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
The preliminary amendment dated 12 December 2022, in which claim 34 has been amended, and claims 4, 6, 9, 11-12, 14-16, 19-20, 22-23, 25, 27, 29-30, 33, 35-36, 38-44 and 47-135 have been cancelled, is acknowledged.
Claims 1-3, 5, 7-8, 10, 13, 17-18, 21, 24, 26, 28, 31-32, 34, 37, 45 and 46 are pending in the instant application.
Claims 2, 26, 28, 31, 32, 37, 45, 46 are withdrawn, as being drawn to a non-elected invention or to a non-elected species.
Claims 1, 3, 5, 7-8, 10, 13, 17-18, 21, 24, 34 are examined herewith.
Priority
This application is a National entry under 371 of International Patent Application PCT/US2021/037524, filed on 15 June 2021, which claims priority from U.S. Provisional Patent Application 63/039,331, filed on 15 June 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 28 February 2023 (two documents), 30 January 2024 and 27 May 2025, are acknowledged and considered.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 5, 7-8, 10, 13, 17-18, 21, 24, 26, 28, 31-32, 34, drawn to a composition comprising:(a) a liposome; (b) vitamin E; and (c) a polyunsaturated fatty acid having a chain length of at least 24 carbon atoms, or a pharmaceutically acceptable salt thereof, in the reply filed on 24 February 2026, is acknowledged. Claims 37, 45, 46 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant’s election without traverse of
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for initial examination, in the reply filed on 24 February 2026, is acknowledged. Claims 1, 3, 5, 7-8, 10, 13, 17-18, 21, 24, 34 read on the elected species. Claims 2, 26, 28, 31, 32 are withdrawn, as being drawn to a non-elected species.
Because Applicant has set forth no arguments against the requirement for restriction, the election is considered to be made without traverse, the requirement for restriction/election is maintained and is herein made FINAL.
Claims 1, 3, 5, 7-8, 10, 13, 17-18, 21, 24, 34 have been examined to the extent they read on the elected species, and the following objections and rejections are made below.
Objection to the Claims
Claims 2, 26, 28, 31, 32, while currently withdrawn, are objected to because of the following informality: they are presented in a non-compliant form. Specifically, the status identifiers for claims 2, 26, 28, 31, 32 should read "(Withdrawn)" until such time as examiner rejoins the claims for examination. Appropriate correction is required. See MPEP 714(C).
Objection to the Specification
The Specification is objected to because on page 66, first paragraph, the Scheme contains structures and text too small to read.
The Specification is objected to because it recites [00174] “Tween-4 detergent”. What is Tween-4 detergent?
The use of the term Tween [00174], which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term. No generic terminology accompanies Tween®.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. See MPEP 608.01 (v).
Appropriate correction is required.
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 18 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.
Claim 18 is drawn to the composition of claim 1, comprising a plurality of polyunsaturated fatty acids having a chain length of at least 24 carbon atoms; yet claim 1 recites a composition comprising (c) a polyunsaturated fatty acid having a chain length of at least 24 carbon atoms. As such, there is insufficient antecedent basis for the recitation “a plurality of” PUFA of claim 18, in claim 1.
Appropriate correction is required.
Claim Rejections- 35 USC 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 5, 7-8, 10, 13, 17-18, 21, 24, 34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite a composition comprising (a) liposome, (b) vitamin E and (c) a polyunsaturated fatty acid having a chain length of at least 24 carbon atoms; claim 2 states that the liposome is cholesterol or safflower oil; claim 3 states that the liposome is a phosphatidyl choline. Phosphatidyl choline, vitamin E and polyunsaturated fatty acids having a chain length of at least 24 carbon atoms are natural products (see, for example, McMahon et al. Br J Ophthalmol 2010, 94, 1127-1132, cited in PTO-892; Berdeaux et al. J. Chromatography A 2010, 1217, 7738-7748, cited in PTO-892; vitamin E exists in fruits and vegetables, plant seeds, see Jiang, Q. Free Radic Biol Med 2014, 72, 76-90, cited in PTO-892).
Dependent claims serve to limit the claims as compositions for various types of formulations and different ratios between components (a), (b) and (c) in the composition.
