DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 125-147) and Species A (photosensitizer) in the reply filed on 1/29/2026 is acknowledged. Claims 148-149 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 125-147 are currently pending examination.
Claim Objections
Claims 148-149 are objected to because of the following informalities: the status identifiers for these claims should be “withdrawn” (instead of “previously presented”). Appropriate correction is required.
Applicant is reminded to keep claim limitations consistent throughout the entire claim set. For example, “a surrounding target tissue” is referred to as “the target tissue”, “surrounding target tissue”, and “the target”; These should all be “the surrounding target tissue”.
Similarly, while the claims provide inherent/implicit antecedent support for terms like “the emitted radiation”, “the vessel wall” and “the irradiated vessel wall”, it would be clearer and more consistent if applicant could use the same terminology and establish a distinct antecedent basis for these terms. Specifically, the examiner contends that every/all vessels inherently include a vessel wall and the limitation “activating the energy-activatable substance via intraluminal irradiation” provides proper antecedent basis for the emitted radiation. Therefore, these limitations do not rise to the level of being indefinite/unclear; MPEP 2173.05(e). Nonetheless, it would be helpful if applicant could amend the claims to be consistent.
Claim Interpretation
Regarding claims 132, 133, 144 and 145, specifically the term “optionally”, MPEP 2143.03 states “language that suggests or makes a feature or step optional but does not require that feature or step does not limit the scope of a claim under the broadest reasonable claim interpretation”. Therefore, the limitations following “optionally” are not required to be taught/suggested by the prior art in order for the claim language to be met/rejected, as these steps are clearly optional and do not limit the scope of the claim.
Claim Rejections - 35 USC § 112
Claims 141, 146 and 147 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 141] The limitation “an irradiance less than about 200-600 mW/cm2” is indefinite, as it’s unclear if the irradiance has to be less than 600 or less than 200. For examination purposes, the examiner interprets this as “an irradiance less than about 200 mW/cm2”
Claim 146 recites the limitation "the subject" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 147 recites the limitation "the collagen cross-linking" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Further regarding claim 147, it’s unclear what the scope, i.e. metes and bounds, of this claim limitation entails. Specifically, this is seemingly a functional limitation of the energy-emitting element (e.g. light source) and not a positively recited method step. However, it’s unclear what makes an energy-emitting element or light source capable of such an effect, is it a specific wavelength, pulse duration, fluence, intensity, pulse frequency, etc. Therefore, it’s unclear what is required by this functional limitation. MPEP 2173.05(g) states “the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”. For examination purposes, any light source is capable of providing the claimed effect, i.e. the prior art does not have to explicitly teach providing the claimed effect to read on the claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 125-140, 143, 144, 146 and 147 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2015/0005693 to Gerrans et al.
[Claim 125] Gerrans discloses a method (Figs. 2A-C, 6, 9A-B and 10A-C) for isolating a biological vessel (“surrounding healthy tissue”; at least Pars 0015, 0051 and 0066. Specifically, the portion of the vessel wall that surrounds tumor 24/25, especially the tissue outside the chamber formed by the two balloons 48 and 50) from a surrounding target tissue (tumor tissue 24 and/or 25. It is noted that while Gerrans calls the healthy tissue around the tumor the “surrounding” tissue, for purposes of claim interpretation the tumor 24/25 is considered the “surrounding target tissue”, which is consistent with applicant’s claim language and disclosure) comprising:
administering an energy-activatable substance to at least a portion of the target tissue (“oxygenating agent and/or photosensitizing agent”; at least Pars 0044-52 and 0087-96; see steps 420 and 430 of Fig. 9A, as well as step 504 of Fig. 9B); and
activating the energy-activatable substance via intraluminal irradiation of the portion of the target tissue with the energy-activatable substance (ionizing radiation beams 23, e.g. light; at least Pars 0063-65 and 0087-96).
[Claim 126] Gerrans discloses introducing the energy emitting element into the vessel (29, Fig. 2C; Par 0073), wherein the energy-emitting element is configured to emit radiation (23) that irradiates the at least a portion of the target tissue (24) with the energy-activatable substance (at least Pars 0048-52).
[Claims 127-129] Gerrans explicitly teaches isolating the biological vessel (surrounding tissue) from the surrounding target tissue (tumor 24/25), so that only the tumor is damaged/destroyed, i.e. the vessel wall is not damaged (at least Pars 0015, 0051 and 0066). This is considered an energy emitting element that emits energy that is below a vessel wall photochemical damage threshold (so that the surrounding tissue, i.e. tissue near/around the tumor, is left unharmed) and above a photochemical damage threshold for surrounding target tissue (so that the tumor cells are destroyed/killed; Pars 0019, 0091 and 0093). This is a photochemical threshold because it’s based on photodynamical therapy (which is inherently the interaction of light and chemicals, i.e. photochemical).
[Claims 130 and 139] As discussed above, in relation to claims 127-129, Gerrans explicitly teaches that the healthy vessel wall is isolated from the target tissue and therefore not damaged. The examiner interprets this undamaged/healthy tissue as maintaining the structural wall so that the vessel wall that is left substantially intact. Since the light emitted by the light source inherently has a wavelength and fluence, the examiner takes the position that the light source is configured to emit radiation at a wavelength and a fluence that can activate (or excite) the photosensitizer while maintaining structural integrity of the vessel wall.
