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 .
Claim Objections
Claim(s) 19 is/are objected to because of the following informalities:
Claim 19 recites “with at least one of the and the” in line 2 which is a grammatical error; a suggested edit is “with .
Appropriate correction is required.
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. Such claim limitation(s) is/are:
“centering means” in claim 25; structure found in of instant Fig. 5 and instant specification [0031] and [0033] “centering means 25”;
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
“means of a transfer function” in claim 16;
“means of the pumping device” in claims 27-28;
“means of the transfer function” in claims 27-28;
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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.
Claim(s) 16-30 is/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.
Regarding claim 16 and its dependents, claim 16 recites “the external rod and the internal rod” in line 24. There is insufficient antecedent basis for this limitation in the claim. Note that claim 16 recites “an external hollow rod” in line 5 and “an internal hollow rod” in line 6 with additional recitations of “the external hollow rod” and “the internal hollow rod” in lines 5-17 while “the external rod and the internal rod” do not recite modifier of “hollow”; it is thus unclear and indefinite as to whether “the external rod and the internal rod” refers to “external hollow rod” and “internal hollow rod” or other elements. Claim terms should be consistent throughout claim set in order to avoid confusion. For examination purposes below, it will be assumed this is “the external hollow rod and the internal hollow rod”.
Claim 17 recites the limitation "the inflatable" in line 1. There is insufficient antecedent basis for this limitation in the claim. Note that claim 16 recites “an inflatable balloon” and that claim 18 recites “the inflatable balloon” while the instant claim is does not recite “balloon”; it is thus unclear and indefinite as to whether this term refers to “inflatable balloon” or another element. Claim terms should be consistent throughout claim set in order to avoid confusion. For examination purposes below, it will be assumed this is “the inflatable balloon”.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 16-20, 23, 25-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vermandel (WO 2017162869 A1; 9/28/2017; cited in IDS).
Regarding claim 16, Vermandel teaches a system for a photodynamic therapy treatment of a patient's body cavity configured to provide a predetermined dose of light energy to said cavity, the cavity being delimited by tissues comprising cells having a photosensitizer compound or a precursor thereof absorbed therein (p. 5 lines 12-18), the system comprising:
an external hollow rod extending along a central axis and displaying a distal extremity (Fig. 2, 16 reads on external hollow rod),
an internal hollow rod configured to be inserted inside the external hollow rod, the internal hollow rod extending along the central axis and displaying a distal extremity, the distal extremity being at least partially transparent (Fig. 2, 16 reads on external hollow rod, 26 reads on internal hollow rod),
an inflatable balloon secured on the distal extremity of the external hollow rod, the inside of the inflatable balloon being in fluidic communication with the inside of the external hollow rod, the inflatable balloon displaying a symmetry of revolution around the central axis, and being designed to either be vacuumized, or be filled, in a controlled way, with a fluid up to a given volume (Fig. 2, balloon 11; p. 6 lines 22-25; p. 10 lines 31-33 “balloon 11 is emptied by connecting to a pump”),
a handle comprising two openings, a first opening connected to the inside of the internal hollow rod and a second opening connected to the inside of the external hollow rod (Fig. 2, 31 reads on first opening, 21 reads on second opening; p. 6 line 14 to p. 7 line 5),
wherein the inside of the internal hollow rod is isolated from the inside of the external hollow rod (Fig. 2).
Vermandel does not explicitly teach wherein the handle is made of one single piece. Note that instant specification [0053] discusses “handle 20 is still considered as being one single piece as those different parts 20A, 20B, 20C cannot be detached from each other”; depicted in instant Fig. 3b. However, Vermandel teaches handle (Fig. 2; p. 6 line 14 to p. 7 line 5) that assembled together constitutes one piece. Alternatively, it is an obvious modification to combine separate parts into a single piece; MPEP 2144.04 Making Integral.
Vermandel teaches wherein the first opening of the handle is designed to receive, in a sealed way, an illuminating device intended for illuminating the inflatable balloon, the illuminating device being designed to emit a light adapted to activate the photosensitizer compound (Fig. 2, optical fiber 36; p. 7 line 31 to p. 8 line 4),
wherein the second opening of the handle is designed to be connected to a pumping device (Fig. 2, 21; p. 6 lines 21-25).
Vermandel does not explicitly teach wherein the handle, the external rod and the internal rod are designed to be sealingly secured to each other in one single screwing movement. However, Vermandel teaches the claimed structure of handle as discussed above and so would inherently perform the same function (Fig. 2); MPEP 2112.01 “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.”.
Vermandel teaches wherein a given illumination time is determined by means of a transfer function relating each given volume of the inflatable balloon to at least one corresponding distribution of light power at the outer surface of the inflatable balloon and a corresponding illumination time for providing the predetermined dose of light energy (Fig. 4, compare to instant Fig. 4 in which all the constants are the same; p. 8 lines 4-20).
Regarding claim 17, Vermandel teaches wherein the inflatable is adapted to allow diffusion of the light emitted by the illuminating device (Fig. 2; Fig. 4; p. 8 lines 4-10).
