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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed 09/27/2023 has/have been considered by the Examiner.
Status of the Claims
Claims 16-30 are currently pending. Claims 16-30 are currently rejected.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "21" and "22" have both been used to designate “the proximal end of the needle” and “the distal end of the needle” (see for example instant specification pg. 4 ln. 20-23 and pg. 5 ln. 9-12). Additionally, reference character “13” appears to have been used to designate two areas in fig. 10. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “21” and reference character “22” have been used to designate both “the proximal end of the needle” and “the distal end of the needle” (see for example instant specification pg. 4 ln. 20-23 and pg. 5 ln. 9-12). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
A substitute specification excluding the claims is required pursuant to 37 CFR 1.125(a) because the numerous errors noted above regarding the use of reference numbers 21/22 to refer to both the proximal/distal ends of the needle render the specification as written confusing. As these conflicting references occur repeatedly throughout the specification, a substitute specification is required to render the application clear.
A substitute specification must not contain new matter. The substitute specification must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. An accompanying clean version (without markings) and a statement that the substitute specification contains no new matter must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
Claim Objections
Claims 16 and 27 are objected to because of the following informalities:
Claim 16 line 11 reads “after removal of the pen injector to the hub”. It appears that this phase should read “after removal of the pen injector [[to]] from the hub”.
Claim 27 lines 1-2 reads “an hollow body”. This should read “a hollow body”.
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.
Claims 16-30 are 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 16, the independent claim, begins “Safety needle device”. This should read “A safety needle device” in order to properly introduce the device. Furthermore, dependent claims 17-30 currently begin “Safety needle device according to”. Each dependent claim should instead begin with “The safety needle device according to” in order to properly reflect the antecedent basis of the “safety needle device” introduced in claim 16. For the purposes of examination, independent claim is interpreted to begin with “A safety needle device” and each dependent claim is interpreted to begin with “The safety needle device”.
Claim 17 recites the limitation "from initial position" in line 7. Due to the lack of preceding article, it is unclear whether this “initial position” refers to the “initial position” introduced in claim 16, from which claim 17 depends, or is meant to introduce a new, different initial position tied to a different structure/situation. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 18 recites the limitation “the longitudinal axis” on line 4 and 7. There is insufficient antecedent basis for this limitation in the claim. Claim 16, from which claim 18 depends, introduces “a longitudinal direction”, but makes no mention of an axis. It is unclear whether “the longitudinal axis” in claim 18 is meant to refer back to “the longitudinal direction” of claim 16, or is meant to newly introduce “a longitudinal axis”. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 18 recites “the first guiding element” in lines 2 and 5. There is insufficient antecedent basis for this limitation in the claim. Claim 16, from which these claims depend, introduces “a first guide element” in line 20. It is unclear whether the “first guiding element” is meant to introduce a new element, in which case the article should be changed to “a”, or refer back to the “first guide element” previously introduced, in which case the naming convention should be altered to maintain consistency throughout the claims. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 20 recites “the first guiding element” in line 1, and “the second guiding element in lines 1-2. There is insufficient antecedent basis for these limitations in the claim. Claim 16, from which these claims depend, introduces “a first guide element” in line 20 and “a second guide element” in line 21. It is unclear whether the “first/second guiding element” is meant to introduce a new element, in which case the article should be changed to “a”, or refer back to the “first/second guide element” previously introduced, in which case the naming convention should be altered to maintain consistency throughout the claims. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 22 line 4 reads “a second portion of needle”. The term “needle” lacks an article, and thus fails to establish proper antecedent basis in relation to the previously introduced “needle” introduced in the independent claim. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the same structure earlier introduced (in which case the article “the” should be added). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 23 recites the limitation “first guiding element” without an article in line 1. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the “first guide element” earlier introduced (in which case the article “the” should be added and the naming conventions altered to maintain consistency throughout the claims). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 23 recites the limitation “the first stopping area and the second stopping area”. These limitations lack antecedent basis in the claim. Claim 23 depends from claim 19, not claim 20, and the first/second stopping area are not introduced until claim 20. It is unclear whether claim 23 was meant to depend from claim 20 instead of claim 19 (in which case the dependency must be altered), or whether claim 23 was meant to independently introduce the first/second stopping area (first/second stopping area should be preceded by “a” instead of “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 24 recites the limitation “the first guiding element” in line 1. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the “first guide element” earlier introduced (in which case the naming conventions altered to maintain consistency throughout the claims). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 24 recites the limitation “the longitudinal axis” on line 4 and 7. There is insufficient antecedent basis for this limitation in the claim. Claim 16, from which claim 24 depends, introduces “a longitudinal direction”, but makes no mention of an axis. It is unclear whether “the longitudinal axis” in claim 24 is meant to refer back to “the longitudinal direction” of claim 16, or is meant to newly introduce “a longitudinal axis”. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 25 recites the limitation “longitudinal axis” without an article in line 3. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the “longitudinal direction” earlier introduced (in which case the article “the” should be added and the naming conventions altered to maintain consistency throughout the claims). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 26 recites the limitation “opposed outer surface” on line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation is interpreted to read “an opposed outer surface”.
