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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Election/Restrictions
Applicant elected a formulation comprising caffeine, citric acid, and sodium bicarbonate to treat neuronal excitability in the reply filed on 27 Oct, 2025.
Claims Status
Claims 1-19 are pending.
Claims 1, 8, and 13-19 have been amended.
Claims 6-12 and 14-19 have been withdrawn from consideration due to an election/restriction requirement.
Withdrawn Rejections
The rejection of claims 1-5, 13, and 19 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of enablement of the claims in their entirety is hereby withdrawn due to amendment.
The rejection of claim 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to what neuronal excitability comprises is hereby withdrawn due to amendment.
The rejection of claims 1-5, 13, and 19 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite due to uncertainty as to what is considered associated with calcium imbalance is hereby withdrawn due to amendment.
Maintained/Modified Rejections
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
first rejection
Claim(s) 1, 4, 5, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Underwood (US 20110124562) in view of Taymouri et al (J. Rep. Pharm. Sci (2019) 8(2) p236-244).
Underwood discusses apoaequorin containing compositions and methods (title). These can be used to treat disorders associated with neuronal excitability (paragraph 11), a genus that presumably includes diminished neuronal excitability. It can be used with additional therapeutic agents (paragraph 27). Tablet and solution formulations are contemplated (paragraph 40).
The difference between this reference and the examined claims is this reference does not discuss effervescent formulations.
Taymouri et al discuss effervescent tablet formulations (title). Effervescent formulations have the advantage of stability, rapid absorption and onset of action, pleasant taste, good stomach and intestinal tolerance, high patient compliance, ease of use, accurate dosing, and capability to incorporate larger amounts of active ingredients (p237, 1st column, 1st paragraph). The effervescent effect is caused by organic acids, such as citric or tartaric acid, with sodium bicarbonate (p236, 1st column, 1st paragraph). Examples used citric acid and sodium bicarbonate p236, 2nd column, 1st paragraph). Formulations comprised 250 or 500 mg citric acid, with 1:1 or 3:1 bicarbonate/citrate ratio (molar ratio), along with 100 mg mannitol, 70 mg sucrose, and between 3-15% of other ingredients (table 2, p238, top of page). 500 mg citrate, with 3x bicarbonate on a molar basis is 656 mg bicarbonate, well between 5 and 85% bicarbonate. This reference discusses an effervescent formulation comprising citric acid and sodium bicarbonate.
Therefore, it would be obvious to formulate the apoaequorin pharmaceuticals of Underwood with the effervescent formulation of Taymouri et al, for the improved stability, rapid absorption, good tolerance, high patient compliance, and the other advantages described by Taymouri et al for such formulations. As Underwood discusses both tablet and solution formulations, an artisan in this field would make such a formulation with a reasonable expectation of success.
Underwood discusses apoaequorin formulations. Taymouri et al render obvious making effervescent formulations with a bicarbonate concentration between 5-85% by weight Thus, the combination of references renders obvious claim 1.
Taymouri et al discuss using citric acid and sodium bicarbonate for the effervescence, rendering obvious claims 4 and 5.
Underwood discusses treatment of disorders associated with calcium imbalance, including neuronal excitability, rendering obvious claim 13.
response to applicant’s arguments
Applicant argues that the rationale used in the rejection is different than the one they used, and point out that none of the cited references anticipate the claims.
Applicant's arguments filed 13 Feb, 2026 have been fully considered but they are not persuasive.
Applicant argues that the rationale behind their invention is different than that of the rejection. However, there is no legal requirement that the rationale used in a rejection match that used by applicant (MPEP 2144(IV)).
Applicant points out how each cited reference differs from what they have claimed. However, this is not a rejection under 35 USC 102, but rather 35 USC 103; there is no requirement that every limitation be found in a single reference.
second rejection
Claim(s) 1-5, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Underwood (US 20110124562) in view of Taymouri et al (J. Rep. Pharm. Sci (2019) 8(2) p236-244) and Walton et al (J. Physiol. (2002) 545.2 p671-679).
Underwood discusses apoaequorin containing compositions and methods (title). These can be used to treat disorders associated with neuronal excitability (paragraph 11). It can be used with additional therapeutic agents (paragraph 27). Tablet and solution formulations are contemplated (paragraph 40).
