DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/27/2026 has been entered.
AIA Status of the Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Newly submitted claim 76 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: new claim 76 is drawn to a composition comprising ether lipids wherein R3 is hydrogen. In Applicant’s Response to Restriction/Election file 12/02/2024, Applicant elected a composition comprising a first and second ether lipid molecule wherein R3 is, in each case,
PNG
media_image1.png
78
280
media_image1.png
Greyscale
Additionally, claim 13 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 13 is drawn to a composition wherein 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%. In Applicant’s Response to Restriction/Election file 12/02/2024, Applicant elected a composition comprising a first and second ether lipid molecule as follows:
PNG
media_image2.png
160
310
media_image2.png
Greyscale
and
PNG
media_image3.png
150
310
media_image3.png
Greyscale
.
Since Applicant’s elected composition comprising only ether lipids having 18:0 ether groups and 16:0 ether groups, the molar percent of said ether groups must total 100%.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 13 and 76 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments, filed 3/27/2026, have been fully considered.
Applicant first traverses the rejection of claims under 35 U.S.C. 112(a) as failing to comply with the written description requirement (Applicant Arguments, Page 10). As argued by Applicant:
“The claims recite a simple core structure of formula I as follows:
PNG
media_image4.png
120
152
media_image4.png
Greyscale
Each of R1, R2, and R3 are not virtually unlimited, but are instead limited to very specific alkyl or alkenyl groups of limited length of 10-24 carbons or are limited to only three additional structures with similar scope” (Applicant Arguments, Page 11).
The argument is not found persuasive. At the outset, in claim 1, R3 includes C10-25 alkyl or alkenyl groups. Nevertheless:
the genus of “a C10-24 alkyl” embraces 4,346 unique structures and the genus of “a C10-24 alkenyl group” embraces 2,202,753 structures.
the genus of “a C10-25 alkyl” embraces 10,359 unique structures and the genus of “a C10-25 alkenyl group” embraces 8,028,526 structures.
Accordingly, the “simple core structure of formula I” wherein each of R1 and R2 can be “a C10-24 alkyl or a C10-24 alkenyl group” and R3 can be “a C10-25 alkyl or a C10-25 alkenyl group” embraces thirty-nine quintillion, one hundred fifty-nine quadrillion, seven hundred seven trillion, nine hundred twenty-two billion, three hundred fifty-four million, seven hundred twenty-one thousand, eight hundred and eighty-five unique ether lipid molecules. To be clear, Formula (I) actually embraces even more ether lipid molecules, as this number does not include additional structures wherein R2 is hydrogen, R3 is hydrogen, and/or R4 is NH3+. Moreover, the compositions of claim 1 – which embrace combinations of two or more ether lipid molecules of Formula (I) – embrace multiples of this number. As such, it is MAINTAINED that “the genus of compositions embraced by claim 1 is virtually without limit”.
Applicant next traverses the rejection of claims under 35 U.S.C. 103(a). As summarized by Applicant, “[t]he understood basis of the rejection is the assertion that Mendel teaches PAF analogs and that the claimed compositions would have been immediately envisaged or would have been reached by routine optimization of ratios” (Applicant Arguments, Page 12).
As argued by Applicant, “amended claim 1 excludes phosphocholine headgroups and instead requires chemically distinct headgroups” (Applicant Arguments, Page 12).
Yet, as discussed in the basis of the rejection, Mendel et al further teach that the sn3 position can be “selected from the group consisting of… phosphocholine [or] phosphoethanolamine” (Paragraph 0018). Accordingly, it would have been prima facie obvious to utilize Applicant’s instantly claimed mixture (comprising phosphoethanolamine sn3 headgroups), as opposed to lyso-PAF/CI-303 and 1-octadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine (comprising phosphocholine sn3 headgroups) in the compositions thereof with a reasonable expectation of success.
