`\.\_:
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMIVHSSIONER FOR PATENTS
`PO. Box 1450
`Alexandria1 Virginia 22313-1450
`wwwusptogov
`
`
`
`
`
`14/235,246
`
`01/27/2014
`
`Ryoichi Imanaka
`
`2013—2057A
`
`1047
`
`52349
`7590
`10mm
`WENDEROTH,LND&pONACK LL12. —
`
`
`
`DRAGON, KRISTEN MAR ,
`1030 15th Street, NW.
`Suite 400 East
`
`Washington, DC 20005- 1503
`
`ART UNIT
`3715
`
`PAPER NUMBER
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`10/21/2015
`
`ELECTRONIC
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`ddalecki @wenderoth.c0m
`e0a@ wenderoth.c0m
`
`PTOL—90A (Rev. 04/07)
`
`
`
`
`Application No.
`Applicant(s)
`
` 14/235,246 IMANAKA ET AL.
`Examiner
`Art Unit
`AIA (First Inventorto File)
`Office Action Summary
`
`3715KRISTEN DRAGON first“
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply be timely filed
`
`-
`-
`
`Status
`
`1)IXI Responsive to communication(s) filed on 27January 2014.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)lX| This action is non-final.
`2a)I:| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
`
`; the restriction requirement and election have been incorporated into this action.
`
`4)|:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under EX parte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`3) D Interview Summary (PT0_413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`—
`4) I:I Other'
`2) E Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date 27 January 2014.
`US. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20151014A
`
`Disposition of Claims*
`5)|XI Claim(s) His/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6 III Claim s) _ is/are allowed.
`s L7 is/are rejected.
`
`is/are objected to.
`
`I )
`
`_
`
`
`are subject to restriction and/or election requirement.
`9)|:l Claim(s
`I
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`htt
`://w1rvw.usoto. ov/ atents/init events"
`h/index.‘s
`
`
`
`
`
`, or send an inquiry to PRI-Ifeedback{<‘buspto.qov.
`
`Application Papers
`
`10)IXI The specification is objected to by the Examiner.
`11)|Z| The drawing(s) filed on 27 January 2014 is/are: a)lZl accepted or b)I:I objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)IZI Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some” c)I:I None of the:
`a)le All
`1.IZI Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
`
`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`
`
`
`
`Application/Control Number: 14/235,246
`
`Page 2
`
`Art Unit: 37 15
`
`DETAILED ACTION
`
`Notice of Pre-AIA or AIA Status
`
`The present application is being examined under the pre—AIA first to invent provisions.
`
`Specification
`
`1.
`
`The disclosure is objected to because of the following informalities: the reference figure
`
`22 is used to denote both a kidney [0068] and a liver [0068].
`
`Appropriate correction is required.
`
`Claim Objections
`
`1.
`
`Claims 1 and 7 recite the limitation "the line of sight" in lines 7 and 5, respectively.
`
`There is insufficient antecedent basis for this limitation in the claim.
`
`2.
`
`35 USC. 101 reads as follows:
`
`Claim Rejections - 35 USC § 101
`
`Whoever invents or discovers any new and useful process, machine, manufacture, or composition of
`matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the
`conditions and requirements of this title.
`
`3.
`
`Claim 7 is rejected under 35 USC. 101 because the claimed invention is not directed to
`
`patent eligible subject matter. Based upon consideration of all of the relevant factors with
`
`respect to the claim as a whole, claim 7 is determined to be directed to an abstract idea of
`
`software comprising instructions for a cutting simulation, without being tied to a particular
`
`machine or apparatus. The rationale for this determination is explained below:
`
`In order for a claimed method to be considered statutory it must be tied to a particular
`
`machine or apparatus, or transform a particular article into a different state or thing. The use of a
`
`specific machine or transformation of an article must impose meaningful limits on the claim's
`
`
`
`Application/Control Number: 14/235,246
`
`Page 3
`
`Art Unit: 3715
`
`scope to impart patent—eligibility; the involvement of the machine or transformation in the
`
`claimed process must not merely be insignificant extra— solution activity; and the transformation
`
`must be central to the purpose of the claimed process.
`
`In this case, while claim 7 requires “a cutting simulation program for causing a computer
`
`to execute a cutting simulation method”, it is not clear whether a non—transitory machine
`
`readable medium is intrinsically tied to the claimed program. As the claim is not reasonably tied
`
`to any other class of statutory subject matter they are directed to non—statutory subject matter.
`
`35 USC § 112, sixth paragraph
`
`The following is a quotation of 35 USC. 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 USC. 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.
`
`Use of the word “means” (or “step for”) in a claim with fianctional language creates a
`
`rebuttable presumption that the claim element is to be treated in accordance with 35 USC.
