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:
Magnetizing element in claims 1 and 3-25. This element is interpreted to correspond to a permanent magnet or an electromagnet per instant PgPub para 52.
Magnetic Field Tracking System in claims 1 and 3-25. No corresponding structure for tracking a magnetic field is disclosed.
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.
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 1 and 3-25 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. Furthermore, Claims 1 and 3-25 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.
Claim limitation “Magnetic Field Tracking System” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Accordingly, 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. Further, since corresponding structure, material, or acts for performing the entire claimed function are not disclosed. the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claims 1 and 3-25 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. Claims 1 and 14 recite, “impart a magnetic field to the portion of the medical device that… is detectable by a magnetic field tracking device.” No explanation is provided in the written description as to what makes a magnetic field so detectable, and would one of ordinary skill in the art could not know by common experience or engineering expertise such a threshold of detectability. This is at least because the applicant has failed to specify a particular magnetic field tracking device such that the intensity of magnetic field necessary for detection might be ascertained. Since the intensity of magnetic field required in the claims is unknown, the claims are rejected as indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3-7, 10, 12, 14-19, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0217307 A1 [Messina].
Regarding Claim 1:
Messina discloses a magnetizer, comprising:
a housing defining a top face, a bottom face and one or more side faces extending therebetween (see Annotated Fig. 4 below);
a cavity disposed within the housing and communicating with an opening disposed in the top face, the opening and the cavity configured to receive a distal portion of a medical device therein (see Annotated Fig. 4 below);
a magnetizing element disposed in a wall of the cavity (this limitation is interpreted under 112(f) supra as corresponding to a permanent magnet, such as is described in para 32 and shown in Annotated Fig. 4 below), the magnetizing element configured to impart a magnetic field to the portion of the medical device (the interaction of magnet (15) with ferromagnetic sheet (9) necessarily leads to magnetization of (9)) that persists after the medical device is removed from the magnetizer (this limitation describes the magnetizing element, i.e. a magnet. Magnetic fields provided by different magnets are not distinguishable in quality, only in strength and distribution. Any magnetic field is able to magnetize a ferromagnetic material to some extent. As such, the above limitation describing the magnetizing element is met by the prior art magnet, since such magnets provide a magnetic field.); and
an irradiation source disposed in the wall of the cavity and configured to direct ultraviolet radiation into the cavity (para 33, see Annotated Fig. 4 below).
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Regarding Claim 3:
Messina discloses the magnetizer according to claim 1, wherein the magnetizing element is configured to imprint a magnetic signature onto the medical device. In that the ferromagnetic sheet (9) receives any magnetization from its interaction with magnet (15), it is imprinted with a magnetic signature.
Regarding Claim 4:
Messina discloses the magnetizer according to claim 1, wherein the irradiation source is configured to emit electromagnetic radiation between a wavelength range of 100-280 nm (para 33).
Regarding Claim 5:
Messina discloses the magnetizer according to claim 1, wherein the irradiation source is configured to emit one or more of UV-A, UV-B, and UV-C radiation (para 33).
Regarding Claim 6:
Messina discloses the magnetizer according to claim 1, wherein the irradiation source is one of a LED bulb, a light bulb, an incandescent bulb, a fluorescent bulb, a fluorescent tube, or a low-pressure mercury-vapor gas-discharge lamp (para 33).
Regarding Claim 7:
Messina discloses the magnetizer according to claim 1, wherein the opening further includes a switching mechanism configured to transition one or both of the magnetizing element and the irradiation source between an activated state and a deactivated state (para 41, claim 18).
Regarding Claim 10:
Messina discloses the magnetizer according to claim 1, wherein a proximal portion of the medical device engages the opening to:
i) align a distal portion of the medical device with a central axis of the cavity (see Annotated Fig. 4 above).
Regarding Claim 12:
Messina discloses the magnetizer according to claim 7, wherein engaging a proximal portion of the medical device with the opening actuates the switching mechanism (claim 18).
