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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________________________
`
`MOLECULIGHT, INC.
`Petitioner
`
`v.
`
`SWIFT MEDICAL INC.
`Patent Owner
`
`_________________________________
`
`PGR2022-00041
`U.S. Patent 11,266,345
`_________________________________
`
`PETITION FOR POST GRANT REVIEW OF
`U. S. PATENT 11,266,345
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`
`INTRODUCTION ......................................................................................... 1
`I.
`II. MANDATORY NOTICES AND PETITION REQUIREMENTS ........... 1
`A. Notice of Real-Parties-in-Interest (37 C.F.R. § 42.8(b)(1)).............. 1
`B.
`Notice of Related Matters (37 C.F.R. § 42.8(b)(2)) .......................... 1
`C. Notice of Lead and Backup Counsel and Service
`Information (37 C.F.R. § 42.8(b)(3)-(4)) ........................................... 1
`Fees ........................................................................................................ 2
`D.
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.204(a)) .............................. 3
`IV.
`IDENTIFICATION OF GROUNDS FOR CHALLENGE ....................... 3
`V.
`THE ’345 PATENT ....................................................................................... 5
`VI. SUMMARY OF THE RELEVANT PROSECUTION HISTORY........... 9
`VII. CLAIM CONSTRUCTION .......................................................................... 9
`A. Claim Construction ............................................................................. 9
`VIII. PERSON HAVING ORDINARY SKILL IN THE ART .........................14
`IX. REFERENCE ACCESSIBILITY AND PRIOR ART STATUS ............14
`A. Cross – Ex. 1006.................................................................................15
`B.
`Fawzy – Ex. 1008 ...............................................................................15
`C.
`Polidor – Ex. 1010 ..............................................................................16
`D. O’Neill – Ex. 1011 ..............................................................................16
`E. Garcia – Ex. 1012...............................................................................16
`F. Gutkowicz-Krusin – Ex. 1013 ..........................................................17
`G. DaCosta – Ex. 1014 ............................................................................17
`PRECISE REASONS FOR THE RELIEF REQUESTED .....................17
`A. Grounds 1 and 2: Anticipation and Obviousness Based on
`Cross ...................................................................................................17
`Independent Claim 1: A portable illumination apparatus
`for facilitating visualizations of tissue, the apparatus
`comprising: ...................................................................................18
`
`X.
`
`1.
`
`i
`
`

`

`2.
`
`3.
`
`4.
`
`5.
`
`Dependent Claim 4: The portable illumination apparatus
`according to claim 1, wherein the illumination unit further
`comprises at least one of: (i) a controller to control illumination
`of the one or more light sources, or (ii) a rechargeable battery
`for powering the apparatus. ........................................................25
`Dependent Claim 5: The illumination apparatus according to
`claim 1, wherein the one or more light sources are arranged
`about a central aperture of the illumination unit, the central
`aperture having a radius of 0.5-3 cm. ........................................27
`Dependent Claim 6: The illumination apparatus of claim 5,
`wherein the one or more light sources are arranged in a ring
`having a radius of 1.5-6 cm. ........................................................32
`Dependent Claim 7: The illumination apparatus according to
`claim 1, wherein the portable housing comprises a compression
`clip or a spring clip for mounting the apparatus on at least one
`edge of a mobile device and proximal to a camera of the mobile
`device. ............................................................................................34
`Independent Claim 8: A tissue imaging system for visualizing
`of tissue health indicators, the system comprising: ..................36
`Dependent Claim 9: The tissue imaging system of claim 8,
`wherein the computing device comprises a mobile device and
`the image capture unit is a camera integrated with the mobile
`device. ............................................................................................41
`Dependent Claim 10: The tissue imaging system according to
`claim 8, wherein the illumination unit comprises: a portable
`housing for detachable attachment proximal to the image
`capturing unit. ..............................................................................41
`Dependent Claim 11: The tissue imaging system according to
`claim 8, wherein the portable illumination unit further
`comprises a wireless communication module for receiving
`commands from the computing device. .....................................43
`10. Dependent Claim 12: A tissue visualization system
`operatively connected to one or more tissue imaging systems
`according to claim 8, comprising ................................................44
`Independent Claim 13: A method for generating
`visualizations of tissue, the method comprising: .......................47
`
`11.
`
`6.
`
`7.
`
`8.
`
`9.
`
`ii
`
`

