DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/23/2026 has been entered.
Status of the Claims
Claims 11-13 and 15-16 are cancelled. Claims 1, 3, 6, 14, 17, and 18 are currently amended. Claims 1-10, 14, and 17-18 are currently pending. Claims 1-10, 14, and 17-18 are currently rejected.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/23/2026, with respect to the rejection(s) of claim(s) 1 and 17 under 35 USC § 103 have been fully considered, but are not entirely persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of an updated interpretation of Bostrom in view of Darras.
Examiner acknowledges that the amendment to claim 18 overcomes the previous 112(b) rejection.
Applicant argues that “the gripping surface 63 of Darras has a thickness that increases as the gripping surface 63 extends from the Darras proximal end to the Darras distal end where it grips the needle shield 29 as reflected at least in Fig. 10 of Darras”, that “Darras explains ‘a thickness of the distal portion 63.2 may decrease along the length of the inner surface in the proximal direction.’ Darras, para. [0057].”, and notes in the footnote of Remarks pg. 9 that “Darras refers to proximal and distal in the reverse manner compared to Applicant’s definition of proximal and distal.”
The Examiner disagrees with this assertion. Darras fig. 5A and fig. 5B are included below, note that [0045] which describes the proximal/distal arrangement of Darras [0045] “the gripping surface 63 includes a proximal portion 63.1 and a distal portion 63.2.”.
PNG
media_image1.png
270
425
media_image1.png
Greyscale
More particularly, [0047] “proximal end of the distal portion 63.2 along the length of the inner surface may include a ramp feature 63.2.1” See fig. 10 below, which shows that the proximal end of 63.2 is disposed at the “top” of the image (left hand cross-section of 63.2 is shaded to aid identification), establishing that the “proximal” direction points toward non-needle end of the device, and the “distal” direction points toward the needle end of the device.
PNG
media_image2.png
430
323
media_image2.png
Greyscale
Note that [0097] of the instant application describes “distal end wall 9”, and [0085] recites “The elastic sleeve 6 includes an opening 6c located at the proximal end 6a of the elastic sleeve 6.” which as shown in fig. 1 of the instant application below, establishes the interpretation of “distal” and “proximal” directions in the instant application to be the same as that used by Darras. Instant application [0083] further confirms this interpretation, stating “The distal direction in an infusion device represents the direction in which the medicament flows towards the insertion needle. The proximal direction or end is opposite to the distal direction or end.”
PNG
media_image3.png
283
506
media_image3.png
Greyscale
As such, Darras [0057], which recites that “a thickness of the distal portion 63.2 may decrease along the length of the inner surface in the proximal direction”, does actually meet the newly added limitation of “wherein a thickness of the wall varies between the entrance section and the holding section, and wherein the wall thickness of the entrance section is greater than the wall thickness of the holding section” which appears in both amended independent claims 1 and 17. See the 103 rejections of claims 1 and 17 below.
The Applicant notes on Remarks pg. 9 that “Applicant respectfully disagrees with the Examiner’s characterization of Darras, but even if correct, which the Applicant does not concede…”, however, other than the incorrect assertion that Darras includes the opposite distal/proximal thickness relationship, the Applicant fails to point out any particular issues with the Examiner’s characterization of Darras.
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, 3-7, and 18 are rejected under 35 U.S.C. 103 as obvious over Bostrom (US 20210220564 A1) in view of Darras (US 20160310676 A1) or, in the first alternative, under 35 U.S.C. 103 as obvious over Bostrom in view of Darras and further 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 and further in view of 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);
PNG
media_image4.png
506
785
media_image4.png
Greyscale
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 an entrance section and a holding section (see both sections indicated in 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
PNG
media_image5.png
432
677
media_image5.png
Greyscale
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 entrance section is positioned between the distal end wall and the holding section (see annotated fig. 14 above which shows entrance section between holding section and distal end wall; note that [0046] describes the flange/ledge 150 seated in a recess 153 of end wall 142, seen in fig. 10, and that the entrance section is arranged between the flange/ledge 150 and the holding section, and thus between the distal end wall and the holding section),
wherein the entrance section and the holding section extend 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.).
