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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/23/26 has been entered.
Claim Status
Claim 4 is cancelled.
Claims 1-3 and 5-32 are pending.
Claims 16-30 are withdrawn.
Claims 1-3, 5-15, 31 and 32 are under examination.
Withdrawn rejections
Applicant's amendments and arguments filed 1/23/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn. Claims 1-15, 31 and 32 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph and claims 3-4 were rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph. Applicant has amended the claims to overcome these rejections.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-10, 13-14, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Verburgh et al. (US20230085573; IDS filed 8/7/25) and Bredesen et al. (WO2014025905; of record) and Ganio (US20220105128) and Applied Food Sciences ([online] retrieved on 2/13/26 from: https://appliedfoods.com/beverage-expert-applied-food-sciences-makes-breakthrough-with-two-new-launches-in-organic-ingredients/; 2016: 8 pages).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims, for example:
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Claim interpretation: The scope of claim 1 includes aqueous solutions in which the water soluble reaction product would be soluble to at least about 10 mg/L, which is 0.01 mg/mL. That means that the ionic components that form the reaction product are present and the scope of claim 1 includes those embodiments.
Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a nutritional/dietary research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from nutritional compounds and their application to treat diseases/conditions, pharmaceutical formulation methods and techniques, human physiology and general chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 5, 13-14 and 32, Verburgh et al. teach compositions comprising 1 mg lithium and 80 mg ginger extract (Claims 1, 2 and 9), that contains at least 2% gingerols [0019], with a pharmaceutically acceptable carrier (Claim 14) and can be formulated for delayed release or extended release (Claims 11-13; [0022]). Verburgh et al. guide the artisan to PurGinger™ from Applied Food Sciences [0019]. As taught by Applied Food Sciences, PurGinger™ is a powdered organic ginger extract that is highly water soluble and clear in solution (Page 3, 1st paragraph).
Verburgh et al. teach that the pharmaceutically acceptable carriers are “well known to those skilled in the art. For example, oral delivery systems include, for example, tablets, capsules, and powders (such as powders that can be added to water to form a drinkable formulation).” [0013] Thus, the composition of Verburgh et al. is for human ingestion. Verburgh et al. teach: “Preferably, the present composition ( e.g., the embodiments described in this paragraph) is in the form of a powder that, when admixed with a fluid such as water, can be taken orally as a drink by the subject (preferably once daily).” [0021] An oral drink is suitable for human ingestion. It is the Examiner’s position that admixture of the composition in powder form in water provides the water soluble reaction product the extract of ginger with a source of lithium that naturally has a solubility in water of greater than 100 mg/mL and the composition has a solubility in water of at least about 10 mg/L. The same water soluble components dissolved in water will have the same solubility in the absence of evidence to the contrary. Indeed, Applicant’s own claimed method of making the reaction product is to simply provide the extract of ginger and mix with a source of lithium to produce a water soluble form of ginger extract (Claim 23). No special conditions or steps are required.
Regarding claim 7, Verburgh et al. also teach dosage ranges of: 1 mg of micro-dosed lithium (or optionally, any of 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, 0.8 mg, 0.9 mg, 1.1 mg, 1.2 mg, 1.3 mg, 1.4 mg, 1.5 mg, 1.6 mg, 1.7 mg, 1.8 mg, 1.9 mg, or 2.0 mg) and 80 mg of ginger extract (or optionally, any of 10 mg, 20 mg, 30 mg, 40 mg, 60 mg, 70 mg, 90 mg, 100 mg, 110 mg, 120 mg, 130 mg, 140 mg, 150 mg, 160 mg, 170 mg, 180 mg, 190 mg, 200 mg, 250 mg, 300 mg, 350 mg, 400 mg, 450 mg, 500 mg, 600 mg, 700 mg, 800 mg, 900 mg, or 1,000 mg) [0032]. Thus, the composition can have 1 mg of a source of lithium and 100 mg of ginger extract for a weight ratio of 1:100.
