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 .
Election/Restrictions
Applicant's election with traverse of Species 2 in the reply filed on 12/01/2025 is acknowledged. The traversal is on the ground(s) that there would be no serious search and/or examination burden as it would be reasonably expected that search for one of the species would necessarily produce results applicable to the other species. This is not found persuasive because the examination burden is not limited exclusively to a prior art search but also includes that effort required to apply the art by making and discussing all appropriate grounds of rejection. Multiple species, such as those in the present application, normally require additional reference material and further discussion for each additional species examined. Concurrent examination of multiple species would thus typically involve a significant burden even if all searches were coextensive. Examiner notes claims 1-4, 6, and 8-16 are acknowledged as generic claims.
The requirement is still deemed proper and is therefore made FINAL.
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species 1, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/01/2025.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a release element” in claim 1,
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding “a release element” in claim 1, 112(f) is invoked because: (i) it uses a generic placeholder (element), (ii) it is coupled with functional language (release), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 6 and p.8, lines 3-7 disclose the release element as a spring. Examiner is interpreting the limitation as a spring or equivalent structures.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 3, 5, and 11-14 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.
Regarding claim 3, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 5, the phrase “wherein at least one of the proximal abutment surface and the distal abutment surface comprises a chamfer” in lines 1-2 renders the claim indefinite because it is unclear. It is unclear, if the proximal abutment surface comprises a chamfer, if this is the same chamfer claimed in claim 1 or an additional chamfer. In light of the spec., especially Fig. 11, examiner is interpreting this as the same chamfer of the proximal abutment surface of claim 1.
Regarding claim 11, the phrase “a circumferential direction” in lines 1-2 renders the claim indefinite because it is unclear. It is unclear whether this is a different circumferential direction or the same circumferential direction introduced in claim 1. Examiner is interpreting it as the latter.
Regarding claim 12, the phrase “the bump of the body has a first end” in line 1 renders the claim indefinite because it is unclear. It is unclear if this is a different first end of the bump or the same first end of the bump as introduced in claim 1. Examiner is interpreting it as the latter.
Regarding claim 13, the phrase “the device comprises only two bumps” in line 1 renders the claim indefinite because it is unclear. It is unclear whether these are bumps related to the bump of claim 1 or a different structure. In light of the spec., examiner is interpreting this limitation as the bump of claim 1 is comprised of only two bumps. Examiner suggests amending the state “wherein the bump is comprised of only two bumps.”
Regarding claim 14, the phrase “the bump has a first end” in line 1 renders the claim indefinite because it is unclear. It is unclear if this is a different first end of the bump or the same first end of the bump as introduced in claim 1. Examiner is interpreting it as the latter.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-6, 9, 12-14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jansen et al. (U.S Patent Pub. No. 20020026146 A1, “Jansen”).
Regarding claim 1, Jansen discloses (Claim 1) a safety device (14 in at least Fig. 1) for mounting onto a medical container (12 in Fig. 1) provided with a flange (24 in Fig. 1) and an injection needle (18 in Fig. 1, see para. 0032-0033), the safety device (14) comprising:
a tubular body (26 in Fig. 1) extending along a longitudinal axis (see Fig. 1 for axis), the tubular body (26) being configured to receive the medical container (12, see Fig. 2),
a needle cover (28 in Fig. 1) movable relative to said body (26) between a retracted position (see Fig. 3 and para. 0045), and an extended position (see Fig. 4) in which the needle cover (28) distally extends from the retracted position (see Fig. 3) in order to shield the injection needle (18) after activation of the safety device (14, see Fig. 4 and para. 0048-0049),
a release element (30 in Fig. 1) configured to move the needle cover (28) from the retracted (see Fig. 3) to the extended position (see Fig. 4) after activation of the safety device (14, examiner notes the release element is interpreted under 112(f) as a spring or equivalent structures, see para. 0049 – spring 30 is interpreted as the release element), and
a retainer (32 in Fig. 1), the retainer (32) being configured to transmit a user's activation force to the needle cover (28) once the injection operation is completed (see Fig. 4 and para. 0048 – after the injection operation, the retainer 32 transmits a user’s activation force which displaces retainer 32 and thus needle cover 28 to unlock from the tubular body 26 and be extended by the force of spring 30), wherein
the needle cover (28) includes a distal abutment surface (distal surface of 58 in Fig. 3), said distal abutment surface (distal surface of 58) abutting against a proximal abutment surface (proximal surface of 48 in Fig. 3) of a bump (48) protruding from the body (26) in the retracted position (Fig. 3) of the needle cover (28, see para. 0041 and 0045), and wherein the bump (48 in Fig. 3) of the body (28) has a first end provided with a chamfer extending in a circumferential direction (see annotated Jansen drawing 1 below and para. 0041 – the bump 48 has an inclined surface interpreted as the chamfer which is provided on a first end of the bump 48, the bump 48 extends annularly around the body 28 as seen in Fig. 1 and thus the chamfer extends circumferentially as well).
