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 .
Election/Restrictions
Applicant's election of Group I, drawn to a composition comprising protein or any derivative thereof; and Applicants’ species with traverse of SEQ ID NO: 1 in the reply filed on March 16, 2026 is acknowledged. The traversal is on the ground(s) that the product claim is not materially different in scope and that there is no search burden to examine all of the claims together. This is not found persuasive because the test for distinct inventions is whether the products as claimed can be used in a materially different process. The product claims are directed to patentably distinct species that require different search strategies. In the instant case, the product could be a protein, peptide derivative, or a recombinant protein (Plac9).
The requirement is still deemed proper and is therefore made FINAL.
The species of group I, therefore claims 1, 2, 4, 6, 7 and 17 which read on the elected species has been considered. Claims 1, 2, 4, 6, 7 and 17 are hereby examined on the merits.
Claims 5, 8-16 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on March 16, 2026.
Claim Status
Claims 1-16 were originally filed on October 10, 2023.
The amendment filed on March 16, 2026, cancelled claim 3. Claims 1, 2, and 4-6 are amended. Claims 8-16 are withdrawn. Claims 17-18 are new.
Claims 1, 2, 4, 6, 7 and 17 are pending. Claim 5 and 18 is withdrawn for further consideration.
Claims 1, 2, 4, 6, 7 and 17 are currently examined on the merits herein.
Information Disclosure Statement
An Information Disclosure Statement has not been filed.
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.
Claim 6 is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 2nd paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 6, the phrase “effective amount” is a relative term which renders the claim indefinite. The phrase " effective amount" 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. See MPEP § 2173.05(d).
Additionally, the term “effective” is a relative term and implies that the present invention provides a composition comprising an effective amount of the compound, however, it is unclear based on the claim what amount is effective for, making the claim indefinite.
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.
Claims 1, 2, 4, 6, 7, and 17 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 contain 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. This is a written description rejection for derivative on claim 1.
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 includes “a compound capable of lowering circulating glucose level in an insulin-independent manner comprising a protein or any derivative thereof, wherein the protein is a recombinant placenta-specific protein 9 (Plac9).” As such, the scope of the claimed compound encompasses any derivative of recombinant placenta-specific protein 9 protein; any functionally significant structural motifs within any derivative; any homologous proteins capable of lowering circulating glucose level in an insulin-independent or to any functionally significant structural motif; and selecting any source organism when the source organism comprises any homologous proteins. Therefore, the scope of claim 1 and dependent claims 2, 4-7, and 17 encompass a vast array of protein and derivatives, structural motifs, and homologous proteins without a necessary core structure and/or sequence that would be needed for lowering circulating glucose level in an insulin-independent manner as claimed.
Applicants reduced to practice sequence homology of at least 73% similarity to the amino acid sequence of SEQ IDNO: 1 or 2 or to the functionally significant structural motif or mouse Plac9 sequences or variants (see instant specification, Example 1-4 and Figure 2-4). Therefore, the specification supports a limited and specific number of homologous sequences, proteins , derivatives, functional significant structural motifs, and functions.
The claimed invention is directed to a recombinant placenta-specific protein 9 protein comprising amino acid sequence of SEQ IDNO: 1. The limitation in claim 1, and species selection of “a protein comprising an amino acid sequence having a sequence homology of at least 73% similarity to the amino acid sequence of SEQ ID NO: 1” lacks written description because the instant application does not provide sufficient guidance to one of ordinary skill in the art to determine the sequences falling within the scope of the genus or of a recitation of structural features common to the members of the genus. Applicant reduced to practice the SEQ ID NO: 2 or mouse Plac9 sequences or variants in Example 1-4 and Figure 2-4. There is no reduction to practice for the full scope of the human Plac9 sequence SEQ ID NO: 1 as instantly claimed. Since the disclosure fails to describe the common attributes or characteristics that identify all of the members of the genus or even a substantial portion thereof, the specification is insufficient to teach the entire genus.
Alternatively, the written description requirement may be met by providing a representative number of species of the genus. To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention. The description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.” Thus, an applicant complies with the written description requirement by describing the invention, with all its claimed limitations, not that which makes it obvious, and by using such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.
