CTNF 18/286,284 CTNF 92426 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. 07-06 AIA 15-10-15 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 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. Priority US National Stage of PCT Acknowledgment is made that this application is the US national phase of international application PCT/JP2022/006602 filed 02/18/2022 which designated the U.S. and claims the benefit of JP2021-083890 filed 05/18/2021. 02-26 AIA Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement(s) (IDS) submitted on 10/10/2023 & 06/20/2025 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner. Drawings The drawings (fig. 1) are objected to under 37 CFR 1.84(l), and corresponding PCT rule 11.13(a), for being unsatisfactorily reproducible. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning. 06-22 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. Specification Applicant is reminded of the proper content, language, and/or format for an abstract of the disclosure: A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art. If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives. Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps. 06-16 AIA Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied , such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided. Additionally the Examiner notes that 37 CFR 1.438 is summarized as: Preferably 50-150 words. Should contain: (A) Indication of field of invention. (B) Clear indication of the technical problem. (C) Summary of invention’s solution of the problem. (D) Principal use or uses of the invention. (E) Reference numbers of the main technical features placed between parentheses. (F) Where applicable, chemical formula which best characterizes the invention. Should not contain: (A) Superfluous language. (B) Legal phraseology such as “said” and “means.” (C) Statements of alleged merit or speculative application. (D) Prohibited items as defined in PCT Rule 9. The abstract of the disclosure is objected to because: superfluous language that can be implied (“There is provided”). Appropriate correction is required. See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts. The title of the invention is not descriptive nor sufficiently precise. A new title is required that is clearly indicative of the invention to which the claims are directed. This may result in slightly longer titles, but the loss in brevity of title will be more than offset by the gain in its informative value in indexing, classifying, searching, etc. If a satisfactory title is not supplied by the applicant, the Examiner may, at the time of allowance, change the title by an Examiner’s amendment. See MPEP § 1302.04(a) and PCT Rule 4.3. 06-11-01 AIA The following title is suggested: “SAMPLE CONTAINER WITH FLANGE FOR TEST TUBES HAVING DIFFERENT DIAMETERS AND AUTOMATIC ANALYZER” . Claim Objections 07-29-01 AIA Claim (s) 3 is/are objected to because of the following informalities: As to claim 3, the limitation “wherein a concentric step difference is provided on a lower surface of the flange portion” is redundant to the same limitation already provided in independent claim 1 from which claim 3 depends, the Examiner suggesting deletion of said limitation in claim 3 . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. MPEP § 2173.05(b)(II): A claim may be rendered indefinite by reference to an object that is variable. See, e.g., Ex parte Miyazaki , 89 USPQ2d 1207 (Bd. Pat. App. & Inter. 2008) (precedential) and Ex parte Brummer , 12 USPQ2d 1653 (Bd. Pat. App. & Inter. 1989). 07-34-01 AIA Claim (s) 1-9 is/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 pre-AIA the applicant regards as the invention. Regarding independent claim 1: The Examiner identifies that the “upper surface of a conveyance path” is a variable object which is referenced by the claim(s), and that the variability of said object (i.e., the variability of the unevenness) renders said claim(s) indefinite. The Examiner emphasizes that the claim is directed only to the sample container, does not comprise the element of the conveyance path, and that the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. The Examiner additionally notes with specific regards to dependent claim 9, that even with an automatic analyzer, Applicant still does not claim that said analyzer comprise the conveyance path nor the test tube so conveyed along said path. The limitation “wherein, in the bottom portion, an angle formed by an inner wall continuous from the body portion and a central axis has a gradient of less than 20 degrees” is unclear, the Examiner noting that it is particularly unclear what is meant by gradient, including that a gradient of an angle would seemingly be unitless. Applicant explanation of intended meaning of claim limitation is respectfully requested. For the purposes of examination, the Examiner will simplify the interpretation of the limitation wherein the angle is less than 20 degrees instead of the gradient of the angle. Regarding claim 2: The Examiner identifies that the “test tube” and the “sampling dispensing probe” are each a variable object which are referenced by the claim(s), and that the variability of said objects each renders said claim(s) indefinite. Additionally, the “amount of position misalignment of the sample container with respect to the test tube in a horizontal direction” appears to be an intended use circumstantial situation which itself is variable and dependent upon external factors. There is insufficient antecedent basis for the limitation "the sampling dispensing probe" in the claim. Regarding claim 3, the Examiner identifies that the “inner wall of the test tube” is a variable object which is referenced by the claim(s), and that the variability of said