Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4 November 2024 has been entered.
Status of Application, Amendments and/or Claims
3. Applicant’s response dated 11/4/2024 and 6/12/2025 are considered and entered into record. Claim 10 has been amended. Claims 10-13, and 15-16, drawn to a method for treating (ALS) in a subject are currently pending, and being considered for examination in the instant application.
Rejections maintained
Claim Rejections - 35 USC § 103
4. 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.
5. Claims 10-13, and 15-16 are rejected under 35 U.S.C. 103(a) as obvious over Revel et al (WO 2008/026198, published 3/6/2008), in view of Proschel et al WO 2007/025306, 3/1/2007, and Karussis et al (Arch Neurol 67: 1187-1194 (1-17), 2010). The rejection is maintained for reasons of record in the Office Action dated 4/11/2024 and the Advisory action dated 7/30/2024. As noted in the Advisory action, claim 19 (rejected in the Final Office action dated 4.11.2024) was cancelled. Minor modifications are made to address the amendments.
6. The claims are drawn to a method of treating ALS in a human subject in need thereof, comprising only intrathecally administering to the subject, a therapeutically effective amount of non-genetically modified human astrocytes, wherein such cells have been ex vivo differentiated from pluripotent stem cells (PSC), selected from embryonic stem cells (ESC) or induced PSC (iPSC), and subjected to terminal differentiation in the absence of growth factors for 7 days (claim 10); wherein the astrocytes: express each of GFAP, GLAST or AQP4 or a combination of the same (claim 11); display the secretion of neurotrophic factors like BDNF, GDNF or VEGF (claim 12); display glutamate uptake capacity (claim 13); are non-autologous (claim 15); and allogenic (claim 16) to the subject.
7. Revel et al teach a method of treating a medical condition of the central nervous system (CNS) in a subject by administering therapeutically effective amount of cells like human astrocytes that are ex vivo differentiated from human stem cells (PSC) (abstract; clams 1, 2, 6, 9, 53; page 5, lines 12-13; page 25, lines 25-29), wherein the stem cells are allowed to differentiate after removing growth factors until they "show an astrocytic phenotype” (terminal differentiation) from "(culture....without growth factors for 5-15 days)" (includes 7 days) (page 25, lines 28,29); wherein: human stem cells are embryonic stem cells (page 19, lines 11-12, 14-18; page 5, lines 32-33), the condition can be aberration in myelination like ALS (page 1, lines 12, 13, 19), and the administration is done directly to the brain or to the spinal cord (page 33, lines 28-30). Revel et al also teach that astrocytes are characterized by expression of GFAP, GLAST, GLT1 etc. (page 18, lines 10-13) (instant claim 11). The reference teaches that the ALS model to be used in the method is a transgenic mouse comprising SOD1 mutation (page 34, lines 20-21). Because the astrocytes are derived from humans and transplanted to diseased transgenic ALS rats, the cells are non-autologous (instant claim 15). Revel et al also teach that the cells can be from an allogenic donor, or from embryonic stem cells (page 29, lines 12, 13) (instant claim 16). Since there is no teaching of genetic modification of cells, the cells are non-genetically modified (instant claim 10). Even though the reference does not teach that the cells secrete the claimed neurotrophic factors and display glutamate uptake, this is an inherent property of astrocytes that was known to the skilled artisan at the time of filing of the instant invention. Clearly, the skilled artisan need not recognize every inherent feature of the invention at the time the invention is made. MPEP §2112(II) (instant claims 12-13).
8. Even though Revel et al teach culturing for 5-15 days in the absence of growth factors to generate astrocytes, the reference does not teach a culture for 7 days (as recited in amended claim 10).
9. However, the differences between the claimed method and the prior art method appears to be one of optimization of the conditions for culture (e.g., number of days) using the same starting cells to generate the same cell population (astrocytes) in the absence of growth factors. It would have therefore, been obvious to one of ordinary skill in the art at the time the invention was filed to have optimized the culture conditions comprising 5-15 days without growth factors to arrive at 7 days as recited in instant claim 10. See MPEP 2144.05: A. Optimization Within Prior Art Conditions or Through Routine Experimentation.
