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 .
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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the hooks positioned on the distal end of the outer shield (Claims 12, 17, and 19) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Claim Interpretation
The pending claims are given their broadest reasonable interpretation consistent with the specification, as it would be interpreted by one of ordinary skill in the art. The words of the claims are given their plain the ordinary and customary meaning given to the term by those of ordinary skill in the art as of the effective filing date of the patent application, unless such meaning is inconsistent with the specification. The only exceptions to giving the words in a claim their ordinary and customary meaning in the art are: (1) when the applicant acts as their own lexicographer; and (2) when the applicant disavows or disclaims the full scope of a claim term in the specification. See M.P.E.P. § 2111.
Claim 1 is directed to a needle cover which, according to its preamble, is intended to be used with a ‘medical injection device having a needle,’ the claim’s preamble making clear that the ‘medical injection device having a needle’ is part of the unclaimed environment in which the claimed needle cover may be used.
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.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-4, 12, 17, and 19 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.
Claims 2-4 each blur the line between the claimed needle cover and the unclaimed ‘medical injection device having a needle,’ therefore making their scopes unclear, namely, whether or not the ‘medical injection device having a needle’ is actually within the scope of the claims. In Claim 2, line 2, “inner shield contacts a distalmost surface” (emphasis added) creates this ambiguity, because positively reciting “contacts” requires the otherwise unclaimed environment of the ‘medical injection device having a needle’ to be within the scope of the claim. Similarly, in Claim 3, line 2, “creates an axial compression” causes the same ambiguity, as does Claim 4, line 2, “inner shield contacts a distalmost surface.” Because the preamble of Claim 1 makes clear that the ‘medical injection device having a needle’ is an unclaimed, intended use environment of the claimed needle cover, and the broadest reasonable interpretation of the claim is to exclude the ‘medical injection device having a needle’ from the scope of the claims, this is the interpretation afforded these claims.
Claim 3, line 3, the word “reduces” renders the scope of the claim indefinite, because it demands the question, “Reduces relative to what?”
Claims 12, 17, and 19, which are identical except for their dependencies, recite that “the at least one hook is positioned on a distal end of the outer shield” (emphasis added). A complete review of the application as filed reveals that Applicant specifically adopts ([0025]) the otherwise standard (in the medical device arts) definitions of the words distal and proximal:
“In the following discussion, ‘distal’ refers to a direction generally toward an end of a medical injection device adapted for contact with a patient's skin, and ‘proximal’ refers to the opposite direction of distal, i.e., away from the end of a medical injection device.”
That review also reveals that the only “hooks” described in the application as-filed, other than the restatement of the claims in the Summary, assigned reference number 126, are positioned at the proximal end of the outer shield, not the distal end (see Fig. 4). Therefore, a full and fair reading of Claims12, 17, and 19 results in a person of ordinary skill in the art not being able to determine the scope of the claims, because the underlying technical disclosure of the hooks is that they are positioned at the proximal, not distal, end of the outer shield (which is how the claims have been treated).
Claims 2-4 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
See above concerning Claims 2-4, sec. 112(b), and the claims’ scopes. Each of Claims 2-4 present no additional limitations other than stating an interaction with an unclaimed environmental device. As indicated above, the claims have been treated as not including that environmental device, and thus the claims do not further limit Claim 1, from which they each depend.
Applicant may: cancel the claim(s); amend the claim(s) to place the claim(s) in proper dependent form; rewrite the claim(s) in independent form; or, present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-7 and 9-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. 2014/0101912, by Abry (“Abry”).
Abry discloses a device as claimed by Applicant, as follows.
Claim 1: A needle cover for protecting a needle mounted on a tip of a medical injection device, wherein the tip extends from a distal end of the medical injection device, the needle cover (Fig. 2), comprising:
an inner shield (12) extending along a longitudinal axis (2), and an outer shield (51) surrounding at least partially the inner shield (Fig. 2), and operatively connected to said inner shield (Fig. 2), the needle cover being characterized in that:
when the needle cover is positioned on the tip of the medical injection device, a proximal surface of the inner shield contacts a distal end of the tip of the medical injection device (intended use; Fig. 2, needle hub is embedded in shield 12), and
the proximal surface of the inner shield creates an axial compression in a longitudinal direction on the distal end of the tip of the medical injection device (intended use; shield 12 is formed of rubber material which seals the needle tip, [0051], and thus at least slightly compresses the needle tip).