object renders said claim(s) indefinite. The Examiner emphasizes that the size & shape of the test tube affects the relative dimensions of the gap. Regarding claim 7, the Examiner identifies that “a sample dispensing probe” including “tip of the sample dispensing probe” as well as the (amount of sample) “dead volume sample”, are each variable objects which are referenced by the claim, and that the variability of said objects render said claim indefinite. The Examiner emphasizes that the size & shape of the probe and the tip as well as the amount of sample affects the heights, depths, & distances. The Examiner further notes that the actual dispensing is an intended use. Regarding claim 8, the Examiner identifies that “a liquid level height of a dead volume sample” (E) is a variable object which is referenced by the claim(s), and that the variability of said object renders said claim(s) indefinite. The Examiner emphasizes that the volume (and therefore corresponding liquid level height) of the sample can vary according to use. Regarding claim 9, the claim is generally narrative and appears to be a literal translation into English from a foreign document; the claim as written fails to conform to current U.S. practice. The Examiner notes that there are no structural elements positively claimed as belonging to the automatic analyzer, only a preamble pertaining to the intended use of the analyzer, namely “that analyzes the sample contained in the sample container according to claim 1”, and then in the body of the claim a conditional limitation, namely “wherein, when the sample container is position-misaligned with respect to the test tube in a horizontal direction, the position-misalignment is corrected by allowing a sample dispensing probe used for dispensing the sample to be in contact with the inner wall of the bottom portion” which references to the intended use of the preamble, as well as referencing the additional element of a sample dispensing probe. The Examiner identifies that each of the “sample container” and the “sample dispensing probe” are variable objects which is referenced by the claim(s), and that the variability of said object contribute to rendering said claim(s) indefinite. Furthermore, MPEP § 2173.05(p) states in part that “A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph”. In the present case the only limitation in the body of the claim appears to pertain to a method step (which itself appears to be conditional and refer to variable objects) leaving unclear whether infringement occurs when one creates an analyzer capable of being used with the sample container of claim 1, and/or whether infringement occurs when the analyzer is used with said sample container or with said sample container of claim 1 is further limited by the walls cooperatively being capable of correcting position-misalignment, and/or whether infringement occurs only when actually allowing the sample dispensing probe to be in contact with the inner wall of the bottom portion of the sample container of claim 1 for the position/alignment correction. Furthermore, MPEP § 2173.05(g) states in part “when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear”. In the present case, the single limitation appears to be describing the problem of position misalignment and the solution of somehow allowing (via user, probe, and/or analyzer? Examiner notes there are multiple plausible interpretations) to contact the inner wall of the bottom portion of the sample container to somehow allow position/alignment correction without actually claiming the imposed structural limits of the automatic analyzer itself. Applicant’s explanation of the intended scope of the claim is respectfully requested, and correction of the claim to comply with current U.S. practice is required. Dependent claim(s) of rejected claim(s) is/are likewise rejected. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim(s ) 1-5 and 7-8 is /are rejected under 35 U.S.C. 103 as being unpatentable over Ap plicant cited DeYoung et al (US 20030213312 A1; hereafter “DeYoung”). Re garding independent claim 1, as best understood, DeYoung teaches a sample container (figs. 1-6, cup 10) (Title “Serum Transfer Cup”; Abstract “serum transfer cup is nestable in two different size blood collection tubes such as a 13 mm diameter sample tube and a 16 mm diameter sample tube of the same axial length. The serum transfer cup includes a flange stepped down from a top edge of the cup by a distinctive axial distance” and “The serum transfer cup has a higher elevation in the 13 mm sample tube than in the 16 mm sample tube, and the different flange heights”; [0048] “probe (not shown) can be positioned to enter the serum transfer cup or sample tube along the centerline of the sample tube. When an ultrasonic identification determines that a sample tube is a 13 mm tube or a 16 mm tube 32 the corresponding offset measurement is provided to the aspiration probe mechanism (not shown) to ensure that the probe descends into the serum transfer cup 10 with adequate clearance from the sidewall of the serum transfer cup, or from the sidewall of the sample tube 30 or 32”) comprising: a containing unit (figs. 1-6, container section 24) that contains a sample (e.g., blood serum) and is inserted into a test tube (figs. 4 & 5, sample tube 30 or sample tube 32); and a flange portion (flange portion comprising flange 18 with collar 20) that is provided at an upper end (upper end of container section 24) of the containing unit (figs. 1-6, container section 24) and mounted on an open end portion of the test tube (figs. 4 & 5, sample tube 30 or sample tube 32), wherein the containing unit (figs. 1-6, container section 24) has a tubular body portion (body portion of container section 24) and a cup-shaped