DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 1, and 9 are objected to because of the following informalities: “8-paradol” is italicized in lines 2 of the claims when it shouldn’t be. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: “Zingiber officinale” in line 2 of the claim should be italicized since that is the species name. Appropriate correction is .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2 – 4, and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites, the pharmaceutical composition of claim 1, wherein the 8-paradol is extracted from ginger (Zingiber officinale Roscoe). Regarding claim 2, the use of parenthesis in the claim renders the claim indefinite because it is unclear whether the recitation within the parenthesis is a definition or a preferred embodiment. For example, the claim recites extracted from ginger (Zingiber officinale Roscoe) does the method require the 8-paradol to be extracted from any ginger species or only from to Zingiber officinale Roscoe? As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of what ginger the 8-paradol can be extracted from. Therefore, given the uncertainty around the terms within the parenthesis claim 2 is rejected under 35 U.S.C. 112(b).
Claims 3, and 7 are rejected because both claims recite an open list of alternatives. Specifically, claim 3 recites, the pharmaceutical composition of claim 1, wherein the cancer includes one or more selected from the group including. While claim 7 recites, wherein the pharmaceutically acceptable carrier includes one or more selected from the group including. The use of the phrase, “includes one or more selected from the group including,” in not interpreted as meaning a closed group or alternatives but instead is interpreted to mean that the group can include other cancers or pharmaceutically acceptable carriers not directly recited. As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of what other cancers the pharmaceutical composition can treat nor what other pharmaceutically acceptable carriers can be included. Therefore, given the uncertainty around the terms “includes one or more selected from the group including,” both claims 3, and 7 are rejected under 35 U.S.C. 112(b). Additionally, claim 4 is included in the rejection for being dependent on claim 3 and failing to address the deficiency.
Moreover, claim 4 recites, the pharmaceutical composition of claim 3, wherein the cancer includes gastric cancer; however, this claim is indefinite because one ordinary skill in the art cannot ascertain whether the patient receiving the pharmtuically composition must have gastric cancer and a cancer labeled in claim 3 or either the cancers recite in claim 3 or claim 4. As a consequence, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specifically one of ordinary skill in the art would not be reasonably apprised of to the patient population receiving the pharmaceutical composition. Therefore, given the uncertainty around the makeup of the patient population claim 4 is rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 recites, the pharmaceutical composition of claim 1, wherein the 8-paradol is extracted from ginger (Zingiber officinale Roscoe); where as claim 1 recites, a pharmaceutical composition for preventing, ameliorating, or treating cancer, the pharmaceutical composition comprising 8-paradol or a pharmaceutically acceptable salt thereof as an active ingredient. While the limitation of the 8-paradol being extracted from ginger (Zingiber officinale Roscoe) being interpreted as a product by process limitation. Thus for "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I). Moreover, product by process claims are not limited to the manipulation of the recited steps, that is extraction from ginger, but the structure applied by the steps. Thus the only required structure of claim 2 is for the composition to comprise 8-paradol. Hence since the only required the inclusion of 8-paradol; and given that claim 1 already recites 8-paradol claim 2 fails to further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 – 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claims recite a pharmaceutical composition for preventing, ameliorating, or treating cancer, the pharmaceutical composition comprising 8-paradol or a pharmaceutically acceptable salt thereof as an active ingredient. The element of 8-paradol exists in nature, as a component of ginger. See claim 2. Moreover, there is no indication in the specification that the claimed 8-paradol within the composition has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring components. Thus, the 8-paradol in the composition does not have markedly different characteristics from its natural counterpart in its natural state, and is a “product of nature” exception. Accordingly, the claim is directed to a judicial exception.
This judicial exception is not integrated into a practical application because the claims nature do not recite any elements in addition to the naturally occurring products. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because while claim 6 directs to the inclusion of a pharmaceutically acceptable carrier; pharmaceutically acceptable carrier can include water which does not have markedly different characteristics from its natural counterpart in its natural state, and is a “product of nature” exception. See claim 6. Moreover, while claim 7 recites where the pharmaceutically acceptable carrier includes one or more selected from the group including saline, sterile water, Ringer's solution, buffered saline, dextrose solution, maltodextrin solution, glycerol, and ethanol; both saline, sterile water and ethanol which do not have markedly different characteristics from their natural counterparts in their natural state, and are thus “products of nature” exceptions. See claim 7. Therefore claims 1, and 8 – 10 are rejected under 35 U.S.C. 101. Additionally, claims 2 – 7 are included in the rejection for being dependent on claim 1 and failing to address the deficiency.
