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 .
Response to Amendment
In response to the preliminary amendment filed on 7/5/2024, claims 4, 6, 12-14, 19-22, 25-28, 30, 31 have been canceled, and claims 1-3, 5, 7-11, 15-18, 23, 24, 29, 32-35 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities: in [00115], “needle rod 613” should instead recite - - needle rod 113 - -.
Appropriate correction is required.
Claim Objections
Claim 5 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, the claim 5 has not been further treated on the merits.
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 7-11, 15-18, 24, 29, 33 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 7 recites the limitation "the needle rod" twice. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the needle rod". There is insufficient antecedent basis for this limitation in the claim.
Claim(s) 9 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Claim 10 recites the limitation "the distal end portion of the needle rod”. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the needle rod" twice. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the outer diameter of a distal portion of the needle rod". There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitations "the outer needle rod" and “the inner needle rod” multiple times. There is insufficient antecedent basis for these limitations in the claim.
Claim 17 recites the limitations "the inner needle rod", “the outer needle rod”, “the distal end” and “the proximal end” multiple times. There is insufficient antecedent basis for these limitations in the claim. It is therefore further unclear what the distal end and proximal end are in reference to.
Claim 18 recites the limitations “the distal portion”, "the outer needle rod", “the inner needle rod” and “the portion of the inner needle”. There is insufficient antecedent basis for these limitations in the claim.
Claim 24 recites the limitations "the outer diameter”. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitations "the outer diameter”. There is insufficient antecedent basis for this limitation in the claim. Claim 29 further recites “the inner diameter of the shrunk portion is smaller than the outer diameter of the guide tube of 0.05 mm to 1 mm”. It is unclear what is meant by the term “of”. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret the limitation as - - the inner diameter of the shrunk portion is smaller than the outer diameter of the guide tube by 0.05 mm to 1 mm - -.
Claim 33 recites the limitations "the inner diameter” and “the outer diameter”. There is insufficient antecedent basis for these limitations in the claim. Claim 33 further recites “greater than the outer diameter of the guide tube of 0.1 mm to 2 mm”. It is unclear what is meant by the term “of”. For examination purposes and as best understood by the Examiner in light of the specification, the Examiner will interpret the limitation as - - greater than the outer diameter of the guide tube by 0.1 mm to 2 mm - -.
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.
Claim(s) 1 and 7, 8, 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (CN 202277348; wherein the attached English machine translation is cited herein).
Zhang et al discloses the following limitations:
Claim 1. A puncture instrument (Fig. 2), comprising: a puncture needle ([0011]; entire structure of Fig. 2) which comprises a sensor mounting portion (exposed portion of needle head 3, or exposed portion of needle body 2) capable of mounting an electromagnetic sensor. Applicant has not positively recited the electromagnetic sensor. An electromagnetic sensor is capable of being disposed on the cited sensor mounting portion by mounting to the exterior of needle head 3 or needle body 2. This is similar to Applicant’s disclosure that their sensor (2) can be mounted on the exterior of the puncture needle (11) (Fig. 2).
Claim 7. The puncture instrument according to claim 1, wherein an outer diameter of a distal portion (exposed portion of needle head 3) of the needle rod is smaller than an outer diameter of a proximal portion (proximal portion of sleeve 4) of the needle rod (Fig. 2).
Claim 8. The puncture instrument according to claim 1, wherein the needle rod includes an inner needle rod (1) and an outer needle rod (2) (needle body 2 is exterior of needle core 1 and therefore encompasses the claimed limitation of ‘outer’), and the outer needle rod sleeves outside the inner needle rod (Fig. 2).
Zhang et al discloses the outer needle rod (2) is connected with the inner needle rod (1) but is silent as to the method of connected being welding. The claimed phrase “welding” is being treated as a product by process limitation; that is, that the connection is made by welding. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698,227 USPQ 964,966 (Fed. Cir. 1985).
Thus, even though Zhang et al is silent as to the process used to connect the outer needle rod with the inner needle rod, it appears that the product in Zhang et al would be the same or similar as that claimed; especially since both applicant’s product and the prior art product involve the inner needle rod and outer needle rod being connected without relative movement to one another.
