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 .
Continued Examination Under 37 CFR 1.114
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. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 28, 2026 has been entered.
Claims 2, 4, 5, 7, 9, 10, 16 and 18-21 remain pending wherein claims 18-21 remain withdrawn. Applicant amended claims 2 and 5.
Response to Arguments
The amendment necessitated the new grounds of rejection set forth below, rendering moot Applicant’s arguments with respect to the patentability of the claims.
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).
In light of the amendment made to claim 2, claims 2 and 4 appear to be identical in scope.
Claim Rejections - 35 USC § 112
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, 5, 7, 9, 10 and 16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 2 was amended to recite a conditional step (see “confirming or diagnosing…when the concentration of SAA…”). It is unclear whether step (ii) is also a conditional step, or whether it is conducted regardless of whether the condition in step (i) is satisfied.
Relatedly, claim 5 is indefinite because it, via reference to claim 2, recites a step of administering an anti-infective. It is unclear if claim 5 intends to include step (ii) of claim 2. Based on the fact that the intent of the claimed method is to identify/confirm a non-infectious aetiology, step (ii) is presumed to be NOT part of claim 5. Nevertheless, further clarification is requested.
Claims not explicitly rejected are rejected due to dependency.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 5 is rejected under 35 U.S.C. 102(a)(2) as being anticipated by Walshe (US 2014/0322724 A1).
With respect to claim 5, Walshe discloses a method of confirming a non-infectious aetiology in a mammal (e.g. a horse, human, see [0024]), the method comprising:
determining a concentration of SAA in the body fluid sample of a mammal exhibiting a non-infectious aetiology (see [0129]), and confirming the non-infectious aetiology if the concentration of SAA is below a specified level of 30 µg/ml (see [0129] and Table 1 correlating concentration of SAA to “normal” disclosed in [0129]).
As discussed above (see rejection of claim 5 under 35 U.S.C. 112), it is presumed that claim 5 intends to exclude step (ii) recited in claim 2.
Claim Rejections - 35 USC § 102
Claim 5 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stoneham, “Measurement of serum amyloid A in the neonatal foal using a latex agglutination immunoturbidimetric assay: determination of the normal range, variation with age and response to disease” (see IDS).
With respect to claim 5, Stoneham discloses a method of confirming a non-infectious aetiology in a mammal (a foal, see summary), the method comprising:
determining a concentration of SAA in the body fluid sample of a mammal exhibiting a non-infectious aetiology (see right column, p. 599 disclosing “healthy animals”), and confirming the non-infectious aetiology if the concentration of SAA is below a specified level of 30 µg/ml (see Fig. 3 and left column, p. 601).
As discussed above (see rejection of claim 5 under 35 U.S.C. 112), it is presumed that claim 5 intends to exclude step (ii) recited in claim 2.
Claim Rejections - 35 USC § 103
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 left column, p. 601), and confirming without further investigation (the foals were already diagnosed) 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).
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, 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, the claim is identical in scope to claim 2. Consequently, claim 4 is also rejected.
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.
With respect to claim 7, Stoneham does not explicitly disclose that the method is used to diagnose or confirm 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.
As discussed above, 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 Stoneham disclosing different ranges of SAA corresponding to different aetiologies).
Conclusion
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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