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 .
DETAILED ACTION
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-20 have an effective filing date of 06MAR2019.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/12/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restriction
In the response filed on 12/19/2024, Applicant elected, with traverse:
Species
GRP78
The sense of SEQ ID NO: 8 and antisense of SEQ ID NO: 9
Obesity
Oral administration
Status of Claims
Claims 1-20 are currently pending and presented for examination on the merits.
Claims 2, 9, 18, and 20 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected species.
Claims 21-23 are canceled.
Rejections Maintained
Claim Rejections - 35 USC § 103
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.
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 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, 3, 5-8, 10, 12-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Baik et al (KR 20180110419 A), and further in view of Hatanaka et al (US 20180353434 A1).
Baik et al teaches GRP78 is associated with increased ER stress, it is known that insulin resistance plays an important role in maintaining energy metabolism and that GRP78 is a key regulator of energy metabolism, thus overexpression of GRP78 has been shown to increase obesity [2nd paragraph, pg. 2]. Baik et al further teaches a method for screening for an obesity-suppressing agent and treatment of obesity [Abstract]. Baik et al further teaches the obesity inhibitor is capable of binding to GRP78 [Abstract]. Baik et al further teaches treatment with the obesity-suppressing agent inhibits obesity [Abstract]. Baik et al further teaches the expression level of GRP78 was about 1.7 times in obese mice vs normal mice [Example 5, pg. 5]. Baik et al further teaches melanocortin 4 receptor (MC4R) binds GRP78, but when MC4R is mutated in humans, the obese trait is rapidly induced [Description, 3rd paragraph, pg. 1]. Baik et al further teaches heat shock chaperone 70 (HSC70) is known to stabilize MC4R and increase cell membrane expression [1st paragraph, pg. 2]. Baik et al further teaches a substance that increases the binding level of GRP78 and MC4R as an obesity inhibitor [8th paragraph, pg. 2]. Baik et al further teaches inhibition of GRP78 by PVN injection of Lentilox RNAi vector Lenti-shGRP78 [Fig. 8, pg. 2]. Baik et al further teaches the inhibitor of obesity can be formulated into oral formulations [19th paragraph, pg. 3]. Baik et al further teaches administering the oral composition in the form of a pharmaceutically acceptable carrier or with an excipient [3rd paragraph, pg. 4].
Applicant states in Table 0, on page 7 of the specifications that HSC70 is a synonym for HSP70-8/HSP71.
With regard to said inhibitors administered simultaneously or sequentially is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the parameters to achieve the desired results. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention.
The principle of law states from MPEP 2144.05: "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."(Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382); Generally, 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).
Baik et al does not specifically teach lipid nanoparticles with said molecule of interfering RNA. However, this deficiency is made up in the teachings of Hatanaka et al.
Hatanaka et al teaches the use of nanoparticles to treat a subject [0367]. Hatanaka et al further teaches the introduction of lipid nanoparticles into mammalian cells in the intestine [0908]. Hatanaka et al further teaches the lipid nanoparticles using RNA interference [0909].
One of ordinary skill, before the effective filing date, would have been motivated to use Baik’s method of screening for obesity-suppressing agents that decrease free GRP78 for an oral treatment of the insulin dependent pathology obesity, with Hatanaka’s method of using oral lipid nanoparticles to deliver interfering RNA to the intestines, because both demonstrate treating cells using RNA interference. Furthermore, to administer the oral treatment simultaneously or sequentially. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to use Baik and Hatanaka’s method for screening for an obesity-suppressing agent that increases the binding of GRP78 to treat an insulin resistance and/or pathologies derived therefrom by delivering interfering RNA to the intestine, because both teach delivering interfering RNA orally to treat subjects.
Applicant’s Argument:
Included in the Arguments are the topics and statements from the Declaration of Gentrude Mingrone, MD.
Applicant asserts that the rejection should be withdrawn because the cited references do not teach or suggest the presently claimed methods of treating insulin resistance and/or pathologies deriving therefrom or related thereto by administering inhibitors of the secreted, extracellular, or circulating GRP78 protein activity, and the declaration of Professor Geltrude Mingrone confirms that a person of ordinary skill in the art would not have been motivated to arrive at the claimed invention from the cited references, alone or in combination. Office Action pp. 4-7; Declaration 7-9, 23.
