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 .
Information Disclosure Statement
Regarding the Information Disclosure Statement, the IDS has been considered. The last reference on the IDS (US-20190264160-AA) has been lined out because there was no corresponding reference found. It appears that this reference could be an erroneous duplication of the reference stated before it (US-20190264160-Al), which was considered by the Examiner.
Claim Objections
The previous claim objections are withdrawn in light of the amendments.
Claim 16 is objected to because of the following informalities:
Regarding claim 16, the phrase “the inlet, outlet and the receiving device” can be rephrased “the inlet, the outlet, and the receiving device”.
Appropriate correction is required.
Claim Interpretation
This claim interpretation section refers to claim 24:
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a unit for generating a magnetic field” in claim 24.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 24 is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. A review of the specification as filed shows that the following appears to be the corresponding structures, materials, or acts described in the specification as filed for the following 35 U.S.C. § 112(f) limitations:
“For example, the device can further have a unit for generating a magnetic field in the treatment space. The defined movement of charged particles with the aid of an applied magnetic field and the units which can be used for generating a magnetic field are known.” – instant specification, pg. 8, lines 26-30
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 24 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.
Regarding claim 24:
claim 24 includes the limitation “a unit for generating a magnetic field”
which is a limitation invoking 35 U.S.C. 112(f), as described above. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the written description fails to provide adequate support for claim 24 under 35 U.S.C. 112(a).
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 24 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.
Regarding claim 24, the limitation “a unit for generating a magnetic field” is indefinite. See MPEP § 2181(II)(A), “The Corresponding Structure Must Be Disclosed In the Specification Itself in a Way That One Skilled In the Art Will Understand What Structure Will Perform the Recited Function”.
Claim limitation “a unit for generating a magnetic field” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The limitation is not described in the specification, the specification merely restates the claim language and fails to disclose adequate corresponding structure (see instant specification, pg. 8, lines 26-30). Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 16, 19, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamazaki (JP-H01262786).
Regarding claim 16, Yamazaki discloses a device (Fig. 1, abstract), comprising a unit for generating and emitting electric pulses (Fig. 1, element 3 “pulse power supply” and pg. 3 lines 104-106), and a treatment unit (Fig. 1) having an inlet (Fig. 1, element 7 “suspension inlet” and pg. 3, lines 90-93) and an outlet (Fig. 1, element 10 “exit” and pg. 3, line 97), wherein a treatment space (Fig. 1, there is a space inside the device for a flow path of suspended cells) is formed inside the treatment unit (Fig. 1), the treatment space being able to be penetrated by the emitted electric pulses and an electric field resulting therefrom (Fig. 1, from elements 1 and 2 “electrodes” on either side of the space inside the device for a flow path of suspended cells, and pg. 3, lines 107-108), wherein the treatment unit has a geometric shape (Fig. 1) which allows a non-contact passage of a cell material (pg. 3, lines 90-93) entering through the inlet (Fig. 1, element 7 “suspension inlet” and pg. 3, lines 90-93) into the treatment space (Fig. 1), so that the cell material can be moved without contact (pg. 3, lines 107-111) through the treatment space and there are no interactions of the cell material with boundary walls of the treatment space during the movement (pg. 3, lines 107-111), and wherein the electric field penetrates (pg. 3, lines 107-108) the treatment space (Fig. 1) to the outlet (Fig. 1, element 10 “exit” and pg. 3, line 97), and a receiving device (Fig. 1, element 8, chamber formed by partition plate) is provided in the treatment unit (Fig. 1), with which receiving device the cell material moved through the treatment space (Fig. 1, there is a space inside the device for a flow path of suspended cells) can be supplied to the outlet (Fig. 1, element 10 “exit” and pg. 3, line 97), wherein said receiving device is funnel-shaped (Fig. 1, element 8, chamber formed by partition plate), and wherein the diameter of the treatment space (Fig. 1) is wider than the diameter of the inlet (Fig. 1, element 7 “suspension inlet” and pg. 3, lines 90-93), outlet (Fig. 1, element 10 “exit” and pg. 3, line 97) and the receiving device (Fig. 1, element 8, chamber formed by partition plate).
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Yamazaki, Fig. 1
Regarding claim 19, Yamazaki discloses wherein the inlet (Fig. 1, element 7 “suspension inlet” and pg. 3, lines 90-93) comprises a nozzle (Fig. 1, element 11 “jet nozzle” and pg. 3, line 100).
