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 .
Claim(s) 1-3, 6-16 and 18 are pending.
Election/Restrictions
Applicant's election with traverse of Allium porrum agglutinin (APA) for claim 1 and EGCG for claim 7 in the reply filed on March 19, 2026 is acknowledged. Based upon applicants’ election of species for claim 1 and 7, that election will be applied to the remainder of the claim(s). The traversal is on the ground(s) that in regard to the lectin component, “the plant family is not particularly relevant as different plants within the same family may produce lectins with significantly different bioactivity levels with respect to a desired pathogen target” and that in regard to the flavonoid component, “the plant family is not particularly relevant as different plants within the same family may produce lectins with significantly different bioactivity levels with respect to a desired pathogen target”. This is not found persuasive because each of the species listed across claim(s) 1 and 7 includes species that are found within different plant families and/or may come from the same genus but a different species which would let one of ordinary skill in the art know how closely related plants are but also indicate that each of the plants have distinct characteristics, compounds present and functions. Thus, a species of election is required because there is a distinction in which the compounds/components listed can be obtained from a number of plants. The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. In addition, as a result of applicants’ election of species for claim 1, namely, allium porrum agglutinin, claim(s) 4-5 and 17 have been withdrawn.
Claim(s) 1-3, 6-16 and 18 are examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 3, 15-16 and 18 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Undue experimentation would be required to practice the invention as claimed due to the quantity of experimentation necessary; limited amount of guidance and limited number of working examples in the specification; nature of the invention; state of the prior art; relative skill level of those in the art; predictability or unpredictability in the art; and breadth of the claims. In re Wands, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
Claim 3 states “wherein the lectin component comprises a natural lectin extracted or isolated from a plant” and claim 15 states “a lectin component that binds to one of more glycosylated pathogens and that, upon binding, acts as an opsonin and wherein the lectin component comprises at least one of a manufactured mannose binding lectin and a recombinant mannose binding lectin”. It is noted that applicant’s specification, namely par. 20 on pg. 4 and par. 25 on pgs. 6-7 lists example plants that the lectin can be extracted or isolated from. However, given that within claim(s) 3 and 15, the applicant uses the broad recitation of “a natural lectin extracted or isolated from a plant” in claim 3 and “a lectin component that binds to one or more glycosylated pathogens” in claim 15, respectively. In order to determine that the claimed “plants” and “lectins” has a particular function or structure, the applicant would be forced to conduct experiments on all plants that contain lectins and to observe the effects of each and every lectin that can be found across all walks of life; from plants to animals. Applicant must be able to provide evidence that with using the broad term “plants” within claim 3 that all of the plants known in the art has a lectin component. In addition, applicant must also be able to prove that all of the lectins – from plants to animals are capable of binding to one or more glycosylated pathogens and that upon binding, acts as an opsonin (as stated within claim 15 of the present invention). Furthermore, based on the information provided by the applicant, the information is not sufficient to make and use the invention for the purpose as stated by the applicant. The state of the current art, namely, Celis et al (Antiviral Research, (Year: 2024), vol. 227, pp. 1-13) acknowledges that many lectins in their natural forms, are not suitable for use as antiviral therapeutics due to toxicity, other unfavorable pharmacological effects, and/or unreliable manufacturing sources (abstract). Given that the current state of the art shows that the data is limited just in the type of plants that possess lectins that have specific characteristics (e.g. antiviral properties and/or binding properties), proof of all type of lectins (lectins outside of plants but also including plants) being able to possess specific binding properties when attached to a virus as well as viral-inhibition properties would exceed beyond the information that is currently provided by the applicant. This is clearly a burden of undue experimentation. Thus, the claimed are not considered to be enabled for a lectin component or a plant that comprises a lectin component that has the capability of binding to one or more glycosylated pathogens and that, upon binding, acts as a opsonin in which, would affect any virus (based on examiner’s claim interpretations of “virus-inhibiting amount” meaning any virus known in the art).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-3, 6-16 and 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because it is unclear what a “virus-inhibiting amount” encompasses. The specification does not give a range or definition of the term. Thus, the metes and bounds of the claim are unclear.