Regarding claim 18, Vermandel teaches wherein the inflatable balloon has a variable capacity, the balloon being elastic and reversibly extendible, the inflatable balloon presenting a plurality of inflated states depending on the amount of fluid comprised inside the inflatable balloon (Fig. 4; p. 6 lines 3-11; p. 6 lines 20-25; p. 8 lines 4-10).
Regarding claim 19, Vermandel teaches wherein the transfer function relates the volume of each inflated state of the inflatable balloon with at least one of the and the corresponding illumination time for providing a determined dose of light energy (Fig. 4; p. 8 lines 4-20).
Regarding claim 20, Vermandel teaches wherein the inflatable balloon displays an elongated shape (Fig. 2, balloon 11; Fig. 3, balloon 11; p 2 lines 29-31 “balloon can be adapted to the cavity to be treated”); the change in shape of balloon would also be an obvious modification; MPEP 2144.04 Change in Shape.
Regarding claim 23, Vermandel teaches wherein the internal hollow rod comprises a positioning device adapted to lock a distal extremity of the illuminating device inserted inside the internal hollow rod at a desired distance from the tip of the distal extremity of the internal hollow rod (Fig. 2, locking device 31; p. 7 lines 3-5; p. 7 lines 24-30).
Regarding claim 25, Vermandel teaches wherein the internal hollow rod displays centering means aimed at centering said internal hollow rod with regards to the central axis (112f interpreted in light of instant Fig. 5 and instant specification [0031] and [0033] “centering means 25”; Vermandel Fig. 2, guide 26; p. 6 lines 26-35).
Regarding claim 26, Vermandel teaches a kit for a photodynamic therapy treatment of a patient's body cavity configured to provide a predetermined dose of light energy to said cavity (p. 5 lines 12-18), wherein the kit comprises a system according to claim 16 (see regarding claim 16 above), an illumination device configured to be inserted in said system and a control unit configured to control the illumination device (Fig. 3; p. 3 lines 4-7).
Regarding claim 27, Vermandel teaches a method for preparation of a system for photodynamic therapy treatment according to claim 16, the method comprising repeatedly performing steps of:
inserting the internal hollow rod inside the external hollow rod (Fig. 2),
connecting the handle on the external hollow rod (Fig. 2; p. 6 line 14 to p. 7 line 5),
inserting the illuminating device inside the internal hollow rod, through the first opening of the handle (Fig. 2; p. 7 line 24-30),
positioning and/or locking the illuminating device at a predetermined distance from the tip of the distal extremity of the internal hollow rod (Fig. 2; p. 7 lines 3-5; p. 7 lines 24-30),
sealingly securing the handle, the internal hollow rod and the hollow external rod (Fig. 2; p. 7 line 31 to p. 8 line 4),
connecting the second opening of the handle to the pumping device (Fig. 2, 21; p. 6 lines 21-25).
Vermandel does not teach vacuuming, by means of the pumping device, the inflatable balloon in order to completely emptying it and enable a precise determination of the size of the emptied balloon in order to set a referential. However, Vermandel teaches having an empty balloon and stepwise filling it in order to measure (Fig. 2; p. 9 line 27 to p. 10 line 9 “ensured that the internal space of the balloon 11 is emptied”) which is the recited method step in reverse. It would have been obvious to a person of ordinary skill in the art to perform the reverse method steps; MPEP 2144.04 Changes in Sequence of Adding Ingredients.
Vermandel teaches filling, by means of the pumping device, the inflatable balloon with a given volume fluid (Fig. 2; p. 9 line 27 to p. 10 line 9), and
determining the illumination time by means of the transfer function (Fig. 4; p. 8 lines 4-20).
Regarding claim 28, Vermandel teaches a method for treating cancer by photodynamic therapy in a patient in need thereof (p. 5 lines 12-18; claim 1), the method comprising the steps of:
administering a photosensitizer compound or a precursor thereof to the patient (p. 5 lines 12-18);
providing a system according to claim 16 (see above regarding claim 16) or preparing said system by a method comprising repeatedly performing (as an initial matter, merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143). Regarding the specifics of the instant claim(s), one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to engage in routine experimentation to discover the optimal parameters of the instant claim(s). See MPEP 2144.05(II)(A)("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation")(citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCCPA 1955)).) steps of:
inserting the internal hollow rod inside the external hollow rod (Fig. 2),
connecting the handle on the external hollow rod (Fig. 2; p. 6 line 14 to p. 7 line 5),
inserting the illuminating device inside the internal hollow rod, through the first opening of the handle (Fig. 2; p. 7 line 24-30),
positioning and/or locking the illuminating device at a predetermined distance from the tip of the distal extremity of the internal hollow rod (Fig. 2; p. 7 lines 3-5; p. 7 lines 24-30),
sealingly securing the handle, the internal hollow rod and the hollow external rod (Fig. 2; p. 7 line 31 to p. 8 line 4),
connecting the second opening of the handle to the pumping device (Fig. 2, 21; p. 6 lines 21-25)
Vermandel does not teach vacuuming, by means of the pumping device, the inflatable balloon in emptied balloon in order to set a referential. However, Vermandel teaches having an empty balloon and stepwise filling it in order to measure (Fig. 2; p. 9 line 27 to p. 10 line 9 “ensured that the internal space of the balloon 11 is emptied”) which is the recited method step in reverse. It would have been obvious to a person of ordinary skill in the art to perform the reverse method steps; MPEP 2144.04 Changes in Sequence of Adding Ingredients.
