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 .
Priority
The present application claims status as a 371 (National Stage) of PCT/EP2023/050040 filed January 3rd 2023, and claims priority under 119(a)-(d) to European Application No. EP22150173.7 filed on January 4th 2022.
Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d) for European Application No. EP22150173.7 papers have been placed of record in the file. Please note that the European application is in English and therefore no further action is needed.
Information Disclosure Statement
The information Disclosure Statement filed on 08/05/2024 has been considered by the Examiner.
Claim Status
Claims 1-13 were originally filed on 07/01/2024.
The amendment filed on 02/26/2026 cancelled claims 1-13, added new claims 14-29.
Claims 14-29 are currently pending and under consideration.
Drawings
The drawings are objected to because the line graphs depicted in Figs. 1A-4C are illegible. The difference between each concentration cannot be determined. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Regarding the scope of “a duck egg ovomucoid or a fragment thereof” it is noted that the instant specification does not define what constitutes the ovomucoid or a fragment thereof. Pursuant to MPEP 2111.01, under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. Quan et al. teach that ovomucoid is a mayor protein in duck albumin with a molecular weight of 28kDa (see Quan et al. J Food Sci Technol. 2019, 56(3):1104-1115, at pg. 1108, right column, last paragraph and pg. 1107, Table 1). Since a duck egg ovomucoid protein is 28kDa, it would roughly contain 255 to 280 amino acids based on standard biochemical estimation rules. As such, the claimed duck egg ovomucoid is being interpreted as the full amino acid sequence representing the egg ovomucoid of any duck; and a fragment thereof is being interpreted as a peptide chain of any length, that is, as short as two amino acids long (i.e., a dipeptide) or as long as 254 to 279 amino acids.
Regarding the scope of “wherein the pharmaceutical composition prevents or inhibits a plasmin activity in a subject”, it is noted that the instant specification does not define what constitutes “prevents”. Pursuant to MPEP 2111.01, under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the time of the invention. Merriam-Webster Dictionary defines “prevent” as to keep from happening or existing (see Merriam-Webster, https://www.merriam-webster.com/dictionary/prevent, accessed on 07/28/2026). As such, the Examiner is interpreting the scope of “prevent/preventing” encompasses 100% prevention of plasmin activity.
Claim Rejections - 35 USC § 112
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.
1. Claims 14-29 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.
Claim 14 is drawn to a pharmaceutical composition […], wherein the composition prevents or inhibits a plasmin activity in a subject […]. It has not been clearly established which plasmin activity is inhibited or prevented by the pharmaceutical composition. Stated differently, the term “a plasmin activity” makes reference to one specific activity; however the plasmin activity of interest remains ambiguous because it has not been identified. Thus, an ordinary skilled artisan would not be unable to determine the metes and bounds of the claimed invention because it is not clear which of the many biological functions/activities of plasmin is interjected by the claimed pharmaceutical composition. In order to advance prosecution, “a plasmin activity” will be interpreted as “plasmin activity”.
Claims 15-29 are rejected for depending on an indefinite base claim.
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.
2. Claims 14-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
MPEP § 2163 states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus.
Independent claim 14 includes “a duck egg ovomucoid or a fragment thereof”. As discussed in the “Claim Interpretation Section”, the Examiner interprets “a duck egg ovomucoid or a fragment thereof” as a peptide sequence that could be the full length of the peptide (i.e., between 255 to 280 amino acids),or a peptide chain of any length (i.e., as short as a dipeptide and as long as 254 to 279 amino acids). As such, the scope of the claimed pharmaceutical composition encompasses any duck egg ovomucoid or any fragment thereof, wherein the fragment could be of any length, including a dipeptide and still exhibit the desired function of preventing or inhibiting plasmin activity. Therefore, the scope of claim 14 and dependent claims 15-29 encompass a vast array of sequences without a necessary core structure and/or sequence that would be needed for the pharmaceutical composition to exhibit the function of preventing or inhibiting a plasmin activity in a subject.
