DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/15/2026 has been entered.
Claim Objections
Claim 40 is objected to because of the following informalities: Lines 18-20 should be amended to recite “the distal end of each of the first guide tube, the second guide tube, and the third guide tube tapers inwardly toward the central axis in the pre-deployment configuration in order to be grammatically correct. Appropriate correction is required.
Claim 46 is objected to because of the following informalities: On line 14, the phrase “the third guide” should be amended to recite “the third guide tube” to match the language used elsewhere in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 46-52 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 46 has been amended to recite “wherein the distal end of each of the first guide tube, the second guide tube, and the third guide tube comprise a surface parallel to the central axis when the first guide tube, the second guide tube, and the third guide [tube] flex backwards”. Although the original disclosure supports the distal end of each of the guide tubes comprising a surface parallel to the central axis (page 35, lines 11-13; page 44, lines 9-11) and also supports the guide tubes flexing backwards (page 10, lines 23-27; not shown in the drawings), the original disclosure is not specific enough to support the surface being parallel to the central axis when the guide tubes flex backwards1 as claimed. Accordingly, the newly added language of claim 46 is new matter.
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 46-52 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 46 has been amended to recite “wherein the distal end of each of the first guide tube, the second guide tube, and the third guide tube comprise a surface parallel to the central axis when the first guide tube, the second guide tube, and the third guide [tube] flex backwards”. Fig 14,24 show the distal end of the guide tubes having a surface parallel to the central axis when the guide tubes are flexed 90 degrees. However, the common definition of the term “backwards” means “toward the back or rear” 2 and the guide tubes do not turn toward the back or rear at 90 degrees; rather, they would not start to turn backward until they reach 91 degrees. If Applicant intends to define the term “backwards” contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Because what is claimed is not what is supported by the original disclosure, it is unclear how to interpret this limitation in light of the specification. For the sake of examination, the term “backwards” is interpreted as including a 90 degree curve.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 40, 43, 46-49 and 51 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Edwards (US Pat 5,588,960).
Re claim 40, Edwards discloses an ablation system 20 (Fig 1,2; it is noted that all references cited below refer to Fig 2 unless otherwise mentioned) comprising: a catheter body 22 having a central axis (extending horizontally in Fig 2); three guide tubes 52,52,52 (Fig 1 shoes four guide tubes 52) each having a distal end (to the right in Fig 2), comprising a first guide tube 52, a second guide tube 52, and a third guide tube 52, the first guide tube, the second guide tube, and the third guide tube configured to curve toward a vessel wall (as seen in Fig 2) with the distal ends of the first guide tube, the second guide tube, and the third guide tube together having a fully open configuration with a fixed maximum diameter (correlating to when handle 91 is pushed to its distal-most position to the right in Fig 2), wherein a curve of each of the first guide tube, the second guide tube, and the third guide tube allows the distal ends of the first guide tube, the second guide tube, and the third guide tube to press against the vessel wall when at the fixed maximum diameter (because guide tubes 52 press against the vessel wall as they penetrate it, Col 6, Lines 31-34); and three injectors 41,41,41 (Fig 1 shoes four injectors 41),e ach having a distal end (to the right in Fig 2) comprising a first injector 41, a second injector 41, and a third injector 41, wherein the first injector, the second injector, and the third injector are located coaxially inside of the first guide tube, the second guide tube, and the third guide tube, respectively, the three injectors having a pre-deployment configuration wherein the distal end of the first injector is parked just proximal to the distal end of the first guide tube (it is noted that, although the drawings do not show how far back from the distal-most end of the guide tubes that the injectors lie when in the pre-deployment configuration, (1) the specification does disclose that the injectors lie within the guide tubes in the pre-deployment configuration (Col 6, Lines 41-44) and (2) the disclosure does not define how far back from the distal-most end that the “distal end” can extend; that is, the term “end” is not limited to a specific distance – rather, the “distal end” as claimed can be the distal half of the guide tube; because the distal ends of the injectors are parked within the guide tubes in the pre-deployment configuration, they are parked “just proximal” to the distal ends of the guide tubes since the distal ends can extend proximally any distance from the distal-most end of the guide tubes to the halfway point of the guide tubes), wherein the distal end of the second injector is parked just proximal to the distal end of the second guide tube (see explanation above), wherein the distal end of the third injector is parked just proximal to the distal end of the third guide tube (see explanation above), wherein the distal ends of each of the first guide tube, the second guide tube, and the third guide tube taper inwardly toward the central axis in the pre-deployment configuration (for the sake of examination, the pre-deployment configuration is when the distal-most surface of the guide tubes line in the curved portions of tubes 56), wherein the first injector, the second injector, and the third injector are configured to advance relative to the first guide tube, the second guide tube, and the third guide tube, respectively, to penetrate tissue while the distal ends of the first guide tube, the second guide tube and the third guide tube press against the vessel wall at the fixed maximum diameter (Col 6, Lines 50-55), wherein the distal ends of the first injector, the second injector, and the third injector are configured to together have a fixed penetration diameter (correlating to when handle 72 is pushed to its distal-most position to the right in Fig 2) greater than the fixed maximum diameter of the guide tubes through which the injectors advance (due to the arrangement of the handles seen in Fig 2, when handles 72 are pushed to their distal-most position to the right, the distal-most end of the needles (which define the fixed penetration diameter) will be further radially outward than the distal-most end of the guide tubes (which define the fixed maximum diameter)).
