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 .
Response to Amendment
The Amendment filed 12/05/2025 has been entered. Claims 1, 4-7, 9-10, 12-17 and 19-20 remain pending in the application. Claims 10 and 12-15 are withdrawn. Claims 1, 4-7, 9, 16-17 and 19-20 are being examined herein.
Status of Objections and Rejections
All rejections of claims 3, 8 and 18 are obviated by Applicant’s cancellation.
The rejections under 35 U.S.C. 103 are being withdrawn in view of Applicant’s amendments.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
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.
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 1, 4-7, 16-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Motadel, et al. (US 20110183433 A1)(Provided in applicant’s IDS of 3/07/2023) in view of Ingenhoven et al. (US 20040020942 A1).
Regarding claim 1, Motadel teaches a sample adding needle (10) for preparing microdroplets, comprising a liquid storage portion (the portion of pipette tip 10 in the distal region 20 between junction 30 to 5 millimeters from distal terminus 50, see annotated figure, Figure A) and a liquid discharge portion (the portion of pipette tip 10 between 5 millimeters from distal terminus 50 to distal terminus 50, see annotated figure, Figure A)(the examiner interprets the liquid storage portion and the liquid discharge portion have an arbitrary cutoff. Motadel teaches the total length of the pipette tip is about 1.10 inches to about 3.5 inches in para. 0067. The examiner destinates the first 5 mm or 0.20 inches from the distal end to be the liquid discharge portion. The term “portion” means a part of a whole, it is a broad term with no structure associated with it), which are integrally molded and penetrate one another (Fig. 1A), wherein:
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[AltContent: textbox (Figure A. Annotated Fig. 1A of Motadel.)]the liquid storage portion is a hollow truncated cone the radial dimension of which gradually decreases in the direction facing the liquid discharge portion (Fig. 1A, also see annotated Fig. A above),
the liquid discharge portion is a hollow truncated cone the radial dimension of which gradually decreases in the direction away from the liquid storage portion (Fig. 1A, also see annotated Fig. A above),
the taper of the liquid storage portion is C1, the taper of the liquid discharge portion is C2, and C1 = C2 (Fig. 1A and para. 0075 teaches the outer surface taper remains constant. The examiner notes that equations provided on page 12, lines 6-7 in the Specification, C1 = (R1-R2)/H and C2 = (r1-r2)/h are the geometric definition of a taper, which is the change in diameter over a given length. A taper is related to the angle of taper in the following way: tan(angle of taper) = ½ taper. The examiner further notes that the disclosure did not specify R1, R2, r1, and r2 are dimensions of the respective outer diameter or inner diameter. The lack of differentiation between the outer diameter and inner diameter with regard to taper is consistent with the Remarks made by the Applicant on 5/12/2025, which states on p. 10 “because the inner diameter and the outer diameter of the liquid discharge opening are very small, when the liquid discharge portion is produced by an injection molding process, a 10-30° taper of the liquid discharge portion can ensure the machinability and rigidity of the mold core and mold sleeve of the liquid discharge portion. For these reasons, the present inventors have limited the taper of the liquid discharge portion to 10 to 30o.” The differentiation between the outer diameter and inner diameter with regard to the taper appears to be unimportant in the present claimed invention),
the wall thickness of the liquid storage portion is D1, the wall thickness of the liquid discharge portion is D2, and D1>D2 (Fig. 1C, paras. 0006, 0074),
the liquid discharge portion has a liquid discharge opening at the end away from the liquid storage portion (Fig. 1A),
the liquid discharge portion has a height of 5 to 10 mm (the liquid discharge portion has a height of 5 mm, see annotated figure above), a taper angle of 10 to 20o (for the record, based on pages 6-7 of Applicant’s Remarks of 08/19/2025, the claimed taper angle is a full taper angle, which is two times the angle from the central longitudinal vertical axis of the needle)(Para. 0069, each taper in a distal section is between about 0 to about 30 o from the central longitudinal vertical axis of the pipette tip, e.g., about 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29 or 30 degrees. In order to compared with the claimed range, the above measurements are multiplied by two to get the “full taper angle, ” which equal 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20…, or 60 degrees. Several of the listed measurements, e.g. 10, 12, 14 … 20 are within the claimed range of 10 to 20 o) and a wall thickness of 0.1 to 0.15 mm (para. 0006, the wall thickness at the distal region terminus is about 0.0040 inches to about 0.0055 inches, which is about 0.10 mm to about 0.14 mm).