Claim 26 recites the limitation “the protrusions” on line 4. There is insufficient antecedent basis for multiple protrusions in the claim. Claim 16 introduces a single protrusion. It is unclear whether the protrusions in claim 26 is meant to refer back to the single “protrusion” of claim 16, introduce two separate protrusions, or further establish a second protrusion identical to the first protrusion. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 26 recites the limitation “the longitudinal axis” in line 6. There is insufficient antecedent basis for this limitation in the claim. Claim 16, from which claim 26 depends, introduces “a longitudinal direction”, but makes no mention of an axis. It is unclear whether “the longitudinal axis” in claim 26 is meant to refer back to “the longitudinal direction” of claim 16, or is meant to newly introduce “a longitudinal axis”. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 26 includes a period on both lines 4 and 6, making it unclear where the claim is supposed to end. Furthermore, there is no conjunction (and/or) between the last bullet and the penultimate bullet, making it unclear whether the listed bulleted limitations are written in the alternative (and thus “or” should be placed between the last two bullets) or are supposed to all be present together (and thus “and” should be placed between the last two bullets). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 27 recites the limitation “locking position” on line 6. It is unclear whether this limitation is meant to refer back to the previously introduced “locking position” (in which case it should be preceded by “the”), or introduce a different locking position (in which case the naming convention should be altered). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 27 recites the limitation “the longitudinal axis” in line 7. There is insufficient antecedent basis for this limitation in the claim. Claim 16, from which this claim depends, introduces “a longitudinal direction”, but makes no mention of an axis. It is unclear whether “the longitudinal axis” in this claim is meant to refer back to “the longitudinal direction” of claim 16, or is meant to newly introduce “a longitudinal axis”. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 27 recites the limitation “a lateral wall” in line 7. It is unclear whether the instance of this limitation in the dependent claim is meant to introduce a new structure (in which case the naming convention should be altered to distinguish the structures) or refer back to the same structure earlier introduced (in which case the article should be changed to “the”). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 28 recites the limitation “the outer surface of the back-end shield”. It is unclear whether this limitation refers back to the “outer surface” of the “retaining wall” of the hollow body” of the “back-end shield”, or refers to a different portion of the back-end shield. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 30 recites the limitations “two symmetric guides tracks” and “two symmetric protrusions” in lines 2 and 6 respectively. It is unclear whether these limitations are meant to refer back to and include the previously introduced guide track and protrusion introduced in claim 16, or introduce a separate pair of guide tracks and protrusions. Furthermore, “two symmetric guides tracks” should read “two symmetric guide[[s]] tracks” if this limitation is mean to include the previously introduced guide track. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 30 recites the limitation “the annular portion” in the last line. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation is interpreted to read “an annular portion”.
Claims 16-18, 20-24, 26-27, and 29-30 lack any conjunction (and/or) between the last bullet and the penultimate bullet, making it unclear whether the listed bulleted limitations are written in the alternative (in which case “or” should be placed between the last two bullets) or are supposed to all be present together (in which case “and” should be placed between the last two bullets). For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claims 17-30 are rejected for being dependent upon a claim rejected under 112b, since dependent claims inherit the deficiencies of the claims on which they depend.
