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 .
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.
In claim 1, the “drive means” is a member which applies force to the plunger rod.
In claim 1, the “control means” is an electronic processor.
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 6-9 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.
In claim 6, Applicant requires the valve arrangement comprises a needle hub and the needle hub comprises the injection needle. But claim 1 requires “an injection needle fluidly connected to said valve arrangement”. It is unclear how the injection needle can be attached to a structure of which it is a critical part.
In claim 7, “said solenoid” lacks antecedent basis.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6-8 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In claim 1, the valve arrangement and needle hub are separate structures, but in claim 6, they are part of the same structure, which broadens (as opposed to further limits) the claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCullough (US 2017/0119969).
Regarding claim 1, McCullough discloses a medicament delivery device (fig 14) comprising: an attachment surface 804 for attachment to a skin surface of a user (¶138), a drive means 842, a plunger rod 866 connected to said drive means (fig 14), a medicament container 840 containing medicament to be pressurized by said plunger rod and said drive means (fig 13), a valve arrangement 920 fluidly connectable to said medicament container (fig 14), an injection needle 844 fluidly connected to said valve arrangement (fig 14), and control means 900 operably connected to said valve arrangement for opening and closing a fluid path between the medicament container and the injection needle (fig 17; ¶149).
Regarding claim 2, wherein the control means is designed to operate the valve arrangement for providing a pulsed injection sequence (¶149 – designed to change the state of the valve between open and closed states, which allows for a pulsed injection sequence as the control means is programmable as per ¶147).
Regarding claim 3, wherein the pulsed injection sequence is controlled regarding pulse frequency and pulse duration (similar to claim 2, the control means is programmable - ¶147 and thus may be programmed regarding pulse frequency and duration).
Regarding claim 4, wherein said control means comprises a solenoid (¶149).
Regarding claim 5, wherein said control means further comprises a controller programmed to operate said solenoid (¶149).
Regarding claim 6, wherein said valve arrangement comprises a needle hub (part of delivery system extending from 920), the needle hub comprising said injection needle 844 and a cartridge needle 892.
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.
Claim(s) 6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 2017/0119969) further in view of Cronenberg et al (US 9,408,985).
While claim 9 does not depend on claims 7 or 8, the combination in claim 9 is used as a basis for the rejection of claims 7 and 8 (due to limitations regarding the cartridge needle in claim 8) and thus the rejection of claim 9 is addressed first. Further the interpretation of claim 6 under McCullough alone is not consistent with the below rejection and the cartridge needle is changed to be the structure provided by Cronenberg below.
Regarding claims 6 and 9, while McCullough substantially discloses the invention as claimed, it does not disclose wherein said drive means and said plunger rod, upon activation, moves said medicament container into contact with said cartridge needle, causing a fluid connection between said medicament container and said cartridge needle.
Cronenberg discloses wherein said drive means and said plunger rod, upon activation, moves said medicament container into contact with said cartridge needle, causing a fluid connection between said medicament container and said cartridge needle (Col.8 ll 14-38). This allows the medicament container to remain sealed until delivery is intended to occur.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify McCullough such that said plunger rod, upon activation, moves said medicament container into contact with said cartridge needle, causing a fluid connection between said medicament container and said cartridge needle as taught by Cronenberg to allow the reservoir/cartridge/medical container to remain sealed (and thus prevent accidental contamination and/or degradation by oxygen) until use.
The above combination results in the valve arrangement comprising a needle hub which includes the injection needle (right of the valve in fig 14) and the newly introduced cartridge needle (left of the valve in fig 14).
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Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 2017/0119969) further in view of Arnott (US 2016/0045705) and Cronenberg et al (US 9,408,985).
Regarding claims 7 and 8, the combination of MuCullough and Cronenberg is used here as otherwise the valve would not be placed between the needles. Said combination resulting in the valve arrangement having a passage (pathway through said valve), said injection needle and said cartridge needle are fluidly connected to said passage (see annotated fig 14 above).
While McCullough substantially discloses the invention as claimed, it does not disclose wherein: said valve arrangement comprises a piston movable in a passage by said solenoid, and said piston comprises a fluid path, wherein, when said piston is in a first position, the fluid connection between the needles is blocked, and when said piston is in a second position, said fluid path fluidly connects said needles, wherein said fluid path of said piston comprises an annular groove.
Arnott discloses details of a solenoid valve (McCullough discloses a solenoid valve, but no structural details of said valve other than it can open and close the fluid pathway) where said valve arrangement comprises a piston movable in a passage by said solenoid (fig 5), said passage connecting at least two flow paths (figs 5 and 8, among others), and said piston comprises a fluid path (fig 8, among others), wherein, when said piston is in a first position, the fluid connection between the passages is blocked, and when said piston is in a second position, said fluid path fluidly connects said passages (actuation of the valve to block flow paths as desired; ¶40), wherein said fluid path of said piston comprises an annular groove (narrowed section behind seal 28).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify McCullough such that said valve arrangement comprises a piston movable in a passage by said solenoid, and said piston comprises a fluid path, wherein, when said piston is in a first position, the fluid connection between the needles is blocked, and when said piston is in a second position, said fluid path fluidly connects said needles, wherein said fluid path of said piston comprises an annular groove as suggested by Arnott as it is a specific, known type of solenoid valve (of which McCullough gives no specific details) which is capable of opening and closing fluid pathways as desired by McCullough.
