DETAILED ACTION
The receipt is acknowledged of applicants’ amendment and declaration under 37 C.F.R. § 1.132, filed 05/29/2025.
Claims 1-4, 7, 9-15 previously presented. Claim 16 is currently added.
Claims 1-4, 7, 9-16 are pending.
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 invention I, claims 1-4, 7, in the reply filed on 10/11/2024 is acknowledged. Newly added claim 15 will be examined with the elected invention.
Claims 1-4, 7 and 15-16 are examined on the merit.
Claims 9-14 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/11/2024.
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.
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 1-4, 7 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of JP 03292860 (JP ‘860, IDS filed 09/01/2023), George et al. (US 2016/0067293, IDS filed 12/12/2021), and the article by Mohd et al. (“Development of energy chocolate confectionary supplemented with Tongkat Ali and Ginseng extracts from mass propagated roots derived from bioreactor technology”, previously provided), and as evidenced by the article by Porat et al. as applied to claim 7: (”Pathophysiology and treatment of fever”, previously provided).
Applicant Claims
Claim 1 is directed to a food product comprising an agent, wherein the agent comprises:
an extract from Tongkat Ali as an active ingredient of a sleep ingredient agent; and
gelatin,
wherein the food product is a coffee beverage, a milk beverage, a carbonated beverage, a soft drink, noodles, a baked sweet, a cake, a chocolate, a candy, or a dairy product and the food product is not a tea beverage or chewing gum.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
JP ‘860 teaches hot water extract from the root of Eurycoma longifolia (Tongkat Ali) contains active ingredients having antipyretic action, and in the form of chewing gum comprising the extract that reads on candy claimed by claim 1. The chewing gum has a bitter taste (see the entire document).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While JP ‘860 teaches product comprising the claimed extract and teaches chewing gum that implies the presence of other ingredients, e.g. carrier, the reference however does not teach gelatin in the product.
While the reference acknowledges bitter taste of the chewing gum containing Tongkat Ali, the reference does not overcome such a problem.
George teaches orally administered composition comprising Tongkat Ali aqueous extract and nutraceutically acceptable carrier that is nontoxic and non-irritating to the gastrointestinal tract including gelatin. The composition is in the form of syrup, emulsion or gel, etc. Tongkat Ali is known to be mixed with conventional food and beverages (abstract; ¶¶ 0004, 0069-0072).
Mohd teaches Tongkat Ali extract is bitter and teaches a simple, safer and easier consumption of the extract is through incorporation into chocolate products (abstract).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide an oral product comprising Tongkat Ali extract and a carrier as taught by JP ‘860, and use gelatin taught by George as a carrier to the extract. One would have been motivated to do so because George teaches gelatin is suitable nutraceutical nontoxic and non-irritating carrier to Tongkat Ali extract. One would reasonably expect formulating oral composition comprising Tongkat Ali extract and nutraceutical gelatin carrier wherein the composition is non-toxic and non-irritating.
Further, one having ordinary skill in the art would have incorporated Tongkat Ali extract taught by JP ‘860 and George into a chocolate product to overcome its bitter taste as taught by Mohd because Mohd teaches incorporation of Tongkat Ali extract into chocolate products overcomes the bitter taste in a simple, safer and easier way to consume.
Regarding the food product claimed by claims 1 and 15, George teaches including Tongkat Ali in conventional food and beverages, and Mohd suggests incorporation into chocolate.
Regarding the extract is from the root of Tongkat Ali as claimed by claim 2, JP ‘860 teaches extract from the root of the plant.
Regarding hot water extraction as claimed by claim 3, this is taught by JP ‘860.
Regarding claim 4 that the core body temperature reducing effect is more significant during rest than activity period as claimed by claim 4, this is an expected property of the hot water root extract from Tongkat Ali.
Regarding administering the core body temperature reducing agent to the subject in need thereof as claimed by claim 7, this is taught by JP ‘860 evidenced by Porat. Antipyretic action lowers body temperature and reduces fever (see entire document). Fever is an elevation in core body temperature as evidenced by the article by Porat (see the entire document and in particular pages 1, 2, 6 and 7). Reducing fever will inevitably reduce core body temperature. Further, it must be remembered that the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004).