Regarding Claim 14:
Messina discloses a method of magnetizing and sterilizing a medical device, comprising:
placing a portion of a medical device into a cavity defined by a housing, the housing defining a top face, a bottom face and one or more side faces extending therebetween (see Annotated Fig. 4 above);
the cavity disposed within the housing and communicating with an opening disposed in the top face (see Annotated Fig. 4 above);
magnetizing the portion of the medical device (the interaction of magnet (15) with ferromagnetic sheet (9) necessarily leads to magnetization of (9)) using a magnetizing element disposed in a wall of the cavity (para 32 and shown in Annotated Fig. 4 above), the magnetizing element configured to impart a magnetic field to the portion of the medical device that persists after the medical device is removed from the magnetizer (Magnetic fields provided by different magnets are not distinguishable in quality, only in strength and distribution. Any magnetic field is able to magnetize a ferromagnetic material to some extent. As such, the above limitation describing the magnetizing a medical device is met by the prior art magnets, since such magnets provide a magnetic field that magnetizes a medical device.); and
sterilizing the portion of the medical device using an irradiation source disposed in a wall of the cavity and configured to direct ultraviolet radiation into the cavity (para 33, see Annotated Fig. 4 above).
Regarding Claim 15:
Messina discloses the method according to claim 14, wherein magnetizing the portion of the medical device includes imprinting a magnetic signature onto the medical device. In that the ferromagnetic sheet (9) receives any magnetization from its interaction with magnet (15), it is imprinted with a magnetic signature.
Regarding Claim 16:
Messina discloses the method according to claim 14, wherein the irradiation source is configured to emit electromagnetic radiation between a wavelength range of 100-280 nm (para 33).
Regarding Claim 17:
Messina discloses the according to claim 14, wherein the irradiation source is configured to emit one or more of UV-A, UV-B, and UV-C radiation (para 33).
Regarding Claim 18:
Messina discloses the method according to claim 14, wherein the irradiation source is one of a LED bulb, a light bulb, an incandescent bulb, a fluorescent bulb, a fluorescent tube, or a low-pressure mercury-vapor gas-discharge lamp (para 33).
Regarding Claim 19:
Messina discloses the method according to claim 14, further including transitioning one or both of the magnetizing element and the irradiation source between an activated state and a deactivated state by a switching mechanism operably coupled with the opening (claim 18).
Regarding Claim 22:
Messina discloses the method according to claim 14, further including engaging a proximal portion of the medical device with the opening to:
i) align a distal portion of the medical device with a central axis of the cavity (see Annotated Fig. 4 above).
Regarding Claim 24:
Messina discloses the method according to claim 19, wherein engaging a proximal portion of the medical device with the opening actuates the switching mechanism (claim 18).
Claims 1, 9, 11, 14, 21, 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 213642120U [Yang].
Regarding Claim 1:
Yang discloses a magnetizer, comprising:
a housing defining a top face, a bottom face and one or more side faces extending therebetween (see Fig. 1);
a cavity disposed within the housing and communicating with an opening disposed in the top face, the opening and the cavity configured to receive a distal portion of a medical device therein (Fig. 1 disinfection bin (3));
a magnetizing element disposed in a wall of the cavity (this limitation is interpreted under 112(f) supra as corresponding to a permanent magnet, such as is described in Fig. 4 magnets (11)) the magnetizing element configured to impart a magnetic field to the portion of the medical device (the interaction of magnet with ferromagnetic material necessarily leads to magnetization thereof ) that persists after the medical device is removed from the magnetizer (this limitation describes the magnetizing element, i.e. a magnet. Magnetic fields provided by different magnets are not distinguishable in quality, only in strength and distribution. Any magnetic field is able to magnetize a ferromagnetic material to some extent. As such, the above limitation describing the magnetizing element is met by the prior art magnet, since such magnets provide a magnetic field.); and
an irradiation source disposed in the wall of the cavity and configured to direct ultraviolet radiation into the cavity (Fig. 1 ultraviolet disinfection lamp (4)).
Regarding Claim 9:
Yang discloses the magnetizer according to claim 1, wherein the medical device includes one of a needle, guidewire, or stylet that includes a magnetizable material. Fig. 3 (12), claim 7.
Regarding Claim 11:
Yang discloses the magnetizer according to claim 1, wherein a proximal portion of the medical device engages the opening in an interference fir engagement to provide a seal therebetween and prevent UV radiation escaping from the cavity (as shown in Fig. 5).
Regarding Claim 14:
Yang discloses a method of magnetizing and sterilizing a medical device, comprising:
placing a portion of a medical device into a cavity defined by a housing, the housing defining a top face, a bottom face and one or more side faces extending therebetween (see Fig. 1, claim 1);
the cavity disposed within the housing and communicating with an opening disposed in the top face (Fig. 1 disinfection bin (3));
magnetizing the portion of the medical device (the interaction of magnet (11) with needle (12) necessarily leads to magnetization, this result is alluded to in claim 7) using a magnetizing element disposed in a wall of the cavity (this limitation is interpreted under 112(f) supra as corresponding to a permanent magnet, such as is described in Fig. 4 magnets (11)), the magnetizing element configured to impart a magnetic field to the portion of the medical device that persists after the medical device is removed from the magnetizer (Magnetic fields provided by different magnets are not distinguishable in quality, only in strength and distribution. Any magnetic field is able to magnetize a ferromagnetic material to some extent. As such, the above limitation describing the magnetizing a medical device is met by the prior art magnets, since such magnets provide a magnetic field that magnetizes a medical device.); and
sterilizing the portion of the medical device using an irradiation source disposed in a wall of the cavity and configured to direct ultraviolet radiation into the cavity (abstract, Fig. 1 (4)).
