Prosecution Insights
Last updated: April 19, 2026
Application No. 18/379,973

Objective Dried Blood Spot Collection Device

Non-Final OA §103§112
Filed
Oct 13, 2023
Examiner
KREMER, MATTHEW
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Blackfly Investments LLC Dba Molecular Testing Labs
OA Round
1 (Non-Final)
44%
Grant Probability
Moderate
1-2
OA Rounds
4y 5m
To Grant
96%
With Interview

Examiner Intelligence

Grants 44% of resolved cases
44%
Career Allow Rate
196 granted / 448 resolved
-26.2% vs TC avg
Strong +52% interview lift
Without
With
+51.9%
Interview Lift
resolved cases with interview
Typical timeline
4y 5m
Avg Prosecution
58 currently pending
Career history
506
Total Applications
across all art units

Statute-Specific Performance

§101
6.2%
-33.8% vs TC avg
§103
35.5%
-4.5% vs TC avg
§102
14.0%
-26.0% vs TC avg
§112
36.2%
-3.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 448 resolved cases

Office Action

§103 §112
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 The Applicant ’ s election without traverse of species A (FIGS. 3-4) in the reply filed on 3/11/2026 is acknowledged. Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. In particular, claim 11 requires that the plurality of blood collection apertures and the plurality of observation windows are disposed on the top face of the first portion, which reads on the non-elected species B (FIG. 9) and C (FIG. 10). 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. No claim limitations have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph . Claim Objections Claims 4 and 10 are objected to because of the following informalities: in claim 4, line 5: “ the ” should be inserted before “ respective mating pegs ” ; ’ in claim 4, lines 5-6: “ the ” should be inserted before “ respective mating receptacles ” ; in claim 10, line 1: “ further comprising further comprising ” should be “ further comprising ” ; and in claim 10, line 4: “ the ” should be inserted before “ ambient air ” . 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 5-6 and 9-10 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 5 recites “ the back side ” in line 2 in which there is insufficient antecedent basis for this limitation in the claim. Also, it is not clear what structure is being referred to with this recitation. The back side of what? Claim 5 recites “ a view ” in line 2, but it is not clear if this recitation is the same as, related to, or different from “ a view ” of claim 1 , lines 7-8. If they are the same, “ a view ” in claim 5 should be “ the view ” . If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “ first ” and “ second ” should be used to clearly differentiate the elements) . Claim 6 recites “ the plane ” in line 3 in which there is insufficient antecedent basis for this limitation in the claim. Claim 9 recites “ the first ventilation window ” in line 2, but it is not clear if this recitation is the same as, related to, or different from “ a first ventilation opening ” of claim 9, line 1 or one of “ a plurality of observation windows ” from claim 1, line 7. Clarification is required. If “ the first ventilation window ” in claim 9 is different, there is insufficient antecedent basis for this limitation in the claim. Also note that “ the first ventilation window ” is also recited in claim 10, line 3 and suffers from the same indefiniteness issue as “ the first ventilation window ” in claim 9. Claim 10 is rejected by virtue of its dependence from claim 9. Claim 10 recites “ the second ventilation window ” in lines 3-4, but it is not clear if this recitation is the same as, related to, or different from “ a second ventilation opening ” of claim 9, lines 1-2 or one of “ a plurality of observation windows ” from claim 1, line 7. Clarification is required. If “ the second ventilation window ” in claim 10 is different, there is insufficient antecedent basis for this limitation in the claim. 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. Claims 1 , 3 , and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2016/0220992 (Lewis), in view of U.S. Patent No. 5,869 , 345 (Chandler). Lewis teaches a device for collecting dried blood spots for diagnostics, comprising: a body having a first portion (the impermeable cover stratum 20 of Lewis) and second portion (the transparent stratum 24 of Lewis) coupled to each other and surrounding a cavity configured to hold a dried blood spot collection card (the middle absorbent stratum 22 of Lewis). Chandler teaches the use of a gasket or ridge 36 to enclose a sample containing layer 20 between two outer strata 12 and 14 (FIG. 1A and col. 18, lines 1-40 of Chandler). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a ridge or gasket on the outer stratum 20 and 24 of Lewis so as to contain the middle stratum 22 therein so as to better protect the middle stratum. With respect to claim 1 , the combination teaches or suggests a device for collecting dried blood spots for diagnostics, comprising: a body having a first portion (the impermeable cover stratum 20 of Lewis) and second portion (the transparent stratum 24 of Lewis) coupled to each other and encapsulating a cavity configured to hold a dried blood spot collection card (the middle absorbent stratum 22 of Lewis ; the ridge or gasket of Chandler permitting the encapsulation of the cavity ) , the first portion having a top face (the top face of the impermeable cover stratum 20 of Lewis) and the second portion having a bottom face (the bottom face of the transparent stratum 24 of Lewis) ; a plurality of blood collection apertures (the three apertures 2 6a, 26b, and 26c of Lewis) disposed on the top face and configured to direct blood toward the cavity; and a plurality of observation windows (the windows formed from the indicia 28 on the transparent stratum 24 of Lewis) disposed on the body configured to provide a view into the cavity. With respect to claim 3 , the combination teaches or suggests that the plurality of observation windows comprises a number equivalent to the plurality of blood collection apertures (the number of the windows formed from the indicia 28 on the transparent stratum 24 of Lewis is the same number as the three apertures 2 6a, 26b, and 26c of Lewis) . With respect to claim 5 , the combination teaches or suggests the plurality of observation windows disposed on the back side configured to provide a view into the cavity (the windows formed from the indicia 28 on the transparent stratum 24 of Lewis are so configured) . With respect to claim 6 , the combination teaches or suggests a desiccant (paragraph 0060 of Lewis teaches the use of a desiccant. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a desiccant in the combination so as to keep the samples dry) . With respect to claim 7 , the combination teaches or suggests that each of the plurality of blood collection apertures (the three apertures 26a, 26b, and 26c of Lewis) ) further comprises a conical opening having a lower opening that is smaller in diameter than an upper opening, the upper opening disposed in the plane of the top face (see the conical shape of the apertures 26 in F IG. 8 of Lewis) . Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lewis, in view of Chandler, and further in view of U.S. Patent Application Publication No. 2018/0133711 ( Funk ). The combination teaches or suggests a plurality of blood collection apertures (the three apertures 26a, 26b, and 26c of Lewis ) with corresponding collection areas and windows formed from the indicia 28 on the transparent stratum 24 of Lewis . Lewis further teaches the number of specimen areas can be any number (paragraphs 0042-0044, 0046, and 0048 of Lewis). Funk teaches five collection areas (FIG. 20B and paragraph 0099 of Funk). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have five collection areas (and the same corresponding number of apertures and the windows formed from the indicia 28 on the transparent stratum 24 of Lewis ) since (1) Lewis teaches any number of collection areas can be used and Funk teaches such a number and/or (2) it permits for more analysis opportunities. With respect to claim 2 , the combination teaches or suggests that the plurality of blood collection apertures comprises five blood collection apertures (the five collection areas suggested by Funk would result in the same number corresponding apertures of Lewis ). Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lewis, in view of Chandler, and further in view of U.S. Patent Application Publication No. 201 5 / 0251177 ( Kim ). The combination teaches or suggests a body having a first portion (the impermeable cover stratum 20 of Lewis) and second portion (the transparent stratum 24 of Lewis) coupled to each other and encapsulating a cavity configured to hold a dried blood spot collection card (the middle absorbent stratum 22 of Lewis; the ridge or gasket of Chandler permitting the encapsulation of the cavity). Kim teaches the use of peg and receptacle interlocks between top and bottom members (paragraphs 0068 and 0072 and FIG. 9 of Kim) . For example, FIG. 9 of Kim shows a first portion 30 compris ing a plurality of mating pegs disposed on a side of the first portion that is opposite the top face and a second portion 10 comprising a plurality of mating receptacles disposed on a side of the second portion that is opposite the bottom face . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the peg and receptacle interlocks of Kim on the cover stratum 20 and the transparent stratum 24 of Lewis as shown in FIG. 9 of Kim since (1) it makes the arrangement more secure and/or (2) it assists in aligning the strata . With respect to claim 4 , the combination teaches or suggests that the first portion further comprises a plurality of mating pegs (the pegs on the cover stratum 20 of Lewis) disposed on a side of the first portion that is opposite the top face; wherein the second portion further comprises a plurality of mating receptacles (the receptacles on the transparent stratum 24 of Lewis) disposed on a side of the second portion that is opposite the bottom face; and wherein respective mating pegs are configured to mate with respective mating receptacles to removably secure the first portion to the second portion ( paragraphs 0068 and 0072 and FIG. 9 of Kim ). Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lewis, in view of Chandler , and further in view of U.S. Patent No. 5,441,698 (Norell) . The combination teaches or suggests a plurality of observation windows in form of the indicia 28 on the transparent stratum 24 of Lewis. Chandler teaches opaque material with cut-out windows ( col. 18, lines 1-40 of Chandler ). Norell teaches that a transparent sheet is placed between the window 28 and the viewing area (FIGS. 1-2 , col. 2, lines 54-61; col. 3, lines 40-52; col. 4, lines 15-25 of Norell). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the indicia 28 on the transparent stratum 24 with cut-out windows on an opaque material, as suggested by Chandler, with a transparent sheet between the window and the viewing area , as suggested by Norell, since it is a simple substitution of one known element for another to obtain predictable results and /or it focuses the eyes at the viewing areas . With respect to claim 8 , the combination teaches or suggests a transparent material (the transparent sheet suggested by Norell) disposed between the cavity and the plurality of observation windows (the cut-out windows suggested by Chandler). Claims 1, 3, and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis, in view of U.S. Patent Application Publication No. 2019/0099166 ( Naseri ). Lewis teaches a device for collecting dried blood spots for diagnostics, comprising: a body having a first portion (the impermeable cover stratum 20 of Lewis) and second portion (the transparent stratum 24 of Lewis) coupled to each other and surrounding a cavity configured to hold a dried blood spot collection card (the middle absorbent stratum 22 of Lewis). Naseri teaches a construction in which the top and bottom portions form a cover 6 50 in which a dried blood spot card 630 is inserted therein (FIG. 5B and paragraph 0108 of Nase ri). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the impermeable cover stratum 20 and the transparent stratum 24 as a cover for the middle absorbent stratum 22 of Lewis to be inserted therein so as to better protect the middle stratum. With respect to claim 1, the combination teaches or suggests a device for collecting dried blood spots for diagnostics, comprising: a body having a first portion (the impermeable cover stratum 20 of Lewis) and second portion (the transparent stratum 24 of Lewis) coupled to each other and encapsulating a cavity configured to hold a dried blood spot collection card (the middle absorbent stratum 22 of Lewis; the cover formation of the cover stratum 20 and the transparent stratum 2 4, suggested by Naseri, permitting the encapsulation of the cavity), the first portion having a top face (the top face of the impermeable cover stratum 20 of Lewis) and the second portion having a bottom face (the bottom face of the transparent stratum 24 of Lewis); a plurality of blood collection apertures (the three apertures 26a, 26b, and 26c of Lewis) disposed on the top face and configured to direct blood toward the cavity; and a plurality of observation windows (the windows formed from the indicia 28 on the transparent stratum 24 of Lewis) disposed on the body configured to provide a view into the cavity. With respect to claim 3, the combination teaches or suggests that the plurality of observation windows comprises a number equivalent to the plurality of blood collection apertures (the number of the windows formed from the indicia 28 on the transparent stratum 24 of Lewis is the same number as the three apertures 26a, 26b, and 26c of Lewis). With respect to claim 5, the combination teaches or suggests the plurality of observation windows disposed on the back side configured to provide a view into the cavity (the windows formed from the indicia 28 on the transparent stratum 24 of Lewis are so configured). With respect to claim 6, the combination teaches or suggests a desiccant (paragraph 0060 of Lewis teaches the use of a desiccant. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a desiccant in the combination so as to keep the samples dry). With respect to claim 7, the combination teaches or suggests each of the plurality of blood collection apertures (the three apertures 26a, 26b, and 26c of Lewis)) further comprises a conical opening having a lower opening that is smaller in diameter than an upper opening, the upper opening disposed in the plane of the top face (see the conical shape of the aperture 26 in FIG. 8 of Lewis). Claim s 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lewis, in view of Naseri , and further in view of U.S. Patent Application Publication No. 2014/0373645 (Bedrio) and U.S. Patent Application Publication No. 2017/0071520 ( Rudge ). T he combination teaches or suggests a body having a first portion (the impermeable cover stratum 20 of Lewis) and second portion (the transparent stratum 24 of Lewis) coupled to each other and encapsulating a cavity configured to hold a dried blood spot collection card (the middle absorbent stratum 22 of Lewis; the cover formation of the cover stratum 20 and the transparent stratum 24, suggested by Naseri, permitting the encapsulation of the cavity) . Bedrio teaches ventilation holes 106 and 108 to extend into the cavity from the atmosphere so as to assist in drying (paragraphs 0022 and 0044 and FIGS. 1-2 of Bedrio ). Rudge teaches that ventilation holes may be placed at distal ends or side walls adjacent to the distal ends to keep air circulation flowing and there can be several ventilation holes (paragraphs 0093 and 009 8 and claim 50 of Rudge). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include ventilation holes in the body of the combination so as to assist in drying and to permit air circulation . Also, Rudge teaches that the placement of the ventilation holes may be on a distal end or a sidewall adjacent to the distal end ( paragraphs 0093 and 0098 and claim 50 of Rudge ) while Bedrio teaches that the ventilation holes may be on different walls ( the holes 106 and 108 in FIGS. 1-2 of Bedrio ). From these teachings, the placements of the ventilation holes would be placed where drying assistance and air circulation would be optimal. As such, the placement s of the ventilation holes are results-effective variable that would have been optimized through routine experimentation based on the optimal drying assistance and air circulation . It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select placements of the ventilation holes , using the distal end and the sidewalls adjacent to the distal end of Rudge as a starting point, so as to obtain the optimal drying assistance and air circulation . Thus, the features of “ a first ventilation opening disposed between the first portion and the second portion when mated, the first ventilation window exposing the cavity to ambient air ” of claim 9 and “ a second ventilation opening disposed between the first portion and the second portion when mated and disposed in a plane that is different from a plane of the first ventilation window, the second ventilation window exposing the cavity to ambient air ” of claim 10 would have been obvious . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MATTHEW KREMER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3394 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 8 am to 6 pm; every other Friday off . 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, FILLIN "SPE Name?" \* MERGEFORMAT JACQUELINE CHENG can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-5596 . 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. /MATTHEW KREMER/ Primary Examiner, Art Unit 3791
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Prosecution Timeline

Oct 13, 2023
Application Filed
Mar 26, 2026
Non-Final Rejection — §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
44%
Grant Probability
96%
With Interview (+51.9%)
4y 5m
Median Time to Grant
Low
PTA Risk
Based on 448 resolved cases by this examiner. Grant probability derived from career allow rate.

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