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 § 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.
Claims 2, 6-14, 16-19 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 pre-AIA the applicant regards as the invention.
Claim 2 is indefinite for claiming the functionalized surface is “modified to have a biology corresponding to a patient”. “A biology” is considered to be a “branch of knowledge that deals with living organisms and vital processes; the plant and animal life of a region of environment; the life processes especially of an organism or group” (Merriam-Webster dictionary). It is unclear to the Examiner how a surface can be modified to have a “branch of knowledge”, “plant and animal life”, or “life processes” of a patient. The specification mentions the phrase one in its summary, in [0009], but does not elaborate on what exactly this modification might entail in order to “correspond” to biology of a patient. It is equally unclear what must happen or how the surface should be in order to “correspond” to a patient’s biology (e.g. how close must it actually be). Without understanding what exactly “a biology” of a patient is, what it entails, and what it would mean to “correspond” to the patient, the Examiner is unclear on what the phrase means, and accordingly is equally unclear on what the claim means.
Claims 6 and 14 are rejected for being indefinite for the same reasons as claim 2.
Remaining claims are rejected for depending on a rejected claim.
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 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, 3-5, 11 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by “Poly(glycerol-dodecanoate), a biodegradable polyester for medical devices and tissue engineering scaffolds.” Francesco Mignecoa, Yen-Chih Huangc, Ravi K. Birlab, and Scott J. Hollistera. Biomaterials. 2009 November ; 30(33): 6479–6484. doi:10.1016/j.biomaterials.2009.08.021, hereinafter known as Mignecoa.
Regarding claim 1 Mignecoa discloses a device comprising:
a bioresorbable (Abstract: poly-gylcerol-dodecanoate (PGD) shows biodegradability) scaffold (page 2 paragraph 1: rigid scaffold for implantation) comprising a shape memory polymer (Abstract: PGD shows distinct shape memory features) comprising at least one monomer unit of glycerol (page 2 paragraph 5) and at least one monomer unit of dodecanedioate (page 2 paragraph 5), and a functionalized surface (Applicant’s specification [0016]-[0018], [0086] describes a functionalized surface as being suture holes, a functional group, bioactive agent, suture holes laser cut, surface modulations, grooves, wells, ribs, raised portions, other patterns, using subtractive manufacturing, a conjugate, or living/nonliving cells) (page 10 paragraph 1 embedded with drugs).
Regarding claim 3 Mignecoa discloses the device of claim 1 substantially as is claimed,
wherein Mignecoa further discloses the shape memory polymer has a melt transition temperature from approximately 25 to 45°C (the specification [0087] defines “approximately 25°C to approximately 45 °C” as being “from 26 °C to 44 °C, from 27 °C to 43 °C, from 28 °C to 42 °C, from 29 °C to 41 °C, from 30 °C to 40 °C, from 31 °C to 39 °C, from 32 °C to 38 °C, from 33 °C to 37 °C from 34 °C to 36 °C, from 30 °C to 39 °C, from 31 °C to 38 °C, from 31 °C to 37 °C, from 31 °C to 36 °C, or from 31 °C to 35 °C”) (page 2 paragraph 1 the material is rigid during implantation at room temperature and soft and compliant at an increased body temperature; page 8 paragraph 4 the transition occurs at 32-35°C).
Regarding claim 4 Mignecoa discloses the device of claim 1 substantially as is claimed,
wherein Mignecoa further discloses the shape memory polymer has a melt transition temperature greater than or equal to the first temperature and less than the second temperature (page 8 paragraph 4 the transition occurs at 32-35°C; page 9 paragraph 2 bullet point 1).
Regarding claim 5 Mignecoa discloses the device of claim 1 substantially as is claimed,
wherein Mignecoa further discloses the shape memory polymer has a melt transition temperature, and the shape memory polymer is an elastomer above the melt transition temperature and is a thermoplastic below the melt transition temperature (Abstract: at room temperature PGD behaves like a stiff elastic-plastic material and at body temperature it shows a compliant non-linear elastic behavior).
Regarding claim 11 Mignecoa discloses the device of claim 1 substantially as is claimed,
wherein Mignecoa further discloses the molar ratio of the monomer unit of glycerol to the monomer unit of dodecanedioate is from approximately 10:1 to approximately 1:10 (Applicant’s specification [0085] describes “approximately 10:1 to approximately 1:10” as “from 9:1 to 1:10, from 8:1 to 1:10, from 7:1 to 1:10, from 6:1 to 1:10, from 5:1 to 1:10, from 4:1 to 1:10, from 3:1 to 1:10, from 2:1 to 1:10, from 1:1 to 1:10, from 10:1 to 1:9, from 10:1 to 1:8, from 10:1 to 1:7, from 10:1 to 1:6, from 10:1 to 1:5, from 10:1 to 1:4, from 10:1 to 1:3, from 10:1 to 1:2, from 10:1 to 1:1, or from 5:1 to 1:5”) (page 3 paragraph 2: 1:1 molar ratio).
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 2, 6-7, 9-14, 16-20, 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mignecoa as is applied above in view of Migneco et al. (US 20100196322 A1) hereinafter known as Migneco.
Regarding claim 2 Mignecoa discloses the device of claim 1 substantially as is claimed,
wherein Mignecoa further discloses the scaffold takes a first shape at a first environmental temperature (page 2 paragraph 1: the device maintains a rigid shape during implantation at room temperature) and a second shape at a second environmental temperature, wherein the second temperature is greater than the first (page 2 paragraph 1: the device becomes soft and compliant at the higher body temperature), and the functionalized surface is modified to have a biology corresponding to a patient (as is best understood (see the 112b rejection above), the Abstract indicates the device is biocompatible, indicating its biology “corresponds” to a patient.),
wherein the device is configured to be implanted in the patient in the first shape at the first temperature (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Mignecoa was considered capable of performing the cited intended use. See, for example page 3 paragraph 1: the device is implanted in a smaller shape at the first temperature that that to which is transitions to as it changes to body temperature),
but is silent with regards to the device being an esophageal sleeve.
However, regarding claim 2 Migneco teaches bioresorbable, biocompatible PGD scaffolds can be used for esophageal sleeves (Abstract, [0071]-[0072]). Mignecoa and Migneco are involved in the same field of endeavor, namely resorbable scaffolds for soft tissue implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Mignecoa so it is useful as an esophageal sleeve as is taught by Migneco in order to apply the benefits of the material scaffold of Mignecoa to a soft tissue implant to help augment an esophagus thus helping patients in need thereof.
Regarding claim 6 Mignecoa discloses the device of claim 1 substantially as is claimed,
wherein Mignecoa further discloses the functionalized surface is modified to have a biology corresponding to a patient (as is best understood (see the 112b rejection above), the Abstract indicates the device is biocompatible, indicating its biology “corresponds” to a patient.), the scaffold has a first shape (page 2 paragraph 1: the device maintains a rigid shape during implantation at room temperature) second shape (page 2 paragraph 1: the device becomes soft and compliant at the higher body temperature), and a melt transition temperature (page 2 paragraph 1 the material is rigid during implantation at room temperature and soft and compliant at an increased body temperature),
wherein the scaffold takes the first shape at a first environmental temperature, and the second shape at a second, greater environmental temperature (page 2 paragraph 1 the material is rigid during implantation at room temperature and soft and compliant at an increased body temperature),
wherein the melt transition temperature is greater than or equal to the first environmental temperature and less than the second environmental temperature (page 8 paragraph 4 the transition occurs at 32-35°C; page 9 paragraph 2 bullet point 1), and
wherein the first shape is different from the second shape (page 3 paragraph 1 the initial (first) shape is smaller than the final (second) shape),
but is silent with regards to the device being an esophageal sleeve.
However, regarding claim 6 Migneco teaches bioresorbable scaffolds can be used for esophageal sleeves (Abstract, [0071]-[0072]). Mignecoa and Migneco are involved in the same field of endeavor, namely resorbable scaffolds for soft tissue implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Mignecoa so it is useful as an esophageal sleeve as is taught by Migneco in order to apply the benefits of the material scaffold of Mignecoa to a soft tissue implant to help augment an esophagus thus helping patients in need thereof.
Regarding claim 7 the Mignecoa Migneco Combination teaches the device of claim 6 substantially as is claimed,
wherein Migneco further teaches the final shape can be tubular ([0071]), and wherein Mignecoa teaches the first shape is simply smaller than the second (page 3 paragraph 1: the device is implanted in a smaller shape at the first temperature that that to which is transitions to as it changes to body temperature), indicating the obviousness of the first and second shapes being tubular.
Regarding claim 9 the Mignecoa Migneco Combination teaches the device of claim 6 substantially as is claimed,
wherein Mignecoa further teaches the functionalized surface comprises at least one functional group (page 10 paragraph 1 embedded with drugs).
Regarding claim 10 the Mignecoa Migneco Combination teaches the device of claim 9 substantially as is claimed,
wherein Mignecoa further discloses the functional group comprises a bioactive agent (page 10 paragraph 1 embedded with drugs).
Regarding claim 12 the Mignecoa Migneco Combination teaches the device of claim 6 substantially as is claimed,
wherein Mignecoa further teaches the scaffold has a biodegradation time when implanted in vivo from approximately 2 months to approximately 24 months (Applicant’s specification defines “2 months to approximately 24 months: as being “from 5 months to 23 months, from 6 months to 22 months, from 7 months to 21 months, from 8 months to 21 months, from 9 months to 20 months, from 10 months to 20 months, from 10 months to 15 months, from 5 months to 15 months, from 4 months to 10 months, or from 12 months to 24 months”) (page 7 paragraph 2 the predicated in-vivo degradation rate is about 16 months. The person of ordinary skill in the art at the time the invention was filed would have found it obvious for the in vivo degradation rate to be 16 months, since this is the estimated degradation time indicated by Mignecoa).
Regarding claim 13 Mignecoa discloses a method of implanting the device of claim 1 substantially as is claimed,
comprising implanting the device of claim 1 into a patient, wherein the scaffold is in a permanent shape after the implanting (page 2 paragraph 1 the implant can fold to go through narrow passages; page 3 paragraph 1 the implant then transitions to the more compliant state at body temperature),
but is silent with regards to the device being an esophageal sleeve.
However, regarding claim 13 Migneco teaches bioresorbable scaffolds can be used for esophageal sleeves (Abstract, [0071]-[0072]). Mignecoa and Migneco are involved in the same field of endeavor, namely resorbable scaffolds for soft tissue implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Mignecoa so it is useful as an esophageal sleeve as is taught by Migneco in order to apply the benefits of the material scaffold of Mignecoa to a soft tissue implant to help augment an esophagus thus helping patients in need thereof.
Regarding claim 14 the Mignecoa Migneco Combination teaches the method of claim 13 substantially as is claimed,
wherein Mignecoa further discloses delivering the device of claim 1 (page 2 paragraph 1 the implant can fold to go through narrow passages),
wherein the scaffold is in a programmed shape during delivering and prior to implanting, and the scaffold takes the programmed shape at a first environmental temperature and a permanent shape at a second greater environmental temperature (page 3 paragraph 1 the device is implanted through narrow passages to the initial shape is smaller than the final one which transitions as it reaches body temperature),
and wherein the functionalized surface is modified to have a biology corresponding to the patient (as is best understood (see the 112b rejection above), the Abstract indicates the device is biocompatible, indicating its biology “corresponds” to a patient.).
Regarding claims 16-17 the Mignecoa Migneco Combination teaches the method of claim 14 substantially as is claimed,
wherein Mignecoa further discloses the shape memory polymer has a melt transition temperature from approximately 25 to 45°C, or (claim 17) (31 to 35°C) (the specification [0087] defines “approximately 25°C to approximately 45 °C” as being “from 26 °C to 44 °C, from 27 °C to 43 °C, from 28 °C to 42 °C, from 29 °C to 41 °C, from 30 °C to 40 °C, from 31 °C to 39 °C, from 32 °C to 38 °C, from 33 °C to 37 °C from 34 °C to 36 °C, from 30 °C to 39 °C, from 31 °C to 38 °C, from 31 °C to 37 °C, from 31 °C to 36 °C, or from 31 °C to 35 °C”) (page 2 paragraph 1 the material is rigid during implantation at room temperature and soft and compliant at an increased body temperature; page 8 paragraph 4 the transition occurs at 32-35°C), and
Regarding claim 18 the Mignecoa Migneco Combination teaches the method of claim 16 substantially as is claimed,
wherein Mignecoa further discloses the shape memory polymer is an elastomer above the melt transition temperature and is a thermoplastic below the melt transition temperature (Abstract: at room temperature PGD behaves like a stiff elastic-plastic material and at body temperature it shows a compliant non-linear elastic behavior).
Regarding claim 19 the Mignecoa Migneco Combination teaches the method of claim 14 substantially as is claimed,
wherein the Combination further teaches the programmed shape is a curved or tubular shape (Mignecoa page 3 paragraph 1: the device is implanted in a smaller shape at the first temperature that that to which is transitions to as it changes to body temperature, Migneco [0071],the shape of the device is tubular).
Regarding claim 20 the Mignecoa Migneco Combination teaches the method of claim 13 substantially as is claimed,
wherein Migneco further discloses the permanent shape is a tubular shape ([0071]).
Regarding claim 22 the Mignecoa Migneco Combination teaches the method of claim 13 substantially as is claimed,
wherein Mignecoa further teaches the functionalized surface comprises at least one functional group (page 10 paragraph 1 embedded with drugs).
Regarding claim 23 the Mignecoa Migneco Combination teaches the method of claim 22 substantially as is claimed,
wherein Mignecoa further discloses the functional group comprises a bioactive agent (page 10 paragraph 1 embedded with drugs).
Regarding claim 24 the Mignecoa Migneco Combination teaches the method of claim 13 substantially as is claimed,
wherein Mignecoa further discloses the molar ratio of the monomer unit of glycerol to the monomer unit of dodecanedioate is from approximately 10:1 to approximately 1:10 (Applicant’s specification [0085] describes “approximately 10:1 to approximately 1:10” as “from 9:1 to 1:10, from 8:1 to 1:10, from 7:1 to 1:10, from 6:1 to 1:10, from 5:1 to 1:10, from 4:1 to 1:10, from 3:1 to 1:10, from 2:1 to 1:10, from 1:1 to 1:10, from 10:1 to 1:9, from 10:1 to 1:8, from 10:1 to 1:7, from 10:1 to 1:6, from 10:1 to 1:5, from 10:1 to 1:4, from 10:1 to 1:3, from 10:1 to 1:2, from 10:1 to 1:1, or from 5:1 to 1:5”) (page 3 paragraph 2: 1:1 molar ratio).
Regarding claim 25 the Mignecoa Migneco Combination teaches the method of claim 13 substantially as is claimed,
wherein Mignecoa further teaches the scaffold has a biodegradation time when implanted in vivo from approximately 2 months to approximately 24 months (Applicant’s specification defines “2 months to approximately 24 months: as being “from 5 months to 23 months, from 6 months to 22 months, from 7 months to 21 months, from 8 months to 21 months, from 9 months to 20 months, from 10 months to 20 months, from 10 months to 15 months, from 5 months to 15 months, from 4 months to 10 months, or from 12 months to 24 months”) (page 7 paragraph 2 the predicated in-vivo degradation rate is about 16 months. The person of ordinary skill in the art at the time the invention was filed would have found it obvious for the in vivo degradation rate to be 16 months, since this is the estimated degradation time indicated by Mignecoa).
Claim 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mignecoa and Migneco as is applied above, or in the alternative, over Mignecoa and Migneco, further in view of Hollister et al. (US 20160051385 A1) hereinafter known as Hollister.
Regarding claim 8 the Mignecoa Migneco Combination teaches the device of claim 6 substantially as is claimed,
wherein Migneco further teaches the functionalized surface comprises a plurality of suture holes ([0076] the device can includes apertures or pores. The description of the holes being “suture” holes is not understood to impart any specific structure, but rather be an intended use for the holes on the device (see the explanation in the rejection above regarding “intended uses”. Any hole which might contact a suture is understood to be a “suture hole”.).
Alternatively see Hollister ([0009]) who teaches esophageal sleeve implants (Abstract) can include suture holes. Mignecoa and Hollister are involved in the same field of endeavor, namely soft tissue implants. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Combination so it included any structural features including suture holes as is taught by Hollister in order to allow the device to have a structure which enables its attachment to a portion of the patient into which it is intended to reside in, thus allowing secure implantation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 02/06/26