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) 16-17, 20, 25, and 27-29 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by Hu (US-20200360624-A1; hereafter Hu) or, in the alternative, under 35 U.S.C. 103 as obvious over Hu in view of Pedersen et al (WO-2019238806-A1; hereafter Pedersen). Text reference is made to the copy of Pedersen included in the Office Action.
Regarding claim 16, Hu discloses safety needle device (see 112b interpretation above) comprising:
- a hub (hub 10, fig. 2, [0038]) configured to be connected to a pen-injector ([0038] As shown in FIG. 1 and FIG. 2, a safe insulin pen needle of this embodiment includes at least a needle hub 10), the hub comprising a lateral wall and an upper wall which define therebetween a cavity extending between the upper wall and a lower aperture able to receive the pen injector (see annotated fig. 2 below);
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- a needle (needle tube 11, fig. 2, [0038]) attached to the hub ([0038] A needle tube 11 is mounted in the needle hub 10), the needle extending along a longitudinal direction between a distal end, configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) for insertion into a patient, and an opposed 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 connected to the pen injector (see fig. 2 above),
- a back-end shield (needle tail protector 50, fig. 2, [0049]) slidable along the longitudinal direction within the cavity of the hub and rotatable about the longitudinal direction ([0049] a second clamping column 54 and a second guide groove 42 which are mutually matched are disposed between the protective sleeve and the needle tail protector; see fig. 4 which includes rotational section 421 and longitudinally extending section 422), the back-end shield being movable irreversibly from an initial position, before connection of the pen injector to the hub, to a locking position, after removal of the pen injector to the hub passing through an intermediate position ([0051] In the structure of this embodiment, the needle tail protector is triggered during the screw-in connection of the insulin pen and the insulin pen needle, and a second spring is in a state of compression and energy storage, during the separation of the insulin pen from the insulin pen needle after the insulin injection is completed, the needle tail protector moves axially relative to the needle hub and completely covers the needle tail under the action of the spring force of the second spring and the guiding action of the second clamping column and the second trigger guide section. The technical problem that the needle tail portion may damage the user is effectively solved by disposing a needle tail protector with the same trigger mechanism as the needle head protector at the needle tail.),
- an elastic member (spring 60, fig. 2, [0049]) arranged within the cavity and acting between the upper wall (see annotated fig. 2) and the back-end shield (50) (see fig. 2) to urge the back-end shield towards the proximal end of the needle along the longitudinal direction (see [0051] “a second spring is in a state of compression and energy storage, during the separation of the insulin pen from the insulin pen needle after the insulin injection is completed, the needle tail protector moves axially relative to the needle hub and completely covers the needle tail under the action of the spring force of the second spring”),
- a locking arrangement comprising at least a first locking member (clamping column 54, fig. 4, [0049]) formed on the back- end shield (50) and at least a second locking member (protective sleeve 40, fig. 4, [0049]), the second locking member cooperating with the first locking member to guide the back-end shield from the initial position to the locking position ([0049] a second clamping column 54 and a second guide groove 42 which are mutually matched are disposed between the protective sleeve and the needle tail protector. The second guide groove 42 includes a second initial fixing section 421 and a second axially extending trigger guide section 422) and to lock the back-end shield in the locking position ([0052] one side of the second initial fixing position 51 is provided with a second check flange 52 for preventing the second clamping column from entering the second initial fixing section when the second clamping column is located in the second trigger guide section.), wherein
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- the second locking member comprises a first guide element (portion of second guide element 40 above the dotted line in modified fig. 4 detail above) formed on the lateral wall of the hub (see fig. 2, second locking member is against the lateral wall of the hub, so the first guide element is formed on the lateral wall of the hub) and a second guide element (portion of second guide element 40 below the dotted line in modified fig. 4 detail above) attached to the lateral wall inside the cavity (see fig. 2, second locking member is against the lateral wall of the hub, so the second guide element is attached to the lateral wall of the hub) at an intermediate aperture defined between the upper wall and the lower aperture (see fig. 2, intermediate aperture is any aperture between the upper and lower aperture, thus an intermediate aperture is present where second locking member 40 lies within the hub), the first guide element and the second guide element defining a guide track inside the cavity (see fig. 4 and [0051]);
- the first locking member (50) comprises a protrusion (54 is a protrusion, see fig. 4) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to engage the first guide element and the second guide element (see [0051]) to slide along the guide track (see [0051] and fig. 4).
