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 .
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.
(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.
Claim(s) 1, 3-4, 7, 12-13, and 18-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Rosenberg (US 5630843 A) "Rosenberg".
Regarding Claim 1, Rosenberg teaches an expander and drug delivery device (tissue expansion device 100, par. (14) Detailed Description, Fig. 1A), comprising:
a first membrane (non-porous material 108, par. (14) Detailed Description, Fig. 1A), wherein the first membrane is a non-permeable shell that forms an expansion cavity (expansion chamber 106, par. (14), Fig. 1A),
an expansion cavity port (expansion fluid tube 112, par. (14) Detailed Description, Fig. 1A) that provides access to the expansion cavity, wherein the non-permeable shell is flexible such that the non-permeable shell inflates in response to insertion of a substance into the expansion cavity via the expansion cavity port (par. (15) Detailed Description);
a second membrane (stretchable porous material 104, par. (14) Detailed Description, Fig. 1A) that forms a drug cavity (infusion chamber 102, par. (14) Detailed Description, Fig. 1A) adjacent to the expansion cavity;
and a drug cavity port (infusion solution tube 110, par. (14) Detailed Description, Figs. 1A and 1B) that connects to the drug cavity and receives a therapeutic solution for delivery to a patient.
Regarding Claim 3, Rosenberg teaches the device of claim 1, wherein the drug cavity port (infusion solution tube 110) is formed on a surface of the second membrane (stretchable porous material 104, Figs. 1A and 1B).
Regarding Claim 4, Rosenberg teaches the device of claim 3, wherein the drug cavity port includes a backing plate (backplate 109, par. (21) Detailed Description, Fig. 1B) to prevent puncture of the first membrane or the second membrane.
Regarding Claim 7, Rosenberg teaches the device of claim 4, wherein the backing plate is mounted to an outer surface of the non-permeable shell (Fig. 1B).
Regarding Claim 12, Rosenberg teaches the device of claim 1, wherein the second membrane (stretchable porous material 104) surrounds the first membrane (non-porous material 108) to form the drug cavity (infusion chamber 102) in between the first membrane and the second membrane (Fig. 1A).
Regarding Claim 13, Rosenberg teaches the device of claim 12, wherein the second membrane is semi-permeable such that the therapeutic substance is able to exit the drug cavity into the patient via the second membrane (pars. (5) and (16) Detailed Description).
Regarding Claim 18, Rosenberg teaches a method of making an expander and drug delivery device (tissue expansion device 100, par. (14) Detailed Description, Fig. 1A), the method comprising:
forming an expansion cavity (expansion chamber 106, par. (14), Fig. 1A) with a first membrane, wherein the first membrane is a non-permeable shell (non-porous material 108, par. (14) Detailed Description, Fig. 1A);
mounting an expansion cavity port (expansion fluid tube 112, par. (14) Detailed Description, Fig. 1A) in communication with the expansion cavity, wherein the expansion cavity port provides access to the expansion cavity, and wherein the non-permeable shell is flexible such that the non-permeable shell inflates in response to insertion of a substance into the expansion cavity via the expansion cavity port (par. (15) Detailed Description);
forming a drug cavity (infusion chamber 102, par. (14) Detailed Description, Fig. 1A) with a second membrane (stretchable porous material 104, par. (14) Detailed Description, Fig. 1A) such that the drug cavity is adjacent to the expansion cavity;
and mounting a drug cavity port (infusion solution tube 110, par. (14) Detailed Description, Figs. 1A and 1B) in communication with the drug cavity, wherein the drug cavity port is sized to receive a therapeutic solution for delivery to a patient.
Regarding Claim 19, Rosenberg teaches the method of claim 18, wherein forming the drug cavity comprises positioning the second membrane external to the first membrane such that the drug cavity is formed in between the first membrane and the second membrane (par. (14) Detailed Description, Fig. 1A).