[Claims 131-133] The examiner interprets the extravasation described in Pars 0051-52, specifically the balloon (46) being repeatedly inflated and deflated such that the outer surface of the balloon contacts the vessel wall/tumor, as protecting the vessel from structural damage by temporarily compressing vasa vasorum (blood vessels that are inherently located within the vessel wall) before and during the light radiation. The examiner takes the position that the limitation “so as to cause temporary deprivation of the irradiated vessel wall from oxygen” is an inherent/implicit effect resulting from this repeated pressure being applied to the vessel wall by the balloon. It is noted that this is the same technique disclosed by applicant that provides oxygen deprivation. Therefore, the same method steps inherently provide the same result. The examiner contends that this repeated and sequential deflating and inflating of the balloon (46) occurs both before (during the delivery of the photosensitizer which clearly happens before irradiation) and during (as shown in Figs. 2A-C, the balloon 46 is inflated at the same time as the light emission 23) the delivery of light. If applicant disagrees; see alternative 103 below.
[Claims 134-135] This is an inherent characteristic/property of all emitted light. Stated differently, all light inherently has a predefined energy emission function, i.e. a controlled dose of energy. If applicant disagrees, see alternative 103 below.
[Claims 136 and 137] As best seen in Figs. 2A-C, the target tissue (tumor 24/25) is in contact with a portion of an external surface of the vessel and the activation of the light generates cell death that effects isolation of a part of the at least a portion of the target tissue from the vessel surface (at least Pars 0051-52 and 0092-93). The takes the position that this cell death, i.e. destruction, damage, killing of the cancer cells/tumor, taught by Gerrans “allows” subsequent surgical isolation, as “subsequent surgical isolation” is not required, i.e. is not a positively recited method step.
[Claim 138] As seen in Fig. 2B and described in Pars 0071, specifically “the radiation beams are transmitted concentrically from the entire outer surface of the balloon, which is particularly advantageous in cases where the tumor tissue (24, 25) is located on more than one side of the cavity or where it is desired to uniformly treat the entire inner surface of the cavity”, Gerrans teaches an intensity distribution profile so to cause isolation in an at least partly circumferential pattern around the vessel surface.
[Claim 140] A cancerous tumor (24/25), by definition, includes diseased cells (i.e. cancerous cells, malignant cells or tumor cells).
[Claims 143 and 144] Gerrans discloses a photosensitizer, specifically porfimer sodium (Pars 0090-91). It is noted that porfimer sodium is a porphyrin or a pharmaceutically acceptable derivative therefore, specifically a salt.
[Claims 146] Gerrans discloses that the energy-activatable substance (photosensitizer) is administered intra-luminally (via openings 52 in the catheter; Fig. 2A; Par 0052), specifically intra-arterially (when the target blood vessel is an artery) or intravenously (when the target blood vessel is a vein), as well as injected directly into the target (needle; Fig. 4; Par 0055)
[Claim 147] The examiner contends that pulsed laser light operating in the red to infrared wavelengths (which is the same light used by applicant in their specification) is configured to provide the same/claimed results (Pars 0064-65 and 0091; See also 112b rejection above).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 132 and 133 are rejected under 35 U.S.C. 103 as being unpatentable over Gerrans.
Gerrans is discussed above, and while the examiner takes the position that the step of protecting the vessel from damage (extravasation) occurs both before and during the delivery of light, it’s not definitively clear. Specifically, Gerrans explicitly discloses this protection before light emission, i.e. during the delivery of the photosensitizer, which has to happen before the light is emitted. And while the figures 2A-C seemingly shown the balloon (46) inflated while light (23) is being delivered, it’s not necessarily clear if this means that the protection/extravasation occurs during light delivery. However, the examiner takes the position that it would be obvious to try this technique at any point in time during the light treatment procedure, including before, during and after the emission of light, as the benefits of this technique are explicitly taught by Gerrans (Par 0052)
Claims 134, 135, 141, 142 and 145 are rejected under 35 U.S.C. 103 as being unpatentable over Gerrans as applied to claim 125 above, and further in view of US 2002/0127230 to Chen.
[Claims 134 and 135] As discussed above, it is the examiner’s position that all/any emission of light (including that taught by Gerrans) inherently has a predefined energy emission function, and more specifically a controlled dose of energy. However, if applicant disagrees, such an energy emission function and controlled dose of energy is known/used in the art for similar vascular photodynamic therapy procedures. Specifically, Chen discloses a vascular photodynamic therapy for the treatment of cancer/tumors (at least Abstract), including a specific intensity and fluence (Par 0058 and Claims 19-21). Therefore, it would have been obvious to one of ordinary skill in the art to modify the method of Gerrans to include irradiation having a predefined emission function and specifically a controlled dose of energy, as taught by Chen, as this is a known/used technique for similar vascular PDT treatments of cancerous tissue.
[Clams 141 and 142] Gerrans is silent to a specific wavelength, intensity or fluence, but does make it clear that “the radiation sources emit various types of light, depending on desired application” (Par 0065). However, Chen, in the same field of endeavor, specifically vascular photodynamic therapy of cancer/tumors, teaches the claimed wavelength (Pars 0030 and 0046-47), the claimed irradiance/intensity (less than 200 mW/cm2; Par 0058) and the claimed fluence (between 1 and 1000 J/cm2; Par 0058 and Claims 19-21). MPEP 2144.05 states… In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. Therefore, it would have been obvious to one of ordinary skill in the art to try/choose the wavelength, irradiance/intensity and fluence taught by Chen as these are known emission parameters for light used for the same/similar treatment.
[Claim 145] Gerrans is discussed above, but fails to explicitly teach a targeting moiety. However, in the same field of endeavor, Chen discloses the use of a targeting moiety, specifically an antibody or antibody fragment (at least Pars 0041, 0055 and 0067). Therefore, it would have been obvious to modify the method taught by Gerrans to include/add a target moiety taught by Chen, as this “may permit lowering of the required dose level since the material is more selectively target and less is wasted in distribution into other tissues whose destruction must be avoided” (Par 0055 of Chen).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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