Claim 2 is indefinite because the claim discusses a “manufactured mannose binding lectin” and a “recombinant mannose binding lectin” and it is unclear what are the structural differences between the two types of mannose binding lectins. The specification does not give a clear description of the two terms and thus, the metes and bounds of the claim are unclear.
Claim 8 recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 8 recites the broad recitation “the lectin component in the composition for a single dose comprises at least one half of 1/7th the amount of a lectin necessary to reach an EC50 level of the lectin” and the claim also recites “less than 3 times the amount of lectin necessary to reach the EC50 level of the lectin” which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Furthermore, it is unclear if the term “EC50” is in reference to the amount needed of the lectin in order to exhibit virus inhibition effects or if “EC50” is in reference to the amount of the lectin that is needed to elicit an immune response.
Claim 10 recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 10 recites the broad recitation “the flavonoid component in the composition for a single dose comprises at least one half of one tenth the amount of a flavonoid necessary to reach an IC50 level of the flavonoid” and the claim also recites “less than 20 times the amount of lectin necessary to reach the IC50 level of the flavonoid” which are the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In addition, it is unclear if “lectin” within the statement “less than 20 times the amount of lectin necessary to reach the IC50 level of the flavonoid” is supposed to read “flavonoid”. Furthermore, it is unclear if the term “IC50” is in reference to the amount needed of the lectin in order to exhibit virus inhibition effects.
Claim 15 is indefinite because the claim discusses a “manufactured mannose binding lectin” and a “recombinant mannose binding lectin” and it is unclear what are the structural differences between the two types of mannose binding lectins. The specification does not give a clear description of the two terms and thus, the metes and bounds of the claim are unclear.
Claim Rejections - 35 USC § 112
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 pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 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 3 states “wherein the lectin component comprises a natural lectin extracted or isolated from a plant”. Claim 3 is dependent on claim 1 and claim 3 does not further specify what plant is desired in order to retrieve the natural lectin and therefore, claim 3 is not further limiting claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-3, 6-16 and 18 rejected under 35 U.S.C. 101 because the claimed invention is directed to natural products without significantly more. A pharmaceutical composition comprising a lectin component (from Allium porrum agglutinin), a flavonoid component (e.g. EGCG) and a pharmaceutically acceptable carrier (e.g. water) of claim(s) 1-3, 6-16 and 18 encompasses naturally occurring substances.
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 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(s) 1 and 15 are drawn to a composition
comprises lectin component (from Allium porrum agglutinin), a pharmaceutically acceptable carrier (e.g. water) and a flavonoid component (e.g. EGCG). In addition, applicants’ claim(s) 12, 14 and 16 further recite the combination of a lectin component (from Allium porrum agglutinin), a pharmaceutically acceptable carrier (e.g. water), a flavonoid component (e.g. EGCG), saline (e.g. salt water) and calcium. Allium porrum is a naturally occurring plant and EGCG (a flavonoid) are extracted from a naturally occurring plant. In addition, saline (e.g. salt water) and calcium are also naturally occurring. 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, extraction of plants only concentrates and portions the naturally
occurring compounds in the plants which are soluble or insoluble in the particular solvent. General extraction does not necessarily result in a markedly distinct change in
the naturally occurring compounds from the plant. Thus, while a solvent extract itself
may not be found in the nature, the compounds which are present in the plant and soluble
in the selected solvent are found in nature. The creation of a solvent extract only
partitions and concentrates the molecules that are naturally in the plant. There is no
evidence or reason to expect that any new compounds are formed. The extract itself is a
mixture of the naturally occurring compounds that are simply soluble in a particular
solvent. Thus, while extraction of the compounds with the selected solvent would
separate a portion of the plant matter away from the naturally-occurring ingredients, the
result of extraction is still a mixture of ingredients which are naturally-found in the plant
material; i.e., the compound is not inventive or "man-made." Thus, the extract in turn is a
mixture of the naturally occurring compounds found in the particular plant. The extract
from the individual plant leads to a combination of the naturally occurring compounds
from the plant. Thus, the claim is drawn to a mixture of naturally occurring products.
