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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1,2,5,10,13,15-20,23,28,34,36 in the reply filed on 04/03/2026 is acknowledged.
Claims 37,49-50,53 and 59 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/04/2026.
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 5,13 and 15-16 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 5 is unclear because it limits the concentration of two of the three options of caspase inhibitors but those two are not required by parent claim 2. Thus, it is not clear if claim 5 is intended to require the caspase inhibitor be Q-VD-Oph or Emricasan. Otherwise, there are embodiments of claim 2 that are not further limited by claim 5.
Claim 10 is unclear because it limits the concentration of DFO or Hsp70, which are optional in parent claim 2. Limiting the concentration of the DFO when Hsp70 is the LMP inhibitor chosen in claim 2 does not further limit claim 2. Thus, it is not clear if claim 10 is intended to require both DFO and Hsp70 be used in claim 2 or if there are embodiments of claim 2 that are not further limited by claim 5.
It is not clear if claim 13 is limiting an optional embodiment or if it is requiring that option be chosen. Claim 13 depends from claim 2, which requires an antioxidant be present but does not require the antioxidant be NAC given the use of “and/or” at line 6. Thus, there are embodiments of claim 2 that are not limited by claim 13. One means to make the claim more clear would be to require the antioxidant be NAC wherein the NAC is present at the recited concentration.
Claim 15 and dependent claim 16 are also unclear for limiting an optional embodiment of parent claim 2. Claim 2 does not require the growth factor be a stimulator of the PI3K/Akt pathway. It is not clear if claim 15 is intended to require claim 2 include the limitation “stimulator of the PI3K/Akt pathway”.
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 36 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 36 is drawn to the composition of claim 1 and fails to recite any further limitation. 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 § 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.
A) Claim(s) 1,2,10,15-16,20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loison (Journal of Clinical Investigation, Volume 124 Number 10 2014 4445-4458).
Claim 1 is directed to a composition comprising 4 individual components, a caspase inhibitor, a lysosomal membrane permeabilization (LMP) inhibitor and a growth factor. Claim 36 is drawn to a kit comprising the composition of claim 1.
Loison studied neutrophil death and teaches that in aging neutrophils, procaspase-3 cleavage was mediated by PR3 which leaks into the cytosol through LMP. Loison taught culture of neutrophils (claim 34) in z-VAD-fmk (a caspase inhibitor) and Hsp70, a LMP inhibitor (see page 4456, first para) to decrease spontaneous cell death and LMP. The culture medium (claim 20) used was RPMI-1640 which contains the antioxidant glutathione. Thus, Loison taught culture of neutrophils in a medium comprising a caspase inhibitor, a LMP inhibitor and an antioxidant.
Loison did not teach including a growth factor in the neutrophil culture with the caspase inhibitor, LMP inhibitor and antioxidant. However, Loison did teach that inclusion of G-CSF (a growth factor) alone in the culture with neutrophils reduced spontaneous death at a level similar to the inclusion of the other 3 components together (see Figure 1).
More specifically, Loison discusses that human neutrophil cultures in the presence of 2 well-characterized LMP inhibitors, Hsp70 (claim 2) at 150nM (claim 10) and deferoxamine (DFO, 2mM claim 10), as well as in the presence of 50 ng/mL G-CSF (claims 2d, 15, 16), all underwent decreases in the percentage of cells with a reduced number of intact granules; inhibition of LMP was 30% for DFO, nearly 40% for Hsp70, and 50% for G-CSF (Figure 7, A and B). Treatment of neutrophils with DFO or Hsp70 consequently decreased the quantity of PR3 in the cytosolic fraction of aging neutrophils (Figure 7C). Culturing neutrophils in the presence of either Hsp70 or DFO led to nearly 50% inhibition of cell death, comparable to the inhibitory effect of G-CSF (Figure 7D).
Thus, Loison expressly teaches culture of neutrophils in culture media comprising 3 of the 4 components recited in claim 1 (a growth factor was lacking in that culture) and separately teaches that inclusion of G-CSF (a growth factor) has similar effect on reducing neutrophil death.
It would have been obvious at the time of filing to add G-CSF to the culture comprising a caspase inhibitor, LMP inhibitor and antioxidant to arrive at the invention as claimed. One would have been motivated to make the combination as Loison taught multiple mechanisms of cell death in neutrophils and that the various media supplements act through different mechanisms to prevent LMP, oxidative damage, and inhibit caspase activity such that the combination would prevent cell death through multiple, different mechanisms. One would have had a reasonable expectation of success in the combination preventing cell death as there is no evidence that the addition of two positive culture conditions would lead to a decreased positive effect of either one.