An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. MPEP 2163 (I)(A).
Applicant reduced to practice purified egg ovomucoid (see instant specification, pg. 12, Example 3). However, the instant specification is silent about the specific structure of the purified egg ovomucoid that would be required or sufficient to exhibit the claimed plasmin inhibition. Moreover, there is no indication of whether the purified egg ovomucoid reduced to practice constitutes the full peptide sequence of the ovomucoid or a fragment thereof. Therefore, the scope of claims 14-29 encompass a vast array of duck egg ovomucoid without a necessary core structure and/or sequence that would be needed for the ovomucoid or fragment thereof to exhibit the desired function of inhibiting a plasmin activity.
The purified egg ovomucoid reduced to practice is not represented by a common core structure; without an indication of a core structure, sequence or residues that would be necessary in order for a duck egg ovomucoid to exhibit the claimed function (i.e., preventing or inhibiting a plasmin activity), it would be difficult for a skilled artisan to envision the correlation between structure and function for the whole genus and/or to predict what would be covered by the functionally claimed genus because Applicants have failed to provide a representative number of species of duck egg ovomucoids or fragments thereof to support the scope of the whole genus.
The written description requirement may be met by provided a representative number of species of the genus and/or in light of the state of the art. With regard to the state of the art, Scott et al. teach that ovomucoid consists of three tandem Kazal domains that can be readily separated by hydrolysis of the short connecting peptides and each domain can function independently (see Scott et al. 1987. The Journal of Biological Chemistry. Vol. 262, No. 12, Issue of April 25, pp. 5899-5907 at pg. 5899, right column, first paragraph). Therefore, Scotts’ teachings present compelling evidence that the ovomucoid peptide sequence could at least be fragmented into three portions wherein each fragment can function independently. Thus, the instant pharmaceutical composition comprises a duck egg ovomucoid or a fragment with a certain function but no correlated structure associated with that function. Without such structure, the specification does not convey possession of the breadth of the claimed genus.
As previously mentioned, purified duck egg ovomucoid was reduced to practice; thus, evidence of a positive integrant and replicative experiment of purified duck egg ovomucoid, is not sufficient representation for the skilled artisan to envisage the entire genus of pharmaceutical compositions comprising any fragment of a duck egg ovomucoid that would constitute a necessary core structure and/or sequence and still exhibit the desired function of preventing or inhibiting a plasmin activity.
Therefore, claims 14-19 do not meet the written description requirement.
3. Claims 14-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for failing to comply with the enablement requirement. This is a scope of enablement rejection, because the specification while being enabling for inhibiting a plasmin activity in vitro, does not reasonably provide enablement for preventing a plasmin activity in a subject as compared to the plasmin activity in the subject in the absence of the pharmaceutical composition comprising a duck egg ovomucoid. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected to make and/or use the invention. The claims are drawn to a pharmaceutical composition comprising a duck egg ovomucoid or a fragment thereof, wherein the composition prevents or inhibits a plasmin activity.
To address whether sufficient evidence supports the determination that the disclosure does not satisfy the enablement requirement and whether undue experimentation might be needed, the below factors are considered:
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The breadth of the claims: The claims encompass preventing a plasmin activity in a subject; wherein preventing includes 100% prevention plasmin activity.
The nature of the invention: The invention pertains to a pharmaceutical composition comprising a duck egg ovomucoid or a fragment thereof; wherein the pharmaceutical composition prevents or inhibits a plasmin activity in a subject as compared to the plasmin activity in the subject in the absence of the pharmaceutical composition.
The state of the prior art: The art teaches the inventive concept of plasmin inhibitors to prevent or treat hyperfibrinolysis and hemorrhage, for instance CN108676090 (A) teaches using plasmin inhibitors that inhibit fibrous protein dissolving effect of plasmin and reduces hemorrhage during operation thereby serving as medicine for preventing or treating hyperfibrinolysis and hemorrhage (see CN108676090 A, Machine Translation, cited in the IDS filed on 08/05/2024).
