DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 33-49 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 33 in the last line refers to “the elongated housing”; there is insufficient antecedent basis for this limitation in the claim as earlier the claim defines an elongate housing (no d). The same issue is found in claim 49. For the purposes of examination, all references will be treated as though to an elongate housing; correction is required.
Claim 48 now defines a channel which is “configured to… improve aqueous humor”. It is entirely unclear how a channel can improve a fluid – does the channel somehow alter the composition of the fluid? Or is the channel somehow used to improve some other aspect of the fluid? Clarification is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 33-42, 45, 47 is/are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Marshall (US 2012/0302861; see also WO 2012/146740).
Regarding claim 33, Marshall discloses an implantable physiological measurement device comprising:
a sensing module configured to output a signal representative of intraocular pressure in an anterior chamber of an eye (paragraph [0043]; element 510 which comprises elements 605, 610);
an antenna (element 520) and a transmitter, each of which is disposed on a flexible carrier member (element 620) and configured to wirelessly communicate intraocular pressure measurements to an external device (paragraph [0045]); and
a battery configured to supply operating power to the device (paragraph [0149]);
wherein the flexible carrier member is disposed within an elongate housing (figures 5-8; figure 5 shows a generally elongate shape and figures 6-8 show the carrier member inside the housing) having a fluid channel with a fluid inlet port and a fluid outlet port (paragraph [0102], [0103]), such that the antenna, the transmitter, and the battery are disposed inside the elongate housing (figures 6-8),
the elongate housing being sized and shaped to be at least partially implanted in the supraciliary/suprachoroidal space of the eye (figure 2),
wherein the sensing module is disposed at a proximal end of the elongate housing, such that the sensing module resides in the anterior chamber of the eye when a distal end of the elongate housing, along with at least a portion of the antenna or battery, resides in the supraciliary/suprachoroidal space (paragraph [0046]; figures 2, 5), and
wherein the sensing module is detachable from the proximal end of the elongated housing (any two objects are inherently able to be detached at least once and are thus detachable, particularly in the absence of any particular definition of how the detachment is achieved, any structural features involved in detaching, or any subsequent characteristics relating to being detached such as being reattached, such that Marshall’s sensing module is thus “detachable” from the housing).
Regarding claim 34, Marshall further discloses a controller module disposed on the flexible carrier member (paragraph [0043], [0149]-[0154]).
Regarding claim 35, Marshall further discloses that the controller module is configured to perform data compression on the intraocular pressure measurements (paragraph [0162]).
Regarding claim 36, Marshall further discloses that the controller module is configured to cause the sensing module or the transmitter to shut down or enter a power-saving state when the sensing module is not in use (paragraphs [0165]-[0172]).
Regarding claim 37, Marshall further discloses a signal conditioning and analog-to-digital conversion module disposed on the flexible carrier member (paragraphs [0150]-[0154], [0161]).
Regarding claim 38, Marshall further discloses a measurement storage device that is configured to store intraocular pressure measurements (paragraph [0161]).
Regarding claim 39, Marshall further discloses that the device is configured to automatically measure intraocular pressure at least every hour (paragraph [0162]).
Regarding claim 40, Marshall further discloses that the device is configured to automatically measure intraocular pressure at least every 15 minutes (paragraph [0162]).
Regarding claim 41, Marshall further discloses that the device is configured to automatically measure intraocular pressure at least every minute (paragraph [0162]).
Regarding claim 42, Marshall further discloses that the elongate housing is biocompatible (abstract).
Regarding claim 45, Marshall further discloses that the proximal end of the elongate housing includes a flange to prevent over-insertion of the device within the supraciliary/suprachoroidal space of the eye (figure 5, formed by element 560).
Regarding claim 47, Marshall further discloses that the elongate housing has a “length” of 22 mm or less (paragraph [0110]; the Examiner notes that “length” is a relative term dependent upon a user’s orientation when presented without any other context, and Marshall discloses that at least one dimension of the device which could be considered its “length” is less than 22 mm).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 46 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marshall (US 2012/0302861; see also WO 2012/146740).
