DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-10 and 12-21 are currently pending and under examination.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The term “Pharmaceuticla” is a misspelling in the title of the term –pharmaceutical--.
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.
Claims 3-5, 10, 12, 16, 17 and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 3, 10, 16 and 20, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). In claim 10, the phrase “as a” is also indefinite because it is not clear if the composition is a.) in the form of the recited oral dosage form or b.) included in the recited oral dosage form (the composition is not in that form itself).
Claim 12 depends on cancelled claim 11. There is insufficient antecedent basis for the limitation recited in this claim. Therefore, it is not clear what composition is being referred to by the Applicant. If the base claim has been canceled, a claim which is directly or indirectly dependent thereon should be rejected as incomplete. See MPEP 608.01(n).
The term “typical” in claim 17 is a relative term which renders the claim indefinite. The term “typical” 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. Each disease presents with different symptoms in different people and thus it is not possible to determine what a “typical” symptom is without further clarification.
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 1-8, 10, 13 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to pharmaceutical composition for use in a method for the treatment of virus-induced disease, wherein the composition comprises an extract of Trigonella foenum-graecum and optionally pharmaceutically acceptable additives wherein the method comprises administration of between 24mg and 240mg Trigonella foenum-graecum extract at least once daily, which is a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, applicant’s claim 1 recites a pharmaceutical composition for use in a method for the treatment of virus-induced disease, wherein the composition comprises an extract of Trigonella foenum-graecum and optionally pharmaceutically acceptable additives wherein the method comprises administration of between 24mg and 240mg Trigonella foenum-graecum extract at least once daily, which is a product of nature. Dependent claims 13 and 14 recite the optional additional ingredient is bentonite and the bentonite can comprise 50% by weight of smectite, which is also a product of nature. Thus, the claims do recite products of nature. MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
In this case, the closest naturally occurring counterpart for each ingredient is the ingredient itself. There is no indication that mixing the specified ingredients together as commensurate in scope with the stated claims changes the structure, function, or other properties of the ingredients in any marked way in comparison with the closest naturally occurring counterpart. Each ingredient appears to maintain its naturally occurring structure and properties and is merely present in the combination. In addition, there is nothing to show that mixing the ingredients in the particular concentrations or amounts produces any sort of marked distinction. Thus, the claimed mixture as a whole does not display markedly different characteristics in comparison with the naturally occurring counterparts. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, applicant’s claims are directed to a composition with an intended use as pharmaceutical for treating a virus-induced disease. MPEP § 2106.04(d)(2) specifically states that a claim is only directed to “an intended use of a claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” Therefore, applicant’s intended use is not sufficient to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the additional element in the claims is the combination of the ingredients. However, MPEP § 2106.05(d) states that well-understood, routine, and conventional activities are not sufficient to show that the claims amount to significantly more than the judicial exception. Mixing specific compounds does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field. Thus, mixing the ingredients together does not amount to significantly more than a combination of judicial exception because mixing compounds is well-understood, routine, and conventional in the field.
In addition, applicant’s dependent claims drawn to the type of formulation: a solution for spraying, as a topical medication, nasal or pulmonal administration or a lotion is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A), “Generally linking the use of the judicial exception to a particular technological environment or field of use” is not considered to be enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use. Therefore, the additional elements are not considered to amount to significantly more. Thus, the answer to Step 2B is No. Consequently, the claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 102/103
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 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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6 and 17-21 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Laila et al. (U).
Laila teaches an antidiabetic oral aqueous sprouted Trigonella foenum-graecum extract (which reads on a pharmaceutical composition comprising an extract of Trigonella foenum-graecum) administered in a dosage of 100 mg/kg bw (which falls within the range claimed) per day (See e.g. “Experimental design and treatment schedule”. p 1537).
Laila does not teach that the composition is for use in a method for the treatment of virus-induced disease and the diseases claimed or that the composition is a preventative treatment initiated for a person prior to contact with another person with symptoms, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
“[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). See also MPEP § 2112.01 with regard to inherency and product-by-process claims.
Although Laila does not teach a component that diminishes the ability of the virus to replicate or effects a change in or contacts the viral lipidic membrane, the claimed functional properties are inherent to the preparation taught by Laila because the ingredients, the amounts of the ingredients, and the route of administration for the delivery of the ingredients taught by Laila are one and the same as disclosed in the instantly claimed invention of Applicant. Thus, these effects are inherent to the composition taught by Laila. Therefore, the reference anticipates the claimed subject matter.
In the alternative, even if the claimed composition taught by the cited reference with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the composition taught by the cited reference is likely to intrinsically possess the same characteristics (including with respect to the instantly claimed functional effects) of the claimed particularly in view of the similar characteristics which they have been shown to share. Thus, the claimed composition would have been obvious to those of ordinary skill in the art within the meaning of USC 103. Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the cited reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
With respect to the USC 102/103 rejection above, please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s claimed composition is different and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
Claims 1-6 and 17-21 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Olsen (N).
