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 is a DIV of 17/420,411 filed on 07/02/2021, which is a 371 of PCT/US2020/013595 filed on 01/15/2020, which claims the benefit under 35 U.S.C 119 (e) to U.S. Provisional Application No. 62/792,650 filed on 01/15/2019. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C 119 (e) or under 35 U.S.C 120, 121, or 365 (c ) is acknowledged.
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).
For claim 1, regarding the scope of “treating an autoimmune disease in a subject”, it is noted that the instant specification does not define what constitutes “treating”. 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. The Britannica Dictionary defines “treat/treating” as to deal with (a disease, infection, etc.) in order to make someone feel better or become healthy again (see The Britannica Dictionary, definitions 4a and 4b, at https://www.britannica.com/dictionary/treat, pp. 1-2, accessed on 02/27/2026). As such, the Examiner is interpreting the scope of “treating” an autoimmune disease in a subject as dealing with an autoimmune disease by administering the claimed composition in order to make the subject feel better or become healthy again.
Response to Arguments
1. Applicants’ arguments, see Remarks, filed 06/09/2026, with respect to the 35 U.S.C. 112(a) rejection, have been fully considered and are persuasive. The 35 U.S.C. 112(a) (i.e., written description) of claims 1-5, 7-8, 11-17, 19-20 has been withdrawn.
2. Applicants’ arguments, see Remarks, filed 06/09/2026, with respect to the 35 U.S.C. 112(a) rejection, have been fully considered but are not persuasive. The 35 U.S.C. 112(a) (i.e., scope of enablement) of claims 1 and 6-20 has been maintained.
3. Applicants’ arguments, see Remarks, filed 06/09/2026, with respect to the 35 U.S.C. 103, have been fully considered and are persuasive. The 35 U.S.C. 103 of claims 1-5, and 14-17 has been withdrawn.
4. Applicants’ arguments, see Remarks, filed 06/09/2026, with respect to the 35 U.S.C. 103, have been fully considered and are persuasive. The 35 U.S.C. 103 of claims 1, 6-13 and 18-28 has been withdrawn.
5. Applicants’ arguments, see Remarks, filed 06/09/2026, with respect to the 35 U.S.C. 103, have been fully considered and are persuasive. The 35 U.S.C. 103 of claims 1, 6-13 and 18-28 has been withdrawn.
New Rejections Necessitated by Amendment
Improper Markush Grouping Rejection
1. Claim 22 rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of chronic inflammatory diseases is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the list of alternatives not only includes conditions/disorders, but also symptoms (i.e., allergic disorders, inflammation of the feet, period pain). Although the listed conditions/disorders all involve the body's immune response; the underlying triggers, dominant immune cells, chemical signals (cytokines/mediators), and target organs differ significantly. Accordingly, the Markush grouping is improper because the alternatives do not share a single structural similarity.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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.
2. Claims 1-5, 7-17, 19-22 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 2-5, 7-17, 19-22 are also indefinite because of their dependency upon a rejected claim.
Claim 1 has been amended to recite a composition consisting of two components (1) a glycated α-lactalbumin that has 1 to 12 glucose moieties, a glycated ß-lactoglobulin that has 1 to 16 glucose moieties, or a combination thereof; and (2) an optional nutraceutically acceptable carrier. However the presence of the second component, i.e., nutraceutically acceptable carrier, is optional and does not limit the claim to a particular structure. Thus the scope of a composition that comprises a glycated α-lactalbumin that has 1 to 12 glucose moieties, a glycated ß-lactoglobulin that has 1 to 16 glucose moieties, or a combination thereof, is limited to a glycated α-lactalbumin that has 1 to 12 glucose moieties, a glycated ß-lactoglobulin that has 1 to 16 glucose moieties. The optional presence of the nutraceutically acceptable carrier is not encompassed by the composition. Therefore, an ordinary skilled artisan would not be able to ascertain the metes and bounds of the claimed invention because the optional language causes ambiguity since the transitional phrase “consisting of” excludes any element that does not limit the structure of the composition.