`
`112(f) (pre—AIA 35 USC. 112, sixth paragraph). The presumption that 35 USC. 112(f) (pre—
`
`AIA 35 USC. 112, sixth paragraph) is invoked is rebutted when the function is recited with
`
`
`
`Application/Control Number: 14/235,246
`
`Page 4
`
`Art Unit: 3715
`
`sufficient structure, material, or acts within the claim itself to entirely perform the recited
`
`function.
`
`Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption
`
`that the claim element is not to be treated in accordance with 35 U.S.C. 112(f) (pre—AIA 35
`
`U.S.C. 112, sixth paragraph). The presumption that 35 U.S.C. 112(f) (pre—AIA 35 U.S.C. 112,
`
`sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to
`
`recite sufficiently definite structure, material or acts to perform that function.
`
`Claim elements in this application that use the word “means” (or “step for”) are
`
`presumed to invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
`
`Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to
`
`invoke 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
`
`4.
`
`Claim limitations “acquisition step of acquiring tomographic image information”,
`
`“volume rendering step of sampling voxel information”, “first display step of displaying
`
`calculation results”, and “second display step of displaying" have been interpreted under 35
`
`U.S.C. 112(f) or pre—AIA 35 U.S.C. 112, sixth paragraph, because they use a generic placeholder
`
`“step” coupled with functional language “acquiring tomographic image information”, “sampling
`
`voxel information in a direction perpendicular to the line of sight, on the basis of voxel
`
`information about the tomographic image information”, “displaying calculation results from the
`
`volume rendering”, and “displaying on the display unit the status of the cutting object after
`
`cutting on the basis of the cutting instructions inputted with respect to the displayed cutting
`
`object and displaying non—cutting objects included inside the cutting object, on the display unit in
`
`a pre—cut state even after cutting, even when included in a cut portion according to the cutting
`
`
`
`Application/Control Number: 14/235,246
`
`Page 5
`
`Art Unit: 3715
`
`instructions” without reciting sufficient structure to achieve the function. Furthermore, the
`
`generic placeholder is not preceded by a structural modifier.
`
`Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre—AIA 35 U.S.C. 112, sixth
`
`paragraph, claim 7 has been interpreted to cover the corresponding structure described in the
`
`specification that achieves the claimed function, and equivalents thereof.
`
`A review of the specification shows that the following appears to be the corresponding
`
`structure described in the specification for the 35 U.S.C. 112(f) or pre—AIA 35 U.S.C. 112, sixth
`
`paragraph limitation: Paragraph [0003] discloses acquiring an X—ray CT image, a nuclear MRI,
`
`or an image acquired by PET; paragraphs [0064]—[0066] disclose calculating volume based on a
`
`plurality of slices and voxel coordinates; paragraph [0067] discloses a generic display;
`
`paragraphs [0077]—[0083] disclose an algorithm for processing cutting instructions; paragraphs
`
`[0090]—[0095] disclose displaying non—cutting objects on the display in a pre—cut state by
`
`interchanging voxel information.
`
`If applicant wishes to provide further explanation or dispute the examiner’s interpretation
`
`of the corresponding structure, applicant must identify the corresponding structure with reference
`
`to the specification by page and line number, and to the drawing, if any, by reference characters
`
`in response to this Office action.
`
`If applicant does not intend to have the claim limitations treated under 35 U.S.C. 112(f)
`
`or pre—AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim so that it will clearly
`
`not invoke 35 U.S.C. 112(f) or pre—AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient
`
`showing that the claim recites sufficient structure, material, or acts for performing the claimed
`
`function to preclude application of 35 U.S.C. 112(f) or pre—AIA 35 U.S.C. 112, sixth paragraph.
`
`
`
`Application/Control Number: 14/235,246
`
`Page 6
`
`Art Unit: 3715
`
`For more information, see MPEP § 2173 et seq. and Supplementary Examination
`
`Guidelines for Determining Compliance With 35 US. C. 112 and for Treatment of Related Issues
`
`in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
`
`Claim Rejections - 35 USC § 112
`
`5.
`
`The following is a quotation of 35 USC. 112(b):
`(b) CONCLUSION.7The 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 USC. 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.
`
`6.
`
`Claim 2 is rejected under 35 USC. 112(b) or 35 USC. 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. Claim 2 recites the limitation "the voxel data" in line 3. There is insufficient
`
`antecedent basis for this limitation in the claim, as it is unclear if the recited “voxel data” is the
`
`same “voxel information” as claimed in claim 1, or is a different type of data.
`
`Claim Rejections - 35 USC § 102
`
`7.
`
`In the event the determination of the status of the application as subject to AIA 35 USC.
`
`102 and 103 (or as subject to pre—AIA 35 USC. 102 and 103) is incorrect, any correction of the
`
`statutory basis 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.
`
`8.
