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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-7, 9-11, 13-14, 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Johansson (U.S. PGPub 2013/0299371, cited in IDS) in view of Collet et al. (U.S. PGPub 20070295620) and Staunton et al. (U.S. PGPub 2014/0276949).
Claim 1: Johansson discloses a packaging body (30 – especially Figs. 3a-3b) for use with an elongated tool (10) that includes a distal cutting bur (14), a first shaft portion proximal to the distal cutting bur (e.g. portion of 26 proximal to 14), and a second shaft portion extending from the first shaft portion (e.g. portion of 26 distal to 14), the packaging body comprising: a distal casing comprising a first distal section (left portion of 32a in Fig. 3a) and a second distal section (32b) each comprising a distal cavity (defined by 33a-c and 33d) shaped to conform to the distal cutting bur (paragraph 67 – The U-shaped sidewall is designed to enclose the drill), and wherein the first distal section and the second distal section are configured to couple to one another to collectively encase the distal cutting bur within the distal cavities (paragraph 67); and a proximal section (right portion of 32a) comprising a proximal cavity (36) that is elongated and sized to receive the second shaft portion (paragraph 52).
While the claimed tool is not positively recited, the first and second distal sections do not each have a distal cavity with a hemi-spherical cavity portion shaped to conform to half of the spherical head of the distal cutting bur such that they encase the spherical head. Johansson does disclose that the cavities may adopt other designs than the U-shape form (paragraph 67). Collet et al. in turn teaches a similar packaging body (1) wherein first and second distal sections (11, 12) each have a distal cavity (2’, 2”, 5’, 5”) with a portion shaped to conform to half of a tool therein such that they encase the tool (paragraphs 118-119, 121, and 148). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped the cavities of Johansson as halves shaped to conform to half of a tool as taught by Collet since it provides good handling of the tool therein.
The cavities are not necessarily hemi-spherical shaped to conform to half of the spherical head of the distal cutting bur. However, Staunton teaches an alternative medical cutting tool having a spherical head (bur 50 - e.g. Figs. 12-13). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further shaped the cavities of Johansson as claimed in order to have accommodated a different type or form factor of medical tool such as that of Staunton. It is further noted that to the extent that the type and shape of the tool is arbitrary (see instant specification at paragraph 36), and the claimed hemi-spherical shape of the cavities are merely associated with a tool of corresponding shape, the claimed shapes would have been obvious since it has been held that the configuration of a claimed product is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed product is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Please note that the instant application lacks of any mention of “spherical”, and paragraph 36 contemplates other tool types and shapes, and thus Applicant has not disclosed any criticality for the shape of the tool or the cavity shape conforming to it.
It is also noted that in light of Applicant’s disclosure, “shaped to conform” is not necessarily interpreted as a 1:1 mirroring of the shape of the tool. Paragraphs 4 and 50 state that the purpose of the package is to avoid contact between the package and the tool. Paragraph 50 describes “substantially contoured to the distal end of the tool” as allowing for suspending the tool within the casing with a spacing or clearance. Paragraph 66, while describing an arguably more closely contoured shape, still describes the alternate embodiment using the same term “substantially contoured”.
Claim 2: Referring to Collet, each distal cavity has a second cavity portion (5’, 5”) that is shaped to conform to half of a shaft portion. Staunton also comprises a first shaft portion (e.g. proximal to the spherical burr). As discussed above, it would have been obvious to have conformed the second cavity portions to have similarly conformed to the first shaft portion of the tool for similar reasons.
Claim 3: The elongated tool comprises a tool axis (e.g. longitudinal axis T of Staunton), and wherein the distal cavities of the first and second distal sections are symmetrically constructed in relation to the tool axis (Collet, paragraphs 118 and 121).
Claim 4: Referring to Collet, each distal cavity has a second cavity portion (5’, 5”) that is shaped to conform to half of a shaft portion. The second shaft portion of Staunton comprises a second diameter and the first shaft portion includes a tapered surface that tapers to a first diameter that is less than the second diameter (Figs. 12-13). As discussed above, it would have been obvious to have conformed the second cavity portions to have similarly conformed to the first shaft portion of the tool for similar reasons.
