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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/8/2026 has been entered.
Withdrawn Rejection
The 103 rejections are withdrawn in response to the amendments and the arguments. Specifically, the argument made on the Remarks 6/8/2026 that the “proposed modification would make Yu operate in a different way, to provide sedimentation” (page 11 para. 4) is persuasive.
Declaration under 37 CFR 1.132
The Declaration under 37 CFR 1.132 filed 6/8/2026 is sufficient to overcome the rejection of claims 12-14, 17 and 24 under 103 based upon the declaration that the “proposed modification would make Yu operate in a different way, to provide sedimentation” (page 4 para. 2). This argument is found persuasive.
Priority
The present application was filed as a proper National Stage (371) entry of PCT Application No. PCT/EP2020/066292, filed 06/12/2020. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. EP19382496.8, filed on 06/13/2019 in Europe.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of the Claims
Claims 1, 4-9, 11-14, 17, 19 and 24-28 are pending; claim 1 is amended; claims 2-3, 10, 15-16, 18 and 20-23 are cancelled; claims 1, 4-9, 11, 19 and 25-26 are withdrawn; claims 27-28 are newly recited. Claims 12-14, 17, 24 and 27-28 are examined below.
New Objection
Claim Objections
Claims 12 and 14 are objected to because of the following informalities:
Claims 12 and 14 are dependent on withdrawn product claim 1. It is recommended that Applicant incorporates all limitations of claim 1 into claims 12 and 14, thereby improving clarity.
Appropriate correction is required.
New Rejections
In further consideration of the art and Applicant’s amendments, arguments and Declaration, a new issue of enablement is raised.
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 12-14, 17, 24 and 27-28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for detecting and/or characterizing pathogens/pathogen-binding antibodies using the coloured particles as defined in claim 1, wherein the particles have a diameter from 5 to 10 μm, and using a 5 to 20 min. of sedimentation time, the specification does not reasonably provide enablement for detecting and/or characterizing a pathogens/pathogen-binding antibodies using the coloured particles as defined in claim 1 and 1 to 20 minutes of sedimentation time by passive gravitational force. This is a scope of enablement rejection.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The specification does not reasonably provide enablement for detecting and/or characterizing pathogens or pathogen-binding antibodies present in an isolated test sample using microparticles comprising a density of 1.5 to 2.5 g/cc and a diameter of 3 to 5 µm, and using a passive gravitational sedimentation time of 1 to 5 minutes.
The specification does not provide sufficient evidence that the claimed method of using the coloured particles as defined in claim 1, wherein the particles have a diameter from 3 to 5 μm, is effective for detecting and/or characterizing pathogens or pathogen-binding antibodies present in an isolated test sample using a gravitational sedimentation time of 1 to 5 minutes.
Fig. 5A shows that the 3 µm particles take 1 hour to sediment under passive gravitational force (“and Sicastar blue 3 μm bead suspensions were not completely settled down until 1 hour later” page 31 lines 2-3). Fig. 5A also shows that 5 µm particles take longer than 12 minutes to sediment (“Sicastar blue 5 μm needed approximately 15 min” page 31 lines 1-2).
Therefore, the specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with the claims.
MPEP § 2164.01 states:
The standard for determining whether the specification meets the enablement
requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S.261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied.
In re Wands, 858F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation.
In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
In regard to Wands factors (A) and (B), the breadth of the claims needed to enable the invention is determined by whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought in the claims. AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). The propriety of a rejection based upon the scope of a claim relative to the scope of the enablement concerns (1) how broad the claim is with respect to the disclosure and (2) whether one skilled in the art could make and use the entire scope of the claimed invention without undue experimentation.
The nature of the invention is a biological/chemical case, where there is natural unpredictability in performance of certain species other than those specifically enumerated; see MPEP § 2163. Accordingly, it is the Office’s position that undue experimentation would be required to practice the claimed method(s), with a reasonable expectation of success, because it would not have been predictable from the disclosure that the claimed particles and sediment time would function as claimed with respect to detecting and/or characterizing pathogens or pathogen-binding antibodies in an isolated test sample (see MPEP § 2164.03).
In regard to Wands factors (C), (D) and (E), the state of the prior art is what one skilled in the art would have known, at the time the application was filed, about the subject matter to which the claimed invention pertains and provides evidence for the degree of predictability in the art; see MPEP § 2164.05(a).
