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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the flat top and bottom surface, outer edge, first set of protrusions, second set of protrusions, inner surface of the frustoconical shape, bottom ring, etc., must be shown or the feature(s) canceled from the claim(s). Note that Fig. 1 does not include any reference numbers point out what the claimed elements correspond to in the Fig. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Motadel et al., (US2020/0001287; hereinafter “Motadel”) in view of Kretz (EP 1795264) and O’Brien et al., (US 2017/0210552; herein “O’Brien”).
As to claim 1, Motadel teaches a single-use, disposable container, wherein the single-use, disposable container is stackable and fluidically sealable within a fluid path comprising a liquid sample analyzer, the single-use, disposable container comprising:
(a) a material that accommodates a pressure up to about +250 kPa (polypropylene is disclosed in the instant specification as capable of accommodating a pressure up to about +250 kPa, Motadel teaches at para [0131] et seq., a pipette made of polypropylene, thus the pipette tip of Motadel is capable of accommodating a pressure up to about +250 kPa);
(b) a frustoconical shape having an open top end and open bottom end to flow liquid through the container (see Fig. 1A);
(c) a flat top surface of the open top end comprising a top ring 65, (note: the wherein clause “the flat top surface of the open top end of the container is fluidically sealable within the fluid path” is considered a mere capability and does not serve to distinguish over the prior art. It has been held that the recitation that an element is "capable of" performing a function is not a positive limitation but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. In re Hutchison, 69 USPQ 138.;
(d) a flat bottom surface of the open bottom end comprising a bottom ring 53, (again note the wherein clause to “the flat bottom surface of the open bottom end of the container is fluidically sealable within the fluid path” has not received patentable weight for the reasons delineated above);
(e) an outer surface of the frustoconical shape tapering from the inner edge of the top ring to the outer edge of the bottom ring (see Fig. 1A);
(f) a first set of spaced protrusions (reads on ribs 80, 85) on the outer surface of the frustoconical shape supporting the top ring of the flat top surface,
(note: the wherein clause “the first set of spaced protrusions are adapted to facilitate stacking and de-stacking the container” has not received patentable weight for the reasons delineated above;
(g) a second set of spaced protrusions (reads on steps 55 on the outer surface of the frustoconical shape located below the first set of spaced protrusions and above the flat bottom surface,
(note: the wherein clause “the second set of spaced protrusions minimizes surface area contact of the outer surface of the frustoconical shape with the inner surface of the frustoconical shape of an adjacent stacked container” has not received patentable weight for the reasons delineated above); and
(h) an inner surface of the frustoconical shape (see Figs 1A);
The Office has interpreted claims 1-5 as product-by-process claims, since a product-by-process claims is one in which the structural scope of the product is defined at least in part in terms of the method or process by which it is made.
In this case, the end product is defined by the following steps: “wherein the flat top surface, the flat bottom surface, and the inner surface of the frustoconical shape are polished with a surface average roughness (Ra) of not more than about 0.15 micrometers”.
Applicant is reminded that the product-by-process claim is always to a product. The reference need only to substantially meet the structure of the end product. As set forth above, the pipette of Motadel meets the structural requirements of the end product as set forth in the instant claims. Note: that a roughness not more than about 0.15 micrometers includes zero toughness which is implicitly recited in Motadel.
Note: The instant claims contain a large amount of functional language (ex: “disposable, sealable with within a fluid path comprising a liquid sample analyzer, stackable, etc.”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
In addition, the claimed “about 0.15 um” appears to be in the manufacturing tolerances of Motadel. However, if not, then it would have been obvious to one of ordinary skill in the art at the time the claimed invention was filed to have made the surface roughness of the container surfaces of Motadel at least not more than 0.15 micrometers, since Kretz teaches that in order to reduce cross-contamination in an autosampler needle to provide a polished autosampler needle which reduces undesired carry over of fluidic material. Kretz teaches it is possible to reduce the surface roughness of the hollow injector needle to a value below Ra=20 nanometers by an adequate process (for instance abrasive mechanical polishing, electrochemical polishing, electron beam polishing, etc.) Kretz teaches the advantages of having a container surface with a surface roughness of below Ra=20 nanometers is such that it does not retain the specimen after emptying thereby reducing cross-contamination or dead volume loss.
