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 .
Claim Status
Claims 1-20 are pending.
Claims 9, 15-18 and 20 are withdrawn.
Claims 1-8 and 10-14 and 19 are under examination.
Election/Restrictions
Applicant’s election with traverse of the following invention
Invention
Group I, claims 1-11, drawn to drawn to a method of treating conditions in a subject, classified in A61K 35/50,
in the reply filed on 8th, September, 2026 is acknowledged.
Applicant’s traversal is on the grounds that “the invention of Group I is basically the same as that of Group II and Group III, and any prior art searched for one group is applicable to the other group. Hence, there would not be a serious search and/or examination burden” (pg. 1-2).
In response, while this is not found persuasive because the conditions, target sites and cancers represent structurally and functionally distinct diseases with distinct disease mechanisms. For these reasons, consideration of the full scope of the breadth of Inventions I-III poses a serious examination burden for considerations for non-prior art issues under 35 U.S.C. 112a for these structurally and functionally distinct diseases.
Applicant is directed to MPEP § 808.02. which states that a serious examination burden, for example, may be prima facie shown by appropriate explanation of non-prior art issues under 35 U.S.C. 101, pre-AIA 35 U.S.C. 112, first paragraph, and/or 35 U.S.C. 112(a) relevant to one invention that are not relevant to the other invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election of the following species
Species
• Species A. Composition further comprises components: one of or a single
specific combination of: allantoamnion membrane and amniotic fluid (claims 3-4)
• Species B. Condition Types: inflammatory disease (claim 7)
• Species C. Composition is combined or mixed with type: platelet plasma
protein solutions (claim 11)
in the reply filed on 8th, September, 2026 is acknowledged. Claims 1, 3-7 and 11 encompass the elected species.
It is noted that Applicant states that the election is with traverse, but Applicant’s grounds of traversal refer to the Inventions of the Groups and do not distinctly and specifically point out the supposed errors in the species election requirement. Because applicant did not distinctly and specifically point out the supposed errors in the species election requirement, the election has been treated as a species election without traverse (MPEP § 818.01(a)). The Examiner further notes that the species represent structurally and functionally distinct diseases that have distinct mechanisms and specific and distinct considerations under 35 U.S.C. 112a as discussed above and therefore represent a serious examination burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2 and 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Rejoinder
Upon further consideration, in view of the examination below, the following Inventions and Species are rejoined because cancer is a specific type of a condition, cancer is a specific type of inflammatory disease, and cancer is a specific type of a target site. Additionally, the species of treating Wounds and tendon lesions are rejoined as they are also encompassed by the broadest reasonably interpretation of inflammatory disease. The remaining species of Invention III are not yet rejoined because they represent structurally and functionally distinct conditions and require additional consideration under 35 U.S.C. 112 (a) and therefore pose a serious search and examination burden, as set forth in the Restriction and species election requirement mailed on 28th, July, 2026.
For Invention I, the following species are rejoined because they do not pose a serious examination burden.
Composition further comprises components: one of or a single specific combination of
canine-specific chorioallantois membrane or canine-specific allantoamnion membrane particles (claims 2-3)
micronized canine-specific umbilical cord, micronized canine-specific Wharton's jelly, micronized canine-specific umbilical cord particles or micronized canine-specific Wharton's jelly particle (claims 2-3)
canine-specific amniotic fluid (claim 4)
canine-specific allantoic fluid (claim 4)
canine-specific stem cells (claim 4)
The species of “the condition is a tendon and/or ligament injury” as recited in claim 8 is rejoined.
The species of “the composition is combined or mixed with stem cells” as recited in claim 10 is rejoined.
Invention II, claim 12, drawn to a method of treating cancer in a subject, is rejoined.
Invention III, claim 13, drawn to a method of treating a target site in a subject, is rejoined with respect to the specific species below.
For Invention III, the following species are rejoined because they do not pose a serious examination burden.
The species of “the target site is a wound or an operative incision” recited in claim 14 is rejoined.
The species of “the target site is a tumor” recited in claim 19 is rejoined.
In view of the examination below, Invention II, claim 12 has been rejoined.
In view of the examination below, Invention III and specifically the species of target site types of “Wound or an operative incision (claim 14)
Therefore, in view of the reasons stated above, claims 2, 8, 10, 12, 14 and 19 are rejoined.
Once a restriction requirement or species election is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Priority
It is noted that the instant Application, filed 27th, September 2024, is a Continuation in part of U.S. Application No. 18/056,145 filed on 16th, November, 2022, now U.S. Patent No. 12128073. U.S. Patent No. 12128073 claims domestic benefit to U.S. Provisional Application No. 63/280,024 filed 16th, November, 2021.
Applicant is directed to MPEP 201.08 which provides information on Continuation-in-Part (CIP) Applications.
MPEP 201.08 states the Office does not need to make a determination as to whether the requirement of 35 U.S.C. 120 that the earlier nonprovisional application discloses the invention of the second application in the manner provided by 35 U.S.C. 112(a) is met unless the filing date of the earlier nonprovisional application is relied upon in a proceeding before the Office.
Applicant is directed to MPEP 211.02 which sets forth the guidance for reference to prior Applications, and MPEP 211.05 which sets forth the Sufficiency of Disclosure in Prior-Filed Application.
MPEP 211.05 states, the disclosure of the prior-filed application must provide adequate support and enablement for the claimed subject matter of the later-filed application in compliance with the requirements of 35 U.S.C. 112(a) except for the best mode requirement.
MPEP 211.05 further states where the prior application (a nonprovisional application) is found to be fatally defective because of insufficient disclosure to support allowable claims, a later-filed application filed as a "continuation-in-part" of the first application to supply the deficiency is not entitled to the benefit of the filing date of the first application. Hunt Co. v. Mallinckrodt Chemical Works, 177 F.2d 583, 587, 83 USPQ 277, 281 (2d Cir. 1949) and cases cited therein. Any claim in a continuation-in-part application which is directed solely to subject matter adequately disclosed under 35 U.S.C. 112 in the parent nonprovisional application is entitled to the benefit of the filing date of the parent nonprovisional application. However, if a claim in a continuation-in-part application recites a feature which was not disclosed or adequately supported by a proper disclosure under 35 U.S.C. 112 in the parent nonprovisional application, but which was first introduced or adequately supported in the continuation-in-part application, such a claim is entitled only to the filing date of the continuation-in-part application. See, e.g., In re Chu, 66 F.3d 292, 36 USPQ2d 1089 (Fed. Cir. 1995); Transco Products, Inc. v. Performance Contracting Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994); In re Van Lagenhoven, 458 F.2d 132, 136, 173 USPQ 426, 429 (CCPA 1972).