3. Claims 19-20 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 19-20 are indefinite because of their claim dependency upon a canceled claim. Stated differently, the limitations recited in claims 19-20 require the base limitations of canceled claim 18.
4. Claim 22 is 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.
Regarding claim 22, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In the instant case, it is unclear whether the examples (i.e., rheumatoid arthritis, asthma, and systemic lupus erythematosus) of conditions/disorders such as arthritis, allergic disorders and autoimmune disorders are intended to be covered by the scope of the claim or correspond to preferred conditions to be treated. Therefore, the exemplary language makes the claim indefinite because the examples and/or preferences create confusion as to what the metes and bounds of the claim encompass.
5. Claim 22 is 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. Regarding claim 22, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Therefore, an ordinary skilled artisan would not be able to determine whether the Markush grouping (i.e., arthritis, sinusitis, psoriasis, acne, inflammatory bowel disease, chronic fatigue syndrome, Sjogren’s syndrome, inflammation of the prostate, inflammation of the urinary tract, pancreatitis, vasculitis, diabetes, inflammation of the feet including gout, and period pain) is intended to be covered by the scope of the claim or correspond to preferred chronic inflammatory diseases to be treated by the instantly claimed method.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
5. Claims 19-20 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 19-20, fail to include every limitation of the claim from which they depend. In other words, the claims include a reference to a previous canceled claim, therefore, the limitations recited in the instant claims are improper because content of claims 19-20 further limit nonexistent limitations. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
6. Claims 1, 7-17, and 19-21 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 claims 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.
Please note that claims 2-5 and 22 are not included in this rejection because these claims further limit claim 1 by including a species of autoimmune disease.
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 1 is drawn to a method for treating an autoimmune disease. The method comprises administering a composition consisting of a glycated a-lactalbumin, a glycated p-lactoglobulin, or a combination thereof, wherein the glycated α-lactalbumin has 1 to 12 glucose moieties, and the glycated ß-lactoglobulin has 1 to 16 glucose moieties. As such, the scope of the claimed method encompasses treating any autoimmune disease in a subject by administering the claimed composition. Therefore, the scope of claims 1, 7-17, 19-21 encompass a vast array of autoimmune diseases that can be treated with the claimed method.
Applicants reduced to practice two autoimmune diseases, i.e., T1D and autoimmune prostatitis, treated with the claimed composition, as shown in Examples 1 and 2. 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). The autoimmune conditions/diseases reduced to practice (i.e., T1D and autoimmune prostatitis) do not share a common core structure (i.e., underlying triggers, dominant immune cells, chemical signals (cytokines/mediators), and target organs); without an indication of a core structure, that would be necessary in order for the claimed composition to exhibit the claimed function of treating, it would be difficult for a skilled artisan to envision the correlation between structure and function for the whole genus of autoimmune diseases 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 autoimmune diseases that would be successfully treated with the claimed composition, 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. However, the state of the art pertaining to the treatment of an autoimmune diseases by administering a composition consisting of a glycated α-lactalbumin having 1 to 12 glucose moieties, a glycated ß-lactoglobulin having 1 to 16 glucose moieties, or a combination thereof is nonexistent. Therefore, there is no compelling evidence establishing that an autoimmune disease or any autoimmune disease can be successfully treated by administering a composition comprising a glycated α-lactalbumin, a glycated ß-lactoglobulin, or a combination thereof, wherein the glycated α-lactalbumin has 1 to 12 glucose moieties, and glycated ß-lactoglobulin has 1 to 16 glucose moieties.
Thus, the instantly claimed invention is directed to a method of treating a vast array of diseases with no correlated structure (i.e., underlying triggers, dominant immune cells, chemical signals (cytokines/mediators) and target organs/tissues) by administering the claimed composition. Furthermore, the specification fails to teach a representative number of species of autoimmune diseases successfully treated with the claimed composition. Thereby, the specification does not convey possession of the breadth of the claimed genus.
