DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/12/2026 has been entered.
Election/Restrictions
Applicant’s election of Group (I) in the reply filed on 01/18/2024 is maintained.
Priority
This application is a continuation of U.S. Application Serial No. 14/574,649, filed on
December 18, 2014, which claims the benefit of priority to U.S.S.N. U.S. Application Serial No. 61/920,970, filed on December 26, 2013.
Claim Status
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on August 20, 2025. Claims 1, 2, 4, 6-7, 9-26, and 28-41 are pending. Claims 21-26 and 28 remain withdrawn. Claims 3, 5, 8, and 27 are canceled. Claims 1, 2, 4, 6, 7, 9-20, and 29-41 are under examination.
Action Summary
Claims 1, 2, 4, 6, 7, 9-20, and 29 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, are maintained, but modified and revisited.
Claims 1, 2, 4, 6, 7, 9-20 and 29 rejected under 35 U.S.C. 103 as being unpatentable over by Williams et al. (US7,553,923) in view of in view of Rizk et al. (US7,943,683 B2), Nettles (Conference paper, NASA STI, October 2012), and Levine et al (Material Science, 2009), are maintained, but modified and revisited.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4, 6-7, 9-20, and 29-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The recitations of “the material of the first layer is directly bonded to the material of the second layer”; “the first layer comprises a P4HB blend or a P4HB copolymer blend, and wherein the second layer comprises a P4HB blend or a P4HB copolymer blend”; “the material of the first layer is heat press laminated directly to the material of the second layer”; and “the material of the first layer is laminated directly to the material of the second layer at a temperature between a softening temperature of the P4HB or the P4HB copolymer and a de-orientation temperature of the P4HB or the P4HB copolymer,” and the medical implant is substantially free from any intervening positioned between the first layer and the second layer” are not described in the specification. In fact, although the originally filled specification described laminated P4HB materials, stacked films, and certain lamination techniques, the specification does not reasonably convey the presently claimed ordered laminate architecture comprising specifically recited first and second layers having the presently claimed structural relationship to one another. The originally filed disclosure lacks adequate description of the presently claimed discrete ordered layer arrangement and the direct interfacial relationship recited between the specifically identified first and the second layers. Moreover, nowhere the specification describes the medical implant is substantially free from any intervening material positioned between the first layer and the second layer and the material of the first layer is heat pressed laminated directly to the material of the second layer. As such, said recitations are considered new matters.
Applicant argues that the rejection should be withdrawn because claim 1 allegedly does not recite a “first construct” or “second construct” as stated in the Office Action. Applicant further argues that the rejection is unclear on this basis.
The Examiner acknowledges the inadvertent use of the terms “first construct” and “second construct” in the prior Office Action. However, the substance of the rejection remains applicable to the presently claimed subject matter and the terminology error does not overcome the rejection.
As clarified herein, claim 1 recites a laminate structure comprising:
a first layer comprising P4HB or a copolymer thereof, and
a second layer comprising P4HB or a copolymer thereof;
wherein the material of the first layer is directly bonded to the material of the second layer.
The rejection is maintained because the amendment filed on 08/20/2025 introduces subject matter not reasonably supported by the originally filed disclosure. Specifically, the originally filed specification does not describe the presently claimed ordered relationship between the recited first and second layer, namely, that the material of the first is directly bonded to the material of the second later in the presently claimed manner.
Although the originally filed disclosure may generally discuss laminates, films, sheets, or layered structures, the disclosure does not specifically describe the presently amended configuration requiring:
(1) a distinct first layer and a distinct second layer arranged relative to one another, and
(2) direct bonding of the first layer material to the second layer material without an intervening0 material positioned therebetween.
The presently amendment therefore adds specificity regarding the arrangement and direct interfacial relationship of the recited layers that was not originally disclosed. The issue is not whether “layers” were originally disclosed, but whether the originally filed specification conveyed the particular ordered layer-to-layer relationship being claimed.
Accordingly, the amendment introduces subject matter which extends beyond the content of the application as originally filed.
