DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 10, 2026 has been reviewed by the examiner and entered of record in the file.
3. Claims 1, 7-9, and 19-25 are amended.
4. Applicant previously elected the neurosteroid species: allopregnanolone. The neurosteroid species pregnenalone is herein rejoined for examination.
5. Claims 1, 3 4, 7-9 and 19-25 are under examination and are the subject of this office action.
Priority
6. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 35 U.S.C. 120 as follows:
7. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
8. In this case, the disclosure of the prior-filed application, Provisional Application No. 62/674,379, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application, as follows:
the instantly recited limitation “wherein the TLR-mediated inflammatory condition is non-responsive to GABAergic drugs” in independent claims 1 and 20 lacks description or support in Provisional Application No. 62/674,379.
9. Therefore, the instant claims are afforded benefit of priority to PCT/US2019/ 033053, filed May 20, 2019.
Previous Claim Objections
10. Previously misnumbered claims 22-26 have been renumbered as claims 21-25; therefore, the previous claim objections are withdrawn.
11. Claim 7 was previously objected to for missing a period at the end of the claim. In view of the amendment to add a period, the previous objection is withdrawn.
New Claim Objections
12. Claim 22 (previously numbered as claim 23) now depends from itself. A dependent claim may refer to any preceding independent claim, but not to itself.
It is assumed that Applicant intended claim 22 to be dependent upon claim 21.
Withdrawn Claim Rejections - 35 USC § 112(b)
13. Claim 9 was previously rejected for reciting the limitation “the peripheral blood mononuclear cells” in lines 4-5, which lacked antecedent basis because claim 8 is limited to assaying the sample of “peripheral blood,” not of “peripheral blood mononuclear cells.
In view of Applicant’s amendment to claim 9 to delete the text “mononuclear cells” such that the limitation is now “peripheral blood,” the previous indefiniteness rejection is withdrawn.
14. Original claim 23 (now claim 22) was previously rejected for reciting the limitation “the peripheral blood mononuclear cells” in lines 4-5, which lacked antecedent basis because claim 20 is limited to assaying the sample of “peripheral blood,” not of “peripheral blood mononuclear cells.
In view of Applicant’s amendment to claim 22 to delete the text “mononuclear cells” such that the limitation is now “peripheral blood,” the previous indefiniteness rejection is withdrawn.
Maintained Claim Rejections - 35 USC § 112(b)
15. 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.
16. Claims 1, 3, 4, 7-9 and 19-25 remain 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.
17. Claim 1 remains rejected as being unclear in the following aspects:
(a) The limitation “wherein the inflammatory condition is non-responsive to GABAergic drugs,” renders the claim indefinite because the term “GABAergic drugs” is not defined by the claim nor in the Specification, such that one of ordinary skill in the art would not reasonably be apprised of the scope of the invention.
(b) It is not clear if the limitation that “the TLR-mediated inflammatory condition is non-responsive to GABAergic drugs” previously occurred in the subject having the TLR-mediated inflammatory condition, or if it is an additional step subsequent to the administration of the neurosteroid in the subject, or if the property of being non-responsive refers to the TLR-mediated inflammatory condition itself and not the subject being treated. Clarification is requested.
18. Claims 3, 4, 7-9, 19 and 25 remain rejected as being dependent upon and including all of the limitations of claim 1.
19. Claim 20 remains unclear in the following aspects:
(a) The limitation “wherein the alcoholism or alcohol detoxification is non-responsive to GABAergic drugs,” renders the claim indefinite because the term “GABAergic drugs” is not defined by the claim nor in the Specification, such that one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
(b) It is not clear if the limitation that “the alcoholism or alcohol detoxification is non-responsive to GABAergic drugs” previously occurred in the subject having alcoholism or alcohol detoxification or if it is an additional step subsequent to the administration of the neurosteroid in the subject, or if the property of being non-responsive refers to the condition of alcoholism or alcohol detoxification itself and not the subject being treated. Clarification is requested.