Claim 2: (The needle cover of claim 1,) wherein the proximal surface of the inner shield contacts a distalmost surface of the distal end of the tip of the medical injection device (not further limiting of Claim 1, prior art applies the same).
Claim 3: (The needle cover of claim 1), wherein the inner shield creates an axial compression on the distal end of the tip of the medical injection device and reduces a radial compression on the distal end of the tip of the medical injection device (not further limiting of Claim 1, prior art applies the same).
Claim 4: (The needle cover claim 1,) wherein a proximal-most surface of the inner shield contacts a distalmost surface of the distal end of the tip of the medical injection device (not further limiting of Claim 1, prior art applies the same).
Claim 5: (The needle cover of claim 1,) wherein the inner shield is made of a deformable material (rubber, [0051]).
Claim 6: (The needle cover of claim 1, wherein the inner shield is configured to receive at least a portion of the needle (Fig. 2).
Claim 7: (The needle cover of claim 1,) wherein the outer shield includes at least one hook (55) that assists in removing the inner shield from the tip of the medical injection device when the needle cover is removed from the medical injection device ([0072]).
Claim 9: (The needle cover of claim 7,) wherein the at least one hook is made of a flexible material that allows the at least one hook to bend under pressure ([0048], made of “plastics” which will deform under load at least a de minimus amount).
Claim 10: (The needle cover of claim 7,) wherein the at least one hook is angled inwardly relative to the longitudinal axis of the inner shield (Fig. 2, look 55 includes an angled inner surface) and distally relative to a proximal portion of the tip of the medical injection device (same).
Claim 11: (The needle cover of claim 7,) wherein the at least one hook is configured to contact a shoulder (at 54 in Fig. 2) defined on the tip of the medical injection device when the needle cover is positioned on the tip of the medical injection device (same).
Claim 12: (The needle cover of claim 7,) wherein the at least one hook is positioned on a distal end of the outer shield (see treatment above; treated as ‘proximal;’ see Fig. 2).
Claim 13: (The needle cover of claim 7,) wherein, when the needle cover is removed from the tip of the medical injection device, the at least one hook is configured to slide along an outer surface of the tip to assist in peeling the inner shield off of the tip ([0072], 55 slides along outer surface of needle hub).
Claim 14: A medical injection device, comprising:
a barrel (10) extending [sic: “from”] a proximal face (7 in Fig. 1) to a distal face (at 54 in Fig. 2), wherein a tip (surrounding proximal portions of needle 8 in Fig. 2) is provided on the distal face of the barrel (same); and
a needle cover (12, 51) for protecting a needle (8) mounted on the tip of the medical injection device (Fig. 2), the needle cover, comprising:
an inner shield (12) extending along a longitudinal axis (2), and
an outer shield (51) surrounding at least partially the inner shield (Fig. 2), and operatively connected to said inner shield (at least by 55),
the medical injection device being characterized in that:
when the needle cover is positioned on the tip of the medical injection device, a proximal surface of the inner shield contacts a distal end of the tip of the medical injection device (intended use; Fig. 2, needle hub is embedded in shield 12), and
the proximal surface of the inner shield creates an axial compression in a longitudinal direction on the distal end of the tip of the medical injection device (intended use; shield 12 is formed of rubber material which seals the needle tip, [0051], and thus at least slightly compresses the needle tip).
Claim 15: A medical injection device, comprising:
a barrel (10) extending [sic: “from”] a proximal face (7 in Fig. 1) to a distal face (at 54 in Fig. 2), wherein a tip (surrounding proximal portions of needle 8 in Fig. 2) is provided on the distal face of the barrel (same); and
a needle cover (12, 51) for protecting a needle (8) mounted on the tip of the medical injection device (Fig. 2), the needle cover, comprising:
an inner shield (12) extending along a longitudinal axis (2), and
an outer shield (51) surrounding at least partially the inner shield (Fig. 2), and operatively connected to said inner shield (at least by 55),
the medical injection device being characterized in that:
the outer shield includes at least one hook (55) that assists in removing the inner shield from the tip of the medical injection device when the needle cover is removed from the medical injection device ([0072]).
