Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Claim status
Claims 1-13, and 15-21 are pending
Claims 2, 4, 6, 12-13, 15-19, and 21 are withdrawn
Claims 1, 3, 5, 7-11, and 20 are under examination
Election/Restrictions
Applicant’s election of the following invention without traverse in the reply filed on 2/26/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Group I, claims 1-11, and 20, drawn to placental tissue grafts.
Claims 12-13, 15-19, and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable linking claim.
Applicant’s election of the following two species is acknowledged.
The intermediate layer as partially perforated.
Claims 2 and 4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic claim.
The chorion layer as partially perforated.
Applicant traverses this species election, arguing that there is no burden to examine a chorion fully perforated.
This is not found persuasive because examiner was able to provide art which satisfied the limitations of the partially perforated chorion claims without being able to satisfy the limitations of the fully perforated chorion claims thereby demonstrating that a search burden exists between the restricted groups.
Claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/29/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
However, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 20 is objected to because it is dependent on withdrawn Claim 12. Claim 20 and Claim 12 are directed to different statutory categories of inventions (i.e., a product and method, respectively), and if the product of Claim 20 is eventually found allowable, the method of Claim 12 would not necessarily require all the limitations of the allowable product claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 7 is 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 pre-AIA the applicant regards as the invention.
Claim 7 recites the limitation that the intermediate layer is “substantially” uniform. A claim may be rendered indefinite by reference to term of degree (see MPEP 2173.05(b), I). Specifically, when a term of degree is used in the claim, the examiner should determine whether the specification provides some standard for measuring that degree. Hearing Components, Inc. v. Shure Inc., 600 F.3d 1357, 1367, 94 USPQ2d 1385, 1391 (Fed. Cir. 2010); Enzo Biochem, Inc., v. Applera Corp., 599 F.3d 1325, 1332, 94 USPQ2d 1321, 1326 (Fed. Cir. 2010); Seattle Box Co., Inc. v. Indus. Crating & Packing, Inc., 731 F.2d 818, 826, 221 USPQ 568, 574 (Fed. Cir. 1984). In instant case, the specification does not provide some standard for measuring that degree (i.e., what constitutes substantially uniform). Furthermore, given the broad genus of layers claimed, a determination was made by the Examiner that one ordinary skill in the art could not ascertain the scope of the claim (e.g., arrive at a standard that is recognized in the art for measuring the meaning of the term of degree). For example, in Ex parte Oetiker, 23 USPQ2d 1641 (Bd. Pat. App. & Inter. 1992), the phrases "relatively shallow," "of the order of," "the order of about 5mm," and "substantial portion" were held to be indefinite because the specification lacked some standard for measuring the degrees intended.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5, and 7-9 and rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Daniel et al., (US 11,116,871, filed 9/16/2016, patented 9/14/2021, see IDS filed 8/29/2023).
Daniel claims a human placental tissue comprising an unseparated layer of amnion, intermediated layer, and a layer of chorion which comprises a perforation that “partially traverses” the thickness of a layer (claims 1-3 and 5 of Daniel). With respect to the partial perforation, Daniel explains the partial perforation partially traverses the thickness of at least one sheet, wherein the sheet is selected from the intermediate layer (col 3, 5th para.). In regard to the partial perforation of the intermediated layer, while not the amnion layer, MPEP 2144.08. II. 4(a) states that a genus of options may be so small that, when considered in light of the totality of the circumstances, it would anticipate the claimed species or subgenus. In instant case, there are just three layers, and one of ordinary skill in the art would have immediately envisioned the intermediate layer as the partially perforated layer.
Note that, Applicant’s specification defines “partially perforated” as having at least one microneedle penetrate part of the entire thickness of the layer [0040], thus the partial perforation of the intermediate layer as taught by Daniel appears to be encompassed by this limitation, as well as the perforation of a sublayer of the chorion (e.g., reticular layer of chorion).
In regard to the placental tissue being a “graft”, Daniel explains that the placental tissue is to be used as a graft for transplantation (Introduction, col 1 to col 3, 1st para.). Furthermore, this term describes the intended use of the taught composition, and 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 claim.
In regard to claim 3, as stated supra, Daniel teaches the perforation partially traverses the intermediate layer.
In regard to claim 5, as stated supra, Daniel claims the perforation partially traverses a chorion sheet layer (see also col 3, 5th para), and specifically teaches the combination of partial traversal of layers of the chorion and the intermediate layer (e.g., the intermediate layer and the reticular layer of the chorion) (col 4, lines 23-25).
In regard to claim 7, Daniel explains that the intermediate layer, or spongy layer, is the interface between the amnion and the chorion (col 15, 2nd para.), and in embodiments where the amnion is unseparated from the chorion, the intermediated layer would have been naturally uniform throughout.