New Written Description Rejection
Claims 1, 2, 4, 6-7, 9-20, and 29-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to broad classes of medical implants comprising laminated structures comprising laminated including first- and second-layers comprising poly-4-hydroxybutyrate (P4HB) or a P4HB copolymer, wherein each layer is at least partially mono-axially or bi-axially oriented and directly laminated to one another.
The specification does not reasonably convey to a person of ordinary skill in the art that Applicant had possession of the full scope of the claimed invention at the time of filing. Although the specification provides limited examples involving specific oriented P4HB films laminated under narrowly defined processing conditions the claims broadly encompass monoaxially and biaxially oriented laminate structures, P4HB homopolymers and copolymers, films. Sheets, tapes, meshes, woven, and nonwoven fabrics, porous and non-porous laminate structures, and numerous medical implant configuration and applications. The disclosure does not sufficiently describe the structural and processing parameters necessary to achieve and maintain the claimed oriented laminate structures across the full breadth of the claims.
For example, Example 3 discloses biaxial orientation of a 60 µm film stretched 4x in the machine and cross direction yield a 17 µm biaxially oriented film. Example 4 discloses lamination of biaxially oriented films under specific conditions including approximately 1650 psi pressure, 55oC temperature, and 15 minutes lamination time. However, the specification itself recognizes that preservation of orientation is technically difficult and process-sensitive. Specifically, Example 4 states that the measured burst strength “is very good because it means that the lamination process did not result in significant de-orientation of the film,” and further states that producing a biaxially oriented film of 200-micron thickness from an 8-10 mm thick film “would be technically very difficult as you would need to elongate the film 7x.” Thus, the specification itself acknowledges that orientation retention within laminated P4HB structures depends upon processing limitations and technical constraints.
Furthermore, the disclosure does not adequately describe how orientation may be consistently achieved and maintained across the full scope of the claimed laminate structures and implant embodiments, particularly where orientation retention depends upon variables including molecular weight, crystallinity, film thickness, draw ratio, thermal history, lamination temperature, pressure, and processing conditions.
Extrinsic evidence further demonstrates that P4HB properties are dependent upon molecular weight and related processing variables. Boesel et al. (International Journal of Biological Macromolecules 71 (2014) 124–130) teach molecular weight significantly affects crystallinity, mechanical properties, and processability of P4HB. (See Abstract.) Abdeladhim et al. (Materials 2024, 17, 5415, pages 1-30) further teach that PHA properties vary according to molecular weight and polydispersity index. (See Table 1 and last paragraph of page 4.)
Accordingly, the specification does not reasonably convey possession of the full scope of the claimed oriented laminate structures as presently claimed.
New scope of Enablement Rejection
Claims 1, 2, 4, 6-7, 9-20, and 29-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling forP4HB laminated structure comprising a biaxially stretching of a 60 µm P4HB film stretched 4x to yield a 17 µm oriented film and under 1650 psi pressure at 55oC for 15 minutes, does not reasonably provide enablement for full scope of the claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The claims broadly encompass medical implant comprising directly laminated monoaxially and/or biaxially oriented P4HB or P4HB copolymer layers across numerous laminate forms, implant configurations, thickness, and processing conditions.
The specification provides only limited working examples directed to narrowly defined embodiments and processing conditions. For example, Example 3 discloses biaxial orientation of a 60 µm film stretched 4x in the machine and cross direction yield a 17 µm biaxially oriented film. Example 4 discloses lamination of biaxially oriented films under specific conditions including approximately 1650 psi pressure, 55oC temperature, and 15 minutes. However, the claims are not limited to these specific embodiments or processing parameters. However, the specification itself acknowledges that orientation preservation during lamination is technically difficult and process-sensitive. Specifically, Example 4 states that the measured burst strength demonstrates that “the lamination process did not result in significant de-orientation of the film,” and further states that producing thicker biaxially oriented film of P4HB “would be technically very difficult because substantial elongation would be required.
Extrinsic evidence further demonstrates that P4HB properties are sensitive to numerous interrelated variables. Boesel et al. (International Journal of Biological Macromolecules 71 (2014) 124–130) teach molecular weight significantly affects crystallinity, mechanical properties, and processability of P4HB. (See Abstract.) Abdeladhim et al. (Materials 2024, 17, 5415, pages 1-30) further teaches that PHA properties vary according to molecular weight and polydispersity index, and that degradation and physical behavior are influenced by molecular weight, crystallinity, and thermal properties. (See Table 1 and last paragraph of page 4.)