Alternatively, the written description requirement may be met by providing a representative number of species of the genus. Applicants reduce to practice two examples, wherein glycated whey proteins protected non- obese diabetic mice (NOD) against Type 1 Diabetes by increasing anti-inflammatory responses and decreasing autoreactivity to self-antigens (see instant specification, Example 1, pg. 17); and wherein chronic oral exposure to glycated whey proteins increases survival of aged male NOD mice with autoimmune prostatitis by regulating gut microbiome and anti-inflammatory responses (see instant specification, Example 2, pg. 31). The specification teaches that a solution containing whey protein isolate (WPI) and glucose was freeze-dried, and the powders were further incubated in sealed desiccator maintained at aw 0.53 and 55 °C for different durations; glycation markers were quantitated and the 8 h samples were determined as early glycation products (EGPs) (see instant specification, pg. 17, para[0081]). Consequently, after 8 h reaction, no original forms of α-La (i.e., α-lactalbumin) or ß-Lg (i.e., ß-lactoglobulin) remained (see instant specification, pg. 22, para[0105] and Fig. 1 B, lower panel). All the α-La reacted with 3-11 glucoses, with the 6-glucose attached α-La being the most abundant and the average degree of substitution per protein (DSP) of 7.2 (see instant specification, pg. 22, para[0105]). Both variants of ß-Lg were attached by 5-15 glucoses; the 10-glucose attached form was the most abundant and the average DSP was 9.7 for both variants (see instant specification, pg. 22, para[0105]). As such, the specification only teaches treating two autoimmune diseases (i.e., T1D and autoimmune prostatitis) with α-La glycated/reacted with 3-11 glucoses and with ß-Lg glycated/reacted with 5-15 glucoses.
Thus, evidence of two positive integrant and replicative experiments of is not sufficient for the skilled artisan to envisage what constitutes treating any autoimmune disease in a subject by administering the claimed composition. Accordingly, claims 1, 7-17, and 19-21 do not meet the written description requirement.
Maintained/Modified Rejections in light of Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
7. Claims 1, 7-17 and 19-22 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 treating type 1 diabetes and autoimmune prostatitis, by administering to the subject a composition comprising α-La reacted with 3-11 glucoses with the 6-glucose attached α-La being the most abundant and the average DSP of 7.2; and variants of ß-Lg (i.e., ß-Lg variant B and ß-Lg variant A) reacted with 5-15 glucoses with the 10-glucose attached form as the most abundant and the average DSP of 9.7 for both variants; does not reasonably provide enablement for treating an autoimmune disease in a subject comprising administering to the subject a composition consisting of (1) a glycated α-La, a glycated ß-Lg, or a combination thereof and (2) an optional nutraceutically acceptable carrier, wherein the glycated α-lactalbumin has 1 to 12 glucose moieties, and the glycated ß-lactoglobulin has 1 to 16 glucose moieties. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
As stated in MPEP §2164.01(a), “there are many factors to consider when determining
whether there is sufficient evidence to support a determination that a disclosure does not satisfy
the enablement requirement and whether any experimentation is ‘undue’.” These factors
include, but are not limited to:
1.The breadth of the claims;
2.The nature of the invention;
3.The state of the prior art;
4.The level of skill in the art;
5.The level of predictability in the art;
6.The amount of direction provided by the inventor;
7.The presence or absence of working examples;
8.The quantity of experimentation needed to make or use the invention based on the disclosure.
See In re Wands USPQ 2d 1400 (CAFC 1988).
The eight In re Wands factors are applied to claims 1, 7-17 and 19-22 as follows:
Breadth of the Claims and the Nature of the Invention
Claims 1, 7-17 and 19-22 are drawn to a “method for treating an autoimmune disease in a subject …” The Applicant claims treating any autoimmune disease by administering to the subject a composition consisting of (1) a glycated α-lactalbumin, a glycated ß-lactoglobulin, or a combination thereof and (2) an optional nutraceutically acceptable carrier, wherein the glycated α-lactalbumin has 1 to 12 glucose moieties and the glycated ß-lactoglobulin has 1 to 16 glucose moieties.
