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 .
Election/Restrictions
Applicant's election with traverse of Species D (Fig. 9 – i.e. assembly 200 with a porous membrane 224 and opposed filling septum 238) in the reply filed on 14 October 2025 is acknowledged. The traversal is on the ground(s) that the identified Species D-F are “variations on a common configuration, of a drug delivery assembly having a housing with at least one open end and an external textured section. It would not be a burden and would be more efficient, for the Patent Office to consider the patentability of Species D-F”. This is not found persuasive. Specifically, while the disclosed species do present with some shared characteristics (reflected in the presence of SOME generic claims) the presence of search burden does not present from these shared characteristics (which will be commonly examined), but rather the divergent features. Specifically, Species C (Fig. 5-8) presents with opposed porous membranes (224, 226) and opposed end of the housing (212) whereby these porous membranes each regulate the delivery of drug/active agent therethrough (Par. 121). Species D (Fig. 9) replaces the second porous membrane with a septum member (238) which serves as a fillable access point for active agent to be introduced to the system, but does not permit release of the medicament therefrom like a porous membrane does (Par. 128). Species E (Fig. 10-11), instead of having a porous membrane or a septum, presents with a “loading port 240”, which while permitting filling of the housing therethrough does so in a different manner than the septum (238) of Species D since it does not present with a septum to prevent egress of the medicament therefrom. Species F (Fig. 12) presents with a completely sealed/closed off second end (Par. 130) which does not permit the egress of drug (like Species C) or the refilling of the housing (like Species D and E). While these species do share a common concept of a housing with an external textured section and a first drug release port having a porous membrane, the second ends diverge from one another in both form and utility. A burdensome search would be required to separately address the function of each separate and distinctive second end with consideration as to how these different second ends would alter operation of the device and would be read upon by distinctive prior art or combinations of prior art. Examiner submits that in the event it is a common, shared feature that defines and distinguished over the prior art all species will be enjoined and (if as alleged by Applicant such features form a novel and nonobvious common configuration of invention) then there will be no imposition upon Applicant. However, in the event that the shared subject matter is not distinctive over the prior art then search and examination will necessarily diverge between the identified species with separate considerations as to whether or not these distinctive features are separately patentable over the prior art whereby burdensome search and examination will be clearly sustained.
Examiner notes that while elected Species D (Fig. 9) was suggested to read upon Claims 26-31 and 34, Claim 28 is not held to be directed toward the invention of Species D. Specifically, Claim 28 requires “a second porous membrane secured to the first end of the housing via a second end cap”. However, the septum (238) of the elected Species D (Fig. 9) is not a porous membrane, but rather presents as a septum to be “attached to a filling apparatus or the like in order to fill compartment 214”.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 26, 29, and dependents thereof is/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.
Regarding Claim 26, Applicant recites “raised textures on the housing of from 200 to 500 microns” [emphasis added]. However, the grammar of this claim creates confusion as to what exact structure is being claimed. The use of two prepositions is grammatically incorrect and the meaning of “of” implies a function word to indicate the component material, parts, or elements of the contents, while the meaning of “from” implies a function word used to indicated a starting point in measuring or reckoning or in a statemen to limits. It is unclear if Applicant is claiming a textured element, wherein the height of the textured elements lies in a range between 200 to 500 microns (inclusive) OR if Applicant is claiming textured elements which vary in height from a starting point of 200 microns and increasing in size to reach an endpoint of 500 microns. For the sake of prosecution it will be presumed that the claim is requiring textured elements wherein the textured elements have a height of at least 200 microns, but no more than 500 microns.
Regarding Claim 29, Applicant recites “and wherein the area that is external to the housing includes subcutaneous tissue”. However, this limitation creates confusion as to whether Applicant is attempting to functionally claim the device as being configured for implantation into subcutaneous tissue or if Applicant is attempting to assert the positive state of the device being ACTUALLY implanted in subcutaneous tissue. For the sake of prosecution it will be presumed that the claim functionally requires the device to be configured for such a utility without attempting to assert that the device is positively provided in such a state such that the subcutaneous tissue presents as part of the claimed workpiece.
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.
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) 26, 27, 29, 30, 31, 34, is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/139896 (“Steele”) in view of U.S. Publication No. 2019/0224322 (“Watkins”) and U.S. Publication No. 2005/0203637 (“Edman”).
