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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group 1, claim(s) 1-2 and 16-19, drawn to details of a magnetic system of an imaging system.
Group 2, claim(s) 1 and 3-8, drawn to an imaging system and details of the waveguide thereof.
Group 3, claim(s) 1, 9-13 and 15, drawn to an imaging system and details of an extension thereof.
Group 4, claim(s) 1, 10 and 14, drawn to an imaging system having ultrasound.
Group 5, claim(s) 1 and 20, drawn to an imaging system having a spring about the waveguide.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The common technical feature uniting groups 3-4 is an imaging system, comprising: a power source; a catheter having a proximal end and a distal end and defining a lumen therebetween; and an imaging assembly including a proximal portion and a distal portion disposed within the lumen adjacent to the distal end of the catheter, the imaging assembly comprising: a waveguide centered in the imaging assembly and extending a length of the catheter, at least one permanent magnet positioned in the proximal portion of the imaging assembly and disposed radially around the waveguide, an optical element coupled to an outer surface of the at least one permanent magnet, the optical element being disposed beyond the distal portion of the imaging assembly and into the distal end of the catheter, and one or more electromagnetic coils positioned in the proximal portion of the imaging assembly radially outward from the at least one permanent magnet and in electrical communication with the power source, further comprising an extension coupling the optical element to the outer surface of the one or more permanent magnet. (this is applicant’s claims 1 and 10)
This element cannot be a special technical feature under PCT rule 13.2 because the element is shown in the prior art. Yamazaki et al. (US 2015/0320318) Yamazaki discloses an imaging system, comprising:
a power source [the power source supplying cable 14a, Fig.1, para.41, 72];
a catheter [the optical imaging probe of Fig.1 and nondepicted parts of 70, Fig.1, para.11] having a proximal end [proximal end of 70, para.41] and a distal end [61-62, Fig.1] and defining a lumen [interior of the optical imaging probe, Fig.1] therebetween; and
an imaging assembly [portions of the imaging optical probe within 42 to 82, Fig.1, para.35] including a proximal portion [portions proximal to 21, Fig.1] and a distal portion [21, Fig.1, para.60] disposed within the lumen adjacent to the distal end of the catheter, the imaging assembly comprising:
a waveguide [30, 31, Fig.1, para.35, 63] centered in the imaging assembly and extending a length of the catheter,
at least one permanent magnet [11, Fig.1, para.35, 38] positioned in the proximal portion of the imaging assembly and disposed radially around the waveguide,
an optical element [60, Fig.1, para.35] coupled to an outer surface of the at least one permanent magnet [via shaft 20, Fig.1], the optical element being disposed beyond the distal portion of the imaging assembly and into the distal end of the catheter [Fig.1], and
one or more electromagnetic coils [12, Fig.1, para.37, 40-41, 72] positioned in the proximal portion of the imaging assembly radially outward from the at least one permanent magnet and in electrical communication with the power source
further comprising an extension [20, Fig.1, para.35, 74, indirectly to the circumferentially outer surface of the magnet, at least indirectly to other surfaces of the magnet] coupling the optical element to the outer surface of the one or more permanent magnet.
