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 .
Claims 2, 4, 7-9, 12, 14-23, 26-28, 31, 35-37, 39-42, 44-50, 52-56 and 60-66 have been cancelled. Claims 1, 3, 5-6, 10-11, 13, 24-25, 29-30, 32-34, 38, 43, 51 and 57-59 are pending.
The information disclosure statements filed 2/14/25, 4/17/2026 and 8/17/26 have been considered and initialed copies are enclosed.
Election/Restrictions
Applicant’s election of Group I, claims: 1, 3, 5-6, 10-11, 13, 24-25, 29-30 and 32-34, and the species a) P. multocida from serogroup A; b) the PmSLP-1 as the selected phylogenic cluster; and 1) SEQ ID NO:13, encoding the PmSLP-1 of SEQ ID No:14, as the nucleic acid and protein sequences. in the reply filed on 7/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants’ reply does not state which claims read on the elected species.
Claims 38, 43, 51 and 57-59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/17/2026..
Claim Objections
Claims 3 and 11 are objected to because of the following informalities:
In claim 3, please spell out the full meaning of “PmSLP”.
In claim 11, the limitation of part d and part f is repeated.
Appropriate correction is required.
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.
Claim 10 is 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.
Claim 10 is drawn to new matter. This is because the original specification and claims as filed does not disclose that the vaccine formulation according to claim 1 further comprises a P. multocida strain.
Claims 1, 3, 5, 6, 10, 11, 13, 24, 25, 29-30 and 32-34 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.
The claims are drawn to a veterinary vaccine formulation for the prevention, treatment or amelioration of P. multocida infection in a ruminant animal susceptible to P. multocida infection, the vaccine formulation comprising an effective amount of at least one PmSLP protein, or an immunogenically equivalent portion thereof, together with a veterinary pharmaceutically acceptable excipient, carrier, or diluent, and, optionally, a veterinary pharmaceutically acceptable adjuvant.
The specification discloses that the terms “PmSLP protein” or “PmSLP polypeptide”, as may be used herein, interchangeably refer to any and all protein comprising a sequence of amino acid residues which is (i) substantially identical to the amino acid sequences constituting any PmSLP polypeptide set forth herein, including, for example, SEQ.ID NO: 2, or (ii) encoded by a nucleic acid sequence capable of hybridizing under at least moderately stringent conditions to any nucleic acid sequence encoding any PmSLP protein set forth herein, but for the use of synonymous codons. PmSLP proteins may also be numbered in order to facilitate distinguishing different PmSLP proteins referred to herein, e.g., PmSLP-1, PmSLP-2, PmSLP-3, and so on.
The specification defines the term “substantially identical” to mean that two amino acid sequences preferably are at least 70% identical, and more preferably are at least 85% or 90% identical, and most preferably at least 95% identical, for example 96%, 97%, 98%, 99%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9% identical.
The specification disclose that at least moderately stringent hybridization conditions” it is meant that conditions are selected which promote selective hybridization between two complementary nucleic acid molecules in solution. Hybridization may occur to all or a portion of a nucleic acid sequence molecule. The hybridizing portion is typically at least 15 (e.g., 20, 25, 30, 40 or 50) nucleotides in length. See paragraph 170 of the specification.
The claims are drawn a very large and variant genus of PmSLP proteins wherein the genus comprises species that substantially identical to the amino acid sequences constituting any PmSLP polypeptide set forth in the specification, for example but not limited to sequences that are at least 70% identical (see definition above); encoded by a nucleic acid sequence capable of hybridizing under at least moderately stringent conditions to any nucleic acid sequence encoding any PmSLP protein set forth herein, but for the use of synonymous codons and also immunogenically equivalent portion thereof.
A nucleic acid sequence capable of hybridizing under at least moderately stringent conditions to any nucleic acid sequence encoding any PmSLP protein will be a complement to said nucleic acid sequence. The specification does not disclose that the genus of complements encode a PmSLP protein.
The genus of PmSLP proteins also encompasses functional variants which encompasses modified a polypeptide wherein, relative to a noted reference polypeptide, the modification includes a substitution, deletion, or addition of one or more amino acids.
In addition, the PmSLP proteins are encoded by nucleic acid sequences having a least 70% identity to nucleic acid sequences encoding the disclosed PmSLP proteins; encoded a nucleic acid that is substantially identical to said nucleic acid sequences but for the degeneration of the genetic code; encoded by nucleic acid sequence that is complementary the said nucleic acid sequence; encoded by chimeric nucleic acid sequences obtained by a fusion between at least two nucleic acid sequences of the above or a portion thereof; and nucleic acid sequences that encode a functional variant of any of the PmSLP amino acid sequences.
Similarly to the proteins, the claims are drawn to a large genus of nucleic acid species encoding PmSLP proteins or variants thereof and the species are highly variant from one another, for example, at least 70% identity, a nucleic acid that is substantially identical to said nucleic acid sequences but for the degeneration of the genetic code; encoded by nucleic acid sequence that is complementary the said nucleic acid sequence; encoded by chimeric nucleic acid sequences obtained by a fusion between at least two nucleic acid sequences of the above or a portion thereof; and nucleic acid sequences that encode a functional variant of any of the PmSLP amino acid sequences.
