Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Pursuant to the preliminary amendment dated 10/4/2023, claims 17-21 are cancelled and claims 4-6 and 9-16 are amended. No claims are newly added.
Claims 1-16 are pending in the instant application and are examined on the merits herein.
Priority
This application is a National Stage Application of PCT/JP2022/015872, filed on 3/30/2022. The instant application claims foreign priority to JP 2021065419 filed on 4/7/2021. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application on 10/4/2023.
Information Disclosure Statement
The information disclosure statement (IDS) dated 10/4/2023, 1/4/2024 and 3/6/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS has been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-8 and 10-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) that does not integrate the judicial exception into a practical application, without significantly more.
The rejected claims are directed to a composition comprising: A) a glycosyl naringenin and B) one or more of the compounds selected from alpha-pinene, β-pinene, sabinene, camphene, valencene, β-caryophyllene, β-ionone, methyl anthranilate, methyl N-methylanthranilate, thymol, and nootkatone, where components A and B are naturally occurring compounds and/or occur together in naturally occurring compositions. Zhu et al. (CN 101829243 A, 2010, PTO-892) discloses a composition comprising salipurposide (where salipurposide is a glycosyl naringenin), derived from Peach twig, camphene and caryophyllene, derived from Perilla frutescens. (Abstract)
PNG
media_image1.png
201
429
media_image1.png
Greyscale
Salipurposide
Puig et al. (Plants Medica, 1995, PTO-892) discloses that grapefruit extracts comprises naringin, narirutin and nootkatone, where naringin and narirutin are both glycosyl naringenins. (Abstract) The disclosure of Zhu and Puig show that the instantly claimed compositions are naturally occurring compositions and are not patent eligible subject matter. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception. With respect to claim 1 and its’ dependents, the limitations regarding “promoting GLP-1 secretion” do not amount to significantly more because said property is inherent to all claimed compounds, as per the instant specification at Table 1 and ¶0112. With respect to claims 12-16 and the limitations that the composition is in the form of a food, drug, supplement, etc., this does not amount to significantly more because these limitations amount to generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application. The limitations regarding amount and/or ratio of components A and B are recited with a high degree of generality and are insufficient to distinguish the claims from that which would naturally occur. The claimed invention does not rise to the level of a product having markedly different characteristics, compared to the closest naturally occurring counterpart.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4-9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uchida et al. (US 5,494,667; 1996, PTO-892), as evidenced by Sakamoto et al. (JP 2016108272 A, PTO-892).
Uchida et al. discloses a composition comprising a pine extract, which necessarily comprises pinene and camphene, and alpha-glucosyl naringin. (Claim 8, Col. 2, Ln. 37-45) Uchida also discloses that the ratio of pine extract to alpha-glucosyl naringin is in the range 1:0.1 to 1:100 and that the glucosyl bioflavanoid is present at 2 parts by weight. (Claim 9; Example 2)
Sakamoto discloses that alpha-glucosyl naringin has the structure of formula (I), where G=glucose, where formula (I) is identical to the compound of claim 2: (pp. 4 and 36)
PNG
media_image2.png
365
570
media_image2.png
Greyscale
With respect to claim limitations regarding GLP-1 secretion or any of the condition listed in claim 6, these limitations are considered an intended use of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Accordingly, the instant claims are anticipated by the prior art.
Claims 1, 3, 6, 7, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Puig et al. (Plants Medica, 1995, PTO-892).
Puig et al. discloses that grapefruit extracts comprises naringin, narirutin and nootkatone, where naringin and narirutin are both glycosyl naringenins. (Abstract)
With respect to claim limitations regarding GLP-1 secretion or any of the condition listed in claim 6, these limitations are considered an intended use of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Accordingly, the instant claims are anticipated by the prior art.
Claims 1, 6 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al. (CN 101829243 A, 2010, PTO-892).
Zhu et al. discloses a composition comprising salipurposide, camphene and caryophyllene, where salipurposide is a glycosyl naringenin. (Abstract)
PNG
media_image1.png
201
429
media_image1.png
Greyscale
Salipurposide
With respect to claim limitations regarding GLP-1 secretion or any of the condition listed in claim 6, these limitations are considered an intended use of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Accordingly, the instant claims are anticipated by the prior art.
Claims 1, 6 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by El-Hawary et al. (J. Food. Sci., 2011, PTO-892).
El-Hawary et al. discloses an extract of Rumex vesicarius comprising 6-C-glucosylnaringenin and caryophyllene. (Tables 2, 3)
With respect to claim limitations regarding GLP-1 secretion or any of the condition listed in claim 6, these limitations are considered an intended use of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Accordingly, the instant claims are anticipated by the prior art.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
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.
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 1-13 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kawashima et al. (JP 2021155376A, 2021), in view of Chauhan et al. (Alcohol, 2015, PTO-892).
Kawashima et al. discloses a cosmetic, food or drink composition for promoting collagen production, suppressing MMP-9 expression, promoting TIMP-2 expression, and promoting collagen gel contraction, where the composition comprises a compound of formula II (at 0.0001 to 10 wt%), which is identical to the instant compound 3”-alpha-monoglucosyl naringin: (p. 3, ¶4; p. 5; p. 7; p.13)
PNG
media_image3.png
292
441
media_image3.png
Greyscale
Kawashima does not teach that the composition comprises any of the compounds of instant “compound B”.
