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 .
Status of the Claims
Claims 1-17 are currently pending. Claim 18 is newly added. Claims 1-18 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/21/2026, with respect to the rejection(s) of claim(s) 1, 16, and 17 under 35 USC § 103 have been fully considered and are persuasive, since the scope of all independent claims has been changed from the previous iteration. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an alternative interpretation of the prior art, and additional art as noted below.
Examiner acknowledges that the amendments to claims 1, 3, 11, 16, and 17 obviate the previous 112b rejections, which are not extended to the claims as currently amended.
Applicant argues at multiple points against the combination of Bostrom with Darras, Bunch, or Bruns. Specifically, Applicant that one would not have been motivated to modify Bostrom to form the remover 148 of Bostrom to “be formed of or include an elastic, tubular sleeve that functions such that the elastic material of the holding section is deformed radially into the bore and the inner diameter matches the outer diameter of the needle shield along the longitudinal axis” as recited in amended claim 1, or similar limitations regarding other claims and combinations.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, the tongues 168 of Bostrom must be formed of an elastic material in order to pass over the needle shield when pushed in one direction but dig into the needle shield when pulled in the opposite direction. Note that the sleeve of Bostrom must have flexibility in order to perform the intended purpose, see 102 and 103 rejections of independent claims as amended below. Also, see references noted in the Conclusion which deal with similar designs to Bostrom and explicitly discuss how the sleeve and/or protrusions must be flexible in order to function properly
Applicant argues that one would not have been motivated to modify Bostrom with Darras since the modification would “add complexity to Bostrom for no apparent purpose” and cites to MPEP 2143.01(V) saying that “If proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, then there is no suggestion or motivation to make the proposed modification.” However, Bostrom as modified by Darras is still able to perform the intended purpose of needle shield removal. Incorporating the thermoplastic material of Darras, as previously noted, helps the elastic sleeve of Bostrom to better grip the needle shield during removal, thus improving, not detracting from, the capability of Bostrom to perform the intended purpose. Note again that the sleeve of Bostrom must have flexibility in order to perform the intended purpose, see 102 and 103 rejections of independent claims as amended below.
In response to applicant's argument that the combination of Bostrom and Darras, Bunch, or Bruns is improper, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Additionally, regarding the combination of Bostrom and Darras, Applicant argues that “the skilled artisan would apply the gripping surface 63 to the Bostrom cap 132 or the remover 148”. As of the gripping surface 63 of Darras being combined with the cap 132 or remover 148 of Bostrom, the previous rejection of claim 1 notes that the gripping surface 63 is applied to the elastic, tubular sleeve/medicament delivery member guard remover 148 of Bostrom. Thus, Applicant admits that the skilled artisan would apply the gripping surface 63 to the remover 148 as previously described by Examiner.
Regarding the combination of Bostrom and Bunch or Bostrom and Bruns, Applicant imports limitations from Bunch and Bruns which are not incorporated into the modification of Bostrom as previously described and motivated.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues that the combination of Bostrom and Darras would not arrive at the needle shield remover having a holding section with elastic material that is arranged and functions in the manner recited in claim 1 as amended. Examiner notes that since amended claim 1 introduces the new limitations to which Applicant refers, the prior combination of Bostrom and Darras did not address this new limitation. See rejection of amended claims below. Similar arguments are presented regarding newly introduced limitations in independent claims 16 and 17.
Applicant argues that Bostrom and Darras fail to disclose the limitation “wherein the holding section extends freely into the bore to a proximal end such that an external surface of the holding section is separated in the bore radially from an internal surface of the side wall of the cap” is met by Bostrom, as shown for example in figures 12 and 13. See further detail in the rejection of claim 1 below. Note that this limitation was also not previously included.
Applicant argues that the sheath removal beams 11.3 of Bunch do not meet the limitation of an “elastic, tubular sleeve”. However, multiple beams 11.3 are arranged around a circular opening and form a hollow tube, as shown in figs. 13a-b. The elastic, tubular sleeve does not necessarily lack any openings as claimed. Note that fig. 13b additionally shows “continuous rotational symmetry” since any two opposing points around the circumference of the multiple beams 11.3 and gaps between them are symmetrical.
Applicant argues that Bunch does not “disclose or suggest the above functions of the holding section of amended independent claim 1”. Examiner notes that claim 1 is a device claim, and when there is functional language in a device claim, the prior art must only be capable of performing the recited function.
Applicant argues that one would not have been motivated to modify Bostrom with Bunch or Bruns since the modification would “add complexity to Bostrom for no apparent purpose” and cites to MPEP 2143.01(V) saying that “If proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, then there is no suggestion or motivation to make the proposed modification.” However, Bostrom as modified by Bunch or Bruns is still able to perform the intended purpose of needle shield removal. Incorporating the elastic deflection of Bunch, as previously noted, helps the elastic sleeve of Bostrom to better grip the needle shield during removal, thus improving, not detracting from, the capability of Bostrom to perform the intended purpose. Note again that the sleeve of Bostrom must have flexibility in order to perform the intended purpose, see 102 and 103 rejections of independent claims as amended below.
Claim Objections
Claims 11 and 16 are objected to because of the following informalities:
Claim 11, on the last line, recites “relaxes to envelope and hold”. This should be “relaxes to envelop and hold” since envelope is a noun, and envelop is a verb.
Claim 16, on the last line, recites “to thereby envelope and hold”. This should be “to thereby envelop and hold” since envelope is a noun, and envelop is a verb.
Appropriate correction is required.
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.
Claim 18 is 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 18 recites the limitation “wherein only radial forces act on the needle shield by the holding section.” This phrasing is unclear since “by the holding section” could be seen to modify the limitation such that the radial forces noted are occurring near the holding section, or that the radial forces are being applied by the holding section. Additionally, even if the holding section is applying only radial forces to the needle shield in the assembled state, during removal of the cap, holding section, and attached needle shield, the holding section would not only apply radial forces, but would apply at least a normal force and a static frictional force, perpendicular to the radial normal force, since this frictional force is, necessarily, the force which causes the needle shield to move with the holding section if there is no other longitudinal force applied by a different element to the needle shield. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1, 7, and 18 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by Bostrom (US 20210220564 A1) or, in the first alternative, under 35 U.S.C. 103 as obvious over Bostrom in view of Holmqvist (US 20160082198 A1), or, in the second alternative, under 35 U.S.C 103 as obvious over Bostrom in view of Darras (US 20160310676 A1) and Doyle (US 4787838 A).