As an initial matter, the declaration explains that Baik does not teach or suggest inhibiting secreted, extracellular, or circulating GRP78 protein activity for treating insulin resistance or related pathologies. Rather, Baik is directed to screening obesity inhibitors based on substances that increase the binding between GRP78 and MC4R, and Baik expressly teaches that such substances may be nucleic acids or compounds that increase expression of GRP78 or MC4R. Declaration 10. Dr. Mingrone further explains that Baik teaches that MC4R mutant forms associated with obesity remain in the endoplasmic reticulum, inducing ER stress and inhibiting cell-membrane expression, and that heat-shock chaperone proteins can be used to reduce ER stress and improve MC4R function as a treatment method for obesity-related diseases. Declaration 11.
The declaration is particularly clear that Baik teaches the opposite from the present claims. According to Dr. Mingrone, Baik teaches that obesity can be suppressed when binding between GRP78 and MC4R is increased and that such binding can be increased by substances that increase expression of GRP78. Declaration 12. The declaration also identifies Baik's teaching that when GRP78 expression was suppressed in obese mice, weight gain occurred, including in experiments where a lentiviral shGRP78 vector was injected in the PVN. Declaration 13. Based on those teachings, the declaration concludes that a POSA reading Baik as a whole would have understood that treatment of obesity in Baik requires increasing GRP78 expression levels, because increased GRP78 would increase binding with MC4R and thereby treat obesity. Declaration 14.
The declaration also demonstrates that Baik concerns a materially different biological context from the pending claims. As Dr. Mingrone explains, Baik concerns GRP78 functioning as an intracellular chaperone in hypothalamic neurons, specifically in the PVN of the hypothalamus, and that the interaction between GRP78 and MC4R discussed in Baik is confined to the intracellular compartment. Declaration 14-16.
Applicant also respectfully submits that the declaration directly rebuts the Examiner's statement that, in Baik, "using the siRNA Baik inhibited all GRP78, to include secreted, extracellular, and circulating GRP78." Office Action p. 7. The declaration explains that Baik specifically states that the lentiviral vector was injected into the PVN of the hypothalamus and inhibited GRP78 expression specifically in that region of the mouse brain. Declaration 20.
Dr. Mingrone further notes that the claimed invention specifies that interfering RNAs such as siRNAs are used to silence synthesis of the desired molecules, such as GRP78, exclusively in the intestine, and that the specification explains that inhibition in intestinal cells is desired. Declaration 21.
Examiner’s Response:
MPEP 2143.01 (I)states that
The disclosure of desirable alternatives does not necessarily negate a suggestion for modifying the prior art to arrive at the claimed invention. In In re Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004), the claims of a utility patent application were directed to a shoe sole with increased traction having hexagonal projections in a "facing orientation." 391 F.3d at 1196-97, 73 USPQ2d at 1142. The Board combined a design patent having hexagonal projections in a facing orientation with a utility patent having other limitations of the independent claim. 391 F.3d at 1199, 73 USPQ2d at 1144. Applicant argued that the combination was improper because (1) the prior art did not suggest having the hexagonal projections in a facing (as opposed to a "pointing") orientation was the "most desirable" configuration for the projections, and (2) the prior art "taught away" by showing desirability of the "pointing orientation." 391 F.3d at 1200-01, 73 USPQ2d at 1145-46. The court stated that "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." Id. In affirming the Board’s obviousness rejection, the court held that the prior art as a whole suggested the desirability of the combination of shoe sole limitations claimed, thus providing a motivation to combine, which need not be supported by a finding that the prior art suggested that the combination claimed by the applicant was the preferred, or most desirable combination over the other alternatives. Id. See also In re Urbanski, 809 F.3d 1237, 1244, 117 USPQ2d 1499, 1504 (Fed. Cir. 2016).
Applicant states, “Baik is directed to screening obesity inhibitors based on substances that increase the binding between GRP78 and MC4R, and Baik expressly teaches that such substances may be nucleic acids or compounds that increase expression of GRP78 or MC4R”.
