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/Restriction
Applicant’s election with traverse of group I in the reply filed on 01/16/2026 is acknowledged. Claims 75-96 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Applicant disagrees with the restriction requirement mailed 11/19/2025. Applicant traverses on grounds that it should be no undue burden on the Examiner to consider all claims in the single application.
Examiner notes that the invention of groups I and II do not relate to a single general inventive concept.
Examiner recognizes that the same corresponding technical feature is common to the groups. MPEP 1850 (II) states, in part:
Lack of unity of invention may be directly evident "a priori," i.e., before considering the claims in relation to any prior art, or may only become apparent "a posteriori," i.e., after taking the prior art into consideration. For example, independent claims to A + X, A + Y, X + Y can be said to lack unity a priori as there is no subject matter common to all claims. In the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art.
Examiner’s citation of art establishes that the common technical feature does not make over the art. As the technical feature does not define over the art, unity of invention is lacking.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/05/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 54-96 are pending with claims 54-74 being examined, claims 75-96 are deemed withdrawn. Claims 1-53 are canceled.
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 kit, three or more longitudinal protrusions, assembly, vessel, housing of the vessel and the neck of the vessel must be shown or the feature(s) canceled from the claim(s). 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 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.
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.
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 limitation “element for receiving the material sample” in claim 54 has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder “element” coupled with functional language “for receiving the material sample” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier. The term “element” is merely a generic placeholder for the term “means.”
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim 54 has/have been interpreted to cover “a porous or fibrous material” corresponding to structure described in the specification that achieves the claimed function, and equivalents thereof (Spec., Pg. 7, lines 9-10 from the bottom of the page).
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 55-74 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
As to line 14 of claim 54, recites “a preferably cylindrical shape”. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
As to line 16 of claim 54, recites “a preferably prism shape”. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
Claims 55-74 are rejected based on dependency on a rejected base claim.
As to line 2 of claim 56, recites “a preferably cylindrical shape”. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
As to line 2 of claim 57, recites “preferably has the lateral surface formed by three or more lateral faces”. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
As to line 3 of claim 58, a preferably prism shape”. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
As to line 3 of claim 59, a preferably prism shape”. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
As to line 2 of claim 60, recites “a preferably cylindrical shape”. The term "preferably" renders the claim indefinite because it is unclear whether the limitation following the term is part of the claimed invention. See MPEP § 2173.05(d).
Appropriate action is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 54-56, 60-66 and 68-74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ling (AU 2021200665 A1; hereinafter “Ling” already of record).
Regarding claim 54, Ling teaches a kit for analysis (Ling; fig. 2. 100) of a material sample for one or more analytes (Ling; page 8, lines 8-9), the kit comprising: a test device (Ling; fig. 2. 100) for receiving the material sample and for displaying the result of the analysis of the material sample (Ling; page 7, lines 12-13), and a container (Ling; fig. 2. 30) for storing a buffer fluid required for the analysis of the material sample; the test device comprises a housing configured in a shape of a tube made of the transparent material (Ling; fig. 2. 20 and page 2, lines 13-14), wherein the housing comprises a first end of the housing and a second end of the housing (Ling; fig. 1. 20 illustrates a housing with a first and second end), a locking tip connected to the first end of the housing, an assembly for receiving the material sample connected to the second end of the housing), at least one test strip (Ling; fig. 1. 50) for analysis of the material sample for the analyte and for display of the result of the analysis; a test strip holder (Ling; fig. 1. 90 and page 8. Lines 21-24 “test strip is fixed to cover 90”) for holding at least one test strip fixed inside that is located inside the housing; the assembly for receiving the material sample comprises a rod and an element for receiving the material sample (Ling; fig. 1. 11, 12), wherein the first end of the rod is connected to the second end of the housing in such a way that a portion of the rod is arranged inside the orifice of the second end of the housing (Ling; fig. 1. 11, 20); the element for receiving the material sample is mounted on the rod (Ling; page 7 lines 19-20 describes a “collecting rod”), wherein the test strip holder is configured
in a cylindrical shape (Ling. Fig. 2. 90 and page 8, lines 21-24 “test strip is fixed to cover 90”), wherein the surface of the test strip holder comprises at least one recess for holding the test strip fixed (Ling; fig. 3. 91).
