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 .
Response to Amendment
The amendment filed on August 7, 2026 is acknowledged. Claims 2, 4, 7, 9, 10, 16 and 18-21 remain pending, wherein claims 18-21 remain withdrawn. Applicant amended claim 2.
Response to Arguments
Despite the amendment, the outstanding claim warning and obviousness rejections are maintained. That said, Applicant's arguments with respect to the claims have been fully considered but they are not persuasive.
Regarding the outstanding claim warning, the warning has been updated to address the amended claim language.
Regarding the outstanding rejections under 35 U.S.C. 103, Applicant argues that Stoneham does not disclose the recitation, “diagnosing without further investigation, that the inflammatory response results from an infectious aetiology…”, because the mammal disclosed by Stoneham was already known to have a focal infection. Remarks 7.
The argument is not persuasive because the limitation “diagnosing” does not preclude previous assessment(s)/diagnoses. In fact, the preamble of claim 2 specifies that the mammal is “exhibiting an inflammatory response”, which suggests the method is preceded by a prior assessment of the mammal. That said, within the context of the claimed invention, “diagnosing” is indistinguishable from the re-diagnosis/confirmation taught by Stoneham as the limitation “diagnosing” is explicitly defined in claim 2 as a mental determination derived directly from observing SAA concentration exceeding 30 µg/ml. In other words, the limitation “diagnosing” does not inherently further limit the scope of a mental process such that it is distinguishable from the re-diagnosis/confirmation taught by Stoneham. A method is defined by its step(s), and in this instance the claimed “diagnosing” step is explicitly defined as a conclusion derived directly from SAA concentration exceeding 30 µg/ml, regardless of whether a separate diagnosis was previously conducted. That said, because Stoneham teaches deriving a conclusion of an infectious aetiology directly based on SAA concentration exceeding 30 µg/ml, Stoneham teaches the recitation, “diagnosing without further investigation, that the inflammatory response results from an infectious aetiology…”.
Applicant also argues that Stoneham does not correlate a concentration of SAA above 30 µg/ml with an inflammatory response resulting from an infectious aetiology. Remarks 7. According to Applicant, Stoneham teaches that levels between 27 µg/ml and 100 µg/ml may indicate “a changing SAA level” rather than an infection, meaning based on the disclosure of Stoneham, it would not have been obvious to automatically make a diagnosis of infectious aetiology without further investigation for values falling within the range. Id.
The argument is not persuasive because Applicant’s argument is not commensurate with the scope of the claims. Contrary to the implication of Applicant’s argument, the claimed invention encompasses correlating any value above 30 µg/ml with an infectious aetiology. As indicated in the rejection below, the value used for the diagnosis is 195.5 µg/ml. Consequently, Stoneham’s disclosure directed to SAA concentrations falling between 27 µg/ml and 100 µg/ml is not applicable to the rejection.
Applicant also argues that Stoneham merely correlates levels exceeding 100 µg/ml to a condition that is “highly suggestive of infection” (as opposed to a definitive diagnosis of infection), and hence based on the disclosure of Stoneham, it would not have been obvious to make a diagnosis for even very high SAA concentrations without further investigation. Remarks 8. The argument is not persuasive because the claims merely preclude “further investigation”. The claims do not preclude prior measurements or findings that, together with an SAA measurement above 100 µg/ml, can be used to make a definitive diagnosis without “further investigation”. Consequently, Applicant’s argument that it would not have been obvious to administer antibiotics based on the measurement of 195.5 µg/ml taught by Stoneham is not persuasive.
Applicant’s arguments directed to the patentability of the dependent claims derive from the patentability of claim 2. Consequently, Applicant’s arguments directed to the patentability of the dependent claims are also not persuasive.
For the foregoing reasons, the outstanding obviousness rejections are maintained, albeit they have been updated to address the amended claim language.