There is no indication that the specified extract as commensurate in scope with
the stated claim changes the structure, function, or other properties of the extract in any
marked way in comparison with the closest naturally occurring counterpart. The closest
naturally occurring counterpart for the extract is a mixture of the naturally occurring
compounds that are present in the extract. Because, as discussed above, the plant extract
contains only a mixture of the naturally occurring compounds found in the plant. The
extract composition 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 produces any sort of marked distinction. In addition, the closest naturally occurring counterpart for each ingredient is
the ingredient itself. There is no indication that mixing the following ingredients together
such as a lectin component (from Allium porrum), a pharmaceutically acceptable carrier (e.g. water), a flavonoid component (e.g. EGCG), saline (e.g. salt water) and calcium as
commensurate in scope with the stated claims changes the structure, function, or other
properties of the components in any marked way in comparison with the closest naturally
occurring counterpart. Thus, the claims are drawn directly to a product of nature. 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 molecular pattern recognition based targeting and activating an innate immune response. 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." 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. In this case, the additional element is the mixing of the
claimed ingredients. Mixing a lectin component (from Allium porrum), a pharmaceutically acceptable carrier (e.g. water), a flavonoid component (e.g. EGCG), saline (e.g. salt water) and calcium 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, the answer to Step 2B is No. Consequently, the claims are not directed to
patent eligible subject matter.
In addition, applicant's intended use as molecular pattern recognition based targeting and activating an innate immune response 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 § 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.
Claim(s) 1-3, 6-16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Eslamian (WO 2021222965 A1) in view of Myhill (CN 1956726 A – English translation provided) and Walsh et al (Cytokine & Growth Factor Reviews, (Year: 2013), vol. 24, issue. 02, pp. 91-104).
Eslamian teaches [that] mannose-binding lectin ([MBL]) can be effective in the treatment or prophylaxis of infectious diseases caused by viruses, particularly by viruses having a viral envelope (pg. 9). Eslamian teaches [that] the plant-derived mannose-binding lectin can particularly be selected from the group of APA (Allium porrum) (pg. 8 and claim 5). Eslamian teaches [that] such a composition can be applied orally, nasally, to the lung (claim 2). Eslamian teaches [that] pharmaceutically acceptable carriers may be included (pg. 14). Eslamian teaches [that] when species-specific mannose-binding lectin, e.g. MBL is used, the pathogen bound by MBL is detected by the immune system and the immune response is initiated (pg. 6). Eslamian teaches [that] MBL is a key component in opsonization of microbial pathogens (pg. 3). Eslamian teaches [that] the invention can also be carried out by applying portions of plant- derived, recombinant derived mannose-binding lectins (pg. 8). Eslamian teaches [that the] composition for use according to any of the preceding claims, comprising mannose binding lectin is applied in a concentration of 150 μg/ml or more (claim 16).