Claim Rejections - 35 USC § 102
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 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.
Claims 1 – 6, and 8 – 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 6518315 B1 to Roufogalis et. al. (Roufogalis’315).
Regarding claims 1 – 6, and 8 – 10, Roufogalis’315 teach the use of phenylalkanols (gingerol analogues) in the treatment or prophylaxis of diseases by the inhibition of platelet aggregation. See column 1 lines 8 – 10. Specifically, Roufogalis’315 teach 1 -(4-hydroxy-3-methoxyphenyl)dodecan-3-one ([8]paradol) as a known substance. See column 17 lines 11 – 12. Furthermore, Roufogalis’315 teach that attention has been paid to the activity of COX-2 with increased evidence that downregulation of this enzyme activity will be important in control of inflammation and pain and an important strategy for preventing cancer since the enzyme catalysis the formation of prostaglandins which respectively mediate inflammation, pain, and have multiple effects that favor tumorigenesis. See column 44 lines 18 – 25. Additionally, Roufogalis’315 teach that cells in culture prepared from rat basophilic leukemia (RBL) 2H3 cell lines were used to assess COX activity. See column 44 lines 28 – 30. Moreover, Roufogalis’315 teach that all compounds in the assay, which includes 8-paradol, were dissolved in DMSO and assayed at a final concentration of 10 μM in buffer which contained 5 mM Hepes, 140 mM NaCl, 5 mM KCl, 0.6 mM MgC12, 1 mM CaC12 and 55 mM glucose. See column 44 lines 35 – 36 and 51 – 52. See claim 1 limitation for a composition comprising 8-paradol as an active ingredient. See claim 5 limitation for a composition where the 8-paradol concentration is between 5 µM to 50 µM. See claim 6 limitation for a composition further comprising a pharmaceutically acceptable carrier.
Even though the preamble of claim 1 recites a pharmaceutical composition for preventing, ameliorating, or treating cancer; the preamble does not provide any structural limitation to the composition as recited in claim 1. Thus the preamble, for preventing, ameliorating, or treating cancer, is a statement of purpose or use. Therefore, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II). Therefore, the composition comprising 8-paradol in buffer taught by Roufogalis’315 anticipates a pharmaceutical composition comprising 8-paradol as the active ingredient as recited in claim 1.
Regarding claim 2, limitation for a composition wherein 8-paradol is extracted from ginger, the prior art of Roufogalis’315 teach that all compounds in the assay, which includes 8-paradol, were dissolved in DMSO and assayed at a final concentration of 10 μM in buffer which contains 5 mM Hepes, 140 mM NaCl, 5 mM KCl, 0.6 mM MgC12, 1 mM CaC12 and 55 mM glucose. See column 44 lines 35 – 36 and 51 – 52. Thus the prior art teach a composition comprising 8-paradol which is identical to the 8-paradol recited in claim 2. Hence, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I). Thus, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01(I).
With regards to claims 3 – 4, which recite a pharmaceutical composition where the cancer is selected; these limitations are not structural limitations. Thus these limitations, for preventing, ameliorating, or treating cancer a selected cancer, is a statement of purpose or use. Therefore, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II). Therefore, the composition comprising 8-paradol in buffer taught by Roufogalis’315 anticipates a pharmaceutical composition comprising 8-paradol as the active ingredient as recited in claims 3 – 4.
