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 65-67, 69-70, 72, 75, 77 and 82-83 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.
Regarding claims 65-67, 69-70, 72, 75, 77 and 82-83, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 64-67, 70-71, 73-75 and 78-83 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Pub. No. 2005/0177099 to Dahan et al. (“Dahan”).
Regarding claim 64, Dahan discloses a device adapted to be fitted over at least the nipple region of a woman's breast (see Figs. 3, 5, 8, 10, 12 and 14) for providing an indication of milk flow from the breast to a baby (see paras. [0035-0040]), the device comprising: a flexible layer of material (see para. [0042] disclosing utilization as a nipple on a bottle therefore the layer of material is inherently flexible) having a nipple shaped protrusion (320) with an inner surface and an outer surface (see Figs. 3, 5, 8, 10, 12 and 14), the inner surface adapted to face the nipple region of the woman's breast (340), and the outer surface adapted to face the mouth of a baby (see Figs. 3, 5, 8, 10, 12 and 14 and para. [0034]); and a passageway (380/1350/1510) formed either within the flexible layer (as shown in Figs. 3, 5, 8, 10, 12 and 14 a portion of the pathway is within the flexible layer), or at least partially on the surface of the flexible layer, or partially detached from the flexible layer (see combinations of Figs. 3 and 4; 5 and 6; 12 and 13; and 14 and 15 showing the pathway being at least partially on the surface of the flexible layer and partially detached from the flexible layer), the passageway connecting a first location on the inner surface of the nipple-shaped protrusion (390/1490), with at least one opening in the outer surface in the apex region of the protrusion (395/1495), wherein at least one part of the passageway is disposed in a region radially remote from the nipple-shaped protrusion (see Figs. 4, 6-7, 13 and 15), and is adapted to provide a physical indication of milk flow when the baby is sucking on the nipple-shaped protrusion (see paras. [0038] and [0059]).
Regarding claim 65, Dahan teaches the device according to claim 64, and also wherein the region radially remote from the nipple-shaped protrusion, is such that the at least one part of the passageway is not obscured by the lips of the baby sucking on the nipple-shaped protrusion. It is noted that since the passageway (380) is spaced from the nipple protrusion (320), the configuration of the nipple protrusion and passageway meet this claim limitation. See also Figs. 4, 6-7, 13 and 15.
Regarding claim 66, Dahan teaches the device according to claim 64, and also wherein the at least one part of the passageway is transparent or translucent, such that the flow of milk is visible through the at least one part. See para. [0039].
Regarding claim 67, Dahan teaches the device according to claim 64, and also wherein the at least one part of the passageway comprises a material which changes color when exposed to milk, such that the flow of milk is rendered visible by such a color change. See para. [0039].
Regarding claim 70, Dahan teaches the device according to claim 64 and further comprising a closed, at least partially transparent container (1360), connected to the passageway (1350), such that milk passing through the passageway is visible surging in the at least partially transparent container (see para [0054] and [0059]).
Regarding claim 71, Dahan teaches the device according to claim 64, and also wherein the at least one part of the passageway comprises a mechanical element (check valve) which undergoes deflection in a flow of milk. See para. [0041].
Regarding claim 73, Dahan teaches the device according to claim 64, further comprising at least one valve (check valve) disposed along the at least one passageway and adapted to enable milk to flow through the passageway only in a direction from the location on the inner surface of the nipple-shaped protrusion towards the at least one opening in the apex region. See para. [0041].
Regarding claim 74, Dahan teaches the device according to claim 73, and also wherein the at least one valve (check valve) essentially closes when suction is not applied at the least one opening in the apex region (this is how check valves inherently work).
Regarding claim 75, Dahan teaches the device according to claim 64, further comprising a container (1360) fluidly connected to the passageway, such that a fluid in the container can be provided to the baby (it is connected via the passageway 1350). See Fig. 13.
Regarding claim 78, Dahan teaches the device according to claim 64, and also wherein the device is electronics-free. See Figs. and disclosure.
Regarding claim 79, Dahan teaches the device according to claim 78, and also wherein the electronics-free status of the device reduces the presence of electro-magnetic radiation in the region of the baby. Considered inherently necessary if the device is electronics-free and in comparison to a device with electronics.
Regarding claim 80, Dahan teaches the device according to claim 64, and also further comprising at least one additional passageway (1220 a and b) connecting the inner surface of the nipple-shaped protrusion with at least one opening in the outer surface in the apex region of the protrusion. See Fig. 12.
Regarding claim 81, Dahan teaches the device according to claim 64, and further comprising a valve (check valve) disposed in the passageway, the valve adapted to enable flow of milk through the passageway from the woman's breast to the baby, but limiting the inflow of air or milk from the outside surface of the nipple shaped protrusion to the inner surface. See para. [0041].