The art teaches that duck egg ovomucoid effectively inhibited Human leukocyte elastase (HLE), porcine pancreatic elastase (PPE), chymotrypsin and human cathepsin G (HCG) in a 1:1 molar ratio, and trypsin in a 1:2 molar ratio; however inhibition of human plasmin was not observed (see Valueva et al. Immunopharmacology 32 (1996), pp. 108-110, at pg. 108, abstract).
The level of one of ordinary skill: Practitioners in this art (medical clinicians, pharmacists, doctors and/or pharmaceutical chemists) would presumably be highly skilled in the art of plasmin activity inhibition.
The level of predictability in the art: The instant claimed invention is highly unpredictable. If one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains (i.e., preventing a plasmin activity in a subject), then there is a lack of predictability in the art. Moreover, it is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. The court has indicated that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. (See In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970)). This is because it is not obvious from the disclosure of one species (i.e., a duck egg ovomucoid), what other species will work. In the instant case, Applicants do not demonstrate that any pharmaceutical composition comprising any duck egg ovomucoid or any fragment thereof prevents a plasmin activity in a subject. Applicant appears to rely on the assumption that by providing evidence that purified duck egg ovomucoid has a comparably inhibitory effect on plasmin as the known cyklokapron when compared in vitro (see pg. 12, Example 12 and Figure 5A and 5B); that the claimed composition would exhibit similar intended results for the prevention of plasmin activity in a subject as compared to the plasmin activity in the subject in the absence of the pharmaceutical composition. However, such an assumption cannot be made because there is no indication that duck egg ovomucoid would exhibit such results. Additionally, since the instant specification fails to demonstrate any data or evidence that the claimed composition comprising a duck egg ovomucoid or a fragment thereof prevents a plasmin activity in a subject, as compared to the plasmin activity in the subject in the absence of the pharmaceutical composition, there would be no way of determining without undue experimentation, whether the claimed composition exhibits such a desired results. Without more experimentation demonstrating the efficacy of the claimed composition for preventing a plasmin activity, the level of unpredictability remain high. Therefore, it is unpredictable that the claimed composition will 100 % prevent a plasmin activity in a subject.
The amount of direction provided by the inventor: The specification does not enable any person skilled in the art to which it pertains to use the invention commensurate in scope with the claims. There is a lack of adequate guidance from the specification with regard to the actual prevention of a plasmin activity as recited in the claims. Applicant fails to provide the guidance and information required to ascertain whether the claimed pharmaceutical composition prevents a plasmin activity without resorting to undue experimentation. Applicant’s limited disclosure is noted but is not sufficient to justify claiming that any pharmaceutical composition comprising a duck egg ovomucoid or a fragment thereof prevents a plasmin activity in a subject.
The existence of working examples: The specification does not articulate the use a duck egg ovomucoid or a fragment thereof in the prevention of a plasmin activity. Instead, the working examples pertain to comparative analysis between purified duck egg ovomucoid to known medications that stop blood clots from breaking down too quickly (i.e., Trasylol and Cyklokapron) (see Examples 1 and 2, instant specification, pp. 11-12). The third working example quantifies the kinetics of plasmin inhibition by ovomucoid (see instant specification, pg. 12-13). However the working examples lack evidence of 100% prevention of a plasmin activity in a subject as compared to plasmin activity in the subject in the absence of the pharmaceutical composition.
The quantity of experimentation needed to make or use the invention based on the content of the disclosure: Due to the breadth of the claim, preventing a plasmin activity in a subject as compared to the plasmin activity in the subject in the absence of the pharmaceutical composition comprising a duck egg ovomucoid or a fragment therefor would require substantive experimentation, given the claimed duck egg ovomucoid or a fragment thereof is not known to inhibit human plasmin.