Claim 10. The puncture instrument according to claim 8, wherein at the distal portion of the needle rod, the inner needle rod (1) extends beyond the outer needle rod (2) (Fig. 2).
Claim(s) 1, 2, 8-11, 15, 16 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ji et al (CN 109009425; wherein the attached English machine translation is cited herein).
Ji et al discloses the following limitations:
Claim 1. A puncture instrument, comprising: a puncture needle (entirety of Fig. 2) which comprises a sensor mounting portion (exposed portion of needle head 5 at main body 5a, or inside hollow structure 18) capable of mounting an electromagnetic sensor. Applicant has not positively recited the electromagnetic sensor. An electromagnetic sensor is capable of being disposed on the cited sensor mounting portion by mounting to the exterior of needle head 5 or being disposed within the lumen of hollow structure 18. This is similar to Applicant’s disclosure that their sensor (2) can be mounted on the exterior of the puncture needle (11) (Fig. 2) or inside the hollow interior (111) of the needle (11) (Fig. 1).
Claim 2. The puncture instrument according to claim 1, wherein the sensor mounting portion is an internal cavity (18) of the puncture needle (Fig. 2).
Claim 8. The puncture instrument according to claim 1, wherein the needle rod includes an inner needle rod (5) and an outer needle rod (7), and the outer needle rod sleeves outside the inner needle rod (Fig. 2).
Ji et al discloses the outer needle rod (7) is connected with the inner needle rod (5) but is silent as to the method of connected being welding. The claimed phrase “welding” is being treated as a product by process limitation; that is, that the connection is made by welding. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698,227 USPQ 964,966 (Fed. Cir. 1985).
Thus, even though Ji et al is silent as to the process used to connect the outer needle rod with the inner needle rod, it appears that the product in Ji et al would be the same or similar as that claimed; especially since both applicant’s product and the prior art product involve the inner needle rod and outer needle rod being connected without relative movement to one another. Furthermore, Ji et al discloses various connections in the puncture instrument being welded together (page 6, paragraph 6). Therefore, at the least, the outer needle rod is connected with the inner needle by indirect welding of the intermediate elements.
Claim 9. The puncture instrument according to claim 8, wherein the inner needle rod (5) and the outer needle rod (7) are sealed by welding (page 6, paragraph 6; various intermediate elements are welded together within the puncture instrument of Fig. 2 and therefore forms a seal. In other words, fluid would not be able to flow between inner needle rod (5) and outer needle rod (7).
Claim 10. The puncture instrument according to claim 8, wherein at the distal portion of the needle rod, the inner needle rod (5) extends beyond the outer needle rod (7).
Claim 11. The puncture instrument according to claim 1, wherein the puncture needle comprises an auxiliary portion (6), the auxiliary portion sleeves outside the needle rod (proximal portion of needle head 5 having the smaller diameter 5b), and a friction coefficient of the auxiliary portion is smaller than that of the needle rod (page 6, paragraphs 5-6; the sleeve 6 is made of polytetrafluoroethylene (PTFE); which has a general coefficient of friction of 0.05 to 0.10; the needle rod (5) can be made of various magnetic alloys such as titanium alloy which has a general coefficient of friction of 0.3 to 0.6). Furthermore, Applicant discloses in their own specification that polytetrafluoroethylene (PTFE) is a material of very low friction coefficient ([0124] of the instant published application).
Claim 15. The puncture instrument according to claim 11, wherein the auxiliary portion is a sleeve (6); and an outer diameter of a distal portion of the needle rod is smaller than an outer diameter of a proximal portion of the needle rod (the needle rod is interpreted as needle 5 together with needle bar 7; therefore the diameter at a distal portion (5b) of the needle rod is stepped and therefore smaller than a proximal portion of the needle rod containing needle bar (7)), and the sleeve sleeves at the distal portion (5b) of the needle rod (Fig. 2; page 4, paragraph 7).
