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 .
Status of Application
The Amendments and Remarks filed on 01/08/26 are acknowledged.
Claim 3 was cancelled.
Claims 1 and 4 amended.
Claims 4-9 were previously withdrawn from consideration.
Claims 1-2 and 4-9 are pending.
Claims 1-2 are included in the prosecution.
References provided by Applicant
Applicant provided seven references along with the Remarks on 01/08/26. it is recommended that Applicant file an information disclosure statement (IDS) listing these references. MPEP 609.04(a)(I) states: “A separate list is required so that it is easy to confirm that applicant intends to submit an information disclosure statement and because it provides a readily available checklist for the examiner to indicate which identified documents have been considered. A separate list will also provide a simple means of communication to applicant to indicate the listed documents that have been considered and those listed documents that have not been considered. Use of form PTO/SB/08, Information Disclosure Statement, to list the documents is encouraged.”
Notice for all US Patent Applications filed on or after March 16, 2013
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.
Maintained & Updated Rejections
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 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.
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.
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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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.
Claim 1 is again rejected under 35 U.S.C. 103 as being unpatentable over Ko et al. (JP 2013-023498 A – English Google Patents Translation – “Ko”) in view of Li (CN 101199763 A – English Translation from Espacenet) and Jung et al. (WO 02/065978 A2 – “Jung”).
The claimed invention is an anti-cancer composition, comprising an ethanol extract of green propolis, an ethanol extract of wheatgrass, and an ethanol extract of mulberry leaves, wherein a weight ratio of the ethanol extract of green propolis, the ethanol extract of wheatgrass, and the ethanol extract of mulberry leaves is 1:0.5:0.5.
Ko teaches a medicament for retarding progress of cancer and treating cancer, wherein the medicament includes an extract of Taiwanese green propolis (Abstract, claim 1). The “Taiwan green propolis extract” means a product extracted from Taiwan green propolis using a solvent, and the solvent includes ethanol (Page 4/15).
Ko does not expressly teach an ethanol extract of wheatgrass or an ethanol extract of mulberry leaves, or the weight ratio of the ethanol extract of green propolis, the ethanol extract of wheatgrass, and the ethanol extract of mulberry leaves is 1:0.5:0.5.
Li teaches a capsule composition for treating cancers including an extract of wheat grass (Abstract, [0007], [0009], [0012], [0015], [0020], [0022], [0025], [0028], [0032], [0034], [0037], [0040], claims 1, 3, and 5).
Jung teaches a functional agent including extracts of mulberry leaves, wherein the functional agent reduces the generation rate of lung cancer (Abstract, Page 10, lines 5-11 and 16-22, Page 13, lines 13-22, Example 1, Example 12, Fig. 23, TABLE 3, claim 1). The effects of the functional agent treatment on lung tumorigenesis as chemopreventive agent are shown in TABLE 3.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition for retarding progress of cancer and treating cancer, wherein the medicament includes an extract of Taiwanese green propolis, and the extract is prepared by using the solvent ethanol, as taught by Ko, in view of the use of an extract of wheat grass for treating cancers, as taught by Li, the use of an extract of mulberry leaves for reducing the generation of lung cancer, as taught by Jung, include the extracts in different ratios in order to effectively treat cancer, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because all the references are drawn to compositions for the treatment of cancer and it is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). Moreover, MPEP 2144.06 states: "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." Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine said extracts with a reasonable expectation of success because each extract is taught to be useful for the same purpose (treating cancer) and it is prima facie obvious to combine said actives to form a third composition to be used for the very same purpose.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Regarding instant claim 1, the limitation of an anti-cancer composition comprising an ethanol extract of green propolis would have been obvious over the medicament for retarding progress of cancer and treating cancer which includes an extract of Taiwanese green propolis (Abstract, claim 1), wherein the “Taiwan green propolis extract” means a product extracted from Taiwan green propolis using a solvent, and the solvent includes ethanol (Page 4/15), as taught by Ko.