The claims requires that the members of the genus of proteins function as a veterinary vaccine for the prevention, treatment or amelioration of P. multocida infection and the genus of nucleic acid sequence comprises members that encode a protein can function as a veterinary vaccine for the prevention, treatment or amelioration of P. multocida infection.
The specification reduces to practice PmSLP variants which separated into five discrete clusters (PmSLP-1, PmSLP-2, PmSLP-3, and PmSLP-4.1, and PmSLP-4.2). BRD-PmSLP variants represent two of the four major clusters (PmSLP-1 and PmSLP-2) while HS-PmSLP variants represent a single cluster (PmSLP-3). BRD-PmSLP variants were predominantly isolated from samples originating from North America or Europe, while HS-PmSLP variants were primarily isolated from samples originating from Asia and Africa.
PmSLP sequences for each cluster include PmSLP-1 (e.g., SEQ.ID NO: 2) from cluster PmSLP-1, PmSLP-2 (e.g., SEQ.ID NO: 4) from cluster PmSLP-2, PmSLP-3 (e.g., SEQ.ID NO: 6) from cluster PmSLP-3, PmSLP-4.1 (e.g., SEQ.ID NO: 8) from cluster PmSLP-4.1, and PmSLP-4.2 (e.g., SEQ.ID NO: 10) from cluster PmSLP-4.2. PmSLP-1 is at minimum 99.7% identical to the cluster PmSLP-1 sequences. PmSLP-2 is at minimum 99.7% identical to the cluster PmSLP-2 sequences and on average 100.0% identical to the cluster PmSLP-2 sequences. PmSLP-3 is at minimum 93.9% identical to cluster PmSLP-3 sequences and on average 99.4% identical to the cluster PmSLP-3 sequences. PmSLP-4.1 is at minimum 99.7% identical to the cluster PmSLP-4.1 sequences and on average 99.8% identical to the cluster PmSLP-4.1 sequences. PmSLP-4.2 is at minimum 96.8% identical to the cluster PmSLP-4.2 sequences and on average 97.2% identical to the cluster PmSLP-4.2 sequences.
The immunogenicity of PmSLP-1 protein (SEQ ID NO: 14) formulated with various adjuvants were administered to 4-6-week-old C57BL/6 mice. All five vaccine formulations were able to elicit PmSLP-1 specific IgG in serum after just one dose, and the IgG titre was further augmented after the second dose.
The vaccine formulation was used to immunize and then challenge mice with a P. multocida isolate that harbours a different PmSLP gene but from the same phylogenetic cluster as the PmSLP-1 protein included in the vaccine.
PmSLP-1 (SEQ.ID NO: 14) was formulated as a vaccine using 20 μg of protein mixed with Montanide™ Gel 02 (Seppic) combined with Poly (I:C) (Invivogen) to a final volume of 100 μl per dose. 4-6-week-old male C57Bl/6 mice (Charles River) were given two doses of vaccine at three-week intervals via sub-cutaneous injection. Pre-challenge bleeds were collected prior to infection.
Two weeks after the second dose, anaesthetized animals were challenged via intra-peritoneal injection with approximately 10^4 CFU of log-phase P. multocida strain H246 (antigen-matched BRD isolate, the confirmed sequence of the PmSLP in this strain is defined in SEQ.ID NO: 22. Strain H246 is a serogroup A strain.). It is noted that SEQ.ID NO: 14 and SEQ.ID NO: 22 exhibit a sequence identity of 100% over the portion of the antigen contained in the immunizing protein.
All mice that received the PmSLP-1 vaccine survived the infection, compared to all animals that received only adjuvant which reached endpoint between 24 and 32 hours post infection.
The formulation did not prevent infection by the challenge strain as evidenced by figure 4E as evidenced by the presence of the challenge strain in the blood a few hours post infection. 100% of the animals receiving the formulation survived (figure 4A). Similar results was obtained for PmSLP-2 and PmSLP-3 as set forth in the examples.
The disclosure of PmSLP-1, PmSLP-2, PmSLP-3, PmSLP-3, PmSLP-4.1, and PmSLP-4.2 is not representative of the very large and variant genus of PmSLP proteins and the corresponding large and variant genus of nucleic acid sequences which encode members of the genus of said PmSLP proteins. There is no reduction to practice of immunogenically equivalent portions, functional variants, proteins encoded by the complement encoding any of PmSLP-1, PmSLP-2, PmSLP-3, PmSLP-3, PmSLP-4.1, and PmSLP-4.2 and all the variants included in the definition of PmSLP that function to prevent or treat or ameliorate P. multocida infection.
The definition of treating and treatment encompasses the prevention (i.e., prophylactic treatment), inhibition, amelioration, attenuation, reversal of a sign, symptom or cause of a disorder, or disease, attributable to the disorder, or disease. See paragraph 185.
