DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of DHM, L-cysteine, milk thistle, ginger root and prickly pear in the reply filed on 2/26/2025 is acknowledged.
Applicant noted that claims 9-14, 19, 20 are non-elected and therefore withdrawn from further consideration by the Examiner.
The restriction/election requirement is hereby made FINAL.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 16 and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2011/116963 and as evidenced by “Natu.care”.
WO teaches that Silybum marianum (milk thistle), opuntia ficus indica (prickly pear), dihydromyricetin, ginger and cysteine (same as L-cysteine-as evidenced by “Natu.care”) can all be used in a capsule, see entire reference, especially the abstract, pages 18, 23, 28, 30, the examples, and the claims.
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for the same purpose and for the following reasons: In KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed "the conclusion that 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." Id. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The Supreme Court also emphasized a flexible approach to the obviousness question, stating that the analysis under 35 U.S.C. § 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418; see also id. at 421 ("A person of ordinary skill is... a person of ordinary creativity, not an automaton."). The Supreme Court thus implicitly endorsed the principle, stated in In re Kerkhoven, 626 F.2d 846, 850 (CCPA 1980) (citations omitted), that: It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose .... [T]he idea of combining them flows logically from their having been individually taught in the prior art.
Since Silybum marianum (milk thistle), opuntia ficus indica (prickly pear), dihydromyricetin, ginger and cysteine (same as L-cysteine) were all known in the art to be used in a capsule at the time the invention was made then it would have been obvious for one having ordinary skill in the art to put them all together in the same capsule since they were known individually in the art to be used for the same purpose, namely to be in a capsule.
MPEP 2144.05, subsection II.
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
Generally, 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. "[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); 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."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
B. There Must Be an Articulated Rationale Supporting the Rejection
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017 ("Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’"); Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362, 119 USPQ2d 1822 (Fed. Cir. 2016) ("[R]eferences to ‘common sense’ … cannot be used as a wholesale substitute for reasoned analysis and evidentiary support … .").
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
It also would have been obvious to use the claimed components at the claimed amounts because clearly these are result effective variables since they were all known in the art at the time the invention was made to be put into a capsule for therapeutic effects.
Note in the different examples of WO, that the claimed components (Silybum marianum same as milk thistle, opuntia ficus indica same as prickly pear, ginger, dihydromyricetin and cysteine same as L-cysteine-as evidenced by “Natu.care”) were each used at different amounts thus making it clearly obvious to use the claimed components at different amounts which is clearly the choice of the artisan in an effort to optimize the desired results. Note also that the claimed amounts are very low as are the amounts used in the examples of WO.
Please also note that ginger root is well known in the prior art to be used as it is the most highly utilized part of the ginger plant known to be used for its medicinal properties.
Applicant argues that allegedly WO is not analogous prior art. Applicant argues that allegedly WO is directed to the technical field of nanoparticles.
While this is noted, it is also noted that WO clearly in its title recites, “Capsules”. While there may be nanoparticles in it, it is still a capsule and reads right on the claims.
Applicant argues that allegedly the only overlap between WO and the present application is that WO broadly mentions one category of intended use as “alimentary,” but, importantly, does not mention (consumable) alcohol even a once—let alone preventing or recovering from deleterious effects of alcohol consumption.
Therefore, WO fails the Same Field of Endeavor test, according to applicant. WO is not reasonably pertinent to the problem faced/addressed by the claimed invention, according to applicant. That is, WO and the present application are directed to completely different problems to which each proposes completely different solutions, according to applicant. WO addresses the challenges of incorporating a more diverse set of substances (including peptides and proteins) in SLNs and NLCs due to the hydrophobic nature of the lipid matrix and improving their stability, according to applicant. See WO at pg. 2-4. WO’s solution to address these problems is creating a polymeric coating “which solves the problems presented by the classic systems described in the prior art, according to applicant.” WO at pg. 4, lines 19-21. Also see WO at pg. 5, lines 22-30. In contrast, the present application “addresses problems caused by alcohol consumption including significant visible symptoms of a hangover consciously felt by the alcohol consumer, and also physical effects of the alcohol on the body that may not be consciously experienced, according to applicant. See present application at §[0015] and 9[0021], according to applicant. The present application “formulat[es] ingredients capable of effectively and comprehensively treating multiple symptoms of hangovers and the negative effects of alcohol.” See present application at ][0009]. Thus, like the technical fields of endeavor, the problems to be addressed (and, thereby, the proposed solutions) are starkly different, according to applicant.
WO does not have to teach the same use or results as applicant since this is a composition claim and NOT a method of use.
Applicant argues that WO teaches a nanoparticle delivery system that is a plurality of lipid nanoparticles formed by one or both of SLNs and NLCs containing “at least one active ingredient,” where the lipid nanoparticles are encased within a polymeric coating. See WO at Description of the Invention section (pg. 5, lines 28-33) and WO’s claim 1 (pg. 60, lines 3-5) according to applicant. WO requires a two-stage synthesis process to create the lipid nanoparticle delivery system: first, preparation of the lipid nanoparticles (i.e., SLNs and NLCs, including formation of lipid matrices around the at least one active ingredient), and second, encapsulation of the nanoparticles by the polymeric coating, according to applicant.
