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 .
Applicant’s amendment and response filed on March 19, 2026 has been received and entered.
Claim(s) 3-4 and 8-9 are currently pending.
Withdrawn Rejections
Applicant’s arguments filed on March 19, 2026 have been fully considered.
In regards to the rejection under 35 U.S.C. 112(b) for indefiniteness, Applicant has elected to cancel claim(s) 1-2, 5-7 and 10 and applicant has elected to amend claim(s) 3-4 and 8-9 and therefore, the rejection of claim(s) 3-4 and 8-9 has been withdrawn.
In regards to the rejection under 35 U.S.C. 101 for the invention being directed to natural products without significantly more, Applicant has elected to cancel claim(s) 1-2, 5-7 and 10.
In regards to the rejection under 35 U.S.C. 103 for obviousness, Applicant has elected to cancel claim(s) 1-2, 5-7 and 10.
Withdrawn Objections
Applicant’s arguments filed on March 19, 2026 have been fully considered.
In regards to the objection of the specification for the following terms listed in the Non-Final Rejection sent on January 07, 2026, the applicant has elected to amend the specification to make the necessary corrections and therefore, the objection of the specification has been withdrawn.
In regards to the claim objection for claim(s) 1-2, 4, 7 and 9, applicant has elected to cancel claim(s) 1-2 and 7 and applicant has elected to amend claim(s) 4 and 9 to remove the informalities and therefore, the objection of claim(s) 4 and 9 have been withdrawn.
Claim Objections
Claim 3 is objected to because of the following informalities:
In claim 3, line 4, “preparinga” should read “preparing a”
Appropriate correction is required.
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, 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.
Claim(s) 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Youn (KR 20120018556 A – English translation provided) in view of Hamada (U.S. Pub. No. US 5529779 A) and Kim Eui (KR 100412785 B1 – English translation provided).
Regarding claim(s) 3 and 8, the Youn reference teaches a pharmaceutical composition for the inhibition of inflammation that contains the extract of Sorbus commixta (abstract). The reference teaches [a method of] that extract[ion] [in which, the S. commixta] is isolated using anhydrous or hydrous low alcohol of 1-4 carbon atoms ([ethanol]) (abstract). Youn also teaches that the rowan extract is filtered and lyophilized ([which produces a dry powdered form of rowan/S. commixta]) (page 4). In addition, the reference teaches that the extract is a health function food (claims).
The Youn reference does not teach the inclusion of propolis within the composition.
Hamada teaches a crude-propolis-extract prepared by extracting a crude propolis specimen with a readily water-soluble organic solvent (col. 3, lines 60-63). Hamada teaches an appropriate solvent is ethanol (col. 4, lines 5-7). Hamada teaches that propolis ethanolic extract that has anti-inflammatory and immunoregulatory activity (col. 1, lines 22 and 24). Hamada teaches a propolis specimen was roughly grinded ([contributing to the powder form of propolis]) and added within ethanol to conduct the extraction, followed by filtration (col. 12, lines 32-36). The Hamada reference teaches that the composition can be added to food products (col. 3, line 24). In addition, the Hamada reference teaches [that] the aqueous high-concentration solutions of a readily water-soluble organic solvent containing a crude propolis-extract are usually those which contain a 70 v/v % or higher, preferably, 80 v/v % or higher of a readily water-soluble organic solvent such as ethanol (paragraph 0007).
Kim Eui teaches a process of preparing a tea composition containing an extract of Sorbus commixta Hedl ([that is in the form of a powder]) (abstract and page 5). Kim Eui teaches a method of manufacturing a powder (page 5). Kim Eui teaches that the Sorbus commixta Hedl [is] extracted in 20 to 70% ethanol or pure water (abstract).
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that alleviates and treats inflammatory diseases. 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 there having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to alleviate and treat inflammatory diseases, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to alleviate and treat inflammatory diseases. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. 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 MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
It would have been obvious to one of ordinary skill in the art to modify Youn’s method of obtaining the S. commixta composition to include additional information that the S. commixta extract can be prepared in 20 to 70% ethanol as taught by Kim Eui and that part of Kim Eui’s manufacturing method discusses the production of the S. commixta powder which is what can be used in order to accommodate for deficiencies in Youn. In addition, Youn’s method can also include Hamada’s method of obtaining a crude propolis extract by using an ethanol concentration of 80 v/v% or higher. Given that the claims of the present invention use the term “comprising” that means that the method of obtaining the extracts (in this case, S. commixta and propolis) can include a variety of methods in order to achieve the present claims invention. Thus, one of ordinary skill in the art would reasonably expect to optimize the ethanol concentrations needed in order to produce the desired extracts, thus, the combination of the aforementioned references would produce a composition (whether a pharmaceutical or a food composition – which can both be ingested by the subject) that would be targeted towards alleviating and treating inflammatory diseases.