In the instant case, because there appears to be a prior public disclosure as well as published prior art that occurred in between the filing date of the Parent Application and the filing date of the present CIP Application, the claims under examination are considered as to whether they are entitled to the priority date of the parent Application or the provisional Application.
In the instant case, claims 1-8, 10-14 and 19 are not fully supported by the parent patent or provisional Application because the full scope of these claims is not enabled. The instant specification does not enable the full scope of the present claims (see 112 (a) Scope of Enablement rejection below). The parent patent and the provisional Application provide less specific guidance and less working examples than the instant Application and therefore also do not enable the full breadth of the claims.
Furthermore, claims 5, 8 and 11 are also not fully supported by the parent patent or provisional Application because these claims are not supported by these Application documents under the 35 U.S.C. 112a Written Description Requirement.
Specifically, claim 5 recites “the composition comprises proteins, exosomes, or a combination thereof; wherein the proteins include one or a combination of alpha- 2-microglobulin (A2M), interleukin-1 receptor antagonist (IL-1 ra), Trappin- 2,interleukin-2 (IL-2), IL-4, IL-6, IL-8, IL-10, tissue inhibitor of metalloproteinases 1 (TIMP-1 ), TIMP-2, TIMP-3, TIMP-4, monocyte chemoattractant protein-1 (MCP- 1 /CCL2), epidermal growth factor receptor (EGFR), or vascular endothelial growth factor (VEGF).” This includes proteins of Trappin-2 and EGFR as well as exosomes which are not disclosed or contemplated by the parent Application or provisional Application and are therefore not supported.
Claim 8 recites the disease is a “tendon and/or ligament injury” respectively while the parent Application mention broader genera of disease or the specific disease of a canine calcanean tendon lesion (Figure 8), and the provisional Application only contemplates tendon injection. These do not provide support for the full genus of tendon and ligament injuries specifically encompassed by Applicant’s claims.
Claim 11 recites “the composition is combined or mixed with platelet plasma protein solutions prior to administration” which is not recited or contemplated by the parent Application or provisional Application and is therefore not supported.
For the sake of compact prosecution, it is noted that the enabled scope discussed below is not supported under 112a for written description and is not supported by under 112a for enablement by the parent patent Application or the provisional Application.
As set forth below (see Scope of Enablement below), the following embodiment is enabled by Applicant’s specification.
A method of reducing the size or removing a squamous cell carcinoma mass in a canine subject, the method comprising administering a canine-specific therapeutic composition comprising a micronized canine-specific allantoamnion membrane, in a solution to the canine subject;
wherein the administering comprises implanting 2.0 cc of the canine-specific therapeutic composition under and around the squamous cell carcinoma mass without mass removal;
wherein the canine-specific therapeutic composition is a colorless or clear suspension
This embodiment is not specifically disclosed or contemplated from the massive genus of conditions contemplated in the parent patent and provisional Application and the Disclosure of the specific example 2 that enabled this embodiment is not present in these documents. General disclosure of conditions and cancer in these documents does not provide support or specific guidance for one of ordinary skill to arrive at this one specific enabled embodiment.
Therefore, for the reasons set forth above the instant claims are given the effective filing date of the instant Application of 27th, September, 2024.
Claim Rejections - 35 USC § 112 (a)
Scope of Enablement
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 1-7, 10-13 and 19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for:
A method of reducing the size of or removing a squamous cell carcinoma mass in a canine subject, the method comprising administering a canine-specific therapeutic composition comprising a micronized canine-specific allantoamnion membrane, in a solution to the canine subject;
wherein the administering comprises implanting 2.0 cc of the canine-specific therapeutic composition under and around the squamous cell carcinoma mass without mass removal;
wherein the canine-specific therapeutic composition is a colorless or clear suspension
does not reasonably provide enablement for:
Treatment of all other symptoms;
Treatment of all other conditions;
All other subjects;
All other administration types;
All other cancer types;
All other target types; and
All other inflammatory disease types.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the method of the invention commensurate in scope with these claims.
Wands Factors
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: “Enablement is not precluded by the necessity for some 'experimentation.'” Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
Breadth of the Claims
Instant claims encompass “A method of treating conditions in a subject, the method comprising administering a therapeutic amount of the canine-specific therapeutic composition comprising a micronized canine-specific allantoamnion membrane, in a solution” (claim 1 and dependents),
“A method of treating cancer in a subject, the method comprising administering a therapeutic amount of the canine-specific therapeutic composition comprising a micronized canine-specific allantoamnion membrane, in a solution to the subject” (claim 12)
“A method of treating a target site in a subject, the method comprising administering a therapeutic amount of the canine-specific therapeutic composition comprising a micronized canine-specific allantoamnion membrane, in a solution, to the target site in the subject” (claim 13)
These each include
“treating”
The broadest reasonable interpretation of “treating” includes decreasing, ameliorating, or eliminating one or more or all symptoms.
“conditions”
The broadest reasonable interpretation of “conditions” includes all possible beneficial or disorders conditions.
“a subject”
The broadest reasonable interpretation of “subject” includes all possible subjects including all possible human and non-human animals.
“administering”
The broadest reasonable interpretation of “administering” includes all possible routes of administration such as but not necessarily limited to oral administration, topical administration, or injection.
“the condition is an inflammatory disease” (dependent claim 7)
The broadest reasonable interpretation of “an inflammatory disease” includes all possible diseases that involve inflammation.
“treating cancer” (claim 12)
The broadest reasonable interpretation of this includes all possible cancer types including solid tumors, blood cancers, metastasis and others.
