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
Examiner notes upon further consideration, the Species requirement for Species C has been withdrawn. It is has been determined from the disclosure that the locking mechanism between the wings 57 and hooks 46 in Fig. 10-14a and the locking mechanism between arm 70 and hooks 46 in Fig. 11-11a are not mutually exclusive. Therefore, the Species requirement of Species C has been withdrawn.
Examiner further notes that claim 3 is withdrawn due to being drawn to nonelected Species B1 (i.e. the two wings 36 extending laterally from a radially oriented wall 34 of the locking member 32 are only present in the embodiments with leg 21 of Species B1, see Fig. 1-9).
Claims 3, 6, 11, 14-15, and 17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/20/2026.
Examiner notes that applicant’s election is being interpreted as Species A2 and Species B2, and that the recitation in the “Remarks” filed on 05/20/2026 stating “Applicant hereby elects Species A1, encompassing claim 13, with traverse” is a typo intended to state Species A2, encompassing claim 13.
Applicant's election with traverse of Species A2 and Species B2 in the reply filed on 05/20/2026 is acknowledged. The traversal is on the ground(s) that there would be no serious search and/or examination burden between Species A and Species B. 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 inventions, such as those in the present application, normally require additional reference material and further discussion for each additional invention examined. Concurrent examination of multiple inventions would thus typically involve a significant burden even if all searches were coextensive.
The requirement is still deemed proper and is therefore made FINAL.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
reference character “50” has been used to designate both “the one or more guiding tabs” as seen at least in Fig. 13a and 15-15a and as a different structure as seen at least in Fig. 11a-12.
reference character “55” has been used to designate both “the longitudinal tongue” as seen in at least Fig. 12-12a and as a different structure as seen at least in Fig. 14-14a.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “31” in Fig. 10, 10a, and 11. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
P.12, line 13, the phrase “the annular head 12” should read “the annular head 14” for the propre reference number.
Appropriate correction is required.
Claim Objections
Claims 2, 5, 9, 12, 16, and 20 are objected to because of the following informalities:
Regarding claim 2, the phrase “at least one locking hooks“ in lines 1-2 should read “at least one locking hook” to remove the “s” for proper grammar,
Regarding claim 2, the phrase “at least one wings” in line 3 should read “at least one wing” to remove the “s” for proper grammar,
Regarding claim 5, the phrase “into on opening provide on the tubular body” in lines 2-3 should read “into an opening provided on the tubular body” for proper grammar,
Regarding claim 9, the phrase “wherein at least one the hinges is a living hinge” in lines 1-2 should read “wherein at least one of the proximal hinge, the distal hinge, and the intermediate hinge is a living hinge” for proper grammar and proper antecedent basis,
Regarding claim 12, the phrase “the finger receiving member (comprises” should remove the parantheses,
Regarding claim 16, the phrase “the locking hooks” in line 3 should read “the at least one locking hook” for proper antecedent basis,
Regarding claim 20, the phrase “a barrel comprising with a flange at its proximal end” in lines 1-2 should read “a barrel comprising a flange at its proximal end” to remove the term “with” for proper grammar,
Regarding claim 20, the phrase “distally convergent configured” in line 4 should read “distally convergent and configured” for proper grammar,
Regarding claim 20, “the phrase “the actuations arms in a collapsed position” in line 5 should read “the actuation arm in the collapsed position” to remove the “s” and add “the” for proper antecedent basis,
Appropriate correction is required.
