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 .
Claims 10 and 11 are withdrawn.
Claims 1-9 and 12-20 are being examined in this Office Action.
Election/Restrictions
Claims 10 and 11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/04/2026.
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 driving component … driving the driven component to move along an inserting direction", "an actuating component abutting against the driving component and configured to bias the driving component to rotate around a rotating axis", "an abutting kit configured to engage with the driving component at a first position for stopping the driving component from rotating from the first position to a second position around the rotating axis", "a driven component movably engaged with the driving component", and "an inserting component disposed on the driven component and movable along the inserting direction together with the driven component" in claim 1.
“a driving component… the driving component driving the driven component to move along an inserting direction… the driving component driving the driven component to move along a retracting direction”, “an actuating component abutting against the driving component and configured to bias the driving component to rotate around a rotating axis”, “an abutting kit configured to engage with the driving component”, “a driven component movably engaged with the driving component”, and “an inserting component disposed on the driven component and movable along the inserting direction or the retracting direction together with the driven component” in claim 13.
“a driving component… the driving component driving the driven component to move along an inserting direction”, “an actuating component abutting against the driving component and configured to bias the driving component to rotate around a rotating axis”, “an abutting kit configured to engage with the driving component at a first position for stopping the driving component from rotating from the first position to a second position around the rotating axis”, “a driven component movably engaged with the driving component”, and “an inserting component disposed on the driven component and movable along the inserting direction together with the driven component” in claim 14.
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.
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.
Claim 20 is 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 20 recites the limitation "the second rotating direction"" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the second rotating direction” to be a rotating direction opposite to the first rotating direction.
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 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.
Claim(s) 1, 2, and 14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hostettler et al. (WO 2017219155 A1, herein Hostettler).
Regarding Claim 1, Hostettler discloses an inserting assembly (Figs 30-38) comprising:
a driving component (70);
an actuating component (71) abutting against the driving component and configured to bias the driving component to rotate around a rotating axis (“The steering drum (70) is biased by the spring (71) to rotate in one rotation direction” – Page 33 Lines 8-9);
an abutting kit (72a) configured to engage with the driving component at a first position (Fig. 30) for stopping the driving component from rotating from the first position to a second position (Fig. 34) around the rotating axis (“The steering drum (70) is biased by the spring (71) to rotate in one rotation direction and rotation of the steering drum (70) is prevented by a stop means (72) with a counter arrester (72a) which abuts the first arrester (70a) of the steering drum (70)” – Page 33 Lines 8-11);
a first ratchet component (70a) coaxially rotatable relative to the driving component (Figs 30 and 34), the first ratchet component driving the abutting kit to disengage from the driving component at the first position when the first ratchet component rotates along a first rotating direction (“The steering drum (70) is biased by the spring (71) to rotate in one rotation direction and rotation of the steering drum (70) is prevented by a stop means (72) with a counter arrester (72a) which abuts the first arrester (70a) of the steering drum (70).” – Page 33 Lines 8-11), such that the actuating component drives the driving component to rotate from the first position to the second position (“the stop means (72) is rotated around the rotational axis (72c), for example by the third part (3), such that the counter arrester (72a) is moved out of abutment with the first arrester (70a) of the steering drum (70), such that the spring (71) rotates the steering drum over a first angle until the stop means (72) catches the second arrester (70b), see also Figure 33. The counter arrester is preferably shaped as a semi-circular arch or rim and rotation of the stop means over the first angle releases the contact between the counter arrester and the first arrester (70a), but brings the semi-circular arch or rim within the line or rotation of the second arrester (70b)” – Page 33 Lines 22-28);
a driven component (35) movably engaged with the driving component, the driving component driving the driven component to move along an inserting direction when the actuating component drives the driving component from the first position to the second position (“the guiding means (74) on the steering drum (70) drives the canula holder (35) to the needle inserted position (Figures 33 and 34)” – Page 33 Lines 28-29); and
an inserting component (36) disposed on the driven component and movable along the inserting direction together with the driven component (Figs 30 and 34).
Regarding Claim 2, Hostettler discloses the inserting assembly of claim 1, wherein the abutting kit is further configured to engage with the driving component at the second position for stopping the driving component from rotating away from the second position when the actuating component drives the driving component to rotate from the first position to the second position around the rotating axis (Figs 36-37, “The zero angle position is hereby defined by the starting position of the stop means (72) when the counter arrester (72a) abuts the first arrester (70a) of the steering drum (70), The release of the second arrester (70b) ensures that the spring or biasing means (71 ) can rotate the steering drum (71 ) further in the same rotation direction as the first rotation. The further rotation of the steering drum (70) ensures that the guiding means (74) drives the canula holder (35) back to the needle retracted position as the guiding means goes from the minimum to the maximum of the sinus curve (Figure 37).” – Page 34 Lines 4-9).