`

`12. Dependent Claim 17: The method according to claim 13,
`wherein pre-processing comprises at least one of: (i) registering
`images to avoid camera motion artifacts, (ii) subtracting
`images with no illumination from the illumination unit from
`images with illumination from the illumination unit to account
`for a presence of ambient light, (iii) recalibrating each
`measurement accordingly to control parameters related to
`intensity of illumination using a self-reference object
`positioned within the target area, (iv) dividing the captured
`images on reference images to obtain reflectance images, or (v)
`flattening the reflectance images to account for reflections
`from curved surfaces....................................................................59
`13. Dependent Claim 20: The method according to claim 13,
`wherein the measurement data comprises wound-related data.
` ........................................................................................................60
`B. Grounds 3 and 4: Anticipation and Obviousness Based On
`Fawzy ..................................................................................................60
`Independent Claim 1: A portable illumination apparatus
`for facilitating visualizations of tissue, the apparatus
`comprising: ...................................................................................62
`Dependent Claim 3: The portable illumination apparatus
`according to claim 1, wherein the one or more light sources is
`configured to provide flashes that are at least one of: (i) 405±10
`nm wavelength, and having at least one of: (a) a long pass filter
`with a cut-on wavelength of 450±25 nm or (b) a bandpass filter
`with transmission in a 425 nm-1000 nm range, (ii) two
`wavelengths in a 450 nm-750 nm range, at least one of which in
`a green range, (iii) three wavelengths in a 450 nm-750 nm
`range, at least one of which in the green range, or (iv) 970±10
`nm wavelength. .............................................................................64
`Dependent Claim 4 .......................................................................65
`Independent Claim 8: A tissue imaging system for visualizing
`of tissue health indicators, the system comprising: ..................66
`Dependent Claim 9 .......................................................................70
`Dependent Claim 10 .....................................................................70
`Dependent Claim 11 .....................................................................71
`
`5.
`6.
`7.
`
`3.
`4.
`
`1.
`
`2.
`
`iii
`
`

`

`8.
`
`Independent Claim 13: A method for generating
`visualizations of tissue, the method comprising: .......................71
`Dependent Claim 17 .....................................................................77
`9.
`10. Dependent Claim 18 .....................................................................78
`11. Dependent Claim 20 .....................................................................78
`C. Ground 5: Obviousness Based on Cross in View of Fawzy ...........79
`1.
`Dependent Claim 3 .......................................................................79
`2.
`Dependent Claim 18 .....................................................................80
`3. Motivation to Combine ................................................................81
`a)
`Claim 3 ..........................................................................................81
`b)
`Claim 18 ........................................................................................82
`D. Ground 6: Obviousness Based on Fawzy in View of Cross ...........83
`1.
`Dependent Claim 5 .......................................................................83
`2.
`Dependent Claim 6 .......................................................................84
`3.
`Dependent Claim 12: A tissue visualization system operatively
`connected to one or more tissue imaging systems according to
`claim 8, comprising ......................................................................85
`4. Motivation to Combine ................................................................87
`a)
`Claims 5 and 6 ..............................................................................87
`b)
`Claim 12 ........................................................................................87
`E. Grounds 7 and 8: Cross (Ground 7) or Fawzy (Ground 8) in
`View of Polidor ..................................................................................88
`Dependent Claim 2: The portable illumination apparatus of
`claim 1, wherein the illumination unit further comprises a lens
`covering the one or more light sources, the lens having a focal
`length that is 80%-120% of a working distance between the
`illumination unit and the target area of the tissue. ...................88
`2. Motivation to Combine ................................................................91
`F. Grounds 9-11: Cross (Ground 9), Fawzy in View of Cross
`and Further in View of O’Neill (Ground 10), or Fawzy in
`View of O’Neill (Ground 11) ............................................................92
`Dependent Claims 5 and 6. ..........................................................92
`
`1.
`
`1.
`
`iv
`
`