Claim(s) 10, 11, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCullough (US 2017/0119969) further in view of Gross et al (US 6,186,982).
Regarding claim 10, while McCullough substantially discloses the invention as claimed, it does not disclose a base member provided with said attachment surface and a unit pivotably connected to said base member, which unit comprises said drive means, said plunger rod, said medicament container, said valve arrangement, said injection needle and said control means, wherein a pivoting action of said unit in relation to said base member causes a penetration of said injection needle.
Gross discloses a base member 52 provided with said attachment surface 56 and a unit pivotably connected to said base member (unit is portion of device which is connected to base 52 via hinge 54), which unit comprises said drive means, said plunger rod, said medicament container, said valve arrangement, said injection needle and said control means (all parts of device, except for attachment portion are contained in the unit as evidenced by fig 4), wherein a pivoting action of said unit in relation to said base member causes a penetration of said injection needle (fig 5).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify McCullough such that it comprises a base member provided with said attachment surface and a unit pivotably connected to said base member, which unit comprises said drive means, said plunger rod, said medicament container, said valve arrangement, said injection needle and said control means, wherein a pivoting action of said unit in relation to said base member causes a penetration of said injection needle as taught by Gross to allow the device to be placed and securely attached to the skin before the needle penetrates the patient via a manual motion (the manual penetration being a less efficient but more robust, and cheaper, means by which to place the injection needle).
Regarding claim 11, while McCullough substantially discloses the invention as claimed, it does not disclose wherein said unit comprises an attachment surface for attachment to a skin surface of a user when pivoted in relation to said base member.
Currently only the base of McCullough and Gross attaches directly to the skin. However, one of ordinary skill in the art is aware that the larger the attachment area, the more stable the device (as the forces are applied over a wider area).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify McCullough such that said unit comprises an attachment surface for attachment to a skin surface of a user when pivoted in relation to said base member in order to provide a wider attachment area and more securely attach the device to a patient.
Regarding claim 14, while McCullough substantially discloses the invention as claimed, it does not disclose wherein one of the base member and the unit comprises a protrusion and the other of the base member and the unit comprises a lock-out plate during said pivoting action of the unit in relation to the base member to cause a penetration of said injection needle, the protrusion causes movement of the lock-out plate, whereby, after one use of the device, the lock-out plate prevents the pivoting action of the unit in relation to the base member from being repeated.
Gross discloses the base member comprises a protrusion 65 (fig 8) and the other of the base member and the unit comprises a lock-out plate 70 during said pivoting action of the unit in relation to the base member to cause a penetration of said injection needle (fig 7 to fig 8), the protrusion causes movement of the lock-out plate (inwardly), whereby, after one use of the device, the lock-out plate prevents the pivoting action of the unit in relation to the base member from being repeated (Col.12 ll 49-52).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify McCullough such that one of the base member and the unit comprises a protrusion and the other of the base member and the unit comprises a lock-out plate during said pivoting action of the unit in relation to the base member to cause a penetration of said injection needle, the protrusion causes movement of the lock-out plate, whereby, after one use of the device, the lock-out plate prevents the pivoting action of the unit in relation to the base member from being repeated as taught by Gross to prevent reuse of the device.
Regarding claim 15, wherein the lock-out plate prevents the pivoting action of the unit in relation to the base member from being repeated, as a result of the protrusion moving past a flexible ledge on the lock-out plate (see combination in claim 14 above and compare figs 7 and 8 of Gross).
Allowable Subject Matter
Claims 12 and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 12, the examiner did not find a teaching or suggestion for modifying closest art McCullough in view of Gross such that it has a stop ledge attached to the holding lever, wherein before use, the stop ledge holds the medicament container in an initial position, and
the examiner did not find a teaching or suggestion for modifying closest art McCullough in view of Gross such that it has at least one blocking ledge on the blocking lever, wherein before use, the start button engages the drive means to prevent the drive means applying pressure to the plunger rod, the start button being blocked from movement by contact with the at least one ledge, and said pivoting action of the unit in relation to the base member causes pivoting of the blocking lever, whereby the at least one blocking ledge comes out of contact with the start button to free the start button to move out of engagement with the drive means, in addition to the other limitations, absent impermissible hindsight.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shor et al (US 2019/0009019) discloses claims 1-3, claim 1 is mapped below.
Shor discloses a medicament delivery device (fig 25A) comprising: an attachment surface for attachment to a skin surface of a user (unlabeled in fig 25A, 110 in fig 2), a drive means (¶189), a plunger rod 120/122 (unlabeled in fig 25D, see ¶189) connected to said drive means (fig 25D), a medicament container 106/106a/106b containing medicament to be pressurized by said plunger rod and said drive means (¶189), a valve arrangement fluidly connectable to said medicament container (fig 25E), an injection needle 216 fluidly connected to said valve arrangement (fig 25E), and control means operably connected to said valve arrangement for opening and closing a fluid path between the medicament container and the injection needle (¶187, electronically controlled via control unit 116).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783