In the first alternative regarding claim 1, Bostrom discloses a needle shield remover (protective safety cap 132, fig. 1, [0045]) for a medicament delivery device (medicament delivery device 10, fig. 1, [0039]) comprising a syringe (medicament container 56, fig. 3, [0040] medicament container holder 38 is arranged to accommodate a medicament container 56 that in the embodiment shown is a syringe) with a needle (needle 58, fig. 3, [0040]) attached to a distal end of the syringe ([0040] syringe has attached injection needle 58), the needle covered by a needle shield (medicament delivery member shield 170, see fig. 2, [0047]), the needle shield remover (132) comprising:
a cap (generally tubular body 134, fig. 10, [0045]) comprising a side wall (see annotated fig. 11) providing a bore (see fig. 10 and fig. 11 which show a bore between distal passage 136 and central circular passage 144, see annotated fig. 11 where the dotted double arrow shows the bore, see [0045] and [0046]), wherein a proximal section (circumferential ledge 138, [0045]) of the side wall is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) for attachment to the medicament delivery device (10) ([0045] inner surface of the body 134 of the safety cap 132 may be arranged with a circumferential ledge 138 which functions as a first holding element by interacting with protrusions 140; [0048] ledge 138 retains the safety cap 132 relative to the medicament delivery device 10);
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an elastic, tubular sleeve (medicament delivery member guard remover 148, fig. 10, [0046]) positioned in the bore (see fig. 12, [0046] medicament delivery member guard remover 148 will extend into the body 134 of the safety cap 132), wherein the elastic sleeve (148) comprises a holding section (see annotated fig. 14) for holding the needle shield (170), the elastic sleeve (148) comprising a wall (see cylindrical wall forming the elastic sleeve in fig. 10 and 11) constructed from an elastic material (Examiner notes that the elastic sleeve 148 must be made of an elastic material due to the fact that the inclined tongues 168 of the elastic sleeve/remover 148 must deflect radially outward in order to allow the insertion of the needle shield while sliding in one relative direction but prevent the removal of the needle shield from the elastic sleeve/remover 148 when a user pulls on the cap, and therefore the remover 148, and thus also removes the needle shield.); and
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a distal end wall (end wall 142, fig. 10, [0046]) connecting the elastic sleeve (148) to the cap (134) (see fig. 12), wherein a passage (central circular passage 144, fig. 10, [0046]) is provided in the distal end wall ([0046] end wall 142 is arranged with a central circular passage 144) connecting the inner space of the elastic sleeve (148) to an exterior (see fig. 15 which shows an air passage from the exterior of the device through the passage 144 and into the inner space of the elastic sleeve 148), wherein an inner dimension of the passage (144) is greater than an outer diameter of the needle shield (170) (see fig. 15 which shows that the inner dimension of the passage 144, in which the elastic sleeve 148 is positioned as noted in [0046], is wide enough to accommodate the elastic sleeve 148 which is arranged around the needle shield 170 as shown in fig. 2 and described in [0047]; thus an inner diameter of the passage 144 is greater than the outer diameter of the elastic sleeve 148 which is greater than the outer diameter of the needle shield 170),
wherein the holding section extends freely into the bore (see fig. 12 and 13) to a proximal end such that an external surface of the holding section is separated in the bore radially from an internal surface of the side wall of the cap (see radial separation of holding section and internal surface of side wall of cap in fig. 14 above; see also figs. 12 and 13 for a simplified view), and
wherein the elastic sleeve comprises a circular cross-section (see fig. 10 which shows that elastic sleeve 148 has a circular cross section at and adjacent to flange 150) and a continuous rotational symmetry about a longitudinal axis defined by the needle (see fig. 10 which shows that elastic sleeve 148 has a continuous rotational symmetry since each portion opposed radially from the other side of the elastic sleeve 148 is symmetrical) such that (Claim language of “such that” implies functional language and the prior art must only be capable of performing the recited function.) prior to insertion of the needle shield (Examiner notes that, as previously introduced, the needle shield is only functionally claimed.), an inner diameter of the holding section along the longitudinal axis is smaller than a maximum radial outer diameter of the needle shield, and upon insertion of the needle shield, the elastic material of the holding section is deformed radially into the bore and the inner diameter matches the outer diameter of the needle shield along the longitudinal axis (Examiner notes that since the needle shield is only functionally claimed in conjunction with the positively claimed needle shield remover, there exists a needle shield that would, in conjunction with the elastic sleeve of Bostrom, satisfy the functionally claimed limitations since the elastic sleeve of Bostrom is necessarily formed from an elastic material which could deflect during insertion of a needle shield of the appropriate size.).
In the second alternative regarding claim 1, Bostrom discloses all limitations as described in the first alternative, except that Bostrom is silent to the elastic sleeve having a wall constructed from an elastic material, and the functional limitations following “such that” noted in the 102 rejection of claim 1 above.
Holmqvist, directed to a needle shield remover, teaches an elastic sleeve (remover body 12, fig. 1, [0050]). having a wall (generally tubular body noted in [0050], see fig. 1) constructed from an elastic material ([0050] Preferably, the elongated members are resilient tongues made integral with the remover body 12.; Examiner notes that since the tongues are resilient and integral with the body 12, then both must be made of an “elastic material”.) and
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wherein the elastic sleeve comprises a circular cross-section (see fig. 1 exploded view in fig. 2 which shows sleeve 12 has a circular cross section) and a continuous rotational symmetry about a longitudinal axis defined by the needle (see fig. 2 which shows that elastic sleeve 12 has a continuous rotational symmetry since each portion opposed radially from the other side of the elastic sleeve 12 is symmetrical) such that (Claim language of “such that” implies functional language and the prior art must only be capable of performing the recited function.) prior to insertion of the needle shield (Examiner notes that, as previously introduced, the needle shield is only functionally claimed.), an inner diameter of the holding section (see area between dotted double ended arrows above) along the longitudinal axis is smaller than a maximum radial outer diameter of the needle shield (note [0056] below describes the deflection of the gripping members 18, and the inner diameter of the holding section is the inner diameter of the flexible gripping members 18. Since the gripping members 18 are deflected, then they must originally define an inner diameter for the holding section that is smaller than the maximum radial outer diameter of the needle shield), and upon insertion of the needle shield, the elastic material of the holding section is deformed radially into the bore and the inner diameter matches the outer diameter of the needle shield along the longitudinal axis ([0056] “when the rigid needle shield 52 enters the interior of the remover body 12 , the first set of gripping members 18 will come in contact or interact with the outer surface of the rigid needle shield and will be pushed somewhat outwards in the radial direction, FIG. 5a”… “the first set of gripping members 18 pushing against the surface of the rigid needle shield due to the flexing force in the generally radial direction of the first set of gripping members, FIG. 5b.”).
In the third alternative regarding claim 1, Bostrom discloses all limitations as described in the first alternative, except that Bostrom is silent to the elastic sleeve having a wall constructed from an elastic material, and the functional limitations following “such that” noted in the 102 rejection of claim 1 above.
