DETAILED ACTION
Comments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Claims 1-7, 15-21, 29-33, and 36 are pending and examined in the instant Office action.
Information Disclosure Statement
The IDS of 10/10/2023 has been considered in part. Since only the abstract of Sigwarth et al. (2000) has been provided, this document has not been considered.
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.
35 U.S.C. 101 Rejection #1:
Claims 15-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because there is no limiting description in the specification requiring the computer-readable media to consist only of non-transitory media. In the absence of this limiting description, computer-readable media are interpreted to comprise transitory subject matter, such as carrier waves, which are not subject matter eligible.
35 U.S.C. 101 Rejection #2:
Claim(s) 1-7, 15-21, 29-33, and 36 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea/law of nature/natural phenomenon without significantly more. Claims 1-7 are drawn to methods, and claims 29-33 and 36 are drawn to a system comprising a resistometer.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1 : YES; except for claims 25-31) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
The independent claims recite the mental step of receiving biological indicator data from test samples exposed to nitrogen dioxide sterilization processing conditions of a gas phase injection.
The independent claims recite the mental step of determining D values from the data.
The independent claims recite the mental step of receiving biological indicator data indicating viable spore counts after a second gas phase injection.
The independent claims recite the mental and mathematical limitations of determining D values and using fraction negative method.
The independent claims recite the mental and mathematical limitation of establishing an inactivation profile of the biological indicator based on combined viable spore counts determined from an enumeration fraction negative method.
Claims 2, 16, and 30 recite the mental step of extrapolating the inactivation profile of the biological indicator to be representative of a full sterilization cycle and compares double the exposure conditions as compared to the half sterilization cycle.
Claims 3, 17, and 31 recite the mental step of the full sterilization cycle results in at least a 12 spore log reduction in viable spore counts.
Claims 4, 18, and 32 recite the mental step of requiring the first gas injection to be associated with a 4 log reduction in viable spore counts of the biological indicator.
Claims 7 and 21 recite the mathematical limitation of requiring non-linear inactivation kinetics for the biological indicator.
These recitations are similar to the concepts of collecting information, analyzing it and displaying certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom (830 F.3d 1350, 119 USPQ2d 1739 (Fed. Cir. 2016)), organizing and manipulating information through mathematical correlations in Digitech Image Techs., LLC v Electronics for Imaging, Inc. (758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)) and comparing information regarding a sample or test to a control or target data in Univ. of Utah Research Found. v. Ambry Genetics Corp. (774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014)) and Association for Molecular Pathology v. USPTO (689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)) that the courts have identified as concepts that can be practically performed in the human mind or mathematical relationships. Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Merely reciting that a mental process is being performed in a generic computer environment does not preclude the steps from being performed practically in the human mind or with pen and paper as claimed. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then if falls within the “Mental processes” grouping of abstract ideas. As such, claim(s) 1-7, 15-21, 29-33, and 36 recite(s) an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 1 : YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). This judicial exception is not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology or applies or uses the recited judicial exception to affect a particular treatment for a condition. Rather, the instant claims recite additional elements that amount to mere instructions to implement the abstract idea in a generic computing environment or mere instructions to apply the recited judicial exception via a generic treatment.
As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible in Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. As such, claims 1-7, 15-21, 29-33, and 36 is/are directed to an abstract idea/law of nature/natural phenomenon (Step 2A, Prong 2 : NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment.
The document of Dufresne [US PGPUB 2016/0160261 A1] teaches that resistometers and testing a chamber for sterilization using resistometers and biological indicators are routine and conventional in the prior art.
As discussed above, there are no additional limitations to indicate that the claimed analysis engine requires anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B : No). As such, claims 1-7, 15-21, 29-33, and 36 is/are not patent eligible.
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.
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(s) 1-7, 15-21, 29-33, and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dufresne [US PGPUB 2016/0160261 A1] in view of Sigwarth et al. [PDA Journal of Pharmaceutical Science and Technology, volume 57, 2003, pages 3-11] in view of Robbins et al. [US PGPUB 2015/0335777 A1].
Claim 1 is drawn to a method for evaluating inactivation kinetics of a biological indicator using data obtained from studies utilizing a resistometer. The resistometer is configured to implement a gaseous sterilization process. The method comprises receiving a first set of biological indicator data from test samples exposed to nitrogen dioxide sterilization processing conditions of at least one first sterilant gas injection phase. The first set of biological indicator data is representative of viable spore counts of the biological indicator. The method comprises determining D values using an enumeration method for determining viable spore counts based on the first set of biological indicator data. The method comprises receiving a second set of biological indicator data during at least one additional sterilant gas injection phase. The second set of biological indicator data is representative of viable spore counts of the biological indicator. The method comprises determining D values using a fraction negative method for determining viable spore counts, based on the second set of biological indicator data. The method comprises establishing an inactivation profile of the biological indicator based on combined viable spore counts determined from an enumeration fraction negative method.