Accordingly, preparation and maintenance of the claimed oriented laminate structures would depend upon numerous variables including molecular weight, crystallinity, film thickness, stretching ratio, processing temperature, pressure, thermal history, and orientation retention characteristics. The specification does not provide sufficient guidance enabling a person of ordinary skill in the art to determine appropriate combinations of such variables across the full breadth of the claims without undue experimentation.
Application of the Wands factors further support that undue experimentation would have been required.
(1) Quantity of experimentation necessary:
Substantial experimentation would have been required to determine suitable polymer compositions, molecular weights, film thickness, orientation conditions, and lamination conditions capable of preserving the claimed orientation across the full claim scope.
(2) Amount of direction or guidance presented:
The specification provides limited guidance directed to only a small number of working embodiments employing specific processing conditions.
(3) Presence or absence of working examples:
Only limited examples are disclosed involving relatively thin films and narrowly defined orientation/lamination parameters.
(4) Nature of the invention:
The invention concerns polymer processing and preservation of orientation within laminated P4HB structures, which is highly sensitive to processing conditions and material properties.
(5) State of the prior art:
The prior art demonstrates that P4HB properties and processability vary according to the molecular weight, crystallinity, and processing history. (See Abstract of Boesel.)
(6) Relative skill in the art:
Although those skilled in the polymer processing arts possess considerable technical skill, such skill would not eliminate the need of undue experimentation in view of the breadth of the claims and limited guidance provided.
(7) Predictability or unpredictability of the art:
The art is relatively unpredictable because orientation retention and mechanical behavior of laminated P4HB structures depend upon numerous interrelated variables.
(8) Breadth of the claims:
The claims broadly encompass numerous laminate structures, implant forms, polymer compositions, orientation states, and processing conditions extending well beyond the limited embodiments described in the specification.
Therefore, the specification fails to enable the full scope of the claimed invention without undue experimentation.
Rejection maintained, but modified and revisited
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 non-obviousness.
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 1, 2, 4, 6, 7, 9-20, and 29-41 are rejected under 35 U.S.C. 103 as being unpatentable over by Williams et al (US7,553,923) in view of in view of Rizk et al.(US7,943,683 B2), Levine et al (Material Science, 2009), Tsushimaa et al (US4,041,206A), and Wu (WO2011/044417 A2). Copies of Williams, Rizk, Nettles, and Levine can be found in the IDS dated 10/24/2022.
Williams teaches a device comprising biodegradable or bioresorbable polyhydroxyalkanoate (PHAs) with controlled degradation rates wherein the devices include implants, stent, hernia mesh, soft/ hard tissue, and a filer. (See Abstract.) Williams teaches the PHAs can be fabricated into devices suitable for wound healing. For example, non-woven fibrous materials for this purpose may be prepared from the polymers by first producing polymer fibers, by pressing the polymers through a perforated outlet, using procedures known to those skilled in the art. The fibers can then be fabricated into a porous membrane (cloth) by spreading them on a solid support and subjecting them to compression molding. (See column 25, lines 47-55.) Williams also teaches Polyhydroxyalkanoates such as the homopolymer P4HB and copolymers containing 4HB have physical properties and degradation characteristics which make them very attractive as implants for use in medical applications. These polymers can be fabricated into fibers, sheets, foams, coating, structures, filaments and the like for use of these as implantable medical materials. (See column 39, lines 24-31.) Moreover, Williams teaches the preferred PHAs for medical application is P4HB, i.e., poly-4-hydroxybutyrate. (See column 7, lines 35-37.) The polyhydroxyalkanoates may be manipulated using a wide range of processing techniques wherein the preferred techniques solvent casting, melt processing, fiber processing/spinning/weaving, extrusion, injection and compression molding, and lamination, (See column 12, lines 6-12.) Other techniques include machining methods. (See column, lines62.) Williams teaches the P4HB formed a thin film (layer) at a temperature of 115oC. (See Example 5.) The temperature of 115oC taught by Williams would be a temperature equal to or greater than softening temperature of P4HB copolymer as evidenced by the instant specification. Williams teaches the PHAs may be in almost any physical form, such as a powder, film, molded item, particles, spheres, latexes, and crystalline or amorphous materials. They can be combined with