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 .
Response to Arguments
In response to the previous Restriction/Election Requirement dated 01/22/2026, the Applicant’s arguments have been fully considered, but are not persuasive for the following reason.
Regarding the Restriction (i.e. Groups I and II) the Applicant argued that there is no serious search burden because both inventions are classified in the same class A61B 18/00. The Examiner respectfully disagrees. Group I is directed to a device adapted to induce a “narrowing spasm in the vessel”, whereas Group II is directed to a method that “cause ablation of the artery feeding the tumor.” These are unrelated functions that require different structures that are not obvious variants and do not share overlapping features.
Regarding the Species election (i.e. Species 1-9), the Applicant argued that there is no serious search burden since the Examiner has not distinctly grouped each of the Specifies under different class/subclasses. This argument is not persuasive. Each of the above identified Species corresponds to a different drawing Figures. 2-5 corresponding to a structurally different distal tip. Similarly, the Applicant’s own Specification [0032-0038] refers to each of these drawings as different embodiments which are not capable of being used together in a single device. In view of this, there is a serious search burden because these various different embodiments have different status in the claim due to their recognized divergent subject matter.
In view of the above, the Examiner maintains both Restriction and Election Requirements.
Claim Status
Claims 6-7, 9-12, 17-19, 21-26 and 38 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species Groups 1-2 and 4-9, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/22/2026.
Claims 6-7, 9-12, 17-19, 21-26 and 38 are withdrawn, and claims 1-5, 8, 13-16, 20, 27-37 are examined below.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“spasm-inducing system” in claim 1.
“actuator” in claim 15
“actuatable probe” in claim 29
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 15 is objected to because of the following informalities: Claim 15, clause c) has the following typographical error “whereupon”. 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.
Claim 3 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 3 is recites the limitation "the emitter" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 5, 8, 13-16, 20, 27-29 and 33-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zikorus et al. US 2009/0125009 A1 (hereinafter “Zikorus”, cited in Applicant’s IDS).
Regarding claim 1, Zikorus teaches a therapeutic system (abstract and Fig. 1) for treatment in a vessel of a patient (see [0028] “FIG. 1 is a schematic view of one embodiment of a device for ligating a hollow anatomical structure (HAS), including a handle and connections”, HAS is interpreted as “vessel” in the claims), comprising:
a) a catheter (catheter 10) having a proximal end (Fig.1, the end annotated by handle 14) and a distal end (Fig.1: distal end annotated tip 36) with a distal tip (as shown in Fig. 2), a first lumen (Fig. 2 illustrates a plurality of lumens, this is analogous to Fig. 32: lumens 575; see [0149, 0215]) defined from the proximal end and extending to the distal tip and opening at a distal orifice passing through the distal tip (see distal tip shown in Fig. 2); and
b) a spasm-inducing system ([0016, 0203] HAS treatment device) including an activatable probe (capacitive element/structure as discussed in Figs. 30-35 and [0143, 0214, 0203], the capacitive element comprising electrodes/leads and energy element that are activatable by an energy supply to generate electric fields and apply heat to treat tissue) at the distal end of the catheter ([0016] capacitive element is an elongate structure near the distal end of catheter; also see [0203: last sentence]) , which when activated is adapted to induce a narrowing spasm in the vessel (see [0023] “Energy can then be applied from the leads to create a heating effect in the surrounding tissue of the anatomical structure. The diameter of the hollow anatomical structure is reduced by the heating effect, and the electrodes of the primary leads are moved closer to one another as the diameter reduces.” Also see [0236] and [0326], causing reduction in diameter is taken to encompass “narrowing spasm in the vessel”).
Regarding claim 2, Zikorus teaches the therapeutic system of claim I, wherein the distal tip protrudes beyond the probe. (see Fig. 38 and [0238] it is shown that the distal tip of catheter expends beyond the electrodes of the capacitive element, i.e. “probe”- which is annotated 704)
Regarding claim 5, Zikorus teaches the therapeutic system of claim 1, further comprising a hub (Fig. 1: handle 14 is interpreted as “hub” in this claim) at the proximal end of the catheter (catheter 10).
