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 .
Specification
The disclosure is objected to because of the following grammatical/consistency informalities:
Para [0045], line 10, “coil spring 72”, should read, “compression spring 88”.
Para [0019], line 1, recites “drive means is a spring” and Para [0041], lines 3-4, recites “ biasing means is a compression spring”. Correction is needed to indicate that the drive means and the biasing means is the same structure.
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.
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 2-5 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 2, it recites the limitation "the intermediate driver" in line 1. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets “the intermediate driver” as the “intermediate member” from claim 1. Claim 5 is rejected since it is dependent on claim 1, rendering it indefinite.
Regarding claim 3, it recites the limitation "the intermediate driver" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets “the intermediate driver” as the “intermediate member” from claim 1.
Regarding claim 4, it recites the limitation "the intermediate driver" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the examiner interprets “the intermediate driver” as the “intermediate member” from claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 6-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Markussen et al. (US 20130218093 A1, herein, Markussen).
Regarding claim 1, Markussen discloses an injection device comprising:
i) a drive means (360 – Fig.1a);
ii) a plunger (321 – Fig.1a);
iii) a shroud (311- Fig.1f); and
iv) an intermediate member (330 – Fig.1b) disposed between the drive means and the plunger (Fig.1b) and releasably engaged (300 – Fig.1b) with the plunger thereby to selectively transmit force from the drive means to the plunger (“actuator thrust member is moved distally forcing the actuator connector, the piston driver… forward” – Para [0125]) and from the drive means to the shroud (Fig.1a-Fig.1f, “piston driver enlarged rim section 311 abuts the rim section” – Para [0127]).
Regarding claim 2, Markussen discloses an injection device as recited above, wherein the intermediate driver (330 – Fig.1b) has a compressed configuration (Fig.1b) and a relaxed configuration (Fig.1g, Fig.1h) wherein in the compressed configuration the intermediate member is in engagement with the plunger to transmit force from the drive means to the plunger (Fig.1a, “deflectable head portions to cooperate with enlarged head of actuator connector” – para [0120]) and in the relaxed configuration the intermediate member is released from engagement with the plunger such that force is not transmitted from the drive means to the plunger (“the connection between the deflectable head portions and the enlarged head of actuator connector is discontinued” – Para [0128]).
Regarding claim 3, Markussen discloses an injection device as recited above, wherein the injection device further comprises a housing (200 – Fig.1c) arranged to selective maintain the intermediate driver in the compressed configuration (Fig.1b).
Regarding claim 6, Markussen discloses an injection device as recited above, wherein the intermediate member comprises an outer portion and an inner portion connected by a connecting portion (See Annotated Fig.2 below).
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Regarding claim 7, Markussen discloses an injection device as recited above, wherein the outer portion comprises one or more flexible fingers (332 – Fig.1d, “deflectable” – Para [0120]).
Regarding claim 8, Markussen discloses an injection device as recited above, wherein the flexible fingers or non-contiguous wall portion are closer together in the compressed configuration (Fig.1b) than the relaxed configuration (Fig.1g, Fig.1h).
Regarding claim 9, Markussen discloses an injection device as recited above, wherein the intermediate member is provided with an angled surface which contacts a corresponding angled surface of the plunger (See annotated Fig.1a below).
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Regarding claim 10, Markussen discloses an injection device as recited above, wherein the intermediate member comprises an outer portion and an inner portion connected by a connecting portion (See annotated Fig.2 below); the outer and inner portion extending distally from the connecting portion to receive the proximal end of the drive means (Fig.2).
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Regarding claim 11, Markussen discloses an injection device as recited above, wherein the drive means is a spring (360 – Fig.1a).
Regarding claim 12, Markussen discloses an injection device as recited above, wherein the spring is a compression spring (“compression spring” – Fig.1a).
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Markussen in view of Wotton et al. (US 20130303985 A1, herein, Wotton).
Regarding claim 4, Markussen discloses an injection device as recited above, comprising a housing (200 – Fig.1c) but Markussen does not expressly disclose wherein the housing comprises a distal length with a reduced inner diameter to a proximal portion of the housing, the reduced inner diameter maintaining the compressed configuration of the intermediate driver.
Wotton discloses an injection device, wherein a housing (14, 64 – Fig.6B) comprises a distal length with a reduced inner diameter (See annotated Fig.6B below) to a proximal portion of the housing (64 - Fig.6B), the reduced inner diameter maintaining a compressed configuration of an intermediate driver (54, 56 – Fig.6B)(“to retain the trigger protrusions in the blocking association in the recess to hold ram in the proximal position until firing is actuated” – Para [0062]).
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It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the housing of Markussen to comprise a distal length with a reduced inner diameter to a proximal portion of the housing as taught by Wotton Since Wotton teaches that the reduced inner diameter retains the trigger protrusions to hold the piston rod in place before being actuated (Wotton, Para [0062]), this is beneficial to Markussen since this maintains the spring in the compressed configuration avoiding unwanted lateral movement or shifting of the spring.
Regarding claim 5, Markussen discloses an injection device as recited above, comprising a housing with a diameter (200 – Fig.1c) but Markussen does not expressly disclose wherein a reduced diameter is provided by one or more support ribs or an increased thickness of the wall of the housing.
Wotton discloses an injection device, wherein a housing (14, 64 – Fig.6B) comprises a reduced diameter provided by an increased thickness of the wall of the housing (as shown at 64 – Fig.6B).
It would be obvious to one in the ordinary skill in the art, before the effective filing date of the applicant’s claimed invention to modify the housing of Markussen to comprise a reduced diameter provided by an increased thickness of the wall of the housing as taught by Markussen since Wotton teaches that the increased thickness of the wall retains the trigger protrusions to hold the piston rod in place before being actuated (Wotton, Para [0062]), this is beneficial to Markussen since this maintains the spring in the compressed configuration avoiding unwanted lateral movement or shifting of the spring.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Holroyd et al. (US 20210023301 A1) discloses an injection device with a compression spring, a plunger, and an intermediate member.
Stevens et al. (US 20200238014 A1) discloses an injection device with a coil spring, a plunger, and an intermediate member.
Cowe (US 20120220954 A1) discloses an injection device with a compressed spring and a plunger.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marissa Taylor whose telephone number is (571)272-3542. The examiner can normally be reached Monday-Thursday 6:30am-3:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571) 272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISSA TAYLOR/Examiner, Art Unit 3783 /BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783