WO teaches a nanoparticle delivery system that is a plurality of lipid nanoparticles formed by one or both of SLNs and NLCs containing “at least one active ingredient,” where the lipid nanoparticles are encased within a polymeric coating, according to applicant. See WO at Description of the Invention section (pg. 5, lines 28-33) and WO’s claim 1 (pg. 60, lines 3-5). WO requires a two-stage synthesis process to create the lipid nanoparticle delivery system: first, preparation of the lipid nanoparticles (i.e., SLNs and NLCs, including formation of lipid matrices around the at least one active ingredient), and second, encapsulation of the nanoparticles by the polymeric coating, according to applicant. See WO at pg. 5, lines 31-34, according to applicant. The polymeric encapsulation is carried out by coacervation; and in some embodiments, a covalent cross-linker is used (which can include toxic, non-biocompatible substances like formaldehyde, glutaraldehyde, or other unsafe substances for an ingestible capsule or tablet) , according to applicant. See WO at pg. 7, lines 14-27. Importantly, the at least one ingredient is contained within a lipid nanoparticle packaging within a nanometer regime, 1.e., “between | to 1000 nm, preferably between 10 and 500 nm, and more preferably 100 to 200 nm.” , according to applicant. See WO at pg. 7, lines 4-5. These features (among others disclosed in WO’s lengthy disclosure) are completely different and unlike the claimed capsule or tablet of Claims 1 and 16, according to applicant.
First, the claimed capsule or tablet includes a mixture of specially selected constituents (i.e., dihydromyricetin (DHM), L- cysteine, milk thistle, prickly pear, and ginger root extract) that are uncoated, unpackaged, and intermixed within the interior of a capsule or tablet.
Claims 1, 16, 21 and 22 do NOT claim “uncoated, unpackaged, and intermixed within the interior of a capsule or tablet”. As for claims 23-26, it would have been obvious to one having ordinary skill in the art to intermix the different components in an effort to optimize the desired results and to not coat the capsule or tablet in an effort for the components to interact that much more effectively.
Next Applicant argues that allegedly the claimed capsule or tablet does not incorporate nanosized and nanostructured carriers for its ‘active ingredients’ like WO’s nanoparticle system. If the claimed capsule or tablet did utilize nanoparticles, it would result in a different internal structure that would change the functionality of the claimed capsule or tablet, according to applicant. Moreover, WO encapsulates its nanoparticles (SLNs and/or NLCs) carrying the ingredient(s) in an additional polymeric coating to achieve the aims described in WO, according to applicant. WO thus has a two-layered structure to carry and deliver its active ingredient(s), which is structurally different than the claimed capsule or tablet, according to applicant. A person of ordinary skill in the art (POSITA) would recognize that this would be an inefficient and ineffective approach for designing a capsule or tablet to achieve the aims of the present technology, according to applicant. See WO at pg. 5, lines 31-34. The polymeric encapsulation is carried out by coacervation; and in some embodiments, a covalent cross-linker is used (which can include toxic, non-biocompatible substances like formaldehyde, glutaraldehyde, or other unsafe substances for an ingestible capsule or tablet) , according to applicant. See WO at pg. 7, lines 14-27. Importantly, the at least one ingredient is contained within a lipid nanoparticle packaging within a nanometer regime, 1.e., “between 1 to 1000 nm, preferably between 10 and 500 nm, and more preferably 100 to 200 nm.” See WO at pg. 7, lines 4-5. These features (among others disclosed in WO’s lengthy disclosure) are completely different and unlike the claimed capsule or tablet of Claims 1 and 16, according to applicant.
Once again, WO teaches the claimed elements thus it would have been obvious to use them all together for the same purpose.
First, the claimed capsule or tablet includes a mixture of specially selected constituents (i.e., dihydromyricetin (DHM), L- cysteine, milk thistle, prickly pear, and ginger root extract) that are uncoated, unpackaged, and intermixed within the interior of a capsule or tablet, according to applicant. The claimed capsule or tablet does not incorporate nanosized and nanostructured carriers for its ‘active ingredients’ like WO’s nanoparticle system, according to applicant. If the claimed capsule or tablet did utilize nanoparticles, it would result in a different internal structure that would change the functionality of the claimed capsule or tablet, according to applicant.
The capsule will still be a capsule that reads on the claims.
Moreover, WO encapsulates its nanoparticles (SLNs and/or NLCs) carrying the ingredient(s) in an additional polymeric coating to achieve the aims described in WO, according to applicant. WO thus has a two-layered structure to carry and deliver its active ingredient(s), which is structurally different than the claimed capsule or tablet, according to applicant. A person of ordinary skill in the art (POSITA) would recognize that this would be an inefficient and ineffective approach for designing a capsule or tablet to achieve the aims of the present technology, according to applicant.
Once again, a capsule is formed which reads right on the claimed invention.
