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 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 § 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 17 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 17 recites the limitation "the adequate sterilization process" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to amend to, “the sterilization process”. Appropriate action is required.
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 1-13 and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xia (Document Identification No. WO 2020/217173 A1).
Concerning claims 1, 15 & 16, Xia discloses a sterilization system and method, comprising:
A sterilizer (104) having a chamber (112) configured to receive medical devices for sterilization (paragraphs 30-34); and
Providing a sensor (102) device disposed in the chamber (112), and exposing the sensor device to a sterilant in a sterilization process (Figure 1; paragraphs 30-37, 110 & 111);
Wherein the sensor device comprises:
A first electrode and a second electrode (214 and 216), each of the first and second electrodes being electrically coupled to an electrical bridge (208) as set forth in paragraphs 43-46 and 52;
The electrical bridge comprising:
A conductive polymer having a first impedance state and a second impedance state that is different than the first impedance sate (paragraphs 43-45, 48 & 49); and
A latent base (204) as set forth in paragraphs 45 & 57.
Regarding claims 2, 3, 6 and 7, Xia continues to disclose that the conductive polymer is configured to change from the first impedance state to the second impedance state in response to a change and exposure to one or more adequate environmental adequate environmental condition(s) comprising presence of a steam sterilant (paragraphs 47-49 and 111-113).
With respect to claims 4 & 5, the reference also discloses that the latent base (204) is configured to activate upon a change and exposure to an adequate environmental condition (paragraphs 57-59).
Regarding claim 8, Xia continues to disclose that the latent base (204) is disposed relative to the conductive polymer such that upon activation of the latent base (204) the conductive polymer changes from the first impedance state to the second impedance state (paragraphs 45-50).
Concerning claim 9, Xia further discloses that the first and second electrodes (214 and 216) are electrically coupled to the electrical bridge (208) such that when the conductive polymer is in the first impedance state, a first resistance is measurable across the first and second electrode (214 and 216), and when the when the conductive polymer is in the second impedance state a second resistance is measurable across the first and second electrode (214 and 216), and wherein the first resistance is different than the second resistance (paragraphs 43-47).
Concerning claims 10-12, Xia further discloses that the conductive polymer comprises a repeat unit of pyrrole or thiophene, and/or comprises an acid doped polyaniline (paragraph 50).
Regarding claim 13, Xia continues to disclose that the latent base (204) comprises a metal carbonate (paragraphs 57, 77 & 130).
With respect to claim 14, Xia also discloses that the electrical bridge (208) further comprises a polymeric binder and wherein the conductive polymer and latent base (204) are dispersed in the polymeric binder (paragraphs 47-51, 56, 101 and 102).
With respect to claim 17, Xia also discloses that the sterilant comprise at least 95% saturated steam and the adequate sterilization process is at least 132 degrees Celsius for at least 2 minutes or at least 121 degrees Celsius for at least 8 minutes (paragraph 111).
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 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-14 of copending Application No. 18/555,642 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because all of the limitations of claims 1-17 are met by claims 1-4 and 6-14 of the reference application. More specifically, each disclose a sterilization system and method that includes a sterilizer having a chamber configured to receive medical devices for sterilization by providing a sensor device disposed in the chamber, and exposing the sensor device to a sterilant in a sterilization process (claims 11-13 of the reference application). Each further disclose that the sensor device includes a first electrode and a second electrode, wherein each of the first and second electrodes are electrically coupled to an electrical bridge (claim 1 of reference application). Further, each disclose that the electrical bridge includes a conductive polymer having a first impedance state and a second impedance state that is different than the first impedance sate (claim 1 of reference application), and a latent base (as broadly defined, the metal containing particles and/or polymeric binder as set forth in claims 1, 6 & 7 of the reference application will meet the limitations of a latent base).
As such, the obviousness type double patenting rejection exists.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
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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.
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/KEVIN JOYNER/Primary Examiner, Art Unit 1799
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