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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 02/01/2024. Claims 1-14 are currently pending and being examined.
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 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.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the tip” in lines 21 and 22. However, there is a lack of antecedent basis for this limitation. Examiner suggests reciting “a tip”. 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.
The following claim limitations
latching means (claims 9 & 10)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
means (latching means - claims 9 & 10)
coupled with functional language
the first tubular element and the second tubular element comprise latching means (latching means - claims 9 & 10)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“ramps supported against each other, having undercuts so that after a relative movement of the ramps with respect to each other, they are locked and no reverse rotation can take place” (specification, ¶0026)(latching means - claims 9 & 10)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Cross (USPAP 2013/0046246) in view of Ward (USPAP 2014/0236100).
In reference to independent claim 1, Cross discloses a needle safety device (fig 1-8) for a medical injection device (para 0007-0009), the needle safety device comprising:
an elongated hub portion (housing 2, fig 1, 2) having a longitudinal axis (longitudinal axis of 2), wherein the hub portion comprises a cannula (3) extending from the hub portion (2) substantially along the longitudinal axis and a guide pin (11);
a first tubular element (locking collar 5) being movably arranged on the hub portion (2) to move along the longitudinal axis, wherein the first tubular element (5) comprises a guide track (12, fig 3) which slidably engages with the guide pin (11),
wherein the guide track (12) is configured such that the first tubular element (5) rotates relative to the hub portion (2) when the guide pin (11) moves along the guide track (12), wherein the guide track (12) comprises a final position (16) configured to retain the guide pin (para 0060 discloses “As shown in FIG. 3, track 12 has three paths, 14, 15, and 16, that have a specific geometry such that after a single use of the needle assembly 1, the inwardly protruding feature 11 is blocked from further axial movement and the guard 6 (and, thus, the device) is "locked" in a guarded, e.g. distal, position”);
a second tubular element (needle guard 6) being arranged on the first tubular element (5) such that the second tubular element (6) is movable along the longitudinal axis together with the first tubular element (5), wherein the first tubular element (5) is at least partially enclosed by the second tubular element (5 encloses the axial end of 5), wherein the second tubular element (6) comprises a contact surface (33) for establishing pressure contact with an injection area (para 0063 discloses “When the needle assembly 1 is used, the needle guard 6 is pushed in the proximal direction as the planar surface 33 comes into contact with an injection site”), and
a spring element (4) which biases the first and/or second tubular element (6) in a distal direction relative to the hub portion (2) such that the contact surface is further spaced apart from the hub portion (2) along the longitudinal axis than the tip of the cannula (3) when the contact surface (33) is not in pressure contact with the injection area (para 0062 discloses “the spring 4 applies force in the distal direction on the proximal end of locking collar 5 such that the collar 5 is urged to move axially and is rotationally biased along the angled bearing surfaces 31 and 32”), however
Cross does not teach the guide pin extending outward from the hub portion as seen from the longitudinal axis.
Ward, a similar needle safety device, teaches the guide pin (2.2.1, fig 1) extending outward from the hub portion (2.2) as seen from the longitudinal axis (as seen down the longitudinal axis the pin 2.2.1 extends out radially from the hub).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the parts relationship of Ward in the device of Cross “to provide an improved safety needle assembly that minimizes the risk of an accidental needle stick injury, that is safe to handle, and that provides needle safety before and after the medicament is delivered” para 0002; Ward. To be clear the modification is done by inverting the parts, so the track 12 is on 5 and the pin is on the hub 2 extending out to make contact with it. By inverting the components the size of 5 would increase thereby making the moving components larger and less likely to accidently deform making the needle device less likely to fail.
In reference to dependent claim 2, Cross in view of Ward discloses the needle safety device according to claim 1, Cross further discloses a device wherein the guide track comprises:
a first guide segment (portion of 12 from 14-15) extending from an initial position (14, fig 3) to an injection position (15, fig 3), wherein in the injection position the tip of the cannula (3) is further spaced apart from the hub portion (2) along the longitudinal axis than the contact surface (in the injection position, in order to inject the medicant, the tip of the cannula 3 is farther away from the hub 2 than the contact surface 33, because 33 is depressed), wherein the guide track (12) is configured such that the guide pin (11) moves into the injection position (15) by the contact surface being in pressure contact with the injection area (when 33 is pressed down), and a second guide segment (portion of 12 from 15-16) extending from the injection position to the final position (area of 15 referenced by 16 in fig 3), wherein the guide pin (11) moves into the final position (16) when the contact surface (33) is released from pressure contact with the injection area (located on the skin of the patient).
In reference to dependent claim 3, Cross in view of Ward discloses the needle safety device according to claim 1, Cross further discloses a device wherein in the initial position (14) and the final position (16) the contact surface (33) is further spaced apart from the hub portion (2) along the longitudinal axis than the tip of the cannula (in the final position, shown in fig 2, the contact surface 33 is spaced farther from the hub 2 than the tip of the cannula).