The instant specification teaches that when early glycation products were administered to two T1D mice models (MLD-STZ model and Non-Obese Diabetic (NOD) model), one or more symptoms of T1D were reduced or ameliorated. For instance, the specification at pg. 26, para[0119] recites that NOD males and females showed decreased and stabilized non-fasting blood glucose levels (BGLs), increased glucose metabolism during glucose tolerance test (GTT) and increased insulin sensitivity during insulin tolerance test (ITT), which were accompanied with reduced pancreatic immune infiltrates. The specification also discusses that in the STZ-induced T1D model, which is much less immune-dependent, the protective effect of EGPs against T1D diminished, thus suggesting that early glycation products were likely to exert their effect through modulating the immunity (see pg. 26, para[0119-0120]).
With respect to the second autoimmune disease reduced to practice (i.e., autoimmune prostatitis), the specification teaches that chronic exposure to glycated whey protein alleviated autoimmune prostatitis and increased the survival rate in aged NOD male mice, thus extending the potential application of EGPs from T1D to a broader spectrum of autoimmune diseases (see pg. 40, para[0167]). Since exposure to EGPs increases the survival rate and moderately reduces the prostatic inflammation in NOD mice with autoimmune prostatitis, alters the systemic immunity and modulate gut microbiome (see pg. 34, para[0145, 0149, 0153]). However, Applicants failed to provide evidence in the specification that a composition consisting of (1) a glycated α-Lactalbumin, a glycated ß-lactoglobulin, or a combination thereof and (2) an optional nutraceutically acceptable carrier, wherein the glycated α-lactalbumin has 1 to 12 glucose moieties, and the glycated ß-lactoglobulin has 1 to 16 glucose moieties can treat any autoimmune disease in a subject. Accordingly, claims 1, 7-17 and 19-22 are unduly broad with respect to treating any autoimmune disease.
The State of the Prior Art
Administering a glycated α-lactalbumin, a glycated ß-lactoglobulin or a combination thereof wherein the wherein the glycated α-lactalbumin has 1 to 12 glucose moieties, and the glycated ß-lactoglobulin has 1 to 16 glucose moieties; is not the standard of care for treating an autoimmune disease; let alone any autoimmune disease. The prior art teaches that although there are treatments to slow down the progression of autoimmune diseases, there is currently no cure (see Institut Pasteur, “Autoimmune diseases: when our defenses turn against us” in The Research Journal, 04/03/2018, retrieved from https://www.pasteur.fr/en/home/research-journal/reports/autoimmune-diseases-when-our-defenses-turn-against-us on 3/04/2026, pp. 1-16, at pg. 2). Instead most autoimmune diseases are treated by methods to control and reduce the immune and inflammatory responses (see Institut Pasteur, pg. 10, second paragraph). For instance, corticosteroids, known for their anti-inflammatory properties, are the standard therapy but can have harmful long-term effects. Immunosuppressive drugs such as cyclosporine, also used to prevent organ rejection in transplant patients, may be administered. But by suppressing the autoimmune reaction, they also reduce the body's ability to defend against microorganisms (bacteria, viruses, etc.) or to eliminate cancer cells. This risk of developing infection or cancer means that patients need to be carefully monitored (see Institut Pasteur, pg. 10, second paragraph). Other methods of treatment include lifestyle and diet changes which can help improve the condition (see University of Kansas Health Systems, “6 Diet Tips for Healing from Autoimmune Disease”, 2017retrieved from https://www.kansashealthsystem.com/news-room/blog/2017/02/autoimmune-disease-diet, on 3/4/2026, pp. 1-2).
