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 1 is objected to because of the following informalities: the limitation “its upper end” and “its opposite end” should be rewritten as “the upper end” and “an opposite end” to reflect their pattern of recitation. Appropriate correction is required.
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 1, 5, 7 and any of their dependent claims 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 1 recites in its preamble “a pumping membrane for artificial circulatory assistance” but the body of the claim does not describe any structure or function to demonstrate how said membrane carries out any “artificial circulatory assistance”. In other words, it is not clear what circulatory assistance is done by anything recited in the claim. Examiner finds the preamble indefinite as a result.
Claim 5 recites the limitation “kinetic motion similar to physiological cardiac blood flow” on lines 17 & 21-22. This term is a relative term which renders the claim indefinite. The term “similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not quantitatively or qualitatively clear how “similar” would differ from “dissimilar” for “physiological cardiac blood flow”.
Claim 7 recites the limitation “other plastic material with similar characteristics”. This term is a relative term which renders the claim indefinite. The term “similar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not quantitatively or qualitatively clear how “similar” would differ from “dissimilar” for “characteristics” for “transparent polycarbonate”.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 7 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The limitation “other plastic material with similar characteristics” in Claim 7 is not supported in the instant Specification or in the parent application 16/338,446. Thus, this is considered new matter and would result in this claim having a EFD of April 30, 2024, and a potential continuation-in-part classification instead of continuation classification.
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 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.
Claim(s) 1-3, 5 & 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Polaschegg et al., (“Polaschegg”, US 4,552,552), in view of Franchi, (US 6,030,335).
Claims 1-3 are directed to a pumping membrane for artificial circulatory assistance, an apparatus type invention group.
Regarding Claims 1-3, Polaschegg discloses a pumping membrane for artificial circulatory assistance, (See Abstract, and See column 7, lines 53-68, column 8, lines 1-57, Polaschegg), the pumping membrane comprising: a circular base provided with a securing tab, (Liner 66 with Rims secured into Grooves 54 of Plates 48, See Figure 2 or 3, See column 1, lines 47-48, column 7, lines 63-68, column 8, lines 1-10, Polaschegg); an upper end provided with an attachment tab, (Liner 66 with Rims secured into Grooves 50 of Plates 46, See Figure 2 or 3, See column 1, lines 47-48, column 7, lines 63-68, column 8, lines 1-10, Polaschegg); and a cylindrical section arranged between the circular base and the upper end of the pumping membrane, (Portion of Liner 66 between Rims secured into Grooves 50/54 of Plates 46/48, See Figure 2 or 3, See column 1, lines 47-48, column 7, lines 63-68, column 8, lines 1-10, Polaschegg), wherein the cylindrical section of the pumping membrane is formed of recesses and edges alternating from its upper end to its opposite end, (Liner 66 is recessed on either side and inherently has edges as it extends from top to bottom, See Figure 2 or 3), wherein the cylindrical section adopts the shape of a cross or star with at least 3 points when the pumping membrane is in a rest state, and wherein the cylindrical section of the pumping membrane adopts a circular shape when at a maximum volume capacity, (Liner 66, See Figure 2 or 3, See column 1, lines 47-48, column 7, lines 63-68, column 8, lines 1-10, Polaschegg; tubular shape is cylindrical which means a circular cross section).
Polaschegg does not disclose wherein the cylindrical section adopts the shape of a cross or star with at least 3 points when the pumping membrane is in a rest state.
Franchi discloses wherein the cylindrical section adopts the shape of a cross or star with at least 3 points when the pumping membrane is in a rest state, (Figures 5, 6, See column 5, lines 36-47, Franchi).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the pumping membrane of Polaschegg by incorporating wherein the cylindrical section adopts the shape of a cross or star with at least 3 points when the pumping membrane is in a rest state as in Franchi because “this configuration is particularly advantageous because it generates little turbulence, particularly when pressure is reversed, because of the unambiguous shape of the membrane”, (See column 5, lines 44-47, Franchi).
Additional Disclosures Included:
Claim 2: The pumping membrane according to claim 1, wherein a diameter of the circular base is equal to a diameter of the upper end, (Portions of Liner 66 in Rims secured into Grooves 50/54 of Plates 46/48 are the same width, See Figure 2 or 3, See column 1, lines 47-48, column 7, lines 63-68, column 8, lines 1-10, Polaschegg).