Darras, in the field of a needle shield removal, teaches wherein an elastic sleeve (gripping surface 63, fig. 10, [0057]) comprises a wall (distal portion 63.2 of the gripping surface 63, see fig. 10 and fig. 6 which show gripping surface portion 63.2 as a cylindrical wall) constructed from an elastic material ([0046] gripping surface 63 may be elastomer thermoplastic), and
wherein the elastic sleeve comprises a circular cross-section (see fig. 5a, fig. 6, and fig. 10) and a continuous rotational symmetry about a longitudinal axis defined by the needle (see again figs. 5a, 6, and 10 which show that elastic sleeve 63 has a continuous rotational symmetry since each portion opposed radially from the other side of the elastic sleeve 12 is symmetrical).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to replace the wall of the elastic sleeve of Bostrom with the wall of the elastic sleeve taught by Darras since both deal with needle shield removers and the elastic sleeve in both engages the needle shield. One would have been motivated to make the modification because having the elastic sleeve made of an elastic material which could relax inward when applied around the needle shield would improve the ability of the elastic sleeve to grip the needle shield along the length of the holding section since the elastic sleeve could better conform to the surface of the needle shield and provide a normal force due to being stretched around the needle shield that would increase the friction between the two and thus better help the elastic sleeve grip the needle shield and ensure that the needle shield is also removed when the elastic sleeve is removed. Additionally, since both the needle shield removers of Bostrom and Darras include cylinders which cooperate with the needle shield to facilitate removal in different ways, both types of cooperation between elastic sleeve and needle shield were known to work and allow removal of the needle shield, it would have been an obvious matter to one of ordinary skill in the art to substitute the gripping surface 63 of Darras for the remover 148 of Bostrom, it would have been an obvious matter of simple substitution resulting in predictable results with a reasonable expectation of success (See MPEP 2143(I)(B)).
Bostrom modified by Darras is silent to the relative diameters of the elastic sleeve and needle shield during insertion.
Doyle, in the art of tubing expanders, teaches an elastic sleeve (tubing 30, fig. 3-6, col. 7 ln. 29-45) and a fitting (fitting 286, fig. 5-6, col. 7 ln. 50-61) such that (Claim language of “such that” implies functional language and the prior art must only be capable of performing the recited function.) prior to insertion of the fitting (Examiner notes that, as previously introduced, the needle shield is only functionally claimed; here “needle shield” is replaced with “fitting” for clarity, as Doyle does not teach a needle shield.), an inner diameter of the holding section (area of tubing deformed in fig. 5) along the longitudinal axis is smaller than a maximum radial outer diameter of the needle shield (col. 7 ln. 50-61 “A male portion 284 of a fitting 286, having a larger outside diameter than the inside diameter of the unexpanded tubing 30”), and upon insertion of the fitting, the elastic material of the holding section is deformed radially and the inner diameter matches the outer diameter of the fitting along the longitudinal axis (col. 7 ln. 62-col. 8 ln. 4, “After the male portion of the fitting is received within the expanded tubing, the tubing, because of its resilient nature, will contract back towards its original dimensions, as depicted in FIG. 3. However, as best shown in FIG. 6, because the inserted male portion 284 of the fitting has a greater outside diameter than the inside diameter of unexpanded tubing, the tubing 30 will instead conform about and tightly engage the inserted male portion, providing a tight seal about the connector”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bostrom as modified by Darras to have the various diameter relationships taught by Doyle, since Bostrom modified by Darras applies an elastic sleeve around a needle shield requiring a good connection between the inner surface of the elastic sleeve and the outer surface of the needle shield. One would have been motivated to make the modification because having the elastic sleeve have a relaxed diameter smaller than the outer diameter of the needle shield ensures that upon application of the elastic sleeve to the needle shield, the elastic sleeve applies plenty of normal force ensuring good frictional cooperation between the two elements which aids in the removal of the needle shield when the needle shield remover and cap are removed from the medicament device.
Regarding claim 7, Bostrom modified in any alternative discloses the needle shield remover according to claim 1, as described above. Bostrom further teaches wherein an inner surface of the holding section (see annotated fig. 14 above) of the elastic sleeve (148, fig. 10) is roughened or textured ([0047] the distal end of the medicament delivery member guard remover 148 is arranged with generally proximally and inwardly inclined tongues 168 that are designed to be in contact with and engage a medicament delivery member shield 170).
Regarding claim 18, Bostrom modified in any alternative discloses the needle shield remover according to claim 1, as described above, including wherein only radial forces act on the needle shield by the holding section (see 112b interpretation above) (Examiner notes that in all alternative rejections the holding section necessarily surround and contacts the needle shield, thereby applying radial forces.).
Claim(s) 2-6 are rejected under 35 U.S.C. 103 as being unpatentable over Bostrom as modified in any alternative above, and further in view of Atterbury et al (US 20170354790 A1), and AcmePlastics (“What are Polycarbonates?”. AcmePlastics.com. https://www.acmeplastics.com/what-are-polycarbonates. Accessed: 27 Oct. 2025.; see previously attached pdf for citations).
Regarding claim 2, Bostrom as modified in any alternative discloses the needle shield remover according to claim 1, as described above.
In the first and second alternatives above, Bostrom is silent to whereby an elastomer is selected for the elastic sleeve.
In the third alternative, Bostrom modified by Darras already discloses including whereby an elastomer is selected for the elastic sleeve (Darras: [0046] gripping surface 63 may be elastomer thermoplastic).
Bostrom as modified in any alternative is silent to wherein the needle shield remover is manufactured by multi-component injection molding of at least two different thermoplastic polymers for the cap and the elastic sleeve.
Atterbury, directed to a needle shield puller cap assembly, teaches wherein the needle shield remover (puller assembly cap 30, fig. 14, [0045]) is manufactured by a multi-component injection molding ([0045] cap 30 is formed of a two shot molding having a central body portion 125 and a gripping periphery 130) of at least two different thermoplastic polymers for the cap (central body portion 125, fig. 14) and the elastic sleeve (gripping periphery 130, fig. 14) ([0045] Body portion 125 is formed of a rigid material such as polycarbonate. Periphery 130 is molded onto body portion 125 out of a softer material, such as a thermoplastic elastomer), whereby an elastomer is selected for the elastic sleeve ([0045] describes the gripping periphery 130 as being made of a thermoplastic elastomer).
Examiner notes that AcmePlastics.com states that “Polycarbonate plastic is a thermoplastic”. Since polycarbonate is a polymer and is inherently a thermoplastic, using polycarbonate and a thermoplastic elastomer as noted by Atterbury above meets the limitation of using at least two different thermoplastic polymers.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the needle shield remover of Bostrom, Bostrom modified by Holmqvist, or Bostrom modified by Darras to be explicitly formed by multi-component injection molding as taught by Atterbury, since all noted references deal with needle shield removal. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to select the claimed materials for each part, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. (See MPEP 2144.07.) One would have been motivated to make the modification because using multi-shot injection molding would allow for the formation of a needle cap remover with multiple materials bonded to each other for strong construction, each material suited to the specific purpose and form of the structure. Since Bostrom modified in any alternative involves deflection of the elastic sleeve but not of the cap body, so it would have been obvious to one of ordinary skill in the art to select a softer thermoplastic elastomer as the elastic sleeve which engages the needle shield, it would make sense to use the stiffer polycarbonate for the cap which supports the elastic sleeve.
Regarding claim 3, Bostrom as modified in any alternative discloses the needle shield remover according to claim 2, as described above. Bostrom further discloses wherein the elastic sleeve (148) is a cylindrical sleeve (see fig. 10-13 which show that guard remover 148 is a cylindrical sleeve) comprising a flange (ledge 150; figs. 10, 11, and 13; [0046]) that extends radially outward from the distal end (see 112b interpretation above) of the elastic sleeve ([0046] medicament delivery member guard remover 148 is arranged with an outwardly extending ledge 150).