additional non-PHA materials, for example, other polymers. They are Suitable for use in applications requiring slowly degrading, biocompatible, moldable materials, for example, medical devices including implants. (See column 28, lines 30-52.) Williams teaches compression molded strips of P4HB were uniaxially stretched (oriented); the sample narrowed and became clear, showing signs of necking; after this stretching process, the polymer appeared stronger and somewhat more flexible, demonstrating uniaxial orientation of the sample. (See Example 8.) Additionally, Williams teaches PGA (poly glycolic acid) can be used. (See Examples 10 and 11.) Williams teaches exposure of a PHA containing article to vapors of ethylene oxide prior to implantation sterilizes the article making it suitable for implantation. During sterilization with cold ethylene oxide gas, gamma-irradiation, the PHA containing article maintains its shape. (See col. 28, lines 63-67.) Williams further teaches the PHA polymers can also be configured in porous and non-porous forms for spinal fusion cages. (See col. 21, lines 29-30.) Lastly, Williams teaches the tensile strength of the P4HB is 7,500 Psi which is 52 MPa. Williams teaches the PHA materials may contain bioactive or therapeutic agents. (See col. 27, lines 22-25.) The polyhydroxyalkanoate polymers can be a blends or composites of other materials. (See column 21, lines 17-18.)
In sum, Williams expressly teaches P4HB, implants, films/sheets, lamination processing, orientation/stretching, blends/composites, medical implants contexts. Williams expressly teaches both compression molding and lamination amount suitable polymer processing techniques for producing P4HB medical materials. Therefore, one of ordinary skill in the art would have understood lamination to represent an alternative known fabrication technique for forming multilayer P4HB implant structures
Williams does not specifically teach a first layer of a poly-4-hydroxybutyrate (P4HB) and a second layer of a P4HB, wherein each of the first and second layers of the laminated structure are at least partially mono-axially or bi- axially oriented, wherein the material of the first layer is laminated directly bonded to the material of the second layer at a temperature between the softening temperature of the P4HB and a de-orientation temperature of the P4HB. Additionally, Williams et al. does not teach the medical implant is substantially free from any intervening material positioned between the first layer and the second layer, wherein the material of the first layer is heat pressed laminated directly to the material of the second layer.
Rizk teaches a film of poly-4-hydroxybutyrate or copolymer thereof, wherein the film has a tensile strength greater than 5.5 kgf/mm2 and wherein the film is derived by a continuous process, followed by orientation such that the film is stretched by more than 25% of the film's original length in one or more directions. (See claim 1.) A particular preference of a film is P4HB, see Abstract. The film of claim 1 formed by melt extrusion or solvent casting. (See claim 2.) Moreover, Rizk teaches with appropriate choice of solvent, polymer and casting conditions, thinner films of P4HB can be produced. Ro the cast films, can be stretched and oriented uniaxially or biaxially to yield thinner and stronger film than the unoriented cast films. (See page 6, paragraph [0035].) Rizk teaches orientation is the process by which the film is stretched beyond its yield point and plastically deformed, but does not break (i.e., it retains mechanical and physical integrity). The degree of orientation may be expressed as the percentage or ratio that the film is stretch when compared to the original film prior to orientation. Films are preferably oriented by stretching the film by at least 25% of the film's original length in one or more directions. (See paragraph [0022].) Rizk further teaches the melt-extrusion films and solvent cast films show improved mechanical properties when stretched. The melt-extrusion film may be stretched by several methods such as a roll stretching and/or a stretching method using a tenter frame. The melt-extrusion film can be stretched at a temperature between room temperature and 150.degree. C. at a stretch ratio of 0.25 to 15. To increase the processing rate, the stretching may be more preferably carried out at a temperature in the range of from 40 to 80. degree. C. The stretching may be monoaxial stretching for forming a monoaxially oriented film, consecutive biaxial stretching for forming a biaxially oriented film and simultaneous biaxial stretching for forming a plane-oriented film. When the melt-extrusion film is stretched, the tensile strength at break in the direction in which the film is stretched is increased. (See paragraph [0056].) Rizk teaches stretching/orientating P4HB films at temperatures of about 40-80oC, which overlaps the presently claimed temperature range between the softening and de-orientation temperatures of P4HB. In the absence of evidence demonstrating criticality of the claimed range, overlapping ranges establish a prima facie case of obviousness.
