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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 4, 2026 has been reviewed by the examiner and entered of record in the file.
3. Claims 1 and 11 are amended. Claims 21 and 22 are newly added.
Status of the Claims
4. The scope of the examined subject matter as previously set forth is as follows: a compound of formula (I) wherein R1 and R2 are hydrogen; R3 and R4 are as defined in claim 1; R5 is substituted or unsubstituted aryl; and X is NH; and the Cisd2 insufficiency-associated disorder is non-alcoholic steatohepatitis.
5. As all pending art rejections are herein withdrawn (see below), the scope of the examined subject matter is expanded to include all compounds according to Formula (I) of claims 1 and 11, wherein the Cisd2 insufficiency-associated disorder is non-alcoholic fatty liver disease, non-alcoholic steatohepatitis and hepatotoxicity.
6. Claims 1, 2, 4-9, 11, 12, 14-19, 21 and 22 are under examination with the elected species and are the subject of this office action.
Previous Claim Rejections - 35 USC § 103
7. Claims 1, 2, 4-9, 11, 12 and 14-19 were previously rejected under 35 U.S.C. 103 as being unpatentable over Chaudhary et al., U.S. 8,138,356 B2, as evidenced by North and Sinclair, Circulation Research 2012.
8. In view of Applicant’s amendment to delete the recitation of “aging related cardiac pathological change” from claims 1 and 11, the previous obviousness rejection is withdrawn.
New Claim Rejections - 35 USC § 112(b)
9. 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.
10. Claims 1, 2, 4-9, 11, 12, 14-19, 21 and 22 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.
11. Claim 1 recites the limitation: "identifying a subject suffering from a Cisd2 insufficiency-associated disorder, and administering to the subject an effective amount of a compound of formula (I)…" in lines 3-4, however there is insufficient antecedent basis for this limitation in the claim because the preamble of the claim recites a method of treating a disorder rather than a subject. That is, the preamble fails to recite a method of treating a subject in need of treatment. It is recommended that the preamble be amended to recite “a method of treating a Cisd2 insufficiency-associated disorder in a subject in need thereof, the method comprising:…”.
12. Claims 2, 4-9, and 21 are rejected as being dependent upon and including all of the limitations of claim 1.
13. Claim 11 recites the limitation ": "identifying a subject in need of increase in Cisd2 gene expression, and administering to the subject an effective amount of a compound of formula (I)…" in lines 3-4, however there is insufficient antecedent basis for this limitation in the claim because the preamble of the claim recites a method of treating a disorder rather than a subject. That is, the preamble fails to recite a method of treating a subject in need of treatment. It is recommended that the preamble be amended to recite “a method of treating a Cisd2 insufficiency-associated disorder in a subject in need thereof, the method comprising:…”.
14. Claims 12, 14-19, and 22 are rejected as being dependent upon and including all of the limitations of claim 11.
New Claim Rejections - 35 USC § 112(a)
15. 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.
16. Claims 1, 2, 4-9, 11, 12, 14-19, 21 and 22 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In particular, support cannot be found for the full scope of compounds of Formula (I), as instantly claimed.
17. The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus.
18. In the instant case, it is evident that the genus of compounds embraced by Formula (I) has substantial variance. The Markush group of compounds according to Formula (I) embraces hundreds of thousands of potential compounds which bear little structural resemblance to one another aside from a central tetrasubstituted 2-(amino/amide)-5-carbonyl-thiophene moiety. For example, within Formula (I), R5 can be any monocyclic or bicyclic aryl or heteroaryl moiety including phenyl, pyridinyl, oxazolyl, triazolyl, thienyl, furanyl, thiazolyl, isoxazolyl, benzimidazoyl, quinolinyl, indolyl, and benzothiazolyl (Specification, page 3, lines 13-17), which can be incorporated in hundreds of thousands of possible combinations, if not millions, with almost no structural overlap whatsoever.
19. The Specification teaches that the instant compounds are activators of Cisd2, which are useful for ameliorating various aging-related disorders (page 1, lines 11-22). The Specification discloses the preparation of just 35 compounds of Formula (I) at pages 10-25 wherein said compounds 1-35 are limited to species wherein R5 is phenyl, pyridyl or thiazolyl; and X is NH or CH2 (see also Table 1, pages 4-5). The instant Specification fails to disclose the preparation of any other compound species. The Specification discloses the ability of compounds 1-35 to agonize Cisd2 in vitro in Table 2 (see page 26).
20. While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that the instant disclosure does not adequately describe a subgenus embracing hundreds of thousands of additional compound species bearing no structural relationship. That is, the Specification does not disclose a sufficient variety of species to reflect the extreme variance in the genus.
21. The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”). Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of Formula (I) recited in the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
As such, claims 1, 2, 4-9, 11, 12, 14-19, 21 and 22 are rejected.
