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 .
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.
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.
Claims 1-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over 6,048,359 to Biel in view of US 2007/0112343 to Mische et al.
[Claim 1] Biel discloses a light applicator system (10, Figs. 1-7; Abstract) for examination and/or treatment of an organic body, the light applicator system comprising:
at least one light applicator (probe 14; Figs. 1-4) and
a positioning element (alignment grid 18; Figs. 1-2 and 5-7),
wherein the light applicator comprises a distal-side insertion portion (shaft 20; Figs. 2-3, specifically portion of the shaft 20 that is inserted into tissue body 16, as shown in Fig. 2) with at least one actively light-emitting element (light emitting devices 22; Figs. 3-4) at the distal end for piercing tissue of the organic body (see discussion related to “sharpened portion 21”; Col 3, line 6 to Col 4, line 32),
wherein the insertion portion comprises a needle tip (sharpened portion 21; although element number 21 does not appear in the drawings, it’s clear that a sharpened portion, i.e. needle tip, exists; see discussion above and Figs. 1-4) arranged at least partially distally of the at least one actively light-emitting element and tapering distalwards (see Figs. 1-4, e.g. element 14 in Fig. 2),
wherein the positioning element is fixable at least temporarily in a defined position and orientation relative to the organic body (see Fig. 2 which shows the alignment grid 18 being at least temporarily fixable, i.e. capable of being fixed, in a defined position and orientation relative to tissue body 16. For example, there are numerous ways in which the alignment grid 18 is capable of being fixed in the claimed manner, e.g. a user holding it in place, the inclusion/addition of a support arm or fixing element. "[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; see MPEP 2114) and has at least one receptacle (aperture 24, Figs. 5-6) for the at least one light applicator, in which the at least one light applicator has, at least temporarily, a defined orientation relative to the organic body (“Each alignment grid 18 is a relatively rigid body having a plurality of interspaced apertures 24 which are sized to permit the probes 14 to pass therethrough. The particularly spacing between apertures 24 may vary. In use, the grid 18 can maintain one or more probes 14 in substantially parallel alignment within the tissue body 16”; Col 4, lines 33-44)
Biel fails to explicitly disclose an axially movable protective sleeve, as claimed. However, in the same field of endeavor, specifically tissue-piercing light/laser-delivery surgical devices, Mische discloses a light applicator (10) having a needle tip (20) to deliver laser light (at least Par 0018) which includes a retractable protective sleeve (16). The sleeve (16) is axially movable relative to the insertion portion (18 and 20) and which in a first axial position (non-retracted position) relative to the insertion portion protectively surrounds the needle tip (Fig. 1A; Par 0034) and in a second axial position (retracted position) determined by an axial position of the insertion portion relative to the positioning element is pushed back relative to the insertion portion proximalwards from the needle tip (Fig. 1B; Par 0034. While Mische discloses pulling the sleeve back, the examiner contends that the sleeve is also capable of being pushed back, if such a force were applied; see MPEP 2114. If applicant disagrees; see alternative obviousness statement below). Therefore, it would have been obvious to one of ordinary skill in the art to modify the tissue-piercing light delivery surgical device of Biel with the protective sleeve of Mische in order to protect the tip of the device from damage when it is not “in use”, as well as protecting users from injury (at least Pars 0018, 0030 and 0036 of Mische).
Regarding the limitation of pushing versus pulling back, the examiner considers these known alternative equivalents, e.g. pushing a door open versus pulling a door open, and it would be obvious to design/configure the sleeve to be retractable when either/both of these forces are applied. Par 0010 of Mische seemingly supports the examiner’s position.
Regarding the limitation, wherein the protective sleeve serves as an insertion sleeve into the at least one receptacle of the positioning element, the combined teachings of Biel and Mische suggest such a configuration. Specifically, Mische makes it clear that the purpose of the protective sheath is to protect the tip when “not in use”, i.e. when the needle tip is not piercing tissue, and expose the tip when the surgical tip is in use, i.e. actively piercing (Par 0018). Additionally, it’s clear from Biel that the positioning element (18) is located at a distance away from the body (Figs. 2 and 7), i.e. the piercing of the tissue does not occur until after the light applicator has passed through the positioning element. Therefore, it would have been obvious to design/size the receptacles of the positioning element to secure/align/position the light applicator including the protective sleeve, i.e. so that the protective sleeve is inserted into the receptacle/aperture, in order to protect the needle/sharpened tip, as the needle/piercing is not yet in use when it is located within the positioning element.
