DETAILED ACTION
The receipt is acknowledged of applicants’ declaration under 37 C.F.R. § 1.132, request for RCE, and amendment, all filed 03/25/2025.
Claims 1-4 and 7-14 previously presented. Claim 8 is currently canceled and claim 15 is currently added.
Claims 1-4, 7, 9-15 are pending.
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 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Claims 9-14 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention II, there being no allowable generic or linking claim.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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/25/2025 has been entered.
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 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”, currently 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; 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).
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 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”, currently 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; 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).
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 05/10/2024 have been fully considered but they are not persuasive.
Issues over the Cited References
Distinctions over the Cited References
Applicants argue that amended independent claim 1 recites the subject matter of claim 8. With respect to claim 8, the Examiner asserts that the chewing gum of JP ‘860 reads on the claimed candy. The Examiner also asserts that the tea of CN ‘204 reads on the claimed beverage (although the Examiner does not specify the exact beverage). In response, independent claim 1 is amended so as to explicitly exclude tea beverages and chewing gum.
This argument is moot in view of the newly cited reference by Mohd that teaches chocolate is safe easy food product to consume the bitter tasted Tongkat Ali extract.
With specific respect to claim 7, Applicants argue that CN ‘204 discloses a health tea containing a hot water extract of Tongkat Ali to improve sleep. The Examiner relies on Reid to disclose that lowered nocturnal core temperatures are associated with increased sleep quality. Thus, the Examiner asserts that improved sleep quality with Tongkat Ali extract is associated with reduced core body temperature. Although Reid may disclose that lowered nocturnal core temperatures are associated with increased sleep quality, the Tongkat Ali extract does not necessarily improve sleep by reducing core body temperature.
Applicant’s attention is directed to the scope of the present claims that are directed to composition, and all the elements of the claimed composition are taught by combination of the cited references. Claim 7 depends on claim 1 and is directed to the intended use of the composition of claim 1. In response to the above argument, applicant’ attention is directed to the teaching of CN ‘204 In paragraph [0042] that Tongkat Ali “clears away heat”. Further, with the teaching of Reid that 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).
Applicants argue that the combinations of references do not render the claimed invention obvious. 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. 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. A prima facie case of obviousness has not been established.
In response to this argument, it is argued that the present claims are directed to composition and its intended use, all the elements of the claimed composition are taught by combination of the cited references, as set forth in this office action. The discovery of a new action underlying a known process does not make it patentable. MEHL/Biophile, 192 F.3d at 1365, 52 U.S.P.Q.2d at 1303. 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.
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 that is to be used for the very same purpose; the idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 205 USPQ 1069.
The cited references show that it was well known in the art at the time of the invention to use the claimed ingredients in oral formulation. It is well known that it is prima facie obvious to combine two or more ingredients 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 useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. ln re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA 1972); ln re Susi, 58 CCPA 1074, 1079-80) 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960).
Based on the disclosure by the cited references that these substances are used in oral formulation, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating an oral formulation.
Therefore, the artisan would have been motivated to combine the claimed ingredients into a single formulation. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See ln re Sussman, 1943 C.D. 518; In re Huellmantel 139 USPQ 496; ln re Crockett 126 USPQ 186.
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 15
Applicants argue that claim 15, which depends from independent claim 1, is allowable for the reasons given above. Claim 15 recites limitations, which are not disclosed or made obvious by the cited references.
In response to this argument, it is argued that claim 15 teaches chocolate product that is taught by the newly cited reference Mohd.
Response to Declaration Under 37 C.F.R. § 1.132
The declaration under 37 CFR 1.132 filed 03/25/2025 is insufficient to overcome the rejection of claims 1-4, 7, 15 based upon combination of each of JP ‘860 or CN ‘204, with George. Applicants argue that Tongkat Ali and gelatin are not expected to have a synergistic effect as set forth in the last Office action, and results in “markedly different” effect.
In response to the declaration, 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. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. The issue of “markedly different” is no longer raised by the examiner. The declaration does not compare the present invention to the prior art composition to establish non-obviousness and synergism. 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.
Further regarding synergistic effect, it has been decided by the court that: “There is no single, appropriate test for determining whether synergism has been demonstrated for chemical combination; rather, facts shown in each case must be analyzed to determine whether chosen method has clearly and convincingly demonstrated existence of synergism or unobvious result”. “Assuming arguendo that the differences in values presented are statistically significant, there is no evidence that they represent a true, practical advantage. In re Freeman, 474 F.2d 1318, 177 USPQ 139 (CCPA 1973); In re Klosak , 455 F.2d 1077, 173 USPQ 14 (CCPA 1972); In re D'Ancicco, 439 F.2d 1244, 169 USPQ 303 (CCPA 1971). Also, prescinding from the Colby formula test, which as we have already indicated is at best controversial and in our view probably invalid, there is no evidence that the differences are unexpected. In re Merck, 800 F.2d 1091, 231 USPQ 375 (Fed.Cir. 1986); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed.Cir. 1985); In re Freeman, supra”.
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.
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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/ISIS A GHALI/ Primary Examiner, Art Unit 1611 /I.G./