DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Applicant’s Request for Continued Examination received on 16 December 2025 have been entered. Amendment and Arguments/Remarks received on 17 November 2025 have been entered.
Claims 1, 3, 7, 9, 20-23, 27, 29-30, 33-35, and 37-41 were previously pending in the application. Claims 9, 20-23, 33-35, and 39-41 have been cancelled, and new claim 42 has been added by Applicant. Claims 1, 3, 7, 27, 29-30, 37-38, and 42 are currently pending in the application. Claims 1 and 27 are independent claims.
The following election of species was in effect in the instant application:
Calcium-free test solution: Less than 20 nM free calcium;
CatSper activation stimulus: Substance: Ligand: Steroid;
Alternative limitation as set forth in claim 16: Alternative (iii): wherein the motility of the sperm detected in step (b) is compared to the motility of the sperm from said subject detected under a control condition comprising a calcium-containing solution.
Examiner has withdrawn the election of species requirement in view of the amendments to independent claim 1 specifically reciting “wherein the test solution comprises less than about 20 nM free calcium ions, and wherein the test solution comprises at least one agent which reduces the free calcium ion concentration” in lines 7-9; reciting “wherein the activation stimulus comprises 10 µM progesterone” in line 12; and specific methods for comparing the motility of the sperm sample in a test solution with the motility of the sperm sample in a control solution in lines 25-28.
Claims 3 and 30 have been rejoined in view of the withdrawal of the species election requirement.
Claims 1, 3, 7, 27, 29-30, 37-38, and 42 are currently pending and under examination in the instant application. An action on the merits follows.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/EP2020/057904, filed 23 March 2020, which claims priority to EPO 19164512.6, filed 22 March 2019, and LU101160, filed 25 March 2019. Filing of a certified copies of the EPO 19164512.6, filed 22 March 2019, and LU101160, filed 25 March 2019, is acknowledged.
Thus, the earliest possible priority for the instant application is 22 March 2019.
Claim Objections
Amended claim 1 is newly objected to because of the following informalities: claim 1 now recites, “wherein the control solution comprises more than about 1mM free calcium, and wherein the control solution is at about 37oC, wherein the ratio of the volume of the sperm sample contacted to the volume of the control solution is 1:9” in lines 16-18. The “and” linking the wherein clauses should be moved to precede the third wherein clause rather than the second.
Appropriate correction is required.
Previously presented and newly rejoined claims 3 and 30 are newly objected to because of the following informalities: claims 3 and 30 each recite “dibromo-1,2-bis(o-aminophenoxy)ethane-N,N-N’,N’,tetraacetic acid (DiBrBAPTA), which appears to be a typographical misspelling of dibromo-1,2-bis(o-aminophenoxy)ethane-N,N,N’,N’-tetraacetic acid (DiBrBAPTA).
Appropriate correction is required.
Amended claim 38 is newly objected to because of the following informalities: claim 38 now recites, “wherein the validation solution further comprises a CatSper inhibitor, which inhibit an activity of the CatSper channel” in lines 13-14. The term “inhibit” should be replaced with “inhibits”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The rejection of amended and cancelled claims 1, 7, 9, 20-23, 27, 29, 33-35, and 37-41 under 35 U.S.C. 112(b) as failing to particularly point out and distinctly claim the subject matter which the inventor(s) regards as the invention for multiple issues of indefiniteness is withdrawn over cancelled claims 9, 20-23, 33-35, and 39-41, maintained over amended claims 1, 7, 27, 29, and 37-38, and newly applied to rejoined and new claims 3, 30, and 42. Applicant's amendments to the claims and arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below. Claims 37 and 42 have been included in this rejection due to their dependence on or encompassing of independent claims 3 and/or 27.
Amended independent claim 1 was amended to overcome some of the issues of a lack of antecedent basis for “the control solution” previously recited in lines 13, 14, 17, and 20; to overcome the issue of recitation of ““counting about 200 sperm in the control solution and in the test solution of step (d)”; and to overcome the issue of recitation of “if the sperm in the test solution and in the control solution are motile”.
