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
Claims 8 and 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.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 05/21/2026.
Examiner notes for the purposes of examination, the phrase “wherein the proximal link comprises two orthogonal finger plates” in claim 11 is interpreted as the distal link comprises two orthogonal finger plates as supported by at least Fig. 3 and p.8, lines 9-14 in the spec.
Applicant's election with traverse of claims 8 and 15-19 in the reply filed on 05/21/2026 is acknowledged. The traversal is on the ground(s) that there would have been no serious search and/or examination burden between Species 1 and 2 and also between Species A1, B1, and C1. 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 under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “the proximal link comprises two orthogonal finger plates” in claim 11 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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: “29a” and “30a” in Fig. 18. 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 abstract of the disclosure is objected to because it is over 150 words. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 1 and 20 are objected to because of the following informalities:
Regarding claim 1, the phrase “and to lock into the flange“ in lines 6-7 should read “and to lock onto the flange” for proper grammar,
Regarding claim 1, the phrase “a collapsed position” in line 16 and “an extended position” in line 17 should read “the collapsed position” and “the extended position” for proper antecedent basis,
Regarding claim 1, the phrase “a locking means” in line 17 should read “a second locking means” for clarity,
Regarding claim 20, the phrase “a barrel comprising with a flange” in line 1 should read “a barrel comprises a flange” to remove the term “with” for proper grammar,
Regarding claim 20, the phrase “a collapsed position” in line 5 should read “the collapsed position” 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 arms in a collapsed position” in line 16 of claims 1 and claim 20,
“a locking means for maintaining the actuation arms in an extended position” in line 17 of 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 locking means for maintaining the actuation arms in a collapsed position” in line 16 of 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. 7 and p.9, lines 9-19 disclose the tubular body 12 comprises legs 21 each having a ramped catch 22. 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 as illustrated in Fig. 7”. Examiner is interpreting the locking means for maintaining the actuation arms 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 arms in a collapsed position.
Regarding “a locking means for maintaining the actuation arms in an extended position” in line 17 of 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. Fig. 14-15, p.8, lines 3-8, and p.11, lines 6-10 disclose that the proximal links 39 of the actuation arms 16 each comprise locking hooks 46 which are sized and shaped to create a snap fit engagement with the wings 36 of the projecting locking member 32. Additionally, “at the end of the pushing on the actuation arms 16, the two locking hooks 46 lock into the wings 36 of the projecting locking member 32 and maintained the actuation arms 16 in their respective extended positions”. 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.
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 1-7, 9-14, and 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 “at least two actuations arms “and “the actuation arm” create a lack of antecedent basis issue because it’s unclear which actuation arm of the at least two actuation arms, “the actuation arm” encompasses. Therefore, the claim scope is unclear based on the lack of antecedent basis. Claim 6 is also rejected for the aforementioned antecedent basis issue discussed above. Examiner notes “the at least two actuation arms”, “the actuation arms”, or “said actuation arms” are all acceptable recitations of the limitation.
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 12-14 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 as seen in Fig. 11 where the tubular body is maintained in a position where its proximal end is adjacent the head arrangement 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 head arrangement shielding the needle” in lines 14-15 renders the claim indefinite because it is unclear. It is unclear whether the head arrangement 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 head arrangements and the needle is shielded.”
Claim 5 recites the limitation "the relaxed position" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6, the phrase “wherein the proximal links comprise 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 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. Thus, it is further unclear whether the locking means of claim 1 should be interpreted as the at least one locking hook, at least one wing, or both structures having the snap-fit engagement therebetween. 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 links of said actuation arms comprise 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 said actuation arms in the extended position.”
Claim 6 recites the limitation "the annular head" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting the head arrangement of claim 1 to comprise an annular head.
Regarding claim 7, the phrase “wherein the head arrangement comprises an annular head comprising a locking member which comprises a radially oriented wall and two wings extending laterally from the wall” 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 arms in the extended position”, whether the two wings 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. Thus, it is further unclear whether the locking means of claim 1 should be interpreted as the at least one locking hook, at least one wing, or both structures having the snap-fit engagement therebetween. 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.
Claim 9 recites the limitation "the plan" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, 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. 15 and p.11, lines 14-16. 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 10 recites the limitation "the annular head" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting the head arrangement of claim 1 to comprise an annular head.
Claim 12 recites the limitation "the annular head" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting the head arrangement of claim 1 to comprise an annular head.
Claim 13 recites the limitation "the annular head" in line 3 and line 5. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting the head arrangement of claim 1 to comprise an annular head.
Regarding claim 13, the phrase “wherein the tubular body comprises a leg extending in cantilever and having a catch at its free end” in lines 1-2 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 collapsed position”, whether the leg and its catch 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 leg and its catch 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 collapsed position which comprises a leg extending in cantilever and having a catch at its free end. Examiner suggests applicant amend the claim to state “where the tubular body comprises the locking means for maintaining the actuation arms in the collapsed position, wherein the locking means comprises a leg extending in cantilever from the tubular body and having a catch at its free end”.