Regarding claim 22, Yamazaki discloses wherein the outlet (Fig. 1, element 10 “exit” and pg. 3, line 97) is arranged below the inlet (Fig. 1, element 7 “suspension inlet” and pg. 3, lines 90-93), so that the outlet is located in the fall line of the inlet (Fig. 1, outlet is below the inlet and suspension flow downwards from the inlet to the outlet).
Claim Rejections - 35 USC § 102 | 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 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.
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.
Claims 20 and 23 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Yamazaki (JP-H01262786) as applied to claim 16 or, in the alternative, under 35 U.S.C. 103 as obvious over Yamazaki (JP-H01262786) as applied to claim 16, in view of Luscher (US 20140030696).
Regarding claim 20, arguably, Yamazaki discloses wherein the treatment space is filled with a dielectric material (pg. 3, lines 108-111, “the protective liquid”).
If it is deemed that the protective liquid is not a dielectric material, Luscher describes wherein a treatment space is filled with a dielectric material, specifically a gas (paragraph [0013] and Figs. 1a, 1b, and 8 describe prior art where the area surrounding the electrostatic interactions with the liquid is empty in the figures and paragraph [0022] describes that the fluid drops through atmospheric gases).
In the analogous art of flow cytometry and cell sorting, it would have been obvious to one skilled in the art before the effective filing date to modify the dielectric material of Yamazaki to be a gas in order to easily deflect liquid droplets into different collectors for cell sorting (Luscher, paragraph [0022] describes the prior art using electrically charged deflector plates for droplets in the air).
Regarding claim 23, Yamazaki discloses wherein the device is a single-flow system (abstract “fluid channel” and “liquid is flowing” and Fig. 1, element 7 “suspension inlet”).
According to the specification (instant specification, pg. 5), a single-flow system is defined to have: “only one inlet for insertion of cell material into the treatment space of the device”.
Although Yamazaki discloses at least two inlets, only one is used for the insertion of cell material into the treatment space of the device (see Fig. 1, element 7 “suspension inlet”); the one or two other inlets are only for the protective fluid to flow around the cell material (see Fig. 1, elements 5 or 6 “protective liquid inlet” or in a different embodiment, Fig. 4, element 5A “protective liquid inlet”).
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Yamazaki, Figs. 2-4
However, if it is interpreted that there is only one inlet in the device, Luscher’s prior art discloses this as well (Fig. 1A and Fig. 6, paragraphs [0015] and [0104] describes the option of having only sample flow, not core-in-sheath flow).
In the analogous art of flow cytometry, it would have been obvious to one skilled in the art before the effective filing date to modify the flow path inlet of Yamazaki with the single flow path inlet only for the insertion of cell material into the device of Luscher so that inputs for a sheath fluid and their respective fluidic pumping setups for core-in-sheath flow would not be needed during the operation or manufacture of the device, while still maintaining the ability to sort and/or electroporate the cells (Luscher, paragraph [0169] for cell sorting achieved using electroporation).
Claim 25 is rejected under 35 U.S.C. 102(a)(1) as anticipated by Yamazaki (JP-H01262786) as applied to claim 16 or, in the alternative, under 35 U.S.C. 103 as obvious over Yamazaki (JP-H01262786) as applied to claim 16, in view of Caiafa (US 20190264160).
Regarding claim 25, Yamazaki discloses wherein the unit for generating and emitting electric pulses comprises two or more electrodes (Fig. 1, elements 1 and 2 “electrodes” and abstract and pg. 3, lines 104-106) or plates (pg. 3, lines 81-83) of a capacitor and can generate electric pulses (pg. 3, lines 104-106).
Yamazaki does not disclose a voltage increase takes place between the two or more electrodes or plates of a capacitor of 10% to 90% of a target voltage of the electric pulses within a period of 0.1 to 1000 ns, the electric pulses have a pulse duration of 5 ns to 50000 ns, and the electric pulses, upon reaching the target voltage, have an electric field strength of 0.5 kV/cm to 100 kV/cm.
However, regarding the limitation, it is regarded as a recitation of intended use or manner of operating the invention. The manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Yamazaki would be fully capable of operating in this manner given the electrodes and pulse power supply.
