Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
The Examiner acknowledges Applicants’ Response to Restriction Requirement filed 13 March 2026 (see below). Upon finalization and entry of the Restriction Requirement, claims 1 – 4 and 6 will be available for substantive examination.
Response to Restriction/Election Requirement
Applicant's election with traverse of the claims of Group I, claims 1 – 4 and 6, in the Response filed 13 March 2026, is acknowledged. The traversal is on the grounds that the Restriction Requirement “has not shown that a serious burden would be required to examine all the claims.” However, the Examiner notes that Applicants have not presented any arguments to support their allegation as to lack of burden arising from examination of all inventive groups. In addition, Applicants have failed to apply the appropriate standard that controls on the question of Identity of Invention for applications filed pursuant to 35 U.S.C. § 103 (see 37 C.F.R. § 1.475(a)). Consequently, Applicants’ argument is unpersuasive and the Restriction Requirement is made FINAL.
Priority
The Examiner acknowledges receipt of papers submitted pursuant to 35 U.S.C. §§ 119(a)-(d), which papers are now of record in the file.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statements (IDS’s) filed 4 September 2023, 14 January 2026, and 13 March 2026, which are now of record in the file.
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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 – 4 and 6 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2014/0105954 A1 to Gleeson, J., et al., published 17 April 2014, identified on the Information Disclosure Statement (IDS) filed 4 September 2023, cite no. 1 (USPATAPP) (“Gleeson ‘954”).
The reference does not disclose quantitative values for the densities of layers in the multi-layer scaffolds with sufficient specificity to anticipate the claimed invention. Hence, this rejection is made pursuant to 35 U.S.C. § 103.
The Invention As Claimed
Applicants claim a layered structure comprising at least two collagen layers, wherein the layered structure includes a gradient of densities, wherein the at least two collagen layers comprise at least one first collagen layer and at least one second collagen layer, wherein the at least one second collagen layer (low density layer) has a density of up to about 90% of the first collagen layer (high density layer), wherein the at least two collagen layers comprise at least two first collagen layers and at least one second collagen layer, wherein the at least one second collagen layer is positioned between each of the at least two first collagen layers, and wherein the at least one second collagen layer (low density layer) has a density of up to about 90% of the at least two first collagen layers each independently.
Applicants also claim a surgical scaffold comprising a layered structure comprising at least two collagen layers, wherein the layered structure includes a gradient of densities.
The Teachings of the Cited Art
Gleeson ‘954 discloses a multi-layer collagen scaffold (see Abstract), wherein the scaffold is prepared by a process wherein each layer is formed in a separate freezing or lyophilization step so that the freezing or lyophilization conditions of each step may be independently varied which allows the pore structure of each layer of the scaffold to be individually optimized (see ¶[0019]), wherein each layer in the multi-layer scaffold is compositionally distinct in that the layers differ in terms of their composition and/or morphology, the layers differing in terms of parameters such as hydroxyapatite (HA) content, type of collagen, amount of collagen, type of glycosaminoglycan (GAG), and quantity of GAG (see ¶[0029]), wherein, preferably, the scaffold has three layers (see ¶[0024]), wherein, in a specific embodiment (a three-layer collagen scaffold) a first layer comprises collagen and hydroxyapatite, a second layer comprises collagen and hydroxyapatite in which the collagen content is different from the first layer, and the third layer comprises collagen and little or no hydroxyapatite, and optionally a polymer and/or a biologically-active molecule (see ¶[0029]), wherein the pore size, and/or pore size distribution gradient, are varied within each layer independently by varying the slurry thickness used for each layer, and the individual layer thickness can be varied in each of the layers of the multi-layer scaffold between 1 mm and 15 mm using different volumes of slurry during the freezing or lyophilization process (see ¶[0040]), and wherein the multi-layer collagen scaffold comprises a plurality of freeze-dried layers in which a first layer comprises collagen, typically Type I collagen, and HA, a second layer comprises one or more types of collagen (typically Type I collagen and a non-Type I collagen, such as Type II collagen), HA and optionally one or more types of GAG, and a third layer comprises one or more types of collagen (typically two types of collagen, i.e. Type I and a non-Type I collagen, such as Type II collagen, and optionally one or more types of GAG and a biologic (see ¶[0068]).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a three-layer collagen scaffold with a first layer comprising collagen and hydroxyapatite, a second layer comprising collagen and hydroxyapatite in which the collagen content is different from the first layer, and a third layer comprising collagen and little or no hydroxyapatite, and optionally a polymer and/or a biologically-active molecule, wherein the pore size, and/or pore size distribution gradient, are varied within each layer independently by varying the slurry thickness used for each layer, wherein the multi-layer collagen scaffold comprises a plurality of freeze-dried layers in which a first layer comprises collagen, typically Type I collagen, and HA, a second layer comprises one or more types of collagen (typically Type I collagen and a non-Type I collagen, such as Type II collagen), HA and optionally one or more types of GAG, and a third layer comprises one or more types of collagen (typically two types of collagen, i.e. Type I and a non-Type I collagen, such as Type II collagen, and optionally one or more types of GAG and a biologic. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of the reference to the effect that the freezing or lyophilization conditions of each step in the process of fabricating individual layers may be independently varied, allowing for the pore structure of each layer of the layered scaffold to be individually optimized, which is vitally important in osteochondral repair applications, as chondrocytes and osteoblasts require vastly different conditions for optimal in vivo behavior (see ¶[0019]).
With respect to the process limitations recited claim 1, it is the Examiner’s position that such recitations effectively render the claim a product-by-process claim. These types of claims are examined on the limitations of the product. See MPEP § 2113, citing In re Thorpe, 111 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) “[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 of 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.” Furthermore, upon establishing a prima facie case, the burden of persuasion shifts to the Applicant. See MPEP 2113, citing In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974) “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.
With respect to the limitations recited in claims 2 and 4 directed to relative densities between adjacent layers in the multi-layer scaffolds, the Examiner notes that the reference does not expressly teach relative densities among the layers of the disclosed scaffolds. However, given the compositional differences disclosed for each layer in an exemplified three-layer scaffold, it is the Examiner’s position that the different layers would necessarily have different densities and, thus, would read on the limitations in question. Furthermore, the reference teaches that each layer in the multi-layer scaffold is compositionally distinct in that the layers differ in terms of their composition and/or morphology, the layers differing in terms of parameters such as hydroxyapatite (HA) content, type of collagen, amount of collagen, type of glycosaminoglycan (GAG), and quantity of GAG (see ¶[0029]). Consequently, it is the Examiner’s position, based on this disclosure, that adjusting the various parameters for the preparation of, and compositional makeup of each layer to achieve specific or relative densities among the layers would amount to nothing more than optimization of result-effective variables, the exercise of which is well with the expertise of one of ordinary skill in the appropriate art. Consequently, in the absence of evidence as to the criticality of such parameter, this limitation cannot support patentability. See MPEP § 2144.05 II. A.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 – 4 and 6 would have been obvious within the meaning of 35 USC § 103.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David J Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619