Regarding claim 10, Verburgh et al. teach “excipients such as binders (e.g., hydroxypropylmethyl-cellulose, polyvinylpyrrolidone, other cellulosic materials and starch), diluents (e.g., lactose and other sugars, starch, dicalcium phosphate and cellulosic materials), disintegrating agents ( e.g., starch polymers and cellulosic materials) and lubricating agents (e.g., stearates and talc). In one embodiment, the oral
delivery system is a powder and comprises one or more of xylitol, malic acid, flavoring, silicon dioxide, calcium silicate, and roadside A.” [0013] Verburgh et al. teach: “the present composition comprises one or more sweeteners such as, without limitation, erythritol, trehalose, maltitol, mannitol, sorbitol, xylitol, isomalt, lactitol, tagatose, monk fruit, inuline, and stevia-derived substances.” [0021] In addition to those food additives, claims 1-8 also add food additives such as vitamin C and glucosamine.
Regarding claim 31, how the ginger extract is obtained such as by total CO2 liquid, reads on a product-by-process type limitation. Please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” See MPEP 2113 Product-by-Process Claims [R-08.2017]
I. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
Further regarding claim 32, the ginger extract of Verburgh et al. naturally contains the one or more active compounds claimed.
Regarding claims 1-2, Bredesen et al. disclose a composition comprising the element lithium, which reads on metallic lithium, and ginger (Claims 1-2), which contains all the active components contained in an extract of ginger, in a single combined formulation (Claim 42) and is inherently fit for human ingestion. Bredesen et al. provide an example with water soluble ionic salt form lithium carbonate, which is the from the weak acid carbonic acid (Page 29). Bredesen et al. distinguish between elements, chemical compounds, minerals and salts (Page 22, lines 19-29; Page 23, Table 1) with lithium salts, such as lithium carbonate, orotate, chloride and aspartate, as sub-types of the element lithium (Page 23, Table 1).
Regarding claim 7, Bredesen et al. disclose that the lithium is present in at least about 1 mg and the ginger is present in at least about 100 mg (Claim 36), thus providing a ratio of at least about 1:100. Claim 37 of Bredesen et al. discloses about 1-20 mg of lithium and about 100-1000 mg ginger.
Regarding claims 1-3, Ganio renders obvious elemental lithium, lithium hydroxide, lithium hydride, lithium orotate, lithium aspartate, lithium chloride and lithium carbonate [0025] for administration to a human subject (Abstract; Claims 1-6 and 10). Formulations include dispersions, suspensions, powders and liquid sprays [0026-0028].
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Verburgh et al. is that Verburgh et al. do not expressly teach a reaction product formed in aqueous solution that has a solubility of at least about 10 mg/L or greater than 100 mg/mL or that the source of the lithium comprises one or more of metallic lithium or the charged lithium species lithium hydroxide or lithium hydride in an amount of at least 0.1% by weight with the total concentration of active compounds in the composition being at least about 1000 micromole/L and the pH of the solution is 8-14. The deficiency in Verburgh et al. is cured by the teachings of Bredesen et al., Applied Food Sciences and Ganio.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the composition of Verburgh et al. with a reaction product formed in aqueous solution that has a solubility of at least about 10 mg/L or greater than 100 mg/mL, as suggested by Applied Food Sciences, and where the source of the lithium comprises one or more of metallic lithium or the charged lithium species lithium hydroxide or lithium hydride, as suggested by Bredesen et al. and Ganio, in an amount of at least 0.1% by weight with the total concentration of active compounds in the composition being at least about 1000 micromole/L and the pH of the solution is 8-14, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the following rationale. First regarding the solubility of the reaction product in aqueous solution, Verburgh et al. guide the artisan to using a highly water soluble extract of ginger to begin with in combination with lithium and admixed with water. It stands to reason that the highly water soluble extract of ginger in combination with lithium forms a reaction product in the aqueous solution with a solubility of at least about 10 mg/L and greater than 100 mg/mL. Where the claimed and prior art products are identical or substantially identical the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on "prima facie obviousness" under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). See MPEP 2112(V).
