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 .
Claim Objections
Claims 1-2, 4-5 and 7 are objected to because of the following informalities:
Claim 1, line 2 recites “the active ingredient” which lacks antecedent basis. For the purpose of this examination, the limitation will be read as “an active ingredient”
Claim 1, line 3 recites “the formulation” which lacks antecedent basis. For the purpose of this examination, the limitation will be read as “a formulation”
Claim 1, line 6 recites “the analyte” which lacks antecedent basis. For the purpose of this examination, the limitation will be read as “the active ingredient”
Claim 1, last line recites “the degradation factor” which lacks antecedent basis. For the purpose of this examination, the limitation will be read as “a degradation factor”
Claim 2, line 1 recites “the method of the previous claim” which would be unclear as to which claim is being referenced, if amendments to claim numbers are considered, and should be replaced with “the method of claim 1”
Claim 4, line 2 recites “the analyzed surface zones” which lacks antecedent basis. For the purpose of this examination, the limitation will be read as “analyzed surface zones”
Claim 5, line 2 recites “the degradation level”, “the base spectrum” and “the analyzed spectrum” where each term lacks antecedent basis. For the purpose of this examination, the limitations will be read as “a degradation level”, “a base spectrum” and “an analyzed spectrum”
Claim 7, line 1 recites “The process of claim 1” where the process lacks antecedent basis and is inconsistent with the previous claims. For the purpose of this examination, the limitation will be interpreted as “The method of claim 1”
Appropriate correction is required.
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.
Claim 5 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 5, line 2 recites “subtracting the base spectrum from the analyzed spectrum using the formula: ” but the referenced formula is not presented in the claim or disclosed in the instant specification. Therefore, it remains unclear what specific calculation is being performed in the determination of the degradation level. Further, as noted in the claim objections section, “the base spectrum” and “the analyzed spectrum” lack antecedent basis and it is unclear as to which what specific spectrums are being considered in the operation. For the purpose of this examination, the limitation is interpreted as “subtracting a base spectrum from an analyzed spectrum”.
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.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balss et al. (US 2008/0228428 A1).
Regarding claim 1, Balss discloses an automated method for determining concentration, content uniformity, and degradation of an active ingredient (API) in pharmaceutical formulations ([0018]; [0019], lines 1-5; [0051]; [0079], last 12 lines; [0083]-[0085]), comprising:
a) Measuring the infrared spectrum (via analysis processing module 120) at at least eight points on the surface of a formulation (Fig. 2; Table 2; [0080], last 4 lines; [0089]; [0097], lines 1-5; [0102]);
b) Collecting spectroscopic data (via analysis processing module 120) (Fig. 2; [0021], lines 1-8; [0051]; [0069]);
c) Analyzing (via the data processing module 130) the obtained data using a data processor that integrates artificial intelligence ([0022]; [0051]; [0103]);
d) Detecting the active ingredient and determining its concentration, content uniformity, and degradation in the analyzed formulation (Table 3; [0022]); [0051]; [0083]-[0085]; [0097]; [0103]).
e) Predicting the presence of degradation and, if applicable, proceeding to the next phase ([0083]-[0085]);
Balss does not explicitly disclose f) Identifying a degradation factor, however, such a determination appears to be contingent on the predicted presence of degradation (see step e above), and, therefore, under the broadest reasonable interpretation of the claim, “[a contingent] step need not be carried out in order for the claimed method to be performed” (see MPEP 2111.04 II). However, Balss does disclose a system and method which, as noted above, can identify degradation and it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to quantify the degradation by assigning a degradation level or factor where the motivation would be to allow a user to track changes in quality of an active ingredient in pharmaceutical formulations, improving reliability of the manufactured devices.
Regarding claim 2, Balss discloses the method of claim 1, as outlined above, and further discloses where the spectroscopic measurement must be performed using a quantum cascade laser (QCL) or any other high-power spectroscopic method (Balss: [0076]; [0097] – where the confocal Raman microscopy (CRM) method combined with other spectroscopic methods for generating spectral images, as disclosed in paragraph [0097], is interpreted as a high-powered spectroscopic method).
Regarding claim 3, Balss discloses the method of claim 1, as outlined above, and further discloses where the artificial intelligence concentration analysis is performed through a partial least squares (PLS) regression, allowing for the determination of the active ingredient concentration level (Balss: [0103]).
Regarding claim 4, Balss discloses the method of claim 1, as outlined above, and further discloses where the prediction of uniformity in the formulation is based on a comparison between the spectra of analyzed surface zones (Balss: [0079], last 12 lines; [0089]).
Regarding claim 5, Balss discloses the method of claim 1, as outlined above, and further discloses where the determination of a degradation level is performed by subtracting a base spectrum from an analyzed spectrum (Balss: Fig. 23b; [0091]; [0103]-[0105]). As noted above in claim 1, Balss does not explicitly disclose determining a specific degradation level, however, Balss appears to track the concentration of an active ingredient by the subtraction of measured spectrums. It would be obvious to one of ordinary skill in the art to use known analytical methods to determine relative concentrations of ingredients in a pharmaceutical formulation and assigning a corresponding degradation level, allowing a user to track changes in quality of an active ingredient and improving reliability of the manufactured devices.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balss et al. (US 2008/0228428 A1) in view of Herzog et al. (US 2023/0116072 A1).
Regarding claim 6, Balss discloses the method of claim 1, as outlined above, and further discloses quantitative analysis methods which allow for the determination of concentrations of an active ingredient using machine learning methods ([0103]-[0104]). Balss does not appear to explicitly disclose where the identification of the degradation factor is performed using a random forest machine learning model that classifies previously trained factors.
However, Herzog, in the same field of endeavor of spectroscopic systems and methods, discloses a method for obtaining a composite spectroscopic signal from a product and determining an active fluorescent marker’s intensity and/or distribution using a random forest machine learning model that classifies previously trained factors ([0032]-[0034]). As noted above in claim 1, though Balss does not explicitly disclose determining a specific degradation level, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use known machine learning methods, including a random forest machine learning model, to determine relative concentrations of ingredients in a pharmaceutical formulation and assigning a corresponding degradation factor, allowing a user to track changes in quality of an active ingredient and improving reliability of the manufactured devices.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Balss et al. (US 2008/0228428 A1) in view of Gehrlein et al. (US 7057722 B2).
Regarding claim 7, Balss discloses the method of claim 1, as outlined above, but does not disclose where all data processing is carried out immediately by a cloud server.
However, Gehrlein, in the same field of endeavor of spectroscopic systems and methods, further discloses a system where all data processing is carried out immediately by a cloud server (Col. 13, lines 46-61).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Balss with a system where all data processing is carried out immediately by a cloud server where the motivation would be to provide a distributed processing system which can be efficiently configured around a plurality of spectroscopic devices (Gehrlein: Col. 13, lines 56-61).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHER YAZBACK whose telephone number is (703)756-1456. The examiner can normally be reached Monday - Friday 8:30 am - 5:30 pm.
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/MAHER YAZBACK/Examiner, Art Unit 2877
/MICHELLE M IACOLETTI/Supervisory Patent Examiner, Art Unit 2877
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