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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/14/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The abstract of the disclosure is objected to because:
Line 1-11 recites “An endoscopic puncture needle unit is an endoscopic puncture needle unit for administering a virus formulation to a tumor site, including a sheath to be inserted through a forceps channel of an endoscope, a cannula to be inserted into the sheath and having a distal end portion processed into a puncture needle, and a grip member configured to support a sheath proximal end portion which is a proximal end portion of the sheath and a cannula proximal end portion which is a proximal end portion of the cannula, a syringe configured to hold the virus formulation being attachable to the grip member”. This is grammatically incorrect. Examiner suggests replacing “a syringe configured to hold the virus formulation being attachable to the grip member” in line 10-11 with “and a syringe configured to hold the virus formulation being attachable to the grip member”.
Line 12-15 recites “The cannula is formed integrally from an attachment portion to be directly attached to a connection base of the syringe to the puncture needle configured to discharge the virus formulation”. This is grammatically incorrect. It is unclear what is meant by “to be directly attached to a connection base of the syringe to the puncture needle configured to discharge the virus formulation”. Examiner suggests replacing “to be directly attached to a connection base of the syringe to the puncture needle configured to discharge the virus formulation” with “to be directly attached to a connection base of the syringe”.
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 Objections
Claim 1 objected to because of the following informalities:
Line 1-2 recites “An endoscopic puncture needle unit for administering a virus formulation to a tumor site, comprising”. Examiner suggests replacing “An endoscopic puncture needle unit for administering a virus formulation to a tumor site, comprising” in line 1-2 of claim 1 with “An endoscopic puncture needle unit for administering a virus formulation to a tumor site, the endoscopic puncture needle unit comprising” to put the claim in clearer form that the components listed in claim 1 are of the endoscopic puncture needle unit.
Line 3-4 recites “a sheath to be inserted through a forceps channel of an endoscope”. Examiner suggests replacing “a sheath to be inserted through a forceps channel of an endoscope” in line 3-4 of claim 1 with “a sheath configured to be inserted through a forceps channel of an endoscope” to put the claim in clearer form that the sheath is only required to be capable of being inserted through a forceps channel of an endoscope.
Line 5 recites “a cannula to be inserted into the sheath”. Examiner suggests replacing “a cannula to be inserted into the sheath” in line 5 of claim 1 with “a cannula configured to be inserted into the sheath” to put the claim in clearer form that the cannula is only required to be capable of being inserted into the sheath.
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 1-8 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.
In regard to claim 1,
Line 5-6 recites “and having a distal end portion processed into a puncture needle”. It is unclear what is meant by this. It is unclear if the distal end portion is a puncture needle. For examination purposes Examiner construes the distal end portion to be a puncture needle. Examiner suggests replacing “and having a distal end portion processed into a puncture needle” in line 5-6 with “and having a distal end portion that is a puncture needle”.
Line 8-13 recites “a grip member configured to support a sheath proximal end portion which is a proximal end portion of the sheath and a cannula proximal end portion which is a proximal end portion of the cannula, a syringe configured to hold the virus formulation being attachable to the grip member”. It is unclear if the syringe is a component of the endoscopic puncture needle unit and is positively required by the claim. For examination purposes Examiner construes the syringe to be positively required. Examiner suggests removing the term “and” in line 7 and replacing “a grip member configured to support a sheath proximal end portion which is a proximal end portion of the sheath and a cannula proximal end portion which is a proximal end portion of the cannula, a syringe configured to hold the virus formulation being attachable to the grip member” with “a grip member configured to support a sheath proximal end portion which is a proximal end portion of the sheath and a cannula proximal end portion which is a proximal end portion of the cannula; and a syringe configured to hold the virus formulation being attachable to the grip member”. If the syringe is not intended to be positively required, Examiner alternatively suggests replacing “a syringe configured to hold the virus formulation being attachable to the grip member” with “the grip member configured to be attached to a syringe configured to hold the virus formulation”.
