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Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Species 1, there being no allowable generic or linking claim.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.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
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.”
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) 1-6, 11-14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brunel (U.S Patent No. 6918889 B1).
Regarding claim 1, Brunel discloses (Claim 1) a safety device (see Fig. 7-8) for mounting onto a medical container (1 in Fig. 7-8) provided with a flange (1b) and an injection needle (2 in Fig. 7-8, see Col.6, lines 33-38 and Col.0, lines 9-16), the safety device comprising:
a tubular body (30 in Fig. 7-8) extending along a longitudinal axis (see annotated Brunel drawing 1 below for axis), the tubular body (30) being configured to receive the medical container (1, see Fig. 7-8 and Col.9, lines 9-16),
a needle cover (39 in Fig. 7-8) movable relative to said body (30) between a retracted position (see Fig. 7), and an extended position (see Fig. 8) in which the needle cover (39) distally extends from the retracted position in order to shield the injection needle (2) after activation of the safety device (see Fig. 8 for extended position and Col.10, lines 32-36),
a release element (46 in Fig. 8) configured to move the needle cover (39) from the retracted (see Fig. 7) to the extended position (see Fig. 8) after activation of the safety device (examiner notes the release element is interpreted under 112(f) as a spring or equivalent structures, see Col.10, lines 32-36 – spring 46 is interpreted as the release element), and
a retainer (43 in Fig. 7-8), the retainer (43) being configured to transmit a user's activation force to the needle cover (39) once the injection operation is completed (see Col.,10, lines 22-36 – the user’s activation force causes displacement of the locking ring 43 which transmits said force indirectly to the needle cover 39 to unlock it from the tubular body 30 and allow the spring 46 to move it to its extended position in Fig. 39), wherein
the needle cover (39) includes a distal abutment surface (41a in Fig. 7), said distal abutment surface (41a in Fig. 7) abutting against a proximal abutment surface (36a in Fig. 7) of a bump (36 in Fig. 7-8) protruding from the body (30) in the retracted position (Fig. 7) of the needle cover (39, see Col.9, lines 43-51), and wherein the bump (36) has a cantilevered portion (34, 35, see Fig. 8 and Col.9, lines 23-30 – the bumps 36 are each formed on a cantilevered tab 34 and 35).
Regarding claim 2, Brunel discloses (Claim 2) the safety device of claim 1, wherein the cantilevered portion (34, 35) of the bump (36) extends in a lateral opening of the body (30, see annotated Brunel drawing 1 below and Col.9, lines 23-30 – cantilevered tabs 34 and 35 extend in a U-shaped cutout situated laterally from the tabs 34 and 35 as annotated below).
PNG
media_image1.png
669
649
media_image1.png
Greyscale
Regarding claim 3, Brunel discloses (Claim 3) the safety device of claim 1, wherein the cantilevered portion (34, 35) extends from a first end of the bump (36) to a lateral wall of the body (30, see annotated Brunel drawing 2 below – the cantilevered portion 34 and 35 are the bent portions of wall that extend from the first end of the bump
PNG
media_image2.png
665
861
media_image2.png
Greyscale
36 to the straight wall that forms a lateral wall of the body 30).
Regarding claim 4, Brunel discloses (Claim 4) the safety device of claim 1, wherein a chamfer is provided at the junction between a lateral wall of the body (30) and the cantilevered portion (34, 35) of the bump (30, see annotated Brunel drawing 2 above and drawing 3 below – where the bent portion of the wall denoting the cantilevered portions 34 and 26 meets the straight portion of the lateral wall of the body 30 occurs a junction where there is a sloping on the outer surface defining a chamfer).
PNG
media_image3.png
426
475
media_image3.png
Greyscale
Regarding claim 5, Brunel discloses (Claim 5) the safety device of claim 1, wherein at least one of the proximal abutment surface (36a in Fig. 7) and the distal abutment surface (41a in Fig. 7) comprises a chamfer configured to ease passage of the needle cover (39) over the bump (36) when the needle cover (39) moves distally to the extended position (see Fig. 8 for extended position, see Col.9, line 29 and line 49 – both surfaces 36a and 41a are inclined surfaces indicating chamfers on both which are capable of being configured to ease passage of the needle cover 39 over bump 36 when it moves distally as the surfaces are inclined in such a way as seen in Fig. 7 to allow for easy passage past one another upon application of a force).
Regarding claim 6, Brunel discloses (Claim 6) the safety device of claim 1, wherein the distal abutment surface (41a in Fig. 7) is located on a reduced thickness portion of the needle cover (39, see Fig. 7 – the distal abutment surface 41a is located on portion of the rib 41 with a decreased diameter in comparison to the full diameter of the rib 41 as seen in Fig. 7).