Further experiments would be required to screen for said other members of the genus of PmSLP protein variants including immunogenically equivalent portion thereof and members of the genus of encoding nucleotide sequences encoding PmSLP protein variants including immunogenically equivalent portion thereof for which proteins can prevent, provide treatment and ameliorate P. multocida infection. The written description provision of 35 U.S.C. § 112 are severable from its enablement provision (see page 1115). Vas-Cath, Inc. v. Mahurkar. "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”. Vas-Cath, Inc. v. Mahurkar, 80USPQ2d 1111. “Without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement”. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Further, possession may not be shown by merely describing how to obtain members of the claimed genus or how to identify their common structural features. See University of Rochester, 358 F.3d at 927, 69USPQ2d at 1895.
For these reasons, Applicants as of the effective filing date were not in possession of the genus of PmSLP proteins including immunogenically equivalent portion thereof that function to prevent or provide treatment or ameliorate P. multocida infection.
Claims 1, 3, 5, 6, 10, 11, 13, 24, 25, 29-30 and 32-34 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 an immunogenic formulation comprising an effective amount of at least one PmSLP protein wherein the PmSLP proteins are PmSLP-1, PmSLP-2, PmSLP-3, PmSLP-4.1 and PmSLP-4.2, together with a veterinary pharmaceutically acceptable excipient, carrier, or diluent, and, optionally, a veterinary pharmaceutically acceptable adjuvant wherein the immunogenic formulation after being administered to a ruminant animal improves the survival of the ruminant animal upon challenge with P. multocida, does not reasonably provide enablement for a veterinary vaccine formulation for the prevention, treatment or amelioration of P. multocida infection in a ruminant animal susceptible to P. multocida infection, the vaccine formulation comprising an effective amount of at least one PmSLP protein, or an immunogenically equivalent portion thereof, together with a veterinary pharmaceutically acceptable excipient, carrier, or diluent, and, optionally, a veterinary pharmaceutically acceptable adjuvant.
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 use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
Enablement is considered in view of the Wands factors (MPEP 2164.01(A)). These include nature of the invention, breadth of the claims, guidance of the specification, the existence of working examples, state of the art, predictability of the art and the amount of experimentation necessary. All of the Wands factors have been considered with regard to the instant claims, with the most relevant factors discussed below.
Nature of the Invention and Breadth of the Claims
The claims are drawn to a veterinary vaccine formulation for the prevention, treatment or amelioration of P. multocida infection in a ruminant animal susceptible to P. multocida infection, the vaccine formulation comprising an effective amount of at least one PmSLP protein, or an immunogenically equivalent portion thereof, together with a veterinary pharmaceutically acceptable excipient, carrier, or diluent, and, optionally, a veterinary pharmaceutically acceptable adjuvant.
The specification discloses that the terms “PmSLP protein” or “PmSLP polypeptide”, as may be used herein, interchangeably refer to any and all protein comprising a sequence of amino acid residues which is (i) substantially identical to the amino acid sequences constituting any PmSLP polypeptide set forth herein, including, for example, SEQ.ID NO: 2, or (ii) encoded by a nucleic acid sequence capable of hybridizing under at least moderately stringent conditions to any nucleic acid sequence encoding any PmSLP protein set forth herein, but for the use of synonymous codons. PmSLP proteins may also be numbered in order to facilitate distinguishing different PmSLP proteins referred to herein, e.g., PmSLP-1, PmSLP-2, PmSLP-3, and so on.
The specification defines the term “substantially identical” to mean that two amino acid sequences preferably are at least 70% identical, and more preferably are at least 85% or 90% identical, and most preferably at least 95% identical, for example 96%, 97%, 98%, 99%, 99.5%, 99.6%, 99.7%, 99.8%, or 99.9% identical.
The specification disclose that at least moderately stringent hybridization conditions” it is meant that conditions are selected which promote selective hybridization between two complementary nucleic acid molecules in solution. Hybridization may occur to all or a portion of a nucleic acid sequence molecule. The hybridizing portion is typically at least 15 (e.g., 20, 25, 30, 40 or 50) nucleotides in length. See paragraph 170 of the specification.
The claims require PmSLP proteins that are substantially identical to the amino acid sequences constituting any PmSLP polypeptide set forth in the specification, for example but not limited to sequences that are at least 70% identical (see definition above); encoded by a nucleic acid sequence capable of hybridizing under at least moderately stringent conditions to any nucleic acid sequence encoding any PmSLP protein set forth herein, but for the use of synonymous codons and also immunogenically equivalent portion thereof.
A nucleic acid sequence capable of hybridizing under at least moderately stringent conditions to any nucleic acid sequence encoding any PmSLP protein will be a complementary to said nucleic acid sequence. The specification does not disclose that the complementary sequences encode a PmSLP protein.
PmSLP proteins also encompasses functional variants which encompasses modified a polypeptide wherein, relative to a noted reference polypeptide, the modification includes a substitution, deletion, or addition of one or more amino acids.