However, the indefiniteness associated with recitation of “reduces” has not been fully overcome. Applicant amended claim 1 to recite, “wherein the test solution comprises at least one agent which reduces the free calcium ion concentration by binding free calcium ions compared to a control solution comprising more than about 1 mM free calcium ions” in lines 8-11. However, the verb “reduces” implies a change from a starting state to an ending state. Applicant’s amendment has applied the term “reduces” to indicate a relative relationship with a control solution rather than a relative relationship with a prior state or alternative state of the test solution (e.g., prior to addition of the agent or otherwise in the absence of the agent). As amended, it is unclear whether Applicant intends that the test solution be specifically derived from the control solution, such that addition of the agent reduces the free calcium concentration from more than about 1 mM free calcium ions to less than about 20 nM free calcium ions, or whether Applicant is merely indicating that the test solution has been reduced by the agent to have a lower free calcium ion concentration than the control solution- which is already indicated by the recitation of “less than about 20 nM free calcium ions” for the test solution and “more that about 1 mM free calcium ions” for the control solution in lines 7-8 and 10-11.
Additionally, issues of a lack of antecedent basis for “the control solution” have not been fully overcome. Claim 1 recites “a control solution comprising more than about 1 mM free calcium ions” in lines 10-11 and “wherein the control solution comprises more than about 1 mM free calcium” in lines 16-17. The recitation in lines 16-17 recites “free calcium” and does not recite “free calcium ions”, as such, the limitation in lines 16-17 is inconsistent with the limitation in lines 10-11 that the control solution comprises more than about 1mM free calcium ions.
Further, Applicant’s amendments have introduced new issues of indefiniteness into independent claim 1.
Claim 1 newly recites, “d) incubating each of the sample mixed with the test solution of step (b), a sperm sample-test solution mixture, and the sample mixed with the control solution of step (c), a sperm sample-control solution mixture, for about 15 minutes” in lines 19-21, which is indefinite because it is unclear whether “a sperm sample-test solution mixture” is meant to be naming “the sample mixed with the test solution of step (b)” or whether the sperm sample-test solution mixture is an additional mixture to be incubated. Likewise, it is unclear whether “a sperm sample-control solution mixture” is meant to be naming “the sample mixed with the control solution of step (c)” or whether the sperm sample-test solution mixture is an additional mixture to be incubated.
Additionally, independent claim 1 is missing a linker word following step h) to indicate whether the method comprises the steps of a)-i) in an “and”, “or”, or “and/or” relationship.
As such, the metes and bounds of the claim cannot be determined.
In the interest of compact prosecution, step d) of claim 1 has been interpreted such that the sperm sample-test solution mixture and sperm sample-control solution mixture are names of the sample mixed with the test solution of step (b) and the sample mixed with the control solution of step (c), respectively.
Additionally, to add clarity to the use of these terms, Examiner suggests amending steps b) and c) to recite, “b) contacting and mixing a first part of the sperm sample with a test solution to obtain a sperm sample-test solution mixture” and “c) contacting and mixing a second part of the sperm sample with the control solution to obtain a sperm sample-control solution mixture”, respectively, as well as amending step d) to recite, “d) incubating each of the sperm sample-test solution mixture of step (b) and the sperm sample-control solution mixture of step (c) for about 15 minutes at about 37oC”.
Previously presented and rejoined claim 3 has multiple issues of indefiniteness.
Firstly, claim 3 recites, “the at least one agent reducing the free calcium concentration” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 3 is dependent on claim 1. Claim 1 recites, “wherein the test solution comprises at least one agent which reduces the free calcium ion concentration”, but does not recite any “agent reducing the free calcium concentration”.
Secondly, claim 3 recites, “wherein the at least one agent reducing the free calcium concentration is a chemical binding Ca2+”, which is further indefinite because it is unclear whether Applicant intents for the scope of “agent” to be different/broader than the scope of the term “chemical”. The specification provides a limiting definition for the phrase “chemical binding Ca2+”: “as used throughout the present invention, the term ‘chemical binding Ca2+’ is any substance or molecule with a distinct molecular composition that is produced by or used in a chemical process and which is able to bind free calcium” [0056]; but does not provide a limiting definition for the term “agent” and does not teach any agents reducing the free calcium ion concentration which are not chemicals.