In reference to dependent claim 4, Cross in view of Ward discloses the needle safety device according to claim 2, Cross further discloses a device wherein the guide track (12, fig 3) is configured such that the first tubular element (5) rotates by a first angle around the longitudinal axis when the guide pin (11) moves from the initial position (14) to the injection position (15), and wherein the first tubular element (5) rotates by a second angle around the longitudinal axis when the guide pin (11) moves from the injection position (15) to the final position (16, the track 12 shows that as 11 moves thru the track significant angular rotation occurs).
In reference to dependent claim 5, Cross in view of Ward discloses the needle safety device according to claim 2, Cross further discloses a device wherein the guide track (14,15,16, fig 3) is configured such that the first tubular element (5) rotates relative to the hub portion in one direction around the longitudinal axis while the guide pin (11) moves from the initial position (14) into the final position (16) via the injection position (15).
In reference to dependent claim 6, Cross in view of Ward discloses the needle safety device according to claim 2, Cross further discloses a device wherein the contact surface (33) has an opening (9) through which the tip of the cannula (3) passes when the guide pin (11) moves from the initial position (14) into the injection position (15).
In reference to dependent claim 7, Cross in view of Ward discloses the needle safety device according to claim 1, Cross further discloses a device wherein the first tubular element (5) and the second tubular element (6) are configured such that they allow for a rotation relative to each other, wherein optionally the first tubular element (5) is in rotatable sliding engagement with the second tubular element (6)(para 0062 discloses “guard 6 is rotationally constrained by outer sleeve 7” and further “In particular, the spring 4 applies force in the distal direction on the proximal end of locking collar 5 such that the collar 5 is urged to move axially and is rotationally biased along the angled bearing surfaces 31 and 32” 5 rotates relative to 6 when 6 is depressed because the system “converts axial movement of the needle guard 6 into rotation of the locking collar 5”).
In reference to dependent claim 8, Cross in view of Ward discloses the needle safety device according to claim 1, Cross further discloses a device wherein the second tubular element (6) is configured such that it substantially cannot rotate relative to the hub portion (para 0061 discloses “needle guard 6 is, preferably permanently, rotationally constrained by the outer sleeve 7 through a splined engagement of one or more protrusions 20 of the outer sleeve 7 in one or more slots 18 of the guard 6 (see FIGS. 5 & 6)”).
In reference to dependent claim 9, Cross in view of Ward discloses the needle safety device according to claim 7, Cross further discloses a device wherein the first tubular element (5) and the second tubular element (6) comprise latching means (36, fig 7 & 8, “locking feature” in the cite below) being configured to allow the first tubular element (5) to rotate relative to the second tubular element (6) in one direction around the longitudinal axis and prevent rotation in the other direction (para 0060 discloses “As shown in FIG. 3, track 12 has three paths, 14, 15, and 16, that have a specific geometry such that after a single use of the needle assembly 1, the inwardly protruding feature 11 is blocked from further axial movement and the guard 6 (and, thus, the device) is "locked" in a guarded, e.g. distal, position”).
In reference to dependent claim 10, Cross in view of Ward discloses the needle safety device according to claim 9, Cross further discloses a device wherein the latching means (36, fig 7 & 8, “locking feature” in the cite below) prevents the guide pin (11) to return into the initial position when it has been moved into the injection position and/or wherein the latching means (36) prevents the guide pin from being moved out of the final position (para 0006 discloses “a secure locking feature that locks the shield in the extended enclosed position following use”).
In reference to dependent claim 11, Cross in view of Ward discloses the needle safety device according to claim 1, Cross further discloses a device wherein the spring element (4) abuts the hub portion (2) and the second tubular element (spring 4 abuts second tubular element 6 thru 5, see fig 3).
In reference to dependent claim 12, Cross in view of Ward discloses the needle safety device according to claim 1, Cross further discloses a device wherein the first tubular element (5) substantially cannot be displaced relative to the second tubular element (6) along the longitudinal axis (spring 4 keeps 5 pressed against 6 so the two cannot be displaced relative to each other).
In reference to dependent claim 13, Cross in view of Ward discloses the needle safety device according to claim 1, Cross further discloses a device wherein the hub portion (2) is substantially cylindrical (fig 3 shows that ).
In reference to dependent claim 14, Cross in view of Ward discloses a medical injection device (para 0058 discloses “The connector 8 is configured for attachment to a drug delivery device.”) comprising the needle safety device according to claim 1 (para 0058 discloses a medical injection device using the safety device of claim 1).
In reference to dependent claim 15, Cross in view of Ward discloses the medical injection device according to claim 14, Cross further discloses a device wherein the medical injection device comprises a housing (housing is an inherent feature of the drug delivery device in the cite below) which engages with the second tubular element (6) such that the second tubular element (6) substantially does not rotate (para 0062 discloses “guard 6 is rotationally constrained by outer sleeve 7”) relative to the hub portion (2 is fixed relative to 7, para 0058 discloses “where the outer sleeve 7 is rotationally and axially fixed to the housing 2 and acts to hold the parts of the assembly together”), wherein optionally the hub portion is affixed to the housing (para 0058 discloses “The connector 8 is configured for attachment to a drug delivery device.”).
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sanders (USPN 9,414,991) discloses a medical connector.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm 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, 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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/CHARLES W NICHOLS/Examiner, Art Unit 3783
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