However, regarding the limitation, if it is deemed to add patentable weight to the claim, this limitation is rejected under Caiafa. Caiafa discloses: a voltage increase takes place between the two or more electrodes (paragraphs [0040] and [0051]; Fig. 8A, elements 246 and 248 “electrodes”), the electric pulses have a pulse duration of 5 ns to 50000 ns (paragraph [0040]), and the electric pulses, upon reaching the target voltage, have an electric field strength of 0.5 kV/cm to 100 kV/cm (paragraph [0040]).
In the analogous art of electric pulse based activation of biological samples, it would have been obvious to one skilled in the art before the effective filing date to modify the pulse generator of Yamazaki with the specific electrical conditions in Caiafa in order to activate the cells in the sample for therapeutic use (Caiafa, paragraph [0003]).
Regarding the limitation “of 10% to 90% of a target voltage of the electric pulses within a period of 0.1 to 1000 ns”, limitation is obvious as a matter of routine optimization, because voltage is a result-effective variable. The motivation for optimizing this result-effective variable is to increase voltage to the point that cells are activated or permeabilized, but are not destroyed during exposure to the electric field. MPEP § 2144.05(II).
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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Yamazaki (JP-H01262786) as applied to claim 20, in view of Luscher (US 20140030696).
Regarding claim 21, Yamazaki does not disclose wherein the dielectric material is a gas.
Luscher discloses wherein the dielectric material is a gas (paragraph [0013] and Figs. 1a, 1b, and 8 describe prior art where the area surrounding the electrostatic interactions with the liquid is empty in the figures and paragraph [0022] describes that the fluid drops through atmospheric gases).
In the analogous art of flow cytometry and cell sorting, it would have been obvious to one skilled in the art before the effective filing date to modify the dielectric material of Yamazaki to be a gas in order to easily deflect liquid droplets into different collectors for cell sorting (Luscher, paragraph [0022] describes the prior art using electrically charged deflector plates for droplets in the air).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Yamazaki (JP-H01262786) as applied to claim 16, in view of Novickij (“Pulsed Electromagnetic Field Assisted in vitro Electroporation: A Pilot Study”).
Regarding claim 24, Yamazaki discloses the device and the treatment space (Fig. 1).
Yamazaki does not disclose wherein the device further has a unit for generating a magnetic field in the treatment space.
Novickij discloses wherein a device has a unit for generating a magnetic field in a treatment space (Fig. 5 and pgs. 5-7 under “Methods”, specifically an “inductor”).
In the analogous art of pulsed electromagnetic field assisted electroporation, it would have been obvious to one skilled in the art before the effective filing date to modify the treatment space of Yamazaki with the inductor of Novickij in order to increase membrane permeability when combining a pulsed electric field with the magnetic field (pulsed electromagnetic fields “PEMF”), which result in considerably lower electric field strengths needed for this permeabilization in comparison to using only pulsed electric fields (“PEF”) (Novickij, abstract).
Response to Arguments
Applicant’s arguments filed June 24, 2025 have been fully considered but they are not persuasive.
Regarding the 35 U.S.C. §§ 112(a) and 112(b) rejections, the Applicant arguments were rejected due to insufficient evidence. The written description fails to provide adequate support for claim 24 under 35 U.S.C. § 112(a). Additionally, the structure is not defined either in the claims or the specification to provide the metes of and bounds of the structure capable of generating a magnetic field. The rejection under 35 U.S.C. § 112(b) indefiniteness stands.
Regarding the Applicant arguments on pg. 7 of 12, the claim amendments to claim 16 have been rejected under the same prior art reference Yamazaki. This rejection is occurring because the location of the funnel-shaped receiving device after being treated through the treatment space has not been claimed with specificity in claim 16. The instant claim 16 currently contains no language about the order of the parts of the apparatus in terms of the flow of the cell through the device to the effect as described in the Applicant arguments.
The closest language to be interpreted under this instant claim is: “a receiving device is provided in the treatment unit, with which receiving device the cell material moved through the treatment space can be supplied to the outlet” (instant claim 16). This limitation, under broadest reasonable interpretation, can be interpreted in plain language as follows:
A receiving device is in the treatment unit. The cell material moves through the receiving device, and additionally, the cell material moves through the treatment space. The receiving device supplies the cell material to the outlet.
There is a lack of clarity within the instant claim 16 in the order in which the cell material has moved through the device. It is possible to amend this limitation to reflect the order in the following way:
“a receiving device is provided in the treatment unit which supplies the cell material to the outlet; and
wherein the cell material moves through the treatment space before it is received at the receiving device and is supplied to the outlet”.