Alternatively, Hu is silent to the second locking member comprises a first guide element formed on the lateral wall of the hub and a second guide element attached to the lateral wall inside the cavity, the first guide element and the second guide element defining a guide track inside the cavity.
Pedersen, in the art of injection devices with needle shields, teaches wherein a second locking member comprises a first guide element (second sloped edge 22, fig. 3, pg. 16/45 ln. 6-9) formed on the lateral wall of the hub (hub includes base part 10 and cartridge holder 20, fig. 3, pg. 14/45 ln. 30-34) and a second guide element (initiator 30 including first sloped edge 35, fig. 3, pg. 14/45 ln. 30-34, pg. 16/45 ln. 6-9) attached to the lateral wall inside the cavity (pg. 15/45 ln. 32-34, “The initiator part 30 is provided with an axial indentation 33 which engages a similar axially raised portion 21 provided on the cartridge holder part 20 such that the cartridge holder part 20 is axially and rotationally fixed to the initiator part 30 and thus to the base part 10”) the first guide element and the second guide element defining a guide track inside the cavity (pg. 16/45 ln. 6-9 “helical track 45 thus continues between the first sloped edge 35 and the second sloped edge 22”), and
the first locking member (needle shield 50, fig. 3, pg. 19/45 ln. 6-14) comprises a protrusion (protrusion 52, fig. 3, pg. 19/45 ln. 6-14) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to engage the first guide element and the second guide element to slide along the guide track (pg. 19/45 ln. 6-14 “the protrusion 52 on the needle shield 50 is located in the start of the helical track 45 on the intermediate part 30”).
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 second locking member of Hu to include the first guide element formed on a lateral wall of the hub and second guide element being attached to the lateral wall, as taught by Pedersen, since both references deal with guiding tracks for protrusions formed on a needle shield. One would have been motivated to make the modification because having the guide track formed of two pieces which can be connected, as taught by Pedersen, better facilitates assembly of the device and fixing of the needle shield protrusions in the guide track, since there is no need to deform the protrusion or otherwise slip the protrusion through a concentric sleeve, the protrusion may more securely be locked into the guiding track. See also MPEP 2144.04 (V-C), which notes that constructing a formerly integral structure in various elements involves only routine skill in the art, and MPEP 2144.04 (V-B), which notes that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art.
Regarding claim 17, Hu, or alternatively Hu modified by Pedersen, discloses safety needle device according to claim 16 as described above. Hu further discloses wherein the second guide element comprises:
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- an annular portion (see annular portion of second locking member 40 in fig. 4, shown in the bottom right quadrant above) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to engage the lateral wall at the intermediate aperture (see fig. 2 which shows engagement of second locking member 40 and lateral wall of hub 10) and defining a passing through channel (see hollow portion of member 40 above) to allow the sliding of the back-end shield (50) along the longitudinal direction ([0050] a second clamping column 54 and a second guide groove 42 which are mutually matched are disposed between the protective sleeve 40 and the needle tail protector 50);
- a guiding wing (see guiding wing in the bottom left quadrant in modified fig. 4 above which forms the second initial fixing section 421) projecting from the annular portion towards the distal end inside the cavity and configured to engage the protrusion (54) and guide it from initial position (see 112b interpretation above) to the locking position ([0050] a second clamping column 54 and a second guide groove 42 which are mutually matched are disposed between the protective sleeve 40 and the needle tail protector 50) ([0050] after the insulin injection is completed, the needle tail protector moves axially relative to the needle hub and completely covers the needle tail under the action of the spring force of the second spring and the guiding action of the second clamping column and the second trigger guide section).
