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 . Claims 1-2, 6, 28-43, 50-53 filed 03/23/2023 are currently pending. Claims 1, 2, 6 and 53 are independent.
Election/Restrictions
Applicant’s election with traverse of Group (I) claims 1-2, 6, 28-43, 50-52 in the reply filed on 10/08/2025 is acknowledged. Applicant asserts that a search of Groups I-IV would not impose a serious search burden on the examiner because a search concerning the patentability of the methods and compounds of Group (I) would likely uncover relevant art for the methods of Groups (II), (III) and the kit of Group (IV).
These arguments have been considered but are not found persuasive as such arguments do not apply when restriction is required under 35 USC 121 and 372, as in the instantly filed application. Thus, when the Office considers international applications as an International Searching Authority, as an International Preliminary Examining Authority, and during the national stage as a Designated or Elected Office under 35 U.S.C. 371, only PCT Rule 13.1 and 13.2 will be followed when considering unity of invention of claims of different categories without regard to the practice in national applications filed under 35 U.S.C. 111. Thus, it is maintained that the technical feature linking the inventions of Groups I-IV does not constitute a special technical feature as defined by PCT Rule 13.2 and does not define a contribution over the prior art for the reasons of record. The requirement is still deemed proper and is therefore made FINAL.
Claims 2, 6 and 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim. Election was made with traverse in the reply filed on 10/08/2025.
Secondly, Applicant’s election with traverse of the compound
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in the reply filed 10/08/2025 is acknowledged. Applicant’s traverse of the elected compound is that the search of the elected compound would likely uncover relevant art for the alternative species of compounds. These arguments have been considered but are not found persuasive as different search queries are required for each species and the prior art applicable to one species would not necessarily be applicable to another species.
Thirdly, Applicant’s election without specifying traverse of the disorder frontotemporal lobar degeneration in the telephonic response with Attorney Benjamin Nagasing on 11/06/2025 is acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 34-43 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of disorder, there being no allowable generic or linking claim. Election was made without traverse in the telephonic reply filed on 11/06/2025.
Priority
Acknowledgement is made of the national stage entry of PCT/US2021/051716 filed 09/23/2021 which claims priority to U.S. Provisional Application 63082185 filed 09/23/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/07/2024, 11/13/2024 and 10/08/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112-Paragraph A
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, 28, 32-33, 50-52 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 treatment of cancer or HIV does not reasonably provide enablement for prevention and or treatment of any disease, disorder or symptom of a disease or disorder caused by a pathophysiological retrotransposon associated process comprising the administration of a therapeutically effective amount of
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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.
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims, (2) The nature of the invention, (3) The state of the prior art, (4) The level of one of ordinary skill, (5) The level of predictability in the art, (6) The amount of direction provided by the inventor, (7) The existence of working examples, (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
(1) The breadth of the claims: The breadth of the claims is directed to the prevention and or treatment of any disease, disorder or symptom of a disease or disorder caused by a pathophysiological retrotransposon associated process comprising the administration of a therapeutically effective amount of
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Wherein the genus of diseases, disorders or symptom of a disease or disorder caused by a pathophysiological retrotransposon associated process excludes cancer or an infectious disease.
The breadth is extensive and embraces the prevention or treatment of any neurodegenerative disorder (claim 32), the prevention or treatment of any autoimmune disorder (claim 34) or the prevention or treatment of any age-associated disease (claim 36). The breadth of the claims is so broad that it embodies the prevention or treatment of disorders and diseases whose pathogenesis has not yet been linked to a retrotransposon associated process at the time of the invention.
(2) The nature of the invention: The nature of the invention is treating neurodegenerative diseases in a subject in need comprising the administration of a therapeutically effective amount of
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. Applicant elected the disorder of frontotemporal lobar degeneration in the telephonic response of 11/06/2025.
(3) The State of the Prior Art: Nomura (J. Med. Chem Vol. 42 pages 2901-2908 published 1999) represents the state of the prior art. Nomura teaches that nucleoside compounds 19-20 are potent anti-leukemic and antiviral agents targeting HSV-1, HSV-2 and HIV-1 in-vitro (abstract, Scheme 1,Table 1).
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Nomura does not teach nor suggest the use of said nucleoside compounds on preventing, let alone treating any disease or disorder caused by pathophysiological retrotransposon associated process excludes cancer or an infectious disease, let alone the subgenus of any neurodegenerative, autoimmune, pulmonary or ocular disorders embraced within the present claims.