Re claim 43, Edwards discloses that the first injector, the second injector, and the third injector are between 25 gauge and 35 gauge (Col 3, Lines 25-26 disclose that the outer diameter of the injectors can be 0.3 mm which is between 25 gauge (0.5 mm) and 35 gauge (0.21 mm)).
Re claim 46, Edwards discloses an ablation system 20 (Fig 1,2; it is noted that all references cited below refer to Fig 2 unless otherwise mentioned) comprising: a catheter body 22 having a central axis (extending horizontally in Fig 2); a first guide tube 52, a second guide tube 52, and a third guide tube 52 (Fig 1 shows four guide tubes 52), wherein the first guide tube, the second guide tube, and the third guide tube flare outward from the central axis (as seen in Fig 1,2) with distal ends (to the right in Fig 2) of the first guide tube, the second guide tube, and the third guide tube together having a fixed maximum diameter (correlating to when handle 91 is pushed to its distal-most position to the right in Fig 2), wherein a curve of each of the first guide tube, the second guide tube, and the third guide tube allows the distal ends of the first guide tube, the second guide tube, and the third guide tube to press against the vessel wall and begin to flex backwards (because guide tubes 52 press against the vessel wall as they penetrate it; Col 6, Lines 31-34), wherein the distal end of each of the first guide tube, the second guide tube, and the third guide tube comprise a surface parallel to the central axis when the first guide tube, the second guide tube, and the third guide tube flex backwards (as seen in Fig 2); and a first injector 41, a second injector 41, and a third injector 41 (Fig 1 shows four injectors 41), wherein the first injector, the second injector, and the third injector are located coaxially inside the first guide tube, the second guide tube, and the third guide tube, respectively (Col 3, Lines 36-39), wherein the first injector, the second injector, and the third injector are configured to advance relative to the first guide tube, the second guide tube, and the third guide tube, respectively, to penetrate tissue (Col 6, Lines 50-55), wherein distal ends (to the right in Fig 2) of the first injector, the second injector, and the third injector are configured to together have a fixed penetration diameter (correlating to when handle 72 is pushed to its distal-most position to the right in Fig 2) greater than the fixed maximum diameter of the guide tubes through which the injectors advance (due to the arrangement of the handles seen in Fig 2, when handles 72 are pushed to their distal-most position to the right, the distal-most end of the needles (which define the fixed penetration diameter) will be further radially outward than the distal-most end of the guide tubes (which define the fixed maximum diameter)).
Re claim 47, Edwards discloses that the advancement of the first injector, the second injector, and the third injector are controlled by a single injector handle 72 (Col 4, Lines 8-25).
Re claim 48, Edwards discloses that advancement of the first guide tube, the second guide tube, and the third guide tube are controlled by a single guide tube handle 91(Col 4, Lines 26-46).
Re claim 49, Edwards discloses that the first injector comprises a radiopaque material (“stainless steel” – Col 3, Lines 18-20).
Re claim 51, Edwards discloses that the first guide tube, the second guide tube, and the third guide tube are configured to flex backwards into engagement with the vessel wall (as seen in Fig 2; Col 3, Lines 43-67).