`

`1.
`
`Dependent Claim 7 .......................................................................93
`2.
`3. Motivation to Combine ................................................................95
`a)
`Claims 5 and 6 ..............................................................................95
`b)
`Claim 7 ..........................................................................................95
`F. Grounds 12 and 13: Obviousness Based on Cross (Ground
`12) or Fawzy (Ground 13) in View of Garcia .................................96
`Dependent Claim 14: The method of claim 13 further
`comprising, prior to capturing the measurement data,
`capturing a reference image, wherein the positioning the
`computing device for the reference image capturing comprises
`positioning the computing device using a reference object. .....96
`2. Motivation to Combine ................................................................99
`G. Grounds 14 and 15: Obviousness Based on Cross (Ground
`14) or Fawzy (Ground 15) in View of DaCosta ............................100
`Dependent Claim 15: The method of claim 13, wherein the
`illumination unit and the computing device are configured to
`provide a working distance of 15±5 cm from the target area of
`tissue. ...........................................................................................100
`2. Motivation to Combine ..............................................................102
`H. Grounds 16 and 17: Obviousness Based on Cross (Ground
`16) or Fawzy (Ground 17) in View of DaCosta, in Further
`View of Garcia .................................................................................103
`Dependent Claim 16: The method of claim 15, wherein the
`positioning of the computing device for capturing the
`measurement data comprises positioning the computing device
`using a self-reference object. .....................................................103
`2. Motivation to Combine ..............................................................104
`Grounds 18 and 19: Obviousness Based on Fawzy in View
`of Gutkowicz-Krusin (Ground 18) and Based on Cross in
`View of Fawzy, Further in View of Gutkowicz-Krusin
`(Ground 19) ......................................................................................104
`Dependent Claim 19: The method according to claim 18,
`wherein the exposure time of the image capturing unit is 50 ms.
` ......................................................................................................104
`
`1.
`
`1.
`
`I.
`
`1.
`
`v
`
`

`

`2. Motivation to Combine ..............................................................105
`XI. CONCLUSION ..........................................................................................106
`
`CERTIFICATE OF SERVICE
`
`CERTIFICATE OF COMPLIANCE WITH 37 C.F.R. § 42.24
`
`
`
`vi
`
`

`

`PETITIONER’S EXHIBIT LIST
`
`Exhibit Description of Exhibit
`
`1001
`
`U.S. Patent No. 11,266,345
`
`1002
`
`Prosecution History of U.S. Patent No. 11,266,345
`
`1003
`
`U.S. Provisional Application No. 62/698,799
`
`1004
`
`Declaration of Irene Georgakoudi, Ph.D. in support of Petition for
`
`Post Grant Review (“Expert”)
`
`1005
`
`Curriculum Vitae of Irene Georgakoudi, Ph.D.
`
`1006
`
`U.S. Patent Application Publication US 2019/0216326 (“Cross”)
`
`1007
`
`U.S. Provisional Application No. 62/378,939
`
`1008
`
`U.S. Patent Application Publication US 2018/0188108 (“Fawzy”)
`
`1009
`
`U.S. Provisional Application No. 62/396,730
`
`1010
`
`U.S. Patent No. 5,690,417 (“Polidor”)
`
`1011
`
`U.S. Patent Application Publication US 2015/0042877 (“O’Neill”)
`
`1012
`
`U.S. Patent No. 9,696,897 (“Garcia”)
`
`1013
`
`U.S. Patent No. 6,208,749 (“Gutkowicz-Krusin”)
`
`1014
`
`U.S. Patent Application Publication US 2017/0236281 (“DaCosta”)
`
`vii
`
`

