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.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: the “resilient adjustment means” in claim(s) 1 and dependents. Here “resilient” is deemed to be a structural limitation for accomplishing the act of “compensating clearances between the plunger rod and the barrel”. As such, the limitation will be interpreted as permitting ANY resilient element which accomplishes the stated goal with no further inference as to materials or structures disclosed as being necessary for performing the claimed act as presented in the specification.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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 “friction element [being] distally located with regard to the fixed end” (see Clm. 4) 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 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.
Claim(s) 4 is/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 4, Applicant recites the limitation “the friction element is distally located with regard to the fixed end”. While this limitation does appear verbatim in the specification (see Par. 17 and 77) it is recited only in the brief summary of the invention in a conclusory fashion without any further exposition or reference to the figures. This limitation appears to be contradictory with the illustrated invention as well as how the invention is described in the Detailed Disclosure (see Par. 48, 108) which recites “the fixed end 70 is distally located with regard to the free end”). Without further exposition it is unclear if Applicant is using a frame of reference for “distally” which is not the same frame of reference (re: “distal” meaning “remote” from the fixed end) of the medicament container (re: the needle end is “distal” and the opposed end is “proximal” for the medicament container), this limitation references an unillustrated and only nominally disclosed alternative embodiment, or this limitation is a typographical error.
Examiner notes that the term distal can be defined as:
“situated away from the point of attachment or origin or a central point especially of the body”, see Merriam-Webster’s Online Dictionary.
Here, it would not be unreasonable to say that the friction element/free end (71) is located away from the point of attachment or origin (re: the fixed end 70), but this is not necessarily consistent with how the phrase “distally located” is used elsewhere (Par. 48) where a consistent frame of reference appears to be used for all elements definable by remoteness from the user.
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) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Publication No. 2017/0290981 (“Hoeholt”).
Regarding Claim 1, Hoeholt discloses an autoinjector (300) for automatic injection of a medical product into an injection site (Abstract), the autoinjector comprising:
A housing (316, 321) extending along a longitudinal axis and configured to receive a medical container (10) having a barrel defining a reservoir for containing a medical product, the barrel having a distal end provided with an injection needle (see Par. 27) and an opened proximal end (NOTICE: the barrel is not a positively recited part of the claimed workpiece, but is recited only functionally as it pertains to defining the utility and resultant necessary structure of the housing TO RECEIVE such a barrel);
A power pack arranged inside the housing for expelling the medical product from the medical container, the power pack including a plunger rod (430) configured to extend through the opened proximal end (see generally Fig. 5) of the barrel for pushing a stopper (11) arranged inside the barrel (Par. 34), the plunger rod being axially movable between an initial position (see generally Fig. 5) and an injection end position distally located with respect to the initial position (not shown – the position assumed after the piston 11 has been displaced to expel a medicament); and
resilient adjustment means (432, 435, 436, 437) arranged between the plunger rod and the barrel for compensating clearances between the plunger rod (5) and the barrel (Par. 34, 35 – see Fig. 5).
Regarding Claim 2, Hoeholt discloses the resilient adjustment means include comprise a spring blade (435, 437) configured to deform in a radial inward direction so that the spring blade exerts a radial pushing force against the inner lateral wall of the barrel (see Par. 34, 35 – Fig. 5).
Regarding Claim 3, Hoeholt discloses the spring blade has a fixed end (circa 435, 432) secured to the plunger rod and a friction element (437) configured to frictionally engage the inner lateral surface of the barrel (see Fig. 5).
Regarding Claim 4, Hoeholt the friction element is distally located with regard to the fixed end (re: the friction element is located away from/remote from fixed end – see Fig. 5 in the same manner and consistent with the only explicitly depicted embodiment of the instant application).
Regarding Claim 5, Hoeholt discloses the friction element is arranged at a free end of the spring blade (see Fig. 5).
Regarding Claim 6, Hoeholt discloses the spring blade comprises an inclined outer side arranged between the fixed end and the friction element for easing insertion of the plunger inside the opened proximal end of the barrel (see Fig. 5 – i.e. the geometry of the spring blade outer side creates a unidirectional barb shape).
Regarding Claim 7, Hoeholt discloses the outer side has a convex and curved shape (see Fig. 5).
Regarding Claim 8, Hoeholt discloses the resilient adjustment means are located at the distal end of the plunger rod (see Fig. 5).
Regarding Claim 9, Hoeholt discloses the resilient adjustment means comprises a distal pushing area (436) configured to push against the stopper (Par. 34).
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.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0290981 (“Hoeholt”) as previously applied above.
Regarding Claim 10, Hoeholt discloses the invention substantially as claimed except that the resilient adjustment means and the plunger rod “form a single piece”. In the instant case Hoeholt does characterize the adjustment means as “a distal head” of the “piston tube 430”, but fails to further expand how such a structure is formed. However, it has been held that constructing in a single piece a component which was formerly constructed as a plurality of separate components which are later affixed together is an obvious design choice and requires only routine and customary skill in the art when only expected and predictable results are to be obtained, see In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). As such, it would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the plunger rod and adjustment means of the invention of Hoeholt to comprise a single piece in order to ensure that the adjustment means does not become accidentally separated from the piston rod.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0290981 (“Hoeholt”) as applied above, and further in view of U.S. Publication No. 2023/0010593 (“Cammish”).
Regarding Claim 11, Hoeholt, as modified, discloses the invention substantially as claimed except that the adjustment means is “overmolded on the plunger rod”. However, overmolding is a well-known and obvious manufacturing technique known to the prior art for integrally forming a piston head and rod. For example, Cammish discloses that resilient piston heads can be integrally formed by processes such as overmolding (Par. 37). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the resilient adjustment means of Hoeholt to be overmolded on the plunger rod, as disclosed by Cammish, in order to allow the resilient means to be securely, integrally affixed to the piston rod to help ensure the two components do not become separated.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2017/0290981 (“Hoeholt”) as applied above, and further in view of U.S. Patent No. 10,675,412 (“Jones”)
Regarding Claims 12-14, Hoeholt discloses the invention substantially as claimed except that that the resilient adjustment means are arranged on a plug attached to a distal end of the plunger rod. Specifically, Hoeholt is silent as to how the structure of the adjustment means and plunger rod are united/connected. However, Jones discloses a related invention comprising a piston rod (21) and resilient piston head (10) which is formed as a plug on which resilient adjustment means (11) are affixed, with the plug being attached to a distal end of the plunger rod (see Fig. 4).
It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the adjustment means of the invention of Hoeholt as a plug, as disclosed by Jones, in order to provide a suitable means of uniting the two components to allow for replacement of the adjustment means as necessary.
Regarding Claim 13, Hoeholt discloses a distal abutment surface (436) configured to distally push against the stopper when the plunger rod moves to the injection end position.
Regarding Claim 14, Hoeholt, as modified by Jones, discloses the invention substantially as claimed except that that the plug includes a “proximal shoulder configured to abut against a distal abutment surface of the plunger rod to stop insertion of the plug inside the plunger rod”. Rather Hoeholt discloses the plug comprises an abutment surface (17) on the proximal section of the plug with the plunger rod comprising a shoulder (not labeled – see Fig. 4 – at the distal end thereof). However, it is well-established that the mere reversal of parts of a connection is an obvious design choice when it confers only predicted and expected results, see In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the plug of modified Hoeholt to have a proximal shoulder and the piston rod to have a distal abutment surface, the reverse of the arrangement disclosed by Jones, merely satisfying an obvious design choice whereby the connection will be expected to work equally well irrespectively of which component carries the shoulder and which component carries the abutment surface.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 01/12/2026