DETAILED ACTION
Notice of 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 .
Status of the Claims
The amendments filed 9/11/2025 have been entered.
Response to Arguments
Applicant’s arguments, filed 9/11/2025, have been fully considered.
Applicant first traverses the rejection of claims 1, 13, 33-34, 59 and 73 under 35 U.S.C. 112(a) for lacking written support. As argued by Applicant, “claim 1 is currently amended… to recite that ‘R1 is C10-24 alkyl or a C10-24 alkenyl group’ and that ‘R2a and R3a are each a C10-25 alkyl or a C10-25 alkenyl group’” and, thus “the variability is limited to alkyl or alkenyl groups of defined length” (Applicant Arguments, Page 11). As further argued by Applicant, “the claims are specific to C10 to C24 lipid molecule combinations that must include C16 and/or C18 components at the claimed ratios. Applicant provides detailed description of numerous species throughout the specification” (Applicant Arguments, Page 12).
The argument is not found persuasive. Even with the amended definitions of groups R1, R2a and R3a in Formula (I), the claimed genus of compositions comprising “a mixture of ether lipid molecules of Formula (I)” continues to be virtually without limit, embracing billions of potential mixtures of ether lipid molecules of Formula (I) bearing no structural resemblance to one another.
Furthermore, it remains that case that the Specification does not appear to disclose even a single composition as recited by amended claim 1, including Applicant’s elected composition (or product thereof) comprising a mixture of ether lipid molecules of Formula (I) as follows:
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and
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.
However, regarding “the elected species at least”, Applicant points to “the disclosure on page 51, line 25 to page 53, line 19 wherein one of ordinary skill in the art readily recognizes C16 and C18 alkyl and alkenyl groups coupled to R2 as hydrogen and R3 such that the compound is an alkyl acyl glycerol, alkyl diacyl glycerol, PC or PE plasmanyl- or plasmenyl-phospholipid as examples” (Applicant Arguments, Page 12)
The argument is not found persuasive. The claims are not drawn to a compound of Formula (I). Rather, the claims are drawn to “[a] composition comprising a mixture of ether lipid molecules of Formula (I)”. While the claim further requires that at least one ether lipid molecule of Formula (I) in said mixture comprise a molar ratio of 18:0 alkyl R1 groups to 18:1 alkenyl R1 groups of 1.2:1 to 2.5:1, a molar ratio of 18:1 alkenyl R1 groups to 16:0 alkyl R1 groups of 0.5:1 to 1:1, or a molar ratio of 18:0 alkyl R1 groups to 16:0 alkyl R1 groups of 0.9:1 to 1.7:1 – as discussed in the previous action, each of the “limited” structures of Formula (I) still comprises substantial variance. Moreover, the remainder of the composition is completely undefined, further comprising any combination of one or more additional lipid ether molecules of Formula (I), without limitation.
Yet, nowhere does the Specification appear to describe even one such composition.
For example, the Specification describes administration of ALKYROL® Shark Liver Oil (SLO) in Example 2 (Pages 85-95). Yet, it is unclear whether ALKYROL® Shark Liver Oil (SLO) entails a composition as recited by claim 1.
Additionally, the Specification describes an “alkylglycerol mix” (AKG) comprising “batyl alcohol, chimyl alcohol and selachyl alcohol” in a 1:1:1 ratio in Example 3 (Pages 95-99). As evidenced by Iannitti et al (Mar Drugs 8:2267-2300, 2010), batyl alcohol, chimyl alcohol and selachyl alcohol have the following structures, each of which read on instantly claimed Formula (I):
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However, a composition comprising batyl alcohol, chimyl alcohol and selachyl alcohol in a 1:1:1 ratio does not appear to meet the limitation of comprising a molar ratio of 18:0 alkyl R1 groups to 18:1 alkenyl R1 groups of 1.2:1 to 2.5:1, a molar ratio of 18:1 alkenyl R1 groups to 16:0 alkyl R1 groups of 0.5:1 to 1:1, or a molar ratio of 18:0 alkyl R1 groups to 16:0 alkyl R1 groups of 0.9:1 to 1.7:1, as recited by claim 1. At minimum, the AKG composition does not entail Applicant’s elected composition.
The Specification further discloses “breast milk samples from… mothers”, as well as “[s]everal animal milks (2 cow milk and 1 goat milk) and formula (n=10)” (Page 107, Lines 10-13 and Page 108, Table).
Lastly, the Specification suggests a “composition of fatty acids in the TG(O) species that could be used in a supplement could include 16:0, 16:1, 18:0, 18:2, 20:0, 20:1 to produce the major species TG(O-50:1), TG(O-52:1), TG(O-52:2), TG(O-54:2), TG(O-54:3) present in breast milk” (Page 113, Lines 2-5).
