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 .
Status of Claims
Claims 1-17 as filed are presently pending.
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:
“a fixing portion configured to be fixed to a target site” in claim 1, 16 and 17, for structure disclosed, see [0012] of instant specification, plate fixing portion; and
“a light reception unit configured to capture an image” in claim 7, for structure disclosed, see [0017] of instant specification, a CMOS camera or a CCD camera .
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 § 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 1-2, 5-12 and 14-17are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kagenow et al., US 20100177182 A1 ("Kagenow").
Regarding claim 1, Kagenow discloses a blood vessel visualization apparatus for visualizing a blood vessel inside a living body with light that has been transmitted through the living body ([abstract], [0002] e.g. [0061], [0094-0095] and Figs. 2a-2d), the blood vessel visualization apparatus comprising:
an irradiation unit configured to emit light from a contact portion with skin of the living body, the irradiation unit comprising: a fixing portion configured to be fixed to a target site of the living body ([0095] “back light 17 is made up of the back light top 12, and the back light bottom 13”, illustration Figs. 2a-2c), wherein the fixing portion includes a surface configured to contact the skin of the living body ([0095], illustration Figs. 2a-2c, back light bottom 13 is configured to contact an arm during use considering teachings in [0020] that “the device itself can be shaped to fit a certain anatomical part e.g. an arm or it can be flexible in its form”) and a plurality of light sources ([0095] “LEDs 7”) located in a light source arrangement area at the surface of the fixing portion that is configured to contact the skin of the living body (illustration Figs. 2a-2c) wherein: a brightness and/or a light distribution angle of respective ones of the light sources differ according to positions of the light sources in the light source arrangement area ([0062] light sources are at an angle, e.g. as depicted in Figs. 2a and 2c, light distribution angle thus differs).
Regarding claim 2, see Kagenow [0062] light sources are at an angle, e.g. as depicted in Figs. 2a and 2c, when in use on an arm, and in view of the distribution of light sources as discussed in [0062] the light distribution angle of each respective one of the light sources would vary according to a thickness of the arm along a line extending from the respective one of the light sources in a direction parallel to a line that connects a light reception unit to a centermost one of the light sources in the light source arrangement area.
Regarding claims 5-6, see [0020] “a fastening means can be used in conjunction with the device … the device itself can be shaped to fit a certain anatomical part e.g. an arm or it can be flexible in its form”.
Regarding claims 7-9, see [0095], “camera 15” and [0044-0045] “CCD”, “CMOS” is a light reception unit [claim 7]; see [0095] regarding “display 4” and [0065-0066] - [claim 8]; and [0061-0062] “trans-illuminating mode”, [0095] and illustration Figs. 2a-2c, irradiation unit and light reception unit are configured to face each other with the target site interposed there between - [claim 9].
Regarding claim 10, see illustration Figs. 2a and 2c, the fixing portion (i.e., “back light 17”) has a shape that is elongated in a direction crossing the target site of the living body, three or more of the light sources are arrayed along a longitudinal axis of the fixing portion, and a light distribution angle of an outer one of the three or more light sources is larger than a light distribution angle of a centermost one of the three or more light sources owing to the curved profile.
Regarding claim 11, see [0029] “The at least one light source preferably emits light of a wavelength between 550 and 1600 nm … and sources capable of emitting either or both, singularly” i.e. the light source is capable of converting transmitted light into a different wavelength.
Regarding claims 12 and 13, see illustration Figs. 2a and 2c, light source comprises protrusion portion [claim 12]; and [0022] “… single use cover, wrapper, … single use wrapper or the like can be of transparent plastic or rubber of any thickness and flexibility”, the cover or wrapper
Regarding claims 14 and 15, see e.g. [0029] “The infrared light may be near-infrared or infrared light of wavelengths between 700 and 1600 nm or more”.
Regarding claim 16 and 17, see overlapping subject matter in claim 1 above, and further, [0019] “real time visualization of subcutaneous structures for the purpose of facilitating the insertion of medical instruments e.g. hypodermic needles, into said subcutaneous structures” and [0066] “aiding in aligning e.g. a hypodermic needle with the displayed image of a blood vessel … for further assistance in inserting the hypodermic needle correctly”, thus the blood visualization apparatus discussed in claim 1 above and the hypodermic needle read on a blood vessel puncture system of claim 16, the discussion and citations in claim 1 are equally applicable here and will not be repeated for brevity’s sake. The method steps of claim 17 are implicit during normal use of the system of claim 16, claim 17 is therefore anticipated.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Kagenow as applied to claim 1 above, and further in view of Kiyomizu et al. US 20090174766 A1 ("Kiyomizu").
Regarding claim 3, Kagenow discloses in view of Fig 2c, the light sources are arranged uniformly, does not explicitly disclose the brightness and/or the light distribution angle of each of the plurality of light sources is set such that an illuminance distribution of the transmitted light to a surface of the target site of the living body is uniform [claim 3]. Kagenow also disclose the fixing portion is formed in a shape is elongated in a direction crossing the target site (see illustration Figs. 2a-2d) and comprise at least three or more light sources arrayed along a longitudinal axis (see illustration Figs. 2a-2d), Kagenow does not explicitly disclose that a brightness of a centermost one of the three or more light sources is highest among the three or more light sources.
Kiyomizu in the same field of endeavor of visualizing and authentication (see Kagenow [0088]), teaches in [0047] importance of irradiating uniform amount of light, [0049] regarding improving image quality by uniformly light sources to achieve uniform brightness and [0085]that adequate amount of light varies with thickness, with small thickness requiring light of less brightness compared with thick finger, and small thickness is associated with the side while the base (center) is thick with advance control of amount of light based on thickness of body part . In view of these teachings, at the time of filing the claimed invention, it would have been obvious to one having ordinary skill in the art to have mounted the light sources uniformly on the irradiation unit of Kiyomizu, so as to improve image quality or alternatively, advance control the brightness of the light sources such that the light sources on thickest part of the body part, that is expected in the middle, to be higher compared to the sides that is less thick, to ensure adequate light on the body part, to improve image quality.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kagenow.
Regarding claim 13, Kagenow does not explicitly disclose that the protrusion porting is made of a soft material that is light-transmissive, examiner does note that LEDs are usually covered with a sealing resin to avoid contact with air, and silicone is a known conventional sealing resin for an LED. In any event, Kagenow does teach in [0022] use of a cover or wrapper for hygienic purposes, and [0063] “LEDs are at a fixed distance to the detection device/camera. The LEDs will be placed upon the body surface of the recipient and rest hereon either directly or at a small distance here from. The distance may provided for by a membrane of a flexible or adaptable material, such as a silicone membrane”. In view of these teachings, inasmuch as Kagenow teaches that the LEDs can be placed either directly or at a small distance from the body surface using a silicone membrane, it would have been obvious to modify the embodiment of Fig. 2a-2c to include a silicone membrane to position the LEDs at a distance from the body surface for hygienic purposes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20110279751 A1 to Liyama et al. see [0048-0049], “An LED usually is covered with a sealing resin to avoid contact with air. As a conventional sealing resin for an LED, epoxy resin, silicone rubber, or the like”.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797