Regarding Claim 20, Rosenberg teaches the method of claim 18, further comprising determining a size and shape of a breast cavity of the patient, and wherein a size and shape of the expansion cavity and the drug cavity of the expander and drug delivery device are based on the determined size and shape of the breast cavity (par. (22) Detailed Description).
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.
Claim(s) 2, and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg (US 5630843 A) "Rosenberg" in view of Lee et al (US 20110137244 A1) “Lee”.
Regarding Claim 2, Rosenberg does not disclose a drug cavity port connecting to the drug cavity remote from the second membrane. However, Lee, in the same field of art, teaches a tissue expander configured for drug delivery (Abstract), wherein the drug cavity port (injection port 112, par. [0033], Fig. 1) connects to the drug cavity by way of a drug cavity port tube (fill lumen 114, par. [0033], Fig. 1) such that the drug cavity port is remote from the second membrane (balloon wall 108, par. [0033], Fig. 1). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosenberg to include a drug cavity port connecting to the drug cavity remote from the second membrane, as taught by Lee, in order for better fluid communication between the injection port and the drug cavity (Lee, par. [0032]).
Regarding Claim 8, Rosenberg does not disclose a plurality of drug cavity ports. However, Lee, in the same field of art, teaches a tissue expander configured for drug delivery (Abstract), further comprising a plurality of drug cavity ports (drug delivery portions 104 and injection port 112, pars. [0033] and [0048], Figs. 1 and 2) that provide access to the drug cavity. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosenberg to include a plurality of drug cavity ports, as taught by Lee, in order to facilitate targeting drug delivery to a larger area (Lee, par. [0100]).
Regarding Claim 9, Rosenberg does not disclose one of the plurality of drug cavity ports connecting to the second membrane. However, Lee, in the same field of art, teaches a tissue expander configured for drug delivery (Abstract), wherein a first drug cavity port (injection port 112, par. [0033], Fig. 1) in the plurality of drug cavity ports connects to the second membrane (balloon wall 108, par. [0033], Fig. 1) by way of a drug cavity port tube (fill lumen 114, par. [0033], Fig. 1) such that the first drug cavity port is remote from the second membrane (Fig. 1), and wherein a second drug cavity port (drug delivery portions 104, par. [0048], Fig. 2) in the plurality of drug cavity ports is formed on a surface of the second membrane (Fig. 2). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosenberg to include one of the plurality of drug cavity ports connecting to the second membrane, as taught by Lee, in order to facilitate targeting drug delivery to a larger area (Lee, par. [0100]).
Claim(s) 5-6, and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg (US 5630843 A) "Rosenberg" in view of McClellan (US 20110153017 A1) “McClellan”.
Regarding Claim 5, Rosenberg does not disclose a backing plate made of magnetic material. However, McClellan, in the same field of art, teaches a tissue expander with a fluid delivery system (Abstract), wherein the backing plate (first plate 1810, par. [00157], Fig. 18) is made from a magnetic material (par. [00157], can be made of titanium or mixtures or alloys thereof). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosenberg to include a backing plate made of magnetic material, as taught by McClellan, in order to provide a sturdy backing and an indication to the user that they are injecting a fluid into a first section 1820 of the dual integrated port 1800 (McClellan, pars. [0157] and [0159]).
Regarding Claim 6, Rosenberg does not disclose a backing plate not in contact with the non-permeable shell. However, McClellan, in the same field of art, teaches a tissue expander with a fluid delivery system (Abstract), wherein the backing plate is mounted as a component of the drug cavity port (second section 1840, par. [00159], Fig. 18) such that the backing plate (second plate 1850, par. [00159], Fig. 18) does not contact the non-permeable shell. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosenberg to include a backing plate not in contact with the non-permeable shell, as taught by McClellan, in order to provide an indication to the user that they are injecting a fluid into a first section 1820 of the dual integrated port 1800 (McClellan, par. [0159]).
