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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-7 in the reply filed on 1/2/26 is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/2/26.
Information Disclosure Statement
The information disclosure statement filed 7/22/23, three of IDS, and the IDS dated 8/20/23 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because there is not date associated with the references. References not considered have been lined through. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112(b)
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 and 27 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.
The following claims appear to be claiming both an apparatus and a method.
As per MPEP 2173.05(p)(1D), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. It is not clear if the claims are drawn only to structures that are capable of performing the method steps or if the claims are intended to be written as method steps. For the sake of examination, the claims have been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed.
A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AJA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). In Katz, a claim directed to “[a] system with an interface means for providing automated voice messages...to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384,77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement ... occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
Claim 1 recites “a guiding element shaft that houses a needle”
Claim 1 recites “a guiding element barrel that houses a vial”
Claim 27 recites “the transition section that controls the depth of a needle can a vial”
It is suggested that claim language can be configured to use the phrase “capable of” prior to the functional limitation.
Claim 27 recites “a needle” in line 2. A needle is already recited in claim 1 from which claim 27 depends. Therefore it is unclear whether the needle of claim 27 is the same or different than the one in claim 1. For purposes of examination the needle of claim 27 is the same as the needle in claim 1 and the claim language should recite –the needle--.
Claim 27 recites “a vial” in line 2. A needle is already recited in claim 1 from which claim 27 depends. Therefore it is unclear whether the vial of claim 27 is the same or different than the one in claim 1. For purposes of examination the vial of claim 27 is the same as the vial in claim 1 and the claim language should recite –the vial--.
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.
Claim(s) 1-4, 6-7, 21-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shemesh et al. (U.S. 2010/0179506 A1).
With regard to claim 1, Shemesh discloses A guiding element device (fig. 4), comprising: a guiding element shaft (16) that houses a needle ([0021], needle of syringe can be pushed on to syringe adapter element connection port 16); a guiding element barrel (formed by 12 and 17) that houses a vial ([0020], [0022]); a transition section (66), comprising a top surface (siding facing the rim 12) and a bottom surface (side facing 16); and a first support arm (64), a second support arm (there are four support arms 64 shown in Fig. 4), and a third support arm (there are four support arms 64 shown in Fig. 4), wherein each support arm is operably connected to the transition section (see arm 64 that extends upwards from a floor 66, [0027]) and the guiding element barrel (17, 64 is connected with the barrel portion 17 as shown in Fig. 4) and each is articulatable (64 is described as a cantilevered arm and thus is articulatable, [0027]).
With regard to claim 2, Shemesh discloses wherein the guiding element barrel comprises: a first recesses portion, a second recessed portion, a third recessed portion, a fourth recesses portion, a fifth recessed portion, and a sixth recessed portion. See annotated Figure below showing the first, second, third, and fourth recessed portion. The fifth and sixth would be located around along the other sides of 17 as the structures for each of the arms 64 is the same all the way around the guiding element barrel).
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With regard to claim 3, Shemesh discloses further comprising: a first window (68), a second window (there are four windows 68), a third window (there are four windows 68), wherein each window is located between the transition section and the guiding element barrel (see Fig. 4).
With regard to claim 4, Shemesh discloses wherein each of the recessed portions comprises an angled edge that slopes inwardly towards the bottom surface of the transition section (best shown in the first recessed portion and second recesses portion in the annotated Fig above showing that the slope of the recessed portion is angled slightly towards the transition section 66).
With regard to claim 6, Shemesh discloses wherein the first recessed portion and the second recessed portion form a first channel (see annotated Fig below); the third recessed portion and the fourth recessed portion form a second channel (the third and fourth recessed portion would form a similar channel as the one shown for the first and second recessed portion); and the fifth recessed portion and the sixth recessed portion form a third channel (the fifth and sixth recessed portion would form a similar channel as the one shown for the first and second recessed portion).
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With regard to claim 7, Shemesh discloses wherein each of the channels is located on an exterior surface of the guiding element barrel (channels (as shown above) are considered located on an exterior surface because they are exposed and open to the external surface of the guiding element barrel).
With regard to claim 21, Shemesh discloses further comprising a fourth support arm (there are four arms 64) operably connected to the transition section and the guiding element barrel (as shown in Fig. 4); wherein the fourth support arm that is articulatable ([0027]); and wherein the guiding element barrel further comprises a seventh recessed portion and an eighth recessed portion (the seventh and eighth recessed portion would follow similar to the recessed portions shown above but along the sides of the fourth arm 64).
With regard to claim 22, Shemesh discloses wherein the seventh recessed portion and the eighth recessed portion form a fourth channel (same as how the channel is formed in the annotated Fig above but with the seventh and eighth recessed portion).
With regard to claim 23, Shemesh discloses wherein each of the channels is rounded (see the channel labeled above in the annotated Fig showing the meeting of the two recessed surfaces which can be considered rounded in shape).
With regard to claim 24, Shemesh discloses further comprising a fourth window (the fourth of 68) located between the transition section and the guiding element barrel (see Fig. 4).
With regard to claim 25, Shemesh discloses wherein the transition section (66) is situated between the guiding element shaft (16) and the guiding element barrel (17).
With regard to claim 26, Shemesh discloses wherein the transition section (66) forms a substantially right angle (see Fig. 4) between the guiding element shaft (16) and the guiding element barrel (17).
With regard to claim 27, Shemesh discloses wherein the transition section that controls the depth a needle can access a vial that has been inserted into the guiding element barrel (without further definition or structure for how the transition section “controls” the depth, the fact that it provides a structure that could inhibit a needle depth via the puncture spike 14, the needle would only be able to be inserted a certain about before “hitting” the transition section 66 or spike 14 which would inhibit the depth of the needle).
With regard to claim 28, Shemesh discloses wherein the transition section further comprises: a first slit, a second slit, a third slit, a fourth slit, a fifth slit, and a sixth slit. See Annotated Fig below showing where the slits would be located, a further fifth and sixth slits can be located along the other sides of element 17 that are not explicitly shown in Fig. 4 as the slits are located along all the sides of 17 in a similar manner.
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With regard to claim 29, Shemesh discloses wherein the first support arm, the second support arm, and the third support arm that are each articulatable independent from each other (see Fig. 4, arms 64 are only cantilevered at the connection with 66. So they could each be pivoted individually).
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shemesh et al. (U.S. 2010/0179506 A1).
With regard to claim 5, Shemesh discloses an angled edge but does not explicitly disclose a 45 degree angle.
However, it would be prima facie obvious to optimize the angle of the angled edge because doing so would not alter the overall function of the device and the claims do not have a significant purpose for the claimed angle.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783