bottom portion (bottom portion of container section 24) connected to the body portion (body portion of container section 24) ([0008] “The serum transfer cup conserves the serum by rearranging it into a usable column of fluid that facilitates further aspiration of small amounts of serum by an aspiration probe”), wherein, in the bottom portion (bottom portion of container section 24), an angle formed by an inner wall continuous from the body portion (body portion of container section 24) and a central axis (long axis) has a gradient of less than 20 degrees (Examiner notes that the angle of the inner wall varies and includes a portion that is less than 20 degrees as shown in figures; additional obviousness analysis provided), wherein a concentric step difference (see lower surface of flange portion comprising flange 18 with collar 20) is provided on a lower surface of the flange portion (flange portion comprising flange 18 with collar 20), and wherein a height of the step difference (see lower surface of flange portion comprising flange 18 with collar 20) is (capable thereof, depending on particular conveyance path; additional obviousness analysis provided) equal to or higher than a height of an unevenness on an upper surface of a conveyance path to which the test tube (figs. 4 & 5, sample tube 30 or sample tube 32) is conveyed (the Examiner emphasizes that the conveyance of the sample container is an intended use). While shown, DeYoung does not explicitly state item 1) the angle formed by an inner wall continuous from the body portion and a central axis has a gradient of less than 20 degrees. DeYoung is silent to details of the conveyance path and therefore is silent to item 2): a height of the step difference is equal to or higher than a height of an unevenness on an upper surface of a conveyance path to which the test tube is conveyed. Regarding item 1): It does not matter that the feature shown is unexplained in the specification. The drawings must be evaluated for what they reasonably disclose and suggest to one of ordinary skill in the art. See MPEP § 2125 and In re Aslanian, 590 F.2d 911, 200 USPQ 500 (CCPA 1979). In the present case, DeYoung shows an angle that varies from substantially parallel to the central axis through substantially perpendicular to the central axis at the very bottom at intersection with said central axis. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP § 2144.05(I), In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), and In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the present case, there are a plurality of points in DeYoung wherein the angle is less than 20°. Legal precedent has condoned the use of particular examples of what may be considered common sense or ordinary routine practice including changes in shape, see MPEP § 2141(I) & 2144.04(IV)(B), and In re Dailey , 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In the present case, it is the Examiner’s position that only ordinary skill in the art is required to change the shape of a cup portion, including the curvature thereof. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, see MPEP § 2144.05 and In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the present case, it is the Examiner's position that only ordinary skill in the art is required to optimize the shape of the cup including for common factors such as volume, depth, and adequate clearance of a probe/sampler, so as to be workable for the sampling/probing of the sample in the container. Furthermore, MPEP § 2145(III)(X)(B) states “An “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. “[A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 538, 421,82 USPQ2d 1385, 1397 (2007).” It is the Examiner’s position that including a portion of less than 20 degrees is within ordinary skill in the art to try with anticipated success and therefore merely requires common sense to purse known options of angles for at least the reasons as put forth above. Therefore, in view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that DeYoung reasonably teaches the aforementioned less than 20°, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try optimizing the angle based on the aforementioned reasons, the Examiner further emphasizing ensuring proper descent of the probe into the cup. Regarding item 2): It has been held that a mere change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP § 2144.04(IV)(A), In re Rose , 105 USPQ 237 (CCP A 1955), In re Rinehart , 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), and Gardnerv.TEC Syst., Inc. , 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the present case, it is the Examiner’s position that only ordinary skill in the art is required to change the height of a step difference. Additionally, it is the Examiner's position that only ordinary skill in the art is required to reduce unevenness of a surface. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, see MPEP § 2144.05 and In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the present case, it is the Examiner's position that only ordinary skill in the art is required to optimize the height of the step difference, including for increasing said height such as for robustness/durability, decreasing change/extent of unwanted tilting/rocking/rattling from slight diameter mismatches, and/or for providing more surface area in the interference fit with the sample tube. Additionally, it is the Examiner's position that only ordinary skill in the art is required to further smooth an upper surface of a path. In view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that the height of the step difference in DeYoung is equal to or higher than a height of an unevenness of at least one arbitrary upper