B) Claim(s) 2,5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loison (Journal of Clinical Investigation, Volume 124 Number 10 2014 4445-4458 as applied to claims 1,2,10,15-16,20 above, and further in view of Gabet (Cell Death and Differentiation (2011) 18, 678–689).
As set forth above, Loison taught Z-VAD-FMK as a caspase inhibitor in combination with HSP70, DFO, an antioxidant and rendered obvious the inclusion of G-CSF. Loison did not teach use of Q-VD-Oph as a caspase inhibitor at a concentration of at least 50 mM (claim 5, which depends from an optional embodiment of claim 2).
With regard to claim 5, Gabet taught both Z-VAD-FMK and Q-VD-OPH as caspase inhibitors and used Q-VD-Oph at both 50 and 200 mM. Gabet taught Q-VD-Oph and Z-VAD-FMK were both effective at inhibiting caspase cleavage of its substrate ROCK-1.
The combination of prior art cited above in all rejections under 35 U.S.C. 103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. ___, 82 USPQ2d 1385 (2007): "Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
In the present situation, rationales A, B and E are applicable. The modification of Loison with the teaching of -VD-Oph and Z-CAD-FMK as functional equivalents in caspase inhibition represent combining prior methods to yield predictable results, substitution for one known element for another, and choosing from a finite number of identified, predictable results. The teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
C) Claim(s) 2,10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loison (Journal of Clinical Investigation, Volume 124 Number 10 2014 4445-4458 as applied to claims 1,2,10,15-16,20 above, and further in view of Huang (J. Nutr. 132: 2151–2156, 2002).
As set forth above, Loison taught a caspase inhibitor in combination with HSP70, DFO, an antioxidant and rendered obvious the inclusion of G-CSF. Loison taught glutathione as an antioxidant as a component of RPMI-1640 cell culture medium. Loison did not teach N-acetyl cysteine as an antioxidant as is recited as an option in claim 2 and appears to be required by claim 13.
However, Huang, in studying apoptosis in cell culture in RPMI1640 media, taught addition of NAC to the culture at 5 mM, which is at least 10 mM as recited in claim 10. Huang also taught that NAC is a precursor of reduced glutathione (present in RPMI1640) that has a role in quenching hydroperxides (oxidants). Huang taught that inclusion of NAC as an antioxidant in the media had an inhibitory effect on caspase activity and apoptosis in the cells (see Figure 2).
It would have been obvious at the time of filing to either substitute or supplement the glutathione as an antioxidant in the RPMI1640 of Loison with NAC as taught by Huang. One would have been motivated to add NAC to the culture media of Loison, which is optimized to prevent apoptosis and other types of cell death in neutrophils, because Huang taught NAC as an effective antioxidant in cell culture to prevent formation of hydroperoxides, inhibit caspase activity and prevent cell death. One would have had a reasonable expectation of success given the known positive effect of NAC in cell culture.
D) Claim(s) 17-19 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loison (Journal of Clinical Investigation, Volume 124 Number 10 2014 4445-4458 as applied to claims 1,2,10,15-16,20 above, and further in view of Shlomovitz (The FEBS Journal 286 (2019) 507–522).
Claims 17-19 add a limitation requiring a necroptosis inhibitor (wherein the inhibitor is Nec-1s) to the composition of claim 2.
Claim 23 is an independent claim directed to a composition comprising 5 individual components, a caspase inhibitor, a lysosomal membrane permeabilization (LMP) inhibitor, an antioxidant, a growth factor and a necroptosis inhibitor.
As set forth above, Loison taught a caspase inhibitor in combination with HSP70, DFO, an antioxidant and rendered obvious the inclusion of G-CSF. Loison did not teach inclusion of a necroptosis inhibitor, Nec-1s.
Shlomovitz taught necroptosis as a caspase-independent form of cell death and thus, direct and indirect caspase inhibitors in the culture media of Loison would not prevent necroptosis (see para bridging pages 508-509). Shlomovitz taught the chemical inhibitor of RIPK1, Nec-1s. More specifically, Shlomovitz taught inducing either apoptosis or necroptosis (by addition of the apoptosis inhibitor z-VAD-fmk) in cells in culture and found 5mM Nec-1s was effective to reduce necroptosis.
It would have been obvious to one of skill in the art at the time of filing to add a necroptosis inhibitor such as Nec-1s to the culture of Loison to arrive at the invention as claimed. One would have been motivated to make such a combination because Shlomovitz taught inhibition of apoptosis in cell culture leads cells to die by necroptosis, which can be prevented by inclusion of Nec-1s. One would have had a reasonable expectation of success in making the combination as it was routine to add cell death inhibitors to cell culture without negative effect as supported by Loison and Shlomovitz.
E) Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loison (Journal of Clinical Investigation, Volume 124 Number 10 2014 4445-4458) in view of Gabet (Cell Death and Differentiation (2011) 18, 678–689), Huang (J. Nutr. 132: 2151–2156, 2002), and Shlomovitz (The FEBS Journal 286 (2019) 507–522).
Claim 28 recites optional combinations of species of an apoptosis inhibitor, LMP inhibitors, an antioxidant, G-CSF and Nec-1s. Option a) of claim 28 recites:
Q-VD-Oph, DFO, Hsp70, NAC, G-CSF and Nec-1s.
As set forth above, Loison taught media comprising Z-VAD-FMK (an alternative to Q-VD-Oph as an apoptosis inhibitor), DFO, Hsp70, Glutathione (an antioxidant formed from NAC), G-CSF and is silent regarding including a necroptosis inhibitor.
Q-VD-Oph -Gabet taught both Z-VAD-FMK and Q-VD-OPH as caspase inhibitors and used Q-VD-Oph at both 50 and 200 mM. Gabet taught Q-VD-Oph and Z-VAD-FMK were both effective at inhibiting caspase cleavage of its substrate ROCK-1.
NAC-Huang, in studying apoptosis in cell culture in RPMI1640 media, taught addition of NAC to the culture at 5 mM, which is at least 10 mM as recited in claim 10. Huang also taught that NAC is a precursor of reduced glutathione that has a role in quenching hydroperoxides (oxidants). Huang taught that inclusion of NAC as an antioxidant in the media had an inhibitory effect on caspase activity and apoptosis in the cells (see Figure 2).
Nec-1s-Shlomovitz taught necroptosis as a caspase-independent form of cell death and thus, direct and indirect caspase inhibitors in the culture media of Loison would not prevent necroptosis (see para bridging pages 508-509). Shlomovitz taught the chemical inhibitor of RIPK1, Nec-1s. More specifically, Shlomovitz taught inducing either apoptosis or necroptosis (by addition of the apoptosis inhibitor z-VAD-fmk) in cells in culture and found 5mM Nec-1s was effective to reduce necroptosis.
As set forth above, it would have been obvious to one of ordinary skill in the art to substitute Q-VD-Oph for Z-VAD-FMK, to include NAC as an antioxidant, and Nec-1s to prevent necroptosis that is pronounced in the presence of apoptosis inhibitors to arrive at the invention as claimed. The motivation for each substitution or addition is set forth in the above rejection and also by the teachings of Shlomovitz regarding multiple pathways to cell death and the supplementation of culture media with inhibitors of multiple cel death pathways. One would have had a reasonable expectation of success in making the combinations as Shlomovitz included apoptosis inhibitors and necroptosis inhibitors together and the remaining combinations are mere substitutions of known equivalents.
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 1,2,5,10,13,15-19,34,36 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claims as a whole, claim(s) is/are determined to be directed to a natural product and do not recite something significantly different than the natural product. The rationale for this determination is explained below:
Base claim 1 is directed to a composition comprising 4 individual components, a caspase inhibitor, a lysosomal membrane permeabilization (LMP) inhibitor an antioxidant and a growth factor. LeBlanc (Progress in Neuro-Psychopharmacology and Biological Psychiatry Volume 27, Issue 2, April 2003, Pages 215-229) discusses natural inhibitors of apoptosis (IAP). Tian (AUTOPHAGY 2025, VOL. 21, NO. 9, 1927–1944) discusses ESCRT-III which is a naturally occurring protein complex that repairs lysosomal membranes and is, therefore, a LMP inhibitor. Naturally occurring antioxidants include vitamins C and E, for example. Growth factors are also natural products including factors such as G-CSF (see Bendall, Cytokine & Growth Factor Reviews 25 (2014) 355–367).
The claimed invention is directed to a natural product without significantly more. The claim(s) recite(s) a combination of molecules each of which can be found in nature. This judicial exception is not integrated into a practical application there are no additional elements that add a meaningful limitation to the product because purifying or isolating and bringing them to a particular concentration (claims 10,16 for Example) does not add a meaningful limitation because altering the concentration does not alter the natural product. With regard to claim 36, merely stating natural products are part of a kit fails to alter the natural product. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. More detailed analysis is set forth below.
The Office published Office’s new guidance document entitled 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), published December 16, 2014. Applicant is directed to the Federal Register at page 74621.
The Office published Office’s new guidance document entitled 2019 Revised Patent Subject Matter Eligibility Guidance, published January 7, 2019. Applicant is directed to the Federal Register, Volume 4, No. 4, pages 50-57 at page 74621.
The Office published the guidance document entitled 2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance), published December 16, 2014.
