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 1-15 are currently amended.
Claims 1-15 are being examined in this Office Action.
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 1-15 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 recites the limitation "the needle" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation “a second antenna leg” in line 2. It is unclear if this is referencing the previously established second antenna leg in claim 1, or if this is a separate antenna leg. Examiner interprets “a second antenna leg” in claim 4 to be the same antenna leg as in claim 1.
Claim 7 recites the limitation “wherein the RFID tag is U-shaped and comprises an integrated circuit and a pair of leg portions having two or more antenna”. It is unclear if each leg portion contains an antenna or if a single leg portion has two or more antennae while the other leg portion has no antenna. Examiner interprets that each leg portion contains an antenna.
Claim 8 recites the limitation “an antenna formed by a first antenna leg, a second antenna leg” in lines 2-3. It is unclear if a first antenna leg and a second antenna leg are the same antenna legs established in claim 1, or if they are separate antenna legs altogether. For the purposes of examination, Examiner interprets “a first antenna leg” and “a second antenna leg” in claim 8 to be the previously recited antenna legs in claim 1.
Claim 10 recites the limitation “the tag” in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the tag” to be the previously recited RFID tag.
Claim 11 recites the limitation “the tag” in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner interprets “the tag” to be the previously recited RFID tag.
All remaining claims are rejected by virtue of their dependance on a rejected 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.
(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, 6, and 9-15. is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bauss et al. (Pub. No. US 20190328485 A1, herein Bauss).
Regarding Claim 1, Bauss discloses a rigid needle shield assembly for covering the needle of a syringe (Fig. 10) comprising:
a rigid shield (203) having an open proximal end (See annotated Fig. 10 below), a distal end (annotated Fig. 10), an exterior sidewall (annotated Fig. 10), and an interior sidewall (annotated Fig. 10);
a flexible needle sheath (201) having an open proximal end (annotated Fig. 10), a closed distal end (annotated Fig. 10), an exterior sidewall (annotated Fig. 10), and an interior sidewall (annotated Fig. 10); and
an RFID tag (202) having at least a first antenna leg and a second antenna leg (left and right portions of 208, Fig. 12),
wherein the flexible needle sheath and the RFID tag are disposed within the rigid shield (Fig. 10);
wherein the RFID tag is positioned between the interior sidewall of the rigid shield and the exterior sidewall of the flexible needle sheath (annotated Fig. 10); and
wherein the first antenna leg and the second antenna leg extend along a length of the rigid shield between the interior sidewall of the rigid shield and the exterior sidewall of the flexible needle sheath (annotated Fig. 10).
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Regarding Claim 6, Bauss discloses the rigid needle shield assembly of claim 1, wherein the RFID tag comprises a bendable, elongated inlay (“the RFID tag is preferably fixedly attached to the rigid outer cover. This can be achieved by one of a variety of fasteners, for example, a snap fit, an inlay, co-molding, an adhesive, lamination, tape, a press fit or a combination of any of these attachment methods.” – Paragraph [0006]) formed of flexible conductive materials (Antenna 208 forming around rigid shield in Fig. 10, “the antenna is electrically connected to the RFID tag 202” – Paragraph [0045], Examiner interprets the antenna is formed of a flexible conductive material since it forms around rigid shield and is electrically connected to RFID tag).
Regarding Claim 9, Bauss discloses the rigid needle shield assembly of claim 1, wherein the flexible needle sheath is formed of an elastomeric material (Paragraph [0042]).
Regarding Claim 10, Bauss discloses the rigid needle shield assembly of claim 1, wherein the tag is at least one of an ultra-high frequency (UHF) RFID tag or a high frequency (HF) RFID tag (Paragraph [0046]).
Regarding Claim 11, Bauss discloses the rigid needle shield assembly of claim 1, wherein the tag is configured to store a unique device identifier (Paragraphs [0051]- [0056]).
Regarding Claim 12, Bauss discloses the rigid needle shield assembly of claim 11, wherein the unique device identifier includes at least one of a batch number, manufacturing line, time stamp, expiry date, drug identification, and component batch number pertaining to contents of the syringe upon which the rigid needle shield assembly is coupled (Paragraphs [0051]- [0056]).
Regarding Claim 13, Bauss discloses the rigid needle shield assembly of claim 1, wherein during assembly of the rigid needle shield assembly, the flexible needle sheath is used to press the RFID tag into position between the interior sidewall of the rigid shield and the exterior sidewall of the flexible needle sheath (Annotated Fig. 10).
This claim is directed to a product-by-process where “the RFID tag… between the interior sidewall of the rigid shield and the exterior sidewall of the flexible needle sheath” is the product and “the flexible needle sheath is used to press the RFID tag into position” is the process. “[E]ven 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 does not depend on its method of production. If the product in product-by process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Bauss discloses the product of “the RFID tag… between the interior sidewall of the rigid shield and the exterior sidewall of the flexible needle sheath” as noted above.
