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 .
Information Disclosure Statement
The information disclosure statements have been considered by the examiner. However, it is noted that the Mexican office action, which was attached with the 01/29/2026 IDS, and the Japanese office action, which was attached with the 03/11/2025 IDS, are not listed on the respective IDS documents. If Applicant would like these documents to be marked as considered, please include them on an IDS.
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 projections must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “14” has been used to designate both the guide member and an additional feature (see Fig. 4).
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.
Claims 11-14 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 11 recites the limitation “a needle” in both lines 3 and line 10. It is unclear if both recitations of “a needle” are intended to refer to the same needle or if these refer to different needles. For the purpose of compact prosecution, both recitations of “a needle” are interpreted as referring to the same needle. Claims 12-14 are also rejected based on their dependency on Claim 11.
Claim 14 recites the limitation "the tapered terminal end" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1, 6, 9, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sanders et al (US 2015/0297454).
Regarding Claim 1, Sanders discloses a membrane (34, Figs. 2, 8, and 55G) for a closed system transfer device (syringe adapter 12, Figs. 2 and 8) comprising:
a body (82, Figs. 2, 8, and 55G) having a first end (84, Figs. 2, 8, and 55G) and a second end (86, Figs. 2, 8, and 55G) positioned opposite the first end (84, Figs. 2, 8, and 55G), the body (82, Figs. 2, 8, and 55G) defining a passageway (92, Figs. 2, 8, and 55G) extending from the first end (84, Figs. 2, 8, and 55G) of the body (82, Figs. 2, 8, and 55G) to a position intermediate the first end (84, Figs. 2, 8, and 55G) of the body (82, Figs. 2, 8, and 55G) and the second end (86, Figs. 2, 8, and 55G) of the body (82, Figs. 2, 8, and 55G); and
a guide member (228, Fig. 55G) positioned within the passageway (92, Fig. 55G) of the body (82, Figs. 2, 8, and 55G), the guide member (228, Fig. 55G) having a first end and a second end positioned opposite the first end (Fig. 55G), the guide member (228, Fig. 55G) having a guide surface (interior surface of 228, Fig. 55G) configured to engage a needle (28, Figs. 2, 8, and 55G) positioned within the passageway (92, Figs. 2, 8, and 55G) of the body (82, Figs. 2, 8, and 55G).
Regarding Claim 6, Sanders discloses the guide member (228, Fig. 55G) is positioned intermediate the first (84, Figs. 2, 8, and 55G) and second ends (86, Figs. 2, 8, and 55G) of the body (82, Figs. 2, 8, and 55G).
Regarding Claim 9, Sanders discloses the passageway (92, Figs. 2, 8, and 55G) comprises a tapered terminal end (the terminal end has a curvature which can be considered a tapered terminal end, Fig. 55G).
Regarding Claim 11, Sanders discloses a syringe adapter (12, Figs. 2 and 8) comprising:
a housing (16, Figs. 2 and 8) having a connector (24, Figs. 2 and 8) configured to be secured to a syringe (¶ [0083]);
a needle (28, Figs. 2 and 8) received within the housing (16, Figs. 2 and 8) and in fluid communication with the connector (24, Figs. 2 and 8), the needle (28, Figs. 2 and 8) having a first end and a second end (30, Figs. 2 and 8) positioned opposite the first end (Figs. 2 and 8); and
a membrane (34, Figs. 2, 8, and 55G) having a body (82, Figs. 2, 8, and 55G) having a first end (84, Figs. 2, 8, and 55G) and a second end (86, Figs. 2, 8, and 55G) positioned opposite the first end (84, Figs. 2, 8, and 55G), the body (82, Figs. 2, 8, and 55G) defining a passageway (92, Figs. 2, 8, and 55G) extending from the first end (84, Figs. 2, 8, and 55G) of the body (82, Figs. 2, 8, and 55G) to a position intermediate the first end (84, Figs. 2, 8, and 55G) of the body (82, Figs. 2, 8, and 55G) and the second end (86, Figs. 2, 8, and 55G) of the body (82, Figs. 2, 8, and 55G); and
a guide member (228, Fig. 55G) positioned within the passageway (92, Fig. 55G) of the body (82, Figs. 2, 8, and 55G), the guide member (228, Fig. 55G) having a first end and a second end positioned opposite the first end (Fig. 55G), the guide member (228, Fig. 55G) having a guide surface (interior surface of 228, Fig. 55G) configured to engage a needle (28, Figs. 2, 8, and 55G) positioned within the passageway (92, Figs. 2, 8, and 55G) of the body (82, Figs. 2, 8, and 55G),
the membrane (34, Figs. 2, 8, and 55G) moveable from a first position (see Fig. 22) within the housing (16, Figs. 2, 8, 22, and 24) where the second end (30, Figs. 2, 8, 22, and 24) of the needle (28, Figs. 2, 8, 22, and 24) is received within the passageway (92, Figs. 2, 8, 22, and 24) of the membrane (34, Figs. 2, 8, 22, and 24) to a second position (Fig. 24) where the second end (30, Figs. 2, 8, 22, and 24) of the needle (28, Figs. 2, 8, 22, and 24) is positioned outside of the passageway (92, Figs. 2, 8, 22, and 24) of the membrane (34, Figs. 2, 8, 22, and 24), the needle (28, Figs. 2, 8, 22, and 24) is engaged with the guide member (228, Fig. 55G) when the membrane (34, Figs. 2, 8, 22, and 24) moves from the first position (Fig. 22) to the second position (Fig. 24).