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Regarding claim 3, Jansen discloses (Claim 3) the safety device (14) according to claim 1, wherein the chamfer comprises a continuously decreasing slope (see annotated Jansen drawing 1 above for chamfer and para. 0041 – the chamfer of the bump 48 has a decreasing slope that continuously decreases from the distal direction to the proximal direction, with no intermittent increases or plateaus).
Regarding claim 4, Jansen discloses (Claim 4) the safety device (14) according to claim 1, wherein the bump (48) of the body (26) has an opposite second end which is adjacent to a first axial slot (46A in Fig. 1) of the body (26, see annotated Jansen drawing 1 above for second end, see Fig. 1, Fig. 3 and para. 0037-0038 – the second end of bump 48 is adjacent to a first opening 46A which is an axially extending opening).
Regarding claim 5, Jansen discloses (Claim 5) the safety device (14) according to claim 1, wherein at least one of the proximal abutment surface (proximal surface of 58 in Fig. 3) and the distal abutment surface (distal surface of 48 in Fig. 3) comprises a chamfer configured to ease passage of the needle cover (28) over the bump (48) when the needle cover (28) moves distally to the extended position (see Fig. 4 for extended position, see annotated Jansen drawing 1 above and para. 0041 for chamfer on distal abutment surface of bump 48, see para. 0048 – the inclined surfaces of the bump 48 and proximal surface of 58 allows for them to slide past each other and thus are configured to ease passage of the needle cover 28 over bump 48).
Regarding claim 6, Jansen discloses (Claim 6) the safety device (14) according to claim 1, wherein the distal abutment surface (distal surface of 58 in Fig. 3) is located on a reduced thickness portion of the needle cover (28, see annotated Jansen drawing 2 below and para. 0041 – a region of the needle cover 28 has an increased thickness at rib 62 and the distal surface of 58 is located on a portion of the needle cover 28 with reduced thickness compared to the rib 62).
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Regarding claim 9, Jansen discloses (Claim 9) the safety device (14) according to claim 1, wherein the body (26) has a first axial slot (46A in Fig. 1 and 3) and a second axial slot (46B in Fig. 1 and 3, see para. 0037-0038 – openings 46A and 46B are axially extending), the first axial slot (46A) and the second axial slot (46B) extending on both sides of the bump (48, see Fig. 1 and 3 and para. 0038 – both slots 46A and 46B extend such that they are on both the distal side and proximal side of bump 48).
Regarding claim 12, Jansen discloses (Claim 12) the safety device (14) according to claim 1, wherein the bump (48 in Fig. 3) of the body (26) has a first end, an opposite second end, and a decreasing height from said second end to said first end (see annotated Jansen drawing 1 above – the height of the bump 48 decreases for at least the proximal chamfer of the bump 48 from the second end to the first end).
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Regarding claim 13, Jansen discloses (Claim 13) the safety device (14) according to claim 1, wherein the device (14) comprises only two bumps (see Fig. 1, annotated Jansen drawing 3 below and para. 0038 – the bump 48 is interrupted by the opens 46A and 46B such that it is split into the two bumps annotated below).
Regarding claim 14, Jansen discloses (Claim 14) the safety device (14) according to claim 1, wherein the bump (48 in Fig. 3) has a first end and an opposite second end (see annotated Jansen drawing 1 above), and the proximal abutment surface (proximal surface of 48) of said bump (48) has a ramp portion, said ramp portion having a decreasing slope towards the first end of said bump (48, see Fig. 3 and annotated Jansen drawing 1 above – the proximal surface of bump 48 is annotated with the chamfer which forms a ramp portion having a decreasing slope towards the first end).