surface, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to either/both increase the height of the step difference in DeYoung and/or smooth the surface of an upper surface which affects conveyance for the expected purpose of reducing the possible jostling of the sample container including detrimental jostling out from the test tube. The Examiner additionally notes that the determination of whether a wherein/whereby/adaptation or similar clause is a limitation in a claim depends on the specific facts of the case as put forth by MPEP § 2111.04. Additionally, it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham , 2 USPQ2d - 164 7 (1987). In the present case, the wherein statement is not directed to the structural limitations of the sample container, and is dependent upon the conveyance path which is an unclaimed element. Regarding claim 2, which depends on claim 1, as best understood, DeYoung reasonably teaches wherein an inner diameter (inner diameter of container section 24) B at an upper end (upper end of bottom portion of container section 24) of the bottom portion (bottom portion of container section 24) satisfies B > A + C/2 when an amount of position-misalignment of the sample container (figs. 1-6, cup 10) with respect to the test tube (figs. 4 & 5, sample tube 30 or sample tube 32) in a horizontal direction is A (Examiner notes this as intended use and that an ordinary artisan would at once envisaged the possibility of the misalignment as being vanishingly reasonably small; additional obviousness analysis provided), and an outer diameter of the sample dispensing probe (not shown) used for dispensing the sample is C (at once envisaged that the probe would be chosen as to reasonably be able to fit and extend to a substantial depth despite the angle of curvature of the cup portion; additional obviousness analysis provided) ([0047] “Thus there is an offset of the center of the 13 mm sample tube 30 relative to the center of the 16 mm sample tube 32 when both sample tubes 30 and 32 are in the same type of rack. The offset is proportional to the tube diameter and is approximately 1.8 mm for the 13 mm and 16 mm sample tubes”; [0048] “determines that a sample tube is a 13 mm tube or a 16 mm tube 32 the corresponding offset measurement is provided to the aspiration probe mechanism (not shown) to ensure that the probe descends into the serum transfer cup 10 with adequate clearance from the sidewall of the serum transfer cup, or from the sidewall of the sample tube 30 or 32”). DeYoung does not explicitly state wherein an inner diameter B at an upper end of the bottom portion satisfies B > A + C/2 when an amount of position-misalignment of the sample container with respect to the test tube in a horizontal direction is A, and an outer diameter of the sample dispensing probe used for dispensing the sample is C. However: It has been held that a mere change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP § 2144.04(IV)(A), In re Rose , 105 USPQ 237 (CCP A 1955), In re Rinehart , 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), and Gardnerv.TEC Syst., Inc. , 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the present case, it is the Examiner’s position that only ordinary skill in the art is required to change the size of the sample container, the test tube, and/or the probe. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, see MPEP § 2144.05 and In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the present case, it is the Examiner's position that only ordinary skill in the art is required to optimize position misalignment with the commonsensical motivation that decreasing misalignment is good (i.e., misalignment is generally bad, and more misalignment is generally worse), and it is further the Examiner’s position that optimizing the size of the container and/or the probe to provide adequate clearance is commonsensically useful for cooperative operability. In view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that DeYoung reasonably teaches a sample container that is operable for the probe to interact with the sample container (inclusive of meeting the claimed inequality), or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the aforementioned parameters for the aforementioned reasons. The Examiner additionally notes that the determination of whether a wherein/whereby/adaptation or similar clause is a limitation in a claim depends on the specific facts of the case as put forth by MPEP § 2111.04. Additionally, it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham , 2 USPQ2d - 164 7 (1987). In the present case, the wherein statement is not directed to the structural limitations of the sample container, and is dependent upon the particular probe as well as to the tolerance of the control thereof for alignment. Regarding claim 3, which depends on claim 1, as best understood, DeYoung reasonably teaches wherein a concentric step difference (see lower surface of flange portion comprising flange 18 with collar 20) is provided on a lower surface of the flange portion (flange portion comprising flange 18 with collar 20) (Abstract “serum transfer cup is nestable in two different size blood collection tubes such as a 13 mm diameter sample tube and a 16 mm diameter sample tube of the same axial length”; [0026] “annular support flange 18 on an enlarged neck or enlarged annular collar 20 has an outside diameter of greater magnitude than the diameter of the top edge 14 and the enlarged annular collar 20. The flange 18 thus projects radially beyond the enlarged annular collar 20”; [0029] “The serum transfer cup 10 is sized such that it can be seated or nested on the open end of a standard 13 mm blood collection tube 30 or 16 mm blood collection tube 32 (FIGS. 5A and 5B)”; [0031] “The outside diameter