Claims 40 and 44 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Chan et al. (US Pat 7,273,469).
Re claim 40, Chan discloses an ablation system (Fig 27,28; since Fig 27,28 are just a distal view of the system, Fig 1 is referred to as showing the rest of the system, where balloon 320 is comparable to balloon 20, guide tubes 340,342 are comparable to guide tubes 40,42 and injectors 346A-346E are comparable to injectors 46,47; it is noted that all references cited below refer to Fig 1,27,28 unless otherwise mentioned) comprising: a catheter body 12 having a central axis (extending horizontally in Fig 1,27); three guide tubes (only two guide tubes 340,342 are shown in Fig 27, but Col 23, Lines 27-29 disclose that the balloon 320 can have three lobes and Col 23, Lines 42-48 discloses that “each lobe section 396 of balloon 32 may have a delivering cannula connected thereto to allow a needle to be delivered to a region of interest”; therefore, there when the balloon has three lobes, there are three guide tubes) each having a distal end (to the left in Fig 27), comprising a first guide tube, a second guide tube, and a third guide tube (as set forth above, Col 23, Lines 27-29 and 42-48 disclose three guide tubes), the first guide tube, the second guide tube, and the third guide tube configured to curve toward a vessel wall (as seen in Fig 27; Col 7, Lines 50-54) with the distal ends of the first guide tube, the second guide tube, and the third guide tube together having a fully open configuration with a fixed maximum diameter (correlating to when balloon 320 is fully inflated, Col 21, Lines 16-22), wherein a curve of each of the first guide tube, the second guide tube, and the third guide tube allows the distal ends of the first guide tube, the second guide tube, and the third guide tube to press against the vessel wall when at the fixed maximum diameter (Col 21, Lines 19-22); and three injectors (Col 23, Lines 27-29 disclose that the balloon 320 can have three lobes and Col 23, Lines 42-48 discloses that “each lobe section 396 of balloon 32 may have a delivering cannula connected thereto to allow a needle to be delivered to a region of interest”; therefore, there when the balloon has three lobes, there are three needles, i.e. “injectors”), each having a distal end (to the left in Fig 27) comprising a first injector, a second injector, and a third injector (as set forth above, Col 23, Lines 27-39 and 42-48 disclose three injectors), wherein the first injector, the second injector, and the third injector are located coaxially inside of the first guide tube, the second guide tube, and the third guide tube (as seen in Fig 27; Col 7, Lines 14-19), respectively, the three injectors having a pre-deployment configuration wherein the distal end of the first injector is parked just proximal to the distal end of the first guide tube (it is noted that, although the drawings do not show how far back from the distal-most end of the guide tubes that the injectors lie when in the pre-deployment configuration, (1) the specification does disclose that the injectors lie within the guide tubes in the pre-deployment configuration (Col 21, Lines 27-30) and (2) the disclosure does not define how far back from the distal-most end that the “distal end” can extend; that is, the term “end” is not limited to a specific distance – rather, the “distal end” as claimed can be the distal half of the guide tube; because the distal ends of the injectors are parked within the guide tubes in the pre-deployment configuration, they are parked “just proximal” to the distal ends of the guide tubes since the distal ends can extend proximally any distance from the distal-most end of the guide tubes to the halfway point of the guide tubes), wherein the distal end of the second injector is parked just proximal to the distal end of the second guide tube (see explanation above), wherein the distal end of the third injector is parked just proximal to the distal end of the third guide tube (see explanation above), wherein the distal ends of each of the first guide tube, the second guide tube, and the third guide tube taper inwardly toward the central axis in the pre-deployment configuration (Col 8, Lines 51-54; as seen in Fig 24), wherein the first injector, the second injector, and the third injector are configured to advance relative to the first guide tube, the second guide tube, and the third guide tube, respectively, to penetrate tissue while the distal ends of the first guide tube, the second guide tube and the third guide tube press against the vessel wall at the fixed maximum diameter (Col 21, Lines 26-37), wherein the distal ends of the first injector, the second injector, and the third injector are configured to together have a fixed penetration diameter (correlating to when they have been pushed distally to the maximum extent) greater than the fixed maximum diameter of the guide tubes through which the injectors advance (as seen in Fig 26).
