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
Newly amended claims 2-4, 7-11, and 13 are directed to inventions that are independent or distinct from the invention originally claimed for the following reasons:
Inventions I (claims 1, 6, 12, and 14) and II (claims 2 and 7-11) are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus, Invention I, can perform a different process such as measuring protein in a sample other than stool (such as urine), as the apparatus does not require stool containing alkaline phosphatase as required by Invention II.
Inventions I and III (claim 3) are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus, Invention I, can perform a different process such as measuring protein in a sample other than stool (such as urine), as the apparatus does not require stool containing alkaline phosphatase as required by Invention III.
Inventions I and IV (claim 4) are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus, Invention I, can perform a different process such as measuring protein in a sample other than stool (such as urine), as the apparatus does not require stool containing alkaline phosphatase as required by Invention IV.
Inventions I and V (claim 13) are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus, Invention I, can perform a different process such as measuring protein in a sample other than stool (such as urine), as the apparatus does not require stool containing alkaline phosphatase as required by Invention V.
Inventions II and III are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design. Invention III requires taking a photograph; quantifying pixels of the photograph; and comparing the number of pixels of the photograph of the chromatography paper with pixels of photographs of standards of alkaline phosphatase, which are not included in Invention II, and Invention II requires comparing the developed color with photographs of standards of alkaline phosphatase, which is not included in Invention III. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions II and IV are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design. Invention IV requires taking a photograph; comparing the photograph of the chromatography paper with photographs of standards of alkaline phosphatase; and wherein the comparison is performed by a computer program for image similarity analysis, which are not included in Invention II, and Invention II requires comparing the developed color with photographs of standards of alkaline phosphatase, which is not included in Invention IV. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions II and V are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design. Invention V requires taking a photograph; counting pixels of the photograph; and performing similarity analysis of the photograph, which are not included in Invention II. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions III and IV are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design. Invention III requires quantifying pixels of the photograph and comparing the number of pixels of the photograph of the chromatography paper with pixels of photographs of standards of alkaline phosphatase, which are not included in Invention IV, and Invention IV requires comparing the photograph of the chromatography paper with photographs of standards of alkaline phosphatase and wherein the comparison is performed by a computer program for image similarity analysis, which is not included in Invention III. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions III and V are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design. Invention III requires quantifying pixels of the photograph and comparing the number of pixels of the photograph of the chromatography paper with pixels of photographs of standards of alkaline phosphatase, which are not included in Invention V, and Invention V requires performing similarity analysis of the photograph, which is not included in Invention III. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions IV and V are directed to related processes. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different design. Invention IV requires comparison performed by a computer program for image similarity analysis, which is not included in Invention V, and Invention V requires counting pixels of the photograph, which is not included in Invention IV. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 2-4, 7-11, and 13 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. The originally presented claims were directed to a device and kit and not a process.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments filed 1/20/2026 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Applicant argues on pp. 2 and 5-6 of Applicant’s Response that the device of Mendoza Montero et al. does not provide any structure to quantify the concentration of an analyte in accordance with the amendments to claim 1, as newly amended claim 1 recites photographs of standards of alkaline phosphatase on the upper panel (lid). The Examiner agrees; however, it would have been obvious to modify the device of Mendoza Montero et al. to include photographs of standards, as will be discussed in further detail in the 35 USC § 103 section below.
Claims 4-14 were previously objected to because they depended on a multiple dependent claim (claims 4-14 depend on claim 3 which is multiple dependent). Applicant’s amendments to the claims have overcome the objections and accordingly, the objections to claims 4-14 have been withdrawn.
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 1 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 1 and 14 recite the broad recitation ", and the claims also recites " which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 1 recites the limitation "the photographs of standards of alkaline phosphatase" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 is directed to a use of a kit and recites both apparatus limitations and method step limitations. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite (MPEP § 2173.05(p)).
Dependent claims are rejected for the same reason as the base claim(s) upon which they depend.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 14 remains rejected under 35 U.S.C. 101 because the claimed invention is directed to non- statutory subject matter (Applicant did not correct this). The claim does not fall within at least one of the four categories of patent eligible subject matter because the claim is directed to “The use of the kit”. It has been held that “use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101, and “use” claims are improper definitions of a process (MPEP § 2173.05(q)). Therefore, it is recommended that claim 14 be amended to recite a process in order to fall within at least one of the four categories of patent eligible subject matter, however this could warrant the claim being non-elected by original presentation.
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.
Claims 1, 6, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mendoza Montero et al. (US 2015/0050720 A1) (already of record) in view of Malo (US 2016/0201110 A1) (already of record).
Regarding claim 1, Mendoza Montero et al. teaches an in vitro device capable of measuring stool alkaline phosphatase, wherein the device comprises a bottom panel (Fig. 1 2 cover) containing a well (Fig. 1 21 third concavity) capable of holding stool, an upper panel (lid) (Fig. 1 1 first bodies) to which is attached a strip of chromatography paper (Fig. 1 7 test strip) impregnated with a substrate (para. 0061), the upper lid containing a hole (Fig. 1 10 first concavity) capable of making the chromatography paper visible.
