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 .
Acknowledgement is made to Applicant’s response filed 07/08/2026.
Claims 1, 3-15, and 17-26 are pending.
Claims 11-15 and 24-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/08/2026.
Claims 1, 3-10, and 17-23 are currently under consideration to the extent that they read upon Applicant’s elected species.
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 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: what the PLGA and PEG are used for. The claim recites that the mixture is used, but does not indicate in what manner or for what purpose. As such, the claim is indefinite. The claim can be read as complete without the final wherein clause, and for the sake of compact prosecution, the claim is being interpreted as such.
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.
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(s) 1, 3-10, and 17-23 (all claims currently under consideration) is/are rejected under 35 U.S.C. 103 as being unpatentable over Lendenmann et al (WO 2015/040106)(IDS Reference) and Kachniarz et al (2019).
Claim 1 of Lendenmann teaches:
a method for the self-assembled production of a topographically surface structured cellulose element (10) wherein in a first step a mold (2) with on one side a first surface (4) which is in a complementary manner topographically surface structured and which is permeable to oxygen is provided, wherein a liquid growth medium containing cellulose producing bacteria is provided, and wherein the mold (2) is placed to form a liquid/air interface of the liquid growth medium such that the side of the mold with the first surface (4) is in direct contact with the liquid growth medium, and with an opposite side (3) is facing air or a specifically provided oxygen containing gas surrounding, allowing for said bacteria to produce and deposit cellulose on said first surface (4) and developing on the interface therewith a topographically surface structured surface complementary thereto, until a contiguous cellulose layer with a thickness of the element (10) of at least 0.3mm is formed; and wherein in a second step the element (10) is removed from said mold.
Lendenmann further teaches that the composition is preferably in the form of a pouch for covering an implant, and particularly pacemakers (see entire document, for instance, claim 10 and page 8, lines 24-32). The thickness of the pouch can be 0.5-10mm (see entire document, for instance, claim 2). The pacemaker can be enclosed by suturing it into the pouch (see entire document, for instance, page 18, lines 20-23). Lendenmann, while teaching a pacemaker in a cellulose pouch, does not expressly teach the presence of a separating layer that comprises an antibiotic or directly recite the water content of the pouch.
Kachniarz teaches a polycaprolactone impregnated with linezolid and rifamipicin that was electrospun into a random pattern sheet (see entire document, for instance, page 58, left column, paragraph labeled METHODS). The sheet is designed to release the active and reduce the risk of infection. The sheet is taught as being 1mm thick (see entire document for instance, page 58, left column, paragraph labeled RESULTS).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the instantly claimed invention to utilize the anti-infective sheets of Kachniarz on the pacemaker of Lendenmann which is then placed in the pouch of Lendenmann. One would have been motivated to do so in order to help prevent infection and complications from the implanting of the pouch of Lendenmann. There would be a reasonable expectation of success since both Lendenmann and Kachniarz are directed to compositions that are implants.
It is noted that the pouch of the prior art is made by the same process as the instantly claimed pouch. As such, the water content of the pouch of the prior art would be the same as the instantly claimed pouch.
With regard to the thickness of the separating layer, it is noted that one would readily be able to optimize the thickness of the layer to ensure that the device and layer and fit within the pouch, and that the appropriate amount of active agent is present. Further, with regard to their being at least two sheets, it is noted that there are multiple sides of a pacemaker, wherein one of ordinary skill in the art would be motivated to put in sufficient number of sheets to be able to provide the anti-infection effect around the implant. As such, one of ordinary skill in the art would be motivated to put in two sheets, one on either side of the implant, in order to ensure the anti-infection effect of both sides of the implant. With regard to the amount of the active present in the separating layer, it is noted that the amount of active necessary to achieve anti-infective effects is a result effective variable, wherein one of ordinary skill in the art would be motivated to optimize the amount of the active in order to achieve the desired anti-infective effects.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR M LOVE whose telephone number is (571)270-5259. The examiner can normally be reached M-F typically 6:30-3.
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, Bethany Barham can be reached at 5712726175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR LOVE/Primary Examiner, Art Unit 1611