Regarding instant claim 1, the limitation of an ethanol extract of wheatgrass would have been obvious over the composition for treating cancers including an extract of wheat grass (Abstract, [0007], [0009], [0012], [0015], [0020], [0022], [0025], [0028], [0032], [0034], [0037], [0040], claims 1, 3, and 5), as taught by Li. One of ordinary skill in the art would have found it obvious to use various solvents for preparing the extract of wheatgrass taught by Li, including the ethanol taught by Ko (Page 4/15).
Regarding instant claim 1, the limitation of an ethanol extract of mulberry leaves would have been obvious over the functional agent including extracts of mulberry leaves, wherein the functional agent reduces the generation rate of lung cancer (Abstract, Page 10, lines 5-11 and 16-22, Page 13, lines 13-22, Example 1, Example 12, Fig. 23, TABLE 3, claim 1), as taught by Jung. One of ordinary skill in the art would have found it obvious to use various solvents for preparing the extract of mulberry leaves taught by Jung, including the ethanol taught by Ko (Page 4/15).
Regarding instant claim 1, the limitation of the weight ratio of 1:0.5:0.5 would have been obvious over the inclusion of Taiwanese green propolis (Abstract, claim 1, Page 4/15), as taught by Ko, the composition including an extract of wheat grass (Abstract, [0007], [0009], [0012], [0015], [0020], [0022], [0025], [0028], [0032], [0034], [0037], [0040], claims 1, 3, and 5), as taught by Li, and the functional agent including extracts of mulberry leaves (Abstract, Page 10, lines 5-11 and 16-22, Page 13, lines 13-22, Example 1, Example 12, Fig. 23, TABLE 3, claim 1), as taught by Jung. One of ordinary skill in the art would have found it obvious to include the extracts in different amounts in order to effectively treat cancer in a particular patient population, thereby rendering obvious the weight ratio of 1:0.5:0.5, unless there is evidence of criticality or unexpected results.
Response to Arguments
Applicant’s arguments (Pages 4-12, filed 01/08/26) with respect to the rejection of claims 1 and 3 under 35 U.S.C. 103 as being unpatentable over Ko in view of Li and Jung have been fully considered but are not persuasive.
Applicant argues (Pages 4-7, filed 01/08/26) that the combination of Ko, Li, and Jung does not arrive at the claimed composition of claim 1 because at least Agropyron cristatum (crested wheatgrass) disclosed in Li, which is translated as "wheatgrass," is a different plant from wheatgrass recited in claim 1. Applicant argues that “Li [is] cited as teaching wheatgrass discloses Agropyron cristatum (crested wheatgrass). Although crested wheatgrass of Li is translated as "wheatgrass," it is a different plant from the claimed wheatgrass.” Applicant points to References 1-5 and argues that based on these references this clearly confirms that the “wheatgrass” of Li and the wheatgrass of claim 1 are plants of different species and genera, and are not interchangeable materials.
The references provided by Applicant have been considered. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the particular wheatgrass genus and species) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Instant claims only recite an ethanol extract of wheatgrass and do not recite any particular genus or species of wheatgrass. Given the broadest reasonable interpretation, one of ordinary skill in the art would have found that the extract of wheat grass (Abstract, [0007], [0009], [0012], [0015], [0020], [0022], [0025], [0028], [0032], [0034], [0037], [0040], claims 1, 3, and 5), as taught by Li, obviates the claimed extract of wheatgrass.
Applicant argues (Page 7, filed 01/08/26) that the beneficial anti-cancer effects of the claimed combination would not have been expected from the cited references. Applicant argues that Li fails to attribute the anticancer activity to the wheatgrass component, much less that the Agropyron “wheatgrass” extract would act synergistically with propolis or mulberry leaf extracts.
