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 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 limitation(s) is/are: an output module configured to process in claim 10. (See 35 USC 112 (a), (b) rejections below).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-35 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims contain subject matter which was not described in the specification in such a way as to reasonably convey one skilled in the relevant art that the inventor had possession to process an harmonic signal and provide a location of the marker as set forth in claim 1.
Claim 27 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. In claim 10 it is set forth an output module configured to process; however, the specification fails to provide what is the element that performs such a processing.
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 16-35 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.
In claims 16, 28, it is unclear which element determines the location of the marker.
In claim 16, it is unclear what is meant by the limitation “from the marker at a second frequency of a second range”.
In claim 23 it is unclear what is meant by the term “preferably <10mm” does this mean that if the marker is 15mm, would not be compatible with the claim language.
In claim 20, the term “substantially” appear to be vague and indefinite.
In claim 27, as set forth above in the 35 USC 112(f) interpretation, since the specification fails to specifically disclose the structure associated to the output module configured to process, such a term is indefinite.
In claim 31 it is unclear what is meant by “receiving the signal from the sense coil”; what element is receiving.
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.
Claim(s) 16, 19, 24, 25, 27-28, 31, 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by von Gutfeld et al. (US 6,230,038, hereinafter Gutfeld).
With respect to claims 16, 28, 31, 32 von Gutfeld discloses a system and method that provides a detection system for locating a marker in a body (see col. 2, line 55 to col. 3, line 2, “The present invention further provides a system for determining the location of a tumor or other internal structure of a living body after implantation, at the aforesaid internal structure, of an element comprising a magnetic material to identify a selected location of the internal structure, the element being capable of emitting a magnetic signal in response to an applied magnetic field. The inventive system comprises: a) a magnetic field generator for irradiating the aforesaid element with an applied magnetic field, b) a movable magnetic field sensor for detecting the aforesaid magnetic signal from a plurality of selected mutually displaced positions to produce a corresponding plurality of element-locating signals, and c) a computing apparatus for converting these signals to a location image of aforesaid tumor or other internal structure”. Further see col. 3, lines 27-63), the detection system comprising:
an implantable marker (see abstract, see col. 3, lines 16-20, “According to a preferred embodiment, the applied magnetic field is an ac field and the element comprises an amorphous magnetic material, said magnetic signal being characterized by non-linear Barkhausen jumps in response to this applied ac magnetic field”.;
at least one drive coil (see coil 4a) arranged to excite the marker with an alternating magnetic field (see abstract, “Preferably, the magnetic element is a length of wire of an amorphous magnetic material which produces a magnetic signal that exhibits non-linear Bark+hausen jumps in response to an applied ac magnetic field.”
and at least one sense coil arranged to detect a signal received from the excited marker (see col. 2, lines 4-6 “Exposure to a low frequency ac magnetic field causes the radiation of non-linear magnetic fields to emanate from the magnetic material which can be detected by one or more externally located pickup coils or other magnetic sensors.;
a magnetic field generator arranged to drive an alternating magnetic field through the at least one drive coil; (see col. 3, lines 55-65, “The inventive system comprises: a) a magnetic field generator for irradiating the aforesaid element with an applied magnetic field,” and
at least one detector configured to receive the signal from the sense coil, wherein the sense coil detects harmonics signal response from the marker at a second frequency of a second range (see col. 6, lines 37-49, “An ac field rather than the dc field can also be applied by the Helmholtz coils, but this will have limited application due to skin depth effects in the ferrous material of element 1. When an ac field is used, a sensor coil 5 can be used to pick up the magnetic signal and if sufficiently non-linear, the applied signal can be filtered leaving only the harmonics from the sphere”; see also switching col. 7, lines 4-14, “A typical wire 1 of length L is shown in FIG. 3a being scanned along its length by a magnetic field sensor comprising pickup coil 5 and voltmeter 5a and the absolute value of the corresponding temporal voltage pulse V.sub.s due to Barkhausen switching is shown in FIG. 3b. Since the wire is extremely anisotropic (so that the applied field H.sub.0 sin wt generally lies in the direction of the wire's axis) it is possible to map the Barkhausen jump field”
With respect to claim 19 von Gutfeld further discloses wherein the implantable marker comprising at least one piece of magnetic material that exhibits a large Barkhausen jump (LBJ) in its magnetization curve is shorter than a critical length required to initiate bistable switching in the LBJ material (see abstract, “Preferably, the magnetic element is a length of wire of an amorphous magnetic material which produces a magnetic signal that exhibits non-linear Bark+hausen jumps in response to an applied ac magnetic field.”.
With respect to claim 24 von Gutfeld further discloses wherein the LBJ material is coated or provided within a hollow tube (see Fig. 4a, col. 4, lines 51-52).
With respect to claim 25 von Gutfeld further discloses wherein the marker is deployable from an initial, compact configuration to an extended, deployed configuration (see Fig. 4B, col. 7, lines 31-39).