`
`The following is a quotation of the appropriate paragraphs of pre—AIA 35 USC. 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 ,
`
`
`
`Application/Control Number: 14/235,246
`
`Page 7
`
`Art Unit: 37 15
`
`(b) the invention was patented or described in a printed publication in this or a foreign country or in
`public use or on sale in this country, more than one year prior to the date of application for patent in the
`United States.
`
`9.
`
`Claims 1, 2, 5, and 7 are rejected under pre—AIA 35 U.S.C. lO2b as being anticipated by
`
`Kaufman et al (US Patent 6,331,116, hereinafter “Kaufman”).
`
`Regarding claims 1 and 7, Kaufman discloses the cutting simulation device and program
`
`for causing a computer to execute a cutting simulation method comprising:
`
`0 A tomographic image information acquisition section configured to acquire tomographic
`
`image information (Col 5, lines 47—57: a scanner acquires tomographic information in the
`
`form of a CT scan or MRI);
`
`0
`
`a memory connected to the tomographic image information acquisition section,
`
`configured to store voxel information about the tomographic image information (Col 15
`
`lines 25—29: a memory stores scanning information and voxel information);
`
`o
`
`a volume rendering calculator connected to the memory, configured to sample voxel
`
`information in a direction perpendicular to the line of sight, on the basis of the voxel
`
`information (Col 15, lines 46—61: a processor samples voxel information based on the
`
`stored voxel information in order to navigate; this navigation is computed based on the
`
`line of sight of the submarine camera model, and is capable of sampling voxel data
`
`perpendicular to the line of sight);
`
`0
`
`a display unit configured to display calculation results from the volume rendering
`
`calculator (Col 15, lines 58—62: a display unit displays results);
`
`
`
`Application/Control Number: 14/235,246
`
`Page 8
`
`Art Unit: 3715
`
`0
`
`an input section with which instructions for cutting a cutting object displayed on the
`
`display unit is inputted (Col 6, lines 24—34: an input section can include a keyboard or a
`
`mouse; Col 14, lines 62—64: the user can input cutting instructions) ;
`
`o
`
`and a display controller configured to display on the display unit the status of the cutting
`
`object after cutting on the basis of the cutting instructions inputted with the input section
`
`(Col 14 lines 17—36: cutting instructions are input by the user and are displayed in the
`
`virtual view),
`
`0
`
`and displaying non—cutting objects included inside the cutting object, on the display unit
`
`in a pre—cut state even after cutting, even when included in a cut portion according to the
`
`cutting instructions (Fig. 13 and Col 14, lines 17—36: a user can cut away layers to reveal
`
`an un—cut object, such as a polyp or cancerous mass; for example, a user could cut away
`
`layers 1305 and 1307 to reveal mass 1309, which is inside of the cut portion and is
`
`therefore included in the cut portion, but is in a pre—cut state).
`
`Regarding claim 2, Kaufman discloses the cutting simulation device according to
`
`claim 1, wherein, if the non—cutting objects are included in the cut portion, the display
`
`controller switches the voxel data for the cut portion with voxel data for the non—cutting
`
`objects, and displays the result on the display unit (Col 14 lines 17—36: layers that are cut
`
`away are removed, revealing the non—cut object beneath; this would switch the voxel data
`
`for the cut portion and the non—cut object, as the voxel data for the non—cut object would
`
`now be shown, and the voxel data for the cut portion would be removed, as that portion
`
`would no longer be on display).
`
`
`
`Application/Control Number: 14/235,246
`
`Page 9
`
`Art Unit: 3715
`
`Regarding claim 5, Kaufman discloses the cutting simulation device according to
`
`claim 1, wherein the cutting object includes an organ or bone (Col 5, lines 14—17: the
`
`object to be examined can be an organ).
`
`Claim Rejections - 35 USC § 103
`
`10.
`
`The following is a quotation of pre—AIA 35 USC. 103(a) which forms the basis for all
`
`obviousness rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or described as set
`forth in section 102 of this title, if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have been obvious at the time the
`invention was made to a person having ordinary skill in the art to which said subject matter pertains.
`Patentability shall not be negatived by the manner in which the invention was made.
`
`11.
`
`The factual inquiries set forth in Graham v. John Deere C0., 383 US. l, 148 USPQ 459
`
`(1966), that are applied for establishing a background for determining obviousness under pre—
`
`AIA 35 USC. 103(a) are summarized as follows:
`
`1. Determining the scope and contents of the prior art.
`
`2. Ascertaining the differences between the prior art and the claims at issue.
`
`3. Resolving the level of ordinary skill in the pertinent art.
`
`4. Considering objective evidence present in the application indicating obviousness or
`
`nonobviousness.
`
`12.
`
`Claim 6 is rejected under pre—AIA 35 USC. 103(a) as being unpatentable over Kaufman
`
`et al (US Patent 6,331,116).