Regarding claim 16, Jansen discloses (Claim 16) an injection device (10 in Fig. 1) comprising a medical container (12) having an injection needle (18) and the safety device (14) according to claim 1 (see rejection of claim 1 above, see Fig. 1 and para. 0032-0033), said safety device (14) being mounted onto said medical container (12, see Fig. 2 and para. 0032).
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.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Srinivasan et al. (U.S Patent Pub. No. 20150157807 A1, “Srinivasan”).
Regarding claim 8, Jansen discloses the safety device of claim 1, as discussed above. However, Jansen fails to disclose (Claim 8) wherein the bump has a cantilevered portion.
Srinivasan discloses a safety device (10 in Fig. 13-14) comprising a tubular body (18) and a needle cover (14), wherein a distal abutment surface (distal surface of 42) abuts against a proximal abutment surface (proximal surface of 40) of a bump (40) protruding from the body (18, see Fig. 17 and para. 0017-0018 and 0020). Srinivasan teaches (Claim 8) wherein the bump (40) has a cantilevered portion (44, see Fig. 14 and para. 0017).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the bump taught by Jansen to incorporate a cantilevered portion as taught by Srinivasan. Srinivasan teaches that providing a cantilevered portion creates a snap-engagement with the tubular body that allows the bump to by-pass the abutting surface in a preferred direction while inhibiting movement in the other direction (see para. 0017-0018).
Claim(s) 10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Brunel (U.S Patent No. 5855839).
Regarding claim 10, Jansen discloses the safety device of claim 1, as discussed above. Jansen further discloses the limitations of (Claim 10) wherein the body (26) has a first axial slot (46A in Fig. 1 and 3) extending from an end of the body (26, see Fig. 1, Fig. 3, and para. 0037 – first axial slot 46A extends from a proximal end of body 26 formed by finger flange 38), and the bump (48) is circumferentially distant from said first axial slot (46A, see Fig. 1, Fig. 3, and para. 0038 – the bump 48 is interrupted by the first axial slot 46A and thus does not extend circumferentially over the axial slot 46A).
However, Jansen fails to disclose (Claim 10) the first axial slot extending from a distal end of the body.
Brunel discloses a safety device (see Fig. 8-9) comprising a tubular body (101) and a needle cover (109), wherein the tubular body (101) comprises a proximal abutment surface (proximal surface of 108 in Fig. 10-11) of a bump (108) for abutting a distal abutment surface (distal surface of 110 in Fig. 10-11) in the retracted position (see Fig. 10-11 and Col.10, lines 14-18). Brunel teaches (Claim 10) the first axial slot (102 in Fig. 8) extending from a distal end of the body (101, see Fig. 8 and Col.8, lines 52-59).
Since the axial slots (46A, 46B in Fig. 1 and 3) of the tubular body (26) of Jansen create a desired amount of flexibility for the tubular body (see para. 0037), and the axial slots (102 in Fig. 8) of the tubular body (101) of Brunel also allows for a desired amount of flexibility that aids in the assembly process of the safety device (see Fig. 8-9 and Col. 9, lines 60-67 – Col.10, lines 1-4), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the axial slot taught by Jansen to extend from the distal end of the body as taught by Brunel to provide the distal end of the tubular body with a desired radial flexibility. This would be advantageous to Jansen as the distal flexibility of the tubular body aids in the assembly of the device when the syringe is inserted at a proximal end of the tubular body (see Fig. 8-9 and Col.9, lines 60-67 – Col.10, lines 1-4).
Regarding claim 15, Jansen discloses the safety device of claim 1, as discussed above. Jansen further discloses the limitations of (Claim 15) wherein the body (26) has a first axial slot (46A in Fig. 1 and 3) extending from an end of said body (26, see Fig. 1, Fig. 3, and para. 0037 – first axial slot 46A extends from a proximal end of body 26 formed by finger flange 38), the first axial slot (46A) having a predetermined length (see para. 0037 – the size of the slot 46A is predetermined based upon desired flexibility).