Mendoza Montero et al. does not teach a device comprising photographs of standards of alkaline phosphatase. However, Malo teaches a kit comprising photographs of standards to compare the color of the stool sample and quantify the amount of alkaline phosphatase in the sample (para. 0044). It would have been obvious to a person of ordinary skill in the art to use the Malo configuration of photographs of standards of alkaline phosphatase in Mendoza Montero et al.’s device with a reasonable expectation that it would allow comparison of the sample with the photographs to quantify the amount of alkaline phosphatase in the sample. This method for improving Mendoza Montero et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Malo. Therefore, 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 teachings of Mendoza Montero et al. and Malo to obtain the invention as specified in claim 1.
Regarding claim 6, Mendoza Montero et al. teaches a device comprising a test strip (Fig. 1 7 test strip) that can be replaced by any support having binding elements (para. 0061), but does not explicitly teach blotting paper, nylon, or a nitrocellulose membrane. However, Malo teaches that nylon and nitrocellulose membranes are known in the art (claim 352).
It would have been obvious to a person of ordinary skill in the art to use nylon or a nitrocellulose membrane in Mendoza Montero et al.’s device because the substitution of one known element for another would have predictably resulted in a substrate for attaching a biological sample (para. 0052) with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the test strip of Mendoza Montero et al. with the teachings of Malo to obtain the invention as specified in claim 6.
Regarding claim 12, Mendoza Montero et al. teaches a kit (abstract “kit comprising such a device”) containing any or all of the following: a device capable of measuring stool alkaline phosphatase (abstract “device for detection of analytes in affinity bioassays”), substrate for alkaline phosphatase, buffer for alkaline phosphatase reaction, gloves, spatula, stool collection pot and information on how to perform alkaline phosphatase assay using the kit.
Regarding the preamble limitation of the apparatus being a device for measuring stool alkaline phosphatase, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims (MPEP § 2115). Therefore, the apparatus disclosed by Mendoza Montero et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be a detection device for bioassays (abstract) and would be structurally capable of measuring stool alkaline phosphatase.
Regarding claim 14, Mendoza Montero et al. teaches a kit (abstract “kit comprising such a device”) containing any or all of the following: a device for measuring stool alkaline phosphatase (abstract “device for detection of analytes in affinity bioassays”), substrate for alkaline phosphatase, buffer for alkaline phosphatase reaction, gloves, spatula, stool collection pot and information on how to perform alkaline phosphatase assay using the kit.
Regarding the preamble limitation of the apparatus being a device for measuring stool alkaline phosphatase, the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims (MPEP § 2115). Therefore, the apparatus disclosed by Mendoza Montero et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be a detection device for bioassays (abstract) and would be structurally capable of measuring stool alkaline phosphatase.
Conclusion
This action is a final rejection and closes the prosecution of this application. Applicant’s reply under 37 CFR 1.113 to this action is limited to an appeal to the Patent Trial and Appeal Board, an amendment complying with the requirements set forth below, or a request for continued examination (RCE) to reopen prosecution where permitted. Please note that the Office also offers initiatives that are available to applicants after the close of prosecution. See https://www.uspto.gov/patents/initiatives/uspto-patent-applications-iniatives-timeline for more information.
General information on the Patent Trial and Appeal Board is available at: www.uspto.gov/patents/ptab. The information at this page includes guidance on time limited options that may assist the applicant contemplating appealing an examiner’s rejection. It also includes information on pro bono (free) legal services and advice available for those who are under-resourced and considering an appeal at: https://www.uspto.gov/patents/ptab/free-legal-assistance. The page is best reviewed promptly after applicant has received a final rejection or the claims have been twice rejected because some of the noted assistance must be requested within one month from the date of the latest rejection. See MPEP § 1204 for more information on filing a notice of appeal.
If applicant should desire to appeal any rejection made by the examiner, a Notice of Appeal must be filed within the period for reply. The Notice of Appeal must be accompanied by the fee required by 37 CFR 41.20(b)(1). The current fee amount is available at: www.uspto.gov/Fees.
If applicant should desire to file an after-final amendment, entry of the proposed amendment cannot be made as a matter of right unless it merely cancels claims or complies with a formal requirement made in a previous Office action. Amendments touching the merits of the application which otherwise might not be proper may be admitted upon a showing of good and sufficient reasons why they are necessary and why they were not presented earlier.
A reply under 37 CFR 1.113 to a final rejection must include cancellation of or appeal from the rejection of, each rejected claim. The filing of an amendment after final rejection, whether or not it is entered, does not stop the running of the statutory period for reply to the final rejection unless the examiner holds all of the claims to be in condition for allowance.
If applicant should desire to continue prosecution in a utility or plant application filed on or after May 29, 2000 and have the finality of this Office action withdrawn, an RCE under 37 CFR 1.114 may be filed within the period for reply. See MPEP § 706.07(h) for more information on the requirements for filing an RCE.
The application will become abandoned unless a Notice of Appeal, an after final reply that places the application in condition for allowance, or an RCE has been filed properly within the period for reply, or any extension of this period obtained under either 37 CFR 1.136(a) or (b).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
Examiner interviews are available via telephone, in-person, 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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. 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.
/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799