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 1-18 are pending and examined on the merits.
Priority
Acknowledgement is made of this national stage entry of Continuation of PCT/CN2023/093879 of Non-provisional Application No. 18/591,010, filed on 5/12/2023, which claims foreign priority under 35 U.S.C. 119(a)-(d) to Chinese Patent Application No. CN202210921653.8, filing date 8/2/2022. The certified copy has been filed in the present application on 4/12/2021.
It is noted, however, that applicant has not filed a certified copy of the English translation as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/14/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Drawings
The Drawings filed on 2/29/2024 are acknowledged and accepted by the examiner.
Claim Rejections - 35 USC § 112(b)
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 1-18 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.
Regarding claim 1 (claims 2-18 dependent therefrom), the recitation of the phrase ‘related substances in a germinal peptide preparation’ is indefinite because it is unclear what the scope of the phrase is intended to encompass structurally and functionally. It is unclear what the ‘related substances in a germinal peptide preparation’ is intended to encompass. It is unclear from the claims and specification what the ‘related substances in a germinal peptide preparation’ is referring to structurally. Accordingly, the metes and bounds upon which patent protection is sought cannot be ascertained from the claims. It is suggested that applicant clarify the meaning of the claims.
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more modifications. The claim(s) recite(s) a method for an analysis of related substances in a germinal peptide preparation, comprising the following steps: (1) preparing a sample; and (2) testing the sample by high-performance liquid chromatography, wherein a chromatographic column with octadecylsilane-bonded silica gel as a packing is adopted for the high-performance liquid chromatography; and mobile phases for the high-performance liquid chromatography comprise a mobile phase A and a mobile phase B, wherein the mobile phase A is a trifluoroacetic acid aqueous solution with a volume ratio of the trifluoroacetic acid to water being 0.05:100 to 0.15:100, and the mobile phase B is trifluoroacetic acid-acetonitrile (claims 1-9); a method for controlling a quality of a germinal peptide preparation, comprising using the method for the analysis of the related substances in the germinal peptide preparation according to claim 1 (claims 10-18).
This judicial exception is not integrated into a practical application because the recitation of ‘analysis of related substances in a germinal peptide preparation (claim 1) and controlling a quality of a germinal peptide preparation (claim 10) are abstract ideas. According to MPEP 2106.04(a), ‘The abstract idea exception has deep roots in the Supreme Court’s jurisprudence. See Bilski v. Kappos, 561 U.S. 593, 601-602, 95 USPQ2d 1001, 1006 (2010) (citing Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174–175 (1853)). Despite this long history, the courts have declined to define abstract ideas. However, it is clear from the body of judicial precedent that software and business methods are not excluded categories of subject matter. For example, the Supreme Court concluded that business methods are not "categorically outside of § 101's scope," stating that "a business method is simply one kind of ‘method’ that is, at least in some circumstances, eligible for patenting under § 101." Bilski, 561 U.S. at 607, 95 USPQ2d at 1008 (2010). See also Content Extraction and Transmission, LLC v. Wells Fargo Bank, 776 F.3d 1343, 1347, 113 USPQ2d 1354, 1357 (Fed. Cir. 2014) ("there is no categorical business-method exception"). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because although the claims recite such limitations such as (1) preparing a sample; and (2) testing the sample by high-performance liquid chromatography, wherein a chromatographic column with octadecylsilane-bonded silica gel as a packing is adopted for the high-performance liquid chromatography; and mobile phases for the high-performance liquid chromatography comprise a mobile phase A and a mobile phase B, wherein the mobile phase A is a trifluoroacetic acid aqueous solution with a volume ratio of the trifluoroacetic acid to water being 0.05:100 to 0.15:100, and the mobile phase B is trifluoroacetic acid-acetonitrile (claim 1), the generically recited conditions for running the HPLC do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a HPLC. The additional elements only recite the method for running a standard HPLC for analysis of samples. Said processes are well-understood, routine, conventional HPLC methods as recognized by the art. For these reasons, the claims are not patent eligible under 35 U.S.C. 101.
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mant et al (2007, Methods in Molecular Biology, Examiner cited) {herein Mant} as evidenced by Agilent wavelength (2025, Marshall Scientific, Examiner cited) {herein Agilent Wavelength.
Claims 1-9 are drawn to a method for an analysis of related substances in a germinal peptide preparation, comprising the following steps: (1) preparing a sample; and (2) testing the sample by high-performance liquid chromatography, wherein a chromatographic column with octadecylsilane-bonded silica gel as a packing is adopted for the high-performance liquid chromatography; and mobile phases for the high-performance liquid chromatography comprise a mobile phase A and a mobile phase B, wherein the mobile phase A is a trifluoroacetic acid aqueous solution with a volume ratio of the trifluoroacetic acid to water being 0.05:100 to 0.15:100, and the mobile phase B is trifluoroacetic acid-acetonitrile.
Claims 10-18 are drawn to a method for controlling a quality of a germinal peptide preparation, comprising using the method for the analysis of the related substances in the germinal peptide preparation according to claim 1.