Regarding Claim 21:
Yang discloses the method according to claim 14, wherein the medical device includes one of a needle, guidewire, or stylet that includes a magnetizable material. Fig. 3 (12), claim 7.
Regarding Claim 23:
The above modified invention teaches the method according to claim 14, further including engaging a proximal portion of the medical device with the opening in a luer lock engagement to provide a seal therebetween and prevent UV radiation escaping from the cavity as (as shown in Fig. 5).
Claims 1, 8, 13, 14, 20, 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0217010 A1 [Whitney].
Regarding Claim 1:
Whitney discloses a magnetizer, comprising:
a housing defining a top face, a bottom face and one or more side faces extending therebetween (see Fig. 1);
a cavity disposed within the housing and communicating with an opening disposed in the top face, the opening and the cavity configured to receive a distal portion of a medical device therein (Fig. 1 (112));
a magnetizing element disposed in a wall of the cavity (this limitation is interpreted under 112(f) supra as corresponding to a permanent magnet, such as is described in paras 26-27 and Fig. 4 (408)as being present on the chamber), the magnetizing element configured to impart a magnetic field to the portion of the medical device (the interaction of magnet with ferromagnetic material necessarily leads to magnetization thereof) that persists after the medical device is removed from the magnetizer (Magnetic fields provided by different magnets are not distinguishable in quality, only in strength and distribution. Any magnetic field is able to magnetize a ferromagnetic material to some extent. As such, the above limitation describing the magnetizing a medical device is met by the prior art magnets, since such magnets provide a magnetic field that magnetizes a medical device.) and
an irradiation source disposed in the wall of the cavity and configured to direct ultraviolet radiation into the cavity (Fig. 3 (122)).
Regarding Claim 8:
Whitney discloses the magnetizer according to claim 1, wherein the opening further includes one of a door or a flap configured to mitigate radiation from the irradiation source escaping from the cavity (Fig. 1 (108B)).
Regarding Claim 13:
Whitney discloses the magnetizer according to claim 1, wherein the irradiation source is disposed between an outer surface of the housing and an inner surface of the cavity (See Fig. 3, wherein (122) is between the outer surface and the article holding surface), the inner surface of the cavity is transparent or translucent (para 27), and the outer surface of the housing is opaque (para 21).
Regarding Claim 14:
Whitney discloses a method of magnetizing and sterilizing a medical device, comprising:
placing a portion of a medical device into a cavity defined by a housing, the housing defining a top face, a bottom face and one or more side faces extending therebetween (see Fig. 1, claim 18);
the cavity disposed within the housing and communicating with an opening disposed in the top face (Fig. 1 (112)).
magnetizing the portion of the medical device (the interaction of magnet (408) with a metal knife (12) necessarily leads to magnetization) using a magnetizing element disposed in a wall of the cavity (this limitation is interpreted under 112(f) supra as corresponding to a permanent magnet, such as is described in Fig. 5 magnets (408)), the magnetizing element configured to impart a magnetic field to the portion of the medical device that persists after the medical device is removed from the magnetizer (Magnetic fields provided by different magnets are not distinguishable in quality, only in strength and distribution. Any magnetic field is able to magnetize a ferromagnetic material to some extent. As such, the above limitation describing the magnetizing a medical device is met by the prior art magnets, since such magnets provide a magnetic field that magnetizes a medical device.); and
sterilizing the portion of the medical device using an irradiation source disposed in a wall of the cavity and configured to direct ultraviolet radiation into the cavity (abstract).
Regarding Claim 20:
Whitney discloses the method according to claim 14, further including closing a door or a flap over the opening to mitigate radiation escaping from the cavity (Fig. 1 (108B)).
Regarding Claim 25:
Whitney discloses the method according to claim 14, wherein the irradiation source is disposed between an outer surface of the housing and an inner surface of the cavity (See Fig. 3, wherein (122) is between the outer surface and the article holding surface), the inner surface of the cavity is transparent or translucent (para 27), and the outer surface of the housing is opaque (para 21).