Baik et al teaches that extracellular GRP78 when bound to MC4R demonstrated improvements of obesity traits [2nd Paragraph, pg. 2]. Baik et al further teaches substances that promote the binding of GRP78 and MC4R is an obesity inhibitor, by inhibiting GRP78 [Abstract].
Applicant states in Specifications, “Also for the inhibition of the activity of GRP78, vehiculated in gastro-resistant capsules or in chitosan glutamate, the DNA-cutting protein Cas9 can be used, which cuts DNA in the required zone, using a suitable guide RNA, thereby inhibiting protein synthesis in situ. As indicated above, the inhibition can be performed by inhibiting the activity of one or more of the abovementioned proteins in circulating form, therefore extracellular, therefore by antibodies or their active fragments and/or by inhibiting, at intestinal level, the intracellular expression of one or both of the abovementioned proteins, therefore by molecules of interfering RNAs as above-defined.” [Pg. 10 Specifications].
Applicant states in claim 1, “inhibitors of the GRP78 activity are selected from one or more of anti-GRP78 monoclonal antibodies or their antigen-binding fragments, or molecules of interfering RNAs that bind uniquely to mRNA encoding GRP78.”, but on pg. 10 of Specifications states, “…the inhibition can be performed by inhibiting the activity of one or more of the abovementioned proteins in circulating form, therefore extracellular, therefore by antibodies or their active fragments and/or by inhibiting, at intestinal level, the intracellular expression of one or both of the abovementioned proteins, therefore by molecules of interfering RNAs as above-defined.”
One of ordinary skill in the art given claim 1 and the instant specifications teaches that by inhibiting GRP78, the intracellular expression of one or both of the above mentioned proteins, therefore by molecules of interfering RNAs is a method of treating insulin resistance and/or pathologies deriving therefrom [Pg. 10 of Specifications]. Baik et al teaches that inhibition of GRP78, through increased binding of MC4R, was an obesity inhibitor and Baik et al teaches using silencing RNA on GRP78 inhibiting the intracellular expression of the protein.
35 U.S.C. 112(a) – Written Description
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, 3, 5-8, 10, 12-17, and 19 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 and 8 are drawn to an inhibitor of GRP78 activity, wherein said inhibitor is an anti-GRP78 monoclonal antibody. The claims encompass a large genus of antibodies that are capable of inhibiting GRP78 activity. Following a review of the Specification, it appears that one inhibitor of GRP78 activity, wherein said inhibitor is an anti-GRP78 monoclonal antibody, has been described, specifically GRP78 monoclonal antibody C38, see p. 10; however in view of this disclosure, Applicant is claiming a broad genus of molecules that would be expected to encompass multiple antigen-binding domains having diverse heavy and light chain CDR sequences. Even though Applicant has disclosed one species within the claimed genera, the specification does not provide adequate written description for the entire claimed genera, because one skilled in the art would be unable to immediately envision, recognize, or distinguish at least most of the members comprised within the genera claimed, specifically, which light and heavy chain CDR sequences (and combinations of said CDR sequences) give rise to an anti-GRP78 antibody capable of inhibiting GRP78 activity. As detailed below Applicant’s disclosure is not sufficient to demonstrate possession of the entire claimed genus, and as such Applicant’s disclosure does not satisfy the written description requirement of 35 U.S.C. 112(a).
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, reduction to drawings, 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 applicant was in possession of the claimed genus. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
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A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. In the instant case, Applicant has disclosed one species within the genera claimed; however given the substantial antibody structure variation within the genera as well as the high level of unpredictability in the antibody arts, the disclosure provided by the specification is not sufficiently representative of the entire genera claimed.
