Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-10, 13, 20 and 24 are cancelled.
Claims 11, 12, 14-18, 21-23 and 25-30 are pending.
Withdrawn rejections
Applicant's amendments and arguments filed 6/25/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 11, 12, 14-18, 21-23 and 25-30 are rejected under 35 U.S.C. 103(a) as being unpatentable over CN101766568A; (English translation provided) and Sugiyama et al. (US5651991) and Hosokawa et al. (CN1227490A; English translation provided).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Applicant claims, for example:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a pharmaceutical research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from pharmaceutical formulation and possess specialized knowledge in drug delivery, material science, and physical chemistry to convert active pharmaceutical ingredients (APIs) into stable, effective medicines. They understand how to select excipients (inactive ingredients), optimize stability, and ensure compliance with regulatory standards (FDA, GMP). Their expertise covers formulation development, dosage form design, and manufacturing processes.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 11-12, 14-17, 21-23 and 25-28, CN101766568 teaches in Example 1 [0017] a composition of:
An effective amount of clevidipine 1g (0.1%) (a);
A lipid soybean oil 200 g (20%) (c);
Emulsifier soy lecithin (which is soybean phospholipids) 20 g (2.0%) (d);
Tonicity agent/osmotic pressure adjusting agent glycerol 22 g (2.2%) (e);
Chelating antimicrobial agent EDTA calcium salt 0.1 g (0.01%) (b); and
Water (g) to 1000 ml.
See also claims 1-9. The same components implicitly make the composition of CN101766568 stable and resistant to microbial growth. Since CN101766568 discloses the same amount of antimicrobial chelating EDTA as claimed, then the composition inherently delays or retards microbial growth such that there is less than 10-fold (1 log) increase in viable microbial colonies over a 24-hour period. See MPEP 2112.01 II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES
“Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
CN101766568 teaches that the emulsion preparation is for quickly lowering the blood pressure and treatment of hypertension (page 2, Description; claim 9), thus reading on methods of administering the composition to a patient in need thereof for treating hypertension.
Further regarding claims 11 and 21, CN101766568 teaches that the emulsifiers include but are not limited to ionic surfactants such as cholic acid and deoxycholic acid, and may be one or several [0010]. Thus, when more than one emulsifier is present it indicates an emulsifier and co-emulsifier (f).
Further regarding claims 14 and 25, CN101766568 discloses that the oil phase includes, but are not limited to, soybean oil, castor oil, safflower oil, olive oil, cottonseed oil, sunflower oil, sesame oil, peanut oil, corn oil, medium chain triglycerides, glycerol triacetate, fatty acid monoglyceride or di-fatty acid glycerides and other pharmaceutically acceptable oils, may be a mixture of one or more of the above-described esters (claim 4).
Further regarding claims 16 and 27, CN101766568 discloses phospholipids including egg yolk phospholipids and soya phospholipids and their hydrogenated derivatives, phosphatidylcholine, synthetic phosphatidylcholine and hydrogenated derivatives thereof, poloxamers, cholic acid, deoxycholic acid, for example (claim 5).
Regarding claims 18 and 29, CN101766568 discloses that the pH is 6-8 [0019] which is overlaps the claimed range of about 6.0 to about 8.8.
Regarding claims 11, 19 and 21, Sugiyama et al. teach fatty emulsion drug carrier compositions (Abstract) that has utility in administration of dihydropyridine calcium antagonists because they are sparingly soluble in water (Column 32, lines 5-13). Sugiyama et teach an emulsion comprising a calcium antagonist, a lipid such as soybean oil and a phospholipid (Claims 1 and 8). Sugiyama et al. teach oleic acid, stearic acid and palmitic acids as emulsification aids (Column 8, lines 18-22).
