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
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “clocking mechanism” in claims 7 and 17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4-8, 11, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith (US 2,072,346).
Regarding claim 1, Smith discloses (Figures 1 and 3-6) a medical device capable of delivering a medicant into a target tissue, the medical device comprising: a first tissue penetrating device (1) including an internal lumen extending from a proximal end to an occluded distal tip (occluded by thrust head 11); a second tissue penetrating device (9) coupled to a stylet (7) extending through the internal lumen capable of extending from the first tissue penetrating device to form a track within the target tissue, in an extended state the second tissue penetrating device forms a plurality of prongs (10) extending from slots (6) in the first tissue penetrating device (Figures 4-6), in a retracted state (Figure 1) the second tissue penetrating device conforms to the first tissue penetrating device; and a handle (Figure 1) comprising: a first component (3) connected to the first tissue penetrating device; a second component (8) connected to the second tissue penetrating device; and a fluid delivery component (2) coupled to the proximal end of the first tissue penetrating device and capable of allowing fluid to pass through the lumen of the first tissue penetrating device and into the track formed in the target tissue by the second tissue penetrating device, wherein when the second component is at a first position relative to the first component, the second tissue penetrating device is in an undeployed configuration (Figure 1), wherein when the second component is at a second position relative to the first component, the second tissue penetrating device is in a deployed configuration (Figures 4-6).
NOTE: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP § 2114. The device disclosed by Smith meets all of the structural limitations recited in claim 1.
Regarding claim 4, Smith discloses (Figure 3) that the plurality of prongs (10) are formed in a distal section of the second tissue penetrating device.
Regarding claim 5, Smith discloses (Figure 3) that the distal section of the second tissue penetrating device is split into multiple sections to form the plurality of prongs (10).
Regarding claim 6, Smith discloses (Figure 3) that a distal end of each prong of the plurality of prongs (10) is coupled together by a distal plug (11).
Regarding claims 7 and 8, the distal plug includes a clocking mechanism to align the plurality of prongs with the slots, wherein the clocking mechanism includes an outer surface of the distal plug (11) that interacts with an interior tip (5) of the first tissue penetrating device to align the plurality of prongs with the slots (page 2, lines 6-65).
NOTE: in claim 7, the limitation "clocking mechanism" has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The corresponding structure described in the specification is: "In one embodiment, the distal plug 54 and the tip 44 are configured such that when the distal plug 54 is forced against the interior of the tip 44, the distal plug 54 rotates into proper alignment so that the prongs 52 rotate to align with the slots 48. This is considered a clocking mechanism. Other clocking mechanisms can be used." See page 5, lines 1-4. The clocking mechanism disclosed by Smith includes an outer surface of the distal plug that interacts with an interior of a tip of the first tissue penetrating device to align the plurality of prongs within the slots, as shown in Figures 4-6 of Smith.
Regarding claim 11, Smith discloses (Figures 1 and 3-6) a medical device capable of delivering a medicant into a target tissue, the medical device comprising: a needle (1) including a lumen extending from a proximal opening to a distal end adjacent an occluded distal tip (occluded by thrust head 11) of the needle; a stylet (7) configured to be delivered to a target tissue through the lumen of the needle, the stylet including a plurality of prongs (10) configured to extend out of slots (6) proximal the distal end from the tip of the needle upon extension of the stylet through the lumen and interaction with the occluded distal tip of the needle; and a handle (Figure 1) comprising: a first component (3) connected to the needle; a second component (8) connected to the stylet; and a fluid delivery component (2) capable of allowing fluid to pass through the needle and into pockets formed in the target tissue by the plurality of prongs of the stylet.
NOTE: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See MPEP § 2114. The device disclosed by Smith meets all of the structural limitations recited in claim 11.
Regarding claim 14, Smith discloses (Figure 3) the plurality of prongs (10) are formed in a distal section (9) of the stylet (7).
Regarding claim 15, Smith discloses (Figure 3) the distal section (9) of the stylet (7) is split into multiple sections to form the plurality of prongs (10).
Regarding claim 16, Smith discloses (Figure 3) a distal end of each prong of the plurality of prongs (10) is coupled together by a distal plug (11).
Regarding claims 17 and 18, Smith discloses the distal plug includes a clocking mechanism to align the plurality of prongs with the slots, wherein the clocking mechanism includes an outer surface of the distal plug (11) that interacts with an interior (5) of the tip of the needle to align the plurality of prongs with the slots (page 2, lines 6-65).
NOTE: in claim 17, the limitation "clocking mechanism" has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The corresponding structure described in the specification is: "In one embodiment, the distal plug 54 and the tip 44 are configured such that when the distal plug 54 is forced against the interior of the tip 44, the distal plug 54 rotates into proper alignment so that the prongs 52 rotate to align with the slots 48. This is considered a clocking mechanism. Other clocking mechanisms can be used." See page 5, lines 1-4. The clocking mechanism disclosed by Smith includes an outer surface of the distal plug that interacts with an interior of a tip of the first tissue penetrating device to align the plurality of prongs within the slots, as shown in Figures 4-6 of Smith.
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 1-5, 11-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over in view of Palasis et al. (US 2005/0261662 A1) (“Palasis”) in view of McGuckin et al. (US 6,425,887 B1) (“McGuckin”).