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 locking means for maintaining the actuation arm in a collapsed position” claim 1 and claim 20,
“a locking means for maintaining the actuation arm in an extended position” in claim 1,
“the locking member” in claim 4,
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 locking means for maintaining the actuation arm in a collapsed position” in claim 1 and claim 20, 112(f) is invoked because: (i) it uses a generic placeholder (means), (ii) it is coupled with functional language (locking), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 9 and p.9, line 33 – p.10, line 4 disclose the tubular body 12 comprises legs 21 each having a ramped catch 22, wherein, when the tubular body 12 is pushed in the proximal direction to move into the collapsed position, “the catch 22 locks against the free end of the proximal ring 25 achieving an appropriate retention of the tubular body 12 onto the annular ring 14”. In the embodiment of Fig. 10-10a and p.12, lines 19-23, another locking means is disclosed wherein the longitudinal finger receiving plate 29 comprises corrugations 52 which engage with a transverse rib 53 on the tubular body 12 to hold the safety device in a locked state in its collapsed position. In the embodiment of Fig. 11-11a and p.13, lines 11-21, another locking means is disclosed wherein the distal link 40 comprises an arm 70 having a tab 71 at its free end for engaging with the at least one locking hooks 46 and providing a supplemental retaining force when the safety device is in a locked state in its collapsed position. In the embodiment of Fig. 12-14a and p.13, lines 1-10, another locking means is disclosed wherein the longitudinal tongue 55 comprises teeth 63 and 64 for engaging in respective openings 61 in the guiding walls 59 of tubular body 12 providing a supplemental retaining force when the safety device is in a locked state in its collapsed position. In the embodiment of Fig. 15-16a and p.13, lines 22-26, another locking means is disclosed wherein the annular head 14 comprises a tab 75 having a transverse corrugation 76 for engaging with a rib 77 on the tubular body 12 to provide an axial locking force when the safety device is in the collapsed position. Examiner is interpreting the locking means for maintaining the actuation arm in a collapsed position as a structure of the safety device such as a catch or equivalent structure that can function as a catch for locking the actuation arm in a collapsed position.
Regarding “a locking means for maintaining the actuation arms in an extended position” in claim 1, 112(f) is invoked because: (i) it uses a generic placeholder (means), (ii) it is coupled with functional language (locking), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. In at least Fig. 9 or Fig. 13a and p.11, lines 4-10 disclose that the proximal link 39 of the actuation arm 16 comprises a locking hook 46 which is sized and shaped to create a snap fit engagement with the wings 36 of the projecting locking member 32 to maintain the actuation arm 16 in its extended position. Examiner is interpreting the locking means for maintaining the actuation arms in an extended position as a structure of the safety device such as a hook or equivalent structure that can form a snap fit engagement.
Regarding “the locking member” in claim 4, 112(f) is invoked because: (i) it uses a generic placeholder (member), (ii) it is coupled with functional language (locking), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Fig. 9 and Fig. 12a and p. 8, lines 19-28 discloses a projecting locking member 32 which extends from the shoulder 24 and the distal ring 23 of the annular head 34. The locking member 32 comprises the at least one wing 36 for snap fit engagement with the at least one locking hook 46. Examiner is interpreting this limitation as a projecting structure from the annular head comprising at least one wing or an equivalent structure.
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 1-20 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 1, the phrase “a collapsed position in which the tubular body is maintained in a position proximally close to the flange uncovering the needle” in lines 11-12 renders the claim indefinite because it is unclear. It is unclear the scope of the collapsed position. It is unclear whether the flange is what is uncovering the needle, if the collapsed position uncovers the needle, or if the needle is just in an uncovered state in said position. Examiner is interpreting this limitation as a collapsed position where the tubular body is maintained in a position where its proximal end is adjacent the annular head and thus the flange therein and where the needle is in an uncovered state. Examiner suggests applicant amend to recite “a collapsed position in which the tubular body is maintained in a position proximally close to the flange and the needle is uncovered.”
Regarding claim 1, the phrase “an extended position in which the tubular body is maintained in a position distally distant from the annular head shielding the needle” in lines 12-14 renders the claim indefinite because it is unclear. It is unclear whether the annular head is what is shielding the needle or if the extended position shields the needle. Examiner is interpreting it as the latter. Examiner suggests applicant amend to recite “an extended position in which the tubular body is maintained in a position distally distant from the annular head and the needle is shielded.”
Claim 2 recites the limitation "the locking member" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 2, the phrase “wherein the proximal link comprises at least one locking hooks configured and sized to enter into resilient snap fit engagement with at least one wings protruding from the annular head to maintain the actuation arm in the extended position” in lines 1-4 renders the claim indefinite because it is unclear. It is unclear, in light of claim 1 and the 112(f) interpretation above of the “locking means for maintaining the actuations arms in the extended position”, whether the at least one locking hook and at least one wing are separate structures from the locking means of claim 1 or the locking means of claim 1 comprises these structures. From the specification, the locking means appears to comprise the at least one locking hook in snap fit engagement with the at least one wing as discussed above in the 112(f) interpretation. Examiner is interpreting this limitation as the locking means of claim 1 for maintaining the actuation arms in the extended position comprises at least one hook disposed on the proximal link of said actuation arms and configured and sized to enter into resilient snap fit engagement with at least one wing protruding from the annular head to maintain the actuation arm in the extended position. Examiner suggests applicant amend the claim to state “wherein the proximal link comprises at least one locking hook configured and sized to enter into resilient snap fit engagement with at least one wing protruding from the annular head, wherein the at least one locking hook forms the locking means for maintaining the actuation arm in the extended position.”