`
`Kaufman does not explicitly disclose that a non—cutting object can include blood vessels
`
`or nerves. However, Kaufman does disclose that a non—cutting object can be a mass or a growth
`
`(Col 14, lines 20—26: the method can be used to examine for cancerous growths). It would be
`
`obvious to also include blood vessels and nerves as non—cutting objects, as they are additional
`
`
`
`Application/Control Number: l4/235,246
`
`Page 10
`
`Art Unit: 37 15
`
`types of tissues in organs, and therefore would be obvious variants of growths or masses that
`
`could be inspected for abnormalities using the method of claim 1.
`
`13.
`
`Claims 3 and 4 are rejected under pre—AIA 35 U.S.C. 103(a) as being unpatentable over
`
`Kaufman in view of Saito et al (US Patent 6,826,297, hereinafter “Saito”).
`
`Regarding claim 3, Kaufman discloses the cutting simulation device of claim 1 and
`
`further discloses generating textures and various greyscale intensities for different types of tissue
`
`(Col 23, lines 6—22: different tissues can have different textures and greyscale intensities), but
`
`fails to disclose wherein color information is added to the voxel information corresponding to the
`
`cutting object and the non—cutting objects in display on the display unit, and the display
`
`controller displays the non—cutting objects on the display unit in a different color from the color
`
`of the cutting object.
`
`Saito teaches adding color information to the voxel information and displaying the
`
`different objects as different colors (Col 2, lines 30—39: voxel information is sorted into objects,
`
`which each have specific color information, and are displayed on a display unit)
`
`Saito is an analogous art with respect to Kaufman, as both are drawn to the art of
`
`displaying 3D tomographical images with voxel data. It would have been obvious to one of
`
`ordinary skill in the art at the time the invention was made to have modified the device of
`
`Kaufman to incorporate the teachings of Saito and add and display color information for
`
`different objects, notably cutting and non—cutting objects. Doing so would allow users to more
`
`easily visually identify the different types of objects displayed on the screen.
`
`Regarding claim 4, Kaufman discloses the cutting simulation device of claim 1 but fails
`
`to disclose wherein a range of CT values indicating the extent of spatial X—ray absorption during
`
`
`
`Application/Control Number: 14/235,246
`
`Page ll
`
`Art Unit: 37 15
`
`X— ray irradiation of a subject is set for the cutting object and the non—cutting objects, and the
`
`display controller displays the desired cutting object and non—cutting objects on the display unit
`
`on the basis of the CT values inputted via the input section.
`
`Saito teaches setting a range of CT values indicating the extent of spatial X—ray
`
`absorption during X— ray irradiation of a subject (Col 4, lines 32—39: an image is processed and
`
`constructed based on CT values, which are equivalent to an X—ray absorption coefficient) and
`
`displaying objects based on the CT values (Col 3, lines 54—57: an object is defined based on a
`
`range of CT values; Col 3, lines 64 and 65: an object set contains a plurality of objects; Col 4,
`
`lines 64—67: an object set can be selected to display specific objects based on input into the object
`
`set selection panel).
`
`It would have been obvious to one of ordinary skill in the art at the time the
`
`invention was made to have modified the device of Kaufman to incorporate the teachings
`
`of Saito and set and display objects based on CT values indicating X—ray absorption,
`
`notably cutting and non—cutting objects. Doing so would allow users to specifically target
`
`which types of tissues are to be displayed.
`
`Conclusion
`
`Any inquiry concerning this communication or earlier communications from the
`
`examiner should be directed to KRISTEN DRAGON whose telephone number is (571)270—0531.
`
`The examiner can normally be reached on Mon—Fri 8:00 a.m.—5:00 p.m..
`
`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s
`
`supervisor, Sam Yao can be reached on 571—272—1224. The fax phone number for the
`
`organization where this application or proceeding is assigned is 571—273—8300.
`
`
`
`Application/Control Number: 14/235,246
`
`Page 12
`
`Art Unit: 3715
`
`Information regarding the status of an application may be obtained from the Patent
`
`Application Information Retrieval (PAIR) system. Status information for published applications
`
`may be obtained from either Private PAIR or Public PAIR. Status information for unpublished
`
`applications is available through Private PAIR only. For more information about the PAIR
`
`system, see http://pair—direct.uspto.gov. Should you have questions on access to the Private PAIR
`
`system, contact the Electronic Business Center (EBC) at 866—217—9197 (toll—free). If you would
`
`like assistance from a USPTO Customer Service Representative or access to the automated
`
`information system, call 800—786—9199 (IN USA OR CANADA) or 571—272—1000.
`
`/K. D./
`
`Examiner, Art Unit 3715
`
`/SAM YAO/
`
`Supervisory Patent Examiner, Art Unit 3715
`
`