It is further noted that the claims require an anti-GRP78 antibody that inhibits GRP78 activity. One skilled in the art would reason that while some anti-GRP78 antibodies are likely inhibitory, other anti-GRP78 antibodies will likely not be capable of inhibiting GRP78 activity. Applicant has not provided any general structure of an anti-GRP78 antibody that is capable of inhibiting GRP78 activity. This is a significant omission, because the ability of an antibody to bind a particular antigen, alone, does not characterize what other properties the antibody may or may not possess. It is well-recognized in the art that antibodies will display markedly different and unpredictable properties depending on the epitope in an antigen to which a particular antibody specifically binds. Stancovski et al. (PNAS, 88: 8691-8695, 1991) developed a panel of monoclonal antibodies specific to HER-2, an art-known tumor antigen, and Stancovski et al. discovered that although each antibody bound the HER-2 antigen, said antibodies displayed a range of different properties, see Abstract and p. 8694, Table 1. Two of the anti-HER-2 antibodies almost completely inhibited tumor growth, two anti-HER-2 antibodies displayed moderate inhibitory effects, and yet another anti-HER-2 antibody accelerated tumor growth, p. 8694, Table 1. Additionally, said panel of anti-HER-2 antibodies demonstrated a range of apparent affinities and a range of abilities to induce complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and tyrosine phosphorylation, p. 8694, Table 1, and p. 8692, second column, second full paragraph. Furthermore, similar to Stancovski et al., Jiang et al. (J. Biol. Chem., 280: 4656-4662, 2005) teach that while many anti-HER-2 antibodies inhibit the proliferation of cancer cells, other anti-HER-2 antibodies actively stimulate cancer growth, see p. 4656, second column, final paragraph. Importantly, Jiang et al. add that “[i]t is well known that different biological effects are associated with the epitope specificity of the antibodies.” See p. 4656, second column, final paragraph. Based upon the teachings of Stancovski et al. and Jiang et al., one skilled in the art would reason that antibodies specific for the same target protein may have different effects depending upon the epitope specificity of a particular target protein-specific antibody.
Although screening techniques can be used to isolate anti-GRP78 antibodies that are capable of inhibiting GRP78 activity, Applicant is reminded that the written description requirement of 35 U.S.C. 112 is severable from the enablement provision. As stated in Vas-Cath Inc. v. Mahurkar (CA FC) 19 USPQ2d 1111, 935 F2d 1555, “The purpose of the ‘written description’ requirement is broader than to merely explain how to ‘make and use’; the applicant must also 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.”
Accordingly given the lack of particularity with which the claimed antibodies are described in the specification, it is submitted that the skilled artisan could not immediately envision, recognize, or distinguish at least most of the members of the genus to which the claims are directed, and therefore the specification would not reasonably convey to the skilled artisan that Applicant was in possession of the claimed invention at the time the application was filed.
Applicant’s Arguments:
Included in the Arguments are the topics and statements from the Declaration of Gentrude Mingrone, MD.
Applicant respectfully asserts that they [claims] are directed to methods of treatment, not to the structural definition of an antibody genus or inhibitor genus per se. The distinction between claims directed to compositions and those directed to therapeutic use is critical under controlling case law.
As explained in Teva, method-of-treatment claims reciting administration of a genus of antibodies can satisfy the written description requirement even where the specification discloses only a limited number of species, provided that the relevant class of antibodies is known and that the specification, in view of the state of the art, demonstrates possession of the claimed therapeutic use. Teva, Slip op. at 14-17.
In particular, the court rejected the contention that a patentee must disclose a "representative number" of structural variants across a functional genus when the invention lies in the use of a known class of antibodies for a defined therapeutic purpose. Id. at 17.
The specification supports this discovery with experimental data demonstrating that inhibition of these proteins, e.g., via monoclonal antibodies, improves glucose levels, prevents insulin resistance, and ameliorates disease phenotypes such as NASH and fibrosis. Declaration 32.
In contrast, the present claims rely on well-known classes of inhibitors (including antibodies and RNAi molecules) and are directed to a newly discovered therapeutic application of those classes. As recognized in Federal Circuit precedent, written description does not require detailed disclosure of subject matter already known in the art when the invention lies in a new use of that subject matter. See, e.g., Ajinomoto Co. v. ITC, 932 F.3d 1342, 1359 (Fed. Cir. 2019); see also In re Herschler, 591 F.2d 693, 701 (CCPA 1979).
This conclusion is supported by the detailed disclosure of the underlying biological mechanism, the identification of relevant therapeutic targets, the use of multiple classes of known inhibitors, and the experimental validation of the claimed therapeutic effect.