Eslamian does not teach that the composition of claim 1, further comprising a flavonoid component including at least a flavonol or flavanol that binds to a main protease for the one or more glycosylated pathogens (as stated within claim 6 of the present invention). Eslamian does not teach that the composition of claim 6, wherein the at least one flavonoid comprises at least one of EGCG (as stated within claim 7 of the present invention). Eslamian does not teach the composition of Claim 1 wherein an amount of the lectin component in the composition for a single dose comprises at least one half of 1/7th the amount of a lectin necessary to reach an EC50 level of the lectin and less than 3 times the amount of lectin necessary to reach the EC50 level of the lectin for at least one of the glycosylated pathogens (as stated within claim 8 of the present invention). Eslamian does not teach the composition of claim 7 wherein an amount of the flavonoid component in the composition for a single dose comprises at least one half of one tenth the amount of a flavonoid necessary to reach an IC50 level of the flavonoid and less than 20 times the amount of lectin necessary to reach the IC50 level of the flavonoid for at least one of the glycosylated pathogens (as stated within claim 10 of the present invention). Eslamian does not teach the composition of claim 10, wherein an amount of the flavonoid component in the composition for a single dose includes at least one of: an amount ranging between approximately 0.19 mg and 756 mg of EGCG (as stated within claim 11 of the present invention). Eslamian does not teach the composition of claim 1, further comprising a supportive component that facilitates binding of the lectin component to the one or more glycosylated pathogens, wherein the support component comprises calcium (as stated within claim 12 of the present invention). Eslamian does not teach the composition of claim 12, wherein an amount of the supportive component in the composition for a single dose ranges between at least 14.75 mg and 625 mg (as stated within claim 13 of the present invention). Eslamian does not teach the composition of claim 1, wherein the pharmaceutical component comprises saline (as stated within claim 14 of the present invention). Eslamian does not teach the pharmaceutical composition that contains a flavonoid component comprising at least one flavonol or flavanol that inhibits the function of a main protease of the one or more glycosylated pathogens (as stated within claim 15 of the present invention). Eslamian does not teach the composition of claim 15, wherein the flavonoid component comprises at least one of EGCG (as stated within claim 18 of the present invention).
Myhill teaches [that] a preferred example of such a carrier or diluents include, but are not limited to, saline (pg. 30). Myhill teaches [that] the composition of the present invention can be used for preventing or treating the above-mentioned disorders and diseases [such as] influenza virus (pg. 15). Myhill teaches [that] the herb-containing composition of the invention comprises EGCG ([from green tea extract]) (pg. 15). Myhill teaches [that the] green tea product ([that contains EGCG]) can be used for promoting immunity function (pg. 15). Myhill teaches the composition comprising herbal medicine of the invention daily administration from about 5 mg to about 2,000 mg of green tea (45% EGCG) (pg. 15).
Walsh et al teaches that MBL ([Mannose-binding lectin]) is calcium dependent (pg. 100).
It would have been obvious to one of ordinary skill in the art to use Elsamian’s composition to further include saline and EGCG as taught by Myhill and to also include additional information from Walsh et al that MBL (Mannose-binding lectin) is known to be calcium-dependent. Therefore, the combination of the aforementioned references is sufficient to achieve the composition of the present invention, which is to create a pharmaceutical composition capable for pattern recognition targeting and activating an innate immune response within a subject in need.
These references show that it was well known in the art prior to the effective filing date of the invention to use the claimed ingredients in compositions that promote an immune response (i.e. innate immune response). It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions that promote an immune response (i.e. innate immune response), an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions promote an immune response (i.e. innate immune response). Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
Regarding claim(s) 8-11 and 13, the combined aforementioned references does not teach some of the amounts of components within the composition as claimed by the aplicant. However, as discussed in MPEP section 2144.05(II)(A), “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).” The references teach the use of each of the ingredients in a pharmaceutical composition. Varying the concentration of ingredients within a pharmaceutical composition is not considered to be inventive unless the concentration is demonstrated as critical. In this particular case, there is no evidence that the claimed concentration of the ingredients produces an unexpected result. Thus, absent some demonstration of unexpected results from the claimed parameter, this optimization of ingredient concentration would have been obvious before the effective filing date of applicant’s claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nashara L Moreau whose telephone number is (571)272-5804. The examiner can normally be reached Monday - Thursday, 8 AM - 4 PM ET.
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NASHARA L MOREAUExaminer, Art Unit 1655
/SUSAN HOFFMAN/Primary Examiner, Art Unit 1655
Prosecution Insights