Regarding claim 55, Ling teaches the kit according to claim 54 (see above), wherein the test strip holder is connected to the locking tip or to the housing (Ling; fig. 2. 20, 90).
Regarding claim 56, Ling teaches the kit according to claim 54 (see above), wherein the housing is configured in a shape of the tube in such a way that it has a preferably cylindrical shape (Ling; fig. 2. 20 and page 10, line 20).
Regarding claim 60, Ling teaches the kit according to claim 54 (see above), wherein the test strip holder is configured in a preferably cylindrical shape (Ling; fig. 2. 90), and further comprises at least one radial ring element, wherein at least one recess on the surface of the test strip holder is configured in such a way that at least one longitudinal plane is formed on the surface of the test strip holder, wherein the radial ring element is configured in such a way that slots are formed between the inner surface of the radial ring element and the surface of the longitudinal planes (Ling; fig. 5, 90 illustrates the strip holder with ring elements surrounding the strip holder and slots between the ring elements).
Regarding claim 61, Ling teaches the kit according to claim 54 (see above), wherein the test device further comprises a sealing ring arranged on an outer portion of the second end of the housing (Ling; fig. 1. 80), and further comprises a protective cap mounted on the second end of the housing in such a way that the protective cap is in contact with the sealing ring and prevents the element for receiving the material sample from contact with other objects (Ling; fig. 1. 30, 80).
Regarding claim 62, Ling teaches the kit according to claim 54 (see above), wherein the element for receiving the material sample is made of porous material or fibrous material (Ling; page 8 lines 27-28 to page 9 lines 1-2 “paper”).
Regarding claim 63, Ling teaches the kit according to claim 54 (see above), wherein the element for receiving the material sample is configured in a cylindrical shape (Ling; fig. 1. 11) with an axial channel (Ling; page 11, lines 10-11 “collecting rod has ribs 111 that to form a diversion trench”).
Regarding claim 64, Ling teaches the kit according to claim 54 (see above), wherein the element for receiving the material sample is configured in a shape of the hollow cylinder (Ling; fig. 4. 116 and page 11 line 29 “barb is hollowed out in the middle”) comprising a first end of the hollow cylinder (Ling; fig. 4, 117) and a second end of the hollow cylinder (Ling; fig. 4. end where 115 is located), wherein the first end of the hollow cylinder is configured to be open (Ling; fig. 4. 116 illustrates the barb open), the second end of the hollow cylinder is configured to be closed (Ling; fig. 4. end where 115 is located illustrates a closed end).
Regarding claim 65, Ling teaches the kit according to claim 54 (see above), wherein the first end of the rod is configured in a hook-like shape in such a way that it comprises a stop element that can be bent back when being pressed and prevents the first end of the rod from getting out from the second end of the housing (Ling; fig. 4. 116), when a portion of the rod is inside the orifice in the second end of the housing (Ling; page 12 line 15 “barb 116 is compressed and sinks into the middle cavity 20”).
Regarding claim 66, Ling teaches the kit according to claim 54 (see above), wherein the container (Ling; fig. 1. 30) comprises a vessel containing the buffer fluid (Ling; fig. 1. 40 and page 13 line 17), a receiving tip for receiving the end of the test device with the attached assembly for receiving the material sample and for holding the test device in a certain position (Ling; fig. 6. 40 illustrates an upper part of the vessel that appears to be a receiving tip for receiving the end of the test device with the attached assembly for receiving the material sample and for holding the test device in a certain position), and an impermeable membrane (Ling; fig. 1. 70); the vessel containing the buffer fluid comprises a housing of the vessel containing the buffer fluid and a neck of the vessel containing the buffer fluid (Ling; fig. 1. 40 illustrates what appears to be a neck of the vessel where the impermeable seal is placed); the impermeable membrane is configured in a shape of the disk made of impermeable material and mounted on the neck in such a way that the impermeable membrane closes the orifice in the neck and prevents the buffer fluid from being split out during transportation and storage (Ling; fig. 1. 40 the limitation was discussed above); the receiving tip is configured in a shape of the tube (Ling; fig. 6. 40 appears to be in a shape of a tube) to be mounted on the housing of the vessel containing the buffer fluid or on the outer portion of the neck of the vessel containing the buffer fluid (Ling; fig. 6).