Regarding claim 4, Bostrom as modified in any alternative discloses the needle shield remover according to claim 3, as described above. Bostrom further discloses wherein the side wall of the cap is a cylinder (see annotated fig. 11 above which shows that the side wall of cap 134 is a cylinder) and wherein the end wall (end wall 142, fig. 10, [0046]) extends radially inward from the side wall (see fig. 10 which shows that end wall 142 extends radially inward from the sidewall).
Regarding claim 5, Bostrom as modified in any alternative discloses the needle shield remover according to claim 3, as described above. Bostrom further discloses wherein the flange (150, fig. 10) of the elastic sleeve (148, fig. 10) and the end wall (142, fig. 10) are connected to each other in an overlap area ([0046] ledge 150 is arranged to be seated in a recess 152 in the end wall 142 of the body 134; see fig. 12 which shows the connected configuration; see fig. 12 which shows overlap).
Regarding claim 6, Bostrom as modified in any alternative discloses the needle shield remover according to claim 3, as described above.
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Bostrom further discloses wherein the elastic sleeve (148, fig. 10) comprises an entrance section (see second annotated version of fig. 14 below) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) for receiving a distal end of an expansion tool (Examiner notes that the expansion tool is only claimed functionally, not positively recited. Since the entrance section could receive a distal end of an expansion tool, the elastic sleeve 148 meets the functional limitation), the entrance section positioned between the holding section and the flange (150, fig. 10) (see second annotated version of fig. 14 below which shows the entrance section positioned between the holding section and the flange).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bostrom as modified in any alternative described above, and further in view of Hilton (Hilton. “A Bio-Polycarbonate that is Better than Petro-Polycarbonates.” Ag Chemi Group Blog. Raw Materials. 19 Nov. 2019.; See previously included pdf for citations).
Regarding claim 8, Bostrom as modified in any alternative discloses the needle shield remover according to claim 1, as described above.
In the first and second alternatives above, Bostrom is silent to wherein a portion of the needle shield remover is made from a thermoplastic.
In the third alternative, Bostrom modified by Darras already discloses including wherein a portion of the needle shield remover is made from a thermoplastic (Darras: [0046] gripping surface 63 may be elastomer thermoplastic).
Bostrom as modified in any alternative is silent to wherein the wherein the cap is made from a thermoplastic biopolymer.
Atterbury, directed to a needle shield puller cap assembly, teaches wherein the cap (central body portion 125, fig. 14) of the needle shield remover (puller assembly cap 30, fig. 14, [0045]) is a thermoplastic polymer (central body portion 125, fig. 14) ([0045] Body portion 125 is formed of a rigid material such as polycarbonate.).
Examiner notes that AcmePlastics.com states that “Polycarbonate plastic is a thermoplastic”. Since polycarbonate is a polymer and is inherently a thermoplastic, using polycarbonate and a thermoplastic elastomer as noted by Atterbury above meets the limitation of using at least two different thermoplastic polymers.
Hilton, in an article directed to bio-polycarbonate, teaches a bio-polycarbonate made largely from glucose, the bio-polycarbonate having has strength and durability to match its petrochemical counterpart (see Hilton pdf pg. 3 para. 5).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use bio-polycarbonate as the material for the cap, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Atterbury teaches using a polycarbonate as part of a needle shield remover, so polycarbonate is a material known to be suitable in the art, and Hilton teaches that bio-polycarbonate has comparable properties to fossil-based polycarbonate, and thus one of ordinary skill in the art would recognize the bio-polycarbonate is a suitable material to use in the application of needle shield removers. AcmePlastics.com notes that polycarbonate is a thermoplastic, which is an inherent material trait. One would have been motivated to make the modification because fossil fuels are a non-renewable resource and finding alternative ways to manufacture useful plastics may beneficially decrease the rate of fossil fuel consumption.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bostrom in any of the three alternative rejections applied to claim 8 above and further in view of Darras and McClements (McClements. “7 Types of Thermoplastic Elastomers (TPEs).” Xometry. 27 Jun. 2022.; See previously pdf for citations).
Regarding claim 9, Bostrom as modified discloses the needle shield remover according to claim 8, as described above.
In the first and second alternatives above, Bostrom is silent to wherein the elastic sleeve is made from a thermoplastic elastomer.
In the third alternative, Bostrom modified by Darras already discloses including wherein the elastic sleeve is made from a thermoplastic elastomer (Darras: [0046] gripping surface 63 may be elastomer thermoplastic).
Darras teaches wherein the elastic sleeve is made from a thermoplastic elastomer ([0046] gripping surface 63 may be elastomer thermoplastic).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the elastic sleeve of the first or second alternative rejections to be made from a thermoplastic elastomer as taught by Darras since all the alternative rejections involve flexible elastic sleeves, and a thermoplastic elastomer is flexible. This would additionally have been obvious since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. One would have been motivated to make the modification because thermoplastic elastomer isa, as shown by Darras, an elastic material which is known to be used in the art of needle shield removers.
Bostrom as modified is silent to the thermoplastic elastomer having a shore-A hardness ranging between 60 and 100.
McClements teaches a thermoplastic elastomer with a shore-A hardness ranging between 60 and 100 (see McClements pdf pg. 4, section 2. Thermoplastic Polyolefins (TPE-O or TPO), para. 1; TPO has a hardness of 80 on the Shore A scale and may be mixed with thermoplastic elastomers).
Bostrom as modified discloses the claimed invention except for wherein thermoplastic elastomer from which the elastic sleeve is made having a shore-A hardness ranging between 60 and 100. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use TPO as taught by McClements, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Since McClements teaches properties of a variety of thermoplastic elastomers, and thermoplastic elastomers were known to be used as needle shield remover materials as taught by Darras [0046], it would have been obvious to one of ordinary skill in the art prior to the filing date of the invention to select a TPO, having a shore-A hardness of 80, as the specific thermoplastic elastomer of the elastic sleeve.
Regarding claim 10, Bostrom as modified discloses the needle shield remover according to claim 9, including the thermoplastic biopolymer used for the cap (see 103 rejection of claim 8 above) and the thermoplastic elastomer with a shore-A hardness ranging between 60 and 100 used for the elastic sleeve (see the 103 rejection of claim 9 above).
Bostrom as modified discloses the claimed invention except for wherein the elastic sleeve is made from a blend of the thermoplastic biopolymer used for the cap and the thermoplastic elastomer with a shore-A hardness ranging between 60 and 100. It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a blend of the thermoplastic biopolymer used for the cap and the thermoplastic elastomer with a shore-A hardness ranging between 60 and 100, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Since Bostrom as modified discloses both materials for use in a needle shield remover, and since McClements notes that TPO may be blended with other elastomers, it would have been obvious to one of ordinary skill in the art prior to the filing date of the invention to select a material that was a blend of the thermoplastic biopolymer and thermoplastic elastomer.
Claim(s) 11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bostrom as modified by Darras and Doyle and applied to claim 1 above, and further in view of Piontek et al (US 5594981 A; hereafter Piontek).