“treating a target site” (claim 13)
The broadest reasonable interpretation of this includes all possible target sites for all possible conditions.
Direction or Guidance Presented
While Applicant contemplates treating (para. [0007, 0011, 0052, 0060, 0089, 0092, 0094-0095, 00118, 00127, 00142, 00144, 00157, 00186, 00198-00200]), conditions (para. [0007, 0010, 0050-0052, 0054-0055, 0080, 0089, 0091, 0097, 0099, 0107, 00127, 00140]), Subjects (para. [0007, 0011, 0050, 0052, 0053, 0056, 0077-0078, 0089-0090, 0098-0099, 0107, 0127, 0139, 0142-0144, 0155, 0157, 0168, 0183, 0198-0200]), administration (para. [0005-0007, 0011, 0056, 0080, 0089, 0091-0095, 0098-0099, 00118, 0127, 0141-0144, 0170, 0182, 0186-0187, 0198-0200]), and inflammatory diseases (para. [0006, 0010, 0080-0081, 0091, 0101-0102, 0135-0136, 0140, 0151-0152, 0164-0165, 0176-0177, 0183]), Applicant provides limited guidance for specific symptoms treated, conditions, subjects, administration steps, target sites, and specific cancers and inflammatory diseases (Examples 1-2; Figures 6-10; para. [0032-0034, 00119-00125]).
Present Working Examples (para. [0032-0034, 00119-00125] and Figures 6-10)
Example 1 (para. [00121])
Treating: symptoms treated include the skin lesion had reduced in size with resolving erythema (FIG. 9B) after two weeks, and resolution of the acral lick dermatitis and hair grown back two months after the canine-specific composition implantation (Figure 9C).
Condition: erythematous and alopecic skin lesion on the carpal joint of the left front limb
Subject: Canine (a three year-old Hound Mix dog)
Administering: the canine-specific composition described herein was implanted subcutaneously around the margins of the wound
It is noted that the additional step of “12 rounds of laser therapy treatments” was performed in this example.
inflammatory disease: erythematous and alopecic skin lesion on the carpal joint of the left front limb includes inflammation and is therefore a specific type of inflammatory disease.
Example 2 (para. [0123])
Treating: symptoms treated include the mass had significantly decreased in size compared to the initial mass (FIG. 10B) after 13 days. 81 Days following canine-specific composition implantation, the gum tissue looked healthy and normal at examination with no sign of recurrent mass (FIG. 10C).
Condition: mass on the right craniolateral mandible which Biopsy samples revealed as squamous cell carcinoma.
Subject: Canine (8 year old, spayed female Doberman Pinscher)
Administering: a 2.0cc of canine-specific composition was implanted under and around the mass without mass removal.
It is noted the additional step of “Light blunt debridement was performed using a gauze by the veterinarian” was performed in this example.
inflammatory disease: squamous cell carcinoma includes inflammation and is therefore a specific type of inflammatory disease.
Present Working Examples - Reduction to Practice in the Drawings
Applicant discloses reduction to practice in the following Description of the Drawings and Associated Drawings. Although these are not labeled as “Examples” they appear to constitute and actual reduction to practice of specific embodiments and are therefore considered as present working examples.
Figure 6 (para. [0032])
Treating: FIG. 6A, 6B, and 6C show a canine chest wound before (6A) and after treatment (9 days after in 6B and 14 days after in 6C) with a canine-specific therapeutic composition and provide a visual representation of symptoms treated.
Condition: chest wound
Subject: canine
Administering: subcutaneous injection with 2.0 mL of a canine-specific therapeutic composition.
Inflammatory disease: chest wounds include inflammation and is therefore a specific type of inflammatory disease.
Figure 7 (para. [0033])
Treating: FIG. 7A, 7B, 7C, and 7D show a canine abdominal thermal wound before (7A), on the day of (7B) and after (7B and 7C) treatment and provide a visual representation of symptoms treated. FIG. 7C and 7D show a canine abdominal thermal wound 2 (FIG. 7C) and 8 (FIG. 7D) weeks after.
Condition: abdominal thermal wound
Subject: canine
Administering: subcutaneous injection with 2.0 mL of the canine-specific therapeutic composition
Inflammatory disease: abdominal thermal wounds include inflammation and is therefore a specific type of inflammatory disease.
Figure 8 (para. [0034])
Treating: FIG. 8A, 8B, and 8C show a canine calcanean tendon lesion before (8A) and after (8B is 1 month after and 8C is two months after) treatment and provide a visual representation of symptoms treated. FIG. 8B and 8C show a canine calcanean tendon lesion 1 month (FIG. 8B) and 2 months (FIG. 8C) after.
Condition: calcanean tendon lesion
Subject: canine
Administering: injection with 1.0 mL of a canine-specific therapeutic composition. It is noted that the specific type of injection is not described.
Inflammatory disease: calcanean tendon lesion includes inflammation and is therefore a specific type of inflammatory disease.
Absent Working Examples
Working Examples are not provided for all other symptoms treated, all other conditions, all other subjects, all other administration steps, or all other inflammatory diseases.
Examples 1-2 rely on images and qualitative description of images to indicate symptoms treated and do not provide quantitative information on symptoms treated.
Figures 6-8 rely on images to indicate symptoms treated and do not provide quantitative information on symptoms treated.
The working Examples 1-2 and Figures 6-8 provide only a treatment subject and do not provide a comparison to a control or the state of the art.
The State of The Prior Art and Unpredictability of the Art
Wounds and Skin Lesions
Applicant’s Examples encompass Skin Lesions, Chest Wounds, Thermal Wounds, and Tendon Lesions (see present working Examples above), which are not compared to a control or the state of the art.
These are each from specific canine examples and are not art established models. Because there is no comparison to a control group and the specific examples are not art established models, a reasonable correlation cannot be ascertained.
Regarding Methods including wounds and skin lesions, Applicant is directed to the art of Allman (Published on 18th, May, 2021accessed at: https://licksleeve.uk/blogs/news/the-healing-stages-of-a-dog-s-wound?srsltid=AU7gw4VRj18IrarFVjzCt3KAFH_2mzNJQb3JuFOVAKHrZrrIGQbGk4L8 on 22nd, September, 2026). Allman evidences wound healing stages and progression in canines. Allman evidences wound closure (Stage 3 repair) is completed after 2-3 week from the injury and is followed by maturation (Stage 4) which can extend to months or years.