Claim 3: The pumping membrane according to claim 1, wherein a perimeter of the circular base is equal to a perimeter of the upper end and is equal to a perimeter of the cylindrical section, (Liner 66, See Figure 2 or 3, See column 8, lines 11-18, Polaschegg; in the expanded form, the liner 66 expands to a width about the same width apart as the rims secured into grooves 50/54).
Regarding Claims 5 & 7, modified Polaschegg discloses an artificial circulatory assistance chamber comprising: the pumping membrane according to claim 1, (see rejection of Claim 1 above); a rigid cocoon having a cylindrical body, (Casing 68, See Figure 2 or 3, See column 4, lines 20-24, column 4, lines 49-55, Polaschegg), provided with inlet and outlet blood connectors positioned in series, (See column 7, lines 53-61, Polaschegg), and respective inlet and outlet one-way valves, (See Abstract, Polaschegg), wherein the pumping membrane is fitted inside the rigid cocoon in a fixed airtight manner, (See column 10, lines 20-30, Polaschegg), wherein the pumping membrane comprises an impermeable membrane that divides the interior of the rigid cocoon into two compartments, including one blood compartment and one external compressible compartment, (Ring Space 78, See Figure 2 or 3, See column 10, lines 62-68, column 11, lines 1-25, Polaschegg), the external compressible compartment being filled with gaseous volume injected or aspirated by an external device connected to an inlet by a connector, (Ring Space 78 joined to Port 80/Line 82, See Figure 2 or 3, See column 8, lines 18-31, See column 10, lines 62-68, column 11, lines 1-25, Polaschegg), wherein the gaseous volume in the external compressible compartment varies between two defined and alternate occurrence volumes, providing filling and emptying of the rigid cocoon at each cycle, (See column 3, lines 46-51, See column 4, lines 25-34, Polaschegg), wherein kinetic motion similar to physiological cardiac blood flow is produced via an interaction between: a pressure variation between the two compartments, at two respective sides of the impermeable membrane, (See column 5, lines 7-32, Polaschegg; Examiner interprets the disclosed movement to be “similar” to physiological blood flow); and a work of the inlet and outlet one-way valves mounted in series produces kinetic motion similar to physiological cardiac blood flow, said chamber being for use as a pumping device, (See column 6, lines 50-68; Examiner interprets the disclosed movement to be “similar” to physiological blood flow).
Claim 7: The chamber according to claim 5, wherein the rigid cocoon is made of transparent polycarbonate, or other plastic material with similar characteristics, (See column 10, lines 58-61, Polaschegg).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Polaschegg et al., (“Polaschegg”, US 4,552,552), in view of Franchi, (US 6,030,335), in further view of Demers et al., (“Demers”, US 2009/0099498).
Regarding Claim 4, modified Polaschegg discloses the pumping membrane according to claim 1, wherein the pumping membrane is made of flexible material, (See column 4, lines 51-56, Demers), but does not disclose it being also non-elastic material.
Demers discloses a membrane made of non-elastic material, (See paragraph [0300], Demers).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the pumping membrane of modified Polaschegg by incorporating the membrane made of non-elastic material as in in order to “reduce or substantially eliminate the stress within the surface/membrane so that at equilibrium, the difference in pressure in the pump and…chambers is reduced or essentially eliminated,”, (See paragraph [0300], Demers).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Polaschegg et al., (“Polaschegg”, US 4,552,552), in view of Franchi, (US 6,030,335), in further view of Vargas Fonseca, (“Vargas”, US 2016/0208940; Examiner relies upon the earlier publication and date of WO 2015024081 from 02/26/2015).
Claim 6 is directed to an artificial circulatory assistance chamber, an apparatus or device type invention group.
Regarding Claim 6, modified Polaschegg discloses the chamber according to claim 5, but does not disclose wherein the one-way inlet valve and the one-way outlet valve are a cartwheel type.
Vargas discloses a device directed towards medicine and blood, (See paragraph [0002] & [0008], Vargas), wherein its valves are a cartwheel type, (See paragraph [0017], Vargas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the pump of modified Polaschegg by incorporating wherein the one-way inlet valve and the one-way outlet valve are a cartwheel type as in Vargas in order to provide “fully automatic and safe operation…with no risk of error in the required flow direction”, (See paragraph [0017], Vargas), while providing “reliability for characteristics such as…flow resistance”, (See paragraph [0012], Vargas), regarding blood, (See paragraph [0008] & [0010], Vargas).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779