Regarding claim 11, Bostrom as modified by Darras and Doyle and applied in the third alternative to claim 1 above discloses a method for applying a needle shield remover to a medicament delivery device, comprising the following steps:
a) the needle shield remover according to claim 1 (see third alternative rejection of claim 1 above);
c) inserting an expansion tool (Doyle: pins 24 and 26, shown in Doyle figs. 3-4, col. 7 ln. 29-45) in the passage of the distal end wall (see Doyle fig. 3 and Bostrom fig. 1) (Bostrom: central circular passage 144, fig. 10, [0046] end wall 142 is arranged with a central circular passage 144);
d) advancing the expansion tool in a proximal direction towards the holding section (see Doyle fig. 3, expansion tool must be advanced proximally to enter tube/elastic sleeve);
e) elastically deforming the holding section of the elastic sleeve into the bore using the expansion tool to a dimension greater than the outer diameter of the needle shield (see Doyle fig. 4);
f) providing the medicament delivery device (see fig. 5 of Doyle, note that the fitting 286 is in the place of the needle shield of Bostrom, see third alternative rejection of claim 1 above);
g) inserting the needle shield in the elastically deformed holding section of the elastic sleeve (see fig. 5 of Doyle, col. 7 ln. 50-61); and
h) retracting the expansion tool in a distal direction such that the holding section elastically relaxes to envelope and hold the needle shield (see fig. 6 of Doyle, col. 7 ln. 62-col. 8 ln. 4).
Bostrom as modified by Darras and Doyle is silent to
a) inserting the needle shield remover according to claim 1 in a holding tool;
b) holding the distal end wall in the holding tool.
Piontek, in the art of elastic tubing assembly, teaches
a) inserting a needle shield remover (first tubular segment end portion 82, fig. 19, noted in col. 14. ln. 25-34) in a holding tool (ends 37a of the ejector arms 31, noted in col. 14. ln. 25-34; additionally see col. 14 ln. 18-24 “The pinch valve element 80 is seen in FIG. 18 to be poised for assembly on the length 49 of flexible tubing with the shank portion 84 of the pinch valve element bent aside to hold the second tubular segment end portion 83 out of the way so the first tubular segment end portion 82 can be slipped over the spreader finger portions 58 that are retracted close together as a cluster as depicted in FIG. 18” which notes that the shank portion 84 must be held out of the way, thus also implying inserting the needle shield remover in a holding tool),
b) holding the distal end wall (inner edge of the first tubular segment end portion noted in col. 14. ln. 25-34) in the holding tool (see fig. 19; col. 14. ln. 25-34 “inner edge of the first tubular segment end portion should be in contact with the ends 37a of the ejector arms 31 to ensure accurate positioning during the assembly process”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Bostrom, Darras, and Doyle to include inserting the needle shield remover of Bostrom, Darras, and Doyle in a holding tool as taught by Piontek since all three references deal with assembled concentric medical tubular members, one of which elastically deforms relative to the other. One would have been motivated to make the modification because immobilizing the needle shield remover of Bostrom modified by Darras and Doyle with the holding tool of Piontek would help to ensure accurate positioning during assembly, as noted by Piontek col. 14. ln. 25-34.
Regarding claim 13, Bostrom modified by Darras, Doyle, and Piontek discloses the method according to claim 11, as disclosed above, including wherein the expansion tool (Doyle: pins 24 and 26, shown in Doyle figs. 3-4, col. 7 ln. 29-45) comprises multiple segments (each pin 24 and 26 is a segment) that are configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to radially expand during step e) (see Doyle figs. 3-6).
Claim(s) 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bostrom as modified and as applied to claim 11 above and further in view of Bunch (US 20170014578 A1; hereafter Bunch) and Prevotat et al (US 6447710 B1; hereafter Prevotat).
Regarding claim 12, Bostrom modified by Darras, Doyle, and Piontek discloses the method according to claim 11, as disclosed above, including wherein the expansion tool (Doyle: pins 24 and 26, shown in Doyle figs. 3-4, col. 7 ln. 29-45) is a tube (see figs. 3-6 of Doyle, note that the pins form a tube together) with an inner diameter greater than the outer diameter of the needle shield (see Doyle figs. 3-6, note that the fitting 286 is in the place of the needle shield of Bostrom and Darras) and an outer diameter smaller than a diameter of the passage (passage 144 of Bostrom; see 103 rejection of claim 1 above).
Bostrom as modified teaches the claimed limitations except for the expansion tool having an outer diameter smaller than a diameter of the passage. This limitation represents only a change in size/proportion (MPEP 2144.04(IV)(A)). Altering the outer diameter of the needle shield to be smaller than a diameter of the passage, or in other words altering the diameter of the passage to be bigger than the outer diameter of the needle shield, would thus be recognized as an obvious matter for one of ordinary skill in the art. Since the expansion tool must be able to enter the passage, this claimed relationship would advantageously allow the expansion tool to enter the passage of Bostrom and deform the elastic sleeve as shown by Doyle figs. 3-6.
Alternatively, Bostrom as modified teaches the claimed limitations except for the expansion tool having an outer diameter smaller than a diameter of the passage.
Bunch, in the art of needle shield removers, teaches wherein the expansion tool (wedge shaped assembly tool 16, fig. 14, [0114]) is a tube (see fig. 14) with an outer diameter smaller than a diameter of the passage (see fig. 14 which shows expansion tool 16 has a smaller diameter than a diameter of passage 11.11).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Bostrom as modified to include the relationship taught by Bunch since Bunch also deals with a method of needle shield removal. One would have been motivated to make the modification because the expansion tool must be able to enter the passage in order to deform the holding section, so the diameter relationship taught by Bunch would advantageously allow the expansion tool to enter the passage of Bostrom and deform the elastic sleeve as shown by Doyle figs. 3-6.
Either alternative thus far presented is silent to the method further comprising the following step between steps c) and d): i) applying pressurized gas to an interface between an outside surface of the tube and an inside surface of the elastic sleeve, thereby creating an air cushion. (Examiner notes that claim 11 as written does not establish any particular order to the steps listed, since the method merely comprises the listed steps.)
Prevotat, in the art of installing plastic tubes, teaches i) applying pressurized gas to an interface (duct 20, fig. 8, col. 9 ln. 38-49) between an outside surface of the tube (blank Te, fig. 10, col. 9 ln. 38-49) and an inside surface of the elastic sleeve (casing 21, fig. 10, col. 9 ln. 38-49), thereby creating an air cushion (col. 9 ln. 38-49 “In order to avoid any friction between the blank Te and the casing 21, as illustrated in FIG. 10, compressed air is injected via the duct 20 into the space contained between the blank Te and the inner surface of the casing 21”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method to include applying pressurized gas between an outside surface of the tube and an inside surface of the elastic sleeve, thereby creating an air cushion, as taught by Prevotat, since all references deal with moving concentric tubes relative to each other. One would have been motivated to make the modification because, as noted by Prevotat, applying the pressurized gas between the two tubular members allows the tube and elastic sleeve to move without friction. This would beneficially reduce the wear on both the expansion tube and the elastic sleeve and facilitate easier removal of the expansion tube from the elastic sleeve when the elastic sleeve is applied to the needle shield.
