DETAILED ACTION
This action is in reply to papers filed 4/13/2020. Claims 1-20 are pending and examined herein.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20240415932A1, Published 12/19/2024.
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 1-20 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.
Each of claims 1, 5, 11 and 15 recite the phrase “capable of.” In the context that it is written (capable of…...), this phrase is a latent property and renders each claim indefinite because it is unclear if the property recited is required or not. For example, in claim 1, is the solution adhered to the structure? Particularly problematic is that it is unclear if treatment would occur should the property not be required. Accordingly, the metes and bounds of the phrase cannot be determined. Claims 2-4, 6-10, 12-14 and 16-20 depend from claim 1 and, because they fail to provide clarity to this specific issue, are also found to be indefinite.
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 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 pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Prior Art Rejection 1
Claim(s) 1-2, 4-6 and 8-10 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Siani-Rose et al. (PgPub US20090317482A1, Published 12/24/2009; Ref. 20 in IDS filed 8/6/2024 ) as evidenced by Lindstedt et al. (Ann. Thor. Surg, 84: 568-573, 2007.; Ref. 2 in IDS filed 8/6/2024) and Bernatchez et al. (The Journal of Biological Chemistry, 274(43): 31047-31054, 1999.; Ref. 47 in IDS filed 8/6/2024).
Regarding to claim 1, Siani-Rose et al. disclose delivering angiogenic factors in the treatment of ischemic heart tissue by utilizing three-dimensional tissue (Pg. 1, para. 4). Lindstedt is provided as evidence that ischemic heart tissue has diminished microvascular blood flow (Pg. 568, Background; Pg. 568, Col. 2, para. 1; Pg. 570, Figure 3). Siani-Rose discloses that the three-dimensional tissue is used to deliver various growth factors (Pg. 1, para. 9), including angiogenic growth factors, such as CTGF (Pg. 6, para. 63), vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), fibroblast growth factors (FGF), platelet derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor (TGF) (as in claim 4) (Pg. 7, para. 72). Bernatchez provides evidence that VEGF is a chemoattractant of endothelial cells (as in claim 5) (Abstract; Pg. 31051, Col. 1, Fig. 6; Pg. 31052, Discussion). Continuing, Siani-Rose discloses that three-dimensional framework can be composed of a scaffold (Pg. 2, para. 34-35); that can comprise a hydrogel (as in claim 2), comprised of polymers that form gels sufficient for the cells to attach and form the structure (Pg. 3, para. 43). Siani-Rose discloses that the cultured three-dimensional tissue can be sutured to the surface of the myocardium (as in claim 9), a soft tissue (claim 10), in the area of ischemia (Pg. 7, para. 82) or, alternatively, injected directly into the ischemic tissue (as in claim 8) (‘Example 2’, Pg. 14, para. 159-160). Additionally, Siani-Rose discloses the composition further comprises embryonic stem cells (as in claim 6) (Pg. 4, para. 53).
Accordingly, Siani-Rose et al. anticipates the claimed invention.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Prior Art Rejection 2
Claim 3 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siani-Rose et al. (PgPub US20090317482A1, Published 12/24/2009; Ref. 20 in IDS filed 8/6/2024 ) as evidenced by Lindstedt et al. (Ann. Thor. Surg, 84: 568-573, 2007.; Ref. 2 in IDS filed 8/6/2024) and Bernatchez et al. (The Journal of Biological Chemistry, 274(43): 31047-31054, 1999.; Ref. 47 in IDS filed 8/6/2024) as applied to claims 1-2, 4-6 and 8-10 above, and further in view of Matheny et al. (PgPub US20070014773A1, Filed 7/15/2005; Ref. 12 in IDS filed 8/6/2024).
The teachings of Siani-Rose et al. as evidenced by Lindstedt et al. and Bernatchez et al. are relied upon as detailed above. However, Siani-Rose et al. fails to teach the composition further comprises at least one member of the group consisting of allograft tissue, synthetic allograft tissue, treated allograft tissue and xenograft tissue (as in claim 3).
