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 .
Response to Amendment
The Amendment filed 9/8/2025 has been entered. Claims 108, 109, 114, 116, 126 and 127 remain pending in the application.
Specification
The disclosure is objected to because of the following informalities:
The reference character “602” has been used to refer to “a threaded female shaft access” in paragraph 0061 and “upper edge” in paragraph 0063.
Appropriate correction is required.
Claim Objections
Claims 108 and 126 are objected to because of the following informalities:
Regarding claim 108, line 6, the recitation “polycaprolactone (PCL) and polylactic-co-glycolic” appears to be amended to recite “polycaprolactone (PCL) or polylactic-co-glycolic” in order to clearly indicate that synthetic absorbable material comprises one of the listed materials.
Regarding claim 126, line 2, the limitation “a therapeutic agent” appears to be amended to recite “the therapeutic agent” in order to refer to “at least one therapeutic agent” recited in claim 108, line 1.
Appropriate correction is required.
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 108 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gardner (US 2017/0319832 A1).
Regarding claim 108, Gardner teaches a device 100 (figure 1, element 100 is capable to deliver therapeutic agent) for delivering at least one therapeutic agent to an organ or tissue for treating a disease, comprising:
a brush 110 of a synthetic absorbable material (paragraph 0026, lines 4-8); and
a handle 120, wherein a distal end (end of element 120 connected to element 110) of the handle is affixed to the brush 110 or a brush head (head of element 110),
wherein the synthetic absorbable material comprises polydioxanone (PDS), polylactic acid (PLA), polyglycolic acid (PGA) (paragraph 0026, lines 4-8), polycaprolactone (PCL), and polylactic-co-glycolic acid (PLGA).
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(s) 108, 109, 114 and 116 are rejected under 35 U.S.C. 103 as being unpatentable over Slokovic et al. (US 8,783,451 B2) in view of Mao et al. (US 2016/0135657 A1).
Regarding claim 108, Slokovic discloses a device 120 (figure 4E, 3B) for delivering at least one therapeutic agent (column 5, lines 34-40) to an organ or tissue for treating a disease, comprising:
a brush 132 of a synthetic absorbable material (column 1, line 67-column 2, line 4, low density polyethylene does have capacity to absorb a material, claim does not recite whether the material is high absorbable or low absorbable therefore, a small amount of absorbable material would also be considered as absorbable material); and
a handle 131, wherein a distal end (end of element 131 connected to element 132) of the handle 131 is affixed to the brush 132 or a brush head.
Slokovic is silent regarding wherein the synthetic absorbable material comprises polydioxanone (PDS), polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), and polylactic-co-glycolic acid (PLGA).
However, Mao teaches a design of a cleaning devices including brush made of a synthetic absorbable material wherein the synthetic absorbable material comprises polydioxanone (PDS), polylactic acid (PLA) (paragraph 0179, lines 1-3), polyglycolic acid (PGA), polycaprolactone (PCL), and polylactic-co-glycolic acid (PLGA) for the purpose of using an alternative well-known synthetic biodegradable material (paragraph 0179) to perform a treatment (paragraph 0017).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the synthetic absorbable material of Slokovic to incorporate wherein the synthetic absorbable material comprises polydioxanone (PDS), polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), and polylactic-co-glycolic acid (PLGA) as taught by Mao for the purpose of using an alternative well-known synthetic biodegradable material (paragraph 0179) to perform a treatment (paragraph 0017).
Regarding claim 109, Slokovic discloses the brush 132 comprises a plurality of strands 132 (see bristles).
Regarding claim 114, Slokovic discloses the brush 132 (figure 3B) comprises one sheet or a plurality of sheets (element 132 is formed of at least one sheet).
Regarding claim 116, Slokovic discloses wherein the sheet (column 6, lines 37-39, “porous”) has perforations configured to improve solution retention on the brush.
Claim(s) 126 and 127 are rejected under 35 U.S.C. 103 as being unpatentable over Gardner (US 2017/0319832 A1) in view of Mark (US 2003/0060746 A1).
Regarding claim 126, Gardner discloses the claimed invention substantially as claimed, as set forth above in claim 108. Garner further discloses wherein the handle 120 further connected to the reservoir and the device 100 comprises a central lumen (paragraph 0027, lines 1-4, the lumen is capable to deliver therapeutic agent to the target tissue or organ and capable to include the listed therapeutic agent) configured to deliver a therapeutic agent to the brush for application to a target organ or tissue, wherein the therapeutic agent comprises one or more agents selected from the group consisting of genetically engineered vectors or cells, proteins, stem cells, small molecule pharmaceuticals, and biologics.
