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 .
Election/Restrictions
Applicant did not specifically state what species they are electing in the response filed on 3/9/2026. However, applicant stated that they request the Examiner to broaden the search to encompass the remaining species of Claim 32. Therefore, the examiner interprets that applicant has elected Species A-1, claim 31. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim 32 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: transfer means in claim 13 and opener means in claim 20.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 14-31 are objected to because of the following informalities: Claims 14-31 should start with “The” so it should read “The apparatus according to claim 13…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18 and 29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites “in which a disc which operates as a tight sliding fit in a bore in the test container, in which the disc is connected by a connecting rod to a hand grip.” This limitation currently does not positively recite the disc, the bore, the connecting rod nor the hand grip, however, the claim is phrase in such a way that it appears to be the intent to positively recite the disc, bore, connecting rod and the hand grip and is therefore unclear.
Claim 29 recites the limitation "the opener means" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 13-16, 19-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2010/0079751, hereinafter Porat.
Regarding claim 13, Porat teaches apparatus for testing a liquid specimen (items 22 and 310), which apparatus comprises: (i) a collection container (item 22) for collecting the liquid specimen (paragraph [0083]); (ii) a test container (item 310) for testing the liquid specimen; (iii) response portions (item 319) which are in the test container (figure 12A) and which are for responding to contact with the liquid specimen to give at least one test result (paragraph [0144]); and (iv) transfer means (items 24 and 312 and paragraph [0141]) which enables the collection container to be connected to the test container for transferring at least some of the liquid specimen from the collection container to the test container such that the transferred liquid specimen is able to contact the response portions in the test container and enable the response portions to react to the liquid specimen for the testing (paragraph [0144]), and characterised in that: (v) the apparatus is such that the liquid specimen is transferred from the collection container to the test container by suction (paragraph [0144]); and (vi) the apparatus is such that the liquid specimen that is transferred to the test container remains in the test container (figure 1E).
Regarding claim 14, Porat teaches in which the transfer means enables the collection container to be separated from the test container, whereby the liquid specimen that has been transferred to the test container is able to be tested without the collection container being present (paragraph [0142]).
Regarding claim 15, Porat teaches in which the liquid specimen can be tested in the test container while the test container remains connected to the collection container (paragraph [0142]).
Regarding claim 16, Porat teaches in which the test container is sealable after the collection chamber has been separated from the test container (paragraph [0142]).
Regarding claim 19, Porat teaches in which the suction is a suction which is formed in the test container during manufacture of the apparatus (paragraph [0142]).
Regarding claim 20, Porat teaches in which the transfer means is operable to enable access to the suction in the test container (paragraph [0142]), and in which the transfer means comprises an opener means (item 24) and a sealable diaphragm (item 312) which is for receiving the opener means (paragraph [0147]).
Regarding claim 21, Porat teaches in which the sealable diaphragm (item 312) is made of a rubber material (paragraph [0142]).
Regarding claim 22, Porat teaches in which the opener (item 24) means is in the form of a hollow needle paragraph [0083]) with a pointed end (figure 1E) which can penetrate the sealable diaphragm when the test container is connected to the collection chamber (paragraph [0147]).
Regarding claim 23, Porat teaches in which the transfer means comprises a conduit for dipping into the liquid specimen (figure 1E, the lower portion of item 24 sticking into the liquid).
Regarding claim 24, Porat teaches in which the transfer means comprises a first part (item 312) and a second part (item 21), in which the first part and the second part are connectable together to form a sealed connection (paragraph [0147]), and in which the first part and the second part are separable from each other to enable the test container to be separated from the collection container after the test container has been provided with the liquid specimen from the collection container (paragraph [0142]).
Regarding claim 25, Porat teaches in which the first part is a short tubular portion (item 312) which contains a sealable diaphragm (item 312) and in which the second part (item 21) is in the form of a recessed portion (figure 1E) which depends from a lid forming part of the collection container (figure 1E).
Regarding claim 26, Porat teaches in which the second part is integrally formed with a flat part of the lid (figure 1E), whereby liquid specimen remaining in the collection container cannot escape from the collection container (figure 1E).
Regarding claim 27, Porat teaches in which the first and second parts are connected together by a push fit (paragraph [0148]).
Regarding claim 28, Porat teaches in which the collection container (item 22) comprises a lid (item 21) and a body portion (item 22), and in which the lid is a removable lid which is a screw fit on the body portion (figure 1E).
Regarding claim 29, Porat teaches in which when the lid is on the body portion (figure 1E), the liquid specimen is able to leave the collection container and enter the test container via the opener means (figure 1E).
Regarding claim 30, Porat teaches in which a plurality of response portions are arranged in a line (figure 12A).
Regarding claim 31, Porat teaches in which the collection container which is an open collection container (when item 21 is off of item 22, the container is considered to be opened).
Claim(s) 13-16, 19, 20, 23, 24, 27-31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2003/0021727, hereinafter Weyker.
Regarding claim 13, Weyker teaches apparatus for testing a liquid specimen (abstract), which apparatus comprises: (i) a collection container (item 4) for collecting the liquid specimen (paragraph [0027]); (ii) a test container (item 1) for testing the liquid specimen (paragraph [0027]); (iii) response portions (the portion of item 39 which displays the result) which are in the test container (paragraph [0033]) and which are for responding to contact with the liquid specimen to give at least one test result (paragraph [0033]); and (iv) transfer means (the lower portion of item 39) which enables the collection container to be connected to the test container for transferring at least some of the liquid specimen from the collection container to the test container such that the transferred liquid specimen is able to contact the response portions in the test container and enable the response portions to react to the liquid specimen for the testing (paragraph [0033]), and characterised in that: (v) the apparatus is such that the liquid specimen is transferred from the collection container to the test container by suction (functional limitation, MPEP § 2114 and is taught in paragraph [0033] as the capillary action); and (vi) the apparatus is such that the liquid specimen that is transferred to the test container remains in the test container (paragraph [0033]).
