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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/18/2026 has been entered.
The office acknowledges Applicants filing of the claim amendments and arguments dated 5/18/2026. Claims 1, 4-5, 15, and 19 have been amended. Applicants arguments and declaration have been fully considered. Rejections not reiterated from previous office actions are hereby withdrawn. Arguments, which are directed to withdrawn rejections, are thus rendered moot. The arguments in regards to the reiterated rejections/references from the previous office action are addressed below. In view of Applicant's claim amendments, the following rejections and/or objections are either reiterated, modified or newly applied. It is noted that Applicants previously elected citicoline (non-caffeine stimulant or nootropic), beta-hydroxybutyric acid (ketone body) and epicatechins (vasodilator) (See Response to Restriction election dated 2/3/2025). It is noted that claim 5 do not recite the elected citicoline species. Claims 5, 7 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being drawn to non-elected subject matter. Claims 1-2, 4-21 are pending. The claims corresponding to the elected subject matter are 1-2, 4, 6, 8-21 and are herein acted on the merits.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 1/21/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Applicants Arguments
Applicants argue that the Office Action fails to provide any rationale for combining Lowery, Wurtman, and French. Rather, Lowery is cited as disclosing a composition containing beta-hydroxybutyrate (a ketone body), Wurtman is cited as disclosing a composition containing citicoline (a nootropic), and French is cited as disclosing a composition containing epicatechin (a vasodilator). However, none of Lowery, Wurtman, or French, or any combination thereof, teaches or suggests combining a ketone body with a nootropic. Examiner merely asserts that it would have been obvious to combine the beta-hydroxybutyrate of Lowery with the citicoline of Wurtman but does not show where the prior art teaches or suggests their combination. The Office Action notes that Lowery discloses that niacin can be included with beta- hydroxybutyrate (page 6). However, niacin is not a non-caffeine stimulant or nootropic selected from the Markush group recited in the claims. Thus, Lowery provides no teaching or suggestion for combining a ketone body component and a non-caffeine stimulant or nootropic as claimed. Magnesium is not a ketone body component. Thus, Wurtman provides no teaching or suggestion for combining a ketone body component and a non-caffeine stimulant or nootropic as claimed.
Applicants argue that in light of the fact that there is no teaching or suggestion in the cited art to combine a ketone body component and a non-caffeine stimulant or nootropic as claimed, the Examiner asserts that the claims are nonetheless obvious in light of the holding in In re Kerkhoven. Applicants argue that In re Kerkhoven does not apply to the claims at issue because a ketone body and a non-caffeine stimulant or nootropic are not "taught by the prior art to be useful for the same purpose" and, when combined, they do not "form a form a third composition to be used for the very same purpose".
In response, the instant claims are to a composition comprising ketone body component and a non-caffeine stimulant or nootropic, for example, the elected agents, citicoline and BHB. Lowery is explicit in teaching beta-hydroxybutyrate (BHB) for improving cognitive function. Wurtman is explicit in teaching the use of citicoline in treating cognitive dysfunction or memory impairment. Thus a skilled artisan would have found it obvious to combine the agents that are known in the art to be useful for improving or treating cognitive function, herein BHB, and citicoline. A skilled artisan would have been motivated to combine the agents known in the art for improving or treating cognitive dysfunction to a single composition with a reasonable amount of success. One of ordinary skill in the art would have been motivated to incorporate the agents herein in a single combination pharmaceutical composition because combining the agents herein each of which is known to be useful to treat cognitive function individually into a single composition useful for the very same purpose is prima facie obvious. See In re Kerkhoven 205 USPQ 1069. The strongest rationale for combining references is a recognition, expressly or implicitly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. See In re Sernaker 17 USPQ 1, 5-6 (Fed. Cir. 1983) and MPEP 2144. It is settled law that the teaching or suggestion to combine references’ disclosures need not be explicitly stated in the prior art, but may be implicit from the state of the prior art considered as a whole. In re Kahn, 441 F.3d 977, 987 (Fed. Cir. 2006); cited with approval in KSR, 127 S.Ct. at 1741. A skilled artisan would have been motivated to combine BHB, citicoline and epicatechin for use in improving cognition with a reasonable expectation of success and to attain additive and/or synergistic benefits. The motivation to combine the agents need not be the same as the Applicants’ and the motivation can be for a different purpose or to solve a different problem.