Regarding claim 14, either rejection of claim 12 above discloses the method according to claim 12 as described above.
Bunch further teaches wherein the needle shield (5, fig. 16) is a rigid needle shield ([0068] protective needle sheath 5 may be a rubber needle sheath or a rigid needle sheath (which is composed of rubber and a full or partial plastic shell) having a stiffness greater than a stiffness of the holding section of the elastic sleeve (11.3, fig. 14 shows elastic sleeve 11.3 being deflected; [0086] compliant sheath removal beams 11.3) (Examiner notes that since the needle shield 5 is a rubber rigid needle shield and the elastic sleeve 11.3 is compliant, the needle shield 5, being rigid, has a greater stiffness than the elastic sleeve 11.3, being compliant.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to further include this relative stiffness as taught by Bunch since the device and method of Bostrom as modified requires elastic behavior of the elastic sleeve to provide a normal force between the elastic sleeve and the needle shield to aid in needle shield removal, but not of the needle shield. One would have been motivated to make the modification because the described stiffness augments the functionality of the modified elastic sleeve of Bostrom as modified by Darras and Doyle.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bostrom as modified and applied to claim 12 above, and alternatively further in view of Binder et al (US 20060004398 A1; hereafter Binder).
Regarding claim 15, Bostrom as modified discloses the method according to claim 12, as described above, including wherein the pressurized gas is pressurized air which is cleaned before applying step i) and/or wherein the surface of the expansion tool is coated with a friction reducing layer (Prevotat: col. 9 ln. 38-49 “In order to avoid any friction between the blank Te and the casing 21, as illustrated in FIG. 10, compressed air is injected via the duct 20 into the space contained between the blank Te and the inner surface of the casing 21”; Examiner notes that the air cushion acts as a friction reducing layer).
Alternatively, Bunch modified by Bostrom, Piontek, and Prevotat is silent to the expansion tool coated with a friction reducing layer.
Binder, in the art of dilator tubes, teaches wherein the surface of an expansion tool (bullet shaped dilator 400, fig. 3, FIG. 3 shows the enlarged distal end 410 of bullet-shaped dilator 400 positioned over guide wire 200, ready to be driven down through the tissue to initially expand the incision 100) is coated with a friction reducing layer ([0047] The handles, bullet-shaped dilator, and dilator tubes may be provided in any one or combination of the materials previously identified, and may have any one or combination of friction-reducing and glare-reducing coatings or polishing).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device and method of Bostrom as modified to include the friction reducing coating taught by Binder on the expansion tool 16 of Bunch or pins 24 and 26 of Doyle, since all references deal with tubular medical devices, and Binder also deals with inserting a tubular member for purposes of expansion. One would have been motivated to make the modification because, as noted by Piontek col. 8 ln. 36-46, friction may damage the surfaces sliding along each other. High friction would reduce the life of the tools and medical devices, thus including a friction reducing layer on the expansion tool would advantageously extend the life of the expansion tool.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Groetzbach et al (US 20190151565 A1; hereafter Groetzbach) in view of Bunch, Atterbury, and AcmePlastics.
Regarding claim 16, Groetzbach discloses a needle shield remover (device cap 2’, fig. 3a-3f, [0092]) and an expansion tool (assembly tool/spreading mandrel 8’, fig. 3a-3f, [0092]) for use with a medicament delivery device (injection device noted as having housing 1’, [0092] see figs. 3a-f) comprising a syringe (product container 3’, fig. 3d, [0092]; note also [0082] A product container (3) configured as a syringe is arranged in the housing (1) of the injection device.) with a needle (injection needle 3e’, fig. 3d, [0092]) attached to a distal end of the syringe (3’) (see fig. 3d), the needle covered by a needle shield (needle protection cap 5’, fig. 3d, [0092] injection needle (3e′) arranged on the product container (3′) is sealed off sterilely against the surroundings by the needle protection cap (5′)),
the needle shield remover (device cap 2’, figs. 3a-3f, [0092] device cap (2′) comprises a sleeve (2b′), a remover element (2d′) and an engagement element (2c′)) comprising:
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a cap (sleeve 2b’, fig. 3a, [0092]) comprising a side wall (see annotated fig. 3f above) providing a bore (see dotted double ended arrow showing space within inner sidewall of sleeve 2b’, annotated fig. 3f above), wherein a proximal section (engagement member 2a’, fig. 3e, [0092]) of the side wall (wall forming sleeve 2b’) is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) for attachment to the medicament delivery device ([0092] An engagement member (2a′) provided on the sleeve (2b′) of the device cap (2′) engages with a mating engagement member (1b′) arranged on the housing.; note that the housing is part of the injection device);
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an elastic, tubular sleeve (remover element 2d’ and engagement element 2c’, fig. 3a, [0092] remover element (2d′) and the engagement element (2c′) are preferably integrally formed) positioned in the bore (see fig. 3f above, also fig. 3a), wherein the elastic sleeve (2d’ and 2c’) comprises a holding section (see section of 2d’ between dotted double arrows in annotated fig. 3e above) for holding the needle shield (5’), the elastic sleeve (2d’ and 2c’) comprising a wall (2d’, see fig. 3e above and [0092]) constructed from an elastic material ([0092] notes that the remover element 2d’ and the engagement element 2c’ are integrally formed and made of a material with a bending strength that allows a plastic and/or elastic deformation); and
a distal end wall connecting the elastic sleeve to the cap (see distal end wall of cap 2’ in annotated fig. 3f above),
wherein the holding section extends freely into the bore such that an external surface of the holding section is separated in the bore radially from an internal surface of the side wall of the cap (see fig. 3e and 3f);
the expansion tool (8’) comprising a proximal end configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to be inserted into the holding section (see fig. 3c),
wherein during inserting of the expansion tool into the holding section, the expansion tool contacts and elastically deforms the holding section radially in the bore (see figs. 3a-3c which show deformation of holding section due to expansion tool contact; note that [0092] specifically notes elastic deformation) to a dimension greater than a maximum radial outer diameter of the needle shield (see fig. 3c) such that the needle shield can be inserted into the elastically deformed holding section (see fig. 3d), and
wherein the elastic material of the holding section elastically relaxes so as to include an inner diameter matching an outer diameter of the needle shield along a longitudinal axis defined by the needle to thereby envelope and hold the needle shield ([0092] engagement element (2c′) comes into engagement with the needle protection cap (5′)).
Groetzbach is silent to a passage provided in the distal end wall (although figs. 3a-3f do appear to show such a passage in the center of the distal end wall), the distal end of the expansion tool extending into the holding section (instead of the proximal end of the expansion tool doing so as shown), inserting of the expansion tool in a proximal direction into the holding section (instead of in a distal direction as shown), and the holding section elastically relaxing upon retracting the expansion tool from the holding section in a distal direction (although [0092] does mention the engagement element 2c’ achieving an undeformed shape during cap removal).