Regarding claim 82, Dahan discloses a device adapted to be fitted over at least the nipple region of a woman's breast (see Figs. 3, 5, 8, 10, 12 and 14) for providing an indication of milk flow from the breast to a baby (see paras. [0035-0040]), the device comprising: a flexible layer of material (see para. [0042] disclosing utilization as a nipple on a bottle therefore the layer of material is inherently flexible) having a nipple shaped protrusion (320) with an inner surface and an outer surface (see Figs. 3, 5, 8, 10, 12 and 14), the inner surface adapted to face the nipple region of the woman's breast (340), and the outer surface adapted to face the mouth of a baby (see Figs. 3, 5, 8, 10, 12 and 14 and para. [0034]); and a passageway (380/1350/1510) formed either within the flexible layer (as shown in Figs. 3, 5, 8, 10, 12 and 14 a portion of the pathway is within the flexible layer), or at least partially on the surface of the flexible layer, or partially detached from the flexible layer (see combinations of Figs. 3 and 4; 5 and 6; 12 and 13; and 14 and 15 showing the pathway being at least partially on the surface of the flexible layer and partially detached from the flexible layer), the passageway connecting a first location on the inner surface of the nipple-shaped protrusion (390/1490), with at least one opening in the outer surface in the apex region of the protrusion (395/1495), and a closed vessel (1360) fluidly connected to the passageway (1360), the closed vessel being disposed in a region which is not expected to be hidden by the baby feeding at the nipple shaped protrusion, such that presence and motion of milk within the at least one closed vessel provides a physical indication of a flow of milk in the passageway from the woman to the baby. It is noted that since the passageway (1350 and container 1360) is spaced from the nipple protrusion (1320), the configuration of the nipple protrusion and passageway meet this claim limitation. See also Figs. 4, 6-7, 13 and 15.
Regarding claim 83, Dahan teaches the device according to claim 82, and also wherein the at least one closed vessel (1360) is either transparent or translucent (see para [0054] and [0059]), such that the presence and motion of milk in the at least one closed vessel is visible.
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.
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.
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.
In the alternative if Dahan is found to teach a layer of material that is not expressly flexible, then claim(s) 64-67, 70-71, 73-75 and 78-83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dahan in view of US Pub. 2019/0374438 to Dellimore et al. (“Dellimore”).
Dahan meets the claim limitations as described above.
Dellimore teaches a nipple shield that is made from flexible silicone. See para. [0013].
At the time of filing, it would have been obvious to make the layer of material as disclosed by Dahan from silicone as taught by Dellimore. Both Dahan and Dellimore are analogous in the art of nipple shields; therefore, a combination is proper. Additionally, the substitution would have been done since Dellimore teaches that silicone is a soft, flexible, non-allergenic material. The substitution of the material would have achieved predictable results and would have continued to perform as disclosed by Dahan.
Claim(s) 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dahan with or without Dellimore.
Regarding claim 72, Dahan with or without Dellimore teaches the device according to claim 64, and but fails to explicitly disclose wherein the distance of the at least one part of the passageway from the protrusion, is at least 3 cm., such that the at least one part is visible outside of the area where the mouth of a baby sucking on the protrusion is expected to be. However, Dahan does show in the embodiment of Fig. 13 container 1360 which could be at least 3cm from the protrusion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Dahan to have a distance between at least one part of the passageway from the protrusion be specifically 3cm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” Gardner v. TEC Syst,. Inc,. 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Dahan would not operate differently with the claimed dimensions and since the container which is part of the passageway is further out that the other portions of the passageway and would function appropriately having a dimension of 3cm.
Claim(s) 68 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dahan with or without Dellimore and in view of US Pat, No. 5,827,191 to Rosenfield (“Rosenfield”).
Regarding claim 68, Dahan teaches the device according to claim 64, and but fails to teach wherein the at least one part of the passageway comprises an element which emits a sound when a predetermined flow of milk exists within the at least one part.
However, Rosenfield teaches a free spinning propeller (10) whose rotation is proportional to the amount of milk passing through. See Fig. 4 and col. 3, ll. 41-60. It is noted that the propeller will generate at least a small amount of sound when rotated by the flow of milk.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Dahan to have a free spinning propeller, which would inherently make sound due to the flow of milk into the passageway. The combination would have been done since Dahan already teaches the objective of calculating the amount of milk delivered to the baby and incorporating the propeller would further the ability to acquire milk flow data.
Claim(s) 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dahan with or without Dellimore and in view of US Pub, No. 2016/0296682 to Phillips et al. (“Phillips”).
Regarding claim 69, Dahan teaches the device according to claim 64, but fails to include comprising a ring formed around a base region of the nipple shaped protrusion, the ring having lower flexibility than the flexible layer of material, such that the device remains more readily latched to the breast when the baby ceases sucking.
However, Phillips discloses a ring or insert (1708) at the base region of the nipple that may create an improved seal against the breast. See para. [0101].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the ring as taught by Phillips into the invention of Dahan with or without Dellimore. The motivation for making the incorporation can be found in Phillips which expressly discloses that the ring can improve the seal between the breast and shield thereby enhancing the performance of the device.
Claim(s) 75-77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dahan with or without Dellimore and in view of WO 2019/050537 to Scheuerle et al. (“Scheuerle”).
Regarding claims 75-77, Dahan teaches the device according to claim 64, further comprising a container (1360) fluidly connected to the passageway, such that a fluid in the container can be provided to the baby (it is connected via the passageway 1350). See Fig. 13. However, if it is determined that the milk in the container (1360) is not capable of being provided to the baby, then it would have been obvious in light of Scheuerle.
Scheuerle discloses a system for delivering an agent to a breastfeeding child. The system includes a container (104) containing a medicament/drug (140) that is supplied via a flow path (120) to the baby at the protrusion opening (101) in a nipple shield (102). See Fig. 1A and 1B and also para. [0027].
At the time of the effective filing date of the invention, it would have been obvious to incorporate the medicament/drug and flow path of Scheuerle into the invention of Dahan with or without Dellimore and connect the flow path of Scheuerle into the passageway of Dahan in order to provide the baby with medicine as an enhanced way to deliver a large quantity of medication in an easier way than by spoon, syringes and dosing cups.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE SERKE WILLIAMS whose telephone number is (571)272-4970. The examiner can normally be reached Monday through Friday core hours 8am-4pm ET.
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/CATHERINE S WILLIAMS/ Primary Examiner, Art Unit 3993