In addition, the PmSLP proteins are encoded by nucleic acid sequences having a least 70% identity to nucleic acid sequences encoding the disclosed PmSLP proteins; encoded a nucleic acid that is substantially identical to said nucleic acid sequences but for the degeneration of the genetic code; encoded by nucleic acid sequence that is complementary the said nucleic acid sequence; encoded by chimeric nucleic acid sequences obtained by a fusion between at least two nucleic acid sequences of the above or a portion thereof; and nucleic acid sequences that encode a functional variant of any of the PmSLP amino acid sequences.
Similarly to the proteins, the claims require nucleic acid species encoding PmSLP proteins or variants thereof and the species are highly variant from one another, for example, at least 70% identity, a nucleic acid that is substantially identical to said nucleic acid sequences but for the degeneration of the genetic code; encoded by nucleic acid sequence that is complementary the said nucleic acid sequence; encoded by chimeric nucleic acid sequences obtained by a fusion between at least two nucleic acid sequences of the above or a portion thereof; and nucleic acid sequences that encode a functional variant of any of the PmSLP amino acid sequences.
The claims requires that the formulation function as a veterinary vaccine for the prevention, treatment or amelioration of P. multocida infection and the nucleic acid sequences encode a proteins that can function as a veterinary vaccine for the prevention, treatment or amelioration of P. multocida infection.
Guidance in the Specification/The Existence of Working Examples
The specification reduces PmSLP variants which separated into five discrete clusters (PmSLP-1, PmSLP-2, PmSLP-3, and PmSLP-4.1, and PmSLP-4.2). BRD-PmSLP variants represent two of the four major clusters (PmSLP-1 and PmSLP-2) while HS-PmSLP variants represent a single cluster (PmSLP-3). BRD-PmSLP variants were predominantly isolated from samples originating from North America or Europe, while HS-PmSLP variants were primarily isolated from samples originating from Asia and Africa.
PmSLP sequences for each cluster include PmSLP-1 (e.g., SEQ.ID NO: 2) from cluster PmSLP-1, PmSLP-2 (e.g., SEQ.ID NO: 4) from cluster PmSLP-2, PmSLP-3 (e.g., SEQ.ID NO: 6) from cluster PmSLP-3, PmSLP-4.1 (e.g., SEQ.ID NO: 8) from cluster PmSLP-4.1, and PmSLP-4.2 (e.g., SEQ.ID NO: 10) from cluster PmSLP-4.2. PmSLP-1 is at minimum 99.7% identical to the cluster PmSLP-1 sequences. PmSLP-2 is at minimum 99.7% identical to the cluster PmSLP-2 sequences and on average 100.0% identical to the cluster PmSLP-2 sequences. PmSLP-3 is at minimum 93.9% identical to cluster PmSLP-3 sequences and on average 99.4% identical to the cluster PmSLP-3 sequences. PmSLP-4.1 is at minimum 99.7% identical to the cluster PmSLP-4.1 sequences and on average 99.8% identical to the cluster PmSLP-4.1 sequences. PmSLP-4.2 is at minimum 96.8% identical to the cluster PmSLP-4.2 sequences and on average 97.2% identical to the cluster PmSLP-4.2 sequences.
The immunogenicity of PmSLP-1 protein (SEQ ID NO: 14) formulated with various adjuvants were administered to 4-6-week-old C57BL/6 mice. All five vaccine formulations were able to elicit PmSLP-1 specific IgG in serum after just one dose, and the IgG titre was further augmented after the second dose.
The vaccine formulation was used to immunize and then challenge mice with a P. multocida isolate that harbours a different PmSLP gene but from the same phylogenetic cluster as the PmSLP-1 protein included in the vaccine.
PmSLP-1 (SEQ.ID NO: 14) was formulated as a vaccine using 20 μg of protein mixed with Montanide™ Gel 02 (Seppic) combined with Poly (I:C) (Invivogen) to a final volume of 100 μl per dose. 4-6-week-old male C57Bl/6 mice (Charles River) were given two doses of vaccine at three-week intervals via sub-cutaneous injection. Pre-challenge bleeds were collected prior to infection.
Two weeks after the second dose, anaesthetized animals were challenged via intra-peritoneal injection with approximately 10^4 CFU of log-phase P. multocida strain H246 (antigen-matched BRD isolate, the confirmed sequence of the PmSLP in this strain is defined in SEQ.ID NO: 22. Strain H246 is a serogroup A strain.). It is noted that SEQ.ID NO: 14 and SEQ.ID NO: 22 exhibit a sequence identity of 100% over the portion of the antigen contained in the immunizing protein.
All mice that received the PmSLP-1 vaccine survived the infection, compared to all animals that received only adjuvant which reached endpoint between 24 and 32 hours post infection.
The formulation did not prevent infection by the challenge strain as evidenced by figure 4E as evidenced by the presence of the challenge strain in the blood a few hours post infection. 100% of the animals receiving the formulation survived (figure 4A). Similar results was obtained for PmSLP-2 and PmSLP-3 as set forth in the examples.