Regarding claims 11, 19 and 21, Hosokawa et al. teach fatty emulsion compositions (Title) where if necessary an emulsifying auxiliary agent can be added (Page 4, 4th paragraph) where emulsifying auxiliary agent is an adjuvant for emulsifying fat emulsions includes palmitic acid, stearic acid and preferably oleic acid in an amount of 3% (w/v) or less and preferably 1% (w/v) (Page 4, 5th paragraph) and teach an emulsion with soybean oil and oleic acid and phosphatidylcholine (Page 5, 4th paragraph).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and CN101766568 is that CN101766568 do not expressly teach adding about 0.01-2.0% w/v of oleic, stearic or palmitic acids or their pharmaceutically acceptable salts co-emulsifier to the composition for use in the method of treating acute hypertension. This deficiency in CN101766568 is cured by the teachings of Sugiyama et al. and Hosokawa et al. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the formulation of CN101766568 and add about 0.01-2.0% w/v of oleic or stearic or palmitic acids or their pharmaceutically acceptable salts co-emulsifier, as suggested by Sugiyama et al. and Hosokawa et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because for the following sound articulated reasoning with rational underpinning based upon the evidence. Sugiyama et al. teach that dihydropyridine calcium antagonists are known to be only sparingly water soluble and to add oleic, stearic and palmitic acids as emulsification aids. It is known through Hosokawa et al. to add less than 3% and preferable 1% (w/v) of emulsifying adjuvants stearic and palmitic acids and preferably oleic acid. It is then obvious to employ less than 3% and preferable 1% (w/v) oleic, stearic and/or palmitic acids as suitable options for an emulsification aid for the sparingly soluble dihydropyridine calcium antagonist clevidipine emulsion of CN101766568 and use the composition to treat acute hypertension in a patient in need thereof with a reasonable expectation of success. It is within the skill of the ordinary artisan to ascertain whether the hypertension is acute or chronic and the pharmaceutical formulation is reasonable expected to treat any hypertension including acute hypertension.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed on 6/25/26 have been carefully considered but are not persuasive.
Applicant states that: “The Examiner has acknowledged that the '568 Ref. does not expressly teach the addition of oleic acid, stearic acid, or palmitic acid as a co-emulsifier to the clevidipine emulsion. That deficiency alone is dispositive as to the '568 Ref. standing alone. The combination with Sugiyama and Hosokawa is offered to supply the missing co-emulsifier limitation. However, neither Sugiyama nor Hosokawa addresses clevidipine formulations, nor does either reference disclose or suggest that an antimicrobial agent present at 0.001 to 0.5% w/v in combination with the specified co-emulsifier would result in a formulation retarding microbial growth to less than 1 log increase over 24 hours.” Respectfully, the Examiner cannot agree for the following reasons. First, it is impermissible to attack references singly when the Examiner relies upon the combined teachings of the references, nor may they attack a reference for not teaching a limitation of the claim when the Examiner has explicitly relied upon another reference as teaching that limitation. See In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). The ‘568 reference is relied upon for teaching clevidipine compositions with 0.01% chelating antimicrobial agent EDTA, which falls within the claimed range of from 0.001 to 0.5% w/v. Secondly, Sugiyama et al. does suggest dihydropyridine calcium antagonists, which is what clevidipine is, in combination with soybean oil, oleic acid, stearic acid and palmitic acid emulsification aids. Lastly, the same amount of antimicrobial chelating agent EDTA within the claimed range is going to also have the same resistance to antimicrobial growth wherein there is less than 10-fold (1 log) increase in viable microbial colonies over a 24-hour period as claimed. The Examiner's finding is based on the principle that products of identical chemical compositions cannot have mutually exclusive properties. This is a well settled principle in patent law. See In re Papesch, 315 F.2d 381,391 (CCPA 1963). Where patentability rests upon a property of the claimed material not disclosed within the art, the USPTO has no reasonable method of determining whether there is, in fact, a patentable difference between the prior art materials and the claimed material. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Therefore, where the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the USPTO can require an applicant to prove that the prior art products do not necessarily possess the characteristics of his claimed product. Id.
Applicant argues: “Even when the '568 Ref., Sugiyama and Hosokawa are considered together, the combined teachings contain no disclosure that adding a co-emulsifier selected from oleic acid, stearic acid, or palmitic acid to a clevidipine emulsion with an antimicrobial agent would preserve, rather than interfere with, the antimicrobial function of that agent.” Respectfully, Applicant needs to expand upon their argument. The Examiner can discern no interaction between any of the named fatty acids with the chelating EDTA, which binds metal ions1; not fatty acids. So, the Examiner does not understand why the artisan might think that adding a fatty acid such as oleic acid might interfere with the antimicrobial function of the agent. Clarification is requested.2 On the contrary, the ordinary artisan might expect an enhancement of antimicrobial activity from the well-known antimicrobial properties of fatty acids.3
Applicant further asserts: “the co-emulsifier did not counteract the antimicrobial function of the agent. This result was not predicted by the combined prior art and constitutes an unexpected result that further supports patentability. The combined prior art simply fails to address- let alone resolve -the question of whether the claimed co-emulsifier is compatible with an antimicrobial agent system in a clevidipine emulsion.” However, that appears to be a predictable result given that EDTA is not expected to chelate a fatty acid. Thus, the antimicrobial effectiveness of EDTA would not be diminished at all.
