DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 “the head arrangement comprises a crown having a proximal plate configured and sized to lock onto the flange and a distal plate mounted on the tubular body, the proximal plate and the distal plate being connected by at least two actuation arms” (claim 16-claim19) with a torsion spring or spring blade (biasing member which invoked 112(f)) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The 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.
Claim 1 recites a locking means and a biasing member. Both limitations invoke 112(f).
Claim 15, recites a means for securing the biasing member onto the tubular body, which invokes 112(f).
Claim Objections
Claim 11 is objected to because of the following informalities: the preamble recites “A” safety device instead of “the” safety device. Appropriate correction is required.
Claim Rejections - 35 USC § 112a
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 16-19 require “the head arrangement comprises a crown having a proximal plate configured and sized to lock onto the flange and a distal plate mounted on the tubular body, the proximal plate and the distal plate being connected by at least two actuation arms” and “a biasing member” which invokes 112(f) and based on the specification is considered to include a torsion spring or a spring blade or elastic band. The specification supports an embodiment with an elastic band as one of the biasing members, however the specification fails to provide written description of an embodiment of two plates that have a spring blade or torsion spring as the biasing member.
Claim Rejections - 35 USC § 112b
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.
Claim 1 recites “at least two actuation arms” and “the actuation arm” which creates a lack of antecedent basis issue because it’s unclear which actuation arm of the least two actuation arms, “the actuation arm” encompasses. Therefore, the claim scope is unclear based on the lack of antecedent basis issue. Claims 2-20 are rejected based incorporating the issues of claim 1.
Claim 3 recites “the biasing element” which is a lack of antecedent basis issue. It appears claim 3 should recite “the biasing member”. Additionally, the claim requires the groups of the element to be a spring blade, a torsion spring and an elastic band, which is not in the alternative, Therefore it unclear if applicant is trying to claim all 3 or only 1. It appears applicant is trying to further define the biasing member being selected from one of the group consisting of A, B, and C, however the wording is not written in such as manner and creates an indefinite issue based on the use of “element” instead of “member” and the wording of “and”. For examination purposes, the examiner will interpret element as member and require one member from the group.
Claim 9, recites “the plan” which lacks antecedent basis. Furthermore, one of ordinary skill in the art would find the claim scope unclear because a plan would not fix the clarity of the claim.
Claim 11, recites “the annular head” which lacks antecedent basis and thus makes the claim indefinite.
Claims 12, 13 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. The claim limitation “locking means” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to clearly link the structure, material, or acts to the function. The specification appears to indicate the leg (Ref. # 21) as a locking mean, however claim 12 introduces at least one leg as an additional limitation and not further defining the locking means, which creates ambiguity. Therefore, it appears a leg maybe be the locking means however, due to the dependent claims (clm. 12 and 13), it’s unclear if the leg is the locking means, thus creating an indefinite issue since the scope of the claim cannot be determined based on the disclosure (lack of clearly linking the locking means to a particular structure) and the dependent claims (clm. 12 and 13). Claim 13 also includes lack of antecedent basis for the legs and legs were never introduced into the claim. The claim scope is unclear based on the lack of antecedent basis and the clarity issue on the locking means. two ramp surfaces configured to guide
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Holland et al. (US 2020/0316311) and further in view of Haber et al. (US 4,935,013) and Wilkinson (US 2005/0159709).
Re. claim 1, 11, Holland et al. discloses a safety device (see fig. 7-8c) for mounting onto a drug delivery device (see fig. 7-8c) having a barrel comprising with a flange at its proximal end and an injection needle at its distal end, and a piston rod comprising a piston flange, the safety device comprising: a tubular body (700, fig. 7) extending along a longitudinal axis, the tubular body being configured to receive the barrel, a head arrangement (top portion of 700, connected to the barrel flange, see fig.7-8c), at least two actuation arms (770a-b) connecting the tubular body and the head arrangement (see fig. 7-8c), said actuation arms having a proximal link connected to the head arrangement by a proximal hinge and a distal link connected to the tubular body by a distal hinge, the proximal link and the distal link being connected by an intermediate hinge (see fig. 7, 8a, 8b), the actuation arm being movable between a collapsed position in which the tubular body is maintained in a position proximally close to the flange uncovering the needle (see fig. 7, 8a) and an extended position in which the tubular body is maintained in a position distally distant from the head arrangement shielding the needle (see fig. 8c); and a biasing member (774a,b, para. 0096) for maintaining the actuation arms in an extended position (see fig. 8c).
Holland et al. discloses teach locking means (556,558) in other embodiments, and the shield assembly which appears to engage the flange of a barrel (see fig. 2a,14a-14d), but fails to explicitly disclose the head arrangement is configured to abut against the flange and to lock into the flange and a locking means for maintaining the actuation arms in a collapsed position in the embodiment discloses in figures 7-8c.
Haber et al. discloses a collapsible needle cover with a locking means (locking catch 86) for maintaining two actuation arms (70) in a collapsed position (see fig. 10). The locking means helps to maintain the needle cover in either an open position or covered position, thus making the device easier to use (col. 2, lines 21-31).
Wilkinson discloses a safety shield device that includes an outer shield (analogous to the head arrangement) with latching projections (84) that engage the flange of a barrel (para. 0033, fig. 4). Wilkinson additional teaches multiple legs (51) with multiple sections (52/54/56) and multiple hinges (58/59) along with a biasing member that is an elastic band (para. 0030-0034).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the device of Holland et al. with the teachings of Holland et al., Haber et al., and Wilkinson to further include the head arrangement being configured to abut against the flange and to lock into the flange and include a locking means for maintaining the actuation arms in a collapsed position because Wilkinson teaches such an arrangement in paragraphs 0030-0034 and figure 4 so that the barrel of the syringe is secured in a proper location and provides the proper orientation for the needle shield to cover the needle. Furthermore, Holland et al. suggestions this arrangement in other embodiments but fails to explicitly illustrate or teach this arrangement. Therefore, it would have been obvious to include latches as taught in Wilkinson to be added to the head arrangement in Holland et al., in order to secure the flange to the head arrangement.
