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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 November 2025 has been entered.
Claim Status
Applicant’s claim amendments filed 10 November 2025 are acknowledged.
Claims 1-31 are pending.
Claims 1, 6, 7, 16 & 25-27 are amended.
Claims 10-18 & 28-31 are withdrawn.
Claims 1-9 & 19-27 are under consideration.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Examination is to the extent of the following species:
A) Polymeric mesh constituents- First polymer: Polylactic acid and Natural Polymers: collagen and chitosan;
B) Growth Factors- epidermal growth factors; and
C) Constituents of the polymeric support mesh- polyglycolic acid.
Priority
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
New & Maintained Rejections
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 1-9 & 19-27 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 1, lines 4-5, recite “configured for hernia repair, chronic wound healing, or fistula repair”. It is unclear what reagents, structures and/or steps (e.g. product-by-process) are required in order to have a polymeric carrier mesh that is “configured for hernia repair, chronic wound healing, or fistula repair”.
Applicant may wish to consider whether deletion of the phrase “configured for hernia repair, chronic wound healing, or fistula repair” would obviate the objection.
Claim 2-9 & 19-27 are rejected under 35 USC 112(b) because they depend from indefinite claim 1 and do not clarify the issue.
Claim 19 recites the limitation "the soft tissue repair" in line 1. There is insufficient antecedent basis for this limitation in the claim.
The examiner notes “soft tissue” is deleted from claim 1, from which claim 19 depends.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 19 depends from claim 1. Claim 19 recites the hernia repair is surgical hernia repair. As evidenced by Cleveland Clinic, while there are nonsurgical treatments for hernias, hernia repair is surgical (i.e. surgical is implicit to hernia repair; pg. 4). “[T]here are many different surgical approaches to repairing a hernia” (pg. 4). Hernia repair involves surgery including but not limited to laparoscopic surgy and robotic surgery (pg. 4). Since “hernia repair” is necessarily a surgical repair, the recitation of “surgical hernia repair” does not further limit claim 1. “Chronic wound healing” and “fistula repair” are already recited by claim 1 and fail to further limit claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1, 2, 4-9 & 19-27 are rejected under 35 U.S.C. 103 as being unpatentable over Vyakarnam (US 2001/0033857, Published: 10/25/2001).
Claim Analysis: The claim 1 recitations of “for use in hernia repair within a patient’s body” is a statement of intended use and does not further limit the mesh implant delivery system other than the components and/or their amounts must be suitable for implantation within a patient’s body.
The claim 1 recitation of “configured for hernia repair, chronic wound healing, or fistula repair…” is a product by process recitation. M.P.E.P. § 2113-PRODUCT BY PROCESS CLAIMS states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
M.P.E.P. § 2113 further states: "Once a product appearing to be substantially identical is found and a 35 U.S.C. 102 /103 rejection made, the burden shifts to the Applicants to shown an unobvious difference.” “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).”
Claim 19 is directed to intended use for biodegradable mesh implant and does not compositionally further limit the mesh implant delivery system in terms of reagents and amounts.
*Please note that in the process of searching for the elected embodiment, the examiner found art which reads on the broader recitation of the claims (i.e. the natural polymer is collagen) and in an effort to expedite prosecution, this art has been applied.
With regard to claim 1, Vyakarnam teaches a three-dimensional foam with interconnected open cell pores (i.e. a sponge-like structure with interconnected pores of different sizes; abstract). With regard to claim 1, Vyakarnam teaches the pores are different sizes in their Figure 1.