Regarding claim 16 that Tongkat Ali comprises yellow, red, black or mixture of all types, applicants failed to show any unexpected results obtained from any type or the mixture thereof.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claims 1-4, 7 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of CN 105031204 (CN ‘204, abstract provided by IDS filed 02/12/2021, and a machine translation is previously provided), George et al. (US 2016/0067293, IDS filed 12/12/2021), and the article by Mohd et al. (“Development of energy chocolate confectionary supplemented with Tongkat Ali and Ginseng extracts from mass propagated roots derived from bioreactor technology”, previously provided), and as evidenced by the article by Reid et al. as applied to claim 7: (“Day-time melatonin administration: Effect of core temperature and sleep onset latency”, previously provided).
Applicant Claims
Claim 1 is directed to a food product comprising an agent, wherein the agent comprises:
an extract from Tongkat Ali as an active ingredient of a sleep ingredient agent; and
gelatin,
wherein the food product is a coffee beverage, a milk beverage, a carbonated beverage, a soft drink, noodles, a baked sweet, a cake, a chocolate, a candy, or a dairy product and the food product is not a tea beverage or chewing gum.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
CN ‘204 discloses health tea that effectively improves sleep and clear away heat. The health agent comprises hot water extract from Tongkat Ali. Tongkat Ali extract has a bitter taste, and therefore, the reference teaches to mix the extract with 6 ingredients to form a tea and to improve the taste (see entire document, and in particular paragraphs: 0004-0008, 0034-0035, 0042, 0058).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012) &
While CN ‘204 teaches Tongkat Ali extract in the form of tea, the reference however does not teach gelatin as claimed by claim 1.
While the reference acknowledges bitter taste of the tea containing Tongkat Ali, the reference overcome such a problem by adding additional 6 ingredients.
George teaches orally administered composition comprising Tongkat Ali aqueous extract and nutraceutically acceptable carrier that is nontoxic and non-irritating to the gastrointestinal tract including gelatin. The composition is in the form of syrup, emulsion or gel, etc. Tongkat Ali is known to be mixed with conventional food and beverages (abstract; ¶¶ 0004, 0069-0072).
Mohd teaches Tongkat Ali extract is bitter and teaches a simple, safer and easier consumption of the extract is through incorporation into chocolate products (abstract).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide an oral product comprising Tongkat Ali extract and a carrier as taught by CN ‘204, and use gelatin taught by George as a carrier to the extract. One would have been motivated to do so because George teaches gelatin is suitable nutraceutical nontoxic and non-irritating carrier to Tongkat Ali extract. One would reasonably expect formulating oral composition comprising Tongkat Ali extract and nutraceutical gelatin carrier wherein the composition is non-toxic and non-irritating.
Further, one having ordinary skill in the art would have incorporated Tongkat Ali extract taught by CN ‘204 and George into a chocolate product to overcome its bitter taste as taught by Mohd because Mohd teaches incorporation of Tongkat Ali extract into chocolate products overcomes the bitter taste in a simple, safer and easier way to consume.
Regarding the food product claimed by claims 1 and 15, George teaches including Tongkat Ali in conventional food and beverages, and Mohd suggests incorporation into chocolate.
Regarding the extract is from the root of Tongkat Ali as claimed by claim 2, CN ‘204 teaches extract from the root of the plant.
Regarding hot water extraction as claimed by claim 3, this is taught by CN ‘204.
Regarding claim 4 that the core body temperature reducing effect is more significant during rest than activity period as claimed by claim 4, this is an expected property of the hot water root extract from Tongkat Ali.