Regarding claim 68, Lin teaches the kit according to claim 54 (see above), wherein the outer portion of the second end of the housing comprises two retaining collars for holding the sealing ring arranged on the outer portion of the second end of the housing (Ling; fig. 3. 80 area around sealing ring appears to illustrate retaining collars for holding the sealing ring).
Regarding claim 69, Ling teaches the kit according to claim 54 (see above), wherein the analyte or analytes are preferably selected from the group of substances consisting of antigens, antibodies, hormones, antibiotics, addictive substances, vitamins, disease markers, markers of allergic reactions, food quality markers, and the like (Ling; page 8 line 20 “drugs of abuse”).
Regarding claim 70, Ling teaches the kit according to claim 69 (see above), wherein the antigens and antibodies are antigens of viruses and antibodies to viruses, such as influenza viruses, coronaviruses, adenoviruses, human respiratory syncytial virus, HIV, hepatitis viruses, Epstein-Barr virus, Zika virus, dengue fever viruses, chikungunya fever virus, rubella virus, human cytomegalovirus, herpes viruses, and the like.
This limitation recited an intended use of the claimed invention since the limitation does not further structurally limit the invention as claimed. Ling further teaches analyzing various analytes (Ling; page 8 lines 1-9). Thus, it is fully expected that the apparatus of Ling can be used with the claimed analytes. Therefore, Ling meets the structural limitations of the claim (see MPEP 2114).
Regarding claim 71, Ling teaches the kit according to claim 69 (see above), wherein the hormones are preferably selected from the group of substances consisting of chorionic gonadotropin, luteinizing hormone, follicle- stimulating hormone, protein-1 that binds insulin-like growth factor, thyroid-stimulating hormone, thyroxine, triiodothyronine, and the like.
This limitation recited an intended use of the claimed invention since the limitation does not further structurally limit the invention as claimed. Ling further teaches analyzing various analytes (Ling; page 8 lines 1-9). Thus, it is fully expected that the apparatus of Ling can be used with the claimed analytes. Therefore, Ling meets the structural limitations of the claim (see MPEP 2114).
Regarding claim 72, Ling teaches the kit according to claim 69 (see above), wherein the addictive substances are preferably selected from the group of substances consisting of cannabinoids, synthetic cannabinoids, morphine, ecstasy, barbiturates, benzodiazepines, cocaine, amphetamine, methamphetamine, mephedrone, tramadol, oxycodone, pregabalin, tricyclic antidepressants, zopiclone, and the like.
This limitation recited an intended use of the claimed invention since the limitation does not further structurally limit the invention as claimed. Ling further teaches analyzing various analytes (Ling; page 8 lines 1-9). Thus, it is fully expected that the apparatus of Ling can be used with the claimed analytes. Therefore, Ling meets the structural limitations of the claim (see MPEP 2114).
Regarding claim 73, Ling teaches the kit according to claim 69 (see above), wherein the diseases are preferably respiratory diseases, infectious diseases, sexually transmitted diseases, hormonal diseases, transmissible diseases, infections of the gastrointestinal tract, cardiovascular diseases, diseases of any organs, kidney diseases, liver diseases, and the like.
This limitation recited an intended use of the claimed invention since the limitation does not further structurally limit the invention as claimed. Ling further teaches analyzing various analytes (Ling; page 8 lines 1-9). Thus, it is fully expected that the apparatus of Ling can be used with the claimed analytes. Therefore, Ling meets the structural limitations of the claim (see MPEP 2114).
Regarding claim 74, Ling teaches the kit according to claim 69 (see above), wherein the allergic reactions are preferably reactions to such factors as drugs, food, milk protein, gluten, egg white, seafood, peanuts, animals, cat hair, dog hair, pollen, ragweed pollen, fungus, mold, and the like.
This limitation recited an intended use of the claimed invention since the limitation does not further structurally limit the invention as claimed. Ling further teaches analyzing various analytes (Ling; page 8 lines 1-9). Thus, it is fully expected that the apparatus of Ling can be used with the claimed analytes. Therefore, Ling meets the structural limitations of the claim (see MPEP 2114).