It is noted that cited ketone body component and a non-caffeine stimulant or nootropic are the properties of the agents. In other words, a compound and its properties are not separable. If the prior art teaches the composition or renders the composition obvious, then the properties are also taught or rendered obvious by the prior art. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990.) See MPEP 2112.01. In the instant case the claimed composition is obvious over Lowery and Wurtman and hence the property of instantly claimed composition will also be rendered obvious by the prior art teachings, since the properties, are inseparable from its composition. As the prior art teaches all the structural limitations of the claims, it expected the composition of the prior art and that of the instant claims would in fact have the same properties, absent evidence to the contrary, which has not been provided by the applicant. When the composition recitations are met, the desired properties are met, as any component that materially affects the composition and its properties would have to be present in the claim to be commensurate in scope.
Further it is noted that a person of ordinary skill in the art is always motivated to pursue the known options within her or his technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.("[T]he motivation in the prior art to combine the references does not have to be identical to that of the applicant to establish obviousness."). A claim may be nonetheless obviousness even if the problem being addressed by the reference solved is not the same one faced by the inventors. In re Dillon, 919 F.2d 688, 692-93 (Fed. Cir. 1990).
Applicant argue that the alleged motivation to combine teachings from unrelated prior art references that disclose completely different compositions is rebutted by the disclosure of the present Application, which teaches that the ketone body component and the non-caffeine stimulant or nootropic are used for very different purposes and affect the body in fundamentally different ways. This is clearly taught in the present Application, which explains how each component affects the body differently and how, when combined, they provide unexpectedly superior benefits.
As to Applicants arguments in regards to unrelated art, it is noted that Lowery and Wurtman are related art and both the agents, BHB and citicoline effects are taught in relation to cognition improvement or treatment. As stated above, it is not required that the references be combined for the reasons contemplated by the inventor, see In re Beattie, 974 F. 2d 1309, 1312, 1992. The problem motivating the applicants may be only one of many addressed by the claimed subject matter. The question is not whether the combination was obvious to the applicant but whether the combination was obvious to a person with ordinary skill in the art. Under the correct analysis, any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 420 (2007).
As to the arguments in regards to unexpectedly superior benefits, the composition comprising the same agents as in the instant claims would provide the same benefits as the properties are an inherent result of a particular composition having the same list of components. Further Applicants have provided data just with two components, e.g. paraxanthine and BHB (figures 4-6, tables 2-3). The data provided do not commensurate in scope with the claims (claims 1, 15 and 19).
“When unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). “In considering unexpected results, courts ask whether the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected” compared to the prior art as of the priority date. Forest Labs., LLC v. Sigmapharm Labs., LLC, 918 F.3d 928, 937 (Fed. Cir. 2019) (cleaned up). The starting reference point for evaluating unexpectedness is the closest prior art. See Bristol-Myers, 752 F.3d at 977; Kao Corp. v. Unilever U.S., Inc., 441 F.3d 963, 970 (Fed. Cir. 2006). Applicants have not shown any comparison data with that of the prior art, even for elected species, for e.g. BHB alone, citicoline alone, citicoline with BHB to provide evidence that it would have been unexpected and unobvious. While Applicants argue that the results presented show unexpected results, there is no clear or specific comparative data or evidence supporting that argument because the data shown are to the combination of unclaimed paraxanthine and BHB. Further single point data (paraxanthine+BHB) cannot be extrapolated to all the non-caffeine stimulant or nootropic as in the instant claims with that of the ketone body agents and being synergistic at all concentrations. It is noted that it is Applicant's burden to demonstrate unexpected results over the prior art. See MPEP 716.02, particularly 716.02 (a) - (g). The unexpected results should be demonstrated with evidence that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Moreover, evidence as to any unexpected benefits must be "clear and convincing" In re Lohr, 137 USPQ 548 (CCPA 1963), and be of a scope reasonably commensurate with the scope of the subject matter claimed, In re Linder, 173 USPQ 356 (CCPA 1972).
