-Yu Wang
September 29, 2025
/CHANG-YU WANG/Primary Examiner, Art Unit 1675