The combination of the aforementioned references does not teach a weight ratio of the propolis ethanolic extract to the Sorbus commixta ethanolic extract of 1:25 to 5:25 (as stated within claims 3 and 8 of the present invention). However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Claim(s) 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Youn (KR 20120018556 A – English translation provided) in view of Hamada (U.S. Pub. No. US 5529779 A) and Kim Eui (KR 100412785 B1 – English translation provided) as applied to claim(s) 3 and 8 above, and further in view of Ristiviojevic et al (Natural Product Communications (Year: 2015), vol. 10, issue. 11, pp 1869-1876).
Regarding claim(s) 4 and 9, the teachings of Youn, Hamada and Kim Eui are discussed above; however, the Hamada reference does not teach the three components in propolis: quercetin, kaempferol, and chrysin within the propolis ethanolic extract at specified amounts.
Ristivojevic et al teaches a list of flavonoid components that are commonly present in propolis such as quercetin, kaempferol, and chrysin (pp 1870, table 1).
It would have been obvious to one of ordinary skill in the art to modify Youn's pharmaceutical composition that contains an S. commixta ethanolic extract and propolis ethanolic extract with the knowledge that the propolis extract contains such flavonoids as taught by Ristivojevic et al. One would have reasonably expected that of the flavonoids present within the propolis ethanolic extract, there will be quercetin, kaempferol, and chrysin present because these are known to be active compounds, as taught by Ristivojevic et al and in figure 3 within the specification of the present invention.
However, as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Therefore, an artisan of ordinary skill would have been motivated to optimize amounts within the flavonoids from an ethanol-based extraction of propolis that would be necessary to achieve the alleviation and treatment of inflammatory diseases.
Response to Arguments
Applicant’s arguments filed March 19, 2026 have been fully considered, and the arguments regarding the rejection under 35 U.S.C. 103 are found to be non-persuasive.
Regarding applicant’s remarks for the 35 U.S.C. 103 rejection wherein obviousness by Youn, Hamada and Ristiviojevic et al references for claim(s) 3-4 and 8-9 fails to teach or suggest the amended specific process parameters within the claims. Beginning with page 7 of applicant’s arguments, applicant states that Youn “does not teach the use of propolis in the composition, nor does Youn teach or suggest the specific ethanol concentrations or weight ratios recited in amended claim(s) 3 and 8”. The applicant goes on to further to say “Hamada does not teach or suggest the combination of a propolis ethanolic extract with a Sorbus commixta ethanolic extract, nor the specific extraction solvent concentrations or the weight ratio of the two extracts as now claimed”. In addition, applicant’s specification illustrates the significance of the ethanolic concentrations for both propolis and S. commixta in terms of ensuring that the flavonoid components and active components are extracted properly with no risk of decomposition. Moreover, applicant illustrates within the specification that “the weight ratio of the propolis extract to the Sorbus commixta ethanol extract of 1:25 to 5:25 provides the most suitable alleviating and therapeutic effects on inflammatory diseases due to synergistic effects…. When the ratio falls outside this range, the synergistic effects are reduced”. Based on the ratio given by the applicant, applicant also insinuates that “these specific process parameters are not taught or suggested by either Youn or Hamada, individually or in combination. A person of ordinary skill in the art would not have been motivated to select the specific ethanol concentrations and the specific weight ratio recited in the amended claims absent the teachings of the present application”. Moving on to pages 8 and 9 of applicant’s arguments, focusing on claim(s) 8-9, applicant states that the Ristiviojevic et al reference “merely identifies flavonoid components generally found in propolis, and does not teach or suggest the specific concentration ranges of 0.5 to 2.5 µg/mL or Quercetin, 1 to 5 µg/mL of Kaempferol and 1 to 2.5 µg/mL of Chrysin”. Applicant goes on further to claim in page 9 of applicant arguments that “as disclosed in the specification, the specific concentrations of Quercetin, Kaempferol, and Chrysin in the propolis ethanolic extract, when combined with the Sorbus commixta ethanolic extract at the claimed weight ratio, produce synergistic anti-inflammatory effects that are critical to the invention. These specific concentrations are achieved through the specific extraction conditions now recited in independent claim(s) 3 and 8 (i.e. using 90% to 95% (v/v) ethanol), and are not the result of mere routine optimization”.
Regarding claim(s) 3 and 8, the combination of the three references: Youn, Hamada and Kim Eui are sufficient to incorporate the suggested specific ethanol concentration as amended in claim(s) 3 and 8. Due to the amended claim(s) 3 and 8 of the present invention being open-ended (e.g. using the term “comprising”), one of ordinary skill in the art would reasonably expect to make the combination of the three references in order to create a method similar or exactly the same to the claims of the present invention when creating the pharmaceutical composition for a subject in need.