Applicant argues that allegedly one of ordinary skill in the art would not be able to use WO’s disclosure of active ingredients and arrive at the claimed capsule or tablet. WO discloses hundreds of substances, if not over a thousand substances, that can be included as the active ingredient, according to applicant. The discussion of the myriad of ingredients that WO discloses begins on page 13, where, notably, it is first mentioned that total weight of the active ingredient does not exceed 50%, according to applicant. See WO at pg. 13, lines 7-9.
This is not applicable since this rejection is based on rejecting a product claim and not a method of use claim.
WO describes the at least one active ingredient (packaged in the SLNs or NLCs) is in a group or class of “active ingredients and/or cosmetic and/or alimentary adjuvants,” which lists over a page worth of general “agents,” such as “re-epithelialization agents,” “bactericidal agents,” “anti-viral agents,” “anti-inflammatory agents,” “anti-stretch agents,” and countless more ‘agents’ for various health uses—none of which mention or even hint at alcohol consumption, according to applicant. See WO at pg. 13, line 10 through pg. 14, line 20. One of WO ’s plethora of ‘agents’ is a “firming and/or redensifying and/or restructuring agent,” which is where WO discloses the single mention of “Silybum marinum” (which is presumably mapped to the claimed “milk thistle” constituent of Claims 1 and 16), according to applicant. See WO at pg. 18, line 29 through pg. 19, line 23. Another of WO’s ‘agents’ is an “anti-atmospheric pollution agent,” which is where WO discloses the single mention of “N-acetylcysteine” (which both the Office and applicant agree is an equivalent of the claimed “L-cysteine”) , according to applicant. See WO at pg. 19, line 31 through pg. 20, line 11. Yet another of WO’s many ‘agents’ is a “desquamating agent and/or keratolytic agent and/or exfoliating agent,” which is where WO discloses one of two mentions of “Opuntia ficus-indica” (which is presumably mapped to the claimed “prickly pear” constituent of Claims 1 and 16) , according to applicant. See WO at pg. 22, line 23 through pg. 23, line 19; also see WO at pg. 28, lines 18-28 for WO’s other mention of “Opuntia ficus-indica” as a “heat shock protein synthesis stimulating agent, according to applicant.” WO discloses a “NO-synthase-inhibiting agent” that lists “Gingko biloba” as one option, and later lists “ginger” as one of nearly a hundred options of an “antioxidant” (one or both of which is/are presumably mapped to the claimed “ginger root extract” constituent of Claims 1 and 16), according to applicant. See WO at pg. 22, lines 20-22 and at pg. 30, line 22 through pg. 31, line 6. Finally, another of WO’s ‘agents’ is a “lipolytic agent [or] venotonic agent and/or anti-cellulite agent,” which is where WO discloses the single mention of “dihydromyricetin” (which is mapped to the “DHM” constituent of Claims 1 and 16), according to applicant. See WO at pg. 28, lines 1-17.
For instance, considering just DHM, WO discloses 40 other substances alongside dihydromyricetin to serve as its nanoparticle-packaged lipolytic / venotonic / anti-cellulite agent. WO’s singular mention of DHM is for a different purpose and function, which is to promote the breakdown of fat cells (lipolysis) and/or treat symptoms of venous blood flow insufficiency and strengthen vein walls (venotonics), according to applicant. This is completely different than what is described for DHM in the present application, e.g., increasing the rate of alcohol and acetaldehyde removal by the liver and/or binding to nervous system receptors (e.g., GABA receptors). See, e.g., present application at § [0023] , according to applicant. As noted in the Office Action (pg. 4), in KSR Int’] Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court reaffirmed “the conclusion that 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.” See KSR. at 417 (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273,282 (1976)). The claims of the present application are distinguished from the holdings in KSR and Sakraida because WO does not disclose, teach, or suggest the same function (or even similar function) for the claimed constituents as described in the WO reference, according to applicant. Thus, a POSITA interested in addressing the problem of effectively and comprehensively preventing and treating multiple symptoms of the negative effects of alcohol would learn nothing from WO, according to applicant. In no way would WO aid a POSITA in deriving a combination of ‘active ingredients’ to arrive at the claimed “capsule or tablet” of Claims 1 and 16, according to applicant. To even attempt, which WO provides no motivation or suggestion to do so, the POSITA would need to look to additional teachings in the prior art and carry out burdensome experimentation, which based on the prior art of record, provides no basis to believe the POSITA would predictably or successfully arrive at the claimed invention, according to applicant.
The claimed elements are clearly taught in the references for the claimed reasons. The results that applicant gets are inherent to the product itself. Since the claims use “comprising” then it is clearly ok if other components are in the composition with the already claimed components.
Applicant argues that allegedly there are unexpected results when using the components together.
The Examiner has carefully reviewed the “unexpected results” but does not find them to be unexpected or persuasive. First of all, the results were not presented in a 35 USC 132 declaration. Secondly, the results are relative and subjective from only a pool of ten healthy adult subjects. This does not constitute unexpected results. The results are subjective because everyone experiences things differently. On page 7 of applicant’s response, it is stated “from their own individual past experience” which only supports the Examiner’s position that the alleged unexpected results are relative and subjective from person to person.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/Primary Examiner, Art Unit 1655
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