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 .
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 21 - 22 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.
Claim 21 recites that the blood vessel comprises a blood vessel of the forearm. Claim 22 recites that the blood vessel location is in an arm of the patient.
The specification does not explicitly discuss an arm or forearm location, but discloses studies involving a basilic vein of a sheep ([0076] - [0078], as published). Although the basilic vein of a sheep is understood to be located in a limb of the sheep, the disclosure of metrics performed upon a basilic vein of a sheep is insufficient to establish 112(a) possession of the genus of ‘blood vessels in the arm or forearm’ at the time of the invention.
Claims 21 - 22 are thus determined to present new matter.
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 and 4 - 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 11 of U.S. Patent No. 12,076,138. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to for ultrasound guided optoacoustic measurement of blood oxygenation. Instant claims 1 and 4 - 9 are directed towards structures for use in the method of the reference claims; and the method of instant claims 10 - 21 is suggested by the method of the reference claims. In particular:
Claims 1, 8, 9, 10, 14, 15, 16, are each suggested by reference claim 2.
Regarding claims 4, 12, and 20, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of reference claim 2 to include the recited features, in order to use conventional probes of differing shapes.
Regarding claims 5, 11, and 13, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of reference claim 2 to include the recited features, in order to facilitate positioning the probes.
Claim 6 is suggested by reference claim 5. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of reference claim 2 to include the features of reference claim 5, in order to facilitate interrogating the blood vessel.
Regarding claims 7, 18, and 19, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of reference claim 2 to include the recited features, in order to facilitate hygienic practices.
Regarding claim 17, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of reference claim 2 to include the recited features, in order to facilitate diagnosis of the patient.
Regarding claims 21 and 22, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of reference claim 2 to include the recited features, in order to facilitate interrogating blood vessels in the forearm.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 - 6 and 8 - 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bruck et al. (US 2008/0071172, of record).
Regarding claims 1 and 8, Bruck shows a patient interface comprising a holder (attachment 3, [0090] and fig. 1A; “adapted to be adjacent to a bodily area,” [0092]) having a hole opening (space 35, [0093] and fig. 1A) that is dimensioned to securely hold an ultrasound probe (ultrasound probe 2, [0090] and fig. 1A) and, in the same hole opening, securely hold an optoacoustic probe (combination of (i) fiber 6, [0090] and fig. 1A, and (ii) opto-acoustic signal receivers, [0092]).
Examiner notes that the device of claim 1 does not comprise an ultrasound probe or an optoacoustic probe. Regarding the functional language of claim 1, applicant is reminded that recitation of intended use or functional language in a claim to a device must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use or recited functions, then it meets the claim. In this case, the patient interface of Bruck is at least physically capable of being used “for ultrasound guided optoacoustic measurement of blood oxygenation in a blood vessel,” as recited in the claim’s preamble. Moreover, the patient interface of Bruck is at least physically capable of being used with an optoacoustic probe that is “subsequently applied to a site on a patient,” as evidenced by [0100] - [0103], which discusses optoacoustic measurement of blood oxygenation (step 3, [0103]) after obtaining an ultrasound image (step 1, [0101]). Further, the patient interface of Bruck is at least physically capable of being used at a site “where the ultrasound probe is able to detect a major vein and the optoacoustic probe is able to detect blood oxygenation in the detected major vein.” The patient interface of Bruck therefore meets the claim.
Regarding claim 4, Bruck discloses the claimed invention substantially as noted above. Further, the patient interface of Bruck is capable of being used with an ultrasound probe and optoacoustic probe that have different geometric shapes (see different probe shapes in fig. 1A).
Regarding claim 5, Bruck discloses the claimed invention substantially as noted above. Further, the patient interface of Bruck includes a sloping rest structure adjacent to the hole opening (see any sloped surface in fig. 1A).
Regarding claim 6, Bruck discloses the claimed invention substantially as noted above. Bruck further shows that the holder is configured to securely hold the optoacoustic probe at an angle different from that of the ultrasound probe (see angles of the probes in fig. 1A).
Regarding claim 9, Bruck discloses the claimed invention substantially as noted above. Bruck further shows a processor configured to approximate blood oxygenation of the detected blood vessel (step 3, [0103]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bruck in view of Adams et al. (US 5,997,481).
Regarding claim 7, Bruck discloses the claimed invention substantially as noted above.
Bruck fails to show a disposable cover that is applied over a surface of the patient interface.
Adams discloses a probe cover for an ultrasonic imaging probe (a disposable, sterile probe cover or sheath is typically placed over the probe prior to use with each patient, and discarded after the examination is complete, col. 1, lines 32 - 36).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the invention of Bruck to include a disposable cover that is applied over a surface of the patient interface, as taught by Adams, in order to facilitate hygienic practices, as is conventional in the art.
Response to Arguments
Applicant's arguments filed 7/1/2025 have been fully considered but they are not persuasive.
Applicant's comments on page 7 regarding the Double Patenting rejections are acknowledged. The rejections are deemed proper and are maintained.
Applicant argues on page 7 that Bruck does not teach the amended features of claim 1.
This is not persuasive for reasons explained in the art rejections above.
Conclusion
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 AMELIE R DAVIS whose telephone number is (571)270-7240. The examiner can normally be reached Monday-Friday, 9:30 - 6:00 PST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at (571)272-72714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIE R DAVIS/Primary Examiner, Art Unit 3798