Regarding claim 8, Zikorus teaches the therapeutic system of claim 1, wherein the probe of the spasm-inducing system (HAS treatment device) is adapted to emit chemicals. ([0132: 1st sentence] “HAS treatment device configured to emit steam through a plurality of openings along a portion of its length.” Also see Figs. 10-14 illustrates openings 95 for infusing fluid into tissue, also see [0123 and Table 1] regarding other chemical fluids regarding chemical fluids compatible with the disclosed HAS treatment device and [0232-0234] for infusing other venoconstrictors)
Regarding claim 13, Zikorus teaches the therapeutic system of claim 1, wherein the catheter defines a second lumen opening at or adjacent the probe. (see Fig. 32: illustrates four lumens 575; also see [0215] “FIG. 32, the device 550 can comprise one or more substantially hollow lumens 575 to provide internal space for a guidewire, fluid infusion, optical fibers, or another purpose.”)
Regarding claim 14, Zikorus teaches the therapeutic system of claim 13, wherein the second lumen (see Fig. 32: illustrates four lumens 575) opens to disperse an infuscate radially relative to the catheter. (also see [0215] “FIG. 32, the device 550 can comprise one or more substantially hollow lumens 575 to provide internal space for a guidewire, fluid infusion, optical fibers, or another purpose.” Also see [0123 and Table 1] regarding chemical fluids compatible with the disclosed HAS treatment device and [0232-0234] for infusing other venoconstrictors; and Figs.10, 14-15 regarding openings 95 on the catheter shaft for dispending fluids radially relative to the catheter)
Regarding claim 15, Zikorus teaches a therapeutic system (abstract and Fig. 1) for treatment in a vessel of a patient (see [0028] “FIG. 1 is a schematic view of one embodiment of a device for ligating a hollow anatomical structure (HAS), including a handle and connections”, HAS is interpreted as “vessel” in the claims), comprising:
a) a catheter (catheter 10) having a proximal end (Fig.1, the end annotated by handle 14) and a distal end (Fig.1: distal end annotated tip 36) with a distal tip (as shown in Fig. 2), a first lumen (Fig. 2 illustrates a plurality of lumens, this is analogous to Fig. 32: lumens 575; see [0149, 0215]) defined from the proximal end and extending to the distal tip and opening at a distal orifice passing through the distal tip (see distal tip shown in Fig. 2); and
b) a probe (HAS treatment device-capacitive element/structure as discussed in Figs. 30-35 and [0143, 0214, 0203], the capacitive element activatable by an energy supply to generate electric fields and apply heat to treat tissue) at the distal end of the catheter ([0016] capacitive element is an elongate structure near the distal end of catheter; also see [0203: last sentence]); and
c) an actuator (controller, [0135: last sentence], and also see [0304: last sentence] and [0306] controller 1220 controlling energy source to supply heat to HAS device) for activating the probe, whereupon activation of the probe, the probe is adapted to cause a physical change in the vessel. (See [0023] “Energy can then be applied from the leads to create a heating effect in the surrounding tissue of the anatomical structure. The diameter of the hollow anatomical structure is reduced by the heating effect, and the electrodes of the primary leads are moved closer to one another as the diameter reduces.” Also see [0236] and [0326]. In here reducing diameter is interpreted to encompass “cause a physical change in the vessel” in the claim)
Regarding claim 16, Zikorus teaches the therapeutic system of claim 15, wherein activation of the probe is adapted to cause a narrowing spasm in the vessel. (see [0023, 0236, 0326] causing reduction in diameter is taken to encompass “narrowing spasm in the vessel”)
Regarding claim 20, Zikorus teaches the therapeutic system of claim 15, wherein the probe (HAS treatment device) is adapted to emit chemicals. ([0132: 1st sentence] “HAS treatment device configured to emit steam through a plurality of openings along a portion of its length.” Also see Figs. 10-14 illustrates openings 95 for infusing fluid into tissue, also see [0123 and Table 1] regarding other chemical fluids regarding chemical fluids compatible with the disclosed HAS treatment device; and [0232-0234] for infusing other venoconstrictors)
Regarding claim 27, Zikorus teaches the therapeutic system of claim 15, wherein the catheter is provided with a second lumen opening at or adjacent the probe. (see Fig. 32: illustrates four lumens 575; also see [0215] “FIG. 32, the device 550 can comprise one or more substantially hollow lumens 575 to provide internal space for a guidewire, fluid infusion, optical fibers, or another purpose.”)