Re claim 44, Chan disclose that the first guide tube, the second guide tube, and the third guide tube are configured to press against, but not penetrate, a vessel wall at the fixed maximum diameter (Col 21, Lines 19-22).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 41, 42 and 45 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Edwards (US Pat 5,588,960).
Re claim 41, Edwards discloses all the claimed features except that the fixed maximum diameter of the guide tubes is between 3 mm and 10 mm. However, it would have been an obvious matter of design choice to provide the guide tubes with a fixed maximum diameter between 3 mm and 10 mm since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. This claim has additionally been rejected with art below.
Re claim 42, Edwards discloses all the claimed features except that the catheter body has a diameter that is less than 2 mm. However, it would have been an obvious matter of design choice to provide the catheter body with a diameter less than 2 mm since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Re claim 45, Edwards discloses all the claimed features except that the fixed penetration diameter of the injectors extends between 0.5 mm and 3 mm beyond the fixed maximum diameter. However, it would have been an obvious matter of design choice to provide the injectors with a length so that they extend between 0.5 mm and 3 mm beyond the guide tubes since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Alternatively, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the injectors with a length so that they extend between 0.5 mm and 3 mm beyond the guide tubes since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Claims 41 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Edwards (UG Pat 5,588,960) in view of Lundquist et al. (US Pat 5,549,644).
Re claim 41, Edwards discloses all the claimed features except that the fixed maximum diameter of the guide tubes is between 3 mm and 10 mm. Lundquist, however, teaches a substantially similar ablation system (seen in Fig 29,31) comprising guide tubes 52 (Fig 31) that extend outward from a longitudinal axis (as seen in Fig 31) and injectors 116 (Fig 31) that extend outwardly therefrom to pierce tissue (as seen in Fig 31), wherein the guide tubes have a fixed maximum diameter between 5 and 10 mm (Col 16, Lines 29-34); Lundquist teaches that providing guide tubes with such a fixed maximum diameter is appropriately sized for use in the urethra (Col 16, Lines 14-24). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Edwards to include the guide tubes with a fixed maximum diameter between 3 and 10 mm, as taught by Lundquist, for the purpose of ensuring proper sizing for use in the urethra (Col 16, Lines 14-24).
Claims 41-43 and 45 are rejected under pre-AIA 35 U.S.C. 103(a) as being obvious over Chan et al. (US Pat 7,273,469).
Re claim 41, Chan discloses all the claimed features except that the fixed maximum diameter of the guide tubes is between 3 mm and 10 mm. However, it would have been an obvious matter of design choice to provide the guide tubes with a fixed maximum diameter between 3 mm and 10 mm since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Re claim 42, Chan discloses all the claimed features except that the catheter body has a diameter that is less than 2 mm. However, it would have been an obvious matter of design choice to provide the catheter body with a diameter less than 2 mm since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Re claim 43, Chan discloses all the claimed features except that the first injector, the second injector, and the third injector are between 25 gauge and 35 gauge. However, it would have been an obvious matter of design choice to provide the injectors with a size between 25 gauge and 35 gauge since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. This claim is also rejected with art below.
Re claim 45, Chan discloses all the claimed features except that the fixed penetration diameter of the injectors extends between 0.5 mm and 3 mm beyond the fixed maximum diameter. However, it would have been an obvious matter of design choice to provide the injectors with a length so that they extend between 0.5 mm and 3 mm beyond the guide tubes since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art.
Alternatively, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide the injectors with a length so that they extend between 0.5 mm and 3 mm beyond the guide tubes since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art.
Claims 43 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chan et al. (US Pat 7,273,469) in view of Lundquist et al. (US Pat 5,549,644).
Re claim 43, Chan discloses all the claimed features except that the injectors are between 25 gauge and 35 gauge. Lundquist, however, teaches a substantially similar ablation system (seen in Fig 29,31) comprising guide tubes 52 (Fig 31) that extend outward from a longitudinal axis (as seen in Fig 31) and injectors 116 (Fig 31) that extend outwardly therefrom to pierce tissue (as seen in Fig 31), wherein the injectors are between 25 gauge and 35 gauge (“a diameter of 0.017 inches”, Col 7, Lines 22-24; a diameter of 0.017 inches is between 26 and 27 gauge); Lundquist teaches that injectors of such a size leave only small holes that can rapidly heal (Col 21, Lines 50-52). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Chan to include the injectors such that they are between 25 gauge and 35 gauge, as taught by Lundquist, for the purpose of ensuring that the holes left behind by the injectors are able to rapidly heal (Col 22, Lines 49-51).