Ohuri (J. Med. Chem Vol. 43 pages 4516-4525 published 2000) represents the state of the prior art. Ohuri teaches that nucleoside compounds 30 and 56 are potent antiviral agents targeting HSV-1, HSV-2 and HIV-1 in-vitro (abstract, page 4516 right col., page 4519 left col., Schemes 4, 6 and Table 1).
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Ohuri does not teach nor suggest the use of said nucleoside compounds on preventing, let alone treating any disease or disorder caused by pathophysiological retrotransposon associated process excludes cancer or an infectious disease, let alone the subgenus of any neurodegenerative, autoimmune, pulmonary or ocular disorders embraced within the present claims.
Kirby (Antimicrobial Agents and Chemotherapeutic Agents Vol. 57 pages 6254-6264 published 2013) teaches compound EdDAP (4) which corresponds to the claimed structure.
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Kirby teaches EdDap as a potent and efficient nucleoside reverse transcriptase inhibitor (Table 3) . Kirby does not teach nor suggest the use of said nucleoside compounds on preventing, let alone treating any disease or disorder caused by pathophysiological retrotransposon associated process excludes cancer or an infectious disease, let alone the subgenus of any neurodegenerative, autoimmune, pulmonary or ocular disorders embraced within the present claims.
Prochiantz (U.S. Patent 10,100,307 published 10/16/2018) teaches the method of treating a degenerative disease in a subject in need, wherein the degenerative disease is Alzheimer’s disease, Parkinson’s disease, Huntington’s disease comprising administering a therapeutically effective amount of a nucleoside reverse transcriptase inhibitor (claims 1, 3, 5-7). Prochiantz teaches that the genus of nucleoside reverse transcriptase inhibitors include stavudine, azidothymidine, zalcitabine, abacavir, lamivudine, emtricitabine and tenofovir (col.2 lines 20-40). The only working embodiment Prochiantz provides is the in-vitro administration of the nucleoside reverse transcriptase inhibitor stavudine to reduce cell death after cells were exposed to oxidative stress (col. 3 lines 35-65). Prochiantz does not provide any in-vivo working embodiments of a patient with either Alzheimer’s disease, Parkinson’s disease, Huntington’s disease to demonstrate the capacity of the claimed compounds to treat the disclosed disease or disorder caused by pathophysiological retrotransposon associated process, let alone prevent the development of said disorder in a subject in need. Moreover, Prochiantz does not teach nor suggest that the nucleoside reverse transcriptase inhibitors are efficacious at treating or preventing diseases or disorder caused by pathophysiological retrotransposon associated process such as autoimmune disorders (rheumatoid arthritis, multiple sclerosis), pulmonary disorders (pulmonary fibrosis) or ocular disorders (vision loss, macular degeneration) in a subject in need.
Sedivy (WO2020/154656 published 07/30/2020) is directed to treating or preventing or reversing age-associated inflammation in a subject in need comprising administering a therapeutically effective amount of the nucleoside reverse transcriptase inhibitors censavudine or elvucatiabine, wherein the age-associated inflammatory disorder includes Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, Huntington’s disease, frontotemporal dementia (claims 1-8). Sedivy teaches that upregulation of long-interspersed element 1 (LINE-1 or L1) is present in senescent cells ([0024], Figure 1). As shown in Figure 4, Sedivy teaches that the nucleoside reverse transcriptase inhibitor inhibits the upregulation of long-interspersed element 1 in-vitro in murine tissue ([0027]). However, Sedivy does not provide any in-vivo working embodiments of a patient with either Alzheimer’s disease, Parkinson’s disease, Huntington’s disease to demonstrate the capacity of the claimed compounds to treat the disclosed disease or disorder caused by pathophysiological retrotransposon associated process, let alone prevent the development of said disorder in a subject in need.
Cottam (U.S. Patent 10,857,122 published 12/8/2020 with priority to U.S. Provisional Application 62177187 filed 03/09/2015) also represents the state of the prior art. Cottam teaches that alpha-synuclein deposits are a main pathology of neurodegenerative diseases such as Parkinson’s disease, Alzheimer’s disease, Lewy Body Dementia, Huntington’s Disease. Development of animal models with human alpha-synuclein exhibit Parkinson’s like pathological effects and neurological alterations which include an impairment in motor coordination, altered fine motor skills, sensorimotor deficits and reduction in spontaneous activity (col. 1 lines 25 to col. 2 line 45). Cottam teaches neuroinflammation mouse models with human alpha-synuclein deposits yield Parkinson’s phenotypes. As shown in Figures 2-3, reduction in alpha-synuclein results in the amelioration of neurodegeneration in patients with Parkinson’s phenotypes and neuron loss. Cottam does not teach nor suggest the prevention of Parkinson’s disease, Alzheimer’s disease, Lewy Body Dementia or Huntington’s disease is possible with administration of a therapeutic agent. Nor does Cottam teach that alternative disorders such as those embraced within the genus of “ a disease or disorder caused by pathophysiological retrotransposon associated process” found within the present claims could be treated let alone prevented with the administration of the same therapeutic compound.