In Sum, Rizk establishes monoaxial/biaxial orientation, stretch conditions, P4HB films, temperature/stretch parameters, and increase strength of oriented films.
Levine taches polymer laminate fabrication offers an alternative that permits iterative and empirical testing without the need for tooling. The result is a superior product that is optimized and well characterized. (See page 3, left column and second paragraph.) Moreover, Levine teaches polymer lamination process involves thin sheets or films of commercially available polymeric materials that are laser cut, then stacked to form fluidic channels and vias and the layers are bonded (laminated) together using pressure sensitive adhesive, thermal or diffusion bonding. (See page 3, left column and third paragraph.)
In sum, Levine teaches lamination fabrication by stacking polymer films/sheets, bonding adjacent layers together, diffusion/thermal bonding methods for laminated polymer structure.
Wu teaches Various multilayer laminated films and related methods of manufacture are known. For example, a multilayer film structure comprising at least one film of a fluoropolymer (e.g., polytetrafluoroethylene), at least one film of a thermoplastic polymer (e.g., polyethylene terephthalate) esters), between which at least one layer of adhesive is placed (for example, a polymer resin formed by an alkyl ester of an olefin having 2 to 8 carbon atoms and an α, β-ethylenically unsaturated carboxylic acid), Wherein the multilayer laminated film is formed by co-extrusion. The multilayer laminated film is said to exhibit high adhesive strength and good moisture and gas barrier properties, and is disclosed as being suitable as a packaging material for food and medicine. Although such multilayer laminated films exhibit moisture and gas barrier properties required for packaging materials, they do not meet the requirements of many other applications. ((See lines 30-34 of page 2 bridging lines 1-10..) Moreover, Wu teaches one approach taken to improve the properties of existing multilayer laminated films is to modify them by stretching thermoplastic polymer films. Stretching is known to significantly improve the properties of polymer films such as polyethylene terephthalate, including their barrier and optical properties, high and low temperature resistance properties, and dimensional stability. (See lines 13-20 of page 4.)
In Sum, Wu teaches multilayer laminated films whose properties are improved through stretching/orientation, and the known benefit of orientation in multilayer laminated systems.
Tsushimaa teaches laminated polyester film having a base layer of biaxially oriented polyethylene terephthalate or polybutylene terephthalate is laminated directly by heat sealing and without the use of any intervening adhesive with a crystalline butylene terephthalate or hexylene terephthalate copolyester blended with from about 10 to 40-weight % of a polyethylene terephthalate or polybutylene terephthalate. (See Abstract.) Moreover, Tsushimaa teaches a superior laminated polyester film which uses no extra adhesive layer to adhere the lamina together and which is much improved in slipperiness and has excellent heat-adhesive strength at high temperature, and which can be manufactured efficiently and with economy. (See lines 8-13 of column 2.)
In sum, Tsushimaa teaches directly heat-laminating oriented polymer layers, bonding without intervening adhesive layers, and multilayer oriented laminate structures.
Tsushima demonstrates that directly heat-laminating oriented polymer films without intervening adhesive layer was a known technique for preserving laminate integrity and adhesive strength while maintaining oriented film properties.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed to modify the P4HB implant material and films of Williams with the orientation/stretching teachings of Rizk, the multilayer lamination fabrication teachings of Levine, the multilayer orientation/stretching teachings of Wu, and the direct heat-lamination teachings of Tsushima in order to produce a multilayer oriented P4HB laminate implant structure having improved mechanical strength, laminate integrity, and adhesive properties while eliminating the need for intervening adhesive layers.