While the general knowledge and level of skill in the art for peptide amino acids is evident, this knowledge and level of skill does not supplement the omitted description because specific, not general guidance is needed for one or more sequences with beneficial effect on improving glucose tolerance, for which guidance is not provided at all. Since the disclosure fails to describe common attributes or core sequences that represent all members of the genus, and because the genus of Plac9 amino acids that correspond to the placenta-specific protein 9 is vast and variant, the examples in the specification is insufficient to teach the entire genus. One would only conclude that Applicant was in possession of a peptide capable of lowering circulating glucose level in an insulin-independent manner as represented in Example 1-4 and Figure 2-4 and not the entirety of sequences within the scope of claims 1, 2, 4, 6, 7, and 17.
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, 2, 4, 6, 7, and 17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., natural phenomenon /natural product) without significantly more.
Claim 1 recites a compound capable of lowering circulating glucose level in an insulin-independent manner comprising a protein, or any derivative thereof. Thus, the claimed invention is directed to a composition of matter, which is one of the statutory categories of invention.
Regarding step 2A, Prong One, of the patent eligible subject analysis, the claims recite a judicial exception of a natural product. Claim 1 recites that a compound capable of lowering circulating glucose level in an insulin-independent manner comprising a protein, or any derivative thereof, wherein the protein is a recombinant placenta-specific protein 9 (Plac9). Dependent claim 2, further comprises an amino acid sequence having a sequence homology of at least 73% similarity to the amino acid sequence of SEQ IDNO: 1 or 2. These limitations therefore recite a natural phenomenon/natural product. This judicial exception is not integrated into a practical application because the claims are drafted such that there is no difference in substance from the sequence claim to a naturally occurring placenta-specific protein 9 (Plac9). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional claim elements do not integrate the judicial exceptions into something more than the judicial exception. Therefore, claims 1 and 2 recite a judicial exception (i.e., natural phenomenon/product of nature). Thus, the answer to step 2A, Prong One is YES.
Regarding step 2A, Prong Two, of the patent eligible subject analysis, the claims do not integrate the judicial exception into a practical application. The judicial exception is not integrated into a practical application because claims 2, 4, 6, 7, and 17, fail to recite a practical application of the product of nature. Although the claims 2, 4, 6, and 17 are directed only to the amino acid sequence and to the function incorporated by the sequence, such recitation of species tell the relevant audience about which biological reactions are being produced or taking place in the source organism or administered organism, and at most adds a suggestion that the relevant audience take those into account when selecting the composition of matter. Similarly, although claims 2, 4, 6, and 17 recite the protein comprises an amino acid sequence having a sequence homology of at least 73% similarity to the amino acid sequence of SEQ IDNO: 1 or 2, wherein the recombinant Plac9 is synthesized and purified from a bacterial expression system; such steps are recited at a high level of generality and would be considered a nominal or tangential addition to the claims. Therefore, the answer to step 2A, Prong Two, is NO.
Claim 7 recites “the composition further comprises a pharmaceutically acceptable carrier, ester, or salt.” The specification defines “a pharmaceutically acceptable carrier or salt” as suitable aqueous and non-aqueous carriers which may be employed in the pharmaceutical composition of the present invention include water.
Regarding Step 2B of the patent eligible subject analysis, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the limitations recited in claims 2, 4, 6, 7, and 17 are directed to insignificant extra-solution activity given that they are drawn to necessary data gathering and do not add anything beyond what is well-understood, routine, and conventional in the art. Although claim 7 recites the composition further comprises a pharmaceutically acceptable carrier, ester, or salt; more specifically, the claims 1, 2, 4, 6, 7, and 17 are drawn to the composition comprising the Plac9 or its derivatives are preferably dissolved in distilled water (see instant specification [0047]), and examples of suitable aqueous and non-aqueous carriers which may be employed in the pharmaceutical composition of the present invention include water (see instant specification [0050]). The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because only the active ingredient Plac9 are claimed. The claim directed to the intended purpose of water, do not amount to significantly more because it does not change the structure or function of the composition such that the claimed active ingredient differ from the judicial exception, naturally occurring pharmaceutically active composition comprising Plac9. Both Plac9 and water occur naturally and there is no indication that mixing Plac9 and water changes the structure, function or other properties of Plac9. Therefore, judicial exception is not integrated into a practical application because claim 7 encompasses nothing more than a product of nature. Thus, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, the answer to Step 2B is NO.
Accordingly, the claimed invention is directed to ineligible patent subject matter.
Therefore, the reasons set for the above, claims 1, 2, 4, 6, 7, and 17 are rejected under 35 U.S.C. 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.
