DETAILED ACTIONStatus of Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-24 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim 1 is drawn to a wound coverage substrate, said composition comprising dehydrated or lyophilized non-live fibroblasts and/or dehydrated or lyophilized fibroblast-derived materials.
The broadest reasonable interpretation of the claimed compositions would be the material that is named, that is a wound coverage substrate, dehydrated or lyophilized non-live fibroblasts and/or dehydrated or lyophilized fibroblast-derived materials. A wound coverage substrate can be a naturally occurring product, non-live fibroblasts and/or fibroblast-derived materials are naturally occurring products and dehydration or lyophilization structurally preserve the tissue therefore the structure is not markedly changed.
Thus, the compositions claimed in claims 1-14 and 24 are not markedly different from how the individual components in nature. It is not integrated into a practical application because nothing in claim 1 relies on or uses the exception. There is nothing significantly more than the judicial exception because there are no additional elements in the claim. With regard to claims 2-14 and 24 the enumeration of the amounts or additional products of nature do not make the combination of the products of nature markedly different from how they occur in nature.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, because the formulation at the broadest interpretation of the claim language is a mixture of products of nature comprising wound coverage substrate, dehydrated or lyophilized non-live fibroblasts and/or dehydrated or lyophilized fibroblast-derived materials, which does not appear to change the biological/pharmacological functions, chemical/physical properties, or the structure/form of said ingredients. Because the claimed formulation does not have markedly different characteristics, it is a product of nature.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim element "means to carry out the method of claim 15" is a limitation that invokes 35 USC 112(f) or pre-AIA 35 USC 112, sixth paragraph in claim 1(iii). It meets the required 3-prong test wherein: (1) "the claim limitation uses the term 'means'", (2) "the term 'means'... is modified by functional language [i.e., " to carry out the method of claim 15"], and (3) "the term 'means' is not modified by sufficient structure materials or acts for performing the claims function [no structure given in the claim]." See MPEP 2181(I).
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 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 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.
Claims 1-24 are rejected under 35 U.S.C. 103 as being obvious over Goldstein et al. (US20230091742A1).
Regarding claims 1-24, Goldstein is drawn to tissue grafts, and in particular human placenta-derived tissue grafts and methods and articles for the manufacture and use thereof (abstract and claims 1-10).
Goldstein discloses the membrane matrix is more resistant to degradation at a wound or graft site as compared to an uncompressed human amniotic membrane. In some embodiments, the membrane matrix releases bioactives in a slow, controlled or extended manner as compared to an uncompressed human amniotic membrane. In some embodiments, the membrane matrix is resistant to degradative enzymes as compared to an uncompressed human amniotic membrane. In some embodiments, the membrane matrix acts as a barrier to pathogens. In some embodiments, the membrane matrix allows for slow, controlled, or extended release of active growth factors and protease inhibitors at a wound or graft site [0008].
Goldstein discloses the membrane comprises active growth factors, protease inhibitors or both. In some embodiments, the membrane comprises cytokines, extracellular matrix proteins, or combinations thereof. In some embodiments, the membrane comprises basic fibroblast growth factor (bFGF), hepatocyte growth factor (HGF), tissue inhibitor of metallopeptidase inhibitor-I (TIMP-1), or combinations thereof [0010].
Goldstein discloses In certain embodiments, the dehydrated isolated human fetal tissue membrane retains effective levels of bioactives from the amnion, chorion, and spongy layer between the amnion and chorion. That is, the levels of bioactives in the tissue membrane product are not be statistically different from that of the natural tissue from which the product is derived. In certain embodiments, the dehydrated isolated human fetal support tissue membrane retains a majority of endogenous bioactives from the amnion and chorion. In some embodiments, the dehydrated isolated human fetal support tissue membrane comprises basic fibroblast growth factor (bFGF) in an amount of at least 5,000 pg/mg, or in an amount of at least 10,000 pg/mg. In some embodiments, the dehydrated isolated human fetal support tissue membrane comprises hepatocyte growth factor (HGF) in an amount of at least 100 pg/mg or in an amount of at least 450 pg/mg. In some embodiments, the dehydrated isolated human fetal support tissue membrane comprises TIMP metallopeptidase inhibitor- I (TIMP-1) in an amount of at least 7,000 pg/mg, or in an amount of at least 10,000 pg/mg. In some embodiments, the dehydrated isolated human fetal support tissue membrane comprises hyaluronic acid (HA) in an amount of at least 5,000 ng/mg, or in an amount of at least 10,000 ng/mg. It is believed that this HA content is associated with the maintenance of the spongy intermediate layer between the amnion and chorion, and provides flexibility in the resulting product. Low HA content in conventionally processed tissue grafts is believed to result in brittleness. In certain embodiments, the tissue graft is configured for use as a wound covering or implant, which, in use, is not antigenic. In certain embodiments, the tissue graft is configured for use as a wound covering and is stable at room temperature [0142-0143].
Goldstein discloses in certain embodiments, the tissue graft is provided in the form of a flat sheet. For example, providing the tissue graft in a flat or planar form [0147].
Goldstein does not explicitly disclose the composition as claimed in a single embodiment.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Goldstein, to arrive at the instant invention.
One of ordinary skill in the art would have been motivated to do so because Goldstein discloses each of the components of the composition and is in the field of human placental tissue grafts that improve retention of bioactives in the processed tissue and reduce the antigenicity of the tissue, in addition to human placental tissue grafts having improved healing and handling properties [0004]. Further, one having ordinary still in the art would reasonably expect success in combining prior art elements according to known methods to yield predictable results, see MPEP 2141.
The Supreme Court has acknowledged:
When 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. If a person of ordinary skill can implement a predictable variation... 103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions......the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUANGLONG N TRUONG whose telephone number is (571)270-0719. The examiner can normally be reached on 8:00 am-5:00 pm.
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, Robert A Wax can be reached on 571-272-0623. 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.
/QUANGLONG N TRUONG/Examiner, Art Unit 1615
Prosecution Insights