PNG
media_image4.png
426
548
media_image4.png
Greyscale
Regarding claim 11, Brunel discloses (Claim 11) the safety device of claim 1, wherein the bump (36 in Fig. 7-8) of the body (30) has a first end provided with a chamfer extending in a circumferential direction (see annotated Brunel drawing 4 below and Col.9, lines 27-28 – the sloped surface 36a of bump 36 defines a chamfer extending partially in the circumferential direction).
Regarding claim 12, Brunel discloses (Claim 12) the safety device of claim 1, wherein the bump (36 in Fig. 7-8) of the body (30) has a first end, an opposite second end, and a decreasing height from said second end to said first end (see annotated Brunel drawing 4 above for ends and Col. 9, lines 28-30 – the bump 36 has its greatest height towards the second end and decreases in height as it reaches the first end of bump 36 that joins with the cantilevered tab 34, 35).
Regarding claim 13, Brunel discloses (Claim 13) the safety device of claim 1, wherein the device includes only two bumps (36, see Fig. 7-8 and Col.9, lines 21-30 – the device comprises only two tabs 34 and 35 each with a bump 36 indicating only two bumps 36).
Regarding claim 14, Brunel discloses (Claim 14) the safety device of claim 1, wherein the bump (36) has a first end and an opposite second end, and the proximal abutment surface (36a) of said bump (36) has a ramp portion, said ramp portion having a decreasing slope towards the first end of said bump (36, see annotated Brunel drawing 4 above and Col.9, lines 28-30 – the chamfer annotated above defines said ramp portion which if viewed from the direction of holding the device, would be a decreasing slope towards the first end of said bump 36).
Regarding claim 16, Brunel discloses (Claim 16) an injection device (see Fig. 7-8) comprising a medical container (1) having an injection needle (2) and the safety device of claim 1 (see Fig. 7-8, Col.9, lines 9-16 and rejection of claim 1 above), said safety device being mounted onto said medical container (1, see Fig. 7-8 and Col.9, lines 9-16).
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) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Brunel in view of Jansen et al. (U.S Patent Pub. No. 20020026146 A1, “Jansen”).
Regarding claim 8, Brunel discloses the safety device of claim 1, as discussed above. However, Brunel fails to disclose (Claim 8) wherein the body has a first axial slot and a second axial slot, the first axial slot and the second axial slot extending on both sides of the bump.
Jansen discloses a safety device (14) for an injection device (10 in Fig. 1) comprising a tubular body (26) and a needle cover (28), wherein the tubular body (26) comprises a bump (48 in Fig. 1) that abuts against a distal abutment surface (distal surface of 58) of the needle cover (28) in the retracted position (see Fig. 3 and para. 0041). Jansen teaches (Claim 8) wherein the body (26) has a first axial slot (46A) and a second axial slot (46B, see Fig. 1, Fig. 3 and para. 0037), the first axial slot (46A) and the second axial slot (46B) extending on both sides of the bump (48, see Fig. 1 – the slots 46A and 46B each extend on one side of the bump 48 thus the slots extend on both sides of the bump 48).
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 tubular body taught by Brunel to incorporate a first and second axial slot extending on both sides of the bump as taught by Jansen to provide a desired amount of flexibility to the tubular body (see para. 0037). In combination, first and second axial slots would be diametrically opposed from one another in between the diametrically opposed bumps (36) of the tubular body (30) of Brunel to provide a desired amount of flexibility to the body (30).
Claim(s) 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Brunel in view of Jansen in view of Brunel (U.S Patent No. 5855839, “Brunel 2”).
Regarding claim 9, Brunel discloses the safety device of claim 1, as discussed above.
However, Brunel fails to disclose (Claim 9) wherein the body has a first axial slot extending from a distal end of the body, and the bump is circumferentially distant from said first axial slot.
Jansen discloses a safety device (14) for an injection device (10 in Fig. 1) comprising a tubular body (26) and a needle cover (28), wherein the tubular body (26) comprises a bump (48 in Fig. 1) that abuts against a distal abutment surface (distal surface of 58) of the needle cover (28) in the retracted position (see Fig. 3 and para. 0041). Jansen teaches (Claim 9) 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).
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 tubular body taught by Brunel to incorporate a first axial slot circumferentially distant from the bump as taught by Jansen to provide a desired amount of flexibility to the tubular body (see para. 0037). In combination, a first axial slot would be incorporated into the tubular body (30) and be circumferentially distant from the diametrically opposed bumps (36).
However, modified Brunel fails to disclose (Claim 9) the first axial slot extending from a distal end of the body.
