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 .
Status of the Claims
Acknowledgement is made of the response filed on March 11, 2026. In that response, claims 44, 51, and 53 were amended. Claims 44-53 are treated on the merits in this action. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 44 is objected to because of the following informalities: ”Alpinia extract” and “Piper extract” in line 4 requires a “the” or “said” preceding each phrase. Appropriate correction is required.
Claim 52 is objected to because of the following informalities: terms such as devil’s claw, prickly ash, omega-3 or omega-6, egg shell membrane, and krill oil need not be capitalized. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 44-53 are rejected under 35 U.S.C. 103 as being unpatentable over Weidner (WO 99/53935A1) in view of Bang (Bang, J.S., et al., Anti-inflammatory and antiarthritic effects of piperine in human interleukin 1β-stimulated fibroblast-like synoviocytes and in rat arthritis models, Arthritis Research & Therapy 2009, 11:R49 (doi:10.1186/ar2662); listed on the 04/22/2023 IDS; a full copy is attached) and Rena (CN 103251910A; the attached machine translation is relied on for citations).
Weidner teaches “compositions of matter containing aromatic compounds and terpenoids which are present in and may preferably be derived from the plant Alpinia galanga (Zingiberaceae)”, for treating rheumatoid arthritis and “alleviation of pain” (abstract; see entire document, esp. title; claims 1-6). “The quantitatively dominating compound of [the aromatic compounds in Alpinia galanga] is 1’-acetoxychavicol acetate” (p.2 first full para.) which is recited in instant claim 46. Weidner teaches a composition comprising 2-99.5% (w/w) of 1’-acetoxychavicol acetate or p-hydroxy-trans-cinnamaldehyde (p.5 l.4-p.6 l.28) which are both in claim 46, and other ingredients such as those in claim 52 (p.19 ll.3-13), in forms such as those in claim 53 (see, e.g., p.29 ll.12-15). Weidner teaches distilling Alpinia galanga parts, preferably the rhizome, using “an organic solvent and subsequently, if necessary, removing the extraction agent to obtain an extract suitable for utilization” (p.7 l.28-p.8 l.2; see p.21 lines 13-25) which would enrich the active agents in the extract.
Weidner does not specifically teach combining the Alpinia extract with a Piper extract that is enriched for an alkaloid by two- to about one thousand-fold as recited in claim 44.
Bang studied anti-inflammatory effects of piperine, an “active phenolic component” of black pepper in IL1β-stimulated rheumatoid arthritis fibroblast-like synoviocytes (FLS) derived from patients with rheumatoid arthritis (p.2 left col. second-third paras.; see title; abstract; p.7 right col. second para.-p.8 right col. first para.). Bang states that piperine “effectively improved the symptoms of arthritic diseases with an effect comparable to prednisolone”, including inhibiting the expression of proinflammatory mediators IL6, MMP13, and PGE2 (p.8 left col. third para.; see Figs.1-3 and accompanying text). Bang suggests piperine as a therapeutic drug or dietary supplement for “antirheumatic effects” (p.8 right col.).
Rena teaches a “method for preparing the compound traditional Chinese medicine, comprising the following specific steps: (1) weight proportion of raw material medicine is: rhizoma galangae, Fructus Piperis Longi, black pepper, …; (2) the rhizoma galangae, Fructus Piperis Longi, black pepper, … mixing: adding sample weight 10 times quantity ethanol to soak for 14 hours at room temperature, water bath heating and refluxing for 3 hours, temperature is 70 degrees centigrade, and then filtering by using gauze, then respectively using 10 times and 8 times of 95% (by weight) ethanol repeatedly extracting for one time every; filtering to obtain the filter liquid, (3) the filtrate (2), combining, decompressing and recycling ethanol, concentrating and drying to obtain the compound traditional Chinese medicine preparation.” (claim 1 (emphases added); see title; abstract; paras.0002-08, 0012-27). The skilled person would understand that the extraction process, including “concentrating and drying” would result in increased concentration of the alkaloids such as piperine per mass of the medicinal material prior to extraction by two-fold or more (paras.0003; see para.0005). The compound preparation has anti-inflammatory effects and can be used to treat various conditions including arthritis (paras.0003, 0008).
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Weidner, Bang, and Rena and combine extracts of Alpinia galanga enriched for phenylpropanoids and Piper species such as Piper nigrum extract comprising piperine which are enriched for the active agents recited in the instant claims. The skilled person would have been motivated to do so because all are drawn to extracts of medicinal plants known to have active agents with anti-inflammatory and anti-rheumatic effects, Bang suggests dietary supplement form of piperine present in black pepper, and Rena teaches enriching the concentration of active agents including piperine via repeat ethanol extraction method. “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.” MPEP §2144.06 (I) (citations omitted).