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 2-4, 11, and 14, these claims are rejected due to their dep
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) 1-3, 9, 11-13, 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 Haber et al. (U.S Patent No. 4935013).
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),
a head arrangement (see annotated Holland drawing for head arrangement 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 annotated below is interpreted as the head arrangement),
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at least two actuation arms (770a, 770b in Fig. 7-8c) connecting the tubular body (700) and the head arrangement (see annotated Holland drawing 1 above for head arrangement and para. 0091-0092 – two lever arms 770a-b are connected between tubular body 700 and a point 772a-b fixed in relation to the barrel of syringe which is interpreted as the head arrangement), said actuation arms (770a-b) having a proximal link (proximal 771 in Fig. 8b) connected to the head arrangement by a proximal hinge (772a, 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 (770a, 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 head arrangement shielding the needle (see annotated Holland drawing 1 above for head arrangement, 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 arrangement and the needle is shielded).
However, Holland fails to disclose (Claim 1) a head arrangement configured to abut against the flange and to lock into the flange, 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) and lock onto said flange (90, see Fig. 4 and 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 head arrangement taught by Holland to incorporate the latching projections of the head arrangement of Wilkinson to yield a head arrangement configured to abut against the flange and to lock onto 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 arms 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 the trigger fingers as taught by Verespej such that the tubular body of Holland would comprise the trigger fingers for locking onto the head arrangement 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).
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 (Claim 1) wherein the cover (1) comprises 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 safety device taught by modified Holland to incorporate the locking catch as taught by Haber such that the actuation arms of Holland would comprise a locking catch and notch, respectively, for a snap-fit engagement in the extended position. Haber teaches that 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).
Regarding claim 2, modified Holland discloses the safety device of claim 1, as discussed above. In modified Holland, Holland discloses (Claim 2) wherein at least one of the proximal hinge, distal hinge, or intermediate hinge 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 3, 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 9, modified Holland discloses the safety device of claim 9, 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 11, modified Holland discloses the safety device of claim 1, as discussed above.
However, modified Holland fails to disclose (Claim 11) wherein the proximal link comprises two orthogonal finger plates.
Haber teaches (Claim 11) wherein the proximal link (6-2 in Fig. 1-5) comprises two orthogonal finger plates (14 in Fig. 1-4, see Col.4, lines 9-20 – arms 14 are elongated structures extended perpendicular to the segment 6-2 such that they are two orthogonal plates for manipulation by a user’s fingers).
Since Holland discloses an actuator (702 in Fig. 7-8c) for manually moving the actuation arms (770a-b, see para. 0091), and Haber discloses finger plates (14) for manually moving the actuation arms (see Fig. 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 substituted the actuator of modified Holland for the finger plates of Haber. Both the actuator of Holland and finger plates of Haber are manually operated mechanism for moving the collapsible, actuation arms between positions, and Haber explicitly teaches that the rotatable, motion transferring arms allow a health care worker to manually and selectively move the cover between open and closed configurations (see Col.2, lines 15-20). Thus, one of ordinary skill in the art would have recognized that such a substitution would have been obvious.
Regarding claim 12, modified Holland discloses the safety device of claim 1, as discussed above. In modified Holland, Wilkinson discloses (Claim 12) 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 13, modified Holland discloses the safety device of claim 1, as discussed above. In modified Holland, Verespej discloses (Claim 13) wherein the tubular body (120 in Fig. 1-2) comprises a leg (121 in Fig. 3, 5, and 9) extending in cantilever and having a catch (129 in Fig. 3) at its free end (examiner notes the leg and catch are being interpreted as the locking means of claim 1 as discussed above, see Fig. 5 and 9 and para. 0060-0061 and 0065-0066 – tubular body 120 comprises trigger fingers 121 that are flexible legs fixed at one end and having a free end with a catch 129 structure such that they are cantilevered), the leg (21) being configured to deflect radially outward to allow the catch (129) to slide over the annular head during mounting and to deflect radially inward after mounting completion so that the catch (129) axially retains the tubular body (120) relative to annular head (see Fig. 3 and para. 0060-0061 and 0065 – legs 21 hold tubular body 120 and body 110 which comprises the head arrangement together and legs 21 are flexible, thus legs 21 and their catches 129 are capable of being configured to deflect radially outwardly to slide over the underside of the annular head at the proximal end of body 110 during mounting, see Fig. 22-23 and para. 0060-0061 – legs 21 flex radially inwardly after mounted such that the catch 129 abuts body seat 111 on the annular head).
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) 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Holland in view of Wilkinson in view of Verespej in view of Haber as applied to claim 1 above, and further in view of Jeremijevic (FR Patent Pub. No. 2778571 A1).
Regarding claim 4, modified Holland discloses the safety device of claim 1, as discussed above.