`

`1015
`
`Extended Search Report issued March 7, 2022 for EP application
`
`19837681 to Swift Medical Inc.
`
`1016 Web archive from The Wayback Machine – “What is an LED?”, All
`
`About LEDs, Adafruit Learning System
`
`1017 Web archive from The Wayback Machine – “Google Nexus 5
`
`Review”, Photography Blog, December 11, 2013
`
`1018 Web archive from The Wayback Machine – F-number,
`
`Wikipedia.com
`
`1019 Web archive from The Wayback Machine – Visible spectrum,
`
`Wikipedia.com
`
`
`
`viii
`
`

`

`Petition for Post Grant Review
`PGR2022-XXXXXX – U.S. Patent 11,266,345
`
`I.
`
`INTRODUCTION
`
`Petitioner MolecuLight, Inc. requests post grant review of claims 1-20 of
`
`U.S. Patent 11,266,345 (“the ’345 patent”). This Petition is more likely than not to
`
`prevail with respect to challenged claims 1-20. The ’345 patent is included as Ex.
`
`1001, and this Petition is supported by the Declaration of Irene Georgakoudi, Ex.
`
`1004.
`
`II. MANDATORY NOTICES AND PETITION REQUIREMENTS
`
`A. Notice of Real-Parties-in-Interest (37 C.F.R. § 42.8(b)(1))
`
`Petitioner certifies that MolecuLight, Inc. is the sole real party-in-interest.
`
`B. Notice of Related Matters (37 C.F.R. § 42.8(b)(2))
`
`There are currently no litigation matters that could be affected by a decision
`
`in this proceeding.
`
`C. Notice of Lead and Backup Counsel and Service Information (37
`C.F.R. § 42.8(b)(3)-(4))
`
`Lead Counsel:
`
`Walter D. Davis, Jr. (Reg. No. 45,137)
`wdavis@dbjg.com
`Davidson Berquist Jackson & Gowdey, LLP
`8300 Greensboro Drive, Suite 500
`McLean, Virginia 22102
`Tel: 571-765-7700
`Fax: 571-765-7200
`
`1
`
`
`
`
`
`

`

`
`
`Backup Counsel:
`
`Elizabeth M. Burke (Reg. No. 38,758)
`elizabeth.burke@jonesrobb.com
`Jones Robb, PLLC
`1420 Spring Hill Road, Suite 325
`McLean, Virginia 22102
`Tel: 202-747-2016
`Fax: 202-315-0396
`
`James Wilson (Reg. No. 41,439)
`jwilson@dbjg.com
`Davidson Berquist Jackson & Gowdey, LLP
`8300 Greensboro Drive, Suite 500
`McLean, Virginia 22102
`Tel: 571-765-7700
`Fax: 571-765-7200
`
`
`
`
`
`Petitioner consents to service by electronic mail to counsel’s email addresses
`
`listed above, with a copy also sent to esong@dbjg.com and
`
`docketing@jonesrobb.com. A Power of Attorney executed by Petitioner’s
`
`authorized representative is filed concurrently herewith.
`
`D. Fees
`
`Payment of the required fees is submitted herewith in accordance with 37
`
`C.F.R. §§ 42.203(a) and 42.15(b). The Director is authorized to charge any
`
`additional required fees to Deposit Account No. 50-1860 associated with
`
`
`
`2
`
`

`

`Petitioner’s counsel, and to credit any over payment to the same account.
`
`III. GROUNDS FOR STANDING (37 C.F.R. § 42.204(a))
`
`Petitioner certifies, pursuant to 37 C.F.R. § 42.204(a), that the ’345 patent is
`
`available for post grant review under 35 U.S.C. § 321 and that Petitioner is not
`
`barred or estopped from requesting post grant review of the ’345 patent on the
`
`grounds identified in this Petition. The ’345 patent was filed under the first
`
`inventor to file provisions of the AIA and issued on March 8, 2022, and this
`
`Petition has been timely-filed on or before December 8, 2022.
`
`IV.
`
`IDENTIFICATION OF GROUNDS FOR CHALLENGE
`
`The following table shows, for each ground of challenge, a summary of the
`
`challenge, a statement of the specific statutory grounds for the challenge permitted
`
`under 35 U.S.C. § 282(b)(2) or (3), and the claims at issue in the challenge:
`
`GROUND
`
`SUMMARY
`
`1
`
`2
`
`Anticipation Based on
`Cross1
`Obviousness in View of
`Cross
`
`STATUTORY
`BASIS
`§ 102
`
`§ 103
`
`CLAIMS
`
`1, 4-13, 17,
`and 20
`1, 4-13, 17,
`and 20
`
`
`
`1 Ex. 1005, U.S. Patent Application Publication US 2019/0216326
`(“Cross”).
`
`3
`
`
`
`

