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 .
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 4, 6, 7, 9 and 10 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 4 recites the limitation "the channel" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, Examiner interprets “the channel” as “the one or more radial channels” as defined in claim 1.
Claim 6 recites the limitation "the interconnection members" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, Examiner interprets “the interconnection members” as “one or more interconnection members” as defined in claim 2.
Claim 6 recites the limitation "the means for securing the first cap to the case" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, Examiner interprets “the means for securing the first cap to the case” as “a means for securing the first cap to the case”.
Claim 7 is rendered indefinite by the limitation “an intern surface of the case” since it is unclear what structure is being encompassed. For examination purposes, Examiner interprets “an intern surface of the case” as “an internal surface of the case”.
Claim 9 recites the limitation "the means for securing the first cap to the case" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, Examiner interprets “the means for securing the first cap to the case” as “a means for securing the first cap to the case”.
Claim 10 recites the limitation "the second cap part" in line 2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, Examiner interprets “the second cap part” as “a second cap part”.
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.
Claim Rejections - 35 USC § 102
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.
Claims 1, 3-5, 7, 8, 10-13, 16-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith (US 2002/0130100).
Regarding claim 1, Smith discloses a hard shell packaging product (See Figs. 1, 2 and 5) capable of containing a needle assembly comprising a canula extending from a hub for receiving a corresponding counterpart of a syringe (the packaging as shown in Fig. 1 is fully capable of holding a needle assembly comprising a canula extending from a hub for receiving a corresponding counterpart of a syringe), the hard shell product comprising a case (at 50 – See Fig. 5 labeled below) and a cap (at 40/44 – See Fig. 5 labeled below) configured to slidingly engage to an assembled configuration defining an enclosed volume (as shown below 42 in Fig. 5) capable of containing at least a portion of a needle assembly, wherein the case and the cap comprises circumferentially overlapping sidewall sections (See wall sections between 40 and 50 in Fig. 5 labeled below) and wherein one or more radial channels (channel at 57/55/59 in Fig. 5) is provided that extends are provided that extend in a longitudinal direction between the overlapping sidewall sections and that provide a gas passage to the enclosed volume (as described in [0091]).
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Regarding claim 3, Smith discloses the cap comprises: at least a first cap part (at 40 in Fig. 5) comprising one of the one or more means (threads) for the securing to the case; and a second cap part (at 44 in Fig. 5) that is connected to the first cap part by one or more interconnection members (at 45) configured to break (the interconnection between 40 and 44 at element 45 is broken when the second cap part is rotated upward from the closed arrangement shown in Fig. 2 to the open arrangement shown in Fig. 1) by displacing the second cap part with respect to the case while retaining a coupled connection between the first cap part and the case (as shown in Figs. 1 and 5).
Regarding claim 4, Smith discloses the channel is at least in part defined by one or more protrusions (material surrounding elements 55) extending outwardly from an inner face of the circumferentially overlapping wall section of the cap towards a corresponding overlapping wall section of the case.
Regarding claim 5, Smith discloses one or more of the interconnection members for securing the first cap part to the case comprise interlocking elements (at 45 and projection that 45 engages) configured to snap into a locked position.
Regarding claim 7, Smith discloses the case is capable of restricting rotational freedom of a needle assembly contained therein along the longitudinal direction by providing one or more engagement faces (faces of the inclined inner walls of the bottom portion of the case 50 in Fig. 2) by an inner surface of the case.
Regarding claim 8, Smith discloses the first cap part comprises one or more outwardly extending push members (outward extending threads).
Regarding claim 10, Smith discloses a second cap part (at 40) comprises members (See vertical ribs on the external surface of 40 in Fig. 2) for external manual grip for displacing the second cap part with respect to the case.
Regarding claim 11, Smith discloses an internal sidewall of the case comprises a retention member (face of the inclined inner wall of the bottom portion of the case 50 in Fig. 2) that is engagable with a needle assembly contained therein capable of restricting displacement of the needle assembly along the longitudinal direction.