Line 14-15 recites “the cannula is formed integrally from an attachment portion”. It is unclear what is meant by this. It is unclear if the attachment portion is required to be a component of the cannula or if the cannula is formed from an attachment portion which somehow forms the cannula. For examination purposes Examiner construes “the cannula is formed integrally from an attachment portion” to be “the cannula comprises an integrally formed an attachment portion”. Examiner suggests replacing “the cannula is formed integrally from an attachment portion” in line 14-15 of claim 1 with “the cannula comprises an integrally formed an attachment portion”.
Line 14-17 recites “wherein the cannula is formed integrally from an attachment portion to be directly attached to a connection base of the syringe to the puncture needle configured to discharge the virus formulation”. It is unclear what is meant by “to be directly attached to a connection base of the syringe to the puncture needle”. For examination purposes Examiner construes “to be directly attached to a connection base of the syringe to the puncture needle configured to discharge the virus formulation” to be “configured to be directly attached to a connection base of the syringe to discharge the virus formulation”. Examiner suggests replacing “to be directly attached to a connection base of the syringe to the puncture needle configured to discharge the virus formulation” with “configured to be directly attached to a connection base of the syringe to discharge the virus formulation”.
Examiner notes claims 2-8 are similarly rejected by virtue of their dependency on claim 1.
In regard to claim 2,
Line 3-4 recites “wherein the endoscopic puncture needle unit is used in conjunction with a gastrointestinal endoscope”. It is unclear if a method step is being claimed due to the phrase “is used”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). Additionally, claim 1 already recites an endoscope in line 4. It is unclear if the endoscope of claim 2 is an additional endoscope or is the same endoscope as claim 1. For examination purposes Examiner construes “wherein the endoscopic puncture needle unit is used in conjunction with a gastrointestinal endoscope” to be “wherein the endoscopic puncture needle unit is configured to be used in conjunction with the endoscope which is a gastrointestinal endoscope”. Examiner suggests replacing “wherein the endoscopic puncture needle unit is used in conjunction with a gastrointestinal endoscope” with “wherein the endoscopic puncture needle unit is configured to be used in conjunction with the endoscope which is a gastrointestinal endoscope”.
In regard to claim 3,
Line 3-4 recites “wherein the endoscopic puncture needle unit is used in conjunction with a bronchoscope”. It is unclear if a method step is being claimed due to the phrase “is used”. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p). Additionally, claim 1 already recites an endoscope in line 4. It is unclear if the bronchoscope of claim 2 is an additional endoscope or is the same endoscope as claim 1. For examination purposes Examiner construes “wherein the endoscopic puncture needle unit is used in conjunction with a bronchoscope” to be “wherein the endoscopic puncture needle unit is configured to be used in conjunction with the endoscope which is a bronchoscope”. Examiner suggests replacing “wherein the endoscopic puncture needle unit is used in conjunction with a bronchoscope” with “wherein the endoscopic puncture needle unit is configured to be used in conjunction with the endoscope which is a bronchoscope”.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 4-6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nishimura (U.S. PG publication 20220183719).
In regard to claim 1,
Nishimura discloses an endoscopic puncture needle unit (figure 1A-2B, item 100 and paragraph [0035]: wherein a syringe is connected to item 5; Examiner notes the endoscopic puncture needle unit is construed as item 100 in conjunction with the syringe) for administering a virus formulation to a tumor site (Examiner notes “for administering a virus formulation to a tumor site” is a functional limitation. The endoscopic puncture needle unit is fully capable of the recited function due to its structure; see paragraph [0003] and [0035]), comprising:
a sheath (figure 2A, item 1) to be inserted through a forceps channel of an endoscope (Examiner notes “to be inserted through a forceps channel of an endoscope” is a functional limitation. The sheath is fully capable of the recited function due to its structure as supported by paragraph [0024]);