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With regard to claims 1, 4, 5, 22 & 23, Vyakarnam teaches their invention relates to porous biocompatible bioabsorbable foams in which the biocompatible, bioabsorbable polymer that could be used include homopolymers and copolymers of lactide (which includes lactic acid, D-,L- and meso lactide; i.e. biodegradable polymeric carrier mesh; [0001] & [0050]). With regard to claims 1, 5, 6, & 24, Vyakarnam teaches various proteins can be adsorbed onto the surface or back filled into the foams after the foams are made and collagen (a protein) is taught as suitable (i.e. wherein the first polymer is covered with at least one natural polymer that is collagen; [0085]). With regard to claims 1 & 8, Vyakarnam teaches suitable cell that may be contacted or seeded into the foam scaffolds include but are not limited to fibroblasts and that these cells “can be harvested from a patient (before or during surgery to repair the tissue” (i.e. the fibroblasts are autologous fibroblasts of the patient that is intended to receive the implant; [0091]). With regard to claim 9, Vyakarnam teaches growth agents, chemotatic agents can be added to the foams during processing, adsorbed onto the surface or back filled into the foams after the foams are made and these include fibroblast growth factor (FgF), epidermal growth factor (EGF), platelet derived growth factor (PDGF), insulin derived growth factor (IGF-I and IGF-II), transforming growth factors (TGF-β), vascular endothelial growth factor (VEGF) [0085]. With regard to claim 3, Vyakarnam teaches “a foam may be formed that transitions from a softer spongy foam to a stiffer more rigid foam similar to the transition from cartilage to bone. Clearly other polymer blends may be used for similar gradient effects or to provide different gradients such as different…degrees of elasticity…… these foams can be used for organ repair replacement or regeneration strategies that may benefit from these unique scaffolds, including…breast tissues”[0057]. As such the ordinary skilled artisan would envisage an elastically deformable scaffold/foam based upon Vyakarnam’s teaching of a soft spongy foam and use in breast tissue.
While there is not a single example comprising each of the claimed components, bioabsorbable polymer (i.e. polylactic acid first polymer having a sponge-like structure with interconnected pores), seeded cells (i.e.fibroblasts), adsorbed protein (i.e. collagen) and growth factors (i.e. epidermal growth factor) are included among short lists of reagents. It would have been obvious to one of ordinary skill in the art at the time of the instant invention to combine the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results.
With regard to the total degradation time in the patient as recited by claims 7 & 25-27, Vyakarnam teaches inclusion of homopolymers and copolymers of lactide (which includes lactic acid, D, L- and meso lactide) and teaches the foams “can be used to repair or regenerate tissue (including organs)” [0027]. It would be obvious to optimize within prior art conditions through routine experimentation to achieve a degradation rate of 2 to 4 months as needed for the given end use of providing a tissue scaffold for tissues and organs.
With regard to the water contact angle as recited by claims 1, 2, 20 & 21, the porous sponge taught by Vyakarnam necessarily has a water contact angle within the range of 0° to 10° since "Products of identical chemical composition can not have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). This assertion is supported by page 4 of the instant specification which discloses that “sponge-like structure with interconnected pores of different sizes and a water contact angle of less than 75°, which means that it is hydrophilic” and Vyakarnam teaches their foam scaffold has interconnected pores made from homopolymers and copolymers of lactide (which includes lactic acid, D, L- and meso lactide) having collagen adsorbed to it.
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Vyakarnam as applied to claims 1, 2, 4-9 & 19-27 above, and further in view of McKay (US 2016/0038642; 02/11/2016; previously cited).
The teachings of Vyakarnam are described above. In brief, Vyakarnam teaches their foams are three dimensional scaffolds [0091]. Vyakarnam teaches their foam may also serve as a scaffold in which suitable cell types for seeding on the scaffolds may be soft tissue cells (i.e. myocytes, adipocytes, muscle cells, endothelial cells, pancreatic cells, hepatocyte, bile duct cells) and bone cells [0091]. Vyakarnam teaches their foam structure can facilitate the repair or regeneration of cartilage ([0029], [0031]-[0034] & [0091]).
Vyakarnam does not teach the three-dimensional scaffold is in a sheet-like shape and inclusion of chitosan.
In the same field of cartilage repair, McKay teaches a matrix utilized as a scaffold for cartilage repair, regeneration and/or augmentation [0028]. McKay teaches their “matrix provides a 3-D structure of interconnecting pores, which acts as a pliant scaffold for cell migration.” [0028]. With regard to claims 1 & 5, McKay teaches their matrix comprises biodegradable polymeric material including poly(L-lactide) and collagen [0061]. With regard to claim 3, McKay teaches their matrix may be “tailored to the site at which it is to be situated. For example, it may be in the shape of…a block…a sheet, as strip, etc.” [0067]. With regard to claim 5, McKay teaches compression resistance is needed for many tissue engineering applications and this is achieved through compression resistant matrices which help facilitate adequate volumes through use of ceramic particles which may be chitosan ([0070], [0071] & [0076]).
With regard to claim 3, at least rationale (G), may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the shape of Vyakarnam’s generically taught 3D scaffolds to sheet shaped as suggested by McKay because Vyakarnam and McKay are directed to tissue engineering cartilage with scaffolds of PLLA and collagen and McKay teaches sheets to be a suitable shape for these scaffolds. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to provide the collagen covered PLLA foam scaffold in a sheet suitable for the implantation site.