As to applicants arguments that the components as in the instant claims provide completely different effects, it is the property of the agents or the components. If the composition comprising the same components as claimed is formulated from the prior art, then the claim is addressed and the composition will substantially have the same effects. As to the effects or to the limitation of increasing neurological and physiological performance, the properties are an inherent result of a particular composition having the same list of components. Further they are to an intended use. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. Further the motivation of a skilled artisan to combine different agents to arrive at a composition as claimed need not be the same. As stated in the rejection below a person skilled in the art would have found it obvious to arrive at the claimed composition with a reasonable expectation of success. One skilled in the art would have been motivated to arrive at the composition comprising BHB, citicoline and epicatechins to use them to enhance cognitive function in a subject.
Applicants argue how Millet Declaration explains how the ketone bodies (such as BHB) affect the body in fundamentally different ways compared to non- caffeine stimulant or nootropics (such as citicoline) recited in the claims (see Arguments p 10-12).
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As to the declaration data, the data is in regards to paraxanthine and BHB, caffeine and BHB (See Figures, Tables 2-3 of instant specification). There is no data for any other combination of nootropic agent with BHB as claimed. Applicants have not provided any data or evidence to support the unexpected or unpredictably superior effects for any other combination other than paraxanthine and BHB. It is noted that it is Applicant's burden to demonstrate unexpected results over the prior art. See MPEP 716.02, particularly 716.02 (a) - (g). The unexpected results should be demonstrated with evidence that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992). Moreover, evidence as to any unexpected benefits must be "clear and convincing" In re Lohr, 137 USPQ 548 (CCPA 1963), and be of a scope reasonably commensurate with the scope of the subject matter claimed, In re Linder, 173 USPQ 356 (CCPA 1972). None of the claims are limited to the compounds tested or to any amounts of the active compounds i.e. the data presented in the specification is not commensurate with the full scope of the claimed invention. The unexpected results are not sufficient to overcome the rejection because the unexpected results have to be unobvious as well. It has been shown that one of ordinary skill in the art would have been motivated to combine Lowery and Wurtman to arrive at the claimed composition. The burden of demonstrating unexpected results rests on the party asserting them. In addition, “when unexpected results are used as evidence of nonobviousness, the results must be shown to be unexpected compared with the closest prior art.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991).
Applicants have not shown any comparison data with that of the prior art, even for elected species, for e.g. BHB alone, citicoline alone, citicoline with BHB, BHB+citicoline+vasodilator component to provide evidence that it would have been unexpected and unobvious. Further single point data (paraxanthine+BHB) cannot be extrapolated to all of non-caffeine stimulant or nootropic +BHB and a vasodilator component as claimed. Applicants have not provided sufficient evidence of unexpected results, that when weighed with the evidence of obviousness, sufficient to support a conclusion of nonobviousness.
Applicants argue that the claimed synergistic composition provides unexpectedly superior benefits.
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In response, there is no claim limitation that recites synergy or to a synergistic composition. The independent claims 1, 15 and 19 are to a composition comprising a non-caffeine stimulant selected from a laundry list, at least one ketone body or ketone body precursor selected from the group consisting of beta-hydroxybutyrate (BHB) salt, BHB ester, beta-hydroxybutyric acid, 1,3-butanediol, medium chain fatty acids, medium chain triglycerides (0.5-20g) and the composition free of sugar components. As stated above, Applicants have provided data with paraxanthine and BHB. However the results provided do not commensurate in scope. The agents citicoline and BHB are individually taught in a related prior art for cognition. Hence it would have been obvious to a skilled artisan to arrive at the claimed composition with a reasonable expectation of success and to use it for cognitive therapy. Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims (See MPEP § 716.02(b)-III).
