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 .
Drawings
The drawings were received on 6/9/2023. These drawings are acceptable.
Election/Restrictions
Groups II and III (claims 15-20) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 18, 2026.
Applicant's election with traverse of Group I, claims 1-14, in the reply filed on February 18m, 2026 is acknowledged. The traversal is on the ground(s) that Group I and Group II are linked as a product and a process of use of said product, and that there are no structural or functional differences between the process of claim 15 and the device of claim 1. This is not found persuasive because the instant application is a national stage entry filed under 35 U.S.C. 371 and is therefore not subject to US restriction practice but rather subject to lack of unity practice, see MPEP 1893.03(d). It is noted that groups being linked as a product and process of use of said product is not a criterion in lack of unity analysis. The test is whether or not special technical features can be established. It is noted that inventions listed as Groups I, II, and III do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features as set forth in the previous Office Action.
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
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: “drive unit” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification (filed 6/9/2023) as performing the claimed function, and equivalents thereof:
Drive unit: Pg. 11 recites that the drive unit preferably comprises an electric motor, but may also contain a hand crank or any other means to rotate the rotatable chamber that may be known to a person skilled in the art.
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 Objections
Claim 1 is objected to because of the following informalities: the term “and” appears to be missing after “container” in line 18. 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.
Claims 1-14 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 refers to a tube “connected or connectable” to the first outlet. This expression gives the impression that the device is operable without the tube being connected to the outlet. However, the effects of the claimed invention are related to the presence of the tube, and the option of excluding the presence of the tube (i.e. “connectable”) would imply that the functions described in the clause with the drive unit are not able to be performed. Utilization of the term “connectable” should be reconsidered to improve clarity of the description of the tube.
Claims 2-14 are ultimately dependent upon claim 1, and thus, inherit the same deficiencies.
Claim 3 refers to the tube “connected or connectable” to the first outlet. This expression gives the impression that the device is operable without the tube being connected to the outlet. However, the effects of the claimed invention are related to the presence of the tube, and the option of excluding the presence of the tube (i.e. “connectable”) would imply that the functions described in the clause with the drive unit are claim 1 are not able to be performed. Utilization of the term “connectable” should be reconsidered to improve clarity of the description of the tube.
Claim 7 recites the limitation "the tip of the tube" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the end of the tube " in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Additionally, applicant has previously only made reference to a “first end” and a “second end” of the rotatable chamber, and as such, it is unclear which end the applicant is referring to with the recitation “the end of the tube.” Clarification is requested.
Claim 9 recites the limitation "the nearest wall of the collection container " in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the end of the tube " in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Additionally, applicant has previously only made reference to a “first end” and a “second end” of the rotatable chamber, and as such, it is unclear which end the applicant is referring to with the recitation “the end of the tube.” Clarification is requested.
Claim 11 recites the limitation "the nearest wall of the collection container " in line 2. There is insufficient antecedent basis for this limitation in the claim.
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) 1, 3-5, 7, 8, 10, and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nash et al (US 2014/0044688 A1).
With respect to claim 1 Nash discloses a device for processing biologic tissue, the device comprising:
a rotatable chamber (combination of piston tapered piston barrel 206 and end cap 215, See Para. 0037 and Fig. 2) arranged to rotate around an axis (See Para. 0036 for discussion of the chamber rotating about longitudinal axis X – X), the rotatable chamber comprising a first end, a second end, a sidewall extending between the first end and the second end (See Fig. 2 reproduced below) and comprising an inner surface that decreases in diameter over at least a portion of the distance between the first end and the second end (See Para. 0036 for discussion of the chamber being a frustoconical shape; Para. 0011 also describes that the barrel may be tapered), and a first outlet (See Fig. 2 reproduced below), the first outlet beginning in the interior of the rotatable chamber at a first radial distance from the axis (See Fig. 2 reproduced below);
a tube (passage 216) connected or connectable to the first outlet, the tube extending in a direction that is at least radially away from the axis over at least part of the tube's length (See Fig. 2 for depiction of the passage 216 extending radially through part of the end cap);
a collection container in fluid communication with the tube (See Para. 0042 for discussion of plasma being discharged from port 227, which is connected to passage 216, into a casing; Figs. 17 and 18 and Para. 0058 depict and discuss an outer casing 500 which surrounds the centrifuge and allows for collection of discharged RBCs and plasma); and
a drive unit (electric motor 201) configured to rotate the rotatable chamber about the axis (See Figs. 2-4 and Para. 0037);
wherein the device is operable such that a centrifugal field is produced via rotation of the rotatable chamber about the axis, thereby causing a sample of biologic tissue present in the rotatable chamber to stratify into at least two constituent layers as a function of the differing specific gravities of the constituents, at least one of the constituent layers being dischargeable from the rotatable chamber via the tube and into the collection container, and
wherein an interior wall of the collection container and the trajectory of the exit of the tube are configured such that the direction of discharge out of the tube is substantially parallel to a tangent line of a wall of the collection container along the same radius from the axis (See Fig. 2 for depiction of the passage 216 terminating at a port 227 positioned within the wall of the endcap 215).