With regard to claim 5, at least rationale (A), may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified collagen covered PLLA scaffold of Vyakarnam by adding chitosan as suggested by McKay because Vyakarnam and McKay are all directed to tissue engineering cartilage with scaffolds of PLLA and collagen and McKay teaches inclusion of chitosan particles provides compression resistance which is needed in many tissue engineering applications. The ordinary skilled artisan would have been motivated to do so, with an expectation of success in order to provide compression resistance and maintain the volume of the foam scaffold.
Claims 1, 2, 4-8 & 19-27 are rejected under 35 U.S.C. 103 as being unpatentable over Sugiyama (Materials Science and Engineering C 32 (2012) 290–295; Published:10/25/2011; previously cited) in view of Mitsuo (JP 2005261610; Published: 09/29/2005; previously cited), and further in view of O’Heeron (WO 2013/070880; Published: 05/16/2013; previously cited).
Claim Analysis: As above.
*Please note that in the process of searching for the elected embodiment, the examiner found art which reads on the broader recitation of the claims (i.e. the natural polymer is collagen) and in an effort to expedite prosecution, this art has been applied.
** All references refer to the English language translation.
With regard to claim 1, Sugiyama teaches poly(l-lactic acid) sponges for tissue engineering (i.e. a first polymer comprising polylactic acid (PLLA) as a main component; title). With regard to claims 1, 4, 22 & 23, Sugiyama in Figure 1 teaches a cross section in which the sponge-like structure is made entirely of PLLA; Figure 1 shows the pores are of different sizes and are interconnected (pg. 292).
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With regard to claims 1, 5, 6 & 24, Sugiyama teaches the PLLA sponges are homogenously covered in collagen (i.e. natural polymer; pg. 292). With regard to claims 1, 5, 6 & 24, Sugiyama teaches the collagen goes into the pores of PLLA sponge and form microsponges in the pores (pg. 292). Sugiyama teaches cell seeding of chondrocytes seeded into the collagen-coated PLLA sponges (emphasis added; pg. 292).
Sugiyama does not teach the cell type of the seeded cells are fibroblasts that are autologous fibroblasts of the patient.
With regard to claim 1, Mitsuo teaches a member for cartilage formation (soft tissue repair) which comprises a holder which has a sponge-like material such as collagen and PLLA (abstract; pg. 7). With regard to claim 1, Mitsuo teaches to promote the formation of bone, cells including chondrocytes and fibroblasts can be introduced (pg. 5).
In the related field of growing cartilage, with regard to claim 1, O’Heeron teaches compositions and methods for differentiating human dermal fibroblasts (HDFs) into chondrocytes ([0008] & [0041]). With regard to claim 8, the HDFs may be autologous to avoid the risk of contamination from another donor ([0007] & [0034]). With regard to claim 1, O’Heeron teaches the HDFs undergo chondrocytic differentiation in-vivo where the micro-environment is suitable such as the intervertebral disc and joints ([0002] & [0037]).
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
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.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Here, at least rationale (A) may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing the invention to have modified Sugiyama’s composition by adding autologous fibroblasts as suggested by the combined teachings of Mitsuo and O’Heeron because Sugiyama, Mitsuo and O’Heeron are to the field of tissue engineering pertaining to the growth of chondrocytes and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motivated to do so, with an expectation of success in order to increase the population of chondrocytes and promote cartilage growth.
With regard to the claim 1 recitation that the implant is biodegradable, the mesh implant taught by the combined teachings of Sugiyama, Mitsuo and O’Heeron consists of PLLA, collagen, chondrocytes, and autologous fibroblasts (emphasis added). These are all biodegradable substances.
With regard to the total degradation time in the patient as recited by claims 7 & 25-27, Sugiyama teaches PLLA has a slower degradation rate and PLLA scaffolds can be used for regeneration of tissues and organs having a slow regeneration speed and load-bearing (pg. 290). Sugiyama teaches PLLA is a biodegradable synthetic poIymer with controllable biodegradation. It would be obvious to optimize within prior art conditions through routine experimentation to achieve a degradation rate of 2 to 4 months as needed for the given end use of providing a tissue scaffold for slow growing tissues comprising chondrocytes such as the joints and the spine.
