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
Applicant’s response filed 22 April 2026 has been received and entered. Claim 17-18, 34 and 36 have been amended and claims 1-16, 19-20, 22-24, 26, 29-33, 49, 52 and 55 have been canceled. Claims 17-18, 21, 25, 27-28, 34-48, 50-51, 53-54 and 56-57 are currently pending in the instant Office action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any objection or rejection of record which is not expressly repeated in this action has been overcome by Applicant’s response and withdrawn.
Applicant’s arguments filed 22 April 2026 have been fully considered but are not deemed to be persuasive.
Withdrawn Rejections
The previous rejections which were made under 35 USC §103 are withdrawn in light of the amendment to the claims for the recitation of “wherein at the time the sample was taken, the subject met all parameters for being issued a hospital discharge decision”. If this limitation is later removed due to rejections which follow, the art rejections may be reintroduced.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 17, 18, 34 and 36 (and dependent claims 21, 25, 27-28, 35, 37-48, 50-51, 53-54 and 56-57) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claims 17, 18, 34 and 36 have been amended to recite the limitation “wherein at the time the sample was taken, the subject met all parameters for being issued a hospital discharge decision”. The instant specification as originally filed does not provide support for such a limitation and therefore, the claims are considered new matter.
Response to Arguments
Applicant asserts that Example 12 provides support for the current claim limitation as asserting that the patients were discharged and “obviously met the requirements that the subject met all parameters for being issued a hospital discharge decision”. Applicant’s argument has been fully considered, but is not found persuasive. There is no evidence that any consideration regarding “parameters” was made or even what those parameters may have been or what they encompass. Additionally, Example 12 does not prepare a sample from a subject at discharge. Example 12 is found on pages 87-89 and clearly states that “plasma samples for ADM measurement were obtained on admission”. There is no sample which is taken at discharge. Therefore, the claims are new matter.
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 17-18, 21, 25, 27-28, 34-48, 50-51, 53-54 and 56-57 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.
Claims 17, 18, 34 and 36 recite “wherein, at the time the bodily fluid obtained from the subject, the subject had received diuretics as a therapy for said acute heart failure, the subject was not diagnosed as suffering from residual congestion, and the subject was suffering from residual congestion”. Claims 21, 25, 27-28, 35, 37-48, 50-51, 53-54 and 56-57 are dependent on claims which include this limitation.
The claims are internally inconsistent. In order to execute the claimed method, one would need to know if the subject was suffering from residual congestion but the claims also require that the subject not be diagnosed as suffering from residual congestion. The claims are indefinite and unclear because one or ordinary skill in the art can’t know if they are preparing a sample which reads on the instant claims or not because the subject is not diagnosed with residual congestion but they are suffering from residual congestion which one would only know if there is a diagnosis. The claims are circular and internally inconsistent and therefore, unclear and indefinite.
Response to Arguments
Applicant argues at page 9 of the response definiteness concerns the question of whether one skilled in the art would understand the scope of what is being claimed and that there is no reasonable question in this case as to what the scope of the claims are. Applicant asserts that the rejection’s point of contention is that one skilled in the art would allegedly not known when they are infringing the claims. Applicant asserts that the metes and bounds of the claims are very clear because if a patient has undiagnosed residual congestion, they are in the scope of the claim and if they do not have residual congestion or if they have diagnosed residual congestion, they are not within the cope of the claim.
Applicant’s argument has been fully considered, but is not found persuasive. Applicant is referred to MPEP § 2173:
It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art of the boundaries of protected subject matter.
The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what the inventor or a joint inventor regards as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph with respect to the claimed invention.
The Examiner cannot envision how one of ordinary skill in the art would be apprised of the metes and bounds of the claims if the subject is to be one that suffers from residual congestion but has not been diagnosed from residual congestion. While one may clearly suffer from a condition which is not diagnosed, one of ordinary skill in the art would not be able to determine if said subject falls within the scope of the claimed invention if they have not been diagnosed. Infringement necessarily involves a determination of the metes and bounds of the claims. This is the reason that the claims must be definite; so that one of ordinary skill in the art will know what the boundaries of the claimed invention are such that they do not infringe the claims.
Claims 17, 18, 34 and 36 have been amended to recite the limitation “wherein at the time the sample was taken, the subject met all parameters for being issued a hospital discharge decision”. Claims 21, 25, 27-28, 35, 37-48, 50-51, 53-54 and 56-57 depend from these claims. The metes and bounds of “all parameters for being issued a hospital discharge decision” is indefinite as the instant specification fails to indicate what such parameters would be or which parameters are intended. One of ordinary skill in the art would not be apprised of what these parameters are as there is no standardized set of parameters for every hospital and such parameters may vary based on locality. Therefore, the metes and bounds of the claims cannot be determined.
Conclusion
No claim is allowed.
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 Christine J Saoud whose telephone number is (571)272-0891. The examiner can normally be reached M-F, 6am-2:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Z Wu, can be reached on 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Christine J Saoud/Primary Examiner, Art Unit 1647
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