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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election of Group III in the reply filed on 1/07/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-3, 6-14, and 18-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/07/2026.
Claim Objections
Claims 37-38 and 54 are objected to because of the following informalities:
in line 2 of Claim 37, insert --biological indicator-- before “system”;
in line 5 of Claim 37, insert --biological indicator-- before “reader”;
in line 6 of Claim 37, insert --biological indicator-- before “holder”;
in line 10 of Claim 37,
insert --plurality of-- before “biological indicators”,
delete “a” and insert --an--;
in line 11 of Claim 37, insert --biological indicator-- before “holder”;
in line 1 of Claim 38 and 54, insert --biological indicator-- before “system”;
in line 2 of Claim 54, insert --plurality of-- before “biological indicators”.
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.
Claims 37-38 and 54 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.
Claim 37 recites the limitation "the effectiveness" in in line 1. There is insufficient antecedent basis for this limitation in the claim.
In Claim 37, it is not clear to which one of the “plurality of biological indicator holder” the limitation “the biological indicator holder” in line 12 is attempting to point to.
In Claim 38, it is not clear what additional structure is being set forth in the claim.
In Claim 54, it is not clear to which one of the “plurality of biological indicator holder” the limitation “the biological indicator holder” in lines 3 and 4 is attempting to point to.
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.
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.
Claim(s) 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Franciskovich (9303283) in view of Pederson (9145573).
As to Claim 37, Franciskovich (‘283) discloses a biological indicator system (600) for detecting effectiveness of a sterilization process (see Figures 1-8), the biological indicator system (600) comprising:
a biological indicator reader (see Figures 4A-6) for reading a plurality of biological indicators (610) to determine the effectiveness of at least a sterilization process, each biological indicator (610) configured to exhibit fluorescence when the sterilization process has failed, the biological indicator reader (see entire document, particularly Figures 1 and 4A-6, Col. 4 lines 28-35, Col. 8 lines 22-67) comprising:
a housing (i.e. body of 600 that contains components such as 400; 502, 504) having a plurality of biological indicator holders (608) (see Figures 4A-6), each of the plurality of biological indicator holders (608) configured to receive one of the plurality of biological indicators (608) (see Figure 6), each biological indicator holder (608; 406) having (see Figures 4A-5C):
a first aperture (412) on a side (see Figure 4A-4B) and a second aperture (i.e. lower end of 406) on a bottom of the biological indicator holder (400) (see Figures 4B-4D);
a heater (512; 114) coupled to the housing (502, 504) (see Figures 5A-5B) and configured to heat the plurality of biological indicator holders (608) to a preselected temperature and a preselected period of time to incubate the plurality of biological indicators (610) (see entire document, particularly Col. 7 lines 1-23, Col. 10 lines 46-50);
a light emitter (118) configured to emit light through the second aperture at the bottom of each biological indicator holder (608) (via 510 - see Figures 1 and 5A); and
an optical detector (122) positioned under the first aperture (412) on the side of each biological indicator holder (608) (via 508 - see Figures 1, 4A-4B and 5A), the optical detector (122) configured to detect an intensity indicating the effectiveness of the sterilization process (see entire document, particularly Col. 8 lines 33-41); and
a biological indicator (610; 110; 300) containing spores (see entire document, particularly Col. 1 lines 31-34, Col. 6 lines 21-39), growth media (112) (see entire document, particularly Col. 6 lines 21-39), and a crushable container (110), the biological indicator (610; 110; 300) being sterilizable and configured to receive light from the light emitter (118) (see Figures 1 and 4A-C).
Franciskovich (‘283) does not appear to specifically teach that the light emitter is an UV light emitter configured to emit IV light through a first aperture on the side of each biological indicator holder, nor that the optical detector is positioned under the second aperture on the bottom of each of the plurality of biological indicator holders.