Greicius (Journal of Neurol Neurosurg Psychiatry Vol. 72 pages 691-700 Published 2002) also represents the state of the prior art. Greicius teaches diagnosis and taxonomy of Alzheimer’s disease. Greicius teaches that Alzheimer’s disease symptoms include deficits in at least two areas of cognition, progressive worsening of memory and other cognitive functions without any other neurological disorder that could explain the cognitive decline, the development of amyloid plaques, neurofibrillary tangles and neuronal loss, wherein the plaques and tangles lead to neuronal loss (page 692 left-right col.). Post-mortem analysis of brain tissue for the characteristics of amyloid plaques is considered necessary for a definitive diagnosis. This is because the art has yet to recognize its presence in essentially all cases. However, to achieve diagnostic status took years of evaluating procedures, both pre and post-mortem, confirming that every case had a degree of this pathology. Even so, diagnostic application is often problematic given variable peptide expression patterns among clinically similar and dissimilar disease states (page 696-697). Greicius further teaches that while there is promise of many agents to prevent Alzheimer’s disease, none have yet proven to be effective (page 693 left col., page 697 right col.).
Given that there a only a few factors that are recognized to have moderate, if any, predictive value in determining the likelihood that patients develop such a disease or to even determine whether patients actually have such a disease, since many of the early signs of Alzheimer’s disease are common complaints of aging or result from other neurological conditions, such as depression, where memory impairment is not present, one of ordinary skill in the art would not accept on its face Applicant's statement that the onset of the disease or disorder caused by pathophysiological retrotransposon associated process, such as Alzheimer’s disease, said disorder could be effectively prevented or treated using the presently claimed compound with the claimed nucleoside chemical structure, such complexity of diagnosis precludes a common, art-accepted protocol for preventing or delaying the onset of Alzheimer’s disease in any patient, given that the circumstances or risk factors are unique to that individual and must be considered on a case-by-case basis when determining the most effective approach to in delaying or preventing Alzheimer’s disease, let alone the fact that while there is promise of many agents to prevent Alzheimer’s disease, none have yet proven to be effective.
In other words, not only is the population in need of such treatment not well defined in the art because of the difficulties associated with making an accurate diagnosis, but the disease is also sufficiently complicated and poorly understood such that the idea that any active agent (including the presently claimed compounds with the nucleoside chemical structure) would be capable of preventing the onset of such a condition via its administration would not have been reasonably expected by the skilled artisan. The artisan would have required sufficient direction as to how the administration of the presently claimed active agent(s) could actually determine the population of patients in need of such delay or prevention and how the presently claimed agent(s) could actually delay or prevent Alzheimer's disease such that the artisan would have been imbued with at least a reasonable expectation of success. Such success would not have been reasonably expected given that the concept of a single agent, or even a combination of agents, that is effective against the development of Alzheimer's disease or treatment thereof would have been unique as cited in Greicius above, and, thus, met with a great deal of skepticism.
(4) The level of one of ordinary skill: The level of skill in the art is high and is at least that of a medical doctor with several years of experience in the art of neurodegenerative diseases.
(5) The level of predictability in the art:
The level of predictability in the art is low given that the state of the prior art (Greicius) teaches that while there is promise of many agents to prevent Alzheimer’s disease and Parkinson’s disease, none have yet proven to be effective (Greicius: page 693 left col., page 697 right col.). Furthermore, the level of predictability in the art is low given that the state of the prior art does not provide any in-vivo working embodiments that detail art-recognized nucleoside reverse transcriptase inhibitors to treat a patient comprising Alzheimer’s disease, Parkinson’s disease, Lewy Body Dementia, mild cognitive impairment or Huntington’s disease, let alone prevent the development of said neurodegenerative disorder in a subject.