Regarding Claims 26 and 34, Steele discloses a drug delivery assembly (Fig. 14B) comprising:
A housing (1404) which extends from a first end (circa 1405) to a second end (circa 1406), the housing defining a first compartment (1400);
An opening (see the negative space closed by porous membrane 1402) in the housing in communication with an area which is external to the housing;
A first porous membrane (1402) positioned proximal to the opening.
Steele discloses the invention substantially as claimed except that that the first porous membrane is “secured to the housing via a first end cap”. Steele provides a “bottom” (1405) for closing off the housing end with the porous membrane, but fails to explicitly disclose how this bottom and porous membrane are structurally connected to one another and the remainder of the housing. However, Watkins discloses a related drug delivery assembly (Fig. 1A) which is provide a housing (12) defining a compartment (14) wherein an opening of the end of the housing is closed off first porous membrane (e.g. 22) provided proximal thereto with the membrane secured to the housing via a first end cap (20 – Par. 116; see Fig. 1C-1K illustrative of various arrangements for securing the porous membrane to the end via an endcap). It would have been obvious for one having ordinary skill in the art at the time the invention was made to secure the porous membrane of the invention of Steele to the housing using an end cap, as disclosed by Watkins, in order to provide a specific, known solution by which such a porous membrane can be secured to the housing in an expected and predictable manner to permit assembly of the device. It has been held that constructing a formerly integral device as a plurality of separately formed parts to be affixed together requires only routine and customary skill in the art and is obvious, particularly where explicitly directed, see Nerwin v. Erlichman, 168 USPQ 177, 179 and In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Steele, as modified, discloses the invention substantially as claimed except that housing comprises a “textured section” thereon which includes a raised texture from 200-500 microns. Steele discloses that the device can be configured to be fixed to an anatomy, but only accomplishes this via surgical loop filaments (1408 – Par. 6, 74). However, Edman disclose related drug delivery assemblies (Abstract) which can be adhered to patient tissue via micron scale ingrowth features in the form of textured sections including raised textures such as a plurality of grooves, channels, pits or other surface topologies to promote surrounding tissue acceptance (Par. 31 – see e.g. Fig. 2-5) wherein the scale of these raised textures may range from 2 to 500 microns depending on application (Par. 30, 32, 33). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the housing of Steele to have a textured surface having raised texture features having a height between 200 and 500 microns (inclusive) and configured as a plurality of grooves, as disclosed by Edman, in order to encourage tissue ingrowth thereby assisting in securing the device in place in the tissue for long term adhesion.
Regarding Claim 27, Steele, as modified by Watkins, discloses the first end cap includes a hood-like feature designed to prevent fibrosis from impeding the diffusion properties of the first porous membrane (see Watkins – Fig. 1, element 1 as it lies over the porous membrane 2 in a hood-like manner to enshroud and recess the membrane). While Watkins fails to explicitly acknowledge the prevention of “fibrosis from impeding the diffusion properties of the first porous membrane” given the shared physical structure and the lack of any specific disclosure by Applicant as to the presence dimensions which permit the disclosed endcap from attaining this function, it must be presumed that the endcap of Watkins (as provided in modification to Steele) would operate in the same manner (particularly pursuant to different rates of tissue fibrosis expected to be encountered from patient to patient and depending upon implantation site).
Regarding Claim 29, Steele discloses the first compartment is configured and dimensioned to house drug or active agent particles (Abstract; Par. 74), that the device is configured to be implanted subcutaneously (Par. 80), wherein a range of a mean pore size of the first porous membrane is between 0.10 to 100 μm (Par. 6).
Regarding Claim 30, Steele discloses the invention substantially as claimed except that housing is fabricated from zinc or titanium. Specifically, Steele is silent as to the composition of housing (1404). However, Watkins discloses that related devices may be formed of titanium (Par. 146). It would have been obvious for one having ordinary skill in the art at the time the invention was made to construct the housing of Steele of titanium, as disclosed by Watkins, in order to select a known, suited material well-known in the art for its biocompatibility to ensure minimal tissue site reactions from implantation. It has been held that selecting a known material recognized by the art for its suitability in a specific purpose is obvious and requires only routine and customary skill in the art, see In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCPA 1960).
Regarding Claim 31, Steele discloses a septum member (1403) secured to the first end of the housing via a second end cap (1410 – Par. 74).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, KEVIN SIRMONS can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 12/15/2025