Regarding administering the core body temperature reducing agent to the subject in need thereof as claimed by claim 7, this is taught by CN ‘204 that teaches Tongkat Ali extract clear away heat, as further evidenced by Reid. Lowered nocturnal core temperatures are associated with an increased in sleep/wake propensity and increased sleep quality, and conversely, increased core body temperature is associated with a reduced sleep propensity and reduced sleep quality as evidenced by the article by Reid (see the entire document, and in particular page 150, right column). Therefore, improved sleep quality by Tongkat Ali extract is associated with reduced core body temperature. Further, it must be remembered that the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004).
Regarding claim 16 that Tongkat Ali comprises yellow, red, black or mixture of all types, applicants failed to show any unexpected results obtained from any type or the mixture thereof.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Response to Arguments
Applicant's arguments filed 09/25/2025 have been fully considered but they are not persuasive.
Issues under 35 U.S.C. § 103
Distinctions over the Cited References
Applicants argue that amended independent claim 1 recites “an extract from Tongkat Ali as an active ingredient of a sleep improving agent.” In contrast, CN ‘204 fails to disclose Tongkat Ali as an active ingredient of a sleep improving agent, paragraphs [0054]. In paragraph [0054], CN ‘204 teaches consuming Tongkat Ali improves mental condition and physical health paragraph, and in paragraph [0056] CN ‘204 teaches Tongkat Ali improves sleep and health condition.
In response to this argument, it is argued that, claim 1 does not recite Tongkat Ali as sleep improving agent as applicants assert. In any event, as applicants themselves admit, CN ‘204 clearly suggests consuming Tongkat Ali to improve sleep. Note claim 1 is directed to a composition and all the elements of the claimed composition are taught by combination of the cited references. Even if CN ‘204 teaches tea, Mohd teaches chocolate is safe easy food product to consume the bitter tasted Tongkat Ali extract. Therefore, combination of the cited reference teaches food comprising Tongkat Ali as claimed.
Applicant argues that CN ‘204 discloses that the tea contains Tongkat Ali as one of its ingredients. However, the tea disclosed in CN ‘204 contains many other components as well. Specifically, CN ‘204 states in paragraph [0004]: The purpose of the present invention is to provide a health tea that is effective in improving sleep, easy to consume, and good in taste. In paragraph [0005] the reference discloses: A first aspect of the present invention is to provide a health tea, which contains raw materials or extracts thereof. The raw materials include many extracts from many plants.
In response to this argument, it is argued that the reference teaches Tongkat Ali among the plants that improves sleep. Even if CN ‘204 teaches tea, its combination with the other references teaches food comprising the extract as required by the claim. It had been decided by Courts that the indiscriminate selection of "some" from among "many" is considered prima facie obvious. In re Lemin, 141 USPQ 814 (1964); National Distillers and Chem. Corp. V. Brenner, 156 USPQ 163.
Applicants argue that CN ‘204 teaches in paragraph [0043] Lily is mainly used for chronic cough due to yin deficiency, hemoptysis in phlegm, lingering heat after febrile diseases, emotional disorders leading to restlessness and palpitations, insomnia with vivid dreams, and mental confusion, as well as for damp- heat sores and swelling. In paragraph [0044] CN ‘204 teaches Albizia flower helps relieve depression, calm the mind, nourish yin and reinforce yang, regulate qi, improve digestion, activate collaterals, and relieve pain, clearing heat, eliminating summer heat, nourishing the skin, removing spots, and relieving hangovers. In paragraph [0045] CN ‘204 teaches “Tongkat Ali”….has a bitter taste and a cooling nature….”. Therefore, one of ordinary skill in the art would reasonably understand from the disclosure of CN ‘204 that the sleep-improving effect of the tea originates from ingredients such as “lily” and “Albizia flower” rather than from Tongkat Ali. Therefore, even if the tea itself exhibits a sleep-improving effect, it would not be obvious to attribute this effect to Tongkat Ali.