Chauhan et al. discloses that thymol is known to suppress MMP-9 secretion. (Abstract)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kawashima and add thymol to the composition, thereby arriving at the instant invention. One would be motivated to add thymol to the composition of Kawashima because Chauhan teaches that thymol suppresses MMP-9 secretion, which is an envisioned function of the composition of Kawashima. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at ___, 82 USPQ2d at 1395; Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
With respect to claim limitations regarding GLP-1 secretion or any of the condition listed in claim 6, these limitations are considered an intended use of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
With respect to the ratios of compound A and compound B, as recited in claims 4 and 8, it would have been prima facie obvious for one of ordinary skill in the art to optimize the weight ratios of formula II and thymol, as taught by the combined prior art, to account for parameters such as age, gender, weight, and condition, thereby arriving at the instant invention. Moreover, the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially in view of the large range instantly claimed) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of one of ordinary skill in the art. See also MPEP § 2144.05.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 1, 3-8, 10-13, 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Brewster et al. (US 2020/0306282, PTO-892), in view of Huang et al. (WO 2012/168474A1, PTO-892).
Brewser et al. discloses a composition for treating diabetes and increasing GLP-1 levels, where the composition comprises eriocitrin, narirutin (a glycosyl naringenin), hesperidin and may further comprise another GLP-1 agonist. (Claims 1, 14, 17; Example 1) Brewster also discloses that the composition may be a food, beverage, supplement or in the various forms for pharmaceutical administration (i.e. injection, suppository, tablet, etc.). (¶0030-0039) Brewster further discloses that the dose of the narirutin is 7.2-28.6 mg or 1-6% and that the dose of additional agent is 50-500 mg. (Claim 14, ¶0026, 0029)
PNG
media_image4.png
150
227
media_image4.png
Greyscale
PNG
media_image5.png
84
247
media_image5.png
Greyscale
eriocitrin
narirutin
PNG
media_image6.png
106
216
media_image6.png
Greyscale
hesperidin
Brewster does not teach that the composition contains any of the compounds listed under “compound B”.
Huang et al. discloses that thymol is known to increase GLP-1 secretion. (p. 11, Ln. 18)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Brewster and add thymol to the composition, thereby arriving at the instant invention, because Brewser teaches that the composition may include another GLP-1 agonist. One would be motivated to add thymol to the composition of Brewster because Huang teaches that thymol also is known to increase secretion of GLP-1. “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 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.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see also MPEP § 2144.06(I))
With respect to the ratios of compound A and compound B, as recited in claims 4 and 8, it would have been prima facie obvious for one of ordinary skill in the art to optimize the weight amounts of narirutin and the additional GLP-1 agonist, specifically thymol, as taught by the combined prior art, to account for parameters such as age, gender, weight, and condition, thereby arriving at the claimed ratios. Moreover, the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially in view of the large range instantly claimed) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of one of ordinary skill in the art. See also MPEP § 2144.05.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 1, 3, 5-7, 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hashizume et al. (US 2022/0401761A1, filed 10-2020, PTO-892), as evidenced by Sakamoto et al. (JP 2016108272 A, PTO-892).
Hashizume et al. discloses a quasi-drug or skin external preparation for cellulite improvement, comprising at least one component (A) selected from alpha-glucosyl hesperidin and alpha-glucosyl naringin, where component (A) is 0.01 to 10 mass%. (Claims 1, 3; ¶0060) Hashizume also discloses that the composition may further comprise a preservative, including thymol. (¶0091)
Sakamoto discloses that alpha-glucosyl naringin has the structure of formula (I), where G=glucose, where formula (I) is identical to the compound of claim 2: (pp. 4 and 36)
PNG
media_image2.png
365
570
media_image2.png
Greyscale
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hashizume and add a preservative to the skin composition because Hashizume suggests such an addition. It would have been further obvious to select thymol as the preservative from the list of preservatives taught by Hashizume because each of the preservatives listed is functionally equivalent and one would expect similar preservative performance from any of the compounds listed.
With respect to claim limitations regarding GLP-1 secretion or any of the condition listed in claim 6, these limitations are considered an intended use of the claimed composition. The “intended use” of the claimed composition does not patentably distinguish the composition, per se, since such disclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Brewster et al. (US 2020/0306282, PTO-892), in view of Huang et al. (WO 2012/168474A1, PTO-892), further in view of Tsuchiya et al. (US 2015/0125589, PTO-892).
The disclosure of Brewster/Huang is referenced as discussed above. The combined prior art does not teach the composition as a flavoring agent.
Tsuchiya et al. discloses that selective improvement or decrease of unpleasant flavor, and not greatly changing savoriness of the food or drink, flavanoid glycosides are particularly preferred, where hesperidin, eriocitrin and narirutin are among the preferred flavanoid glycosides. (¶0086)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the composition of Brewster/Huang could be used as a flavoring agent, thereby arriving at the instant invention. The obviousness of the use of a hesperidin, eriocitrin and narirutin containing composition as a flavoring agent is provided by Tsuchiya, where hesperidin, eriocitrin and narirutin are among preferred flavanoid glycosides to improve or decrease unpleasant flavor.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kawashima et al. (JP 20211155376A, 2021), in view of Chauhan et al. (Alcohol, 2015, PTO-892), further in view of Tsuchiya et al. (US 2015/0125589, PTO-892).
The disclosure of Kawashima/Chauhan is referenced as discussed above. The combined prior art does not teach the composition as a flavoring agent.
Tsuchiya et al. discloses that selective improvement or decrease of unpleasant flavor, and not greatly changing savoriness of the food or drink, flavanoid glycosides are particularly preferred, where naringin is among the preferred flavanoid glycosides. (¶0086)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the composition of Kawashima/Chauhan could be used as a flavoring agent, thereby arriving at the instant invention. The compound of formula II of Kawashima is a naringin derivative and one would expect naringin and formula II to have similar properties. Hence the teaching of Tsuchiya that naringin is among preferred flavanoid glycosides to improve or decrease unpleasant flavor, would also apply to formula II, making it obvious to employ the composition of Kawashima/Chauhan as a flavoring agent.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/DALE R MILLER/Primary Examiner, Art Unit 1693