22. Claims 1, 2, 4-9, 11, 12, 14-19, 21 and 22 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 method of treating a Cisd2 insufficiency-associated disorder selected from NAFLD, non-alcoholic steatohepatitis, doxorubicin-induced chemotoxicity, doxorubicin-induced cachexia, hepatotoxicity, and hypertensive cardiomyopathy, comprising administering a therapeutically effective amount of Compound 1 to a subject in need thereof, is not considered enabled for treating the full scope of said disorders comprising administering any or all compounds embraced by Formula (I), as presently recited. 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.
23. 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:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
24. These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons.
25. 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.”
In the instant case, the claims are drawn to a method of treating a Cisd2 insufficiency-associated disorder selected from NAFLD, non-alcoholic steatohepatitis, chemotherapy-induced chemotoxicity, chemotherapy-induced cachexia, hepatotoxicity, and hypertensive cardiomyopathy, comprising administering a therapeutically effective amount of a compound of Formula (I) to a subject suffering from a Cisd2 insufficiency-associated disorder or to a subject in need of increase in Cisd2 gene expression.
26. The state of the prior art, level of predictability and relative skill level: 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 discussed above, the instantly claimed invention pertains to a method of treating a Cisd2 insufficiency-associated disorder selected from NAFLD, non-alcoholic steatohepatitis, chemotherapy-induced chemotoxicity, chemotherapy-induced cachexia, hepatotoxicity, and hypertensive cardiomyopathy, comprising administering a therapeutically effective amount of a compound of Formula (I) to a subject suffering from a Cisd2 insufficiency-associated disorder or to a subject in need of increase in Cisd2 gene expression.
27. The relative skill of those in the art is high, that of an MD or PhD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, Liao et al. teach that in the case of Cisd2 expression, the role of Cisd2 is complex and unpredictable in human aging-related disease and cancer(s) (Biomedicine & Pharmacotherapy 2021). For example, Cisd2 expression is upregulated in various cancer types including gastric cancer, pancreatic cancer, breast cancer, cervical cancer, etc. (see Table 1 at page 4); however, Cisd2 expression is decreased in certain neurodegenerative diseases including Alzheimer’s disease and WFS2 (see section 3.2 “Cisd2 and neurodegenerative diseases” at pages 4-6). Liao et al. go on to teach that:
“Interestingly, Cisd2 expression has also been closely related to the senescence of human myocardial and skeletal muscle cells and the regulation of mammalian lifespan. Cisd2 is highly expressed to maintain skeletal muscle morphology, delay the aging of the myocardium and skeletal muscle, and prolong the lifespan of mammals. In addition, when highly expressed, Cisd2 can prevent or delay the occurrence of a variety of neurodegenerative diseases that include AD and WFS2. The complex role of Cisd2 makes it difficult to reconcile these seemingly contradictory results between experimental and clinical studies. Moreover, the specific molecular mechanisms and the timing of Cisd2 expression upregulation or downregulation are currently unclear. Thus, the role of Cisd2 in some mammalian diseases and tumorigenesis is complex.” (page 11, left column, under “Summary”).
28. The state of the art regarding treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) is that NAFLD is a complex pathology embracing not only fatty liver but comorbidities including inflammation, fibrosis, cirrhosis, cancer and cardiovascular disease, which complicate treatment plans:
“NAFLD itself summarizes a broad disease spectrum: non‐alcoholic fatty liver (NAFL), which is characterized by simple steatosis but absent inflammation or hepatocyte ballooning, represents the mildest manifestation. Non‐alcoholic steatohepatitis (NASH), however, is characterized by not only steatosis of the liver but also inflammation and hepatocyte ballooning, and is a more severe presentation of the disease spectrum which may lead to advanced fibrosis or even cirrhosis. In approximately 5% [3, 4] of patients [5, 6] with NAFLD complications of cirrhosis and/or hepatocellular carcinoma may occur during long‐term follow‐ up. Of note, however, most patients with non‐advanced NAFLD (i.e. Fibrosis Stage 0–2) primarily show extrahepatic events during follow‐up and the predominant cause of death in these patients derives from cardiovascular disease rather than from liver‐related events [7, 8].” (Paternostro and Turner, Journal of Internal Medicine 2022, page 190, under “Introduction – Definition, Diagnosis and clinical staging of NAFLD,” left column-right column).
Paternostro and Turner go on to discuss the challenges of treating NAFLD patients:
“According to current guidelines [5] pharmacotherapy in NASH patients should be reserved for those with significant fibrosis (≥F2) and those with less severe disease but at high risk of disease progression (i.e. metabolic syndrome, diabetes).
Nevertheless, it needs to be emphasized that once a diagnosis of NAFLD is established patients have increased overall mortality compared to non‐NAFLD patients [6, 21, 22]. However, this increased mortality mostly comes from cardiovascular‐ rather than from liver‐related outcomes; [4, 6] furthermore, cancer‐related mortality is among the leading causes of mortality in NAFLD patients, mainly driven by extrahepatic malignancies followed by hepatocellular carcinoma [23, 24]. Most importantly, once a diagnosis of NASH and/or advanced fibrosis (i.e. fibrosis stage 3 or cirrhosis) and/or portal hypertension is confirmed patients are at an increased risk for liver‐related complications (i.e. hepatic decompensation and hepatocellular carcinoma) and liver‐related mortality [9, 10, 25]. Therefore, lifestyle modifications and treatment of underlying metabolic conditions should be performed in all NAFLD patients, while specific pharmacological treatment should mainly be aimed at patients with biopsy‐proven NASH and fibrosis [6].”