Applicants argue that¸
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In response, as stated above, the claims are directed to a composition comprising ketone body agents and nootropics. The term ketone bodies and nootropics or stimulants define the properties of the agents. Further the same agents can function as other agents or can have additional pharmacological properties. For e.g. medium chain fatty acids can function as ketone bodies as well as nutritional supplement or choline can function as a nutrient as well as a nootropic. It is expected that the composition formulated from the prior art and that of the instant claims would in fact have the same properties, absent evidence to the contrary, which has not been provided by the applicant as the properties of the compounds and the composition are inseparable. The instant specification and the declaration provide data for the effects with the combination of BHB and paraxanthine. However the instant claims are not limited to such combination. For e.g. the combination can be medium chain fatty acids and other non-caffeine stimulant or nootropic as claimed. The unexpected results provided for PX+BHB do not commensurate in scope with the claimed invention.
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.
Claim(s) 1, 2, 6, 8-21 are rejected under 35 U.S.C. 103 as being unpatentable over Lowery et al. (US 20170296501 A1) in view of Wurtman (US 20030114415).
Lowery teachings are to a composition comprising beta-hydroxybutyrate (0.5-10 g) for administration to individuals for improving ketosis, energy, focus, mood and cognitive function ((see abstract) [0004], [0011], [0040], example 14). R-beta-hydroxybutyrate (e.g., greater than 90 percent purity of R-beta-hydroxybutyrate and less than 10 percent L-beta-hydroxybutyrate) and/or mixtures with R-beta-hydroxybutyrate may be administered to humans. In some implementations, one or more specific chiralities of beta-hydroxybutyrate may be utilized [0039]. The composition can include salt(s) of beta-hydroxy butyrate for e.g. sodium beta-hydroxybutyrate, potassium beta-hydroxybutyrate [0038]. Lowery teaches addition of niacin to the composition [0053]. The described composition may be provided in a powdered form that allows the described composition to be sprinkled on food, mixed with a liquid to provide a beverage, and/or directly administered [0093]. The composition may include approximately 0.5 g to approximately 10 g of R-beta-hydroxybutyrate [0006-0007]. Lowery further teach that the composition can be administered parenterally [0093].
The above prior art is not explicit in teaching a nootropic agent, e.g. citicoline in the composition.
Wurtman teachings are to treating cognitive dysfunction or memory impairment with an effective amount of a composition that comprises citicoline or pharmaceutically acceptable salts (Abstract, claim 1). The citicoline dosage may be from about 10 mg to about 1000 mg from one to about 4 times per day [0057] and the formulations include solid, e.g. powder, or liquid (solution or suspension) [0059] and the composition can contain pharmaceutical carriers [0060]. Wurtman teach that the active ingredient also may be in the form of a bolus, electuary, or paste. Formulations of the active ingredient suitable for parenteral administration may comprise a sterile, aqueous preparation of the active ingredient [0059]. Wurtman teach addition of neuroprotective agents, e.g. magnesium [0061].
In summary, Lowery teach composition comprising beta-hydroxybutyrate (0.5-10 g) for administration to individuals for improving ketosis, energy, focus, mood and cognitive function and additional agent, niacin can be added. Wurtman teach effective amount of a composition comprising citicoline treating cognitive dysfunction or memory impairment. Also taught by Wurtman is additional neuroprotective agent magnesium can be added.
From the teachings of Wurtman a person skilled in the art before the effective filing date of the invention would have found it obvious to add citicoline in the composition of Lowery to arrive at the claimed composition. A person skilled in the art would have been motivated to do so is to combine two agents known in the art for same purpose, herein for treating or improving cognitive function. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). Further a skilled person would have been motivated to combine the two agents beta-hydroxybutyrate acid and citicoline into a composition for synergistic or additive benefits. As to the limitation of ‘increasing neurological and physiological performance’, they are to intended use. The prior art structure is capable of performing all of the intended uses in applicant's claimed composition even if they are not specifically disclosed. The intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. Additionally, a person of ordinary skill in the art is always motivated to pursue the known options within her or his technical grasp. (“[T]he motivation in the prior art to combine the references does not have to be identical to that of the applicant to establish obviousness.” As to the amount of BHB, Lowery teach 0.5-10 g of BHB acid or salt. Wurtman teach 10-1000 mg of citicoline. If for example 1000 mg of BHB acid/salt is formulated with 100 mg of citicoline the ratio is about 10:1 of BHB : citicoline and such amounts in the composition addresses the synergistic limitation as the instant specification teach 50-500 mg of the non-caffeine stimulant or nootropic (see [0033], [0037]). The composition formulated from the prior art teachings is free of sugar components. Thus claims 1, 6, 10-11, 17 are addressed. As to the limitation, wherein the ketone body or ketone body precursor is the sole caloric energy source in the composition, the composition formulated from the prior art has BHB as the sole caloric source of energy. As to claims 2, 18, the composition do not contain caffeine and BHB is the sole caloric source of energy. As to claim 15, if BHB acid is 1000 mg and is 100 mg in the composition, the ratio is at least about 10:1 and BHB is the sole caloric source of energy. As to claim 16, if BHB acid is 1000 mg and citicoline (nootropic), is about 70 mg in the composition, the ratio is about 15:1.