Regarding Claim 14, Hostettler discloses an automated injection system comprising:
a case (housing described on Page 32 Lines 35-36); and
an inserting assembly (Figs 30-38) mounted on the case (“A steering drum (70) is positioned with its longitudinal axis preferably perpendicular to the bottom surface of the device and can rotate with respect to the housing” – Page 32 Lines 35-36), and the inserting assembly comprising:
a driving component (70);
an actuating component (71) abutting against the driving component and configured to bias the driving component to rotate around a rotating axis (“The steering drum (70) is biased by the spring (71) to rotate in one rotation direction” – Page 33 Lines 8-9);
an abutting kit (72a) configured to engage with the driving component at a first position (Fig. 30) for stopping the driving component from rotating from the first position to a second position (Fig. 34) around the rotating axis (“The steering drum (70) is biased by the spring (71) to rotate in one rotation direction and rotation of the steering drum (70) is prevented by a stop means (72) with a counter arrester (72a) which abuts the first arrester (70a) of the steering drum (70)” – Page 33 Lines 8-11);
a first ratchet component (70a) coaxially rotatable relative to the driving component (Figs 30 and 34), the first ratchet component driving the abutting kit to disengage from the driving component at the first position when the first ratchet component rotates along a first rotating direction (“The steering drum (70) is biased by the spring (71) to rotate in one rotation direction and rotation of the steering drum (70) is prevented by a stop means (72) with a counter arrester (72a) which abuts the first arrester (70a) of the steering drum (70).” – Page 33 Lines 8-11), such that the actuating component drives the driving component to rotate from the first position to the second position (“the stop means (72) is rotated around the rotational axis (72c), for example by the third part (3), such that the counter arrester (72a) is moved out of abutment with the first arrester (70a) of the steering drum (70), such that the spring (71) rotates the steering drum over a first angle until the stop means (72) catches the second arrester (70b), see also Figure 33. The counter arrester is preferably shaped as a semi-circular arch or rim and rotation of the stop means over the first angle releases the contact between the counter arrester and the first arrester (70a), but brings the semi-circular arch or rim within the line or rotation of the second arrester (70b)” – Page 33 Lines 22-28);
a driven component (35) movably engaged with the driving component, the driving component driving the driven component to move along an inserting direction when the actuating component drives the driving component to rotate from the first position to the second position (“the guiding means (74) on the steering drum (70) drives the canula holder (35) to the needle inserted position (Figures 33 and 34)” – Page 33 Lines 28-29); and
an inserting component (36) disposed on the driven component and movable along the inserting direction together with the driven component (Figs 30 and 34).
Allowable Subject Matter
Claim 13 is allowed.
Claims 3-9, 12, and 15-19 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.
Claim 20 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record fails to disclose or make obvious the claimed invention including the following features:
Regarding Claim 3, a second ratchet component coaxially rotatable relative to the driving component, the second ratchet component being resiliently deformed by the first ratchet component and not driven to rotate along the first rotating direction by the first ratchet component when the first ratchet component rotates along the first rotating direction, and the second ratchet component being driven by the first ratchet component to rotate along a second rotating direction opposite to the first rotating direction when the first ratchet component rotates along the second rotating direction.
Regarding Claim 12, wherein the actuating component biases the driving component to rotate along a second rotating direction opposite to the first rotating direction around the rotating axis.
Regarding Claim 13, a second ratchet component coaxially rotatable relative to the driving component, the second ratchet component being driven by the first ratchet component to rotate along the second rotating direction when the first ratchet component rotates along the second rotating direction, the second ratchet component driving the abutting kit to disengage from the driving component at the second position when the second ratchet component is driven by the first ratchet component to rotate along the second rotating direction, and the actuating component drives the driving component to rotate from the second position to a third position around the rotating axis along the second rotating direction when the second ratchet component drives the abutting kit to disengage from the driving component at the second position.
Regarding Claim 15, wherein the abutting kit is further configured to engage with the driving component at the second position for stopping the driving component from rotating away from the second position when the actuating component drives the driving component to rotate from the first position to the second position around the rotating axis, the inserting assembly further comprises a second ratchet component coaxially rotatable relative to the driving component, the second ratchet component is resiliently deformed by the first ratchet component and not driven to rotate along the first rotating direction by the first ratchet component when the first ratchet component rotates along the first rotating direction, and the second ratchet component is driven by the first ratchet component to rotate along a second rotating direction opposite to the first rotating direction when the first ratchet component rotates along the second rotating direction.
Regarding Claim 20, wherein the actuating component biases the driving component to rotate along the second rotating direction around the rotating axis.
The combination of the claimed limitations is novel and found to be allowable over the prior art. The cited references taken singly or in combination do not anticipate or make obvious the Applicant’s claimed invention.
Examiner notes that the limitations indicated as containing allowable subject above are done so in context of the claims as a whole – e.g. the cited portions of claim 13 are allowable in combination with the rest of the limitations of the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mark Golovan whose telephone number is (571)272-2119. The examiner can normally be reached Monday - Friday 7:30am-4:30pm Alt. Fri off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARK GOLOVAN/Patent Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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