Prior to the time of the claimed invention, Matheny et al. taught compositions of the invention for regenerating defective myocardium comprising an injectable extracellular matrix composition (Abstract). Matheny teaches the matrix is a synthetic matrix, such as a hydrogel (Pg. 6, para. 56), or derived from a mammalian source (i.e. allograft tissue) (as in claim 3) and can further comprise cells and growth factors (Pg. 2, para. 20; Pg. 7, para. 62-63). Matheny adds that the composition can be placed in contact with the defective myocardium, resulting in myocardial tissue regeneration and restoration of contractility, conductivity, or function to the heart muscle. Matheny notes that this invention appreciates the importance of the presence of some amount and form of an extracellular matrix, or extracellular matrix-like scaffold, as a framework for the essential activities of cell-cell, matrix-cell, protein-cell, and protein-protein interactions that form the dynamic tissue regenerative process in vivo, potentially optimized by the presence of added cells, proteins, or other bioactive components (Pg. 2, para. 20).
When taken with the teachings of Matheny et al., one of ordinary skill in the art would have found it prima facie obvious to substitute the synthetic matrix hydrogel of Siani-Rose et al. for the mammalian derived scaffold of Matheny with a reasonable expectation of arriving at the claimed invention. That is, one of ordinary skill in the art would have used the mammalian derived scaffold of Matheny, wherein said scaffold is in an injectable form in carrier solution and comprises angiogenic growth factors, to treat ischemic tissue. The skilled artisan would have certainly been motivated to make such a substitution owing to the minimal immunogenicity and biodegradability of naturally derived scaffolds. A reasonable expectation of success is present here as Siani-Rose taught an injectable scaffold treated ischemic tissue.
Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation.
The cited prior art meets the criteria set forth in both Graham and KSR.
Prior Art Rejection 3
Claim 7 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siani-Rose et al. (PgPub US20090317482A1, Published 12/24/2009; Ref. 20 in IDS filed 8/6/2024 ) as evidenced by Lindstedt et al. (Ann. Thor. Surg, 84: 568-573, 2007.; Ref. 2 in IDS filed 8/6/2024) and Bernatchez et al. (The Journal of Biological Chemistry, 274(43): 31047-31054, 1999.; Ref. 47 in IDS filed 8/6/2024) as applied to claims 1-2, 4-6 and 8-10 above.
The teachings of Siani-Rose et al. as evidenced by Lindstedt et al. and Bernatchez et al. are relied upon as detailed above. And although Siani-Rose does not explicitly teach applying the composition a plurality of times over a time period of at least a week (claim 7), Siani-Rose notes that the frequency of administration and duration between successive applications is well within the capabilities of those skilled in the art (Pg. 9, para. 109) (as in claim 7).
Accordingly, the amount of times that this composition would be applied would be routine optimization of Siani-Rose’s techniques. As noted in In re Aller, 105 USPQ 233 at 235,
More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Thus, the claimed invention, as a whole, is clearly prima facie obvious in view of the teachings Siani-Rose et al.
Prior Art Rejection 4
Claims 11-12 and 14-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siani-Rose et al. (PgPub US20090317482A1, Published 12/24/2009; Ref. 20 in IDS filed 8/6/2024 ) as evidenced by Lindstedt et al. (Ann. Thor. Surg, 84: 568-573, 2007.; Ref. 2 in IDS filed 8/6/2024) and Bernatchez et al. (The Journal of Biological Chemistry, 274(43): 31047-31054, 1999.; Ref. 47 in IDS filed 8/6/2024), Royce et al. (J Biomater Sci Polym Ed. 2004;15(10):1327-36; Ref. 42 in IDS filed 8/6/2024) and Nadeau et al. (WO2001022741A2, Published 3/29/2001; Ref. 7 in IDS filed 8/6/2024).