Taymouri et al discuss effervescent tablet formulations (title). Effervescent formulations have the advantage of stability, rapid absorption and onset of action, pleasant taste, good stomach and intestinal tolerance, high patient compliance, ease of use, accurate dosing, and capability to incorporate larger amounts of active ingredients (p237, 1st column, 1st paragraph). The effervescent effect is caused by organic acids, such as citric or tartaric acid, with sodium bicarbonate (p236, 1st column, 1st paragraph). Examples used citric acid and sodium bicarbonate p236, 2nd column, 1st paragraph). Formulations comprised 250 or 500 mg citric acid, with 1:1 or 3:1 bicarbonate/citrate ratio (molar ratio), along with 100 mg mannitol, 70 mg sucrose, and between 3-15% of other ingredients (table 2, p238, top of page). 500 mg citrate, with 3x bicarbonate on a molar basis is 656 mg bicarbonate, well between 5 and 85% bicarbonate. This reference discusses an effervescent formulation comprising citric acid and sodium bicarbonate.
As noted above, these two references render obvious claims 1, 4, 5, and 13.
The difference between these references and the remaining claims is that the references do not discuss a stimulant.
Walton et al discuss the effects of caffeine in human motor units (title). Among the effects is to increase the frequency of neuronal firing (abstract), i.e. increase neuronal excitability.
As it is prima facie obvious to combine two formulations for the same use (MPEP 2144.06(I)), it is obvious to combine the apoaequorin formulation of Underwood and Taymouri et al, with the caffeine of Walton et al, as both correct defects in neuronal excitation. As most of the country uses caffeine on a regular basis, an artisan in this field would make this combination with a reasonable expectation of success.
response to applicant’s arguments
Applicant presented the same arguments for all rejections under this statute, which were answered above.
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.
first rejection
Claims 1-5 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/286,595 in view of Taymouri et al (J. Rep. Pharm. Sci (2019) 8(2) p236-244) and Kolahdouzan et al (CNS Neurosci. Ther. (2017) 23 p272-290)
Competing claim 1 describes a method of treating neuronal inflammation following ischemia, comprising administering apoaequorin orally.
The difference between the competing claims and the examined claims is that the competing claims do not discuss an effervescent formulation or a stimulant.
Taymouri et al discuss effervescent tablet formulations (title). Effervescent formulations have the advantage of stability, rapid absorption and onset of action, pleasant taste, good stomach and intestinal tolerance, high patient compliance, ease of use, accurate dosing, and capability to incorporate larger amounts of active ingredients (p237, 1st column, 1st paragraph). The effervescent effect is caused by organic acids, such as citric or tartaric acid, with sodium bicarbonate (p236, 1st column, 1st paragraph). Examples used citric acid and sodium bicarbonate p236, 2nd column, 1st paragraph). Formulations comprised 250 or 500 mg citric acid, with 1:1 or 3:1 bicarbonate/citrate ratio (molar ratio), along with 100 mg mannitol, 70 mg sucrose, and between 3-15% of other ingredients (table 2, p238, top of page). 500 mg citrate, with 3x bicarbonate on a molar basis is 656 mg bicarbonate, well between 5 and 85% bicarbonate. This reference discusses an effervescent formulation comprising citric acid and sodium bicarbonate.
Kolahdouzan et al discussed the neuroprotective effect of caffeine (title). Ischemia upregulates the receptor A2AR, which potentiates the inflammatory cascade (p274, 1st column, 2nd paragraph). Caffeine antagonizes this receptor, providing a protective effect (p274, 2nd column, 2nd paragraph). This reference renders obvious using caffeine to treat neuroinflammation caused by ischemia.
Therefore, it would be obvious to formulate the apoaequorin pharmaceuticals of the competing claims with the effervescent formulation of Taymouri et al, for the improved stability, rapid absorption, good tolerance, high patient compliance, and the other advantages described by Taymouri et al for such formulations. As this is described generally, and would be expected to be useful for different types of pharmaceuticals, an artisan in this field would make this modification with a reasonable expectation of success.
Furthermore, it would be obvious to add the caffeine of Kohahdouzan et al, as a combination of formulations for the same purpose. As caffeine is widely used, an artisan in this field would attempt this addition with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
response to applicant’s arguments
Applicant states that the amendments to the claims overcome this rejection.
Applicant's arguments filed 13 Feb, 2026 have been fully considered but they are not persuasive.