[Claims 2 and 3] Biel teaches “each alignment grid 18 is a relatively rigid body having a plurality of interspaced apertures 24 which are sized to permit the probes 14 to pass therethrough” (Col 4, lines 33-44; Figs. 2 and 5-6). In the proposed combination, as detailed above, the probes include the protective sleeve. Therefore, the examiner interprets this as a protective sleeve with an outer diameter that fits accurately into an inner diameter of the receptacle. In terms of the specific shape, the examiner considers this an obvious change in shape, as any shape of the apertures or protective sleeve that allows for an accurate fit would have been obvious. It is noted that there is no criticality or unexpected result to such a design/shape; see MPEP 2144.05.
[Claim 4] Biel teaches that the insertion portion (shaft 20) of the light applicator (probe 14) is rigid (“Implantable probe 14 may include a rigid elongate shaft 20 having a sharpened portion 21 to facilitate injection into the tissue body 16”; Col 4, lines 19-32). Furthermore, as seen in Figs. 1A-B, the shaft/insertion portion (elements 20, 18 and 21) of the light applicator has a greater length in an axial direction that the protective sleeve. In terms of the combination, the protective sleeve is necessarily/inherently shorter than the insertion portion/shaft, as this is the only way that the protective sleeve can be slid along the shaft to expose the distal tip/insertion portion for insertion into tissue.
[Claim 5] The examiner considers the protective sleeve (16) to be captively secure to the insertion portion (shaft including 20, 18 and 21); see Figs. 1a-b. Specifically, while the protective sleeve moves longitudinally/axially over the shaft, it is held securely in place, e.g. via detents 92 and 112 (Figs. 5-6; Pars 0042-43), so that it doesn’t fall off.
[Claims 6 and 7] For BRI purposes, a handle is anything that is capable of being held/grabbed by a user. For example, the cylindrical portion of probe 14 that is located on the proximal end and has an outer diameter that is greater than the rest of the probe so that it does not extend through the positioning element (18) is considered a handle; see Fig. 2. This handle inherently provides manual positioning of the light applicator, including the ability to manually adjust the axial position of the insertion portion/shaft relative to the positioning element, i.e. by holding the handle and moving the shaft/probe/insertion portion into and out of the positioning element (18). Additionally or alternatively, Mische discloses a handle (14) that is capable of the same manual adjustment.
[Claims 8 and 9] These claims relate solely to functional language. It is the examiner’s position that the combination of Biel and Mische, as discussed above, teaches all of the necessary structural elements/configurations in order to be capable of operating in the claimed manner; "[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; MPEP 2114.
[Claims 10 and 12] As discussed above in relation to claim 5, the detents (92, Fig. 5 and/or 112, Fig. 6) are considered a first moveable engagement element arranged between the protective sleeve and insertion portion/shaft that moves upon overcoming an axial force in order to allow the protective sleeve to reach the first position (Pars 0042-43). As shown in Figs. 5-6 and described in Pars 0042-43, the detents are part of the protective sleeve.
Allowable Subject Matter
Claims 11 and 13-17 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 prior art fails to teach or suggest a second engagement element that functions/cooperates with the protective sleeve and receptacle, as claimed. Since neither Biel or Mische disclose a protective sleeve together with a positioning element, it is the examiner’s position that such a modification, i.e. to add the second engagement element arranged/configured in the claimed manner to cooperate/function with the protective sleeve and positioning element, would be impermissible hindsight, as the prior art provides no rationale or motivation to make such a change.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2003/0130575 to Desai discloses a tissue-piercing, light-delivery surgical device that includes a positioning element (18, Fig. 1 and/or 88, Fig. 5).
US 6,371,954 to Lee discloses a tissue-piercing, light-delivery surgical device that includes a protective sleeve that is axially moveable relative to the needle tip (Figs. 2a and 2b)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796