Regarding to claim 11, in-part, Siani-Rose et al. teach delivering angiogenic factors in the treatment of ischemic heart tissue by utilizing three-dimensional tissue (Pg. 1, para. 4). Lindstedt is provided as evidence that ischemic heart tissue has diminished microvascular blood flow (Pg. 568, Background; p. 568, col. 2, para. 1; p. 570, Figure 3). Siani-Rose teaches that the three-dimensional tissue is used to deliver various growth factors (Pg. 1, para. 9), including angiogenic growth factors, such as CTGF (Pg. 6, para. 63), vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), fibroblast growth factors (FGF), platelet derived growth factor (PDGF), epidermal growth factor (EGF), transforming growth factor (TGF) (as in claim 14) (Pg. 7, para. 72). Bernatchez provides evidence that VEGF is a chemoattractant of endothelial cells (as in claim 15) (Abstract; p. 31051, col. 1; p. 31052, Discussion). Siani-Rose teaches that three-dimensional framework can be composed of a scaffold (Pg. 2, para. 34-35); that can comprise a hydrogel (as in claim 12), comprised of polymers that form gels sufficient for the cells to attach and form the structure (Pg. 3, para. 43). Siani-Rose teaches that the cultured three-dimensional tissue can be sutured to the surface of the myocardium (as in claim 19), a soft tissue (claim 20), in the area of ischemia (Pg. 7, para. 82) or injected directly into the ischemic tissue (as in claim 18) (‘Example 2’, Pg. 8, para. 159-160). Additionally, Siani-Rose teaches the composition further comprises embryonic stem cells (as in claim 16) (Pg. 4, para. 53). And although Siani-Rose does not explicitly teach applying the composition a plurality of times over a time period of at least a week, Siani-Rose notes that the frequency of administration and duration between successive applications is well within the capabilities of those skilled in the art (Pg. 9, para. 109) (as in claim 17).
Accordingly, the amount of times that this composition would be applied would be routine optimization of Siani-Rose’s techniques. As noted in In re Aller, 105 USPQ 233 at 235,
More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
And although Siani-Rose teaches an angiogenic factor to be delivered is a Fibroblast Growth Factor (FGF), Siani Rose fails to teach said FGF is FGF-1 (as further in claim 11).
Before the priority date of the claimed invention, Royce et al. examined the feasibility of a hybrid scaffold in which fibroblast growth factor-1 (FGF-1) (as further in claim 11)-encapsulated microspheres are embedded within a fibrin gel. Such a tissue-engineered scaffold could be incorporated into surgical procedures to promote healing while simultaneously delivering therapeutic agents that promote angiogenesis (Abstract). Using a cell-proliferation assay, Royce observed proliferation in NIH-3T3 cells when FGF-1 was released from the microspheres (Pg. 1333, para. 1).
And although Siani-Rose teach treating a patient with a diminished microvascular flow, Siani-Rose fails to teach, after identifying a patient with ischemic tissue resulting from diminished microvascular blood flow, imaging a location in a patient with the diminished microvascular blood flow (as further in claim 11).
Before the priority date of the claimed invention, Nadeau et al. taught in vivo medical and clinical uses of orthogonal polarization spectral (OPS) imaging to directly, and in many cases non- invasively, visualize, characterize, evaluate, monitor, and/or analyze a subject's microvascular and/or vascular system (Pg. 1, para.1). Nadeau notes that different disease states, including, coronary heart disease, produce distinctive microvascular pathologies. To date, imaging of the human microcirculation for diagnosis and/or treatment has been limited to vascular beds, where the vessels are visible and close to the surface. Nadeau teaches OPS imaging is a new method for visualizing and characterizing the microcirculation using reflected light that allows imaging of the microcirculation noninvasively through mucus membranes, as well as on the surface of solid organs (Pg. 5, para. 1).
Towards this end, Nadeau teaches OPS imaging was applied to a beating pig heart using an epicardial stabilization device, to see if it could be used to detect, visualize, and characterize changes in the epicardial microcirculation during regional induced ischemia. Eight pigs underwent median sternotomy under general anesthesia. After exposure of the heart, an epicardial suction device was applied. The two fork-like extensions of the device were placed on top of the left anterior descending (LAD) artery, and the myocardial area was stabilized by applying 400mmHg of suction. The OPS imaging probe was placed in this stablized region to visualize the epicardial microvessels. Regional ischemia of this area was achieved with a monofilament tourniquet suture around the proximal LAD. Nadeau teaches that it was possible to obtain microvascular images of the epicardium in all 8 animals. Semiquantitative analysis showed a decrease in microvascular blood flow on occlusion of the LAD. Nadeau concludes that OPS imaging in conjunction with regional myocardial wall immobilization device allows the visualization and characterization of the microcirculation of the epicardium. From the images obtained, it is possible to quantify changes in epicardial blood flow and allow a unique assessment of the microcirculatory changes during regional ischemia (Pg. 51, para.2-Pg. 52 ‘Conclusions’) (as further in claim 11).