Furthermore, it is noted that there is no current prior art that teaches administering a composition consisting of (1) a glycated α-lactalbumin, a glycated ß-lactoglobulin or a combination thereof for treating an autoimmune disease in a subject. Accordingly, the prior art demonstrates that the scope of claims 1, 7-17 and 19-22 encompass treating any autoimmune disease that would require undue experimentation given that to date, autoimmune diseases are not treated with glycated α-lactalbumin, a glycated ß-lactoglobulin or a combination thereof, wherein the wherein the glycated α-lactalbumin has 1 to 12 glucose moieties, and the glycated ß-lactoglobulin has 1 to 16 glucose moieties.
The Level of Skill in the Art
Practitioners in this art (medical clinicians, pharmacists, doctors and/or pharmaceutical
chemists) would presumably be highly skilled in the art for prevention of an autoimmune disease in a subject.
The Level of Predictability in the Art
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)). In the instant case, Applicants do not demonstrate that a composition consisting of (1) a glycated α-lactalbumin that has 1 to 12 glucose moieties, a glycated ß-lactoglobulin that has 1 to 16 glucose moieties or a combination thereof and (2) an optional nutraceutically acceptable carrier, administered to a subject is an effective method for treating an autoimmune disease. Rather, Applicants only demonstrate that early glycation products (i.e., α-La glycated/reacted with 3-11 glucoses and with ß-Lg glycated/reacted with 5-15 glucoses, averaging 6 glucose moieties per glycated to α-La and 10 glucose moieties per glycated ß-Lg) administered to mice is capable of ameliorating/reducing the symptoms of T1D and autoimmune prostatitis in NOD mice, but fail to demonstrate that a composition comprising a glycated α-Lactalbumin, a glycated ß-Lactoglobulin or a combination thereof administered to a subject treats an autoimmune disease in a subject. Applicants appear to rely on the assumption that by providing evidence early glycation products (i.e., α-La glycated/reacted with 3-11 glucoses and with ß-Lg glycated/reacted with 5-15 glucoses, averaging 6 glucose moieties per glycated to α-La and 10 glucose moieties per glycated ß-Lg) reduce disease symptoms in mice would exhibit similar intended results for the treatment of any autoimmune disease in a subject. However, such an assumption cannot be made because there is no indication that a composition consisting of (1) a glycated α-Lactalbumin having 1 to 12 glucose moieties, a glycated ß-Lactoglobulin having 1 to 16 glucose moieties, or a combination thereof would exhibit such results.
Additionally, since the Specification fails to demonstrate any data or evidence that the claimed composition treats any autoimmune disease in a subject, there would be no way of determining without undue experimentation whether the claimed method comprising administering a composition consisting of a glycated α-Lactalbumin, a glycated ß-Lactoglobulin or a combination thereof wherein the glycated α-lactalbumin has 1 to 12 glucose moieties, and the glycated ß-lactoglobulin has 1 to 16 glucose moieties exhibits such a desired result. Without more experimentation demonstrating the efficacy of the claimed method for treating any autoimmune disease, the level of unpredictability remains high. Therefore, it is unpredictable that the claimed composition will treat an autoimmune disease in a subject.
The Amount of Direction Provided by the Inventor and The Presence or Absence of Working Examples
The specification does not enable any person skilled in the art to which it pertains (i.e. treating any autoimmune disease by administering a composition consisting of a glycated α-Lactalbumin, a glycated ß-Lactoglobulin or a combination thereof to a subject) to make and/or use the invention commensurate in scope with the claims. There is a lack of adequate guidance from the specification or prior art with regard to the actual treatment of an autoimmune disease by administering to a subject the claimed composition. Applicants fail to provide the guidance and information required to ascertain where the claimed composition consisting of a glycated α-Lactalbumin that has 1 to 12 glucose moieties, a glycated ß-Lactoglobulin that has 1 to 16 glucose moieties, or a combination thereof will be effective in treating any autoimmune disease without resorting to undue experimentation.
Absent a reasonable a priori expectation of success for using the claimed composition to treat any autoimmune disease, one skilled in the art would have to extensively test the efficacy of a glycated α-Lactalbumin that has 1 to 12 glucose moieties, a glycated ß-Lactoglobulin that has 1 to 16 glucose moieties or a combination thereof in vitro and in vivo. Since each prospective embodiment, and indeed future embodiments as the art progresses, would have to be empirically tested, and those which initially failed tested further, an undue amount of experimentation would be required to practice the invention as it is claimed in its current scope because the specification provides inadequate guidance to do otherwise.