`

`GROUND
`
`SUMMARY
`
`3
`
`4
`
`5
`
`6
`
`7
`
`8
`
`9
`
`10
`
`11
`
`12
`
`13
`
`Anticipation Based on
`Fawzy2
`
`Obviousness in View of
`Fawzy
`
`Obviousness Based on Cross
`in View of Fawzy
`Obviousness Based on
`Fawzy in View of Cross
`Obviousness Based on Cross
`in View of Polidor3
`Obviousness Based on
`Fawzy in View of Polidor
`Obviousness Based on Cross
`in View of O’Neill4
`Fawzy in View of Cross and
`Further in View of O’Neill
`Obviousness Based on
`Fawzy in View of O’Neill
`Obviousness Based on Cross
`in View of Garcia5
`Obviousness Based on
`Fawzy in View of Garcia
`
`
`
`STATUTORY
`BASIS
`§ 102
`
`§ 103
`
`§ 103
`
`CLAIMS
`
`1, 3, 4, 8-11,
`13, 17, 18, and
`20
`1, 3, 4, 8-11,
`13, 17, 18, and
`20
`3 and 18
`
`§ 103
`
`5, 6, and 12
`
`§ 103
`
`§ 103
`
`2
`
`2
`
`§ 103
`
`5-7
`
`§ 103
`
`5 and 6
`
`§ 103
`
`§ 103
`
`§ 103
`
`7
`
`14
`
`14
`
`2 Ex. 1007, U.S. Patent Application Publication US 2018/0188108
`(“Fawzy”).
`
`3 Ex. 1009, U.S. Patent 5,690,417 (“Polidor”).
`
`4 Ex. 1010, U.S. Patent Application Publication US 2015/0042877
`(“O’Neill”).
`
`5 Ex. 1011, U.S. Patent 9,696,897 (“Garcia”).
`
`
`
`4
`
`

`

`GROUND
`
`SUMMARY
`
`14
`
`15
`
`16
`
`17
`
`18
`
`19
`
`Obviousness Based on Cross
`in View of DaCosta6
`Obviousness Based on
`Fawzy in View of DaCosta
`Obviousness Based on Cross
`in View of DaCosta, in
`Further View of Garcia
`Obviousness Based on
`Fawzy in View of DaCosta,
`in Further View of Garcia
`Obviousness Based on
`Fawzy in View of
`Gutkowicz-Krusin7
`Obviousness Based on Cross
`in View of Fawzy, Further
`in View of Gutkowicz-
`Krusin
`
`
`
`V. THE ’345 PATENT
`
`STATUTORY
`BASIS
`§ 103
`
`§ 103
`
`§ 103
`
`CLAIMS
`
`15
`
`15
`
`16
`
`§ 103
`
`16
`
`§ 103
`
`19
`
`§ 103
`
`19
`
`The ’345 patent suggests a need for a medical diagnostic tool that can be
`
`carried to a patient’s home, remote community, or outpatient facility. ’345 patent,
`
`4:60-67. The tool can be used to detect diabetic foot ulcers, a disabling and costly
`
`complication of diabetes, or other medical conditions. ’345 patent, 5:1-7.
`
`
`
`6 Ex. 1012, U.S. Patent Application Publication US 2017/0236281
`(“DaCosta”).
`
`7 Ex. 1013, U.S. Patent 6,208,749 (“Gutkowicz-Krusin”).
`
`
`
`5
`
`