Motadel teaches the liquid discharge opening has an outer diameter of about 0.02 to 0.7 inches ± 10% (paras. 0067 and 0408), which is between 0.018 inches to 0.77 inches, which is 457 mm to 19,558 mm. (The examiner notes the higher limit of the range 0.7 inches in para. 0067 is likely a typo. The value 0.07 inches is more fitting in the context of the invention; however, the value of the method higher limit does not affect the outcome of the examination of the instant claim).
Motadel teaches the lower limit of the outer diameter of the liquid discharge opening to be 457 mm, which is just above the claimed range, and thus fails to teach the liquid discharge opening has an outer diameter of 400 to 450 mm.
Motadel teaches the liquid discharge opening has an inner diameter of 0.01 inches to 0.03 inches ± 10% (para. 0067 and 0408), which is 0.009 to 0.033 inches, which is 229 mm to 838 mm, and thus fails to teach the liquid discharge opening has an inner diameter of 100 to 200 mm.
However, Motadel teaches polymer-made pipette tips in the reference for handling liquid microliters ranges (paras. 0005, 0022 and 0063). Motadel further teaches pipette tips in general are made in a number of sizes to allow for accurate and reproducible liquid handling for volumes ranging from nanoliters to milliliters which makes the claimed range obvious (para. 0004).
In addition, Ingenhoven teaches a liquid-handling tip (6) that handle small sample volumes in the nanoliter and even in the picoliter range (para. 0008, 0024). Ingenhoven teaches the liquid-handling tip (end piece 6) is an air-displacement tip made of polymer material (para. 0024), and the opening diameter 18 (inner diameter, Fig. 5) of the liquid-handling tip (6) is 20 to 150 mm for the dispensing of samples in the nanoliter range (para. 0024 and Fig. 5). Ingenhoven further teaches the opening diameter 18 can be adjusted as needed to the properties of the liquid to be pipetted or the intended volume of the samples to be separated (para. 0024 and Fig. 5).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inner diameter of the liquid discharge opening taught by Motadel to be 20 to 150 mm taught by Ingenhoven in order to generate nanoliter volume with a reasonable expectation of success (Ingenhoven, para. 0024) (MPEP 2143)(I)(G).
In addition, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the inner diameter of the liquid discharge opening to be 100 to 150 mm, the portion of modified Motadel’s teaching that corresponds to the claimed range (MPEP 2144.05 (I)).
In addition, Ingenhoven further teaches besides the opening diameter 18, the other geometry of the end-piece 6 can be adjusted as needed to the properties of the liquid to be pipetted or the intended volume of the sample (Ingenhoven, para. 0024). Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer diameter of the liquid discharge opening taught by Motadel to a have lower diameter in order to generate nanoliter volume (Ingenhoven, para. 0024). Furthermore, modified Motadel discloses the claimed invention except for the liquid discharge opening has an outer diameter of being in the range of 200 to 450 mm. It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have 450 mm to be the outer diameter of the liquid discharge opening since the claimed ranges (400 to 450 mm) and the lower limit of the range (457 mm) of the prior art Motadel are close enough that one skilled in the art would have expected them to have the same properties. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783 (Fed. Cir. 1985) (a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close).
Regarding claim 4, modified Motadel teaches all of the elements of the current invention as stated above with respect to claim 1. Motadel further teaches the liquid storage portion is provided with an adaptation portion (proximal region 15) at the end away from the liquid discharge portion (Fig. 1A), the adaptation portion is a truncated cone the radial dimension of which gradually decreases in the direction facing the liquid discharge portion (Figs. 1B and 1C and para. 0066), and the adaptation portion and the liquid storage portion are integrally molded (Fig. 1A).
Regarding claim 5, modified Motadel teaches all of the elements of the current invention as stated above with respect to claim 4. Motadel further teaches the adaptation portion (proximal region 15) is provided with a step portion (ribs) (Fig. 1B and para. 0006) surrounding the adaptation portion at the end away from the liquid discharge portion (Figs 1A and 2), the step portion is provided with at least one reinforcing rib at the end facing the liquid discharge portion (Figs. 1A and 2), and the step portion is integrally molded on the adaptation portion (para. 0006, Fig. 1A).
Regarding claim 6, modified Motadel teaches all of the elements of the current invention as stated above with respect to claim 4. Motadel further teaches the adaption portion has a taper angle of 2 to 6o (para. 0068, teaches a half-taper angle of 1, 2, 3 degrees, which means a taper angle of 2 and 4 and 6 degrees.)
Modified Motadel fails to explicitly disclose the adaptation portion has a height of 3 to 8 mm.
