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 .
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 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.
Claim Status
Claims 2-5, 7-13, 18-36, 38-152, and 154-172 are cancelled.
Claims 1, 6, 14-19, and 44 are pending and are examined on the merits in this prosecution.
Claim Objections / Minor Informalities
Claim 16 is objected to because of the following informalities:
a) in the sixth line, “aneurysm” is misspelled;
b) in the eighth line, “cardiac surgery” is recited twice;
c) “critical care medicine” is repeated in the tenth and 21st lines; and
d) “radiation-induced” is misspelled in the 22nd line.
Appropriate corrections are required.
Claim Interpretation
Claim 16 is drawn to a number of injury and disease states, including “general internal medicine” (lines 11-12), “general surgery” (line 12), “emergency medicine (line 11), and “critical care medicine” (line 10). Given the range of injury and disease states treated by general internal medicine, surgery, and critical care medicine, claim 16 is interpreted as reciting any condition treated by a medical professional.
For the claim 17 limitation of “said injury or disease is selected from, results from or is caused by … immune response”, the examiner relies on the description of “immune response” from Wikipedia (first paragraph): “The immune response is the body's response caused by its immune system being activated by antigens. The immune response can include immunity to pathogenic microorganisms and its products, allergies, graft rejections, as well as autoimmunity to self-antigens.”
CLAIM REJECTIONS
Scope of Enablement Rejections
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.
Claims 1, 6, 14-19, and 44 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 treating an injury or disease in a subject, does not reasonably provide enablement for preventing an injury or disease. 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.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (Bd Apls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,5) the state of the prior art,6) the relative skill of those in the art,7) the predictability of the art, and8) the breadth of the claims.
The instant specification fails to provide guidance that would allow the skilled artisan to practice the instant invention without resorting to undue experimentation, as discussed in the subsections set forth hereinbelow.
1. The nature of the invention, state of the prior art, relative skill of those in the art, and the predictability of the art
While the relative skill of those in the art is high, this is outweighed by the highly unpredictable nature of the invention. The prior art recognizes that the ability of a halogen to treat certain injuries or diseases in a subject, the prior art recognizes iodide for the prevention of specific diseases and conditions related to iodine deficiency such as conditions of the thyroid. See for example Pesce and Kopp ("Iodine transport: implications for health and disease,” International Journal of Pediatric Endocrinology 2014, pp 1-12); see the abstract and Table 2, pages 4-5.
2. The breadth of the claims
The rejected claims are extremely broad and inclusive of any and all possible injuries or diseases in a subject. As an example, applicant provides no guidance for the prevention of sickle cell anemia.
Furthermore, with regard to “treating” injury or disease, the Specification provides support for the treatment of the following diseases or injuries: myocardial infarction (Specification, pgs 101, 103, 104); chronic heart failure (pg 104); kidney transplant (pg 107); graft vs. host disease (pg 108); peripheral vascular disease (pg 108); noise induced hearing loss (pg 108); acute ischemic stroke (pg 108); acute myocardial infarction (pg 108); contrast-induced nephropathy (pg 108); postoperative ileus (pg 109); radiation induced lung injury (pg 109); ventilator induced lung injury (pg 109); salmonella infection (pg 109); retinopathy (pg 109); organ preservation (pg 110); hypoxia-ischemia encephalopathy (pg 110); epilepsy (pg 110); and stem cell engraftment (pg 110).
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides no guidance for selecting any amounts for preventing specific injuries and diseases, other than those specified at page 47. The range of concentrations discloses on page 47 are from about 0.0001 mM to about 100 M, or a range of about a billion-fold.
4. The quantity of experimentation necessary
Applicant fails to provide information allowing the skilled artisan to ascertain which the amount of halide that must be used per dose, or the number of doses required to prevent an injury or disease, or which injuries or diseases the claimed method is effective. In the instant case, only a limited number of diseases are exemplified in the specification working examples (see above). It is noted that these examples are neither exhaustive, nor define the class of disease required by the claims. The ability of a halogen to treat or prevent disease is unpredictable, requiring each disease or condition to be individually assessed. The instant claims are very broad and read on any "injury or disease ", encompassing an overwhelming number of possible species, necessitating an exhaustive and undue search for all the embodiments suitable to practice the claimed invention. Accordingly, applicant has failed to provide information sufficient to practice the claimed invention absent resorting to undue experimentation.
Anticipation Rejections
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.
1) Claims 1, 6, 14-16, and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Duan (US 5,885,592).
Duan teaches a method of administering therapeutic iodine for treating a disorder in a mammal (Abstract). Duan teaches that an orally gavaged combination of sodium iodide and sodium iodate, either together or separately administered, were useful in treating fibrocystic breast syndrome (col 12, Example 6), reading on claims 1 and 6.
For claim 14, Duan teaches the method recites the administration of an iodine reductant such as an iodide (col 18, claim 5).
For claim 15, Duan teaches pre-dosing iodide levels of 9-10 g I / dl in serum increases to 148.5-170 9-10 g I / dl in serum two hours after dosing, an increase of over 15-fold or 1500% (Table, col 13), meeting the recited range.
