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
Election/Restrictions
Claims 1-20 are pending.
Applicant's election with traverse of Group I, claims 1-16, in the reply filed on 1/21/26 is acknowledged. The traversal is on the ground(s) that searching for all the invention groups is not a burden. This is not found persuasive because as indicated in the previous office action, the inventions of Group I-III are three distinct inventions for the reason of the record. They have different electronic resources and search queries, and searing for one subject matter will not necessarily lead to another. Applicant is reminded of the extensive literature search in biotechnology which is not co-extensive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 17-20 are withdrawn.
Claims 1-16 are examined on the merits.
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 1-16 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.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
Claim(s) 1, 2, 4, and 6-16 is/are directed to a therapeutic composition comprising: a) an allantoamnion membrane comprising allantoamnion specific postbiotics; and b) a carrier solution, wherein the carrier solution comprises amniotic fluid comprising amniotic fluid specific postbiotics.
Analysis of the flowchart:
Step 1, is the claim directed to a process, machine, manufacture or composition of matter?
Yes. The claim is directed to a composition of matter.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Yes, the claims are directed to nature based components, allantoamnion membrane and amniotic fluid all exist in nature, and they all contain their specific postbiotics, there is no indication that the combination of allantoamnion membrane and amniotic fluid in the claimed compositions to have any characteristics that are different from the naturally occurring allantoamnion membrane and amniotic fluid. For the same reason, an umbilical cord, and protein derived from thereof, protein derived from amniotic fluid, or short-chain fatty acids exist in natural as well.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) of 1, 2, 4, and 6-16 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding claims 1, 2, 4, and 6-16, since there is no absolute amounts of the active ingredients are claimed as compared to the whole composition, the claimed composition encompasses embodiments where the active ingredients are in such small amounts that none of them impart any characteristic or markedly different characteristic. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Step 2B. If additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception).
No, no non-nature based components were recited in the claims.
For the reasons described above, the claimed compositions are not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed compositions themselves. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Claim Rejections –35 USC § 102/103
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1-16 are rejected under 35 USC § 102 (b) as being anticipated by or, in the alternative, under 35 U.S.C. 103(a) as obvious over Duddy et al (Duddy et al, Healing time of experimentally induced distal limb wounds in horses is not reduced by local injection of equine-origin liquid amnion allograft. American journal of veterinary research, (2022 Jul 13) Vol. 83, No. 8. Pages 1-6).
Duddy et al teach AB OBJECTIVE: To assess the efficacy of an equine-origin (thus equine-specific, thus claim 2 is met) liquid amnion allograft (ELAA) derived from both amniotic fluid (thus the claimed carrier solution, thus claim 1b is met, thus necessarily contains the claimed amniotic fluid specific postbiotics, thus allantoic fluid, thus claims 4 and 5 are met) and amniotic membrane (thus the claimed allantoamnion membrane, thus necessarily contains the claimed allantoamnion specific postbiotics, thus claim 1a) is met) on the healing time of experimentally induced distal limb wounds in horses. ANIMALS: 8 adult horses. PROCEDURES: On day 0, horses were anesthetized and a 2.5 X 2.5-cm, full-thickness skin wound was created on the dorsal aspect of each metacarpus and bandaged. On day 9, wound margins were injected with ELAA (treatment) or 0.9% NaCl (control). Bandages were changed at specific intervals through day 91 and, on each occasion, wounds were photographed to allow calculation of wound area. Exuberant granulation tissue was resected, if present. Wounds were deemed healed when completely epithelialized. Mean wound area was compared between groups throughout the study period. RESULTS: Only 1 wound (control) remained unhealed at day 91. No difference was found between the treatment and control groups in either wound area over time (P = 1.0) or time for wounds to reduce in size by 95% (P = .2) Exuberant granulation tissue required resection twice (1 control wound and 1 treatment wound). CLINICAL RELEVANCE: In this model, a single treatment with ELAA administered locally by SC injection did not accelerate distal limb wound healing in horses. However, it is possible that naturally occurring, chronic, or nonhealing wounds would respond differently (see Abstract).
Duddy et al teach although a prior study did not detect epidermal growth factor, transforming growth factor β, basic fibroblast growth factor, or keratinocyte growth factor in equine amnion, it did detect a number of other proteins (thus claims 6 and 7 are met) with known roles in wound healing and tissue regeneration (page 2, 2nd paragraph, 1st column, 1st paragraph).
An acellular equine-origin liquid amnion allograft (ELAA; RenoVō; Equus Innovations) containing amniotic fluid in addition to particularized amniotic membrane has recently become commercially available (Supplementary Appendix S1). This ELAA product is produced by collecting amniotic fluid and membrane during live equine births. Subsequent aseptic processing (thus free or substantially free of contaminants, thus claims 8-11 are met; thus claims 12-14 are met) involves centrifugation and filtration of the amniotic fluid to remove any cells (thus comprising cell-free supernatants, thus claim 16 is met), while the amniotic membranes are rinsed and particularized to approximately 10 μm (thus allatoamnion membrane particles are micronized, thus claim 3 is met), thus or less. The acellular amniotic fluid and particularized membrane are combined to produce the final ELAA product, which is stored at –80°C until use (page 2, 1st column, 3rd paragraph).
As discussed above, the cited references disclose amniotic fluid and amniotic membrane. Although the cited reference does not explicitly teach the claimed amniotic fluid and amniotic membrane contain amniotic membrane specific postbiotics and amniotic fluid specific postbiotics, the claimed amniotic fluid and amniotic membrane would inherently contain the claimed specific postbiotics (microorganisms or their components that confers a health benefit on the host) (thus claims 1 and 15 are met). Consequently, the claimed method appears to be anticipated by the references.
In the alternative, even if the claimed method is not identical to the referenced method with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the referenced method is likely to inherently possess the same characteristics of the claimed method particularly in view of the similar characteristics which they have been shown to share. Thus, the claimed method would have been obvious to those of ordinary skill in the art with the meaning of U.S.C. 103.
Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
With respect to the art rejection above, please note that Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ method differs and, if so, to what extent, from that of discussed references. Therefore, with the showing of the references, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655