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 1-2, 4-9, 11-13, 17-18, 20-23, and 25-27 are currently pending. Claims 1-2, 4-9, 11-13, 17-18, 20-22, and 25-26 are withdrawn as being directed to non-elected inventions. As per the amendments filed on 01/20/2026, claims 23 and 27 are amended and claim 24 is canceled. Claims 23 and 27 are under examination.
Response to Arguments
Applicant’s arguments, see Remarks pages 7-9 (Claim Rejections Under 35 U.S.C. §103), filed 01/20/2026, with respect to the 35 U.S.C. § 103 rejections of claims 23-24 and 27 have been fully considered. Claim 24 is canceled. Regarding claim 23:
Applicant does not agree with the rejection; however, without acquiescing to the rejection and solely to advance prosecution, claim 23 has been amended to include the limitations of claim 24, which was not rejected over Kornfield and Soltz. Withdrawal of the rejection is respectfully requested. The Office Action rejects claims 24 and 27 under 35 U.S.C. § 103 as allegedly being obvious over Kornfield in view of Soltz and in further view of U.S. Publication Ser. No. 2014/0066835 to Muller et al. ("Muller"). Applicant respectfully traverses the rejection because Kornfield in view of Soltz and Muller, alone or in combination, fail to make out a prima facie case of obviousness.
With regard to claim 24, whose limitations are now in claim 23, the Office Action acknowledges that Kornfield does not disclose applying a second photosensitizer, and thus applies Muller to allegedly teach this limitation. Applicant respectfully submits that this is incorrect. First, with regard to photosensitizers, Muller is almost entirely drawn to the use of riboflavin as a single photosensitizer and only mentions an alternative specific photosensitizer, Rose Bengal, at paragraph 148, with no mention of a combination of riboflavin and Rose Bengal. Paragraph 107 of Muller, cited in the Office Action to allegedly teach a mix of photosensitizers, actually is silent as to any particular combination of photosensitizers and is speculative, as it merely states:
"One of the aspects of the present invention relates to formulating extensive relationships where the rates/concentrations of photo-bleaching, oxygen consumption/radicals generation, and photosensitizer/oxygen re-diffusion are used to construct multi-wavelength pulsing regimes (i.e., irradiance/duty cycle/synchronizing wavelength exposure) based on real time feedback of oxygen and photosensitizer consumption and concentrations as a function of depth. For example, an optimized way of delivery of the agents ( e.g., actinic radiance, photo sensitizer, dissolved oxygen) may include maximal oxygen pre-loading of the photosensitizers, multiple wavelength matching a mix of photo sensitizers or a single photo sensitizer for calibrated radical generation and potentially using elasticity mapping feedback for 3D pattern optimization."
Muller is silent as to details on such "multi-wavelength pulsing regimes," "mix of photosensitizers," or how to actually achieve such delivery. (pages 7-8, 01/20/2026 Remarks)
This argument is not persuasive. Both Kornfield ([0007], [0408]) and Soltz ([0010-0011]) establish methods for generally adding a photosensitizer (where a list of possible photoreactive agents is provided) to the eye where a particular wavelength of light activates the photosensitizer for treatment. Muller also establishes a method for applying a cross-linking agent to eye ([0007]). While primarily using Riboflavin, it is recognized other substances may be employed such as Rose Bengal ([0148]). The excerpt in Muller [0107] suggests a modification of the delivery method established in [0007] to include a mix of photosensitizers to the eye and multiwavelength pulsing procedures to activate each photosensitizer. In this regard, a mix would at least be able to include two photosensitizers, such as Riboflavin and Rose Bengal, which have different activation wavelengths. Applicant further argues:
Furthermore, Muller is entirely drawn to "achieving corrective changes in corneal tissue" using a surgical procedure and not treating infection, and cross-linking is only described in the context of "improving the stability of the changes to the corneal tissue" (paragraph 3). The "extensive relationships" and "multiple wavelength matching a mix of photosensitizers or a single photosensitizer for calibrated radical generation and potentially using elasticity mapping feedback for 3D pattern optimization" in paragraph 107 cited in the Office Action are presented specifically in this context of structural cross-linking and not treatment of infection; the "3D pattern optimization" appears to refer to optimization of the desired 3D structure of the cornea to be produced by the crosslinking. Muller gives no reason to apply such a mix of photosensitizers for treating eye infection, rather than the use for creating a desired corrective change in corneal tissue as specifically disclosed by Muller. Furthermore, one of ordinary skill would have had no reason to believe that such an approach specifically taught for making structural "changes to the corneal tissue" would be effective or beneficial in treating infection.