Regarding Claim 12, Sanders discloses a collet (32, Figs. 2 and 8) defining an opening, the membrane (34, Figs. 2 and 8) received within the opening of the collet (32, Figs. 2 and 8; ¶ [0083]).
Regarding Claim 13, Sanders discloses an outer diameter of the needle (28, Figs. 2 and 8) tapers from the first end of the needle (28, Figs. 2 and 8) to the second end (30, Figs. 2 and 8) of the needle (28, Figs. 2 and 8).
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.
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) 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al (US 2015/0297454).
Regarding Claim 2, Sanders is silent whether the guide member is formed integrally with the body.
However, it has been held that "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.” In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). Therefore, it would have been obvious to one of ordinary skill in the art to have the guide member of Sanders formed integrally with the body.
Regarding Claim 7, Sanders does not explicitly state that the guide member extends at least 25 percent of the length of the body.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Sanders to have the guide member extend at least 25 percent of the length of the body since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Sanders would not operate differently with the guide member extending at least 25 precent of the length of the body. Further, applicant places no criticality on the range claimed, indicating simply that the extension of the guide member “may” be within the claimed ranges (¶ [0031]).
Claim(s) 3-5, 8, 10, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sanders et al (US 2015/0297454) in view of Lopez (US 5738663).
Regarding Claims 3-5, 8, 10, and 14, Sanders is silent whether the guide member comprises a projection extending from the body in a radially inward direction, wherein the guide member comprises a plurality of equally-spaced projections extending from the body in a radially inward direction, wherein the guide surface is concave, wherein the body defines a slit extending from the passageway to the second end of the body, wherein the guide surface is convex, and wherein the tapered terminal end of the passageway of the membrane corresponds to the shape of the second end of the needle.
Lopez teaches a medical valve, thus being in the same field of endeavor, where the membrane comprises a plurality of equally-spaced projections (tires 100, Figs. 13-14) extending from the body in a radially inward direction (Figs. 13-14), wherein the interior surface of the membrane is concave and convex (Figs. 13-14, the curvature of the tires and spaces between the tires alternate between concave and convex), and wherein the body defines a slit (11, Fig. 13) extending from the passageway (98, Fig. 13) to the second end (204, Fig. 13) of the body, and wherein the tapered terminal end of the passageway (98, Fig. 4) corresponds to the shape of the second end (32, Fig. 14) of the needle (26, Fig. 14). This structure allows the membrane to easily deform and reform, with the slit being sealingly closed after the membrane reforms (Col. 11 line 58 – Col. 12 line 20).
Therefore, it would have been obvious to modify the guide member of the membrane of Sanders to comprise a plurality of equally-spaced projections extending from the body in a radially inward direction, wherein the guide surface is concave, wherein the body defines a slit extending from the passageway to the second end of the body, wherein the guide surface is convex, and wherein the tapered terminal end of the passageway of the membrane corresponds to the shape of the second end of the needle, as taught by Lopez, to allow the membrane to easily deform and reform, with the slit being sealingly closed after the membrane reforms (as motivated by Lopez Col. 11 line 58 – Col. 12 line 20).
Conclusion
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/JESSICA ARBLE/ Primary Examiner, Art Unit 3781