Claim 16: (The medical injection device of claim 14,) wherein the outer shield includes at least one hook (55) that assists in removing the inner shield from the tip of the medical injection device when the needle cover is removed from the medical injection device ([0072]).
Claim 17: (The medical injection device of claim 16,) wherein the at least one hook is positioned on a distal end of the outer shield (see treatment above; treated as ‘proximal;’ see Fig. 2).
Claim 18: (The medical injection device of claim 16,) wherein, when the needle cover is removed from the tip of the medical injection device, the at least one hook is configured to slide along an outer surface of the tip to assist in peeling the inner shield off of the tip ([0072], 55 slides along outer surface of needle hub).
Claim 19: (The medical injection device of claim 15,) wherein the at least one hook is positioned on a distal end of the outer shield (see treatment above; treated as ‘proximal;’ see Fig. 2).
Claim 20: (The medical injection device of claim 15,) wherein, when the needle cover is removed from the tip of the medical injection device, the at least one hook is configured to slide along an outer surface of the tip to assist in peeling the inner shield off of the tip ([0072], 55 slides along outer surface of needle hub).
Claims 1-7, 9-12, 14-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. 2017/0143893, by Hasumi et al. (“Hasumi”).
Hasumi describes a device as claimed by Applicant, as follows.
Claim 1: A needle cover for protecting a needle mounted on a tip of a medical injection device, wherein the tip extends from a distal end of the medical injection device, the needle cover (see Fig. 6), comprising:
an inner shield (712) extending along a longitudinal axis (axis of needle 66), and an outer shield (722) surrounding at least partially the inner shield (Fig. 6), and operatively connected to said inner shield (at least via 724), the needle cover being characterized in that:
when the needle cover is positioned on the tip of the medical injection device, a proximal surface of the inner shield contacts a distal end of the tip of the medical injection device (intended use; Fig. 6, needle hub is embedded in shield 712), and
the proximal surface of the inner shield creates an axial compression in a longitudinal direction on the distal end of the tip of the medical injection device (intended use; Fig. 2, needle hub 613 attached to 712, made of rubber).
Claim 2: (The needle cover of claim 1,) wherein the proximal surface of the inner shield contacts a distalmost surface of the distal end of the tip of the medical injection device (not further limiting of Claim 1, prior art applies the same).
Claim 3: (The needle cover of claim 1), wherein the inner shield creates an axial compression on the distal end of the tip of the medical injection device and reduces a radial compression on the distal end of the tip of the medical injection device (not further limiting of Claim 1, prior art applies the same).
Claim 4: (The needle cover claim 1,) wherein a proximal-most surface of the inner shield contacts a distalmost surface of the distal end of the tip of the medical injection device (not further limiting of Claim 1, prior art applies the same).
Claim 5: (The needle cover of claim 1,) wherein the inner shield is made of a deformable material (rubber, [0053], noting that the text misstates that 711 is made of rubber).
Claim 6: (The needle cover of claim 1, wherein the inner shield is configured to receive at least a portion of the needle (Fig. 6).
Claim 7: (The needle cover of claim 1,) wherein the outer shield includes at least one hook (724) that assists in removing the inner shield from the tip of the medical injection device when the needle cover is removed from the medical injection device ([0055]).
Claim 9: (The needle cover of claim 7,) wherein the at least one hook is made of a flexible material that allows the at least one hook to bend under pressure.
Claim 10: (The needle cover of claim 7,) wherein the at least one hook is angled inwardly relative to the longitudinal axis of the inner shield and distally relative to a proximal portion of the tip of the medical injection device (Fig. 6 shows the hook 724 having an upper angled surface like that of Abry’s hook).