Additionally, it is unclear whether Applicant’s switch from “calcium ions” recited in claim 1 and “Ca2+” recited in claim 3 is meant to be a further limitation, such that the scope of claim 1 encompasses additional calcium ion species, or whether Applicant intends Ca2+ to be a synonym for the calcium ions recited in claim 1. However, the specification does not teach any calcium ion species other than Ca2+. In fact, the specification only refers to “calcium ion” once [0055], and otherwise refers to “calcium” without the “ion” modifier or to “Ca2+” throughout.
The further limitations recited in claim 3 for specific chemicals binding Ca2+ are preceded by the term “optionally”. Therefore, by not requiring any of the specific calcium binding agents recited, and given that it is unclear whether or not “agent” is synonymous with “chemical” and “calcium ions” is synonymous “Ca2+”, it is also unclear whether claim 3 further limits the invention of independent claim 1 as amended.
Claim 3 also recites “wherein the chemical binding Ca2+ is any one of”, which is indefinite because it is unclear whether the recited list is an open or a closed list.
As such, the metes and bounds of the claim cannot be determined.
Amended claim 7 recites, “wherein step (b) further comprises applying the activation stimulus of the CatSper channel, prior to, simultaneously or after applying the test solution to the sperm sample” in lines 1-4, which is indefinite because independent claim 1, upon which 7 depends, requires the test solution to comprise the progesterone activation stimulus. Therefore, because the test solution comprises the activation stimulus, claim 1 requires that the activation stimulus is contacted with the sperm sample at the same time as the test solution. Accordingly, the limitations of claim 7 for applying the activation stimulus prior to or after applying the test solution to the sperm sample conflict with the limitation of independent claim 1 as amended.
As such, the metes and bounds of the claim cannot be determined.
Amended claim 27 has multiple issues of indefiniteness.
Claim 27 recites “the test solution” in lines 4, 5, 7, and 8. There is insufficient antecedent basis for this limitation in the claim. Claim 27 encompasses independent claim 1 as “A kit for use in a method… of claim 1” recited in lines 1-3. Claim 27 recites “a test solution” in line 4. Claim 1 recites “a test solution” in line 6. Therefore, it is unclear which test solution “the test solution” of lines 4, 5, 7, and 8 are referring to.
Additionally, if “the test solution” recited in lines 4, 5, 7, and 8 are meant to be the same test solution as recited in claim 1, claim 27 is further indefinite for not requiring all of the components of the test solution recited in claim 1. Claim 27 newly recites, “a kit for use in a method for determining or diagnosing infertility due to a loss of function of a cation channel of sperm (CatSper) protein complex of a male human subject of claim 1” and “wherein the test solution comprises less than about 20 nM free calcium ion and/or wherein the test solution comprises at least one agent which binds free calcium ions resulting in reducing the free calcium ion concentration of the test solution”, which by reciting “and/or” in line 5, does not require the test solution to comprise all of the components required for the test solution as recited in claim 1, and so conflicts with the limitations of claim 1. Further, reciting that the test solution can alternatively comprise less than 20 nM free calcium ions or comprise at least one agent reducing the free calcium ion concentration, it is unclear whether the agent required by claim 1 is meant to be a user-supplied ingredient added into the test solution prior to use, whether the agent is meant to be present in the kit but not present in the test solution for addition to the test solution immediately prior to use, or whether the kit is meant to additionally be used in a method wherein the test solution does not comprise an agent reducing the free calcium ion concentration of the test solution.
Further, amended claim 27 recites “the test solution comprising 10 µM progesterone”, which has two issues of indefiniteness. Firstly, the phrase is not linked to the prior limitations with an “and”, “or”, or “and/or”, and as such, it is unclear whether it is a required limitation for the test solution. Secondly, the use of “the test solution comprising” instead of “wherein the test solution comprises” is grammatically unclear by lacking an active verb.