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and G are applicable. At the time of invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Siani-Rose et al., wherein Siani-Rose teaches delivering angiogenic factors in the treatment of ischemic heart tissue by utilizing three-dimensional tissue, with the teachings of Nadeau et al., wherein Nadeau teaches monitoring a subject’s microvascular system by orthogonal polarization spectral (OPS), with a reasonable expectation of arriving at the claimed invention.
That is, one of ordinary skill in the art would have found it prima facie obvious to use the OPS imaging system of Nadeau to detect, visualize, and characterize changes in a patient’s epicardial microcirculation prior to treatment with the composition of Siani-Rose et al. Further, the skilled artisan would have additionally found it prima facie obvious to confirm the success of the therapeutic composition of Siani-Rose by using the OPS imaging system to visualize the patient’s epicardial microcirculation post-treatment.
Moreover, from the genus of FGFs taught by Siani-Rose et al., one of ordinary skill in the art would have found it prima facie obvious to use FGF-1, as taught by Royce, because Royce teaches FGF-1 plays a role in induction of angiogenesis and is well-characterized both in vivo and in vitro (see Royce at Pg. 1328, para. 1).
Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the claimed invention, as a whole, was clearly prima facie obvious.
Prior Art Rejection 5
Claim 13 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Siani-Rose et al. (PgPub US20090317482A1, Published 12/24/2009; Ref. 20 in IDS filed 8/6/2024 ) as evidenced by Lindstedt et al. (Ann. Thor. Surg, 84: 568-573, 2007.; Ref. 2 in IDS filed 8/6/2024) and Bernatchez et al. (The Journal of Biological Chemistry, 274(43): 31047-31054, 1999.; Ref. 47 in IDS filed 8/6/2024), Royce et al. (J Biomater Sci Polym Ed. 2004;15(10):1327-36; Ref. 42 in IDS filed 8/6/2024) and Nadeau et al. (WO2001022741A2, Published 3/29/2001; Ref. 7 in IDS filed 8/6/2024) as applied to claims 11-12 and 14-20 above, and further in view of Matheny et al. (PgPub US20070014773A1, Filed 7/15/2005; Ref. 12 in IDS filed 8/6/2024).
The teachings of Siani-Rose et al., Lindstedt et al., Bernatchez et al., Royce et al. and Nadeau et al. are relied upon as detailed above.
However, none of the references teach the composition further comprises at least one member of the group consisting of allograft tissue, synthetic allograft tissue, treated allograft tissue and xenograft tissue (as in claim 13).
Prior to the time of the claimed invention, Matheny et al. taught compositions of the invention for regenerating defective myocardium comprising an injectable extracellular matrix composition (Abstract). Matheny teaches the matrix is a synthetic matrix, such as a hydrogel (Pg. 6, para. 56), or derived from a mammalian source (i.e. allograft tissue) (as in claim 13) and can further comprise cells and growth factors (Pg. 2, para. 20; Pg. 7, para. 62-63). Matheny adds that the composition can be placed in contact with the defective myocardium, resulting in myocardial tissue regeneration and restoration of contractility, conductivity, or function to the heart muscle. Matheny notes that this invention appreciates the importance of the presence of some amount and form of an extracellular matrix, or extracellular matrix-like scaffold, as a framework for the essential activities of cell-cell, matrix-cell, protein-cell, and protein-protein interactions that form the dynamic tissue regenerative process in vivo, potentially optimized by the presence of added cells, proteins, or other bioactive components (Pg. 2, para. 20).