More guidance is needed to make and use the claimed veterinary vaccine formulation for the prevention, treatment or amelioration of P. multocida infection commensurate with the scope of the claims.
"The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art." "The "amount of guidance or direction" refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling" In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (MPEP 2164.03).
In the instant case the formulation was immunogenic and animals administered the formulation and then challenged with P. multocida survived. The animals were still able to get infected with the challenge dose even though the infection may wane over time. Therefore, the formulation did not prevent infection. Furthermore, there is no evidence that the formulation can treat or ameliorate an active P. multocida infection.
The definition of treating and treatment also encompasses the prevention (i.e., prophylactic treatment), inhibition, amelioration, attenuation, reversal of a sign, symptom or cause of a disorder, or disease, attributable to the disorder, or disease. There is no evidence provided in the specification that the full scope of PmSLP (see definition) or immunogenically equivalent portions can prevent (i.e., prophylactic treatment), inhibit, ameliorate, attenuate, reversal of a sign, symptom or cause of a disorder, or disease, attributable to the disorder, or disease.
For these reasons, the specification is not enabling for the full scope of the claims.
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 10, 11 and 24 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.
In claim 10, it is not clear that the vaccine formulation according to claim 1 is intended to further comprise a P. multocida strain.
In claim 11, does Applicant mean a nucleic acid sequence that is complementary to the complement of any one of the nucleic acid sequences of (a)? What does a nucleic acid that is complement to any of the nucleic acid sequences encode? The complement will be the opposite strand of said nucleic acid sequence. Is the complement strand also coding strand for PmSLP proteins?
In claim 24, “food production animal” lacks antecedent basis in claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 5, 6, 10, 11, 13, 24, 25, 29, 30 and 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more.
The claim(s) recite(s) a combination of judicial exceptions at least one PmSLP protein, or an immunogenically equivalent portion thereof, together with a veterinary pharmaceutically acceptable excipient, carrier, or diluent, and, optionally, a veterinary pharmaceutically acceptable adjuvant.
The combinations do not exist in nature and thus the closet counterpart for comparison of the judicial exception to its closest natural counterpart.
The PmSLP protein or immunogenically equivalent portion thereof is compared to the PmSLP protein and there is no marked difference as the sequence of the PmSLP protein or the immunogenically equivalent remains the same.
A veterinary pharmaceutically acceptable excipient, carrier, or diluent encompasses a water or milk which naturally occur.
There is no evidence the combination of the judicial exception react together or that the combination transforms either of the judicial exception.
Regarding a veterinary pharmaceutically acceptable adjuvant, this is not recited in effective amounts to ensure that the adjuvant is present in the composition in amounts that makes a difference which is to enhances the immune response to antigen.
This judicial exception is not integrated into a practical application because the claims do not recite additional elements that integrate the judicial exception(s) into a practical application (not an intended use) such a particular treatment or prophylaxis for a disease or medical condition i.e. affirmatively reciting an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of said action is a step of actively administering the formulation to the ruminant animal i.e. a method of administering the formulation to a ruminant animal. The claims are drawn to a composition and not a method. See MPEP 2106.04(d)(2).
Next, the claims a whole is analyzed to determine whether any additional element, or combinations of elements, is sufficient to ensure that the claim amounts to significantly more than the exceptions. Integration requires an additional element in the claim to apply, rely on, or use the judicial exception in a manner than imposes a meaningful limit on the judicial exception. The claims do not recite any meaningful additional limitations, modification(s) or transformation(s) that sufficiently ensures that the claim amounts to significantly more than the exceptions.
Thus, the claims as a whole does not amount to significantly more than the “product of nature” by itself. Thus, the claims does not qualify as eligible subject matter under 35 USC 101.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 3, 5, 6, 11, 13, 24, 25 and 30-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moraes et al. US 20190111122 04-18-2019.
Claims 1, 3, 5, 11, 13, 24, 25, Moraes et al disclose a veterinary vaccine formulation comprising an effective amount of at least one PmSLP protein i.e. PM1515-PM1514-Flag tag, wherein the PM1514 (PmSLP (paragraph 298) is encoded by a nucleic acid molecule comprising SEQ ID NO: 13 and is 100% identical to SEQ ID NO: 13 and is substantially identical to SEQ ID NO: 13 and pharmaceutically acceptable excipient, carrier or diluent and optionally a veterinary acceptable adjuvant such as cytokines, e.g., IL-1, IL-2, IL-12, IL-6, and further include inorganic salts, e.g. aluminum hydroxide, aluminum phosphate, and calcium phosphate; oil emulsions, e.g. mineral oil, MF59,QS-21, Montamide ISA51 and ISA-720; Isocoms, e.g. ISCOMATRIX; microbial derivatives, e.g. MPLA, macrophage-activating protein-2, virosomes, LT/CT, CpG; natural polymers, e.g. polysaccharides; and synthetic polymers, e.g. polyanhydrides and polyesters, (see SEQ ID NO: 1083/PM1514 of Moraes et al (see paragraphs 137, 141, 171, 172-178, 268-270, 272). See paragraph 112 and figure 11 disclosing a fusion protein comprising two surface lipoproteins of P. multocida i.e. PM1515-PM1514-Flag tag, wherein the PM1514 is encoded by a nucleic acid molecule comprising SEQ ID NO: 13 and is PM1514 is 100% identical to SEQ ID NO: 13; paragraph 296-297 disclosing: a putative SLAM (PM1515, SEQ ID NO: 1087) was identified in Pasteurella multocida using the Neisseria SLAM as a search. The putative SLAM (PM1515, SEQ ID NO: 1087) was adjacent to a newly predicted lipoprotein gene with unknown function (PM1514, SEQ ID NO: 1083) (FIG. 11A). The encoded protein is SEQ ID NO: 1084 which is 100% identical to SEQ ID NO: 14. See Appendix A and B attached to this Office Action.