Applicant is additionally directed to the art of Ferrari et al. (Vet World. 2015 Oct 28;8(10):1247–1259.; henceforth “Ferrari”). Ferrari evidences “To test the outcome of a wound medication a control group is always necessary” pg. 1255 col. 1).
In the instant case, the specific examples of wound and lesion repair fall within known wound healing times for canines (see Example 1 above which appears to achieve wound closure by two months). Absent comparison to a control group, it is not apparent whether the wound or lesion healing of Applicant’s examples is the result of time progression of the wound healing process or is the result of the claimed method.
Tendon Injury
Concerning the tendon or ligament injuries, Applicant’s Example in Figure 8 appears drawn to
a canine calcanean tendon lesion. As stated above, the injury in Figure 8 appears to have improved at 1 month and 2 months as indicated by the Figure.
Applicant is directed to the art of Canine Fitness (17th, May 2022, https://web.archive.org/web/20220517115426/https://www.thecaninefitnesscentre.co.uk/health/how-long-does-healing-take/, accessed with WayBack Machine on 22nd, September, 2026). Canine Fitness evidences that acute tendon injuries in canines can heal from 2-6 weeks and Subacute tendon injuries can heal from 2-4 months.
In the instant case, the specific example of tendon healing falls within known healing times for canines. Absent comparison to a control group, it is not apparent whether the wound or lesion healing of Applicant’s examples is the result of time progression of the healing process or is the result of the claimed method.
Subjects
Applicant’s claim encompasses all possible subjects while Applicant’s Examples include only canine subjects. Treating a subject that is not a canine with the method of the claims, which includes a canine specific composition would be unpredictable because the treatment would be a xenograft from another subject type and can result in complications including rejection and graft versus host disease.
Applicant is directed to the art of Zhou et al. (Front Immunol. 2022 Jul 28;13:928173.; henceforth “Zhou”) which evidences that xenografts are unpredictable. Specifically, Zhou evidences xenografts can be rejected in a delayed or acute fashion and acute cellular rejection can occur even if immunotherapy is performed but is insufficient (pg. 5). Zhou further evidences that xenograft rejection is also unpredictable between tissue and organ types (pg. 13-14 “Organ-specific barriers and
Challenges”). Zhou further evidences the state of the art around the filing date of the claimed invention is that there are still several problems to xenotransplantation ahead of its use in clinical practice (pg. 14 col. 2).
Therefore, because the state of the art is that xenotransplantation is not predictable, Applicant's invention is not enabled for subject types other than canine.
Evidence of the Specification - Blood Related Contaminants
Concerning Blood-Related Contaminants, Applicant is directed to Applicant’s own specification which evidences that blood-related contaminants may cause allograft rejection in canines. Specifically, Applicant’s specification at para. [0004] states “the presence of blood-related contaminants, indicated by dark green coloration, may trigger alloimmunization responses in canine allograft recipients, thus harming the recipient and/or causing graft failure, decreasing or negating the therapeutic effects of the allograft materials.”
Therefore, because blood-related contaminants, indicated by dark green coloration, may cause allograft rejection, Applicant is not enabled for methods which include blood-related contaminants. Specifically, because blood-related contaminants have a dark green coloration, Applicant is not enabled for methods other than those which use a clear or colorless composition.
Administering
Administration is not predicable as each specific conditions requires that the composition arrive at the relevant location of the specific condition being treated. For example, oral administration of the composition would result in digestion of the product and would not reach a specific site of a condition such as a peripheral wound. Similarly, Topical administration would not result in treatment of an internal condition in a different location.
Applicant is directed to the art of Del Pozo et al.( Medication Routes of Administration. [Updated 2026 Sep 14]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-). Pozo evidences that Medication administration encompasses multiple enteral, parenteral, inhalational, transdermal, and other routes, each with distinct pharmacokinetic characteristics, clinical applications, advantages, limitations, and potential complications and Selection of the most appropriate route requires clinicians to consider medication characteristics, therapeutic goals, patient-specific factors, absorption, bioavailability, contraindications, and the safety and feasibility of administration (“Continuing Education Activity” pg. 1).
Therefore, because administration routes are not predictable for different condition types, Application is not enabled for all other administration routes for all other conditions.
Condition Types and Cancer Types
Applicant’s claims broadly encompass “conditions” (claim 1), “cancers” (claim 12) and “target sites” (claim 13) which encompass numerous structurally and functionally distinct conditions, diseases, disorders and cancers.
Concerning cancers specifically, treatments are not predictable for different cancer types.
Applicant is first directed to the art of National Cancer Institute (accessed at: https://www.cancer.gov/about-cancer/treatment/types on 22nd, September, 2026) which evidences that types of treatment received by a patient are dependent on cancer type (pg. 1).
Applicant is next directed to the art of McLaren (published 1st, September, 2020; accessed at: https://www.mclaren.org/main/blog/understanding-the-three-main-types-of-blood-cancer-1286 on 22nd, September, 2026). McLaren evidences that for blood cancers specifically, treatment differs for specific patient cases and that chemotherapy is the best treatment, while site specific therapies like radiation are not used as often because blood cancers because they are systemic disease (pg. 3-4 “Treatment of blood cancers”).
Therefore, because treatment for specific cancer types is not predictable and specific cancer treatments are dependent on cancer types, Applicant is not enabled for methods of treating all other types of cancers.
Further, since treatments are not predictable from one type of cancer to another, treatments are also not predictable between conditions and diseases of structurally and functionally distinct different types.
Therefore Applicants disclosure of one specific cancer types for does not enable treatment of all other structurally and functionally distinct conditions that have distinct mechanisms.
Unpredictability of the Art and the Quantity of Experimentation Necessary
As the state of the art above demonstrates, the obstacles that hinder the use of the claimed method in all subject types, in all condition types, in all cancer types, for all target site types, and with all administration types are not easy tasks to be done or solely routine experimentation to enabled particular embodiments of the claimed method. The type of experimentation would require new methodologies. This level of experimentation goes beyond what would be routine optimization know at the time of filing. As such, the amount of experimentation would be undue.