Regarding claim 20, Hu or Hu modified by Pedersen discloses the safety needle device according to claim 16, as described above. Hu further discloses wherein the first guiding element and the second guiding element (see 112b interpretation above) define:
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- a first stopping area (see annotated fig. 4.2 detail above) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to engage the protrusion (54, fig. 4) in the initial position of the back-end shield to prevent longitudinal sliding of the back-end shield towards the proximal end of the needle (see modified detail fig. 4.2 above);
- a second stopping area (see modified detail fig. 4.2 above) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to engage the protrusion (54, fig. 4) in the locking position of the back-end shield to prevent longitudinal sliding of the back-end shield both towards the distal end and the proximal end of the needle ([0052] the needle tail protector moves axially relative to the needle hub and completely covers the needle tail under the action of the spring force of the second spring and the guiding action of the second clamping column and the second trigger guide section).
Regarding claim 25, Hu or Hu modified by Pedersen discloses the safety needle device according to claim 16, as described above. Hu further discloses wherein the first guiding element (see 112b interpretation above) comprises:
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- a linear guiding portion (second axially extending trigger guide section 422, fig. 4, [0049]) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to engage the protrusion (second clamping column 54, fig. 4, [0049]) and guide the back-end shield along longitudinal axis (see 112b interpretation above) preventing rotation of the back-end shield (needle tail protector 50, fig. 4, [0049]) from the initial position towards the intermediate position and from the intermediate position towards the locking position (see fig. 4 which shows axially extending portion of the first guiding element; see [0051] which describes movement of needle tail protector 50).
Regarding claim 27, Hu, or Hu modified by Pedersen, teaches the safety needle device according to claim 16, as described above. Hu further discloses wherein the back-end shield comprises:
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an hollow body (see fig. 2 which shows that back-end shield 50 is hollow) extending between a distal portion facing to the upper wall of the hub and a proximal portion facing to the lower aperture of the hub (see fig. 2), the hollow body comprising:
- a lower wall (see fig. 2 above) formed proximal to the distal portion and having an opening (see gap in lower wall shown in fig. 2 above) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to allow a portion of the needle and the proximal end of the needle (11) to pass upon moving of the back-end shield (50) between the initial position and locking position (see that needle 11 would fit through opening as seen in fig. 2 above);
- a lateral wall (see 112b interpretation above) (see annotated fig. 2 above) extending from the lower wall along the longitudinal axis (see 112b interpretation above) and defining a passing through channel (channel formed between opposing sides of lateral wall as seen in fig. 2 above) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to house at least partially the needle (see fig. 2 above, proximal portion of needle 11 lies within passing through channel formed by lateral wall as noted);
- a retaining wall (see annotated fig. 2 above) extending along the longitudinal direction from the lower wall towards the distal end of the needle and surrounding a portion of the lateral wall (see fig. 2 above which shows retaining wall surrounds lateral wall).
Regarding claim 28, Hu, or Hu modified by Pedersen, discloses the safety needle device according to claim 27, as described above.
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Hu further discloses wherein the retaining wall (see Hu modified fig. 2.2 in rejection of claim 27 above) has an inner surface (see modified fig. 2.3 above) facing the surrounded portion of the lateral wall and an outer surface facing to the cavity of the hub (10) and the protrusions are formed on the outer surface of the back-end shield (see 112b interpretation above) (50) (see Hu modified fig. 2.3 above).
Regarding claim 29, Hu, or Hu modified by Pedersen, discloses the safety needle device according to claim 27, as described above. Hu further discloses wherein:
- the elastic member (60, fig. 2) is interposed between the upper wall (see Hu modified fig. 2.1) of the hub (10) and the lower wall (see Hu modified fig. 2.3) of the back-end shield (50);
- the elastic member (60) surrounds at least partially the needle (11) passing inside the cavity of the hub (10) (see fig. 2).
Claim(s) 21-22 are rejected under 35 U.S.C. 103 as obvious over Hu, or alternatively over Hu in view of Pedersen.
Regarding claim 21, Hu or Hu modified by Pedersen discloses the safety needle device according to claim 20, as described above. Hu further discloses wherein:
- the first stopping area and the second stopping area are arranged proximal to the intermediate aperture (note that the intermediate aperture is any aperture between the lower aperture and upper wall, so encompasses all of the first and second guide elements; see fig. 2), and
- the back-end shield (50, fig. 2) in the locking position covers the proximal end of the needle (see fig. 2 which shows that the back-end shield 50 covers the proximal end of the needle; note [0052] which describes the covering of the proximal end of the needle).