Applicant argues that inclusion of a claimed co-emulsifier at a low concentration within the claimed range unexpectedly produced a substantial increase in the absolute value of the zeta potential - from approximately -17.6 mV to -36.1 mV - reflecting enhanced physical emulsion stability that was not predicted by the prior art. Respectfully, the Examiner cannot agree. First of all, the zeta potential of the emulsion is not a claimed parameter. Applicant is arguing a limitation which his not claimed. Applicants are arguing limitations that are not present in the plain meaning of the language of the claim. See Sjolund v. Musland, 847 F.2d 1573, 1581 (Fed. Cir. 1988). Therefore, the argument is not directed at a limitation that actually appears in the claim. See In re Self, 671 F.2d 1344, 1348 (CCPA 1982) ("[A]ppellant's arguments fail from the outset because ... they are not based on limitations appearing in the claims."). Secondly, since the pH of the emulsion is 6 to 8.8 (Claim 18), it is reasonable to assert that in alkaline conditions sodium oleate predominates, increasing charge density and driving the zeta potential more negative resulting in a strong electrostatic repulsion between the negatively charged droplets that prevents coalescence and make a highly stable emulsion. So, what Applicant observed appears completely expected and predictable.
Applicant argues: “According to the Office Action, because the '568 Ref. discloses EDTA calcium salt at 0.01 % w/v, the microbial retardation functional limitation is inherently present. Applicant respectfully submits that this argument does not apply to the amended claims and should be withdrawn. lnherency requires that the prior art composition be the same as the claimed composition such that the functional property necessarily follows. The amended claims require not only a chelating agent at 0.001 to 0.5% w/v, but also a co-emulsifier selected from oleic acid, stearic acid, or palmitic acid at 0.01 to 2.0%.” In response, the Examiner maintains that the prior art composition of ‘568 has the same antimicrobial chelating agent EDTA within the claimed range and the same agent will impart microbial growth resistance as claimed. Common chemical sense and Applicant’s own testing have demonstrated that addition of a co-emulsifier such as oleic acid has no effect on the antimicrobial function of EDTA.
Applicant contends that the Graham factors confirm patentability of the amended claims. Applicant argues that the ‘568 reference “does not disclose a clevidipine formulation or a chelating agent used as an antimicrobial agent at any concentration”. Respectfully, the Examiner does not agree because the ‘568 reference expressly teaches in the preferred embodiment a composition comprising clevidipine and disodium edetate (EDTA). The same compound taught in the prior art in the same amount will also have the same antibacterial properties claimed whether the inventors of ‘568 knew it or not because it is an inherent property of the chemical entity. See MPEP 2112 II: “II. INHERENT FEATURE NEED NOT BE RECOGNIZED AT THE TIME OF THE INVENTION
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).” Accordingly, it remains the Examiner’s position that the combined references teach and suggest each and every limitation. The test for obviousness is "what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 4I3, 425 (CCPA I98I) (MPEP 2145(III)).
Applicant alleges that the specification demonstrates unexpected results as described in [0065-0066] and Tables 9 and 10 where the addition of a co-emulsifier at low concentration produced an unexpected and substantial increase in the absolute value of the zeta potential - a result not predicted by or suggested in any of the cited references and the co-emulsifier did not adversely affect the antimicrobial effectiveness of antimicrobial agent, which was itself a non-obvious and unexpected result. However, that appears to be an expected result as explained in more detail above. Addition of oleic acid is expected to stabilize the emulsion and not interfere with any antimicrobial activity of EDTA. The Examiner does not consider the finding that the co-emulsifier did not adversely affect the antimicrobial effectiveness of the antimicrobial chelating agent non-obvious or unexpected at all. However, what is conspicuously missing in this record is a side-by-side comparison with the clevidipine emulsion of ‘568 that objectively demonstrates significantly improved characteristics. A demonstration of mere improvement, without a showing that the improvement is significant or unexpected, is insufficient evidence of unexpected results. See In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995).
Respectfully, the Examiner is not persuaded by Applicant’s arguments.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 11, 12, 14-18, 21-23 and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11103490. Although the claims at issue are not identical, they are not patentably distinct from each other because anticipates the claimed subject matter by disclosing compositions comprising in claims 1:
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And in claim 6:
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The patent does not expressly teach the co-emulsifier is stearic acid (C18) or palmitic acid (C16). However, the scope for the co-emulsifier the specification defines a co-emulsifier as oleic acid, stearic acid and palmitic acid (column 6, lines 47-56). See MPEP 804: “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.” While the patent does not claim methods of treating acute hypertension, clevidipine is approved for treatment of acute hypertension and the normal and usual operation of the composition is to treat acute hypertension. Consequently, administration to a patient in need thereof is obvious over disclosure of the formulation. Accordingly, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over the patented subject matter.