However, Motadel teaches the proximal region is a section of flexible thickness that reduce the amount of axial force required to engaged and/or disengage a pipette tip from a dispenser (paras. 0076-0078). One of the ordinary skill in the art would recognize it is standard for the proximal region to have a height in the range of 3 to 8 mm for the intended function.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have selected for the proximal region a height in the range of 3 to 8 mm in order to achieve the intended function of reducing the amount of axial force to engage or disengage a pipette tip from a dispenser with a reasonable expectation of success (paras. 0076 and 0078) (MPEP 2143)(I)(G).
Regarding claim 7, modified Motadel teaches all of the elements of the current invention as stated above with respect to claim 4. Motadel further the adaptation portion has an liquid supply opening at the end away from the liquid discharge (Fig. 1A).
Regarding claim 16, modified Motadel teaches all of the elements of the current invention as stated above with respect to claim 6.
Modified Motadel does not teach the adaptation portion has a height of 3 to 5 mm.
However, modified Motadel teaches the adaptation portion has a height of 3 to 8 mm (see above).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have selected for the adaptation portion with a height in the range of 3 to 5 mm, the portion of modified Motadel’s teaching that corresponds to the claimed range (MPEP 2144.05 (I)).
Regarding claim 17, modified Motadel teaches all of the elements of the current invention as stated above with respect to claim 6. Modified Motadel further teaches the adaptation portion has a taper angle of 3 to 4.5o( para. 0068, teaches a half-taper angle of 2 degrees, which means a taper angle of 4 degrees.)
Regarding claim 19, modified Motadel teaches all of the elements of the current invention as stated above with respect to claim 1. Modified Motadel further teach the liquid discharge opening has an inner diameter of 100 to 180 mm (In modified Motadel, the liquid discharge opening has an inner diameter in the range of 100 to 150 mm, see claim 1).
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Motadel, et al. (US 20110183433 A1) in view of Ingenhoven et al. (US 20040020942 A1) as evidenced by Deshmukh et al. (“Studies in Dielectric Properties of Various Polymers and its Correlation with Surface Free Energy. ” IJCPS Vol. 1, No. 2, Nov-Dec 2012, pp. 41-43).
Regarding claim 9, modified Motadel teaches all of the elements of the current invention as stated above with respect to claim 1. Motadel further teaches the sample adding needle is made of a material having a contact angle of not less than 80 degrees with the pure aqueous solution, the material is polypropylene (para. 118) (Deshmukh, pp. 41-43 and Table 2, contact angle of polypropylene with water is 97.15o).
Regarding claim 20, modified teaches all of the elements of the current invention as stated above with respect to claim 9. Modified Motadel further teaches the material is one selected from the group consisting of nylon, polyethylene, polypropylene, and cyclic olefin polymer (the material is polypropylene, see claim 9).
Response to Arguments
Applicant’s arguments filed 12/05/2025 with respect to the rejections under 35 U.S.C. 103 have been fully considered and are not persuasive.
In the argument, see pp. 6 -7, the Applicant argues that a list of the distinguishing technical features are critical to achieving superior results in the claimed invention, which superior results would have been unexpected in view of the deficient teachings of the cited references. The distinguishing technical features include the liquid discharge portion having a height of 5 to 10 mm, a taper angle of 10 to 20° and a wall thickness of 0.1 to 0.15 mm, and the liquid discharge opening having an outer diameter of 400 to 450 mm and an inner diameter of 100 to 200 mm. The Applicant submitted a Rule 1.132 Declaration as evidence in support of the Applicant’s assertions of the unexpected results.
The examiner respectfully disagrees. Overcoming a §103 rejection based on unexpected results requires the combination of three different elements: the results must fairly compare with the prior art, the claims must be commensurate in scope and the results must truly be unexpected. (See MPEP §716.02) Applicant's showing of allegedly unexpected results does not satisfy these requirements.
Results must fairly compare with prior art.
The Applicant uses Example C in the Affidavit to demonstrate that when distinguishing technical features are not satisfied, the results of producing 20,000 microdroplets of 1 nL with a CV less than 3% in 3.3 minutes cannot be achieved. However, Example C in the Affidavit is not a closer prior art than Motadel. The teachings of Motadel anticipates all the claimed features of claim 1 (including all the distinguishing technical features) except the outer diameter and the inner diameter of the liquid discharge opening. Motadel teaches the liquid discharge opening has an outer diameter of 457 mm and above and an inner diameter between 229 mm to 838 mm while the limitations require the outer diameter to be between 400 to 450 mm and the inner diameter to between 100 to 200 mm. In contrast, with the sample adding needle in Example C, the wall thickness of liquid discharge opening is additionally absent along with the outer diameter and the inner diameter. Furthermore, the sample adding needle in Example C has an outer diameter of 950 mm and an inner diameter of 280 mm, which exceed further beyond the claimed ranges as compared to that of Motadel (the outer and inner diameter are 457 mm and 229 mm in the lower end of the range, respectively). Therefore, the results obtained by Example C does not provide insight into whether a sample adding needle closer to the distinguishing technical features, such as one with features of Motadel’s teachings, would be able to achieve the results of producing 20,000 microdroplets of 1 nL with a CV less than 3% in 3.3 minutes. Therefore, Example C is insufficient in providing results to fairly compare the claimed invention with the closest prior art as required (MPEP 716.02(b)(III)).