Brunel 2 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 2 teaches (Claim 9) 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 2 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 Brunel in view of Jansen to extend from the distal end of the body as taught by Brunel 2 to provide the distal end of the tubular body with a desired radial flexibility. This would be advantageous to modified Brunel 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, Brunel discloses the safety device of claim 1, as discussed above. However, Brunel fails to disclose (Claim 15) wherein the body has a first axial slot extending from a distal end of said body, the first axial slot having a predetermined length comprised between 1 mm - 6 mm.
Jansen teaches (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).
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 tubular body taught by Brunel to incorporate a first axial slot with a predetermined length as taught by Jansen to provide a desired amount of flexibility to the tubular body (see para. 0037). In combination, a first axial slot would be incorporated into the tubular body (30) with a predetermined length to achieve a desired flexibility.
However, modified Brunel 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). In combination, Brunel is modified to have the first axial slot of Jansen which it would be obvious to have a predetermined length between 1 mm – 6 mm as a matter of routine optimization.
However, modified Brunel fails to disclose (Claim 15) the first axial slot extending from a distal end of said body.
Brunel 2 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 2 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 modified Brunel to extend from the distal end of the body as taught by Brunel 2 to provide the distal end of the tubular body with a desired radial flexibility. This would be advantageous to modified Brunel 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) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Brunel.
Regarding claim 10, Brunel discloses the safety device of claim 1, as discussed above.
Brunel discloses the limitations of (Claim 10) wherein the bump (36) extends in a circumferential direction according to a central angle (see Fig. 7-8 – the cantilevered portions 34 and 36 and the bumps 36 extend to some degree in the circumferential direction within their U-shaped cut-outs according to a central angle).
However, Brunel does not explicitly disclose the central angle comprised between 22.5º-45º.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Brunel to have a bump that extends in the circumferential direction according to a central angle comprised between 22.5º-45 since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the bump of the tubular body of Brunel would not operate differently within the claimed circumferential extent as the bumps only must be diametrically opposed which is still appropriate with the claimed dimension. Further, providing a bump that extends to the claimed degree would provide increased surface area for engaging the needle cover and locking it in the retracted position until a force overcomes the engagement.
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, 18/088217, 18/088128, 18/088115, 18/088089, 18/088077, 18/087944, 18/088178, 18/087983. 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
7
14
18/088006
8
15
18/087940
9
6
18/088217
7
12
18/088128
7
7
18/088115
8
5
18/088089
7
10
18/088077
8
9
18/087944
8
8
18/088178
9
11
18/087983
8
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 claim which are essentially species claims.
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, 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 5-6, 11-14, and 16 except for “wherein the bump has a cantilevered.”
Brunel discloses a safety device for an injection device (see Fig. 7-8), wherein the needle cover (39) includes a distal abutment surface (41a in Fig. 7), said distal abutment surface (41a in Fig. 7) abutting against a proximal abutment surface (36a in Fig. 7) of a bump (36 in Fig. 7-8) protruding from the body (30) in the retracted position (Fig. 7) of the needle cover (39, see Col.9, lines 43-51), and wherein the bump (36) has a cantilevered portion (34, 35, see Fig. 8 and Col.9, lines 23-30 – the bumps 36 are each formed on a cantilevered tab 34 and 35).
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 cantilevered portion 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 cantilevered portion that naturally radially expands allows for the safety device to be biased into a locking engagement upon loading of the retainer and spring, which ensures upon the activation force displacing the retainer, that the needle cover will be extended (see Col.4, lines 41-49). Further, cantilevered portions that naturally radially expand prevents the injection device from being reused once the retainer has been displace (see Col.4, lines 50-55).
Examiner notes, regarding claims 2-4, similar reasoning would further make obvious the limitations of claims 2-4, as outlined in the 102 rejection in view of Brunel above. As such, claims 2-4 are rejected for double patenting over all of the noted 11 copending applications in view of Brunel.
Examiner notes, regarding claim 8, similar reasoning would further make obvious the limitations of claim 8, as outlined in the 103 rejection over Brunel in view of Jansen above. As such, claim 8 is rejected for double patenting over all of the noted 11 copending applications in view of Brunel in view of Jansen.
Examiner notes, regarding claims 9 and 15, similar reasoning would further make obvious the limitations of claims 9 and 15, as outlined in the 103 rejection over Brunel in view of Jansen in view of Brunel 2. As such, claims 10 and 15 are rejected for double patenting over all of the noted 11 copending applications in view of Brunel in view of Jansen in view of Brunel 2.
Examiner notes, regarding claim 10, similar reasoning would further make obvious the limitations of claim 10, as outlined in the 103 rejection over Brunel above. As such, claim 11 is rejected for double patenting over all of the noted 11 copending applications in view of Brunel.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 5:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.M.T./Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783