Applicant, however, further argues that “Mendel does not teach or provide any reasoned basis or motivation for a person of ordinary skill in the art... to depart from its specific phosphocholine examples [and] select a generic phosphoethanolamine from the broader disclosure or to make mixtures of any particular phosphethanolamine” (Applicant Arguments, Page 13).
The argument is not found persuasive. 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” – listed among a total of four PAF-analogs (Paragraph 0027 and Paragraph 0074), as well as mixtures thereof (Paragraph 0074 and Paragraph 0156) – wherein, as further taught by Mendel et al, the sn3 position can be “selected from the group consisting of… phosphocholine, phosphoethanolamine” (Paragraph 0018).
As such, it would have been obvious to utilize Applicant’s instantly claimed mixture (comprising phosphoethanolamine sn3 headgroups), as opposed to lyso-PAF/CI-303 and 1-octadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine (comprising phosphocholine sn3 headgroups) in the compositions thereof with a reasonable expectation of success (i.e., it would have been obvious to substitute one known PAF analog (comprising a phosphocholine sn3 headgroup) with another known PAF analog (comprising a phosphethanolamine sn3 headgroup with a reasonable expectation of success). As noted by the court in In re Fout, 675 F.2d 297 (CCPA 1982), an express suggestion to substitute one equivalent component (e.g., an equivalent sn3 headgroup on an otherwise identical PAF analog) for another is not necessary to render such substitution obvious. In the instant case, (1) the prior art element performs the function specified in the claim with only insubstantial differences); (2) the claimed component and its function was known in the art; (3) a person of ordinary skill in the art would have recognized the interchangeability of the elements and could have substituted one known element for another; and (4) the results of the substitution would have been predictable. As stated by the Court in KSR International Co., v. Teleflex Inc., 127 US 1727 (2007), “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious” (quoting Sakraida v. AG Pro, Inc., 425 US 273 (1976); see also: Merck v. Biocraft (874 F.2d 804, 807 (Fed. Cir. 1989), indicating that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands; Sundance, Inc. v. DeMonte Fabricated, Ltd., 550 F.3d 1356 (Fed. Cir. 2008): a claimed invention is obvious is it is a combination of known prior art elements that would reasonably have been expected to maintain their respective properties or functions after they had been combined; Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945): indicating that “[r]eading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle”; Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012): finding a “strong case of obviousness based on the prior art references of record [wherein the claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known…agent for another”).
Accordingly, it is maintained that a prima facie case has been established. Since Applicant has not demonstrated otherwise, Applicant's argument is not considered persuasive.
Applicant next argues that “[t]he present claims are further distinguished because amended claim 1 require ether lipids having a predominance of three specific lipids namely those having an 18:1 alkenyl R1 group, an 18:0 alkyl R1 group, and 16:0 alkyl R1 group comprising at least 50% of the ether lipids in the composition” and “Mendal nowhere discloses or reasonably suggests an 18:1 alkenyl species at the sn-1 position” (Applicant Arguments, Page 13).
The argument is not found persuasive. As amended, claim 1 recites:
“[a] composition comprising a mixture of ether lipid molecules of Formula (I)... wherein ether lipids having an 18:1 alkenyl R1 group, ether lipids having an 18:0 alkyl R1 group, and ether lipids having a 16:0 alkyl R1 group together comprise at least 50% of the ether lipids in the composition.”
As such, the amended claim embraces a mixture comprising, for example, 50% ether lipids having an 18:0 alkyl R1 group, 50% ether lipids having a 16:0 alkyl R1 group and 0% ether lipids having an 18:1 alkenyl R1 group (i.e., the claim does not require the presence of ether lipids having an 18:1 alkenyl R1 group).
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, 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):
PNG
media_image5.png
128
124
media_image5.png
Greyscale
,
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; and
wherein:
the ether lipids having an 18:1 alkenyl R1 group, the ether lipids having 18:0 alkyl R1 group, and the ether lipids having a 16:0 alkenyl R1 group together comprise at least 50% of the ether lipids in the composition.
