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 .
Claims 1-2 are being examined on the merits.
Priority
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, filed on February 2, 2024. The priority date is December 21, 2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on December 19, 2023 is being considered by the examiner. The signed IDS forms are attached with the instant office action.
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 1 and 2 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.
It is unclear how a liquid is produced from the dried powder disclosed prior. There is not a step of adding a liquid to the powder to then extract a liquid in claim 1. Claim 2 is not rejected because it appears that supercritical fluid CO2 is used as a step.
It is unclear how the end step of claim 1 results in a bone growth promoting composition as currently claimed. Clarification is requested as to the end product produced in claim 1. Claim 2 is rejected for failing to cure the indefiniteness of claim 1.
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.
Claim(s) 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Kim Ji Young et. al. (KR20160001392A; December 19, 2023 IDS, foreign patent document #1, examiner providing machine translation document used for citations) in view of Gao, Shu-hua (CN 101011565A), and Leone-Bat et.al. (WO-2017185038A1).
The instant claims are drawn to a method for manufacturing bone growth promoting composition, comprising: 25 parts by weight of Astragalus membranceus, 15 parts by weight of manyprickle Acanthopanax, 5 parts by weight of Phlomis umbrosa, 5 parts by weight of bilberry, 5 parts by weight of kelp vinegar, and 5 parts by weight of turmeric vinegar.
Young et.al. ‘392 teaches, “complex extract the active ingredient-containing bone length growth-promoting composition Composition comprising the combined extracts of Phlomis umbrosa, Astragalus membranceus, Discorea japonica, Acanthpanax senticosus and Angelica gigas for stimulating bone growth. (Description [para. 001])”. Young et al. do the combined extracts of Phlomis umbroso, Astragalus membranceus, and Acanthopanax senticosus along with other extracts as active ingredients in bone length growth promotion.
Young et al. also teaches the weight ratio of Hwang, sanyak, gasiohgapi and a pharmaceutical composition for promoting bone growth in length as an active ingredient a compound, including Angelica extract. Young et.al. ‘392 also teaches, the parts by weight of the composition as in claim 1, “In the present invention, one-speed stage, Astragalus, medicinal herb, thorny goose and Angelica may be mixed in a weight ratio of 1-5: 5-15: 10-100: 5-15: 10-50, preferably 2-4: 8-8. It may be mixed in a weight ratio of 12: 40 ~ 60: 8 ~ 12: 20 ~ 30, showing the best bone length growth effect (Embodiment of Invention [Pharmaceutical composition; page 4; para 010]).”
Young et.al does not teach the bilberry, turmeric vinegar and kelp vinegar in a bone growth composition, however, Gao ‘565, teaches the use of turmeric and kelp along with other components for increasing bone density, (Abstract [line 003-005]).
Leone-Bay et.al., teaches the plant-based composition which includes “…Vaccinium myrtillus (bilberry as in claim 1) …, Curcuma longa (turmeric as in claim 1) … or an extract thereof” (Description [para 0135, no. 3]), and “A plant-based composition of embodiment 33 wherein the therapeutically effective amount treats a symptom of acquired …bone loss (Description [Exemplary Embodiments; 34]).
Young et.al. ‘392 teaches, “, the complex extract may be extracted from water, alcohol or a mixed solvent thereof. It is preferable to use C1-C4 lower alcohol (Embodiment of Invention [Pharmaceutical composition; papa 009]).” As in instant claim 2, extracting of the liquid from the powder comprising adding carbon dioxide, which is aqueous. Young et. al. ‘392 includes extraction with the use of aqueous solvent.
Young et. al., Gao, and Leone-Bay et.al. are relied upon for the reasons discussed above of treatment of bone growth. Although the parts by weight of the composition differs in that of instant claim1, one of ordinary skilled in the art could optimize the components to prepare a bone growth promoting composition based upon the overall beneficial teaching provided by the references with respect to Astragalus membranceus, manyprickle Acanthopanax, Phlomis umbrosa, bilberry, kelp vinegar, and turmeric vinegar for bone growth composition.
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); >see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.");< ** In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997).
It would have been obvious to a person of ordinary skill in the art prior to the effective filling date of the instant application to combine the teaching of Young et. al., Gao, and Leone-Bay et. al. to arrive at the claimed invention. The components of all three references were known, and the positive teachings of Young et. al. regarding Astragalus membranceus, manyprickle Acanthopanax, Phlomis umbrosa; and bilberry and turmeric as taught by Leone-Bay et. al.; and kelp and turmeric taught by Gao, would motivate an artisan to provide a composition for bone growth. A skilled artisan could therefore combine the components of the cited references to arrive at the claimed bone growth composition with a reasonable expectation of success.
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 was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the evidence of contrary.
Conclusion
Currently no claims are allowed.
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/ALPA NILESH AMIN/ Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655