Secondly, Verburgh et al. is open to all sources of lithium including metallic/elemental lithium an and charged ionic lithium such as lithium hydroxide or lithium hydride. The art of Bredesen et al. renders obvious at least elemental/metallic lithium the lithium salts lithium carbonate, orotate, chloride and aspartate to combine with ginger. Ganio teach the functional equivalence of lithium hydride and lithium hydroxide with elemental lithium, lithium carbonate, lithium orotate, lithium chloride and lithium aspartate. Thus, the art teaches that these are known alternatives for the same desired function of providing lithium and obvious over one another. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Moreover, “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982). Consequently, having elemental/metallic lithium or lithium hydride or lithium hydroxide in the composition of Verburgh et al. is obvious over the combined references. Regarding the amount of at least 0.1% by weight and the total concentration of active compounds in the composition being at least about 1000 micromole/L, such is readily optimized by the ordinary artisan to achieve the desired outcome with a reasonable expectation of success in the absence of evidence to the contrary. Especially when Verburgh et al. provide ranges of amounts of the ingredients to employ. Regarding the pH range of 8-14, since the same components are employed and Verburgh et al. as modified by Bredesen et al., then it is merely taking a pH meter and measuring the resulting pH of the solution. The ordinary artisan would do so with a reasonable expectation of success.
The difference between the instant application and Verburgh et al. is that Verburgh et al. do not expressly teach all the forms of instant claim 14. However, Verburgh et al. teach that the compositions can be formulated using one or more routinely used pharmaceutically acceptable carriers [0013] and “means to deliver the agent to a subject’s body via any known method.” [0012] The claimed forms of instant claim 14 are common and conventional routinely used forms for compositions in this art to deliver an agent to the subject’s body. The ordinary artisan in this art can readily formulate the composition of Verburgh et al. with the appropriate carrier to produce a tablet, capsule, a solution, an elixir, a syrup, a tincture, a suspension, an emulsion, a mouth wash, a spray, a drop, an ointment, a cream, a gel, a paste, a suppository, a pessary, a cream, a gel, or a foam with a reasonable expectation of success.
Claims 11, 12 and 15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Verburgh et al. (US20230085573) and Bredesen et al. (WO2014025905) and Ganio (US20220105128) and Applied Food Sciences ([online] retrieved on 2/13/26 from: https://appliedfoods.com/beverage-expert-applied-food-sciences-makes-breakthrough-with-two-new-launches-in-organic-ingredients/; 2016: 8 pages), as applied to claims 1-3, 5-10, 13-14, 31 and 32 above, in further view of Zhong et al. (CN1751596A; of record) and Zhou et al. (Molecules 2023;28(7562):16 pages; of record).
Applicant claims:
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The references of Verburgh et al., Bredesen et al., Ganio and Applied Food Sciences are discussed in detail above. As noted above Verburgh et al. suggest a capsule embodiment [0013].
Further regarding claims 11, 12 and 15, Bredesen et al. teach and suggest that the formulations for oral use can be soft capsules with liquid polyethylene glycols (Page 54, lines 1-8).
Regarding claims 11, 12 and 15, Zhou et al. teach that: “Polyethylene glycol 400 (PEG400) is a widely used pharmaceutical excipient in the field of medicine. It not only enhances the dispersion stability of the main drug but also facilitates the absorption of multiple drugs.” (Abstract) And: “PEG 400 is one of the very few polymers approved for injection. Due to its good solubilization and absorption-promoting effects, PEG400 is widely used in oral administration and skin and mucosa applications, especially in TCM soft capsules. It has unique advantages as it provides good dispersion and stabilization effects on the main drug while promoting intestinal drug absorption.” (Page 2, 2nd paragraph). Soft capsules read on softgels.