`

`The ’345 patent refers to that tool as a “tissue imaging system” and Fig. 1
`
`(reproduced below) depicts an example of the overall system architecture for use
`
`with such tissue imaging systems.
`
`
`
`In Fig. 1, an example tissue visualization system 100 connects to tissue imaging
`
`systems 105 via network 110. ’345 patent, 6:40-42. A tissue imaging system 105
`
`may comprise a mobile device 108, a combination of a mobile device 108 and an
`
`illumination unit 104, a combination of a mobile device 108 and an imaging unit
`
`103, or a combination of a mobile device 108 and a combined or separate imaging
`
`unit 103 and illumination unit 104. ’345 patent, 6:51-57, 7:10-24. In an example
`
`
`
`6
`
`

`

`embodiment discussed in this summary, mobile device 108 comprises a
`
`smartphone. ’345 patent, 6:61:62.
`
`Image capturing unit 103 captures images, using a 3 channel (RGB) or 4
`
`channel (RGB-NIR) camera for example. ’345 patent, 7:1-5. Illumination unit 104
`
`is capable of illuminating a target area with required intensity, wavelengths, and
`
`duration, such as a multispectral flash. ’345 patent, 7:6-10. The illumination unit
`
`104 can include a lighting unit 300, which may include multiple light sources 300
`
`(see Fig. 3 of the ’345 patent) and may be connected to the smartphone through a
`
`connector 302 to act as an external flash-generating device. ’345 patent, 11:38-44.
`
`Light units 300 can be arranged in a circular configuration around a central
`
`aperture. ’345 patent, 11:44-48.
`
`The illumination unit 104 can produce a sequence of flashes of
`
`predetermined length. ’345 patent, 18:16-17. Fig. 7 of the ’345 patent
`
`(reproduced below) provides an example of an illumination and image capturing
`
`schema, which accounts for external illumination (’345 patent, 17:10-15):
`
`
`
`
`7
`
`

`

`
`
`
`
`Fig. 7 plots the flash 702 coordinated by illumination unit 104, as a function of
`
`time. The ’345 patent states that “[a]s shown at 702, the illumination schema
`
`(cycle) consists of m flashes (with m=2 in the example of Fig. 7) and one period
`
`without flash, with n/4≤m≤n, where n is the number of wavelengths.” ’345 patent,
`
`17:19-23. The ’345 patent defines “[a] wavelength” with regard to a flash as
`
`referring “to light sources shining at the same wavelength, or the possibility of
`
`multiple wavelengths shining in a single flash.” ’345 patent, 18:17-20 (stating
`
`“[e]ach of the flashes may shine at 1-4 particular wavelengths.”).
`
`The ’345 patent also contemplates “an illumination schema where each
`
`
`
`8
`
`

`

`wavelength shines sequentially (n=m, where n is the number of wavelengths, m is
`
`the number of flashes in one cycle).” ’345 patent, 18:65-19:2. See also Ex. 1004,
`
`¶¶24-32.
`
`VI. SUMMARY OF THE RELEVANT PROSECUTION HISTORY
`
`The ’345 patent’s file history from PAIR is included as Ex. 1002. Most
`
`relevant to this Petition, the Examiner did not consider the prior art relied on in this
`
`Petition. In fact, the Examiner did not issue any rejection of the claims based on
`
`prior art.
`
`In the only Office Action prior to the Notice of Allowance, the Examiner
`
`objected to certain informalities (Ex. 1002 at 72), stated how the claims were going
`
`to be construed (Ex. 1002 at 73-77), and rejected what would become claims 1-20
`
`based on 35 U.S.C. § 112(b) as indefinite (Ex. 1002 at 77-81). Patent Owner did
`
`not comment on the claim constructions and sought to address the objection and
`
`indefiniteness rejections. Ex. 1002 at 57-59. In response, the Examiner allowed the
`
`claims (Ex. 1002 at 29), after entering an Examiner’s Amendment of certain claims
`
`(Ex. 1002 at 30-33).
`
`VII. CLAIM CONSTRUCTION
`
`A. Claim Construction
`
`Petitioner’s analysis below will explain how the references satisfy the plain
`
`
`
`9
`
`