With regard to the water contact angle as recited by claims 1, 2, 4, 5, 20 & 21, the porous sponge suggested by the combined teachings of Sugiyama, Mitsuo and O’Heeron necessarily has a water contact angle within the range of 0° to 10° since "Products of identical chemical composition can not have mutually exclusive properties." A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). This assertion is supported by page 4 of the instant specification which discloses that “sponge-like structure with interconnected pores of different sizes and a water contact angle of less than 75°, which means that it is hydrophilic” and Sugiyama teaches their collagen-coated PLLA sponge absorb water (i.e. hydrophilic; pg. 291; Figure 4).
Claims 3 & 5 are rejected under 35 U.S.C. 103 as being unpatentable over Sugiyama [as evidenced by Ken (US 2009/0062850; Published: 03/05/2009; previously cited)], Mitsuo, and O’Heeron as applied to claims 1, 2, 4-8 & 19-27 above, and further in view McKay (US 2016/0038642; 02/11/2016; previously cited).
*This rejection addresses the elected species for the polymeric mesh constituents including the natural polymers of collagen and chitosan.
Claim Interpretation: Claim 3 recites “to allow folding or rolling…” which is a statement of intended use which does not further limit the mesh implant delivery system other than the implant must be elastically deformable.
The teachings of Sugiyama, Mitsuo and O’Heeron are described above. The combined teachings suggest a porous PLLA sponges having a collagen covering with collagen microsponges in the pores. The sponges as seeded with chondrocytes and autologous fibroblasts. As evidenced by Ken, collagen and polylactic acid are “bunchable” and “malleable” materials [0063]. As such, the porous PLLA sponges having a collagen covering are necessarily “elastically deformable” because they comprise PLLA and collagen and malleability is an intrinsic property of these polymers. Sugiyama teaches their sponges are block shaped (pg. 292; col. 2).
Neither Sugiyama, Mitsuo nor O’Heeron teach the sponge is a flat sheet-like shape or inclusion of chitosan.
In the related field of cartilage repair, teachings of McKay are described above.
With regard to claim 3, at least rationale (G), may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the shape of collagen covered PLLA sponge suggested by the combined teachings of Sugiyama, Mitsuo and O’Heeron from block shaped to sheet shaped as suggested by McKay because Sugiyama, Mitsuo and McKay are all directed to tissue engineering chondrocytes/cartilage with scaffolds of PLLA and collagen and McKay teaches sheets to be a suitable shape for these scaffolds. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to provide the collagen covered PLLA sponge in a sheet suitable for the implantation site.
With regard to claim 5, at least rationale (A), may be employed in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified collagen covered PLLA sponge suggested by the combined teachings of Sugiyama, Mitsuo and O’Heeron by adding chitosan as suggested by McKay because Sugiyama, Mitsuo and McKay are all directed to tissue engineering chondrocytes/cartilage with scaffolds of PLLA and collagen and McKay teaches inclusion of chitosan particles provides compression resistance which is needed in many tissue engineering applications. The ordinary skilled artisan would have been motivated to do so, with an expectation of success in order to provide compression resistance and maintain the volume of the sponge.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sugiyama , Mitsuo, and O’Heeron as applied to claims 1, 2, 4-8 & 19-27 above, and further in view Archer (WO 99/18991; Published: 04/22/1999; previously cited) and Zander (AU 2012201417; Published 04/05/2012; previously cited).
Claim Analysis: The analysis of claims 1 & 19 are as above.
*Please note that in the process of searching for the elected embodiment, the examiner found art which reads on the broader recitation of the claims (i.e. the natural polymer is collagen) and in an effort to expedite prosecution, this art has been applied.
The teachings of Sugiyama, Mitsuo and O’Heeron are described above. The combined teachings suggest a porous PLLA sponges having a collagen covering with collagen microsponges in the pores. The sponges as seeded with chondrocytes and autologous fibroblasts.
Neither Sugiyama, Mitsuo, nor O’Heeron teach inclusion of epidermal growth factor.
In the related field of invention of cartilage repair, with regard to claim 9, Archer teaches an article of manufacture which comprises a first agent which inhibits the apoptotic response to cartilage injury and a second agent which epidermal growth factor that functions as a promoting factor for optimizing the reparative response by enhancing the synthetic potential and proliferation of the rescued and surrounding chondrocyte cells (abstract ; Archer’s claim 33; pg. 6, ll. 1-15). With regard to claim 9, Archer teaches use of a material that prevents diffusible factors from leaving the injury site which may be medical plastics (pg. 5, ll. 1-10).
