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 .
Information Disclosure Statement
The references cited by applicants in the information disclosure statement filed 25 September 2006 have been made of record. Examiner has considered the voluminous references to the best of her ability.
While the statements filed do not comply with the guidelines set forth in MPEP § 2004 regarding both the number of references cited and the elimination of clearly irrelevant art and marginally cumulative information, compliance with these guidelines is not mandatory. Furthermore, 37 CFR §§1.97 and 1.98 do not require that the information be material; rather, they allow for submission of information regardless of its pertinence to the claimed invention. Also, there is no requirement to explain the materiality of the submitted references. However, the cloaking of a clearly relevant reference by inclusion in a long list of citations may not comply with Applicant’s duty of disclosure. See Penn Yan Boats, Inc. v. Sea Lark boats Inc., 359 F. Supp. 948, aff’d 479 F. 2d. 1338.
Applicant is advised that the MPEP states the following with respect to large information disclosure statements:
Although a concise explanation of the relevance of information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted. Concise explanations (especially those that point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more is highly relevant to patentability. MPEP § 609.04(a)(III).
This statement is in accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), states that forcing the Examiner to find “a needle in a haystack” is “probative of bad faith.” Id. at 1888. This case presented a situation where the disclosure was in excess of 700 pages and contained more than fifty references. Id. 1888.
The MPEP provides more support for this position. In a subsection entitled “Aids to Compliance With Duty of Disclosure,” item thirteen states:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant information and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to Applicant’s attention and/or are known to be of the most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F.Supp 948 (S.D. Fla. 1972) aff’d 479 F.2d 1338 (5th Cir 1974). See also MPEP § 2004.
Therefore, it is recommended that if any information that has been cited by Applicants in the previous disclosure statement is known to be material for patentability as defined by 37 CFR § 1.56, Applicant should present a concise statement as to the relevance of that/those particular documents therein cited.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16, 18-25 and 27-37 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2015/085234 to Erickson et al.
In the specification and figures, Erickson discloses the apparatus substantially as claimed by Applicant. With regard to claims 1-3, 18-19, 30, Erickson discloses a medicament delivery device 105 comprising a body portion 110 with an external surface defining a reservoir 130 and a port 155, defining a part of the body portion disposed to facilitate a first passage of the medicament from the reservoir, a tube 115 with first end, a lumen and second end/outlet 135 therein, defining a part of the tube portion disposed to facilitate a second passage of the medication, and a microporous core 150 disposed in the lumen (see FIGS 2A 3A, ¶0053). In an embodiment, the delivery device comprises a solid pellet medicament 160 with a fluid layer 165 such that when the drug elutes from the delivery device, it is in liquid form (see FIG 12, ¶0072-0074).
With regard to claims 4, 5, 20-22, drawn to the therapeutic state and concentration of the medicament, Applicant is setting forth the intended use of the claimed apparatus. It has been held that a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus satisfying the claimed structural limitations. See MPEP § 2114.
With regard to claims 6, 7, 10-12, 31, 32, 35-37, Erickson discloses that porous structure 150 regulates delivery of the medicament through the outlets 135 via its porosity (see ¶0065-0066).
With regard to claims 8, 33, the tube surrounds the porous core 150, comprising a coating (see FIGS 3A, 12).
With regard to claims 9, 34, Applicant sets forth that the tube is a tape wrapped around the core. Applicant fails to define a specific type of tape, which is generally known as a narrow, flexible strip or band1. Erickson discloses that the apparatus may comprise a flexible scaffold, which meets a broad definition of tape (see ¶0017, 0058).
With regard to claims 13, 14, Erickson illustrates that the external surface of the body portion comprises a first portion 112 and second portion 113, with a port 155 therebetween (see FIG 2A) on the first surface.
With regard to claims 15-16, Erickson discloses an embodiment in which the majority of the tube length comprises the reservoir 130 and partially covers the porous core 150 (see FIG 12).
With regard to claims 23-25, the port can be covered by a penetrable material that has a different porosity than the drug-eluting core and is selectively opened and closed (see ¶0063).
With regard to claims 27-29, Erickson illustrates that the first end of the various portions of the apparatus comprise an angle to one another, including right angles and parallel angles (see FIG 2A).
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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/085234 to Erickson et al.
In the specification and figures, Erickson discloses the apparatus substantially as claimed by Applicant (see rejections above). With regard to claim 17, Erickson does not disclose the portion of tube length external to the reservoir. However, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(B).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2015/085234 to Erickson et al in view of US 2008/0277332 to Liu.
In the specification and figures, Erickson discloses the apparatus substantially as claimed by Applicant (see rejections above). Erickson does not disclose a filtering membrane at the first end of the apparatus to filter medicament entering the delivery device. However, Liu discloses an ocular implant with a substrate 70 to provide a therapeutic flow therethrough, wherein the substrate comprises a filter membrane 72 to filter fluids flowing through the substrate (see at least FIG 5B and accompanying text). It would have been obvious to a person having ordinary skill in the art at the time of filing to add an entry filter as disclosed by Liu to the drug delivery apparatus disclosed by Erickson in order to provide filtration of fluid to a substrate, as taught by Liu.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Casler can be reached at 571-272-4956. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 9 October 2025
1 See Merriam-Webster’s Dictionary (https://www.merriam-webster.com/dictionary/tape), accessed 9 October 2025.