Claim Objections
Applicant is advised that should claim 2 be found allowable, claim 4 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Despite the amendment made to claim 2, claims 2 and 4 are identical in scope. The difference between the claims is that claim 4 requires “confirming or diagnosing” as opposed to simply “diagnosing”. However, the distinction between “confirming” and “diagnosing” is based on context that does not further limit the claimed invention (i.e. it is dependent on whether a previous test was performed, and whether a test was previously performed does not change the mental process associated with the limitations). For all intents and purposes, the limitations “confirming” and “diagnosing” are synonymous (i.e. the mental processes are identical in that they consist of interpretating the measured SAA concentration).
Arguendo, even if Applicant successfully argues that “confirming” requires a mental process that is patentably distinct from “diagnosing”, claim 4 would be rejected under 35 U.S.C. 112(d) for impermissibly broadening the scope of claim 1. Specifically, the scope of step (i) of claim 1 is limited to a step of “diagnosing”, and claim 4 broadens the scope of step (i) by adding an alternative mental step of “confirming”.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2, 4, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Stoneham.
With respect to claim 2, Stoneham discloses a method of distinguishing infectious diseases from non-infectious aetiologies in a mammal (a foal, see summary) exhibiting an inflammatory response (see left column, p. 600 disclosing “focal infection group”, which are foals clinically diagnosed with signs of infection) by determining whether the concentration of Serum Amyloid A (SAA) in a body fluid sample of said mammal is above a specified level, the method comprising:
determining a concentration of SAA in the body fluid sample of said mammal (see “Results”, left column, p. 601), and diagnosing without further investigation (the foals were already known to exhibit an inflammatory response) that the inflammatory response results from an infectious aetiology when the concentration of SAA is above a specified level of 30 µg/ml (see left column. P. 601 disclosing value of 195.5 µg/ml for “focal infection”).
The method disclosed by Stoneham differs from the claimed invention in that Stoneham does not disclose a step of administering antibiotics to treat the cause of the inflammatory response. However, given that the mammal was already known to have focal infection, and the test confirmed that the mammal is still exhibiting an inflammatory response, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have treated the mammal with antibiotics.
With respect to claim 4, as discussed above, the method is used to confirm/re-diagnose an infectious disease.
With respect to claim 9, the body fluid sample is a blood sample (see right column, p. 600).
With respect to claim 10, the mammal is a neonate (foal) (see summary).
Claims 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Stoneham as applied to claims 2, 4, 9 and 10 above, and further in view of Walshe (US 2014/0322724 A1).
With respect to claim 7, Stoneham does not explicitly disclose that the method is used to diagnose a bacterial lung infection. However, Stoneham discloses that levels exceeding 100 µg/ml “are highly suggestive of infection in young foals” and this threshold level “is a useful aid to the diagnosis of infectious disease in the young foal” (see right column, p. 602). Based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have either:
used foals suffering from a bacterial lung infection to conduct the method taught by Stoneham; or
used the method to diagnose any and all common bacterial infections known to ail foals, including lung infection. In fact, Walshe discloses that SAA can be a useful prognostic tool to assess horses recovering from respiratory infections (see [0014]), suggesting that the method taught by Stoneham is applicable for diagnosing a bacterial lung infection.
With respect to claim 16, Stoneham does not disclose the use of a portable lateral flow device (LFD) to measure the SAA.
Walshe discloses a method of measuring the concentration of SAA in a bodily fluid sample. The measurement is made using a lateral flow device (LFD) (see [0053]-[0054]), wherein the LFD comprises a housing and a flow path heading from a sample well to a viewing window through which a bodily fluid sample can flow by capillary action, wherein the viewing window provides a signal indicative of the results of the test within minutes (see Fig. 2, [0112] and [0134]). The viewing window indicates whether the SAA falls within various concentration ranges (see [0077]-[0078]). In light of the disclosure of Walshe, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used an LFD to conduct the method taught by Stoneham. The modification would enable one to perform SAA measurements anywhere and obtain immediate results. If the modification is made, then the window of the LFD would have the ability to convey multiple signals, including a signal indicating whether the SAA is below or above the specified level of 30 µg/ml (see right column of p. 602 of Stoneham disclosing different ranges of SAA corresponding to different aetiologies).
Conclusion
THIS ACTION IS MADE FINAL. 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 PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796
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