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
Status of Claims
Claims 1-18 are pending and under examination in the instant office action.
Duplicate Claims, Warning
Applicant is advised that should claim 10 be found allowable, claim 13 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Also, Applicant is advised that should claim 11 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Applicant is advised that should claim 11 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k).
Claim Rejections - 35 USC § 112 (b)
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 1-18 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 pre-AIA the applicant regards as the invention. All the dependent claims are included.
Claim 1 recites “formulating a polystyrene sulfonate based pharmacological composition selected from the group consisting of sodium polystyrene sulfonate, calcium polystyrene sulfonate, formulation variations thereof, or combinations thereof. It appears to recite selecting different types of pharmacological compositions, but the group lists different salt forms of a polystyrene sulfonate, not types of pharmacological compositions. Also, it is unclear what “thereof” in the recitation of “formulation variations thereof” refers to. Does it refer to “polystyrene sulfonate” or “polystyrene sulfonate based pharmacological composition”? In addition, it should be noted that when using the phrase “selected from the group consisting of” the transitional word, “and”, should be used together. Thus, “or” should be corrected to --and--.
For the examination purpose, it is interpreted to recite “formulating a polystyrene sulfonate based pharmacological composition, wherein the polystyrene sulfonate is selected from the group consisting of sodium polystyrene sulfonate, calcium polystyrene sulfonate, and combinations thereof”.
Claims 10 and 13 recite “formulating a polystyrene sulfonate based pharmacological composition selected from the group consisting of fractional purified sodium polystyrene sulfonate, fractional purified calcium polystyrene sulfonate, or combinations thereof”. It appears to recite selecting different types of pharmacological compositions, but the group lists different salt forms of fractional purified polystyrene sulfonate, not types of pharmacological compositions. Also, it is unclear how the term, “factional purified”, limits the formulation. The term, “fractional”, means “relating to or involving a process for separating components of a mixture through differences in physical or chemical properties” If it is intended to mean to use a certain fraction of sodium polystyrene sulfonate or calcium polystyrene sulfonate, what fraction is used for the claimed formulation? The specification does not provide any definition for such term or guidance, thus one of ordinary skill in the art would not ascertain what fraction is encompassed by said “fractional purified sodium polystyrene sulfonate” and “fractional purified calcium polystyrene sulfonate”. In addition, it should be noted that when using the phrase “selected from the group consisting of” the transitional word, “and”, should be used together. Thus, “or” should be corrected to –and--.
For the examination purpose, it is interpreted to recite “formulating a polystyrene sulfonate based pharmacological composition, wherein the polystyrene sulfonate is selected from the group consisting of fractional purified sodium polystyrene sulfonate, fractional purified calcium polystyrene sulfonate, and combinations thereof”. Also, sodium polystyrene sulfonated nano polymer and calcium polystyrene sulfonated nano polymer are considered as “fractional purified” sodium polystyrene sulfonate and calcium polystyrene sulfonate in view of its depended claim 11.
Claims 11 and 12 recite “formulating a polystyrene sulfonate based pharmacological composition selected from the group consisting of sodium polystyrene sulfonated nano polymer, calcium polystyrene sulfonated nano polymer, or combinations thereof”. It appears to recite selecting different types of pharmacological compositions, but the group lists different salt forms of a polystyrene sulfonate nano polymer, not types of pharmacological compositions. In addition, it should be noted that when using the phrase “selected from the group consisting of” the transitional word, “and”, should be used together. Thus, “or” should be corrected to –and--.
For the examination purpose, it is interpreted to recite “formulating a polystyrene sulfonate based pharmacological composition, wherein the polystyrene sulfonate is selected from the group consisting of sodium polystyrene sulfonated nano polymer, calcium polystyrene sulfonated nano polymer, and combinations thereof”.
Claims 7-8 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 pre-AIA the applicant regards as the invention. All the dependent claims are included.
Claim 7 recites the limitation "inhibition of both Factor H and Factor D” in line 1. There is insufficient antecedent basis for this limitation because the claim 1 from which claim 7 depends does not recite said "inhibition of both Factor H and Factor D”.
This rejection may be overcome by amending the claim to be dependent from claim 2.
Claim Rejections - 35 USC § 112 (d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 11 and 13 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112 (pre-AIA ), 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 11 recites “sodium polystyrene sulfonated nano polymer, calcium polystyrene sulfonated nano polymer”. However, while claim 10 from which claim 11 is dependent recites “fractional purified” sodium polystyrene sulfonate and fractional purified calcium polystyrene sulfonate, the claim 11 does not recite “fractional purified” and thus it appears to encompass those which may not be “fractional purified”. As such, claim 11 fails to include all the limitations of the claim 10.
