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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/5/26 has been entered.
Response to Amendment
Claims 1-8 and 11-19 are pending in the application. Claims 9 and 10 have been canceled. Claims 1 and 11 have been amended.
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 6-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6 recites that a distal end of each prong of the plurality of prongs is coupled together by a distal plug. Claim 6 is indefinite because it is unclear if “a distal plug” recited in claim 6 is the same “distal plug” recited in claim 1, or a different distal plug. Appropriate correction is required.
Claims 7 and 8 are dependent on rejected claim 6, thus are also rendered indefinite. Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 4-7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 4 recites that the plurality of prongs are formed in a distal section of the second tissue penetrating device. Claim 5 recites that the distal section of the second tissue penetrating device is split into multiple sections to form the plurality of prongs. Claim 6 recites that a distal end of each prong of the plurality of prongs is coupled together by a distal plug. Claim 1 has been amended to recite “a second tissue penetrating device coupled to a stylet extending through the internal lumen and including a distal portion split into a plurality of prongs a distal plug connecting distal ends of the plurality of prongs…” Claims 4-6 fail to further limit the subject matter of claim 1, as amended. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 11-15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hinchliffe et al. (US 6,989,004 B2) (“Hinchliffe”) in view of Palasis et al. (US 2005/0261662 A1) (“Palasis”).
Regarding claim 11, Hinchliffe discloses (Figures 1-17) a medical device adapted to deliver a medicant into a target tissue, the medical device comprising: a needle (50) including a lumen extending from a proximal opening to a distal end of the needle; a stylet (70) configured to be delivered to a target tissue through the lumen of the needle, the stylet including a plurality of prongs (80) configured to extend out of slots (52) proximal the distal end of the needle upon extension of the stylet through the lumen and interaction with the distal tip of the needle (Column 6, lines 53-63); and a handle (10) comprising: a first component (12) connected to the needle; a second component (30) connected to the stylet; and a fluid delivery component (96) configured to allow fluid to pass through the needle and into pockets formed in the target tissue by the plurality of prongs of the stylet (Column 6, lines 35-36).
Hincliffe fails to explicitly disclose the needle has an occluded distal tip that is integral to the needle.
In the same field of endeavor, Palasis teaches (Figures 1A-7C) a medical device adapted to deliver a medicant into a target tissue, the medical device comprising: a needle (24) including a lumen (38) extending from a proximal opening to a distal end adjacent an occluded distal tip (30) of the needle, wherein the occluded distal tip is integral to the needle (Figure 5); a stylet (paragraph 0030) configured to be delivered to a target tissue through the lumen of the needle, the stylet including a plurality of prongs (26) configured to extend out of slots (34) proximal the distal end of the needle upon extension of the stylet through the lumen and interaction with the occluded distal tip of the needle (paragraphs 0039-0040).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the needle disclosed by Hinchliffe to have an occluded distal tip that is integral to the needle, as taught by Palasis. Palasis teaches that an occluded distal tip that is integral to the needle provides a sharpened distal end that facilitates easy penetration of tissue (Palasis, paragraph 0031).
Regarding claim 12, Hinchliffe as modified by Palasis teaches that when the stylet is at a first position relative to the needle, the plurality of prongs of the stylet are in an undeployed configuration within the lumen; and wherein when the stylet is at a second position relative to the needle, the plurality of prongs of the stylet are in a deployed configuration extending out through the slots in the needle (Hinchliffe, Column 6, lines 53-65).
Regarding claim 13, Hinchliffe as modified by Palasis teaches each prong of the plurality of prongs include sharp edges to facilitate cutting of tissue upon extension out of the slots of the needle (Hinchliffe, Column 2, lines 51-55).
Regarding claim 14, Hinchliffe as modified by Palasis teaches (Hinchliffe, Figure 2) that the plurality of prongs (80) are formed in a distal section of the stylet (70).
Regarding claim 15, Hinchliffe as modified by Palasis teaches (Hinchliffe, Figure 2) that the distal section of the stylet (70) is split into multiple sections to form the plurality of prongs (Hinchliffe, Column 6, lines 40-42).
Regarding claim 19, Hinchliffe as modified by Palasis teaches (Hinchliffe, Figures 1 and 2) that each prong of the plurality of prongs (80) includes a distal end adapted to extend out of one of the slots (52) in the needle (50) upon extension of the stylet through the lumen (Column 6, lines 53-65).
Allowable Subject Matter
Claims 1-3 are allowed.
Claims 4-8 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, and 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: Claim 1 has been amended to recite that the occluded distal tip is integral to the first tissue penetrating device. Claim 1 has been further amended to recite that the second tissue penetrating device is coupled to a stylet extending through the internal lumen and including a distal portion split into a plurality of prongs and a distal plug connecting distal ends of the plurality of prongs. These limitations, in combination with the other limitations in claim 1, are not disclosed or suggested in the prior art of record. The Hinchliffe and Palasis references, individually or in combination, fail to teach a medical device with the combination of features recited in claim 1 as amended. Claims 2 and 3 are dependent on claim 1, thus are also allowable over the prior art of record.
Claims 4-8 are dependent on claim 1. Claims 4-8 are currently not in condition for allowance because they are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, and/or 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph. Appropriate correction is required.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
The following is a statement of reasons for the indication of allowable subject matter: Claim 16 recites that the distal end of each prong of the plurality of prongs is coupled together by a distal plug. This limitation, in combination with the limitations in claim 11 and intervening claim 14, is not disclosed or suggested in the prior art of record. The Hinchliffe and Palasis references, individually or in combination, fail to teach a medical device with the combination of features recited in claims 11, 14, and 16, as amended. Claims 17 and 18 are dependent on claim 16, thus would also be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claims 11-15 and 19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN D KNAUSS whose telephone number is (571)272-8641. The examiner can normally be reached M-F 12:30-8:30.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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