Regarding claim(s) 4 and 9, the combination of the four references (Youn, Hamada, Kim Eui and Ristivojevic et al) are sufficient to conclude that naturally, prior to extraction, propolis would contain such components (e.g. Quercetin, Kaempferol and Chrysin), thus, one of ordinary skill within the field of analytical chemistry would understand that extraction sets to concentrate on particular components in order for one to obtain the desired set of compounds. In addition, given that the specification of the present invention describes on pages 11-15 the importance of ethanol concentrations to be used in order to obtain specific compounds that are devoid of decomposition, the combination of references within this final rejection are sufficient to overcome the amended claims of the present invention just focusing on ethanolic concentrations required for both the propolis extract and the S. commixta extract.
Furthermore, regarding claim(s) 3-4 and 8-9, the weight ratio of the propolis ethanolic extract to the Sorbus commixta ethanolic extract of 1:25 to 5:25 (as stated within amended claim(s) 3 and 8 of the present invention) and wherein the propolis ethanolic extract comprises 0.5 to 2.5 µg/mL or Quercetin, 1 to 5 µg/mL of Kaempferol and 1 to 2.5 µg/mL of Chrysin (as stated within amended claim(s) 4 and 9 of the present invention); as discussed in MPEP section 2144.05(II)(A), “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.’ In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Therefore, an artisan of ordinary skill would have been motivated to optimize the amounts of the flavonoids from an ethanol-based extraction of propolis that would allow one of ordinary skill in the art to produce the optimal food or pharmaceutical composition for a subject in need of alleviating and treating inflammatory diseases. A person of ordinary skill in the art would optimize the flavonoid components found within an ethanolic extraction of propolis given that the propolis was extracted within the concentration ranges of the claims of the present invention, thus, one would reasonably expect for each of the flavonoids stated (e.g. Quercetin, Kaempferol and Chrysin) and for the weight ratio of propolis ethanolic extract and S. commixta ethanolic extract to intrinsically be within the stated ranges, especially with multiple rounds of experimentation by one skilled in the art.
Lastly, the applicant states within the middle of page 9 of applicant arguments, a “synergistic anti-inflammatory effect that are critical to the invention”. Applicant’s specification does not necessarily prove synergism but more so provides examples of the favorable effects of the combination of the S. commixta ethanolic extract and some of the flavonoid components from the propolis ethanolic extract. All of the data provided within the drawings combined with what was discussed within the specification of the present invention are merely not enough to prove synergism as a result of the information presented beginning on page 11 of the specification until page 33. Within the stated pages of the specification, the applicant clearly discusses the effects of some of the flavonoid components from the propolis extract that may or may not have been combined with the S. commixta extract on: cell viability (RAW 264.7) (fig. 4 within the specification of the present invention), fold change (e.g. NO production suppression rate) (fig. 5-6 within the specification of the present invention), and cell viability and degranulation activity (RBL-2H3) (figs. 7-9 within the specification of the present invention). Based on the information provided by the applicant, it appears as though the S. commixta extract is tested but not the propolis extract; it is crucially as important for the applicant to include results using the actual propolis extract in its entirety rather than selected components (e.g. kaempferol, chrysin, quercetin) from the propolis extract; using the entire propolis extract and then combining that with the S. commixta extract is important in order to observe how the two extracts functions together when observing cell viability on two cell types (RAW 264.7 cell lines and RBL-2H3 basophilic cell lines) and NO production. Plus, the applicant has failed to display data inside and outside of the claimed concentration ranges stated (e.g. the concentration ranges used for the flavonoid components from the propolis extract and the S. commixta extract) as well as compare both inside and outside results to show that the ranges are indeed critical; If the results for the combination are greater than expected, i.e. not an expected additive effect, then they have established synergism (MPEP 716.02(a)). Thus, within the present invention, the applicant does not have any convincing data to support their assertion that the combination of both the S. commixta ethanolic extract with the propolis ethanolic extract is synergistic. In order for applicant to demonstrate the combination of two ingredients produces an unexpected result due to the ratios and solvents used within the experiment, applicant should consult MPEP section 716.02(d)(II); MPEP 716.02(d)(II) states “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range.”. Applicant should be prepared to demonstrate the results for each of the individual ingredients (e.g. the propolis ethanolic extract and the S. commixta ethanolic extract) in order to show that the combination of ingredients is indeed synergistic. Thus, applicant’s arguments for patentability based on unexpected results are not persuasive.
One skilled within the field of molecular biology and analytical chemistry would find that the combination of all of the aforementioned references overcomes the present inventions amendments and thus, the rejection under 35 U.S.C. 103 is maintained.
No claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
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