For claim 16, Duan teaches fibrocystic breast disease, a condition treatable by general internal medicine.
For claim 44, Duan teaches oral administration (Abstract).
2) Claims 1, 3, 6, 11-12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chapman (WO 02/24210 A2).
Chapman teaches a method for use with an active pharmaceutical substance comprising a halogen compound (Abstract). Chapman teaches a method comprising a pharmaceutical active substance containing a halogen compound (pg 14, claim 1), reading on instant claim 1. The halogen can be an iodine compound or potassium iodide (pg 14, claims 2, 3, and 7), reading on instant claims 3 and 6. Chapman teaches the halogen compound can be added to food preparations (pg 15, claim 14), reading on claim 14.
Obviousness Rejections
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 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.
1) Claims 15-17 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Chapman (cited above).
The teachings of Chapman with regard to anticipation are discussed above.
In addition, Chapman teaches the method can be applied to intravenous administration of the halides (pg 7, fifth line), reading on claim 44.
For claim 15, Chapman teaches a weekly dose of from 1050 mg to 1400 mg or a unit dose of from 150 mg to 1400 mg (pg 7, 2-5 lines from bottom). As disclosed in the Specification, the iodine compound is greater than or equal to 150 g to 1000 mg (pg 90). As such, the dosage of Chapman is greater than the effective dose set forth in the Specification, and one of ordinary skill would expect blood levels of iodine or iodide to meet the levels claimed in claim 15 with a reasonable expectation of success.
Chapman teaches the methods may be useful for treating or preventing methicillin-resistant staph aureus (MRSA) and malaria, diseases treatable with general internal medicine (pg 8, lines 11-16), reading on claim 16. Chapman also teaches colitis (pg 8, line 14), reading on a disease caused by inflammation as recited in claim 17.
To determine whether a claimed feature is obvious or not, “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions”. KSR v. Teleflex, 82 USPQ2d 1385, 1396 (2007). Here, the prior art discloses various features of the claimed invention, i.e. the method of use of a halide to treat or prevent disease, but it is not anticipatory because “picking and choosing” within the reference disclosure is required to arrive at the instantly claimed subject matter. Nevertheless, it would have been obvious to have utilized a halide compound in a method of treating or preventing disease since Chapman teaches this same invention for treatment of a variety of diseases and conditions (see the claims and the third paragraph on page 8). Since this modification of the prior art represents nothing more than “the predictable use of prior art elements according to their established functions” a prima facie case of obviousness exists.
2) Claim 17 is rejected under 35 U.S.C. 103 as being obvious over Duan (cited above), in view of Chapman (cited above).
The teachings of Duan with respect to anticipation are discussed above.
Duan does not teach the method of claim 17.
Chapman teaches the missing elements of Duan.
As discussed above, Chapman teaches the method of administering an iodide for the treatment of colitis (pg 8, line 14), reading on a disease caused by inflammation as recited in claims 17 and 153.
It would have been obvious for a person of ordinary skill in the art, before the effective filing date of the claimed invention, to include a method of treating colitis using a halogen or halide in the method taught by Duan and as recited by claims 17 and 153. A person of ordinary skill would have been motivated to choose a method for treating colitis using a halogen or halide compound as the specific disease or condition of Duan because Chapman teaches that a halogen or halide is useful as a treatment for colitis, an inflammatory condition that triggers a response of the body’s immune system.
3) Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Chapman (cited above), in view of “The Silent Epidemic of Iodine Deficiency,” (Life Extension Magazine, October, 2011; referred to below as “Iodine Deficiency”).
The teachings of Chapman with regard to anticipation are discussed above.
Chapman does not teach the method of claim 16 wherein the injury is caused by a heart attack or stroke.
The publication Iodine Deficiency teaches that lack of iodine can cause hypothyroidism, and hypothyroidism can contribute to heart disease and stroke (pg 8, “Role of Iodine in Cardiovascular Health.”).
The person of ordinary skill would have had a reasonable expectation of success in utilizing sodium iodide to treat or prevent an injury caused by heart attack or stroke because the publication “Iodine Deficiency” teaches that hypothyroidism can contribute to the incidence of heart attack and stroke, and one of ordinary skill would be motivated to select sodium iodide as a means of treating or preventing a heart attack or stroke.
Nonstatutory 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
1) Claims 1, 3, 6, and 14-17 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,201,570 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the reference patent always recite the inclusion of sodium iodide in a method to treat reperfusion injury, but since this halide and method of treating reperfusion injury reads upon the instantly recited limitation, the copending claims read upon the instantly recited composition.
2) Claims 1, 3, 6, 14-19, and 44 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12,016,880 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the reference patent always recite the inclusion of sodium iodide in a method to treat reperfusion injury heart attack, and injury due to bypass surgery, but since this halide and method of treating reperfusion injury reads upon the instantly recited limitation, the copending claims read upon the instantly recited composition.
CONCLUSION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick Krass can be reached on (571)272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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