In the related field of implants for bone, with regard to claim 9, Zander teaches that PLLA is a medical grade plastic (pg. 5, ll. 20-end).
Here, at least rationale (A), may be applied in which it would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the collagen-coated PLLA sponge suggested by the combined teachings of Sugiyama, Mitsuo, and O’Heeron by adding epidermal growth factor as suggested by Archer because Sugiyama, Mitsuo, O’Heeron, and Archer are in the field of
pertaining to the growth of chondrocytes. Archer teaches epidermal growth factor to be a substance which enhances the synthetic potential and proliferation of chondrocyte cells which may be used in conjunction with medical plastics. The collagen-coated PLLA sponge suggested by the combined teachings of Sugiyama, Mitsuo, and O’Heeron comprises PLLA which is a known medical grade plastic as taught by Zander. The ordinary skilled artisan would have been motivated to do so, with an expectation of success, in order to promote the synthetic potential and proliferation of the chondrocyte cells through inclusion of epidermal growth factor as taught by Archer.
Response to Arguments
In the traverse of the rejection of claims 1, 2, 4-8, and 19-27 under 35 U.S.C. § 103 as obvious over Sugiyama in view of Mitsuo and O'Heeron; claims 3 and 5 over Sugiyama, Mitsuo, O'Heeron, and McKay; claim 9 over Sugiyama, Mitsuo, O'Heeron, and Zander, Applicant argues that Sugiyama “is limited to a PLLA sponge, for which cell growth behavior was tested by culturing chondrocytes on the matrix” (reply, pg. 7). Applicant argues the secondary references of Mitsuo and O'Heeron are both are directed to the field of bone repair (cartilage and discs; reply, pg. 9).
This is not persuasive. Applicant appears to be arguing that Sugiyama, Mitsuo and O'Heeron are in nonanalogous fields of endeavor. However, chondrocytes produce cartilage and form bone through endochondral ossification. As such Sugiyama, Mitsuo and O'Heeron are in related fields of endeavor. “[T]he Supreme Court's instruction in KSR that "[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one." KSR, 550 U.S. at 417, 82 USPQ2d at 1396. The Federal Circuit reads KSR as ‘direct[ing] us to construe the scope of analogous art broadly’ because ‘familiar items may have obvious uses beyond their primary purposes, and a person of ordinary skill often will be able to fit the teachings of multiple patents together like pieces of a puzzle.’ Wyers v. Master Lock Co., 616 F.3d 1231, 1238, 95 USPQ2d 1525, 1530 (Fed. Cir. 2010) (quoting KSR, 550 U.S. at 402, 127 S. Ct. at 1727)” (see MPEP 2141.01(a).
Applicant further argues “the skilled artisan had no incentive to modify the Sugiyama sponges to be configured for hernia repair, treatment of chronic wounds, or fistula repair as claimed…” (reply, pg. 7). “Cartilage repair requires distinct processes from the claimed mesh, which is configured for hernia repair, treatment of chronic wounds, or fistula repair” (reply, pg. 8).
This is not persuasive. As discussed in the “Claim Interpretation section”, this is a product by process limitation (i.e. configured) that does not structurally or compositionally distinguish the recited composition from that of the prior art. As discussed in the rejections above, the PLLA and collagen taught by Sugiyama are elastically deformable and Mitsuo and O’Heeron provide a rationale to add fibroblasts to Sugiyama’s mesh to increase the population of chondrocytes and promote cartilage growth.
Applicant argues cartilage tissue is avascular while the claimed configuration typically involves tissues that are vascularized (have blood supply). The composition of soft tissue contains collagen type I, elastin, and glycoproteins, which provides flexibility, elasticity, and tensile strength” (reply, pg. 8).
This is not persuasive. Applicant is arguing the intended use of the composition. Again, the intended use of the claimed composition does not further structurally or structurally define mesh from that suggested by the combined teachings of Sugiyama, Mitsuo and O'Heeron. A recitation of the intended use of the claimed 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 limitations of the claim.