This judicial exception is not integrated into a practical application because the claims do not include any elements other than natural products.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, although the combination in the claims, namely a mixture of (a) a phosphatidyl choline (b) vitamin E and (c) a polyunsaturated fatty acid having a chain length of at least 24 carbon atoms such as VLC-PUFA 32:6 n-3, does not occur in nature, there is no indication that mixing a phosphatidyl choline with vitamin E and a polyunsaturated fatty acid having a chain length of at least 24 carbon atoms such as VLC-PUFA 32:6 n-3, in the ratios instantly claimed, changes the structure, function, or other properties of the natural products in any marked way. There is no showing that the claimed mixture as a whole does or has any markedly different characteristics compared to the closest naturally occurring counterparts. There are no additional elements present in the claims and the claims do not qualify as eligible subject matter.
A demonstration that the claimed combination in claims 1, 3, 5, 7-8, 10, 13, 17-18, 21, 24, 34 does something markedly different than each component in nature; or a limitation requiring the product/preparation to no longer be just a natural product or a mixture of natural products may provide a path toward patent eligibility, such as, for example, a preparation in the form of tablets, granules, creams, ointments, gels, etc.
Claim Rejections- 35 USC 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 5, 7-8, 10, 13, 17-18, 21, 24, 34 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Bazan et al. (US 2020/0009100, published 9 January 2020, cited in PTO-892) and Raman et al. (US 2013/0190399, cited in PTO-892), in view of Bromley et al. (US 2011/0236464, cited in IDS).
Bazan (US 2020/0009100) teaches a composition comprising at least one omega-3 very long chain polyunsaturated fatty acid (n-3 VLC-PUFAs) having at least 23 carbon atoms in its carbon chain [0023], where the n3 VLC-PUFA is in the form of its carboxylic acid [0024]. The genus of VLC-PUFAs having at least 23 carbon atoms in the carbon chain encompasses the (c) polyunsaturated fatty acids having a chain length of at least 24 carbon atoms of the instant claims. By teaching at least one VLC-PUFA in the composition, Bazan implicitly teaches that more than one (a plurality) of VLC-PUFAs may be present in the composition, as in instant claim 18.
Bazan teaches [0025] that the n3 VLC-PUFA compound is selected from formula A or formula B,
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wherein m is 0 to 19 and -COOR is a carboxylic acid group.
Bazan specifically teaches (Figure 1) the following VLC-PUFA
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, where C32:6n3 is the instant elected species. These compounds are VLC-PUFAs of instant claims 1, 13, 21, 24.
Bazan teaches [0033] that the at least one omega-3 very long chain polyunsaturated fatty acid has from about 26 to about 42 carbon atoms in its carbon chain, which is within the genus of PUFAs in instant claims 1, 21, and encompasses the genus in instant claim 24; or [0034] has 32 or 34 carbon atoms in its carbon chain, which is within the genus of PUFAs in instant claim 13.
Bazan teaches [0283] that the fatty acids of the invention are n3 VLC-PUFA, or n6 VLC-PUFA that are produced in cells containing elongase enzymes that elongate n3 and n6 LC-PUFA to n3 and n6 VLC-PUFA containing from 24 to 42 carbons (C24-C42). The most important among these are VLC-PUFA with 28-38 carbons (C28-C38), which are PUFAs of instant claim 13. Bazan teaches [0283] that representative types of VLC-PUFA include C32:6n3 (32 carbons, 6 double bonds, omega-3), C34:6n3, C32:5n3, and C34:5n3.
Bazan teaches [0263], [0340] that the compositions of the invention also contain vitamins. Bazan teaches [0412] that the compositions of the invention further contain antioxidants.
Bazan teaches [0424] that the compositions of the invention include those that comprise a sustained release or controlled release matrix desirably chosen from biocompatible materials such as liposomes ([0254], [0424]), as in instant claim 1, or phospholipids.
Bazan teaches [0412] that the compositions of the invention are formulated for oral, or ocular administration, as in instant claim 34.
Bazan does not exemplify a composition comprising a liposome, vitamin(s) and VLC-PUFA which is C32:6n3.
Bazan does not teach phosphatidyl choline as the liposome in the composition, as in instant claim 3.