In response to this Action, Applicant is encouraged to indicate whether any of the above compositions entail a composition as recited by claim 1 and, if so, to further define the ether lipid molecules of Formula (I) contained therein. Additionally, Applicant is encouraged to identify any additional composition(s) embodied by the Specification that read on claim 1.
Currently, the Specification does not appear to describe any examples of compositions as recited by claim 1 and it is MAINTAINED that the Specification fails to provide adequate written description for the genus of the claimed composition and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Applicant next traverses the rejection of claims 33-34, 59 and 73 under 35 U.S.C. 112(b) as being indefinite (Applicant Arguments, Page 12).
The rejection is WITHDRAWN in view of Applicant’s amendments to the claims.
Applicant next traverses the rejection of claims 1, 5, 13, 33-34 and 73 under 35 U.S.C. 103(a) as being unpatentable over Mendel et al (US 2011/02304500; of record). As argued by Applicant, “[w]ith respect to the assertion that Mendel teaches only 15 possible combinations… respectfully Mendel teaches far, far more than merely 15 combinations” and, pointing to “paragraphs [0059]-[0065]” argues “that the number of species of PAF analogues taught is actually vast and unknowable” (Applicant Arguments, Page 13).
The argument is not found persuasive. While it is acknowledged that Mendel et al generically describe PAF analogs of Formula I embracing thousands of hypothetical compound species that could be arranged in countless combinations (Paragraphs 0059-0065), Mendel et al also specifically teach four “[e]xemplary PAF-analogs according to embodiments of the invention” which include lyso-PAF/CI-303 and 1-octadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine (Paragraph 0027 and Paragraph 0074), as well as mixtures thereof (Paragraph 0074 and Paragraph 0156). Considering that the genus of potential combinations of the four “[e]xemplary PAF-analogs according to the embodiments of the invention” (Paragraph 0074) disclosed by Mendel et al entails only 15 combinations (i.e., 2n-1, wherein n=4), it is MAINTAINED that the skilled artisan would have immediately envisaged a composition comprising a mixture lyso-PAF/CI-303 and 1-octadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine as instantly claimed.
Applicant further notes that “nowhere does Mendel teach or suggest the claimed ratios of the C18 and/or C16 species as claimed” (Applicant Arguments, Page 14). And, as argued by Applicant, “[t]here must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify… reference teachings” (Applicant Arguments, Page 14).
The argument is not found persuasive. As stated by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454 (CCPA): “where 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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he 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” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))). As indicated by the court in Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1293 (Fed. Cir. 2015), every ordinary artisan in medicine performs “merely routine optimization of drug dosage to maximize therapeutic effect.”
Claim Rejections - 35 USC § 112
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.
Claims 1, 13, 33-34, 59 and 73-75 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
The claims contain 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, at the time the application was filed, had possession of the claimed invention.
In the instant case, support cannot be found for the claimed genus of compositions (and products thereof) embraced by a mixture of ether lipid molecules of Formula (I):
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,
wherein the composition comprises ether lipids having:
a molar ratio of 18:0 alkyl R1 groups to 18:1 alkenyl R1 groups of 1.2:1 to 2.5:1;
a molar ratio of 18:1 alkenyl R1 groups to 16:0 alkenyl R1 groups of 0.5:1 to 1:1; and/or
a molar ratio of 18:0 alkyl R1 groups to 16:0 alkenyl R1 groups of 0.9:1 to 1.7:1.
More specifically, support cannot be found for Applicant’s elected composition (or product thereof) comprising a mixture of ether lipid molecules of Formula (I) as follows:
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and
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wherein the molar ratio of 18:0 alkyl R1 groups to 16:0 alkenyl R1 groups is 0.9:1 to 1.7:1.
The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus.”
Turning to the instant claims, claim 1 requires that the composition comprises a mixture of ether lipid molecules of Formula (I) wherein the composition comprises ether lipids having:
a molar ratio of 18:0 alkyl R1 groups to 18:1 alkenyl R1 groups of 1.2:1 to 2.5:1;
a molar ratio of 18:1 alkenyl R1 groups to 16:0 alkyl R1 groups of 0.5:1 to 1:1; and/or
a molar ratio of 18:0 alkyl R1 groups to 16:0 alkyl R1 groups of 0.9:1 to 1.7:1.
As such, claim 1 requires that composition comprise at least one of the following mixtures:
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and
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;
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and
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; and/or
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and
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.
Yet, each of the required structures of Formula (I) comprises substantial variance. For example, the structure
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includes:
(1) alkyl phosphatidylcholines
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abbreviated in the Specification as “PE(P)”);
(2) alkyl phosphatidylethanolamines
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(abbreviated in the Specification as “PE(O)”);
(3) lysoalkylphosphatidylcholine
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(abbreviated in the Specification as “LPC(O)”);
(4) alkylglycerol
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(abbreviated in the Specification as “AG”);
(5) alkyl-diacylglycerols
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(abbreviated in the Specification as “TG(O)”); and
(6) alkyl-acylglycerols
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(abbreviated in the Specification as “DG(O)”).