Claim 27 also recites, “the control solution comprising more than about 1 mM free calcium ions” in lines 10-11. There is insufficient antecedent basis for this limitation in the claim. Claim 27 encompasses independent claim 1 as “A kit for use in a method… of claim 1” recited in lines 1-3. Claim 27 recites “a control solution comprising more than about 1 mM free calcium ions” in lines 7-8. Claim 1 recites, “a control solution comprising more than about 1 mM free calcium ions” in lines 10-11. Therefore, it is unclear whether “the control solution comprising more than about 1 mM free calcium ions” recited in claim 27 lines 10-11 is meant to refer to the control solution recited in claim 1 lines 10-11 or to the control solution recited in claim 27 lines 7-8, or whether the control solutions recited in claim 27 lines 7-8 is meant to be the same control solution as recited in claim 1 lines 10-11.
Also, as discussed for claim 1, the indefiniteness associated with recitation of “reduces” has not been fully overcome. Applicant amended claim 27 to recite, “wherein the test solution comprises at least one agent which binds free calcium ions resulting in reducing the free calcium ion concentration of the test solution compared to a control solution comprising more than about 1 MM free calcium ions” in lines 5-8. However, “reducing” implies a change from a starting state to an ending state. Applicant’s use of the term “reducing” now indicates an active reduction resulting from the binding of free calcium within the test solution, but is still written to indicate a relative relationship with a control solution rather than a relative relationship with a prior state or alternative state of the test solution (e.g., prior to addition of the agent or otherwise in the absence of the agent). As amended, it is unclear whether Applicant intends that the test solution be specifically derived from the control solution, such that addition of the agent reduces the free calcium concentration from more than about 1 mM free calcium ions to less than about 20 nM free calcium ions, or whether Applicant is merely indicating that the test solution has been reduced by the agent to have a lower free calcium ion concentration than the control solution- which is already indicated by the recitation of “less than about 20 nM free calcium ions” for the test solution and “more that about 1 mM free calcium ions” for the control solution in lines 5 and 8.
As such, the metes and bounds of the claim cannot be determined.
Amended claim 29 newly recites, “further comprising a validation solution comprising the test solution of claim 27 and a CatSper-inhibitor”, which is indefinite because claim 27 is directed to a kit comprising a test solution and not to a test solution itself.
As such, the metes and bounds of the claim cannot be determined.
Previously presented and newly rejoined claim 30 has multiple issues of indefiniteness.
Claim 30 recites, “the at least one agent reducing the free calcium concentration” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Claim 30 is dependent on claim 27, which encompasses independent claim 1. Claim 30 recites, “wherein the test solution comprises at least one agent reducing the free calcium concentration” in line 2. Claim 27 recites “wherein the test solution comprises at least one agent which binds free calcium ions resulting in reducing the free calcium ion concentration” in lines 5-7. Claim 1 recites “wherein the test solution comprises at least one agent which reduces the free calcium ion concentration by binding free calcium ions” in lines 8-10.
Claim 30 also recites, “wherein the at least one agent reducing the free calcium concentration is a chemical binding Ca2+” in lines 2-3, which is indefinite it is unclear to what extent the terms “agent” and “chemical” have different scopes and to what extent the terms “calcium ion” and “Ca2+” have different scopes. Additionally, claim 27 and claim 1 each already recite wherein the agent binds to free calcium ions. The specification provides a limiting definition for the phrase “chemical binding Ca2+”: “as used throughout the present invention, the term ‘chemical binding Ca2+’ is any substance or molecule with a distinct molecular composition that is produced by or used in a chemical process and which is able to bind free calcium” [0056]; but does not provide a limiting definition for the term “agent” and does not teach any agents reducing the free calcium ion concentration which are not chemicals. Also, the specification does not teach any calcium ion species other than Ca2+. In fact, the specification only refers to “calcium ion” once [0055], and otherwise refers to “calcium” without the “ion” modifier or to “Ca2+” throughout. Therefore, it is unclear whether Applicant intends for “chemical” to further limit “agent” and for “Ca2+” to further limit “calcium ions”.