Claim 16. The puncture instrument according to claim 11, wherein the auxiliary portion is a sleeve (6); and the outer needle rod (5+7) comprises a distal outer needle rod (5) and a proximal outer needle rod (7), the distal outer needle rod sleeves at a distal end of the inner needle rod (14), the proximal outer needle rod sleeves at a proximal end of the inner needle rod (14), and the sleeve sleeves outside the inner needle rod between the distal outer needle rod and the proximal outer needle rod (Fig. 2; portion 6a of sleeve 6 is between the distal outer needle rod (5) and proximal outer needle rod (7)).
Claim 18. The puncture instrument according to claim 11, wherein the auxiliary portion is a sleeve (6); and at the distal portion of the needle rod, the inner needle rod (5) extends beyond the outer needle rod (7), and the sleeve (portion 6a of sleeve 6) sleeves at the portion (5b) of the inner needle rod (5) that extends beyond the outer needle rod (7) (Fig. 2; page 4, paragraph 7).
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ormsby et al (US 2011/0130750).
Ormsby et al discloses the following limitations:
Claim 1. A puncture instrument, comprising: a puncture needle (10) (entirety of Fig. 2) which comprises a sensor mounting portion (14) capable of mounting an electromagnetic sensor (30) ([0025]).
Claim 2. The puncture instrument according to claim 1, wherein the sensor mounting portion is an internal cavity (14) of the puncture needle (Fig. 2; [0025]).
Claim 3. The puncture instrument according to claim 1, wherein the puncture needle is tubular ([0022]), one end of a tubular cavity of the puncture needle is opened at a proximal end of the puncture needle (Fig. 1; [0025]; wires 34 exit the puncture needle and extend into handle 15 and therefore the proximal end of the puncture needle must be opened to allow the wires to extend into the handle to connect to terminals therein), the other end of the tubular cavity is closed at a distal end of the puncture needle (closed via tip 19), and the tubular cavity forms the sensor mounting portion (14) (Fig. 2; [0025]).
Claim(s) 1, 2 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kunis (US 2015/0258270).
Kunis discloses the following limitations:
Claim 1. A puncture instrument (Fig. 10), comprising: a puncture needle (106+104) which comprises a sensor mounting portion (lumen of elongated member 104) capable of mounting an electromagnetic sensor. Applicant has not positively recited the electromagnetic sensor. An electromagnetic sensor is capable of being mounting to the cited sensor mounting portion by being disposed within the lumen of elongated member 104. This is similar to Applicant’s disclosure that their sensor (2) can be mounted inside the hollow interior (111) of the needle (11) (Fig. 1).
Claim 2. The puncture instrument according to claim 1, wherein the sensor mounting portion is an internal cavity (lumen of elongated member 104) of the puncture needle (Fig. 10).
Claim 23. The puncture instrument according to claim 1, wherein the puncture instrument comprises an interventional catheter instrument (Fig. 10), which comprises:
a guide tube (116) ([0064]); and
a flexible sleeve (102) ([0038], [0055], [0084]; e.g. polymeric tubing) which sleeves outside the guide tube (Fig. 10; [0064]);
wherein the flexible sleeve and the guide tube are capable of moving relatively to each other so that a distal end of the flexible sleeve extends beyond a distal end of the guide tube, or the distal end of the guide tube extends beyond the distal end of the flexible sleeve (Figs. 11, 13; [0065]-[0070]; “the needle sheath may be also be allowed to actuate axially (distal and proximal) within the funnel shaft”).
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.
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.
Claim(s) 32 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis.
Claim 32. Kunis discloses the invention substantially as claimed above, but fails to disclose a thickness specification of the guide tube comprises 13 G, 14 G, 15 G, and 16 G, and a length of the guide tube is 42 cm to 57 cm.