Bunch, in the art of needle shield removers, discloses a needle shield remover (cap 11, fig. 16, [0117]; [0118] removing cap 11 removes protective needle sheath 5) and an expansion tool (wedge shaped assembly tool 16, fig. 14, [0114]) for use with a medicament delivery device (medicament delivery device 1, fig. 16, [0117]) comprising a syringe (medicament container 3, fig. 16, [0117]) with a needle (needle 4, fig. 16, [0115]) attached to a distal end (see fig. 16) of the syringe, the needle covered by a needle shield (needle shield 5, fig. 16, [0117]), the needle shield remover (11) comprising:
a cap (parts of cap 11 excluding 11.3 and 11.6 as shown in fig. 16, [0118] removing cap 11 removes protective needle sheath 5) comprising a side wall providing a bore (see annotated fig. 13a below), wherein a proximal section of the side wall is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) for attachment to the medicament delivery device (1) (fig. 13a shows the proximal section of the noted sidewall attached to the medicament delivery device 1);
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an elastic component (sheath removal beams 11.3, fig. 16, [0117]) positioned in the bore (see annotated fig. 13a and fig. 16 which show the sheath removal beams 11.3 positioned within the bore), wherein the elastic component comprises a holding section for holding the needle shield (see fig. 16 which shows contact between the inner diameter of the needle shield 11.3 in a “holding section”, also see [0117] the sheath removal beams 11.3 are moulded in an inward deflected position which ensures they are always in intimate contact with the protective needle sheath 5 once the tool is removed), the elastic component (11.3) comprising a wall constructed from an elastic material ([0117] Due to their beam stiffness the sheath removal beams 11.3 relax radially inwards); and
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a distal end wall (distal face 11.10, fig. 16, [0117]) connecting the elastic component (11.3) to the cap (11) (see fig. 16), wherein a passage (opening 11.11, fig. 16, [0117]) is provided in the distal end wall (11.10) connecting an inner space of the elastic component to an exterior (see fig. 16), and
the expansion tool (wedge shaped assembly tool 16, fig. 14, [0114]) comprising a distal end (see fig. 14) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to be inserted into the holding section by extending through the passage of the distal end wall (see fig. 14 and [0114]; note that since the expansion tool 16 fits through the passage 11.11, as shown in fig. 14, then the expansion tool could be inserted into the holding section through the passage),
wherein during inserting of the expansion tool in a proximal direction (see fig. 14 and [0114]), the expansion tool elastically deforms the holding section radially in the bore (see fig. 14, [0114] sheath removal beams 11.3 splay apart, deflected in the radial outward direction) to a dimension greater than a maximum radial outer diameter of the needle shield (see fig. 15 which shows protective needle shield 5 is shown to have a smaller maximum radial outer diameter than the dimension of the deformed holding section) such that the needle shield can be inserted into the elastically deformed holding section ([0116] “Due to the assembly tool 16 the clearance between the ledges 11.6 on the compliant sheath removal beams 11.3 is wide enough to allow insertion of the protective needle sheath 5”)), and
wherein upon retracting the expansion tool in a distal direction (see fig. 16), the elastic material of the holding section elastically relaxes ([0117] Due to their beam stiffness the sheath removal beams 11.3 relax radially inwards) so as to include an inner diameter matching an outer diameter of the needle shield along a longitudinal axis defined by the needle to thereby envelope and hold the needle shield ([0117] the sheath removal beams 11.3 are moulded in an inward deflected position which ensures they are always in intimate contact with the protective needle sheath 5 once the tool is removed).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the distal end wall of Groetzbach to have the passage of Bunch, and to introduce the expansion tool of Groetzbach through the passage from the proximal direction to the distal direction as taught by Bunch so that the distal end of the expansion tool of G, as modified by Bunch, contacts and deforms the holding section, and to further have the holding section of Groetzbach elastically relax upon removal of the expansion tool of Groetzbach in a distal direction, as further taught by Bunch. One would have been motivated to make the modification because having a passage in the distal end face of the cap allows a user to check on the structural integrity of the internal components of the cap, and ensure that the needle shield is engaged with the needle shield remover, prior to cap removal. Additionally, one would have been motivated to make the modification to have the holding section elastically relax and engage the needle shield upon removal of the expansion tool ensures proper engagement of the needle shield remover and the needle shield at the end of assembly, instead of requiring further deformation during cap removal which would cause more stress over time on the deformed needle shield remover components.
Groetzbach modified by Bunch is silent to the method of manufacture of the cap.
Atterbury, directed to a needle shield puller cap assembly, teaches wherein the needle shield (puller assembly cap 30, fig. 14, [0045]) is manufactured by a multi-component injection molding ([0045] cap 30 is formed of a two shot molding having a central body portion 125 and a gripping periphery 130) of at least two different thermoplastic polymers for the cap (central body portion 125, fig. 14) and the elastic sleeve (gripping periphery 130, fig. 14) ([0045] Body portion 125 is formed of a rigid material such as polycarbonate. Periphery 130 is molded onto body portion 125 out of a softer material, such as a thermoplastic elastomer), and whereby an elastomer is selected for the elastic sleeve ([0045] describes elastic sleeve 130 formed of a thermoplastic elastomer).
Examiner notes that AcmePlastics.com states that “Polycarbonate plastic is a thermoplastic”. Since polycarbonate is a polymer and is inherently a thermoplastic, using polycarbonate and a thermoplastic elastomer as noted by Atterbury above meets the limitation of using at least two different thermoplastic polymers.
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the needle shield remover of Groetzbach modified by Bunch to be explicitly formed by multi-component injection molding as taught by Atterbury, since all three references deal with needle shield removal. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to select the claimed materials for each part, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. (See MPEP 2144.07.) One would have been motivated to make the modification because using multi-shot injection molding would allow for the formation of a needle cap remover with multiple materials bonded to each other for strong construction, each material suited to the specific purpose and form of the structure. Since the elastic sleeve of Groetzbach modified by Bunch must be flexible to deform around the needle shield, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to select a softer, more flexible thermoplastic for the elastic sleeve and to use a stiffer thermoplastic for the cap which need not deform to stretch around the needle shield.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable Bostrom in view of Darras and Doyle.
