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 .
Claim Objections
Claim 16 is objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Claim 16 currently refers to both claims 1 and 15. Accordingly, the claim has not been further treated on the merits. While claim 16 has not been further treated on the merits, it is noted that claim 16 in its current form would be anticipated by Irland (U.S. Patent Application Publication No. 2009/0005690) since Irland teaches the device and method according to claims 1 and 15, respectively, as set forth below.
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.
Claim 14 is 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 14 is indefinite because the claim is not clearly directed to any proper statutory category of invention, comprising only a “use” claim for a purpose “to hold a fetal heart transducer against a pregnant woman’s abdomen whilst recording a fetal heart rate signal. The metes and bounds of the claim are unclear, as there are no structural features or steps claimed for “use of a device according to claim 1.”
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 14 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to “use” of a device without any steps for said use. Therefore, the claim is not directed to a method, as the claim comprises no steps, and the claim is not directed to an apparatus, composition of matter, or manufacture.
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.
(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) 1-3, 5, 7-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Irland (U.S. Patent Application Publication No. 2009/0005690) hereinafter referred to as Irland
Regarding claim 1, Irland teaches a device for positioning a fetal heart rate transducer (¶[0041] FHR fetal heart rate) against a pregnant women's abdomen (¶[0031]), the device comprising:
a body having a lower surface and an upper surface opposite the lower surface (Fig. 9, ¶[0040]);
wherein the lower surface is non-planar and comprises a protruding portion intended to engage an upper surface of the transducer in use (Fig. 8, e.g. transducer element 1 and belt element 5 engages with bottom surface of device of Figs. 9-10), and configured such that the protruding portion can be positioned to apply a force to a selected area on the upper surface of the transducer (¶[0041] wedge angles the transducer at the necessary angle, applying a force to the area which allows the device to sit at an angle).
Regarding claim 2, Irland teaches a device according to claim 1.
Irland further teaches wherein the lower surface of the body has a flat perimeter region surrounding the protruding portion (Fig. 9, remaining surface is flat, as seen in Fig. 10).
Regarding claim 3, Irland teaches a device according to claim 1.
Irland further teaches wherein the body of the device has a generally planar upper surface (Fig. 10, upper surface is generally planar).
Regarding claim 5, Irland teaches a device according to claim 1.
Irland further teaches wherein the lower surface of the body includes one or more engagement formations adapted to engage a cooperating engagement formation on the upper surface of the transducer (Fig. 13, housing of device, element 12, engages with transducer element 1 through engagement formations, shoulders 5 and 14/16).
Regarding claim 7, Irland teaches a device according to claim 1.
Irland further teaches wherein the upper surface of the device body is configured to engage a belt that can be used to secure the device on the pregnant women's abdomen (¶[0031]).
Regarding claim 8, Irland teaches a device according to claim 7.
Irland further teaches wherein a channel is formed on the upper surface of the device body to receive the belt (Fig. 9, channels visible in arms 14/16 may be considered formed on the upper surface of the device body, housing 12).
Regarding claim 9, Irland teaches a device according to claim 1.
Irland further teaches the device formed from a medical grade polymer (¶[0030] injection molded plastic as well understood in the medical device industry is understood to be a medical grade polymer).
Regarding claim 10, Irland teaches a device according to claim 1.
Irland further teaches the device formed as a unitary moulded component (¶[0030] injection molded plastic).
Regarding claim 11, Irland teaches an apparatus for securing a fetal heart rate transducer to the abdomen of a pregnant women, the system comprising: a device according to claim 1 (see rejection of claim 1, above).
Irland further teaches a fetal heart rate transducer, wherein in use a lower surface of the device is engaged with an upper surface of the transducer to push the transducer against the pregnant women's abdomen (¶[0041]).
Regarding claim 12, Irland teaches an apparatus according to claim 11.
Irland further teaches wherein an outer end of the protruding portion on the body of the device has a smaller surface area than the area of the upper surface of the transducer, whereby the device can be positioned to apply pressure to a selected area on the upper surface of the transducer (Figs. 9-10, ¶[0041]).
Regarding claim 13, Irland teaches an apparatus according to claim 11.
Irland further teaches comprising a belt adapted extend around the torso of the pregnant women, over the upper surface of the device, to apply pressure to the device to push it against the upper surface of the transducer (Fig. 9, channels for belt, visible in arms 14/16 may be considered formed on the upper surface of the device body, housing 12, ¶[0040]).
Regarding claim 14, Irland teaches use of a device according to claim 1.
Irland further teaches to hold a fetal heart rate transducer against a pregnant women's abdomen whilst recording a fetal heart rate signal (¶[0041]).
Regarding claim 15, Irland teaches a method for monitoring fetal heart rate (¶[0041] FHR), the method comprising:
placing a fetal heart rate transducer against a pregnant women's abdomen (¶[0031]);
using a device having a lower surface with a protruding portion to apply pressure to a selected area on the upper surface of the transducer (¶[0041] wedge protrudes from surface of the device and presses transducer, see Figs. 9-10); and
using the transducer to detect a fetal heart rate signal whilst pressure is being applied to it by the device (¶[0041] FHR).
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.
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) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irland as applied to claim 1 above, and further in view of Oz et al. (U.S. Patent Application Publication No. 2021/0068672) hereinafter referred to as Oz.
Regarding claim 4, Irland teaches a device according to claim 1.
Irland further teaches a protruding portion where the size and shape/orientation of the wedge is results effective for monitoring FHR (¶[0041]) and that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the height of such a protrusion (in another embodiment of Irland, the protrusion is configurable ¶[0035]).
Therefore, Irland teaches all of the limitations of claim 4 except for the height of the protruding portion between 15mm and 35mm.
Attention is drawn to the Oz reference, which teaches a protruding portion of a sensing device pressed against an abdomen, where the height of the protruding portion is 15mm (¶[0241]), therefore showing that the relative height claimed would have been known in the art, and predictable to configure within the claimed range of 15-35mm.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the protrusion of Irland to be within the range of 15-35mm, as taught by Oz, because courts have held that (i)t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions. In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929)
Claim(s) 6 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Irland as applied to claim 5 above, and further in view of Penders et al. (U.S. Patent 2018/0000405) hereinafter referred to as Penders.
Regarding claim 6, Irland teaches a device according to claim 5.
Irland does not teach wherein the engagement formation on the lower surface of the device body is an opening and the cooperating formation on the transducer is a button.
Attention is drawn to the Penders reference, which teaches wherein the engagement formation on the lower surface of the device body is an opening and the cooperating formation on the transducer is a button (¶[0085], ¶[0095], a receptacle on the accessory is considered to be an opening, and the protrusion is considered to be a button).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device body engagement to include a opening and button, as taught by Penders, because Penders teaches a reversible coupling for using additional accessories with a sensor device (Penders ¶[0096]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2012/0232398 to Roham et al. teaches a doppler fetal sensor unit attached to an abdomen using a belt.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792