DETAILED ACTION
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a flow restriction device, a pressure variance mechanism, a gross volume measurement system, a hydrostatic pressure determination system, and a CVP analysis system in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-14 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 1 recites a gross volume measurement system configured “to determine a plurality of gross volumes of the terminal aspect of the limb, where each gross volume is determined at a transmural pressure that is different from the transmural pressures at which other gross volume determinations are made”. It’s not clear whether this determination of a plurality of gross volumes is made concurrently (e.g. via measurement at multiple sites at the same time with different applications of transmural pressures at each site) or at disparate times (e.g. where each measurement is made at a separate time with a different application of transmural pressure at each point in time) or even a combination of both.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,144,596. Although the claims at issue are not identical, they are not patentably distinct from each other because various combinations of claims recite similar subject matter.
For example, the ‘596 patent recite an enclosure for determining CVP of an individual (claim 1, preamble) comprising:
(a) an enclosure having an inside volume and separating the inside volume from the atmosphere external to the enclosure and having an aperture allowing communication between the inside volume and the atmosphere external to the enclosure and configured to receive a terminal aspect of a limb of the individual into the inside volume through the aperture (claim 4);
(b) a flow restriction device at the aperture enabling a pressure difference between the inside volume and the atmosphere external to the enclosure (claim 8);
(c) a pressure variance mechanism configured to vary transmural pressure on the terminal aspect of the limb within the inside volume (claim 4);
(d) a gross volume measurement system responsive to the gross volume of the terminal aspect of the limb and configured to determine a plurality of gross volumes of the terminal aspect of the limb, where each gross volume is determined at a transmural pressure that is different from the transmural pressures at which other gross volume determinations are made; (claim 1 – assessing changes as the system varies the transmural pressure)
(e) a hydrostatic pressure determination system configured to determine a vertical distance between the terminal aspect of the limb and the heart of the individual, and to determine a hydrostatic pressure from the vertical distance (claim 1 – height information system); and
(f) a CVP analysis system configured to determine central venous pressure of the individual from the hydrostatic pressure and from the plurality of gross volumes and the corresponding transmural pressures (claim 1 – CVP determination system).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art of record fails to teach and/or fairly suggest, the determination of a central venous pressure of an individual by passing a terminal part of a limb into an aperture of an enclosure/flow restriction device and varying pressure on the terminal aspect of the limb and determining a plurality of gross volumes to determine central venous pressure of the individual. Ward et al. (US 2004/0044290) teaches the measurement of CVP by applying varying pressure on a limb of a user, but fails to teach that the limb is inserted into an enclosure ([0020]). Kleinberg (NPL - "A Volume-Displacement Plethysmograph to Measure Limb Blood Flow in the Newborn Infant") teaches that a closed enclosure can be used to determine volume changes but not the pressure variance mechanism as recited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIAN JANG whose telephone number is (571)270-3820. The examiner can normally be reached Monday-Friday (7-3:30 EST).
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 6/11/26
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