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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 14 May 2026 has been entered.
Response to Amendment
The Examiner notes that the Claims in the Claim Amendment are renumbered. However, the renumbering appears to be the result of a typo in deleting and reintroducing the number of Claim 1. The result is that the Claims are the same and in the same order as those previously presented.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the fluid inlet having a substantially vertical central axis must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1, 3-12, 14-16 and 21-26 are 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.
Claim 1 recites the limitation “a fluid inlet having a substantially vertical central axis”. This amendment appears to lack support in the application as originally filed and therefore would qualify as new matter. Applicant relies on the Specification for these limitations. However, the specification does not appear to disclose a fluid inlet having a substantially vertical central axis.
Therefore, this limitation appears to lack support in the application as originally filed and therefore would qualify as new matter.
Claims not specifically referenced are rejected as being dependent on a rejected base claim.
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, 3-12, 14-16 and 21-26 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.
Claim 1 recites the limitation "the fluid flow path" in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the fluid flow path” will be interpreted as “the biological fluid flow path”.
Claim 1 recites the limitation "the fluid " in line 20. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, “the fluid” will be interpreted as “the biological fluid”.
In Claims 5, 6, 7 and 26 the limitation “a central axis of the fluid inlet” is unclear. It is unclear if this is the same axis as “a substantially vertical central axis” from Claim 1, line 6 or another central axis. For purposes of examination, “a central axis” from Claims 5, 6 and 7 will be interpreted as being the same axis as the substantially vertical central axis of Claim 1.
Claim 15 recites the limitation "the volume sidewall " in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 depends on cancelled claim 17. Therefore Claim 23 is unclear. Since Claim 23 appears to intend to depend from Claim 7 (see the Claim set filed 5 Nov 2025), Claim 23 will be interpreted as depending on Claim 7.
Claim 26 recites the limitation "the fluid in " in line 3. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination “the fluid in” will be interpreted as “the fluid inlet”.
Claims not specifically referenced are rejected as being dependent on a rejected base claim.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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, 3-12, 14-16, 21-23, 25-26 is/are rejected under 35 U.S.C. 103 as being unpatentable as obvious over Charest et al (US 9784396) in view of Butcher et al (US 2016/0208708) in further view of Sloan (US 7,458,532) in further view of Moore (US 1,905,733).
Regarding Claim 1, Charest et al disclose a biological fluid1 flow path (abstract). The flow path comprising:
a biological fluid2 comprising cells (regardless of the recitation of the actual fluid handled has been given no patentable weight in the apparatus claims per MPEP 2115, Charest et al disclose blood, which is a biological fluid comprising cell); and
a manifold (Figure 2A) for moving the biological fluid3 through the fluid flow path (from 202 to 206 of Figure 2A), the manifold comprising:
a body (200 generally) defining:
a fluid inlet (to 202);
a plurality of fluid outlets (206a-206d); and
a volume (the channels shown in Figure 2A from 202 to 206) disposed between and in fluid communication with the fluid inlet and the plurality of fluid outlets (Figure 2A),
wherein at least one outlet of the plurality of fluid outlets (206a-206d in Figure 2A; Col 7, lines 1-4) has a substantially circular cross-section (Col 7, lines 1-4),
but fails to expressly disclose a fluid inlet having a substantially vertical central axis,
wherein the volume defines:
a first width, W1, as measured at a first location near the fluid inlet,
a second width, Wo, as measured at a second location near the plurality of fluid outlets,
a first thickness, T1, as measured at the first location perpendicular to W1, and
a second thickness, To, as measured at the second location perpendicular to Wo,
wherein Wo > W1>T1 > To,
wherein a cumulative opening size of the plurality of fluid outlets is greater than an opening size of the fluid inlet to reduce shear and culture damage to the cells contained within the fluid,
wherein the plurality of fluid outlets each define openings defining diameters greater than a diameter of the corresponding fluid outlet,
wherein the volume defines a storage area of less than 5 cc.