Claim 50 is rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Edwards et al. (US Pat 5,588,960) in view of Mirza et al. (US Pat 8,192,425).
Re claim 50, Edwards discloses all the claimed features except that the first guide tube comprises a radiopaque material. Mirza, however, teaches providing an insulative material (like that of Edwards’ guide tubes) with a radiopaque material (Col 14, Lines 41-44) for the purpose of highlighting the location of important landmarks of a medical device (Col 14, Lines 33-37). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Edwards to include the first guide tube with radiopaque material, as taught by Mirza, for the purpose of highlighting the location of the guide tube (Col 14, Lines 33-37).
Claim 52 is rejected under pre-AlA 35 U.S.C. 103(a) as being unpatentable over Edwards et al. (US Pat 5,588,960) in view of Morris et al. (PG PUB 2006/0224118).
Re claim 52, Edwards discloses that, although four guide tubes are shown in Fig 1, the system can include only three guide tubes (Col 10, Lines 54-57); however, Edwards does not explicitly disclose that three guide tubes would be evenly spaced. Morris, however, teaches evenly spacing three guide tubes 120,122,124 (Fig 8) around a catheter body 112 (Fig 8) to provide an even distance between delivery sites (Para 40) Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Edwards to include the three guide tubes such that they are evenly spaced, as taught by Morris, for the purpose of providing an even distance between delivery sites (Para 40).
Allowable Subject Matter
Claims 31-35, 37 and 38 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of independent claim 31 could not be found nor was suggested in the prior art of record.
Claim 31 has been amended to require the distal end of each of the guide tubes to comprise “at least two points at the fixed maximum diameter in the fully open configuration. This requirement overcomes the combination of Morris and Makower applied to the claim in the last Office Action.
Although the above cited Edwards and Chan references disclose most of the features of claim 31, Edwards’ guide tubes do not assume “pre-set curves when extending outward from the catheter body” since cover tubes 56 cause the guide tubes to curve as the guide tubes move through the cover tubes (Col 3, Lines 43-67) and -Chan’s guide tubes do not assume “pre-set curves when extending outward from the catheter body” because their degree of curvature is dependent on the inflation amount of the balloon (Col 21, Lines 16-19).
Additionally, an ablation system comprising (1) a catheter body, (2) three guide tubes that (a) each assume a pre-set curve when extending outward from the catheter body, (b) are evenly spaced around a circumference, (c) together have a fixed maximum diameter in a fully open configuration, and (d) each comprise at least two points at the fixed maximum diameter in the fully open configuration, (3) three injectors that (a) are coaxially inside the three guide tubes, (b) each comprise a pre-set curve that is shaped parallel to the respective guide tube, (c) are configured to advance relative to the respective guide tube to penetrate tissue, (d) are evenly spaced around a circumference, and (e) together have a fixed penetration diameter greater than the fixed maximum diameter – as required by independent claim 31 – could not be found nor was suggested elsewhere in the prior art of record.
Response to Arguments
Applicant's arguments filed 4/15/2026 have been fully considered. They amount to a general allegation that the claims overcome the previously-cited prior art without explicitly showing how they overcome the cited art. The arguments directed to claim 31 are moot in view of the above indication of allowable subject matter. The arguments directed to the rejection of claim 40 by Edwards are not persuasive since, as set forth above, Edwards still reads upon the amended features. The arguments directed to the rejection of claim 40 by Blewett are moot as Blewett is not used in the present rejections. The arguments directed to claim 46 are moot in view of the rejections above that utilize Edwards as the primary reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached Monday - Thursday 8 am - 4 pm.
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/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 The term “backwards” is defined as meaning “toward the back or rear” under the common definition. http://www.merriam-webster.com/dictionary/backward
2 “backward”. Merriam Webster Online Dictionary. http://www.merriam-webster.com/dictionary/backward
Prosecution Insights