Regarding claim 6: SEQ ID NO: 1084 has 92.4 % identity to the PmSLP-3 protein (SEQ ID NO: 12). See Appendix C. The definition of PmSLP encompasses variants that are substantially identical. See paragraphs 167-169 of the instant specification.
Regarding claim 30-32: the vaccine formulation comprises a second P. multocida PmSLP protein i.e. PM1515 in addition to PM1514 i.e. PM1515-PM1514-Flag tag. Morae et al disclose the two proteins are obtained from the same P. multocida strain, thus the proteins are necessarily obtained from same serogroup or same phylogenetic cluster as PM1514 which is 100% identical to SEQ ID NO: 13 which represents a PmSLP protein from phylogenetic cluster 1 as disclosed by the instant specification.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moraes et al. US 20190111122 04-18-2019.
Claim 1: Moraes et al disclose a veterinary vaccine formulation comprising an effective amount of at least one PmSLP protein i.e. PM1515-PM1514-Flag tag, wherein the PM1514 (PmSLP (paragraph 298) is encoded by a nucleic acid molecule comprising SEQ ID NO: 13 and is 100% identical to SEQ ID NO: 13 and is substantially identical to SEQ ID NO: 13 and pharmaceutically acceptable excipient, carrier or diluent and optionally a veterinary acceptable adjuvant such as cytokines, e.g., IL-1, IL-2, IL-12, IL-6, and further include inorganic salts, e.g. aluminum hydroxide, aluminum phosphate, and calcium phosphate; oil emulsions, e.g. mineral oil, MF59,QS-21, Montamide ISA51 and ISA-720; Isocoms, e.g. ISCOMATRIX; microbial derivatives, e.g. MPLA, macrophage-activating protein-2, virosomes, LT/CT, CpG; natural polymers, e.g. polysaccharides; and synthetic polymers, e.g. polyanhydrides and polyesters, (see SEQ ID NO: 1083/PM1514 of Moraes et al (see paragraphs 137, 141, 171, 172-178, 268-270, 272). See paragraph 112 and figure 11 disclosing a fusion protein comprising two surface lipoproteins of P. multocida i.e. PM1515-PM1514-Flag tag, wherein the PM1514 is encoded by a nucleic acid molecule comprising SEQ ID NO: 13 and is PM1514 is 100% identical to SEQ ID NO: 13; paragraph 296-297 disclosing: a putative SLAM (PM1515, SEQ ID NO: 1087) was identified in Pasteurella multocida using the Neisseria SLAM as a search. The putative SLAM (PM1515, SEQ ID NO: 1087) was adjacent to a newly predicted lipoprotein gene with unknown function (PM1514, SEQ ID NO: 1083) (FIG. 11A). The encoded protein is SEQ ID NO: 1084 which is 100% identical to SEQ ID NO: 14. See Appendix A and B attached to this Office Action.
Morae et al does not disclose the vaccine formulation comprises from about 0.001% to about 20% by weight of the PmSLP protein or the immunogenically equivalent portion thereof, and a veterinary pharmaceutically acceptable adjuvant constituting from about 0.1% to about 60% by weight or volume of the vaccine formulation. However, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.”[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5-6, 11, 13, 24-25, 29-30 and 32-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 7, 10-11, 20, 24-25, 29-30, 32-34, 38, 46, 48, 51 and 57-59 of copending Application No. 18/858,473 (‘473). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘473 claims disclose:
1: A veterinary vaccine formulation, the vaccine formulation comprising an effective amount of at least one PmSLP protein, or an immunogenically equivalent portion thereof, together with a veterinary pharmaceutically acceptable excipient, carrier, or diluent, and, optionally, a veterinary pharmaceutically acceptable adjuvant.
The recitation of for the prevention, treatment or amelioration of P. multocida infection in a ruminant animal susceptible to P. multocida infection is drawn to the intended use of the formulation
3. A veterinary vaccine formulation according to claim 1, wherein the vaccine formulation comprises a P. multocida PmSLP protein, or an immunogenically equivalent portion thereof, selected from the group of phylogenetic clusters consisting of PmSLP-1, PmSLP-2, PmSLP-3, PmSLP-4.1, and PmSLP-4.2, wherein the selected P. multocida PmSLP protein, or an immunogenically equivalent portion thereof, belongs to the same phylogenetic cluster as a PmSLP protein present in the infecting P. multocida strain.
