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 Objections
Claim 16 is objected to because of the following informalities: Claim 16 recites “wherein the barrier is comprised of a material comprises”. Appropriate correction of this grammatical error is required.
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, 3-16 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.
Claim 1 (the rest by dependency) recites “the barrier”. It is unclear if Applicant is referring to the “disposable barrier” recited in claim 1 or another barrier.
Claim 13 recites “a user”. It is unclear if Applicant is referring to the user recited in claim 1 or another user.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 2-4, 11-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by George et al. (US 20170172486 A1 – cited by Applicant), hereinafter George.
Regarding Claim 1, George teaches: A prostate measurement system (figure 1) comprising:
a measurement assembly (figure 1; element 104) operably couplable to a control unit (element 106) and comprising a probe configured to collect measurement data associated with a patient's anatomy during an examination procedure (figure 2; paragraph 0114-0118); and
a disposable barrier shaped and/or sized to be removably fitted over the probe and provide a sterile layer of protection between a patient's anatomy and the probe during performance of the examination procedure (paragraph 0120; membrane 112; figure 1-2); wherein the barrier comprises:
a closed distal end shaped and/or sized to fully accommodate the probe within (figure 2); and
an open proximal end shaped and/or sized to allow for the probe and portions of the measurement assembly to pass therethrough and to further accommodate a user's hand (figure 2-3); and a rigid insert member provided within an interior of the barrier and positioned adjacent to the closed distal end (paragraph 0021 – substrate of polyethylene), the rigid insert member comprising an aperture shaped and/or sized to allow for a user's finger and the probe mounted thereto to pass therethrough and into the distal end of the disposable barrier (paragraph 0126; 0023; 0021; figures 14-17), wherein the aperture is substantially centered with the distal end of the disposable barrier to thereby effectively center and provide a guide for the user's finger into the distal end so as to avoid any unintentional contact with an interior surface of the disposable barrier until the user's finger equipped with the fingertip probe is sufficiently advanced into the distal end of the disposable barrier (figure 14-15).
Regarding Claim 3, George teaches: The prostate measurement system of claim 2, wherein the closed distal end comprises an inner diameter that is greater than an outer diameter of the probe (figure 2).
Regarding Claim 4, George teaches: The prostate measurement system of claim 3, wherein the closed distal end is shaped and/or sized to fully accommodate the probe within when an inflatable portion of the probe is fully inflated (figure 2; paragraph 0120).
Regarding Claim 11, George teaches: The prostate measurement system of claim 1, wherein the barrier comprises a durable material capable of withstanding pressure placed upon the barrier and resisting tearing during performance of the examination procedure (paragraph 0120).
Regarding Claim 12, George teaches: The prostate measurement system of claim 1, wherein the barrier comprises a flexible material allowing for sufficient tactile feedback to be felt by the user when the user is performing the examination procedure with the probe (paragraph 0120).
Regarding Claim 13, George teaches: The prostate measurement system of claim 12, wherein the probe is configured to be mounted to a user's finger (figure 2) and the probe is to be used in a digital rectal examination (DRE) procedure (paragraph 0179; figure 1).
Regarding Claim 14, George teaches: The prostate measurement system of claim 1, wherein the barrier is single use (paragraph 0114).
Regarding Claim 15, George teaches: The prostate measurement system of claim 1, wherein the barrier comprises a non-stick material allowing for improved and unobstructed insertion and withdrawal of the probe into and out of the interior of the barrier (paragraph 0120; Vytex is a known non-stick coating).
Regarding Claim 16, George teaches: The prostate measurement system of claim 15, wherein the barrier is comprised of a material comprises a coating provided on an interior surface thereof that exhibits non-stick properties (paragraph 0120).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over George.
Regarding Claim 5, George teaches: The prostate measurement system of claim 2 but does not explicitly mention wherein the closed distal end comprises a first inner diameter of at least 41 mm and a second inner diameter of at least 101 mm. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system wherein the closed distal end comprises a first inner diameter of at least 41 mm and a second inner diameter of at least 101 mm as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Regarding Claim 6, George teaches: The prostate measurement system of claim 2, but does not explicitly mention wherein the closed distal end comprises a length of between 10 cm and 50 cm. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system wherein the closed distal end comprises a length of between 10 cm and 50 cm as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Regarding Claim 7, George teaches: The prostate measurement system of claim 6, but does not explicitly mention wherein the closed distal end comprises a length of between 15 cm and 25 cm. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system wherein the closed distal end comprises a length of between 15 cm and 25 cm as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Regarding Claim 8, George teaches: The prostate measurement system of claim 2, but does not explicitly mention wherein the barrier comprises an overall length of between 50 cm and 150 cm. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system wherein the barrier comprises an overall length of between 50 cm and 150 cm as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Regarding Claim 9, George teaches: The prostate measurement system of claim 7, but does not explicitly mention wherein the barrier comprises an overall length of between 75 cm and 100 cm. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system wherein the barrier comprises an overall length of between 75 cm and 100 cm as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Regarding Claim 10, George teaches: The prostate measurement system of claim 8, but does not explicitly mention wherein the barrier comprises an overall length of approximately 90 cm. However, it would have been obvious to one of ordinary skill in the art, before the effective filing date to have modified the system wherein the barrier comprises an overall length of approximately 90 cm as it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involve only routine skill in the art (In re Aller, 105 USPQ 233; MPEP 2144.05 II A).
Response to Arguments and Amendments
Regarding 112 Rejection, Applicant’s amendments have been fully considered. Some rejections were withdrawn. Other rejections were maintained.
Regarding Prior Art rejections, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. The rejections are maintained.
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 JAY B SHAH whose telephone number is (571)272-0686. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at 571-272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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JAY SHAH
Primary Examiner
Art Unit 3791
/JAY B SHAH/Primary Examiner, Art Unit 3791
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