Gardner does not explicitly recite if the handle comprises a central lumen. However, one of ordinary skill in the art could construe that the handle could comprise a central lumen due to lack of the detailed structure. Additionally, Mark teaches a design of a liquid applicator (figure 1) wherein the handle 15 (or 17, 18, 19) comprises a central lumen (hollow portion inside elements 15, 17, 18, 19, paragraph 0022) for the purpose of allowing the communication between the reservoir and the sponge (paragraph 0022).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the handle of Gardner to incorporate wherein the handle includes a central lumen as taught by Mark for the purpose of allowing the communication between the reservoir and the sponge (paragraph 0022).
Regarding claim 127, Gardner discloses the claimed invention substantially as claimed, as set forth above in claim 108. Gardner further discloses wherein the therapeutic agent is provided in the treatment of a disease selected from the group consisting of conduction system disease, sinus node dysfunction, atrial fibrillation, myocardial infarction, and heart failure (paragraph 0027, claim does not positively recite a therapeutic agent or a disease therefore, Gardner is capable to select a therapeutic agent appropriate to treat the diseases recited in claim 127. The fact that Gardner discloses the option to select one of the many types of possible fluids or therapeutic agents, user can select a therapeutic agent that is specific to treat the disease even if the therapeutic agent is not disclosed by Gardner).
Response to Arguments
Applicant's arguments filed 8/25/2025 have been fully considered but they are not persuasive.
Applicant requests to withdrawn the specification (see page 4, lines 8-11) because the specification has been amended. Examiner respectfully disagrees. Examiner has not received any amended specification.
Applicant argues on page 5, line 20-27 that the rejection of claim 108 should be withdrawn because Slokovic does not disclose any of the disclosed synthetic absorbable material as claimed in the amended claim 108 and Mao does not disclose the claimed material. Examiner respectfully disagrees. According to the specification (see paragraph 0043) in the applicant’s original disclosure, brush material could be including one of the listed materials. It appears when reading claim in light of the specification that the applicant intended to claim that synthetic bioabsorbable material could include one of the claimed materials but not all. Mao discloses at least one of the disclosed materials Polycaprolactone (PLA). Thus, Slokovic in view of Mao discloses each and every claimed limitation.
Applicant argues on page 5, line 28-page 6, line 21 that Mao relates to the field of cleaning devices and methods and not medical devices or medical treatment. Applicant further argues that Mao would not have been reasonably pertinent to the problem faced by the inventors of the present application. Therefore, applicant argues that Mao is non-analogous art and may not serve as a basis for the alleged combined teachings of the prior art. Examiner respectfully disagrees. Slokovic discloses an applicator that includes an absorbing pad 132 (column 6, lines 37-39) without going much in detail about the designing of the absorbing pad other than the non-degradable materials used for designing absorbing pad. Mao, as applicant acknowledged, is focused on designing a “bioabsorbable” pad wherein the materials could include a biodegradable as well as non-biodegradable (paragraph 0098). One of ordinary skill in the art would certainly use the teachings from Mao to design an absorbent pad of Slokovic using an alternative material that imparts same functionality of Slokovic i.e. deliver the solution and further add a benefit of reducing the space in a landfill (paragraph 0090, lines 2-6). Therefore, even though the application of Slokovic device and Mao device are different, Mao is certainly pertinent prior art for Slokovic since Mao discloses further details on designing an absorbent pad for Slokovic’s device.
Applicant further argues on page 6, line 22-page 7, line 2 that even if Mao were analogous art, one of ordinary skill in the art would not combine with Slokovic because element 132 of Slokovic is immersed in liquid 106 disposed in vial 104 of Slokovic. Therefore, applicant argues that the device of Slokovic would be impractical and/or inoperable since the claimed material, as taught by Mao, would degrade. Examiner respectfully disagrees. Slokovic discloses in column 7, lines 16-25 that element 132 of Slokovic does not necessarily need to remain immersed in the liquid all the times. Slokovic further discloses in column 7, lines 21-25 that the “requirement for either complete or partial continuous immersion of the applicator element 132 in the liquid 106 typically depends on the composition of one or both of the liquid 106 and the applicator element 132”. Thus, Slokovic already teaches to consider the material and compatibility of both elements 132 and 106 before letting element 132 remain immersed in the liquid 106. Thus, one of ordinary skill in the art when modifying Slokovic in view of Mao would take into account the compatibility between the material selected for element 132 and element 106 and make necessary design modifications to either keep elements 132 and 106 complete or partial continuous immersion at all the times.
Conclusion
THIS ACTION IS MADE FINAL. 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 NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783