One of ordinary skill in the art would have motivated to combine the references because Williams expressly teaches P4HB medical implant materials fabricated as films/sheets and further teaches lamination as a known polymer processing technique for producing implantable materials. Rizk teaches that orientating/stretching P4HB films improves mechanical properties and film strength. Levine teaches conventional fabrication of laminated polymer structures by stacking and bonding polymer film layers together using thermal or diffusion bonding methods. Wu further teaches that multilayer laminated polymer films may be stretched/oriented to improve laminate properties, thereby evidencing that orientation techniques were compatible with multilayer laminate systems. Tsushimaa teaches directly heat laminating-oriented polymer layers without intervening adhesive layers while maintaining laminate integrity and adhesive strength.
Accordingly, one of ordinary skill in the art would have reasonably expected that oriented P4HB films could be stacked and thermally stacked and thermally laminated together to form directly bonded multilayer laminate implant structures while preserving desirable oriented film properties. The recitation of the “first layer” and the “second layer” are interpreted as identifying adjacent layers within a laminate structure and do not require any particular compositional distinction, manufacturing sequence, or additional structural relationship beyond expressly recited bonding relationship. The applied references collectively teach adjacent laminated polymer film layers satisfying these limitations.
Furthermore, the combination merely involves the application of known polymer film orientation and lamination techniques to known P4HB implant materials for their known purpose of improving structural and mechanical properties. The combination represents the predictable use of prior art elements according to their established functions. See KDR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
With respect to the presently claimed temperature range “between a softening temperature and a de-orientation temperature,” the instant specification itself identifies preferred orientation/stretching temperatures for P4HB films and sheets as about 40-80oC. (See instant specification, page 15, lines 20-30.) Risk likewise teaches stretching/orientating P4HB films at temperatures of about 40-80oC, which is the same preferred temperature range disclosed in the instant specification for orientating P4HB films/sheets to be used as layers for lamination. Accordingly, Rizk teaches the claimed temperature condition.
To the extent applicant argues that the claimed language “between a softening temperature and a de-orientation temperature” is narrow or critical, no evidence of criticality or unexpected results has provided.
Furthermore, the instant specification itself recognizes the oriented- P4HB films and sheets may be laminated and heat treated to minimize shrinkage during lamination, thereby evidencing that preservation of orientation during lamination was expected and known processing consideration within the art.
Affidavit
The declaration by David Martin under 37 CFR 1.132 filed 02/12/2026 is insufficient to overcome the rejection of claim 1, 2, 4, 6-7, 9-20, and 29-41.
Declarant David Martin argues that:
1. He has extensive experience with P4HB materials and implantable medical devices, including development, processing, and characterization of P4HB biomaterial.
2. The Examiner’s rejection allegedly proposes stretching/orientating already-laminated P4HB layers after lamination.
3. According to the declarant, stretching a previously laminated P4HB structure enough to impart monoaxial or biaxial orientation (approximately 30-300% elongation) would allegedly:
introduce sheer stress between layers,
weaken interlayer bonding,
cause peeling or delamination,
and result in an unsuitable structure.
4. The declarant therefore concludes one of ordinary skill in the art would not have been
Motivated to orient/stretch an already laminated P4HB multilayer structure because the process would allegedly destroy laminate integrity.
In response, Applicant’s declaration has been fully considered but is not persuasive for at least the following reasons.
First, the declaration attacks a combination and process that is not required by the rejection. The rejection does not require stretching an already fully laminated structure to the extent allegedly by the Declarant Martin. Rather, the rejection relies on the collective teachings of Williams, Risk, Levine, Wu, and Tsushimaa, which together teach:
P4HB films/sheets suitable for implantable medical device (Williams, Rizk,
monoaxial and biaxial orientation of P4HB flim/sheets (Rizk),
lamination/bonding of polymer film layers (Levine),
multilayer laminated films whose properties are improved through orientation/stretching (Wu),
and direct heat lamination of oriented polymer layers without intervening adhesive layers (Tsushimaa).
Thus, the declaration improperly characterizes the rejection as requiring a single
post-lamination deformation step allegedly sufficient to destroy the laminate structure.
Second, the declaration is consistent with the express teaching applied references. In particular, Rizk expressly teaches that films and sheets of P4HB “to be used as layers for lamination, may be oriented,” including monoaxial or biaxial orientation at temperature preferably between 40-80oC. Rizk additionally teaches that oriented films/sheets may be heat set or annealed to minimize shrinkage during lamination. These teachings directly contemplate oriented P4HB films being incorporated into laminated structures while maintaining laminate integrity.