5. A veterinary vaccine formulation according to claim 1, wherein the vaccine formulation comprises a P. multocida PmSLP protein from a BRD causing P. multocida strain, or an immunogenically equivalent portion thereof, wherein the PmSLP protein is selected from the group of phylogenetic clusters consisting of PmSLP-1, PmSLP-2, and PmSLP-4.2, wherein the selected P. multocida PmSLP protein, or an immunogenically equivalent portion thereof, belongs to the same phylogenetic cluster as a PmSLP protein present in the infecting P. multocida strain.
6. A veterinary vaccine formulation according to claim 1 ,wherein the vaccine formulation comprises a P. multocida PmSLP protein from an HS causing P. multocida strain, or an immunogenically equivalent portion thereof, wherein the PmSLP protein is selected from the phylogenetic cluster PmSLP-3 i.e. SEQ ID NO: 12 or SEQ ID NO: 20 wherein the selected P. multocida PmSLP protein, or an immunogenically equivalent portion thereof, belongs to the same phylogenetic cluster as a PmSLP protein present in the infecting P. multocida strain. See claim 11.
11. A veterinary vaccine formulation according to claims 1 wherein the at least one PmSLP protein, or immunologically equivalent portion thereof, is a protein expressed by a nucleic acid sequence selected from the group of nucleic acid sequences consisting of:(a) SEQ.ID NO: 1, SEQ.ID NO: 3, SEQ.ID NO: 5, SEQ.ID. NO: 7, SEQ.ID NO: 9, SEQ.ID NO: 11, SEQ.ID NO: 13, SEQ.ID NO: 15, SEQ.ID NO: 17, SEQ.ID. NO: 19, SEQ.ID.NO: 21, SEQ.ID. NO: 23, SEQ.ID. NO: 25, SEQ.ID. NO: 27, SEQ.ID NO: 29, SEQ.ID NO: 31, SEQ.ID NO: 33, SEQ.ID NO: 35, SEQ.ID NO: 37, SEQ. ID NO: 39, SEQ.ID NO: 50, SEQ.ID NO: 52, SEQ.ID NO: 54, SEQ.ID NO: 56, SEQ.ID NO: 58, SEQ.ID NO: 60, SEQ.ID NO: 62, SEQ.ID NO: 64, SEQ.ID NO: 66, SEQ.ID NO: 68, SEQ.ID NO: 70, SEQ. ID NO: 72, SEQ.ID NO: 74, SEQ.ID NO: 76, SEQ.ID NO: 78, SEQ.ID NO: 80, SEQ.ID NO: 82, SEQ.ID NO: 84, SEQ.ID NO: 86, SEQ.ID NO: 88, SEQ.ID NO: 90, SEQ.ID NO: 92, SEQ.ID NO: 94, or SEQ.ID NO: 96;(b) a nucleic acid sequence having at least 70% identity with any one of the nucleic acid sequences of (a);(c) a nucleic acid sequence that is substantially identical to any one of the nucleic acid sequences of (a) but for the degeneration of the genetic code; (d) a nucleic acid sequence that is complementary to any one of the nucleic acid sequences of (a);(e) a chimeric nucleic acid obtained by a fusion between at least two nucleic acid sequences of (a), (b), (c), and (d), or a portion thereof;(f) a nucleic acid sequence that is complementary to any one of the nucleic acid sequences of (a);(g) a nucleic acid sequence encoding a polypeptide having any one of the amino acid sequences set forth in SEQ.ID NO: 2, SEQ.ID NO: 4, SEQ.ID NO: 6, SEQ.ID. NO: 8, SEQ.ID NO: 10, SEQ.ID NO: 12, SEQ.ID NO: 14 SEQ.ID NO: 16, SEQ.ID NO: 18, SEQ.ID. NO: 20, SEQ.ID. NO: 22, SEQ.ID. NO: 24, SEQ.ID. NO: 26, SEQ.ID. NO: 28, SEQ.ID NO: 30, SEQ.ID NO: 32, SEQ.ID NO: 34, SEQ.ID NO: 36, SEQ.ID NO: 38, SEQ.ID NO: 40, SEQ.ID NO: 51, SEQ.ID NO: 53, SEQ.ID NO: 55, SEQ.ID NO: 57, SEQ.ID NO: 59, SEQ.ID NO: 61, SEQ.ID NO: 63, SEQ.ID NO: 65, SEQ.ID NO: 67, SEQ.ID NO: 69, SEQ.ID NO: 71, SEQ. ID NO: 73, SEQ.ID NO: 75, SEQ.ID NO: 77, SEQ.ID NO: 79, SEQ.ID NO: 81, SEQ.ID NO: 83, SEQ.ID NO: 85, SEQ.ID NO: 87, SEQ.ID NO: 89, SEQ.ID NO: 91, SEQ.ID NO: 93, SEQ.ID NO: 95,or SEQ.ID NO: 97, or an immunogenically equivalent portion thereof;(h) a nucleic acid sequence that encodes a functional variant of any one of the amino acid sequences set forth in SEQ.ID NO: 2, SEQ.ID NO: 4, SEQ.ID NO: 6, SEQ.ID. NO: 8, SEQ.ID NO: 10, SEQ.ID NO: 12, SEQ.ID NO: 14 SEQ.ID NO: 16, SEQ.ID NO: 18, SEQ.ID.NO: 20, SEQ.ID. NO: 22, SEQ.ID. NO: 24, SEQ.ID. NO: 26, SEQ.ID. NO: 28, SEQ.ID NO: 30, SEQ.ID NO: 32, SEQ.ID NO: 34, SEQ.ID NO: 36, SEQ.ID NO: 38, SEQ.ID NO: 40, SEQ.ID NO: 51, SEQ.ID NO: 53, SEQ.ID NO: 55, SEQ.ID NO: 57, SEQ.ID NO: 59, SEQ.ID NO: 61, SEQ.ID NO: 63, SEQ.ID NO: 65, SEQ.ID NO: 67, SEQ.ID NO: 69, SEQ.ID NO: 71, SEQ. ID NO: 73, SEQ.ID NO: 75, SEQ.ID NO: 77, SEQ.ID NO: 79, SEQ.ID NO: 81, SEQ.ID NO: 83, SEQ.ID NO: 85, SEQ.ID NO: 87, SEQ.ID NO: 89, SEQ.ID NO: 91, SEQ.ID NO: 93, SEQ.ID NO: 95, or SEQ.ID NO: 97, or an immunogenically equivalent portion thereto; and(i) a nucleic acid sequence that hybridizes under stringent conditions to any one of the nucleic acid sequences set forth in (a), (b), (c), (d), (e), (f), (g), or (h).
