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
Claims 1-6 were originally filed August 21, 2023.
The amendment filed July 29, 2026 amended claims 1 and 3 and canceled claims 2 and 4-6.
Claims 1 and 3 are currently pending.
Claims 1 and 3 are currently under consideration.
Election/Restrictions
Applicant’s election without traverse of human, treating ALS, a plant extract obtained from Lycium barbarum using a “specific method” which is a mixture and inseparable, a dosage of 20 mg/kg, deionized water, and extracting to obtain Lycium barbarum glycopeptide comprising soaking the fruits of wolfberry in deionized water as the species in the reply filed on March 28, 2026 is acknowledged.
Please note: human, a plant extract obtained from Lycium barbarum using a “specific method” which is a mixture and inseparable, deionized water, and extracting to obtain Lycium barbarum glycopeptide comprising soaking the fruits of wolfberry in deionized water are not part of the present claims and, therefore, are not required for any rejection of record.
Claims 4-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 28, 2026.
Priority
The present application claims status as a CIP of PCT/CN2022/112447 filed August 15, 2022 which claims foreign priority to China 202111047838.02 filed September 8, 2021.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. PCT/CN2022/112447 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The new limitation in independent claim 1 of “produced from Lycium barbarum as a sole raw material” was not found in Application No. PCT/CN2022/112447. Therefore, the priority date is the present filing date of August 21, 2023.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in China on September 8, 2021. It is noted, however, that applicant has not filed a certified copy of the China 202111047838.2 application as required by 37 CFR 1.55.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome any rejection of record because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Withdrawn Objections
The objection to claim 2 regarding an active, positive method step should be utilized (i.e. wherein administering the Lycium barbarum glycopeptide is at a dosage) is withdrawn in view of the cancellation of the claim in the amendment received July 29, 2026.
The objection to claim 3 regarding an active, positive method step should be utilized (i.e. wherein administering the Lycium barbarum glycopeptide is at a dosage) is withdrawn in view of the amendment received July 29, 2026.
New Objections
Claim Objections
Claim 1 is objected to because of the following informalities: “thereof Lycium barbarum” should read “thereof a Lycium barbarum” (see line 2). Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “Lycium barbarum” should read “Lycium barbarum” (see line 3). Appropriate correction is required.
Withdrawn Rejections
The rejection of claims 1-3 under 35 U.S.C. 102(a)(1) as being anticipated by Baek et al. KR 10-2019-0083962 published July 15, 2019 is withdrawn in view of the amendment received July 29, 2026.
The rejection of claims 1-3 under 35 U.S.C. 102(a)(1) as being anticipated by Baek et al. U.S. Patent Application Publication 2020/0384057 published December 10, 2020 (see also PCT/KR2018/004917 filed April 27, 2018 and published as WO 2019/135450 on July 11, 2019 and KR 10-2018-0001904 published January 5, 2018) is withdrawn in view of the amendment received July 29, 2026.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection. Support in the originally filed specification was not found for “produced from Lycium barbarum as a sole raw material”. Applicants point to paragraph 33 of the originally filed specification for support, however, LBP is a glycopeptide composition extracted from the fruits of Lycium barbarum does provide support for a sole raw material (e.g. purification, etc. is not disclosed). In addition, paragraph 33 reads that LBP is a glycopeptide composition extracted from the fruits of Lycium barbarum comprising primarily glucose, arabinose, galactose, rhamnose, mannose, and xylose. It is reported that there are at least five glycopeptides. Therefore, it appears that the glycopeptide is not the sole raw material. In addition, paragraph 46 states that the “portion with a molecular weight of 1000-10000 Da accounts for 80% in the product, the protein content is at 35% weight percentage”. Therefore, the glycopeptide is not the sole raw material. In addition, “raw material” suggests a starting material and not a purified material.
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 3 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. One of skill in the art would not be able to determine the scope of the presently claimed method. For example, there is not a nexus between the preamble and the subject. In addition, there is not a nexus between the preamble and the body of the claim.
Claims 1 and 3 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. One of skill in the art would not be able to determine the scope of the presently claimed method. For example, it is unclear what is required by “produced from Lycium barbarum as a sole raw material” requires. It is unclear if an additional method step necessary, if the limitation is attempting to limit what is administered (i.e. only a Lycium barbarum glycopeptide), etc. If applicants are attempting to limit what is administered, applicants should utilize closed language regarding the product and not a product by process limitation.