Regarding “wherein the composition has a 1:2 ratio of [said] Alpinia extract to [said] Piper extract” in claim 44, it is noted that the claim does not recite the active agents in each extract. As noted above Weidner, Bang and Rena teach Alpinia and Piper extracts. Each goes further to elucidate the active agents that confer therapeutic effects, i.e., the specific phenylpropanoids such as those in instant claim 46 and piperine. For example Weidner teaches that 1’-actoxychavicol acetate combined with p-hydroxy cinnamaldehyde produces a synergistic inhibitory effect in leukotriene C4 synthetase assay (p.4 second-last para; Example 2). Bang states, “piperine (100 mg/kg) effectively improved the symptoms of arthritic diseases with an effect comparable to prednisolone, although at 20 mg/kg, piperine did not have a significant analgesic effect in the arthritic animal model” (p.8 left col). Therefore the skilled person would understand that efficacy of each extract and their combination depends on what is actually present in the extract. Thus the ratio of “Alpinia extract to Piper extract” generally does not patentably distinguish the subject matter over prior art. Applicant discloses in Example 15 that the “Alpinia:Pepper (AP) composition …in 1:2 ratio by weight… contained about 7% 1’-acetoxychavicol acetate and 20% [p]iperine” (para.0150 (emphasis added), pre-grant publication US 2022/0000964). Notably this disclosure specifies both the weight ratio and the concentration of the active agents in each extract.
Regarding “for cartilage repair and cartilage synthesis” in claim 44, line 1, it is noted that the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. MPEP § 2111.02. Here all of Weidner, Bang, and Rena teach anti-inflammatory effect of its respective active agents with specific reference to arthritis. Therefore the skilled person would understand that the compositions they teach are capable of performing the cartilage repair and synthesis.
Regarding “wherein the composition reduces bone erosion, regulates ….and synthesize cartilage” in claim 44, the following is noted:
Language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation. The following types of claim language may raise a question as to its limiting effect:
(A) statements of intended use or field of use, including statements of purpose or intended use in the preamble,
(B) "adapted to" or "adapted for" clauses,
(C) "wherein" or "whereby" clauses,
(D) contingent limitations,
(E) printed matter, or
(F) terms with associated functional language.
This list of examples is not intended to be exhaustive... For more information about these types of claim language and how to determine whether they have a limiting effect on claim scope, see MPEP §§ 2111.02 through 2111.05.
MPEP §2103(I)(C) (emphases added). Here the phrase regarding the composition’s function does not require the particular structure, e.g., the relative concentration of each of the Alpinia and Piper extracts, the specific active compounds therein and their relative concentrations, and therapeutically effective dosage and route of administration, among others that obtain the function recited in the phrase. Thus the functions do not limit the scope of the claim and are not afforded patentable weight. As noted above Weidner, Bang, and Rena teach extracts of Alpinia and Piper that are known to have active agents with anti-inflammatory and anti-rheumatic effects, and therefore the skilled person would expect beneficial effects for damaged joints and cartilage.
It is further noted that “[s]omething which is old does not become patentable upon the discovery of a new property… [T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer…. Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.” MPEP §2112(I)(citations omitted)(emphasis added). In other words extracts of Alpinia and Piper enriched for active agents are known in prior art and “old”, does not become patentable merely by recitation of the function “wherein the composition reduces bone erosion, regulates ….and synthesize cartilage” as recited in claim 44 without any specifics (e.g., the relative concentration of each of the Alpinia and Piper extracts, the specific active compounds therein and their relative concentrations, and therapeutically effective dosage and route of administration) that the cited art does not teach.
Response to Arguments
Applicant's arguments filed March 11, 2026 have been fully considered but they are not persuasive. Applicant argues ”as shown in the Examples, the synergistic combination of the enriched Alpinia extract and the enriched Piper extract go way beyond just anti-inflammatory and anti-arthritic effects and the claims herein are amended to reflect this synergistic result” (Remarks, 6, 8-9, March 11, 2026.)
In response it is noted that Applicant discloses in Example 15 that the “Alpinia:Pepper (AP) composition …in 1:2 ratio by weight… contained about 7% 1’-acetoxychavicol acetate and 20% [p]iperine” (para.0150 (emphasis added), pre-grant publication US 2022/0000964). However claim 44 recites “a 1:2 ratio of Alpinia extract to Piper extract” without any recitation of the active compounds and their concentrations. Therefore any disclosure relating to the composition of Example 15 does not relate to “ 1:2 ratio of any Alpinia extract to any Piper extract other than those used in Example 15.
Regarding Examples 37-39 it is unclear whether used the same combination of Example 15. At any rate the “evidence of non-obviousness must be reasonably commensurate in scope with the claimed invention”. MPEP § 2145 (citations omitted).
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614
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