Furthermore, the claimed compositions can comprise one or more additional ether lipid molecules of Formula (I), without limitation.
Collectively, the genus of compositions embraced by claim 1 is virtually without limit, embracing billions of potential mixtures of ether lipid molecules of Formula (I) bearing no structural resemblance to one another.
Yet, it is unclear whether the Specification discloses even a single composition as recited by claim 1. In particular, the Specification does not appear to disclose Applicant’s elected composition (or product thereof) comprising a mixture of ether lipid molecules of Formula (I) as follows:
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and
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.
Rather, the Specification discloses ALKYROL® Shark Liver Oil (SLO) enriched in alkyl-diacylglycerols wherein “[t]he composition of the 1-O-alkyl groups on the SLO was found to be predominantly O-18:1 (71%), O-16:0 (18%), and O-18:0 (5%)” further pointing to Figure 9 but which appears to be Figure 10, “1-O-Alkylglycerols in SLO” (Page 88, Lines 10-11). Additionally, the Specification discloses an AKG mix comprising “three alkylglycerols (batyl alcohol, chimyl alcohol and selachyl alcohol) (1:1:1:)” (Page 96, Lines 17-18). The Specification further evaluated the “breast milk samples from… mothers”, as well as “[s]everal animal milks (2 cow milk and 1 goat milk) and formula (n=10)” (Page 107, Lines 10-13 and Page 108, Table). Lastly, the Specification suggests a “composition of fatty acids in the TG(O) species that could be used in a supplement could include 16:0, 16:1, 18:0, 18:2, 20:0, 20:1 to produce the major species TG(O-50:1), TG(O-52:1), TG(O-52:2), TG(O-54:2), TG(O-54:3) present in breast milk” (Page 113, Lines 2-5).
While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that the disclosure of potentially four largely undefined mixtures of ether lipid molecules does not adequately describe a the instantly claimed genus of compositions embracing billions of mixtures of ether lipid molecules bearing no identifiable relationship with those four compositions. That is, the Specification does not disclose a sufficient variety of species to reflect the extreme variance in the genus.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
As such, claims 1, 13, 33-34, 59 and 73-75 are rejected.
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.
Claims 1, 5, 13, 33-34 and 73-75 are rejected under 35 U.S.C. 103(a) as being unpatentable over Mendel et al (US 2011/0230450).
Claim 1 is drawn to a composition comprising a mixture of ether lipid molecules of Formula (I) as follows:
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wherein the molar ratio of 18:0 alkyl R1 groups to 16:0 alkenyl R1 groups is 0.9:1 to 1.7:1, and wherein:
the composition is for in vivo maintenance of ether lipids at levels and/or ratios associated with a non-disease state; or
the composition is for in vivo modification of ether lipids towards levels and/or ratios associated with a non-disease state.
Mendel et al teach “compositions… [comprising] analogs of platelet activating factor (PAF)” (Abstract), specifically wherein “the PAF-analog is selected from the group consisting of… 1-hexadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine [aka lyso-PAF or CI-303] and 1-octadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine” – which, respectively, entail the instantly claimed 16:0 alkyl and 18:0 alkyl compounds of Formula (I) above – listed among a total of four PAF-analogs (Paragraph 0027 and Paragraph 0074), as well as mixtures thereof (Paragraph 0074 and Paragraph 0156), specifically disclosing a composition comprising lyso-PAF/CI-303 (Paragraph 0165).
Although Mendel et al do not specifically disclose embodiments comprising a mixture of lyso-PAF/CI-303 and 1-octadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine, as recognized by In re Schaumann, 572 F.2d 312 (CCPA 1978), claims to a species are anticipated where the prior art teaches a genus embracing a limited number of members closely related to each other such that one of ordinary skill in the art could immediately envisage each member. Notably, in In re Petering, 301 F.2d 676 (CCPA 1962) the court determined that a prior art genus containing only 20 compounds anticipated a claimed species within the genus because “one skilled in [the] art would... envisage each member” of the genus (emphasis in original)). Thus, considering that the genus of potential combinations of the four “[e]xemplary PAF-analogs according to the embodiments of the invention” (Paragraph 0074) disclosed by Mendel et al entails only 15 combinations (i.e., 2n-1, wherein n=4), the skilled artisan would have immediately envisaged a composition comprising a mixture lyso-PAF/CI-303 and 1-octadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine as instantly claimed.