Regarding claim 5, the phrase “wherein the longitudinal tongue comprises at least one tooth configured and sized to engage into on opening provide on the tubular body” in lines 1-3 renders the claim indefinite because it is unclear. It is unclear, in light of claim 1 and the 112(f) interpretation above of the “locking means for maintaining the actuations arm in the collapsed position”, whether the longitudinal tongue and its teeth are a separate structure from the locking means of claim 1 or the locking means of claim 1 comprises these structures. From the specification, the locking means appears to comprise the longitudinal tongue and its teeth as discussed above in the 112(f) interpretation. Examiner is interpreting this limitation as the locking means of claim 1 for maintaining the actuation arm in the collapsed position comprises a longitudinal tongue comprising at least one tooth configured and sized to engage into an opening provided on the tubular body to maintain the actuation arm in the collapsed position. Examiner suggests applicant amend the claim to state “wherein the longitudinal tongue comprises at least one tooth configured and sized to engage into on opening provide on the tubular body, wherein the at least one tooth forms the locking means for maintaining the actuation arm in the collapsed position.”
Claim 7 recites the limitation "the plan" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 7, the phrase “wherein the intermediate hinge inwardly overtakes the plan defined by the proximal hinge and distal hinge” in lines 1-2 renders the claim indefinite because it is unclear. The scope of this limitation cannot be ascertained based upon the disclosure, i.e. Fig. 5-6 and p.11, lines 11-13. It is unclear what overtaking the plan would consist of. Examiner is interpreting this limitation as the intermediate hinge moves inwardly relative to the proximal and distal hinges.
Claim 12 recites the limitation "the finger receiving member" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner notes it is further unclear whether the finger receiving member of claim 12 is the same as the aforementioned “one finger resting arrangement” in claim 1 or a different structure. Examiner is interpreting it as the same.
Regarding claim 13, the phrase “wherein the longitudinal finger receiving plate comprises at least on corrugation configured to engage onto a rib protruding from the tubular body when the actuation arm is in its collapsed state” in lines 1-3 renders the claim indefinite because it is unclear. It is unclear, in light of claim 1 and the 112(f) interpretation above of the “locking means for maintaining the actuation arm in the collapsed position”, whether the at least one corrugation is a separate structure from the locking means of claim 1 or the locking means of claim 1 comprises these structures. From the specification, the locking means appears to comprise the at least one corrugation as discussed above in the 112(f) interpretation. Examiner is interpreting this limitation as the locking means of claim 1 for maintaining the actuation arm in the collapsed position comprises at least one corrugation on the longitudinal finger receiving plate configured to engage onto a rib protruding from the tubular body. Examiner suggests applicant amend the claim to state “wherein the longitudinal finger receiving plate comprises at least on corrugation configured to engage onto a rib protruding from the tubular body when the actuation arm is in its collapsed state, wherein the at least one corrugation forms the locking means for maintaining the actuation arm in the collapsed position.”
Claim 16 recites the limitation "the distal link inner face" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, the phrase “wherein the distal link comprises an arm extending from the distal link inner face, having at its free end, a tab configured to enter into resilient snap fit engagement with the locking hooks” in lines 1-3 renders the claim indefinite because it is unclear. It is unclear, in light of claim 1 and the 112(f) interpretation above of the “locking means for maintaining the actuation arm in the collapsed position”, whether the tab is a separate structure from the locking means of claim 1 or the locking means of claim 1 comprises this structure. From the specification, the locking means appears to comprise the tab as discussed above in the 112(f) interpretation. Examiner is interpreting this limitation as the locking means of claim 1 for maintaining the actuation arm in the collapsed position comprises the tab on the free end of the arm extending from the distal link and configured to enter into resilient snap fit engagement with the locking hooks. Examiner suggests applicant amend the claim to state “wherein the distal link comprises an arm extending from the distal link inner face, having at its free end, a tab configured to enter into resilient snap fit engagement with the locking hooks, wherein the tab forms the locking means for maintaining the actuation arm in the collapsed position.”