Olsen teaches a pharmaceutical composition comprising a mixture of Trigonella foenum-graecum extract and bentonite (See e.g. abstract) in a ratio of 1:10-10:1 based on dry matter (which reads on claim 15) (See e.g. page 8, lines 24-27). Olsen further teaches that the extract is useful for preventing or treating a viral infection, wherein the virus is chosen from viruses having a lipid membrane and can be herpes simplex virus (HSV), influenza virus, human papilloma virus (HPV) or HIV 1 or 2 (See e.g. page 13, lines 25-32 and page 14). Olsen further teaches a pharmaceutical composition comprises 50% by weight or more of smectite (See e.g. page 27, claim 10)(which reads on 50% by weight and falls within the amount claimed in claims 13 and 14). Olsen further teaches that the weight of the mixture of Trigonella foenum-graecum extract and bentonite is at least 0.01 wt.% of the final formulation (which falls within the range of amounts claimed in claim 16, See e.g. claim 13). Olsen further teaches that the composition is administered in the form of gel, cream, mouth-wash, chewing gum, tooth-paste, balm, plaster, lip salve, spray, liquid, ointment, capsule, drop or tablet, or by topical route (See e.g. claim 15, which reads on the forms claimed in claims 7-10). Olsen further teaches a formulation containing 250 mg bentonite (See e.g. Example 3 on page 24)(please note that although the claim recites administration between 25mg and 240mg Trigonella, that the originally filed specification of the instant applicant discloses that 250mg of the extract can be administered and the claim states that this amount is administered at least once daily, thus the amount can be more). Olsen further teaches that the composition can be administered in a range of 2 to 10 times a day (See e.g. page 13, lines 14-17).
Olsen does not teach that the composition is a preventative treatment initiated for a person prior to contact with another person with symptoms, the intended use of the claimed composition does not patentably distinguish the composition, per se, since such undisclosed use is inherent in the reference composition. In order to be limiting, the intended use must create a structural difference between the claimed composition and the prior art composition. In the instant case, the intended use does not create a structural difference, thus the intended use is not limiting.
“[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). See also MPEP § 2112.01 with regard to inherency and product-by-process claims.
Although Olsen does not teach a component that diminishes the ability of the virus to replicate or effects a change in or contacts the viral lipidic membrane, the claimed functional properties are inherent to the preparation taught by Olsen because the ingredients, the amounts of the ingredients, and the route of administration for the delivery of the ingredients taught by Olsen are one and the same as disclosed in the instantly claimed invention of Applicant. Thus, these effects are inherent to the composition taught by Olsen. Therefore, the reference anticipates the claimed subject matter.
In the alternative, even if the claimed composition taught by the cited reference with regard to some unidentified characteristics, the differences between that which is disclosed and that which is claimed are considered to be so slight that the composition taught by the cited reference is likely to intrinsically possess the same characteristics (including with respect to the instantly claimed functional effects) of the claimed particularly in view of the similar characteristics which they have been shown to share. Thus, the claimed composition would have been obvious to those of ordinary skill in the art within the meaning of USC 103. Accordingly, the claimed invention as a whole was at least prima facie obvious, if not anticipated by the cited reference, especially in the absence of sufficient, clear, and convincing evidence to the contrary.
With respect to the USC 102/103 rejection above, please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicant’s claimed composition is different and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 and 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen (WO 2017207010).
The teachings of Olsen are set forth above and applied as before. Olsen further teaches that the composition can be administered mucosally (See e.g. page 10) or transmucosally (See e.g. page 11).
Olsen does not expressly teach that the extract is in an amount of between 24 and 240 mg and administered in this amount once a day, is formulated as claimed in claim 7, that the spray is for nasal or pulmonary administration, or a lozenge or tablet is administered sublingually and dissolved during a time period of 1 to 20 minutes.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to prepare the instantly claimed as taught by Olsen in a spray for nasal or pulmonary administration, a lozenge or tablet is administered sublingually and dissolved during a time period of 1 to 20 minutes and to modify the amount of the extract administered because Olsen clearly teaches the same extract and that the amount of the extract can be formulated in an amount of 250 mg and other amounts for administration, and teaches a spray and that the composition can be administered orally, topically, and mucosally or transmucosally. A person of ordinary skill in the art would have understood to prepare the instantly claimed composition as taught by Olsen before the effective filing date of the claimed invention in a spray for nasal or pulmonary administration, a lozenge or tablet is administered sublingually and dissolved during a time period of 1 to 20 minutes and to modify the amount of the extract administered because Olsen clearly teaches the same extract and that the amount of the extract can be formulated in an amount of 250 mg and other amounts for administration, and teaches a spray and that the composition can be administered orally, topically, and mucosally or transmucosally with expectation of success. Therefore, the skilled artisan would have been motivated to prepare the instantly claimed as taught by Olsen in a spray for nasal or pulmonary administration, a lozenge or tablet is administered sublingually and dissolved during a time period of 1 to 20 minutes and to modify the amount of the extract administered based upon the beneficial teachings of Olsen.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy L. Clark whose telephone number is (571)272-1310. The examiner can normally be reached M-F 8:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Michener can be reached at 571-272-1424. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY L CLARK/ Supervisory Patent Examiner, Art Unit 1628
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