Regarding Claim 14, Bauss discloses the rigid needle shield assembly of claim 13, wherein the pressing of the RFID tag into position between the interior sidewall of the rigid shield and the exterior sidewall of the flexible needle sheath causes the first antenna leg and the second antenna leg to bend (Annotated Fig. 10).
This claim is directed to a product-by-process where “the first antenna leg and the second antenna leg to bend” is the product and “pressing of the RFID tag into position… causes the first antenna leg and the second antenna leg to bend” is the process. “[E]ven 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 does not depend on its method of production. If the product in product-by process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Bauss discloses the product of the first antenna leg and the second antenna leg being bent as noted above.
Regarding Claim 15, Bauss discloses the rigid needle shield assembly of claim 1, wherein during assembly of the rigid needle shield assembly, the RFID tag (202) is selected from an RFID tag packaging strip comprising a plurality of serially-packaged RFID tags.
This claim is directed to a product-by-process where “the RFID tag” is the product and “the RFID tag is selected from an RFID tag packing strip comprising a plurality of serially-packaged RFID tags” is the process. “[E]ven 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 does not depend on its method of production. If the product in product-by process claim is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Bauss discloses the product of “the RFID tag” as noted above.
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.
Claim(s) 2-5, 7, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bauss in view of Hockey et al. (US 7839338 B2, herein Hockey).
Regarding Claim 2, Bauss discloses the rigid needle shield assembly of claim 1.
Bauss does not expressly disclose wherein the RFID tag comprises a dipole antenna.
Hockey teaches an RFID tag (400, Fig. 4) comprising a dipole antenna (Col. 7 Lines 13-16).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rigid needle shield assembly disclosed by Bauss wherein the RFID tag comprises a dipole antenna as taught by Hockey so that the RFID tag may be relatively small and cost effective (Hockey, Col. 1 Lines 30-33).
Regarding Claim 3, Bauss discloses the rigid needle shield assembly of claim 1.
Bauss does not expressly disclose wherein the RFID tag comprises an integrated circuit coupled to a substrate.
Hockey teaches wherein the RFID tag comprises an integrated circuit coupled to a substrate (Col. 3 Lines 9-18, Fig. 4).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rigid needle shield assembly disclosed by Bauss wherein the RFID tag comprises an integrated circuit coupled to a substrate as taught by Hockey so that the RFID tag may be relatively small and cost effective (Hockey, Col. 1 Lines 30-33).
Regarding Claim 4, modified Bauss in view of Hockey discloses the rigid shield assembly of claim 3, wherein the first antenna leg and second antenna leg (Bauss, left and right portions of 208) are coupled to the substrate (Hockey, Col. 3 Lines 9-18, Fig. 4) and are bendable relative to the substrate (Bauss, Fig. 10, Paragraph [0045] and Hockey, Col. 5 Lines 49-53). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rigid needle shield assembly disclosed by Bauss wherein the first antenna leg and second antenna leg are coupled to the substrate and are bendable relative to the substrate as taught by Hockey in order to provide a configuration that has increased communication ranges (Hockey, Col. 1 Lines 30-32).
Regarding Claim 5, modified Bauss in view of Hockey discloses the rigid shield assembly of claim 3, wherein the integrated circuit and the substrate are positioned between the closed distal end of the flexible needle sheath and the distal end of the rigid shield (Bauss, annotated Fig. 10).
Regarding Claim 7, Bauss discloses the rigid needle shield assembly of claim 1.
Bauss does not expressly disclose wherein the RFID tag is U-shaped and comprises an integrated circuit and a pair of leg portions having two or more antennae.
Hockey teaches wherein the RFID tag (Fig. 6) is U-shaped (Col. 7 Lines 50-55) and comprises an integrated circuit (Col. 3 Lines 9-17) and a pair of leg portions (604, 606, 608) having two or more antennae (Col. 8 Lines 1-7).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rigid needle shield assembly disclosed by Bauss wherein the RFID tag is U-Shaped and comprises and integrated circuit and a pair of leg portions having two or more antennae as taught by Hockey in order to provide a configuration that has increased communication ranges (Hockey, Col. 1 Lines 30-32).
Regarding Claim 8, Bauss discloses the rigid needle shield assembly of claim 1.
Bauss does not expressly disclose wherein the RFID tag comprises an integrated circuit, a substrate, and an antenna formed by a first antenna leg, a second antenna leg, a third antenna leg, and a fourth antenna leg.
Hockey teaches wherein the RFID tag (Fig. 6) comprises an integrated circuit, a substrate, and an antenna (Col. 3 Lines 9-17) formed by a first antenna leg (606), a second antenna leg (608), a third antenna leg (left segment of 604), and a fourth antenna leg (right segment of 604).
Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the rigid needle shield assembly disclosed by Bauss wherein the RFID tag comprises an integrated circuit, a substrate, and an antenna formed by a first antenna leg, a second antenna leg, a third antenna leg, and a fourth antenna leg as taught by Hockey so that there may be a configuration that has increased communication ranges (Hockey, Col. 1 Lines 30-32).
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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/MARK GOLOVAN/Patent Examiner, Art Unit 3783 /James D Ponton/Primary Examiner, Art Unit 3783
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