Butcher et al teach a fluid manifold (Figure 9c; Abstract). The manifold comprising:
a body (generally at 100 in Figure 9c) defining:
a fluid inlet (102);
a plurality of fluid outlets (Figure 9c; the openings between support structures 106a and 106b); and
a volume (within 100 between 102 and 104; ¶ 38) disposed between and in fluid communication with the fluid inlet (102) and the plurality of fluid outlets (Figure 9c; the openings between support structures 106a and 106b),
wherein the volume (within 100 between 102 and 104; ¶ 38) defines:
a first width, W1, (see Annotated Figure A) as measured at a first location (near 102 shown in Annotated Figure A) near the fluid inlet (102),
a second width, Wo, (see Annotated Figure A) as measured at a second location (near 104 shown in Annotated Figure A) near the plurality of fluid outlets (Figure 9c; the openings between support structures 106a and 106b),
a first thickness, T1, (see Annotated Figure A) as measured at the first location (near 102 shown in Annotated Figure A) perpendicular to W1 (see Annotated Figure A), and
a second thickness, To, (see Annotated Figure A) as measured at the second location (near 104 shown in Annotated Figure A) perpendicular to Wo (see Annotated Figure A), and
wherein Wo > W1 ≥ T1 > To (see Annotated Figure A; ¶ 38).
Since Charest et al discloses providing the manifold in different shapes (Col 7, lines 7-9 and Col 7, lines 51-54), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the manifold of Charest et al with the manifold shape as taught by Butcher et al for the advantage of combining prior art elements according to known methods (the shape of the manifold of Butcher et al with the manifold of Charest et al) to yield predictable results (to allow fluid flow through the manifold).
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Annotated Figure A – Butcher et al
Sloan teaches a fluid manifold (generally at 10 of the Figures) with a fluid inlet (14) and a fluid outlet (18) wherein a cumulative opening size of the fluid outlet is greater than an opening size of the fluid inlet (Figures 5 and 6; Col 4, lines 42-46 disclose where the opening size of the fluid outlet is 9 in sq (1.5 inches tall times 6 inches long) which is greater than the disclosed opening size of the fluid inlet at 7.06 in sq (for an inlet height of the 3 inch pipe)) to reduce shear and culture damage to the cells contained within the fluid4 (inherently, increasing the opening size will slow the fluid, thereby reducing shear and damage to the fluid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the manifold of Charest et al, as modified by Butcher et al with the relative dimensions as taught by Sloan for the advantage of slowing the speed of the fluid exiting the manifold, as taught by Sloan (Col 4, lines 14-17).
Moore teaches a manifold (generally in Figures 1-2) with a body (10) defining a fluid inlet (from 11; page 1, lines 43-47) and a plurality of fluid outlets (to 12 and 13; page 1, lines 47-50),
wherein the plurality of fluid outlets (to 12 and 13; page 1, lines 47-50) each define openings (see Annotated Figure B) defining diameters greater than a diameter of the corresponding fluid outlet (see Annotated Figure B; where the diameter of the fluid outlet is smaller than the diameter of the opening by the distance of the step/shoulder from the fluid outlet to the opening).
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Annotated Figure B
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the manifold of Charest et al, as modified by Butcher et al, and Sloan, with the manifold as taught by Moore for the advantage of providing a larger diameter opening to function to attach a pipe or conduit to the manifold’s plurality of fluid outlets, thereby allowing communication and connection to other part of a system.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the location of the fluid inlet to have a substantially vertical central axis since rearranging parts of an invention involves only routine skill in the art. The motivation for doing so would be to locate and fit the manifold in a location with limited horizontal space.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide for the relative volume of 5 cc 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 patentable 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 manifold of Butcher et al would not operate differently with the claimed housing dimensions since the fluid manifold dimensions function in the same manner as the inventor’s disclosed dimensions. MPEP § 2144.05(II)(A): Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.").