Claim 5: Referring to Collet, each distal cavity has a third cavity portion (14) that is shaped to conform to half of a shaft portion. The second shaft portion of Staunton has a cylindrical shape in a region proximal to the first shaft portion (Figs. 12-13). As discussed above, it would have been obvious to have conformed the cavity to have third cavity portions to have similarly conformed to the second shaft portion of the tool for similar reasons.
Claim 6: Referring to Johansson, the proximal section comprises a primary surface (e.g. the surface of 32a); and the proximal cavity (36) is formed below (noting that directionality is relative – the extension direction of 36 could be considered “below”) the primary surface by a depth that is greater than a second diameter of the second shaft portion to enable the second shaft portion to be disposed below the primary surface when received in the proximal cavity (again noting that the tool is not positively recited and so this would depend on the relative dimension of the tool compared to the cavity – though it appears that cavity 36 in Fig. 3b is deeper than the shaft diameter of the shown tool).
Alternatively, the upper end surfaces of cavity portion 36 in Figs. 3a-3b could be considered the “primary surface”, and the cavity would be “below” it by a depth that is greater than a second diameter of the second shaft portion to enable the second shaft portion to be disposed below the primary surface when received in the proximal cavity.
Claim 7: The second shaft portion comprises a proximal end opposite the distal cutting bur, and wherein: the proximal cavity comprises a length sufficient to enable the proximal end of the second shaft portion to be disposed within the proximal cavity (noting again that the tool is not positively recited and the cavity 36 could generally enable a proximal end of a second shaft portion to be disposed within the proximal cavity depending on the tool and its relative placement in the package).
Claim 9: The distal casing and the proximal section are discrete structures (they can each be defined as discrete, e.g. separated by a fold line 42 shown in Fig. 2c and paragraph 57, noting that the embodiment of Figs. 3a-3b is disclosed to be similar to the first embodiment, paragraph 66).
Claim 10: The distal casing is coupled to the proximal section (paragraphs 51 and 57; evident in figures).
Claim 11: The proximal section is pivotably coupled to the distal casing (paragraph 57; Fig. 2c).
Claim 13: The second distal section is pivotably attached to the first distal section (evident in Figs. 3a-3b; see also paragraph 65).
Claim 14: Referring to Collet, the first distal section comprises one of a recess or a protrusion (e.g. protrusion 4’) and the second distal section comprises the other of the recess or the protrusion (recess 4”), and wherein the protrusion and recess are configured to couple by interference fit to enable the first distal section and the second distal section to couple to one another (paragraph 119, 132). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included a recess or a protrusion in order to have locked the package halves together.
Claim 16: Johansson discloses a packaged tool assembly comprising: an elongated tool (10) that includes a distal cutting bur (14), a first shaft portion proximal to the distal cutting bur (e.g. portion of 26 proximal to 14), and a second shaft portion extending from the first shaft portion (e.g. portion of 26 distal to 14); and a packaging body (30 – especially Figs. 3a-3b) that houses the elongated tool, the packaging body comprising: a distal casing comprising a first distal section (left portion of 32a in Fig. 3a) and a second distal section (32b) each comprising a distal cavity (defined by 33a-c and 33d) being shaped to conform to the distal cutting bur (paragraph 67), and wherein the first distal section and the second distal section are coupled to one another to collectively encase the distal cutting bur (Id.) within the distal cavities; and a proximal section (right portion of 32a) comprising a proximal cavity (36) that is elongated and sized to receive the second shaft portion.
The tool does not have a distal cutting bur having a spherical head, and each distal cavity does not have a hemi-spherical cavity portion shaped to conform to half of the spherical head to collectively encase the spherical head of the distal cutting bur. Johansson does disclose that the cavities may adopt other designs than the U-shape form (paragraph 67). Collet et al. in turn teaches a similar packaging body (1) wherein first and second distal sections (11, 12) each have a distal cavity (2’, 2”, 5’, 5”) with a portion shaped to conform to half of a tool therein such that they encase the tool (paragraphs 118-119, 121, and 148). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have shaped the cavities of Johansson as halves shaped to conform to half of a tool as taught by Collet since it provides good handling of the tool therein.