Bazan does not teach vitamin E as the vitamin in the composition, nor does he teach the relative amounts of liposome, vitamin E and VLC-PUFA in the composition, as in instant claims 5, 7, 8, 10, 17.
Raman (US 2013/0190399) teaches [0019] a composition comprising at least one VLC-PUFA having a chain length of 28, 30, 32, 34, 36, 38, 40 or 42 carbons; in particular, the VLC-PUFA may be any one of the (C28-C42) n-3 fatty acids, including but not limited to, 28:4n3, 28:5n3, 28:6n3, 30:4n3, 30:5n3, 30:6n3, 32:4n3 32:5n3, 32:6n3, 34:4n3, 34:5n3, 34:6n3, 36:4n3, 36:5n3, 36:6n3, 38:4n3, 38:5n3, 38:6n3, 40:4n3, 40:5n3, 40:6n3, 42:4n3, 42:5n3, 42:6n3, which are omega-3 VLC-PUFA of instant claims 1, 13, 21, and overlap with the genus in instant claim 24.
By teaching at least one VLC-PUFA in the composition, Raman implicitly teaches that more than one (a plurality) of VLC-PUFAs may be present in the composition, as in instant claim 18.
Raman teaches specifically a composition comprising C28:6 n3 VLC-PUFA [0222], or C34:6 n3 VLC-PUFA [0227], which are PUFAs of instant claims 1, 13, 21, 24.
Raman teaches [0167] that the compositions of the invention also contain vitamins.
Raman teaches [0182], [192] that the compositions of the invention include liposomes, as in instant claim 1, such as dipalmitoyl phosphatidylcholine [0182], which is a phosphatidylcholine, as in instant claim 3.
Raman teaches formulations prepared by entrapping the drug in liposomes [0182], [0199], such as dipalmitoyl phosphatidylcholine [0182], as in instant claim 3.
Raman teaches that the compositions of the invention are formulated for oral [0153], or administration to the eye [0182], as in instant claim 34.
Raman does not exemplify a composition comprising a liposome dipalmitoyl phosphatidylcholine, vitamin(s) and a VLC-PUFA.
Bromley (US 2011/0236464) discloses a composition ([0010]) comprising, for example,: (a) surfactants such as, for example, liposomes [0086]; [0109] in liposomes, non-polar active ingredients typically are partitioned within the bilayers whereas hydrophilic active ingredients typically are trapped within the aqueous compartments;
(b) vitamin E [0039], [0262], [0027]; and
(c) non-polar active ingredients that contain at least one omega-3 fatty acids, such as, for example, 24:5 omega.3 and nisinic acid (24:6.omega.3) [0155], [0258], which are VLC-PUFA compounds of instant claims 1, 21, 24.
Bromley teaches that the concentration of the non-polar compound in the composition is between 5% and 10% wt. of the composition [0012]; two or more (a plurality, as in instant claim 18) of non-polar ingredients may be present in the composition in a total amount of 5% to 10% [0035], which is within the range in instant claim 10.
Bromley teaches [0405] vitamin E oil as a non-polar solvent in the composition, where commercially available vitamin E oil contains 67.2% tocopherol (the rest being soybean oil); the concentration of the non-polar solvent in the composition is about 1% of the composition [0406], which, for the tocopherol component of vitamin E oil, is within the range in instant claim 8.
Bromley teaches [0109], [0111] liposomes as a carrier/encapsulation system stable which protects the active ingredients from degradation, where phospholipids are used, such as lecithin, phosphatidylcholine (PC), as in instant claim 3, or distearoylphosphatidylcholine (DSPC), which is Applicant’s elected species. Bromley teaches [0387], [0388] that the phospholipid such as PC represents 0.1% to 1.0%, or between 0.15% and 0.7% of the composition, which overlaps with the range in instant claim 5.
The compositions taught by Bromley are beverages, thus for oral administration, as in instant claim 34.
Bromley does not exemplify a composition comprising (a), (b) and (c).