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Step 2A was revised to include two prongs (Federal Register / Vol. 84, No. 4 / Monday, January 7, 2019):
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Step 1: The claim is directed to a composition of matter (cells and an inhibitor; Step 1: Yes).
Step 2A – Prong 1: Examiners evaluate whether the claim recites a judicial exception. The composition of matter (the 4 naturally occurring molecules, inclusion of a cell and their proximity in proximity as a kit) is directed to a natural phenomenon (Step 2A, prong 1: Yes). MPEP §2106.04(b)(I) which shows that isolated DNA, cloned animals are considered natural phenomenon, for example.
Step 2A- Prong 2: Examiners evaluate whether the claim recites additional elements that integrate the exception into a practical application of that exception. This judicial exception is not integrated into a practical application because the claims do not recite additional elements that integrate the judicial exception into a practical application as no other elements are recited.
Step 2B- Step 2B the claim is evaluated as to whether it recites additional elements that amount to significantly more than the judicial exception. Claim 17 is the only claim that appears to add a non-natural element to the composition of claim 1. Claim 2 limits the generic compounds to, in some cases, non-naturally occurring species. These, however, do not alter or change the remaining natural components. For example, in claim 2, when non-naturally occurring caspase inhibitor Q-VD-Oph is present with naturally occurring G-CSF, the G-CSF is not altered in its properties.
The claim(s) are directed to a composition of matter (Step 1). This composition of matter is directed to a natural phenomenon (Step 2A) without additional elements (Step 2B) for claim 1. The claimed composition of matter fails to differ markedly from that found in nature. Markedly different characteristics can be expressed as the product' s structure, function, and/or other properties. In accordance with this analysis, a product that is purified or isolated, for example, will be eligible when there is a resultant change in characteristics sufficient to show a marked difference from the product' s naturally occurring counterpart. 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. Non-limiting examples of the types of characteristics considered by the courts when determining whether there is a marked difference include: Biological or pharmacological functions or activities; Chemical and physical properties; Phenotype, including functional and structural characteristics; and Structure and form, whether chemical, genetic or physical. It is concluded, here, that the claimed natural products are not markedly different from their natural counterparts as a result of their co-packaging or being present in the same vicinity.
Step2B then asks if the claim(s) include additional elements that are sufficient to amount to significantly more than the judicial exception.
Based on the guidance, The Supreme Court has identified a number of considerations for determining whether a claim with additional elements amounts to significantly more than the judicial exception itself. Limitations that may be enough to qualify as ‘‘significantly more’’ when recited in a claim with a judicial exception include: Improvements to another technology or technical field; improvements to the functioning of the computer itself; applying the judicial exception with, or by use of, a particular machine; effecting a transformation or reduction of a particular article to a different state or thing; adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application; or other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Limitations that were found not to be enough to qualify as ‘‘significantly more’’ when recited in a claim with a judicial exception include: Adding the words ‘‘apply it’’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer; simply appending well-understood, routine and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry; adding insignificant extrasolution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea; or generally linking the use of the judicial exception to a particular technological environment or field of use. In this case, limiting a subset of the independent components to non-naturally occurring species (claims 2,5,13,17,19) or reciting addition of cells is a recitation with a high level of generality and fails to add significantly more to the judicial exceptions.
A claim to an inoculant comprising a plurality of strains of different bacterial species whereby the strains are unaffected by each other was found to not add significantly more to the judicial exception of a nature-based product. The inoculant of claim 1 was held to be ineligible subject matter in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948):
Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of non-inhibition. It is no more than the discovery of some of the handiwork of nature and hence is not patentable. The aggregation of select strains of the several species into one product is an application of that newly-discovered natural principle. But however ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants. Each of the species of root-nodule bacteria contained in the package infects the same group of leguminous plants which it always infected. No species acquires a different use. The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee.
Recently, the Supreme Court looked back to this claim as an example of ineligible subject matter, stating that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way.” Myriad, 133 S. Ct. at 2117.
In the instant case, the combination of cells and agent is unchanged one by the presence of the other.
Similarly, any packaging as a kit fail to add significantly more to the judicial exceptions. Significantly more includes improvements to function, applying the judicial exception with, or by use of, a particular machine; effecting a transformation to a different state; adding a specific limitation other than what is well-understood, routine and conventional in the field, or adding unconventional steps that confine the claim to a particular useful application. None of these additions or alterations to the judicial exception occur.
Addition of the culture media is found to add significantly more to the individual components. The culture media is transformative as the combination provides a practical application of the natural products in combination.
Conclusion
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VALARIE E. BERTOGLIO, Ph.D.
Examiner
Art Unit 1632
/VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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