After applying the Wands factors and analysis to claims 14-29, in view of the Applicant' s entire disclosure, and considering the In re Wright, In re Fisher and Genentech decisions discussed above, it is concluded that the practice of the invention as claimed in claims 14-29 would not be enabled by the written disclosure for a pharmaceutical composition comprising a duck egg ovomucoid or a fragment thereof, wherein the pharmaceutical composition prevents a plasmin activity in a subject as compared to the plasmin activity in the subject in the absence of the pharmaceutical composition.
Therefore, claims 14-29 are rejected under 35 U.S.C. §112(a) for failing to disclose sufficient information to enable a person of skill in the art to prevent a plasmin activity in a subject.
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.
4. Claims 14-18, and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product (i.e., a judicial exception) without significantly more. The claims are drawn to a pharmaceutical composition comprising a duck egg ovomucoid or a fragment thereof. Based upon an analysis with respect to the claims as a whole, claims 14-18, and 20-22 do not recite something significantly different than a judicial exception, a product of nature, which is not markedly different from its closest-occurring naturally-occurring counterpart and does not present “significantly more” than the judicial exception. The rationale for this determination is explained below and in the MPEP § 2106.
Claims 1418 are drawn to a pharmaceutical composition comprising a duck egg ovomucoid or a fragment thereof; wherein the duck egg ovomucoid is extracted from an egg or recombinantly produced. Claim 15 lists the administration routes of the claimed composition and includes oral administration, which would correspond to eating duck ovomucoid or a fragment thereof (i.e., eating duck egg whites). Claim 16 includes that the claimed composition is administered to a human; therefore administration to a human subject does not change or alter the structure of the natural product (i.e., ovomucoid or fragment thereof ). Claim 18 recites that the pharmaceutical composition further comprises a stabilizer, an excipient, an adjuvant, or combinations thereof. Since the inclusion of one of the further components is an alternative between a stabilizer or an excipient or an adjuvant; the additional component (i.e., excipient) can be a natural product such as water.
Claims 20-22 are drawn to a method of managing or inhibiting plasmin activity which comprises administering the pharmaceutical composition of claim 14 as an active step. Thus the scope of claim 20 encompasses administering a duck egg ovomucoid or a fragment thereof to any patient population, with the intended result of managing or inhibiting a plasmin activity. As such, the claimed method does not alter the structure and/or function of the natural product (i.e., duck egg whites). Similarly, the limitations which further limit the claimed method (i.e., a human subject, and oral administration) as recited in claims 21-22, correspond to taking duck egg whites through the mouth by a human being. Thereby the process of a human being eating duck egg whites does not in any way alter the structure and/or function of the claimed duck egg ovomucoid or a fragment thereof. Accordingly, claims 20-22 are ineligible subject matter because the claims include a product of nature which is not markedly different from its closes-occurring naturally-occurring counterpart and the claimed method does not present significantly more than the judicial exception.
Furthermore, MPEP § 2106.04 (c) states that when the judicial exception is a natural product, the markedly different characteristics analysis is used to identify product of nature exceptions. For example, Chakrabarty relied on a comparison of the claimed bacterium to naturally occurring bacteria when determining that the claimed bacterium was not a product of nature because it had "markedly different characteristics from any found in nature". Diamond v. Chakrabarty, 447 U.S. 303, 310, 206 USPQ 193, 197 (1980). Similarly, Roslin relied on a comparison of the claimed sheep to naturally occurring sheep when determining that the claimed sheep was a product of nature because it "does not possess ‘markedly different characteristics from any [farm animals] found in nature.’" In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (quoting Chakrabarty, 447 U.S. at 310, 206 USPQ at 197 (alterations in original)).