As to the limitation that the light emitter is an UV light emitter, it was known in the art before the effective filing date of the claimed invention to provide an UV light emitter in a biological indicator system. Pederson (‘573) discloses a biological indicator system (10) (see Figure 1) for detecting effectiveness of a sterilization process, the biological indicator system (10) comprising:
a biological indicator reader (12) for reading a plurality of biological indicators (100) to determine the effectiveness of at least a sterilization process, each biological indicator (100) configured to exhibit fluorescence when the sterilization process has failed, the reader comprising:
a housing (see Figures 1 and 3-5) having a plurality of biological indicator holders (14), each holder configured to receive one of the plurality of biological indicators (100) (see Figures 1-4), each biological indicator holder (14) having:
a heater (21) coupled to the housing and configured to heat the plurality of biological indicator holders (100) to a preselected temperature and a preselected period of time to incubate the biological indicators;
a UV light emitter (47; 72) configured to emit UV light through a first aperture on the side of each biological indicator holder (14) (see entire document, particularly Figures 3-4, Col. 36 lines 39-42); and
an optical detector (49, 55, 75) configured to detect fluorescence intensity indicating the effectiveness of the sterilization process; and
a biological indicator (100) containing spores (115), growth media containing a fluorescent moiety (122) (see entire document, particularly Col. 18 lines 21-60), and a crushable container (102, 120) (see entire document, particularly Col. 11 lines 1-11 and 18-32), the biological indicator (100) being sterilizable and configured to receive UV light from the UV light emitter (see Figures 1-3),
in order to provide an excitation source for the plurality of biological indicators (see entire document, particularly Col. 36 lines 39-42).
It would have been obvious to one of ordinary skill in this art before the effective filing date of the claimed invention to provide an UV light emitter as the light source/emitter in the system of Franciskovich as a known alternate form of a light source in order to be an excitation source for the biological indicators as shown by Pederson.
As to the limitation that the UV light emitter is positioned to emit light through the first aperture on the side of each biological indicator holder and that the optical detector is positioned under the second aperture on the bottom of each of the plurality of biological indicator holders, as Franciskovich (‘283) discloses the opposite configuration, it would have been obvious and well within the purview of one of ordinary skill in the art before the effective filing date of the claimed invention to provide the UV light emitter of Franciskovich as modified by Pederson through the first aperture on the side of each biological indicator holder and the optical detector of Franciskovich as modified by Pederson through the second aperture on the bottom of each biological indicator holder as an alternate configuration as a matter of obvious engineering design choice. Only the expected results would be attained.
As to Claim 38, fluorescence intensity is detected when the UV light emitter (47, 72) of Pederson (‘573) is on and when the UV light emitter (47, 72) of Pederson (‘573) is off, a baseline value for the fluorescence intensity is capable of being obtained (via 51, 62, 66 - see Figures 3-5).
Thus, Claims 37-38 would have been obvious within the meaning of 35 U.S.C. 103 over the combined teachings of Franciskovich (‘283) and Pederson (‘573).
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.
Claim 37 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of US. Patent Application 18/259,830 allowed but not yet assigned U.S. Patent No.. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim 17 of the Patent sets forth all limitations of the claim 37 of the current application.
Allowable Subject Matter
Claim 54 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the primary reason for the indication of allowable subject matter is due to inclusion of limitation that the crusher is “aligned with the biological indicator holders and that receives the crushable container and, upon movement of the crushable container from a first side of the biological indicator holder to a second side of the biological indicator holder, crushes the crushable container, thereby activating the biological indicator”. While prior art of Pederson (9145573) discloses a crusher (13), Pederson (‘573) does not specifically teach that the crusher is “aligned with the biological indicator holders and that receives the crushable container and, upon movement of the crushable container from a first side of the biological indicator holder to a second side of the biological indicator holder, crushes the crushable container, thereby activating the biological indicator”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following references relate either to the field of the invention or subject matter of the invention, but are not relied upon in the rejection of record: 6025189 and WO2006086547 (a biological indicator system).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REGINA M YOO whose telephone number is (571)272-6690. The examiner can normally be reached Monday - Friday, 9:00 am - 5:00 pm EST.
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/REGINA M YOO/ Primary Examiner, Art Unit 1758