Regarding claim 28, Zikorus teaches the therapeutic system of claim 27, wherein the second lumen opens to disperse an infusate radially relative to the catheter. (Also see [0215] “FIG. 32, the device 550 can comprise one or more substantially hollow lumens 575 to provide internal space for a guidewire, fluid infusion, optical fibers, or another purpose.” Also see [0123 and Table 1] regarding chemical fluids compatible with the disclosed HAS treatment device, and [0232-0234] for infusing other venoconstrictors; also see Figs.10, 14-15 regarding openings 95 on the catheter shaft for dispending fluids radially relative to the catheter.)
Regarding claim 29, Zikorus discloses a method of therapeutic treatment (abstract, Fig.1, and [0028] “FIG. 1 is a schematic view of one embodiment of a device for ligating a hollow anatomical structure (HAS), including a handle and connections”, HAS is interpreted as “vessel” in the claims comprising:
a) providing a catheter (catheter 10) having a proximal end (Fig.1, the end annotated by handle 14) and a distal end (Fig.1: distal end annotated tip 36) with a distal tip (as shown in Fig. 2), and a lumen (Fig. 2 illustrates a plurality of lumens, this is analogous to Fig. 21: lumen 186- fluid cavity, see [0150]) extending from the proximal end to the distal end and opening at a distal orifice passing through the distal tip (see distal tip shown in Fig. 2), the catheter provided with an actuatable probe ([0016, 0203] HAS treatment device-capacitive element/structure as discussed in Figs. 30-35 and [0143, 0214, 0203], the capacitive element comprising electrodes/leads and energy element that are activatable by an energy supply to generate electric fields and apply heat to treat tissue) at the distal end of the catheter ([0016] capacitive element is an elongate structure near the distal end of catheter; also see [0203: last sentence]);
b) advancing the distal end of the catheter into a vessel; (see Figs.6-9, illustrating advancing distal 36 into HAS, and providing treatment, e.g. Figs. 6-7 is before treatment, and Figs. 8-9 is after treatment, also see [0129-0130])
c) actuating the probe to cause the vessel to narrow about the probe ((see [0023] “Energy can then be applied from the leads to create a heating effect in the surrounding tissue of the anatomical structure. The diameter of the hollow anatomical structure is reduced by the heating effect, and the electrodes of the primary leads are moved closer to one another as the diameter reduces.” Also see [0236] and [0326]); and
d) infusing a therapeutic agent (see [0123 and Table 1] regarding other chemical fluids regarding chemical fluids compatible with the disclosed HAS treatment device; and [0232-0234] for infusing other venoconstrictors) through the lumen (lumen 186- fluid cavity, see [0150]) and out of the distal orifice into the vessel while the vessel is narrowed about the probe to a location distal of the narrowing in the vessel ([0138: 2nd sentence] “the energy element 81 comprises only a single distal opening such that fluid may exit through only the very distal tip of the energy element 81.”).
Regarding claim 33, Zikorus teaches the method of claim 29, wherein the therapeutic treatment is to treat internal bleeding. (Zikorus [0232] application of adhesive and/or venoconstrictor is a treatment for or internal bleeding)
Regarding claim 34, Zikorus teaches the method of claim 33, wherein the therapeutic agent is one of a gelfoam, a glue embolic, a liquid embolic, an embolic coil, and embolic beads. (Zikorus [0232] “The lumen may be used for fluid delivery such as saline, a venoconstrictor, sclerosant, high-impedance fluid, adhesive, hydrogel, or the like”; also see [0232-0234])
Regarding claim 35, Zikorus discloses the method of claim 29, wherein the narrowed vessel constricts into contact with the probe. (See Figs. 8-9 and [0129-0130])
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.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Zikorus as applied to claim 1 above, and further in view of Hunter et al. US 2005/0149175 A1 (hereinafter “Hunter”),
Regarding claims 3 and 4, Zikorus teaches the therapeutic system of claim 1, Zikorus does not disclose the system further comprising at least one marker provided in association with the emitter to identify the location of the probe under imaging and wherein the at least one marker is radio-opaque. However, this would have been an obvious modification, because it is necessary for a physician to locate the HAS treatment device and its relative to the patient’s vessel to properly perform a medical procedure.
Alternatively, Hunter, another prior art reference in analogous art discloses an intravascular device for injecting a therapeutic agent, in which the carrier, such as an intra-arterial catheter ([0021: 2nd sentence]) comprises radio-opaque marking bands or magnetic resonance imaging (MRI) responsive materials (i.e., MRI contrast agents) to aid in visualization of the device under ultrasound, fluoroscopy and/or MRI ([0259: 1st sentence], also see [0385]). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Zikorus in view of Hunter to modify the catheter to include radio-opaque markers that are visible under imaging, to aid in visualization of the device during a medical procedure.
