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 .
Terminal Disclaimer
The terminal disclaimer filed on December 8, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 10,907,126 and U.S. Patent No. 11,965,151 have been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claim 21 is objected to because of the following informalities: In claim 21, “the housing” recited in lines 8-9 should read -- the first enclosure – for consistency. 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 2-6 and 8-13 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 2 recites the limitation "an abutment surface" in line 7. Applicant’s specification defined the abutment surface as “a surface of an object that contacts another object.” See paragraph [0022] of the application publication. The abutment surface rests upon or abuts support of a housing that receives an insert (see paragraph [0053] and [0061]). However, claim 2 requires an abutment surface but does not require a housing. Therefore, it is unclear which surface or element of the claimed method is abutted by the abutment surface. Claims 3-6 and 8-13 are included in this rejection by virtue of their dependency upon a rejected base claim.
Appropriate correction is required.
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) 2-3, 5-6, 8 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillis et al. (already of record; US 2005/0074833; hereinafter “Gillis”).
Regarding claim 2, Gillis discloses a method of using a biological sterilization indicator comprising:
PNG
media_image1.png
635
429
media_image1.png
Greyscale
(a) breaking an ampule to release a liquid (FIG. 1 above: ampoule 20; [0048]); (b) allowing passage of a first volume of the liquid through a first void formed in an insert (sieve (26) including openings in a top surface of the platform and thereby allowing passage of fluid through the platform; see annotated FIG. 1 of Gillis above; [0044]); and (c) allowing passage of a second volume of the liquid through a second void through a portion of a side surface of the insert, the second void being an enclosed opening enclosed by a portion of the side surface and a portion of an abutment surface of the insert (sieve (26) disposed in a firs enclosure of the container (18); sieve (26) includes openings in a side surface and abutment surface (surface abutting element 28 and ampule 20) of the platform and thereby allowing passage of fluid through the sidewall; at least one opening is defined by a portion of the side surface and the abutment surface, i.e., openings at that boundary between the side surface and the abutment surface; see FIG. 1 above; [0044]). Gillis discloses the claimed invention except for the shape of the second void being an angled cut. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the second void of Gillis to have the claimed shape to arrive at the claimed invention. One of ordinary skill in the art would have made said modification for the purpose of achieving desired fluid profile. Further, one of ordinary skill in the art would have made said modification since it has been held that a mere change in shape of an element is generally recognized as being within the level of ordinary skill in art when the change in shape is not significant to the function of the combination (see MPEP 2144.04 IV.B.). Further, one of ordinary skill in the art would have made said modification because said modification would have been a matter of a design choice which a person of ordinary skill in the art would have found obvious.
Regarding claim 3, modified Gillis further discloses wherein the liquid is a growth medium ([0085]).
Regarding claim 5, modified Gillis further discloses wherein the insert is disposed at least partially inside a first enclosure (see FIG.1 of Gillis).
Regarding claim 6, modified Gillis further discloses wherein the insert includes a platform including a top surface, the abutment surface, and the side surface (see FIG. 1 above).
Regarding claim 8, modified Gillis further discloses wherein the angled cut is disposed entirely beneath the top surface (i.e., openings at that boundary between the side surface and the abutment surface; see FIG. 1 above).
Regarding claim 12, modified Gillis further discloses wherein at least a portion of the ampule is disposed inside a first enclosure (see FIG. 1 above).
Regarding claim 13, modified Gillis further discloses wherein the biological sterilization indicator includes a cap having an inner surface and an outer surface, the cap disposed on a portion of the first enclosure (cap 14; see annotated FIG. 1 above).
Claim(s) 4 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillis as applied to claim 2 above, and further in view of Chandrapati et al. (already of record; US 2013/0210048; hereinafter “Chandrapati”).