Regarding Claim 3, Butcher et al teach where the plurality of fluid outlets (Figure 9c; the openings between support structures 106a and 106b) are disposed along a same plane (Figure 9c; with the same plane being along the width Wo direction shown in Annotated Figure A through the plurality of fluid outlets).
Regarding Claim 4, Charest discloses where the plurality of fluid outlets (206a – 206d; Figure 2A) are disposed along at least two planes (at least 6 planes shown in Figure 2A), and wherein the at least two planes are parallel with respect to one another (Figure 2A).
Regarding Claim 5, Butcher et al teach where internal ends (Annotated Figure B at “fluid outlet”) of the plurality of fluid outlets (Figure 9c; the openings between support structures 106a and 106b) are disposed along a single line extending perpendicular to a central axis of the fluid inlet (the line is along the plane of Wo as seen in Annotated Figure A which extends perpendicular to a central axis of the fluid inlet which as seen in Annotated Figure A would extend into the page at the junction of the T1 and W1 along the centerline of the circular inlet opening).
Regarding Claim 6, Butcher et al teach where at least one of the plurality of fluid outlets has a central axis parallel with a central axis of the fluid inlet (where the central axis of the fluid inlet runs at least through and above 106b and so at least the two outlets on either side of 106b would have a central axis parallel to the central axis of the inlet; Figure 9c).
Regarding Claim 7, Butcher et al teach where all of the plurality of fluid outlets have a central axis parallel with a central axis of the fluid inlet (where the central axis of the fluid inlet runs at least through and above 106b and so the outlets at 104 would all have a central axis parallel to the central axis of the inlet by being both on the side of, and below, the central axis of the fluid inlet; Figure 9c).
Regarding Claim 8, Butcher et al teach where an area of the volume (within 100 between 102 and 104; ¶ 38), as viewed parallel with a plane along the plurality of fluid outlets is constant along a length of the volume (¶ 38 discloses “the cross-sectional area of the circular portion is the same as the cross-sectional area of the elliptical portion”).
Regarding Claim 9, Butcher et al teach where the volume (within 100 between 102 and 104; ¶ 38) defines a quadrilateral cross section (Figure 9c), as viewed from a side view (where the inlet and outlet planes are the right and the left sides of the quadrilateral respectively).
Regarding Claim 10, Butcher et al teach where the inlet (102) has a diameter greater than any of the plurality of outlets (the openings between support structures 106a and 106b; Figure 9c).
Regarding Claim 11, Butcher et al teach where the plurality of outlets (the openings between support structures 106a and 106b) have generally the same shape (generally oblong with width greater than height as seen in Figure 9c).
Regarding Claim 12, Moore teaches a fluid manifold (generally at 10) with a plurality of fluid outlets (to 12 and 13; Figure 1) where each of the plurality of fluid outlets defines an opening adapted to receive an end of a hose (hoses 12 and 13; Page 1, lines 47-50).
Regarding Claim 14, Charest et al disclose all essential elements of the current invention as discussed above except where the volume sidewall thickness is greater than the inlet sidewall thickness.
Moore teaches a fluid manifold (generally at 10) where the volume sidewall thickness (along the middle of the manifold in the area where the reference numeral 10 for the manifold points) is greater than the inlet sidewall thickness (Figure 1; the sidewall thickness surrounding the leg 18 upstream of 17).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify the volume sidewall thickness to be greater than the inlet sidewall thickness since a change in shape of an element involves only routine skill in the art. The motivation for doing so would be to provide a greater strength area at the volume or to better insulate the area at the volume.
Furthermore, absent a teaching as to criticality that having the volume sidewall thickness to be greater than the inlet sidewall thickness, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Regarding Claim 15, Moore teaches where the volume sidewall thickness tapers (along the middle of the manifold in the area where the reference numeral 10 for the manifold points), as measured along a portion of the sidewall between the fluid inlet and the plurality of fluid outlets (Figure 1).
