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 .
Election/Restrictions
Applicant's election with traverse of Group I, corresponding to claims 1-14 in the reply filed on January 22nd, 2026 is acknowledged. The traversal is on the ground(s) that there will be overlapping search amongst the groups and therefore there is no serious search burden.
This is not found persuasive because as noted in the restriction requirement filed on November 26th, 2025, Groups I & II are separately classified in different CPC Sections (B25J 9/1671 vs. A61L 2/24). Further, the Applicant is reminded that The Manual of Patent Examining Procedures specifically states that, "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original); and a claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim (See MPEP 2114 II). Because of this, prior art apparatuses may meet the limitations of claims 1-14 directed to an apparatus, while the same art may not meet the limitations of the method claims (Group II, claims 15—20). As such, a serious search burden would exist if the restriction were not required. Nonetheless, the Applicant is reminded that previously withdrawn process claims will be rejoined with the apparatus claims when/if said apparatus claims are deemed allowable, provided that said withdrawn process claims includes all the limitations of the allowable apparatus claim.
However, as currently constituted, the requirement is still deemed proper and is made FINAL.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6-8 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kirckof et al. (U.S. Patent No. 6,485,978).
Kirckof discloses a sterilization system for a medical device, the system comprising:
(a) a processor and a memory;
(b) a communication device;
(c) a user input; and
(d) a display as set forth in Figure 4 and column 25, lines 53-56 (column 19, lines 49-62);
Wherein the processor is configured to:
receive a device indicator associated with the medical device (column 20, lines 1-17);
access a set of medical device records and determine an identity of the medical device based upon an association of the device indicator with the set of medical device records (column 25, lines 15-35);
configure at least one risk mitigation process based upon the identity of the medical device (column 23, lines 34-44; column 25, lines 15-35; column 26, lines 10-20);
configure a sterilization cycle to be performed on the medical device based upon the at least one risk mitigation process (column 21, lines 37-52); and
communicate the identity of the medical device and results of the sterilization cycle to a communication hub (numeral 304/306; column 18, lines 59-65; column 21, lines 3-11; column 25, lines 15-38).
Concerning claims 6-8, Kirckof continues to disclose that the communication hub is configured to further communicate with a laptop/desktop computer, a biological indicator analyzer (327) and a hospital local area server (Figure 4; column 19, lines 49-62; column 23, lines 58-64). Note that only one of these items is needed to satisfy the limitations of the claims.
Regarding claim 10, Kirckof also discloses that the device indicator is a set of device tracking information;
Wherein the set of device tracking information indicates an in-transit medical device leaving from an origin and having a destination of the system;
Wherein the set of medical device records associate the in-transit medical device with the identity of the medical device (column 20, lines 1-22); and
Wherein the processor is further configured to determine that the medical device is the in-transit medical device (column 20, lines 25-40).
With respect to claim 11, Kirckof further discloses that the user input comprises an optical reader that is operable to read data encoded in an optical identifier (column 15, lines 20-29);
Wherein the optical reader is configured to receive the device indicator after the optical reader reads the optical identifier (column 15, lines 35-64);
Wherein the set of medical device records associate the optical identifier with the identity of the medical device (column 18, line 59 to column 19, line 12).
Concerning claim 12, Kirckof also discloses that the user input comprises a text input that is operable to provide a text identifier to the device (column 20, lines 1-5);
Wherein the text input is configured to receive the device indicator as the text identifier (column 20, lines 10-20); and
Wherein the set of medical device records associate the text identifier with the identity of the medical device (column 20, lines 1-35).
Regarding claim 14, the reference of Kirckof also discloses that the at least one risk mitigation process comprises an automatic cycle selection, wherein the automatic cycle selection is configured to cause the processor to:
determine an approved cycle configuration based upon the identity of the medical device; and
configure the sterilization cycle based upon the approved cycle configuration as set forth in column 22, lines 20-51.
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kirckof et al. (U.S. Patent No. 6,485,978) in view of Cookson et al. (U.S. Publication No. 2018/0289846).