Bostrom is silent to wherein a thickness of the wall varies between the entrance section and the holding section, and wherein the wall thickness of the entrance section is greater than the wall thickness of the holding section.
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),
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), and
PNG
media_image6.png
430
392
media_image6.png
Greyscale
wherein a thickness of the wall varies between the entrance section (see annotated fig. 10) and the holding section (see annotated fig. 10; noted [0047] describes the proximal end of the distal portion ending in ramp feature 63.2.1, establishing the proximal/distal relationship noted in annotated fig. 10), and wherein the wall thickness of the entrance section is greater than the wall thickness of the holding section ([0047] a thickness of the distal portion 63.2 may decrease along the length of the inner surface in the proximal direction.)
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. Furthermore, as noted by Darras in reference to the ramp feature 63.2.1 of the distal portion 63.2, having the proximal portion (holding section) of the elastic sleeve be less thick than the distal portion (entrance section) may better facilitate the insertion of the needle shield into the elastic sleeve by guiding the needle shield into the elastic sleeve. 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)).
In the second alternative regarding claim 1, Bostrom as modified discloses all limitations as described in the first alternative, except that Bostrom modified by Darras is silent to the functional limitations following “such that” noted 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
PNG
media_image7.png
284
555
media_image7.png
Greyscale
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.”).
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 modified by Darras to have the various diameter relationships noted above, since Holmqvist is also directed to a needle shield remover. 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.
In the third alternative regarding claim 1, Bostrom as modified discloses all limitations as described in the first alternative, except that Bostrom modified by Darras is silent to the functional limitations following “such that” noted above.
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 3, Bostrom as modified in any alternative discloses the needle shield remover according to claim 1, as described above, including (references to Darras) wherein the wall thickness of the entrance section (see wall thickness in annotated fig. 10 of Darras above) is greater than a wall thickness of the flange (see thinner wall thickness of flange noted in fig. 10 of Darras 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.
PNG
media_image5.png
432
677
media_image5.png
Greyscale
Bostrom further discloses wherein the entrance section (see annotated fig. 14 above) is 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 entrance section of the elastic sleeve 148 meets the functional limitation), the entrance section positioned between the holding section and the flange (150, fig. 10) (see annotated fig. 14 above which shows the entrance section positioned between the holding section and the flange).
Regarding claim 7, Bostrom as 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 as modified in any alternative discloses the needle shield remover according to claim 1, as described above, including wherein radial forces act on the needle shield by the holding section (Examiner notes that in all alternative rejections the holding section necessarily surround and contacts the needle shield, thereby applying radial forces.).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bostrom as modified 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 discloses the needle shield remover according to claim 1, as described above.
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 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 as modified 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 as modified 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.
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, 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 included pdf for citations).
Regarding claim 9, Bostrom as modified discloses the needle shield remover according to claim 8, as described above, including wherein the elastic sleeve is made from a thermoplastic elastomer (Darras: [0046] gripping surface 63 may be elastomer thermoplastic).
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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bostrom as modified and as applied to claim 1 above, or alternatively further in view of Holmqvist, or alternatively further in view of Bunch (US 20170014578 A1; hereafter Bunch).
Regarding claim 14, Bostrom as modified discloses the needle shield remover according to claim 1, as described above. Bostrom further teaches wherein the needle shield is a rigid needle shield (170, fig. 2, [0047] medicament delivery member shield 170 may be a rigid needle shield) having a stiffness greater than a stiffness of the holding section of the elastic sleeve (medicament delivery member guard remover 148, fig. 10) (Examiner notes that the elastic sleeve 148 must be made of an elastic material, instead of being rigid like the needle shield 170, as described in the first alternative 103 rejection above. As such, the rigid needle shield 170, being rigid, must have a greater stiffness than the elastic sleeve 148, being elastic.).
