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 .
Status of the Application
This Office action is in response to the amendment of October 23, 2024 which amended claims 3, 5, 6, 9, 10, , 12, 14-17, 19, 22-24, 27, 30 and 33-36; and, canceled claims 4, 7, 8, 11, 13, 18, 20, 21, 25, 26, 28, 29, 31, 32, 37 and 38.
Claim Objections
Claim 1 is objected to because of the following informalities: in lines 4-7 each of the lines should be “tabbed over” one additional tab-space to make clear that the body, lumen and the flexible legs are part of the connector (12), similar to lines 10 and 13 for the duct cap body and the engagement element. 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.
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: the “tamper resistant or tamper evident feature…configured to…” 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.
Claims 1-3, 5, 6, 9, 10, 12, 14-17, 19, 22-24, 27, 30, 33, 34, 35 and 36 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.
Claim 1 is vague and indefinite because the construction of the connector element is not clear. It is noted that the claimed connector assembly includes a connector element (see element 12 in Fig. 5 & 6) and a dust cap 14 (see Fig. 6). In paragraph [0092] the connector element is set forth as having a body 18, a lumen (see Fig. 8), beams 31, and 1st and 2nd legs 20, 22. The dust cap is set forth as having a body 46 and a peripheral skirt 44. In lines 3 and 4 the claim sets forth “a connector element comprising: a body comprising a peripheral skirt surrounding the connector element”. This is unclear because if the connector element comprises the body it is unclear how the body can surround the thing it is part of. Also, the perimeter skirt is set forth as part of the body but the perimeter skirt is only mentioned in association with the dust cap. It is noted that claim 10 mentions to the dust cap having a circumferential skirt, but the specification refers to the skirt 47 of the dust cap being a circumferential skirt. It is unclear if the perimeter skirt of line 4 is a reference to the skirt of the dust cap, see line 10 where the dust cap is said to surround “the body of the connector element to enclose the lumen”. This is also unclear because the dust cap body (46 of Fig. 8) does not surround the body of the connector element (12), it is within the connector element and as shown in Fig. 8 surrounds the syringe 16 which has the lumen 15 located therein. The examiner believes the connector element 12 has a body 18 in the form of a circumferential skirt, the circumferential skirt is surrounding a syringe having a lumen 15 therein, and the dust cap includes a body 46 and a circumferential skirt 47 that surrounds the syringe 16 and the lumen 15. If this is true the specification should be amended to clarity the differences between the two skirts (47 and 18) and the claims should be amended to be consistent with such an interpretation. Claim 14 is similarly confusing for the language in lines 3, 4 and 6-8.
Claims not specifically mentioned are indefinite since they depend from one of the above claims.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 14-17, 19, 22, 23, 30, 33, 35 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spohn et al (USPN 11,938,093) in view of Riedel (USPAP 2023/0001091) .
With regards to claim 14, as understood, Spohn et al disclose a fluid path connector assembly (see for example Figs. 5A & 5B) for a medical fluid delivery system (title), the fluid path connector assembly comprising: a connector element (12) comprising a body (32, 20, 22, 26, 28) comprising a circumferential skirt (18) surrounding the connector element, a lumen (formed within 16) extending through the body, a first flexible leg (20) connected to the body, and a second flexible leg (22) connected to the body; a dust cap (14) removably connected to the connector element, the dust cap comprising a dust cap body (46) positioned between the first flexible leg and the second flexible leg and surrounding (51) the body of the connector element to enclose the lumen. Spohn et al does not disclose a removeable/disconnectable tamper resistant or tamper evident feature connecting the dust cap to the connector element, wherein, when present, the tamper resistant or tamper evident feature is configured to at least one of prevent removal of the dust cap from the connector element, indicate prior tampering with the connection between the connector element and the dust cap, and prevent or indicate reinstallation of the dust cap onto the connector element after the dust cap is removed from the connector element.
Riedel et al disclose a fluid path connector assembly including a connector element (the portion of 20 to the left of element 81 in Fig. 2) and a cap 30 which are connected by a removeable/disconnectable tamper resistant or tamper evident feature, wherein, when present, the tamper resistant or tamper evident feature (activation lock 50) is configured to at least one of prevent removal of the dust cap from the connector element (when present the cap and connector prevent removal until the elements 59 are broken), and indicate prior tampering (by elements 59 being broken and/or 50 not being present) with the connection between the connector element and the dust cap.
At the time of the effective filing date of the instant application it would have been obvious to one of ordinary skill in the art to utilize a tamper resistant or tamper evident feature such as disclosed by Reide in order to allow the cap of Spohn et al from being tampered with or discharged prior to its intended time of use.