13. A veterinary vaccine formulation according to claims 1, wherein the P. multocida infection causes respiratory tract disease, bovine respiratory disease (BRD) or hemorrhagic septicemia (HS).
24. A veterinary vaccine formulation according to claims 1, wherein the veterinary vaccine formulation is a cross-protective vaccine formulation comprising a PmSLP protein, or immunogenically equivalent portion thereof, obtained from a first P. multocida strain, and the vaccine formulation is a formulation for the administration to the food production animal to prevent or ameliorate an infection caused by another P. multocida strain.
25. A veterinary vaccine formulation according, wherein the vaccine formulation is substantially free of other P. multocida constituents.
29. A veterinary vaccine formulation according to claim 1, wherein the vaccine formulation comprises from about 0.001% to about 20% by weight of the PmSLP protein or the immunogenically equivalent portion thereof, and a veterinary pharmaceutically acceptable adjuvant constituting from about 0.1% to about 60% by weight or volume of the vaccine formulation.
30. A veterinary vaccine formulation according to claims 1, wherein the vaccine formulation comprises a second P. multocida PmSLP protein, or immunologically equivalent portion thereof.
32. A veterinary vaccine formulation according to claim 30, wherein the second P. multocida PmSLP protein, or immunologically equivalent portion thereof, belongs to the same or a different phylogenetic cluster as the first P. multocida PmSLP protein, or immunologically equivalent portion thereof or optionally the same phylogenetic cluster as the first P. multocida PmSLP protein, or immunologically equivalent portion thereof.
33. A veterinary vaccine formulation according to of claim 32,wherein the vaccine formulation comprises a fusion polypeptide selected from the group consisting of a (i) PmSLP protein, or immunologically equivalent portion thereof, belonging to phylogenetic cluster 1 and a PmSLP protein, or immunologically equivalent portion thereof, belonging to phylogenetic cluster 3; (ii) PmSLP protein, or immunologically equivalent portion thereof, belonging to phylogenetic cluster 1 and a PmSLP protein, or immunologically equivalent portion thereof, belonging to phylogenetic cluster 2; (iii) a PmSLP protein, or immunologically equivalent portion thereof, belonging to phylogenetic cluster 1 and a PmSLP protein, or immunologically equivalent portion thereof, belonging to phylogenetic cluster 4.1; and (iv) a PmSLP protein, or immunologically equivalent portion thereof, belonging to phylogenetic cluster 1 and a PmSLP protein, or immunologically equivalent portion thereof, belonging to phylogenetic cluster 4.2.
34. A veterinary vaccine formulation according to claim 33,wherein the second P. multocida PmSLP protein, or immunologically equivalent portion thereof, is obtained from a P. multocida strain belonging to the same or a different serogroup as the P. multocida strain of the first P. multocida PmSLP protein, or immunologically equivalent portion thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Status of Claims
Claims 1, 3, 5-6, 10-11, 13, 24-25, 29-30 and 32-34 are rejected. Claims 38, 43, 51 and 57-59 are withdrawn.
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/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
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