Regarding claim 4, modified Gillis discloses the method according to claim 2. Modified Gillis does not disclose wherein the method further comprising inhibiting a liquid lock from forming. Chandrapati discloses a method including breaking an ampule ([0157])-[0158]) and inhibiting a liquid lock from forming through a void ([0099], [0176]). In view of Chandrapati, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Gillis to include the step of inhibiting a liquid lock from forming as disclosed by Chandrapati ([0099], [0176]). One of ordinary skill in the art would have made said modification for the purpose of preventing fluid flow blockage through the voids of Gillis.
Regarding claim 11, modified Gillis discloses the claimed insert, and wherein the claimed insert rests within an enclosure (see Gillis at FIG. 1) but does not explicitly disclose wherein the insert includes a leg. Chandrapati further disclose wherein the insert includes a leg. In view of Chandrapati, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the insert of modified Gillis with the insert of Chandrapati to arrive at the claimed invention. One of ordinary skill in the art would have made said modification in order to secure the insert to the housing during the breakage of the ampule, as disclosed by Chandrapati ([0158]). Further, one of ordinary skill in the art would have made said modification because said modification would have been the substitution one known means of resting an insert in an enclosure for another.
Claim(s) 14-17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gillis (already of record; US 2005/0074833) in view of Chandrapati (already of record; US 2013/0210048).
Regarding claim 14, Gillis discloses a method of using a biological sterilization indicator comprising: (a) breaking an ampule at least partially disposed inside a first enclosure to release a
liquid growth medium (FIG. 1 above: ampoule 20; [0048]); (b) allowing passage of a first volume of the liquid growth medium through a first void
formed in an insert at least partially disposed inside the first enclosure (sieve (26) including openings in a top surface of the platform and thereby allowing passage of fluid through the platform; see annotated FIG. 1 of Gillis above; [0044]); and (c) allowing passage of a second volume of the liquid growth medium through a second
void angled cut through a portion of a side surf ace of the insert, the second void being an enclosed opening enclosed by portions of the insert (sieve (26) disposed in the firs enclosure of the container (18); sieve (26) includes openings in the side surface of the platform and thereby allowing passage of fluid through the sidewall; see FIG. 1 above; [0044]). Modified Gillis does not disclose wherein the method further comprising inhibiting a liquid lock from forming. Chandrapati discloses a method including breaking an ampule ([0157])-[0158]) and inhibiting a liquid lock from forming through a void ([0099], [0176]). In view of Chandrapati, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Gillis to include the step of inhibiting a liquid lock from forming as disclosed by Chandrapati ([0099], [0176]). One of ordinary skill in the art would have made said modification for the purpose of preventing fluid flow blockage through the voids of Gillis.
Regarding claim 15, modified Gillis further discloses wherein the insert includes a platform including a top surface, an abutment surface, and the side surface (see FIG. 1 above).
Regarding claim 16, modified Gillis further discloses wherein the second void is enclosed by a portion of the side surf ace and a portion of the abutment surface (sieve (26) disposed in a firs enclosure of the container (18); sieve (26) includes openings in a side surface and abutment surface (surface abutting element 28 and ampule 20) of the platform and thereby allowing passage of fluid through the sidewall; at least one opening is defined by a portion of the side surface and the abutment surface, i.e., openings at that boundary between the side surface and the abutment surface; see FIG. 1 above; [0044]).
Regarding claim 17, modified Gillis further discloses wherein the angled cut is disposed entirely beneath the top surface (i.e., openings at that boundary between the side surface and the abutment surface; see FIG. 1 above).
Regarding claim 20 modified Gillis further discloses wherein the biological sterilization indicator includes a cap having an inner surface and an outer surface, the cap disposed on a portion of the first enclosure (cap 14; see annotated FIG. 1 above).
Allowable Subject Matter
Claim(s) 9-10 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.
Claim 18-19 are 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.
Claim 21 is allowed.
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-21 have been considered but are moot in view of the new ground of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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 on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LIBAN M HASSAN/Primary Examiner, Art Unit 1799