of the collar portion 20 is of lesser magnitude than the inside diameter of the sample tube 32 to permit easy nesting and removal of the serum transfer cup 10 from the sample tube 32”), and wherein a value obtained by dividing an outer diameter of the step difference (see lower surface of flange portion comprising flange 18 with collar 20) by an outer diameter of the bottom portion (bottom portion of container section 24) is 1.6 or more (see figures; additional obviousness analysis provided), or a gap between an inner wall of the test tube (figs. 4 & 5, sample tube 30 or sample tube 32) and an outer wall of the bottom portion (bottom portion of container section 24) is 2.3 mm or more (see figures; additional obviousness analysis provided). DeYoung does not explicitly state wherein a value obtained by dividing an outer diameter of the step difference by an outer diameter of the bottom portion is 1.6 or more, or a gap between an inner wall of the test tube and an outer wall of the bottom portion is 2.3 mm or more. However: It does not matter that the feature shown is unexplained in the specification. The drawings must be evaluated for what they reasonably disclose and suggest to one of ordinary skill in the art. See MPEP § 2125 and In re Aslanian, 590 F.2d 911, 200 USPQ 500 (CCPA 1979). In the present case, DeYoung shows the features (the Examiner notes that the Examiner measured in fig. 5, and then further used the aforementioned citations for estimating the gap). It has been held that a mere change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP § 2144.04(IV)(A), In re Rose , 105 USPQ 237 (CCP A 1955), In re Rinehart , 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), and Gardnerv.TEC Syst., Inc. , 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the present case, it is the Examiner's position that only ordinary skill in the art is required to change the size of the diameters of the flange portion as well as only ordinary skill in the art to change the size of the cup portion. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, see MPEP § 2144.05 and In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the present case, it is the Examiner’s position that only ordinary skill in the art is required to optimize the size of the diameters of the flanges for fitting the sizes of chosen test tubes, and likewise only ordinary skill in the art to optimize the size of the cup portion (and therefore the corresponding gap) for common factors such as volume and depth, especially for where there is only a small volume of sample (i.e., the smaller diameter increase the column height of the sample). Therefore, in view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that DeYoung reasonably teaches each/both of the aforementioned 1.6 diameter ratio and/or gap (as shown), or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try optimizing the dimensions for aforementioned reasons, the Examiner further emphasizing the ensuring of the proper nesting of the sample container into different size test tubes and the narrowing of the cup for increasing the column height of the sample. Regarding claim 4, which depends on claim 3, DeYoung reasonably teaches wherein corners of the step difference (see lower surface of flange portion comprising flange 18 with collar 20) are not chamfered (Examiner notes that these particular corners are shown as not chamfered; additional obviousness analysis follows). DeYoung does not explicitly state wherein corners of the step difference are not chamfered. However: It does not matter that the feature shown is unexplained in the specification. The drawings must be evaluated for what they reasonably disclose and suggest to one of ordinary skill in the art. See MPEP § 2125 and In re Aslanian, 590 F.2d 911, 200 USPQ 500 (CCPA 1979). In the present case, DeYoung shows the non-chamfered corners of the step difference and especially contrasts this to corners elsewhere that are shown & discussed as chamfered. Legal precedent has condoned the use of particular examples of what may be considered common sense or ordinary routine practice including changes in shape, see MPEP § 2141(I) & 2144.04(IV)(B), and In re Dailey , 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In the present case, it is the Examiner’s position that only ordinary skill in the art is required to have sharp angles (e.g., 90°) as opposed to chamfering. In view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that DeYoung teaches non-chamfered corners (shown as about 90° and in contrast to the labeled and clearly shown other portions of the drawing that are chamfered), or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to abstain from the additional complexity of chamfering as well as for the reasons of providing a stable fit when used with the larger diameter size of test tube. Regarding claim 5, which depends on claim 1, DeYoung teaches wherein a height of the step difference (see lower surface of flange portion comprising flange 18 with collar 20) is about 3 mm (approximation based on drawing) ([0030] “Under this arrangement the flange top surface 19 is spaced above the open end of the sample tube 30 by an amount equal to the axial height of the enlarged neck 20, from the engagement surface 31 to the annular flange 18, plus the axial thickness of the annular flange 18”). DeYoung does not teach wherein the height of the step difference is in a range of 0.5 mm to 2.0 mm. However: It has been held that a mere change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP § 2144.04(IV)(A), In re Rose , 105 USPQ 237 (CCP A 1955), In re Rinehart , 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), and Gardnerv.TEC Syst., Inc. , 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the present case, it is the Examiner's position that changing the axial height of the neck is within ordinary skill in the art. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, see MPEP § 2144.05 and In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the present case, it is the Examiner's position that the workable range of DeYoung’s neck is inclusive of smaller sizes including sizes such as 2 mm. Furthermore, choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success is obvious to try, see MPEP § 2143(I)(E). The Examiner also notes that MPEP § 2145(III)(X)(B) states “An “obvious to try” rationale may support a conclusion that a claim would have been obvious where one skilled in the art is choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. “[A] person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.” KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 538, 421,82 USPQ2d 1385, 1397 (2007).” It is the Examiner’s position that using less material to choose a smaller size merely requires common sense and has the reasonable expectation of saving money on material costs, additionally the decreased thickness also may provide a smaller profile which can be useful for analyzers where there is less room for clearance. In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to decrease the thickness/height of DeYoung’s step difference including to a height at/under 2.0 mm for the aforementioned reasons including saving on costs and/or for a smaller profile. Regarding claim 7, which depends on claim 1, as best understood, DeYoung reasonably teaches (the sample container is at least capable of use herewith) wherein, when a sample dispensing probe (not shown) used for dispensing the sample is inserted from a liquid level height E to a depth F of a dead volume sample (small amount, remainder is dead volume), a tip (tip of probe) of the sample dispensing probe (not shown) is at a predetermined distance Δ1 or more (at once envisaged; conventional practice of offsetting minimum safe clearance from bottom) from a bottom surface (bottom surface of container section 24) of the bottom portion (bottom portion of container section 24) ([0013] “It is also desirable to provide a serum transfer cup that makes maximum use of relatively small amounts of serum remaining in a blood collection tube, provides a safe clearance height up from the bottom of the inside of a serum transfer cup and allows an aspiration probe to have a safe clearance”). The Examiner acknowledges that DeYoung does not show the probe, including not showing the method of dispensing the sample by inserting the sample dispensing probe from a liquid level height E to a depth F of a dead volume sample, where a tip of the sample dispensing probe is at a predetermined distance Δ1 or more from a bottom surface of the bottom portion. However, the Examiner takes Official Notice that a probe with a tip for dispensing the sample is a conventional element in the art, and further takes Official Notice that inserting the sample dispensing probe where a tip thereof is at an offset distance from a bottom surface of the sample container is a conventional practice. Therefore, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that DeYoung reasonably teaches a conventional dispensing probe and conventional use thereof, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Examiner asserted conventional probe—including a probe having a tip—and the associated Examiner asserted conventional method of use thereof with DeYoung’s sample container for the expected utilization of said sample container for dispensing samples therefrom while maintaining a safe clearance. The Examiner additionally notes that the determination of whether a wherein/whereby/adaptation or similar clause is a limitation in a claim depends on the specific facts of the case as put forth by MPEP § 2111.04. Additionally, it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham , 2 USPQ2d - 164 7 (1987). In the present case, the wherein statement is not directed to the structural limitations of the sample container, and is dependent upon the particular probe as well as the control thereof for dispensing. Regarding claim 8, which depends on claim 1, as best understood, DeYoung reasonably teaches wherein a depth D of the bottom portion (bottom portion of container section 24) is D>E where E satisfies a liquid level height of a dead volume sample ([0008] “The serum transfer cup conserves the serum by rearranging it into a usable column of fluid that facilitates further aspiration of small amounts of serum by an aspiration probe”; [0013] “It is also desirable to provide a serum transfer cup that makes maximum use of relatively small amounts of serum remaining in a blood collection tube, provides a safe clearance height up from the bottom of the inside of a serum transfer cup and allows an aspiration probe to have a safe clearance”; additional obviousness analysis provided). The Examiner additionally notes that the determination of whether a wherein/whereby/adaptation or similar clause is a limitation in a claim depends on the specific facts of the case as put forth by MPEP § 2111.04. Additionally, it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham , 2 USPQ2d - 164 7 (1987). In the present case, the wherein statement is not directed to the structural limitations of the sample container, and is dependent upon the volume of sample that occupies a corresponding liquid level height. The Examiner emphasizes that DeYoung’s sampling container is so capable of satisfying holding a liquid level less than the depth of the bottom portion and that either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged the method of so limiting the volume of sampling to be less than the capacity of the bottom portion of sampling container, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to conventionally (i.e., Examiner is taking Official Notice of the conventionality) so limit the sampling volume according to the useful size of the sampling container for useful column that facilitates a probe . 