a cannula (figure 2A and 4B, item 2, 3, 5C, and item 5 not including item 5G, 5F, 5A, or 5B) to be inserted into the sheath (Examiner notes “to be inserted into the sheath” is a functional limitation. The cannula is fully capable of the recited function as supported by figure 2A) and having a distal end portion (figure 2A, item 3) processed into a puncture needle (see figure 2A); and
a grip member (figure 2A and 4B, item 4, 5A, 5B, 5G, and 5F) configured to support a sheath proximal end portion which is a proximal end portion of the sheath (see figure 2A) and a cannula proximal end portion (portion formed by item 5C and item 5 not including item 5G, 5F, 5A, or 5B) which is a proximal end portion of the cannula (see figure 2A; Examiner notes “configured to support a sheath proximal end portion which is a proximal end portion of the sheath and a cannula proximal end portion which is a proximal end portion of the cannula” is a functional limitation. The grip member is fully capable of the recited function due to its structure as shown in figure 2A), a syringe (syringe described in paragraph [0035]) configured to hold the virus formulation (Examiner notes “configured to hold the virus formulation” is a functional limitation. The syringe is fully capable of the recited function as supported by paragraph [0035]) being attachable to the grip member (Examiner notes “being attachable to the grip member” is functional limitation. The syringe is fully capable of being attachable to the grip member via item 5 as supported by paragraph [0035]), wherein
the cannula is formed integrally from an attachment portion (See 112 rejection above for claim interpretation. Examiner notes the attachment portion is construed as item 5C and item 5 not including item 5G, 5F, 5A, or 5B; Examiner notes the attachment portion is integrally formed as the cannula is one piece as shown in figure 2A) to be directly attached to a connection base of the syringe to the puncture needle configured to discharge the virus formulation (See 112 rejection above for claim interpretation Examiner notes “to be directly attached to a connection base of the syringe to the puncture needle configured to discharge the virus formulation” is a functional limitation. The attachment portion is fully capable of the recited function as supported by paragraph [0035]).
In regard to claim 4,
Nishimura discloses the endoscopic puncture needle unit according to claim 1, wherein a material of the cannula is stainless steel (paragraph [0033]).
In regard to claim 5,
Nishimura discloses the endoscopic puncture needle unit according to claim 4, wherein a material of the sheath is fluororesin (paragraph [0031]).
In regard to claim 6,
Nishimura discloses the endoscopic puncture needle unit according to claim 1, wherein
the grip member (figure 2A and 4B, item 4, 5A, 5B, 5G, and 5F) has a fixing section (figure 2A, item 4) configured to support the sheath proximal end portion (see figure 2A) and a movable section (figure 2A and 4B, item 5A, 5B, 5G, and 5F) configured to support the cannula proximal end portion (see figure 2A) and to be capable of moving forward/backward with respect to the fixing section in an insertion direction of the cannula into the sheath (see position of the movable section shown in figure 2B compared to figure 2A), and
the puncture needle protrudes from an open distal end portion of the sheath or is stored in the open distal end portion when the movable section is moved forward/backward with respect to the fixing section (see figure 2A and 2B).
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:
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura (U.S. PG publication 20220183719).
In regard to claim 2,
Nishimura discloses the endoscopic puncture needle unit according to claim 1, wherein
the endoscopic puncture needle unit is used in conjunction with a gastrointestinal endoscope (see 112 rejection above for claim interpretation. It is noted that the endoscopic puncture needle unit is used in conjunction with a gastrointestinal endoscope is construed as “wherein the endoscopic puncture needle unit is configured to be used in conjunction with the endoscope which is a gastrointestinal endoscope” and is a functional limitation. The endoscopic puncture needle unit is fully capable of being used in conjunction with a gastrointestinal endoscope due to its structure as supported by paragraph [0001]).
Nishimura is silent as to the cannula has an inner cavity diameter of more than or equal to 0.2 mm and less than or equal to 1.0 mm and a total length of more than or equal to 1.5 m and less than or equal to 2.6 m.
It would have been an obvious matter of design choice to modify Nishimura to include the cannula has an inner cavity diameter of more than or equal to 0.2 mm and less than or equal to 1.0 mm and a total length of more than or equal to 1.5 m and less than or equal to 2.6 m since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device.