Also, claim 13 recites “fractional purified sodium polystyrene sulfonate, fractional purified calcium polystyrene sulfonate”. While claim 12 from which claim 13 is dependent recites sodium polystyrene sulfonated nano polymer and calcium polystyrene sulfonated nano polymer, claim 13 does not recite “nano polymer”. As such, claim 13 fails to further limit the subject matter of claim 12 or fails to include all the limitations of the claim 12.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 10-14, and 18 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 2016/0317573 (hereafter SHAH, cited in the IDS filed on 3/10/2024).
SHAH teaches a method for treating a subject suffering from diabetes related illnesses comprising providing a formulation comprising an anti-diabetic medication and a functionalized Nano Polymer compound of less than 100 nm that inhibits Factor D and Factor H to reduce C3a-C5a and formation of C3adesArg to improve insulin sensitivity ; and orally administering the formulation to the subject to down regulate Factor D and Factor H, thereby providing therapy to treat diabetes related illness wherein the functionalized Nano Polymer compound is Nano polymer Sodium Polystyrene Sulfonate (abstract and claim 1 and 11). The sodium polystyrene sulfonate nano polymer is a “fractional purified” sodium polystyrene sulfonate as claimed (see instant claim 11).
SHAH discloses that in type 2 diabetes, there is an increased expression of:
a. Anaphylotoxins such as C3a-C5a: Increased expression of these proteins contributes to inflammation of islet cells and endothelial surface leading to progressive destruction of islet cells
b. Acylation stimulating protein C3adesArg: This is a breakdown product of C3a that has cross talk effects with Fat cells contributing to increased fatty acid synthesis;
c. Factor H and AM: There is increased expression of Factor H that has inhibitory effects on Insulin secretion. Since Factor H is also binding protein for AM, AM causing insulin resistance potentiates the effect; and
d. Factor B: This is increased causing formation of C3bB complex that interacts with Factor D or adipsin causing formation of C3bB convertase ([0063])-[0067]).
SHAH further teaches the dysfunction of alternate complement system due to above events cause islet cell inflammation, ischemic reperfusion injury, decrease secretion of insulin and increased fat synthesis and this precipitates insulin resistance syndrome, morbid obesity, metabolic syndrome, nonalcoholic fatty liver disease, microvascular diseases of diabetes affecting eyes, kidneys and nerves as well as macro vascular disease leading to coronary atherosclerosis and other cardiovascular diseases (vascular complication of diabetes) ([0068]). Thus, the subject of the prior art is a patient at risk of or suffering vascular complication of diabetes as claimed.
SHAH also teaches that since many of the complications seen in diabetes are related to insulin resistance state, down regulation of Factor D and H in FIGS. 5A and 5B and in 6A and 6B are thought to be of particular value in both prophylaxis and therapy, and thus prophylaxis and therapy of insulin resistance syndrome is down regulation of Factor D and Factor H and this in turn will down regulate serine proteases, C3a-C5a, ASP and AM ([0084]).
In addition, SHAH teaches said administering step further includes: secondary inhibition of a cross talk path of Factor D comprising inhibiting serine proteases and an amplification loop for down regulating anaphylotoxins or Acylation Stimulating Protein (ASP) or combinations thereof (claim 3). SHAH further teaches said administering step further includes: secondary inhibition of a cross talk path of Factor H comprising down regulating Adrenomedullin (AM), serine proteases or combinations thereof (claim 4).
SHAH teaches said administering step further includes inhibiting the adverse effects of Factor H in diabetic retinopathy (vascular complication of diabetes) (claim 6).
As to claims 7-8 and 14, the prior art teaches inhibiting both factor H and factor D by administering the same compound, claimed intended results necessarily occurs. It is noted that products of identical chemical composition cannot have mutually exclusive properties and a chemical composition and its properties are inseparable. “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir.1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). “[N]ewly discovered results of known processes directed to the same purpose are not patentable." Bristol-Myers Squibb, 246 F.3d at 1376. Also, see In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (a case indicating that the burden of proof can be shifted to the applicant to show that the subject matter of the prior art does not possess the characteristic relied on whether the rejection is based on inherency under 35 U.S.C.102 or obviousness under 35 U.S.C. 103).
As such, the instant claims are anticipated by SHAH.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0317573 (hereafter SHAH, cited in the IDS filed on 3/10/2024) in view of US 6805857.