In regard to claim 8, Daniel claims the placental tissue is dehydrated (see claim 1 of Daniel).
In regard to claim 9, Daniel reduces to practice the rehydration of the placental tissue in distilled water (see Example 16 of Daniel).
Accordingly, Daniel anticipates instant claims.
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 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(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 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al., (US 11,116,871, filed 3/16/2018, patented 9/14/2021, see IDS filed 8/29/2023)., in view of Daniel et al., (US 8,357,403, filed 3/29/2012, patented 1/22/2013).
As discussed previously, Daniel (2021) anticipates a human placental tissue graft comprising an unseparated layer of amnion, intermediated layer, and a layer of chorion which comprises a perforation that “partially traverses” the thickness of the intermediate layer, while there is no perforation in the amnion.
In regard to claims 10 and 11, although Daniel (2021) teaches the placental tissue was dehydrated by lyophilization (col 5, 6th para. col 13, 3rd para., Example 4, last para), they are silent to a sealed pouch.
In regard to claims 10 and 11, Daniel (2013), who is the same inventor as Daniel (2021), teaches a placental tissue for grafting that is placed in a sterile Tyvex dehydration bag (i.e., pouch), sealed, and placed in an oven or incubator under vacuum, which would deoxygenate the bag (col 8, last two para.).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the placental tissue graft for dehydration and lyophilization as taught by Daniel (2021), and place the placental tissue in a Tyvex pouch for dehydration and lyophilization under vacuum as taught by Daniel (2013) with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so for several reasons. First, it is standard practice to analyze the related patents from common inventors for more detailed disclosures, and turning to an inventors own prior patent publication would have been common knowledge to the ordinary artisan seeking to modify Daniel (2021). Furthermore, Daniel (2013) teaches the Tyvex pouches are a breathable dehydration bag that prevents tissue from drying too quickly and prevents cross-contamination when multiple samples are being dehydrated at the same time (col 8, 5th para.).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Daniel et al., (US 11,116,871, filed 3/16/2018, patented 9/14/2021, see IDS filed 8/29/2023)
As discussed previously, Daniel anticipates a human placental tissue graft comprising unseparated layers of amnion, intermediated layer, and a layer of chorion which comprises a perforation that “partially traverses” the thickness of the intermediate layer, while there is no perforation in the amnion.
Furthermore, Daniel teaches the combining of separated layers of amnion, intermediate layer, and chorion layer. Note that the transitional phrase of “comprising” in instant claims does not limit the placental graft to just the separated layers.
In regard to step (a), Daniel teaches the step of separating the chorion from the amnion before perforating and washing (col 12, last para., col 17 2nd para.). Daniel explains that when the chorion and amnion are separated along the intermediate layer, the cells derived from the intermediate layer remain associated with the reticular layer of the chorion (col 15, 2nd para.).
In regard to step (b), Daniel teaches the perforation is in the separated intermediated layer and the reticular layer of the chorion (col 5, 1st para. col 10, last two para.).
In regard to step (c), as stated supra, Daniel teaches washing the separated layers.
In regard to step (d), Daniel teaches layering the separated amnion sheet and the separated perforated chorion sheet on the surface of the tissue graft (col 13, 1st para., col 33-34, Section H, Exemplary Embodiments for Layering Sheets).
Finally, Daniel teaches combining unseparated amnion/chorion with separated amnion and separated chorion that has been perforated prior to preservation may have unique properties resulting in better handling of the graft during transplant or improved healing capacity (col 3, 1st para.).
In regard to the product-by-process limitation of claim 12, Daniel teaches a multilayered placental tissue graft comprising unseparated amnion/chorion layers and separated amnion and chorion layers with intermediate layer cells attached, and perforations in the intermediate layer and reticular side of the chorion layer. Although Daniel is silent to a preferred embodiment of multilayered placental tissue graft, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to have prepared such a graft because each of the individual elements of the instant claims are independently presented by Daniel as embodiments and are taught that they can be combined in various embodiments; therefore a combination of all the elements into a single embodiment would be apparent to an artisan skilled in tissue graft preparation in light of the Supreme Court’s KSR decision (see MPEP 2143 Exemplary Rationale (A)). Regarding the rationale for combining prior art elements according to known methods to yield predictable results, all of the claimed elements were known in the prior art and one skilled in the art could have combined the element as claimed by known methods, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of filing of the invention. Each of the elements (separated amnion layers with intermediate layers attached, separated chorion layers with intermediate layer cells attached, washing steps, perforations in the intermediate layer and reticular side of the chorion layers, and layering methods) are taught by Daniel and further they are taught in various combinations and are shown to be used in a method for producing multilayered placental tissue graft. It would have been therefore predictably obvious to use a combination of these elements in said product.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. 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.
/ARTHUR S LEONARD/Examiner, Art Unit 1631
Prosecution Insights