The physiological art is recognized as unpredictable (MPEP 2164.03). As set forth in In re Fisher, 166 USPQ 18 (CCPA 1970), compliance with 35 USC 112(a) requires: “That scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved.” Moreover, the courts have also stated that reasonable correlation must exist between scope of exclusive right to patent application and scope of enablement set forth in the patent application (27 USPQ2d 1662 Ex parte Maize!.). In view of the foregoing, due to the lack of sufficient guidance provided by the specification regarding the issues set forth above, the state of the relevant art, and the breadth of the claims, it would have required undue experimentation for one skilled in the art to practice the method of the instant broadly claimed invention.
Scope of Enablement - Conclusion
In conclusion, the breadth of the claims lack enablement because the specification provides limited working examples in canines subjects specifically, with limited routes of administration and since examples do not have a control group, a reasonable correlation cannot be ascertained. The art at the time of effective filing fail to provide specific guidance that supplement to shortcomings of the specification and further teaches that the breadth of claims cannot predictably be performed to arrive at treating conditions, cancers or target sites. Further, a great deal of new methodology would need to be developed to enable the full breadth of the claims and this level of experimentation is undue.
Claim Rejections - 35 USC § 112 (a)
Enablement
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 8 and 14 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.
Wands Factors
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: “Enablement is not precluded by the necessity for some 'experimentation.'” Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
Breadth of the Claims
Instant claims encompass methods of treating a:
“tendon and/or ligament injury” (claim 8)
This encompasses decreasing, ameliorating, or eliminating one or more or all symptoms of all possible tendon or ligament injuries.
Target site of “a wound or an operative incision” (claim 14)
This encompasses decreasing, ameliorating, or eliminating one or more or all symptoms of all possible wounds of operative incisions of all possible sizes.
Direction or Guidance Presented
While Applicant contemplates treating tendon or ligament injury (claim 8) (para. [0034, 0056, 0088, 0091, 0140-0141, 0156, 0170, 0182]) or target sites of a wound or an operative incision (claim 14) (para. [0006, 0011, 0032-0033, 0084, 0091, 0096, 0099, 0101, 0121, 0140, 0169, 0183-0183), Applicant provides limited specific guidance on treating (Examples 1-2; Figures 6-10; para. [0032-0034, 00119-00125]) which is insufficient to enable these claims for the reasons set forth below.
Present Working Examples (para. [0032-0034, 00119-00125] and Figures 6-10)
Examples pertinent to the instant rejection are discussed below.
Skin Lesion
Example 1 (para. [00121])
Treating: symptoms treated include the skin lesion had reduced in size with resolving erythema (FIG. 9B) after two weeks, and resolution of the acral lick dermatitis and hair grown back two months after the canine-specific composition implantation (Figure 9C).
Condition: erythematous and alopecic skin lesion on the carpal joint of the left front limb
Subject: Canine (a three year-old Hound Mix dog)
Administering: the canine-specific composition described herein was implanted subcutaneously around the margins of the wound
It is noted that the additional step of “12 rounds of laser therapy treatments” was performed in this example.
Present Working Examples - Reduction to Practice in the Drawings
Applicant discloses reduction to practice in the following Description of the Drawings and Associated Drawings. Although these are not labeled as “Examples” they appear to constitute and actual reduction to practice of specific embodiments and are therefore considered as present working examples.
Wounds
Figure 6 (para. [0032])
Treating: FIG. 6A, 6B, and 6C show a canine chest wound before (6A) and after treatment (9 days after in 6B and 14 days after in 6C) with a canine-specific therapeutic composition and provide a visual representation of symptoms treated.
Condition: chest wound
Subject: canine
Administering: subcutaneous injection with 2.0 mL of a canine-specific therapeutic composition.
Figure 7 (para. [0033])
Treating: FIG. 7A, 7B, 7C, and 7D show a canine abdominal thermal wound before (7A), on the day of (7B) and after (7B and 7C) treatment and provide a visual representation of symptoms treated. FIG. 7C and 7D show a canine abdominal thermal wound 2 (FIG. 7C) and 8 (FIG. 7D) weeks after.
Condition: abdominal thermal wound
Subject: canine
Administering: subcutaneous injection with 2.0 mL of the canine-specific therapeutic composition
Tendon Injury
Figure 8 (para. [0034])
Treating: FIG. 8A, 8B, and 8C show a canine calcanean tendon lesion before (8A) and after (8B is 1 month after and 8C is two months after) treatment and provide a visual representation of symptoms treated. FIG. 8B and 8C show a canine calcanean tendon lesion 1 month (FIG. 8B) and 2 months (FIG. 8C) after.
Condition: calcanean tendon lesion
Subject: canine
Administering: injection with 1.0 mL of a canine-specific therapeutic composition. It is noted that the specific type of injection is not described.
Absent Working Examples
Example 1 relies on images and qualitative description of images to indicate symptoms treated and do not provide quantitative information on symptoms treated.
Figures 6-8 rely on images to indicate symptoms treated and do not provide quantitative information on symptoms treated.
The working Examples1 and Figures 6-8 provide only a treatment subject and do not provide a comparison to a control or the state of the art.
The State of The Prior Art and Unpredictability of the Art
Wounds and Skin Lesions
Applicant’s Examples encompass Skin Lesions, Chest Wounds, Thermal Wounds, and Tendon Lesions (see present working Examples above), which are not compared to a control or the state of the art.
These are each from specific canine examples and are not art established models. Because there is no comparison to a control group and the specific examples are not art established models, a reasonable correlation cannot be ascertained.
Regarding Methods including wounds and skin lesions, Applicant is directed to the art of Allman (Published on 18th, May, 2021accessed at: https://licksleeve.uk/blogs/news/the-healing-stages-of-a-dog-s-wound?srsltid=AU7gw4VRj18IrarFVjzCt3KAFH_2mzNJQb3JuFOVAKHrZrrIGQbGk4L8 on 22nd, September, 2026). Allman evidences wound healing stages and progression in canines. Allman evidences wound closure (Stage 3 repair) is completed after 2-3 week from the injury and is followed by maturation (Stage 4) which can extend to months or years.
