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 .
Detailed Action
Summary
This is the Final Office Action based on application 18/331313 response filed 11/19/2025.
Claim 21-24, 26-30 & 34 have been examined and fully considered.
Claims 1-20, 25, & 31-33 are cancelled.
Claims 35-39 have been newly added. However, the invention of claims 21-24, 26-30 & 34 is elected by original presentation. Therefore, claims 35-39 are withdrawn.
Election/Restrictions
Newly submitted claims 35-39 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Additional Claim 35 is drawn towards a package containing a plurality of the claimed tissues testers. Though the plurality of testers is just duplication of the claimed singular tester, the package is an additional part/parts and a package adds more in a way which make the claimed device different and search burdensome were the examiner to search all inventions.
Additional Claims 36-39 is drawn towards a method for indicating presence of bacterial infection. This is drawn towards a different statutory category of invention in comparison to the claim device/tissue tester. Therefore, search burdensome were the examiner to search all inventions.
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 Accordingly, claims 35-39 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
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.
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 21-24, 26-30 & 34 are rejected on the ground of non-statutory double patenting as being unpatentable over claims 1- 6 of U.S. Patent No. 11053531 in view of RHODIUM, LANGE and HENDRIX and shown below.
U.S. Patent No. 11053531 teaches a tester for indicating whether a subject has a bacterial infection based on a sample of respiratory secretion of the subject, the tester comprising: a paper having a portion comprising turmeric, wherein the paper has a caliper of about 3 to about 6 (1 ply, mil), and one or more of: (a) a basis weight of about 20 to about 30 on a #500 scale; (b) an average tensile strength of about 10 to about 20 #/in; (c) a porosity of about 2 to about 4 (8 ply, 100 cc, sec.); (d) a moisture content of about 2% to about 10% by weight of the total paper; (e) a brightness of about 70% to about 90%; and/or (f) a stretch of about 1% to about 5% of the total dimensions of the paper.
U.S. Patent No. 11053531 does not teach of the tester having alcohol mixed with the turmeric to form a solution.
However, RHODIUM teaches of this as shown below ( in addition to the teaches of LANGE and HENDRIX). It would have been obvious to one of ordinary skill in the art to mix the turmeric indicator with an alcohol as is done in RHODIUM due to the advantage this offers for solutionizing an otherwise solid compound/powder (turmeric), and therefore allowing for easier impregnation/incorporation into strip device.
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 21-24, 26-30 & 34 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.
With respect to Claim 21, it is unclear because a device is claimed, but a conditional detection is also claimed, “wherein when the solution treated tester paper changes color…” The claim does not and should not contain detection limitations since it is a device and not a method. However the “wherein when,” limitation makes the claim unclear as to whether there is a structural limitation within the “wherein when,” clause and if it is only conditional---the color change--- or if there is another claimed structural difference.
Claims 21-24, 26-30 & 34 are rejected as being unclear by virtue of being dependent on Claim 21.
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.
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 21-24, 26-30 & 34 are rejected under 35 U.S.C. 103 as being obvious over RHODIUM in Making of pH Indicators (cited on notice of references for parent case 13/970932) in view of LANGE in US 3802842 in further view of HENDRIX in US 20060116334.
With respect to Claim 21, RHODIUM teaches of a method and a lab for making pH indicators (abstract). RHODIUM further teach of making a turmeric indicator by mixing turmeric with alcohol and teaches of making the turmeric indicator solution into an indicator paper test strip and allowing the turmeric/ alcohol solution to dry on the paper (Page 3- also see where talks about the cabbage test strips). More specifically, RHODIUM teaches of using coffee filters as the paper (Page 4, cabbage indicator paper section).
Specifically, RHODIUM teach of adding ¼ teaspoon of turmeric to 4 tablespoons of rubbing alcohol (3 teaspoons in 1 tablespoon= ratio of .25/12) = which reads on the instantly claimed ratio of “about,” 20ml turmeric /237 ml in Claim 26) to a solution and then onto a paper (Page 3, Solution # 3).
RHODIUM teaches that the turmeric indicator solution stays yellow in the presence of acids and changes to purple/brown in the presence of bases or that the paper turns to bright red in the presence of bases (Page 3, turmeric indicator solution #3). RHODIUM does not call out that the indicator paper can indicate presence of a respiratory secretion- or that there is color change specifically based on pathogen presence, however since RHODIUM teaches that the paper changes color based on the presence of what is in the sample and uses the sample indicator compound turmeric as instantly claimed—it would be capable of the claimed intended use of using it to indicate a bacterial infection in a respiratory sample. The examiner notes that this is a capability and intended use of the solution/indicator taught in RHODIUM. Since RHODIUM does not call out the tissue tester itself though or the two layers of “tissue,” paper affixed thereto the claimed tester paper, LANGE is used to remedy this.
LANGE teach of a tissue tester for providing an indication of the presence of disease/pathological components(pathogen)(Column 1, lines 6-23): “reagent papers have been in use for a long time, pH indicator papers being the most widely used but other reagent papers are also employed: for example, curcuma paper(paper impregnated with curcuma, the active ingredient in turmeric) is used for the detection of acids…test papers have also achieved considerable importance in the field of clinical chemistry.”