10. Culture times are result-effective variables which can be optimized. In the case of generating astrocytes in the absence of growth factors by culturing for 7 days, one of skill in the art would clearly recognize that culture days could easily be optimized by a cell biologist having an expertise in culture. In in re Boesch, 617 F.2d 272,276, 205 USPQ 215, 219 (CCPA 1980), it was held that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art."
11. Revel et al do not teach the administration of human astrocytes in a human subject.
12. Revel et al however, explicitly state that information pertaining to cell delivery in disease animal models would be used for administering and treating humans (para spanning pages 33 and 34), wherein the disease can be ALS (claim 53), a known fatal human disease. It would therefore, have been obvious to the person of ordinary skill in the art, that treating a human disease would necessarily involve human subjects requiring human stem cells or human cells to avert consequences arising from species differences, serious graft versus host disease and to maintain allogeneicity of the cells (same species of donor and recipient). Furthermore, in considering the disclosure of a reference, it is proper to take into account not only specific teaching of the reference but also the inferences which one skilled in the art would reasonably be expected to draw therefrom (In re Preda, 401 F.2d 825, 159 USPQ 342, 344 (CCPA 1968)). Also, a reference must be considered, under 35 U.S.C. 103, not only for what it expressly teaches but also for what it fairly suggests; all disclosures of prior art, including unpreferred embodiments, must be considered in determining obviousness (In re Burckel 201 USPQ 67 (CCPA 1979)).
13. Even though Revel et al teach that the cells can be delivered directly to the spinal cord, the reference does not teach that the administration is ‘intrathecal’ (as in instant claims 10 and 19).
14. Proschel et al teach treating CNS lesions and degenerative diseases of the CNS, comprising administration of glial restricted precursor derived astrocytes (GDAs) (page 2, Summary; page 7, lines 28-29). The reference teaches methods for the treatment of CNS lesions, including amyotrophic lateral sclerosis (page 12, last para), wherein the GDAs can be derived from pluripotent stem cells (page 8, para 3; para spanning pages 9, 10; claim 14). The reference also teaches that the cell suspension can be injected by lumbar puncture without laminectomy (i.e., intrathecal administration) (page 13, lines 7, 10-12).
15. Karussis et al teach a clinical trial study using mesenchymal stem cell (MSC) transplantation in ALS patients (human). The reference teaches advantages of intrathecal delivery for cell-based therapies in neurological diseases like ALS. Karussis et al explain that intrathecal cell therapy in ALS (characterized by widespread tissue damage throughout the neuroaxis), increases “migration of the injected cells to the proximity of the CNS lesions”, so that the cells “circulate with the flow of the cerebrospinal fluid” and reach the affected areas in the brain, as opposed to other systemic forms of administration, which can lead the therapeutic cells travel to other organs, resulting in less availability to the CNS. The reference adds that intrathecal delivery of cells produces “immunomodulatory and trophic effects directly on the CNS, without producing systemic adverse effects” (para spanning pages 7 and 8).
16. It would therefore, have been obvious to the person of ordinary skill in the art at the time the invention was effectively filed, to modify the method of treating neurological or demyelinating disorders like ALS with astrocyte cells as taught by Revel et al, by intrathecal administration of astrocytes to ALS subjects as taught by Proschel et al, in view of the advantages of intrathecal cell delivery for ALS treatment based upon the teachings of Karussis et al. The person of ordinary skill would have been motivated to pursue intrathecal administration as this increases “migration of the injected cells to the proximity of the CNS lesions”, thereby producing “immunomodulatory and trophic effects directly on the CNS” (Karussis et al), and resulting in greater therapeutic efficacy. The person of ordinary skill would have been motivated to administer astrocytes to patients having neurodegenerative diseases like ALS, as this would help promoting CNS regeneration (Proschel et al, page 12, lines 15, 24, 29). The person of ordinary skill would have expected reasonable success because non-invasive and effective modes of cell delivery into the CNS for treating neurodegenerative diseases were being actively tested, at the time the invention was filed.
