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 1, 3-4, 7-14, and 16-20 in the reply filed on 3/30/26 is acknowledged.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. For example, Applicant refers to the use of ION Endoluminal System (e.g. Model IF1000) by Intuitive Surgical Inc. as a prior art displacement-control arrangement, and the use of FleXeneedle (e.g. Model 10005) by Broncus Medical, Inc., USA as the flexible needle device, and mentions that the delivery apparatus is assembled from parts “each obtained from a different provider”. Applicant is reminded of 37 CFR 1.56.
Specification
The use of the term “ION” in “ION Endoluminal System” (page 28), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Abstract:
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because it is over 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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.
1) In Claim 1, line 3, it is not clear whether the “a delivery apparatus” is the same or different than the “delivery apparatus” of line 2. Does this refer to the same delivery apparatus or a different delivery apparatus? In addition, this creates more issues of clear antecedence in Claim 10. Which of the two (“delivery apparatus” in line 2 of Claim 1, and “a delivery apparatus” in line 3 of Claim 1) does “the delivery apparatus” of Claim 10 refer to?
2) In Claim 1, line 12, the “an optical fiber” clause (ii) ends with “and comprising” as part of said clause (ii). Thus, it is unclear whether the last of the claim, right after the “and comprising” of clause (ii) further limits the optical fiber of clause (ii) or the delivery apparatus of line 3.
3) Claims 16 and 18 improperly depends on cancelled Claim 15. This, in turn, creates a series of issues of lack of antecedence.
3) Regarding Claim 20, the “an assembly of claims 1” lacks clear antecedence.
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 1, 3-4, 7-8, 10-14, 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2021/0023386 by Mamiya.
Regarding Claim 1, Mamiya teaches a PDT assembly for use in photodynamic therapy (PDT) of a target tissue (e.g. abstract: PDT method with needle catheter), comprising delivery apparatus:
a delivery apparatus that comprises:
(i) a flexible needle device comprising an elongated flexible tube having a fiber-receiving lumen (e.g. ¶¶ 24, 62, Fig. 1, Fig. 2 and Fig. 6: together, the flexible sheath 3 with the needle tube 2, which has a lumen capable of receiving fiber 6, meet the “flexible needle device”, which is flexible enough to curve along with endoscope 100 within a human body, as shown in Fig. 6), extendable in a proximal-distal direction along a delivery axis (e.g. ¶ 36, 62, Fig. 6: sheath 3 and fiber 2 are capable of being advanced and retracted in the human body along with the endoscope; Note that this limitation does not require any type of mechanism, and so long as the structure is capable of being extended manually, the limitation is met; Furthermore, ¶ 24-25 discloses that the needle tube 2 of the flexible needle device 2/3 is movable in the longitudinal direction via needle slider 5), and a pointed, needle-like distal tip for penetrating said tissue (e.g. ¶ 24, 62: needle tube 2 has a needle blade surface which “is made to protrude” in order to penetrate tissue); and
(ii) an optical fiber insertable and axially displaceable within said lumen and couplable at its proximal end to a light source (e.g. ¶ 24,61,71: fiber 6 is inserted in the needle tube 2 and is capable of axial displacement therein; ¶¶ 29, 35: the fiber is capable of being coupled to a PDT light source capable of activate a photosensitive drug to damage cancer), emitting a PDT-effective light at a wavelength applicable for said PDT, to permit light from said source to enter the optical fiber (¶¶ 29, 35: the fiber is capable of emitting PDT light), and said fiber having a distal end portion with a light-diffusing section, for emitting light from within the fiber in one direction (¶¶ 29, 41, Fig. 2, Fig. 7, Fig. 10-13: the distal portion of fiber 6, called “emission area A” is clad free, may be covered by a white translucent cover 17, and emits sideways “in all radial directions from the emission area A” toward target X), said diffuser having one X- ray marker (¶ 30, Fig. 2, Fig. 7, Fig. 10-13: metal, such as radiopaque heavy metal tantalum, marker(s) 11 at a distal and/or proximal position of diffusing section A of fiber 6); and comprising
a displacement-control arrangement couplable to a proximal portion of the flexible needle device and to a proximal portion of the optical fiber accommodated within the flexible needle device with the proximal portion projecting out of the proximal end of the flexible needle device, and configured for selective axial displacement of said flexible needle device and said optical fiber one versus the other (e.g. abstract, ¶¶ 5, 27-32, 40, Fig. 3-4: the fiber 6 is advanced in the needle tube 2 and, when desired, is secured in the slider 5/7, which is used to couple to needle 2, and to advance or retreat needle 2, thus enabling relative translation of the needle 2 versus the fiber 6; Fig. 1: the proximal end of fiber 6 is capable of and extends proximal to the entire needle device 2/3, and even the handle 5; Note here that “selective displacement of A and B one versus the other” requires only one of A and B to move relative to the other, as “one versus the other” is an expression that includes the selection of one of two options).