LANGE et al. also teach of testing body fluids(abstract) (which can read on what applicant is instantly claiming, of testing a respiratory secretion/breath sample). They permit the rapid, easy and semi-quantitative determination of pathological components, such as glucose, protein, and the like, in body fluids, such as urine, serum, and the like (Column 1, lines 5-23).
LANGE teach of a tissue tester for providing an indication of the presence of disease/pathological components(pathogen) (Column 1, lines 6-23) in a bodily fluid. The claimed use of the tester on a respiratory secretion in a subject that has bacterial infection is intended use for the claimed device and therefore not limiting for the device claim. The device taught by the prior art as shown above for claim 1 is capable of this intended use.
LANGE further teaches that the tissue tester comprises a holder, 2 which can be made of paper or cardboard (Column 3, lines 37-42). LANGE teaches that an adhesive layer is on the holder, and then a meshwork 1 is on top of the adhesive layer in some places on the tester and in others, there is an indicator layer 4 on top of the adhesive layer and then the meshwork 1 over the indicator layer (See Figures 4 & 6). LANGE teaches that there can be and indicator/meshwork pair (see items 4 on Figure 6) on both sides of the holder 2.
LANGE further teaches that the indicator 4 can include a filter paper and that there can also be a filter paper under the pH test paper indicator layer (Filter paper can be considered a tissue paper through broadest reasonable interpretation, so the layer under the indicator which is also a filter paper can read on the claimed first tissue paper which is affixed to one side of the test paper 4) (Column 3, lines 66-67, Column 5, lines 52-62). LANGE also teaches that there is a meshwork layer, 1, over the indicator test paper layer 4. This can be considered a second item affixed to a second side of the test paper. LANGE teaches that this meshwork layer is thin filaments or fabrics and can be made of cellulose (meshwork made of cellulose describes paper), and wherein the thickness of the fibers are 4-200.mu (Column 4, lines 14-42). So—this reads on the claimed tissue paper as well.
Therefore, overall, LANGE reads on the claimed tissue tester comprising a test paper, with a first side having a first “tissue,” paper affixed therefore, and a second side that directly contacts the sample and a second “tissue paper.”
It is noted that the term “tissue,” paper can be interpreted very broadly, and that this term could either indicate a thin paper of some sort, or just any paper that is used to test tissues.
LANGE further teach of treating a surface of the paper/filter with the curcuma (curcumin) (which is the active ingredient in curcumin) —which acts a pH indicator (Column 2, line 65-Column 3, line 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to test for pathogens/infections as is done in LANGE using pH indicators as is done in RHODIUM and one would have had reasonable expectation of success due to the advantage that test papers using pH indicators offer for easy and rapid determination of pathological components in body fluids (LANGE, Column 2, line 65-Column 3, line 11). Further- the examiner notes that the use of the device as claimed and the changing of colors “when” contacting a sample are not limiting from a patentability standpoint as the instant elected claims are drawn towards a device and not a method.
RHODIUM and LANGE do not directly teach of curcumin being the active ingredient in turmeric however this is understood to be common knowledge in the art. However, in the case that this is not apparent to one of ordinary skill that curcumin in the active ingredient in turmeric and that it would be obvious to interchange the use of curcumin/turmeric with one another, HENDRIX is used to show this.
HENDRIX et al. specifically teach of curcumin being the active ingredient in turmeric with turmeric being the root (as in root of a vegetable) and curcumin being the active compound (paragraph 0026). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to interchangeably use turmeric and curcumin due to the fact that curcumin is the active ingredient in turmeric and the same benefits and properties would be expected for either compound (HENDRIX, paragraph 0026).
With respect to Claims 22-24 LANGE teaches of test strip sizes (column 5, example 1), and that you can adjust the size dependent on purpose and the specification is not limiting of other embodiments such as change of size which would be obvious/might present themselves to one of ordinary skill in the art (column 8, line 39-45).
With respect to the instantly claimed size of a treatment area (with dimensions of 6 cm to 9 cm, 6 cm to 11 cm, and at least 36 square cm and less than 99 square cm) the size of a treated portion of substrate being 6cm by 6cm, this is not a limitation that would deem this invention different enough to make it patentable. LANGE et al. teach of a size of a treated portion of substrate. It would be obvious to one of ordinary skill in the art to change the size or shape of the treated section in accordance with what the desired purpose is. See MPEP 2144:
A.Changes in Size/Proportion
In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package “of appreciable size and weight requiring handling by a lift truck” where held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (“mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled.” 531 F.2d at 1053, 189 USPQ at 148.).
In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
B.Changes in Shape
In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was 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 container was significant.).
With respect to Claim 26, RHODIUM teach of adding ¼ teaspoon of turmeric to 4 tablespoons of rubbing alcohol (3 teaspoons in 1 tablespoon, 14.78 ml in one Tablespoon, and 4.928 ml in 1 teaspoon) stirring to mix to form solution (Page 3, Solution # 3). Therefore RHODIUM teaches of a ratio of 1.92ml turmeric to 59.12 ml alcohol= .03 concentration ratio. What is instantly claimed is 20ml/237 ml= .08 concentration ratio- and this reads “about,” 20ml turmeric/237 ml as instantly claimed. Further- it would have been obvious to one of ordinary skill in the art to optimize the concentration through routine experimentation. See MPEP 2144.05.
With respect to Claims 27-28, RHODIUM teaches of the color change being yellow to brown/purple (Page 3).
With respect to Claims 29-30, LANGE et al. also teach of the treated filter patch comprising white filter paper (col 3, line 48-51: “the carrier materials can be colorless and transparent but advantageously there are used opaque materials which, for increasing the color contrast can also be appropriately colored.”) In addition, LANGE et al. teach of the treated filter patch comprising an area smaller than the first paper tissue sheet (Col 4, lines 20-24).
With respect to Claim 34, LANGE teach of a tissue tester for providing an indication of the presence of disease/pathological components(pathogen) (Column 1, lines 6-23) in a bodily fluid. The claimed use of the tester on a respiratory secretion in a subject that has bacterial infection is intended use for the claimed device and therefore not limiting for the device claim. The subject and that the subject “has shown symptoms of infection for at least one day,” is also not limiting from a device standpoint in the claim as this again is intended use for the claimed device. The device taught by the prior art as shown above for claim 1 is capable of this intended use.
Response to Arguments
Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive.
The prior 112 rejections were overcome by the amendments dated 11/19/2025, however there are further clarity issues which were introduced by these amendments as shown in the 112 rejection above.
The double patenting rejections are maintained. Applicant has indicated that filing a terminal disclaimer at this time in prosecution is premature, however applicant will consider filing one if the application moves towards allowance. Therefore, at this time, the double patenting rejection is maintained.
With respect to the 103 rejection, applicant argues that the office have not meant the burden to establish prima facie obviousness. The examiner disagrees and the rejection is maintained.
With respect to the prior art, applicant argues that there is no reasonable expectation of success or motivation to combine the claimed references. Applicant further argues that “obviousness cannot be predicted on what is unknown.” Applicant also argues that the claims do not merely recite capabilities or inherent properties and are patentable. The examiner disagrees with applicants arguments that there is no reasonable expectation of success and instead maintains that there would be expectation of success. The examiner also disagrees with applicant’s other arguments.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the examiner has provided proper reason for combination of the references as shown in the above rejection.
Applicant argues that the cite references do not teach of detecting respiratory secretions from subjects having bacterial infections and that subjects not having bacterial infections would have a pH difference distinguishable by turmeric composition and there is no motivation to combine references to do this based on what is unknown.
With respect to this--- the examiner points out that this is a methodical/process argument and not an argument with respect to the claimed device. Intended use and methodical limitations are not limiting for device claims. The instant device is drawn towards a layered testing device with turmeric impregnated thereon. The prior art makes this obvious as it shown in the above rejection.
Applicant argues that there is no expectation of success since it is applicant’s opinion that LANGE teaches away from the claimed tester and does not teach of the intended purpose/use of the claimed tester (that the color change is based on pathogen presence). The examiner disagrees with this for the same reason above, in that the claims are drawn towards a device and applicant is arguing about the intended purpose/use of the device.
Applicant argues that the color change referenced in the claim needs to be dependent on presence of pathogens in respiratory secretions, and that this is more than recitation of merely unknown properties of an old formulation. The examiner disagrees—as these are methodical limitations. Further- RHODIUM and LANGE, and HENDRIX teach of the claimed composition/reagent being used as an indicator (turmeric/curcumin as the active compound). Therefore--- since the claimed compound is taught as used on an indicator/test strip--- it would necessarily result in the same claimed color change if used in the method applicant is arguing about. Therefore—applicant is not claiming new properties, but known properties of turmeric/curcumin being sensitive to pH changes. Again--- the use of the claimed tissue tester in a respiratory sample for detecting pathogens is not limiting for the claimed device.
Therefore--- there would be reasonable expectation of success in combining the claimed references, particularly for the claimed device.
Applicant further argues that it would not be obvious to use a respiratory secretion as mentioned in the claimed device, instead of what LANGE teaches which urine. The examiner again notes—that the sample used is not part of the claimed device so is not limiting in the claim. Further--- the examiner maintains that LANGE would be capable of use for indication of pH changes in any body fluid as the same compound as claimed as an indicator is used therein.
All claims remain rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Reference by applicant, entitled, Machery- Nagel- “turmeric paper”, cited on IDS 09/30/2020 in parent case 16/200521, also seems to make the instant case that turmeric/curcumin are interchangeable- as on the last page, Page 5, the invention is called, “turmeric paper,” though the description specifically says curcumin is impregnated, turmeric. The Machery Nagel paper is also makes the instant invention obvious as the change is size is obvious to one of ordinary skill in the art, but teaches the other specific claimed aspects.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 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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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758