Accordingly, see Lentfer et al. Journal of Archaeological Science (2003) 30, 149–168 doi:10.1006/jasc.2001.0786 (“Lentfer”). Lentfer teaches “Particle Settling Times for Gravity Sedimentation and Centrifugation: A Practical Guide for Palynologists” (Title). Lentfer teaches the calculated passive gravitational sedimentation time for microparticles (Table 1). Lentfer further teaches that particles with a diameter of 3.9 and “Specific gravity (g/cc) of…2.3” require approximately 3 hours to sediment a vessel of 10 cm (see Table 1, page 150). Lentfer teaches that particles with a diameter of 5 micrometers and a Specific gravity (g/cc) of…2.3” require approximately 2 hours to sediment a vessel of 10 cm (see Table 1, page 150). Note that Lentfer teaches that “[t]he settling times, for example, are calculated over 10 cm; this distance approximates to the size of most commonly-used centrifuge or test tubes” (page 152 col. 2 para. 2).
Furthermore, see Nekovic et al. Silicon, Volume 14, pages 589–596 (2022) https://doi.org/10.1007/s12633-020-00895-3 (“Nekovic”). Nekovic teaches the “use Stokes’ Law calculations to investigate the likely settling velocities for silicon particles” (page 2 col. 1 para. 4). Nekovic teaches that “solid silicon (2.33 g/cm3)” particles with a diameter of 10 microns take longer than 10 minutes to sediment a distance of 5 cm in water according to Stoke’s law (“10.2 mins” Table 2, page 4). Nekovic also teaches that “Oxidised porous silicon” particles with a density of “1.67 g/cm3”, with a diameter of 10 microns take approximately 20 minutes to sediment a distance of 5 cm (“19.9 mins” Table 2 page 4).
See also Prof Steven Abbot “Stokes Sedimentation Calculator + Boycott Effect” (retrieved online https://www.stevenabbott.co.uk/practical-solubility/stokes.php on 9/8/2026). Prof Steve Abbot teaches an “[a]pp [that] uses Stokes’ law to estimate the rate at which a dispersion will settle” (page 1 para. 1). Prof Steven Abbot’s app calculates that particles with a diameter of approximately 5 microns and a density of approximately 2.5 g/cc take “8.4 min” to sediment a distance of 10 millimeters (page 1). Note that as evidenced by Corning (retrieved online https://www.corning.com/catalog/cls/documents/drawings/MicroplateDimensions96-384-1536.pdf on 9/8/2026), the well depth of a microplate well is approximately 10 mm in depth (see row 6 “96 well V-bottom…11.3” page 1). Therefore, the art teaches that even when considering small sedimentation distances, such as the well depth of a microplate, the recited particles, wherein the particle diameter is 3 to 5 micrometers, are not expected to sediment under passive gravitational force in 1 to 5 minutes.
Given the cited teachings of the prior art that particles comprising a density of 1.5 to 2.5 g/cc and a diameter of 3 to 5 µm require more than 5 minutes to sediment under gravity, the cited references demonstrate that the use of the particles as defined in claim 1 for detecting and/or characterizing pathogens or pathogen-binding antibodies using a sedimentation time of 1 to 5 minutes is unpredictable.
While the level of skill in the art is high, the amount of guidance provided regarding how to use the claimed particles in the claimed method is scant. Accordingly, the amount of experimentation required to determine how to use the recited particles as defined in claim 1 for detecting and/or characterizing pathogens or pathogen-binding antibodies is quite extensive.
Due to the large quantity of experimentation necessary to determine how to use the recited particles for detecting and/or characterizing pathogens or pathogen-binding antibodies using a sedimentation time of 1 to 20 minutes, the lack of direction/guidance presented in the specification regarding the same, the absence of working examples directed to the same, the complex nature of the invention, the limited state of the prior art, the unpredictability of the effects of physical and biological systems, and the breadth of the claims, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention.
In view of all of the above, one of skill in the art would be forced into undue experimentation to practice the claimed invention commensurate in scope with the claims, and thus, the claimed invention does not satisfy the requirements of 35 U.S.C. §112 first paragraph.
Response to Arguments
Applicant’s arguments with respect to claim(s) s 12-14, 17, 24 and 27-28 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 FERNANDO IVICH whose telephone number is (703)756-5386. The examiner can normally be reached M-F 9:30-6:00 (E.T.).
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/Fernando Ivich/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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