Maintained and/or Modified* Rejections
*wherein the modification is due to amendment
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 and 3 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a Lycium barbarum glycopeptide composition (i.e. naturally occurring goji berry) without significantly more. The claims recite administering a Lycium barbarum glycopeptide composition (i.e. naturally occurring goji berry). This judicial exception is not integrated into a practical application because the claims amount to stating “apply it” regarding a Lycium barbarum glycopeptide composition (i.e. naturally occurring goji berry). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only a Lycium barbarum glycopeptide composition (i.e. naturally occurring goji berry) is administered.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 101 for claims 1 and 3 were considered but are not persuasive for the following reasons.
Applicants contend that incorporating the dosage of canceled claim 2 negates the rejection. Applicants contend that the claims are directed to a concrete therapeutic application (i.e. practical application). Applicants contend that paragraph 34-45 teach that the glycopeptide is obtained through a specific preparation.
Applicants’ arguments are not convincing since the dosage alone cannot negate the 35 USC 101, a practical application is not present because there is a nexus missing between the preamble and the subject and a nexus is missing between the preamble and the body of the claim (i.e. causing a question as to the practical application), and limitations from the specification cannot be read into the claims.
New Rejections Necessitated by Amendment
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.
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Baek et al. KR 10-2019-0083962 published July 15, 2019 and Lu et al. U.S. Patent Application Publication 2020/0030403 published January 30, 2020.
For present claims 1 and 3, Baek et al. teach a method of administering a goji berry extract (i.e. a Lycium barbarum glycopeptide composition) to a subject with Lou Gehrig’s disease (i.e. amyotrophic lateral sclerosis (ALS)) at 0.0001 to 2000 mg/kg per day (please refer to the entire specification particularly the abstract and pages 3-13).
For present claims 1 and 3, Lu et al. teach methods of preparing Lycium barbarum glycopeptide as a pharmaceutical (please refer to the entire specification particularly the abstract; paragraphs 2-20).
All the claimed elements were known (i.e. method of utilizing a goji berry extract to treat Lou Gehrig’s disease; Lycium barbarum glycopeptide) in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. treatment of Lou Gehrig’s disease) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of goji berry extract) for another (i.e. species of Lycium barbarum glycopeptide) would have yielded predictable results (i.e. treatment of Lou Gehrig’s disease) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. extraction of Lycium barbarum glycopeptide) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Baek et al. U.S. Patent Application Publication 2020/0384057 published December 10, 2020 (see also PCT/KR2018/004917 filed April 27, 2018 and published as WO 2019/135450 on July 11, 2019 and KR 10-2018-0001904 published January 5, 2018) and Lu et al. U.S. Patent Application Publication 2020/0030403 published January 30, 2020.
For present claims 1 and 3, Baek et al. teach methods of administering a goji berry extract (i.e. a Lycium barbarum glycopeptide composition) to a subject with amyotrophic lateral sclerosis (ALS) at 1 mg/ml to 10 mg/ml or 0.0001 to 2000 mg/kg per day (please refer to the entire specification particularly the abstract; paragraphs 1, 3,-5, 7, 8, 12-14, 17-21, 25, 28, 29, 34-38, 43, 51, 54, 55, 62, 63, 65-72, 79, 80, 83, 84; Examples; claims).
For present claims 1 and 3, Lu et al. teach methods of preparing Lycium barbarum glycopeptide as a pharmaceutical (please refer to the entire specification particularly the abstract; paragraphs 2-20).
All the claimed elements were known (i.e. method of utilizing a goji berry extract to treat Lou Gehrig’s disease; Lycium barbarum glycopeptide) in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in the respective functions and the combination would have yielded predictable results (i.e. treatment of Lou Gehrig’s disease) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because the substitution of one known element (i.e. genus of goji berry extract) for another (i.e. species of Lycium barbarum glycopeptide) would have yielded predictable results (i.e. treatment of Lou Gehrig’s disease) to one of ordinary skill in the art at the time of the invention. The claims would have been obvious because a particular known technique (i.e. extraction of Lycium barbarum glycopeptide) was recognized as part of the ordinary capabilities of one skilled in the art. The claims would have been obvious because a person of ordinary skill has good reason to pursue the known options within their technical grasp. If this leads to the anticipated success, it is likely the product no of innovation but of ordinary skill and common sense. See KSR International Co v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yu et al., 2005, Neuroprotective effects of anti-aging oriental medicine Lycium barbarum against b-amyloid peptide neurotoxicity, Experimental Gerontology, 40: 716-727.
Ho et al., 2007, Characterizing the neuroprotective effects of alkaline extract of Lycium barbarum on beta-amyloid peptide neurotoxicity, Brain Research, 1158: 123-134.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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