Claims 1, 2, , 6, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ouyang et. al. (“Placenta-specific 9, a putative secretory protein, induces G2/M arrest and inhibits the proliferation of human embryonic hepatic cells”, Cong Ouyang, Yi-Zhi Pu, Xu-Hui Qin, Jinhua Shen, Qing-Hua Liu, Liqun Ma and Lu Xue, Bioscience Reports (38) SR20180820, published November 7, 2018)
Ouyang et. al. discloses a composition comprising Plac9 as the active compound (see page 4, Materials and Methods, Cell Culture, transient transfection, and clones that stably overexpress Plac9). Ouyang et. al. teaches that Plac9 is highly enriched in the placenta, and the sequence analysis of the promoter revealed that the expression of Plac9 could be regulated by sets of relatively widely expressed transcription factors (see page 2, 2nd paragraph). The genomic structure and protein structure (see page 2, Figure 1B and C) disclosed by Ouyang et. al. is the same as the instant SEQ ID NO: 1.
The secondary and tertiary structure analysis indicated that human Plac9 protein contains two helices and two coils (see Results: Characterization of the Plac9 gene; Figure 1B,C). The secondary structure prediction of Plac9 and the tertiary structure prediction of Plac9 are shown below:
PNG
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565
349
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Greyscale
(see page 2, Figure 1B and C)
Regarding the limitation “capable of lowering circulating glucose level in an insulin-independent manner”, any properties exhibited by or benefits provided by the composition are considered inherent, absent evidence to the contrary, and are not given patentable weight over the prior art. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties Applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP 2112.01. The burden is shifted to Applicant to show that the prior art product does not inherently possess the same properties as instantly claimed product. Thus, Ouyang et. al. anticipates the instant claim 1.
Ouyang et. al. discloses the entire protein-coding sequences of Plac9 were amplified from cellular cDNA by PCR using the primer pairs listed in Table 1 (see Table 1, page 4).
The instant limitation “amino acid sequence having a sequence homology of at least 73% similarity”, reads on 100% as “at least 73%” is a range of 73%-100% of the sequence homology. Ouyang et. al. discloses the same genomic structure, protein structure of Plac9 (see Ouyang et. al. page 2, Figure 1B). Thus, Ouyang et. al. anticipates claim 2.
Ouyang et. al. describes protein-coding sequences of Plac9 (instant SEQ ID NO: 1) were amplified from cellular cDNA by PCR (see Materials and Methods, page 4, 1st paragraph). Ouyang et. al. discloses protein sequence of Plac9 (see Figure 1B, shown above) (which is 100% homologous to the instantly claimed amino acid sequence of SEQ ID NO: 1). The instant specification states that the human Plac9 (represented by SEQ ID NO: 1) having a sequence homology of about 73% similarity to that of mouse Plac9 (represented by SEQ ID NO: 2) may also have similar beneficial effect (see instant Specification Example 1, [0060]). Thus Ouyang et. al. anticipates claims 6 and 17.
Therefore, the disclosures of Ouyang et al. anticipate the instantly claimed invention.
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.
Claims 1, 2, 4, 6, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US 20030054443 (published 03/20/2003) in view of Ouyang et. al. (“Placenta-specific 9, a putative secretory protein, induces G2/M arrest and inhibits the proliferation of human embryonic hepatic cells”, Cong Ouyang, Yi-Zhi Pu, Xu-Hui Qin, Jinhua Shen, Qing-Hua Liu, Liqun Ma and Lu Xue, Bioscience Reports (38) SR20180820, published November 7, 2018).
US’443 discloses polypeptide with SEQ ID NO:132 (see [0185]) (which is 100% homologous to the instantly claimed amino acid sequence of Plac9 (i.e. human Plac9 sequence, instantly claimed SEQ ID NO: 1). US’443 specifies the gene encoding the cDNA is believed to reside on chromosome 10 (see [0183]). US’443 teaches that disorders that may be treated, prevented, and/or diagnosed by polynucleotides, polypeptides, and/or agonists or antagonists include insulin dependent diabetes mellitus (see [0872]), diabetes mellitus (often characterized, e.g., by cell-mediated and humoral islet cell antibodies) (see [0873]), or diabetes mellitus (i.e., type 1 diabetes) (see [0882]). US’443 further teaches that expression in fetal kidney indicates that this gene or gene product could be used in the treatment, prevention, diagnosis and/or detection of kidney diseases including renal failure (see [0186]). US’443 teaches a method of treatment of an individual in need of an increased level of a secreted protein activity, which method comprises administering to such an individual a pharmaceutical composition comprising an amount of an isolated polypeptide, polynucleotide, or antibody of the claimed invention effective to increase the level of said protein activity in said individual (see [1165]). Polypeptides may be administered using any method known in the art, including, but not limited to, direct needle injection at the delivery site, intravenous injection (see [0980]). In a preferred embodiment, the composition is formulated in accordance with routine procedures as a pharmaceutical composition adapted for intravenous administration to human beings. Typically, compositions for intravenous administration are solutions in sterile isotonic aqueous buffer (see [0726]).