The amount of direction or guidance presented in the specification is very limited. The Specification discloses two working examples where a composition c comprising α-La reacted with 3-11 glucoses with the 6-glucose attached α-La being the most abundant and the average DSP of 7.2; and variants of ß-Lg (i.e., ß-Lg variant B and ß-Lg variant A) reacted with 5-15 glucoses with the 10-glucose attached form as the most abundant and the average DSP of 9.7 for both variants or a combination thereof administered to mice demonstrated improved disease activity based on a reduction in bodyweight loss, blood glucose levels and/or measurement of key cytokines involved in inflammation and immune regulation (see Specification, Example 1 and 2). For Example 1, the data indicated that oral intake of whey protein isolates (WPI) derived EGPs delayed the T1D onset in NOD females through modulating the immunity, and that EGP consumption reduced CD8+ T cells and IAAs, and increased IL-10, CD4+CD25+ regulatory T cells and the anti-inflammatory responses by shifting M2/M1 balance toward M2 (see instant specification, pg. 28, para[0124]). Therefore although delayed, the occurrence of the autoimmune disease persisted. Additionally, delaying the onset of an autoimmune disease does not translate to treating an autoimmune disease. Similarly, for Example 2, the data revealed that chronic exposure to EGPs increases the survival rate and moderately reduces the prostatic inflammation (see instant specification, pg. 33, para[0145] and pg. 40, para[0167]). However the data does not translate to dealing and/or fixing an underlying autoimmune disease, and a moderate reduction in inflammation is not the same as treating any autoimmune disease. Therefore, a person of ordinary skill in the art would reasonably require an undue quantity of experimentation.
The Quantity of Experimentation Needed
In light of the unpredictability surrounding the claimed subject matter, the breadth of the claimed invention, and the lack of adequate guidance, one wishing to practice the presently claimed invention would be unable to do so without engaging in undue experimentation. To practice the presently claimed invention, one would have to gather additional data and perform experimentation to determine whether the claimed composition is capable of treating any autoimmune disease in a subject. Additional experimentation may include, but is not limited to, performing additional analysis in animal models as well as performing clinical trials in subjects.
Conclusion of 35 U.S.C. 112(a) (Enablement) Analysis
MPEP §2164.01(a), 4th paragraph, provides that, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1157, 1562; 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Genentech Inc. v. Novo Nordisk A/S, 42 USPQ2d 1001, 1005 (CA FC), states that, “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable,” citing Brenner v. Manson, 383 U.S. 519, 536 (1966) (stating, in the context of the utility requirement, that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion”). The Genentech decision continued, “tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” Id. at p. 1005.
After applying the Wands factors and analysis to claims 1, 7-17 and 19-22, in view of Applicants’ 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 1, 7-17 and 19-22, would not be enabled by the written disclosure excluding that of treating T1D and autoimmune prostatitis in aged male NOD mice by administering the claimed composition, where treating comprises delaying the onset of T1D and alleviating or moderately reducing inflammation of prostatic inflammation.
Accordingly, claims 1, 7-17 and 19-22 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 treat an autoimmune disease, let alone to treat any autoimmune disease by administering the claimed composition to a subject.
Response to Arguments
Applicant's arguments filed 06/09/2026 with respect to the 35 U.S.C 112(a) rejection of claims 1 and 6-20 have been fully considered but are not persuasive.
It is acknowledged that claim 1 has been amended to omit the reference to “preventing” an autoimmune disease. However the lack of enablement to use the claimed invention still persists because the claims contain subject matter (i.e., treating an autoimmune disease or any autoimmune disease) which was not described in the specification. Accordingly, the 35 U.S.C 112(a) rejection, has been maintained and modified accordingly.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CLAUDIA ESPINOSA/Patent Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654
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