However, Kunis does disclose the device may include variations in length and diameter for various applications ([0036]) indicating the exact dimensions of the device are not critical. Therefore, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the guide tube to have a thickness and length within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the thickness and length of the guide tube to the claimed range as a matter of routine optimization, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Furthermore, Applicant has not provided evidence of the criticality of the claimed thickness and range in the instant specification. In paragraph [0104] and [0105] of the instant specification, Applicant discloses exemplary thicknesses and lengths of the guide tube for specific applications, including values beyond the claimed ranges, such as 18G, 19G, 20G, 21G and lengths up to 65 cm. However, Applicant has not provided evidence, such as how the claimed thicknesses and lengths have unexpected results in the performance of the claimed instrument over the prior art. It is the Examiner's position that since both Kunis and the instant application are puncture instruments for the body, one of ordinary skill in the art at the time the invention was made would have known the approximate dimensions of the anatomy to be accessed and treated and determined the necessary thickness and length of the guide tube to treat the site. Therefore, the claimed range is merely a range discoverable by routine skill in the art and fails to patentably distinct the claimed invention of claim 32 from the prior art.
Claim 33. Kunis discloses the invention substantially as claimed above, but fails to disclose the inner diameter of the flexible sleeve is greater than the outer diameter of the guide tube of 0.1 mm to 2 mm.
However, Kunis does disclose the device may include variations in length and diameter for various applications ([0036]) indicating the exact dimensions of the device are not critical. Therefore, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the flexible sleeve to have an inner diameter greater than the outer diameter of the guide tube within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the inner diameter of the flexible sleeve to be greater than the outer diameter of the guide tube by the claimed range as a matter of routine optimization, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Furthermore, Applicant has not provided evidence of the criticality of the claimed difference in diameter. In paragraph [0145] of the instant specification, Applicant discloses the difference in diameter is 0.1 mm to 2 mm to allow relative movement between the guide tube and the flexible sleeve. However, Applicant has not provided evidence, such as how the claimed difference in diameter has unexpected results in the performance of the claimed instrument over the prior art. Like the instant application, Kunis discloses the cited flexible sleeve (102) and guide tube (116) can move axially relative to one another (Figs. 11, 13; [0065]-[0070]; “the needle sheath may be also be allowed to actuate axially (distal and proximal) within the funnel shaft”) and therefore there must be a difference in the inner diameter of the flexible sleeve and the outer diameter of the guide tube for clearance to allow for movement. It is the Examiner's position that one of ordinary skill in the art at the time the invention was made would have been able to determine through routine optimization the necessary difference in diameters to allow for such axial actuation. Therefore, the claimed range is merely a range discoverable by routine skill in the art and fails to patentably distinct the claimed invention of claim 33 from the prior art.
Claim(s) 34 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kunis et al in view of Breznock (US 2007/0021767).
Claim 34. Kunis discloses the invention substantially as claimed above, but fails to disclose a connector through which a proximal end of the guide tube is connected with a proximal end of the flexible sleeve, and the guide tube and the flexible sleeve are able to move relative to each other through the connector. Instead, Kunis broadly discloses a handle (22) located on the proximal end of the device (Fig. 1; [0041]) and that the guide tube (116) and flexible sleeve (102) are axially movable relative to one another (Figs. 11, 13; [0065]-[0070]; “the needle sheath may be also be allowed to actuate axially (distal and proximal) within the funnel shaft”).
However, in the same field of endeavor of puncture instruments, Breznock teaches a puncturing instrument (Fig. 6) having an interventional catheter instrument (620), wherein a connector (600) through which a proximal end of a guide tube (106) is connected with a proximal end of a flexible sleeve (622), and the guide tube and the flexible sleeve are able to move relative to each other through the connector (Fig. 6; [0038]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Kunis with a connector as taught by Breznock to allow to provide a mechanism that allows for holding and adjusting the relative position between the guide tube and flexible sleeve.
Claim 35. The combination discloses the invention substantially as claimed above, wherein Breznock further teaches a connection method of the connector comprises threaded connection (Fig. 6; [0038]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 7, 8, 10, 11, 16-19, 23, 24, 29, 32-341 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4, 6, 8, 9, 11, 12, 15-18, 24, 25, 30, 33, 35 of copending Application No. 18/293,465 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the elements of the claims of the instant application are to be found in the claims of the reference application. Thus the difference between the claims of the instant application and the claims of the reference application lies in the fact that the reference application claims include many more elements and is thus much more specific. Thus, the invention of the claims of the reference application is in effect a “species” of the “generic” invention of the claims of the instant application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the claims of the instant application are anticipated by the claims of the reference application, it is not patentably distinct from the claims of the reference application as detailed below:
Claim 1 of the instant application is recited substantially in claim 2 of the reference application.