Regarding claims 11, 12 and 15, Zhong et al. teach soft capsules comprising ginger and PEG400 (Claims 1, 3, 7; embodiments 5-7). Soft capsules read on softgels.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Verburgh et al. as modified by Bredesen et al. is that Verburgh et al. as modified by Bredesen et al., Ganio and Applied Food Sciences does not teach adding PEG400 to the composition. This deficiency in Verburgh et al. as modified by Bredesen et al., Ganio and Applied Food Sciences is cured by the teachings of Zhou et al. and Zhong et al.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add PEG400, as suggested by Zhou et al. and Zhong et al., to the composition of Verburgh et al. as modified by Bredesen et al., Ganio and Applied Food Sciences, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because to practice the capsule embodiment of Verburgh et al. the artisan must select some sort of capsule and Bredesen et al. direct the artisan to soft gelatin capsules that contain polyethylene glycols. Not only is PEG400 a commonly used pharmaceutical excipient in the field of medicine well-known to the ordinary artisan as taught by Zhou et al. but also Zhong et al. guides the artisan to PEG400 for softgel compositions comprising ginger. Since Verburgh et al. is open to adding pharmaceutically acceptable excipients [0013], then it is obvious to add the widely used pharmaceutical excipient PEG400 in at least the softgel embodiment of the combined references with a reasonable expectation of success.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments Applicant’s arguments filed on 1/23/26 have been carefully considered but are not persuasive.
On page 7 of remarks, Applicant asserts that “Open to all sources of lithium” premise is not an evidence-based teaching or motivation to select Applicant’s specific lithium sources. Respectfully, the Examiner has a different perspective because Ganio teaches and suggest Applicant’s specific lithium sources as well as those employed by Verburgh et al. and Bredesen et al. Thus, the art teaches and suggests that these are known alternatives for the same desired function of providing lithium and obvious over one another. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007). Moreover, “Where two known alternatives are interchangeable for a desired function, an express suggestion to substitute one for the other is not needed to render a substitution obvious." In re Fout 675 F.2d 297, 301 (CCPA 1982).
On page 7 of remarks, Applicant asserts that: “Critically, the specification also explains why Applicant selected this class and why "ordinary" lithium salts are not equivalent in practice. It expressly contemplates that a person having ordinary skill in the art could theorize substitution with weak-acid lithium salts (e.g., lithium citrate), but then provides experimental results showing the theory fails: "However as shown in Example 9, the use of lithium citrate, lithium lactate, or lithium ascorbate as the source of lithium did not result in any appreciable difference in solubility of the ginger extract
... However, adding ... an excess of lithium (as Li, LiOH or LiH) results in the formation of a soluble complex."” Respectfully, this is an expected result. Extracts of ginger are based on a phenol structure as shown in Figure 1 of Shahrajabian et al. (Acta Agriculturae Scandinavica, Section B — Soil & Plant Science 2019; 12 pages) below:
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It is commonly known chemistry that phenol compounds react with metal or strong bases like NaOH to form phenoxide salts which enhance their solubility shown below from the chapter on Alcohols and Phenols ([online] retrieved on 2/12/26 from: 7.4 Alcohols and Phenols | NCERT 12 Chemistry; 4 pages):
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The reaction with an alkali metal, such as sodium or lithium, or a strong base such as NaOH or LiOH, is expected to deprotonate the water insoluble phenol to form the polar phenoxide ion which increases solubility in aqueous solution. This is exactly what applicant observed in Example 9 where weakly basic compounds lithium citrate, lithium ascorbate and lithium lactate had no notable dissolution but lithium hydroxide dissolved the phenol containing ginger extract. The fact that citric acid did not convert the phenoxide back to phenol lies in the fact that citric acid is a weak acid. Applicant should try a strong acid like hydrochloric acid or sulfuric acid to precipitate the phenol. The Examiner has a further comment concerning Applicant’s observation that “no notable dissolution in water” [0093]. However, that appears a conclusion based upon visual observation and not by any chemical analysis of the water. There could have been a detectable amount of solubilized ginger extract over time that simply was not observable to the eye. Moreover, the Examiner has serious concerns about the safety of such a composition for human ingestion comprising lithium hydroxide as in Example 9. In no uncertain terms the Safety Data Sheet for lithium hydroxide (ThermoFisher Scientific Safety Data Sheet created 2010, revised 2025; 9 pages) expressly teaches that it is harmful if swallowed and to call a physician or poison control center immediately if ingested because of possible perforation of the stomach or esophagus (Pages 1-3 of the Safety Data Sheet). The Safety Data Sheet states: “Do not ingest.” (Page 4 top). Respectfully, the Examiner has carefully considered Applicant’s arguments and data but did not find them persuasive.