In the instant case, the closest-occurring natural counterpart to the claimed invention is naturally occurring duck egg ovomucoid (see Quan et al. J Food Sci Technol. 2019, 56(3):1104-1115, at pg. 1108, right column, last paragraph and pg. 1107, Table 1). Thus, naturally occurring duck egg ovomucoid is the closest-occurring natural counterpart to the claimed invention ant the excipient can be a natural product such as water. Therefore, all of the components that make up the claimed pharmaceutical composition appear to be identical to the components as they occur in nature. Hence the claimed composition would not appear to be markedly different from its nature-based counterpart.
This judicial exception is not integrated into a practical application because there is nothing in the original disclosure which would suggest that the combination of natural products in claims 14-18 and 20-22 would change the structure or function of the natural products (i.e., a duck egg ovomucoid or a fragment thereof and an excipient such as water); hence, the judicial exception is not integrated into a practical application because the claims, directed to a pharmaceutical composition, recite nothing in addition to the natural products. Furthermore, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims only recite combinations of natural products which do not appear to change the structure or function of the natural products.
Accordingly, claims 14-18 and 20-22 are rejected under 35 U.S.C 101 as directed to patent ineligible subject matter.
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.
5. Claims 14 and 20-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Quan et al. J Food Sci Technol. 2019, 56(3):1104-1115 (herein after “Quan”).
Regarding claim 14, Quan discloses that eggs generally consist of three important parts: the yolk, the albumen or white, and the eggshell with the eggshell membrane (see pg. 1105, left column, last paragraph). Quan adds that the major proteins in duck albumen are ovalbumin, ovomucoid, ovomucin, conalbumin, and lysozyme (see pg. 1104, abstract). As such, Quan’s disclosure reads on a composition comprising a duck egg ovomucoid or a fragment thereof, as recited in instant claim 14.
Pursuant to MPEP 2111.02(I), any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation. See, e.g., Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 1966 (Fed. Cir. 1989). In the instant case, the term “pharmaceutical” does not limit the structure of the claimed composition comprising a duck egg ovomucoid or a fragment thereof.
Furthermore, with respect to the intended use of the claimed composition (i.e., prevents or inhibits a plasmin activity in a subject as compared to the plasmin activity in the subject in the absence of the pharmaceutical composition), the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See M.P.E.P. § 2112.02.
Moreover, “[t]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable.
As such, claim 14 can be deemed to recite an intended use of the claimed composition comprising a duck egg ovomucoid or a fragment thereof. A recitation of an intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Accordingly, since Quan discloses that duck egg comprises ovomucoid as one of the major proteins present in albumin; the intended use of a duck egg ovomucoid or a fragment thereof is also anticipated.
Regarding claims 20-22, Quan also discloses that the demand for duck meat and eggs in Asian countries increases every year and that duck egg albumen has become an important ingredient in the food industry, alongside its hen counterpart, because of its excellent nutritive and functional properties (see pg. 1104, abstract). Therefore, Quan’s disclosure is being interpreted as the oral ingestion or consumption of dug eggs/duck albumen by human subjects for its nutritive and functional properties. Therefore, Quan’s disclosure reads on the claimed composition (i.e., a duck egg ovomucoid or a fragment thereof) being administered to a human subject, thereby it also reads on a method of managing or inhibiting plasmin activity in a subject.
As previously mentioned, any terminology in the preamble that limits the structure of the claimed invention must be treated as a claim limitation. See, e.g., Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257, 9 USPQ2d 1962, 1966 (Fed. Cir. 1989). See MPEP 2111.02(I).
In the instant case, the preamble of claim 20, recites managing or inhibiting plasmin activity in a subject. Claim 20 is dependent upon claim 14, which is drawn to a composition comprising duck egg ovomucoid or a fragment thereof; Therefore the intended use of managing or inhibiting plasmin activity in a subject does not limit the structure of the claimed composition comprising a duck egg ovomucoid or a fragment thereof.