In response to this argument, the examiner respectfully disagrees because the reference teaches lily as mainly used for chronic cough and has no effect on the sleep or body temperature. The same for Albizia flower, has many effects none of them on the sleep or body temperature. To the contrary, as applicants noted, CN ‘204 teaches Tongkat Ali has cooling effect. This teaching, in combination with the other cited references, would have suggested to use Tongkat Ali to reduce body temperature. Applicant’ attention is directed to the teaching of CN ‘204 In paragraph [0042] that Tongkat Ali “clears away heat”. Further, combining this teaching with the teaching of Reid that teaches: “lowered nocturnal core temperatures are associated with an increased in sleep/wake propensity and increased sleep quality, and conversely, increased core body temperature is associated with a reduced sleep propensity and reduced sleep quality”, one would expect improved sleep quality by Tongkat Ali extract that is associated with reduced core body temperature. Further, it must be remembered that the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). Additionally, it does not matter if the reference teaches other plant extracts having different effects as long as it teaches the Tongkat Ali can cool body temperature. Improved sleep quality by Tongkat Ali extract is associated with reduced core body temperature. Further, it must be remembered that the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004). Also, it is irrelevant that the prior art observers did not recognize the property or function of the disputed claim; if the prior art inherently possessed that characteristic, it anticipates. See Verdeegal Brothers, lnc. v. Union Oil Co. of Cal., 814 F.2d 628, 633, 2 U.S.P.Q.2d 1051, 1054 (Fed. Cir. 1987). This is believed to be applicable here because anticipation is the epitome of obviousness.
Summary
Applicants argue that to establish a prima facie case of obviousness of a claimed invention, all of the claim limitations must be disclosed by the cited references. As discussed above, the cited references fail to disclose all of the claim limitations of independent claim 1, and those claims dependent thereon. Accordingly, the combinations of references do not render the claimed invention obvious. Furthermore, the cited references or the knowledge in the art provide no proper reason or rationale that would allow one of ordinary skill in the art to arrive at the claimed invention.
In response to this argument, it is argued that all the elements of the claimed composition are taught by combination of the cited references. Motivation to combine the references exists, and reasonable expectation to achieve the present invention was provided. It is well established that the claims are given the broadest interpretation during examination. A conclusion of obviousness under 35 U.S.C. 103 (a) does not require absolute predictability, only a reasonable expectation of success; and references are evaluated by what they suggest to one versed in the art, rather than by their specific disclosure. In re Bozek, 163 USPQ 545 (CCPA 1969). In the light of the foregoing discussion, the Examiner’s ultimate legal conclusion is that the subject matter defined by the claims would have been obvious within the meaning of 35 U.S.C. 103 (a). It should be noted that the motivation to combine references can be different from the ones set forth by Applicant. That is, as long as motivation exists to combine the elements, the problem to be solved does not have to involve the same reason. As such, the examiner respectfully submits that there is motivation to combine the cited references as set forth in this office action. The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done.
Furthermore, it has been held that the obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
New Claim 16
Applicants argue that new claim 16, which depends from independent claim 1, is allowable for the reasons given above. In addition, claim 16 recites further limitations, which are not disclosed or made obvious by the cited references.
In response to tis argument, it is argued that claim 1 is not allowable for the reasons discussed above. Claim 16 has been addressed as set forth in this office action.
Response to Declaration Under 37 C.F.R. § 1.132
The declaration under 37 CFR 1.132 filed 09/29/2025 is insufficient to overcome the rejection of claims 1-4, 7, 15-16. The declaration seems to be only an expert opinion that include(s) statements which amount to an affirmation that the claimed subject matter functions as it was intended to function based on the mechanism of action of the Tongkat Ali. The mechanism of action to of Tongkat Ali by inhibiting COX-2 activity, and consequently reduced hypothalamic effect on core body temperature is inherit property of Tongkat Ali and expected from the cited prior art. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. The declaration does not provide side by side comparison of the present composition with the prior art composition to establish non-obviousness. It refer(s) only to the system described in the above referenced application and not to the individual claims of the application. Thus, there is no showing that the objective evidence of nonobviousness is commensurate in scope with the claims. See MPEP § 716.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Isis A D Ghali whose telephone number is (571)272-0595. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ISIS A GHALI/ Primary Examiner, Art Unit 1611 /I.G./
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