07-21-aia AIA Claim (s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited DeYoung in view of Applicant cited Bauer et al (US 20160278680 A1; hereafter “Bauer”) . Regarding claim 6, which depends on claim 1, DeYoung teaches wherein a portion (figs. 1-5, footing portions 28) having a shape and a flat lower surface (figs. 1-5, flat ends 33) is provided on an outer periphery of the bottom portion (bottom portion of container section 24) ([0028] “footing portions 28 with flat ends 33 (FIGS. 1,2, 5A and 5B) that extend below the closed end of the serum transfer cup 10”; [0042] “The flat ends 33 of the rib footing portions 28 that extend below the closed end of the serum transfer cup 10 permit the serum transfer cup 10 to stand upright on a flat surface”). DeYoung does not teach wherein a (footing) portion has a cylindrical shape. However: Legal precedent has condoned the use of particular examples of what may be considered common sense or ordinary routine practice including changes in shape, see MPEP § 2141(I) & 2144.04(IV)(B), and In re Dailey , 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In the present case, it is the Examiner's position that only ordinary skill in the art is required to provide a conventional cylindrical footing shape. Furthermore, and as supporting factual evidence of the aforementioned assertion, Bauer teaches a sample container (Title “COLLECTION ASSEMBLY, IN PARTICULAR FOR BLOOD SAMPLES”; Abstract “sample container (2), the flange (13)”) comprising: a containing unit (figs. 1-3, collecting space 12) that contains a sample (e.g., blood) and is inserted into a test tube (fig. 3, tube 34); and a flange portion (figs. 1-3, flange 13) that is provided at an upper end of the containing unit figs. 1-3, collecting space 12) and mounted on an open end portion of the test tube (fig. 3, tube 34), wherein the containing unit (figs. 1-3, collecting space 12) has a tubular body portion (tubular portion of collecting space 12) and a cup-shaped bottom portion (bottom portion of collecting space 12) connected to the body portion (tubular portion of collecting space 12), and wherein, in the bottom portion (bottom portion of collecting space 12), an angle formed by an inner wall continuous from the body portion (bottom portion of collecting space 12) and a central axis (longitudinal axis) has a gradient of less than 20 degrees (Examiner notes that the angle of the inner wall varies and includes a portion that is less than 20 degrees as shown in figures), wherein a cylindrical portion (figs. 1-3, tubular edge 21) having a cylindrical shape (tubular) and a flat lower surface (flat lower surface of edge 21) is provided on an outer periphery of the bottom portion (bottom portion of collecting space 12). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Bauer’s cylindrical-shape for footing with DeYoung’s footing for the expected purpose of providing increased footing surface without the gaps and therefore increasing stability . 07-21-aia AIA Claim (s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited DeYoung in view of Applicant cited Ogawa* et al (JP 3185113 U; hereafter “Ogawa”) . *machine translation provided by Examiner with foreign document and utilized for English citations Regarding claim 9, which depends on claim 1, as best understood, DeYoung teaches the sample container (figs. 1-6, cup 10) according to claim 1, wherein the sample container (figs. 1-6, cup 10) contains a sample which can be analyzed, wherein, when the sample container (figs. 1-6, cup 10) is position-misaligned with respect to the test tube (figs. 4 & 5, sample tube 30 or sample tube 32) in a horizontal direction, the position-misalignment is correctable (so capable) by allowing a sample dispensing probe used for dispensing the sample to be in contact with the inner wall of the bottom portion (bottom portion of container section 24) (Examiner notes that the force on the curved wall will have a horizontal component that can allow for correction). DeYoung does not teach item 1): an automatic analyzer that analyzes the sample contained in a sample container. DeYoung does not explicitly state item 2): the method of correcting position-misalignment with respect to the test tube in a horizontal direction by allowing the sample dispensing probe used for dispensing the sample to be in contact with the inner wall of the bottom portion. Regarding item 1), Ogawa teaches an automatic analyzer (automatic analyzer; not fully shown) that analyzes a sample contained in a sample container (figs. 1-3, sample cup 11) (Background Art “In automatic analyzers and diagnostic devices, sample storage tubes such as blood collection tubes and test tubes that store samples (or specimens) such as blood are placed in the rack, and the suction probe is lowered into the sample storage tube to aspirate the sample”; first paragraph page 3 “the automatic analyzer or the automatic diagnostic device”; fifth paragraph page 3 “The sample cup 11 is, for example, an automatic analyzer or an automatic diagnostic device. When it is necessary to perform analysis or diagnosis with a small amount of sample, the sample cup 11 is opened in a sample storage tube 21 that stores a sample used in the automatic analyzer or automatic diagnostic device”), the sample container (figs. 1-3, sample cup 11) (Title “Sample Cup”; Abstract “a sample cup that can be attached to a plurality of types of sample storage tubes and can suppress displacement in the sample storage tube” and “can be engaged with an open end of a sample storage tube having a different inner diameter” and “stepped collar portion 17”) comprising: a containing unit (figs. 1-3, sample holding member 13) that contains a sample and is inserted into a test tube (fig. 3, sample storage tube 21); and a flange portion (figs. 1-3, flange portion with collar portion 17) that is provided at an upper end of the containing unit (figs. 1-3, sample holding member 13) and mounted on an open end portion of the test tube (fig. 3, sample storage tube 21), wherein the containing unit (figs. 1-3, sample holding member 13) has a tubular body portion (tubular portion comprising cylindrical portion 13a) and a cup-shaped bottom portion (figs. 1-3, cup portion 13b) connected to the tubular body portion (tubular portion comprising cylindrical portion 13a), wherein, in the cup-shaped bottom portion (cup portion comprising cup portion 13b), an angle formed by an inner wall continuous from the tubular body portion (tubular portion comprising cylindrical portion 13a) and a central axis (longitudinal axis) has a gradient of less than 20 degrees (Examiner notes that by delineating the cup-shaped bottom portion as including the edge of the tubular portion at the boundary, there is a portion starting at less than 20 degrees prior to the larger angle of cup portion 13b),wherein a concentric step difference (see step difference across stepped collar portion 17) is provided on a lower surface of the flange portion (figs. 1-3, flange portion with collar portion 17), wherein, when the sample container (figs. 1-3, sample cup 11) is position-misaligned with respect to the test tube (fig. 3, sample storage tube 21) in a horizontal direction, the position-misalignment is correctable (so capable) by allowing a sample dispensing probe (suction probe; not shown) used for dispensing the sample to be in contact with the inner wall of the cup-shaped bottom portion (cup portion comprising cup portion 13b) (Examiner notes that the force on the curved wall will have a horizontal component that can allow for correction). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Ogawa’s automatic analyzer for a sample with DeYoung’s sample for the expected advantage of being able to analyze DeYoung’s samples including through the convenience of automation which saves on costs and effort. The Examiner additionally notes that it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art, see MPEP § 2144.04(III) and In re Venner , 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958). In the present case it is the Examiner’s position that only ordinary skill in the art is required to automate a process of sampling from the sample container and analyzing. Regarding item 2), the Examiner notes that the determination of whether a wherein/whereby/adaptation or similar clause is a limitation in a claim depends on the specific facts of the case as put forth by MPEP § 2111.04. Additionally, it has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. Ex parte Masham , 2 USPQ2d - 164 7 (1987). In the present case, the wherein statement is not fully directed to the structural limitations of the sample container, and is dependent upon the control of the sample dispensing probe to manipulate the sample container. The Examiner emphasizes that the shape of DeYoung’s sample container is capable of so being manipulated by a sample dispensing probe to fix positioning/alignment of the sample container . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure. Applicant is invited to review PTO form 892 accompanying this Office Action listing Prior Art relevant to the instant invention cited by the Examiner . Examiner interviews are available via telephone 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. Any inquiry concerning this communication or earlier communications from the Examiner should be directed to DAVID L SINGER whose telephone number is 303-297-4317 . The Examiner can normally be reached Monday - Friday 8:00 am - 6:00pm CT, EXCEPT alternating Friday. If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, John Breene can be reached on 571-272-4107. 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. /DAVID L SINGER/Primary Examiner, Art Unit 2855 30MAR2026 Application/Control Number: 18/286,284 Page 2 Art Unit: 2855 Application/Control Number: 18/286,284 Page 3 Art Unit: 2855 Application/Control Number: 18/286,284 Page 4 Art Unit: 2855 Application/Control Number: 18/286,284 Page 5 Art Unit: 2855 Application/Control Number: 18/286,284 Page 6 Art Unit: 2855 Application/Control Number: 18/286,284 Page 7 Art Unit: 2855 Application/Control Number: 18/286,284 Page 8 Art Unit: 2855 Application/Control Number: 18/286,284 Page 9 Art Unit: 2855 Application/Control Number: 18/286,284 Page 10 Art Unit: 2855 Application/Control Number: 18/286,284 Page 11 Art Unit: 2855 Application/Control Number: 18/286,284 Page 12 Art Unit: 2855 Application/Control Number: 18/286,284 Page 13 Art Unit: 2855 Application/Control Number: 18/286,284 Page 14 Art Unit: 2855 Application/Control Number: 18/286,284 Page 15 Art Unit: 2855 Application/Control Number: 18/286,284 Page 16 Art Unit: 2855 Application/Control Number: 18/286,284 Page 17 Art Unit: 2855 Application/Control Number: 18/286,284 Page 18 Art Unit: 2855 Application/Control Number: 18/286,284 Page 19 Art Unit: 2855 Application/Control Number: 18/286,284 Page 20 Art Unit: 2855 Application/Control Number: 18/286,284 Page 21 Art Unit: 2855 Application/Control Number: 18/286,284 Page 22 Art Unit: 2855 Application/Control Number: 18/286,284 Page 23 Art Unit: 2855 Application/Control Number: 18/286,284 Page 24 Art Unit: 2855 Application/Control Number: 18/286,284 Page 25 Art Unit: 2855
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