However, Jansen fails to disclose (Claim 15) the first axial slot extending from a distal end of said body and does not explicitly disclose the predetermined length comprised between 1 mm – 6 mm.
Jansen discloses that the size of the axial slot (46A) needs to be optimized to achieve “the amount of flexibility desired” (see para. 0037). As seen in Fig. 1 and para. 0037, the size and thus the length of the axial slot (46A) of the tubular body (26) is disclosed to be a result effective variable in that changing the size of the axial slot (46A) changes the amount of flexibility of the tubular body (26) which affects the assembly and operation of the safety device (14). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the axial slot of Jansen to have a predetermined length comprised between 1 mm – 6 mm, as it involves adjusting the size of the axial slot (46A) which is disclosed as being selectable (see para. 0037). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the axial slot (46A) of Jansen by making the predetermined length to be between 1 mm – 6 mm as a matter of routine optimization since it has been that “where the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
However, Jansen fails to disclose (Claim 15) the first axial slot extending from a distal end of said body.
Brunel teaches (Claim 15) the first axial slot (102 in Fig. 8) extending from a distal end of said body (101, see Fig. 8 and Col.8, lines 52-59).
Since the axial slots (46A, 46B in Fig. 1 and 3) of the tubular body (26) of Jansen create a desired amount of flexibility for the tubular body (see para. 0037), and the axial slots (102 in Fig. 8) of the tubular body (101) of Brunel also allows for a desired amount of flexibility that aids in the assembly process of the safety device (see Fig. 8-9 and Col. 9, lines 60-67 – Col.10, lines 1-4), it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the axial slot taught by Jansen to extend from the distal end of the body as taught by Brunel to provide the distal end of the tubular body with a desired radial flexibility. This would be advantageous to Jansen as the distal flexibility of the tubular body aids in the assembly of the device when the syringe is inserted at a proximal end of the tubular body (see Fig. 8-9 and Col.9, lines 60-67 – Col.10, lines 1-4).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Jansen.
Regarding claim 11, Jansen discloses the safety device of claim 1, as discussed above. Jansen further discloses the limitations of (Claim 11) wherein the bump (48 in Fig. 1) extends in a circumferential direction according to a central angle (see annotated Jansen drawing 4 below for central angle).
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However, Jansen fails to explicitly disclose (Claim 11) a central angle comprised between 22.5º-45º.
Jansen discloses that the circumferential extent according to a central angle of the bump (48) is a function of the size of the axial slots (46A, 46B) as the axial slots interrupt the bump (48, see Fig. 1 and para. 0048), and Jansen discloses that the size of the axial slots (46A, 46B) needs to be optimized to achieve “the amount of flexibility desired” (see para. 0037). As seen in Fig. 1 and para. 0037, the size of the axial slots (46A, 46B) and thus the circumferential extent of the bump (48) according to a central angle are disclosed to be a result effective variables in that changing the size of the axial slots (46A, 46B) and thus the circumferential extent of the bump (48) according to a central angle changes the amount of flexibility of the tubular body (26) which affects the assembly and operation of the safety device (14). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the axial slots and thus circumferential extent of the bump of Jansen such that the bump extends in the circumferential direction according to a central angle comprises between 22.5º-45º, as it involves adjusting the size of the axial slots (46A, 46B) which is disclosed as being selectable (see para. 0037). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the circumferential extent of the bump according to a central angle of Jansen by making the central angle between 22.5º-45º as a matter of routine optimization since it has been that “where the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Jansen in view of Brunel.