Regarding claim 17, Bostrom discloses a needle shield remover (protective safety cap 132, fig. 1, [0045]) for a medicament delivery device (medicament delivery device 10, fig. 1, [0039]) comprising a syringe (medicament container 56, fig. 3, [0040] medicament container holder 38 is arranged to accommodate a medicament container 56 that in the embodiment shown is a syringe) with a needle (see 112b interpretation above) (needle 58, fig. 3, [0040] syringe has attached injection needle 58) attached to a distal end of the syringe, the needle covered by a needle shield (medicament delivery member shield 170, fig. 2, [0047]), the needle shield remover (132) comprising:
a cap (generally tubular body 134, fig. 10, [0045]) comprising a side wall (see annotated fig. 11) providing a bore (see fig. 10 and fig. 11 which show a bore between distal passage 136 and central circular passage 144, see annotated fig. 11 where the dotted double arrow shows the bore, see [0045] and [0046]), wherein a proximal section (circumferential ledge 138, [0045]) of the side wall is configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) for attachment to the medicament delivery device (10) ([0045] inner surface of the body 134 of the safety cap 132 may be arranged with a circumferential ledge 138 which functions as a first holding element by interacting with protrusions 140; [0048] ledge 138 retains the safety cap 132 relative to the medicament delivery device 10);
an elastic, tubular sleeve (medicament delivery member guard remover 148, fig. 10, [0046]) positioned in the bore (see fig. 12, [0046] medicament delivery member guard remover 148 will extend into the body 134 of the safety cap 132), wherein the elastic sleeve (148) comprises a holding section (see annotated fig. 14) for holding the needle shield (170), the elastic sleeve (148) comprising a wall (see cylindrical wall forming the elastic sleeve in fig. 10 and 11), the holding section comprising a circular cross-section and a continuous rotational symmetry about a longitudinal axis defined by the needle (see fig. 10 which shows that elastic sleeve 148 has a continuous rotational symmetry since each portion opposed radially from the other side of the elastic sleeve 148 is symmetrical); and
a distal end wall (end wall 142, fig. 10, [0046]) connecting the elastic sleeve (148) to the cap (134) (see fig. 12), wherein a passage (central circular passage 144, fig. 10, [0046]) is provided in the distal end wall ([0046] end wall 142 is arranged with a central circular passage 144) connecting an inner space of the elastic sleeve (148) to an exterior (see fig. 15 which shows an air passage from the exterior of the device through the passage 144 and into the inner space of the elastic sleeve 148),
wherein the elastic sleeve (148) is a cylindrical sleeve (see fig. 10-13 which show that guard remover 148 is a cylindrical sleeve) comprising a flange (ledge 150; figs. 10, 11, and 13; [0046]) that extends radially outward from a distal end of the elastic sleeve ([0046] medicament delivery member guard remover 148 is arranged with an outwardly extending ledge 150) and wherein the flange and the end wall (end wall 142, fig. 10, [0046]) are connected to each other in an overlap area ([0046] ledge 150 is arranged to be seated in a recess 152 in the end wall 142 of the body 134; see fig. 12 which shows the connected configuration; see fig. 12 which shows overlap), and
wherein the holding section extends freely into the bore (see fig. 12 and 13) to a proximal end such that an external surface of the holding section is separated in the bore radially from an internal surface of the side wall of the cap (see radial separation of holding section and internal surface of side wall of cap in fig. 14 above; see also figs. 12 and 13 for a simplified view), and
Bostrom is silent to the elastic sleeve having a wall constructed from an elastic material.
Darras, in the field of a needle shield removal, teaches wherein an elastic sleeve (gripping surface 63, fig. 10, [0057]) comprises a wall (distal portion 63.2 of the gripping surface 63, see fig. 10 and fig. 6 which show gripping surface portion 63.2 as a cylindrical wall) constructed from an elastic material ([0046] gripping surface 63 may be elastomer thermoplastic), and
wherein the elastic sleeve comprises a circular cross-section (see fig. 5a, fig. 6, and fig. 10) and a continuous rotational symmetry about a longitudinal axis defined by the needle (see again figs. 5a, 6, and 10 which show that elastic sleeve 63 has a continuous rotational symmetry since each portion opposed radially from the other side of the elastic sleeve 12 is symmetrical).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to replace the wall of the elastic sleeve of Bostrom with the wall of the elastic sleeve taught by Darras since both deal with needle shield removers and the elastic sleeve in both engages the needle shield. One would have been motivated to make the modification because having the elastic sleeve made of an elastic material which could relax inward when applied around the needle shield would improve the ability of the elastic sleeve to grip the needle shield along the length of the holding section since the elastic sleeve could better conform to the surface of the needle shield and provide a normal force due to being stretched around the needle shield that would increase the friction between the two and thus better help the elastic sleeve grip the needle shield and ensure that the needle shield is also removed when the elastic sleeve is removed. Additionally, since both the needle shield removers of Bostrom and Darras include cylinders which cooperate with the needle shield to facilitate removal in different ways, both types of cooperation between elastic sleeve and needle shield were known to work and allow removal of the needle shield, it would have been an obvious matter to one of ordinary skill in the art to substitute the gripping surface 63 of Darras for the remover 148 of Bostrom, it would have been an obvious matter of simple substitution resulting in predictable results with a reasonable expectation of success (See MPEP 2143(I)(B)).
Bostrom modified by Darras is silent to the relative diameters of the elastic sleeve and needle shield during insertion.
Doyle, in the art of tubing expanders, teaches an elastic sleeve (tubing 30, fig. 3-6, col. 7 ln. 29-45) and a fitting (fitting 286, fig. 5-6, col. 7 ln. 50-61)
wherein prior to insertion of the fitting (Examiner notes that, as previously introduced, the needle shield is only functionally claimed; here “needle shield” is replaced with “fitting” for clarity, as Doyle does not teach a needle shield.), an inner diameter of the holding section along the longitudinal axis is smaller than a maximum radial outer dimension of the fitting (see fig. 3 of Doyle, col. 7 ln. 50-61 “A male portion 284 of a fitting 286, having a larger outside diameter than the inside diameter of the unexpanded tubing 30”),
wherein during insertion of the fitting, the holding section is elastically deformed radially in the bore by an expansion tool (pins 24 and 26, figs. 3-6, col. 7 ln. 29-45) contacting and expanding the elastic material of the holding section to a dimension greater than a maximum radial outer diameter of the fitting (col. 7 ln. 29-45, “the second pin 26 moves away from the first pin 24…the tubing 30 on the pins expands in a substantially diametric manner without localized or sudden stress being sustained by the tubing 30”) (see fig. 5) such that the fitting can be inserted into the elastically deformed holding section (see fig. 5), and
wherein upon insertion of the needle shield, the elastic material of the holding section is deformed such that the inner diameter matches the outer diameter of the needle shield along the longitudinal axis (col. 7 ln. 62-col. 8 ln. 4, “After the male portion of the fitting is received within the expanded tubing, the tubing, because of its resilient nature, will contract back towards its original dimensions, as depicted in FIG. 3. However, as best shown in FIG. 6, because the inserted male portion 284 of the fitting has a greater outside diameter than the inside diameter of unexpanded tubing, the tubing 30 will instead conform about and tightly engage the inserted male portion, providing a tight seal about the connector”).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bostrom as modified by Darras to have the various diameter relationships taught by Doyle, since Bostrom modified by Darras applies an elastic sleeve around a needle shield requiring a good connection between the inner surface of the elastic sleeve and the outer surface of the needle shield. One would have been motivated to make the modification because having the elastic sleeve have a relaxed diameter smaller than the outer diameter of the needle shield ensures that upon application of the elastic sleeve to the needle shield, the elastic sleeve applies plenty of normal force ensuring good frictional cooperation between the two elements which aids in the removal of the needle shield when the needle shield remover and cap are removed from the medicament device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please note all references cited in the previous Non-Final Office Action.
All of the following references deal with similar designs to Bostrom which explicitly discuss how the sleeve and/or protrusions must be flexible in order to function properly: Bruns (US 20210093798 A1), Wang et al (US 20200030547 A1), Newton et al (US 20190201634 A1), Grunhut et al (US 11426531 B2), Holmqvist et al (US 20200282150 A1), Stewart et al (US 20180369495 A1), and Schader et al (US 20160296713 A1).
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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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 02/20/2026