Claim 19 recites the limitations the junction", “the shoulder”, and “the distal ring” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Regarding claim 20, the phrase “and a piston rod comprising a piston flange fitted with a safety device according to claim 1” in lines 2-3 renders the claim indefinite because it is unclear. It is unclear whether the drug delivery device is fitted with a safety device according to claim 1 or if specifically the piston flange is fitted with said safety device. If the latter is the case, this configuration is unclear based upon the disclosure as the safety device is not depicted or discussed as being fitted to the piston flange. Examiner is interpreting this limitations as the former scenario and suggests amending to state “and a piston rod comprising a piston flange, wherein the drug delivery device is fitted with a safety device according to claim 1”.
Regarding claims 4, 8-10, and 18, these claims are rejected due to their dependency upon a rejected base claim.
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.
Claim(s) 1, 7, 9, 10, 12, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Holland et al. (U.S Patent Pub. No. 20200316311 A1, “Holland”) in view of Wilkinson (U.S Patent Pub. No. 20050159709 A1) in view of Verespej et al. (U.S Patent Pub. No. 20140039406 A1, “Verespej”) in view of Parmigiani (U.S Patent No. 6719731 B1).
Regarding claim 1, Holland discloses the limitations of (Claim 1) a safety device (see Fig. 7-8c) for mounting onto a drug delivery device having a barrel comprising a flange at its proximal end and an injection needle at its distal end, and a piston rod comprising a piston flange (see para. 0090 – the safety syringe apparatus is fitted to a syringe and is thus capable of being configured for mounting to the claimed drug delivery device having the structures of a conventional syringe), the safety device comprising:
a tubular body (700 in Fig. 7) extending along a longitudinal axis (see Fig. 7), the tubular body (700) being configured to receive the barrel (see Fig. 7),
an annular head (see annotated Holland drawing for head and para. 0091-0092 – arms 770a-b are fixed to points 772a-b which are fixed with respect to the barrel of the syringe, the structure attached to points 772a-b and annularly extending between the arms 770a-b is annotated below is interpreted as the annular head),
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one actuation arm (770b in Fig. 7-8c) connecting the tubular body (700) and the annular head (see annotated Holland drawing 1 above for head and para. 0091-0092 – the lever arm 770b is connected between tubular body 700 and a point 772b fixed in relation to the barrel of syringe which is interpreted as the annular head), said actuation arm (770b) having a proximal link (proximal 771 in Fig. 8b) connected to the annular head by a proximal hinge (772b in Fig. 8a-8b) and a distal link (distal 771 in Fig. 8b) connected to the tubular body (700) by a distal hinge (see annotated Holland drawing 1 above and para. 0092), the proximal link (proximal 771) and the distal link (distal 771) being connected by an intermediate hinge (see annotated Holland drawing 1 above for intermediate hinge), the actuation arm (770b) being movable between a collapsed position (see Fig. 7) in which the tubular body (700) is maintained in a position proximally close to the flange uncovering the needle and an extended position (see Fig. 8c) in which the tubular body (700) is maintained in a position distally distant from the annular head shielding the needle (see annotated Holland drawing 1 above for head, see Fig. 7 and para. 0091 – collapsed position in Fig. 7 has the proximal end of the tubular body 700 maintained adjacent to distal end of the syringe barrel and the needle is uncovered, see Fig. 8b and para. 0096 – extended position in Fig. 8c has the tubular body 700 separated distally from the head and the needle is shielded).
However, Holland fails to disclose (Claim 1) an annular head configured to abut against the flange, one finger arresting arrangement connected to the annular head, a locking means for maintaining the actuation arms in a collapsed position and a locking means for maintaining the actuation arms in an extended position.
Wilkinson discloses a safety shield assembly (70 in Fig. 1-4) for a syringe assembly (20 in Fig. 1-4), wherein the safety shield assembly (70) comprises a rear section (56 in Fig. 4, analogous to the head arrangement) of an outer shield (50) having latching projections (84 in Fig. 4) configured to abut against a flange (90 in Fig. 4) of a syringe barrel (24 in Fig. 4, see para. 0029 and 0033).