With regards to claim 15, as understood, Spohn et al in view of Riedel disclose a fluid path connector assembly as set forth in claim 14, but does not disclose wherein tamper resistant or tamper evident feature comprising a polymeric shrink wrap or a paper wrap at least partially enclosing the connector element and the dust cap, the polymeric shrink wrap or the paper wrap having at least one removal feature for removing the shrink wrap from the fluid path connector assembly. Riedel does disclose the tamper resistant or tamper evident feature 50 being a relatively thin wrap made of a plastic material, see [0031], and having perforations (57, 58). The examiner gives official notice that polymeric shrink wraps having perforations are common tamper evident features and that at the time of the invention it would have been obvious to make the tamper evident and tamper resistant feature of such a polymeric material as a common and relatively cheap mechanism of preventing or indicating tampering or noting damage. Further, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. It is additionally noted that shrink wrapping is a method of making or assembling the warp and in accordance to MPEP 2113, the method of forming the device is not germane to the issue of patentability of the device itself. Therefore, this limitation has not been given patentable weight. Please note that even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product, i.e. the wrapped connector assembly, does not depend on its method of production, i.e., shrink wrapping. In re Thompson, 227 USPQ 964, 966 (Federal Circuit 1985).
With regards to claim 16, as understood, Spohn et al in view of Riedel disclose a fluid path connector assembly as set forth in claim 14, wherein Riedel additionally teach the removal feature comprises a tearable pre-cut, a gripable tab 72, and a perforation feature (56, 57, 58) for removing the tamper resistant or tamper evident feature.
With regards to claim 17, as understood, Spohn et al in view of Riedel disclose a fluid path connector assembly as set forth in claim 14, wherein Riedel additionally teach wherein the tamper resistant or tamper evident feature (50) comprises a cap (since the band 50 covers the junction of 20 and 30 it may broadly be considered as a cap) at least partially enclosing the connector element (20) and the dust cap (30), and wherein the cap is secured to a syringe (90) via a tearable strip (strips 59).
With regards to claim 22, as understood, Spohn et al in view of Riedel disclose a fluid path connector assembly as set forth in claim 14, wherein Riedel additionally teach that the tamper resistant or tamper evident feature comprises a first portion (the right side of element 50 in Fig. 2A) connected to the connector element (20) and a second portion (the left side of element 50 in Fig. 2A) connected to the first portion and the dust cap (30) wherein the first portion comprises a pull tab 72) configured for removing the first portion from the connector element or wherein the second portion is configured to break from the first portion or the dust cap with rotation of the dust cap about a longitudinal axis.
With regards to claim 23, as understood, Spohn et al in view of Riedel disclose a fluid path connector assembly as set forth in claim 14, wherein Riedel additionally teaches the tamper resistant or tamper evident feature (50) has a first end (the right side of element 50 in Fig. 2A) connected to the connector element (20) and a second end (the left side of element 50 in Fig. 2A) connected to the dust cap (30), and wherein the first end is configured to break or separate (via longitudinally extending elements 59) from the connector element with rotation of the dust cap about a longitudinal axis.
With regards to claim 30, as understood, Spohn et al in view of Riedel disclose a fluid path connector assembly as set forth in claim 14, with respect to the limitation “wherein, when the dust cap and the tamper resistant or tamper evident feature are connected to the connector element, air pressure within the lumen of the connector element may equalize with the outside atmospheric pressure while maintaining a sterility within the lumen of the connector element” this limitations sets forth a desired result and does not further structurally limit the claimed invention. Since Spohn et al in view of Riedel discloses all the structure the claim is made obvious.
With regards to claim 33, as understood, Spohn et al in view of Riedel disclose a fluid path connector assembly as set forth in claim 14, and Spohn et al additionally teach of an engagement element (the outer circumferential edge of plate 46) at the distal end of the dust cap body, the engagement element comprising a sloping member (66) defined by a distal edge of the dust cap body.
With regards to claim 35, as understood, Spohn et al in view of Riedel disclose a fluid path connector assembly as set forth in claim 33, wherein the sloping member (66) extends around at least a portion of an outer perimeter of the distal edge of the dust cap body.
With regards to claim 36, as understood, Spohn et al in view of Riedel disclose a fluid path connector assembly as set forth in claim 33, wherein the sloping member (66) is a rounded circumferential edge (the circumferential edge as shown in Fig. 5A is rounded) or a chamfered circumferential edge.
Allowable Subject Matter
Claims 1-3, 5, 6, 9, 10 and 12 would be allowable if rewritten or amended 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.
Claims 24, 27 and 34 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:
With regards to claims 1-3, 5, 6, 9, 10, 12 and 34 the prior art does not disclose the fluid path connector as claimed where the engagement element “at the distal end of the dust cap body, the engagement element comprising a sloping member defined by a distal edge of the dust cap body, wherein the engagement element is in contact with the first flange of the first flexible leg and the second flange of the second flexible leg of the connector element to prevent disengagement of the dust cap from the connector element, and wherein the first flange of the first flexible leg and the second flange of the second flexible leg of the connector element are configured to contact the sloping member when the dust cap is moved distally relative to the connector element such that the first flexible leg and the second flexible leg expand radially outward to permit removal of the dust cap from the connector element”.
With regards to claims 24 and 27 the prior art does not disclose the fluid path connector as claimed where the tamper resistant or tamper evident feature comprises a tearable pull tab monolithically formed with the dust cap (claim 24); or wherein the first portion and the second portion have at least one reinsertion prevention element to prevent reinstallation of the dust cap on the connector element after the dust cap is removed from the connector element (claim 27).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES G FREAY whose telephone number is (571)272-4827. The examiner can normally be reached Mon - Fri: 8:00 - 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Essama Omgba can be reached at (469)295-9278. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES G FREAY/Primary Examiner, Art Unit 3746
CGF
September 23, 2026