Hu or Hu modified by Pedersen teaches all the limitations except:
- the back-end shield in the initial position covers the proximal end of the needle;
- the back-end shield in the intermediate position leaves uncovered a first portion of the needle arranged inside the cavity and the proximal end of the needle.
These limitations represent only a change in shape of the guide track, which determines the relative position of the back-end shield and the needle during use of the device. It would thus have been an obvious matter of changing the shape, which has been held to be a matter of choice obvious to one of ordinary skill in the art. See MPEP 2144.04 (IV-B). The modified device could still perform the function of uncovering the proximal end of the needle for insertion into the patient, and subsequent recovering of the proximal end of the needle for avoiding accidental needle sticks after use of the device. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Regarding claim 22, Hu or Hu modified by Pedersen discloses the safety needle device according to claim 20, as described above. Hu further discloses wherein:
- the first stopping area is arranged towards the distal end of the needle and the second stopping area is arranged towards the proximal end of the needle (see modified fig. 4.2 detail above, note that first stopping area is on the distal side of the second stopping area);
- the back-end shield (50, fig. 2) in the locking position covers the proximal end of the needle (see fig. 2 which shows that the back-end shield 50 covers the proximal end of the needle; note [0052] which describes the covering of the proximal end of the needle).
Hu or Hu modified by Pedersen teaches all the limitations except:
- the back-end shield in the initial position leaves uncovered a second portion of needle (see 112b interpretation above) arranged inside the cavity and the proximal end of the needle;
- the back-end shield in the intermediate position leaves uncovered a first portion of the needle arranged inside the cavity and the proximal end of the needle, the second portion being shorter than the first portion.
These limitations represent only a change in shape of the guide track, which determines the relative position of the back-end shield and the needle during use of the device. It would thus have been an obvious matter of changing the shape, which has been held to be a matter of choice obvious to one of ordinary skill in the art. See MPEP 2144.04 (IV-B). The modified device could still perform the function of uncovering the proximal end of the needle for insertion into the patient, and subsequent recovering of the proximal end of the needle for avoiding accidental needle sticks after use of the device. Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation.
Claim(s) 18 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hu or Hu modified by Pedersen as applied to claims 16 or 17 above, and further in view of Cross et al (US-20130046246-A1; hereafter Cross).
Regarding claim 18, Hu, or alternatively Hu modified by Pedersen, discloses safety needle device according to claim 17 as described above. Hu further discloses wherein the guiding wing comprises a first wing rotating portion (see rotationally slanted portion of guiding wing noted in Hu modified fig. 4 included again below) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to cooperate with the first guiding element (see 112b interpretation above) (see Hu modified fig. 4) to guide and to rotate the back-end shield (50, fig. 2) upon sliding of the back-end shield along the longitudinal axis (see 112b interpretation above) from the initial position towards the intermediate position ([0055] describes the rotation from the initial position toward the intermediate position, and how the protrusion 54 is prevented from reentering the second initial fixing section after the moving to the axially extending portion of the guide track).
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Hu is silent to the guiding wing comprising a second wing rotating portion.
Cross, in the art of a needle shield with a guide track, teaches wherein a guiding wing (see modified fig. 8) comprises:
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- a first wing rotating portion (see annotated fig. 8) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to cooperate with the first guiding element (see 112b interpretation above) (portion below the dotted line in modified fig. 8; note that together with the second guiding element above the dotted line this forms a guide track) to guide and to rotate the back-end shield upon sliding of the back-end shield along the longitudinal axis (see 112b interpretation above) from the initial position (protrusion 11 first follows path 14, then path 15, then path 16, see fig. 7 and [0062]) towards the intermediate position (see dotted path in fig. 7 below);
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- a second wing rotating portion (see annotated fig. 8) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to cooperate with the first guiding element (see 112b interpretation above) (portion below dotted line in modified fig. 8; note that together with the second guiding element above the dotted line this forms a guide track) to guide and rotate the back-end shield upon sliding of the back-end shield along the longitudinal axis (see 112b interpretation above) from the intermediate position towards the locking position (see dashed path in fig. 7 above and [0062]).