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 annular head taught by Holland to incorporate the latching projections of the head arrangement of Wilkinson to yield an annular head configured to abut against the flange. Wilkinson teaches that the latching projections secure the barrel of the syringe in a proper location and orientation relative to the needle cover (see para. 0030-0034).
Verespej discloses a safety device (100 in Fig. 1-2) for mounting on a prefilled syringe (300 in Fig. 1 and 4), wherein the safety device (100) comprises a tubular body (120 in Fig. 1-2), a head arrangement (proximal end of 110 in Fig. 6), and two actuation arms therebetween (see Fig. 6 and 25-26 - the two longitudinally extending arms from the proximal end of structure 110 which couple at their distal ends to tubular body 120). The tubular body (120) and structure (110) and its arms are movably connected between a collapsed configuration (see Fig. 5 and 9) and an extended configuration (see Fig. 26), wherein the safety device (100) comprises locking means for maintaining the actuation arms in the collapsed position (see Fig. 5 and 9, examiner notes the locking means is being interpreted under 112(f) as a catch or equivalent structure that can function as a catch for locking the actuation arm in a collapsed position, see para. 0060 and 0065 – trigger fingers 121 comprise a catch at their free ends that locks onto a seat 110 of the head arrangement to lock the structure 110 in its collapsed configuration).
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 safety device taught by modified Holland to incorporate a trigger finger as taught by Verespej such that the tubular body of Holland would comprise a trigger finger for locking onto the annular head of Holland in the collapsed position. Verespej teaches that a safety device comprising the trigger fingers discussed above ensures that the needle of the syringe is exposed for use until the plunger of said syringe is fully depressed and thus incidental actuation of safety device is prevented (see para. 0061).
Parmigiani discloses a collapsible needle cover (1 in Fig. 1-10) comprising two actuation arms formed from segments (21, 22 in Fig. 1), wherein the actuation arms are configured to hinge between a collapsed position (see Fig. 3) and an extended position (see Fig. 7, see Col.4, lines 59-65). Parmigiani teaches (Claim 1) one finger arresting arrangement (23 in Fig. 1 and 10) connected to the annular head (30 in Fig. 1, see Col.6, lines 10-30 – elements 30 are finger rests as seen in Fig. 10 which are connected to segment 21 of the actuation arms and thus indirectly connected to the base portion 30 where arms are hinged to), and wherein the cover (1) comprises locking means for maintaining the actuation arm in the extended position (see Fig. 7, examiner notes the locking means is interpreted under 112(f) as a structure of the safety device such as a hook or equivalent structure that can form a snap fit engagement, see Fig. 1 and 7, see Col.5, lines 25-34 – segments 21 comprise extensions 41 having at their free ends a tooth 43 configured to snap-engage onto the opposing segment 21 at the seat 431 to lock the segments 21, 22 in their extended position in Fig. 7).
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 safety device taught by modified Holland to incorporate the finger resting arrangement and locking tooth as taught by Parmigiani such that the actuation arms of Holland would the finger resting arrangement for actuation of the safety device and comprise a locking catch and notch, respectively, for a snap-fit engagement in the extended position. Parmigiani provides that the textured finger resting arrangements facilitate the user’s fingers pressing on the hinged joints of the safety device in a non-slip manner to change the position of the safety device (see Col. 4, lines 53-58). Parmigiani further provides that the snap-engagement elements ensure a firm and secure locking of the arm segments in their extended position and thus shielding of the needle (see Col.6, lines 42-50).
Regarding claim 7, modified Holland discloses the safety device of claim 1, as discussed above. In modified Holland, Holland discloses (Claim 9) wherein the intermediate hinge inwardly overtakes the plan defined by the proximal hinge (772a, 772b) and distal hinge when the actuation arm (770a, 770b) is in its extended position (examiner notes this limitation is being interpreted as the intermediate hinge moves inwardly relative to the proximal and distal hinges, see Fig. 8c and annotated Holland drawing 1 above for hinges).
Regarding claim 9, modified Holland discloses the safety device of claim 1, as discussed above. In modified Holland, Holland discloses (Claim 9) wherein at least one the hinges is a living hinge (see annotated Holland drawing 1 above for distal and intermediate hinge and para. 0092 and 0095 – the intermediate and distal hinges are integral hinges with the arms 770a and 770b formed from a thinner, cut-out in the arms 770a and 770b).