(6) The amount of direction provided by the inventor and (7) The existence of working examples:
Applicant fails to provide any working embodiments that demonstrate the nucleoside compounds comprise any capacity to treat a patient comprising Alzheimer’s disease, Parkinson’s disease, Lewy Body Dementia, mild cognitive impairment or Huntington’s disease, let alone prevent the development of said neurodegenerative disorder in a subject. Applicant provides in-vitro analysis of said compounds on inhibiting LINE-1 in a cervical cancer cell (HeLa; Example 4), yet cancer is a disorder excluded from the claimed methodology. Applicant has not even provided an in-vitro working embodiment of the claimed compounds to treat LINE-1 in a neuron or provided known in-vitro assays for the claimed neurodegenerative disorders of Alzheimer’s disease, Parkinson’s disease, Lewy Body Dementia, mild cognitive impairment or Huntington’s disease with the associated compounds. Applicant relies on LINE-1 inhibition to establish that the methodology is enabled in the prior art. In light of the fact that the specification fails to provide the skilled artisan with any direction or guidance as to how the prevention or treatment of the claimed neurodegenerative disorders with the claimed compounds could actually be achieved, since the disclosure is solely directed to the concept of preventing or treating diseases, disorders or symptoms of a disease or disorder caused by a pathophysiological retrotransposon associated process without a working example, the present specification is viewed as lacking an enabling disclosure of the entire scope of the claimed invention and requiring an undue level of experimentation for this aspect of the invention.
(8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The basis for the present rejection is not simply that experimentation would be required, since it is clear from the state of the prior art and Applicant's disclosure that experimentation in this particular art is not at all uncommon, but that the experimentation required in order to practice this aspect of the invention would be undue. Please reference In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976), which states, "The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue." (emphasis added). In the present case, Applicant fails to address the unpredictability in the art by providing adequate direction or guidance as to how to practice this aspect of the invention, in terms of disclosing how to use the presently claimed nucleoside compounds such that treating any disease or disorder caused by pathophysiological retrotransposon associated process such as Alzheimer’s disease, Parkinson’s disease could be reasonably achieved, let alone preventing the onset of said disorders with the administration of the claimed nucleoside compounds. Applicant also fails to address the unpredictability in the art by providing adequate direction or guidance as to how to practice this aspect of the invention, in terms of disclosing how to or even any basis for extrapolating the LINE-1 inhibitory results shown in the in-vitro working embodiments and the correlation of treating or preventing a disease or disorder caused by pathophysiological retrotransposon associated process in a subject in need. As a result, the specification is viewed as lacking an enabling disclosure of the same.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 28, 50-51 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 17-19 and 21 of copending Application No. 18550498 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following. Claim 1 of copending Application 18550498 is directed to a method of treating or preventing a disease in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a LINE-1 inhibitor, or a pharmaceutical composition thereof, wherein the disease is ataxia-telangiectasia, age-related macular degeneration, systemic lupus erythematosus, IFN-associated autoimmune disease, Fanconi Anemia, idiopathic pulmonary fibrosis, or cardiovascular disease, and the LINE-1 inhibitor is.
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Said LINE-1 inhibitors are embraced within the present claims. Additionally, as disclosed instant claims 34-43, said disorders lie inside the genus of “disease, disorder or condition caused by a pathophysiological retrotransposon-associated process” as recited in claims 1, 2, 6, 28 of the present application. Claim 19 of copending Application 18550498 is directed to administration of said LINE-1 inhibitor with an additional therapeutic agent while claim 21 is directed to wherein the patient population treated does not comprise a HIV virus. The subject matter embraced within claims 19 and 21 of copending Application 18550498 overlaps with the subject matter of pending claims 50-51 of the present application.
Claims 1, 28, 32-33, 50-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3-5, 31-32 and 34-35 of copending Application No. 18566413 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following. Claim 1 of copending Application 18556413 is directed to a method to enhance cognition, inhibit cognitive decline, treat or prevent a cognitive deficit disorder, or treat or prevent Creutzfeldt-Jakob disease (CJD) in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a LINE-1inhibitor, wherein the LINE-1 inhibitor is
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Said LINE-1 inhibitors are embraced within the present claims. Additionally, the treatment of or prevention of a cognitive deficit disorder reads on Alzheimer’s disease, Parkinson’s disease, dementia with Lewy Bodies, Huntington’s disease, frontotemporal lobar degeneration, mild cognitive impairment , Rett Syndrome and Aicardi-Goutieres syndrome as disclosed in claims 32-33 of the present application. Claim 31 of copending Application 18556413 is directed to administration of said LINE-1 inhibitor with an additional therapeutic agent while claim 32 is directed to wherein the patient population treated does not comprise a HIV virus. The subject matter embraced within claims 31-32 of copending Application 18556413 overlaps with the subject matter of pending claims 50-51 of the present application.
Conclusion
In view of the rejections set forth above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CLINTON A BROOKS can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621