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 guiding wing of Hu or Hu modified by Pedersen to include both first and second wing rotating portions as taught by Cross, since cross also deals with guiding a needle shield. One would have been motivated to make the modification because having the rotational component to the motion both between the initial and intermediate positions and between the intermediate and locking position helps to ensure that no backward rotation occurs, and that the transition between each position is gradual and thus less likely to damage the device as the rotation occurs.
Regarding claim 24, Hu or Hu modified by Pedersen discloses the safety needle device according to claim 16, as described above.
Hu further teaches the first guiding element (see 112b interpretation above) comprising - a first rotation portion (see slanted upper surface of slot 421 as seen in fig. 4) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to engage the protrusion and cooperating with the second guiding element (see 112b interpretation above) to rotate the back-end shield upon sliding of back-end shield along the longitudinal axis (see 112b interpretation above) from the initial position towards the intermediate position ([0055] describes the rotation from the initial position toward the intermediate position, and how the protrusion 54 is prevented from reentering the second initial fixing section after the moving to the axially extending portion of the guide track).
Hu is silent to wherein the first guiding element (see 112b interpretation above) comprises:
- a second rotation portion configured to engage the protrusion and cooperating with the second guiding element (see 112b interpretation above) to rotate the back-end shield upon sliding of the back-end shield along the longitudinal axis (see 112b interpretation above) from the intermediate position towards the locking position.
Cross, in the art of guide tracks, teaches wherein the first guiding element (see 112b interpretation above) comprises:
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- a second rotation portion (see second rotation portion above) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to engage the protrusion and cooperating with the second guiding element (see 112b interpretation above) to rotate the back-end shield upon sliding of the back-end shield along the longitudinal axis (see 112b interpretation above) from the intermediate position towards the locking position (protrusion 11 first follows path 14, then path 15, then path 16, see fig. 7 and [0062]).
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 guiding wing of Hu or Hu modified by Pedersen to include both first and second rotation portions as taught by Cross, since Cross also deals with guiding a needle shield. One would have been motivated to make the modification because having the rotational component to the motion both between the initial and intermediate positions and between the intermediate and locking position helps to ensure that no backward rotation occurs, and that the transition between each position is gradual and thus less likely to damage the device as the rotation occurs.
Claim(s) 19, 23, 26, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hu or Hu modified by Pedersen as applied to claims 16 or 17 above, and further in view of Pedersen.
Regarding claim 19, Hu, or alternatively Hu modified by Pedersen, discloses the safety needle device according to claim 17, as described above.
Hu is silent to wherein the annular portion has retaining members configured to engage with the lateral wall at the intermediate aperture.
Pedersen further teaches wherein the annular portion (see gray highlighted portion of second guide element 30 below) has retaining members (protrusions 31 and 32, fig. 3, pg. 15/45 ln. 21-26) configured to engage with the lateral wall (longitudinally extending wall of hub/base part 10) at the intermediate aperture (see openings 12 and 13 which occur at an intermediate aperture in hub 10) (pg. 15/45 ln. 21-26, “initiator 30 is on the outer surface provided with a number of protrusions 31 , 32 which engages a similar number of openings 12, 13 provided in the base part 10. The respective protrusions 31 , 32 and the respective openings 12, 13 are rotationally spaced from each other such that, once clicked together, the initiator part 30 is axially and rotational locked to the base part 10”)
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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 Hu or Hu modified by Pedersen to include the retaining members taught by Pedersen since both references deal with guiding tracks for needle shields. One would have been motivated to make the modification because the protrusions and cooperative openings taught by Pedersen allow the two components of the second guide member to be securely linked, ensuring that the protrusion does not escape from the guide track during use.