The teachings of US’443 differ from that of the instantly claimed invention in that US’443 does not teach about the claimed protein, or any derivative function of enhancing glucose uptake by liver cells or hepatocytes independent from insulin, that lowers the circulating glucose level in a subject as detailed in the instant specification about the role of Plac9 in regulating hepatic gluconeogenesis (see Example 3 and 4 in the instant specification); but only discloses the tissue distribution in liver, combined with the homology of the polynucleotides and polypeptides corresponding to this gene for the detection, diagnosis, prevention and/or treatment of the disorders or conditions associated with energy metabolism, e.g., diabetes mellitus (see US’443 [0087]).
Ouyang et. al teaches the Plac9 may play a role in the liver development and its potential role in liver cell physiology (see Abstract). The placenta plays an interactive role between maternal mammals and their babies until delivery (see Introduction, 1st paragraph). Ouyang et. al. teaches Plac9 is involved in liver protein interaction networks and may participate in liver development; the expression levels of Plac9 were detected in a series of hepatic cell lines (see The expression pattern of Plac9 in hepatic cell lines, page 3).
It would have been obvious to combine the teachings of US’443 and Ouyang et. al. before the effective filing date of the claimed invention by considering the potential role of Plac9 in regulating hepatic gluconeogenesis for the treatment of diabetes as in the instantly claimed invention. One of ordinary skill in the art would have been motivated to utilize polypeptides of US’443 to replace absent or decreased levels of the polypeptide like insulin with a reasonable expectation of success to attain hepatocyte growth factor as taught by Ouyang et. al.
It would have been prima facie obvious for one of ordinary skill in the art to optimize the US‘443 disclosure expressing polypeptides related to lowering circulating glucose level in an insulin-independent manner along with the pivotal role played by Plac9 in the proliferation of liver cells (see Ouyang et. al. Discussion, 6th paragraph).
Regarding claim 1, US’443 teaches, the polynucleotides or polypeptides, and/or agonists or antagonists of the invention, could be used to treat or prevent the onset of diabetes mellitus. In patients with newly diagnosed Types I and II diabetes, where some islet cell function remains, the polynucleotides or polypeptides, and/or agonists or antagonists of the invention, could be used to maintain the islet function so as to alleviate, delay or prevent permanent manifestation of the disease (see [1016]). Moreover, US’443 elaborates that the polypeptides can be used to treat, prevent, and/or diagnose disease. For example, patients can be administered a polypeptide of the present invention in an effort to replace absent or decreased levels of the polypeptide (e.g., insulin) (see [0822]).
Regarding claims 2, 6 and 17, US’443 discloses that fragments and variants of the polypeptides (such as, for example, fragments as described herein, polypeptides at least 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99%, or 100% identical to these polypeptides, or polypeptides encoded by a polynucleotide which hybridizes, under stringent conditions, to the polynucleotide encoding these polypeptides) are encompassed by the invention. Polynucleotides encoding these polypeptides are also encompassed by the invention (see [0182]).
Regarding claim 4, US’443 teaches that in bacterial systems, a number of expression vectors may be advantageously selected depending upon the use intended for the antibody molecule being expressed. For example, when a large quantity of such a protein is to be produced, for the generation of pharmaceutical compositions of an antibody molecule, vectors which direct the expression of high levels of fusion protein products that are readily purified may be desirable. Such vectors include, but are not limited, to the E. coli expression (see [0668]).
Regarding claim 7, US’443 provides pharmaceutical compositions. Such compositions comprise a therapeutically effective amount of a compound, and a pharmaceutically acceptable carrier; a diluent, adjuvant, excipient, or vehicle with which the therapeutic is administered, such pharmaceutical carriers can be sterile liquids, such as water [0725]. Additionally, the compounds of the invention can be formulated as neutral or salt forms [0727].
Therefore, the presently claimed invention was prima facie obvious to one of ordinary skill in the art at the time of the effective filing date.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KOYELI BANERJEE whose telephone number is (571)272-5751. The examiner can normally be reached Monday-Friday 8-4PM.
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/KOYELI BANERJEE/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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