The rejection has been modified to take into account applicant’s amendments.
second rejection
Claims 1-5 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, and 14 of copending Application No. 17/801,619 (US 20230078821) in view of Taymouri et al (J. Rep. Pharm. Sci (2019) 8(2) p236-244) and Walton et al (J. Physiol. (2002) 545.2 p671-679).
Competing claim 1 describes a formulation of apoaequorin. Competing claim 3 specifies a Markush group of formulations, including tablets, capsules, and solutions. Competing claim 5 is a method of improving health, while competing claim 14 specifies that the sufferer suffers from a condition associated with neuronal excitation.
The difference between the competing claims and the examined claims is that the competing claims do not discuss an effervescent formulation or a stimulant.
Taymouri et al discuss effervescent tablet formulations (title). Effervescent formulations have the advantage of stability, rapid absorption and onset of action, pleasant taste, good stomach and intestinal tolerance, high patient compliance, ease of use, accurate dosing, and capability to incorporate larger amounts of active ingredients (p237, 1st column, 1st paragraph). The effervescent effect is caused by organic acids, such as citric or tartaric acid, with sodium bicarbonate (p236, 1st column, 1st paragraph). Examples used citric acid and sodium bicarbonate p236, 2nd column, 1st paragraph). Formulations comprised 250 or 500 mg citric acid, with 1:1 or 3:1 bicarbonate/citrate ratio (molar ratio), along with 100 mg mannitol, 70 mg sucrose, and between 3-15% of other ingredients (table 2, p238, top of page). 500 mg citrate, with 3x bicarbonate on a molar basis is 656 mg bicarbonate, well between 5 and 85% bicarbonate. This reference discusses an effervescent formulation comprising citric acid and sodium bicarbonate.
Walton et al discuss the effects of caffeine in human motor units (title). Among the effects is to increase the frequency of neuronal firing (abstract), i.e. increase neuronal excitability.
Therefore, it would be obvious to formulate the apoaequorin pharmaceuticals of the competing claims with the effervescent formulation of Taymouri et al, for the improved stability, rapid absorption, good tolerance, high patient compliance, and the other advantages described by Taymouri et al for such formulations. As this is described generally, and would be expected to be useful for different types of pharmaceuticals, an artisan in this field would make this modification with a reasonable expectation of success.
As it is prima facie obvious to combine two formulations for the same use (MPEP 2144.06(I)), it is obvious to combine the apoaequorin formulation of the competing claims and Taymouri et al, with the caffeine of Walton et al, as both correct defects in neuronal excitation. As most of the country uses caffeine on a regular basis, an artisan in this field would make this combination with a reasonable expectation of success.
response to applicant’s arguments
Applicant states that the amendments to the claims overcome this rejection.
Applicant's arguments filed 13 Feb, 2026 have been fully considered but they are not persuasive.
The rejection has been modified to take into account applicant’s amendments.
third rejection
Claims 1-5 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 8,796,213 in view of Taymouri et al (J. Rep. Pharm. Sci (2019) 8(2) p236-244) and Walton et al (J. Physiol. (2002) 545.2 p671-679).
Competing claim 1 describes a method of treatment of disorders associated with a calcium imbalance. Competing claim 7 describes a Markush group of disorders, including neuronal excitation.
The difference between the competing claims and the examined claims is that the competing claims do not discuss an effervescent formulation or a stimulant.
Taymouri et al discuss effervescent tablet formulations (title). Effervescent formulations have the advantage of stability, rapid absorption and onset of action, pleasant taste, good stomach and intestinal tolerance, high patient compliance, ease of use, accurate dosing, and capability to incorporate larger amounts of active ingredients (p237, 1st column, 1st paragraph). The effervescent effect is caused by organic acids, such as citric or tartaric acid, with sodium bicarbonate (p236, 1st column, 1st paragraph). Examples used citric acid and sodium bicarbonate p236, 2nd column, 1st paragraph). Formulations comprised 250 or 500 mg citric acid, with 1:1 or 3:1 bicarbonate/citrate ratio (molar ratio), along with 100 mg mannitol, 70 mg sucrose, and between 3-15% of other ingredients (table 2, p238, top of page). 500 mg citrate, with 3x bicarbonate on a molar basis is 656 mg bicarbonate, well between 5 and 85% bicarbonate. This reference discusses an effervescent formulation comprising citric acid and sodium bicarbonate.