Applicant should note the italicized limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Nash and the apparatus of Nash is capable of the recitation of claim 1. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Nash (see MPEP §2114).
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Fig. 2 (reproduction)
With respect to claim 3 Nash depicts that the tube is connected to the first outlet at a distance greater than the first radial distance (Sed Fig. 2 for depiction of the passage 216 extending radially past the first outlet).
With respect to claim 4 Nash depicts that the tube is positioned such that it rotates with the rotatable chamber (See Fig. 4 and Paras. 0041-0042).
With respect to claim 5 applicant should note these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Nash and the apparatus of Nash is capable of the recitation of claim 5. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Nash (see MPEP §2114).
With respect to claim 7 Nash depicts that a tip of the tube (area depicted by port 227, See Figs. 2-4 and Para. 0042) rotates along with the rotatable chamber and the tube traces a path as it rotates around the axis that is substantially parallel to an interior wall of the collection container (See Fig. 17).
With respect to claim 8 applicant should note these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Nash and the apparatus of Nash is capable of the recitation of claim 8. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Nash (see MPEP §2114).
With respect to claim 10 applicant should note these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus. All the structural limitations of the claim have been disclosed by Nash and the apparatus of Nash is capable of the recitation of claim 10. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Nash (see MPEP §2114).
With respect to claim 12 Nash depicts that the tube comprises a first portion extending in a direction that is at least radially away from the axis and a second portion that extends in a direction that is at least axially along the axis (See magnification of the passage 216 of Fig. 4 below).
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Fig. 4 (reproduced and magnified)
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(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nash et al (US 2014/0044688 A1) in view of Peytavi et al (US 9,562,262 B2).
Refer above for the disclosure of Nash.
Nash fails to disclose a first valve operable to control fluid communication from the first outlet to the tube, wherein the at least one of the constituent layers is dischargeable from the rotatable chamber via the tube and into the collection container by operating the valve (applicant should note that the italicized recitations are being interpreted as a function of how the device is intended to operate; the recitation does not provide for any additional structural limitations).
Peytavi teaches a fluidic centripetal device 1 composed of at least two component layers. As shown in FIGS. 1C and 1D, a fluidic layer has features on the bottom face and/or the upper face of the fluidic centripetal device 1. The fluidic layer 3 is composed of intake receptacle 5, chambers 6a, 6b, 6c, channels and fluidic valves. It will be understood that the fluidic layer 3 can be made by using several layers bonded together. The thin bottom layer 4 is bonded to the fluidic layer 3. The bottom surface of the fluidic layer 3, when mated to the thin bottom layer 4, forms a fluidic network of enclosed reservoirs, channels and valves through which fluid flows under the centripetal force (See Col. 16, lines 40-52). FIG. 6 illustrates an optional exit outlet 312 to the bottom-fillable chamber to fluidly connect the bottom-fillable chamber to a subsequent chamber 313 with the transfer channel 314. The exit outlet is located on one of the longitudinal sides of the bottom-fillable chamber. The exit outlet can be a burst valve having micrometric dimension (See Col. 19, lines 34-39). The volume of fluid metered by the exit outlet can be comprised between 10 to and 50 µl. In an example embodiment, the volume defined is 20 µl (See Col. 19, lines 51-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a valve into the first outlet of Nash’s device, such as taught by Peytavi, such that the flow of fluid can be controlled out of the rotatable chamber (See Col. 19, lines 34-53 of Peytavi).
Allowable Subject Matter
Claims 6, 9, 11, 12, and 14 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of reference fails to disclose or fairly teach:
tube discharges into the collection container at a direction that is substantially parallel to the direction of the perimeter of the wall of the collection container along the same radius from the axis (claim 6);
the distance from the end of the tube to the nearest wall of the collection container along the direction of discharge out of the tube is from 5 to 200 times the internal diameter of the end of the tube at any given position of the tube about the axis (claim 9);
the distance from the end of the tube to the nearest wall of the collection container along the direction of discharge out of the tube is at least 15 mm (claim 11);
the tube comprises a portion that extends in a direction that is both radially away from the axis and axially along the axis (claim 13); and
the tube comprises a portion that extends in a direction substantially circularly around the axis (claim 14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRITTANY I FISHER whose telephone number is (469)295-9182. The examiner can normally be reached IFP.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Lin can be reached at (571) 272-8902. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITTANY I FISHER/Examiner, Art Unit 1796 September 1, 2026
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