Response to Arguments
Applicant's arguments filed 12/19/25 have been fully considered but they are not persuasive.
Applicant submits extensive assertions as to magnetic fields, particularly regarding ferromagnetism and paramagnetic. Arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”). MPEP §§ 2145, 2129, 2144.03, 716.01. As such, applicant’s arguments depending from these assertions are not persuasive.
Applicant argues that a “magnetic field tracking system” is explicitly disclosed in the instant specification by the incorporation by reference of a number of patents. However, this limitation invokes 35 USC 112(f). The proper test for meeting the definiteness requirement of a 35 USC 112(f) limitation is that the corresponding structure (or material or acts) of a means- (or step-) plus-function limitation must be disclosed in the specification itself in a way that one skilled in the art will understand what structure (or material or acts) will perform the recited function. See Atmel Corp. v. Information Storage Devices, Inc., 198 F.3d 1374, 1381, 53 USPQ2d 1225, 1230 (Fed. Cir. 1999). The corresponding structure, material, or acts cannot include any structure, material, or acts disclosed only in the material incorporated by reference or a prior art reference. See Pressure Prods. Med. Supplies, Inc. v. Greatbatch Ltd., 599 F.3d 1308, 1317, 94 USPQ2d 1261, 1267 (Fed. Cir. 2010) (stating, "[s]imply mentioning prior art references in a patent does not suffice as a specification description to give the patentee outright claim to all of the structures disclosed in those references."); Atmel Corp. v. Info. Storage Devices, Inc., 198 F.3d 1374, 1381, 53 USPQ2d 1225, 1230 (Fed. Cir. 1999). The disclosure must be reviewed from the point of view of one skilled in the relevant art to determine whether that person would understand the written description to disclose the corresponding structure, material, or acts. Tech. Licensing Corp. v. Videotek, Inc., 545 F.3d 1316, 1338, 88 USPQ2d 1865, 1879 (Fed. Cir. 2008); Med. Instrumentation & Diagnostics Corp. v. Elekta AB, 344 F.3d 1205, 1211-12, 68 USPQ2d 1263, 1269 (Fed. Cir. 2003). One of ordinary skill in the art would not be able to identify the structure, material or acts from description in the specification for performing the recited functions of the “magnetic field tracking system” from the specification itself. As such, the 35 USC 112(f) limitation is indefinite. Further, since the 35 USC 112(f) limitation is found to be indefinite under 35 U.S.C. 112(b) based on failure of the specification to disclose corresponding structure, material or act that performs the entire claimed function, it also lacks adequate written description. See MPEP 2184 IV.
Applicant argues that the requirement for “absolute numbers for the needle magnetic field intensity or the tracking system sensitivity” are extraneous. This is unpersuasive. Applicant has spent pages arguing that the claimed magnetic field is neither anticipated nor obvious by the degree to which it is detectable, but now argues that any objective standard for determining that degree of detectability is unnecessary. Terms of degree will fail for indefiniteness unless they “provide objective boundaries for those of skill in the art” when read in light of the specification and the prosecution history. Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1370–71 (Fed. Cir. 2014), cert. denied, 136 S. Ct. 59 (2015). These claims are rejected for indefiniteness until such an objective boundary for “detectable” is provided.
Applicant argues that the prior art references fail to teach “the magnetizing element configured to impart a magnetic field to the portion of the medical device that persists after the medical device is removed from the magnetizer and is detectable by a magnetic field tracking system.” This is not persuasive. The claim is not directed to the substance being magnetized, but rather to the magnetizing element, i.e., a magnet. All of the prior art references of record include a magnet. Thus, they all produce magnetic fields that could, if used with ferromagnetic materials, impart persistent and detectable magnetizations.
Information Disclosure Statement
Applicant’s arguments regarding the information disclosure statements filed 10/3/25 and 1/28/26 are persuasive. Office personnel, being neither required nor expected to track the number of items submitted1, misjudged the number of references submitted prior to January 19, 2025. Both IDSs are considered herewith.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WYATT A STOFFA whose telephone number is (571)270-1782. The examiner can normally be reached M-F 0700-1600 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ROBERT KIM can be reached at 571 272 2293. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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WYATT STOFFA
Primary Examiner
Art Unit 2881
/WYATT A STOFFA/Primary Examiner, Art Unit 2881
1 https://www.uspto.gov/sites/default/files/documents/quick-reference-guide-to-the-information-disclosure-statement-ids.pdf, FAQ 10.
Prosecution Insights