17. Thus, the claimed invention as a whole was prima facie obvious over the teachings of the prior art.
Applicant’s Remarks:
18. Summarizing the rejection, Applicant argues that the teachings of the cited references cannot be combined as: (i) Karussis teaches the migration of MSCs, while Proschel teaches localization of cells using gels, and mentions intrathecal for “treating local damage”; (ii) Karussis teaches stem cells, while Proschel and Revel teach astrocyte like cells; (iii) Karussis teaches a “combined intrathecal and intravenous administration” for maximizing therapeutic efficacy, while instant amended claims limit to intrathecal administration only. Applicant therefore, asserts that the instant results are unexpected and surprising. Applicant also provides a post-dated reference (Gotkine et al, 2023) by instant inventive entity, showing evidence of clinical efficacy in ALS patients using intrathecal administration of astrocytes. Applicant thereby concludes that the rejection is moot.
19. In the 6/12/2025 Remarks, Applicant refers to the amendment of claim 10 reciting that the administered cells are subjected to a terminal differentiation step in the absence of growth factors for 7 days. Applicant asserts that these cells are surprisingly “effective in ALS treatment of an animal model, as compared to astrocytes deprived of growth factors for 42 days”.
20. Applicant's arguments are fully considered, however, are not found to be persuasive. As stated in the rejection, Proschel is teaching administration of astrocytes for treating degenerative diseases of the CNS like ALS by lumbar puncture (intrathecal injection (without laminectomy) of the cell suspension) (page 12, lines 27-29; page 7, lines 28, 29; page 13, lines 10-12). The reference also teaches the application of cells in a paste or gel at the site of a lesion (page 13, lines 13-15). Proschel et al therefore, provides modes of delivery for treating different conditions (e.g., damage or injury of the nervous system as well as degenerative disorders of the nervous system). “The prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also MPEP § 2123.
21. Applicant’s argument about the combined treatment (intravenous and intrathecal delivery of stem cells) of Karussis is considered, however, is not found to be persuasive. Karussis uses MS and ALS patients in the study (page 4, Treatment Protocol). Even though Karussis teaches treatment of ALS by a combination of intravenous and intrathecal delivery of stem cells, the reference clearly emphasizes the advantages of intrathecal cell administration for treating ALS (para spanning pages 7 and 8). Karussis also points to the fact that in recent studies, intravenous injections of MSC showed effective immunomodulation and efficacy “at least in the case of MS” (page 7, last para; page 8, para 3), implicitly suggesting that the intravenous mode is more known to be efficacious in MS. Karussis is therefore, a pertinent art for underscoring the only step of intrathecal injection of cells as a therapeutic measure. A prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Karussis et al not only teaches intrathecal cell delivery, the reference adds a motivation for the same for treating ALS. It is noted that Karussis was only selected for its emphasis on the advantage of intrathecal mode of delivery. Upon considering the teachings of Karussis et al, a person of ordinary skill in the art would certainly be motivated to administer cells by intrathecal delivery for treating ALS.
22. Applicant argues that Karussis teaches stem cells, while Revel and Proschel teach astrocytes. It is again repeated that Karussis was used in the rejection as it provided a strong motivation for the intrathecal mode of administration of cells for treating ALS. Applicant is reminded that this being a 103 rejection, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
23. The Gotkine reference provided by Applicant is fully considered. The reference teaches that an intrathecal administration of a single low or high dose (100 x 106 cells; 250 x 106 cells respectively) of human astrocytes to ALS patients, is safe and results in a beneficial clinical effect, which is maintained for 3 months (Abstract; Conclusions). In other words, Gotkine et al teach single intrathecal injections of specific doses of astrocytes to be effective for a specific time interval, none of which are required by instant claims. The results of Gotkine et al are therefore, not commensurate in scope with the instant claims. Moreover, the combination of the cited references proves that the knowledge and expertise of the claimed method for treating ALS by intrathecal administration of astrocytes was known in the art and the results were expected to be successful.
