The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The amendment filed on 2-24-2026 is acknowledged. Claims 13, 28, 35, 38-40 and 48-89 have been amended. Claims 14 and 15 have been canceled. Claims 52-53 have been added. Claims 3, 8-9, 12-13, 16, 23-25, 28-29, 31-33, 35-36 and 38-53 are pending. In light of the amendments claim 24 is hereby rejoined. Consequently, claims 12-13, 16, 29, 31-33 and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 3, 8-9, 23, 24-25, 28, 35, 38-46 and 48-53 are currently under examination.
New Claim Objections
Claim 35 is objected to for containing an obvious grammatical error. The phrase “…reduces severity of…” should read “…reduces the severity of…”.
Claim 53 is objected to for containing an obvious punctuation error. The phrase “…reduces the severity of the adrenal cortex, chest glioma of the optical nerve, heart, spine, spleen…” Should read “…reduces the severity of the adrenal cortex, chest, glioma of the optical nerve, heart, spine, spleen…”.
Claim Rejections Withdrawn
The rejection of claim 14 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph recites for lacking proper antecedent basis for the limitation "wherein the condition associated with hyperproliferative cellular division is…" in lines 1-2 is withdrawn. Cancellation of said claim has rendered the rejection moot. There is insufficient antecedent basis for this limitation in the claim.
The rejection of claim 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph recites for lacking proper antecedent basis for the limitation "wherein the condition associated with hyperproliferative cellular division is…" in lines 1-2 is withdrawn. Cancellation of said claim has rendered the rejection moot. There is insufficient antecedent basis for this limitation in the claim.
The rejection of claim 28 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “… wherein the composition cis-7,10,13,16-Docosatetraenoic acid, trimethylsilyl ester; 9,12-Octadecadienoic acid (Z,Z)-, trimethylsilyl ester; trans-9-Octadecenoic acid, trimethylsilyl ester; octadecanoic acid, trimethylsilyl ester; a sterol; galacturonic acid; glucosamine; glucose; arabinose; palmitic acid; oleic acid; palmitoleic acid; myristic acid; stearic acid; G-15; G-17; lauric acid; or derivatives thereof, optionally, amidation or acetylation derivatives thereof.” is withdrawn in light of the amendment thereto.
The rejection of claim 35 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…wherein the composition at least one of mitigate…” is withdrawn in light of the amendment thereto.
The rejection of claim 35 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…reduces a severity…” is withdrawn in light of the amendment thereto.
The rejection of claim 40 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being rendered vague and indefinite by the use of the phrase “…a non-infectious dead extract of Actinomyces bovis…” is withdrawn in light of the amendment thereto.
The rejection of claim 48 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for lacking proper antecedent basis for the limitation "the lipopolysaccharide” in line 1 is withdrawn in light of the amendment thereto.
Claim Rejections Maintained
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.
Claims 24, 35, 39 and 51-53 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 is maintained for the reasons set forth in the previous Office action in the rejection of claims 14-15, 35 and 39. 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.
Applicant argues:
1. Applicant has amended claims 35 and 38 to recite 16 of the specific cancers that were shown in the declaration of Eroca Daniel previously submitted on July 18, 2024, to be effectively treated with the disclosed compositions. In addition, claims 52 and 53 have been added herein to recite an additional seven specific cancers that were shown in the declaration of Eroca Daniel previously submitted on July 18, 2024, to be effectively treated with the disclosed compositions.
Applicant’s arguments have been fully considered and deemed non-persuasive.
With regard to Point 1, the amendment is insufficient to overcome the rejection. Applicant’s arguments are predicated on the declaration by Eroca Daniel filed on 7-18-2024. Said declaration is limited to the use of the composition “referred to in the specification as Protein B” but fails to disclose the methodologies by which said “Protein B” was obtained. The specification discloses two differing methods, utilizing differing immunogens, to obtain compositions comprising “Protein B” (see Examples 1 and 2). Both Examples, while using differing immunogens, utilize multiple specific “separation/extraction” methods. The instant claims have no limitation with regard to pretreatment of the animal or the specific “separation/extraction” methods required to obtain the claimed therapeutic composition. The in vivo data disclosed in the specification is limited to the therapeutic use of a single compound (PB-LPN) which is the result of very specific methodologies outlined in Examples. Said composition appears to be so unique that Applicant maintains a sample in private depository (see paragraph [0129]). Given, the lack of clarity with regarding what constitutes the “Protein B” utilized in the treatment protocols described by the declarant, the declaration cannot be relied upon for providing proper description of the rejected claims.
As outlined previously, the rejected claims are drawn to methods of producing compositions for the treatment bone, brain, breast, colon, kidney, leukemia, liver, lung, lymph nodes, melanoma, ovary, pancreas, prostate, rectum, testicle, or uterine carcinoma (claim 35 and 39); or of conditions associated with hyperproliferative cellular division (claim 51); or exhibits cytotoxic activity towards the adrenal cortex, chest glioma of the ocular nerve, heart, spine, spleen or stomach carcinoma; wherein said compositions IgE containing fractions of a blood sample from horses inoculated with Actinomyces bovis. The claims optionally require the composition is substantially non-toxic to non-cancerous cells (claim 24) or is formulated for the treatment of the adrenal cortex, chest glioma of the ocular nerve, heart, spine, spleen or stomach carcinoma and wherein the fraction comprising IgE exhibits cytotoxic activity towards cells exhibiting conditions associated with hyperproliferative cellular division (claim 52).