Additionally, It would have been an obvious matter of design choice to modify Nishimura to include the cannula has an inner cavity diameter of more than or equal to 0.2 mm and less than or equal to 1.0 mm and a total length of more than or equal to 1.5 m and less than or equal to 2.6 m since applicant has not disclosed that having the cannula has an inner cavity diameter of more than or equal to 0.2 mm and less than or equal to 1.0 mm and a total length of more than or equal to 1.5 m and less than or equal to 2.6 m solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of the cannula has an inner cavity diameter of more than or equal to 0.2 mm and less than or equal to 1.0 mm and a total length of more than or equal to 1.5 m and less than or equal to 2.6 m, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
In regard to claim 3,
Nishimura discloses the endoscopic puncture needle unit according to claim 1, wherein
the endoscopic puncture needle unit is used in conjunction with a bronchoscope (see 112 rejection above for claim interpretation. It is noted that the endoscopic puncture needle unit is used in conjunction with a bronchoscope is construed as “wherein the endoscopic puncture needle unit is configured to be used in conjunction with the endoscope which is a bronchoscope” and is a functional limitation. The endoscopic puncture needle unit is fully capable of being used in conjunction with a bronchoscope due to its structure as supported by paragraph [0001]),
Nishimura is silent as to the cannula has an inner cavity diameter of more than or equal to 0.2 mm and less than or equal to 1.0 mm and a total length of more than or equal to 0.6 m and less than or equal to 1.0 m.
It would have been an obvious matter of design choice to modify Nishimura to include the cannula has an inner cavity diameter of more than or equal to 0.2 mm and less than or equal to 1.0 mm and a total length of more than or equal to 0.6 m and less than or equal to 1.0 m since the only difference between the prior art and what is claimed is a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device.
Additionally, It would have been an obvious matter of design choice to modify Nishimura to include the cannula has an inner cavity diameter of more than or equal to 0.2 mm and less than or equal to 1.0 mm and a total length of more than or equal to 0.6 m and less than or equal to 1.0 m since applicant has not disclosed that having the cannula has an inner cavity diameter of more than or equal to 0.2 mm and less than or equal to 1.0 mm and a total length of more than or equal to 0.6 m and less than or equal to 1.0 m solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs. Furthermore, absent a teaching as to the criticality of the cannula has an inner cavity diameter of more than or equal to 0.2 mm and less than or equal to 1.0 mm and a total length of more than or equal to 0.6 m and less than or equal to 1.0 m, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nishimura (U.S. PG publication 20220183719) further in view of Kim (U.S. PG publication 20190201591).
In regard to claim 7,
Nishimura discloses the endoscopic puncture needle unit according to claim 6, wherein the grip member has a protruding amount adjustment mechanism (figure 2A and 2B, item 4A, 4C, 5A and 5A) configured to change a protruding amount of the puncture needle configured to protrude from the open distal end portion (see figure 2B compared to figure 2A; paragraph [0038]-[0041]).
Nishimura is silent as to a protruding amount adjustment mechanism configured to change in a stepwise manner a protruding amount of the puncture needle configured to protrude from the open distal end portion.
Kim teaches a protruding amount adjustment mechanism (figure 3A and 3B, item 33, 32, 31, and 3B) configured to change in a stepwise manner a protruding amount of the puncture needle configured to protrude from the open distal end portion (paragraph [0036]-[0038]).
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 modify the protruding amount adjustment mechanism of Nishimura to be configured to change in a stepwise manner a protruding amount of the puncture needle configured to protrude from the open distal end portion, as taught by Kim, for the purpose of enabling precise treatment utilizing multiple fixed needle lengths depending on the desired treatment type (paragraph [0014] and [0038] of Kim).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nishimura (U.S. PG publication 20220183719) further in view of Snoke (U.S. PG publication 20210299358).
In regard to claim 8,
Nishimura discloses the endoscopic puncture needle unit according to claim 6.
Nishimura fails to disclose wherein the puncture needle is curved with respect to the insertion direction.
Snoke teaches wherein the puncture needle (figure 1 and 3, item 114) is curved with respect to the insertion direction (see figure 1 and 3; paragraph [0031]).
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 modify Nishimura to include wherein the puncture needle is curved with respect to the insertion direction, as taught by Snoke, for the purpose of providing a curved needle suitable for a specific need or application (paragraph [0031] of Snoke) and for the purpose of enabling an endoscope through which the cannula passes to observe a greater viewing field of motion of the needle compared with conventional injection needles, and to require no or minimal motion of the endoscope or introducer relative to the patient, thus providing greater patient comfort because of less torquing or other motion relative to the patient (paragraph [0062] of Snoke).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA ELIZABETH LALONDE whose telephone number is (313)446-6594. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDRA LALONDE/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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