Claims 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Zikorus as applied to claim 29 above, and further in view of Raabe et al. US 2010/0217313 A1 (hereinafter “Raabe”).
Regarding claim 30, Zikorus discloses a device and method for applying energy to a reduce a diameter of a vessel, as disclosed in the method of claim 29, including infusing a therapeutic agent into a treatment site in the vessel (see Table 1); but does not disclose wherein the therapeutic agent is infused from the vessel toward a tumor. However, Raabe, another prior art reference in the analogous art for treat, discloses a method and device for treating venous insufficiency in which the vein is compressed at least partially along a treatment zone, including applying a therapeutic agent is infused from the vessel toward a tumor ([0027] and [0039] “embolization of tumors”). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Zikorus at the time of invention in view of Raabe to use the HAS treatment device of Zikorus for infusing a therapeutic agent towards a tumor, the motivation is for modifying Zikorus’s HAS treatment device to constrict vessel tissue and to also treat tumor without swapping to catheters.
Regarding claim 32, Zikorus modified discloses the method of claim 29 comprising infusing a therapeutic agent to constrict a vein ([0232-0234]), but does not disclose wherein the infusing comprising multiple infusions spaced apart in time. However, Raabe, another prior art reference in the analogous art for treat, discloses a method and device for treating venous insufficiency in which the vein is compressed at least partially along a treatment zone, including applying a therapeutic agent to compress a vein at interval ([0033] “releasing periodic boluses of vein-occluding substance at specified time and/or distance intervals… the injector includes a safety feature, such as an electronic lockout that prevents unintended multiple bolus injections of glue within a specified period of time, such as, for example, requires that bolus injections be spaced apart by at least about 0.5, 1, 2, 3, 4, 5 seconds, or more”). Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Zikorus in view of Raabe, so as to infuse venoconstrictor at customized doses and intervals; the motivation for doing so is for maintain controlled injection rate that is relatively constant throughout a medical procedure (Raabe [0033])
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Zikorus as applied to claim 29 above, and further in view of Raabe et al. US 2010/0217313 A1 (hereinafter “Raabe”).
Regarding claim 31, Zikorus does not discloses wherein between the distal end of the catheter and the tumor, the vessel branches to healthy vasculature and tumor vasculature, and after activating the probe and before infusing the therapeutic agent, causing the healthy vasculature to narrow more than the tumor vasculature. However, this would have been obvious to a person of ordinary skill in the art in cancer treatment, because Zikorus discloses in [0236] “Reducing the intra-luminal diameter of the vein can decrease the distance between the vein wall and the energy delivering device to increase the efficiency and uniformity of energy delivery to the vein wall. The vein can then be treated with the RF electrode element to further shrink the vein.” (Also see Zikorus: [0235] “Compression methods can include external mechanical means to achieve compression, such as, for example, tumescent anesthesia, manual compression, vessel collapsing mechanisms that include spreadable opposed elements, reciprocating jaw mechanisms having penetrating elements, and devices for applying negative pressure to collapse the blood vessel.”)
Claims 36 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Zikorus as applied to claim 29 above, and further in view of Parry et al. US 2010/0189654 A1 (hereinafter “Parry”).
Regarding claims 36 and 37, Zikorus discloses the method of claim 29, including infusing a therapeutic agent to constrict a vein ([0232-0234]), but does not disclose after infusing the therapeutic agent, dilating the narrowed vessel and wherein the dilating includes introducing a vasodilator to the narrowed vessel.
Parry, another prior art reference in the field of evaluating the effect of a compound on vasomotor response in vivo, comprising: determining a baseline diameter of a vessel lumen, then administering a vasoconstrictor, followed by administration of a vasodilator ([0012-0013]). These steps allow for determining the effect of the compound (i.e. vasoconstrictor) on the changes in baseline diameter of the vessel in response to the vasodilator by measuring again the diameter of the vessel lumen. Based on these steps taught by Parry, it would have been obvious to a person of ordinary skill in the art at the time of invention to modify Zikorus in view of Parry, to first infuse a vasoconstrictor to constrict a vein, followed by infusing a vasodilator; the motivation would be to find a particular patient’s vasomotor response to a particular vasoconstrictor therapeutic agent so amount/dosage of vasoconstrictor agent can be determined for a particular medical procedure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
March 21, 2026