The common technical feature uniting groups 1 with 2 with 3-4 with 5 together is an imaging system, comprising: a power source; a catheter having a proximal end and a distal end and defining a lumen therebetween; and an imaging assembly including a proximal portion and a distal portion disposed within the lumen adjacent to the distal end of the catheter, the imaging assembly comprising: a waveguide centered in the imaging assembly and extending a length of the catheter, at least one permanent magnet positioned in the proximal portion of the imaging assembly and disposed radially around the waveguide, an optical element coupled to an outer surface of the at least one permanent magnet, the optical element being disposed beyond the distal portion of the imaging assembly and into the distal end of the catheter, and one or more electromagnetic coils positioned in the proximal portion of the imaging assembly radially outward from the at least one permanent magnet and in electrical communication with the power source. (this is the text of claim 1)
This element cannot be a special technical feature under PCT rule 13.2 because the element is shown in the prior art. Yamazaki et al. (US 2015/0320318) Yamazaki discloses an imaging system, comprising:
a power source [the power source supplying cable 14a, Fig.1, para.41, 72];
a catheter [the optical imaging probe of Fig.1 and nondepicted parts of 70, Fig.1, para.11] having a proximal end [proximal end of 70, para.41] and a distal end [61-62, Fig.1] and defining a lumen [interior of the optical imaging probe, Fig.1] therebetween; and
an imaging assembly [portions of the imaging optical probe within 42 to 82, Fig.1, para.35] including a proximal portion [portions proximal to 21, Fig.1] and a distal portion [21, Fig.1, para.60] disposed within the lumen adjacent to the distal end of the catheter, the imaging assembly comprising:
a waveguide [30, 31, Fig.1, para.35, 63] centered in the imaging assembly and extending a length of the catheter,
at least one permanent magnet [11, Fig.1, para.35, 38] positioned in the proximal portion of the imaging assembly and disposed radially around the waveguide,
an optical element [60, Fig.1, para.35] coupled to an outer surface of the at least one permanent magnet [via shaft 20, Fig.1], the optical element being disposed beyond the distal portion of the imaging assembly and into the distal end of the catheter [Fig.1], and
one or more electromagnetic coils [12, Fig.1, para.37, 40-41, 72] positioned in the proximal portion of the imaging assembly radially outward from the at least one permanent magnet and in electrical communication with the power source
During a telephone conversation with Thomas J. Keating on 22 June, 2026 a provisional election was made without traverse to prosecute the invention of Group 1, claims 1-2 and 16-19. Affirmation of this election must be made by applicant in replying to this Office action. Claims 3-15 and 20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species or invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention or species may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected invention or species.
Should applicant traverse on the ground that the inventions have unity of invention (37 CFR 1.475(a)), applicant must provide reasons in support thereof. Applicant may submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. Where such evidence or admission is provided by applicant, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
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.
Claims 1-2 and 16-19 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 pre-AIA the applicant regards as the invention.
In regards to claim 1, the claim reads “an imaging assembly including a proximal portion and a distal portion disposed within the lumen” [lines 4-5]. Here, it is unclear if the imaging assembly is disposed in the lumen or if the distal portion is disposed in the lumen. Therefore, the claim is unclear. For the purposes of prosecution, it will be assumed that the latter is the case.
In regards to claim 1, the claim reads “an imaging assembly including a proximal portion and a distal portion” [line 4] and “the imaging assembly comprising… an optical element… the optical element being disposed beyond the distal portion of the imaging assembly” [lines 5, 10-12]. Here, this could be interpreted to be self-contradicting, requiring some of the imaging assembly to be distal to itself. Alternatively this could be understood to mean that “distal portion” is an obvious drafting error or an empty title, merely being a portion of the imaging assembly besides the proximal portion. Therefore, the claim is unclear. For the purposes of prosecution, it will be assumed the latter is the case.
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 and 16-18 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Yamazaki et al. (US 2015/0320318).
In regards to Claim 1, Yamazaki discloses an imaging system, comprising:
a power source [the power source supplying cable 14a, Fig.1, para.41, 72];
a catheter [the optical imaging probe of Fig.1 and nondepicted parts of 70, Fig.1, para.11] having a proximal end [proximal end of 70, para.41] and a distal end [61-62, Fig.1] and defining a lumen [interior of the optical imaging probe, Fig.1] therebetween; and
an imaging assembly [portions of the imaging optical probe within 42 to 82, Fig.1, para.35] including a proximal portion [portions proximal to 21, Fig.1] and a distal portion [21, Fig.1, para.60] disposed within the lumen adjacent to the distal end of the catheter, the imaging assembly comprising:
a waveguide [30, 31, Fig.1, para.35, 63] centered in the imaging assembly and extending a length of the catheter,
at least one permanent magnet [11, Fig.1, para.35, 38] positioned in the proximal portion of the imaging assembly and disposed radially around the waveguide,
an optical element [60, Fig.1, para.35] coupled to an outer surface of the at least one permanent magnet [via shaft 20, Fig.1], the optical element being disposed beyond the distal portion of the imaging assembly and into the distal end of the catheter [Fig.1], and
one or more electromagnetic coils [12, Fig.1, para.37, 40-41, 72] positioned in the proximal portion of the imaging assembly radially outward from the at least one permanent magnet and in electrical communication with the power source.
