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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/12/2026 has been entered.
Claims 1-30 have been cancelled. Claims 46-48 have been newly added.
Applicant's arguments filed 4/17/2026 with the after final response have been fully considered but they are not persuasive.
The power of attorney filed 7/23/2026 has not been accepted. There is no valid power of attorney in this application.
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 33-37 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 33 recites “measuring an extent to which said product stimulates or inhibits the production of the one or more pro-inflammatory mediators in said synovial cell line, said extent represented by a product value.”
The specification does not define what constitutes a “product value” particularly when more than one pro-inflammatory mediator is involved. The specification provides no explanation or examples of what this value is or how it is generated, derived, determined, or calculated. None of the examples provides or uses a “product value.” Claim 33 and dependent claims 34-37 are not enabled for this reason as they all require the “product value” of claim 33. Note that the prior art of record provides no examples of “product values” in the context of the current method of claim 31. There is no evidence of record that such a “product value” would have been well-known to one of ordinary skill in the art at the time of the effective filing date. There is no evidence of record that one of ordinary skill in the art would have known how to generate, derive, determine, or calculate such a “product value” at the time of the effective filing date.
In addition, claim 34 recites “comparing the product value to a reference value to determine a standardized value.” The specification provides no explanation or examples of what a reference value for a product value would be or how this reference value is generated, derived, determined, or calculated. None of the examples uses a reference value. Similarly, the specification provides no explanation or examples of determining a standardized value from any reference value or how it is determined from the reference value. Claim 34 is not enabled.
Claim 35 is directed to method of claim 34, “wherein the reference value is calculated by a process comprising: adding a standard to the test system; incubating the standard with the test system for the period of time; and determining a change in concentration of said one or more pro-inflammatory mediators produced by the test system to calculate the reference value.” However, the specification and claim provide no calculation steps, particularly where more than one pro-inflammatory mediator is involved. No mathematical formulas or explanations of how to calculate a reference value is provided. In addition, the claim does not identify what product(s) meet the definition of a “standard” to add to the test system. It is unknown what is added to the test system. Claim 35 is not enabled. None of the examples add an identified standard to the test system or calculate a reference value. Claim 35 is not enabled.
Claim 36 is directed to a method for determining, prior to administration of a product to a subject, whether administration of the product to the subject is likely to produce an anti-inflammatory effect in the subject. Claim 36 sets forth no steps by which this determination is made. Claim 36 is not enabled as it lacks critical steps. There are no positive active steps set forth for the required determination of whether administration of the product is likely to produce an anti-inflammatory effect in the subject. One of ordinary skill in the art is not informed as to what steps to perform. This deficiency is not remedied by claim 37.
Claim 37 depends upon claim 36. Claim 37 is directed to the method of claim 36, comprising: “comparing the product value to a reference value to produce a standardized value: comparing the standardized value to a threshold value; and determining that administration of the product to the subject is likely to produce an anti-inflammatory effect in the subject if the standardized value is equal to or greater than the threshold value.” This method is not enabled, particularly for combinations of two or more pro-inflammatory mediators. The specification does not provide any threshold values, particularly for all pro-inflammatory mediators in claim 31. In particular, the claim lacks critical steps where multiple mediators are involved. For example, if one mediator is less than the threshold value and a second mediator is equal to or greater than the threshold value, it is unknown whether administration of the product to the subject is likely to produce an anti-inflammatory effect in the subject. The specification does not disclose how to make these determinations when multiple mediators are involved.
None of the examples include the steps of any of claims 33-37.
In In re Wands (8 USPQ2d 1400 (CAFC 1988)) the CAFC considered the issue of enablement in molecular biology. The CAFC summarized eight factors to be considered in a determination of "undue experimentation." These factors include: (a) the quantity of experimentation necessary; (b) the amount of direction or guidance presented; (c) the presence or absence of working examples; (d) the nature of the invention; (e) the state of the prior art; (f) the relative skill of those in the art; (g) the predictability of the art; and (h) the breadth of the claims.
Particularly with respect to claims 36-37, none of the examples in the specification provides a product value or a reference value or a standardized value or a threshold value and compares the threshold value with the extent to which the product stimulates or inhibits the production of the pro-inflammatory mediator in the synoviocyte cell line. There is no example that determines that when this extent is equal to or greater than the threshold value the anti-inflammatory effect is likely to be produced in a subject. There are no examples where a determination, prior to administration of a product to a subject, is made as to whether administration of the product to the subject is likely to produce an anti-inflammatory effect in the subject. None of the in vitro culture experiments is tied to or disclosed as extrapolating to results or predicting results an in vivo situation where the product or substance derived from the product of the assay is administered to a subject.
The specification does not disclose the determination of any thresholds that could be used as cut-offs or predictors. That is, there are no working examples of the claimed methods.
It is not considered to be so predictable that one of ordinary skill in the art could have practiced the claimed method without undue experimentation, particularly with respect to repeatability and reproducibility.
Applicant’s arguments are not persuasive. The specification must provide sufficient disclosure to explain and inform one of ordinary skill in the art as to what was intended. The instant specification is deficient. Contrary to applicant’s example of “nailing a bracket to a board” the person skill in the art would not understand how to generate, derive, determine, or calculate the various values or make the recited determinations set forth in the claims. Applicant cannot assert that this would have been well-known in the art without providing evidentiary support. Applicant is invited to point by page and line number in the specification for a disclosed “product value” for (A) one and (B) more than one pro-inflammatory mediator according to the claimed methods.
With respect to various cut-off values and so forth argued on pages 14-16 of the 4/17/2026 response, these are not limitations of the claims and do not reflect situations where multiple pro-inflammatory mediators are involved. The claims are not limited to TNF-α production or concentrations.
Claims 33-37 are not enabled.
Claims 46-48 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.
Claims 46-48 are not original claims. The were added by amendment in the 4/17/2026 after final response. Applicant did not point to basis in the specification for these claims.
New claim 46 is directed to the method of claim 31, wherein the ADP comprises processed placental membrane.
New claim 47 is directed to the method of claim 31, wherein the ADP comprises processed amnion.
New claim 48 is directed to the method of claim 31, wherein the ADP comprises particulate amnion tissue.
Page 28, lines 11-17, of the 29 June 2021 substitute specification recites:
In a particular embodiment, the product is a human amniotic suspension allograft (ASA). In a particular embodiment, human ASA is obtained from donated human placentas processed in accordance with the Food and Drug Administration's Good Tissue Practices and the American Association of Tissue Bank standards. ASA contains particulated human amniotic membrane and amniotic fluid cells. These components are combined and cryogenically preserved. A preferred ASA is ReNu® (Organogenesis, Canton, MA). Another preferred ASA is NuCel (Organogenesis, Canton, MA).
This portion of the specification does not provide support for what applicant is claiming in new claims 46-48. This disclosure is limited the human amniotic suspension allografts that have been processed in a particular way. There is no disclosure of generically processed placental membrane nor any description of what this would mean. There is no disclosure of generically processed amnion nor any description of what this would mean. There is no disclosure of particulated human amniotic membrane in the absence of amniotic fluid cells. Claims 46-48 are broader than the supporting disclosure and constitute new matter.
Claims 31-32 and 38-45 are allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
mpa
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