However, because this is not the claimed limitation under broadest reasonable interpretation of the claim, this hypothetical limitation has not been searched and/or considered.
Furthermore, the diameter of the treatment space, which is a funnel-shaped device of Yamazaki, is still wider than the diameter of the inlet, outlet, and the receiving device of Yamazaki (Fig. 1). The funnel-shaped treatment space comprises a space with both a wide end and a narrow end, with funnel-shaped curvature to these two ends. Alleging that the treatment space is only the portion of the funnel-shaped space of Yamazaki that corresponds to a narrow pipe at the outlet of the funnel is a mischaracterization of the idea of funnel shape. The cell material passes through both the wide end of the funnel-shaped space and the narrow end of the funnel-shaped space. Indeed, ports 5 and 6 located at the wide end of the funnel-shaped space of Yamazaki appear to be crucial to the function of Yamazaki as a sheath flow for the cells to be protected and focused into the narrow pipe at the end of the funnel-shaped space. As the claim is currently written, there is no contact of the cell material with the narrow end of the funnel-shaped device, as the cell material is focused within a protective sheath layer of fluid that focuses the cell material within the core of moving fluids. Yamazaki specifically discloses no contact of the cell material at the boundaries of the flow near the internal surface of the narrow pipe (Yamazaki, pg. 7, lines 107-111 “At this time, the suspension flows through the center of the channel protected by the protective liquid, so that the electrodes and the channel are not contaminated with cells or genes.”). In summary, Applicant arguments describe this combined flow as “the composition” (Applicant arguments, top of pg. 9 of 12); however, in the claims, the term claimed that is not in contact with the surface is “the cell material”. Hypothetically, future amendments to this effect can be searched and/or considered at the time they are presented.
Regarding Applicant arguments on pg. 9 of 12 and the hypothetical contact of cell material with the narrow side walls of Yamazaki, Figs. 3b and 3c of Yamazaki discuss different flow patterns that could exclude the cell material from interacting with this region. This non-contact of cell material flow with the channel is due to the various embodiments of differently shaped openings of the treatment device located inside the treatment space that flow biological material through the treatment space. One such example given in Yamazaki is the multiple funnel shaped treatment devices of Fig. 3b. Another example is given in Fig. 4, which has a more cylindrically shaped narrow end of the funnel. Nevertheless, the Examiner emphasizes the specification of Yamazaki directly states that the electrodes and channel are not contaminated with the cells or genes, see citation above. The remaining arguments are considered evidentially unsupported allegations of Yamazaki not working to this specifically disclosed feature.
Regarding Applicant arguments on pg. 10 of 12, on the 35 U.S.C. §§ 102 | 103 rejections over claims 20, 23, and 25, no arguments are given. The rejections stand. Regarding these dependent claims, these claims are rejected as the independent claim is still rejected and no further arguments were made regarding the dependent claims. However, the Examiner would like to note for the sake of compact prosecution, that claim 23 cites a “single-flow system” with a definition cited above in the rejection as well as in the Applicant specification for this term (instant specification, pg. 5): a single-flow system is defined to have: “only one inlet for insertion of cell material into the treatment space of the device”. This definition is fulfilled by Yamazaki as well. Yamazaki has a single inlet for insertion of cell material into the treatment space in the Figs. 1, 2, 3a, 3b, 3c, and 4. Even if each of the different nozzles or openings in the embodiments of Figs. 3b and 3c are broadly considered cell material inlets to the treatment space, at least Fig. 4 would still disclose the single-flow system limitation.
Regarding the arguments on the bottom of pg. 10 and the top of pg. 11, Yamazaki, due to the explanation provided above still is functional and recites limitations that are within the bounds of the instant claims. No evidence has been given that Yamazaki does not function properly at its task and the remaining arguments are unconfirmed allegations.
Regarding the arguments on the middle of pg. 11, Yamazaki fulfills the instant independent claim as written. Also, a thin sheet of the suspension is not the only format that Yamazaki can support. Additionally, the Yamazaki invention may describe a protective sheath fluid, but due to the “comprising” language of the claim, such a flow is not necessarily precluded.
Conclusion
THIS ACTION IS MADE FINAL. 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 NATHAN G ESPERON whose telephone number is 571-272-9807, and whose fax number is 571-273-8464. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday.
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, Michael Marcheschi can be reached at 571-272-1374. 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.
/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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