This is not persuasive because instant claims under examination are not drawn to a method of treating cancer. Instant claims also do not recite any synergism between the three extracts. Instant claim 1 recites an anti-cancer composition and one of ordinary skill in the art would have found it obvious to include the components used in the anti-cancer composition taught by Ko, Li, and Jung. It is obvious to combine prior art elements according to known methods to yield predictable results. Please see MPEP 2141(III)(A). Moreover, MPEP 2144.06 states: "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." Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine said extracts with a reasonable expectation of success because each extract is taught to be useful for the same purpose (treating cancer) and it is prima facie obvious to combine said actives to form a third composition to be used for the very same purpose.
Applicant argues (Page 8, filed 01/08/26) that the effects of the combination of plant extracts are unpredictable and points to References 6 and 7. Applicant argues (Page 9, filed 01/08/26) that the interaction between natural extracts and biological systems is highly complex; the combined effect of multiple extracts cannot be reliably inferred from the known effects of individual components; and careful experimental evaluation of the actual formulation (the final composite product) is essential. Applicant argues that polysaccharides are known to have synergistic effects in chemotherapy, and such synergistic effects, particularly effects that are obtained by a specific mixing ratio, are unpredictable.
This is not persuasive because firstly, instant claim 1 does not recite any limitation regarding synergy.
Secondly, the synergism disclosed in the instant specification is regarding the GP-WM extract in combination with PDT (photodynamic therapy). Instant claim 1 does not recite the combination of the extracts with PDT.
Thirdly, instant claim 1 is silent with respect any therapeutically effective dose or dose range, dosage form or mode of administration (oral, tablet, injection, solution, etc.), or dosage regimen that provides synergism. As discussed above, instant claim 1 is drawn to a composition and not to a method of treating cancer or a method of providing a synergistic combination.
Fourthly, MPEP 716.02(a)(I) states: “Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).” In the present case, Applicant has not provided evidence demonstrating synergism with the claimed combination of extracts alone, i.e., without PDT. One of ordinary skill in the art would have found it obvious to include the extracts disclosed in the prior art in different amounts in order to effectively treat cancer in a particular patient population, thereby rendering obvious the weight ratio of 1:0.5:0.5, unless there is evidence of criticality or unexpected results.
Lastly, the instant specification discloses that the three extracts when used in combination with PDT can synergistically exhibit an improved efficacy (emphasis added) ([0072]). There is no evidence demonstrating synergism with just the claimed extracts. The disclosure is that there can be synergism with the extracts and PDT, the latter is not recited in the composition claims. Furthermore, MPEP 716.02(d) states: “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.””
Applicant argues (Page 10, filed 01/08/26) that there is no reason to expect that the claimed weight ratio of the ethanol extract of green propolis, the ethanol extract of wheatgrass, and the ethanol extract of mulberry leaves (1:0.5:0.5) would have been obtained by routine optimization. Applicant argues that the results of Example 3 demonstrate a functional relationship between:
1. The selection of specific plant species and ethanol extracts thereof; and
2. The ratio of 1:0.5:0.5.
This is not persuasive because just as the instant specification discloses that the extract mixture, i.e., the GP-WM extract, is effective in inhibiting the growth of U87 (human glioblastoma cell line) in Example 3, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to combine the claimed extracts based on the teachings of the prior art with a reasonable expectation of success because each extract is taught to be useful for the same purpose (treating cancer). Regarding the claimed ratio of 1:0.5:0.5, one of ordinary skill in the art would have found it obvious to start with a 1:1 weight ratio of the green propolis extract to the extracts of wheatgrass and mulberry leaf. This 1:1 weight ratio means there is 1 part by weight (pbw) of green propolis extract to one pbw of the combination of wheatgrass and mulberry leaf extracts. One of ordinary skill in the art would have found it obvious to include the wheatgrass and mulberry leaf extracts in a 1:1 ratio. Based on this the 1:1 ratio of the green propolis extract to the extracts of wheatgrass and mulberry leaf, is calculated to be 1 pbw green propolis extract : 0.5 pbw wheatgrass extract : 0.5 pbw mulberry leaf extract.