Regarding claim 14, Weyker teaches in which the transfer means enables the collection container to be separated from the test container (paragraph [0038]), whereby the liquid specimen that has been transferred to the test container is able to be tested without the collection container being present (paragraph [0038]).
Regarding claim 15, Weyker teaches in which the liquid specimen can be tested in the test container while the test container remains connected to the collection container (intended use MPEP § 2114 (II) and is taught in paragraph [0037]).
Regarding claim 16, Weyker teaches the test container is sealable after the collection chamber has been separated from the test container (a cover would be able to be put over the test container thereby sealing the test container).
Regarding claim 19, Weyker teaches in which the suction is a suction which is formed in the test container during manufacture of the apparatus (paragraph [0033], the pore size provides the suction and therefore formed during manufacture).
Regarding claim 20, Weyker teaches in which the transfer means is operable to enable access to the suction in the test container (paragraph [0033]), and in which the transfer means comprises an opener means (the end of item 1) and a sealable diaphragm (item 3) which is for receiving the opener means (paragraph [0037]).
Regarding claim 23, Weyker teaches in which the transfer means comprises a conduit for dipping into the liquid specimen (figure 5).
Regarding claim 24, Weyker teaches in which the transfer means (items 1 and 2) comprises a first part (item 1) and a second part (item 2), in which the first part and the second part are connectable together to form a sealed connection (figure 5), and in which the first part and the second part are separable from each other to enable the test container to be separated from the collection container after the test container has been provided with the liquid specimen from the collection container (paragraph [0038]).
Regarding claim 27, Weyker teaches in which the first and second parts are connected together by a push fit (paragraph [0034]).
Regarding claim 28, Weyker teaches in which the collection container (item 4) comprises a lid (item 2) and a body portion (item 4), and in which the lid is a removable lid which is a screw fit on the body portion (paragraph [0036]).
Regarding claim 29, Weyker teaches in which when the lid is on the body portion, the liquid specimen is able to leave the collection container and enter the test container via the opener means (paragraph [0033]).
Regarding claim 30, Weyker teaches in which a plurality of response portions are arranged in a line (figure 7).
Regarding claim 31, Weyker teaches in which the collection container which is an open collection container (figure 1, when item 2 is off).
Claim(s) 13, 15, 17, 18, 20, 23, 28, 29 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 2724003, hereinafter Yang.
Regarding claim 13, Yang teaches apparatus for testing a liquid specimen (figure 1), which apparatus comprises: (i) a collection container (items 1 and 2) for collecting the liquid specimen (abstract); (ii) a test container (item 4) for testing the liquid specimen (abstract); (iii) response portions (different portions of item 46) which are in the test container (figure 3) and which are for responding to contact with the liquid specimen to give at least one test result (abstract); and (iv) transfer means (items 5, 7, 44 and 45) which enables the collection container to be connected to the test container (figure 2) for transferring at least some of the liquid specimen from the collection container to the test container such that the transferred liquid specimen is able to contact the response portions in the test container and enable the response portions to react to the liquid specimen for the testing (figures 2 and 3), and characterised in that: (v) the apparatus is such that the liquid specimen is transferred from the collection container to the test container by suction (functional limitation, MPEP § 2114 and is taught in the abstract); and (vi) the apparatus is such that the liquid specimen that is transferred to the test container remains in the test container (abstract and figure 3).
Regarding claim 15, Yang teaches the liquid specimen can be tested in the test container while the test container remains connected to the collection container (abstract).
Regarding claim 17, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Yang and the apparatus of Yang is capable of having the suction provided by a syringe. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Yang (see MPEP §2114). Further, this limitation is taught in the abstract of Yang.
Regarding claim 18, Yang teaches in which a disc (item 44) which operates as a tight sliding fit in a bore in the test container (figure 3), in which the disc is connected by a connecting rod (the rod of item 45) to a hand grip (the top of item 45), and in which if the hand grip is pulled upwardly then a suction is formed in the test container (abstract).
Regarding claim 20, Yang teaches in which the transfer means is operable to enable access to the suction in the test container (figures 2 and 3), and in which the transfer means (item 7) comprises an opener means (item 5) and a sealable diaphragm (item 7) which is for receiving the opener means (figure 2).
Regarding claim 23, Yang teaches in which the transfer means comprises a conduit (item 5) for dipping into the liquid specimen (figure 2).
Regarding claim 28, Yang teaches in which the collection container (items 1 and 2) comprises a lid (item 2) and a body portion (item 1), and in which the lid is a removable lid which is a screw fit on the body portion (abstract).
Regarding claim 29, Yang teaches in which when the lid is on the body portion (figure 2), the liquid specimen is able to leave the collection container and enter the test container via the opener means (item 5 and figure 2).
Regarding claim 31, Yang teaches in which the collection container which is an open collection container (abstract, when item 2 is off of the container).
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.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weyker in view of United States Application Publication No. 2002/0001854, hereinafter Lee.
Regarding claim 16, Weyker teaches all limitations of claim 13; however, if it is determined that Weyker fails to teach the test container is sealable after the collection chamber has been separated from the test container.
Lee teaches an analyte assay device which has a protective cap to seal the protruding ends of the analyte test strips from exposure while not in use (Lee, paragraph [0008]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a protective cap (sealing the test container) because it would seal the protruding ends of the analyte test strips from exposure while not in use (Lee, paragraph [0008]).
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.
Claim 14 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of copending Application No. 18/268194 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim anticipates or renders obvious the examined claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
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