With respect to claim 27 von Gutfeld further discloses comprising an output module for processing the received harmonic signal and providing at least one indicator to the user relating to a location of the marker relative to the sense coil (see element 6, Fig. 6, computing apparatus).
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 17, 18, 29, 30 are rejected under 35 U.S.C. 103 as being unpatentable over von Gutfeld et al. (US 6,230,038, hereinafter Gutfeld) in view of Hattersley (WO 2014/140566).
Von Gutfeld discloses the system as disclosed above, but fails to explicitly teach
wherein the first frequency is between 10kzh and 40khz or the second frequency is less than 100khz.
Hattersley discloses wherein the first frequency is between 10kzh and 40khz or the second frequency is less than 100khz (see para 0048).
It would have been obvious to one skilled in the art before the effective filling date to modify von Gutfeld to wherein the first frequency is between 10kzh and 40khz or the second frequency is less than 100khz as disclosed by Hattersley because doing so will allow for improve detection of the magnetic marker.
Claims 22, 23, 35 are rejected under 35 U.S.C. 103 as being unpatentable over von Gutfeld et al. (US 6,230,038, hereinafter Gutfeld) in view of Hattersley (WO 2014/140566), as applied to claim 17 above, in view of Susuma et al. “Dependence of large barkhousen jump on length of a vicoalloy fine wire with torsion stress” IEE Transactions on magnetics Vol. 34, July 1998.
Von Gutfeld discloses the system as disclosed above, but fails to explicitly teach
wherein the implantable marker comprising at least one piece of magnetic material that magnetisation curve comprises less than 5mg of LBJ material and lenght.
Susuma discloses having a magnetic sensor coil vicalloy wire in which a vicoalloy wire is excited through magnetic field and such a wire can be as small as 7mm in length and 0.1mm in diameter (see abstract, see Experimental method, pg. 1312, second column). Such a wire of 7mm in length wich 0.1mm in diameter with the density of the vicoalloy wire will provide a weight less than 5mg.
Therefore, it would have been obvious to one skilled in the art before the effective filling date to provide such a wire as disclosed by Susuma because doing so will allow for miniaturization of the magnetic sensor (see Introduction) while maintaining a stable measurement (see conclusion).
Claims 20, 33 are rejected under 35 U.S.C. 103 as being unpatentable over von Gutfeld et al. (US 6,230,038, hereinafter Gutfeld) in view of Hattersley (WO 2014/140566), in view of Richardson (US 4,222,517)
Von Gutfeld discloses the system as disclosed above, but fails to explicitly teach
comprises pieces of magnetic material substantially along at least orthogonal axes x, y z.
Richardson discloses a method and apparatus for a magnetic marker and further “The magnetic marker includes a signal strip of ferromagnetic material of low coercivity which has a relatively long length as compared to a narrow width. A plurality of control elements of ferromagnetic material of relatively higher coercivity are coupled at intervals along the length of the signal strip. Each of the control elements may be magnetized for magnetically saturating adjacent sections of the signal strip for precluding the radiation of the higher level harmonic frequencies. Each of the control elements has a width generally equal to the width of the signal strip, and the control elements are spaced from each other along the length of the signal strip. A method for manufacturing the magnetic marker is also provided.” (co.4, lines 1-12)
It would have been obvious to one skilled in the art before the effective filling date to modify von Gutfeld for the marker to have pieces of magnetic material substantially along at least orthogonal axes x, y z as disclosed in Richardson because doing so will allow the determination of a stable measurement using an expanded range of frequencies which will therefore increase the options of magnetic field generators that could be use to detect the magnetic marker in the body.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over von Gutfeld et al. (US 6,230,038, hereinafter Gutfeld) in view of Chi Sing et al. (US 2011/0313288, hereinafter Chi Sing)
Von Gutfeld discloses the system as disclosed above, but fails to explicitly teach
wherein at least one of the drive and sense coils is provided in a handheld probe.
Chi Sing discloses an apparatus and method for locating markers structures within the body in which the drive emission coil and sense receiver coil is located in a probe (see Fig. 3, see para. 0107).
It would have been obvious to one skilled in the art before the effective filling date to modify von Gutfeld to incorporate the driver and sense coils within a probe because doing so will allow for the elements to be portable and therefore increasing benefits to the patient such as having a faster diagnosis since the could get to the patient instead of the other way around or the benefit of not having to move an injured patient to get a standard system, but the portable can be used.
Examiner’s Comment
Claims 21, 34 are not rejected under prior art since the current prior art fails to disclose the subject matter. However, rejections under 35 USC 112(a) and (b) are still currently outstading.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M SANTOS RODRIGUEZ whose telephone number is (571)270-7782. The examiner can normally be reached Monday-Friday 8:30am to 5:30pm.
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/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3793