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 .
Response to Arguments
Applicant’s amendments overcome the claim objection, and rejections under 35 U.S.C. §§ 101 and 112 and therefore the rejections are withdrawn. Applicant’s amendments further merit new grounds for rejection under 35 U.S.C. § 103 as unpatentable over Irland in view of Oz, previously cited.
Oz teaches a protruding portion of a sensing device pressed against an abdomen comprising a central bulge (Fig. 5, Fig. 6), therefore showing that the bulge location claimed would have been known in the art, and predictable to configure for one of ordinary skill in the art.
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 centrally located, 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), and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Applicant's arguments filed 7/12/2026 have been fully considered but they are not persuasive. Applicant’s arguments are directed to an embodiment of Irling comprising inflatable portions. However, the Examiner relied on the embodiment of Fig. 9, which comprises a rigid protrusion that does not require any air bladder or inflation, ¶¶[0040-0041]. Therefore, applicant’s comments with respect to the passive, structural shaping required by the claims are not persuasive, as the embodiment of Irling relied upon is also rigid and reliant upon passive shaping. All of applicant’s arguments appear to be directed to this alternative embodiment of Irling and are therefore unpersuasive.
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) 1-5, 7-13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Irland (U.S. Patent Application Publication No. 2009/0005690) hereinafter referred to as Irland; in view of Oz et al. (U.S. Patent Application Publication No. 2021/0068672) hereinafter referred to as Oz.
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 molded protruding portion (¶[0030]) 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).
Irland does not teach that the protrusion is a central bulge. It is noted that Applicant discloses no criticality to the location of the bulge, instead characterizing the location of such a protrusion as useful in any location depending on the choice of the practitioner (Applicant’s Specification dated 12/15/2023 “The nose 20 of the bulge can, for example, be placed centrally on the upper surface of the transducer (T) to apply an even (straight up and down) pressure to the transducer or more towards an edge of the transducer's upper surface to apply a pressure that tilts the transducer (T) towards that edge.”)
Attention is drawn to the Oz reference, which teaches a protruding portion of a sensing device pressed against an abdomen comprising a central bulge (Fig. 5, Fig. 6), therefore showing that the bulge location claimed would have been known in the art, and predictable to configure for one of ordinary skill in the art.
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 centrally located, 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), and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 2, Irland as modified 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).
Oz further teaches wherein the lower surface of the body has a flat perimeter region surrounding the central bulge (Fig. 5-6).
Regarding claim 3, Irland as modified 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 4, Irland as modified 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)
Regarding claim 5, Irland as modified 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 as modified 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 as modified 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 as modified 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 as modified 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 as modified 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 as modified 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]).
Oz further teaches wherein an outer end of the central bulge 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 (Fig. 5-6, the apex of the bulge is smaller than the overall diameter).
Regarding claim 13, Irland as modified 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 15, Irland as modified 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 according to claim 1, 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(s) 6 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Irland and Oz 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 as modified teaches a device according to claim 5.
Irland as modified 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 an 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. 2021/0186459 to Elder teaches a fetal sensor cooperating with a belt and an external positioning device configuring a protrusion.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMANDA L STEINBERG/ Examiner, Art Unit 3792
Prosecution Insights