Regarding claim 1, Jansen discloses the limitations of (Claim 1) a safety device (14 in at least Fig. 1) for mounting onto a medical container (12 in Fig. 1) provided with a flange (24 in Fig. 1) and an injection needle (18 in Fig. 1, see para. 0032-0033), the safety device (14) comprising:
a tubular body (26 in Fig. 1) extending along a longitudinal axis (see Fig. 1 for axis), the tubular body (26) being configured to receive the medical container (12, see Fig. 2),
a needle cover (28 in Fig. 1) movable relative to said body (26) between a retracted position (see Fig. 3 and para. 0045), and an extended position (see Fig. 4) in which the needle cover (28) distally extends from the retracted position (see Fig. 3) in order to shield the injection needle (18) after activation of the safety device (14, see Fig. 4 and para. 0048-0049),
a release element (30 in Fig. 1) configured to move the needle cover (28) from the retracted (see Fig. 3) to the extended position (see Fig. 4) after activation of the safety device (14, examiner notes the release element is interpreted under 112(f) as a spring or equivalent structures, see para. 0049 – spring 30 is interpreted as the release element), and
a retainer (32 in Fig. 1), the retainer (32) being configured to transmit a user's activation force to the needle cover (28) once the injection operation is completed (see Fig. 4 and para. 0048 – after the injection operation, the retainer 32 transmits a user’s activation force which displaces retainer 32 and thus needle cover 28 to unlock from the tubular body 26 and be extended by the force of spring 30), wherein
the needle cover (28) includes a distal abutment surface (distal surface of 58 in Fig. 3), said distal abutment surface (distal surface of 58) abutting against a proximal abutment surface (proximal surfaces of 48 in Fig. 3) of a bump (48) protruding from the body (26) in the retracted position (Fig. 3) of the needle cover (28, see para. 0041, 0045, and 0048 – the bump 48 may be a series of discrete bumps 48 and thus the proximal surfaces of the bumps 48 would abut against the distal surface of 58).
However, Jansen fails to disclose wherein the series of discrete bumps (48) each has a first end provided with a chamfer extending in a circumferential direction.
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Brunel discloses a safety device (see Fig. 8-9) comprising a triangular-shaped, projecting notch (111 in Fig. 6-7) with the notch 111 having a decreasing thickness in the distal direction. Brunel teaches wherein a series of discrete bumps (111) each has a first end provided with a chamfer extending in a circumferential direction (see annotated Brunel drawing 1 below for end annotated and Col.9, lines 37-42 – the thickness of the bump 111 decreases in the distal direction and since the bump 111 is triangular shaped this also yields a thickness decrease partially in the circumferential direction and thus a chamfer partially in the circumferential direction.
Since Jansen discloses a series of discrete bumps (48) on the tubular body (26) for abutting the needle cover (28, see Fig. 3 and para. 0048), and Brunel discloses a series of discrete bumps (111) having a triangular shape with a thickness decreasing in the distal direction providing a first end with a chamfer extending in a circumferential direction, it would have been obvious to have modified the series of discrete bumps on the tubular body of Jansen to have a triangular shape with a thickness decreasing in the distal direction providing a first end with a chamfer extending in a circumferential direction as taught by Brunel. Brunel teaches that the triangular shaped bumps having a decreasing thickness in the distal direction allows for an initial engagement with the increased thickness at the proximal end of the bumps (111) and then easy passage over the bumps (111) with the decreasing thickness moving in either direction (see Fig. 6 and Col.9, lines 60-67- Col.10, lines 1-9). In combination, the triangular-shaped bumps of Jansen having this decreasing thickness in the distal direction would allow the bumps to abut against the distal abutment surface (distal surface of 58) of the needle cover (28) and upon an activation force, the chamfer provided by the decreasing thickness would ease passage of the needle cover (28) distally.
Regarding claim 2, modified Jansen discloses the safety device of claim 1, as discussed above. In modified Jansen, Brunel discloses (Claim 2) wherein the chamfer is configured so that the height of the first end of the bump (111 in Fig. 6) decreases in an outward circumferential direction (see annotated Brunel drawing 1 above and Col.9, lines 37-42 – the thickness of the bump 111 decreases in the distal direction and since the bump 111 is triangular shaped this also yields a height decrease of the first end of the bump 111 in a partially outward, circumferential direction as annotated with the arrows on bump 111 above).