As to claim 8, Lowery teach the composition can comprise BHB acid salts, e.g. sodium, potassium etc. Hence it would have been obvious to a skilled artisan to formulate the composition comprising BHB anions and sodium, potassium ions and its mixtures. Claim 9 is addressed by the combined prior art teaching of the composition as a beverage, powder, liquid etc. As to claims 12-13, Lowery teach ketone body (BHB acid), enriched R-enantiomer or enriched S-enantiomer can be utilized in the composition. As to claim 14, Lowery teaches the composition can be mixed with a liquid to provide beverage and Wurtman teach addition of pharmaceutical carriers to the composition. As to claims 19-20, a person skilled in the art would have found it obvious to arrive at a dosage form, e.g. liquid comprising BHB acid (1000 mg) and a nootropic, e.g. citicoline (100 mg) and a pharmaceutically acceptable carrier to arrive at claimed 10:1 ratio from the teachings of the prior art. As to claim 21, a skilled artisan would have found it obvious that the composition can be administered parenterally (via injection) as both Lowery and Wurtman teach that the active agents can be delivered parenterally. Hence a skilled artisan would have found it obvious to configure the composition to be administered via injection.
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lowery et al. (US 20170296501 A1) in view of Wurtman (US 20030114415) and further in view of French (US 20080161386).
Lowery and Wurtman teachings as discussed above. The references/teachings are incorporated herein
Lowery and Wurtman do not teach that the composition further comprises a vasodilator, e.g. epicatechins.
French is explicit in teaching epicatechin composition and its use in a method of enhancing executive cognitive function in a subject in need thereof (See Claims 1, 6, Table 3).
From the teachings of French a skilled artisan before the effective filing dated of the invention would have found it obvious to add epicatechin to a composition derived from Lowery and Wurtman’s teachings. A person skilled in the art would have been motivated to do so is to combine agents known in the art for same purpose, herein for improving cognitive function. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted). Further a skilled person would have been motivated to combine the agents beta-hydroxybutyrate acid, citicoline and epicatechin into a composition for synergistic or additive benefits. It is noted that though French do not teach epicatechin as a vasodilator compound, it is the inherent property of the agent whether it is explicitly taught or not. Thus claims 3-4 would have been obvious over the combined prior art teachings.
Note: TW 200305371 A reference teach infant formula composition comprising BHB, arginine, phenylalanine, tryptophan and tyrosine (claim 7). The reference is drawn to non-elected species with regard to the composition comprising BHB, a non-caffeine stimulant or nootropic and a vasodilator and was found during the search for the elected species. It should not be interpreted that a comprehensive search was performed for all non-elected species.
Claim Rejections - 35 USC § 112
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.
Claim 21 is 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.
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A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).. In claim 21, subdermal modality is broad and subdermal implant or transdermal patches are types. Similarly inhalable pulmonary composition include nasal spray or vapor or nebulizing liquid or smokable bolus.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Further as to claim 21, it is not clear how a syringe for intravenous injection can be a composition. Also vaporizable cartridge is to a device that can comprise composition but it is not a composition. Appropriate correction is required. As to the term ‘injectable bolus’ is it bolus injection or the medication composition. Clarification is required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 5712705239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627
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