`

`and ordinary meaning of the claims as would be understood by a person of
`
`ordinary skill in the art (“POSITA”) at the time of the invention, consistent the
`
`Phillips claim construction standard and its progeny. See Phillips v. AWH Corp.,
`
`415 F.3d 1303 (Fed. Cir. 2005) (en banc). Petitioner respectfully submits that no
`
`explicit construction is necessary when applying the prior art presented, although
`
`the Board may wish to construe “a central aperture of the illumination unit” in
`
`claim 5 and “proper distance” in claim 13, and may wish to consider the
`
`application of 35 U.S.C. § 112(f) in view of the prosecution history of the ’345
`
`patent.
`
`With regard to “a central aperture of the illumination unit,” the specification
`
`of the ’345 patent only uses the term “central aperture” in the summary of the
`
`invention (“the one or more light sources are arranged along a central aperture
`
`having a radius of 0.5-3 cm”) (‘345 patent, 2:57-59) (emphasis added) and when
`
`describing an embodiment where “light units 300 are arranged in a circular
`
`configuration around a central aperture” (11:46-48). A POSITA would
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`understand from these disclosures that the “central aperture of the illumination
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`unit” includes an aperture lying at the center of an arrangement of light units such
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`that the claimed “light sources” are concentric with the central aperture. A
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`POSITA would not understand the recitation “of the illumination unit” to require
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`that the central aperture lies at the geometric center of the housing of an
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`illumination unit (although the central aperture could be at the geometric center of
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`the housing of the illumination unit, as depicted in Fig. 8 of the ’345 patent).
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`Rather, the recitation “of the illumination unit” merely describes on which
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`component the “central aperture” is located.
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`With regard to the term “proper distance,” the specification defines “proper
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`distance” as including a “working distance.” ’345 patent, 14:48-50 (“positioned at
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`a proper distance (working distance) in relation to an area of tissue”) (emphasis
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`added). A POSITA would understand that the positioning merely locates the
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`claimed computing device at a location where a medically-relevant image of tissue
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`may be captured, that is, that the device works to capture a medically-relevant
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`image. The requirement in claim 13 to position the computing device at a proper
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`distance from the target area of the tissue does not require any steps to confirm,
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`verify, or measure that the computing device is, in fact, positioned properly, as
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`claim 13 states nothing about confirming, verifying, or measuring the distance.
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`With regard to § 112(f), none of the claim elements recite the terms “means”
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`or “step,” creating a presumption that § 112(f) does not apply. Petitioner believes
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`that the presumption should be determinative for each element of the claims as
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`each element itself connotes some structure to a person of ordinary skill in the art.
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`See Dyfan, LLC v. Target Corp., No. 2021-1725, slip. op. at 9 (Fed. Cir. Mar. 24,
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`2022) (citing Apex Inc. v. Raritan Comput., Inc., 325 F.3d 1364, 1373 (Fed. Cir.
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`2003)). Nevertheless, the Examiner construed the terms “image capturing unit” in
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`claims 1, 8, 10, and 13, “controller” in claim 4, and “communication(s) module” in
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`claims 11 and 12 under § 112(f). The Examiner also felt that the term “illumination
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`unit” in claims 1, 8, 10, 13, 15, and 17 did not invoke § 112(f) because the claims
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`recite “one or more narrow band light sources” and that the term “image capture
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`unit in claim 9 did not invoke § 112(f) because the claim recites “a camera.” See
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`Ex. 1002 at 75-77.
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`For the purposes of this PGR, the issue of whether the terms should be
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`construed under § 112(f) should be moot, as the references applied disclose the
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`same or equivalent structures as found in the specification of the ’345 patent for
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`performing the claimed functions. For the sake of completeness, Petitioner
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`provides the following analysis of the terms construed by the Examiner to invoke §
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`112(f).
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`A POSITA would interpret the function corresponding to the term “image
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`capturing unit” in claims 1, 8, 10, and 13 to be “capturing an image” and that the
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`structure for capturing an image in the ’345 patent includes a “camera” (claim 9), a
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`“smartphone camera (front or back)” (11:29-30), “an internal … or external device
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`capable of capturing images” (7:1-3), and a “3 channel (RGB) or 4 channel (RGB-
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`NIR) camera” (7:3-5), or its equivalents.