While Holland in modified Holland discloses the actuation arms (770a-b) having the collapsed position and extended position, modified Holland fails to explicitly disclose (Claim 4) a relaxed state in which the actuation arms return from being in the collapsed position or from being in the extended position.
Jeremijevic discloses a collapsible needle guard (10 in Fig. 1-5) having two actuation arms (see Fig. 2) that are hinged between a collapsed position (see Fig. 4) and an extended position (see Fig. 5), wherein Jeremijevic teaches (Claim 4) a relaxed state (see Fig. 3) in which the actuation arms return from being in the collapsed position (see Fig. 4, se para. 05 and 037 – the actuation arms return to their original position in Fig. 3 when the applied force is removed after being in the collapsed position).
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 relaxed state as taught by Jeremijevic such that the flexible actuation arms of Holland would resiliently return to a relaxed state after being in the collapsed or extended positions. Jeremijevic teaches that without applied force, the safety device takes on the relaxed state in Fig. 3 as a safety feature for covering the needle tip (see para. 039).
Regarding claim 5, modified Holland discloses the safety device of claim 1, as discussed above.
While Holland in modified Holland discloses the actuation arms (770a-b) having the proximal link and distal link (see annotated Holland drawing 1 above ) and the collapsed position and extended position, modified Holland fails to disclose (Claim 5) wherein the proximal link and the distal link form an angle between 75º and 105º in the relaxed position.
Jeremijevic discloses a collapsible needle guard (10 in Fig. 1-5) having two actuation arms (see Fig. 2) that are hinged between a collapsed position (see Fig. 4) and an extended position (see Fig. 5), wherein the actuation arms comprise a proximal link (22 in Fig. 1) and a distal link (13 in Fig. 1) that have a relaxed state (see Fig. 1 and 3, see para. 05 and 037). Jeremijevic teaches wherein the proximal link (22) and the distal link (13) form an acute angle when in equilibrium (see Fig. 1 and Fig. 3 for equilibrium which is analogous to original position, see para. 05 and 011). Examiner notes that an acute angle would be any angle that is less than 90º, and thus Jeremijevic discloses said angle between 75º and 105º.
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 relaxed state with an angle between the proximal link and distal link being between 75º and 105º as taught by Jeremijevic such that the flexible actuation arms of Holland would resiliently return to a relaxed state after being in the collapsed or extended positions. Jeremijevic teaches that due to the proximal link and distal link having an acute angle therebetween in equilibrium, without applied force, the safety device takes on the relaxed state in Fig.1 and 3 as a safety feature for covering the needle tip (see para. 011 and 039).
Claim(s) 10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Holland in view of Wilkinson in view of Verespej in view of Haber in view of Jeremijevic as applied to claim 5 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 5, as discussed above. However, modified Holland, fails to disclose (Claim 10) 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 10) 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 14, modified Holland discloses the safety device of claim 10, as discussed above.
In modified Holland, Chelak discloses the shoulder and distal ring as discussed above. However, modified Holland fails to disclose (Claim 14) wherein the safety device comprises at least one recess positioned at the junction between the shoulder and the distal ring.
Chelak teaches (Claim 14) 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 (252, 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 252).
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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 1-3, 9-10, 12-13, 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.
(18/383,722)
Claim # of Reference App. (18/383,748)
1
1
2
2
3
3
9
9
10
10
12
11
13
12
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 “a locking means for maintaining the actuations arms in an extended position” and the reference application does not disclose this limitation.
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 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 incorporate the 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 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, 6-7, 9-10, 12-14, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-11, and 18-20 of copending Application No. 18/383,628 in view of Rimlinger et al. (U.S Patent Pub. No. 2004/0267206 A1, “Rimlinger”) in view of Wilkinson (U.S Patent Pub. No. 20050159709 A1). See Table below for claim mapping.
Claim # of Instant App. (18/383,722)
Claim # of Reference App. (18/383,628)
1
1
2
9
3
18
6
2
7
3
9
7
10
8
12
10
13
11
14
19
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 “at least two actuation arms” and “a head arrangement configured to lock into the flange” and the reference application claims “one actuation arm” and “an annular head configured to abut the flange”.
Rimlinger discloses a safety device (2 in Fig. 1) with a tubular body (10 in Fig. 1) and preferably two actuation arms (16 in Fig. 1) that are elastically deformable (see para. 0047).
Since Rimlinger discloses a similar safety device having elastically deformable actuation arms, 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 singular actuation arm taught by the reference application to be two actuation arms as taught by Rimlinger. Rimlinger provides that it is preferable to have two arms in number which are disposed facing each other (see para. 0012), and thus one of ordinary skill in the art could have duplicated the singular arm of the reference application to be two actuation arms that are disposed facing each other as taught by Rimlinger according to known methods to yield predictable results.
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) and lock onto said flange (90, see Fig. 4 and 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 head arrangement taught by the reference application to incorporate the latching projections of the head arrangement of Wilkinson to yield a head arrangement configured to abut against the flange and to lock onto 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).
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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