The cavities are not necessarily hemi-spherical shaped to conform to half of the spherical head of the distal cutting bur. However, Staunton teaches an alternative medical cutting tool having a spherical head (bur 50 - e.g. Figs. 12-13). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further shaped the cavities of Johansson as claimed in order to have accommodated a different type or form factor of medical tool such as that of Staunton. It is further noted that to the extent that the type and shape of the tool is arbitrary (see instant specification at paragraph 36), and the claimed hemi-spherical shape of the cavities are merely associated with a tool of corresponding shape, the claimed shapes would have been obvious since it has been held that the configuration of a claimed product is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed product is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Please note that the instant application lacks of any mention of “spherical”, and paragraph 36 contemplates other tool types and shapes, and thus Applicant has not disclosed any criticality for the shape of the tool or the cavity shape conforming to it.
It is also noted that in light of Applicant’s disclosure, “shaped to conform” is not necessarily interpreted as a 1:1 mirroring of the shape of the tool. Paragraphs 4 and 50 state that the purpose of the package is to avoid contact between the package and the tool. Paragraph 50 describes “substantially contoured to the distal end of the tool” as allowing for suspending the tool within the casing with a spacing or clearance. Paragraph 66, while describing an arguably more closely contoured shape, still describes the alternate embodiment using the same term “substantially contoured”.
Claim 17: Referring to Collet, each distal cavity has a second cavity portion (5’, 5”) that is shaped to conform to half of a shaft portion. Staunton also comprises a first shaft portion (e.g. proximal to the spherical burr). Based on the above, it would have been obvious to have conformed the second cavity portions to have similarly conformed to the first shaft portion of the tool for similar reasons.
Claim 18: Referring to Staunton, the second shaft portion has a cylindrical shape (evident in figures) and comprises a second diameter; the first shaft portion includes a tapered surface that tapers to a first diameter that is less than the second diameter (e.g. Figs 12-13). Collet further discloses that each distal cavity comprises a second cavity portion (5’, 5”) that is shaped to conform to half of a tapered surface of a first shaft portion; and a third cavity portion (14) that is shaped to conform to half of a cylindrical shape of a second shaft portion in a region proximal to the first shaft portion. As discussed above, it would have been obvious to have conformed the cavity to have second and third cavity portions to have similarly conformed to the shaft portions of the tool for similar reasons.
Claim 19: The elongated tool comprises a tool axis (e.g. longitudinal axis T of Staunton), and wherein the distal cavities of the first and second distal sections are symmetrically constructed in relation to the tool axis (Collet, paragraphs 118 and 121).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Johansson, Collet et al., and Staunton et al. as applied to claim 1 above, and further in view of Richman (U.S. Patent 9,179,978).
Johansson, Collet et al., and Staunton et al. teach a packaging body substantially as claimed except for wherein the proximal cavity includes a circular cutout to remove the second shaft portion from the proximal cavity. However, Richman teaches a packaging body having a cavity including a circular cutout (204) to remove a tool from the cavity (column 4, lines 7-9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided circular cutouts in the cavity of Johansson in order to have similar aided the removal of the tool therefrom.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Johansson, Collet et al., and Staunton et al. as applied to claim 11 above, and further in view of Kelly (U.S. PGPub 2008/0257758, cited in IDS).
Johansson, Collet et al., and Staunton et al. teach a packaging body substantially as claimed except for wherein a perforation is formed at a boundary between the proximal section and the distal casing to facilitate detachment of the proximal section from the distal casing. It is noted that Johansson suggests the packaging may be for a one-time use (paragraph 11) and that the flexible portion (42) may take various forms (paragraph 59). Kelly in turn teaches a foldable package wherein a fold line (20) between movable sections of the package may be perforated such that the sections may be separated from one another (paragraph 25). It thus would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed a perforation at a boundary between the proximal section and the distal casing, in order to have further facilitated removing the proximal package portion from the tool shaft during tool installation, for example.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Johansson, Collet et al., and Staunton et al. as applied to claim 1 above, and further in view of Rowe et al. (U.S. Patent 5,842,567, cited in IDS).