Claim 2 of the instant application is recited substantially in claim 2 of the reference application.
Claim 3 of the instant application is recited substantially in claim 4 of the reference application.
Claim 7 of the instant application is recited substantially in claim 8 of the reference application.
Claim 8 of the instant application is recited substantially in claim 9 of the reference application.
Claim 10 of the instant application is recited substantially in claim 11 of the reference application.
Claim 11 of the instant application is recited substantially in claim 12 of the reference application.
Claim 16 of the instant application is recited substantially in claim 15 of the reference application.
Claim 17 of the instant application is recited substantially in claim 16 of the reference application.
Claim 18 of the instant application is recited substantially in claim 17 of the reference application.
Claim 19 of the instant application is recited substantially in claim 18 of the reference application.
Claim 23 of the instant application is recited substantially in claim 24 of the reference application.
Claim 24 of the instant application is recited substantially in claim 25 of the reference application.
Claim 29 of the instant application is recited substantially in claim 30 of the reference application.
Claim 32 of the instant application is recited substantially in claim 33 of the reference application.
Claim 33 of the instant application is recited substantially in claim 33 of the reference application.
Claim 34 of the instant application is recited substantially in claim 35 of the reference application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 24 and 29 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 and rewritten to obviate the 35 U.S.C. 112 rejections. The double patenting rejections above must be obviated as well.
The following is a statement of reasons for the indication of allowable subject matter: the closest prior art of record, Kunis, discloses the invention substantially as claimed above. The prior art of record does not disclose or fairly suggest either singly or in combination the claimed puncture instrument comprising, inter alia, the distal end of the flexible sleeve is provided with a shrunk portion, an inner diameter of the shrunk portion is smaller than the outer diameter of the guide tube, and the shrunk portion is provided with a weakened portion which is easy to be damaged; when the interventional catheter instrument abuts against a puncture target, the weakened portion is capable of being destroyed by causing the guide tube to move to the distal end relative to the flexible sleeve, so that the guide tube extends beyond the distal end of the flexible sleeve; wherein the weakened portion extends to a distal opening of the flexible sleeve; and the weakened portion is provided on an inner surface or an outer surface of the shrunk portion (as per claim 24), or the distal end of the flexible sleeve is provided with a shrunk portion, an inner diameter of the shrunk portion is smaller than the outer diameter of the guide tube, and the shrunk portion is provided with a weakened portion which is easy to be damaged; when the interventional catheter instrument abuts against a puncture target, the weakened portion is capable of being destroyed by causing the guide tube to move to the distal end relative to the flexible sleeve, so that the guide tube extends beyond the distal end of the flexible sleeve; and the inner diameter of the shrunk portion is smaller than the outer diameter of the guide tube by 0.05 mm to 1 mm (as per claim 29). Instead, Kunis discloses the distal end of the flexible sleeve (102) is provided with a funnel portion (122), an inner diameter of this portion greater than the outer diameter of the guide tube with no weakened portion that is capable of being destroyed when the guide tube moving to the distal end relative to the flexible sleeve.
Therefore, in view of the prior art and its deficiencies, Applicant’s invention is rendered novel and non-obvious, and thus, is allowable as claimed.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sharerh et al (US 2020/0029856) teaches it is known to put sensors (32) on to a concavity of a distal portion of a needle (Fig. 2).
ピーター・シー・シンプソン (JP 2017510347 A) teaches it is known in the art to put sensors (802) into the concavity of a hollow needle (Fig. 8).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771
1 It is noted claim 5 is not presently treated under the merits due to the multiple dependency issue under the Claim Objections section above. However, if and when corrected, the limitations of claim 5 are recited substantially in claim 6 of the reference application.