**In view of a broadest reasonable interpretation as understood by one of skill in the art, consistent with the specification, the limitation that the inflammatory condition/ alcoholism or alcohol detoxification “is non-responsive to GABAergic drugs” is construed to mean that the inflammatory condition/ alcoholism or alcohol detoxification does not demonstrate clinical benefit in general, and wherein “GABAergic drugs” encompass drugs that enhance the effects of gamma-aminobutyric acid (GABA), a neurotransmitter responsible for reducing neuronal excitability in the brain, including benzodiazepines, barbiturates, and certain anticonvulsants.
20. Renumbered claims 21-24 remain rejected as being dependent upon and including all of the limitations of claim 20.
Response to Arguments
21. Applicant traverses the previous indefiniteness rejections and argues the following points:
(i) Regarding the term "GABAergic drug," Applicant argues that based on knowledge in the art and would be reasonably apprised of the scope of the combination of features of the claims accordingly, i.e., “[t]he term "GABAergic drugs" is a well-established term of art in neuropharmacology that a person of ordinary skill would immediately understand as referring to agents that modulate GABAergic signaling, including benzodiazepines, barbiturates, and related anticonvulsants. The Office's own broadest reasonable interpretation confirms this, construing the term to mean "drugs that enhance the effects of gamma-aminobutyric acid (GABA)... including benzodiazepines, barbiturates, and certain anticonvulsants." (see, Office Action, page 7).” (Applicant’s Remarks, pages 2-3).
Applicant alleges that: “[a] term that admits a coherent, consistent broadest reasonable interpretation is not indefinite under 35 U.S.C. § 112(b).” Applicant argues that a skilled artisan in this field would understand that GABA refers to "gamma-aminobutyric acid," the main inhibitory neurotransmitter in the central nervous system, and that the GABAergic system in the CNS is implicated in pathophysiology of various neuropsychiatric disorders, for example, controlling impulsivity and the initiation of binge alcohol drinking (see Specification at page 12, lines 1-4).” Applicant contends that a skilled artisan would therefore also understand that a "GABAergic drug" encompasses any drug that modulates the activity of the GABA receptor.
22. Applicant's arguments have been fully considered but they are not persuasive. While the Office broadly interpreted the term “GABAergic” in the 35 USC 103 rejection(s) to mean drugs that enhance the effects of gamma-aminobutyric acid (GABA), including benzodiazepines, barbiturates, and certain anticonvulsants, Applicant’s disclosure does not define the claim term such that one skilled in the art would not be reasonably apprised of the scope of the invention. The term is indefinite because the specification does not clearly define the term.
(ii) Regarding the limitation: "wherein the [condition] is non-responsive to GABAergic drugs" Applicant argues that said limitation is clear such that a skilled artisan would be reasonably apprised of the scope of the invention, and references the specification at page 2, line 30-31, i.e.: "In some embodiments, the TLR-mediated inflammatory condition is a medical disorder that is non-responsive to GABAergic drugs..." In light of the specification, a skilled artisan would understand that the term "wherein the [condition] is non-responsive to GABAergic drugs" refers to the condition.” (Applicant’s Remarks, page 8). Applicant contends that this should be clear from the plain language of the claim, which recites "wherein the TLR-mediated inflammatory condition is non-responsive to GABAergic drugs," and that from the plain language of the claim, it is the condition that is non-responsive to GABAergic drugs and not the subject. Applicant contends that it is not a step subsequent to administration, and that the plain language of the claim recites it being a property of the TLR-mediated inflammatory condition: “[a]s a property of the TLR-mediated inflammatory condition, it therefore is not a separate step of the method because again it is a property of the condition itself.” (Applicant’s remarks, page 8).
26. Applicant's arguments have been fully considered but they are not persuasive. Applicant alleges that the limitation “wherein the TLR-mediated inflammatory condition is non-responsive to GABAergic drugs” is a property of the TLR-mediated inflammatory condition itself, and therefore is not a separate step of the method. However the disclosure does not define said limitation as a property inherent to the recited TLR-mediated inflammatory condition(s). The specification mentions this limitation at page 2, line 30-31, i.e.: "In some embodiments, the TLR-mediated inflammatory condition is a medical disorder that is non-responsive to GABAergic drugs...," but fails to clarify in the claim itself whether the non-responsiveness is a property of said condition or a previously occurring or additional step.