With regard to Applicant’s argument that “the composition of soft tissue contains collagen type I, elastin, and glycoproteins, which provides flexibility, elasticity, and tensile strength”, the invention under examination is a mesh. The composition of soft tissue is not germane to structure or composition of the claimed mesh. If Applicant’s inventive mesh contains “collagen type I, elastin, and glycoproteins…”, Applicant’s representative is encouraged to consider whether claim amendments to recite these reagents could be a possible mechanism to differentiate their inventive composition from that suggested by Sugiyama, Mitsuo and O'Heeron.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1-9 & 19-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 5, 9, 16-23, 25 & 31 of U.S. Patent No. 12,059,510 (hereinafter the ‘510) in view of Mitsuo (JP 2005261610; Published: 09/29/2005; previously cited), O’Heeron (WO 2013/070880; Published: 05/16/2013; previously cited) and Archer (WO 99/18991; Published: 04/22/1999; previously cited).
Claim Analysis: The claim 1 recitations of “for use in hernia repair within a patient’s body” is a statement of intended use and does not further limit the mesh implant delivery system other than the components and/or their amounts must be suitable for implantation within a patient’s body.
The claim 1 recitation of “configured for hernia repair, chronic wound healing, or fistula repair…” is a product by process recitation. M.P.E.P. § 2113-PRODUCT BY PROCESS CLAIMS states: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
M.P.E.P. § 2113 further states: "Once a product appearing to be substantially identical is found and a 35 U.S.C. 102 /103 rejection made, the burden shifts to the Applicants to shown an unobvious difference.” “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983).”
Claim 19 is directed to intended use for biodegradable mesh implant and does not compositionally further limit the mesh implant delivery system in terms of reagents and amounts.
*Please note that in the process of searching for the elected embodiment, the examiner found art which reads on the broader recitation of the claims (i.e. the natural polymer is collagen) and in an effort to expedite prosecution, this art has been applied.
** All references refer to the English language translation.
The ‘510 and the instant application are both directed to mesh implants (see ‘510 col. 4, ll. 1-5 wherein “the term “matrix: ….refers to a three-dimensional support, e.g. mesh or a scaffold…”). Both the instant application and the ‘510 recite that polylactic acid is a the main component. The ‘510 recites for the top layer the polylactic acid is the main component and a further polymer is optional and in the bottom layer the main component is at least one of polylactic acid. The ‘510 further recites the first polymer comprises least 70% polylactic acid and may consist of polylactic acid. Both the instant application and the ’510 recite the matrix/mesh has a flat-sheet like shape and is elastically deformable. The ’510 recites the two layers form porous scaffolds comprising a sponge-like structure of interconnected pores of different sizes. The ‘510 recites the top layer comprises or is covered with at least one natural polymer which may be collagen and/or chitosan. The ‘510 recites the top layer which comprises mainly polylactic acid has water contact angle of 0° to 10°. The ‘510 recites the degradation time of the top layer is less than 4 months and the bottom layer has a degradation time of between 4 and 12 months (i.e. about 4 months). The ‘510 does not teach the matrix/mesh comprises autologous fibroblast cells or epidermal growth factor. The teachings of Mitsuo are described above under 35 USC 103(a) in which it admixtures of chondrocytes and fibroblasts are used with scaffolds of PLLA or collagen to restore cartilage. The teachings of O’Heeron are described above in 35 USC 103(a) that autologous fibroblasts from the patient are used in tissue engineering in order to avoid donor contamination. The teachings of Archer are described above under 35 USC 103(a) in which epidermal growth factor is recognized as a promoting factor for optimizing the reparative response in cartilage tissue engineering by enhancing the synthetic potential and proliferation of the rescued and surrounding chondrocyte cells (abstract ; Archer’s claim 33; pg. 6, ll. 1-15). It would have been prima facie obvious to the ordinary skilled artisan at the time of filing to have modified the matrix/mesh taught by the ‘510 patent by adding chondrocytes, autologous fibroblast cells and epidermal growth factor as suggested by the combined teachings of Mitsuo, O’Heeron, and Archer because the ‘510 patent, Mitsuo, O’Heeron, and Archer are directed to surgical implants in tissue engineering and it is obvious to modify similar compositions in the same way. The ordinary skilled artisan would have been motived to do so, with an expectation of success, in order to promote cartilage growth and repair. The instant claims are an obvious variant of the ‘510 patent in view of the prior art.
Response to Arguments
Applicant makes no argument pertaining to the double patenting rejection. As such, the rejection is maintained because Applicant has taken no action and the scope of the claims overlap with the ‘510 patent in view of the prior art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORI K MATTISON whose telephone number is (571)270-5866. The examiner can normally be reached 9-7 (M-F).
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/LORI K MATTISON/Examiner, Art Unit 1619
/NICOLE P BABSON/Primary Examiner, Art Unit 1619