Claim 30 also recites “wherein the chemical binding Ca2+ is any one of”, which is indefinite because it is unclear whether the recited list is an open or a closed list.
As such, the metes and bounds of the claim cannot be determined.
Amended claim 38 has multiple issues of indefiniteness.
Amended claim 38 has been rewritten to recite all of the steps of a)-i) from independent claim 1 except that a validation sample is used in place of the test sample. Claim 38 newly recites, “wherein the validation samples replaces the sperm sample of step a) of claim 1” in line 5. However, as written, it is unclear whether the method as recited in claim 38 is meant to be an alternative method to the method of claim 1 (and therefore conflict with the limitations of claim 1) or whether the method of claim 38 is meant to provide additional method steps to the method of claim 1.
As addressed above for independent claim 1, the indefiniteness associated with recitation of “reduces” has not been fully overcome. Applicant amended claim 38 to recite, “wherein the validation solution comprises at least one agent which reduces the free calcium ion concentration by binding free calcium ions compared to the control solution comprising more than about 1 mM free calcium ions” in lines 8-11. However, the verb “reduces” implies a change from a starting state to an ending state. Applicant’s amendment has applied the term “reduces” to indicate a relative relationship with a control solution rather than a relative relationship with a prior state or alternative state of the validation solution (e.g., prior to addition of the agent or otherwise in the absence of the agent). As amended, it is unclear whether Applicant intends that the validation solution be specifically derived from the control solution, such that addition of the agent reduces the free calcium concentration from more than about 1 mM free calcium ions to less than about 20 nM free calcium ions, or whether Applicant is merely indicating that the validation solution has been reduced by the agent to have a lower free calcium ion concentration than the control solution- which is already indicated by the recitation of “less than about 20 nM free calcium ions” for the validation solution and “more that about 1 mM free calcium ions” for the control solution in lines 7-8 and 10-11.
Claim 38 recites, “d) incubating each of the validation sample mixed with the validation solution of step (b), a validation sample- validation solution mixture, and the validation sample mixed with the control solution of step (c), a validation sample-control solution mixture, for about 15 minutes” in lines 19-21, which is indefinite because it is unclear whether “a validation sample- validation solution mixture” is meant to be naming “the validation sample mixed with the validation solution of step (b)” or whether the validation sample- validation solution mixture is an additional mixture to be incubated. Likewise, it is unclear whether “a validation sample-control solution mixture” is meant to be naming “the validation sample mixed with the control solution of step (c)” or whether the validation sample-test solution mixture is an additional mixture to be incubated.
Additionally, claim 38 is missing a linker word following step h) to indicate whether the method comprises the steps of a)-i) in an “and”, “or”, or “and/or” relationship.
As such, the metes and bounds of the claim cannot be determined.
In the interest of compact prosecution, Examiner has interpreted amended claim 38 such that the method of claim 1 further comprises the steps outlined in amended claim 38. Additionally, step d) of claim 38 has been interpreted such that the validation sample- validation solution mixture and validation sample-control solution mixture are names of the validation sample mixed with the validation solution of step (b) and the validation sample mixed with the control solution of step (c), respectively.
To add clarity to the claim, Examiner suggests re-labeling the steps outlined in claim 38 to have labels which are not the same as the labels recited in claim 1 and to remove the clause “wherein the validation samples replaces the sperm sample of step a) of claim 1” from line 5. For example, Applicant could alternatively label the steps j)-r), a’)-i’), a2)-i2), or some other system to indicate that the steps of claim 38 are distinct from the steps recited in claim 1.
Additionally, to add clarity to the use of these terms, Examiner suggests amending steps b) and c) to recite, “b) contacting and mixing a first part of the validation sample with a test solution to obtain a validation sample- validation solution mixture” and “c) contacting and mixing a second part of the validation sample with the control solution to obtain a validation sample-control solution mixture”, respectively, as well as amending step d) to recite, “d) incubating each of the validation sample- validation solution mixture of step (b) and the validation sample-control solution mixture of step (c) for about 15 minutes at about 37oC”.