New Claim Rejections - 35 USC § 112
27. 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.
28. Claims 1, 3, 4, 8, 9, and 19-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a few in vitro assays demonstrating the ability of the instantly recited neurosteroids to modulate TLR2 and TLR4 in RAW264.7 cells, P rat VTA cells, and P rat NAc cells, does not reasonably provide enablement for a method of treating the full scope of TLR-mediated inflammatory conditions including sepsis, gastrointestinal disease, chronic obstructive pulmonary disease, asthma, atherosclerosis, alcohol detoxification, and dementia. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
29. The standard for determining whether the Specification meets the enablement requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242 U.S. 261 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? As recognized by the court in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), that is still the standard to be applied, determined by consideration of the Wands factors (MPEP 2164.01(A)); namely, nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered, with the most relevant factors discussed below.
30. Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
31. In the instant case, the claims are drawn to a method of treating a TLR-mediated inflammatory condition selected from sepsis, gastrointestinal disease, chronic obstructive pulmonary disease, asthma, atherosclerosis, alcohol detoxification, and dementia, comprising administering a neurosteroid selected from pregnenolone or alloprepnanolone or a combination thereof.
32. The State of the Prior Art and the Level of Predictability in the Art:: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art refers to the skill of those in the art in relation to the subject matter to which the claimed invention pertains at the time the application was filed.”
As described above, the claims are drawn to a method of treating any TLR-mediated inflammatory condition selected from sepsis, gastrointestinal disease, chronic obstructive pulmonary disease, asthma, atherosclerosis, alcohol detoxification, and dementia.
33. The state of the art regarding neurosteroids is that Pinna (Frontiers in Endocrinology 2020) teach that the neurosteroid allopregnanolone is a positive allosteric modulator of GABA action at GABAA receptor and is implicated in acute and chronic stress, has pharmacological effects as an anxiolytic and antidepressant agent in animal models and humans, is suggested for mood disorders, and is an effective therapeutic agent in the treatment of postpartum depression. The state of the art does not teach the use of neurosteroids including pregnanolone or allopregnanolone across the broad scope of recited conditions.
Regarding the support provided in the Specification (i.e., in vitro assays demonstrating TLR inhibitory activity on RAW264.7 cells and P rat cells), AcceGen (webpage printout 2026) teaches that “the RAW-264. 7 cell line is a widely used model for studying mouse macrophage biology, particularly in immunology and microbiology research. These cells are instrumental in investigating cellular responses to microbial components, inflammation, and immune signaling. This cell line is also extensively used in osteoclast research.” (see page 2 under “Application”). Stewart (Alcohol Health Research World 1997) teaches that the P rat line are selectively bred “alcohol-preferring” (P) rats, which are a useful model for investigating the possible neurobiological processes underlying alcoholism (see abstract). VTA cells are isolated from the Ventral Tegmental Area (VTA) of alcohol-preferring (P) rats, NAc cells are isolated from the Nucleus Accumbens (NAc) of alcohol-preferring (P) rats, likewise, hypothalmus and amygdala cells are isolated from their respective organs in alcohol-preferring (P) rats. However, inhibition of TLR2, TLR4, and/or TLR7 activity in said cell lines is not predictive/ does not translate directly into treatment of the full scope of recited conditions.
34. This unpredictability is certainly true in the case of treating the vast scope of conditions embraced by the claims; while they share a feature of being mediated by proinflammatory toll-like receptors, they encompass a broad, complex spectrum of morbidity and mortality, embracing different pathologies having vastly different etiologies and patient populations, for example: “gastrointestinal diseases” embrace stomach flu, irritable bowel syndrome, pancratitis, constipation, ulcerative colitis, hemorrhoids, inflammatory bowel disease, gastritis, celiac disease, Crohn’s disease, peptic ulcer disease, gallstones, gastroesophageal reflux disease, diverticulitis, gastroparesis, and food poisoning; and “dementia” embraces Alzheimer’s disease, vascular dementia, Lewy Body dementia, Frontotemporal dementia, Parkinson’s dementia, Creutzfeldt-Jakob disease, and mixed dementia, wherein this non-limiting list includes autoimmune diseases and neurodegenerative diseases, which are incredibly difficult to diagnose, let alone treat, such that it is evident that said conditions embrace an unpredictable spectrum.