Applicant is additionally directed to the art of Ferrari et al. (Vet World. 2015 Oct 28;8(10):1247–1259.; henceforth “Ferrari”). Ferrari evidences “To test the outcome of a wound medication a control group is always necessary” pg. 1255 col. 1).
In the instant case, the specific examples of wound and lesion repair fall within known wound healing times for canines (see Example 1 above which appears to achieve wound closure by two months). Absent comparison to a control group, it is not apparent whether the wound or lesion healing of Applicant’s examples is the result of time progression of the wound healing process or is the result of the claimed method.
Tendon Injury
Concerning the tendon or ligament injuries, Applicant’s Example in Figure 8 appears drawn to
a canine calcanean tendon lesion. As stated above, the injury in Figure 8 appears to have improved at 1 month and 2 months as indicated by the Figure.
Applicant is directed to the art of Canine Fitness (17th, May 2022, https://web.archive.org/web/20220517115426/https://www.thecaninefitnesscentre.co.uk/health/how-long-does-healing-take/, accessed with WayBack Machine on 22nd, September, 2026). Canine Fitness evidences that acute tendon injuries can heal from 2-6 weeks and Subacute tendon injuries can heal from 2-4 months.
In the instant case, the specific examples of tendon healing fall within known healing times for canines. Absent comparison to a control group, it is not apparent whether the wound or lesion healing of Applicant’s examples is the result of time progression of the healing process or is the result of the claimed method.
Unpredictability of the Art and the Quantity of Experimentation
As the state of the art above demonstrates, the obstacles that hinder the use of the claimed method in to treat wounds, incisions, tendon or ligament injuries are not easy tasks to be done or solely routine experimentation. Specifically, as set forth above, because wounds, incisions, tendon injuries and ligament injuries are known in the art to heal over time, and Applicant’s Examples heal in times encompassed by known healing times and are not compared to a control group, a reasonable correlation cannot be ascertained between Applicant’s results and the ability of the ordinary skilled artisan to perform the claimed method. The type of experimentation to perform the method would require new methodologies. This level of experimentation goes beyond what would be routine optimization know at the time of filing. As such, the amount of experimentation would be undue.
The physiological art is recognized as unpredictable (MPEP 2164.03). As set forth in In re Fisher, 166 USPQ 18 (CCPA 1970), compliance with 35 USC 112(a) requires: “That scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific laws; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved.” Moreover, the courts have also stated that reasonable correlation must exist between scope of exclusive right to patent application and scope of enablement set forth in the patent application (27 USPQ2d 1662 Ex parte Maize!.). In view of the foregoing, due to the lack of sufficient guidance provided by the specification regarding the issues set forth above, the state of the relevant art, and the breadth of the claims, it would have required undue experimentation for one skilled in the art to practice the methods of the invention.
Enablement – Conclusion
In conclusion, the claims lack enablement because while the specification provides working examples, the healing times provided overlap with those known in the art. Because no comparison to a control or the state of the art is provided, a reasonable correlation cannot be ascertained and it would therefore have required undue experimentation for one skilled in the art to practice the methods of the invention.
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.
Claims 1-8 and 10-14 and 19 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 12 and 13 each recite “the canine-specific therapeutic composition comprising a micronized canine-specific allantoamnion membrane, in a solution.” However, claim 1 does not previously recite a canine-specific therapeutic composition and therefore there is improper antecedent basis for “the canine-specific therapeutic composition” within claims 1, 12 and 13. More specifically, it is unclear what the scope of “the canine-specific therapeutic composition” encompasses and whether it is intended to encompass additional unrecited limitations, and what those limitations may be.
By nature of their ultimate dependency on claim 1, claims 2-8 and 10-11 are also rejected because they do not clarify the issue.
By nature of their ultimate dependency on claim 13, claims 14 and 19 are also rejected because they do not clarify the issue.
Claim 6 recites the subjective term “substantially,” with no corresponding definition. Therefore the scope of the claim is unclear. A claim may be rendered indefinite by reference to subjective term. (see MPEP 2173.05(b), IV). Specifically, the term “substantially” is a subjective term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for some standard for measuring the scope of the term, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Generally, when the claims are indefinite, vague or unclear, they cannot be construed without speculation or conjecture; therefore, the indefinite claims are not treated on the merits with respect to prior art. See In re Steele, 305 F.2d 859, 862 (CCPA 1962) (A prior art rejection cannot be sustained if the hypothetical person of ordinary skill in the art would have to make speculative assumptions concerning the meaning of claim language.); see also In re Wilson, 424 F.2d 1382, 1385 (CCPA 1970) ("If no reasonably definite meaning can be ascribed to certain terms in the claim, the subject matter does not become obvious-the claim becomes indefinite."). Notwithstanding Steele, the Office has made every attempt to construe the claims in what the Office believes is the intent of the Applicants in the interest of compact prosecution.
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.
Examiner’s Remark
The examiner notes that the prior art of Zhang applied below is as enabling as Applicant’s disclosure.
Claims 1-3, 7-8, 10 and 13-14 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Zhang et al. (US-2021/0269775-A1; published 2nd September, 2021 with benefit to 28th, February, 2020; see IDS filed 10th, December, 2021; henceforth “Zhang”).
Regarding claims 1 and 7, Zhang discloses a method of treating a condition of inflammatory disease in a subject (“methods of their use, as disclosed herein, may be used in surgical procedures, for example, in grafts or in transplant medicine, for example, to reduce inflammation and rejection of a graft” para. [0017]: “inflammatory conditions” para. [0086]; the method comprising administering a therapeutic amount (“administering to the subject in need thereof a composition comprising decellularized preterm placental tissue” para. [0008]; see also para. [0009-0010, 0023, 0080, 0083-0085, 0087-0088, 0094-0096]) of a canine-specific (“the animal is a mammal, such as… canine”; para. [0005] see also para. [0007-0008, 0032, 0071, 0076, 0092-0094] and claim 10) therapeutic composition comprising a micronized (“granulate, powder” and “dried (air dried or freeze dried) to form granulated powder” para. [0042]; see also para. [0065, 0073]) canine-specific allantoamnion membrane (“the decellularized preterm placental tissue may comprise one or more of an amnion layer, a chorion layer, and an allantois layer” para. [0005] and “preterm placental tissue may be decellularized without processing to separate one or more of the placental membranes or layers thereof, such as the amnion, chorion, or allantois” para. [0060]; because this encompasses the placenta with all the layers, it includes the allantoamnion) in a solution (“injectable” para. [0042, 0065] or lyophilized with a cryoprotectant para. [0066]).