Vermandel teaches filling, by means of the pumping device, the inflatable balloon with a given volume fluid (Fig. 2; p. 9 line 27 to p. 10 line 9), and
determining the illumination time by means of the transfer function (Fig. 4; p. 8 lines 4-20);
positioning the inflatable balloon of the system in a body cavity of the patient (p. 4 lines 10-13),
activating the illuminating device (p. 4 lines 14-19);
disactivating the illuminating device (p. 4 lines 14-19; p. 8 lines 15-21);
optionally, repeating once or several times the two previous steps (as an initial matter, merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143). Regarding the specifics of the instant claim(s), one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to engage in routine experimentation to discover the optimal parameters of the instant claim(s). See MPEP 2144.05(II)(A)("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation")(citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCCPA 1955)).).
Regarding claim 29, Vermandel does not teach wherein the inflatable balloon is deflated between two activations of the illuminating device. However, Vermandel teaches the steps of the deflated balloon being placed in cavity, inflating balloon, activating photosensitizer by delivering light (p. 4 lines 10-19) and deflating balloon by removing fluid of balloon (p. 6 lines 23-25). It would have been obvious to modify Vermandel to repeat these steps in the process of treating different tissues or adjusting the device location which would result in the instant claim limitations. As an initial matter, merely replicating the treatment step one or more additional times would have been obvious to one of ordinary skill in the art, at least until the desired outcome was achieved. For example, in Perfect Web Tech., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1328-29, 92 USPQ2d 1849, 1854 (Fed. Cir. 2009), the Federal Circuit held that mere repetition of a known procedure until success is achieved was merely the logical result of common sense application of the maxim "try, try again." (see MPEP 2143). Regarding the specifics of the instant claim(s), one of ordinary skill in the art before the effective filing date of the invention would have found it obvious to engage in routine experimentation to discover the optimal parameters of the instant claim(s). See MPEP 2144.05(II)(A)("[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation")(citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCCPA 1955)).).
Claim(s) 21, 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vermandel as applied to claim 16 above, in view of Lundahl (US 4998930 A; 3/12/1991; cited in IDS).
Regarding claim 21, Vermandel does not teach wherein the distal extremity of the internal hollow rod is designed to be in permanent contact with the inflatable balloon. Note that Vermandel teaches distal extremity internal hollow rod in contact with inflatable balloon (Fig. 2; p. 2 lines 4-5 “hollow sheath having a balloon arranged at the distal end of the illuminating member”). However, Lundahl teaches in the same field of endeavor (Abstract; Fig. 2) the internal hollow rod is designed to be in permanent contact with the inflatable balloon (Col. 6 lines 54-68). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Vermandel to include these features as taught by Lundahl because this enables accurate delivery of therapy after balloon is inflated (Col. 5 line 65 to Col. 7 line 10).
Regarding claim 24, Vermandel does not teach wherein the internal hollow rod is flexible. However, Lundahl teaches in the same field of endeavor (Abstract; Fig. 2) wherein the internal hollow rod is flexible. (Col. 6 lines 54-68 “flexible”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Vermandel to include these features as taught by Lundahl because this enables accurate delivery of therapy by having device be flexible to be maneuvered to target tissue (Col. 5 lines 65-68).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vermandel and Lundahl as applied to claim 21 above, and further in view of Brown (US 20080306441 A1; 12/11/2008; cited in IDS).
Regarding claim 22, the combination of Vermandel and Lundahl does not teach wherein the internal hollow rod comprises a slidable element, slidable along the central axis. However, Brown teaches in the same field of endeavor (Abstract) wherein the internal hollow rod comprises a slidable element, slidable along the central axis ([0054]; [0055] “sliding arrangement”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Vermandel and Lundahl to include this feature as taught by Brown because this enables adjustment and stability ([0055]-[0056]).
The combination of Vermandel, Lundahl, and Brown teaches in order to enable a permanent contact between the inflatable balloon and the distal extremity of the internal hollow rod (Lundahl Col. 6 lines 54-68; Brown [0054]-[0056]).
Claim(s) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vermandel as applied to claim 16 above, in view of Hamblin (Combination immunotherapy and photodynamic therapy for cancer; Published 2008).
Regarding claim 30, Vermandel does not teach treating the patient with an immunotherapy treatment before, concomitantly with and/or after photodynamic therapy. However, Hamblin teaches in the same field of endeavor (Abstract) treating the patient with an immunotherapy treatment before, concomitantly with and/or after photodynamic therapy (Abstract “Combination regimens using PDT and immnostimulating treatments are likely to even further enhance post-PDT immunity”; Fig. 5; p. 8 Conclusions and Future Outlook). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of to include this feature as taught by Hamblin because this can enhance treatment effect (Abstract).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792