With respect to claim 9, Kirckof also discloses that the system includes a sterilizing cabinet (20);
wherein the communication device is a wireless transceiver configured to be connected to the sterilization system via a wireless communication network (column 19, lines 49-67);
wherein the user input comprises a screen (Figures 21-30) and an optical reader (column 15, lines 20-29);
wherein the device indicator is a model number associated with a unique description of the medical device (column 15, lines 35-64); and
wherein the identity is the unique description of the medical device (column 18, line 59 to column 19, line 12).
Kirckof does not appear to disclose that the user input comprises a touchscreen. Cookson discloses a device usable with a sterilization system, wherein the device is a sterilizing cabinet (110) that includes a user input screen (150) that operates the system (paragraph 59). The reference continues to disclose that the screen is a touchscreen in order to allow an operator to easily and conveniently input processing parameters for the system (paragraph 60). As such, it would have been obvious to one of ordinary skill in the art at the effective filing date of the claimed invention to utilize a touchscreen as the screen in Kirckof, as Cookson discloses that such a screen is easy and convenient for operators to input processing parameters for the system.
Therefore, claim 9 is met by Kirckof in view of Cookson.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,016,964 (herein referred to as ‘964) in view of Kirckof et al. (U.S. Patent No. 6,485,978).
More specifically, each of the instant application and ‘964 claim a sterilization system for a medical device comprising a processor and a memory, a communication device, a user input, and a display (See clams 1 & 6-9 of ‘964). Each further claim that the processor is configured to receive a device indicator associated with the medical device, access a set of medical device records and determine an identity of the medical device based upon an association of the device indicator with the set of medical device records, configure at least one risk mitigation process based upon the identity of the medical device, and configure a sterilization cycle to be performed on the medical device based upon the at least one risk mitigation process (See claims 1, 13 & 18 of ‘964).
‘964 does not appear to disclose that the processor is configured to communicate the identity of the medical device and results of the sterilization cycle to a communication hub. Nonetheless, as noted above, Kirckof discloses a similar sterilization system with a processor that is configured to perform steps i-iv (See reference to claim 1 above) in which said processor is further configured to communicate the identity of the medical device and results of the sterilization cycle to a communication hub in order to allow an operator to access that information from a plurality of locations (numeral 304/306; column 18, lines 59-65; column 21, lines 3-11; column 25, lines 15-38). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the processor of ‘964 to communicate the identity of the medical device and results of the sterilization cycle to a communication hub in order to allow an operator to access that information from a plurality of locations as exemplified by Kirckof.
Therefore, the obviousness type double patenting rejection exists.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,000,614 (herein referred to as ‘614) in view of Kirckof et al. (U.S. Patent No. 6,485,978).
More specifically, each of the instant application and ‘614 claim a sterilization system for a medical device comprising a processor and a memory, a communication device, a user input, and a display (See clams 1 & 15 of ‘614). Each further claim that the processor is configured to receive a device indicator associated with the medical device, access a set of medical device records and determine an identity of the medical device based upon an association of the device indicator with the set of medical device records, configure at least one risk mitigation process based upon the identity of the medical device, and configure a sterilization cycle to be performed on the medical device based upon the at least one risk mitigation process (See claims 1 & 15 of ‘614).
‘614 does not appear to disclose that the processor is configured to communicate the identity of the medical device and results of the sterilization cycle to a communication hub. Nonetheless, as noted above, Kirckof discloses a similar sterilization system with a processor that is configured to perform steps i-iv (See reference to claim 1 above) in which said processor is further configured to communicate the identity of the medical device and results of the sterilization cycle to a communication hub in order to allow an operator to access that information from a plurality of locations (numeral 304/306; column 18, lines 59-65; column 21, lines 3-11; column 25, lines 15-38). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the processor of ‘614 to communicate the identity of the medical device and results of the sterilization cycle to a communication hub in order to allow an operator to access that information from a plurality of locations as exemplified by Kirckof.
Therefore, the obviousness type double patenting rejection exists.
Allowable Subject Matter
Should the Applicant overcome the obviousness type double patenting rejections noted above, then claims 2-5 and 13 would be merely objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN C JOYNER whose telephone number is (571)272-2709. The examiner can normally be reached Monday-Friday 8:00AM-4:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL MARCHESCHI can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KEVIN JOYNER/Primary Examiner, Art Unit 1799
Prosecution Insights