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:
PNG
media_image2.png
160
310
media_image2.png
Greyscale
and
PNG
media_image3.png
150
310
media_image3.png
Greyscale
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
the ether lipids having 18:0 alkyl R1 group, and the ether lipids having a 16:0 alkenyl R1 group together comprise at least 50% of the ether lipids in the composition.
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:
PNG
media_image6.png
120
156
media_image6.png
Greyscale
and
PNG
media_image7.png
118
166
media_image7.png
Greyscale
;
PNG
media_image7.png
118
166
media_image7.png
Greyscale
and
PNG
media_image8.png
114
158
media_image8.png
Greyscale
; and/or
PNG
media_image6.png
120
156
media_image6.png
Greyscale
and
PNG
media_image8.png
114
158
media_image8.png
Greyscale
.
Yet, each of the required structures of Formula (I) comprises substantial variance. For example, the structure
PNG
media_image6.png
120
156
media_image6.png
Greyscale
includes:
(1)
PNG
media_image9.png
200
254
media_image9.png
Greyscale
(2)
PNG
media_image10.png
218
370
media_image10.png
Greyscale
(3)
PNG
media_image11.png
226
374
media_image11.png
Greyscale
(4)
PNG
media_image12.png
232
382
media_image12.png
Greyscale
(5)
PNG
media_image13.png
270
304
media_image13.png
Greyscale
(6)
PNG
media_image14.png
278
368
media_image14.png
Greyscale
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. Moreover, 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:
PNG
media_image2.png
160
310
media_image2.png
Greyscale
and
PNG
media_image3.png
150
310
media_image3.png
Greyscale
.
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, 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, 33-34 and 73-75 are rejected under 35 U.S.C. 103(a) as being unpatentable over Mendel et al (US 2011/0230450; of record).
Claim 1 is drawn to a composition comprising a mixture of ether lipid molecules of Formula (I) as follows:
PNG
media_image2.png
160
310
media_image2.png
Greyscale
and
PNG
media_image3.png
150
310
media_image3.png
Greyscale
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” 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.
As such, the composition of Mendel et al differs from the instantly claimed composition in the follow ways:
Mendel et al teach a composition comprising a mixture of the related ether lipid molecules:
PNG
media_image15.png
144
240
media_image15.png
Greyscale
and
PNG
media_image16.png
142
242
media_image16.png
Greyscale
,
as opposed to:
PNG
media_image2.png
160
310
media_image2.png
Greyscale
and
PNG
media_image3.png
150
310
media_image3.png
Greyscale
;
Mendel et al teach do not teach the molar ratio of 18:0 alkyl R1 groups to 16:0 alkenyl R1 groups is 0.9:1 to 1.7:1.
Yet, as to (A): 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 ether lipids (comprising phosphoethanolamine sn3 headgroups), as opposed to lyso-PAF/CI-303 and 1-octadecyl-2-hydroxy-sn-glycero-3-phosphoethanolamine (comprising phosphocholine sn3 headgroups) in the compositions thereof with a reasonable expectation of success (i.e., it would have been obvious to substitute one known PAF analog (comprising a phosphocholine sn3 headgroup) with another known PAF analog (comprising a phosphethanolamine sn3 headgroup) with a reasonable expectation of success).
And, as to (B): it would have been obvious to include each the ether lipid molecules in the mixture in the same amount (i.e., in a 1:1 ratio) as a starting point.
As such, claim 1 is 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 liquid 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, claim 34 is also rejected as prima facie obvious.
Claims 59 and 73-75 is drawn to the product of claims 33 or 34, wherein the composition comprises ether lipid molecules in a concentration in the range of from 75 to 400 µM (claim 59), in 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 59 and 73-75 are also rejected as prima facie obvious.
Conclusion
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
Prosecution Insights