Further, Tsushimaa expressly teaches directly heat-laminating oriented polymer films without an intervening adhesive layer while maintaining adhesive strength and laminate integrity. Wu additionally teaches that orientation/stretching improves the properties of multilayer laminated films. Accordingly, the cited prior art demonstrates that orientation and lamination were known to be compatible processing in multilayer polymer systems.
Third, the declaration does not provide comparative experimental evidence demonstrating that the specific combinations proposed by the applied references would necessarily fail or be inoperable. The declaration merely provides unsupported opinion that delamination “would likely” occur. Such conclusionary statements, unsupported by comparative data or testing against the teachings of the applied references, are insufficient to outweigh the strong evidence of obviousness established by the cited art.
Additionally, the declaration does not establish that all forms of lamination or bonding would fail under the claimed conditions. Levine expressly teaches thermal and diffusion bonding techniques for polymer laminates, while Tushimaa teaches direct heat lamination with high adhesive strength and without extra adhesive layers. The declaration does not address why such known bonding techniques would have been inoperable for the applied combination.
Moreover, the declaration fails to rebut the articulated rationale for combination. One of ordinary skill in the art would have been motivated to combine the teachings of the references to produce stronger multilayer P4HB implant structures having improved mechanical properties, adhesive strength, dimensional stability, and laminate integrity, as expressly taught by Wu, Tsushimaa, Rizk, and Levine. The applied references collectively provide a reasonable expectation of success because each references addresses compatible polymer film processing techniques involving orientation, lamination, and bonded multilayer structures.
Accordingly, the declaration is not sufficient to overcome the prima facie case of obviousness.
Applicant’s general hindsight/non-enabling combination arguments and response to Applicant’s arguments
Applicant argues that the applied references fail to teach or enable laminating oriented P4HB layers and that the rejection allegedly relies on impermissible hindsight reconstruction using Applicant’s own disclosure. Applicant further argues that none of the references individually disclose the entirety of the claimed laminate structure.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the present case, the ejection relies upon the collective teachings of Williams, Rizk, Levine, Wu, and Tushimaa, rather than any single reference alone.
Applicant repeatedly argues that Williams alone does not disclose the entirely of the claimed laminate structure. However, the rejection expressly acknowledges this point and relies upon the additional references to teach the remaining limitations. Accordingly, Applicant’s arguments directed solely to the deficiencies of Williams individually do not rebut the articulated combination.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the present case, the rejection does not rely upon impermissible hindsight reconstruction. Rather, the references themselves provide the express teachings and motivations for the proposed combination. Specifically, Williams teaches P4HB biomaterials, implantable medical devices, films/sheets, lamination processing, and oriented P4HB materials. Rizk teaches monoaxial and biaxial orientation of P4HB films/sheets and suitable orientation/stretching conditions, Levine teaches polymer laminate fabrication involving stacked polymer films/sheets bonded together through thermal/diffusion bonding techniques. Wu teaches that orientation/stretching improves properties of multilayer laminate films. And Tsuchimaa teaches direct heat lamination of oriented polymer layers without intervening adhesive layers while maintaining laminate integrity and adhesive strength.
Thus, the references themselves collectively suggest the claimed combination and provide articulated reasoning with rational underpinning supporting the modification.
Applicant’s argument and response to said argument regarding Rizk
Applicant argues that Rizk is directed solely to oriented P4HB films and allegedly fails to disclose laminated oriented structures or enable lamination or oriented P4HB layers.
In response, Applicant’s argument is deemed unpersuasive. The rejection relies upon Rizk for teachings to:
oriented P4HB films/sheets,
monoaxial and biaxial orientation,
stretching conditions,
orientation temperatures,
and improved mechanical properties resulting from orientation.