Regarding claim 12, Smith discloses the case has an external section that is essentially circular and free of protrusions and that is bound by an outwardly extending ledge (the bottom-most thread on at the top of 50 is considered a ledge).
Regarding claim 13, Smith discloses the case comprises a lip (the bottom-most thread on at the top of 50 is considered a lip) that restricts formation of a flush contact areas between exterior and interior faces of stacked cases.
Regarding claim 16, Smith discloses cap (at 40/44) and a case (at 50) for assembly into a hard shell packaging product (as shown in Figs. 1-2 and 5), such as the hard shell product capable of packaging a needle assembly according to claim 1, the cap and the case defining an enclosure (cavity beneath 42 in Fig. 5) for a product to be stored in a coupled configuration, wherein the case and cap are configured to, in the coupled configuration, provide circumferentially overlapping sidewall sections (See wall sections between 40 and 50 in Fig. 5 labeled above) and wherein one or more radial channels (at 57/55/59 in Fig. 5) are provided that extend in a longitudinal direction between the overlapping sidewall sections so as to provide a gas passage to the needle assembly.
Regarding claim 17, Smith discloses the cap comprises: at least a first cap part (at 40 in Fig. 5) comprising means (threads) for the securing to the case; and a second cap part (at 44) that is connected to the first cap part by one or more interconnection members (at 45) members configured to break by displacing the second cap part with respect to the case while retaining a coupled connection between the first cap part and the case.
Regarding claim 18, Smith discloses a packaged needle assembly (shown at 71/83 in Fig. 6) partially enclosed by the packing product or the cap and the case.
Regarding claim 20, Smith discloses a method of packaging a product, comprising closing a storage volume (cavity within 50 in Fig. 2) around a product to be packaged by coupling the case (50) and the cap (at 40/44) according to claim 1.
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.
Claims 2, 6, 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2002/0130100) as applied to claims 1, 2, 5 and 8 above, in view of Gelov et al. (US 10,518,943).
Regarding claims 2 and 14, as described above, Smith discloses the claimed invention except for the single use means for securing the cap to the case. However, Gelov teaches a packaging (See Figure 15) comprising a case (at 184 in Fig. 15) and a cap (at the top of Fig. 15), wherein the packaging is provided with a single use means for securing the cap to the case (tamper evident label 186) extending circumferentially across the boundary between the cap and the case, for the purpose of indicating that the packaging was opened (column 6, lines 38-43). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the boundary between the cap and the case of Smith with a tamper evident label as taught by Gelov in order to indicate that the packaging was opened.
Further regarding claim 6, Smith-Gelov discloses the interconnection members and the tamper evident label are configured to break at a force smaller than a snap out force for releasing the interlocking elements from the locked position.
Further regarding claim 9, Smith-Gelov discloses the tamper evident label overlaps with the push members.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2002/0130100) in view of Gelov et al. (US 10,518,943) as applied to claim 14 above, and further in view of Shinkle, II et al. (US 2020/0365061). As described above, Smith-Gelov discloses the claimed invention except for the label comprising perforation lines. However, Shinkle teaches a tamper evident label (100) comprising perforation lines (at 101) for the purpose of tearing the label if an attempt is made to remove the label from the surface of the object ([0035] and [0066]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the label of Smith-Gelov with perforations as taught by Shinkle in order to tear the label if an attempt is made to remove the label from the packaging, to indicate tampering.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 2002/0130100) as applied to claim 18 above, in view of Domonkos (US 2014/0135713). As described above, Smith discloses the claimed invention except for the needle assembly comprising a needle guard. However, Domonkos teaches it is well known in the art for a needle assembly (at 310/210 in Figs 1-2) to include a needle guard (at 110) for the purpose of protecting the needle immediately after withdrawal of the needle from the skin of a patient ([0009]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the needle assembly of Smith with a needle guard as taught by Domonkos in order to better protect the needle after use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEVEN A REYNOLDS whose telephone number is (571)272-9959. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anthony Stashick can be reached at (571) 272-4561. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEVEN A. REYNOLDS/Primary Examiner, Art Unit 3735