In regards to claim 16, Yamazaki discloses the imaging system of claim 1, wherein the electromagnetic coils are in electrical communication with the power source via one or more wires [14a, Fig.1, para.35, 72].
In regards to claim 17, Yamazaki discloses the imaging system of claim 1, wherein the electromagnetic coils generate a magnetic field when a current is supplied by the power source [para.37-38, 40, 42].
In regards to claim 18, Yamazaki discloses the imaging system of claim 17, wherein the at least one permanent magnet and optical element rotate based on a strength and a frequency of the magnetic field [para.37: this is how electric motors work].
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Yamazaki et al. (US 2015/0320318) in view of Iwami et al. (US 2006/0055266).
In regards to claim 1, Yamazaki discloses the imaging system of claim 1, however does not positively disclose wherein the at least one permanent magnet comprises a ring magnet.
Yamazaki additionally discloses wherein the at least one permanent magnet is an inner rotor of an inner rotor electric motor [Fig.1, para.37-38].
Iwami teaches that magnets used in inner rotors of electric motors may be ring magnets [para.4].
Therefore, it would have been obvious to one having ordinary skill in the art to modify the at least one permanent magnet disclosed by Iwami to be a ring magnet in accordance with the teaching of Iwami. This would be done as Iwami teaches that this is known in the art.
Allowable Subject Matter
Claim 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112, 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: The prior art fails to teach, among other features, an imaging system comprising:
a catheter, an imaging assembly and a power source,
the catheter with a lumen between proximal and distal ends of the catheter,
an assembly having proximal and distal portions, the distal portion in the lumen near the distal end of the catheter,
the imaging assembly comprising a waveguide, a permanent magnet, an optical element, an electromagnetic coil and a back iron.
the waveguide centered in the assembly,
the permanent magnet in the proximal portion and disposed radially around the waveguide,
the optical element coupled to an outer surface of the permanent magnet, and disposed beyond the distal portion of the assembly and within the distal end of the catheter,
the electromagnetic coil within the proximal portion of the assembly radially outward from the permanent magnet and in electrical communication with the power source,
the back iron within the proximal portion of the assembly, positioned radially between the coil and an inner surface of the catheter.
Le et al. (US 2012/0182631) discloses the above except instead teaches the optical element being distal to the waveguide and not disposed radially around the waveguide, or in another embodiment instead teaching the optical element within the permanent magnet and not beyond the distal portion of the assembly,
and does not teach the back iron.
Peeters Weem et al. (US 2013/0079644) discloses the above except for instead teaching wherein the permanent magnet is disposed radially outward of the electromagnetic coil,
and does not teach the back iron.
Yamazaki et al. (US 2015/0320318) discloses the above, except for that the back iron is between the coil and an inner surface of the catheter. Instead, Yamazaki teaches a back iron which forms an outer surface of the catheter.
There is no reason or suggestion provided in the prior art to modify the above prior art to teach the limitations as claimed above, and the only reason to modify the references would be based on Applicant's disclosure, which is impermissible hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Le et al. (US 2012/0182631)
Peeters Weem et al. (US 2013/0079644)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON B FAIRCHILD whose telephone number is (571)270-5276. The examiner can normally be reached 8:30am-5pm Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON B FAIRCHILD/Primary Examiner, Art Unit 3795
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