Regarding Claim 14, Rosenberg does not disclose the first membrane surrounding the second membrane. However, McClellan, in the same field of art, teaches a tissue expander with a fluid delivery system (Abstract), wherein the first membrane (capsule 670, par. [0077], Fig. 6) surrounds the second membrane (implant shell 615, par. [0063], Fig. 6) such that the drug cavity (inside cavity 605, par. [0063], Fig. 6) is formed within the expansion cavity (pocket 630, par. [0066], Fig. 6). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosenberg to include the first membrane surrounding the second membrane, as taught by McClellan, in order to form a physical barrier from the subject's body, vascular system, and immune system (McClellan, par. [0077]).
Regarding Claim 15, Rosenberg does not disclose a permeable channel extending from the drug cavity to the first membrane. However, McClellan, in the same field of art, teaches a tissue expander with a fluid delivery system (Abstract), further comprising a permeable channel (communication channel 1285, par. [00120], Fig. 12B) that extends from the drug cavity to the first membrane (pars. [00120] and [00121], may provide fluid communication between pocket port 1280 located at the center of the tissue expander 1200’ (within drug cavity) and surface of tissue expander (which can include first membrane)). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosenberg to include a permeable channel extending from the drug cavity to the first membrane, as taught by McClellan, in order to provide better and more controlled fluid communication (McClellan, par. [0121]).
Regarding Claim 16, Rosenberg does not disclose at least semi-permeable end walls of the permeable channel. However, McClellan, in the same field of art, teaches a tissue expander with a fluid delivery system (Abstract), wherein end walls of the permeable channel are at least semi-permeable to allow the therapeutic solution to move from the drug cavity into the patient (par. [00121]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosenberg to include at least semi-permeable end walls of the permeable channel, as taught by McClellan, in order to provide better and more controlled fluid communication (McClellan, par. [0121]).
Regarding Claim 17, Rosenberg does not disclose a non-permeable sidewall of the permeable channel. However, McClellan, in the same field of art, teaches a tissue expander with a fluid delivery system (Abstract), wherein a sidewall of the permeable channel (implant port 620, par. [0063], Fig. 6) is non-permeable to prevent the therapeutic solution from entering the expansion cavity as the therapeutic solution travels from the drug cavity to the patient (pars. [0063], port 620 only reaches to implant shell 615, and expansion cavity (pocket 630) is outside of shell 615). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Rosenberg to include a non-permeable sidewall of the permeable channel, as taught by McClellan, in order to provide better and more controlled fluid communication to the drug cavity (McClellan, par. [0063]).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosenberg (US 5630843 A) "Rosenberg".
Regarding Claim 10, the first embodiment of Rosenberg does not disclose an expansion cavity port connected to the expansion cavity by way of an expansion cavity port tube. However, another embodiment of McClellan teaches the device of claim 1, wherein the expansion cavity port (expansion fluid tube 112) connects to the expansion cavity (expansion chamber 106) by way of an expansion cavity port tube (injection port 116, par. (23) Detailed Description, Fig. 5A) such that the expansion cavity port is remote from the non-permeable shell. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Rosenberg to include an expansion cavity port connected to the expansion cavity by way of an expansion cavity port tube, as taught by another embodiment of Rosenberg, in order to allow for fluid expansion without causing a leak (par. (23) Description).
Regarding Claim 11, the first embodiment of Rosenberg does not disclose an outer surface of the expansion cavity port tube forming a seal. However, another embodiment of McClellan teaches the device of claim 10, wherein an outer surface of the expansion cavity port tube forms a seal (sealing means 500, par. (24) Detailed Description, Figs. 5A and 5B, seal 500 forms with transport tube 110, which opens in the stretchable porous material 104) with an opening in the second membrane. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the first embodiment of Rosenberg to include an outer surface of the expansion cavity port tube forming a seal, as taught by another embodiment of Rosenberg, in order to allow for fluid expansion without causing a leak (par. (23) Description).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
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, Jerrah Edwards can be reached at (408)918-7557. 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.
/NATALIE N THOMAS/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights