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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 8, 2024, that includes a response to the Final Office Action mailed July 7, 2023, has been entered. Claim 50 has been amended; claims 1, 3, and 57 have been canceled; and claim 59 has been newly added. Claims 2, 4-49, 52, 53, and 56 have been withdrawn. Claims 50, 51, 54, 55, 58, and 59 are currently under examination.
Claim Objections
Claim 50 is objected to because of the following informalities:
1. In claim 50, there is an extraneous colon between “comprising” and “one or more enclosures”.
2. The expression “wherein the…being” appears to be in improper English grammatical format. Applicant is advised to amend the expression to “wherein the…is”. Further, the expression “wherein the one or more enclosures being collapsible or expandable or both or neither” is awkward and in improper English grammatical form. Applicant is advised to amend the expression to e.g. “wherein, optionally, the one or more enclosures is collapsible, expandible, or both”.
3. In claim 50, element (i), there is an extraneous comma between “adjacent to” and “at least one layer of cells”.
4. In claim 50, following element (ii), there appears to be an extraneous comma followed by an extraneous “and”. Applicant is advised to follow the recitation of element (ii) with the semicolon and then the wherein clause, i.e. “wherein the bioreactor…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 50, 51, 54, 55, 58, and 59 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.
Claim 50 is directed to “an implantable bioreactor” which necessarily comprises one or more enclosures when comprise elements (i) and (ii). Claim 50 then provides in a wherein clause that “the bioreactor enclosure is mounted on a wire or a catheter”. One of ordinary skill in the art cannot definitively ascertain whether the claimed implantable bioreactor itself necessarily includes e.g. a wire or a catheter as a requisite structural element of the claimed implantable bioreactor, or, alternatively, whether “is mounted on a wire or a catheter” is merely describing an “intended use” of the claimed implantable bioreactor, i.e. the wire or the catheter is thus not a required constituent element of the implantable bioreactor itself as claimed.
Claim 51 is indefinite for the following reasons:
1. Claim 51, which depends from claim 50, references in a wherein clause “the medical device”. However, prior to this reference to “the medical device”, there is no explicit mention of “medical device”. While the “implantable bioreactor”, the “wire” and the “catheter” mentioned in claim 50 would reasonably fall under the purview of “medical device” generally, one of ordinary skill in the art cannot definitively ascertain which one is ”the medical device”. Finally, claim 51 further limits “the medical device” to elements that one of ordinary skill in the art would not generally recognize as being an implantable bioreactor, a wire, or a catheter, such as e.g. a stent, a valve, a clip, a ring, etc.
2. Claim 51 recites at least one broader limitation together with at least one narrower limitation that falls within the corresponding broader limitation in the alternative in the same claim, which is indefinite.
Claim 54, which depends from claim 50, stipulates in a wherein clause that “said enclosure comprises a port and a pouch”. In claim 50, the enclosures defining an enclosed space is essentially a “pouch” although the term never appears in claim 50. Hence, one of ordinary skill in the art cannot definitively ascertain whether the “enclosure” and the “pouch” are essentially one and the same, or rather whether the “pouch” is a separate and distinct element.
Claim 55, which depends from claim 54, and ultimately from claim 50, stipulates that the implantable bioreactor “further comprises” a catheter which is “attached to said pouch through said port”. One of ordinary skill in the art cannot definitively ascertain whether this required catheter is one and the same as the catheter mentioned in claim 50 (which may or may not be required), or rather is a separate catheter from the catheter mentioned in claim 50.
Claim 58 stipulates in a wherein clause that the “enclosures being semi-permeable for containment of cells in the enclosed space and preventing egress of the cells while also providing an immunological barrier and allowing egress of paracrine factors out of the enclosure”. One of ordinary skill in the art cannot definitively ascertain whether claim 58 is merely stating the intended purpose of the semi-permeable membrane, or rather further limiting the requisite constituents in the claimed device. For example, while claim 50 has clearly established that there must be “at least one layer of cells” in contact with or adjacent to the interior facing surface of the enclosure, claim 50 says nothing about the required inclusion of paracrine factors in or out of the enclosure. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
***For examination at this time, claim 58 is being interpreted as stating the intended purpose of the semi-permeable membrane while the claimed device is in use. In other words, the device as claimed does not necessarily contain paracrine factors in the enclosure.
Claim 59 is indefinite for the following reasons:
1. Claim 59 is directed to “an implantable bioreactor” which necessarily comprises one or more enclosures when comprise elements (i) and (ii). Claim 50 then provides in a wherein clause that “the bioreactor enclosure is mounted on a wire or a catheter”. One of ordinary skill in the art cannot definitively ascertain whether the claimed implantable bioreactor itself necessarily includes e.g. a wire or a catheter as a requisite structural element of the claimed implantable bioreactor, or, alternatively, whether “is mounted on a wire or a catheter” is merely describing an “intended use” of the claimed implantable bioreactor, i.e. the wire or the catheter is thus not a required constituent element of the implantable bioreactor itself as claimed.
2. Claim 59 stipulates in a wherein clause that “said enclosure comprises a port and a pouch”. In claim 50, the enclosures defining an enclosed space is essentially a “pouch” although the term never appears in claim 50. Hence, one of ordinary skill in the art cannot definitively ascertain whether the “enclosure” and the “pouch” are essentially one and the same, or rather whether the “pouch” is a separate and distinct element.
3. Claim 59 stipulates that the implantable bioreactor comprises element b), i.e. a catheter which is “attached to said pouch through said port”. Said pouch and said port are disclosed in element a), along with mention of a catheter. One of ordinary skill in the art cannot definitively ascertain whether this required catheter is one and the same as the catheter mentioned in element a) (which may or may not be required), or rather is a separate catheter.
Claims 51, 54, 55, and 58 are (also) indefinite for depending from an indefinite claim.
Obviousness-Type Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 50, 51, 54, 55, 58, and 59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10,772,716, in view of DeBeer (U.S. Patent Application Pub. No. 2005/0015140).
Applicant’s elected subject matter is directed to an implantable bioreactor comprising an enclosure comprising i) a “semipermeable” layer in contact with or adjacent to a layer of cells within a cell culture matrix on the interior surface of the enclosure, and ii) a “permeable” layer on the exterior facing surface of the enclosure; wherein a catheter is attached at one end via a port to the enclosure, said catheter being at least partially implantable such that the end attached to the enclosure is implantable while the other end is adapted to extend exterior to a patient’s body; and wherein the enclosure can also contain mesenchymal stem cells, provide an immunological barrier, and allow the egress of paracrine factors out of the enclosure.
Claims 1-24 of U.S. Patent No. 10,772,716 disclose a method of promoting regeneration of tissue in a subject comprising delivering a bioreactor to the subject, the said bioreactor comprising i) an enclosure comprising e.g. a semipermeable layer and cells (i.e. capable of producing paracrine factors) in the enclosure; and ii) a catheter attached at one end via a port to the enclosure; wherein the enclosure can provide containment of the cells, provide an immunological barrier, and allow the egress of paracrine factors out of the enclosure.
DeBeer discloses an implantable bioreactor comprising a dual layer enclosure comprising a first membrane and a second membrane within the first membrane, wherein the exterior facing first membrane is more porous than the second membrane and permits adhesive or other fluids to weep through the pores; and wherein the implantable bioreactor is thus configured to expand to conform to the shape of a target site e.g. in the human body and get secured at the target site (see abstract; paragraphs 0014, 0019, 0022, 0086, 0163, 0164; Figure 57).
Although the claims at issue are not identical, they are not patentably distinct from each other because the disclosure of U.S. Patent No. 10,772,716 discloses that by “cells within the enclosure” is meant, at least in part, a layer of cells within a cell culture matrix on the interior surface. Further, the original disclosure of the present application discloses that the bioreactor can be employed in a method of promoting regeneration of tissue in a subject. Moreover, since DeBeer discloses that an implantable bioreactor comprising a dual layer enclosure comprising a first membrane and a second membrane within the first membrane, wherein the exterior facing first membrane is more porous than the second membrane, permits adhesive or other fluids to weep through the outer pores; and wherein the bioreactor is thus configured to expand to conform to the shape of a target site e.g. in the human body and get secured at the target site; one of ordinary skill in the art would be motivated to outfit the bioreactor disclosed in claims 1-24 of U.S. Patent No. 10,772,716 with an outer “permeable” membrane, such that the resulting bioreactor will thus comprise a dual layer enclosure comprising a first membrane and a second membrane within the first membrane, wherein the exterior facing first membrane is more porous than the second membrane, with the reasonable expectation that the resulting bioreactor will be successfully configured to expand to conform to the shape of a target site e.g. in the human body and get secured at the target site.
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 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 50, 51, 54, 55, 58, and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Gerstenblith et al. (U.S. Patent Application Pub. No. 2012/0083767), in view of DeBeer (U.S. Patent Application Pub. No. 2005/0015140).
Applicant Claims
Applicant’s elected subject matter is directed to an implantable bioreactor comprising an enclosure comprising i) a “semipermeable” layer in contact with or adjacent to a layer of cells within a cell culture matrix on the interior surface of the enclosure, and ii) a “permeable” layer on the exterior facing surface of the enclosure; wherein a catheter is attached at one end via a port to the enclosure, said catheter being at least partially implantable such that the end attached to the enclosure is implantable while the other end is adapted to extend exterior to a patient’s body; and wherein the enclosure can also contain mesenchymal stem cells, provide an immunological barrier, and allow the egress of paracrine factors out of the enclosure.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Gerstenblith et al. disclose an implantable bioreactor comprising an enclosure comprising a semipermeable layer in contact with or adjacent to a layer of cells within a cell culture matrix on the interior surface, and cells (i.e. capable of producing paracrine factors) within a cell culture matrix in the enclosure; wherein a catheter is attached at one end via a port to the enclosure, said catheter being at least partially implantable; wherein the enclosure can provide containment of the cells, provide an immunological barrier, and allow the egress of paracrine factors out of the enclosure.
DeBeer discloses an implantable bioreactor comprising a dual layer enclosure comprising a first membrane and a second membrane within the first membrane, wherein the exterior facing first membrane is more porous than the second membrane and permits adhesive or other fluids to weep through the pores; and wherein the implantable bioreactor is thus configured to expand to conform to the shape of a target site e.g. in the human body and get secured at the target site (see abstract; paragraphs 0014, 0019, 0022, 0086, 0163, 0164; Figure 57).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Gerstenblith et al. do not explicitly disclose that the bioreactor contains a “permeable layer” on the exterior facing surface of the enclosure. This deficiency is cured by the teachings of DeBeer.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Gerstenblith et al. and DeBeer, outlined supra, to devise Applicant’s presently claimed bioreactor.
Gerstenblith et al. disclose an implantable bioreactor comprising an enclosure comprising a semipermeable layer in contact with or adjacent to a layer of cells within a cell culture matrix on the interior surface, and cells (i.e. capable of producing paracrine factors) within a cell culture matrix in the enclosure; wherein a catheter is attached at one end via a port to the enclosure, said catheter being at least partially implantable; wherein the enclosure can provide containment of the cells, provide an immunological barrier, and allow the egress of paracrine factors out of the enclosure. Since DeBeer discloses that an implantable bioreactor comprising a dual layer enclosure comprising a first membrane and a second membrane within the first membrane, wherein the exterior facing first membrane is more porous than the second membrane, permits adhesive or other fluids to weep through the outer pores; and wherein the bioreactor is thus configured to expand to conform to the shape of a target site e.g. in the human body and get secured at the target site; one of ordinary skill in the art would be motivated to outfit the Gerstenblith et al. bioreactor with an outer “permeable” membrane, such that the resulting bioreactor will thus comprise a dual layer enclosure comprising a first membrane and a second membrane within the first membrane, wherein the exterior facing first membrane is more porous than the second membrane, with the reasonable expectation that the resulting bioreactor will be successfully configured to expand to conform to the shape of a target site e.g. in the human body and get secured at the target site.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments filed August 8, 2024 have been fully considered but are not found persuasive.
i) Applicant contends that “Gerstenblith…describes a pouch fabricated with a semi-porous membrane, or fabricated with a microporous polymer matrix encapsulating the cells” while “in contrast, Applicant describes a bioreactor that includes at least one semi-permeable layer and a permeable layer of material” and “Gerstenblith…is silent with at least these features”.
The Examiner, however, would like to point out the following:
1. The prior art rejection under 35 USC 103 is not over Gerstenblith alone. Rather, the prior art rejection is based on the combination of Gerstenblith and DeBeer, and what these references disclose and reasonably suggest to one of ordinary skill in the art, who is one of ordinary creativity and not an automaton.
2. Both Gerstenblith and DeBeer are concerned with an implantable bioreactor with one or more membranes surrounding and defining an enclosure. Gerstenblith, the cited primary reference, discloses all aspects of the presently claimed implantable bioreactor, with the exception that Gerstenblith does not explicitly disclose that the bioreactor contains a “permeable layer” on the exterior facing surface of the enclosure. This deficiency is cured by the teachings of DeBeer for reasons explained in detail in the prior art rejection, supra.
3. As explained in the prior art rejection, since DeBeer discloses that an implantable bioreactor comprising a dual layer enclosure comprising a first membrane and a second membrane within the first membrane, wherein the exterior facing first membrane is more porous (permeable) than the second membrane, permits fluids to weep through the outer pores; and wherein the bioreactor is thus configured to expand to conform to the shape of a target site e.g. in the human body and get secured at the target site; one of ordinary skill in the art would be motivated to outfit the Gerstenblith bioreactor with an outer “permeable” membrane, such that the resulting bioreactor will thus comprise a dual layer enclosure comprising a first membrane and a second membrane within the first membrane, wherein the exterior facing first membrane is more porous (permeable) than the second membrane (Gerstenblith’s semipermeable membrane), with the reasonable expectation that the resulting bioreactor will be successfully configured to expand to conform to the shape of a target site e.g. in the human body and get secured at the target site. Hence, the resulting bioreactor will thus have the added advantage provided by the outer permeable membrane without sacrificing or hindering any of the features and functions of the Gerstenblith bioreactor. Applicant has provided no hard evidence to the contrary.
For the foregoing reasons, the 35 USC 103 rejection is hereby maintained.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617