Thus, Muller read together with Kornfield and Stolz would not have actually led one of ordinary skill in the art to specifically combine another photosensitizer with Rose Bengal, especially in a method of treating eye infection. (page 8, 01/20/2026 Remarks)
This argument is not persuasive. Soltz teaches: “The invention provides for the use of essentially any photoactive therapeutic agent with the desired activity, e.g., cell killing activity, including anti-pathogen activity and antineoplastic activity, and/or cross-linking activity to rigidify the cornea. In a preferred embodiment, the activity of the photoactive therapeutic agent is a result of the activity of the agent as a crosslinking agent, or the activity of the agent as a generator of singlet oxygen species” ([0011]). Therefore, both cross-linking and anti-pathogenic activities are presented as achievable using the invention in Soltz via generation of reactive oxygen species by the interaction of the photosensitizer and irradiated light.
Both Kornfield ([0408]) and Muller ([0007]) present applications in cross-linking, where the mechanism of cross-linking is dependent on reactive oxygen species generation from the reaction of the photosensitizer and light (Kornfield - [0015]). While the extent of reactive oxygen generation needed for cross-linking and anti-pathogenic effects may be different, Soltz establishes cross-linking and anti-pathogenic treatment as achievable via the same photodynamic therapy mechanism of producing reactive oxygen species (see Soltz [0025]). Applicant also argues:
Furthermore, presently amended claim 23 requires photosensitizers that are not described in any of the cited references. The cited references do not disclose erythrosin B, dihematoporphyrinether, or verteporfin, let alone their combination with Rose Bengal. One of ordinary skill in the art would not have had any reason from the cited references to combine Rose Bengal with erythrosin B, dihematoporphyrinether, or verteporfin as required by the present claims.
Applicant notes that in the present claims, riboflavin is not included among the recited
alternatives required for the second photosensitizer to combine with Rose Bengal (i.e., erythrosine B, dihematoporphyrinether, or verteporfin). In contrast, Muller describes a single-photosensitizer treatment with riboflavin (see, for example, paragraphs 34-68), with only one other specifically disclosed photosensitizer as an alternative (Rose Bengal, paragraph 148). Soltz also describes a single-photosensitizer treatment with riboflavin (see paragraph 59 and Examples 1 and 2). Kornfield also describes a single-photosensitizer treatment with riboflavin or eosin Y; see, for example, paragraphs 59-81 and the examples. This further supports that one of ordinary skill in the art would not have had any reason from the cited references to combine Rose Bengal with erythrosin B, dihematoporphyrinether, or verteporfin as required by the present claims. (pages 8-9, 01/20/2026 Remarks)
This argument is persuasive. None of Kornfield, Soltz, or Muller teach erythrosin B, dihematoporphyrinether, or verteporfin as a photosensitizer. Therefore, the rejections of claims 23 and 27 are withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Chen (US PG Pub 2003/0167033 A1), see “Claim Rejections - 35 USC § 103” section.
Summary: The 35 U.S.C. § 103 rejections of claims 23, 24, and 27 are withdrawn. New 35 U.S.C. § 103 rejection for claims 23 and 27 over Kornfield in view of Soltz, Muller, and Chen are added (see “Claim Rejections - 35 USC § 103”). Note new 35 U.S.C. § 112(b) rejections are added (see “Claim Rejections - 35 USC § 112”).
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 23 and 27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 23: Claim 23 recites the limitation “the group consisting of erythrosin B, dihematoporphyrinether, and verteporfin” where “the group” lacks an antecedent basis.
Claim 27 is rejected for being dependent on rejected claim 23.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 23 and 27 are rejected under U.S.C 103 as being unpatentable over Kornfield (US PG Pub 2015/0359668 A1, see previously cited) in view of Soltz (US PG Pub 2009/0192437 A1, see previously cited), Muller (US PG Pub 2014/0066835 A1, see previously cited), and Chen (US PG Pub 2003/0167033 A1, see “Notice of References Cited”).
Regarding Claim 23, Kornfield discloses a method of photodynamic therapy treatment ([0007]), the method comprising:
• applying Rose Bengal as a first photosensitizer to a cornea of an eye ([0407] – Rose Bengal used as a photosensitizer for cross-linking: “Consistent with previous results, collagen can be cross-linked in the presence of a photo sensitizer (e.g. riboflavin [40, 104, 115], eosin Y [52, 116], Rose Bengal [ 64, 65, 115, 117], methylene blue [97], and brominated 1,8-naphthalimide [118]) upon irradiation and no cross-linking was observed in the absence of either the sensitizer or irradiation [64, 65]”, [0408] – corneal cross-linking).
• positioning a corneal surface of the eye at a focal point of a cupula structure (Fig 3, [0028] - the “obliquely oriented sources” treat the eye where each LED is positioned to irradiate in a pattern around a central point; [0122] – LED’s can be arrayed to irradiate along a central axis over the target area, such as the cornea: “by way of example and not of limitation, the target may be the cornea 400 as illustrated in FIG. 3. In particular, the light delivery device can be positioned such that the central axis (e.g. 201 of FIG. 6A) of the light delivery device is positioned directly over the center of the target region that is desired to be irradiated such that when the LEDs are turned on, the desired target region is irradiated with a therapeutic distribution of irradiance at the target”; see also Fig 7C); and
• applying at least one wavelength of light to the cornea of the eye for a predetermined period of time ([0015] – “directing a light source at the target ocular region for a time and under conditions to allow a desired extent of cross-linking of a protein to occur in the ocular tissue” where any light would automatically have at least one wavelength and the wavelength activates a photosensitizer to produce reactive oxygen species) using a plurality of light sources emitting light ((Fig 3, [0028] – “shows a simulation of a cornea being irradiated with the light delivery device. The plurality of obliquely oriented sources can treat the target (e.g., cornea) while avoiding the anti-target region (e.g., macula)”) having the at least one wavelength that corresponds approximately to the excitation peak of the Rose Bengal ([0202] – the light emitted by the device is used to match the excitation wavelength of the photosensitizer), the plurality of light sources housed in the cupula structure (Fig 4A, [0113] – the multiple LED’s 104 are arranged on a curved cupula-like surface):
-the cupula structure (Fig 4A, [0111] – cupula-shaped structure) having a radius of curvature that focuses the light emitted from each of the plurality of light sources (Fig 3, [0028] - the “obliquely oriented sources” treat the eye where each LED is positioned to irradiate in a pattern over the target – giving the cornea as an example target) at the focal point onto the corneal surface of the eye positioned at the focal point of the cupula structure ([0122] – LED’s can be arrayed to irradiate along a central axis over the target area), wherein at least a subset of the plurality of light sources is arranged in at least two concentric rings having different radii ([0134] - “In some embodiments, multiple light delivery device can be used simultaneously to irradiate the target region as shown in FIGS. 11A-11B. Alternatively, a single light delivery device can have more than one set of light emitting arrangements (e.g., two sets of ring-shape patterned LEDs). The multiple sets of light emitting arrangements can all have the same angle, as shown in FIG. 11A, or can have different angles, as shown in FIG. 11B”). Kornfield therefore describes the use of multiple light arrangements within a single light delivery device, further providing the example of LED arrangements taking the form of two ring-shaped patterns (instead of the one ring-shaped pattern established in Figure 4A). The disclosure in [0134] is interpreted as providing additional embodiments to increase the number of light sources irradiating the target (such as using multiple devices or using another ring of LED’s on a single device). In light of the above evidence, the light emitting arrangements form distinct rings (two rings), can be focused on the same point (concentric), and cannot occupy the same space on the light delivery device while forming multiple discernable rings (necessarily different ring sizes with different radii).
Kornfield discloses “other desired effects” in addition to cross-linking can be generated ([0006]). However, Kornfield does not disclose a photodynamic therapy treatment of a corneal eye infection and applying Rose Bengal to an infected cornea of an eye. Additionally, Kornfield does not disclose applying a second photosensitizer to the cornea, wherein the second photosensitizer is selected from the group consisting of erythrosin B, dihematoporphyrinether, and verteporfin.
Soltz, in the same field of endeavor of providing photodynamic therapy with a photosensitizer ([0011], [0071]), teaches the use of photodynamic therapy for treating infections of the eye ([0011]), specifically referencing treatment of infectious keratitis ([0003, 0019, 0059]). Soltz teaches either cross-linking or anti-pathogen therapies can be applied to the cornea with the same device ([0011] – “The invention provides for the use of essentially any photoactive therapeutic agent with the desired activity, e.g., cell killing activity, including anti-pathogen activity and antineoplastic activity, and/or cross-linking activity to rigidify the cornea. In a preferred embodiment, the activity of the photoactive therapeutic agent is a result of the activity of the agent as a crosslinking agent, or the activity of the agent as a generator of singlet oxygen species”). Therefore, both cross-linking and anti-pathogenic activities are presented as achievable using the invention in Soltz via generation of reactive oxygen species by the interaction of the photosensitizer and irradiated light. Soltz teaches the use of Rose Bengal as a photosensitizer for treating infections ([0011]).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Kornfield’s method for providing photodynamic therapy to the cornea by incorporating the photodynamic treatment of a corneal infection in Soltz. This would have been obvious because both Kornfield and Soltz discuss the application of photodynamic therapy to the cornea and Soltz provides a solution/improvement for settings where the photodynamic therapy is used to treat corneal infections, thereby increasing the number of conditions which can be treated with the device. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Kornfield by incorporating the photodynamic treatment of a corneal infection in Soltz.
Muller, in the same field of endeavor of applying a photoreactive agent to the eye and photoactivating light to activate that agent ([0007]) with an LED array ([0108]), teaches the use of multiple wavelengths of irradiation applied to match each photosensitizer in a photosensitizer mixture during treatment ([0107] - “One of the aspects of the present invention relates to formulating extensive relationships where the rates/concentrations of photo-bleaching, oxygen consumption/radicals generation, and photosensitizer/oxygen re-diffusion are used to construct multi-wavelength pulsing regimes … For example, an optimized way of delivery of the agents (e.g., actinic radiance, photo sensitizer, dissolved oxygen) may include maximal oxygen pre-loading of the photosensitizers, multiple wavelength matching a mix of photosensitizers or a single photosensitizer”; [0108] – the LED array allows for multiple wavelengths to be emitted). Riboflavin and Rose Bengal are discussed as cross-linking agents ([0148]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to alter Kornfield’s method for LED irradiance of different photosensitizers by incorporating the multiple wavelengths of light applied to activate a photosensitizer mixture in Muller. This would have been obvious because both Kornfield and Muller discuss applying photoactivating light to the eyes with an LED array and Muller provides a solution/improvement via use of an LED array emitting different wavelengths to effectively activate mixtures of different photosensitizers for more specialized treatments. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Kornfield by incorporating the multiple wavelengths of light simultaneously applied to activate a photosensitizer mixture in Muller.
Chen, in the same field of endeavor of applying photoactivating light to treat the eyes ([0010]) with a light array ([0080-0081]), teaches photodynamic therapy to damage target cells via the production of reactive oxygen species ([0003], [0049]). Chen suggests a mixture of photoreactive agents can be provided to the target organ for therapy ([0227-0228]). With respect to photoreactive agents, Chen states “Any chemical compound that absorbs light may be used in the methods provided herein (see, e.g., Kreimer Birnbaum (1989) Sem. Hematol. 26:157-173)” ([0084]). Chen then specifically mentions Rose Bengal ([0084]), erythrosin B ([0164]), dihematoporphyrinether ([0171]), and verteporfin ([0090]) as potential photoreactive agents.
12. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornfield’s photodynamic therapy using photoreactive agent applied to tissue with the specific photoreactive agents in Chen. At the time, there would have been a recognized need to select a photoreactive agent(s) to use in photodynamic therapy of the eye. Given both Kornfield and Chen describe photodynamic therapy of the eye, the photoreactive agents listed in Chen (Rose Bengal, erythrosin B, dihematoporphyrinether, and verteporfin) would be obvious to try. A person of ordinary skill in the art would have a reasonable expectation of implementing the photoreactive agents in Chen for use with the phototherapy device in Kornfield.
Therefore, Claim 23 is obvious over Kornfield in view of Soltz, Muller, and Chen.
Regarding Claim 27, the method of photodynamic therapy treatment of a corneal eye infection according to Claim 23 is obvious over Kornfield in view of Soltz, Muller, and Chen, as indicated hereinabove. Kornfield further discloses wherein applying at least one wavelength of light to the cornea of the eye ([0015]) comprises:
• the use of multiple types of photosensitizers ([0202] - riboflavin and Eosin Y are specifically mentioned as being tested; [0047] - Rose Bengal, methylene blue, and brominated 1,8-naphthalimide have been used in previous testing).
• the use of light sources of different wavelengths of light to activate different photosensitizers ([0015] – the light sources are used to activate the photosensitizer; [0202] – “Riboflavin is a UVA light activated photosensitizer (370 nm ultraviolet irradiation). Eosin Y is a visible light activated photosensitizer having a maximum absorption peak at approximately 514 nm (green light)”).
However, Kornfield does not disclose the use of two photosensitizers used simultaneously and irradiated with their respective activating wavelengths in:
• applying a first wavelength of light to the cornea of the eye by controlling a first subset of the plurality of lights to emit light at the first wavelength to excite Rose Bengal; and
• applying a second wavelength of light to the cornea of the eye by controlling a second subset of the plurality of lights, which is different from the first subset, to emit light at the second wavelength to excite the second photosensitizer.
Muller, in the same field of endeavor of applying a photoreactive agent to the eye and photoactivating light to activate that agent ([0007]) with an LED array ([0108]), teaches the use of multiple wavelengths of irradiation applied to match each photosensitizer in a photosensitizer mixture during treatment ([0107] - “One of the aspects of the present invention relates to formulating extensive relationships where the rates/concentrations of photo-bleaching, oxygen consumption/radicals generation, and photosensitizer/oxygen re-diffusion are used to construct multi-wavelength pulsing regimes … For example, an optimized way of delivery of the agents (e.g., actinic radiance, photo sensitizer, dissolved oxygen) may include maximal oxygen pre-loading of the photosensitizers, multiple wavelength matching a mix of photosensitizers or a single photosensitizer”; [0108] – the LED array allows for multiple wavelengths to be emitted).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to alter Kornfield’s method for LED irradiance of different photosensitizers by incorporating the multiple wavelengths of light applied to activate a photosensitizer mixture in Muller. This would have been obvious because both Kornfield and Muller discuss applying photoactivating light to the eyes with an LED array and Muller provides a solution/improvement via use of an LED array emitting different wavelengths to effectively activate mixtures of different photosensitizers for more specialized treatments. Therefore, a person of ordinary skill in the art would be motivated to improve the method of Kornfield by incorporating the multiple wavelengths of light simultaneously applied to activate a photosensitizer mixture in Muller.
Chen, in the same field of endeavor of applying photoactivating light to treat the eyes ([0010]) with a light array ([0080-0081]), teaches photodynamic therapy to damage target cells via the production of reactive oxygen species ([0003], [0049]). Chen suggests a mixture of photoreactive agents can be provided to the target organ for therapy ([0227-0228]). With respect to photoreactive agents, Chen states “Any chemical compound that absorbs light may be used in the methods provided herein (see, e.g., Kreimer Birnbaum (1989) Sem. Hematol. 26:157-173)” ([0084]). Chen then specifically mentions Rose Bengal ([0084]), erythrosin B ([0164]), dihematoporphyrinether ([0171]), and verteporfin ([0090]) as potential photoreactive agents (the second photosensitizer in the claim language).
12. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kornfield’s photodynamic therapy using photoreactive agent applied to tissue with the specific photoreactive agents in Chen. At the time, there would have been a recognized need to select a photoreactive agent(s) to use in photodynamic therapy of the eye. Given both Kornfield and Chen describe photodynamic therapy of the eye, the photoreactive agents listed in Chen (Rose Bengal, erythrosin B, dihematoporphyrinether, and verteporfin) would be obvious to try. A person of ordinary skill in the art would have a reasonable expectation of implementing the photoreactive agents in Chen for use with the phototherapy device in Kornfield.
Therefore, Claim 27 is obvious over Kornfield in view of Soltz, Muller, and Chen.
Conclusions
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Benjamin Schmitt, whose telephone number is 703-756-1345. The examiner can normally be reached on Monday-Friday from 8:30 am to 5:00 pm.
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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796