Regarding Claim 3, Mamiya discloses the PDT assembly of claim 1, comprising two X-ray markers flanking the light-diffusing section (e.g. ¶¶ 30, 46, Fig. 10-11: two ring or side markers 11, each one of which flanking the core 9).
Regarding Claim 4, Mamiya discloses the PDT assembly of claim 1, wherein said diffuser section is configured for emitting light in a radial direction (e.g. ¶ 41: light is emitted in radial directions).
Regarding Claim 7, Mamiya discloses the PDT assembly of claim 1, wherein at least one of the X-ray markers is an X-ray opaque annular element (e.g. ¶¶ 30: ring shaped tantalum markers 11).
Regarding Claim 8, Mamiya discloses the PDT assembly of claim 1, comprising an X-ray opaque rod element at a distal end portion of the optical fiber (e.g. ¶¶ 30: ring shaped tantalum markers 11, a ring also being a hollow rod/cylinder).
Regarding Claim 10, Mamiya discloses the PDT of claim 1, wherein the displacement-control arrangement is configured for: (i) retaining said distal tip within the delivery apparatus during deployment to a site proximal to said tissue; and (ii) axially displacing the flexible needle device and extracting said distal tip following deployment (e.g. ¶37).
Regarding Claim 11, Mamiya discloses the PDT assembly of claims 1, wherein the displacement-control arrangement comprises a tube coupling element that can axially reciprocate with respect to other said displacement-control arrangement elements, between a rearward state and a forward state, and having a coupled state in which it is physically coupled to a proximal portion of said flexible needle device for its respective axial displacement in both proximal and distal directions along said delivery axis, and having a decoupled state in which the axial displacement of said tube coupling element does not cause displacement of said flexible needle device (e.g. ¶¶ 31-32, Fig. 3-4: tube coupling slider 5 couples to proximal end of needle 2 and moves forward and back with respect to grip portion 19 and fixing mechanism 7, and clearly when the needle is not coupled to the slider 7, it doesn’t slide with the slider 7).
Regarding Claim 12, Mamiya discloses the PDT assembly of claims 1, wherein the displacement-control arrangement comprises an optical fiber coupling element that can axially reciprocate, with respect to other said control device elements, between a retracted state and an extended state, and having a coupled state in which it is physically coupled to said optical fiber for respective axial displacement of the fiber in both proximal and distal directions along said delivery axis, and having a decoupled state in which the axial displacement of said optical fiber coupling element does not cause displacement of said optical fiber (e.g. ¶¶ 31-32, Fig. 3-4: elastic body 14 which couples with optical fiber 6, is elastic thus retracts and expands, and slides together with the optical fiber 6 when it is coupled with the fiber, and does not affect fiber movement when uncoupled to the fiber).
Regarding Claim 13, Mamiya discloses the PDT assembly of claim 12, wherein: the displacement-control arrangement comprises a tube coupling element that can axially reciprocate, with respect to other said control device elements, between a rearward state and a forward state, having a coupled state in which it is physically coupled to a proximal portion of said flexible needle device for its respective axial displacement in both proximal and distal directions along said delivery axis, and having a decoupled state in which the axial displacement of the tube coupling element does not cause displacement of said flexible needle device; and wherein the coupling of the tube coupling element to a proximal portion of said flexible needle device and coupling of the optical fiber coupling element to said optical fiber are independent of one another permitting discrete axial displacement of the flexible needle device and the optical fiber (e.g. ¶¶ 31-32, Fig. 3-4: tube coupling slider 5 couples to proximal end of needle 2 and moves forward and back with respect to grip portion 19 and fixing mechanism 7, and clearly when the needle is not coupled to the slider 7, it doesn’t slide with the slider 7; ¶¶ 31-32, Fig. 3-4: elastic body 14 which couples with optical fiber 6, is elastic thus retracts and expands, and slides together with the optical fiber 6 when it is coupled with the fiber, and does not affect fiber movement when uncoupled to the fiber; abstract, ¶¶ 5, 27-28, 31-32,39: this mechanism permits the selective discrete retreat of the needle relative to the fiber, which meets the claimed limitations).
Regarding Claim 14, Mamiya discloses the PDT assembly of claim 13, wherein said tube coupling element and said optical fiber coupling element are physically coupled to one another to define a reciprocating block (e.g. Fig. 3-4: elements 5/7/14 are coupled to one another and do reciprocate, thus reading on a reciprocating block).
Regarding Claim 16, Mamiya discloses the PDT assembly of claims 15 (read as Claim 1 under the broadest reasonable interpretation), wherein the displacement-control arrangement has operational modes that comprise:(i) a tissue penetration mode in which the flexible needle device and the optical fiber are axially displaced in a distal direction to an extended state to permit said distal tip to penetrate said tissue; (ii) an exposure mode in which said flexible needle device is retracted in a proximal direction to expose said optical fiber's distal end portion in said tissue and retain it therein; and (iii) an internalization mode for retracting said end portion to within said flexible needle device (Note that the claim does not require any type of automation; e.g. abstract, ¶¶ 5, 27-28, 31-32, 39, 70-71, Fig. 5: needle 2 and fiber 6 are capable of being advanced together to puncture tissue, the needle is capable of being retracted to expose the fiber, and the fiber is capable of being pulled back by releasing it from the lock of slider mechanism 5/7/14/19).