Regarding claim 2, further to the discussion of claim 1 above, as stated above (see claim 1 rejection above), Zhang discloses the canine-specific therapeutic composition is micronized and comprises the placental layer including the chorion layer and it would therefore include micronized canine-specific chorioallantois membrane.
Regarding claim 3, further to the discussion of claim 1 above, as stated above (see claim 1 rejection above) , Zhang discloses the canine-specific therapeutic composition is micronized and comprises the placental layers which would include the allantoamnion, the composition would further comprise micronized canine-specific allantoamnion membrane particles.
Regarding claim 8, further to the discussion of claim 1 above, Zhang discloses the condition is a tendon or ligament injury (para. [0081]).
Regarding claim 10, further to the discussion of claim 1 above, Zhang discloses the composition is combined or mixed with stem cells prior to administration (para. [0053]).
Regarding claim 13, as stated above (see claim 1 rejection above), Zhang discloses the method step of administering a therapeutic amount of the canine-specific therapeutic composition comprising a micronized canine-specific allantoamnion membrane, in a solution to the subject. Zhang discloses the target sites (“the site in need of tissue regeneration” para. [0087]).
Regarding claim 14, further to the discussion of claim 13 above, Zhang discloses the site is a wound (“method of treating a wound in a subject” para. [0009]).
Accordingly, Zhang anticipates instant claims.
Claims 1-8 and 13-14 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention on the date of 4th, November, 2021 as evidenced by AlphaFlo1 (https://alphaflocanine.com/calcanean-tendon-lesion-rh/; accessed on 21st, September, 2026), AlphaFlo2 (https://alphaflocanine.com/about/alphaflo/; accessed on 21st, September, 2026) and AlphaFlo3 (https://alphaflocanine.com/about/ accessed on 21st, September, 2026).
Regarding claims 1 and 13, AlphaFlo1 evidences a case study in which on 4th, November, 2021, 1.0 CC of “Alpha-Flo®” was implanted into the calcanean tendon lesions under ultrasound guidance in a canine. AlphaFlo2 evidences that the “Alpha-Flo®” that was used in the method on 4th, November, 2021, is a liquid, acellular, canine amniotic tissue allograft and appears to be the “canine-specific therapeutic composition comprising a micronized canine-specific allantoamnion membrane, in a solution” encompassed by instant claims.
Regarding claims 2-4, AlphaFlo3 evidences the composition includes amnion (pg. 2) and it therefore includes canine-specific chorioallantois membrane (instant claim 2), canine-specific allantoamnion membrane particles, micronized canine-specific chorioallantois membrane particles (instant claim 3) and canine-specific amniotic fluid, canine-specific allantoic fluid (instant claim 4).
Regarding claim 5, AlphaFlo3 evidences the composition includes A2M, IL-1ra, IL-10, TIMP-2, MCP-1, Trappin-2, EGFR and VEGF (pg. 6).
Regarding claim 6, AlphaFlo2 evidences the composition is clear or colorless (see vial on pg. 3) and therefore it is substantially free of blood-related contaminants and/or uteroverdin.
Regarding claims 7-8, as stated above (see claim 1 rejection above), AlphaFlo1 evidences the condition calcanean tendon lesion which is an inflammatory disease (instant claim 7) and is also a tendon injury (instant claim 8).
Regarding claim 13, the calcanean tendon lesions evidenced above are a target site.
Regarding claim 14, the calcanean tendon lesions evidence above are an injury and fall under the broadest reasonable interpretation of a wound.
Accordingly, the method of the claims was publicly available.
Claims 1-7 and 13-14 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention on the date of 27th, May, 2022, as evidenced by AlphaFlo4 (https://alphaflocanine.com/chest-wound/ ; accessed on 21st, September, 2026), AlphaFlo2 (https://alphaflocanine.com/about/alphaflo/; accessed on 21st, September, 2026) and AlphaFlo3 (https://alphaflocanine.com/about/ accessed on 21st, September, 2026).
Regarding claim 1, AlphaFlo4 evidences a caser study in which on 27th, May, 2022, 2.0 CC of “Alpha-Flo®” was distributed subcutaneously around the non-healing wound edges of a chest wound of a canine. AlphaFlo2 evidences that the “Alpha-Flo®” that was used in the method is a liquid, acellular, canine amniotic tissue allograft and appears to be the “canine-specific therapeutic composition comprising a micronized canine-specific allantoamnion membrane, in a solution” encompassed by instant claims.
Regarding claims 2-4, AlphaFlo3 evidences the composition includes amnion (pg. 2) and it therefore includes canine-specific chorioallantois membrane (instant claim 2), canine-specific allantoamnion membrane particles, micronized canine-specific chorioallantois membrane particles (instant claim 3) and canine-specific amniotic fluid, canine-specific allantoic fluid (instant claim 4).
Regarding claim 5, AlphaFlo3 evidences the composition includes A2M, IL-1ra, IL-10, TIMP-2, MCP-1, Trappin-2, EGFR and VEGF (pg. 6).
Regarding claim 6, AlphaFlo2 evidences the composition is clear or colorless (see vial on pg. 3) and therefore it is substantially free of blood-related contaminants and/or uteroverdin.
Regarding claims 7 and 14, as stated above, AlphaFlo4 evidences the condition is a wound.
Regarding claim 13, the wound lesions evidenced above is a target site.
Accordingly, the method of the claims was publicly available.