Regarding Claim 16, Butcher et al teach where the plurality of fluid outlets (Figure 9c; the openings between support structures 106a and 106b) comprise adjacent fluid outlets (Figure 9c, only separated by 106a or 106b) that are spaced apart from one another by a wall of the body (106a or 106b), but fails to expressly disclose wherein an upstream side of the wall defines a curved profile.
Moore teaches where wherein an upstream side of the wall (the wall surrounding flow path 20 for example) defines a curved profile (Figure 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify wherein an upstream side of the wall defines a curved profile since a change in shape of an element involves only routine skill in the art. The motivation for doing so would be to provide a smooth flow path from the inlet to the outlet.
Furthermore, absent a teaching as to criticality that having an upstream side of the wall defines a curved profile, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Regarding Claim 21, Moore teaches wherein each outlet of the plurality of fluid outlets (13 in Figures 1-2) has a substantially circular cross-section (Figures 1-2 together show the outlet to 13 to be circular in cross section).
Regarding Claim 22, Sloan teaches where the fluid outlet is configured to have a greater cumulative flow than the fluid inlet (Figures 5 and 6; Col 4, lines 42-46 disclose where the opening size of the fluid outlet is 9 in sq which is greater than the disclosed opening size of the fluid inlet at 7.06 in sq and therefore a greater cumulative flow area) and Butcher et al disclose not generating internal pressure within the manifold causing excess fluid to be retained in the manifold (Figure 9C; ¶ 38 discloses the volume of fluid flow remains the same, therefore no fluid is retained).
Regarding Claim 23, Butcher et al teach wherein the plurality of fluid outlets lie along a straight line perpendicular to the central axis of the fluid outlets (see Annotated Figure A along Wo).
Regarding Claim 25, Butcher et al teach where a central axis of at least one of the fluid outlets (Figure 9c with the outlets out 104 and separated by 106a or 106b) is generally parallel with respect to another of the fluid outlets (with the outlets on the other side of 106a or 106b).
Regarding Claim 26, Butcher et al disclose where a central axis of at least one of the fluid outlets (Figure 9c with the outlets out 104 and separated by 106a or 106b) is generally parallel with a central axis of the fluid inlet (from 102; Figure 9c).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable as obvious over Charest et al (US 9784396) in view of Butcher et al (US 2016/0208708) in further view of Sloan (US 7,458,532) in further view of Moore (US 1,905,733) in further view of Hui et al (US 2016/0120098).
Regarding Claim 24, Charest et al, as modified by Butcher et al and Sloan and Moore teach all essential elements of the current invention as discussed above but fails to expressly teach wherein at least one outlet of the plurality of fluid outlets comprises an entry portion from the volume to the opening, wherein the entry portion tapers narrower from the volume toward the opening.
Hui et al teach wherein at least one outlet of the plurality of fluid outlets (56) comprises an entry portion (82) from the volume (the interior of 50) to the opening (the opening that forms the outlet 56), wherein the entry portion tapers narrower from the volume toward the opening (Figure 3).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the application to modify wherein the entry portion tapers narrower from the volume toward the opening since a change in shape of an element involves only routine skill in the art. The motivation for doing so would be to provide a smooth flow path from the inlet to the outlet.
Response to Arguments
Applicant’s amendment has overcome the rejection of record. However, a new ground of rejection is applied to the amended claims.
Conclusion
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/NICOLE GARDNER/
Examiner, Art Unit 3753
1 The recitation of the actual fluid handled has been given no patentable weight in the apparatus claims, MPEP 2115.
2 The recitation of the actual fluid handled has been given no patentable weight in the apparatus claims, MPEP 2115.
3 The recitation of the actual fluid handled has been given no patentable weight in the apparatus claims, MPEP 2115.
4 The recitation of the actual fluid handled has been given no patentable weight in the apparatus claims, MPEP 2115.
Prosecution Insights