Regarding Claim 17, Mamiya discloses the PDT assembly of claim 16, wherein: in said tissue penetration mode, the tube coupling element and the optical fiber coupling element are both in their coupled state for joint axial displacement of the flexible needle device and the optical fiber in a distal direction along said delivery axis to reach the extended state for penetration of the target tissue; and wherein in said exposure mode, the tube coupling element is in the coupled state and the optical fiber coupling element is in the decoupled state for retracting said flexible needle device's pointed distal tip, to thereby expose said optical fiber's distal end portion (e.g. abstract, ¶¶ 5, 27-28, 31-32, 39, 70-71, Fig. 5: needle 2 and fiber 6 are capable of being advanced together to puncture tissue in the locked mode of the slider mechanism 5/7/14/19, and when unlocked the needle is capable of being retracted to expose the fiber, and the fiber is capable of being pulled back).
Regarding Claim 18, Mamiya discloses the PDT assembly of claim 15 (read as Claim 1 under the broadest reasonable interpretation), wherein the displacement-control arrangement has operational modes that comprise:(i) a tissue penetration mode in which the flexible needle device is axially displaced in a distal direction to the forward state to cause its pointed, needle-like distal tip to penetrate the target tissue; (ii) a retraction mode in which said flexible needle device is axially displaced in a proximal direction to retract said distal tip from said tissue; (iii) a fiber placement mode in which said optical fiber is axially displaced in a distal direction into a channel formed in said tissue by said distal tip; and (iv) an internalization mode for retracting said end portion to within said flexible needle device (Note that the claim does not require any type of automation; e.g. abstract, ¶¶ 5, 27-28, 31-32, 39, 70-71, Fig. 5: needle 2 and fiber 6 are capable of being advanced together to puncture tissue in the locked mode of the slider mechanism 5/7/14/19, and when unlocked the needle is capable of being retracted to expose the fiber, and the fiber is capable of being pulled back relative to the needle 2 and the sheath 3).
Regarding Claim 19, Mamiya discloses the PDT assembly of claim 18, wherein: in said tissue penetration mode and said retraction mode the tube coupling element is in its coupled state for axial displacement of said distal tip in a distal direction to the forward state for penetrating the target tissue, and in the opposite direction, respectively; and wherein in said fiber placement mode the optical fiber coupling element is in its coupled state for axial displacement of the optical fiber in a distal direction to the extended state for positioning said distal end portion of the optical fiber within said tissue (e.g. abstract, ¶¶ 5, 27-28, 31-32, 39, 70-71, Fig. 5: needle 2 and fiber 6 are capable of being advanced together to puncture tissue in the locked mode of the slider mechanism 5/7/14/19, and when unlocked the needle and the fiber are capable of being advanced or retracted independently of one another).
Regarding Claim 20, Mamiya discloses a system for photodynamic therapy (PDT) in a target tissue, comprising an assembly of claim 1 and a light source emitting light at a wavelength applicable for said PDT and connectable to said optical fiber (e.g. title, abstract, ¶ 29: a light source for PDT is coupled to the fiber 6).
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mamiya in view of NPL by Reisenauer et al., Ion: Technology and Techniques for Shape-sensing Robotic-assisted Bronchoscopy, Ann Thorac Surg, Epub 2021 Aug 8.
Regarding Claim 9, Mamiya discloses the PDT assembly of claims 1, yet does not teach wherein a distal portion of said flexible needle device is highly flexible, such that it can bend, without loss of its integrity, to define a curvature with a radius of 20 mm or less.
However, Reisenauer teaches an analogous endoscopic system having a needle and a fiber therewith, the needle having a radiopaque sheath tip, wherein a distal portion of said flexible needle device is highly flexible, such that it can bend, without loss of its integrity, to define a curvature with a radius of 20 mm or less (e.g. abstract: ION endoluminal system, which Applicant mentions as prior art and as at least part of their system on page 28; Section “Technology”: Flexision needles and thin fiber; Fig. 5: the tip bend radius is 14 mm).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate a needle navigation mechanism with a needle flexible distal portion that is capable of bending with a bending radius of 20 mm or less for the flexible needle device of a device according to the teachings of Mamiya, as taught by Reisenauer, in order to predictably navigate, control and articulate the tip of the needle so as to enhance precision in treatment and make it easier to traverse the tortuous paths of the body without causing damage to surrounding tissues, while also reaching to locations around an initial puncture without requiring multiple punctures.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2001/0025174 by Daniel teaches individual, mechanically controlled and automated control of advancement and retraction of both a needle relative to a fiber and a fiber relative to a needle.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANOLIS Y PAHAKIS whose telephone number is (571)272-7179. The examiner can normally be reached M-F 9-5, EST.
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/MANOLIS PAHAKIS/Examiner, Art Unit 3796