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.
Claims 57-59 are rejected under 35 U.S.C. 103 as being unpatentable over Ling (AU 2021200665 A1; hereinafter “Ling” already of record).
Regarding claims 57, Ling teaches the kit according to claim 54 (see above), wherein the housing is configured in a shape of the tube (Ling; fig. 1. 20) in such a way that it preferably has the lateral surface formed by three or more lateral faces, each of which is a rectangle or parallelogram. Ling teaches the housing (test cavity 20) can be designed in various shapes (Ling; page 10 lines 17-187).
However, without some statement of criticality or unexpected results, it would have been obvious to one of ordinary skill in the art at the time the invention was made to configure the shape of the tube to be formed by three or more lateral faces to allow for more area inside the housing.
Regarding claim 58, Ling teaches the kit according to claim 54 (see above), wherein the test strip holder comprises the central longitudinal element (Ling; fig. 4. 115), three longitudinal protrusions (Ling; fig. 4. 12), and one radial ring element (Ling; fig. 4. 121).
Ling does not explicitly teach the radial ring element is configured to form three slots. It would have been obvious to one of ordinary skill in the art to modify the ring element to form three slots in order to provide connection with the barb illustrated in fig. 4.116).
Ling does not explicitly teach the central longitudinal element is configured in a preferably prism shape with three lateral edges and the lateral surface formed by three lateral faces.
However, without some statement of criticality or unexpected results, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have the central longitudinal element to have a prism shape with three lateral edges and the lateral surface formed by three lateral faces to allow for more area inside the central longitudinal element. It was held in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) that the shape was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape was significant. (see MPEP 2144.04(IV)(B)).
Regarding claim 59, Ling teaches the kit according to claim 54 (see above), wherein the test strip holder comprises the central longitudinal element (Ling; fig. 4. 115), four longitudinal protrusions (Ling; fig. 4. 112, 113, 114, 118) and one radial ring element (Ling; fig. 4. 121).
Ling does not explicitly teach the radial ring element is configured to form four slots. It would have been obvious to one of ordinary skill in the art to modify the ring element to form four slots in order to provide connection with the barb illustrated in fig. 4.116).
Ling does not explicitly teach the central longitudinal element is configured in a preferably prism shape with four lateral edges and the lateral surface formed by four lateral faces.
However, without some statement of criticality or unexpected results, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have the central longitudinal element to have a prism shape with four lateral edges and the lateral surface formed by four lateral faces to allow for more area inside the central longitudinal element. It was held in re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) that the shape was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular shape was significant. (see MPEP 2144.04(IV)(B)).
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Ling (AU 2021200665 A1; hereinafter “Ling” already of record) in view of Loudermilk et al. (US 20200383664 A1; hereinafter “Loudermilk”).
Regarding claim 67, Ling teaches the kit according to claim 54 (see above) to include a second end of the housing (see above).
Ling fails to teach the outer portion of the second end of the housing comprises a sealing collar.
However, Loudermilk teaches the analogous art of an analysis of a material of a sample (Loudermilk; Title) that includes a housing (Loudermilk; fig. 6A. 5A) and a sealing collar on a first and second end (Loudermilk; fig. 6B. 9A, 11A) wherein the outer portion of the second end of the housing comprises a sealing collar (Loudermilk; fig. 1. 9A).
To one of ordinary skill in the art before the effective filing date of the invention it would have been obvious to modify Ling’s second end of the housing to include a sealing collar as taught by Loudermilk because Loudermilk teaches an analysis of a material of a sample (Loudermilk; Title) that includes a housing (Loudermilk; fig. 6A. 5A) and a sealing collar on a first and second end (Loudermilk; fig. 6B. 9A, 11A) wherein the outer portion of the second end of the housing comprises a sealing collar (Loudermilk; fig. 1. 9A).
This modification allows for a seal between the inner surface of the receiving tip and the housing.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX RAMIREZ whose telephone number is (571)272-9756. The examiner can normally be reached Monday - Friday 8:00 - 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.R./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798