Rizk expressly teaches that films and sheets of P4HB “to be used as layers for lamination, may be oriented.” Rizk also teaches monoaxial stretching, biaxial stretching, plane-oriented films, orientation temperatures of about 40-80oC, and orientation method including roll stretching and tenter frame stretching. Importantly, Rizk does not need to independently disclose the entirety of the laminate structure because Leving and Tsushimaa provide teachings regarding lamination and direct bonding of polymer layers. The rejection properly relies upon the references collectively. Additionally, Rizk expressly contemplates oriented films/sheets being used as layers for lamination, which directly undermines Applicant’s argument that Rizk allegedly teaches away from laminated oriented structures.
Applicant’s argument and response to said argument regarding Levine
Applicant argues that Levine relates to diagnostic products and allegedly does not disclose P4HB materials or lamination of orientated P4HB.
In response, Applicant’s argument is not persuasive. Levine is relied upon for its teachings regarding laminate fabrication techniques and bonded polymer layer structures, not for disclosure of P4HB specifically. A reference is not limited only to its preferred field of use when relied upon for general processing teachings known in the art.
Levine expressly teaches polymer lamination processes involving:
stacking polymer sheets/films,
bonding adjacent layers,
and thermal/diffusion bonding techniques for laminate fabrication.
Three teachings are reasonably applicable to polymer film lamination generally and would have been recognized by one of ordinary skill in the art as suitable for use with the known P4HB polymer film taught by Williams and Rizk. Further, the fact that Levine does not specifically mention P4HB does not negate its relevance as evidence of known lamination techniques for polymer film structures.
Applicant’s argument and response to said argument regarding Nestles
Applicant argues that Nestles does not disclose P4HB structures.
In response, Applicant’s argument is not persuasive. To the extent Nestles was previously relied upon regarding laminate composite structures and damage tolerance concepts, the rejection is no longer applicable to Nestles as Nestles is not cited in the updated and revised rejection. Moreover, Applicant fails to address the collective teachings of Levine, Wu, Rizk, and Tsushimaa concerning lamination, orientation, and bonded multilayer polymer structures.
Applicant’s argument and response to said argument regarding direct bonding and absence of adhesive.
Applicant argues that the present specification allegedly distinguishes the prior art because no sealant/glue is required and because the presently claimed laminate maintains orientation after lamination.
In response, Applicant’s argument is not found persuasive. Tsushimaa expressly teaches directly heat-laminating oriented polymer layers without the use of intervening adhesive layer. Tsushimaa further teaches maintaining laminate integrity and adhesive strength in directly bonded laminates structures. Thus, Tsushimaa directly addresses Applicant’s argument regarding the absence of adhesive layers.
Additionally, Wu teaches that orientation/stretching improves multilayer laminate properties, thereby evidencing that orientation and multilayer lamination were known to be compatible technologies.
Accordingly, the applied art collectively teaches:
oriented polymer films,
multilayer laminate structures,
direct bonding without any intervening adhesive layers,
and preservation/improvement of laminate properties in oriented laminated systems.
Applicant’s argument and response to said argument regarding lack of enablement and against the prior art combination
Applicant argues that the references fail to “enable” one of ordinary skill in the art to laminate oriented P4HB layers.
In response, Applicant’s argument is not found persuasive. A prior art references need not to describe the claimed invention in ipsissmis verbis or disclosed every implementation detail to support an obviousness rejection. The relevant inquiry is whether the combined teaching would have suggested the claimed subject matter to one of ordinary skill in the art with a reasonably expectation of success.
Here, the references collectively teach:
P4HB films/sheets,
Orientation/stretching techniques,
lamination fabrication methods,
direct thermal bonding methods,
and multilayer oriented laminate systems.
The combination merely applies known polymer film orientation, and lamination
Techniques according to their established functions to obtain predictable results, namely stronger and improved multilayer polymer implant structures.
Applicant has not provided persuasive objective evidence demonstrating that the proposed claimed combination would have been uniquely challenging or inoperable. Mere attorney argument that the combination allegedly would not work is insufficient to outweigh the express teachings of the applied references.
Conclusion
Claims 1, 2, 4, 6, 7, 9-20, and 29-41 are not allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEAN P CORNET whose telephone number is (571)270-7669. The examiner can normally be reached on Monday-Thursday from 7.00am-5.30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JEAN P CORNET/Primary Examiner, Art Unit 1628
Prosecution Insights