Regarding claim 1, Palasis discloses (Figures 1-7C) a medical device adapted to deliver a medicant (paragraph 0004) into a target tissue, the medical device comprising: a first tissue penetrating device (24) including an internal lumen (38) extending from a proximal end to an occluded distal tip (30); a second tissue penetrating device coupled to a stylet (tubular member, paragraph 0039) extending through the internal lumen and adapted configured to extend from the first tissue penetrating device to form a track within the target tissue, in an extended state the second tissue penetrating device forms a plurality of prongs (26) extending from slots (34) in the first tissue penetrating device, in a retracted state the second tissue penetrating device conforms to the first tissue penetrating device; and a fluid delivery component (20) coupled to the proximal end of the first tissue penetrating device and configured to allow fluid (62) to pass through the lumen of the first tissue penetrating device and into the track formed in the target tissue by the second tissue penetrating device (paragraph 0044).
Palasis fails to disclose a handle comprising: a first component connected to the first tissue penetrating device and a second component connected to the second tissue penetrating device, wherein when the second component is at a first position relative to the first component, the second tissue penetrating device is in an undeployed configuration, and wherein when the second component is at a second position relative to the first component, the second tissue penetrating device is in a deployed configuration.
In the same field of endeavor, McGuckin teaches a medical device with a handle (76) comprising: a first component (77) connected to the first tissue penetrating device and a second component (79) connected to the second tissue penetrating device, wherein when the second component is at a first position relative to the first component, the second tissue penetrating device is in an undeployed configuration (Figure 21), and wherein when the second component is at a second position relative to the first component, the second tissue penetrating device is in a deployed configuration (Figure 22).
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 medical device disclosed by Palasis to include a handle comprising: a first component connected to the first tissue penetrating device and a second component connected to the second tissue penetrating device, wherein when the second component is at a first position relative to the first component, the second tissue penetrating device is in an undeployed configuration, and wherein when the second component is at a second position relative to the first component, the second tissue penetrating device is in a deployed configuration, as taught by McGuckin. This modification would provide a handle for a physician to control actuation of the medical device with a single hand (McGuckin, Column 10, line 66 – Column 11, line 38).
Regarding claim 2, the first and second tissue penetrating devices taught by Palasis in view of McGuckin are capable of repeatedly allowing the second tissue penetrating device to extend from and retract into the first tissue penetrating device (Palasis, paragraphs 0055-0056).
Regarding claim 3, Palasis as modified by McGuckin teaches that each prong of the plurality of prongs (26) include sharp edges to facilitate cutting of tissue upon extension out of the slots of the first tissue penetrating device (Palasis, paragraph 0031).
Regarding claim 4, Palasis as modified by McGuckin teaches (Figures 1B, 2, 6C, 7C) that the plurality of prongs (26) are formed in a distal section of the second tissue penetrating device.
Regarding claim 5, Palasis as modified by McGuckin teaches (Figures 1B, 2, 6C, 7C) that the distal section of the second tissue penetrating device is split into multiple sections to form the plurality of prongs (26).
Regarding claims 11 and 12, Palasis discloses (Figures 1-7C) a medical device adapted to deliver a medicant (paragraph 0004) into a target tissue, the medical device comprising: a needle (24) including a lumen (38) extending from a proximal opening to an occluded distal tip (30) of the needle; a stylet (tubular member, paragraph 0039) 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 from the tip of the needle upon extension of the stylet through the lumen and interaction with the occluded distal tip of the needle; and a fluid delivery component (20) configured to allow fluid (62) to pass through the needle and into pockets formed in the target tissue by the plurality of prongs of the stylet (paragraph 0044).
Palasis fails to explicitly disclose a handle comprising: a first component connected to the needle and a second component connected to the stylet, wherein 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.
In the same field of endeavor, McGuckin teaches a medical device with a handle (76) comprising: a first component (77) connected to a needle and a second component (79) connected to a stylet, wherein when the stylet is at a first position (Figure 21) relative to the needle, the plurality of prongs (13) of the stylet are in an undeployed configuration within the lumen; and wherein when the stylet is at a second position (Figure 22) relative to the needle, the plurality of prongs (13) of the stylet are in a deployed configuration.
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 medical device disclosed by Palasis to include a handle comprising: a first component connected to the needle and a second component connected to the stylet, wherein 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, as taught by McGuckin. This modification would provide a handle for a physician to control actuation of the medical device with a single hand (McGuckin, Column 10, line 66 – Column 11, line 38).
Regarding claim 13, Palasis as modified by McGuckin teaches that each prong of the plurality of prongs (26) include sharp edges to facilitate cutting of tissue upon extension out of the slots (34) of the needle (Palasis, paragraph 0031).
Regarding claim 14, Palasis as modified by McGuckin teaches (Figures 1B, 2, 6C, 7C) that the plurality of prongs (26) are formed in a distal section of the stylet.
Regarding claim 15, Palasis as modified by McGuckin teaches (Figures 1B, 2, 6C, 7C) the plurality of prongs (26) are formed in a distal section of the stylet.
Regarding claim 19, Palasis as modified by McGuckin teaches (Figures 1B, 2, 6C, 7C) that each prong of the plurality of prongs (26) includes a distal end adapted to extend out of one of the slots (34) in the needle upon extension of the stylet through the lumen.
Response to Arguments
Applicant’s arguments with respect to claims 1-8 and 11-19 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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