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 of Group I, claims 1-9, in the reply filed on 07 January 2026 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an irradiation unit” in claim 1, “a second irradiation unit” in claim 3, “a fixing portion” in claim 5, and “a detection unit” in claim 9. The irradiation units are taught to be an optical fiber or an optical waveguide. The fixing portion is taught to be a balloon. The detection unit is taught to be an optical waveguide such as an optical fiber, along with an optical sensor.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 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 2, 3, and 8 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 2 recites the limitations “a direction substantially perpendicular” in lines 2-3 and “a substantially distal direction” in lines 4-5. The term “substantially” in these limitations is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of these directions are not clear; e.g., is a direction that is 85 degrees to the axial center considered to be substantially perpendicular, or must this be within a narrower range around 90 degrees, or could it be even farther away from 90 degrees?
Claim 2 also recites the limitation “an axial center of the distal shaft” in line 3. It is not clear what is meant by “axial center” in this limitation. Does this mean a central axis? The center of an axis? Which axis?
Claim 3 recites the limitations “a direction substantially perpendicular” in lines 2-3 and “a substantially distal direction” in line 4. The term “substantially” in these limitations is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The metes and bounds of these directions are not clear; e.g., is a direction that is 85 degrees to the axial center considered to be substantially perpendicular, or must this be within a narrower range around 90 degrees, or could it be even farther away from 90 degrees?
Claim 3 also recites the limitation “an axial center direction” in line 3. It is not clear what is meant by “axial center” in this limitation. Does this mean a central axis? The center of an axis? Which axis?
Claim 8 recites the limitations “an axial center of the disk portion” in lines 1-2 and “an axial center of the main shaft” in line 2. It is not clear what is meant by “axial center” in these limitations. Does this mean a central axis? The center of an axis? Which axis? Further, a shaft has an inherent longitudinal axis but a disk does not.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, 5, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Goodrich et al. (U.S. Pub. No. 2019/0290360 A1; hereinafter known as “Goodrich”), in view of Seibel (U.S. Pub. No. 2001/0055462 A1).
Regarding claim 1, Goodrich discloses a treatment apparatus configured to irradiate an antibody-photosensitive substance accumulated in a tumor cell with excitation light (Abstract; [0024]; [0074]; [0137]; [0192]; while Goodrich does not teach irradiating an antibody-photosensitive substance, Goodrich’s apparatus is capable of doing such, as it emits near-infrared light to tumors), the treatment apparatus comprising: a tubular device 113 including an elongated tubular member ([0084]-[0085]) and an irradiation device 202 configured to be inserted into the tubular member and including an irradiation unit configured to emit the excitation light ([0080]; [0086]; [0094]). Goodrich fails to disclose that the irradiation device includes a main shaft including a distal portion and a proximal portion, a disk portion disposed on a distal side of the main shaft, a distal shaft protruding from the disk portion toward the distal side, and the irradiation unit disposed on the distal shaft. Seibel discloses a similar apparatus (Abstract; Figs. 3A-B) comprising an irradiation device 80 that is an optical fiber and that includes a main shaft 82/88 including a distal portion and a proximal portion, a disk portion 93 disposed on a distal side of the main shaft, a distal shaft 95 protruding from the disk portion toward the distal side, and an irradiation unit 94 disposed on the distal shaft, in order to integrate therapeutic and diagnostic functions into a single optical fiber ([0010]-[0011]; [0055]; [0077]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Goodrich with the irradiation device taught by Seibel in order to integrate therapeutic and diagnostic functions into a single optical fiber.
Regarding claim 4, the combination of Goodrich and Seibel discloses the invention as claimed, see rejection supra, and Goodrich further discloses that a distal portion of the tubular member is configured to be deformed ([0109]; supple and flexible).
Regarding claim 5, the combination of Goodrich and Seibel discloses the invention as claimed, see rejection supra, and Goodrich further discloses a fixing portion configured to fix the irradiation device to the tubular device ([0094]; [0100]; [0115]).
Regarding claim 8, the combination of Goodrich and Seibel discloses the invention as claimed, see rejection supra, and Seibel further discloses that an axial center of the disk portion is inclined with respect to an axial center of the main shaft (Fig. 3B; [0077]).
Regarding claim 9, the combination of Goodrich and Seibel discloses the invention as claimed, see rejection supra, and Seibel further discloses a detection unit 92 configured to detect fluorescence emitted by the antibody-photosensitive substance ([0077]; again, while this detection unit is not expressly taught to detect fluorescence emitted by the antibody-photosensitive substance, the photon detectors taught by Seibel would be capable of detecting such fluorescence).
Allowable Subject Matter
Claims 2 and 3 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 6 and 7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: regarding claim 2, as the claim can best be understood, none of the prior art of record teaches or reasonably suggests such an apparatus wherein the distal shaft is configured to emit the excitation light in a direction substantially perpendicular to an axial center of the distal shaft and the disk portion is configured to emit the excitation light in a substantially distal direction. Regarding claim 3, as the claim can best be understood, none of the prior art of record teaches or reasonably suggests such an apparatus wherein the tubular member includes a second irradiation unit configured to emit the excitation light in a direction substantially perpendicular to an axial center direction of the tubular member and/or in a substantially distal direction. Regarding claims 6 and 7, none of the prior art of record teaches or reasonably suggests a fixing portion for fixing the irradiation device to the tubular device, wherein the fixing portion is an inflatable balloon disposed on either the disk portion or the tubular member, in combination with the other recited components.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Svanberg (U.S. Pub. No. 2008/0249517 A1) teaches a PDT apparatus that includes optical fibers positioned between disk portions, wherein a shaft protrudes from a disk portion. Yang et al. (KR 101924492 B1) teaches a PDT apparatus that includes optical fibers that are inserted into tubular members and are positioned between disk portions. Samuel et al. (U.S. Pub. No. 2009/0198173 A1) teaches a PDT apparatus that includes a disc-shaped diffusing member. Vermandel et al. (U.S. Pub. No. 2020/0289840 A1) teaches a PDT apparatus that includes an optical fiber and a tubular device, along with various locking members that are circle-shaped. Kaneda et al. (U.S. No. 5,871,521 A) teaches a PDT apparatus with disk portions as shields.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791