SHAH as applied supra is herein applied for the same teachings in their entirety.
SHAH does not teach a dose as recited in claims 15-16.
US 6805857 teaches the use of a formulation comprising polystyrene sulfonate (PSS) for immune modulation action on Factor D, Factor H and CD4 cells in the mammal (claim 1). US 6805857 further teaches that the drug is preferably given in the dose of 5-10 mg/kg body weight (col 12, lines 3-6 and claims 1 and 3). US 6805857 further teaches that it is given as intravenous infusion in 250 ml-500 ml 0.85% saline over 2-3 hours to permit action of this drug at tissue or blood level where it is needed most (col 12, lines 3-6 and claims 1 and 3).
US 6805857 also teaches that the fractionation of PSS with sieve results in different fractions ranging from <20 microns to>105 microns (fractional purification) and the immune modulation action of PSS on Factor D and Factor H is size independent (col 10, line 61-col 11, line 47). US 6805857 teaches the use of a mixture comprising at least one of a large molecular fractionation of polystyrene sulfonate greater than or equal to 100 microns and a small molecular fractionation of polystyrene sulfonate less than or equal to 20 microns (fractional purified polystyrene sulfonate) (claim 14). US 6805857 further teaches that use of mixtures of different sizes of polystyrene sulfonate will result in therapeutic reprogramming of the immune system and indirectly, boosts human defense system functioning by suppressing harmful complement activation in the first hierarchy (col 11, lines 40-45).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use similar dose of polystyrene sulfonate taught by US 6805857 in the treatment of a subject suffering from diabetes related illnesses such as vascular complication of diabetes because such dose is taught to be effective for inhibition of Factor D and Factor H, thereby modulating immune system. The skilled artisan would have been motivated to do so on the reasonable expectation that similar dose of polystyrene sulfonate would be required for the same effects (i.e., inhibiting Factor D and Factor H), thereby useful for treating a subject suffering from diabetes related illnesses such as vascular complication of diabetes.
As to “fractional purified sodium polystyrene sulfonate and fractional purified calcium polystyrene sulfonate” in claims 10-11 and 13, US 6805857 teaches the mixtures of different sizes of polystyrene sulfonate (fractional purified) result in therapeutic reprogramming of the immune system and boosts human defense system functioning by suppressing harmful complement activation. Thus, it would have been prima facie obvious to employ the fractional purified form of sodium polystyrene sulfonate taught by US 6805857 for obtaining combined beneficial effects of different sizes of polystyrene sulfonate in the prophylaxis and treatment of vascular complication of diabetes with immune boosting via inhibition of harmful complement activation. The skilled artisan would have been motivated to do so with a reasonable expectation of success as taught and suggested by US 6805857.
As to claim 9, SHAH teaches the polystyrene sulfonate inhibits complement Factor D and Factor H, thereby providing therapy to treat diabetes related illness as stated above. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the polystyrene sulfonate in combination with other known individually targeted complement inhibitors on the reasonable expectation that they would provide combined inhibitory effects on those complements. According to M.P.E.P. § 2144.06, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
As to claim 17, it would have been prima facie obvious to prepare polystyrene sulfonate in suitable dosage form including topical dosage form using appropriate topical carrier depending on desired administration route because it was known in the art that polystyrene sulfonate could be topically administered safely and effectively as evidenced by US 6805857 (p2, other publication).
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, and 11 of copending application 18/506725.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of ‘725 application are drawn to a method of prophylaxis and therapy for complement-mediated hyper-inflammatory ocular diseases comprising: formulating a polystyrene sulfonate based pharmacological composition selected from the group consisting of fractional purified sodium polystyrene sulfonate, fractional purified calcium polystyrene sulfonate, formulation variations thereof, or and combinations thereof; forming the pharmacological composition into a gel; selecting a patient suffering from a complement-mediated hyper-inflammatory ocular disease; and administering the pharmacological composition to the patient, wherein the pharmacological composition selectively targets key proteins involved in the C3 amplification loop to provide prophylaxis and therapy for the complement- mediated hyper-inflammatory ocular disease, wherein the complement-mediated hyper-inflammatory ocular diseases include diabetic retinopathy (vascular complication of diabetes; see claim 4) and the pharmacological composition selectively targets key proteins involved in the C3 amplification loop, wherein the key proteins are selected from the group consisting of Factor B, Factor D, Factor H, or its amplifying proteins of classical based systems, proteins of lectin based systems, or combinations thereof.
As such, the claims of the instant application and those of the ‘725 application encompass overlapping subject matter and are obvious variant to each other.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
