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 .
Response to Arguments
Applicant’s amendment, filed 07/08/2026, with respect to trademarks in the Specification have been fully considered in light of the amendments. The objection of 04/17/2026 has been withdrawn.
Applicant’s amendments, filed 07/08/2026, with respect to c have been rendered moot as claim 3 has been canceled.
Applicant’s amendments, filed 07/08/2026, with respect to 35 U.S.C. 101 rejections have been rendered moot as claim 7 has been canceled.
Applicant’s amendment, filed 07/08/2026, with respect to 35 U.S.C. 112(b) have been fully considered in light of the amendments. The rejection of 04/17/2026 has been withdrawn regarding claim 1.
Applicant’s amendments, filed 07/08/2026, with respect to 35 U.S.C. 112(b) rejections have been rendered moot as claim 2-7 have been canceled.
Applicant argues the Liu fails to teach the method of claim 1. Applicant argues that Liu discloses HPLC standard fingerprint of the Hui Tong Jiaonang has 25 common peaks, while the fingerprint spectrum of the aloe capsule of claim 1 consists of 6 peaks. The applicant argues the transitional phrase “consisting of” excludes any other peaks not specified in claim 1. Applicant further argues Zang does not cure the deficiencies of Liu.
The examiner respectfully disagrees. “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions” (See MPEP 2144.05(II)(A)). Liu teaches multiple well-known aloe laxative capsules with similar compounds and peaks when characterized (para 0044). It would be is obvious to one of ordinary skill in the art to perform the method of constructing a fingerprint for the capsule in claim 1 and characterized it with any number of peaks with the motivation to thoroughly evaluate aloe laxative capsule for quality control. It would be obvious for one in the art to modify Liu to only detect those 6 peaks listed in the claimed invention because those ingredients are abundant in the compound aloe capsule thus making it easier to use in testing for quality control.
Applicant's arguments filed 07/08/2026 have been fully considered but they are not persuasive. The rejection below has been modified based on the amendments, however, still relies on the previously cited prior art.
Claim Rejections - 35 USC § 112
Claim 1 is 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.
Claim 1 contains the trademark/trade name “Hyperpsil ODS”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982).
The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a chromatography column and, accordingly, the identification/description is indefinite.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al.
(Machine Translation of CN 109270181 B), and further in view of Zang et al. (Machine Translation of CN 110057927 B) as cited in a previous office action.
Regarding Claim 1, Liu teaches a method for fingerprint construction for aloe laxative pill which comprises of taking powder of the capsule, doing a reflux extraction, adding methanol, carrying out ultrasonic treatment, filtering, and taking a subsequent filtrate as a test solution (para 0012 and 0016). Liu further teaches injecting the test solution and the reference solutions into a high-performance liquid chromatograph for gradient elution to obtain a chromatogram of the aloe laxative capsules and chromatograms of the reference solutions, respectively (para 0018) and labeling chemical components of peaks on the chromatogram of the aloe laxative capsule according to the chromatogram of the aloe laxative capsule and the chromatograms of the reference solutions to obtain a fingerprint spectrum of the aloe laxative capsule (para 0019-0022). Liu further teaches a mobile phase used in the gradient elution comprises: acetonitrile and 0.08% aqueous phosphoric acid solution (para 0013) and an elution procedure (para 0014). Liu further teaches a chromatographic column used in the high-performance liquid chromatograph is C18 column (para 0013).
However, Liu does not teach the method for fingerprint construction being done on the aloe compound and the corresponding reference compounds which are barbaloin, aloe emodin, indirubin, tryptanthrin, aloesin, and P-sitosterol.
Although, Liu does not teach the method for fingerprint construction being done on the aloe compound and the corresponding reference compounds which are barbaloin, aloe emodin, indirubin, tryptanthrin, aloesin, and P-sitosterol, it would have been obvious for one of ordinary skill in the art to modify the aloe laxative capsules taught in Liu to the aloe compound capsule because it is a type of aloe laxative capsule. Since Liu teaches multiple well known aloe laxative capsules with similar compounds and peaks when characterized (para 0044), it would be obvious for one of ordinary skill in the art to modify the existing well known aloe laxative capsules of Liu to the capsule as claimed in the instant invention as these would add an extra basis of quality control and evaluation of aloe laxative capsules. Liu further teaches obtaining the standard fingerprint of the aloe cathartic capsule consisting of the common characteristic peaks (pg 4, para 0015) and Liu further teaches the barbaloin peak in the Hlhui laxative capsule (pg 10, para 0102). Thus, it would have been obvious for one of ordinary skill in the art before the effective filing date to modify the teachings of Liu with the common characteristic peaks being barbaloin, aloe emodin, indirubin, tryptanthrin, aloesin, and P-sitosterol because they common compound/peaks of the compound aloe capsule used in the claimed invention, making those peaks useful in testing the compound aloe capsule for quality control.
Liu further does not teach that the chromatograms are determined at a wavelength of 300nm.
Zang teaches a method of constructing a fingerprint spectrum with liquid chromatography and mass spectrometry for Qilong capsules. It would have been obvious to one of ordinary skill in the art before the effective filing date to try various wavelengths to determine the most ideal wavelength for the greatest number of peaks and good separation of each peak. Zang further teaches a method wherein multiple wavelengths, ranging from 190nm-400nm, were tested to determine the most ideal wavelength with the best separation of peaks (para 0023). It would have been obvious to try various wavelength to find the ideal wavelength. The ideal wavelength is 300nm because more peaks are obtained with good absorption and a stable baseline.
Liu further does not teaches adding mass spectrometry analysis of the compound aloe capsule.
However, Zang teaches a method of constructing a fingerprint spectrum with liquid chromatography and mass spectrometry for Qilong capsules. Zang teaches adding mass spectrometry analysis to the method of constructing finger print spectrums for the benefit of detection at a high sensitivity and more accurate detection (para 0091). Thus, it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify Liu with adding mass spectrometry analysis of the compound aloe capsule as taught by Zang for the benefit of detection at a high sensitivity and more accurate detection (para 0091).
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.
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/H.R.B./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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