In teaching the lock (4), Collet further teaches that more than one lock may be provided (paragraph 132), thus implying more than one of each of portions 4’ and 4”, though the claimed configuration is not necessarily taught. However, Rowe et al. teaches a foldable package for a surgical tool, wherein two protrusions (23a and 23b) are respectively located on opposing sides of a cavity (18) of a first distal section (14); a second distal section (12) comprises two recesses (22a and 22b) respectively located on opposing sides of a distal cavity (18) of the second distal section; and the two protrusions and the two recesses are configured to couple by interference fit to enable the first distal section and the second distal section to couple to one another (friction/snap fit - implied at column 2, lines 20-23). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided protrusions and recesses as taught by Rowe et al. since it provides a sterilizable package for medical devices that protects the delicate product and is easy to open (column 1, lines 37- 39).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Johansson in view of Collet et al., Staunton et al., and O’Toole et al. (U.S. Patent 5,284,244).
It is noted that claim 20 recites the features of claim 16 and additionally a sealed pouch that includes the packaging body and the elongated tool disposed within the sealed pouch. Johansson, Collet et al., and Staunton et al. teach the assembly of claim 16 as previously discussed. Johansson further discloses “an outer package may cover the drill 10 and its package 30” (paragraph 54), but not necessarily a sealed pouch. However, O’Toole discloses a packaged tool assembly (10) having a tool and a packaging body (13) sealed within a pouch (11/12 – column 2, lines 34-46). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a sealed pouch in order to have improved the protective barrier and the sterility of tool packaged within.
Response to Arguments
Applicant's arguments filed 7/29/2025 have been fully considered.
Applicant’s arguments mainly rely on amendments to the claims to overcome the rejections over Johansson, specifically by introducing that each of the first and second distal sections comprise a distal cavity “with a hemi-spherical cavity portion”. Applicant’s arguments pertaining to Johansson alone are effectively moot in view of the new grounds of rejection presented above.
On page 9, Applicant also argues that “Johansson does not disclose that its sections can couple together at all to collectively encase a tool. In Figures 3a-b, there is no encasing and the packaging is open on all sides”. The examiner notes that according to Dictionary.com, “encase” means “to enclose in or as in a case”. In turn, Johansson discloses that “The U-shaped sidewall is designed to enclose the drill”. Thus, Johansson does at least support a structure which encases the tool, and the embodiment shown in Fig. 3b is certainly not “open on all sides”, nor does the claim necessarily preclude this if it were.
Arguments pertaining to Kinyon are moot as Kinyon is no longer relied upon.
Starting on page 11, Applicant disagrees with the examiner’s citation of in re Dailey with regard to the obviousness of the shape of the cavities, and cites alleged evidence that the shape is significant. First, the examiner does not rely solely on in re Dailey, but cites it in addition to the prior art and motivations to combine presented in the rejection. Furthermore, paragraph 36 of the instant application states that the tool 24 may take on other shapes and other types of tools are contemplated. The specification is silent regarding the spherical or hemispherical nature of the tool or the cavities, and the drawings only depict it as an exemplary embodiment. As noted elsewhere in the Action, the cavity need only be "substantially contoured" to the tool, regardless of the tool's shape. The claimed spherical shape of the cavity is only significant insomuch as it happens to be "substantially contoured" to the arbitrary example of spherical tool. The spherical shape itself does not provide any advantages, but if anything does it is only the concept of contouring to whichever shape the tool happens to be. The concept of generally contouring a package cavity to its contents is generally known, as are tools having the claimed spherical burr shape. It does not take a leap of innovation to imagine a package for enclosing such a tool provided with correspondingly shaped cavities.
Applicant’s arguments pertaining to the additional dependent claims essentially depend from the arguments above.
Applicant’s arguments pertaining to claim 16 are essentially repeated from those of claim 1.
Applicant’s arguments pertaining to claim 20 essentially depend from the arguments above.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P TRAVERS whose telephone number is (571)272-3218. The examiner can normally be reached 10:00AM-6:30PM.
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/Matthew P Travers/Primary Examiner, Art Unit 3726