Applicant argues that the term “about” in regard to the temperature is not indefinite. As discussed in the prior advisory action, this is agreed in view of the instant specification providing a limiting definition for the term “about”. The specification states that the “term ‘about’ means plus or minus 10%, preferably plus or minus 5%, more preferably plus or minus 2%, most preferably plus or minus 1%” [00133]. Therefore, the term “about 37 oC” is interpreted to be limited in scope to 37 ± 3.7 oC (i.e., 33.3 oC - 40.7 oC). As such, Applicant’s arguments have overcome a finding of indefiniteness for claims 1, 27, and 38 with respect to the use of the term “about” to describe the 37 oC temperature.
Applicant additionally argues that addition of “by binding free calcium ions” to claims 1, 27, and 38 makes it clear how the agent could reduce the free calcium ion concentration. Examiner acknowledges that the phrase adds a function to the agent to facilitate the reduction of free calcium ions within the test and/or validation solution, but the issue of what the reduction is relative to is outstanding in that the test and/or validation solutions are distinct solutions from the control solution. Therefore, it is unclear whether the test and/or validation solutions are meant to be derived from the control solution or whether Applicant is merely stating that the final calcium ion concentration of the test and/or validation solutions are lower than the calcium ion concentration of the control solution.
Therefore, Applicant’s amendments and arguments partially overcome the finding of indefiniteness for amended claims 1, 7, 27, 29, and 37-38, and the rejection is maintained.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Previously presented and newly rejoined claim 3 is newly rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 3 recites, “wherein the at least one agent reducing the free calcium concentration is a chemical binding Ca2+”, which as discussed above is indefinite because it is unclear to what extent the terms “agent” and “chemical” have different scopes and to what extent the terms “calcium ion” and “Ca2+” have different scopes. Additionally, claim 1 already recites wherein the agent binds to free calcium ions. The specification provides a limiting definition for the phrase “chemical binding Ca2+”: “as used throughout the present invention, the term ‘chemical binding Ca2+’ is any substance or molecule with a distinct molecular composition that is produced by or used in a chemical process and which is able to bind free calcium” [0056]; but does not provide a limiting definition for the term “agent” and does not teach any agents reducing the free calcium ion concentration which are not chemicals. The specification does not teach any calcium ion species other than Ca2+. In fact, the specification only refers to “calcium ion” once [0055], and otherwise refers to “calcium” without the “ion” modifier or to “Ca2+” throughout. Therefore, it is unclear whether Applicant intends for “chemical” to further limit “agent” and for “Ca2+” to further limit “calcium ions”.
Further, the limitations recited in claim 3 for specific chemicals binding Ca2+ are preceded by the term “optionally”. Therefore, by not requiring any of the specific calcium binding agents recited, and given that it is unclear whether or not “agent” is synonymous with “chemical” and “calcium ions” is synonymous “Ca2+”, it is also unclear whether claim 3 further limits the invention of independent claim 1 as amended.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a)- Scope of Enablement
The rejection of amended and cancelled claims 1, 7, 9, 20-23, 27, 29, 33-35, and 37-41 under 35 U.S.C. 112(a) for being enabled for the scope recited in the prior action, but not enabled for the full scope of the claims filed 23 May 2025 as written is withdrawn in view of Applicant’s amendments to the claims such that they now recite an enabled scope.
Claim Rejections - 35 USC § 112(a)- Written Description New Matter
The rejection of amended and cancelled claims 1, 7, 9, 20-23, 27, 29, 33-35, and 37-41 under 35 U.S.C. 112(a) for new matter for reciting “a control solution comprising more than about 20 nM free calcium ions” is withdrawn in view of Applicant’s amendments to the claims such that the concentration of free calcium ions in the control solution has been amended to more than about 1 mM.
Conclusion
No claim is allowed.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
Prosecution Insights