Furthermore, in doing so, it would have been obvious to include each of lyso-PAF/CI-303 and 1-octadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine in the same amount (i.e., in a 1:1 ratio) as a starting point.
Finally, regarding the recitation that:
the composition is for in vivo maintenance of ether lipids at levels and/or ratios associated with a non-disease state; or
the composition is for in vivo modification of ether lipids towards levels and/or ratios associated with a non-disease state;
Applicant is advised that use limitations (e.g., “for in vivo maintenance…”) within product claims do not carry patentable weight unless the recitation of the intended use of the claimed invention results in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
As such, claim 1 is rejected as prima facie obvious.
Claim 13 is drawn to the composition of claim 1 wherein the composition is for in vivo maintenance of ether lipids at, or in vivo modification of ether lipids towards, an in vivo plasmalogen lipid profile in which the ether lipids have a molar percent of 18:0 ether groups in the range of from 32.6% to 45.8%, and a molar percent of 16:0 ether groups in the range of from 26.8% to 37.4%.
As discussed above, use limitations (e.g., “for in vivo maintenance…”) within product claims do not carry patentable weight unless the recitation of the intended use of the claimed invention results in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
As such, claim 13 is also rejected as prima facie obvious.
Claim 33 is drawn a product comprising the composition of claim 1 in the form of a syrup, liquid, and so on (see Specification Page 57, Lines 5-6 which indicates that a “product” merely entails the composition “combined with one or more ingredients”).
Mendel et al teach pharmaceutical compositions comprising “one or more of the active ingredients… with other chemical components such as physiologically acceptable carriers and excipients” (Paragraph 0122) wherein “the pharmaceutical compositions are formulated for oral administration” (Paragraph 0130), more specifically “as… liquids… syrups… and the like, for oral ingestion by a patient” (Paragraph 0135).
As such, claim 33 is also rejected as prima facie obvious.
Claim 34 is drawn to the product of claim 33, wherein the product is, for example, a supplement for addition to infant food.
Applicant is advised that use limitations (e.g., “for addition to infant food”) within product claims do not carry patentable weight unless the recitation of the intended use of the claimed invention results in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
As such, claims 34 is also rejected as prima facie obvious.
Claims 73-75 is drawn to the product of claim 33, wherein the amount of the composition present in the product based on the total weight of the product is between about 0.001 to about 80 wt.% (claim 73), more specifically about 0.2 to about 50 wt.% (claim 74), even more specifically about 1.0 to about 20 wt.% (claim 75).
As stated by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454 (CCPA): “where 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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he 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” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the concentration of active ingredients in a pharmaceutical composition/product is clearly a result-effective variable. Indeed, as taught by Mendel et al, “[p]harmaceutical compositions suitable for use in context of the present invention include compositions wherein the active ingredients are contained in an amount effective to achieve the intended purpose” (Paragraph 0144) wherein “[d]etermination of a therapeutically effective amount is well within the capability of those skilled in the art” (Paragraph 0145). Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal amount of the composition comprising lyso-PAF/CI-303 and 1-octadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine to include in the product in order to best achieve the desired results.
As such, claims 73-75 is also rejected as prima facie obvious.
Claims 1, 5, 13, 33-34 and 73-75 (as to Applicant’s elected composition) are ALSO rejected under 35 U.S.C. 103(a) as being unpatentable over Mendel et al (US 2011/0230450).
Claim 1 is drawn to a composition comprising a mixture of ether lipid molecules of Formula (I) as elected by Applicant as follows:
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wherein the molar ratio of 18:0 alkyl R1 groups to 16:0 alkenyl R1 groups is 0.9:1 to 1.7:1, and wherein:
the composition is for in vivo maintenance of ether lipids at levels and/or ratios associated with a non-disease state; or
the composition is for in vivo modification of ether lipids towards levels and/or ratios associated with a non-disease state.
As discussed above, Mendel et al render obvious a composition comprising a mixture of related ether lipid molecules of Formula (I) as follows:
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wherein the molar ratio of 18:0 alkyl R1 groups to 16:0 alkenyl R1 groups is 0.9:1 to 1.7:1, which differ from Applicant’s elected mixture of ether lipid molecules of Formula (I) in comprising an sn3 phosphoethanolamine in place of an sn3 phosphocholine.
Yet, as further taught by Mendel et al, the sn3 position can be “selected from the group consisting of… phosphocholine, phosphoethanolamine” (Paragraph 0018).
Accordingly, it would have been prima facie obvious to utilize Applicant’s instantly claimed mixture, as opposed to lyso-PAF/CI-303 and 1-octadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine, in the compositions thereof with a reasonable expectation of success.
As such, claim 1 is rejected as prima facie obvious.
Claims 1, 5, 13, 33-34 and 73-75 are also rejected for the same reasons as discussed above.
Conclusion
Any new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611