Claims must be commensurate in scope
On page 5 in the Affidavit, Weng, the inventor of the instant, states that “[i]t was found that the sample adding needle can be used repeatedly and stably for a long time, and the produced droplets were all 1 nL with a CV less than 3%. The good hydrophobicity and lipophilicity of the sample adding needle surface ensure the ability of the needle to work stably for a long time. See also the para. bridging pages 28 and 29 of the specification.” Based on the statement, hydrophobicity and lipophilicity is crucial in achieving the results of generating 20, 000 microdroplets of 1 nL with a CV less than 3%. However, hydrophobicity and lipophilicity of the needle surface is not one of the distinguishing technical features nor is it a claimed feature in the independent claim 1. In addition, other factors such as the type of dispensed liquids (aqueous vs. organic) could also influence the outcome of the results, but they are claimed in the claims. For these reasons, it has not been shown that the results are due to the claimed features, not to unclaimed features (e.g. hydrophobicity/lipophilicity of the needle material and the type dispensed liquid). Therefore the claims are not commensurate in scope with the unexpected results argued since hydrophobicity and lipophilicity seems critical and nothing about these features/structures are claimed.
Claim 9 does require the sample adding needle to be made of a material “having a contact angle of not less than 80 degrees with a pure aqueous solution,” and the material is to be selected from a list of polymers. However, Examples 1, A, B and C, using only polypropylene with a contact angle of 88 degrees with the pure aqueous solution (p. 26, lines 22- 23 of specification and p. 2 of the Affidavit) as the material, do not appear to employ any other polymers on the list. Therefore, claim 9 is still not commensurate in scope.
Results must truly be unexpected
Inventor Weng states in p. 5 in the Affidavit that with the sample adding needle in Example C, “it is not possible to achieve microdroplets having a volume in the 1 nanoliter range, and wherein the coefficient of variation (CV) of the radius of the microdroplets is more than 3%.” However, it is not unexpected that a larger inner diameter and outer diameter at the liquid discharge opening in Example C would result in the inability to generate droplets of 1 nL in volume, and droplets of 2 nL in volume were generated instead (Affidavit, Table A). In addition, it would have been obvious for one of ordinary skill in the art to decrease the inner diameter and outer diameter to in Example C to obtain a droplet size of 1 nL. It is also not unexpected that a certain range of inner diameter and outer diameter is more suitable in dispensing a certain volume consistently, and thus tuning the inner and outer diameters in order to improve % CV is not unexpected.
Furthermore, no data immediately outside of the claimed ranges has been provided. Therefore, it is unclear whether results obtained by a sample needle with values immediately outside of the claimed ranges would follow an expected trend or they are unexpected as the Applicant claims.
For the above reasons, the argument is unpersuasive.
In the argument, see p. 8, the Applicant further argues that the pipette tips taught by Motadel and Ingenhoven have a different function and belong to completely different fields, and thus a person of ordinary skill would have lacked motivation to consider the teachings of Motadel and Ingenhoven when considering the presently claimed invention.
The examiner respectfully disagrees. It has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See in re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the pipette tips taught by Motadel and Ingenhoven essentially have the same functionality as the sample adding needle in the instant claimed invention. They are all conduits to discharge liquid in a microscale, and they are all in the field of liquid handling and microanalysis technology in the medical and research laboratories (Motadel, para. 0003 and Ingenhoven, abstract). Therefore, a person having ordinary skill in the art would have been motivated to consider the teachings of Motadel and Ingenhoven when considering the claimed invention, and hence this argument is unpersuasive.
In the argument, see p. 8, the Applicant further argues the rejections of claims 9 and 20 under 35 U.S.C. 103 should be withdrawn on the basis that independent claim 1 is patentable. However, for the reasons discussed above, claim 1 is not patentable over Motadel in view of Ingenhoven. In addition, the Applicant does not provide any specific supposed errors in the examiner's action regarding the rejections of claims 9 and 20. Therefore, this argument is unpersuasive.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MAY CHIU whose telephone number is (571)272-1054. The examiner can normally be reached 9 am - 5 pm.
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/M.L.C./Examiner, Art Unit 1758
/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758