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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/23/2026 has been entered.
Claim Interpretation
Regarding limitations recited in claims 81, 83, 88-93, and 102-104 which are directed to a manner of operating the disclosed particle orientation system, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. Further, it has been held that process limitations do not have patentable weight in an apparatus claim. See Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969) that states “Expressions relating the apparatus to contents thereof and to an intended operation are of no significance in determining patentability of the apparatus claim.”
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 81, 83, 88-93, and 102-104 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 81 recites the limitation "the direction of the laminar flow" in line 20. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “a direction of the laminar flow” is one way to resolve the indefiniteness issues.
Claims 83, 88-93, and 102-103 depend on claim 81.
Claim 104 recites the limitation "the propagation direction" in line 2. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “a propagation direction” is one way to resolve the indefiniteness issues.
Claim 104 recites the limitation "the axis of flow" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. The Applicants are advised, amending the limitation to recite “an axis of flow” is one way to resolve the indefiniteness issues.
Appropriate corrections are required.
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) 81, 83, 88-93, and 102-104 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Durack et al. (US 2011/0215111 A1, cited in IDS filed 12/11/2023).
Regarding claim 81, Durack discloses a particle orientation and sorting system configured for at least positioning and/or orienting particles in a fluid flow within a microfluidic channel or chamber, the system comprising:
a microfluidic channel or chamber sized to at least one of receive and flow at least a sheath fluid (Fig. 11, see: nozzle 137); and
a particle orientation and delivery tube ("PODT") (Fig. 11, see: cylindrical flow body 133) including a distal end with an outlet (see: threaded projection 149 having outlet), the PODT being sized to deliver a particle-containing fluid comprising at least a plurality of particles within a fluid into the sheath fluid within the microfluidic channel or chamber such that following said delivery (see: Conduit (Tubular Needle) 157, Radial Bore in Flow Body (Sheath Fluid) 173), the particle-containing fluid is surrounded by the sheath fluid in a laminar flow ([0816], see: flow remains laminar);
wherein the microfluidic channel or chamber is sized to receive the PODT via insertion thereof within the microfluidic channel or chamber, such that the distal end projects into the microfluidic channel or chamber (Fig. 11, see: threaded projection 149 inserts into the nozzle 137), and includes at least one structural feature which provides an orienting torque to the plurality of particles within the sheath fluid, the at least one structural feature comprises the microfluidic channel or chamber being conically converging in the direction of the laminar flow (Fig. 11, see: interior surface 233 comprising a plurality of axially tapered regions), and the conically converging microfluidic channel or chamber providing the torque orients the particle at one or more stable points relative to a frame of reference comprising the microfluidic channel or chamber (Fig. 23, see: torsional forces),
at least one radiation source (RS) configured to direct radiation on the plurality of particles for sorting one or more of the particles following orientation of the particles by the structural feature (Fig. 38; [0857]-[0859], see: light source (not shown)); and
at least one of free-space optics and fiber-optics configured to direct the radiation onto the fluid flow (Fig. 38; [0857]-[0859], see: fiber optic cable 4205);
wherein at least one of the RS, the free-space optics or the fiber-optics are configured to generate a static, spatial pattern within the fluid flow, and wherein the spatial pattern is non-circular or comprises a plurality of circles (Fig. 106 and 109; [1156], see: plurality of flow cytometry units configured to receive a plurality of beams from beam guidance system 1273 which guides a common beam 1007).
Regarding claim 83, Durack further discloses a sheath fluid tube configured to direct sheath fluid into the microfluidic channel or chamber (Fig. 11, see: Radial Bore in Flow Body (Sheath Fluid) 173).
Regarding claim 88, Durack further discloses at least the distal end of the PODT is arranged at a particular location within the microfluidic channel or chamber in at least one location relative to a frame of reference comprising the microfluidic channel or chamber (Fig. 11, see: threaded projection 149 inserts into the nozzle 137).
Regarding claim 89, Durack further discloses the plurality of particles comprise asymmetric particles (Fig. 23, see: sperm).
Regarding claim 90, Durack further discloses the plurality of particles comprise cells (Fig. 23, see: sperm).
Regarding claim 91, Durack further discloses the plurality of particles comprise sperm (Fig. 23, see: sperm).
Regarding claim 92, Durack further discloses the system is configured as an orientation and sorting stage within a microfluidic system (Claim 81, see: apparatus to sort sperm and orient them).
Regarding claim 93, Durack further discloses the microfluidic system comprises a cell sorting system (Claim 81, see: apparatus to sort sperm and orient them).
Regarding claim 102, Durack further the at least one structural feature is configured to generate an asymmetric compression of the fluid that contains the plurality of particles within the laminar flow of the sheath fluid and fluid that contains the plurality of particles (Fig. 23, see: torsional forces).
Regarding claim 103, Durack further at least one structural feature generates an asymmetric pattern of laminar flow of the sheath fluid and fluid that contains the plurality of particles (Fig. 9 and Fig. 18, see: nozzle body shapes; Fig. 23, see: torsional forces).
Regarding claim 104, Durack further the spatial pattern is based at least upon an alignment of the propagation direction of a beam of the at least one RS with the axis of flow of the microfluidic channel (Fig. 38, see: light area and shape is dependent on focal length).
Response to Arguments
Applicant’s arguments with respect to claim(s) 81, 83, 88-93, and 102-104 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J EOM whose telephone number is (571)270-7075. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM).
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, Lyle Alexander can be reached at 5712721254. 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.
/ROBERT J EOM/ Primary Examiner, Art Unit 1797