As discussed above, Motadel teaches a single-use, disposable container, wherein the single-use, disposable container is stackable and fluidically sealable within a fluid path comprising a liquid sample analyzer (note: any container can be single use and disposable). However, Motadel does not specifically teach the container having a flat bottom, a first set of spaced protrusions on the outer surface of the frustoconical shape supporting the top ring of the flat top surface, and a second set of spaced protrusions on the outer surface of the frustoconical shape located below the first set of spaced protrusions and above the flat bottom surface.
In the related art of transport and storage of containers, O’Brien teaches a single-use, disposable container, wherein the single-use, disposable container is stackable and fluidically sealable within a fluid path of dispensing system, the container comprising:
frustoconical shape having an open top end 16 and open bottom end 22 to flow liquid through the container;
a flat top surface of the open top end comprising a top ring 18, (wherein the flat top surface of the open top end of the container is fluidically sealable within the fluid path is considered an intended use/capability);
a flat bottom surface of the open bottom end comprising a bottom ring 20, (wherein the flat bottom surface of the open bottom end of the container is fluidically sealable within the fluid path is considered an intended use/capability);
an outer surface of the frustoconical shape tapering from the inner edge of the top ring to the outer edge of the bottom ring (see Fig. 4);
a first set of spaced protrusions 19 on the outer surface of the frustoconical shape supporting the top ring of the flat top surface, wherein the first set of spaced protrusions are adapted to facilitate stacking and de-stacking the container (see Fig. 1); and
a second set of spaced protrusions 24 on the outer surface of the frustoconical shape located below the first set of spaced protrusions and above the flat bottom surface, wherein the second set of spaced protrusions minimizes surface area contact of the outer surface of the frustoconical shape with the inner surface of the frustoconical shape of an adjacent stacked container; and
an inner surface of the frustoconical shape (see Fig. 6).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have substituted the configuration of Motadel with the particular container configuration of O’Brien since containers that are stackable provides the predictable advantage of being easy to transport and space savings.
Note that 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 container of O’Brien is reasonably pertinent to the particular problem with which the inventor was concerned, (i.e., stacking and storage of containers).
Note: the wherein clause “the first set of spaced protrusions are adapted to facilitate stacking and de-stacking the container” and “the second set of spaced protrusions minimizes surface area contact of the outer surface of the frustoconical shape with the inner surface of the frustoconical shape of an adjacent stacked container” has not received patentable weight for the reasons delineated above).
Note: The instant claims contain a large amount of functional language (ex: “disposable, sealable with within a fluid path comprising a liquid sample analyzer, stackable, etc.”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
For apparatus claims, if the prior art structure is capable of performing the intended use, then it meets the claim. Apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim (see MPEP § 2114 & § 2173.05(g)).
As to claims 2-5, Motadel does not explicitly disclose the container having a liquid volume of at least 20mL, a wall thickness of about 0.7 mm when measured at a location within the frustoconical shape of the container; the container height is about 58.5 mm; the top ring has an external diameter of about 51 mm; the top ring has an internal diameter of about 45 mm; the open bottom end of the container has a diameter of about 5 mm; and the container has a stacking height of about 5 mm; wherein the stacking height is defined as the distance between the flat top surface and a distal end of the first set of spaced protrusions; and wherein the surface average roughness (Ra) is from about 0.01 micrometers to about 0.15 micrometers.
However, it would have been obvious to provide a container with these specific dimensions since has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, the dimensions are considered a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed device is significant, see MPEP 2144.04 and Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine the optimum dimensions for the container.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No.12,203,954. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the instant claims and the conflicting claims lies in the fact that the conflicting claims include more elements (e.g., the container is configurable to receive a volume of liquid of at least about 20 mL; the container has a wall thickness of about 0.3 mm to about 2.0 mm when measured at a location within the frustoconical shape of the container; the container height is up to about 60 mm; the top ring has an external diameter of about 45 to about 55 mm; the top ring has an internal diameter of about 40 to about 50 mm; the open bottom end of the container has a diameter of about 3.8 mm to about 12 mm; and wherein a distance between the flat top surface and a distal end of the first set of at least two spaced protrusions is about 1.5 mm to about 10 mm) and are thus more specific. Therefore, the invention of the conflicting claims is in effect a “species” of the “generic” invention of the instant claims. It has been held that the generic invention is “anticipated” by the “species”.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
Huth et al., (US 2020/0198813) teach a storage vessel wherein, at its inner side (IS), the main body (G) has a substantially constant surface roughness, in particular an average roughness depth of less than 0.8 Rz, particularly preferably of less than 0.4 Rz.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on Monday-Thursday 5:30am-3pm EST.
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E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798