With respect to claims 1, 5-6, 10, 14-15, Mant teaches a method wherein short peptide samples (5aa to 20aa) are analyzed via an Agilient HPLC column (page 11, para 2, page 14, para 2). Absent evidence otherwise, it is the Examiner’s position that Mant teaches related substances in a germinal peptide that are successfully measured and separated by HPLC (Mant: page 16, para 1) as related substances in a germinal peptide preparation related substances could be small peptides of 7 amino acids etc., of which are taught by Mant (figure 2). The HPLC column is packed with silica-based supports containing octadecyl (page 11, para 2). Mant further teaches the mobile phases are carried out using aqueous trifluoroacetic acid (page 11, para 2). Absent evidence otherwise, it is the Examiner’s position that said mobile phases include the recited mobile phases A and B. Evidentiary reference of Agilent Wavelength is cited to demonstrate that the range at which said column can detect protein is 190nm – 950nm (page 2). As such, absent evidence otherwise, it is the Examiner’s position that a wavelength of 210 nm, as recited in claims 5 and 14 of the instant application would be detected. Said method is also able to remove contaminants from the sample (page 48, para 2), thereby improving the quality of the sample. Although the reference of Mant does not explicitly teach the limitations of claim 1, MPEP 2144.05 states"[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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the ratios of mobile phases A and B depending on the particular application. It would be routine for one to arrive at the volume ratio for the application they intend on using the germinal peptide preparation. Therefore, the above invention would have been prima facie obvious.
With respect to claims 2, 11, although the reference of Mant does not explicitly teach the limitations of claims 2, 11 (wherein a volume ratio of trifluoroacetic acid to acetonitrile in the mobile phase B is 0.05:100 to 0.15:100), MPEP 2144.05 states"[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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the volume ratio of trifluoroacetic acid to acetonitrile in the mobile phase B depending on the particular application. It would be routine for one to arrive at the volume ratio for the application they intend on using the germinal peptide preparation. Therefore, the above invention would have been prima facie obvious.
With respect to claims 3, 12, although the reference of Mant does not explicitly teach the limitations of claims 3, 12 (wherein a column temperature of the chromatographic column is 30°C to 40°C), MPEP 2144.05 states"[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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the temperature of the column depending on the particular application. It would be routine for one to arrive at the temperature for the application they intend on using the germinal peptide preparation. Therefore, the above invention would have been prima facie obvious.
With respect to claims 4, 13, although the reference of Mant does not explicitly teach the limitations of claims 4, 13 (wherein an injection volume for the high-performance liquid chromatography is 90 μL to 110 μL), MPEP 2144.05 states"[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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the injection volume for the high-performance liquid chromatography depending on the particular application. It would be routine for one to arrive at the injection volume for the application they intend on using the germinal peptide preparation. Therefore, the above invention would have been prima facie obvious.
With respect to claims 7, 16, although the reference of Mant does not explicitly teach the limitations of claims 7, 16 (wherein the chromatographic column has a specification of 4.6 × 150 mm, 3 μm), MPEP 2144.05 states"[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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the specification of the chromatographic column depending on the particular application. It would be routine for one to arrive at the specification of the column for the application they intend on using the germinal peptide preparation. Therefore, the above invention would have been prima facie obvious.
With respect to claims 8, 17, although the reference of Mant does not explicitly teach the limitations of claims 8, 17 (a gradient elution as follows: 0 min: a volume ratio of the mobile phase A to the mobile phase B is 100:0; 8 min: the volume ratio of the mobile phase A to the mobile phase B is 83:17 to 87:13; 8 min to 13 min: the volume ratio of the mobile phase A to the mobile phase B is 83:17 to 87:13; and 13 min to 20 min: the volume ratio of the mobile phase A to the mobile phase B is 100:0), MPEP 2144.05 states"[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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the gradient elution depending on the particular application. It would be routine for one to arrive at the gradient elution for the application they intend on using the germinal peptide preparation. Therefore, the above invention would have been prima facie obvious.
With respect to claims 9, 18, although the reference of Mant does not explicitly teach the limitations of claims 9, 18 (a gradient elution as follows: 0 min: a volume ratio of the mobile phase A to the mobile phase B is 100:0; 8 min: the volume ratio of the mobile phase A to the mobile phase B is 85:15; 8 min to 13 min: the volume ratio of the mobile phase A to the mobile phase B is 85:15; and 13 min to 20 min: the volume ratio of the mobile phase A to the mobile phase B is 100:0), MPEP 2144.05 states"[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) (MPEP 2144.05 IIA)." One of ordinary skill would desire to optimize the gradient elution depending on the particular application. It would be routine for one to arrive at the gradient elution for the application they intend on using the germinal peptide preparation. Therefore, the above invention would have been prima facie obvious.
.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the method for the analysis and control of the quality of small peptides to include related substances in a germinal peptide preparation, as said ‘related substances,’ are successfully measured and separated by HPLC (Mant: page 16, para 1).
One of ordinary skill in the art would be motivated to utilize the method taught by Mant for the analysis and control of the quality of substances within a germinal peptide preparation as said method is ideal for the analysis of short peptides (4 aa – 20 aa) (figure 2), as said method provides excellent resolution of small peptide separations (page 16, para 1. One o fordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, based on the specific teachings of Mant and the evidientary reference. Furthermore, said method reduces the number of contaminants in a sample (page 13, para 1), thereby resulting in a better quality sample that can be more readily utilized in therapeutic studies. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
Claims 1-18 are pending.
Claims 1-18 are rejected.
No claims are in condition for an allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA NICOLE JONES-FOSTER whose telephone number is (571)270-0360. The examiner can normally be reached mf 7:30a - 4:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA NICOLE JONES-FOSTER/ Examiner, Art Unit 1656
/MANJUNATH N RAO/ Supervisory Patent Examiner, Art Unit 1656