Claim 11: (The needle cover of claim 7,) wherein the at least one hook is configured to contact a shoulder defined on the tip of the medical injection device when the needle cover is positioned on the tip of the medical injection device (intended use; hook 724 is fully capable of contacting such a shoulder).
Claim 12: (The needle cover of claim 7,) wherein the at least one hook is positioned on a distal end of the outer shield (see treatment above; treated as ‘proximal;’ see Fig. 6).
Claim 14: A medical injection device, comprising:
a barrel (611) extending [sic: “from”] a proximal face (Fig. 3, top surface of cylinder) to a distal face (Fig. 6, unlabeled, from which 613 protrudes distally), wherein a tip (613) is provided on the distal face of the barrel (Fig. 6); and
a needle cover (712, 722) for protecting a needle mounted on the tip of the medical injection device, the needle cover, comprising:
an inner shield (712) along a longitudinal axis, and
an outer shield (722) surrounding at least partially the inner shield (Fig. 6), and operatively connected to said inner shield (at least via 724),
the medical injection device being characterized in that:
when the needle cover is positioned on the tip of the medical injection device, a proximal surface of the inner shield contacts a distal end of the tip of the medical injection device (Fig. 6, unlabeled, at distalmost surface of 613), and
the proximal surface of the inner shield creates an axial compression on the distal end of the tip of the medical injection device (because inner shield 712 is formed of rubber, it axially compresses 613).
Claim 15: A medical injection device, comprising:
a barrel (611) extending [sic: “from”] a proximal face (Fig. 3, top surface of cylinder) to a distal face (Fig. 6, unlabeled, from which 613 protrudes distally), wherein a tip (613) is provided on the distal face of the barrel (Fig. 6); and
a needle cover (712, 722) for protecting a needle mounted on the tip of the medical injection device, the needle cover, comprising:
an inner shield (712) along a longitudinal axis, and
an outer shield (722) surrounding at least partially the inner shield (Fig. 6), and operatively connected to said inner shield (at least via 724),
the medical injection device being characterized in that:
the outer shield includes at least one hook (724) that assists in removing the inner shield from the tip of the medical injection device when the needle cover is removed from the medical injection device ([0055]).
Claim 16: (The medical injection device of claim 14,) wherein the outer shield includes at least one hook (724) that assists in removing the inner shield from the tip of the medical injection device when the needle cover is removed from the medical injection device ([0055]).
Claim 17: (The medical injection device of claim 16,) wherein the at least one hook is positioned on a distal end of the outer shield (see treatment above; treated as ‘proximal;’ see Fig. 6).
Claim 19: (The medical injection device of claim 15,) wherein the at least one hook is positioned on a distal end of the outer shield (see treatment above; treated as ‘proximal;’ see Fig. 6).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over each of Abry and Hasumi as applied to Claim 7 above, and further in view of U.S. Patent App. Pub. No. 2019/0217018, by Bauss et al. (“Bauss”).
Abry and Hasumi both describe a device substantially as claimed by Applicant; see above. Each does not, however, describe that the at least one hook comprises three or four hooks formed on the outer shield.
Bauss relates to injection devices having two coaxial, nested needle shields (Fig. 4) and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Bauss teaches that the hooks/barbs (54) by which the outer shield (52) grabs the inner shield (50b) to pull the inner shield off the needle tip (16c) can include three or four hooks formed on the outer shield (six are shown), which a person of ordinary skill in the art would understand improves the likelihood that the outer shield will successfully pull the inner shield off the needle in the event there are defects in any of the hooks/barbs.
It 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, to construct the outer shield of each of Abry‘s and Hasumi‘s devices so that the at least one hook comprises three or four hooks formed on the outer shield, because Bauss teaches doing so in a closely related device, which a person of ordinary skill in the art would understand improves the likelihood that the outer shield will successfully pull the inner shield off the needle in the event there are defects in any of the hooks/barbs.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. No. 2021/0330893 describes another coaxial, nested double needle shield.
The balance of the documents cited with this Office Action relate generally to double needle shields.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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:// patentcenter.uspto.gov.
If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Bhisma Mehta, can be reached on 571.272.3383. The fax phone number for the organization where this application or proceeding is assigned is 571.273.8300.
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/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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