When taken with the teachings of Matheny et al., one of ordinary skill in the art would have found it prima facie obvious to substitute the synthetic matrix hydrogel of Siani-Rose et al. for the mammalian derived scaffold of Matheny with a reasonable expectation of arriving at the claimed invention. That is, one of ordinary skill in the art would have used the mammalian derived scaffold of Matheny, wherein said scaffold is in an injectable form in carrier solution and comprises angiogenic growth factors, to treat ischemic tissue. The skilled artisan would have certainly been motivated to make such a substitution owing to the minimal immunogenicity and biodegradability of naturally derived scaffolds. A reasonable expectation of success is present here as Siani-Rose taught an injectable scaffold treated ischemic tissue.
Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation.
The cited prior art meets the criteria set forth in both Graham and KSR.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10624952 and claims 1-14 of U.S. Patent No. 12168038 . Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Instant independent claim 1 is drawn to a method of treating a patient having ischemic tissue resulting from diminished microvascular blood flow comprising: identifying a patient with ischemic tissue resulting from diminished microvascular blood flow; obtaining a composition comprising a carrier solution combined with an angiogenic growth factor, the carrier solution capable of adhering to an anatomical structure of the patient proximal to the ischemic tissue resulting from diminished microvascular blood flow; and applying the composition to the anatomical structure of the patient proximal to the ischemic tissue resulting from the diminished microvascular blood flow, thereby inducing angiogenesis within at least a portion of the ischemic tissue.
Instant independent claim 11 is drawn to a method of treating a patient having ischemic tissue resulting from diminished microvascular blood flow comprising: identifying a patient with ischemic tissue resulting from diminished microvascular blood flow; imaging a location in a patient with the diminished microvascular blood flow; obtaining a composition comprising a carrier solution combined with a fibroblast growth factor - 1 (FGF-1 ), the carrier solution capable of adhering to an anatomical structure of the patient proximal to the ischemic tissue resulting from diminished microvascular blood flow; and applying the composition to the anatomical structure of the patient proximal to or in the ischemic tissue resulting from the diminished microvascular blood flow, thereby inducing angiogenesis within at least a portion of the ischemic tissue.
The claims of U.S. Patent ‘952 are drawn to a method of diagnosing and treating a patient having ischemic tissue resulting from diminished microvascular blood flow comprising:
a) obtaining a vascular anatomy image and a dynamic perfusion image of a hypoperfused tissue of the patient, wherein the tissue is a vertebral body; b) calculating an ischemic index from the vascular anatomy image and the dynamic perfusion image, wherein the ischemic index identifies an extent of degeneration and a degree of segmental artery stenosis to determine diminished microvascular blood flow within the hypoperfused tissue portion; c) obtaining a composition comprising a carrier solution combined with an angiogenic growth factor; and d) applying the composition to the anatomical structure of the patient proximal to the microvasculature, thereby inducing angiogenesis within at least a portion of the microvasculature.
51. The claims of U.S. Patent ‘038 are drawn to treating a patient having ischemic tissue resulting from diminished microvascular blood flow consisting of: identifying a patient with ischemic tissue resulting from diminished microvascular blood flow; obtaining a vascular anatomy image and a dynamic perfusion image of a hypoperfused tissue of the patient;
calculating an ischemic index from the vascular anatomy image and the dynamic perfusion image, wherein the ischemic index identifies an extent of degeneration and a degree of segmental artery stenosis to determine diminished microvascular blood flow within the hypoperfused tissue portion; administering a composition consisting of a carrier solution with FGF-1 at 0.1 to 400 μg and at least one member of the group consisting of allograft tissue, synthetic allograft tissue, treated allograft tissue and xenograft tissue, wherein the carrier solution adheres to an anatomical structure of the patient proximal to the ischemic tissue resulting from diminished microvascular blood flow; and applying the composition to the anatomical structure of the patient proximal to the ischemic tissue resulting from the diminished microvascular blood flow, thereby inducing angiogenesis of capillaries within at least a portion of the ischemic tissue
It is clear that all the elements of the application claims are to be found in patent claims (as the application claims fully encompasses patent claims). The difference between the application claims and the patent claims lies in the fact that the patent claim includes many more elements and is thus much more specific (e.g. patent claims require a vascular anatomy image and application claims do not). Thus, the invention of claims of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims is anticipated by claims of the patent, it is not patentably distinct from claims of the patent.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/Primary Examiner, Art Unit 1632
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