35. There is no question Applicant’s instant neurosteroid may play a role in future methods of treating certain of the aforementioned types of TLR-mediated inflammatory conditions. What is disputed is the claim that the recited method could be employed by one skilled in the art at the effective filing date of the claimed invention and used as treatment for any/ all types and kinds of TLR-mediated conditions embraced by the claims without undue experimentation. There is simply no evidence to be found in the literature suggesting that Applicant’s compounds are capable of being used in the manner recited. In essence, there is no absolute predictability in pharmacology, even with compounds whose properties have been determined, despite the extraordinarily high skill possessed by the ordinary artisan. Hence, in the absence of a showing of correlation between all of the types of TLR-mediated inflammatory conditions embraced by the claims as capable of being treated by a neurosteroid of claim 1, one of skill in the art is unable to fully predict possible results from the administration of the compound(s) of the instant claims for treating the full scope of conditions encompassed by the claims.
36. As such, one of skill in the art would be unable to fully predict the therapeutic effects of administering pregnenolone or allopregnanolone for the treatment of the full scope of TLR-mediated inflammatory conditions recited by the instant claims.
37. Relative Skill of those in the Art: The level of skill in the art of one tasked with treating or preventing any type of autoimmune disease or disorder in a subject, i.e., scientists or physicians, represent one of ordinary skill in the art.
38. The Amount of Direction Provided by the Inventor / Existence of Working Examples: The amount of direction provided by the Applicant is considered to be determined by the Specification and the working examples. In the instant case, Applicant provides no working examples demonstrating the in vitro or in vivo effect(s) of any neurosteroid of claim 1, on any of the recited inflammatory conditions. The only guidance provided at all are a few in vitro studies demonstrating the effects of pregnanolone or allopregnanolone on TLR2, TLR4, and TLR7 signaling in in vitro assays with RAW264.7 cells and P rat cells (Examples 1-2 in the Specification, pages 19-36). AcceGen (webpage printout 2026) teaches that “the RAW-264. 7 cell line is a widely used model for studying mouse macrophage biology, particularly in immunology and microbiology research. These cells are instrumental in investigating cellular responses to microbial components, inflammation, and immune signaling. This cell line is also extensively used in osteoclast research.” (see page 2 under “Application”). Stewart (Alcohol Health Research World 1997) teaches that the P rat line are selectively bred “alcohol-preferring” (P) rats, which are a useful model for investigating the possible neurobiological processes underlying alcoholism (abstract). No guidance is provided demonstrating the administration of pregnanolone or allopregnanolone for treating any of the recited inflammatory conditions whatsoever. As such, the Specification does not support the broad claim of treatment of any of the multitude of types of conditions embraced by the claims.
39. Scope or Breadth of the Claims: As stated in MPEP 2164.01(c), “[w]hen a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation.” Thus, as stated in MPEP 2164.08, “[t]he focus of the examination inquiry is whether everything within the scope of the claim is enabled” (emphasis added). The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557 (Fed. Cir. 1993) (emphasis added).
40. At the same time, however, it is also recognized that not everything necessary to practice the invention need be disclosed. Nor is it necessary that an Applicant test all the embodiments of his invention. In re Angstadt, 537 F.2d 498 (CCPA 1976) (emphasis added). In fact, as stated by the court in In re Buchner, 929 F.2d 660 (Fed. Cir. 1991), a patent need not teach, and preferably omits, what is well known in the art.
41. Accordingly, for purposes of enablement, the relevant concern is whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate in scope with the protection sought by the claims. Thus, while “a patent application is entitled to claim his invention generically” it is necessary that “he provide a disclosure sufficient to enable one skilled in the art to carry out the invention commensurate with the scope of his claims.” Amgen, Inc, v. Chugai Pharmaceutical Co., Ltd. (Fed. Cir. 1991). As noted by the court in In re Fisher, 427 F.2d 833 (CCPA 1970), the scope of enablement must bear a “reasonable correlation” to the scope of the claims. As stated in MPEP 2164.08, resolution of this concern requires two stages of inquiry: “[t]he first is to determine how broad the claim is with respect to the disclosure. The entire claim must be considered. The second inquiry is to determine if one skilled in the art is enabled to make and use the entire scope of the claim without undue experimentation”.
42. As to the first inquiry, as discussed above, the claims are drawn to a method of treating
43. Considering that the conditions to be treated include but are not limited to “gastrointestinal diseases” which embrace stomach flu, irritable bowel syndrome, pancratitis, constipation, ulcerative colitis, hemorrhoids, inflammatory bowel disease, gastritis, celiac disease, Crohn’s disease, peptic ulcer disease, gallstones, gastroesophageal reflux disease, diverticulitis, gastroparesis, and food poisoning; and “dementia” embraces Alzheimer’s disease, vascular dementia, Lewy Body dementia, Frontotemporal dementia, Parkinson’s dementia, Creutzfeldt-Jakob disease, and mixed dementia, wherein this non-limiting list includes autoimmune diseases and neurodegenerative diseases, which are incredibly difficult to diagnose, let alone treat, it is evident that the claims are broad.
Yet, as discussed above, the instant Specification discloses a few in vitro assays demonstrating the effects of pregnenolone or allopregnanolone on TLR activity in RAW264.7 cells, P rat cells, and fails to disclose any examples of treating or mitigating any of the recited diseases whatsoever. As such, the claim is extremely broad with respect to the disclosure. The second inquiry is discussed in detail below.
44. Amount of Experimentation Necessary: In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the invention as claimed.
Since identifying any TLR-mediated inflammatory condition that is capable of being treated by administering one or more of the recited compounds is extremely complex, the nature of the instant invention considered to be one of extreme complexity. In the instant case, this complexity is exacerbated by the challenges of treating any/ of the recited inflammatory conditions which can include autoimmune and neurodegenerative diseases. Although the relative skill of those in the art to which the invention pertains is high, the state of the art and unpredictability within the art is such that even the most talented artisan could not reasonably predict what autoimmune disease or inflammatory skin disease encompassed by the claims would be treatable based on the limited disclosure which fails to provide any working examples.
To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure.
Withdrawn Claim Rejections - 35 USC § 103
45. Claims 1, 3, 4, 7 and 25 were previously rejected under 35 U.S.C. 103(a) as being obvious over Chen et al., PLoS One (2011), in view of Nava-Mesa et al. and in view of Gambuzza et al., CNS & Neurological Disorders - Drug Targets, (2014), regarding the treatment of Alzheimer’s disease.
46. Claims 8 and 9 were previously rejected under 35 U.S.C. 103(a) as being obvious over Chen et al., PLoS One (2011), in view of Nava-Mesa et al. and in view of Gambuzza et al., CNS & Neurological Disorders - Drug Targets, (2014), as applied to claims 1, 3, 4, 7 and 25, and further in view of Kandimalla et al., Nucleic Acids Research (2013).
47. In view of Applicant’s amendatory changes to delete the recitation of “Alzheimer’s disease” from the TLR-mediated condition to be treated, the previous obviousness rejections of claims 1, 3, 4, 7-9 and 25 are withdrawn.
48. Claims 1, 3, 4, 7, and 20-25 were previously rejected under 35 U.S.C. 103 as being unpatentable over Finn et al., Pharmacology and Therapeutics (2004), in view of Liu et al, PNAS (2011), regarding the limitation of treating alcohol detoxification.
49. Claims 8, 9, 21 and 22 were previously rejected under 35 U.S.C. 103(a) as being obvious over Finn et al., Pharmacology and Therapeutics (2004), in view of Liu et al, PNAS (2011), as applied to claims 1, 3, 4, 7, 20 and 23-25, and further in view of Kandimalla et al., Nucleic Acids Research (2013).
50. In view of Applicant’s persuasive arguments, the previous obviousness rejections of claims 1, 3, 4, 7-9 and 25 are withdrawn.
Conclusion
51. Claims 1, 3, 4, 7-9, and 19-25 are present in the application. Claims 1, 3, 4, 7-9, and 19-25 are rejected. Claim 22 is objected to. No claim is presently allowable.
52. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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