Walton et al discuss the effects of caffeine in human motor units (title). Among the effects is to increase the frequency of neuronal firing (abstract), i.e. increase neuronal excitability.
Therefore, it would be obvious to formulate the apoaequorin pharmaceuticals of the competing claims with the effervescent formulation of Taymouri et al, for the improved stability, rapid absorption, good tolerance, high patient compliance, and the other advantages described by Taymouri et al for such formulations. As this is described generally, and would be expected to be useful for different types of pharmaceuticals, an artisan in this field would make this modification with a reasonable expectation of success.
As it is prima facie obvious to combine two formulations for the same use (MPEP 2144.06(I)), it is obvious to combine the apoaequorin formulation of the competing claims and Taymouri et al, with the caffeine of Walton et al, as both correct defects in neuronal excitation. As most of the country uses caffeine on a regular basis, an artisan in this field would make this combination with a reasonable expectation of success.
response to applicant’s arguments
Applicant states that the amendments to the claims overcome this rejection.
Applicant's arguments filed 13 Feb, 2026 have been fully considered but they are not persuasive.
The rejection has been modified to take into account applicant’s amendments.
fourth rejection
Claims 1-5 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,005,096 in view of Taymouri et al (J. Rep. Pharm. Sci (2019) 8(2) p236-244) and Kolahdouzan et al (CNS Neurosci. Ther. (2017) 23 p272-290).
Competing claim 1 describes a method of treatment disorders related to cell death following ischemia, comprising administering apoaequorin.
The difference between the competing claims and the examined claims is that the competing claims do not discuss an effervescent formulation or a stimulant.
Taymouri et al discuss effervescent tablet formulations (title). Effervescent formulations have the advantage of stability, rapid absorption and onset of action, pleasant taste, good stomach and intestinal tolerance, high patient compliance, ease of use, accurate dosing, and capability to incorporate larger amounts of active ingredients (p237, 1st column, 1st paragraph). The effervescent effect is caused by organic acids, such as citric or tartaric acid, with sodium bicarbonate (p236, 1st column, 1st paragraph). Examples used citric acid and sodium bicarbonate p236, 2nd column, 1st paragraph). Formulations comprised 250 or 500 mg citric acid, with 1:1 or 3:1 bicarbonate/citrate ratio (molar ratio), along with 100 mg mannitol, 70 mg sucrose, and between 3-15% of other ingredients (table 2, p238, top of page). 500 mg citrate, with 3x bicarbonate on a molar basis is 656 mg bicarbonate, well between 5 and 85% bicarbonate. This reference discusses an effervescent formulation comprising citric acid and sodium bicarbonate.
Kolahdouzan et al discussed the neuroprotective effect of caffeine (title). Ischemia upregulates the receptor A2AR, which potentiates the inflammatory cascade (p274, 1st column, 2nd paragraph). Caffeine antagonizes this receptor, providing a protective effect (p274, 2nd column, 2nd paragraph). This reference renders obvious using caffeine to treat neuroinflammation caused by ischemia.
Therefore, it would be obvious to formulate the apoaequorin pharmaceuticals of the competing claims with the effervescent formulation of Taymouri et al, for the improved stability, rapid absorption, good tolerance, high patient compliance, and the other advantages described by Taymouri et al for such formulations. As this is described generally, and would be expected to be useful for different types of pharmaceuticals, an artisan in this field would make this modification with a reasonable expectation of success.
Furthermore, it would be obvious to add the caffeine of Kohahdouzan et al, as a combination of formulations for the same purpose. As caffeine is widely used, an artisan in this field would attempt this addition with a reasonable expectation of success.
response to applicant’s arguments
Applicant states that the amendments to the claims overcome this rejection.
Applicant's arguments filed 13 Feb, 2026 have been fully considered but they are not persuasive.
The rejection has been modified to take into account applicant’s amendments.
New Rejections
Claim Rejections - 35 USC § 112(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.
Claim 19 is 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.
Claim 19 has been amended to include diminished neuronal excitability. While the disclosure mentions neuronal excitability, it does not mention diminished neuronal excitability. Thus, this amendment constitutes new matter.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED REYNOLDS whose telephone number is (571)270-7214. The examiner can normally be reached M-Th 9-3:30.
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/FRED H REYNOLDS/Primary Examiner, Art Unit 1658