24. With reference to the 6/12/25 amendment of claim 10, necessary modification of the rejection is made as presented above. Applicant argues that transplanted astrocytes obtained after 7 days of terminal differentiation in the absence of growth factors, were more effective in ALS treatment than those obtained after 42 days of the same differentiation protocol. As stated in the rejection above, the cited art (Revel et al) teaches (terminal) differentiation of cells to astrocyte phenotype by culturing without growth factors for 5-15 days (which certainly includes 7 days, however, excludes 42 days). Therefore, Revel et al render a 7 day culture for generating astrocytes in the absence of growth factors, and use of the cells for ALS treatment, as obvious.
25. Moreover, the instant claims do not require a comparison with 42 days of terminal differentiation. Narrow limitation contained in the specification cannot be inferred in the claims where the elements not set forth in the claims are linchpin of patentability. See In re Philips Industries, Inc. v. State Stove & Mfg. Co., 522 F.2d 1137, 186 USPQ 458 (CA6 1975), 237 PTJA A-12. While the claims are to be interpreted in light of the specification, it does not follow that limitations from the specification may be read into claims. On the contrary, claims must be interpreted as broadly as their terms reasonably allow. See Ex parte Oetiker, 23 USPQ2d 1641 (BPAI, 1992). Applicant is reminded that the claims define the subject matter of his invention and that the specification cannot be relied upon to read limitations into the claims.
26. Applicant’s assertion of unexpected and surprising results is considered but not found to be persuasive. Based upon the 103 rejection, and the analysis presented above, the prima facie obviousness of the claimed invention in view of the combined references, provides sufficient reasoning, and nullifies Applicant’s allegations of the improper teachings in the individual references. Applicant’s assertion of unexpected results does not overcome the rejection because of obvious expected properties taught in the prior art, either explicitly or implicitly. “Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness”. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977).
27. In summary, Revel et al teach administration of astrocytes to spinal cord for treating ALS, Proschel et al teach intrathecal administration of astrocytes for treating neurodegenerative diseases like ALS, and Karussis highlights the advantages of intrathecal delivery of therapeutic cells for treating ALS. That is, despite the differences between astrocytes and MSCs, both cells are taught in the prior art for intrathecal delivery for treating ALS. Hence the cited references are appropriately combinable to provide motivation to a skilled artisan and show obviousness of instant claims. The rejection is therefore, maintained.
Double Patenting
28. 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).
29. 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).
30. 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.
31. 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.
32. Claims 10-13, 15-16 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 8 and 9 of US Patent 10,258,651. The rejection is maintained for reasons of record in the Office Action dated 4/11/2024. Minor modifications are made to address the amendments. Please note that previously rejected claim 19 is now canceled.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims recite treating ALS comprising intrathecally administering a therapeutically effective amount of astrocytes, which are ex vivo differentiated from human embryonic stem cells, to a human subject, wherein the astrocytes are generated (terminal differentiation) using a medium "devoid of EGF and bFGF" (in the absence of growth factors). It is noted that the instant specification teaches growing astrocytes in the “absence of growth factors (EGF+bFGF)” (page 28, line 14).
The only differences are as follows:
(i) Instant claims 11-13 recite the markers and cellular properties of astrocytes, while the ‘651 claims do not have these limitations. However, these will be inherent to astrocyte cells.
(ii) Instant claims recite non-genetically modified cells, while the ‘651 claims do not. However, the ‘651 specification does not teach genetic modification of cells, other than describing this as an alternative mode in col 17, lines 5-8.
(iii) Instant claims recite that the cells are non-autologous or allogenic, while the ‘651 patent claims do not have these limitations. However, the ‘651 patent teaches that the cells can be non-autologous or allogenic (col 21, para 8; col 20, lines 26, 27).
(iv) Instant claims recite differentiation to astrocytes in the absence of growth factors for 7 days, while the ‘651 patent claims recite 6-10 days. However, since the starting cells, the resulting cell population, and the condition for differentiation to astrocytes in a medium devoid of growth factors are the same in both sets of claims, the person skilled in the art of cell culture would clearly recognize that culture days could obviously be modified by routine optimization.
33. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 10,258,651.
Applicant’s Remarks:
34. Applicant requests that addressing the rejection on grounds of nonstatutory obviousness-type double patenting be deferred until indication of allowable subject matter.
35. The rejection has not been overcome by amendment or the filing of an approved terminal disclaimer. Thus, the rejection is maintained.
36. Claims 10-13, 15-16 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, of US Patent 9,631,175 in view of Proschel et al (2007) and Karussis et al (2010). The rejection is maintained for reasons of record in the Office Action dated 4/11/2024. Minor modifications are made to address the amendments. Please note that previously rejected claim 19 is now canceled.
NOTE: No arguments were presented against this rejection in the remarks associated with the 11.4.2024 RCE or the 6.12.2025 amendments. That is, the stated amendments are not fully responsive [MPEP 714.03]. However, in the interest of advancing prosecution, the rejection is reiterated and maintained.
Although the conflicting claims are not identical, they are not patentably distinct from each other because in each case the claims recite treating a myelination or neurodegenerative disease by administering human astrocytes that are ex vivo differentiated from human embryonic stem cells, wherein the astrocytes are generated (terminal differentiation) using a medium "devoid of EGF and bFGF" (in the absence of growth factors). It is noted that the instant specification teaches growing astrocytes in the “absence of growth factors (EGF+bFGF)” (page 28, line 14).
The only differences are as follows:
(i) Instant claims recite treating ALS, while the ‘175 patent claims do not. However, the ‘175 disclosure teaches ALS as one of the demyelinating neurodegenerative diseases that can be treated with administration of astrocytes (para 0003 of PGPB). Even though the ‘175 claims do not recite the astrocyte characteristics as recited in instant claims 11-13, the features will be inherent to the cells, and moreover, is taught in the ‘175 specification (Fig 1e, 3 a-c; para 0111, 0134 of the PGPB).
(ii) Instant claims do not recite the process of generating astrocytes presented in ‘175 patent claims, however, the instant claims represent a genus claim reciting the use of ex vivo differentiated astrocytes. The steps of isolating astrocytes in the ‘175 claims indicate a product-by-process limitation. "Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by- process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695,698,227 USPQ 964,966 (Fed. Cir. 1985).
(iii) Instant claims recite intrathecal administration, while ‘175 patent claims do not. However, the ‘175 patent teaches that cells can be administered into the spinal cord by injection such that the circulation is in the brain and blood (col 23, lines 29-32, col 21, lines 46-49). The mode of intrathecal administration would be obvious in view of the teachings of Proschel et al and Karussis et al as stated above.
(iv) Instant claims recite differentiation to astrocytes in the absence of growth factors for 7 days, while the ‘175 patent claims do not recite the number of culture days. However, the ‘175 patent teaches the generation of glial cells like astrocytes by differentiation in the absence of growth factors for 6-10 days (col 3, lines 41-47; col 4, para 1; col 5, lines 1-2, 61-62; col 6, lines 9-11). Since the starting cells, the resulting cell population, and the condition for differentiation to astrocytes in a medium devoid of growth factors are the same in both sets of claims, the person skilled in the art of cell culture would clearly recognize that culture days could obviously be modified by routine optimization.
(v) Instant claims recite that the cells are non-autologous or allogenic, while ‘175 patent claims do not have these limitations. However, the ‘175 patent teaches that the cells can be non-autologous or allogenic (col 21, para 8; col 20, lines 26, 27).
37. Therefore, the instant claims are not patentably distinct over the issued claims in U.S. patent 9,631,175.
Conclusion
38. No claims are allowed.
39. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aditi Dutt whose telephone number is (571)272-9037. The examiner can normally be reached on M-F 9:00am-5:00pm.
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/A. D./
Examiner, Art Unit 1675
5 January 2026
/KIMBERLY BALLARD/Primary Examiner, Art Unit 1675