Additionally, it would have also been obvious to further to include locking means on the actuation arms as disclosed by Haber et al. in order to secure the actuation arms in the collapsed position and prevent accidently movement of the arms.
With regards to claim 2, Holland et al. teaches at least one of the hinges are living hinges (see fig. 7-8c); with regards to claim 3, the limitation “formed in a single shot injection molding process” is a product by process limitation, therefore the combined device of Holland, Haber et al. and Wilkinson has the same structure of the claim and thus meets the requirements of the claim (see MPEP 2113); with regards to claim 9, Holland et al. teaches wherein the intermediate hinge inwardly overtakes the plan defined by the proximal hinge and distal hinge when the actuation arm is in its extended position (see fig. 7-8c);
With regards to claim 4, the combined device of Holland, Haber et al. and Wilkinson fails to include a biasing element that is an elastic band, however Wilkinson teaches the use of an elastic band in order to force the legs inward and maintain the legs in an extended position (see Wilkinson, para. 0032, 0034), thus making it an obvious modification to further include an elastic band as a biasing element in order to help the inward deflection of the actuation arms as well as maintain the actuation arms in an extended position.
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Holland et al. (US 2020/0316311), Haber et al. (US 4,935,013), Wilkinson (US 2005/0159709) and further in view of Chelak et al. (US 8,496,627).
With regards to claim 10, the combined device of Holland, Haber et al. and Wilkinson teaches the claimed invention as taught in the rejection of claim 1 above, but fails to explicitly discloses an annular head which comprises a proximal ring and distal ring jointed by a shoulder whereon the flange abuts.
Chelak et al. teaches a head arrangement that includes an annular head which comprises a proximal ring and distal ring jointed by a shoulder (256) whereon the flange abuts (see fig. 42-45), therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined device of Holland, Haber et al. and Wilkinson with the teachings of Chelak et al., so that the head arrangement includes an annular head which comprises a proximal ring and distal ring jointed by a shoulder whereon the flange in order to secure the injection device in place (as taught by Chelak et al. in col. 10, ll. 38 – col. 11, ll. 67). Additionally, it would have only taken routine skill in the medical syringe art to modify and adjust the mechanisms that secure injectors to needle guards/covers since these arrangements as illustrated by Holland et al., Wilkinson, and Chelak et al. are commonly used, thus making modifications to the arrangement of Holland, Haber et al. and Wilkinson would have been an obvious modification in order to arrive at the claimed invention.
With regards to claim 12, the combined device of Holland, Haber et al., Wilkinson and Chelak teaches the claimed invention as taught in the rejection of claim 1 and 10 above, but fails to teach the tubular body comprises at least one leg extending in cantilever and having a catch at its free end, the leg being configured to deflect radially outward to allow the catch to slide over the annular head during mounting and to deflect radially inward after mounting completion so that the catch axially retains the tubular body relative to annular head, however it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the combined device of Holland, Haber et al. and Wilkinson with the teachings of Chelak et al. because Chelak et al. teaches leg structures extending in cantilever and having a catch at its free end, the leg being configured to deflect radially outward to allow the catch to slide over the annular head during mounting and to deflect radially inward after mounting completion so that the catch axially retains the tubular body relative to annular head (see fig. 40,42-47 and col. 10, ll. 38 – col. 11, ll. 67) in order to allow the two structures to be releasably attached upon movement of a plunger. Therefore, it would have been obvious to incorporate the leg features of Chelak with the modified combined device of Holland, Haber et al., Wilkinson and Chelak (of claim 1/claim 10) for the benefit of having a secured arrangement and prevent accidently release.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Holland et al. (US 2020/0316311), Haber et al. (US 4,935,013), Wilkinson (US 2005/0159709) and further in view of Parmigiani (US 6,719,731).
The combined device of Holland, Haber et al., and Wilkinson teaches the claimed invention as taught in the rejection of claim 1 above, but fails to teach wherein at least one distal link comprises two longitudinal ribs having a proximal side perpendicular to the distal link and arcuate distal side.
Parmigiani teaches multiple gripping elements that consist of longitudinal ribs (23) having a proximal side perpendicular to the distal link and arcuate distal side (see fig. ) that are located on a distal link (20/21) of a needle shielding device arm (see fig. 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add multiple gripping elements that have longitudinal rib with a proximal side perpendicular to the distal link and arcuate distal side as taught by Parmigiani to the combined device of Holland, Haber et al., and Wilkinson because adding the multiple gripping elements helps to grip and control the device during use (see, Parmigiani, col. 4, ll. 53-58). Furthermore, modifying the distal link to include two longitudinal ribs (gripping elements) is an obvious modification that only requires routine skill and experimentation in the medical device art as this would be a mere duplication of parts, thus making the modification an obvious modification based on design choice. Moreover, the MPEP supports duplication of parts as an obvious modification, (See MPEP 2144.04.IV.) thus one of ordinary skill in the art would find it obvious modify the device of Holland, Haber et al., and Wilkinson to include two longitudinal ribs instead of one because this would be a mere duplication of parts.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW F DESANTO whose telephone number is (571)272-4957. The examiner can normally be reached M-F 7:30am-4pm(est.).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Boyer Ashley can be reached at 571-272-4502. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Matthew DeSanto
/MATTHEW F DESANTO/Primary Examiner, Art Unit 3700