Regarding claim 10, modified Holland discloses the safety device of claim 1, as discussed above. In modified Holland, Wilkinson discloses (Claim 10) wherein the annular head (56 in Fig. 4) comprises at least one locking tab (84 in Fig. 5) configured to retain the flange (90 in Fig. 4, see para. 0029 and 0033).
Regarding claim 12, modified Holland discloses the safety device of claim 1, as discussed above. In modified Holland, Parmigiani discloses (Claim 12) wherein the finger receiving member (23 in Fig. 1 and 10) (comprises a longitudinal finger receiving plate and a radial finger receiving plate (see annotated Parmigiani drawing 1 below).
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Regarding claim 18, modified Holland discloses the safety device of claim 1, as discussed above. Examiner notes, the limitation “formed in a single shot injection molded process” is considered a product-by-process limitation. It is noted by the examiner that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself and does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 227 USPQ 964. Therefore, as the injection molding process does not impart a physical limitation which differentiates over the prior art, the safety device of modified Holland is considered as reading on the claim.
Regarding claim 20, modified Holland discloses the safety device according to claim 1. In modified Holland, Holland discloses safety devices (see Fig. 1-8c) for fitting on conventional syringes (see at least Fig. 2a) such that Holland discloses (Claim 20) a drug delivery device having a barrel comprising with a flange at its proximal end and an injection needle (126 in Fig. 1 and 2a) at its distal end (see Fig. 1-2a), and a piston rod (116 in Fig. 1-2a) comprising a piston flange (see Fig. 1-2a for the conventional syringe structures).
In modified Holland, Vesperej discloses (Claim 20) wherein the piston flange (142 in Fig. 15) comprises a ramped surface (143 in Fig. 15) distally convergent configured to outwardly deflect the locking means maintaining the actuation structure (110) in a collapsed position (see Fig. 15 and 28 and para. 0065 – plunger head 142 has an angled surface 143 that is at the plunger head’s distal end such that it is distally convergent, angled surface 143 outwardly deflects the catch of trigger fingers 121 which maintain the actuation structure 110 in its collapsed position).
Claim(s) 8 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Holland in view of Wilkinson in view of Verespej in view of Parmigiani as applied to claim 1 above, and further in view of Chelak et al. (U.S Patent Pub. No. 20070239117 A1, “Chelak”).
Regarding claim 10, modified Holland discloses the safety device of claim 1, as discussed above. However, modified Holland, fails to disclose (Claim 8) wherein the annular head comprises a proximal ring and a distal ring jointed by a shoulder whereon the flange abuts.
Chelak discloses a safety device (200 in Fig. 39) for mounting to a syringe assembly (212 in Fig. 39), wherein the safety device (200) comprises a tubular body (214 in Fig. 39) and an annular head (247 in Fig. 39 and 41, see para. 0099 and 0102). Chelak teaches (Claim 8) wherein the annular head (247) comprises a proximal ring (252 in Fig. 41) and a distal ring jointed by a shoulder (258 in Fig. 41) wherein the flange (232 in Fig. 39) abuts (see Fig. 41 and para. 0102 – “When injection device 212 is secured within head 247 of inner sheath 216, flats 258 of head 247 engage flats sidewalls 232a (FIG. 39) of proximal flange 232 of syringe body 224 to prevent rotation of syringe body 224 within inner sheath 216, thus when the sidewalls 258 are engaged, said shoulder 258 joins the proximal ring 252 and a distal ring formed from the remaining distal portion of head 247 distal of said shoulder).
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 annular head taught by modified Holland to have a distal ring, proximal ring, and shoulder joining them with the flange abutting the shoulder as taught by Chelak. Chelak teaches that the flange of the syringe is frictionally retained within the annular head by the indented portion (258, see para. 0102), and thus a frictional engagement alongside the locking engagement of modified Holland would yield an even more secure seating of the syringe within the safety device.
Regarding claim 19, modified Holland discloses the safety device of claim 1, as discussed above.
However, modified Holland fails to disclose (Claim 19) wherein the safety device comprises at least one recess positioned at the junction between the shoulder and the distal ring.
Chelak teaches (Claim 19) wherein the safety device (200) comprises at least one recess positioned at the junction between the shoulder (258 in Fig. 41) and the distal ring (see Fig. 41 and annotated Chelak drawing 1 below and para. 0102 – adjacent the shoulder 258 is a recessed portion relative to the shoulder 258 which is positioned at a junction between said shoulder 258 and the distal ring formed from the remaining distal portion of head 247 distal of said shoulder).