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`A POSITA would interpret the function corresponding to the term
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`“controller” in claim 4 to be “control[ling] illumination of the one or more light
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`sources” and that the structure for controlling illumination of the one or more light
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`sources in the ’345 patent includes “any type of general-purpose microprocessor or
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`microcontroller, a digital signal processing (DSP) processor, an integrated circuit, a
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`central processing unit (CPU), a graphics processing unit (GPU), a field
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`programmable gate array (FPGA), a reconfigurable processor, a programmable
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`read-only memory (PROM), or any combination thereof” (11:61-12:5), or its
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`equivalents.
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`A POSITA would interpret the function corresponding to the term “wireless
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`communication module” in claim 11 to be “receiving commands from the
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`computing device” and that the structure for receiving commands from the
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`computing device in the ’345 patent includes “known … wireless communications
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`protocols” (7:22-24) and “known wireless connections (for example,
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`Bluetooth™)” (7:29-34, 17:53-56); and “Bluetooth, …, WiFi, near-field
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`communication” (11:54-56), or its equivalents.
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`A POSITA would interpret the function corresponding to the term
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`13
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`“communications module” in claim 12 to be “communicating with the one or more
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`tissue imaging systems” and that the structure for communicating with the one or
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`more tissue imaging systems in the ’345 patent includes a “data I/O unit” (8:35-36,
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`9:49-51) allowing “wired connections, wireless connections, or a combination
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`thereof” and “different network communication technologies, standards, and
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`protocols” (8:27-31), or its equivalents. See also Ex. 1004, ¶¶50-61.
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`VIII. PERSON HAVING ORDINARY SKILL IN THE ART
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`A POSITA at the time of the purported invention would have had at least a
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`bachelor’s degree in engineering with relevant coursework, and the equivalent of at
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`least two years of work experience in the design, operation, and functioning of
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`imaging systems, amounting to familiarity with concepts related to illumination
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`and detection schemes for optical imaging systems. Additional relevant work
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`experience could substitute for a bachelor’s degree, and additional education or
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`training could substitute for relevant work experience. Ex. 1004, ¶48.
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`IX. REFERENCE ACCESSIBILITY AND PRIOR ART STATUS
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`The ’345 patent is based on a PCT application filed on July 16, 2019 (“the
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`PCT filing date”) and claims the benefit of a provisional application filed on July
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`16, 2018 (“the ’345 provisional filing date”).
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`“A reference will be considered publicly accessible if it was disseminated or
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`otherwise made available to the extent that persons interested and ordinarily skilled
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`in the subject matter or art exercising reasonable diligence, can locate it.” GoPro,
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`Inc. v. Contour IP Holding LLC, 908 F.3d 690, 693 (Fed. Cir. 2018). As
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`discussed below, each prior art reference relied upon was publicly accessible under
`
`this standard.
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`A. Cross – Ex. 1006
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`Cross is prior art against the ’345 patent under 35 U.S.C. § 102(a)(2), having
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`an effective filing date no later than August 24, 2017, which is prior to the ’345
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`provisional filing date and prior to the PCT filing date, and having been published
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`as a U.S. Patent Application Publication on July 18, 2019. Cross claims the benefit
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`of provisional application 62/378,939 filed on August 24, 2016. (Ex. 1007). No
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`exception under 35 U.S.C. § 102(b) applies to disqualify Cross as prior art.
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`B. Fawzy – Ex. 1008
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`Fawzy is prior art against the ’345 patent under 35 U.S.C. § 102(a)(1) and/or
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`102(a)(2) having an effective filing date no later than September 13, 2017, which is
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`prior to the ’345 provisional filing date and prior to the PCT filing date, and having
`
`been published as a U.S. Patent Application Publication on July 5, 2018, which is
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`prior to the PCT filing date. Fawzy claims the benefit of provisional application
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`62/396,730 filed on September 19, 2016. (Ex. 1009). No exception under 35
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`U.S.C. § 102(b) applies to disqualify Fawz