In addition, even if the artisan did not use the highly water soluble ginger extract of Verburgh et al. and selected, for example 4-gingerol or 6-gingerol, these extract components of ginger have water solubilities of 0.18 g/mL (180 mg/mL) and 1 mg/mL respectively ([4]-Gingerol [online] retrieved on 2/13/26 from: https://foodb.ca/compounds/FDB001886, 2 pages; and Cayman Chemicals Product Information 6-Gingerol; 2022, 1 page), which are greater than the claimed solubility of 10 mg/L (0.01 mg/mL). So, just mixing these ginger extracts with any source of lithium, including those claimed, would read on the solubility limitation of claim 1.
On pages 9-11 of remarks, Applicant argues that Bredesen’s “element lithium” does not teach metallic lithium (or LiH or LiOH) ingestion chemistry, nor does it cure the lack of a reasoned expectation of success. Applicant further asserts that metallic lithium, lithium hydride and lithium hydroxide are deliberately selected and has explained why they matter chemically. As shown above, the Examiner understands the chemical behavior of the claimed compounds and how they interact with the ginger extracts. The Examiner has also shown that these are obvious lithium species to select for combination with the highly water soluble ginger extract of Verburgh et al. in view of the combined references. The Examiner has met the Federal Circuit’s “particular findings” requirement. The fact that highly reactive metallic lithium produces lithium hydroxide in water is a known fact and is not “mechanistic backfill”. Applicant references Example 9, which the Examiner has addressed above where reaction of a phenolic compound with a metal such as lithium or a strong base like lithium hydroxide is going to produce the corresponding phenoxide and enhance the solubility is a predictable and expected result contrary to Applicant’s assertions of “new chemistry” and unexpected results. Applicant’s argument has been considered but is not persuasive for these reasons and those provided supra.
On pages 12-13 of remarks, Applicant argues that the references do not teach or suggest a water-soluble reaction product with the claimed high-solubility outcome. Respectfully, the Examiner cannot agree because the Examiner has shown that Verburgh et al. guide the artisan to highly water soluble ginger extract comprising gingerols. Highly water soluble means that when mixed in water the extract of ginger is dissolved and upon mixing with the source of lithium in the aqueous solution the artisan is going to have some reaction product dissolved in the water meeting the claimed solubility limitations. Applicant’s supplied Appendix A would confirm “highly soluble” is at least in the range of “freely soluble” to “very soluble” in the Table below:
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Accordingly, the only reasonable conclusion based on the evidence of record is that the highly water soluble ginger extract of Verburgh et al. dissolves in water freely and when admixed with lithium in that aqueous solution forms a reaction product in solution with the claimed solubility parameters. The burden is properly thrust upon Applicant to prove otherwise. Respectfully, Applicant’s arguments are not persuasive.
On pages 14-15 of remarks, Applicant comments on the rejection of claims 11, 12 and 15 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Verburgh and Bredesen as applied to claims 1-10, 13-14, 31 and 32 above, and further in light of Zhou et al. (Molecules 2023). Applicant left out the reference to Zhong et al. (CN1751596A; of record). Applicant argues: “However, that reasoning is precisely the type of conclusory "open to" substitution that the Federal Circuit has rejected: "rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning" for the proposed modification, (In Re Leonard R. Kahn, 441 F. 3 d 977
(Fed. Cir. 2006))”. The Examiner has provided articulated reasoning with some rational underpinning" for the proposed modification. The Examiner asserted: “to practice the capsule embodiment of Verburgh et al. the artisan must select some sort of capsule and Bredesen et al. direct the artisan to soft gelatin capsules that contain polyethylene glycols. Not only is PEG400 a commonly used pharmaceutical excipient in the field of medicine well-known to the ordinary artisan as taught by Zhou et al. but also Zhong et al. guides the artisan to PEG400 for softgel compositions comprising ginger.” The Examiner did not make any conclusory statements but rather walked Applicant down a path of evidence step by step where it is already known through Zhong to formulate softgel compositions comprising ginger with PEG400. No hindsight was used. Respectfully, Applicant’s arguments are not persuasive.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613