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 5-15 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims outlined in the table below of copending Application No. (reference applications) 18/088169, 18/088006, 18/087940, 18/088234, 18/088217, 18/088128, 18/088115, 18/088089, 18/088077, 18/087944, 18/088178. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
All 11 reference applications and the instant application include the following limitations in claim 1, either in exactly the following terms or terms which refer to identical subject matter:
"A safety device for mounting onto a medical container provided with a flange and an injection needle, the safety device comprising: a tubular body extending along a longitudinal axis, the tubular body being configured to receive the medical container, a needle cover movable relative to said body between a retracted position, and an extended position in which the needle cover distally extends from the retracted position in order to shield the injection needle after activation of the safety device, a release element configured to move the needle cover from the retracted to the extended position after activation of the safety device, a retainer, the retainer being configured to transmit a user's activation force to the needle cover once the injection operation is completed, wherein the needle cover comprises a distal abutment surface, said distal abutment surface abutting against a proximal abutment surface of a bump protruding from the body in the retracted position of the needle cover.”
Each of the 11 reference applications includes a dependent claim which contains all of the limitations of a corresponding dependent claim of the instant application (see Table below).
Instant App. Claim #
Reference App. #
Reference App. Claim #
13
18/088169
11
14
18/088006
12
15
18/087940
13
8
18/088234
11
6
18/088217
11
12
18/088128
11
7
18/088115
12
5
18/088089
11
11
18/088077
11
10
18/087944
11
9
18/088178
12
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over each noted “Reference App. Claim #” of the Table above corresponding to the “Reference App. #” of the Table above (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because each dependent claim noted in the Table above contains all of the subject matter of the independent claim plus additional limitations, so claim 1 of the instant application is essentially a genus claim which is anticipated by each noted copending dependent claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 2-6 and 8-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of the 11 copending applications noted in the “Reference App. #” column of Table 1 above and in view of the 102 and 103 rejections made above.
Regarding claims 5-6, 9, 11-14, and 16, all 11 noted applications (18/088169, 18/088006, 18/087940, 18/088234, 18/088217, 18/088128, 18/088115, 18/088089, 18/088077, 18/087944, 18/088178) include dependent claims which include all the limitations of claims 5-7, 9, 11-14, and 16 except for “wherein the bump of the body has a first end provided with a chamfer extending in a circumferential direction.”
Jansen discloses a safety device (14) for an injection device (10), wherein Jansen teaches the bump (48 in Fig. 3) of the body (28) has a first end provided with a chamfer extending in a circumferential direction (see annotated Jansen drawing 1 below and para. 0041 – the bump 48 has an inclined surface interpreted as the chamfer which is provided on a first end of the bump 48, the bump 48 extends annularly around the body 28 as seen in Fig. 1 and thus the chamfer extends circumferentially as well).
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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 have the bump with a first end provided with a chamfer in the circumferential direction since all 11 reference applications note that the bump includes an abutment surface for engaging with an abutment surface of a needle cover. Providing a chamfer that extends in the circumferential direction at a first end of the bump allows for this chamfer to engage a chamfer on the complementary abutment surface of the needle cover (28) which upon an activation force allows the two structures to easily slide past one another (see para. 0041 and 0048).
Examiner notes, regarding claim 2, similar reasoning would further make obvious the limitations of claim 2, as outlined in the 103 rejection over Jansen in view of Brunel above. As such, claim 2 is rejected for double patenting over all of the noted 11 copending applications in view of Jansen in view of Brunel.
Examiner notes, regarding claims 3-4, similar reasoning would further make obvious the limitations of claims 3-4, as outlined in the 102 rejection over Jansen above. As such, claims 3-4 are rejected for double patenting over all of the noted 11 copending applications in view of Jansen.
Examiner notes, regarding claim 8, similar reasoning would further make obvious the limitations of claim 8, as outlined in the 103 rejection over Jansen in view of Srinivasan above. As such, claim 8 is rejected for double patenting over all of the noted 11 copending applications in view of Jansen in view of Srinivasan.
Examiner notes, regarding claims 10 and 15, similar reasoning would further make obvious the limitations of claims 1 and 15, as outlined in the 103 rejection over Jansen in view of Brunel above. As such, claims 10 and 15 are rejected for double patenting over all of the noted 11 copending applications in view of Jansen in view of Brunel.
Examiner notes, regarding claim 11, similar reasoning would further make obvious the limitations of claim 11, as outlined in the 103 rejection over Jansen above. As such, claim 11 is rejected for double patenting over all of the noted 11 copending applications in view of Jansen.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/K.M.T./Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783