(page 192, right column- page 193, left column).
29. The amount of direction or guidance provided and the presence or absence 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, the specification provides no direction or guidance for the use of the full scope of the aforementioned Cisd2 activators of Formula (I) for the treatment of all recited diseases. The Specification discloses the preparation and in vitro activity of only approximately 35 Cisd2 agonists as recited in the claims, i.e., compounds 1-35 (see Table 2 at page 26). The Specification teaches the therapeutic efficacy of just one compound, i.e., Compound 1, in in vivo murine models of NAFLD (Example 3), NASH (Example 4), doxorubicin-induced cardiotoxicity (Example 5), doxorubicin-induced cachexia and heptatotoxicity (Example 6), and hypertensive cardiomyopathy (Example 9). No reasonably specific guidance is provided concerning useful therapeutic protocols for treating a subject in need thereof comprising administering any other compound(s) according to Formula (I).
30. The 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). Indeed, 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). 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.
31. 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. See also Ak Steel Corp. v. Sollac, 344 F.3d 1234 (Fed. Cir. 2003) and In re Moore, 439 F.2d 1232 (CCPA 1971). 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”.
32. As to the first inquiry, as discussed above, it is evident that the recited genus of claims 1 and 11 has substantial variance. The Markush group of compounds according to Formula (I) embraces hundreds of thousands of potential compounds which bear little structural resemblance to one another aside from a central tetrasubstituted 2-(amino/amide)-5-carbonyl-thiophene moiety. For example, within Formula (I), R5 can be any monocyclic or bicyclic aryl or heteroaryl moiety including phenyl, pyridinyl, oxazolyl, triazolyl, thienyl, furanyl, thiazolyl, isoxazolyl, benzimidazoyl, quinolinyl, indolyl, and benzothiazolyl (Specification, page 3, lines 13-17), which can be incorporated in hundreds of thousands of possible combinations, if not millions, with almost no structural overlap whatsoever.
33. Considering that the scope of said compounds encompasses hundreds of thousands of compound species, and potentially millions of compound species, it is evident that the claims are broad. Yet, as discussed above, the instant Specification discloses the efficacy of just one compound species, i.e., Compound 1, in an in vivo murine model of each recited disorder. As such, the claim is extremely broad with respect to the disclosure. The second inquiry is discussed in detail below.
34. The 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. As discussed above, the claims are drawn to a method of treating a Cisd2 insufficiency-associated disorder selected from NAFLD, non-alcoholic steatohepatitis, chemotherapy-induced chemotoxicity, chemotherapy-induced cachexia, hepatotoxicity, and hypertensive cardiomyopathy, comprising administering a therapeutically effective amount of a compound of Formula (I) to a subject suffering from a Cisd2 insufficiency-associated disorder or to a subject in need of increase in Cisd2 gene expression.
35. Since identifying any compound which is capable of modulating the activity of a specific receptor, ion channel, or enzyme 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 broadness of the scope of Formula (I) with respect to the disclosure since the scope of said inhibitors encompasses hundreds of thousands of compound species, whereas the instant Specification discloses the administration of just one compound species exerting the disclosed activity. 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 which of the hundreds of millions of compounds encompassed by the claims would exert the alleged activity based on the limited disclosure. Although the skilled artisan would have known that certain chemical modifications to the disclosed compounds may predictably provide structurally related compounds having similarly activity, the skilled artisan would have also known that even minor structural changes can, and frequently will, drastically alter or eradicate a parent compound’s ability to modulate the activity of a specific receptor or enzyme. As evidenced by Liao et al., above, the role of Cisd2 expression demonstrates significant unpredictability in human diseases/disorders, and Paternostro teaches that current treatment regimens of NAFLD and NASH present many challenges Thus, it is highly unpredictable whether any compound of Formula (I) within the genus of compounds encompassed by the claims based on the instant disclosure would, in fact, be usable. Whether the other compounds encompassed by the claims would be usable is even less predictable. As such, the only way to ascertain which of the thousands, and potentially hundreds of thousands of claimed compounds presently encompassed by the claims are usable based on the limited disclosure would require undue experimentation. That is, the only way one skilled in the art is enabled to use the entire scope of the claim based on the instant disclosure entails undue experimentation.
To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure.
Conclusion
36. Claims 1, 2, 4-9, 11, 12, 14-19, 21 and 22 are present in the application. Claims 1, 2, 4-9, 11, 12, 14-19, 21 and 22 are rejected. No claim is presently allowed.
37. 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