Claims 11, 12, 14-18, 21-23 and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10010537. Although the claims at issue are not identical, they are not patentably distinct from each other because anticipates the claimed subject matter by disclosing compositions comprising, for example:
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The patent does not express teach wherein microbial growth is delayed or retarded such that there is less than 10-fold (1 log) increase in viable microbial colonies over a 24-hour period. However, the functional parameter is inherent in the composition because it comprises the same components. See MPEP 2112.01 II. COMPOSITION CLAIMS — IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES
“Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
The patent does not expressly teach the co-emulsifier is stearic acid (C18) or palmitic acid (C16). However, the scope for the co-emulsifier the specification defines a co-emulsifier as oleic acid, stearic acid and palmitic acid (column 6, lines 43-54). See MPEP 804: “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.”. Accordingly, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over the patented subject matter.
While the patent does not claim methods of treating acute hypertension, clevidipine is approved for treatment of acute hypertension and the normal and usual operation of the composition is to treat acute hypertension. Consequently, administration to a patient in need thereof is obvious over disclosure of the formulation.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over the patented subject matter.
Claims 11, 12, 14-18, 21-23 and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 8658676. Although the claims at issue are not identical, they are not patentably distinct from each other because anticipates the claimed subject matter by disclosing compositions comprising, for example:
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The patent does not expressly teach the amount of oleic acid is about 0.01 to about 2.0% w/v. However, the patent does teach addition of oleic acid (claim 7) and it is merely routine optimization by the ordinary artisan to determine the optimal amount of oleic acid to add. See MPEP 2144.05 (II) (A): “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)…see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
The patent does not expressly teach the co-emulsifier is stearic acid (C18) or palmitic acid (C16). However, the scope for the co-emulsifier the specification defines a co-emulsifier as oleic acid, stearic acid and palmitic acid (column 6, lines 32-43). See MPEP 804: “The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim.” Accordingly, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over the patented subject matter.
While the patent does not claim methods of treating acute hypertension, clevidipine is approved for treatment of acute hypertension and the normal and usual operation of the composition is to treat acute hypertension. Consequently, administration to a patient in need thereof is obvious over disclosure of the formulation.
Accordingly, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over the patented subject matter.
Response to Arguments: Applicant requested that the double patenting rejections be held in abeyance until there are allowable claims. MPEP 804(I)(B)(1) states: “A complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer in accordance with 37 CFR 1.321 in the pending application(s) with a reply to the Office action (see MPEP § 1490 for a discussion of terminal disclaimers). Such a response is required even when the nonstatutory double patenting rejection is provisional.” And MPEP 714.03 states: “Where an amendment substantially responds to the rejections, objections, or requirements in a non-final Office action (and is a bona fide attempt to advance the application to final action) but contains a minor deficiency (e.g., fails to treat every rejection, objection, or requirement), the examiner may simply act on the amendment and issue a new (non-final or final) Office action. The new Office action may simply reiterate the rejection”. Accordingly, the double patenting rejections are reiterated and the claims remain rejected.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
1 By binding metal ions, EDTA exerts an antimicrobial effect by restricting the availability of essential metal ions to the microbes.
2 The Examiner reviewed the art again and found Chen et al. (CN101032468A), which teaches soybean oil emulsions with oleic acid or oleate as a stabilizer and emulsifying agent and EDTA as a complex used for controlling metal ions (Abstract; claims 1-3, 6 and 7). No adverse interactions of EDTA and oleic/oleate are reported. Similarly, Xie et al. (CN101797227A) also teach emulsions composed of soybean oil, metal ion chelant disodium edetate (EDTA) and stabilizing oleic acid or sodium oleate (Claims 1, 2 and 6-7). No adverse interactions of EDTA and oleic/oleate are reported. In fact, Xie et al. report that addition of the metal chelant greatly reduces the oxidation of the emulsion [0007-0008].
3 See Table 1 of Sun et al. (FEMS Immunology and Medical Microbiology 2003;36:9-17) and Table 1 of Kabara et al. (ANTIMICROBIAL AGENTS AND CHEMOTHERAPY, July 1972, p. 23-28).
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