Alternatively, Bostrom as modified wherein the needle shield is a rigid needle shield having a stiffness greater than a stiffness of the holding section of the elastic sleeve.
Holmqvist, in the art of needle shield removal, teaches wherein the needle shield is a rigid needle shield (rigid needle shield 52, fig. 5a, [0056]) having a stiffness greater than a stiffness of the holding section of the elastic sleeve (remover body 12, fig. 5a, [0051] “Preferably the remover body comprises a first 18 and a second 24 set of gripping members, FIG. 1”) ([0056] “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, and thereafter slide along the outer surface of the rigid needle shield”). (Examiner notes that since the rigid needle shield is “rigid”, and the remover body flexes, then the stiffness of the rigid needle shield must be greater than the flexible remover body.)
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 modified by Darras to have the various diameter relationships noted above, since Holmqvist is also directed to a needle shield remover. 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.
Alternatively, Bostrom as modified wherein the needle shield is a rigid needle shield having a stiffness greater than a stiffness of the holding section of the elastic sleeve.
Bunch, in the art of needle shield removal, 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 modify the device of Bostrom as modified to include this relative stiffness as taught by Bunch since the device 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 does not require elastic behavior 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 as being able to flexibly deform to surround a needle shield with a wider diameter than a relaxed diameter of the elastic sleeve, and the elastic sleeve conforming to the shape of the needle shield once the needle shield is inserted into the elastic sleeve.
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 an entrance section (see annotated fig. 14) for receiving an expansion tool (Examiner notes that “for receiving an expansion tool” is a functional limitation. Since a user could insert an expansion tool into the entrance section, the entrance section meets this functional limitation.) and 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
PNG
media_image5.png
432
677
media_image5.png
Greyscale
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 entrance section is positioned between the flange and the distal end wall and the holding section (see annotated fig. 14 above which shows entrance section between holding section and distal end wall; note that [0046] describes the flange/ledge 150 seated in a recess 153 of end wall 142, seen in fig. 10, and that the entrance section is arranged between the flange/ledge 150 and the holding section, and thus between the distal end wall and the holding section),
wherein the entrance section and the holding section extend 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), and
PNG
media_image8.png
430
392
media_image8.png
Greyscale
wherein a thickness of the wall varies between the entrance section (see annotated fig. 10) and the holding section (see annotated fig. 10; noted [0047] describes the proximal end of the distal portion ending in ramp feature 63.2.1, establishing the proximal/distal relationship noted in annotated fig. 10), and wherein the wall thickness of the entrance section is greater than the wall thickness of the holding section ([0047] a thickness of the distal portion 63.2 may decrease along the length of the inner surface in the proximal direction.)
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. Furthermore, as noted by Darras in reference to the ramp feature 63.2.1 of the distal portion 63.2, having the proximal portion (holding section) of the elastic sleeve be less thick than the distal portion (entrance section) may better facilitate the insertion of the needle shield into the elastic sleeve by guiding the needle shield into the elastic sleeve. 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.
Lambert (US 20040016564 A1) - thicker portion at ends of a crushable support tube help to keep entire tube shape, see fig. 3, [0007], [0034], and [0049]; [0034] Increasing the cross sectional diameter of the end rings 36, 38 makes them stronger to provide uniform strength and support characteristics along the length of the crushable support core 30.
Taylor (US 20210361903 A1) - tubing connector with thickened end portions to resist radial deformation, see [0043]-[0044] and fig. 5a-c
Carlson (US 20150276097 A1) - tubes having thicker end portions helps avoid deformation over time, see fig. 1a, [0008], and [0044]
Dickson (US 20230233248 A1) - thickened end for reducing the likelihood of tubing rupture, see [0039], figs. 2 and 3
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 08/25/2026
Prosecution Insights