Consequently, the rejected claims minimally encompass the use a myriad of extraction products produced utilizing a multitude of undefined extraction processes wherein said extraction products have efficacy in treating an untold number of diseases, conditions and symptoms.
To fulfill the written description requirements set forth under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. To adequately describe the genus of therapeutic compositions, Applicant must adequately describe the specific reagents and method steps used to “extract” a therapeutic composition with efficacy against a given type of cancer. The specification discloses the methodology for producing a single composition (PB-LPN) comprising IgE antibodies (which were demonstrated to have antitumor effects against breast cancer xenografts in mice models) raised in either full or part blood Arabian horses that have been primed with an unidentified Aspergillus species and subsequently inoculated ten days later with Actinomyces bovis (see Example 2). However, methodologies disclosed for the production of the PB-LPN are not encompassed by the rejected claims nor does the specification outline any other methodologies by which said composition can be produced. While the specification discloses methods for the preparation of a L-S product (see Example 1), it is silent with regard to any immunological efficacies of said product. Consequently, the specification does not disclose distinguishing and identifying features of a representative number of members of the genus of therapeutic compositions to which the claims are drawn, such as a correlation between the structure/identity of the active ingredient that elicit a specific therapeutic immune response so that the skilled artisan could immediately envision, or recognize at least a substantial number of members of the claimed genus therapeutic compositions.
MPEP § 2163.02 states, “[a]n objective standard for determining compliance with the written description requirement is, 'does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed' ”. The courts have decided:
The purpose of the “written description” requirement is broader than to merely explain how to “make and use”; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the “written description” inquiry, whatever is now claimed.
See Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
MPEP 2163.02 further states, “[p]ossession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention” See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was “ready for patenting” by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed.
Additionally, MPEP 2163 states:
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”
And:
For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date." See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014) (Holding that claims to all human antibodies that bind IL-12 with a particular binding affinity rate constant (i.e., koff) were not adequately supported by a specification describing only a single type of human antibody having the claimed features because the disclosed antibody was not representative of other types of antibodies in the claimed genus, as demonstrated by the fact that other disclosed antibodies had different types of heavy and light chains, and shared only a 50% sequence similarity in their variable regions with the disclosed antibodies.).
Given, the specification specific provides no guidance with regard to the inoculation and extraction processes that would lead to a composition (other than the PB-LPN compositions) with efficacy in treating any of the maladies encompassed by the instant claims and because the art is unpredictable, only the PB-LPN composition (and the specific methods of producing it as exemplified in Example 2), but not the full breadth of the claims meet the written description provision of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph.
New Grounds of Rejection
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.
Claims 35, 39, 51-52 and 53 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.
The term “substantially” in claim 24 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 35 is rendered vague and indefinite by the use of the phrase “…reduces the severity of the bone, brain, breast, colon, kidney, leukemia, liver, lung, lymph nodes, ovary, pancreas, prostate, rectum, testicle or uterine carcinoma.”. It is unclear what is meant to be engendered by said phrase. What constitutes the “severity” of bone, brain, breast, colon, kidney, liver, lung, lymph nodes, ovary, pancreas, prostate, rectum and testicle? As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 39 is rendered vague and indefinite by the use of the phrase “…exhibits cytotoxic activity towards the bone, brain, breast, colon, kidney, leukemia, liver, lung, lymph nodes, ovary, pancreas, prostate, rectum, testicle or uterine carcinoma.”. It is unclear what is meant to be engendered by said phrase as the specification is drawn to the use of IgE fractions to treat various cancers. It is unclear why one would target the bone, brain, breast, colon, kidney, liver, lung, lymph nodes, ovary, pancreas, prostate, rectum or testicle of a healthy individual? As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 51 is rendered vague and indefinite by the use of the phrase “…a non-infectious dead extract of Actinomyces bovis…”. It is unclear what is meant to be engendered by said phrase as all extracts are necessarily “dead” and “non-infectious”. Moreover, it is unclear whether the extract of Actinomyces bovis is an additional component of the inoculant or the sole antigenic portion of the inoculant. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 52 is rendered vague and indefinite by the use of the phrase “…exhibits cytotoxic activity towards the adrenal cortex, chest glioma of the optical nerve, heart, spine, spleen or stomach carcinoma.”. It is unclear what is meant to be engendered by said phrase as the specification is drawn to the use of IgE fractions to treat various cancers. It is unclear why one would target the adrenal cortex, chest, heart, spine or spleen of a healthy individual? As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 53 is rendered vague and indefinite by the use of the phrase “…reduces the severity of the adrenal cortex, chest glioma of the optical nerve, heart, spine, spleen…”. It is unclear what is meant to be engendered by said phrase. What constitutes the “severity” of the adrenal cortex, chest glioma of the optical nerve, heart, spine, spleen? As written, it is impossible to determine the metes and bounds of the claimed invention.
Conclusion
Claims 3, 8-9, 23, 25, 28, 35, 38 and 40-50 are allowed.
Claims 24, 35, 39 and 51-53 are rejected.
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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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 March 18, 2026