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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 annular head taught by modified Holland to have the shoulder and recess adjacent thereto as taught by Chelak. Chelak teaches that the flange of the syringe is frictionally retained within the annular head by the indented portion (258, see para. 0102). Examiner notes that the indented portion (258) requires a recess adjacent thereto in order to extend inwardly and engage the flange. Thus, a frictional engagement alongside the locking engagement of modified Holland would yield an even more secure seating of the syringe within the safety device.
Double Patenting
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.
Claims 1, 7-11, 18, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9-12, and 20 of copending Application No. 18/383,748 in view of Haber et al. (U.S Patent No. 4935013). See Table below for claim mapping.
Claim # of Instant App.
(18/383,628)
Claim # of Reference App. (18/383,748)
1
1
7
9
8
10
9
2
10
11
11
12
18
3
20
20
Claim 1 of the instant application and claim 1 of the reference application both claim a safety device for mounting onto a drug delivery device incorporating all of the same limitations except the instant application claims “an annular head”, “one finger resting arrangement connected to the annular head” and “a locking means for maintaining the actuations arms in an extended position” and the reference application does not disclose these limitations.
Haber discloses a collapsible needle cover (1 in Fig. 1-5) comprising two actuation arms formed from segments (6-1, 6-2 in Fig. 1-2), wherein the actuation arms are configured to hinge between a collapsed position (see Fig. 1 and 4) and an extended position (see Fig. 1 and 5, see Col.5, lines 1-26). Haber teaches wherein the cover (1) comprises an annular head (10 in Fig. 1, see Col.3, lines 55-59), one finger resting arrangement (14 in Fig. 1-2) connected to the annular head (10, see Fig. 6-7 for finger resting), and locking means for maintaining the actuation arms in the extended position (see Fig. 5, examiner notes the locking means is interpreted under 112(f) as a structure of the safety device such as a hook or equivalent structure that can form a snap fit engagement, see Col.5, lines 1-26 – locking catch 16 is a hook-like structure that snaps onto the notch 20 to maintain the arms in the extended position in Fig. 5).
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 safety device of the reference application to have an annular head arrangement, finger resting arrangement, and a locking catch as taught by Haber such that the actuation arms of the reference application would comprise a locking catch and notch, respectively, for a snap-fit engagement in the extended position. Haber teaches that the arms (14) allow a user to transfer motion to the needle-cover segments and the locking catch and notch engagement forms a releasable and reliable mechanism for retaining the needle cover in the open, expanded configuration allowing for operation of the syringe for infusion into the patient (see Col.5, lines 13-26).
Claims 1-3, 7-11, and 18-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7, 9-10, 12-14, and 20 of copending Application No. 18/383,722 in view of Haber et al. (U.S Patent No. 4935013). See Table below for claim mapping.
Claim # of Instant App. (18/383,628)
Claim # of Reference App. (18/383,722)
1
1
2
6
3
7
7
9
8
10
9
2
10
12
11
13
18
3
19
14
20
20
Claim 1 of the instant application and claim 1 of the reference application both claim a safety device for mounting onto a drug delivery device incorporating all of the same limitations except the instant application claims “an annular head” and “one finger resting arrangement connected to the annular head” which the reference application does not disclose.
Haber discloses a collapsible needle cover (1 in Fig. 1-5) comprising two actuation arms formed from segments (6-1, 6-2 in Fig. 1-2), wherein the actuation arms are configured to hinge between a collapsed position (see Fig. 1 and 4) and an extended position (see Fig. 1 and 5, see Col.5, lines 1-26). Haber teaches wherein the cover (1) comprises an annular head (10 in Fig. 1, see Col.3, lines 55-59), and one finger resting arrangement (14 in Fig. 1-2) connected to the annular head (10, see Fig. 6-7 for finger resting).
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 safety device of the reference application to have an annular head arrangement and finger resting arrangement as taught by Haber. One of ordinary skill in the art would have recognized that modifying the head arrangement of the reference application to have an annular shape would have been obvious according to known methods to yield predictable results. Haber further teaches that the arms (14) allow a user to transfer motion to the needle-cover segments for moving said segments between positions (see Col.5, lines 1-26).
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/K.M.T./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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