Even though the preambles of claims 8 – 10 recite a food/feed/or cosmetic composition for preventing, ameliorating, or treating cancer; these preambles do not provide any structural limitation to the composition as recited in claims 8 – 10. Thus the preamble, for preventing, ameliorating, or treating cancer, is a statement of purpose or use. Therefore, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II). Therefore, the composition comprising 8-paradol in buffer taught by Roufogalis’315 anticipates a food/feed/or cosmetic composition comprising 8-paradol as the active ingredient as recited in claims 8 – 10. Moreover, given that the compositions of Roufogalis’315 comprises 8-paradol in buffer which contains 5 mM Hepes, 140 mM NaCl, 5 mM KCl, 0.6 mM MgC12, 1 mM CaC12, 55 mM glucose these compositions can be administered orally as food/feed or cosmetically.
Claims 1 – 4, and 6 – 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US patent No. 4623665A to Lee (Lee’665).
Regarding claims 1 – 4, and 6 – 10, Lee’665 teach a method for treating pains in human beings in need of such treatment, comprising administering to the human beings a safe and effective amount of [n]-paradol. See column 2 lines 9 – 12. Specifically, Lee’665 teach that testing compounds, which include 8-paradol, were administered, to Sprague Dawley, male 100-150 g, via i.p. injection with sequentially increasing doses of 4, 8, 12, 16 mg/kg at 2 hr. interval and via p.o. administration of 50, 25, 100, 150 mg/kg at 4 hr. interval during the phenylquinone writing method. See column 3 lines 23 – 26 and column 4 lines 27 – 28. Furthermore, Lee’665 teach that the test compounds which includes 8-paradol, was suspended in 2% polysorbate saline via p.o. or i. v.. See column 4 line 32. See claim 1 limitation for a composition comprising 8-paradol as an active ingredient. See claim 6 limitation for a composition further comprising a pharmaceutically acceptable carrier. See claim 7 limitation for a composition where the pharmaceutically acceptable carrier includes one or more selected from the group including saline, or buffered saline. See claim 8 limitation for a food composition comprising 8-paradol as an active ingredient. See claim 9 limitation for a feed composition comprising 8-paradol as an active ingredient.
Even though the preamble of claim 1 recites a pharmaceutical composition for preventing, ameliorating, or treating cancer; the preamble does not provide any structural limitation to the composition as recited in claim 1. Thus the preamble, for preventing, ameliorating, or treating cancer, is a statement of purpose or use. Therefore, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II). Therefore, the composition comprising 8-paradol in buffer taught by Lee’665 anticipates a pharmaceutical composition comprising 8-paradol as the active ingredient as recited in claim 1.
Regarding claim 2, limitation for a composition wherein 8-paradol is extracted from ginger, the prior art of Lee’665 teach that the test compounds which includes 8-paradol, was suspended in 2% polysorbate saline via p.o. or i. v. See column 4 line 32. Thus the prior art teach a composition comprising 8-paradol which is identical to the 8-paradol recited in claim 2. Hence, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113 (I). Thus, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01(I).
With regards to claims 3 – 4, which recite a pharmaceutical composition where the cancer is selected; these limitations are not structural limitations. Thus these limitations, for preventing, ameliorating, or treating cancer a selected cancer, is a statement of purpose or use. Therefore, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II). Therefore, the composition comprising 8-paradol in 2% polysorbate saline taught by Lee’665 anticipates a pharmaceutical composition comprising 8-paradol as the active ingredient as recited in claims 3 – 4.
Even though the preambles of claims 8 – 10 recite a food/feed/or cosmetic composition for preventing, ameliorating, or treating cancer; these preambles do not provide any structural limitation to the composition as recited in claims 8 – 10. Thus the preamble, for preventing, ameliorating, or treating cancer, is a statement of purpose or use. Therefore, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02(II). Therefore, the composition comprising 8-paradol in 2% polysorbate saline taught by Lee’665 anticipates a food/feed/or cosmetic composition comprising 8-paradol as the active ingredient as recited in claims 8 – 10. Moreover, given that the compositions of Lee’665 comprising was administered p.o. or orally the teaching of Lee’665 further anticipates claim 8 - 9. Furthermore, given that the compositions of Lee’665 comprises 8-paradol in 2% polysorbate saline none of the components restrict the ability to administer the composition cosmetically.
Conclusion
Claims 1 – 10 are rejected.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
/JULIET C SWITZER/Primary Examiner, Art Unit 1682
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