It would have been obvious to a person of ordinary skill in the art to combine the teachings of Bazan, Raman and Bromley to arrive at the instant invention. The person of ordinary skill in the art would have been motivated to prepare a composition comprising a VLC-PUFA taught by Bazan or Raman, by adding vitamin E and a liposome distearoylphosphatidylcholine (DSPC), because
Bazan teaches compositions comprising
(a) a liposome such as a phospholipid;
(b) vitamins; and
(c) at least one n3 VLC-PUFA fatty acid containing from 24 to 42 carbons (C24-C42), including (C28-C38), and specifically teaches C32:6n3, C34:6n3, C32:5n3, C34:5n3;
the compositions further contain antioxidants, and are formulated for oral administration;
Raman teaches compositions comprising
(a) a liposome such as dipalmitoyl phosphatidylcholine;
(b) vitamins; and
(c) at least one n3 VLC-PUFA fatty acid containing from 28 to 42 carbons (C28-C42), and specifically teaches C28:6 n3 VLC-PUFA, or C34:6 n3 VLC-PUFA,
the compositions being formulated for oral administration; and
Bromley teaches a composition for oral administration comprising
(a) liposomes as carrier/encapsulation system, such as phospholipids, such as lecithin, phosphatidylcholine (PC), or distearoylphosphatidylcholine (DSPC), representing 0.1% to 1.0%, or between 0.15% and 0.7% of the composition,
(b) vitamin E oil as non-polar solvent, present at about 1% of the composition; and
(c) non-polar active ingredients that contain at least one omega-3 VLC-PUFA containing 24 C atoms, namely 24:5 omega.3 or nisinic acid (24:6.omega.3) present in the composition in a total amount of 5% to 10%.
Thus, the person of ordinary skill in the art would have prepared a composition of VLC-PUFA having a chain length of at least 24 C atoms, using the VLC-PUFAs taught by Bazan or Raman or Bromley, and would have added to the composition vitamin E as the vitamin/non-polar solvent/ antioxidant, and a phosphatidylcholine taught by Raman and Bromley, as liposome for encapsulation, in the relative amounts taught by Bromley, with a reasonable expectation of success. Since Bazan, Raman, Bromley teach compositions comprising at least one VLC-PUFA, vitamins and a liposome, preparing such a composition of a VLC-PUFA C32:6 n3 (Applicant’s elected species) by mixing the VLC-PUFA, a vitamin and antioxidant vitamin E and a phospholipid which is lecithin or distearoylphosphatidylcholine, which are ingredients taught by the prior art, is within the skill of the artisan.
Regarding the relative concentration of the ingredients in the composition, as in instant claims 5, 7, 8, 10, 17, MPEP §2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" aprimafacie case of obviousness exists." In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) and "a prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish aprimafacie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). In the instant case, the Bromley reference discloses concentrations/ratios of VLC-PUFA, vitamin E oil and liposome which demonstrate clear and significant overlap with the concentrations/ratios instantly claimed and as such the Examiner advances that a person of ordinary skill in the art (e.g., Applicants) would have been motivated to employ routine experimentation in arriving at the claimed ratio range, absent a clear showing of criticality for the instantly claimed range.
"[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).
As such, claims 1, 3, 5, 7-8, 10, 13, 17-18, 21, 24, 34 are rejected as being prima facie obvious.
Claims 1, 3, 5, 7-8, 10, 13, 17-18, 21, 24, 34 are rejected under AIA 35 U.S.C. 103 as being unpatentable over Bazan et al. (US 2020/0009100, published 9 January 2020, cited in PTO-892) and Raman et al. (US 2013/0190399, cited in PTO-892), in view of Steinfeld et al. (US2015/0139973, cited in IDS).
Bazan (US 2020/0009100) and Raman are as above.
Bazan and Raman teaches that the compositions of the invention are formulated for administration to the eye, as in instant claim 34.
Steinfeld (US2015/0139973) teaches an ophthalmic composition comprising, for example,: (a) liposomes [0147] as “sustained-release” drug-delivery systems;
(b) vitamin E (tocopherols) as an anti-inflammatory- and/or anti-oxidatively- acting substance, preferably in a quantity of 0.01 and 5% by weight, relative to the total composition [0118]; and
(c) at least one ω-3 fatty acid tetracosapentaenoic acid C24:5 n3, or tetracosahexaenoic acid C24:6 n3, which are VLC-PUFA compounds of instant claims 1, 21, 24.
Steinfeld teaches that the concentration of the content of the at least one ω-3 fatty acid relative to the total composition, is between 0.01 and 49.9% by weight [0042], which encompasses the range in instant claim 10.