Examiner’s Response:
Applicant states, “they [claims] are directed to methods of treatment, not to the structural definition of an antibody genus or inhibitor genus per se.”.
Examiner agrees with Applicant that functionally defined claims can meet the written description requirement, but only if a reasonable structure-function correlation is established. Applicant states in claim 1, “…inhibitors of the secreted, extracellular, or circulating GRP78 protein activity…”, “…selected from one or more of anti-GRP78 monoclonal antibodies or their antigen-binding fragments, or molecules of interfering RNAs that bind uniquely to mRNA encoding GRP78.”, but has not stated the structure that achieves this function, nor characteristics, nor by a reasonable structure-function correlation.
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." See AlbbVie, 759 F.3d at 1300-01. "It is true that functionally defined claims can meet the written description requirement if a reasonable structure- function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date."I. at 1301 .
"[T]he test for sufficiency [of written description] is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the time of filing." Ariad Pharms., 598 F.3d at 1351. Arad explains that "the test requires an objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art." Id.
Applicant states Teva teaches, “method-of-treatment claims reciting administration of a genus of antibodies can satisfy the written description requirement even where the specification discloses only a limited number of species, provided that the relevant class of antibodies is known and that the specification, in view of the state of the art, demonstrates possession of the claimed therapeutic use. Teva, Slip op. at 14-17.”.
Teva further teaches, “The asserted claims here are unlike the claims in Amgen and Baxalta, however, because they do not claim humanized anti-CGRP antagonist antibodies themselves; instead, they claim only the use of such antibodies for the different, limited purpose of treating headache. In light of the well-known status of anti-CGRP antagonist antibodies and the routine nature of humanization, the more relevant “research assignment” in this case would have been determining which humanized anti-CGRP antagonist antibodies treat headache. See Amgen, 987 F.3d at 1084 (observing that the specification’s teachings must be “at least commensurate with the scope of the claims”). That assignment was completed; the specification disclosed that all such antibodies work for that purpose.” [pgs. 22-23 Teva].
Applicant has not demonstrated what characteristics or structure one of ordinary skill in the art would use to identify “…inhibitors of secreted, extracellular, or circulating GRP78 protein activity…”, “…selected from one or more of anti-GRP78 monoclonal antibodies or their antigen-binding fragments, or molecules of interfering RNAs that bind uniquely to mRNA encoding GRP78.”
The Specifications teaches GRP78 antibody, (76-E6), Santa Cruz Biotechnology, and GRP78 Monoclonal antibody (C38), eBioscience directed towards to C terminus, or by GRP78 Monoclonal antibody directed towards the N terminus [Page 10 of Specifications]. Molecules for interference on RNA (RNAi) can be selected from any siRNA capable of inhibiting the activity of the GRP78 protein, a non-limiting example of such siRNA is given by GRP78 siRNA (sense SEQ ID NO 8 antisense SEQ ID NO 9) Sigma-Aldrich (St. Louis, MO, U.S.A.) (mRNA, GenBank accession number NM_005347) or even siGRP78-1, sense: SEQ ID NO 10 and siGRP78-2, sense SEQ ID NO 10 [Page 10 of Specifications].
Applicant further states, “Also for the inhibition of the activity of GRP78, vehiculated in gastro-resistant capsules or in chitosan glutamate, the DNA-cutting protein Cas9 can be used, which cuts DNA in the required zone, using a suitable guide RNA, thereby inhibiting protein synthesis in situ. As indicated above, the inhibition can be performed by inhibiting the activity of one or more of the abovementioned proteins in circulating form, therefore extracellular, therefore by antibodies or their active fragments and/or by inhibiting, at intestinal level, the intracellular expression of one or both of the abovementioned proteins, therefore by molecules of interfering RNAs as above-defined.” [Pg. 10 Specifications].
One of ordinary skill in the art would not recognize the necessary structure to practice the claims as broadly written.
Conclusion
Claim 11 is objected to for depending from a rejected claim.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/ Examiner, Art Unit 1642
/NELSON B MOSELEY II/ Primary Examiner, Art Unit 1642
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