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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09-19-2025 has been entered.
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 1-2 and 4-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al. (U.S. Pub. 2012/0060626).
Regarding claim 1, Zhu discloses (Figs. 1-4) a method of detecting a change in a lumen (i.e. tube A: see pars. [0052] and [0059]) property of a lumen device (i.e. plugged/blocked: see pars. [0056] and [0059]), the method comprising:
a. obtaining or having obtained a flow measurement for the device to be inspected (i.e. a reference flow value, below which the tube is determined to be plugged: [0059]); and
b. comparing the flow measurement in the device (i.e. the mass flow through tube A: [0059]) to an acceptance range of flow (i.e. the flow is below the reference value: [0059]) obtained for a occluded representative device with a defined level of occlusion (i.e. plugged/blocked flow: [0056]/[0059]);
wherein the lumen property of the device to be inspected (either of tubes A or B) is determined to be changed (i.e. unblocked [0056]/[0059]; see Figs. 3a/b and [0062]) if the flow measurement for the device to be inspected is outside of the acceptance range (i.e. back to full flow after the blockage passes through: see Figs. 3a/b and [0062]; the flow would be above the reference value of a plugged tube: [0059]),
and the lumen property of the device to be inspected is determined to be unchanged (plugged: [0056]) if the flow measurement for the device to be inspected is within the acceptance range (i.e. plugged/obstructed if the flow is below the reference value: [0059]).
Regarding claim 2, Zhu discloses (Figs. 1-4) determining the acceptance range of the occluded representative device (i.e. plugged/obstructed = when the flow is less than a 1:1 ratio, i.e. reduced: [0056]/[0059]).
Regarding claim 4, Zhu discloses (Figs. 1-4) the occluded representative device is an unused originally manufactured device (OM) – (i.e. in an experimental setup before use: [0062]) or a used OM device (i.e. during use of the device: [0059]/[0064]).
Regarding claim 5, Zhu discloses (Figs. 1-4) the change in the lumen property comprises a change in device-specific parts attached along the lumen (i.e. plugged with a rubber plug during an experimental setup: [0062]; implicit that if/when the plug is removed then the flow returns to normal).
Regarding claim 6, Zhu discloses (Figs. 1-4) the change in material of the lumen comprises a change in material caused by intended alteration of the device (i.e. plugged with a rubber plug during an experimental setup: [0062]; implicit that if/when the plug is removed then the flow returns to normal), a defect caused during use of the device (i.e. occlusion/plugging: [0056]/[0059]/[0062]).
Regarding claim 7, Zhu discloses (Figs. 1-4) the change in the dimensions of the lumen comprises an occlusion in the lumen (see pars. [0056]/[0059]/[0062]), or a damaged lumen (i.e. occlusion/plugging: [0056]/[0059]/[0062], which could be considered damage).
Regarding claim 8, Zhu discloses (Figs. 1-4) the change in a property of the device occurred during manufacture (i.e. plugged with a rubber plug during an experimental setup: [0062]) or during use (see pars. [0059]/[0062]).
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 1-3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 10,830,682 and claim 13 of U.S. Patent 12,025,483. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the current application are anticipated by the claims of U.S. Patents ‘682 and ‘483.
Regarding claim 1, U.S. Patents ‘682 and ‘483 claim (see claim 13 of each patent):
A method of detecting a change in a lumen property of a lumen device, the method comprising: (see claim 13 of each patent)
a. obtaining or having obtained a flow measurement for the device to be inspected; and (see claim 13 of each patent)
b. comparing the flow measurement in the device to acceptance range of flow obtained for an occluded representative device with a defined level of occlusion; (see claim 13 of each patent; upper test limit in ‘483)
wherein the lumen property of the device to be inspected is determined to be changed (occluded: see claim 13 of each patent) if the flow measurement for the device to be inspected is outside of the acceptance range (lower than: see claim 13 of each patent),
and the lumen property of the device to be inspected is determined to be unchanged (unoccluded: see claim 13 of each patent) if the flow measurement for the device to be inspected is within the acceptance range (higher than = equal to the criteria: see claim 13 of each patent).
Regarding claim 2, U.S. Patents ‘682 and ‘483 claim (see claim 13 of each patent):
determining the acceptance criteria of the representative device. (see claim 13 of each patent: upper test limit is the acceptance criteria)
Regarding claim 3, U.S. Patents ‘682 and ‘483 claim (see claim 13 of U.S. Patent ‘682 and claim 15 of U.S. Patent ‘483):
the acceptance criteria is determined using a method comprising: (see claim 13 of U.S. Patent ‘682 and claim 15 of U.S. Patent ‘483)
a. obtaining or having obtained a flow measurement for a representative device, wherein the defined level of occlusion includes a defined number of one or more occluding particles; and (see claim 13 of U.S. Patent ‘682 and claim 15 of U.S. Patent ‘483)
b. calculating an upper test limit flow rate for the occluded representative device; (see claim 13 of U.S. Patent ‘682 and claim 15 of U.S. Patent ‘483)
wherein the upper test limit flow rate is the acceptance criteria, and wherein the device to be inspected is determined to be occluded if a flow measurement for the inspected device is equal to or lower than the acceptance criteria, and the inspected device is determined to be unoccluded if the flow measurement in the device to be inspected is higher than the acceptance criteria. (see claim 13 of U.S. Patent ‘682 and claim 15 of U.S. Patent ‘483)
Response to Arguments
Applicant's arguments filed 09-19-2025 have been fully considered but they are not persuasive. Applicant argues that Zhu does not disclose “comparing a flow measurement in the device to be inspected to an acceptance range obtained for an occluded representative device with a defined level of occlusion to determine whether the lumen of the device to be inspected has changed” (Remarks, p. 6) and that “it is clear that Zhu uses a comparison of a clear (e.g., unoccluded) tube (measuring tube A) - before any plugging has occurred - to determine if either of measuring tube A or B are plugged.”
However, the examiner disagrees. Zhu does disclose: comparing a flow measurement [0059] in the device to be inspected (either of tubes A or B) to an acceptance range (is the flow below a reference value of flow: [0059]) obtained for an occluded representative device (i.e. the limit value is predetermined, meaning that a flow value of aplugged tube is known/has been determined) with a defined level of occlusion (plugged: [0059]) to determine whether the lumen of the device to be inspected has changed (see Zhu at par. [0059] “If the subset flow value deviates significantly from the reference value to be expected, especially by more than a predetermined limit value, a plugging of a measuring tube is then detected. Based on the direction of the deviation of the subset flow value from the reference value to be expected, it is additionally determined via electronics 18 which of the measuring tubes A, B is plugged.”) It is also clear from this quote from par. [0059] of Zhu that does use a comparison to a plugged tube to determine if either of measuring tube A or B are plugged.
Therefore, for at least the reasons above, the previous grounds of rejection are maintained.
Conclusion
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/BENJAMIN R SCHMITT/Primary Examiner, Art Unit 2852