Regarding claim 23, Hu modified by Pedersen discloses the safety needle device according to claim 19, as described above. Hu further discloses wherein first guiding element (see 112b interpretation above) defines:
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- a third stopping area (see fig. 4.2 detail above) configured (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) to engage the protrusion (54, fig. 4) in the intermediate position to prevent longitudinal sliding of the back-end shield towards the distal end of the needle ([0051] describes intermediate position);
- the third stopping area being spaced apart from the first stopping area and the second stopping area (see 112b interpretation above) along the longitudinal direction towards the distal end of the needle (see fig. 2 above, third stopping area is closest to the distal end of the protective sleeve 40).
Regarding claim 26, Hu, or alternatively Hu modified by Pedersen, discloses the safety needle device according to claim 16, as described above. Hu further discloses wherein:
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- the hub (10) has an inner surface (inner wall of needle tail protection chamber 15, see fig. 4, [0049]) facing to the cavity (see fig. 2 and 4) and opposed outer surface (see 112b interpretation above) (see modified fig. 4 above);
- the protrusions (see 112b interpretation above) are pins (see protrusion/pin 54 in fig. 4 above, note fig. 2 shows multiple protrusions). (see 112b interpretation above)
- the elastic member comprises a spring element (see spring 60 in fig. 4 above) extending between a distal portion and a proximal portion along the longitudinal axis (see 112b interpretation above) (see fig. 4 which shows labeled ends of spring 60 and fig. 2 which shows spring arranged along longitudinal axis).
Hu teaches all limitations except wherein- the first guide element comprises a groove formed on the inner surface.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to arrange the first guide element on the inner surface of the hub, where it would form a groove, since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of guiding the protrusion. Furthermore, one would have been motivated to make the modification because having the protrusion of the needle shield directly engage with the hub ensures that the relative motion of the needle shield to the hub is simple, based on direct engagement instead of a more complicated mechanism, thus better ensuring the prevention of accidental needle exposure.
Regarding claim 30, Hu, or alternatively Hu modified by Pedersen, discloses the safety needle device according to claim 16, as described above.
Hu further discloses:
- the back-end shield (needle tail protector 50, fig. 2, [0049]) comprises two symmetric protrusions (see 112b interpretation above) (second clamping column 54, see protrusion clearly in fig. 4) circumferentially spaced apart on the back-end shield (see symmetric protrusions in fig. 2; note also [0023] “at least two sets of second clamping columns and second guide grooves which are mutually matched and disposed uniformly in a circumferential direction are included”),
- the second guiding element (see 112b interpretation above) comprises two symmetric guiding wings circumferentially spaced apart on the annular portion (see modified fig. 4 detail which shows symmetric second guide element with noted guiding wing and annular portion; note also [0023] “at least two sets of second clamping columns and second guide grooves which are mutually matched and disposed uniformly in a circumferential direction are included”).
and two symmetric guides tracks (see 112b interpretation above) (second guide grooves 42, fig. 4, [0049]) circumferentially spaced apart (see symmetric second guide member in fig. 4; note also [0023] “at least two sets of second clamping columns and second guide grooves which are mutually matched and disposed uniformly in a circumferential direction are included”).
Hu is silent to - the hub comprises two symmetric guides tracks on the lateral wall.
Pedersen further teaches wherein - the hub (hub includes base part 10 and cartridge holder 20, fig. 3, pg. 14/45 ln. 30-34) comprises two symmetric guides tracks (pg. 16/45 ln. 6-9 “helical track 45 thus continues between the first sloped edge 35 and the second sloped edge 22”; note that second sloped edge 22 is part of cartridge holder 20) on the lateral wall (longitudinally extending wall of base part 10 and cartridge holder 20).
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 symmetric guide tracks of Hu to be part of the hub lateral wall as taught by Pedersen, since both references deal with guide tracks for needle shields. It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the rearrangement as such since it has been held that rearranging parts of an invention involves only routine skill in the art. See MPEP 2144.04 (VI-C). The modified device could still perform the function of guiding the needle shield. Furthermore, one would have been motivated to make the modification because having the protrusion of the needle shield directly engage with the hub ensures that the relative motion of the needle shield to the hub is simple, based on direct engagement instead of a more complicated mechanism, thus better ensuring the prevention of accidental needle exposure.
Conclusion
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 05/28/2026
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