Therefore, the rejection of 09/08/25 is maintained and applied to amended claim 1.
Claim Rejections - 35 USC § 103
Claim 2 is again rejected under 35 U.S.C. 103 as being unpatentable over Ko et al. (JP 2013-023498 A – English Google Patents Translation – “Ko”) in view of Li (CN 101199763 A – English Translation from Espacenet) and Jung et al. (WO 02/065978 A2 – “Jung”), as applied to claims 1 and 3 above, in view of Nishibe et al. (JP 2003081868 A – English Google Patents Translation – “Nishibe”).
Instant claim 2 is drawn to the anti-cancer composition as claimed in Claim 1, wherein each of the ethanol extract of green propolis, the ethanol extract of wheatgrass, and the ethanol extract of mulberry leaves is dissolved in propylene glycol.
The teachings of Ko, Li, and Jung are discussed above.
Ko, Li, and Jung do not expressly teach that the extracts are dissolved in propylene glycol.
Nishibe teaches a composition comprising various plant extracts (Abstract) including propolis ((25)-Page 8/17, (27) and (28)-Page 9/17), Triticum (wheatgrass) ([0145] - Page 14/17), and mulberry ((20)-Page 8/17). Propylene glycol is added to a mixture of the extracts after extraction (lines 9-10 - Page 3/17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition for retarding progress of cancer and treating cancer, wherein the medicament includes an extract of Taiwanese green propolis, and the extract is prepared by using the solvent ethanol, as taught by Ko, in view of the use of an extract of wheat grass for treating cancers, as taught by Li, the use of an extract of mulberry leaves for reducing the generation of lung cancer, as taught by Jung, and the use of propylene glycol to dissolve the extracts, as taught by Nishibe, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because Nishibe teaches the use of propylene glycol with the same extracts, i.e., propolis, wheatgrass, and mulberry. Furthermore, Nishibe teaches the use of propylene glycol as a polyhydric alcohol component of the composition as well ((6)-Page 3/17). One of ordinary skill in the art would have found it obvious to combine the propylene glycol of Nishibe with the extracts taught by Ko, Li, and Jung and have a reasonable expectation of success in producing a functional composition.
Regarding instant claim 2, the limitation of propylene glycol would have been obvious over the propylene glycol added to a mixture of the plant extracts after extraction (lines 9-10 - Page 3/17) and as a polyhydric alcohol component of the composition ((6)-Page 3/17), as taught by Nishibe.
Response to Arguments
Applicant’s arguments (Page 12, filed 01/08/26) with respect to the rejection of claim 2 under 35 U.S.C. 103 as being unpatentable over Ko in view of Li, Jung, and Nishibe have been fully considered but are not persuasive.
Applicant argues that Nishibe merely lists numerous plant species that could be used for stress control, but does not teach or suggest the combination of an ethanol extract of green propolis, an ethanol extract of wheatgrass, and an ethanol extract of mulberry leaves, much less the weight ratio thereof.
This is not persuasive because the limitations regarding the combination of an ethanol extract of green propolis, an ethanol extract of wheatgrass, and an ethanol extract of mulberry leaves, and the weight ratio thereof are rendered obvious by the combination of Ko, Li, and Jung, as discussed in detail above. The deficiency in these references regarding the dissolution of the extracts in propylene glycol is cured by Nishibe. The references are properly combined because Nishibe teaches the use of propylene glycol with the same extracts, i.e., propolis, wheatgrass, and mulberry. Furthermore, Nishibe teaches the use of propylene glycol as a polyhydric alcohol component of the composition as well ((6)-Page 3/17). One of ordinary skill in the art would have found it obvious to combine the propylene glycol of Nishibe with the extracts taught by Ko, Li, and Jung and have a reasonable expectation of success in producing a functional composition.
Therefore, the rejection of 09/08/25 is maintained.
Conclusion
No claims are allowed.
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 extension fee 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.
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/ARADHANA SASAN/Primary Examiner, Art Unit 1615