Claim 15 is drawn to similar subject matter as claim 1, except claim 15 is drawn to a computer-readable medium.
Claim 29 is drawn to similar subject matter as claim 1, except claim 29 is drawn to a system comprising a resistometer.
The document of Dufresne studies a method for establishing characteristics of a biological indicator [title]. The abstract of Dufresne teaches monitoring resistance characteristics of a biological indicator in the sterilization process by measuring D values as a chamber is injected with hydrogen peroxide vapor. Paragraph 14 of Dufresne teaches use of the ANSI/AAMI/ISO 11138-1 resistometer. Paragraph 15 of Dufresne teach the relationship between D values, survival time, and kill time. Figures 3 through 6 of Dufresne teach the fraction negative algorithm for fitting logarithmic curves to biological indicator data.
Dufresne does not teach multiple cycles of vapor injection. Dufresne does not teach nitrogen dioxide sterilization.
The document of Sigwarth et al. studies the effect of carrier materials on the resistance of spores of Bacillus stearothermophilus to gaseous hydrogen peroxide [title]. Figures 4 and 5 on page 10 of Sigwarth et al, illustrate the analysis of D values for multiple cycles of vapor injection.
Dufresne and Sigwarth et al. do not teach nitrogen dioxide sterilization.
The document of Robbins et al. studies a process challenge device for gas sterilization [title]. Paragraphs 8 and 16 of Robbins et al. teach nitrogen dioxide as an alternative to hydrogen peroxide for the sterilization process.
With regard to claims 2-4, 16-18, and 30-32, Figures 4 and 5 on page 10 of Sigwarth et al. illustrate data from a full sterilization cycle, a half sterilization cycle, wherein the cycle results in a 12 spore log and (as a result) a 4 log reduction in spore concentration.
With regard to claims 5-6, 19-20, and 33, Figures 4 and 5 on page 10 of Sigwarth et al. illustrate the result of a single sterilant injection cycle as a starting point for future sterilant injection cycles.
With regard to claims 7 and 21, while Figures 4 and 5 on page 10 of Sigwarth et al. illustrate linear plots, since the originate axes are on a logarithmic scale, these figures illustrate non-linear inactivation kinetics of the biological indicator.
With regard to claim 36, paragraphs 54-55 of Dufresne teach vapor sterilant pressure sensors.
It would have been obvious to someone of ordinary skill in the art at the time of the filing date of the instant application to modify the usage of the resistometer to measure D values and fraction negative analysis of biological indicators during sterilization of Dufresne by use of the multiple cycles of similar analysis of Sigwarth et al. wherein the motivation would have been that the additional cycles of sterilant vapor injections yield additional data that facilitate analysis of sterilization [Figures 4 and 5 of Sigwarth et al.]. It would have been obvious to repeat the multiple cycles of sterilant vapor injections of Sigwarth et al. in series because it is obvious to try the same procedures multiple times in a single chamber. There would have been a reasonable expectation of success in combining Dufresne and Sigwarth et al. because both studies are analogously applicable to assess sterilization achieved from vapor injections by measuring properties of a biological indicator over time.
It would have been obvious to someone of ordinary skill in the art at the time of the filing date of the instant application to modify the usage of the resistometer to measure D values and fraction negative analysis of biological indicators during hydrogen peroxide sterilization of Dufresne and the multiple cycles of similar analysis of Sigwarth et al. by use of sterilization using nitrogen dioxide of Robbins et al. because it is obvious to substitute known elements in the prior art to yield a predictable result. In this instance, nitrogen dioxide is an alternative to hydrogen peroxide. There would have been a reasonable expectation of success in combining Dufresne, Sigwarth et al., and Robbins et al. because all three studies are analogously applicable to sterilizing chambers using sterilant vapors.
Related Prior Art
The document of Yabuta et al. [International Journal of Pharmaceutics, volume 548, 2018, pages 466-473] studies design-oriented regression models for hydrogen peroxide decontamination processes in sterile drug product manufacturing considering rapidity and sterility [title]. Figure 5 on page 470 of Yabuta et al. illustrates D values calculates as a function of hydrogen peroxide injection rate.
E-mail Communications Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Russell Negin, whose telephone number is (571) 272-1083. This Examiner can normally be reached from Monday through Thursday from 8 am to 3 pm and variable hours on Fridays.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s Supervisor, Larry Riggs, Supervisory Patent Examiner, can be reached at (571) 270-3062.
/RUSSELL S NEGIN/Primary Examiner, Art Unit 1686 23 August 2026
Prosecution Insights