Additionally, the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See M.P.E.P. § 2112.02. In the instant case, management or inhibition of plasmin activity in a subject would be a result or property of consuming or ingesting a duck egg or duck egg albumin. Therefore the intended use of managing or inhibiting plasmin activity in a subject is also anticipated because it would result from a property of the claimed composition comprising a duck egg ovomucoid or a fragment thereof.
Accordingly, claims 14 and 20-22 are anticipated by Quan’s disclosure.
6. Claims 14-15 and 17-18, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RU 2639414 (C1) Published on 12/21/2017, Espacenet Machine Translation (cited in the IDS filed on 08/05/2024) (herein after “RU ‘414”); as evidenced by Pharma Excipients “Mannitol as Pharmaceutical Excipient” first available online on 12/08/2024 at https://www.pharmaexcipients.com/mannitol-pharmaceutical-excipient/, retrieved on 08/03/2026 (herein after “Pharma Excipients”).
Regarding claim 14, RU ‘414 discloses an antiproteinase preparation based on a proteinase inhibitor of protein nature - ovomucoid from duck egg protein, sodium chloride and water for injection, characterized in that it additionally contains mannitol (see RU ‘414, claim 1). Thereby, the instantly claimed pharmaceutical composition comprising a duck egg ovomucoid or a fragment thereof is anticipated by RU ‘414.
With respect to wherein the pharmaceutical composition prevents or inhibits a plasmin activity in a subject as compared to the plasmin activity in the subject in the absence of the pharmaceutical composition:
The MPEP 2112-2112.02 states that when a reference discloses all the limitations of a claim except for a property or function, and the Examiner cannot determine whether or not the reference inherently possesses properties which anticipate or render obvious the claimed invention but has basis for shifting the burden of proof to applicant as in In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). In the instant case, RU ‘414 discloses an antiproteinase preparation comprising ovomucoid from duck egg protein. The Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether or not the antiproteinase preparation comprising ovomucoid from duck egg protein prevents or inhibits a plasmin activity in a subject as compared to the plasmin activity in the subject in the absence of the pharmaceutical composition. The cited art taken as a whole demonstrates a reasonable probability that the antiproteinase preparation based on a proteinase inhibitor of protein nature ovomucoid from duck egg protein is either identical or sufficiently similar to the claimed pharmaceutical composition comprising a duck egg ovomucoid or a fragment thereof and that whatever differences exists are not patentably significant. Therefore, with the showing of the reference, the burden of establishing novelty or non-obviousness by objective evidence is shifted to the Applicants.
Additionally, with respect to the intended result (i.e., prevention or inhibition of a plasmin activity in a subject), the discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966). See MPEP § 2112.02. Moreover, “[t]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999).
Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. As such, claim 14 can be deemed to recite an intended use of the claimed composition comprising a duck egg ovomucoid or a fragment thereof. A recitation of an intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 15, RU ‘414 discloses administering the composition intravenously to Wistar rats at the rate of 10mg or ovomucoid per 1 kg of body weight (see pg. 5, para[0027]).
Regarding claim 17, RU ‘414 discloses that 10.0 g of ovomucoid was obtained under aseptic conditions, purified by ultrafiltration and feezed-dried from duck egg whites (see pg. 3, para[0016]).
Regarding claim 18, As previously mentioned, RU ‘414 discloses that the antiproteinase preparation based on a proteinase inhibitor of protein nature - ovomucoid from duck egg protein, additionally contains mannitol (see RU ‘414, claim 1).
As evidenced by Pharma Excipients, mannitol is widely used as an excipient in the pharmaceutical industry and is also used as a stabilizing agent for certain drugs, particularly proteins and peptides because it helps prevent denaturation and aggregation of these substances, maintaining their stability during storage (see pg. 2).
As such, RU ‘414’s composition comprising ovomucoid from duck egg anticipates the instantly claimed pharmaceutical composition recited in claims 14-15 and 17-18.
Conclusion
No claims are allowed.
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/CLAUDIA ESPINOSA/Patent Examiner, Art Unit 1654
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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