Regarding claim 46, Marshall does not further disclose the elongate housing being “generally cylindrical” and having a diameter of 0.6mm or less. However, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have made the elongate housing “generally cylindrical” with a particular diameter less than 6mm, since Applicant has not disclosed use of this particular shape and size as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the average values used by both Marshall and the Applicant, particularly as there is no disclosure of what level of cylindricality is required to be considered “generally cylindrical” and the disclosure contemplates numerous other shapes as being equal in merit or even potentially more advantageous (paragraph [0070] as filed) and Marshall’s device is elongated with rounded edges on its cross-section, see figures 5, 7, making it “generally cylindrical”. Moreover, it appears that a “generally cylindrical” device or a more flattened device would perform equally well to allow monitoring of intraocular pressure. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Marshall to have a “generally cylindrical” elongate housing with a diameter of 6mm or less, , because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Marshall.
Claim 43 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marshall in view of Alt (US 2005/0137480).
Regarding claim 43, Marshall teaches a battery but does not specify its output; Alt teaches an implantable device with a battery having a power output of at least 10 µW (paragraph [0058)). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the device of Marshall with the battery having a power output of at least 10 µW, as taught by Alt, in order to allow for a small, compact design and efficient power consumption.
Claim 44 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marshall in view of Silvestrini (US 2009/0182421).
Marshall does not disclose the distal end of the elongate housing also including a barbed retention feature; Silvestrini teaches an implantable measurement device configured to be at least partially implanted in a supraciliary/suprachoridal space of an eye (paragraph [0007]) which includes on its distal end of its elongate housing a barbed retention feature to maintain the device within the supraciliary/suprachoroidal space of the eye (paragraph [0108]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the device of Marshall with a barbed retention feature on the distal end of the elongate housing, as taught by Silvestrini, in order to maintain the device in its desired location.
Claim 48 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marshall in view of Tai (US 2010/0294041).
Regarding claim 48, Marshall does not disclose particulars of the sensing module, such as the sensing module comprising a channel configured to serve as a fluid channel and/or to improve aqueous humor across the sensing module. Tai teaches a sensing module for sensing intraocular pressure (abstract) comprising a channel configured to serve as a fluid channel (elements 216; paragraphs [0053], [0054]; the channels are connected to the chamber such that the chamber fluid would also be in the channels, thus fluid channels). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the device of Marshall with a channel in the sensing module configured to serve as a fluid channel, as taught by Tai, in order to enable sensing of external pressure.
Allowable Subject Matter
Claim 49 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The prior art of record fails to anticipate or make obvious the subject matter of claim 49, including, inter-alia, a device comprising a sensing module configured to measure intraocular pressure, the sensing module disposed at an end of an elongate housing having within an antenna, transmitter, flexible carrier, and battery, the sensing module being configured to reside in the anterior chamber of the eye while the remainder of the housing extend into the supraciliary/suprachoridal space, where the sensing module comprises a channel configured to physically mate with the proximal end of the elongate housing and is detachable from the proximal end of the elongate housing, in combination with all other limitations in the claims.
Marshall discloses a similar device, but Marshall’s sensor module is within the elongate housing at its proximal end, such that it cannot also comprise a channel to mate with that proximal end.
Response to Arguments
Applicant's arguments filed 13 March 2026 have been fully considered but they are not persuasive.
Regarding the objections to drawings and 112a rejections, these have been obviated by the amendments to the claims; Applicant’s remarks will not be further addressed.
Regarding the art rejections, Applicant argues only that the sensor module of Marshall is not detachable from its elongate housing; as this is not the case, as set forth above, these arguments are moot.
The Examiner notes that Applicant’s arguments do not address any teachings of Alt or Silvestrini.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 6579235 to Abita.
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 KAREN E TOTH whose telephone number is (571)272-6824. The examiner can normally be reached Mon - Fri 9a-6p.
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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAREN E TOTH/Examiner, Art Unit 3791
Prosecution Insights