Examiner’s Remark
It is noted that the disclosure above by AlphaFlo appears to potentially be by the inventors (see AlphaFlo “We are AlphaLogix, the team behind AlphaFlo® canine allograft” from
https://alphaflocanine.com/about/ accessed on 21st, September, 2026). The “About” page of the website lists members Ann Kolesar, Ginger Johnson, Jodie Lamb and Alli Winn as part of the “team behind AlphaFlo® canine allograft” that are not listed as inventors on the instant Application.
It is noted that, as set forth above, the instant claims are given the filing date of the instant Application of 27th, September, 2024. Therefore, both of the prior public disclosures are more than one year before the effective filing date of the instant claims. To overcome this rejection, Applicant must show the claims are entitled to a priority date within the grace-period and also show that disclosure of the invention (for both the 4th, November, 2021 date evidenced by AlphaFlo1 and the date of 27th, May, 2022, evidenced by AlphaFlo2 is excepted as prior art under 102 (b)(1)(A) or 102 (b)(1)(B) (see MPEP 2153) or otherwise overcome the rejection by amendment or argument.
Claims 1-8 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AlphaFlo5 (19th, December, 2022; accessed at: https://www.youtube.com/watch?v=ATEvkwICmIU on 23rd, September, 2026) as evidenced by AlphaFlo2 (https://alphaflocanine.com/about/alphaflo/; accessed on 21st, September, 2026) and AlphaFlo3 (https://alphaflocanine.com/about/ accessed on 21st, September, 2026).
Regarding claims 1 and 13, AlphaFlo5 discloses a method comprising administering Alpha-Flo to a canine (“received the dose of alpha Flo” pg. 3 timestamp 4:47 and “she had a slight re-injury in July and a few more doses of alpha flow” pg. 3 timestamp 4:47 ) to treat a condition (“bilateral ilioso as insertional tears” pg. 3 timestamp 3:45) which is a target site. AlphaFlo2 evidences that the “Alpha-Flo®” that was used in the method is a liquid, acellular, canine amniotic tissue allograft and appears to be the “canine-specific therapeutic composition comprising a micronized canine-specific allantoamnion membrane, in a solution” encompassed by instant claims.
Regarding claims 2-4, AlphaFlo3 evidences the composition includes amnion (pg. 2) and it therefore includes canine-specific chorioallantois membrane (instant claim 2), canine-specific allantoamnion membrane particles, micronized canine-specific chorioallantois membrane particles (instant claim 3) and canine-specific amniotic fluid, canine-specific allantoic fluid (instant claim 4).
Regarding claim 5, AlphaFlo3 evidences the composition includes A2M, IL-1ra, IL-10, TIMP-2, MCP-1, Trappin-2, EGFR and VEGF (pg. 6).
Regarding claim 6, AlphaFlo2 evidences the composition is clear or colorless (see vial on pg. 3) and therefore it is substantially free of blood-related contaminants and/or uteroverdin.
Regarding claims 7-8, as stated above (see claim 1 rejection above), AlphaFlo5 discloses the condition bilateral ilioso as insertional tears which is an inflammatory disease (instant claim 7) and is also a tendon injury (instant claim 8).
Regarding claim 13, the bilateral ilioso as insertional tears disclosed above are a target site.
Regarding claim 14, the bilateral ilioso as insertional tears disclosed above are an injury and fall under the broadest reasonable interpretation of a wound.
Accordingly, the AlphaFlo Interview Anticipates instant claims.
Claims 1-7 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AlphaFlo6 (19th, December, 2022; accessed at: https://www.youtube.com/watch?v=qpb08ZotQfU on 23rd, September, 2026) as evidenced by AlphaFlo2 (https://alphaflocanine.com/about/alphaflo/; accessed on 21st, September, 2026) and AlphaFlo3 (https://alphaflocanine.com/about/ accessed on 21st, September, 2026).
Regarding claims 1 and 13-14, AlphaFlo6 discloses a method comprising administering Alpha-Flo to a canine to treat a condition ( wound pg. 3 see “know she had a good size it was probably about two to three inches and it had been like that for almost two months so that yeah for it just to have not even a dime size scar”) which is a target site. AlphaFlo2 evidences that the “Alpha-Flo®” that was used in the method is a liquid, acellular, canine amniotic tissue allograft and appears to be the “canine-specific therapeutic composition comprising a micronized canine-specific allantoamnion membrane, in a solution” encompassed by instant claims.
Regarding claims 2-4, AlphaFlo3 evidences the composition includes amnion (pg. 2) and it therefore includes canine-specific chorioallantois membrane (instant claim 2), canine-specific allantoamnion membrane particles, micronized canine-specific chorioallantois membrane particles (instant claim 3) and canine-specific amniotic fluid, canine-specific allantoic fluid (instant claim 4).
Regarding claim 5, AlphaFlo3 evidences the composition includes A2M, IL-1ra, IL-10, TIMP-2, MCP-1, Trappin-2, EGFR and VEGF (pg. 6).
Regarding claim 6, AlphaFlo2 evidences the composition is clear or colorless (see vial on pg. 3) and therefore it is substantially free of blood-related contaminants and/or uteroverdin.
Regarding claims 7, as stated above (see claim 1 rejection above), AlphFlo6 discloses the wound which is an inflammatory disease.
Regarding claim 13, the wound disclosed above are a target site.
Accordingly, the AlphaFlo6 Anticipates instant claims.
Pertinent Art
The prior art of Suddarth et al. (US-2022/0401496-A1; henceforth “Suddarth”) made of record but not relied upon is considered pertinent to Applicant’s disclosure.
Suddarth discloses a method of treating inflammatory diseases (“method for a therapeutic compound from a plurality of birth tissues for the treatment of at least breathing and
inflammation ailments”; abstract) in a canine subject (“for the use in mammals, specifically equine, canine” para. [0010]) comprising a therapeutic amount of a therapeutic composition comprising a micronized (“further processed such as by lyophilizing (freezing-drying)” para [0054]; see also “substantially dehydrated to about a powder” claim 41) equine allantoamnion membrane (“including but not limited to amnion, allantois, allantoamnion” para. [0024]; see also para. [0073]), in a solution.
Suddarth does not teach the therapeutic composition is canine-specific.
Conclusion
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