Steinfeld teaches [0118] the concentration of tocopherol /vitamin E in the composition overlaps with the range in instant claim 8.
Steinfeld teaches [0167], [0168], [0172], [0173] lecithin, which contains stearoyl phosphatidyl choline (Applicant’s elected species), as liposome. Steinfeld teaches [0167] lecithin at 0.3% to 6% of the composition, which overlaps with the range in instant claim 5.
The compositions taught by Steinfeld are for administration to the eye, as in instant claim 34.
Steinfeld does not exemplify a composition comprising (a), (b) and (c).
It would have been obvious to a person of ordinary skill in the art to combine the teachings of Bazan, Raman and Steinfeld to arrive at the instant invention. The person of ordinary skill in the art would have been motivated to prepare a composition comprising a VLC-PUFA taught by Bazan or Raman, by adding vitamin E and a liposome lecithin (which contains distearoylphosphatidylcholine), because
Bazan teaches compositions comprising
(a) a liposome such as a phospholipid;
(b) vitamins; and
(c) at least one n3 VLC-PUFA fatty acid containing from 24 to 42 carbons (C24-C42), including (C28-C38), and specifically teaches C32:6n3, C34:6n3, C32:5n3, C34:5n3;
the compositions further contain antioxidants, and are formulated for ocular administration;
Raman teaches compositions comprising
(a) a liposome such as dipalmitoyl phosphatidylcholine;
(b) vitamins; and
(c) at least one n3 VLC-PUFA fatty acid containing from 28 to 42 carbons (C28-C42), and specifically teaches C28:6 n3 VLC-PUFA, or C34:6 n3 VLC-PUFA,
the compositions being formulated for ocular administration; and
Steinfeld teaches a composition for ophthalmic administration comprising
liposomes as “sustained-release” drug-delivery systems, at 0.3% to 6% of the composition;
vitamin E (tocopherols) as an anti-inflammatory- and/or anti-oxidatively- acting substance, at 0.01 and 5% by weight relative to the total composition; and
at least one ω-3 fatty acid tetracosapentaenoic acid C24:5 n3, or tetracosahexaenoic acid C24:6 n3, which are VLC-PUFA compounds of instant claims 1, 21, 24, present in the composition in an amount of 0.01 and 49.9% wt.
Thus, the person of ordinary skill in the art would have prepared a composition of VLC-PUFA having a chain length of at least 24 C atoms, using the VLC-PUFAs taught by Bazan or Raman or Steinfeld, and would have added to the composition vitamin E as the vitamin/non-polar solvent/ antioxidant, and a phosphatidylcholine taught by Raman and Steinfeld, as liposome for encapsulation, in the relative amounts taught by Steinfeld, with a reasonable expectation of success. Since Bazan, Raman, Steinfeld teach compositions comprising at least one VLC-PUFA, vitamins and a liposome, preparing such a composition of a VLC-PUFA C32:6 n3 (Applicant’s elected species) by mixing the VLC-PUFA, a vitamin and antioxidant vitamin E and a phospholipid which is lecithin, which are ingredients taught by the prior art, is within the skill of the artisan.
Regarding the relative concentration of the ingredients in the composition, as in instant claims 5, 7, 8, 10, 17, MPEP §2144.05(I) states that "[i]n the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" aprimafacie case of obviousness exists." In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) and "a prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish aprimafacie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). In the instant case, the Steinfeld reference discloses concentrations/ratios of VLC-PUFA, vitamin E oil and liposome which demonstrate clear and significant overlap with the concentrations/ratios instantly claimed and as such the Examiner advances that a person of ordinary skill in the art (e.g., Applicants) would have been motivated to employ routine experimentation in arriving at the claimed ratio range, absent a clear showing of criticality for the instantly claimed range.
"[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).
As such, claims 1, 3, 5, 7-8, 10, 13, 17-18, 21, 24, 34 are rejected as being prima facie obvious.
Conclusion
Claims 1, 3, 5, 7-8, 10, 13, 17-18, 21, 24, 34 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IRINA NEAGU whose telephone number is (571)270-5908. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JEFFREY S. LUNDGREN can be reached at (571)272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/IRINA NEAGU/Primary Examiner, Art Unit 1629
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